Maternal and fetal outcomes in pregnant women with heart failure.

PubMed

Ng, Angie T; Duan, Lewei; Win, Theresa; Spencer, Hillard T; Lee, Ming-Sum

2018-05-25

The goal of this study is to report the prevalence, aetiology and clinical outcome of pregnant women with heart failure. This is a retrospective community-based cohort study that included pregnant women in the Kaiser Permanente Health System between 2003 and 2014. Women with heart failure were identified using International Classification of Disease, Ninth Revision codes. Medical records were manually reviewed to confirm diagnosis and adjudicate outcomes. In a cohort of 385 935 pregnancies, 488 (0.13%) had a diagnosis of heart failure, corresponding to 126 cases per 100 000 pregnancies. Peripartum cardiomyopathy was the most common cause of heart failure, accounting for 333 (68.2%) cases. Preterm birth and caesarean delivery were more common in patients with heart failure. Neonatal death rate was higher in the heart failure group (1.0% vs 0.4%, p=0.03). Infants delivered to women with heart failure had lower birth weights (3112.0±774.0 g vs 3331.9±575.5 g, p<0.001) and lower Apgar score at 1 min (7.9±1.5 vs 8.3±1.1, p<0.001). Median follow-up was 6.2 years (IQR 3.2-9.2). During follow-up, 7 (1.4%) in the heart failure group and 423 (0.11%) in the control group died. Heart failure was associated with a 7.7-fold increase risk of death (adjusted HR 7.7, 95% CI 3.6 to 16.4, p<0.001). Heart failure during pregnancy is associated with unfavourable fetal outcomes including prematurity and low birth weight. While the overall mortality rate was low, pregnant women with heart failure carried an excess risk of death compared with controls. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A Randomized Trial of Heart Failure Disease Management in Skilled Nursing Facilities: Design and Rationale

PubMed Central

Boxer, Rebecca S.; Dolansky, Mary A.; Bodnar, Christine A.; Singer, Mendel E.; Albert, Jeffery M.; Gravenstein, Stefan

2013-01-01

Background Heart failure disease management can improve health outcomes for older community dwelling patients with heart failure. Heart failure disease management has not been studied in skilled nursing facilities, a major site of transitional care for older adults. Methods and Anticipated Results The objective of this trial is to investigate if a heart failure disease management program (HF-DMP) in skilled nursing facilities (SNF) will decrease all-cause rehospitalizations for the first 60 days post SNF admission. The trial is a randomized cluster trial to be conducted in 12 for-profit SNF in the greater Cleveland area. The study population is inclusive of patients with heart failure regardless of ejection fraction but excludes those patients on dialysis and with a life expectancy of 6 months or less. The HF-DMP includes 7 elements considered standard of care for patients with heart failure: documentation of left ventricular function, tracking of weight and symptoms, medication titration, discharge instructions, 7 day follow up appointment post SNF discharge, patient education. The HF-DMP is conducted by a research nurse tasked with adhering to each element of the program and regularly audited to maintain fidelity of the program. Additional outcomes include health status, self-care management, and discharge destination. Conclusion The SNF-Connect Trial is the first trial of its kind to assess if a HF-DMP will improve outcomes for patients in SNFs. This trial will provide evidence on the effectiveness of HF-DMP to improve outcomes for older frail heart failure patients undergoing post-acute rehabilitation. PMID:23871475

A Systematic Review of the Outcomes of Posterolateral Corner Knee Injuries, Part 1: Surgical Treatment of Acute Injuries.

PubMed

Geeslin, Andrew G; Moulton, Samuel G; LaPrade, Robert F

2016-05-01

There is a paucity of outcome data to guide the surgical treatment of acute grade III posterolateral corner (PLC) knee injuries. To systematically review the literature to compare clinical outcomes of the treatment for acute grade III PLC injuries. Systematic review; Level of evidence, 4. A systematic review of the literature including Cochrane, PubMed, Medline, and Embase was performed. The following search terms were used: posterolateral corner knee, posterolateral knee, posterolateral instability, multiligament knee, and knee dislocation. Inclusion criteria were outcome studies of surgically treated acute PLC injuries with a minimum 2-year follow-up, subjective outcomes, objective outcomes including varus stability, and subgroup data on PLC injuries. Two investigators independently reviewed all abstracts. Accepted definitions of varus stability on examination or stress radiographs and the need for revision surgery were used to categorically define success and failure. Eight studies with a total of 134 patients were included. The mean patient age was reported in 7 studies (range, 21-31.5 years). The mean time to surgery was reported in 5 studies (range, 15-24.3 days); surgery was performed within 3 weeks in the other 3 studies. Four studies reported International Knee Documentation Committee scores (range, 78.1-91.3); 5 studies reported Lysholm scores (range, 87.5-90.3). Only 3 studies obtained bilateral varus stress radiographs. Based on an objective evaluation with varus stress examinations or radiographs, there was an overall success rate of 81% and failure rate of 19%. In 2 studies, the fibular collateral ligament and popliteus tendon were repaired and staged cruciate reconstruction performed in most patients; there were 17 failures of 45 patients (38%). In the remainder of the studies, patients were treated with local tissue transfer, hybrid repair for amenable structures or reconstruction for midsubstance tears, or reconstruction of all torn structures; the failure rate was 9%. The repair of acute grade III PLC injuries and staged treatment of combined cruciate injuries were associated with a substantially higher postoperative PLC failure rate. Further research is required to identify the reconstruction technique that provides optimal subjective and objective outcomes. © 2015 The Author(s).

"Proprietary Processed" Allografts: Clinical Outcomes and Biomechanical Properties in Anterior Cruciate Ligament Reconstruction.

PubMed

Roberson, Troy A; Abildgaard, Jeffrey T; Wyland, Douglas J; Siffri, Paul C; Geary, Stephen P; Hawkins, Richard J; Tokish, John M

2017-11-01

The processing of allograft tissues in anterior cruciate ligament (ACL) reconstruction continues to be controversial. While high-dose irradiation of grafts has received scrutiny for high failure rates, lower dose irradiation and "proprietary-based" nonirradiated sterilization techniques have become increasingly popular, with little in the literature to evaluate their outcomes. Recent studies have suggested that the specifics of allograft processing techniques may be a risk factor for higher failure rates. To assess these proprietary processes and their clinical outcomes and biomechanical properties. Systematic review. A systematic review was performed using searches of PubMed, EMBASE, Google Scholar, and Cochrane databases. English-language studies were identified with the following search terms: "allograft ACL reconstruction" (title/abstract), "novel allograft processing" (title/abstract), "allograft anterior cruciate ligament" (title/abstract), "anterior cruciate ligament allograft processing" (title/abstract), or "biomechanical properties anterior cruciate ligament allograft" (title/abstract). Duplicate studies, studies not providing the allograft processing technique, and those not containing the outcomes of interest were excluded. Outcomes of interest included outcome scores, complication and failure rates, and biomechanical properties of the processed allografts. Twenty-four studies (13 clinical, 11 biomechanical) met inclusion criteria for review. No demonstrable difference in patient-reported outcomes was appreciated between the processing techniques, with the exception of the Tutoplast process. The clinical failure rate of the Tutoplast process was unacceptably high (45% at 6 years), but no other difference was found between other processing techniques (BioCleanse: 5.4%; AlloTrue: 5.7%; MTF: 6.7%). Several studies did show an increased failure rate, but these studies either combined processing techniques or failed to delineate enough detail to allow a specific comparison for this study. The biomechanical studies showed overall maintenance of satisfactory biomechanical properties throughout multiple testing modes with normalization to the percentage of control specimens. A comparison of proprietary allograft processing techniques is difficult because of the variability and lack of specificity of reporting in the current literature. Among the available literature, except for the Tutoplast process, no notable differences were found in the clinical outcomes or biomechanical properties. Future study with a longer follow-up is necessary to determine the role and limitations of these grafts in the clinical setting.

Morbidity from in-hospital complications is greater than treatment failure in patients with Staphylococcus aureus bacteraemia.

PubMed

Holmes, Natasha E; Robinson, J Owen; van Hal, Sebastiaan J; Munckhof, Wendy J; Athan, Eugene; Korman, Tony M; Cheng, Allen C; Turnidge, John D; Johnson, Paul D R; Howden, Benjamin P

2018-03-05

Various studies have identified numerous factors associated with poor clinical outcomes in patients with Staphylococcus aureus bacteraemia (SAB). A new study was created to provide deeper insight into in-hospital complications and risk factors for treatment failure. Adult patients hospitalised with Staphylococcus aureus bacteraemia (SAB) were recruited prospectively into a multi-centre cohort. The primary outcome was treatment failure at 30 days (composite of all-cause mortality, persistent bacteraemia, or recurrent bacteraemia), and secondary measures included in-hospital complications and mortality at 6- and 12-months. Data were available for 222 patients recruited from February 2011 to December 2012. Treatment failure at 30-days was recorded in 14.4% of patients (30-day mortality 9.5%). Multivariable analysis predictors of treatment failure included age > 70 years, Pitt bacteraemia score ≥ 2, CRP at onset of SAB > 250 mg/L, and persistent fevers after SAB onset; serum albumin at onset of SAB, receipt of appropriate empiric treatment, recent healthcare attendance, and performing echocardiography were protective. 6-month and 12-month mortality were 19.1% and 24.2% respectively. 45% experienced at least one in-hospital complication, including nephrotoxicity in 19.5%. This study demonstrates significant improvements in 30-day outcomes in SAB in Australia. However, we have identified important areas to improve outcomes from SAB, particularly reducing renal dysfunction and in-hospital treatment-related complications.

Profile, risk factors and outcome of acute kidney injury in paediatric acute-on-chronic liver failure.

PubMed

Lal, Bikrant B; Alam, Seema; Sood, Vikrant; Rawat, Dinesh; Khanna, Rajeev

2018-01-11

There are no studies on acute kidney injury in paediatric acute-on-chronic liver failure. This study was planned with aim to describe the clinical presentation and outcome of acute kidney injury among paediatric acute-on-chronic liver failure patients. Data of all children 1-18 years of age presenting with acute chronic liver failure (Asia pacific association for the study of the liver definition) was reviewed. Acute kidney injury was defined as per Kidney Diseases-Improving Global Outcomes guidelines. Poor outcome was defined as death or need for liver transplant within 3 months of development of acute kidney injury. A total of 84 children with acute-on-chronic liver failure were presented to us in the study period. Acute kidney injury developed in 22.6% of patients with acute-on-chronic liver failure. The median duration from acute-on-chronic liver failure to development of acute kidney injury was 4 weeks (Range: 2-10 weeks). The causes of acute kidney injury were hepatorenal syndrome (31.6%), sepsis (31.6%), nephrotoxic drugs (21%), dehydration (10.5%) and bile pigment related acute tubular necrosis in one patient. On univariate analysis, higher baseline bilirubin, higher international normalized ratio, higher paediatric end stage liver disease, presence of systemic inflammatory response syndrome and presence of spontaneous bacterial peritonitis had significant association with presence of acute kidney injury. On logistic regression analysis, presence of systemic inflammatory response syndrome (adjusted OR: 8.659, 95% CI: 2.18-34.37, P = .002) and higher baseline bilirubin (adjusted OR: 1.07, 95% CI: 1.008-1.135, P = .025) were independently associated with presence of acute kidney injury. Of the patients with acute kidney injury, 5(26.3%) survived with native liver, 10(52.6%) died and 4 (21.1%) underwent liver transplantation. Acute kidney injury developed in 22.6% of children with acute-on-chronic liver failure. Bilirubin more than 17.7 mg/dL and presence of systemic inflammatory response syndrome were high risk factors for acute kidney injury. Development of acute kidney injury in a child with acute-on-chronic liver failure suggests poor outcome and need for early intervention. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Virological outcomes of antiretroviral therapy in Zomba central prison, Malawi; a cross-sectional study.

PubMed

Mpawa, Happy; Kwekwesa, Aunex; Amberbir, Alemayehu; Garone, Daniela; Divala, Oscar H; Kawalazira, Gift; van Schoor, Vanessa; Ndindi, Henry; van Oosterhout, Joep J

2017-08-02

Antiretroviral therapy (ART) outcomes that include viral suppression rates are rarely reported among African prison populations. Prisoners deal with specific challenges concerning adherence to ART. We aimed to describe virological outcomes of ART in a large prison in Malawi. A cross-sectional study of ART outcomes was conducted at the Zomba Central Prison HIV clinic, Malawi, following the introduction of routine viral load monitoring. All prisoners on ART for at least 6 months were eligible for a viral load test. Patients with ≥1,000 copies/ml received adherence support for 3 months, after which a second VL sample was taken. Patients with ≥5,000 copies/ml on the second sample had virological failure and started 2nd line ART. We describe demographics and patient characteristics and report prevalence of potential- and documented virological failure. In the potential virological failure rate, those who could not be sampled after 3 months adherence support are included as virological failures. Logistic regression analysis was used to determine factors associated with potential ART failure. Viral load testing was started at the end of 2014, when 1054 patients had ever registered on ART. Of those, 501 (47.5%) had transferred out to another clinic, 96 (9.1%) had died, 11 defaulted (1.0%) and 3 (0.3%) stopped ART. Of 443 (42.0%) remaining alive in care, an estimated 322 prisoners were on ART >6 months, of whom 262 (81.4%) were sampled. Their median age was 35 years (IQR 31-40) and 257 (98.1%) were male. Self-reported adherence was good in 258 (98.5%). The rate of potential ART failure was 8.0%, documented ART failure was 4.6% and documented HIV suppression 95.0%. No patient characteristics were independently associated with potential ART failure, possibly due to low numbers with this outcome. Good virological suppression rates can be achieved among Malawian prisoners on ART, under challenging circumstances.

People with heart failure and home health care resource use and outcomes.

PubMed

Madigan, Elizabeth A

2008-04-01

Patients with heart failure represent a common patient population in home health care, yet little is known about their outcomes. Patients with heart failure, regardless of site of care, experience substantial numbers of rehospitalisations in the United States. Home health care is a common postacute care service for patients with heart failure. Retrospective analysis. The study employed a large administrative data base from 2003 - the Outcomes and Assessment Information Set, which is required for all US Medicare and Medicaid patients receiving home health care. There were 145 191 patients with a primary diagnosis of heart failure represented in the data set. The outcomes of interest were the trajectory of care (point of entry and discharge from home health care), hospitalisation, length of stay and change in functional status. Almost three-quarters (73.9%) of patients entered home health care following a hospital stay. Nearly two-thirds (64%) remained at home at discharge from home health care. Approximately 15% of patients are hospitalised during the home health care episode, most often for symptoms consistent with exacerbation of the heart failure, if a reason could be identified. The average length of stay in home health care was 44 days. There was only a small improvement in functional status: 0.50 points for activities of daily living and 0.57 points for instrumental activities of daily living. Similar small improvement occurred in depressive symptoms, 0.68. There may be room for improvement in these outcomes with more recent evidence that suggests strategies for reducing hospitalisation and improving patient functional status abilities. Yet, the chronic progressive nature of heart failure may also provide a limiting factor in the outcomes that can be attained.

Outcomes of hospitalization in adults with Fontan palliation: The Mayo Clinic experience.

PubMed

Egbe, Alexander; Khan, Arooj R; Al-Otaibi, Mohamad; Said, Sameh M; Connolly, Heidi M

2018-04-01

The outcomes of hospitalization in the Fontan population have not been specifically studied. The purpose of this study was to describe outcomes of hospitalization (frequency and indications for hospitalization, and in-hospital mortality) in this population and to determine how these outcomes differ from those of other adults with congenital heart disease (CHD). This was a retrospective study of adult Fontan patients hospitalized at Mayo Clinic Rochester in 1990-2015. We selected age- and gender-matched control group of patients with repaired CHD and biventricular circulation hospitalized within the study period. A total of 367 Fontan patients (age 31±7 years and 259 [71%] with atriopulmonary Fontan) had 853 hospital admissions in 4 years (58 hospitalizations per 100 patient-years). The most common indications were arrhythmia (n=188, 22%), heart failure (n=169, 20%), and cardiac surgery (n=133, 16%). Overall in-hospital mortality was 4% (n=38), and the highest in-hospital mortality occurred in patients hospitalized for cardiac surgery (n=15, 11%) and heart failure (n=13, 8%). In comparison to the repaired CHD and biventricular circulation group, the Fontan group had more frequent hospitalizations (22 vs 58 per 100 patient-years, P<.001) and higher overall in-hospital mortality (1% vs 5%, P<.001), mortality after cardiac surgery (2% vs 11%, P=.01), and mortality for heart failure-related hospitalizations (2% vs 8%, P=.04). Adults with Fontan palliation had more frequent hospitalization and in-hospital mortality compared to the rest of the CHD population. Arrhythmia and heart failure were the most common indications for hospitalization. Perhaps optimal management of heart failure and arrhythmia may improve outcomes in this population. Copyright © 2017 Elsevier Inc. All rights reserved.

Variation in readmission and mortality following hospitalisation with a diagnosis of heart failure: prospective cohort study using linked data.

PubMed

Korda, Rosemary J; Du, Wei; Day, Cathy; Page, Karen; Macdonald, Peter S; Banks, Emily

2017-03-21

Hospitalisation for heart failure is common and post-discharge outcomes, including readmission and mortality, are often poor and are poorly understood. The purpose of this study was to examine patient- and hospital-level variation in the risk of 30-day unplanned readmission and mortality following discharge from hospital with a diagnosis of heart failure. Prospective cohort study using data from the Sax Institute's 45 and Up Study, linking baseline survey (Jan 2006-April 2009) to hospital and mortality data (to Dec 2011). Primary outcomes in those admitted to hospital with heart failure included unplanned readmission, mortality and combined unplanned readmission/mortality, within 30 days of discharge. Multilevel models quantified the variation in outcomes between hospitals and examined associations with patient- and hospital-level characteristics. There were 5074 participants with a heart failure admission discharged from 251 hospitals; 1052 (21%) had unplanned readmissions, 186 (3.7%) died, and 1146 (23%) had either/both outcomes within 30 days of discharge. Crude outcomes varied across hospitals, but between-hospital variation explained little of the total variation in outcomes (intraclass correlation coefficients (ICC) after inclusion of patient factors: 30-day unplanned readmission ICC = 0.0125 (p = 0.24); death ICC = 0.0000 (p > 0.99); unplanned readmission/death ICC = 0.0266 (p = 0.07)). Patient characteristics associated with a higher risk of unplanned readmission included: being male (male vs female, adjusted odds ratio (aOR) = 1.18, 95% CI: 1.00-1.37); prior hospitalisation for cardiovascular disease (aOR = 1.44, 1.08-1.91) and for anemia (aOR = 1.36, 1.14-1.63); comorbidities at admission (severe vs none: aOR = 1.26, 1.03-1.54); lower body-mass-index (obese vs normal weight: aOR = 0.77, 0.63-0.94); and lower social interaction scores. Similarly, risk of 30-day mortality was associated with patient- rather than hospital-level factors, in particular age (≥85y vs 45-< 75y: aOR = 3.23, 1.93-5.41) and comorbidity (severe vs none: aOR = 2.68, 1.82-3.94). The issue of high readmission and mortality rates in people with heart failure appear to be system-wide, with the variation in these outcomes essentially attributable to variation between patients rather than hospitals. The findings suggest that there are limitations in using these outcomes as hospital performance measures in this patient population and support the need for patient-centred strategies to optimise heart failure management and outcomes.

Seizure outcome after AED failure in pediatric focal epilepsy: impact of underlying etiology.

PubMed

Wirrell, Elaine C; Wong-Kisiel, Lily C; Nickels, Katherine C

2014-05-01

This study aimed to identify long-term seizure outcome in pediatric nonsyndromic focal epilepsy after failure of serial antiepileptic drugs (AEDs) due to lack of efficacy. Children (1 month-17 years) with new-onset focal epilepsy not meeting the criteria for a defined electroclinical syndrome diagnosed between 1980 and 2009 while residing in Olmsted County, MN, were retrospectively identified. Medical records of those followed for ≥2 years were reviewed to assess etiology, the number of AEDs that failed due to lack of efficacy, and seizure outcome at final follow-up. Etiology was classified into structural/metabolic, genetic, or unknown. Favorable outcome was defined as seizure freedom ≥1 year, on or off AEDs, without prior epilepsy surgery. Poor outcome was defined as ongoing seizures in the preceding year or having undergone prior epilepsy surgery. Nonsyndromic focal epilepsy accounted for 275/468 (59%) of all patients with newly diagnosed epilepsy--of these, 256 (93%) were followed for a minimum of two years and were included in the study. Median duration of follow-up was 10.0 years. At least one AED had failed due to lack of efficacy in 100 (39.1%) children. Favorable outcomes occurred in 149/156 (95.5%) children with no AED failure, 16/30 (53.3%) with one AED failure, 8/25 (32%) with two AED failures, and only 2/45 (4.4%) with three AED failures. After two AED failures, the seizures of nearly one-quarter of children who had epilepsy with an unknown cause responded favorably to the third AED compared with only 7.8% of the cohort that had epilepsy with a structural/metabolic cause. Children with a remote brain insult had a significantly higher likelihood of favorable outcome with serial AEDs than those with other structural abnormalities. Etiology is an important determinant of pharmacoresistance in nonsyndromic focal epilepsy. Surgical evaluation should be considered after failure of 1-2 AEDs in those who have epilepsy with structural causes, excluding remote brain insults. Conversely, as surgical success is lower with normal MRI or more diffuse brain insults, it appears reasonable to hold off surgical evaluation until 2-3 AEDs have failed in such children. Copyright © 2014 Elsevier Inc. All rights reserved.

Autograft versus nonirradiated allograft tissue for anterior cruciate ligament reconstruction: a systematic review.

PubMed

Mariscalco, Michael W; Magnussen, Robert A; Mehta, Divyesh; Hewett, Timothy E; Flanigan, David C; Kaeding, Christopher C

2014-02-01

An autograft has traditionally been the gold standard for anterior cruciate ligament reconstruction (ACLR), but the use of allograft tissue has increased in recent years. While numerous studies have demonstrated that irradiated allografts are associated with increased failure rates, some report excellent results after ACLR with nonirradiated allografts. The purpose of this systematic review was to determine whether the use of nonirradiated allograft tissue is associated with poorer outcomes when compared with autografts. Patients undergoing ACLR with autografts versus nonirradiated allografts will demonstrate no significant differences in graft failure risk, laxity on postoperative physical examination, or differences in patient-oriented outcome scores. Systematic review. A systematic review was performed to identify prospective or retrospective comparative studies (evidence level 1, 2, or 3) of autografts versus nonirradiated allografts for ACLR. Outcome data included graft failure based on clinical findings and instrumented laxity, postoperative laxity on physical examination, and patient-reported outcome scores. Studies were excluded if they did not specify whether the allograft had been irradiated. Quality assessment and data extraction were performed by 2 examiners. Nine studies comparing autografts and nonirradiated allografts were included. Six of the 9 studies compared bone-patellar tendon-bone (BPTB) autografts with BPTB allografts. Two studies compared hamstring tendon autografts to hamstring tendon allografts, and 1 study compared hamstring tendon autografts to tibialis anterior allografts. The mean patient age in 7 of 9 studies ranged from 24.5 to 32 years, with 1 study including only patients older than 40 years and another not reporting patient age. The mean follow-up duration was 24 to 94 months. Six of 9 studies reported clinical graft failure rates, 8 of 9 reported postoperative instrumented laxity measurements, 7 of 9 reported postoperative physical examination findings, and all studies reported patient-reported outcome scores. This review demonstrated no statistically significant difference between autografts and nonirradiated allografts in any outcome measure. No significant differences were found in graft failure rate, postoperative laxity, or patient-reported outcome scores when comparing ACLR with autografts to nonirradiated allografts in this systematic review. These findings apply to patients in their late 20s and early 30s. Caution is advised when considering extrapolation of these findings to younger, more active cohorts.

Acute Liver Failure in Children: The First 348 Patients in The Pediatric Acute Liver Failure Study Group

PubMed Central

Squires, Robert H.; Shneider, Benjamin L.; Bucuvalas, John; Alonso, Estella; Sokol, Ronald J.; Narkewicz, Michael R.; Dhawan, Anil; Rosenthal, Philip; Rodriguez-Baez, Norberto; Murray, Karen F.; Horslen, Simon; Martin, Martin G.; Lopez, M. James; Soriano, Humberto; McGuire, Brendan M.; Jonas, Maureen M.; Yazigi, Nada; Shepherd, Ross W.; Schwarz, Kathleen; Lobritto, Steven; Thomas, Daniel W.; Lavine, Joel E.; Karpen, Saul; Ng, Vicky; Kelly, Deirdre; Simonds, Nancy; Hynan, Linda S.

2008-01-01

Objectives To determine short-term outcome for children with acute liver failure (ALF) as it relates to etiology, clinical status, patient demographics and to determine prognostic factors. Study design A prospective, multi-center case study collecting demographic, clinical, laboratory and short-term outcome data on children from birth to 18 years with ALF. Patients without encephalopathy were included if the prothrombin time and INR remained ≥ 20 seconds and/or >2, respectively, despite vitamin K. Primary outcome measures three weeks after study entry were death, death after transplant, alive with native liver, alive with transplanted organ. Results The etiology of ALF in 348 children included acute acetaminophen toxicity (14%), metabolic disease (10%), autoimmune liver disease (6%), non-APAP drug-related hepatotoxicity (5%), infections (6%), other diagnosed conditions (10%); 49% were indeterminate. Outcome varied between patient sub-groups; 20% with non-acetaminophen ALF died or underwent liver transplantation and never developed clinical encephalopathy. Conclusions Etiologies of ALF in children differ from adults. Clinical encephalopathy may not be present in children. The high percentage of indeterminate cases provides an opportunity for investigation. PMID:16737880

New-Onset Heart Failure and Mortality in Hospital Survivors of Sepsis-Related Left Ventricular Dysfunction.

PubMed

Vallabhajosyula, Saraschandra; Jentzer, Jacob C; Geske, Jeffrey B; Kumar, Mukesh; Sakhuja, Ankit; Singhal, Akhil; Poterucha, Joseph T; Kashani, Kianoush; Murphy, Joseph G; Gajic, Ognjen; Kashyap, Rahul

2018-02-01

The association between new-onset left ventricular (LV) dysfunction during sepsis with long-term heart failure outcomes is lesser understood. Retrospective cohort study of all adult patients with severe sepsis and septic shock between 2007 and 2014 who underwent echocardiography within 72 h of admission to the intensive care unit. Patients with prior heart failure, LV dysfunction, and structural heart disease were excluded. LV systolic dysfunction was defined as LV ejection fraction <50% and LV diastolic dysfunction as ≥grade II. Primary composite outcome included new hospitalization for acute decompensated heart failure and all-cause mortality at 2-year follow-up. Secondary outcomes included persistent LV dysfunction, and hospital mortality and length of stay. During this 8-year period, 434 patients with 206 (48%) patients having LV dysfunction were included. The two groups had similar baseline characteristics, but those with LV dysfunction had worse function as demonstrated by worse LV ejection fraction, cardiac index, and LV diastolic dysfunction. In the 331 hospital survivors, new-onset acute decompensated heart failure hospitalization did not differ between the two cohorts (15% vs. 11%). The primary composite outcome was comparable at 2-year follow-up between the groups with and without LV dysfunction (P = 0.24). Persistent LV dysfunction was noted in 28% hospital survivors on follow-up echocardiography. Other secondary outcomes were similar between the two groups. In patients with severe sepsis and septic shock, the presence of new-onset LV dysfunction did not increase the risk of long-term adverse heart failure outcomes.

Making the Failure More Productive: Scaffolding the Invention Process to Improve Inquiry Behaviors and Outcomes in Invention Activities

ERIC Educational Resources Information Center

Holmes, N. G.; Day, James; Park, Anthony H. K.; Bonn, D. A.; Roll, Ido

2014-01-01

Invention activities are Productive Failure activities in which students attempt (and often fail) to invent methods that capture deep properties of a construct before being taught expert solutions. The current study evaluates the effect of scaffolding on the invention processes and outcomes, given that students are not expected to succeed in their…

Change Trajectories for the Youth Outcome Questionnaire Self-Report: Identifying Youth at Risk for Treatment Failure

ERIC Educational Resources Information Center

Cannon, Jennifer A. N.; Warren, Jared S.; Nelson, Philip L.; Burlingame, Gary M.

2010-01-01

This study used longitudinal youth outcome data in routine mental health services to test a system for identifying cases at risk for treatment failure. Participants were 2,715 youth (M age = 14) served in outpatient managed care and community mental health settings. Change trajectories were developed using multilevel modeling of archival data.…

Depression and Anxiety Outcomes Associated with Failed Assisted Reproductive Technologies: A Systematic Review and Meta-Analysis.

PubMed

Milazzo, Adriana; Mnatzaganian, George; Elshaug, Adam G; Hemphill, Sheryl A; Hiller, Janet E

2016-01-01

Our study examined the psychological outcomes associated with failed ART treatment outcomes in men and women. A systematic search for studies published between January 1980 and August 2015 was performed across seven electronic databases. Studies were included if they contained data on psychosocial outcomes taken pre and post ART treatment. A standardised form was used to extract data and was verified by two independent reviewers. Studies were meta-analysed to determine the association of depression and anxiety with ART treatment outcomes. Narrative synthesis identified factors to explain variations in the size and directions of effects and relationships explored within and between the studies. Both depression and anxiety increased after a ART treatment failure with an overall pooled standardised mean difference (SMD) of 0.41 (95% CI: 0.27, 0.55) for depression and 0.21 (95% CI: 0.13, 0.29) for anxiety. In contrast, depression decreased after a successful treatment, SMD of -0.24 (95% CI: -0.37,-0.11). Both depression and anxiety decreased as time passed from ART procedure. Nonetheless, these remained higher than baseline measures in the group with the failed outcome even six months after the procedure. Studies included in the narrative synthesis also confirmed an association with negative psychological outcomes in relation to marital satisfaction and general well-being following treatment failure. Linking ART failure and psychosocial outcomes may elucidate the experience of treatment subgroups, influence deliberations around recommendations for resource allocation and health policy and guide patient and clinician decision making.

An integrated review of interventions to improve psychological outcomes in caregivers of patients with heart failure.

PubMed

Evangelista, Lorraine S; Strömberg, Anna; Dionne-Odom, J Nicholas

2016-03-01

This article examines interventions aimed at improving psychological outcomes (e.g., caregiver burden, quality of life, anxiety, depression, perceived control, stress mastery, caregiver confidence and preparedness, and caregiver mastery) in family caregivers of patients with heart failure. Eight studies meeting the inclusion criteria were included in the review. The most common intervention involved psychoeducation facilitated by a nurse (6/8) and supplemented with a combination of follow-up face-to-face sessions (2/6), home visits (2/6), telephone calls (3/6), and telemonitoring (3/6). Two studies used a support group intervention of four to six sessions. Half of the interventions reported a significant effect on one or more primary outcomes, including caregiver burden (n = 4), depressive symptoms (n = 1), stress mastery (n = 1), caregiver confidence and preparedness (n = 1), and caregiver mastery (n = 1). Compared with dementia and cancer family caregiving, few interventions have been evaluated in caregivers of patients with heart failure. Of the existing interventions identified in this review, considerable variability was observed in aims, intervention content, delivery methods, duration, intensity, methodological rigor, outcomes, and effects. Given this current state of the science, direct comparison of heart failure caregiver interventions and recommendations for clinical practice are premature. Thus, research priority is strongly warranted for intervention development and testing to enhance heart failure caregiver support and education.

Urine Injury Biomarkers and Risk of Adverse Outcomes in Recipients of Prevalent Kidney Transplants: The Folic Acid for Vascular Outcome Reduction in Transplantation Trial

PubMed Central

Carpenter, Myra A.; Weiner, Daniel E.; Levey, Andrew S.; Pfeffer, Marc; Kusek, John W.; Cai, Jianwen; Hunsicker, Lawrence G.; Park, Meyeon; Bennett, Michael; Liu, Kathleen D.; Hsu, Chi-yuan

2016-01-01

Recipients of kidney transplants (KTR) are at increased risk for cardiovascular events, graft failure, and death. It is unknown whether urine kidney injury biomarkers are associated with poor outcomes among KTRs. We conducted a post hoc analysis of the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial using a case-cohort study design, selecting participants with adjudicated cardiovascular events, graft failure, or death. Urine neutrophil gelatinase–associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), IL-18, and liver–type fatty acid binding protein (L-FABP) were measured in spot urine samples and standardized to urine creatinine concentration. We adjusted for demographics, cardiovascular risk factors, eGFR, and urine albumin-to-creatinine ratio. Patients had 291 cardiovascular events, 257 graft failure events, and 359 deaths. Each log increase in urine NGAL/creatinine independently associated with a 24% greater risk of cardiovascular events (adjusted hazard ratio [aHR], 1.24; 95% confidence interval [95% CI], 1.06 to 1.45), a 40% greater risk of graft failure (aHR, 1.40; 95% CI, 1.16 to 1.68), and a 44% greater risk of death (aHR, 1.44; 95% CI, 1.26 to 1.65). Urine KIM-1/creatinine and IL-18/creatinine independently associated with greater risk of death (aHR, 1.29; 95% CI, 1.03 to 1.61 and aHR, 1.25; 95% CI, 1.04 to 1.49 per log increase, respectively) but not with risk of cardiovascular events or graft failure. Urine L-FABP did not associate with any study outcomes. In conclusion, among prevalent KTRs, higher urine NGAL, KIM-1, and IL-18 levels independently and differentially associated with greater risk of adverse outcomes. PMID:26538631

Patient satisfaction and regret with decision differ between outcomes in the composite definition of success after reconstructive surgery.

PubMed

Khoder, Waseem; Hom, Emily; Guanzon, Anna; Rose, Sarah; Hale, Douglass; Heit, Michael

2017-04-01

To evaluate patient satisfaction and regret with their decision for reconstructive surgery, and determine if they valued each item equally in the composite definition of success after making the decision for surgery. A list was created including all patients who underwent laparoscopic sacral colpopexy or laparoscopic uterosacrocolpopexy. Patients were placed in mutually exclusive outcome categories (retreatment, symptomatic failure, anatomic failure, and surgical success). Retreatment included any postoperative treatment for urinary incontinence, pelvic organ prolapse including pessary use, or surgery for mesh complications. The validated modified Decision Regret Scale (DRS) and the Satisfaction Decision Scale (SDS) questionnaires were administered by telephone. Higher DRS scores indicate greater regret and higher SDS scores indicate greater satisfaction with the decision for surgery. Of 715 patients, 197 were successfully contacted by telephone following reconstructive surgery and surveyed as study participants. Composite surgical outcomes were available for 150. Information on the need for retreatment was available for all the study participants. Surgery was successful in 101 (67.3 %) of the study participants. Anatomic failure occurred in 14, symptomatic failure occurred in 10, and retreatment was required in 25 of the study participants. Overall, the study participants were more satisfied than regretful with their decision for reconstructive surgery. Regret and satisfaction with their decision differed between outcomes in the composite definition of success after reconstructive surgery. Surgeons and patients should focus on retreatment rates during preoperative outcome discussions because retreatment will result in the least satisfaction and greatest regret with the decision for reconstructive surgery.

Galectin-3 in ambulatory patients with heart failure: results from the HF-ACTION study.

PubMed

Felker, G Michael; Fiuzat, Mona; Shaw, Linda K; Clare, Robert; Whellan, David J; Bettari, Luca; Shirolkar, Shailesh C; Donahue, Mark; Kitzman, Dalane W; Zannad, Faiez; Piña, Ileana L; O'Connor, Christopher M

2012-01-01

Galectin-3 is a soluble ß-galactoside-binding lectin released by activated cardiac macrophages. Elevated levels of galectin-3 have been found to be associated with adverse outcomes in patients with heart failure. We evaluated the association between galectin-3 and long-term clinical outcomes in ambulatory heart failure patients enrolled in the HF-ACTION study. HF-ACTION was a randomized, controlled trial of exercise training in patients with chronic heart failure caused by left ventricular systolic dysfunction. Galectin-3 was assessed at baseline in a cohort of 895 HF-ACTION subjects with stored plasma samples available. The association between galectin-3 and clinical outcomes was assessed using a series of Cox proportional hazards models. Higher galectin-3 levels were associated with other measures of heart failure severity, including higher New York Heart Association class, lower systolic blood pressure, higher creatinine, higher amino-terminal proB-type natriuretic peptide (NTproBNP), and lower maximal oxygen consumption. In unadjusted analysis, there was a significant association between elevated galectin-3 levels and hospitalization-free survival (unadjusted hazard ratio, 1.14 per 3-ng/mL increase in galectin-3; P<0.0001). In multivariable modeling, the prognostic impact of galectin-3 was significantly attenuated by the inclusion of other known predictors, and galectin-3 was no longer a significant predictor after the inclusion of NTproBNP. Galectin-3 is elevated in ambulatory heart failure patients and is associated with poor functional capacity and other known measures of heart failure severity. In univariate analysis, galectin-3 was significantly predictive of long-term outcomes, but this association did not persist after adjustment for other predictors, especially NTproBNP. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00047437.

Galectin-3 in Ambulatory Patients with Heart Failure: Results from the HF-ACTION Study

PubMed Central

Felker, G. Michael; Fiuzat, Mona; Shaw, Linda K.; Clare, Robert; Whellan, David J.; Bettari, Luca; Shirolkar, Shailesh C.; Donahue, Mark; Kitzman, Dalane W.; Zannad, Faiez; Piña, Ileana L.; O’Connor, Christopher M.

2011-01-01

Background Galectin-3 is a soluble ß-galactoside-binding lectin released by activated cardiac macrophages. Elevated levels of galectin-3 have been found to be associated with adverse outcomes in patients with heart failure. We evaluated the association between galectin-3 and long-term clinical outcomes in ambulatory heart failure patients enrolled in the HF-ACTION study. Methods and Results HF-ACTION was a randomized controlled trial of exercise training in patients with chronic heart failure due to left ventricular (LV) systolic dysfunction. Galectin-3 was assessed at baseline in a cohort of 895 HF-ACTION subjects with stored plasma samples available. The association between galectin-3 and clinical outcomes was assessed using a series of Cox proportional hazards models. Higher galectin-3 levels were associated with other measures of heart failure severity, including higher NYHA class, lower systolic blood pressure, higher creatinine, higher NTproBNP, and lower maximal oxygen consumption. In unadjusted analysis, there was a significant association between elevated galectin-3 levels and hospitalization-free survival (unadjusted hazard ratio = 1.14 per 3 ng/mL increase in galectin-3, P<0.0001). In multivariable modeling, the prognostic impact of galectin-3 was significantly attenuated by the inclusion of other known predictors and galectin-3 was no longer a significant predictor after the inclusion of NTproBNP. Conclusions Galectin-3 is elevated in ambulatory heart failure patients and is associated with poor functional capacity and other known measures of heart failure severity. In univariate analysis, galectin-3 was significantly predictive of long-term outcomes, but this association did not persist after adjustment for other predictors, especially NTproBNP. PMID:22016505

Association of low body temperature and poor outcomes in patients admitted with worsening heart failure: a substudy of the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial.

PubMed

Payvar, Saeed; Spertus, John A; Miller, Alan B; Casscells, S Ward; Pang, Peter S; Zannad, Faiez; Swedberg, Karl; Maggioni, Aldo P; Reid, Kimberly J; Gheorghiade, Mihai

2013-12-01

Risk stratification in patients admitted with worsening heart failure (HF) is essential for tailoring therapy and counselling. Risk models are available but rarely used, in part because many require laboratory and imaging results that are not routinely available. Body temperature is associated with prognosis in other illnesses, and we hypothesized that low body temperature would be associated with worse outcomes in patients admitted with worsening HF. The Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial was an event-driven, randomized, double-blind, placebo-controlled study of tolvaptan in 4133 patients hospitalized for worsening HF with an EF <40%. Co-primary endpoints were all-cause mortality and cardiovascular (CV) death or HF rehospitalization. Body temperature was measured orally at randomization and entered in analyses both as a continuous variable and categorized into three groups (<36 °C, 36-36.5 °C, and >36.5 °C) using Cox regression models. The composite of CV death or HF rehospitalization occurred in 1544 patients within 1 year. For every 1 °C decrease in body temperature, the risk of adverse outcomes increased by 16% [hazard raio (HR) 1.16, 95% confidence interval (CI) 1.04-1.28], after adjustment for age, gender, race, systolic blood pressure, EF, blood urea nitrogen, and serum sodium. In fully adjusted analysis, the risk of adverse outcomes in the lowest body temperature group (<36 °C) was 51% higher than that of the index group (>36.5 °C) (HR 1.35, 95% CI 1.15-1.58). Low body temperature is an independent marker of poor cardiovascular outcomes in patients admitted with worsening HF and reduced EF.

Heart failure.

PubMed

Metra, Marco; Teerlink, John R

2017-10-28

Heart failure is common in adults, accounting for substantial morbidity and mortality worldwide. Its prevalence is increasing because of ageing of the population and improved treatment of acute cardiovascular events, despite the efficacy of many therapies for patients with heart failure with reduced ejection fraction, such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), β blockers, and mineralocorticoid receptor antagonists, and advanced device therapies. Combined angiotensin receptor blocker neprilysin inhibitors (ARNIs) have been associated with improvements in hospital admissions and mortality from heart failure compared with enalapril, and guidelines now recommend substitution of ACE inhibitors or ARBs with ARNIs in appropriate patients. Improved safety of left ventricular assist devices means that these are becoming more commonly used in patients with severe symptoms. Antidiabetic therapies might further improve outcomes in patients with heart failure. New drugs with novel mechanisms of action, such as cardiac myosin activators, are under investigation for patients with heart failure with reduced left ventricular ejection fraction. Heart failure with preserved ejection fraction is a heterogeneous disorder that remains incompletely understood and will continue to increase in prevalence with the ageing population. Although some data suggest that spironolactone might improve outcomes in these patients, no therapy has conclusively shown a significant effect. Hopefully, future studies will address these unmet needs for patients with heart failure. Admissions for acute heart failure continue to increase but, to date, no new therapies have improved clinical outcomes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Ventilatory support in critically ill hematology patients with respiratory failure

PubMed Central

2012-01-01

Introduction Hematology patients admitted to the ICU frequently experience respiratory failure and require mechanical ventilation. Noninvasive mechanical ventilation (NIMV) may decrease the risk of intubation, but NIMV failure poses its own risks. Methods To establish the impact of ventilatory management and NIMV failure on outcome, data from a prospective, multicenter, observational study were analyzed. All hematology patients admitted to one of the 34 participating ICUs in a 17-month period were followed up. Data on demographics, diagnosis, severity, organ failure, and supportive therapies were recorded. A logistic regression analysis was done to evaluate the risk factors associated with death and NIVM failure. Results Of 450 patients, 300 required ventilatory support. A diagnosis of congestive heart failure and the initial use of NIMV significantly improved survival, whereas APACHE II score, allogeneic transplantation, and NIMV failure increased the risk of death. The risk factors associated with NIMV success were age, congestive heart failure, and bacteremia. Patients with NIMV failure experienced a more severe respiratory impairment than did those electively intubated. Conclusions NIMV improves the outcome of hematology patients with respiratory insufficiency, but NIMV failure may have the opposite effect. A careful selection of patients with rapidly reversible causes of respiratory failure may increase NIMV success. PMID:22827955

Heart failure in patients presenting with dyspnoea to the emergency department in the Asia Pacific region: an observational study

PubMed Central

Kelly, Anne-Maree; Cullen, Louise; Klim, Sharon; Craig, Simon; Kuan, Win Sen; Jones, Peter; Holdgate, Anna; Lawoko, Charles; Laribi, Said

2017-01-01

Objectives To describe demographic features, assessment, management and outcomes of patients who were diagnosed with heart failure after presenting to an emergency department (ED) with a principal symptom of dyspnoea. Design Planned substudy of the prospective, descriptive cohort study: Asia, Australia and New Zealand Dyspnoea in Emergency Departments (AANZDEM). Setting 46 EDs in Australia, New Zealand, Singapore, Hong Kong and Malaysia collected data over 3 72-hour periods in May, August and October 2014. Participants Patients with an ED diagnosis of heart failure. Outcome measures Outcomes included patient epidemiology, investigations ordered, treatment modalities used and patient outcomes (hospital length of stay (LOS) and mortality). Results 455 (14.9%) of the 3044 patients had an ED diagnosis of heart failure. Median age was 79 years, half were male and 62% arrived via ambulance. 392 (86%) patients were admitted to hospital. ED diagnosis was concordant with hospital discharge diagnosis in 81% of cases. Median hospital LOS was 6 days (IQR 4–9) and in-hospital mortality was 5.1%. Natriuretic peptide levels were ordered in 19%, with lung ultrasound (<1%) and echocardiography (2%) uncommonly performed. Treatment modalities included non-invasive ventilation (12%), diuretics (73%), nitrates (25%), antibiotics (16%), inhaled β-agonists (13%) and corticosteroids (6%). Conclusions In the Asia Pacific region, heart failure is a common diagnosis among patients presenting to the ED with a principal symptom of dyspnoea. Admission rates were high and ED diagnostic accuracy was good. Despite the seemingly suboptimal adherence to investigation and treatment guidelines, patient outcomes were favourable compared with other registries. PMID:28246137

Study of relapse and failure cases of CAT I retreated with CAT II under RNTCP--an eleven year follow up.

PubMed

Mehra, R K; Dhingra, V K; Nish, Aggarwal; Vashist, R P

2008-10-01

To analyse the treatment outcome of Cat I smear positive relapse and failure cases and their fate when treated with Cat II regimen under RNTCP. All Cat I smear positive relapse and failure TB patients treated with Category II regimen from 1994 to 2005 in a chest clinic of Delhi were analysed in this retrospective study. The re-treatment outcome data for relapse and failure cases of Cat I when treated with Cat II regimen was reviewed. The study population included 5576 registered as Cat I sputum positive cases in Gulabi Bagh chest clinic from 1994 to 2005. A total of 190 (3.4%) failed on Cat I regimen. Further out of 4905 (87.9%) successfully treated Cat I patients, 442 (9%) presented as relapses. The treatment success rate for relapse and failure cases of Cat I when subsequently treated with Cat II regimen were 76.4% and 48.8% respectively, with a significantly higher failure rate (27.6%) among Cat I failures subsequently treated with Cat II regimen. The failure cases of Cat I subsequently treated with Cat II were observed to have a significantly lower success rates (p < 0.05) as compared to relapse cases. The need for reappraisal of Cat II re-treatment regimen for failure cases among Cat I is suggested.

Pediatric CLIF-SOFA score is the best predictor of 28-day mortality in children with decompensated chronic liver disease.

PubMed

Bolia, Rishi; Srivastava, Anshu; Yachha, Surender Kumar; Poddar, Ujjal

2018-03-01

Early identification of children with decompensated chronic liver disease (DCLD) at risk of short-term mortality helps improve outcome. We aimed to evaluate the predictors of outcome and role of Child-Pugh, pediatric end-stage liver disease (PELD) and pediatric chronic liver failure sequential organ failure assessment (pCLIF-SOFA) score for prognosticating 28-day mortality in children with DCLD. DCLD children were prospectively evaluated with a clinico-laboratory proforma and followed for 28 days to determine outcome. Child-Pugh, PELD and pCLIF-SOFA were calculated at admission. Univariate and multivariate analysis was performed to identify the best predictors of outcome. A total of 110 children (74 boys, 96 [4-204] months) were enrolled and 37 (33.6%) died at 28 days. Significant risk factors for mortality were a higher international normalized ratio (hazard ratio [HR] 1.17; 95% CI 1.04-1.31; p <0.001) and bilirubin (HR 1.04; 95% CI 1.01-1.08; p <0.001), lower albumin (HR 0.46; 95% CI 0.27-0.77; p = 0.03) and sodium (HR 0.93; 95% CI 0.89-0.98; p = 0.01), absence of treatable etiology (HR 2.00; 95% CI 1.40-2.87; p = 0.001) and presence of organ failure (HR 3.22; 95% CI 1.98-10.58; p <0.001). Organ failure and serum sodium were independent predictors of poor outcome on multivariate analysis. pCLIF-SOFA (16 [9-22] vs. 9 [5-15]), Child-Pugh (11 [9-15] vs. 10 [8-14]) and PELD (22.2 [7.5-45.3] vs. 15.3 [4.5-23.9]) scores were significantly higher in non-survivors. The area under the curve was 0.977 for pCLIF-SOFA, 0.815 for Child-Pugh score, and 0.741 for PELD score. A pCLIF-SOFA score of ≥11 identified 28-day mortality with a sensitivity and specificity of 94.9% and 91.5%, respectively. Thirty-four percent of children with DCLD have a poor short-term outcome. Organ failure and low serum sodium are independent predictors of outcome. pCLIF-SOFA performs better than Child-Pugh and PELD in prognostication of 28-day mortality. Our study supports the use of scores based on organ failure in prognosticating children with DCLD. The ability to predict the course of a disease is an important part of the assessment, enabling timely interventions that improve outcomes. We evaluated the outcome (death vs. survival) and compared three different scoring systems for their ability to predict mortality within 28 days in children with decompensated chronic liver disease (DCLD). One-third of children with DCLD died within 28 days and the pediatric chronic liver failure sequential organ failure assessment score, which considers the main organ systems of the body (lungs, liver, brain, kidney, blood and cardiac) fared better for identification of children with a poor outcome than the Child-Pugh and pediatric end-stage liver disease score which comprise of only liver-related parameters. Our study supports the use of scores based on organ failure in prognosticating children with DCLD. Copyright © 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Treatment of anemia with darbepoetin alfa in systolic heart failure.

PubMed

Swedberg, Karl; Young, James B; Anand, Inder S; Cheng, Sunfa; Desai, Akshay S; Diaz, Rafael; Maggioni, Aldo P; McMurray, John J V; O'Connor, Christopher; Pfeffer, Marc A; Solomon, Scott D; Sun, Yan; Tendera, Michal; van Veldhuisen, Dirk J

2013-03-28

Patients with systolic heart failure and anemia have worse symptoms, functional capacity, and outcomes than those without anemia. We evaluated the effects of darbepoetin alfa on clinical outcomes in patients with systolic heart failure and anemia. In this randomized, double-blind trial, we assigned 2278 patients with systolic heart failure and mild-to-moderate anemia (hemoglobin level, 9.0 to 12.0 g per deciliter) to receive either darbepoetin alfa (to achieve a hemoglobin target of 13 g per deciliter) or placebo. The primary outcome was a composite of death from any cause or hospitalization for worsening heart failure. The primary outcome occurred in 576 of 1136 patients (50.7%) in the darbepoetin alfa group and 565 of 1142 patients (49.5%) in the placebo group (hazard ratio in the darbepoetin alfa group, 1.01; 95% confidence interval, 0.90 to 1.13; P=0.87). There was no significant between-group difference in any of the secondary outcomes. The neutral effect of darbepoetin alfa was consistent across all prespecified subgroups. Fatal or nonfatal stroke occurred in 42 patients (3.7%) in the darbepoetin alfa group and 31 patients (2.7%) in the placebo group (P=0.23). Thromboembolic adverse events were reported in 153 patients (13.5%) in the darbepoetin alfa group and 114 patients (10.0%) in the placebo group (P=0.01). Cancer-related adverse events were similar in the two study groups. Treatment with darbepoetin alfa did not improve clinical outcomes in patients with systolic heart failure and mild-to-moderate anemia. Our findings do not support the use of darbepoetin alfa in these patients. (Funded by Amgen; RED-HF ClinicalTrials.gov number, NCT00358215.).

Acetaminophen Adducts Detected in Serum of Pediatric Patients With Acute Liver Failure.

PubMed

Alonso, Estella M; James, Laura P; Zhang, Song; Squires, Robert H

2015-07-01

Previous studies in patients with acute liver failure identified acetaminophen (APAP) protein adducts in the serum of 12% and 19% of children and adults, respectively, with acute liver failure of indeterminate etiology. This article details the testing of APAP adducts in a subset (n = 393) of patients with varied diagnoses in the Pediatric Acute Liver Failure Study Group (PALFSG). Serum samples were available from 393 participants included in the PALFSG registry. Adduct measurement was performed using validated methods. Participants were grouped by diagnostic category as known APAP overdose, known other diagnosis, and indeterminate etiology. Demographic and clinical characteristics and participant outcomes were compared by adduct status (positive or negative) within each group. APAP adduct testing was positive in 86% of participants with known APAP overdose, 6% with other known diagnoses, and 11% with an indeterminate cause of liver failure. Adduct-positive participants were noted to have marked elevation of serum alanine aminotransferase and aspartate aminotransferase coupled with total serum bilirubin that was significantly lower than adduct-negative patients. In the indeterminate group, adduct-positive patients had different outcomes than adduct-negative patients (P = 0.03); spontaneous survival was 16 of 21 (76%) in adduct-positive patients versus 75 of 169 (44%) in adduct-negative patients. Prognosis did not vary by adduct status in patients with known diagnoses. Furthermore, study is needed to understand the relation of APAP exposure, as determined by the presence of APAP adducts, to the clinical phenotype and outcomes of children with acute liver failure.

Pharmacists' role in the post-discharge management of patients with heart failure: a literature review.

PubMed

Ponniah, A; Anderson, B; Shakib, S; Doecke, C J; Angley, M

2007-08-01

The incidence of heart failure is increasing in developed countries. In the aged population, heart failure is a common cause of hospitalization and hospital readmission, which in conjunction with post-discharge care, impose a significant cost burden. Inappropriate medication management and drug-related problems have been identified as major contributors to hospital readmissions. In order to enhance the care and clinical outcomes, and reduce treatment costs, heart failure disease management programmes (DMPs) have been developed. It is recommended that these programmes adopt a multi-disciplinary approach, and pharmacists, with their understanding and knowledge of medication management, can play a vital role in the post-discharge care of heart failure patients. The aim of this literature review was to assess the role of pharmacists in the provision of post-charge services for heart failure patients. An extensive literature search was undertaken to identify published studies and review articles evaluating the benefits of an enhanced medication management service for patients with heart failure post-discharge. Seven studies were identified evaluating 'outpatient' or 'post-discharge' pharmacy services for patients with heart failure. In three studies, services were delivered prior to discharge with either subsequent telephone or home visit follow-up. Three studies involved the role of a pharmacist in a specialist heart failure outpatient clinic. One study focused on a home-based intervention. In six of these studies, positive outcomes, such as decreases in unplanned hospital readmissions, death rates and greater compliance and medication knowledge were demonstrated. One study did not show any difference in the number of hospitalizations between intervention and control groups. The quality of evidence of the randomized controlled trials was assessed using the Jadad scoring method. None of the studies achieved a score of more than 2, out of a maximum of 5, indicating the potential for bias. The DMPs carried out by pharmacists have contributed to positive patient outcomes, which has highlighted the value of extending the traditional roles of pharmacists from the provision of professional guidance to the delivery of continuity of care through a more holistic and direct approach. This review has demonstrated the effectiveness of pharmacists' interventions to reduce the morbidity and mortality associated with heart failure. However, there is an on-going need for the development and evaluation of pharmacy services for these patients.

The Impact of Re-tear on the Clinical Outcome after Rotator Cuff Repair Using Open or Arthroscopic Techniques – A Systematic Review

PubMed Central

Galanopoulos, Ilias; Ilias, Aslanidis; Karliaftis, Konstantinos; Papadopoulos, Dimitrios; Ashwood, Neil

2017-01-01

Background: It is generally accepted that rotator cuff repair gives satisfactory results in the long term, although most studies have so far shown a fairly high rate of structural failure or re-tear. The purpose of this review study is to assess whether failure of the repaired cuff to heal could negatively affect the functional outcome. Methods: This article includes an extensive Internet PubMed based research in the current English-language literature including level I to level V studies as well as systematic reviews. Results: According to this extended study research, the results are mixed; certain reports show that patients with a healed rotator cuff repair have improved function and strength compared to those with structural failure, whereas other studies support the generally perceived concept that tendon re-tear does not lead to inferior clinical outcome. Conclusion: Further high-level prospective studies with larger numbers of patients and longer follow up are needed to overcome the current debate over function between healed and failed rotator cuff repairs. PMID:28400878

Use of biomarkers to guide outpatient therapy of heart failure.

PubMed

DeBeradinis, Benedetta; Januzzi, James L

2012-11-01

Among patients with heart failure, concentrations of natriuretic peptides are strongly linked to the presence and severity of structural heart disease and are strongly prognostic in this setting. Additionally, favorable reduction in the concentration of either B-type natriuretic peptide (BNP) or B-type natriuretic peptide and its amino-terminal cleavage fragment (NT-proBNP) may be seen during treatment of heart failure, with parallel improvement in prognosis. This has led to the hypothesis that intensified treatment directed at reducing natriuretic peptide concentrations may improve outcomes in heart failure. In chronic heart failure, studies suggest that a strategy of standard-of-care management together with a goal to suppress BNP or NT-proBNP concentrations leads to greater application of guideline-derived medical therapy and is well tolerated. In certain studies of this BNP or NT-proBNP 'guided' approach, patients treated with biomarker-guided care had superior outcomes when compared with standard heart failure management alone, particularly in younger study populations, in patients with left ventricular systolic dysfunction, and particularly when substantial reductions in natriuretic peptides were achieved in association with biomarker-guided care. Natriuretic peptide 'guided' management appears promising in patients suffering from chronic heart failure. Large-scale pivotal trials to confirm the approach are planned.

Combined Association of Albuminuria and Cystatin C–Based Estimated GFR With Mortality, Coronary Heart Disease, and Heart Failure Outcomes: The Atherosclerosis Risk in Communities (ARIC) Study

PubMed Central

Waheed, Salman; Matsushita, Kunihiro; Sang, Yingying; Hoogeveen, Ron; Ballantyne, Christie; Coresh, Josef; Astor, Brad C.

2013-01-01

Background Serum cystatin C level has been shown to have a stronger association with clinical outcomes than serum creatinine level. However, little is known about the combined association of cystatin C–based estimated glomerular filtration rate (eGFRcys) and albuminuria with clinical outcomes, particularly at levels lower than current chronic kidney disease (CKD) cutoffs. Study Design Prospective cohort. Setting & Participants 10,403 ARIC (Atherosclerosis Risk in Communities) Study participants followed up for a median of 10.2 years. Predictor eGFRcys, albuminuria. Outcomes Mortality, coronary heart disease (CHD), and heart failure, as well as a composite of any of these separate outcomes. Results Both decreased eGFRcys and albuminuria were associated independently with the composite outcome, as well as mortality, CHD, and heart failure. Although eGFRcys of 75-89 mL/min/1.73 m2 in the absence of albuminuria (albumin-creatinine ratio [ACR] <10 mg/g) or albuminuria with ACR of 10-29 mg/g with normal eGFRcys (90-104 mL/min/1.73 m2) was not associated significantly with any outcome compared with eGFRcys of 90-104 mL/min/1.73 m2 and ACR <10 mg/g, the risk of each outcome was significantly higher in those with both eGFRcys of 75-89 mL/min/1.73 m2 and ACR of 10-29 mg/g (for mortality, HR of 1.4 [95% CI, 1.1-2.0]; for CHD, HR of 1.9 [95% CI, 1.4-2.6]; for heart failure, HR of 1.8 [95% CI, 1.2-2.7]). Combining the 2 markers improved risk classification for all outcomes (P < 0.001), even in those without overt CKD. Limitations Only one measurement of cystatin C. Conclusions Mildly decreased eGFRcys and mild albuminuria independently contributed to the risk of mortality, CHD, and heart failure. Even minimally decreased eGFRcys (75-89 mL/min/1.73 m2) is associated with increased risk in the presence of mild albuminuria. Combining the 2 markers is useful for improved risk stratification even in those without clinical CKD. PMID:22537422

Bone-Patellar Tendon-Bone Versus Soft-Tissue Allograft for Anterior Cruciate Ligament Reconstruction: A Systematic Review.

PubMed

Joyce, Christopher D; Randall, Kyle L; Mariscalco, Michael W; Magnussen, Robert A; Flanigan, David C

2016-02-01

To describe the outcomes of bone-patellar tendon-bone (BPTB) and soft-tissue allografts in anterior cruciate ligament (ACL) reconstruction with respect to graft failure risk, physical examination findings, instrumented laxity, and patient-reported outcomes. A search of the PubMed, Scopus, CINAHL (Cumulative Index to Nursing and Allied Health Literature) Complete, Cochrane Collaboration, and SPORTDiscus databases was performed. English-language studies with outcome data on primary ACL reconstruction with nonirradiated BPTB and soft-tissue allografts were identified. Outcome data included failure risk, physical examination findings, instrumented laxity measurements, and patient-reported outcome scores. Seventeen studies met the inclusion criteria. Of these studies, 11 reported on BPTB allografts exclusively, 5 reported on soft-tissue allografts exclusively, and 1 compared both types. The comparative study showed no difference in failure risk, Lachman grade, pivot-shift grade, instrumented laxity, or overall International Knee Documentation Committee score between the 2 allograft types. Data from all studies yielded a failure risk of 10.3% (95% confidence interval [CI], 4.5% to 18.1%) in the soft-tissue group and 15.2% (95% CI, 11.3% to 19.6%) in the BPTB group. The risk of a Lachman grade greater than 5 mm was 6.4% (95% CI, 1.7% to 13.7%) in the soft-tissue group and 8.6% (95% CI, 6.3% to 11.2%) in the BPTB group. The risk of a grade 2 or 3 pivot shift was 1.4% (95% CI, 0.3% to 3.3%) in the soft-tissue group and 4.1% (95% CI, 1.9% to 7.2%) in the BPTB group. One comparative study showed no difference in results after ACL reconstruction with nonirradiated BPTB and soft-tissue allografts. Inclusion of case series in the analysis showed qualitatively similar outcomes with the 2 graft types. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Accounting for Complexity in Home Telemonitoring: A Need for Context-Centred Evidence.

PubMed

Ware, Patrick; Seto, Emily; Ross, Heather J

2018-01-31

Heart failure represents a significant burden for patients and the Canadian health care system. Home telemonitoring is proposed as an intervention that can improve heart failure outcomes by identifying opportunities for earlier clinical intervention and by providing patients with self-management support between scheduled clinic visits. The objective of this review is to provide clarity with respect to the most recent evidence of the effect of home telemonitoring on heart failure outcomes. Despite some strong evidence that telemonitoring can reduce the risk of mortality and heart failure-related hospitalizations, important inconsistencies exist in the evidence. This article proposes that much of the inconsistency results from differences in the patient population being studied, the type of home telemonitoring intervention, and the implementation setting. Also important is the degree to which intervention fidelity is maintained throughout the course of a study; this is emphasized through a review of the factors that influence the degree to which patients and health care providers use home telemonitoring interventions as intended. In this article we propose that for researchers to produce definitive answers regarding the effect of home telemonitoring on heart failure outcomes, interventions and studies need to be designed and tailored according to the characteristics of the target patient population and the implementation context. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Mood, body image, fear of kidney failure, life satisfaction, and decisional stability following living kidney donation: Findings from the KDOC study.

PubMed

Rodrigue, J R; Schold, J D; Morrissey, P; Whiting, J; Vella, J; Kayler, L K; Katz, D; Jones, J; Kaplan, B; Fleishman, A; Pavlakis, M; Mandelbrot, D A

2018-06-01

Prior studies demonstrate that most living kidney donors (LKDs) report no adverse psychosocial outcomes; however, changes in psychosocial functioning at the individual donor level have not been routinely captured. We studied psychosocial outcomes predonation and at 1, 6, 12, and 24 months postdonation in 193 LKDs and 20 healthy controls (HCs). There was minimal to no mood disturbance, body image concerns, fear of kidney failure, or life dissatisfaction, indicating no incremental changes in these outcomes over time and no significant differences between LKDs and HCs. The incidence of any new-onset adverse outcomes postdonation was as follows: mood disturbance (16%), fear of kidney failure (21%), body image concerns (13%), and life dissatisfaction (10%). Multivariable analyses demonstrated that LKDs with more mood disturbance symptoms, higher anxiety about future kidney health, low body image, and low life satisfaction prior to surgery were at highest risk of these same outcomes postdonation. It is important to note that some LKDs showed improvement in psychosocial functioning from pre- to postdonation. Findings support the balanced presentation of psychosocial risks to potential donors as well as the development of a donor registry to capture psychosocial outcomes beyond the mandatory 2-year follow-up period in the United States. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

Self-esteem and counterfactual thinking.

PubMed

Roese, N J; Olson, J M

1993-07-01

Two studies examined the relation between self-esteem and counterfactual thinking (consideration of "might-have-been" alternatives to reality). Ss imagined themselves in scenarios with another actor that resulted in either success or failure. Ss then "undid" the outcome by altering events that preceded the outcome. Following success, high self-esteem (HSE) Ss were more likely than low self-esteem (LSE) Ss to mutate their own actions. Following failure, LSE Ss were more likely than HSE Ss to mutate their own actions. Also, the structure of counterfactuals was influenced by outcome valence but not by self-esteem: Subtractive structures (in which antecedents are removed) were elicited by success, whereas additive structures (in which antecedents are added) were elicited by failure. The importance of the self and individual differences in self-esteem to counterfactual thinking is discussed.

Factors associated with dental implant survival: a 4-year retrospective analysis.

PubMed

Zupnik, Jamie; Kim, Soo-woo; Ravens, Daniel; Karimbux, Nadeem; Guze, Kevin

2011-10-01

Dental implants are a predictable treatment option for replacing missing teeth and have strong survival and success outcomes. However, previous research showed a wide array of potential risk factors that may have contributed to dental implant failures. The objectives of this study are to study if implant survival rates were affected by known risk factors and risk indicators that may have contributed to implant failures. The secondary outcome measures were whether the level of expertise of the periodontal residents affected success rates and how the rate of implant success at the Harvard School of Dental Medicine (HSDM) compared to published standards. A retrospective chart review of patients at the HSDM who had one of two types of rough-surface implants (group A or B) placed by periodontology residents from 2003 to 2006 was performed. Demographic, health, and implant data were collected and analyzed by multimodel analyses to determine failure rates and any factors that may have increased the likelihood of an implant failure. The study cohort included 341 dental implants. The odds ratio for an implant failure was most clearly elevated for diabetes (2.59 implant surface group B (7.84), and male groups (4.01). There was no significant difference regarding the resident experience. The success rate for HSDM periodontology residents was 96.48% during the 4-year study period. This study demonstrates that implant success rates at HSDM fell within accepted published standards, confirmed previously identified risk factors for a failure, and potentially suggested that other acknowledged risk factors could be controlled for. Furthermore, the level of experience of the periodontology resident did not have an impact on survival outcomes.

Mechanical ventilation during extracorporeal membrane oxygenation.

PubMed

Schmidt, Matthieu; Pellegrino, Vincent; Combes, Alain; Scheinkestel, Carlos; Cooper, D Jamie; Hodgson, Carol

2014-01-21

The timing of extracorporeal membrane oxygenation (ECMO) initiation and its outcome in the management of respiratory and cardiac failure have received considerable attention, but very little attention has been given to mechanical ventilation during ECMO. Mechanical ventilation settings in non-ECMO studies have been shown to have an effect on survival and may also have contributed to a treatment effect in ECMO trials. Protective lung ventilation strategies established for non-ECMO-supported respiratory failure patients may not be optimal for more severe forms of respiratory failure requiring ECMO support. The influence of positive end-expiratory pressure on the reduction of the left ventricular compliance may be a matter of concern for patients receiving ECMO support for cardiac failure. The objectives of this review were to describe potential mechanisms for lung injury during ECMO for respiratory or cardiac failure, to assess the possible benefits from the use of ultra-protective lung ventilation strategies and to review published guidelines and expert opinions available on mechanical ventilation-specific management of patients requiring ECMO, including mode and ventilator settings. Articles were identified through a detailed search of PubMed, Ovid, Cochrane databases and Google Scholar. Additional references were retrieved from the selected studies. Growing evidence suggests that mechanical ventilation settings are important in ECMO patients to minimize further lung damage and improve outcomes. An ultra-protective ventilation strategy may be optimal for mechanical ventilation during ECMO for respiratory failure. The effects of airway pressure on right and left ventricular afterload should be considered during venoarterial ECMO support of cardiac failure. Future studies are needed to better understand the potential impact of invasive mechanical ventilation modes and settings on outcomes.

Mechanical ventilation during extracorporeal membrane oxygenation

PubMed Central

2014-01-01

The timing of extracorporeal membrane oxygenation (ECMO) initiation and its outcome in the management of respiratory and cardiac failure have received considerable attention, but very little attention has been given to mechanical ventilation during ECMO. Mechanical ventilation settings in non-ECMO studies have been shown to have an effect on survival and may also have contributed to a treatment effect in ECMO trials. Protective lung ventilation strategies established for non-ECMO-supported respiratory failure patients may not be optimal for more severe forms of respiratory failure requiring ECMO support. The influence of positive end-expiratory pressure on the reduction of the left ventricular compliance may be a matter of concern for patients receiving ECMO support for cardiac failure. The objectives of this review were to describe potential mechanisms for lung injury during ECMO for respiratory or cardiac failure, to assess the possible benefits from the use of ultra-protective lung ventilation strategies and to review published guidelines and expert opinions available on mechanical ventilation-specific management of patients requiring ECMO, including mode and ventilator settings. Articles were identified through a detailed search of PubMed, Ovid, Cochrane databases and Google Scholar. Additional references were retrieved from the selected studies. Growing evidence suggests that mechanical ventilation settings are important in ECMO patients to minimize further lung damage and improve outcomes. An ultra-protective ventilation strategy may be optimal for mechanical ventilation during ECMO for respiratory failure. The effects of airway pressure on right and left ventricular afterload should be considered during venoarterial ECMO support of cardiac failure. Future studies are needed to better understand the potential impact of invasive mechanical ventilation modes and settings on outcomes. PMID:24447458

Antiretroviral therapeutic drug monitoring in HIV-infected pregnant women: maternal immunovirological outcome at delivery and during the 18 month follow-up period.

PubMed

Nicastri, Emanuele; Ivanovic, Jelena; Signore, Fabrizio; Tempestilli, Massimo; Bellagamba, Rita; Viscione, Magdalena; Pisani, Giuseppe; Vallone, Cristina; Tommasi, Chiara; Gallo, Anna L; De Nardo, Pasquale; Pucillo, Paolo L; Narciso, Pasquale

2012-10-01

No data are available on the long-term immunovirological outcome of HIV-positive pregnant women experiencing sub-therapeutic antiretroviral drug (ARV) concentrations during pregnancy. The objective of our study was to assess the long-term virological outcome in pregnant women treated with HAART. A prospective, multi-center study enrolled 60 HIV-infected pregnant women stratified into 3 groups according to the response to HAART. Group A, women successfully treated with HAART; Group B, women with confirmed virological failure during HAART; Group C, women successfully treated with HAART during pregnancy for prevention of vertical transmission only. Smoking, alcohol use, low adherence to therapy, and increased viral load at delivery were significantly associated to virological failure at univariate analysis. At multivariate regression analysis, only adherence to therapy was reported as an independent variable related to the virological response (p < 0.001). Virological failure during follow-up was reported in 2 (25.0%) of the 8 women with sub therapeutic Ctrough and in 4 of the 33 (12.1%) women with therapeutic Ctrough (p=0.33). In group C, the viro-immunological set points during follow-up did not differ from those observed before HAART initiation. No significantly increased rate of virological failure after delivery was reported in women with sub-therapeutic ARV concentrations during pregnancy and long-term follow-up. The long-term virological outcome was independently associated to reduced adherence to therapy. Evaluation of the clinical impact of the low plasma ARV concentrations during pregnancy on the long-term virological outcome deserves further larger studies.

Failure of the Laryngeal Mask Airway Unique™ and Classic™ in the pediatric surgical patient: a study of clinical predictors and outcomes.

PubMed

Mathis, Michael R; Haydar, Bishr; Taylor, Emma L; Morris, Michelle; Malviya, Shobha V; Christensen, Robert E; Ramachandran, Satya-Krishna; Kheterpal, Sachin

2013-12-01

Although predictors of laryngeal mask airway failure in adults have been elucidated, there remains a paucity of data regarding laryngeal mask airway failure in children. The authors performed a retrospective database review of all pediatric patients who received a laryngeal mask anesthetic at their institution from 2006 to 2010. Device brands were restricted to LMA Unique™ (Cardinal Health, Dublin, OH) and LMA Classic™ (LMA North America, San Diego, CA), and primary outcome was laryngeal mask failure, defined as any airway event requiring device removal and tracheal intubation. Potential risk factors were analyzed with both univariate and multivariate techniques and included medical history, physical examination, surgical, and anesthetic characteristics. Of the 11,910 anesthesia cases performed in the study, 102 cases (0.86%) experienced laryngeal mask failure. Common presenting features of laryngeal mask failures included leak (25%), obstruction (48%), and patient intolerance such as intractable coughing/bucking (11%). Failures occurred before incision in 57% of cases and after incision in 43%. Independent clinical associations included ear/nose/throat surgical procedure, nonoutpatient admission status, prolonged surgical duration, congenital/acquired airway abnormality, and patient transport. The findings of the study support the use of the LMA Unique™ and LMA Classic™ as reliable pediatric supraglottic airway devices, demonstrating relatively low failure rates. Predictors of laryngeal mask airway failure in the pediatric surgical population do not overlap with those in the adult population and should therefore be independently considered.

Comparison of peritoneal dialysis and hemodialysis after kidney transplant failure.

PubMed

Kang, G W; Jang, M H; Hwang, E A; Park, S B; Han, S Y

2013-10-01

Patients with a failed kidney transplant represent a unique chronic kidney disease population that is increasing in number and is at high risk of morbidity and mortality. Among transplant-naïve patients, those treated with peritoneal dialysis (PD) show an early survival advantage compared with those treated with hemodialysis (HD). But any advantage of PD after allograft failure is unknown. The aim of this study was to investigate the clinical outcomes of patients with failed allografts according to the type of dialysis modality. We reviewed medical records of patients who initiated dialysis after kidney transplant failure from November 1982 to May 2011. Demographics features, clinical data, and survival outcomes were compared between PD and HD patients who had experienced allograft failure. The 182 patients with failed allografts showed the most common cause to be chronic rejection. The median duration of function before allograft failure was 74.0 months. After allograft failure, 145 (79.7%) patients returned to HD and 37 (20.3%) to PD. Twenty-three patients (12.6%) died over the median 69.1 months duration of follow-up. During the observation period, 16 HD (11%) and 7 PD (8.9%) patients died. The survival rates of PD patients at 1 year were 91.2% and 84.4%, respectively, at 1 and 3 years, and those of HD patients 94.8% and 88.9%. There was no significant difference in the survivals of the 2 groups. The study suggests that the outcome of patients starting PD after kidney transplant failure was similar to those starting HD. Therefore, PD can be regarded to be a good treatment option for patients returning to dialysis after kidney transplant failure. Crown Copyright © 2013. Published by Elsevier Inc. All rights reserved.

Epidemiology and Outcome of Acute Kidney Injury According to Pediatric Risk, Injury, Failure, Loss, End-Stage Renal Disease and Kidney Disease: Improving Global Outcomes Criteria in Critically Ill Children-A Prospective Study.

PubMed

Volpon, Leila C; Sugo, Edward K; Consulin, Julio C; Tavares, Tabata L G; Aragon, Davi C; Carlotti, Ana P C P

2016-05-01

We aimed to investigate the epidemiology, risk factors, and short- and medium-term outcome of acute kidney injury classified according to pediatric Risk, Injury, Failure, Loss, End-Stage Renal Disease, and Kidney Disease: Improving Global Outcomes criteria in critically ill children. Prospective observational cohort study. Two eight-bed PICUs of a tertiary-care university hospital. A heterogeneous population of critically ill children. None. Demographic, clinical, laboratory, and outcome data were collected on all patients admitted to the PICUs from August 2011 to January 2012, with at least 24 hours of PICU stay. Of the 214 consecutive admissions, 160 were analyzed. The prevalence of acute kidney injury according to pediatric Risk, Injury, Failure, Loss, End-Stage Renal Disease and Kidney Disease: Improving Global Outcomes criteria was 49.4% vs. 46.2%, respectively. A larger proportion of acute kidney injury episodes was categorized as Kidney Disease: Improving Global Outcomes stage 3 (50%) compared with pediatric Risk, Injury, Failure, Loss, End-Stage Renal Disease F (39.2%). Inotropic score greater than 10 was a risk factor for acute kidney injury severity. About 35% of patients with acute kidney injury who survived were discharged from the PICU with an estimated creatinine clearance less than 75 mL/min/1.73 m and one persisted with altered renal function 6 months after PICU discharge. Age 12 months old or younger was a risk factor for estimated creatinine clearance less than 75 mL/min/1.73 m at PICU discharge. Acute kidney injury and its severity were associated with increased PICU length of stay and longer duration of mechanical ventilation. Eleven patients died; nine had acute kidney injury (p < 0.05). The only risk factor associated with death after multivariate adjustment was Pediatric Risk of Mortality score greater than or equal to 10. Acute kidney injury defined by both pediatric Risk, Injury, Failure, Loss, End-Stage Renal Disease and Kidney Disease: Improving Global Outcomes criteria was associated with increased morbidity and mortality, and may lead to long-term renal dysfunction.

Aetiology and prognostic factors of patients with AIDS presenting life-threatening acute respiratory failure.

PubMed

Torres, A; El-Ebiary, M; Marrades, R; Miró, J M; Gatell, J M; Sanchez-Nieto, J M; Xaubet, A; Agustí, C; Rodriguez-Roisin, R

1995-11-01

Respiratory failure is a significant contributor to morbidity and mortality in patients with the acquired immune deficiency syndrome (AIDS). We performed a study to investigate the aetiology, prognostic factors, and short- and long-term outcome of AIDS patients with life-threatening respiratory failure and pulmonary infiltrates. Forty-two AIDS patients (29 of whom required mechanical ventilation), admitted to a Respiratory Intensive Care Unit (ICU) from 1985 to 1992 because of severe respiratory failure (arterial oxygen tension/fractional inspiratory oxygen (Pa,O2/FI,O2) ratio at hospital admission 19 +/- 14 kPa (mean +/- SD)) and diffuse pulmonary infiltrates, were studied for evaluation of the aetiology and outcome. Necropsy studies were performed in 14 out of 23 (61%) patients who died. Pneumocystis carinii was the most common aetiology of pulmonary infiltrates (28 patients (67%)). Overall, 19 patients survived (45%) and 23 (55%) died. A multivariate analysis of prognostic factors influencing the outcome of the whole population showed that the presence of P. carinii pneumonia and the requirement for mechanical ventilation (MV) were the major determinants of outcome for this type of patient. The median survival time after ICU discharge for P. carinii pneumonia patients was lower (49 days) when compared to that of the remaining patients (154 days). Median survival time after ICU discharge for patients needing MV (112 days) did not differ from that observed in patients not requiring artificial ventilatory support (154 days). Although the ICU survival rate in this study was reasonable, 55% for the whole population, and 36% for P. carinii pneumonia patients, the poor outcome after ICU discharge, in particular for P. carinii pneumonia patients, deserves the reassessment of ICU admission criteria for this type of AIDS population.

Development and Validation of an Abbreviated Questionnaire to Easily Measure Cognitive Failure in ICU Survivors: A Multicenter Study.

PubMed

Wassenaar, Annelies; de Reus, Jorn; Donders, A Rogier T; Schoonhoven, Lisette; Cremer, Olaf L; de Lange, Dylan W; van Dijk, Diederik; Slooter, Arjen J C; Pickkers, Peter; van den Boogaard, Mark

2018-01-01

To develop and validate an abbreviated version of the Cognitive Failure Questionnaire that can be used by patients as part of self-assessment to measure functional cognitive outcome in ICU survivors. A retrospective multicenter observational study. The ICUs of two Dutch university hospitals. Adult ICU survivors. None. Cognitive functioning was evaluated between 12 and 24 months after ICU discharge using the full 25-item Cognitive Failure Questionnaire (CFQ-25). Incomplete CFQ-25 questionnaires were excluded from analysis. Forward selection in a linear regression model was used in hospital A to assess which of the CFQ-25 items should be included to prevent a significant loss of correlation between an abbreviated and the full CFQ-25. Subsequently, the performance of an abbreviated Cognitive Failure Questionnaire was determined in hospital B using Pearson's correlation. A Bland-Altman plot was used to examine whether the reduced-item outcome scores of an abbreviated Cognitive Failure Questionnaire were a replacement for the full CFQ-25 outcome scores. Among 1,934 ICU survivors, 1,737 were included, 819 in hospital A, 918 in hospital B. The Pearson's correlation between the abbreviated 14-item Cognitive Failure Questionnaire (CFQ-14) and the CFQ-25 was 0.99. The mean of the difference scores was -0.26, and 95% of the difference scores fell within +5 and -5.5 on a 100-point maximum score. It is feasible to use the abbreviated CFQ-14 to measure self-reported cognitive failure in ICU survivors as this questionnaire has a similar performance as the full CFQ-25.

Drug Does Not Improve Set of Cardiovascular Outcomes for Diastolic Heart Failure

MedlinePlus

... preserved systolic function, is a common heart condition accounting for about half of all heart failure cases. ... study showed that participants enrolled via elevated BNP measurements who received spironolactone fared better in the composite ...

Predictors of failure of awake regional anesthesia for neonatal hernia repair: data from the General Anesthesia compared to Spinal anesthesia (GAS) study: comparing apnoea and neurodevelopmental outcomes

PubMed Central

Frawley, Geoff; Bell, Graham; Disma, Nicola; Withington, Davinia E.; de Graaff, Jurgen C.; Morton, Neil S.; McCann, Mary Ellen; Arnup, Sarah J.; Bagshaw, Oliver; Wolfler, Andrea; Bellinger, David; Davidson, Andrew J.

2015-01-01

Background Awake regional anesthesia (RA) is a viable alternative to general anesthesia (GA) for infants undergoing lower abdominal surgery. Benefits include lower incidence of postoperative apnea and avoidance of anesthetic agents that may increase neuroapoptosis and worsen neurocognitive outcomes. The General Anesthesia compared to Spinal anesthesia (GAS) study compares neurodevelopmental outcomes following awake RA or GA in otherwise healthy infants. Our aim was to describe success and failure rates of RA in this study and report factors associated with failure. Methods This was a nested cohort study within a prospective randomized, controlled, observer blind, equivalence trial. Seven hundred twenty two infants ≤ 60 weeks postmenstrual age, scheduled for herniorrhaphy under anesthesia were randomly assigned to receive RA (spinal, caudal epidural or combined spinal caudal anesthetic) or GA with sevoflurane. The data of 339 infants, where spinal or combined spinal caudal anesthetic was attempted, was analyzed. Possible predictors of failure were assessed including: patient factors, technique, experience of site and anesthetist and type of local anesthetic. Results RA was sufficient for the completion of surgery in 83.2% of patients. Spinal anesthesia was successful in 86.9% of cases and combined spinal caudal anesthetic in 76.1%. Thirty four patients required conversion to GA and an additional 23 (6.8%) required brief sedation. Bloody tap on the first attempt at lumbar puncture was the only risk factor significantly associated with block failure (OR = 2.46). Conclusions The failure rate of spinal anesthesia was low. Variability in application of combined spinal caudal anesthetic limited attempts to compare the success of this technique to spinal alone. PMID:26001028

Surgical outcomes analysis of pediatric peritoneal dialysis catheter function in a rural region.

PubMed

Stone, Matthew L; LaPar, Damien J; Barcia, John P; Norwood, Victoria F; Mulloy, Daniel P; McGahren, Eugene D; Rodgers, Bradley M; Kane, Bartholomew J

2013-07-01

The purpose of this study was to analyze the experience with peritoneal dialysis (PD) at a high-volume, single center institution that supports a rural population. From 2000 to 2010, 88 children (median age: 1.98 years, [range: 2 days-20.2 years]) received 134 PD catheters for the management of acute and chronic renal failure. The primary outcome of interest was the incidence of primary PD catheter failure (replacement or revision within 60 days). Operative technique, longitudinal outcomes, and time intervals to transplantation were analyzed. Median time to transplant from the institution of dialysis was 1.4 years [range: 0.3-6.4 years]. Primary catheter failure occurred in 24.6% of cases. Infants less than 6 months of age demonstrated an increased incidence of primary catheter failure (p = 0.02). The operative technique for catheter placement was not associated with the incidence of primary failure. Postoperative complications included peritonitis (22.7%), omental plugging (11.9%), pericatheter drainage (9.0%), and exit site infection (3.0%). Peritoneal dialysis provides a safe and effective renal replacement therapy for regional pediatric centers that serve a rural population. However, primary catheter failure rates remain high at 24.6%. The surgical technique for placement had no effect on this failure rate in our patient population. Infants less than 6 months of age are at increased risk for primary catheter failure and warrant intensive surveillance. Copyright © 2013. Published by Elsevier Inc.

Structured telephone support or non-invasive telemonitoring for patients with heart failure.

PubMed

Inglis, Sally C; Clark, Robyn A; Dierckx, Riet; Prieto-Merino, David; Cleland, John G F

2015-10-31

Specialised disease management programmes for heart failure aim to improve care, clinical outcomes and/or reduce healthcare utilisation. Since the last version of this review in 2010, several new trials of structured telephone support and non-invasive home telemonitoring have been published which have raised questions about their effectiveness. To review randomised controlled trials (RCTs) of structured telephone support or non-invasive home telemonitoring compared to standard practice for people with heart failure, in order to quantify the effects of these interventions over and above usual care. We updated the searches of the Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology AsseFssment Database (HTA) on the Cochrane Library; MEDLINE (OVID), EMBASE (OVID), CINAHL (EBSCO), Science Citation Index Expanded (SCI-EXPANDED), Conference Proceedings Citation Index- Science (CPCI-S) on Web of Science (Thomson Reuters), AMED, Proquest Theses and Dissertations, IEEE Xplore and TROVE in January 2015. We handsearched bibliographies of relevant studies and systematic reviews and abstract conference proceedings. We applied no language limits. We included only peer-reviewed, published RCTs comparing structured telephone support or non-invasive home telemonitoring to usual care of people with chronic heart failure. The intervention or usual care could not include protocol-driven home visits or more intensive than usual (typically four to six weeks) clinic follow-up. We present data as risk ratios (RRs) with 95% confidence intervals (CIs). Primary outcomes included all-cause mortality, all-cause and heart failure-related hospitalisations, which we analysed using a fixed-effect model. Other outcomes included length of stay, health-related quality of life, heart failure knowledge and self care, acceptability and cost; we described and tabulated these. We performed meta-regression to assess homogeneity (the null hypothesis) in each subgroup analysis and to see if the effect of the intervention varied according to some quantitative variable (such as year of publication or median age). We include 41 studies of either structured telephone support or non-invasive home telemonitoring for people with heart failure, of which 17 were new and 24 had been included in the previous Cochrane review. In the current review, 25 studies evaluated structured telephone support (eight new studies, plus one study previously included but classified as telemonitoring; total of 9332 participants), 18 evaluated telemonitoring (nine new studies; total of 3860 participants). Two of the included studies trialled both structured telephone support and telemonitoring compared to usual care, therefore 43 comparisons are evident.Non-invasive telemonitoring reduced all-cause mortality (RR 0.80, 95% CI 0.68 to 0.94; participants = 3740; studies = 17; I² = 24%, GRADE: moderate-quality evidence) and heart failure-related hospitalisations (RR 0.71, 95% CI 0.60 to 0.83; participants = 2148; studies = 8; I² = 20%, GRADE: moderate-quality evidence). Structured telephone support reduced all-cause mortality (RR 0.87, 95% CI 0.77 to 0.98; participants = 9222; studies = 22; I² = 0%, GRADE: moderate-quality evidence) and heart failure-related hospitalisations (RR 0.85, 95% CI 0.77 to 0.93; participants = 7030; studies = 16; I² = 27%, GRADE: moderate-quality evidence).Neither structured telephone support nor telemonitoring demonstrated effectiveness in reducing the risk of all-cause hospitalisations (structured telephone support: RR 0.95, 95% CI 0.90 to 1.00; participants = 7216; studies = 16; I² = 47%, GRADE: very low-quality evidence; non-invasive telemonitoring: RR 0.95, 95% CI 0.89 to 1.01; participants = 3332; studies = 13; I² = 71%, GRADE: very low-quality evidence).Seven structured telephone support studies reported length of stay, with one reporting a significant reduction in length of stay in hospital. Nine telemonitoring studies reported length of stay outcome, with one study reporting a significant reduction in the length of stay with the intervention. One telemonitoring study reported a large difference in the total number of hospitalisations for more than three days, but this was not an analysis of length of stay per hospitalisation. Nine of 11 structured telephone support studies and five of 11 telemonitoring studies reported significant improvements in health-related quality of life. Nine structured telephone support studies and six telemonitoring studies reported costs of the intervention or cost effectiveness. Three structured telephone support studies and one telemonitoring study reported a decrease in costs and two telemonitoring studies reported increases in cost, due both to the cost of the intervention and to increased medical management. Adherence was rated between 55.1% and 98.5% for those structured telephone support and telemonitoring studies which reported this outcome. Participant acceptance of the intervention was reported in the range of 76% to 97% for studies which evaluated this outcome. Seven of nine studies that measured these outcomes reported significant improvements in heart failure knowledge and self-care behaviours. For people with heart failure, structured telephone support and non-invasive home telemonitoring reduce the risk of all-cause mortality and heart failure-related hospitalisations; these interventions also demonstrated improvements in health-related quality of life and heart failure knowledge and self-care behaviours. Studies also demonstrated participant satisfaction with the majority of the interventions which assessed this outcome.

Evolution of Biomarker Guided Therapy for Heart Failure: Current Concepts and Trial Evidence

PubMed Central

Pruett, Amanda E; Lee, Amanda K; Patterson, Herbert; Schwartz, Todd A; Glotzer, Jana M; Adams, Jr, Kirkwood F

2015-01-01

Optimizing management of patients with heart failure remains quite challenging despite many significant advances in drug and device therapy for this syndrome. Although a large body of evidence from robust clinical trials supports multiple thera-pies, utilization of these well-established treatments remains inconsistent and outcomes suboptimal in “real-world” patients with heart failure. Disease management programs may be effective, but are difficult to implement due to cost and logistical issues. Another approach to optimizing therapy is to utilize biomarkers to guide therapeutic choices. Natriuretic peptides pro-vide additional information of significant clinical value in the diagnosis and estimation of risk inpatients with heart failure. Ongoing research suggests a potential important added role for natriuretic peptides in heart failure. Guiding therapy based on serial changes in these biomarkers may be an effective strategy to optimize treatment and achieve better outcomes in this syn-drome. Initial, innovative, proof-of-concept studies have provided encouraging results and important insights into key as-pects of this strategy, but well designed, large-scale, multicenter, randomized, outcome trials are needed to definitively estab-lish this novel approach to management. Given the immense and growing public health burden of heart failure, identification of cost-effective ways to decrease the morbidity and mortality due to this syndrome is critical. PMID:24251462

An Intervention to Enhance Goals-of-Care Communication Between Heart Failure Patients and Heart Failure Providers.

PubMed

Doorenbos, Ardith Z; Levy, Wayne C; Curtis, J Randall; Dougherty, Cynthia M

2016-09-01

Heart failure patients contend with a markedly impaired quality of life, experiencing emotional distress and severe physical discomfort that increases in frequency in the last months of life. Improving communication between patients and providers about goals of care has the potential to improve patient-provider communication and patient outcomes. To determine the effects of a goals-of-care (GoC) intervention compared to usual care on the number of GoC conversations, quality of communication between patients and providers, referrals to palliative care services and completion of advance care directives. A two-group randomized study (n = 40/group) compared a GoC intervention to usual care, conducted in an academic heart failure (HF) clinic. The GoC intervention was a previsit patient activation-education, telephone-based intervention delivered by a nurse. The primary outcome of the study was number of GoC conversations between HF patients and HF providers. Secondary outcomes were quality of communication, number of referrals to palliative care, and completion of advance directives. Patients averaged 58.15 ± 11.26 years of age, with mean left ventricular ejection fraction = 30.31 ± 9.72% and Seattle Heart Failure Model scores = 95.1 ± 1.60. There was a significant increase in goals-of-care conversations (58% vs. 2.6%, P < 0.001) and quality of end-of-life communication (P = 0.03) in the GoC group compared to usual care after the intervention. There were no differences between groups on the other outcomes. The GoC intervention resulted in more GoC conversations and higher quality communication between HF patients and providers without increased anxiety or depression. Further studies are needed to assess impact on longer term quality of care and patient outcomes. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Cardiorenal syndrome: new developments in the understanding and pharmacologic management.

PubMed

House, Andrew A

2013-10-01

Cardiorenal syndromes (CRSs) with bidirectional heart-kidney signaling are increasingly being recognized for their association with increased morbidity and mortality. In acute CRS, recognition of the importance of worsening kidney function complicating management of acute decompensated heart failure has led to the examination of this specific outcome in the context of acute heart failure clinical trials. In particular, the role of fluid overload and venous congestion has focused interest in the most effective use of diuretic therapy to relieve symptoms of heart failure while at the same time preserving kidney function. Additionally, many novel vasoactive therapies have been studied in recent years with the hopes of augmenting cardiac function, improving symptoms and patient outcomes, while maintaining or improving kidney function. Similarly, recent advances in our understanding of the pathophysiology of chronic CRS have led to reanalysis of kidney outcomes in pivotal trials in chronic congestive heart failure, and newer trials are including changes in kidney function as well as kidney injury biomarkers as prospectively monitored and adjudicated outcomes. This paper provides an overview of some new developments in the pharmacologic management of acute and chronic CRS, examines several reports that illustrate a key management principle for each subtype, and discusses opportunities for future research.

Prospective assessment of the occurrence of anemia in patients with heart failure: results from the Study of Anemia in a Heart Failure Population (STAMINA-HFP) Registry.

PubMed

Adams, Kirkwood F; Patterson, James H; Patterson, John H; Oren, Ron M; Mehra, Mandeep R; O'Connor, Christopher M; Piña, Ileana L; Miller, Alan B; Chiong, Jun R; Dunlap, Stephanie H; Cotts, William G; Felker, Gary M; Schocken, Douglas D; Schwartz, Todd A; Ghali, Jalal K

2009-05-01

Although a potentially important pathophysiologic factor in heart failure, the prevalence and predictors of anemia have not been well studied in unselected patients with heart failure. The Study of Anemia in a Heart Failure Population (STAMINA-HFP) Registry prospectively studied the prevalence of anemia and the relationship of hemoglobin to health-related quality of life and outcomes among patients with heart failure. A random selection algorithm was used to reduce bias during enrollment of patients seen in specialty clinics or clinics of community cardiologists with experience in heart failure. In this initial report, data on prevalence and correlates of anemia were analyzed in 1,076 of the 1,082 registry patients who had clinical characteristics and hemoglobin determined by finger-stick at baseline. Overall (n = 1,082), the registry patients were 41% female and 73% white with a mean age (+/-SD) of 64 +/- 14 years (68 +/- 13 years in community and 57 +/- 14 years in specialty sites, P < .001). Among the 1,076 patients in the prevalence analysis, mean hemoglobin was 13.3 +/- 2.1 g/dL (median 13.2 g/dL); and anemia (defined by World Health Organization criteria) was present in 34%. Age identified patients at risk for anemia, with 40% of patients >70 years affected. Initial results from the STAMINA-HFP Registry suggest that anemia is a common comorbidity in unselected outpatients with heart failure. Given the strong association of anemia with adverse outcomes in heart failure, this study supports further investigation concerning the importance of anemia as a therapeutic target in this condition.

Coronary artery disease prevalence and outcome in patients hospitalized with acute heart failure: an observational report from seven Middle Eastern countries.

PubMed

Salam, Amar M; Sulaiman, Kadhim; Al-Zakwani, Ibrahim; Alsheikh-Ali, Alawi; Aljaraallah, Mohammed; Al Faleh, Husam; Elasfar, Abdelfatah; Panduranga, Prasanth; Singh, Rajvir; Abi Khalil, Charbel; Al Suwaidi, Jassim

2016-12-01

The purpose of this study was to report prevalence, clinical characteristics, precipitating factors, management and outcome of patients with coronary artery disease (CAD) among patients hospitalized with heart failure (HF) in seven Middle Eastern countries and compare them to non-CAD patients. Data were derived from Gulf CARE (Gulf aCute heArt failuRe rEgistry), a prospective multicenter study of 5005 consecutive patients hospitalized with acute HF during February-November 2012 in 7 Middle Eastern countries. The prevalence of CAD among Acute Heart Failure (AHF) patients was 60.2% and varied significantly among the 7 countries (Qatar 65.7%, UAE 66.6%, Kuwait 68.0%, Oman 65.9%, Saudi Arabia 62.5%, Bahrain 52.7% and Yemen 49.1%) with lower values in the lower income countries. CAD patients were older and more likely to have diabetes, hypertension, dyslipidemia and chronic kidney disease. Moreover, CAD patients were more likely to have history of cerebrovascular and peripheral vascular disease when compared to non-CAD patients. In-hospital mortality rates were comparable although CAD patients had more frequent re-hospitalization and worse long-term outcome. However, CAD was not an independent predictor of poor outcome. The prevalence of CAD amongst patients with HF in the Middle East is variable and may be related to healthcare sources. Regional and national studies are needed for assessing further the impact of various etiologies of HF and for developing appropriate strategies to combat this global concern.

Neurodevelopmental and health outcomes in term infants treated with surfactant for severe respiratory failure.

PubMed

Auten, R L; Merzbach, J; Myers, G; Goldstein, R F; Palumbo, D

2000-01-01

Analysis of health, neurodevelopmental, and school performance outcomes in a pilot study of term and near-term infants with respiratory failure due to pneumonia or meconium aspiration treated with surfactant. Retrospective review of medical records, neurodevelopmental and psychosocial evaluations, and parent and teacher surveys. Of the 14 patients enrolled, only one was rehospitalized, for pneumonia. Three were reported to have episodes of wheezing, two of whom required bronchodilators. One patient had unilateral hearing loss, one had a full-scale intelligence quotient that was below normal, and all but one patient for whom complete results were obtained were performing at or above grade level. Term and near-term newborns with moderately severe respiratory failure treated with surfactant can, in general, be expected to recover completely and have normal general health, neurodevelopmental outcome, and school performance.

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

PubMed

Harris, P N A; McNamara, J F; Lye, D C; Davis, J S; Bernard, L; Cheng, A C; Doi, Y; Fowler, V G; Kaye, K S; Leibovici, L; Lipman, J; Llewelyn, M J; Munoz-Price, S; Paul, M; Peleg, A Y; Rodríguez-Baño, J; Rogers, B A; Seifert, H; Thamlikitkul, V; Thwaites, G; Tong, S Y C; Turnidge, J; Utili, R; Webb, S A R; Paterson, D L

2017-08-01

To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Factors associated with quality of life in Arab patients with heart failure.

PubMed

Alaloul, Fawwaz; AbuRuz, Mohannad E; Moser, Debra K; Hall, Lynne A; Al-Sadi, Ahmad

2017-03-01

The aim of this study was to examine the relationships of demographic characteristics, medical variables and perceived social support with quality of life (QOL) in Arab patients with heart failure. A cross-sectional study was conducted to identify factors associated with QOL in Arab patients with heart failure. Participants with heart failure (N = 99) were enrolled from a nonprofit hospital and an educational hospital. Data were collected on QOL using the Short Form-36 survey. Perceived social support was measured with the Medical Outcomes Study Social Support Survey. The majority of the patients reported significant impairment in QOL as evidenced by subscale scored. Left ventricular ejection fraction was the strongest correlate of most QOL domains. Tangible support was significantly associated with most QOL domains. Other social support dimensions were not significantly related to QOL domains. Most patients with heart failure had significant disrupting pain and limitations in performing activities which interfered with their usual role. Due to the importance of understanding QOL and its determinants within the context of culture, the outcomes of this study may provide valuable guidance to healthcare providers in Arabic countries as well as Western society in caring for these patients. Further studies are needed to explore the relationship between social support and QOL among patients with heart failure in the Arabic culture. © 2016 Nordic College of Caring Science.

Preoperative Determinants of Outcomes of Infant Heart Surgery in a Limited-Resource Setting.

PubMed

Reddy, N Srinath; Kappanayil, Mahesh; Balachandran, Rakhi; Jenkins, Kathy J; Sudhakar, Abish; Sunil, G S; Raj, R Benedict; Kumar, R Krishna

2015-01-01

We studied the effect of preoperative determinants on early outcomes of 1028 consecutive infant heart operations in a limited-resource setting. Comprehensive data on pediatric heart surgery (January 2010-December 2012) were collected prospectively. Outcome measures included in-hospital mortality, prolonged ventilation (>48 hours), and bloodstream infection (BSI) after surgery. Preoperative variables that showed significant individual association with outcome measures were entered into a logistic regression model. Weight at birth was low in 224 infants (21.8%), and failure to thrive was common (mean-weight Z score at surgery was 2.72 ± 1.7). Preoperatively, 525 infants (51%) needed intensive care, 69 infants (6.7%) were ventilated, and 80 infants (7.8%) had BSI. In-hospital mortality (4.1%) was significantly associated with risk adjustment for congenital heart surgery-1 (RACHS-1) risk category (P < 0.001). Neonatal status, preoperative BSI, and requirement of preoperative intensive care and ventilation had significant individual association with adverse outcomes, whereas low birth weight, prematurity, and severe failure to thrive (weight Z score <-3) were not associated with adverse outcomes. On multivariable logistic regression analysis, preoperative sepsis (odds ratio = 2.86; 95% CI: 1.32-6.21; P = 0.008) was associated with mortality. Preoperative intensive care unit stay, ventilation, BSI, and RACHS-1 category were associated with prolonged postoperative ventilation and postoperative sepsis. Neonatal age group was additionally associated with postoperative sepsis. Although severe failure to thrive was common, it did not adversely affect outcomes. In conclusions, preoperative BSI, preoperative intensive care, and mechanical ventilation are strongly associated with adverse outcomes after infant cardiac surgery in this large single-center experience from a developing country. Failure to thrive and low birth weight do not appear to adversely affect surgical outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

A Markov chain model for reliability growth and decay

NASA Technical Reports Server (NTRS)

Siegrist, K.

1982-01-01

A mathematical model is developed to describe a complex system undergoing a sequence of trials in which there is interaction between the internal states of the system and the outcomes of the trials. For example, the model might describe a system undergoing testing that is redesigned after each failure. The basic assumptions for the model are that the state of the system after a trial depends probabilistically only on the state before the trial and on the outcome of the trial and that the outcome of a trial depends probabilistically only on the state of the system before the trial. It is shown that under these basic assumptions, the successive states form a Markov chain and the successive states and outcomes jointly form a Markov chain. General results are obtained for the transition probabilities, steady-state distributions, etc. A special case studied in detail describes a system that has two possible state ('repaired' and 'unrepaired') undergoing trials that have three possible outcomes ('inherent failure', 'assignable-cause' 'failure' and 'success'). For this model, the reliability function is computed explicitly and an optimal repair policy is obtained.

The impact of age and gender on cardiac resynchronization therapy outcome.

PubMed

Zardkoohi, Omeed; Nandigam, Veena; Murray, Lorne; Heist, E Kevin; Mela, Theofanie; Orencole, Mary; Ruskin, Jeremy N; Singh, Jagmeet P

2007-11-01

Cardiac resynchronization therapy (CRT) outcome varies significantly among patients. We aimed to determine the impact of age, gender, and heart failure etiology on the long-term outcome of patients receiving CRT. A total of 117 patients with drug-refractory heart failure, New York Heart Association (NYHA) Class III or IV, and a wide QRS complex, who received CRT, were followed for one year. Long-term outcome was measured as a combined end point of hospitalization for heart failure and/or all cause mortality. Efficacy of CRT was compared between men and women, between older and younger patients, and between patients with ischemic and nonischemic heart disease. Time to the primary end point was estimated by the Kaplan-Meier method and comparisons were made using the Breslow-Wilcoxon test. Baseline clinical characteristics were comparable between gender, age, and heart failure etiology subgroups. There was no significant difference in the combined end point between older versus younger (age >70, (n = 71), versus age < 70, (n = 46), P = 0.52); both genders (men, n = 91 vs women, n = 26, P = 0.46) and etiology of the cardiomyopathy (ischemic (n = 79) vs nonischemic (n = 38), P = 0.12). Substratification of the genders by the etiology of the cardiomyopathy, showed that women with ischemic cardiomyopathy (IW, n = 10) had a trend to a worse outcome compared to the other groups i.e., nonischemic women (NIW, n = 16), ischemic men (IM, n = 69), and nonischemic men (NIM, n = 22), P = 0.04. After adjusting for potential covariates, a Cox regression analysis showed no significant difference between the groups (P = 0.61). CRT outcome appears independent of age, gender, and heart failure etiology in this single institution study.

Risk factors for implant failure: a retrospective study in an educational institution using GEE analyses.

PubMed

Borba, Marcelo; Deluiz, Daniel; Lourenço, Eduardo José Veras; Oliveira, Luciano; Tannure, Patrícia Nivoloni

2017-08-21

This study aimed to evaluate dental implant outcomes and to identify risk factors associated with implant failure over 12 years via dental records of patients attending an educational institution. Dental records of 202 patients receiving 774 dental implants from 2002 to 2014 were analyzed by adopting a more reliable statistical method to evaluate risk factors with patients as the unit [generalized estimating equation (GEE)]. Information regarding patient age at implantation, sex, use of tobacco, and history of systemic diseases was collected. Information about implant location in the arch region and implant length, diameter, and placement in a grafted area was evaluated after 2 years under load. Systemic and local risk factors for early and late implant failure were studied. A total of 18 patients experienced 25 implant failures, resulting in an overall survival rate of 96.8% (2.84% and 0.38% early and late implant failures, respectively). The patient-based survival rate was 91.8%. GEE univariate and multivariate analyses revealed that a significant risk factor for implant failure was the maxillary implant (p = 0.006 and p = 0.014, respectively). Bone grafting appeared to be a risk factor for implant failure (p = 0.054). According to GEE analyses, maxillary implants had significantly worse outcomes in this population and were considered to be a risk factor for implant failure. Our results suggested that implants placed in a bone augmentation area had a tendency to fail.

Kidney Failure and ESRD in the Atherosclerosis Risk in Communities (ARIC) Study: Comparing Ascertainment of Treated and Untreated Kidney Failure in a Cohort Study

PubMed Central

Rebholz, Casey M.; Coresh, Josef; Ballew, Shoshana H.; McMahon, Blaithin; Whelton, Seamus P.; Selvin, Elizabeth; Grams, Morgan E.

2015-01-01

Background Linkage to the US Renal Data System (USRDS) registry is commonly used to identify end-stage renal disease (ESRD) cases, or kidney failure treated with dialysis or transplantation, but it underestimates the total burden of kidney failure. This study validates a kidney failure definition that includes both kidney failure treated and not treated by dialysis or transplantation. It compares kidney failure risk factors and outcomes using this broader definition to USRDS-identified ESRD risk factors and outcomes. Study Design Diagnostic test study with stratified random sampling of hospitalizations for chart review. Setting & Participants Atherosclerosis Risk in Communities Study (N=11,530; chart review n=546). Index Test USRDS-identified ESRD; treated or untreated kidney failure defined by USRDS-identified ESRD or International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)/ICD-10-CM code from hospitalization or death. Reference Test For ESRD, determination of permanent dialysis or transplantation; for kidney failure, determination of permanent dialysis, transplantation, or eGFR <15 mL/min/1.73 m2. Results Over 13 years' median follow-up, 508 kidney failure cases were identified, including 173 (34.1%) from the USRDS registry. ESRD and kidney failure incidence were 1.23 and 3.66 cases per 1,000 person-years in the overall population, and 1.35 and 6.59 cases per 1,000 person-years among participants older than 70 years, respectively. Other risk factor associations were similar between ESRD and kidney failure, except diabetes and albuminuria which were stronger for ESRD. Survival at 1 and 5 years were 74.0% and 24.0% for ESRD and 59.8% and 31.6% for kidney failure, respectively. Sensitivity and specificity were 88.0% and 97.3% comparing the kidney failure ICD-9-CM/ICD-10-CM code algorithm to chart review; for USRDS-identified ESRD, sensitivity and specificity were 94.9% and 100.0%. Limitations Some medical charts were incomplete. Conclusions A kidney failure definition including treated and untreated disease identifies more cases than linkage to the USRDS registry alone, particularly among older adults. Future studies might consider reporting both USRDS-identified ESRD and a more inclusive kidney failure definition. PMID:25773483

Outcomes and Complications of Ahmed Tube Implantation in Asian Eyes.

PubMed

Choo, Jessica Qian Hui; Chen, Ziyou David; Koh, Victor; Liang, Shen; Aquino, Cecilia Maria; Sng, Chelvin; Chew, Paul

2018-06-18

There is a lack of long-term Asian studies on the efficacy and safety of Ahmed glaucoma valve (AGV) implantation. This study seeks to determine the outcomes and complications of AGV implantation in Asians. Retrospective review of AGV surgeries performed at a single centre in Singapore was conducted. 76 patients with primary and secondary glaucoma who underwent their first AGV surgery from 1st January 2010 to 31st December 2012 were considered for our study. Primary outcomes evaluated were: failure, intra-ocular pressure, best-corrected visual acuity (BCVA), number of IOP-lowering medications and complications. Failure was defined by: IOP >21▒mm Hg on two consecutive visits after 3 months, IOP ≤5▒mm Hg on two consecutive visits after 3 months, reoperation for glaucoma, removal of implant or loss of light perception vision. Mean follow-up duration was 33.2±6.9 months. There was significant reduction in IOP (mean reduction 25.9%, P<0.001) and number of IOP-lowering medications (mean reduction 77.8%, P<0.001) at 3 years. Absolute failure rate was 23.9% at 3 years with no difference between eyes with or without previous trabeculectomy and between eyes with primary or secondary glaucoma. Occurrence of post-operative hyphema was a significant risk factor for failure. Commonest post-operative complications were hyphema and tube exposure. At 3 years after AGV surgery in Asian eyes, less than one-quarter of the eyes fulfilled the criteria for surgical failure.

Psychological distress and in vitro fertilization outcome

PubMed Central

Pasch, Lauri A.; Gregorich, Steven E.; Katz, Patricia K.; Millstein, Susan G.; Nachtigall, Robert D.; Bleil, Maria E.; Adler, Nancy E.

2016-01-01

Objective To examine whether psychological distress predicts IVF treatment outcome as well as whether IVF treatment outcome predicts subsequent psychological distress. Design Prospective cohort study over an 18-month period. Setting Five community and academic fertility practices. Patients Two hundred and two women who initiated their first IVF cycle. Interventions Women completed interviews and questionnaires at baseline and at 4, 10, and 18 months follow-up. Main Outcome Measures IVF cycle outcome and psychological distress. Results Using a binary logistic model including covariates (woman’s age, ethnicity, income, education, parity, duration of infertility, and time interval), pre-treatment depression and anxiety were not significant predictors of the outcome of the first IVF cycle. Using linear regression models including covariates (woman’s age, income, education, parity, duration of infertility, assessment point, time since last treatment cycle, and pre-IVF depression or anxiety), experiencing failed IVF was associated with higher post-IVF depression and anxiety. Conclusions IVF failure predicts subsequent psychological distress, but pre-IVF psychological distress does not predict IVF failure. Instead of focusing efforts on psychological interventions specifically aimed at improving the chance of pregnancy, these findings suggest that attention be paid to helping patients prepare for and cope with treatment and treatment failure. PMID:22698636

Outcomes of endodontic therapy in general practice: a study by the Practitioners Engaged in Applied Research and Learning Network.

PubMed

Bernstein, Susan D; Horowitz, Allan J; Man, Martin; Wu, Hongyu; Foran, Denise; Vena, Donald A; Collie, Damon; Matthews, Abigail G; Curro, Frederick A; Thompson, Van P; Craig, Ronald G

2012-05-01

The authors undertook a study involving members of a dental practice-based research network to determine the outcome and factors associated with success and failure of endodontic therapy. Members in participating practices (practitioner-investigators [P-Is]) invited the enrollment of all patients seeking treatment in the practice who had undergone primary endodontic therapy and restoration in a permanent tooth three to five years previously. If a patient had more than one tooth so treated, the P-I selected as the index tooth the tooth treated earliest during the three- to five-year period. The authors excluded from the study any teeth that served as abutments for removable partial dentures or overdentures, third molars and teeth undergoing active orthodontic endodontic therapy. The primary outcome was retention of the index tooth. Secondary outcomes, in addition to extraction, that defined failure included clinical or radiographic evidence (or both) of periapical pathosis, endodontic retreatment or pain on percussion. P-Is in 64 network practices enrolled 1,312 patients with a mean (standard deviation) time to follow-up of 3.9 (0.6) years. During that period, 3.3 percent of the index teeth were extracted, 2.2 percent underwent retreatment, 3.6 percent had pain on percussion and 10.6 percent had periapical radiolucencies for a combined failure rate of 19.1 percent. The presence of preoperative periapical radiolucency with a diagnosis of either irreversible pulpitis or necrotic pulp was associated with failure after multivariate analysis, as were multiple canals, male sex and Hispanic/Latino ethnicity. These results suggest that failure rates for endodontic therapy are higher than previously reported in general practices, according to results of studies based on dental insurance claims data. The results of this study can help guide the practitioner in deciding the most appropriate course of therapy for teeth with irreversible pulpitis, necrotic pulp or periapical periodontitis.

Salvage Surgery for Locoregional Failure in Anal Squamous Cell Carcinoma.

PubMed

Guerra, Glen R; Kong, Joseph C; Bernardi, Maria-Pia; Ramsay, Robert G; Phillips, Wayne A; Warrier, Satish K; Lynch, A Craig; Ngan, Samuel Y; Heriot, Alexander G

2018-02-01

Anal squamous cell carcinoma is a rare cancer with a high cure rate, making research into the treatment of locoregional failure difficult. The purpose of this study was to examine factors related to local treatment failure and determine the outcomes of patients undergoing local salvage resection. This was a retrospective cohort study. This study was conducted at a quaternary referral center. Patients with anal squamous cell carcinoma treated with chemoradiotherapy between January 1983 and December 2015 were included. The influence of patient-, tumor-, and treatment-related factors on the primary outcome measures of locoregional failure, overall survival, and disease-free survival were investigated. Of 467 patients with anal squamous cell carcinoma, 63 experienced locoregional failure with 41 undergoing salvage resection. Twenty-seven patients (38%) had persistent disease and 36 (62%) developed locoregional recurrence. Multivariate analysis identified tumor stage (HR, 3.16; p < 0.002) as an independent predictor of locoregional failure. Thirty abdominoperineal resections and 11 pelvic exenterations were undertaken with no surgical mortality. At a median follow-up of 20 months (range, 4-150 months), 5-year overall and disease-free survival for the salvage cohort was 51% and 47%. Margin positivity was an independent predictor for relapse post-salvage surgery on multivariate analysis (HR, 20.1; p = 0.027). Nineteen patients (48%) developed further relapse, which included all 10 patients with a positive resection margin, 3 of whom underwent re-resection. Of the 19 patients with relapse, 3 remain alive and 2 have persistent disease. Limitations include the retrospective nature of the database, the prolonged time period of the study, and episodes of incomplete data. Advanced T stage is an independent predictor of local failure in anal squamous cell carcinoma. Most patients can be salvaged, with a positive resection margin being a strong predictor of further relapse and poor outcome. See Video Abstract at http://links.lww.com/DCR/A515.

Risk Factors, Clinical Presentation, and Outcomes in Overdose With Acetaminophen Alone or With Combination Products: Results From the Acute Liver Failure Study Group.

PubMed

Serper, Marina; Wolf, Michael S; Parikh, Nikhil A; Tillman, Holly; Lee, William M; Ganger, Daniel R

2016-01-01

Acetaminophen (APAP) is the most common cause of acute liver failure (ALF) in the west. It is unknown if APAP overdose in combination with diphenhydramine or opioids confers a different clinical presentation or prognosis. Study objectives were to compare (1) baseline patient characteristics; (2) initial clinical presentation; and (3) clinical outcomes among patients with ALF due to APAP alone or in combination with diphenhydramine or opioids. We analyzed 666 cases of APAP-related liver failure using the Acute Liver Failure Study Group database from 1998 to 2012. The database contains detailed demographic, laboratory, and clinical outcome data, including hemodialysis, transplantation, and death and in-hospital complications such as arrhythmia and infection. The final sample included 666 patients with APAP liver injury. A total 30.3% of patients were overdosed with APAP alone, 14.1% with APAP/diphenhydramine, and 56.6% with APAP/opioids. Patients taking APAP with opioids were older, had more comorbidities, and were more likely to have unintentional overdose (all P<0.0001). On presentation, 58% in the APAP/opioid group had advanced encephalopathy as compared with 43% with APAP alone (P=0.001) The APAP/diphenhydramine group presented with the highest serum aminotransferase levels, no differences in laboratory values were noted at 3 days postenrollment. No significant differences were observed in clinical outcomes among the groups. Most patients with APAP-induced ALF were taking APAP combination products. There were significant differences in patient characteristics and clinical presentation based on the type of product ingested, however, there were no differences noted in delayed hepatotoxicity or clinical outcomes.

Sex Differences in Device Therapy for Heart Failure: Utilization, Outcomes, and Adverse Events

PubMed Central

Herz, Naomi D.; Engeda, Joseph; Zusterzeel, Robbert; Sanders, William E.; O'Callaghan, Kathryn M.; Strauss, David G.; Jacobs, Samantha B.; Selzman, Kimberly A.; Piña, Ileana L.

2015-01-01

Abstract Background: Multiple studies of heart failure patients demonstrated significant improvement in exercise capacity, quality of life, cardiac left ventricular function, and survival from cardiac resynchronization therapy (CRT), but the underenrollment of women in these studies is notable. Etiological and pathophysiological differences may result in different outcomes in response to this treatment by sex. The observed disproportionate representation of women suggests that many women with heart failure either do not meet current clinical criteria to receive CRT in trials or are not properly recruited and maintained in these studies. Methods: We performed a systematic literature review through May 2014 of clinical trials and registries of CRT use that stratified outcomes by sex or reported percent women included. One-hundred eighty-three studies contained sex-specific information. Results: Ninety percent of the studies evaluated included ≤35% women. Fifty-six articles included effectiveness data that reported response with regard to specific outcome parameters. When compared with men, women exhibited more dramatic improvement in specific parameters. In the studies reporting hazard ratios for hospitalization or death, women generally had greater benefit from CRT. Conclusions: Our review confirms women are markedly underrepresented in CRT trials, and when a CRT device is implanted, women have a therapeutic response that is equivalent to or better than in men, while there is no difference in adverse events reported by sex. PMID:25793483

Identifying core NANDA-I nursing diagnoses, NIC interventions, NOC outcomes, and NNN linkages for heart failure.

PubMed

Park, Hyejin

2014-02-01

The purpose of the study was to identify the core nursing diagnoses, interventions, outcomes, and linkages using standardized nursing terminologies for patients with heart failure (HF). For this study a retrospective descriptive design was used. The frequently used NANDA-I, NIC, NOC, and NNN linkages were identified through 272 inpatient records of patients discharged with HF in a midwestern community. The findings indicate that the top 10 NANDA-I, NIC, and NOC accounted for more than 50% of nursing diagnoses, interventions, and outcomes. The most frequently used top 10 NNN linkages were identified for patients with HF. The identified core NANDA-I, NIC, NOC, and NNN linkages for HF from this study provide scope of practice of nurses working in HF clinics. © 2013 NANDA International, Inc.

Addressing the conundrum of multimorbidity in heart failure: Do we need a more strategic approach to improve health outcomes?

PubMed

Stewart, Simon; Riegel, Barbara; Thompson, David R

2016-02-01

There is clear evidence across the globe that the clinical complexity of patients presenting to hospital with the syndrome of heart failure is increasing - not only in terms of the presence of concurrent disease states, but with additional socio-demographic risk factors that complicate treatment. Management strategies that treat heart failure as the main determinant of health outcomes ignores the multiple and complex issues that will inevitably erode the efficacy and efficiency of current heart failure management programmes. This complex problem (or conundrum) requires a different way of thinking around the complex interactions that underpin poor outcomes in heart failure. In this context, we present the COordinated NUrse-led inteNsified Disease management for continuity of caRe for mUltiMorbidity in Heart Failure (CONUNDRUM-HF) matrix that may well inform future research and models of care to achieve better health outcomes in this rapidly increasing patient population. © The European Society of Cardiology 2015.

Prediction of the effect of atrasentan on renal and heart failure outcomes based on short-term changes in multiple risk markers.

PubMed

Schievink, Bauke; de Zeeuw, Dick; Smink, Paul A; Andress, Dennis; Brennan, John J; Coll, Blai; Correa-Rotter, Ricardo; Hou, Fan Fan; Kohan, Donald; Kitzman, Dalane W; Makino, Hirofumi; Parving, Hans-Henrik; Perkovic, Vlado; Remuzzi, Giuseppe; Tobe, Sheldon; Toto, Robert; Hoekman, Jarno; Lambers Heerspink, Hiddo J

2016-05-01

A recent phase II clinical trial (Reducing Residual Albuminuria in Subjects with Diabetes and Nephropathy with AtRasentan trial and an identical trial in Japan (RADAR/JAPAN)) showed that the endothelin A receptor antagonist atrasentan lowers albuminuria, blood pressure, cholesterol, hemoglobin, and increases body weight in patients with type 2 diabetes and nephropathy. We previously developed an algorithm, the Parameter Response Efficacy (PRE) score, which translates short-term drug effects into predictions of long-term effects on clinical outcomes. We used the PRE score on data from the RADAR/JAPAN study to predict the effect of atrasentan on renal and heart failure outcomes. We performed a post-hoc analysis of the RADAR/JAPAN randomized clinical trials in which 211 patients with type-2 diabetes and nephropathy were randomly assigned to atrasentan 0.75 mg/day, 1.25 mg/day, or placebo. A PRE score was developed in a background set of completed clinical trials using multivariate Cox models. The score was applied to baseline and week-12 risk marker levels of RADAR/JAPAN participants, to predict atrasentan effects on clinical outcomes. Outcomes were defined as doubling serum creatinine or end-stage renal disease and hospitalization for heart failure. The PRE score predicted renal risk changes of -23% and -30% for atrasentan 0.75 and 1.25 mg/day, respectively. PRE scores also predicted a small non-significant increase in heart failure risk for atrasentan 0.75 and 1.25 mg/day (+2% vs. +7%). Selecting patients with >30% albuminuria reduction from baseline (responders) improved renal outcome to almost 50% risk reduction, whereas non-responders showed no renal benefit. Based on the RADAR/JAPAN study, with short-term changes in risk markers, atrasentan is expected to decrease renal risk without increased risk of heart failure. Within this population albuminuria responders appear to contribute to the predicted improvements, whereas non-responders showed no benefit. The ongoing hard outcome trial (SONAR) in type 2 diabetic patients with >30% albuminuria reduction to atrasentan will allow us to assess the validity of these predictions. © The European Society of Cardiology 2015.

Long-term outcomes of laparoscopic adjustable gastric banding.

PubMed

Khoraki, Jad; Moraes, Marilia G; Neto, Adriana P F; Funk, Luke M; Greenberg, Jacob A; Campos, Guilherme M

2018-01-01

Laparoscopic adjustable gastric banding (LAGB) is an option for the treatment of severe obesity. Few US studies have reported long-term outcomes. We aimed to present long-term outcomes with LAGB. Retrospective study of patients who underwent LAGB at an academic medical center in the US from 1/2005 to 2/2012. Outcomes included weight loss, complications, re-operations, and LAGB failure. 208 patients underwent LAGB. Mean BMI was 45.4 ± 6.4 kg/m 2 . Mean follow-up was 5.6 (0.5-10.7) years. Complete follow-up was available for 90% at one year (186/207), 80% at five years (136/171), and 71% at ten years (10/14). Percentage of excess weight loss at one, five, and ten years was 29.9, 30, and 16.9, respectively. Forty-eight patients (23.1%) required a reoperation. LAGB failure occurred in 118 (57%) and higher baseline BMI was the only independently associated factor (OR 1.1; 95%CI 1.0-1.1; p = 0.016). LAGB was associated with poor short and long-term weight loss outcomes and a high failure rate. With the increased safety profile and greater efficacy of other surgical techniques, LAGB utilization should be discouraged. Copyright © 2017 Elsevier Inc. All rights reserved.

Improving the prognosis of patients with severely decreased glomerular filtration rate (CKD G4+): conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference

PubMed Central

Eckardt, Kai-Uwe; Bansal, Nisha; Coresh, Josef; Evans, Marie; Grams, Morgan E.; Herzog, Charles A.; James, Matthew T.; Heerspink, Hiddo J.L.; Pollock, Carol A.; Stevens, Paul E.; Tamura, Manjula Kurella; Tonelli, Marcello A.; Wheeler, David C.; Winkelmayer, Wolfgang C.; Cheung, Michael; Hemmelgarn, Brenda R.

2018-01-01

Patients with severely decreased glomerular filtration rate (GFR) (i.e., chronic kidney disease [CKD] G4+) are at increased risk for kidney failure, cardiovascular disease (CVD) events (including heart failure), and death. However, little is known about the variability of outcomes and optimal therapeutic strategies, including initiation of kidney replacement therapy (KRT). Kidney Disease: Improving Global Outcomes (KDIGO) organized a Controversies Conference with an international expert group in December 2016 to address this gap in knowledge. In collaboration with the CKD Prognosis Consortium (CKD-PC) a global meta-analysis of cohort studies (n = 264,515 individuals with CKD G4+) was conducted to better understand the timing of clinical outcomes in patients with CKD G4+ and risk factors for different outcomes. The results confirmed the prognostic value of traditional CVD risk factors in individuals with severely decreased GFR, although the risk estimates vary for kidney and CVD outcomes. A 2- and 4-year model of the probability and timing of kidney failure requiring KRT was also developed. The implications of these findings for patient management were discussed in the context of published evidence under 4 key themes: management of CKD G4+, diagnostic and therapeutic challenges of heart failure, shared decision-making, and optimization of clinical trials in CKD G4+ patients. Participants concluded that variable prognosis of patients with advanced CKD mandates individualized, risk-based management, factoring in competing risks and patient preferences. PMID:29656903

Outcome-Dependent Sampling with Interval-Censored Failure Time Data

PubMed Central

Zhou, Qingning; Cai, Jianwen; Zhou, Haibo

2017-01-01

Summary Epidemiologic studies and disease prevention trials often seek to relate an exposure variable to a failure time that suffers from interval-censoring. When the failure rate is low and the time intervals are wide, a large cohort is often required so as to yield reliable precision on the exposure-failure-time relationship. However, large cohort studies with simple random sampling could be prohibitive for investigators with a limited budget, especially when the exposure variables are expensive to obtain. Alternative cost-effective sampling designs and inference procedures are therefore desirable. We propose an outcome-dependent sampling (ODS) design with interval-censored failure time data, where we enrich the observed sample by selectively including certain more informative failure subjects. We develop a novel sieve semiparametric maximum empirical likelihood approach for fitting the proportional hazards model to data from the proposed interval-censoring ODS design. This approach employs the empirical likelihood and sieve methods to deal with the infinite-dimensional nuisance parameters, which greatly reduces the dimensionality of the estimation problem and eases the computation difficulty. The consistency and asymptotic normality of the resulting regression parameter estimator are established. The results from our extensive simulation study show that the proposed design and method works well for practical situations and is more efficient than the alternative designs and competing approaches. An example from the Atherosclerosis Risk in Communities (ARIC) study is provided for illustration. PMID:28771664

Kidney Failure and ESRD in the Atherosclerosis Risk in Communities (ARIC) Study: Comparing Ascertainment of Treated and Untreated Kidney Failure in a Cohort Study.

PubMed

Rebholz, Casey M; Coresh, Josef; Ballew, Shoshana H; McMahon, Blaithin; Whelton, Seamus P; Selvin, Elizabeth; Grams, Morgan E

2015-08-01

Linkage to the US Renal Data System (USRDS) registry commonly is used to identify end-stage renal disease (ESRD) cases, or kidney failure treated with dialysis or transplantation, but it underestimates the total burden of kidney failure. This study validates a kidney failure definition that includes both kidney failure treated and not treated by dialysis or transplantation. It compares kidney failure risk factors and outcomes using this broader definition with USRDS-identified ESRD risk factors and outcomes. Diagnostic test study with stratified random sampling of hospitalizations for chart review. Atherosclerosis Risk in Communities Study (n=11,530; chart review, n=546). USRDS-identified ESRD; treated or untreated kidney failure defined by USRDS-identified ESRD or International Classification of Diseases, Ninth or Tenth Revision, Clinical Modification (ICD-9-CM/ICD-10-CM) code for hospitalization or death. For ESRD, determination of permanent dialysis therapy or transplantation; for kidney failure, determination of permanent dialysis therapy, transplantation, or estimated glomerular filtration rate < 15 mL/min/1.73 m(2). During 13 years' median follow-up, 508 kidney failure cases were identified, including 173 (34.1%) from the USRDS registry. ESRD and kidney failure incidence were 1.23 and 3.66 cases per 1,000 person-years in the overall population and 1.35 and 6.59 cases per 1,000 person-years among participants older than 70 years, respectively. Other risk-factor associations were similar between ESRD and kidney failure, except diabetes and albuminuria, which were stronger for ESRD. Survivals at 1 and 5 years were 74.0% and 24.0% for ESRD and 59.8% and 31.6% for kidney failure, respectively. Sensitivity and specificity were 88.0% and 97.3% comparing the kidney failure ICD-9-CM/ICD-10-CM code algorithm to chart review; for USRDS-identified ESRD, sensitivity and specificity were 94.9% and 100.0%. Some medical charts were incomplete. A kidney failure definition including treated and untreated disease identifies more cases than linkage to the USRDS registry alone, particularly among older adults. Future studies might consider reporting both USRDS-identified ESRD and a more inclusive kidney failure definition. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Clinical outcomes and economic impact of transcatheter mitral leaflet repair in heart failure patients.

PubMed

Asgar, Anita W; Khairy, Paul; Guertin, Marie-Claude; Cournoyer, Daniel; Ducharme, Anique; Bonan, Raoul; Basmadjian, Arsene; Tardif, Jean-Claude; Cohen, David J

2017-01-01

Mitral regurgitation (MR) is a common valvular heart disorder requiring intervention once it becomes severe. Transcatheter mitral repair with the MitraClip device is a safe and effective therapy for selected patients denied surgery. The authors sought to evaluate the clinical outcomes and economic impact of this therapy compared to medical management in heart-failure patients with symptomatic mitral regurgitation. The study was comprised of two phases; an observational study of patients with heart failure and mitral regurgitation treated with either medical therapy or the MitraClip, and an economic model. Results of the observational study were used to estimate parameters for the decision model, which estimated costs, and benefits in a hypothetical cohort of patients with heart failure and moderate-to-severe mitral regurgitation treated with either standard medical therapy or MitraClip. The cohort of patients treated with the MitraClip was propensity matched to a population of heart failure patients, and their outcomes compared. At a mean follow-up of 22 months, all-cause mortality was 21% in the MitraClip cohort and 42% in the medical management cohort (p = .007). The decision model demonstrated that MitraClip increased life expectancy from 1.87-3.60 years and quality-adjusted life years (QALY) from 1.13-2.76 years. The incremental cost was $52,500 Canadian dollars, corresponding to an incremental cost-effectiveness ratio (ICER) of $32,300.00 per QALY gained. Results were sensitive to the survival benefit. In heart failure patients with symptomatic moderate-severe mitral regurgitation, therapy with the MitraClip is associated with superior survival and is cost-effective compared to medical therapy.

The Impact of Worsening Heart Failure in the United States

PubMed Central

Cooper, Lauren B.; DeVore, Adam D.; Felker, G. Michael

2015-01-01

Synopsis In-hospital worsening heart failure represents a clinical scenario in which a patient hospitalized for treatment of acute heart failure experiences a worsening of their condition while in the hospital, requiring escalation of therapy. In-hospital worsening heart failure is associated with worse in-hospital and post-discharge outcomes. In-hospital worsening heart failure is increasingly being used as an endpoint, or as part of a combined endpoint, in many clinical trials in acute heart failure. This endpoint has advantages over other endpoints commonly used in acute and chronic heart failure trials, such as dyspnea relief and mortality or rehospitalization. Despite the extensive study of this condition, no treatment strategies have been approved for the prevention of this condition. However, several prediction models have been developed to identify worsening heart failure. Continued study in this area is warranted. PMID:26462100

Meniscal Repair with Concurrent Anterior Cruciate Ligament Reconstruction: Operative Success and Patient Outcomes at 6-Year Follow-up

PubMed Central

Westermann, RW; Wright, RW; Huston, LJ; Wolf, BR

2015-01-01

BACKGROUND Meniscus repairs are commonly performed concurrently with anterior cruciate ligament reconstruction (ACLR) in the acutely injured knee. No large-scale, prospective, multicenter studies have evaluated long-term success and patient-oriented outcomes after combined ACLR and meniscus repair. PURPOSE To define operative success and patient-oriented outcome scores 6 years after combined meniscus repair and ACLR. STUDY DESIGN Cohort study; Level of evidence, 3. METHODS All ipsilateral primary ACLR and meniscus repair cases from a multicenter study group between 2002 and 2004 were selected. Validated patient-oriented outcome instruments were completed at 3 time points: preoperatively, 2 years and 6 years following the index procedure. Subsequent ipsilateral knee re-operation was confirmed by operative reports to evaluate for failure of meniscal repairs. RESULTS In total, 286 patients of 1440 primary ACLR’s underwent concurrent meniscus repair (298 meniscal repairs). 235/286 (82.2%) were available for follow-up at 6 years (154 medial, 72 lateral and 9 both lateral and medial meniscal repairs). Repaired menisci most commonly involved the peripheral 1/3 of the meniscus (84%); patterns were typically longitudinal (84%) or displaced bucket-handle (10%), with mean length of 16.5 ±5.8mm. Overall, the meniscal repair failure rate was 14% (medial, 21/154; lateral, 10/72; both 2/9) at 6 years. Medial repairs failed earlier than lateral repairs (2.1 versus 3.7 years; p=0.01). Significant improvements in outcome instruments were sustained at 6-year follow-up. No differences in suture number or type were detected between repair failures and successes. Meniscal reoperation was higher in patients who underwent repair compared to those who did have an identified meniscal injury at the time of ACLR (p<0.01). CONCLUSIONS Concurrent meniscal repair with ACLR is associated with failure rates approximating 14% at 6-year follow-up. Improvements in patient-oriented outcome instruments were sustained at 6-year follow-up. Surgeons may expect good clinical outcomes 6 years after combined ACLR and meniscus repairs. PMID:25023440

Early detection of nonneurologic organ failure in patients with severe traumatic brain injury: Multiple organ dysfunction score or sequential organ failure assessment?

PubMed

Ramtinfar, Sara; Chabok, Shahrokh Yousefzadeh; Chari, Aliakbar Jafari; Reihanian, Zoheir; Leili, Ehsan Kazemnezhad; Alizadeh, Arsalan

2016-10-01

The aim of this study is to compare the discriminant function of multiple organ dysfunction score (MODS) and sequential organ failure assessment (SOFA) components in predicting the Intensive Care Unit (ICU) mortality and neurologic outcome. A descriptive-analytic study was conducted at a level I trauma center. Data were collected from patients with severe traumatic brain injury admitted to the neurosurgical ICU. Basic demographic data, SOFA and MOD scores were recorded daily for all patients. Odd's ratios (ORs) were calculated to determine the relationship of each component score to mortality, and area under receiver operating characteristic (AUROC) curve was used to compare the discriminative ability of two tools with respect to ICU mortality. The most common organ failure observed was respiratory detected by SOFA of 26% and MODS of 13%, and the second common was cardiovascular detected by SOFA of 18% and MODS of 13%. No hepatic or renal failure occurred, and coagulation failure reported as 2.5% by SOFA and MODS. Cardiovascular failure defined by both tools had a correlation to ICU mortality and it was more significant for SOFA (OR = 6.9, CI = 3.6-13.3, P < 0.05 for SOFA; OR = 5, CI = 3-8.3, P < 0.05 for MODS; AUROC = 0.82 for SOFA; AUROC = 0.73 for MODS). The relationship of cardiovascular failure to dichotomized neurologic outcome was not significant statistically. ICU mortality was not associated with respiratory or coagulation failure. Cardiovascular failure defined by either tool significantly related to ICU mortality. Compared to MODS, SOFA-defined cardiovascular failure was a stronger predictor of death. ICU mortality was not affected by respiratory or coagulation failures.

Germany's Disease Management Program: Improving Outcomes in Congestive Heart Failure

PubMed Central

Kottmair, Stefan; Frye, Christian; Ziegenhagen, Dieter J.

2005-01-01

Hospital admissions among patients with congestive heart failure (CHF) are a major contributor to health care costs. A comprehensive disease management program for CHF was developed for private and statutory health insurance companies in order to improve health outcomes and reduce rehospitalization rates and costs. The program comprises care calls, written training material, telemetric monitoring, and health reports. Currently, 909 members from six insurance companies are enrolled. Routine evaluation, based on medical data warehouse software, demonstrates benefits in terms of improved health outcomes and processes of care. Economical evaluation of claims data indicates significant cost savings in a pre/post study design. PMID:17288080

Arthroscopic repair of partial-thickness and small full-thickness rotator cuff tears: tendon quality as a prognostic factor for repair integrity.

PubMed

Chung, Seok Won; Kim, Jae Yoon; Yoon, Jong Pil; Lyu, Seong Hwa; Rhee, Sung Min; Oh, Se Bong

2015-03-01

The healing failure rate is high for partial-thickness or small full-thickness rotator cuff tears. To retrospectively evaluate and compare outcomes after arthroscopic repair of high-grade partial-thickness and small full-thickness rotator cuff tears and factors affecting rotator cuff healing. Cohort study; Level of evidence, 3. Included in the study were 55 consecutive patients (mean age, 57.9 ± 7.2 years) who underwent arthroscopic repair for high-grade partial-thickness (n = 34) and small full-thickness (n = 21) rotator cuff tears. The study patients also underwent magnetic resonance imaging (MRI) preoperatively and computed tomography arthrography (CTA) at least 6 months postoperatively, and their functional outcomes were evaluated preoperatively and at the last follow-up (>24 months). All partial-thickness tears were repaired after being converted to full-thickness tears; thus, the repair process was almost the same as for small full-thickness tears. The tendinosis of the torn tendon was graded from the MRI images using a 4-point scale, and the reliabilities were assessed. The outcomes between high-grade partial-thickness tears that were converted to small full-thickness tears and initially small full-thickness tears were compared, and factors affecting outcomes were evaluated. The inter- and intraobserver reliabilities of the tendinosis grade were good (intraclass correlation coefficient, 0.706 and 0.777, respectively). Failure to heal as determined by CTA was observed in 12 patients with a high-grade partial-thickness tear (35.3%; complete failure in 4 and partial failure in 8) and in 3 patients with a small full-thickness tear (14.3%; complete failure in 1 and partial failure in 2). The patients with high-grade partial-thickness rotator cuff tears showed a higher tendinosis grade than did those with small full-thickness tears (P = .014), and the severity of the tendinosis was related to the failure to heal (P = .037). Tears with a higher tendinosis grade showed a 7.64-times higher failure rate (95% CI, 1.43-36.04) than did those with a lower tendinosis grade (P = .013). All functional outcome scores improved after surgery (all P < .001); however, there was no difference between groups. The high-grade partial-thickness rotator cuff tears showed more severe tendinosis compared with the small full-thickness tears in this study. Contrary to previous impressions that tear size or fatty infiltration is the factor that most influences healing, tendinosis severity assessed by preoperative MRI was the only factor associated with failure to heal, given the numbers available for analysis, in patients with partial-thickness and small full-thickness rotator cuff tears. Surgeons should pay more attention to tendon quality during repair surgery or rehabilitation in smaller rotator cuff tears, especially in high-grade partial-thickness tears with severe tendinosis. © 2014 The Author(s).

Liver transplantation for fulminant hepatitis at Stanford University.

PubMed

Lu, Amy; Monge, Humberto; Drazan, Kenneth; Millan, Maria; Esquivel, Carlos O

2002-01-01

To review the clinical characteristics and outcomes of 26 patients evaluated for liver transplantation for fulminant hepatic failure at Stanford University and Lucile Packard Children's Hospital in an attempt to identify risk factors and prognostic predictors of survival. A retrospective review of the records of 26 consecutive patients who were evaluated for possible liver transplantation for acute liver failure from May 1, 1995, to January 1, 2000. Pretransplant patient demographics and clinical characteristics were collected, and the data were analyzed by univariate and multivariate analysis. Clinical assessment of encephalopathy did not predict outcome. Patients with abnormal computed tomography (CT) of the brain had a twofold increase in mortality compared with those patients with normal studies (p = 0.03). Patients requiring mechanical ventilation and continuous venovenous hemofiltration (CVVH) also had a poor prognosis. Predictors of poor outcome after fulminant hepatic failure include abnormal CT scan, mechanical ventilation, and requirement for hemofiltration.

Us versus Them: Social Identity Shapes Neural Responses to Intergroup Competition and Harm

PubMed Central

Cikara, Mina; Botvinick, Matthew M.; Fiske, Susan T.

2013-01-01

Intergroup competition makes social identity salient, which affects how people respond to competitors’ hardships. The failures of a fellow group member are painful, while those of a rival group member may give pleasure—a feeling that may motivate harming rivals. The present study examines whether valuation-related neural responses to rival groups’ failures correlate with likelihood of harming individuals associated with those rivals. Avid fans of the Red Sox and Yankees teams viewed baseball plays while undergoing fMRI. Subjectively negative outcomes (favored-failure, rival-success) activated anterior cingulate cortex and insula, while positive outcomes (favored-success, rival-failure—even against a third team) activated ventral striatum. The ventral striatum effect, associated with subjective pleasure, also correlated with self-reported likelihood of aggressing against a fan of the rival team (controlling for general aggression). Outcomes of social group competition can directly affect primary reward-processing neural systems, with implications for intergroup harm. PMID:21270447

Effects of self-management intervention on health outcomes of patients with heart failure: a systematic review of randomized controlled trials

PubMed Central

Jovicic, Aleksandra; Holroyd-Leduc, Jayna M; Straus, Sharon E

2006-01-01

Background Heart failure is the most common cause of hospitalization among adults over 65. Over 60% of patients die within 10 years of first onset of symptoms. The objective of this study is to determine the effectiveness of self-management interventions on hospital readmission rates, mortality, and health-related quality of life in patients diagnosed with heart failure. Methods The study is a systematic review of randomized controlled trials. The following data sources were used: MEDLINE (1966-11/2005), EMBASE (1980-11/2005), CINAHL (1982-11/2005), the ACP Journal Club database (to 11/2005), the Cochrane Central Trial Registry and the Cochrane Database of Systematic Reviews (to 11/2005); article reference lists; and experts in the field. We included randomized controlled trials of self-management interventions that enrolled patients 18 years of age or older who were diagnosed with heart failure. The primary outcomes of interest were all-cause hospital readmissions, hospital readmissions due to heart failure, and mortality. Secondary outcomes were compliance with treatment and quality of life scores. Three reviewers independently assessed the quality of each study and abstracted the results. For each included study, we computed the pooled odds ratios (OR) for all-cause hospital readmission, hospital readmission due to heart failure, and death. We used a fixed effects model to quantitatively synthesize results. We were not able to pool effects on health-related quality of life and measures of compliance with treatment, but we summarized the findings from the relevant studies. We also summarized the reported cost savings. Results From 671 citations that were identified, 6 randomized trials with 857 patients were included in the review. Self-management decreased all-cause hospital readmissions (OR 0.59; 95% confidence interval (CI) 0.44 to 0.80, P = 0.001) and heart failure readmissions (OR 0.44; 95% CI 0.27 to 0.71, P = 0.001). The effect on mortality was not significant (OR = 0.93; 95% CI 0.57 to 1.51, P = 0.76). Adherence to prescribed medical advice improved, but there was no significant difference in functional capabilities, symptom status and quality of life. The reported savings ranged from $1300 to $7515 per patient per year. Conclusion Self-management programs targeted for patients with heart failure decrease overall hospital readmissions and readmissions for heart failure. PMID:17081306

Outcomes of endodontic therapy in general practice

PubMed Central

Bernstein, Susan D.; Horowitz, Allan J.; Man, Martin; Wu, Hongyu; Foran, Denise; Vena, Donald A.; Collie, Damon; Matthews, Abigail G.; Curro, Frederick A.; Thompson, Van P.; Craig, Ronald G.

2014-01-01

Background The authors undertook a study involving members of a dental practice-based research network to determine the outcome and factors associated with success and failure of endodontic therapy. Methods Members in participating practices (practitioner-investigators [P-Is]) invited the enrollment of all patients seeking treatment in the practice who had undergone primary endodontic therapy and restoration in a permanent tooth three to five years previously. If a patient had more than one tooth so treated, the P-I selected as the index tooth the tooth treated earliest during the three- to five-year period. The authors excluded from the study any teeth that served as abutments for removable partial dentures or overdentures, third molars and teeth undergoing active orthodontic endodontic therapy. The primary outcome was retention of the index tooth. Secondary outcomes, in addition to extraction, that defined failure included clinical or radiographic evidence (or both) of periapical pathosis, endodontic retreatment or pain on percussion. Results P-Is in 64 network practices enrolled 1,312 patients with a mean (standard deviation) time to follow-up of 3.9 (0.6) years. During that period, 3.3 percent of the index teeth were extracted, 2.2 percent underwent retreatment, 3.6 percent had pain on percussion and 10.6 percent had periapical radiolucencies for a combined failure rate of 19.1 percent. The presence of preoperative periapical radiolucency with a diagnosis of either irreversible pulpitis or necrotic pulp was associated with failure after multivariate analysis, as were multiple canals, male sex and Hispanic/Latino ethnicity. Conclusions These results suggest that failure rates for endodontic therapy are higher than previously reported in general practices, according to results of studies based on dental insurance claims data. Clinical Implications The results of this study can help guide the practitioner in deciding the most appropriate course of therapy for teeth with irreversible pulpitis, necrotic pulp or periapical periodontitis. PMID:22547719

Clinical phenotypes and outcome of patients hospitalized for acute heart failure: the ESC Heart Failure Long-Term Registry.

PubMed

Chioncel, Ovidiu; Mebazaa, Alexandre; Harjola, Veli-Pekka; Coats, Andrew J; Piepoli, Massimo Francesco; Crespo-Leiro, Maria G; Laroche, Cecile; Seferovic, Petar M; Anker, Stefan D; Ferrari, Roberto; Ruschitzka, Frank; Lopez-Fernandez, Silvia; Miani, Daniela; Filippatos, Gerasimos; Maggioni, Aldo P

2017-10-01

To identify differences in clinical epidemiology, in-hospital management and 1-year outcomes among patients hospitalized for acute heart failure (AHF) and enrolled in the European Society of Cardiology Heart Failure Long-Term (ESC-HF-LT) Registry, stratified by clinical profile at admission. The ESC-HF-LT Registry is a prospective, observational study collecting hospitalization and 1-year follow-up data from 6629 AHF patients. Among AHF patients enrolled in the registry, 13.2% presented with pulmonary oedema (PO), 2.9% with cardiogenic shock (CS), 61.1% with decompensated heart failure (DHF), 4.8% with hypertensive heart failure (HT-HF), 3.5% with right heart failure (RHF) and 14.4% with AHF and associated acute coronary syndromes (ACS-HF). The 1-year mortality rate was 28.1% in PO, 54.0% in CS, 27.2% in DHF, 12.8% in HT-HF, 34.0% in RHF and 20.6% in ACS-HF patients. When patients were classified by systolic blood pressure (SBP) at initial presentation, 1-year mortality was 34.8% in patients with SBP <85 mmHg, 29.0% in those with SBP 85-110 mmHg, 21.2% in patients with SBP 110-140 mmHg and 17.4% in those with SBP >140 mmHg. These differences tended to diminish in the months post-discharge, and 1-year mortality for the patients who survived at least 6 months post-discharge did not vary significantly by either clinical profile or SBP classification. Rates of adverse outcomes in AHF remain high, and substantial differences have been found when patients were stratified by clinical profile or SBP. However, patients who survived at least 6 months post-discharge represent a more homogeneous group and their 1-year outcome is less influenced by clinical profile or SBP at admission. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

Tobacco use and outcome in radical prostatectomy patients.

PubMed

Curtis, Alexandra; Ondracek, Rochelle Payne; Murekeyisoni, Christine; Kauffman, Eric; Mohler, James; Marshall, James

2017-04-01

Cigarette smoking has been consistently associated with increased risk of overall mortality, but the importance of smoking for patients with prostate cancer (CaP) who are candidates for curative radical prostatectomy (RP) has received less attention. This retrospectively designed cohort study investigated the association of smoking history at RP with subsequent CaP treatment outcomes and overall mortality. A total of 1981 patients who underwent RP at Roswell Park Cancer Institute (RPCI) between 1993 and 2014 were studied. Smoking history was considered as a risk factor for overall mortality as well as for currently accepted CaP treatment outcomes (biochemical failure, treatment failure, distant metastasis, and disease-specific mortality). The associations of smoking status with these outcomes were tested by Cox proportional hazard analyses. A total of 153 (8%) patients died during follow-up. Current smoking at diagnosis was a statistically significant predictor of overall mortality after RP (current smokers vs. former and never smokers, hazards ratio 2.07, 95% confidence interval [CI]: 1.36-3.14). This association persisted for overall mortality at 3, 5, and 10 years (odds ratios 2.07 [95% CI: 1.36-3.15], 2.05 [95% CI: 1.35-3.12], and 1.8 [95% CI: 1.18-2.74], respectively). Smoking was not associated with biochemical failure, treatment failure, distant metastasis, or CaP-specific mortality, and the association of smoking with overall mortality did not appear to be functionally related to treatment or biochemical failure, or to distant metastasis. Smoking is a non-negligible risk factor for death among CaP patients who undergo RP; patients who smoke are far more likely to die of causes other than CaP. © 2017 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Obstetrical and neonatal outcomes following unsuccessful external cephalic version: a stratified analysis amongst failures, successes, and controls.

PubMed

Balayla, Jacques; Dahdouh, Elias M; Villeneuve, Sophie; Boucher, Marc; Gauthier, Robert J; Audibert, François; Fuchs, Florent

2015-03-01

Though on average one out of every two external cephalic versions (ECV) fails to rotate the breech fetus, little is known about the outcomes of pregnancies in which ECV is unsuccessful. The objective of the present study is to compare obstetrical and neonatal outcomes following failure of ECV, relative to cases of breech controls without an attempt at ECV. We conducted a retrospective, population-based, cohort study using the CDC's Birth Data files from the US for the year 2006. We stratified the cohort according to fetal presentation and ECV status: success, failure, and no ECV (controls). The effect of failure of ECV on the risk of several neonatal and obstetrical outcomes was estimated using logistic regression analysis, adjusting for relevant confounders. We analyzed a total of 4 273 225 births, out of which 183 323 (4.3%) met inclusion criteria. Relative to breech controls, failed ECV occurred more frequently amongst Caucasian, college-educated, married women bearing a female fetus. Compared to no ECV, failure of ECV was associated with increased odds of PROM (aOR, 1.75; 95% CI, 1.60-1.90), elective cesarean delivery (aOR, 1.53; 95% CI, 1.36-1.72), cesarean delivery in labor (aOR, 1.38; 95% CI, 1.21-1.57), abnormal fetal heart tracing (aOR, 1.78; 95% CI, 1.50-2.11), assisted ventilation at birth (aOR, 1.50; 95% CI, 1.27-1.78), 5-min APGAR scores <7 (aOR, 1.35; 95% CI, 1.20-1.51), and NICU admission (aOR, 1.48; 95% CI, 1.20-1.82). The delayed spontaneous fetal restitution rate was 13%. When stratifying controls with regards to trial of labor status, the increased risk of failed ECV persisted for cesarean delivery, NICU admission, assisted ventilation and abnormal fetal tracing, independently of whether a trial of labor took place. Relative to breech controls without attempt at ECV, failure of ECV to restitute cephalic presentation appears to be associated with an increased risk of adverse perinatal and obstetrical outcomes.

Cardiorenal Syndrome: New Developments in the Understanding and Pharmacologic Management

PubMed Central

2013-01-01

Summary Cardiorenal syndromes (CRSs) with bidirectional heart-kidney signaling are increasingly being recognized for their association with increased morbidity and mortality. In acute CRS, recognition of the importance of worsening kidney function complicating management of acute decompensated heart failure has led to the examination of this specific outcome in the context of acute heart failure clinical trials. In particular, the role of fluid overload and venous congestion has focused interest in the most effective use of diuretic therapy to relieve symptoms of heart failure while at the same time preserving kidney function. Additionally, many novel vasoactive therapies have been studied in recent years with the hopes of augmenting cardiac function, improving symptoms and patient outcomes, while maintaining or improving kidney function. Similarly, recent advances in our understanding of the pathophysiology of chronic CRS have led to reanalysis of kidney outcomes in pivotal trials in chronic congestive heart failure, and newer trials are including changes in kidney function as well as kidney injury biomarkers as prospectively monitored and adjudicated outcomes. This paper provides an overview of some new developments in the pharmacologic management of acute and chronic CRS, examines several reports that illustrate a key management principle for each subtype, and discusses opportunities for future research. PMID:23929925

The Vascular Marker Soluble Fms-like Tyrosine Kinase 1 is Associated with Disease Severity and Adverse Outcomes in Chronic Heart Failure

PubMed Central

Ky, Bonnie; French, Benjamin; Ruparel, Kosha; Sweitzer, Nancy K.; Fang, James C.; Levy, Wayne C.; Sawyer, Douglas B.; Cappola, Thomas P.

2011-01-01

Objectives We sought to evaluate placental growth factor (PlGF) and soluble fms-like tyrosine kinase 1 (sFlt-1) as clinical biomarkers in chronic heart failure (HF). Background Vascular remodeling is a crucial compensatory mechanism in chronic HF. The angiogenic ligand PlGF and its target receptor fms-like tyrosine kinase 1 (Flt-1) modulate vascular growth and function, but their relevance in human HF is undefined. Methods We measured plasma PlGF and sFlt-1 in 1,403 patients from the Penn Heart Failure Study, a multi-center cohort of chronic systolic HF. Subjects were followed for death, cardiac transplantation, or ventricular assist device placement over a median follow-up of 2 years. Results sFlt-1 was independently associated with measures of HF severity, including NYHA Class (p<0.01) and BNP (p<0.01). Patients in the 4th quartile of sFlt-1 (>379pg/ml) had a 6.17-fold increased risk of adverse outcomes (p<0.01). This association was robust, even after adjustment for the Seattle Failure Model (HR 2.54, 95%CI 1.76–2.27, p<0.01) and clinical confounders including heart failure etiology (HR 1.67, 95%CI 1.06–2.63, p=0.03). Combined assessment of sFlt-1 and BNP exhibited high predictive accuracy at 1-year (AUC 0.791, 95%CI 0.752–0.831), that was greater than either marker alone (p<0.01 and p=0.03, respectively). In contrast, PlGF was not an independent marker of disease severity or outcomes. Conclusions Our findings support a role for sFlt-1 in the biology of human heart failure. With additional study, circulating sFlt-1 may emerge as a clinically useful biomarker to assess the influence of vascular remodeling on clinical outcomes. PMID:21757116

Beta-Blockers (Carvedilol) in Children with Systemic Ventricle Systolic Dysfunction - Systematic Review and Meta-Analysis.

PubMed

Prijic, Sergej; Buchhorn, Reiner; Kosutic, Jovan; Vukomanovic, Vladislav; Prijic, Andreja; Bjelakovic, Bojko; Zdravkovic, Marija

2014-01-01

Numerous prospective randomized clinical trials demonstrated favorable effect of beta-blockers in adults with chronic heart failure. However, effectiveness of beta blockers in pediatric patients with systemic ventricle systolic dysfunction was not recognized sufficiently. Limited number of pediatric patients might be the course of unrecognized carvediolol treatment benefit. Currently, no meta-analysis has examined the impact of carvedilol and conventional therapy on the clinical outcome in children with chronic heart failure due to impaired systemic ventricle systolic function. We have systematically searched the Medline/PubMed and Cochrane Library for the controlled clinical trials that examine carvedilol and standard treatment efficacy in pediatric patients with systemic ventricle systolic dysfunction. Mean differences for continuous variables, odds ratios for dichotomous outcomes, heterogeneity between studies and publication bias were calculated using Cochrane Review Manager (Rev Man 5.2). Total of 8 prospective/observational studies met established criteria. Odds ratio for chronic heart failure related mortality/heart transplantation secondary to carvedilol was 0.52 (95% CI: 0.28-0.97, I(2) = 0%). Our analysis showed that carvedilol could prevent 1 death/ heart transplantation by treating 14 pediatric patients with impaired systemic ventricle systolic function. Meta-analysis demonstrated clinical outcome benefit of carvedilol in children with chronic heart failure.

Enriching the hierarchical model of achievement motivation: autonomous and controlling reasons underlying achievement goals.

PubMed

Michou, Aikaterini; Vansteenkiste, Maarten; Mouratidis, Athanasios; Lens, Willy

2014-12-01

The hierarchical model of achievement motivation presumes that achievement goals channel the achievement motives of need for achievement and fear of failure towards motivational outcomes. Yet, less is known whether autonomous and controlling reasons underlying the pursuit of achievement goals can serve as additional pathways between achievement motives and outcomes. We tested whether mastery approach, performance approach, and performance avoidance goals and their underlying autonomous and controlling reasons would jointly explain the relation between achievement motives (i.e., fear of failure and need for achievement) and learning strategies (Study 1). Additionally, we examined whether the autonomous and controlling reasons underlying learners' dominant achievement goal would account for the link between achievement motives and the educational outcomes of learning strategies and cheating (Study 2). Six hundred and six Greek adolescent students (Mage = 15.05, SD = 1.43) and 435 university students (Mage M = 20.51, SD = 2.80) participated in studies 1 and 2, respectively. In both studies, a correlational design was used and the hypotheses were tested via path modelling. Autonomous and controlling reasons underlying the pursuit of achievement goals mediated, respectively, the relation of need for achievement and fear of failure to aspects of learning outcomes. Autonomous and controlling reasons underlying achievement goals could further explain learners' functioning in achievement settings. © 2014 The British Psychological Society.

Collaborative palliative care for advanced heart failure: outcomes and costs from the 'Better Together' pilot study.

PubMed

Pattenden, Jill F; Mason, Anne R; Lewin, R J P

2013-03-01

Patients with heart failure often receive little supportive or palliative care. 'Better Together' was a 2-year pilot study of a palliative care service for patients with advanced congestive heart failure (CHF). To determine if the intervention made it more likely that patients would be cared for and die in their place of choice, and to investigate its cost-effectiveness. This pragmatic non-randomised pilot evaluation was set in two English primary care trusts (Bradford and Poole). Prospective patient-level data on outcomes and costs were compared with data from a historical control group of clinically comparable patients. Outcomes included death in preferred place of care (available only for the intervention group) and 'hospital admissions averted'. Costs included medical procedures, inpatient care and the direct cost of providing the intervention. 99 patients were referred. Median survival from referral was 48 days in Bradford and 31 days in Poole. Most patients who died did so in their preferred place of death (Bradford 70%, Poole 77%). An estimated 14 and 18 hospital admissions for heart failure were averted in Bradford and Poole, respectively. The average cost-per-heart failure admission averted was £1529 in Bradford, but the intervention was cost saving in Poole. However, there was considerable uncertainty around these cost-effectiveness estimates. This pilot study provides tentative evidence that a collaborative home-based palliative care service for patients with advanced CHF may increase the likelihood of death in place of choice and reduce inpatient admissions. These findings require confirmation using a more robust methodological framework.

What factors determine the severity of hepatitis A-related acute liver failure?

PubMed

Ajmera, V; Xia, G; Vaughan, G; Forbi, J C; Ganova-Raeva, L M; Khudyakov, Y; Opio, C K; Taylor, R; Restrepo, R; Munoz, S; Fontana, R J; Lee, W M

2011-07-01

The reason(s) that hepatitis A virus (HAV) infection may progress infrequently to acute liver failure are poorly understood. We examined host and viral factors in 29 consecutive adult patients with HAV-associated acute liver failure enrolled at 10 sites participating in the US ALF Study Group. Eighteen of twenty-four acute liver failure sera were PCR positive while six had no detectable virus. HAV genotype was determined using phylogenetic analysis and the full-length genome sequences of the HAV from a cute liver failure sera were compared to those from self-limited acute HAV cases selected from the CDC database. We found that rates of nucleotide substitution did not vary significantly between the liver failure and non-liver failure cases and there was no significant variation in amino acid sequences between the two groups. Four of 18 HAV isolates were sub-genotype IB, acquired from the same study site over a 3.5-year period. Sub-genotype IB was found more frequently among acute liver failure cases compared to the non-liver failure cases (chi-square test, P < 0.01). At another centre, a mother and her son presented with HAV and liver failure within 1 month of each other. Predictors of spontaneous survival included detectable serum HAV RNA, while age, gender, HAV genotype and nucleotide substitutions were not associated with outcome. The more frequent appearance of rapid viral clearance and its association with poor outcomes in acute liver failure as well as the finding of familial cases imply a possible host genetic predisposition that contributes to a fulminant course. Recurrent cases of the rare sub-genotype IB over several years at a single centre imply a community reservoir of infection and possible increased pathogenicity of certain infrequent viral genotypes. © 2010 Blackwell Publishing Ltd.

What factors determine the severity of hepatitis A-related acute liver failure?

PubMed Central

Ajmera, V.; Xia, G.; Vaughan, G.; Forbi, J. C.; Ganova-Raeva, L. M.; Khudyakov, Y.; Opio, C. K.; Taylor, R.; Restrepo, R.; Munoz, S.; Fontana, R. J.; Lee, W. M.

2016-01-01

SUMMARY The reason(s) that hepatitis A virus (HAV) infection may progress infrequently to acute liver failure are poorly understood. We examined host and viral factors in 29 consecutive adult patients with HAV-associated acute liver failure enrolled at 10 sites participating in the US ALF Study Group. Eighteen of twenty-four acute liver failure sera were PCR positive while six had no detectable virus. HAV genotype was determined using phylogenetic analysis and the full-length genome sequences of the HAV from a cute liver failure sera were compared to those from self-limited acute HAV cases selected from the CDC database. We found that rates of nucleotide substitution did not vary significantly between the liver failure and non-liver failure cases and there was no significant variation in amino acid sequences between the two groups. Four of 18 HAV isolates were subgenotype IB, acquired from the same study site over a 3.5-year period. Sub-genotype IB was found more frequently among acute liver failure cases compared to the non-liver failure cases (chi-square test, P < 0.01). At another centre, a mother and her son presented with HAV and liver failure within 1 month of each other. Predictors of spontaneous survival included detectable serum HAV RNA, while age, gender, HAV genotype and nucleotide substitutions were not associated with outcome. The more frequent appearance of rapid viral clearance and its association with poor outcomes in acute liver failure as well as the finding of familial cases imply a possible host genetic predisposition that contributes to a fulminant course. Recurrent cases of the rare subgenotype IB over several years at a single centre imply a community reservoir of infection and possible increased pathogenicity of certain infrequent viral genotypes. PMID:21143345

Implications of Infliximab Treatment Failure and Influence of Personalized Treatment on Patient-reported Health-related Quality of Life and Productivity Outcomes in Crohn's Disease.

PubMed

Steenholdt, Casper; Brynskov, Jørn; Thomsen, Ole Ø; Munck, Lars K; Christensen, Lisbet A; Pedersen, Gitte; Kjeldsen, Jens; Ainsworth, Mark A

2015-11-01

This study assessed the effects of infliximab (IFX) treatment failure on patient-reported outcomes and explored the influence of using personalized treatment in this situation. Sixty-nine Crohn's disease patients with IFX treatment failure were randomized to an intensified IFX regimen (n = 36) or personalized treatment defined by IFX and anti-IFX antibodies (n = 33). Health-related quality of life evaluated with the Short Inflammatory Bowel Disease Questionnaire (IBDQ) and productivity evaluated with the Work Productivity and Activity Impairment Questionnaire (WPAI:CD) were assessed at treatment failure and after 4, 8, 12 and 20 weeks. Median IBDQ score at manifestation of IFX treatment failure was 40 and improved markedly in responders by 11 at weeks 4 and 8 (p < 0.001) and by 13 at weeks 12 and 20 (p < 0.001). Non-responders improved modestly at weeks 12 and 20 (increase of median 4, p < 0.05). Overall activity impairment was high at IFX failure (median 70%) and decreased substantially in responders (40-50%, p < 0.001) and to a lesser extent in non-responders (15-40%, p < 0.05). In employed patients (55%), absenteeism was negligible during the entire study period. However, median presenteeism was 40% at manifestation of IFX failure and decreased only among responders across time (decrease 10-30%, p < 0.05). Although anti-tumour necrosis factor (TNF) therapy was discontinued in most patients handled by personalized treatment, IBDQ and WPAI:CD scores were similar in these patients compared with patients routinely dose-intensified on IFX. Regaining low disease activity after IFX failure is necessary for minimizing patient impairment and indirect disease-related costs. A personalized treatment strategy does not have a negative influence on patient-reported outcomes. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Survival analysis for respiratory failure in patients with food-borne botulism.

PubMed

Witoonpanich, Rawiphan; Vichayanrat, Ekawat; Tantisiriwit, Kanit; Wongtanate, Manas; Sucharitchan, Niwatchai; Oranrigsupak, Petchdee; Chuesuwan, Aphinya; Nakarawat, Weeraworn; Tima, Ariya; Suwatcharangkoon, Sureerat; Ingsathit, Atiporn; Rattanasiri, Sasivimol; Wananukul, Winai

2010-03-01

Botulism is a rare presynaptic neuromuscular junction disorder caused by potent toxins produced by the anaerobic, spore-forming, Gram-positive bacterium Clostridium botulinum. Food-borne botulism is caused by the ingestion of foods contaminated with botulinum toxin. In March 2006, there was a large outbreak of food-borne botulism associated with the ingestion of home-canned bamboo shoots in Thailand. The survival analyses for respiratory failure in these patients were studied and are reported here. A prospective observational cohort study was conducted on this outbreak. The primary outcome of interest was the time to respiratory failure. The secondary outcome was the time to weaning off ventilator. The prognostic factors associated with respiratory failure and weaning off ventilator are presented. A total of 91 in-patients with baseline clinical characteristics were included. Most cases first presented with gastrointestinal symptoms followed by neurological symptoms, the most striking of which being difficulty in swallowing. Common clinical features included ptosis, ophthalmoplegia, proximal muscle weakness, pupillary abnormality, and respiratory failure. Forty-two patients developed respiratory failure requiring mechanical ventilation and the median duration on ventilator was 14 days. The median length of hospital stay for all patients was 13.5 days. Difficulty in breathing, moderate to severe ptosis, and dilated and fixed pupils were associated with respiratory failure. Among patients who were on ventilators, a short incubation period and pupillary abnormality were associated with a longer period of mechanical ventilation. All patients had antitoxin injection and there was no mortality in this outbreak. The history of difficult breathing and the findings of moderate to severe ptosis and pupillary abnormality were associated with severe illness and respiratory failure. A long incubation time was associated with a better prognosis. Although botulism is a potentially fatal disease, there was no mortality in this outbreak. All patients had antitoxin injection and good intensive care that resulted in good clinical outcomes.

Serum Uromodulin: A Biomarker of Long-Term Kidney Allograft Failure.

PubMed

Bostom, Andrew; Steubl, Dominik; Garimella, Pranav S; Franceschini, Nora; Roberts, Mary B; Pasch, Andreas; Ix, Joachim H; Tuttle, Katherine R; Ivanova, Anastasia; Shireman, Theresa; Kim, S Joseph; Gohh, Reginald; Weiner, Daniel E; Levey, Andrew S; Hsu, Chi-Yuan; Kusek, John W; Eaton, Charles B

2018-01-01

Uromodulin is a kidney-derived glycoprotein and putative tubular function index. Lower serum uromodulin was recently associated with increased risk for kidney allograft failure in a preliminary, longitudinal single-center -European study involving 91 kidney transplant recipients (KTRs). The Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) trial is a completed, large, multiethnic controlled clinical trial cohort, which studied chronic, stable KTRs. We conducted a case cohort analysis using a randomly selected subset of patients (random subcohort, n = 433), and all individuals who developed kidney allograft failure (cases, n = 226) during follow-up. Serum uromodulin was determined in this total of n = 613 FAVORIT trial participants at randomization. Death-censored kidney allograft failure was the study outcome. The 226 kidney allograft failures occurred during a median surveillance of 3.2 years. Unadjusted, weighted Cox proportional hazards modeling revealed that lower serum uromodulin, tertile 1 vs. tertile 3, was associated with a threefold greater risk for kidney allograft failure (hazards ratio [HR], 95% CI 3.20 [2.05-5.01]). This association was attenuated but persisted at twofold greater risk for allograft failure, after adjustment for age, sex, smoking, allograft type and vintage, prevalent diabetes mellitus and cardiovascular disease (CVD), total/high-density lipoprotein cholesterol ratio, systolic blood pressure, estimated glomerular filtration rate, and natural log urinary albumin/creatinine: HR 2.00, 95% CI (1.06-3.77). Lower serum uromodulin, a possible indicator of less well-preserved renal tubular function, remained associated with greater risk for kidney allograft failure, after adjustment for major, established clinical kidney allograft failure and CVD risk factors, in a large, multiethnic cohort of long-term, stable KTRs. © 2018 S. Karger AG, Basel.

Effective technologies for noninvasive remote monitoring in heart failure.

PubMed

Conway, Aaron; Inglis, Sally C; Clark, Robyn A

2014-06-01

Trials of new technologies to remotely monitor for signs and symptoms of worsening heart failure are continually emerging. The extent to which technological differences impact the effectiveness of noninvasive remote monitoring for heart failure management is unknown. This study examined the effect of specific technology used for noninvasive remote monitoring of people with heart failure on all-cause mortality and heart failure-related hospitalizations. A subanalysis of a large systematic review and meta-analysis was conducted. Studies were stratified according to the specific type of technology used, and separate meta-analyses were performed. Four different types of noninvasive remote monitoring technologies were identified, including structured telephone calls, videophone, interactive voice response devices, and telemonitoring. Only structured telephone calls and telemonitoring were effective in reducing the risk of all-cause mortality (relative risk [RR]=0.87; 95% confidence interval [CI], 0.75-1.01; p=0.06; and RR=0.62; 95% CI, 0.50-0.77; p<0.0001, respectively) and heart failure-related hospitalizations (RR=0.77; 95% CI, 0.68-0.87; p<0.001; and RR=0.75; 95% CI, 0.63-0.91; p=0.003, respectively). More research data are required for videophone and interactive voice response technologies. This subanalysis identified that only two of the four specific technologies used for noninvasive remote monitoring in heart failure improved outcomes. When results of studies that involved these disparate technologies were combined in previous meta-analyses, significant improvements in outcomes were identified. As such, this study has highlighted implications for future meta-analyses of randomized controlled trials focused on evaluating the effectiveness of remote monitoring in heart failure.

Automatic Tube Compensation versus Pressure Support Ventilation and Extubation Outcome in Children: A Randomized Controlled Study

PubMed Central

El-beleidy, Ahmed Saad El-din; Khattab, Asser Abd EL-Hamied; El-Sherbini, Seham Awad; Al-gebaly, Hebatalla Fadel

2013-01-01

Background. Automatic tube compensation (ATC) has been developed to overcome the imposed work of breathing due to artificial airways during spontaneous breathing trials (SBTs). Objectives. This study aimed to assess extubation outcome after an SBT (spontaneous breathing trial) with ATC compared with pressure support ventilation (PSV) and to determine the risk factors for extubation failure. Methods. Patients ready for extubation were randomly assigned to two-hour spontaneous breathing trial with either ATC or pressure support ventilation. Results. In the ATC group (n = 17), 11 (65%) patients passed the SBT with subsequent extubation failure (9%). While in PSV group (n = 19), 10 (53%) patients passed the SBT with subsequent extubation failure (10%). This represented a positive predictive value for ATC of 91% and PSV of 90% (P = 0.52). Five (83%) of the patients who failed the SBT in ATC group were reintubated. This represented a higher negative predictive value for ATC of 83% than for PSV which was 56%. None of the assessed risk factors were independently associated with extubation failure including failed trial. Conclusion. ATC was equivalent to PSV in predicting patients with successful extubation. A trial failure in ATC group is associated with but does not definitely predict extubation failure. PMID:23533800

Factors associated with sealant outcome in 2 pediatric dental clinics: a multivariate hierarchical analysis.

PubMed

West, Nathan G; Ilief-Ala, Melina A; Douglass, Joanna M; Hagadorn, James I

2011-01-01

This study's purpose was to determine whether one-time sealants placed by pediatric dental residents vs dental students have different outcomes. The effect of isolation technique, behavior, duration of follow-up, and caries history was also examined. Records from 2 inner-city pediatric dental clinics were audited for 6- to 10-year-old patients with a permanent first molar sealant with at least 2 years of follow-up. A successful sealant was a one-time sealant that received no further treatment and was sealed or unsealed but not carious or restored at the final audit. Charts from 203 children with 481 sealants were audited. Of these, 281 sealants were failures. Univariate analysis revealed longer follow-up and younger age were associated with sealant failure. Operator type, child behavior, and isolation technique were not associated with sealant failure. After adjusting for follow-up duration, increased age at treatment reduced the odds of sealant failure while a history of caries reduced the protective effect of increased age. After adjusting for these factors, practitioner type, behavior, and type of isolation were not associated with sealant outcome in multivariate analysis. Age at sealant placement, history of caries prior to placement, and longer duration of follow-up are associated with sealant failure.

Reporting outcomes of definitive radiation-based treatment for esophageal cancer: a review of the literature.

PubMed

Main, B G; Strong, S; McNair, A G; Falk, S J; Crosby, T; Blazeby, J M

2015-01-01

Accurate evaluation of radical radiotherapy requires well designed research with valid and appropriate outcomes. This study reviewed standards of outcome reporting and study design in randomized controlled trials (RCTs) of radiation-based therapy for esophageal cancer and made recommendations for future work. Randomized controlled trials reporting outcomes of definitive radiation-based treatment alone or in combination with chemotherapy were systematically identified and summarized. The types, frequency, and definitions of all clinical and patient-reported outcomes (PROs) reported in the methods and results sections of papers were examined. Studies providing a definition for at least one outcome and presenting all outcomes reported in the methods were classified as high quality. From 1425 abstracts, 16 RCTs including 1803 patients were identified. The primary outcome was overall survival in 13 studies, but five different definitions were reported. Outcomes for treatment failure included local, regional, and distant failures, and inconsistent definitions were applied. An observer assessment of dysphagia was reported in seven RCTs but PROs were reported in only one. Only three RCTs were at low risk of bias, with all lacking reports of sequence generation and only a minority reporting allocation concealment. The quality of outcome reporting in RCTs was inconsistent and risked bias. A core outcome set including clinical and PROs is needed to improve reporting of trials of definitive radiation-based treatment for esophageal cancer. © 2014 International Society for Diseases of the Esophagus.

Psychological distress and in vitro fertilization outcome.

PubMed

Pasch, Lauri A; Gregorich, Steven E; Katz, Patricia K; Millstein, Susan G; Nachtigall, Robert D; Bleil, Maria E; Adler, Nancy E

2012-08-01

To examine whether psychological distress predicts IVF treatment outcome as well as whether IVF treatment outcome predicts subsequent psychological distress. Prospective cohort study over an 18-month period. Five community and academic fertility practices. Two hundred two women who initiated their first IVF cycle. Women completed interviews and questionnaires at baseline and at 4, 10, and 18 months' follow-up. IVF cycle outcome and psychological distress. In a binary logistic model including covariates (woman's age, ethnicity, income, education, parity, duration of infertility, and time interval), pretreatment depression and anxiety were not significant predictors of the outcome of the first IVF cycle. In linear regression models including covariates (woman's age, income, education, parity, duration of infertility, assessment point, time since last treatment cycle, and pre-IVF depression or anxiety), experiencing failed IVF was associated with higher post-IVF depression and anxiety. IVF failure predicts subsequent psychological distress, but pre-IVF psychological distress does not predict IVF failure. Instead of focusing efforts on psychological interventions specifically aimed at improving the chance of pregnancy, these findings suggest that attention be paid to helping patients prepare for and cope with treatment and treatment failure. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Riser Pattern Is a Novel Predictor of Adverse Events in Heart Failure Patients With Preserved Ejection Fraction.

PubMed

Komori, Takahiro; Eguchi, Kazuo; Saito, Toshinobu; Hoshide, Satoshi; Kario, Kazuomi

2017-01-25

The cardiovascular prognosis of heart failure with preserved ejection fraction (HFpEF) has been shown to be similar to that of heart failure with reduced ejection fraction (HFrEF). It is unknown which factors predict cardiovascular outcome in HFpEF. We tested the hypothesis that the abnormal pattern of circadian blood pressure (BP) rhythm known as the riser BP pattern is associated with adverse outcomes in HFpEF.Methods and Results:We performed a prospective, observational cohort study of hospitalized HF patients who underwent ambulatory BP monitoring (ABPM). Five hundred and sixteen hospitalized HF patients (age, 69±13 years; male, n=321 [62%]; female, n=195 [38%]) were followed up for a median 20.9 months. The composite outcome consisting of all-cause mortality and cardiovascular events was observed in 220 patients. On Kaplan-Meier analysis, the riser BP pattern subgroup had a significantly higher incidence of the composite outcome than the other subgroups of HFpEF patients (HR, 3.01; 95% CI: 1.54-6.08, P<0.01), but not the HFrEF patients. The riser BP pattern was found to be a novel predictor of cardiovascular outcome in HFpEF patients.

Individual patient data meta-analysis of organ failure in acute pancreatitis: protocol of the PANCREA II study.

PubMed

Das, Stephanie L M; Papachristou, George I; De Campos, Tercio; Panek, Jozefa; Poves Prim, Ignasi; Serrablo, Alejandro; Parks, Rowan W; Uomo, Generoso; Windsor, John A; Petrov, Maxim S

2013-09-10

Organ failure is a major determinant of mortality in patients with acute pancreatitis. These patients usually require admission to high dependency or intensive care units and consume considerable health care resources. Given a low incidence rate of organ failure and a lack of large non-interventional studies in the field of acute pancreatitis, the characteristics of organ failure that influence outcomes of patients with acute pancreatitis remain largely unknown. Therefore, the Pancreatitis Across Nations Clinical Research and Education Alliance (PANCREA) aims to conduct a meta-analysis of individual patient data from prospective non-interventional studies to determine the influence of timing, duration, sequence, and combination of different organ failures on mortality in patients with acute pancreatitis. Pancreatologists currently active with acute pancreatitis clinical research will be invited to contribute. To be eligible for inclusion patients will have to meet the criteria of acute pancreatitis, develop at least one organ failure during the first week of hospitalization, and not be enrolled into an intervention study. Raw data will then be collated and checked. Individual patient data analysis based on a logistic regression model with adjustment for confounding variables will be done. For all analyses, corresponding 95% confidence intervals and P values will be reported. This collaborative individual patient data meta-analysis will answer important clinical questions regarding patients with acute pancreatitis that develop organ failure. Information derived from this study will be used to optimize routine clinical management and improve care strategies. It can also help validate outcome definitions, allow comparability of results and form a more accurate basis for patient allocation in further clinical studies.

Disease management: remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors.

PubMed

Abraham, William T

2013-06-01

Heart failure represents a major public health concern, associated with high rates of morbidity and mortality. A particular focus of contemporary heart failure management is reduction of hospital admission and readmission rates. While optimal medical therapy favourably impacts the natural history of the disease, devices such as cardiac resynchronization therapy devices and implantable cardioverter defibrillators have added incremental value in improving heart failure outcomes. These devices also enable remote patient monitoring via device-based diagnostics. Device-based measurement of physiological parameters, such as intrathoracic impedance and heart rate variability, provide a means to assess risk of worsening heart failure and the possibility of future hospitalization. Beyond this capability, implantable haemodynamic monitors have the potential to direct day-to-day management of heart failure patients to significantly reduce hospitalization rates. The use of a pulmonary artery pressure measurement system has been shown to significantly reduce the risk of heart failure hospitalization in a large randomized controlled study, the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial. Observations from a pilot study also support the potential use of a left atrial pressure monitoring system and physician-directed patient self-management paradigm; these observations are under further investigation in the ongoing LAPTOP-HF trial. All these devices depend upon high-intensity remote monitoring for successful detection of parameter deviations and for directing and following therapy.

Association of HIV diversity and virologic outcomes in early antiretroviral treatment: HPTN 052.

PubMed

Palumbo, Philip J; Wilson, Ethan A; Piwowar-Manning, Estelle; McCauley, Marybeth; Gamble, Theresa; Kumwenda, Newton; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James G; Hosseinipour, Mina C; Melo, Marineide G; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H; Fogel, Jessica M

2017-01-01

Higher HIV diversity has been associated with virologic outcomes in children on antiretroviral treatment (ART). We examined the association of HIV diversity with virologic outcomes in adults from the HPTN 052 trial who initiated ART at CD4 cell counts of 350-550 cells/mm3. A high resolution melting (HRM) assay was used to analyze baseline (pre-treatment) HIV diversity in six regions in the HIV genome (two in gag, one in pol, and three in env) from 95 participants who failed ART. We analyzed the association of HIV diversity in each genomic region with baseline (pre-treatment) factors and three clinical outcomes: time to virologic suppression after ART initiation, time to ART failure, and emergence of HIV drug resistance at ART failure. After correcting for multiple comparisons, we did not find any association of baseline HIV diversity with demographic, laboratory, or clinical characteristics. For the 18 analyses performed for clinical outcomes evaluated, there was only one significant association: higher baseline HIV diversity in one of the three HIV env regions was associated with longer time to ART failure (p = 0.008). The HRM diversity assay may be useful in future studies exploring the relationship between HIV diversity and clinical outcomes in individuals with HIV infection.

Machine Learning Algorithm Predicts Cardiac Resynchronization Therapy Outcomes: Lessons From the COMPANION Trial.

PubMed

Kalscheur, Matthew M; Kipp, Ryan T; Tattersall, Matthew C; Mei, Chaoqun; Buhr, Kevin A; DeMets, David L; Field, Michael E; Eckhardt, Lee L; Page, C David

2018-01-01

Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in heart failure patients with reduced left ventricular function and intraventricular conduction delay. However, individual outcomes vary significantly. This study sought to use a machine learning algorithm to develop a model to predict outcomes after CRT. Models were developed with machine learning algorithms to predict all-cause mortality or heart failure hospitalization at 12 months post-CRT in the COMPANION trial (Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure). The best performing model was developed with the random forest algorithm. The ability of this model to predict all-cause mortality or heart failure hospitalization and all-cause mortality alone was compared with discrimination obtained using a combination of bundle branch block morphology and QRS duration. In the 595 patients with CRT-defibrillator in the COMPANION trial, 105 deaths occurred (median follow-up, 15.7 months). The survival difference across subgroups differentiated by bundle branch block morphology and QRS duration did not reach significance ( P =0.08). The random forest model produced quartiles of patients with an 8-fold difference in survival between those with the highest and lowest predicted probability for events (hazard ratio, 7.96; P <0.0001). The model also discriminated the risk of the composite end point of all-cause mortality or heart failure hospitalization better than subgroups based on bundle branch block morphology and QRS duration. In the COMPANION trial, a machine learning algorithm produced a model that predicted clinical outcomes after CRT. Applied before device implant, this model may better differentiate outcomes over current clinical discriminators and improve shared decision-making with patients. © 2018 American Heart Association, Inc.

Improving the prognosis of patients with severely decreased glomerular filtration rate (CKD G4+): conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference.

PubMed

Eckardt, Kai-Uwe; Bansal, Nisha; Coresh, Josef; Evans, Marie; Grams, Morgan E; Herzog, Charles A; James, Matthew T; Heerspink, Hiddo J L; Pollock, Carol A; Stevens, Paul E; Tamura, Manjula Kurella; Tonelli, Marcello A; Wheeler, David C; Winkelmayer, Wolfgang C; Cheung, Michael; Hemmelgarn, Brenda R

2018-06-01

Patients with severely decreased glomerular filtration rate (GFR) (i.e., chronic kidney disease [CKD] G4+) are at increased risk for kidney failure, cardiovascular disease (CVD) events (including heart failure), and death. However, little is known about the variability of outcomes and optimal therapeutic strategies, including initiation of kidney replacement therapy (KRT). Kidney Disease: Improving Global Outcomes (KDIGO) organized a Controversies Conference with an international expert group in December 2016 to address this gap in knowledge. In collaboration with the CKD Prognosis Consortium (CKD-PC) a global meta-analysis of cohort studies (n = 264,515 individuals with CKD G4+) was conducted to better understand the timing of clinical outcomes in patients with CKD G4+ and risk factors for different outcomes. The results confirmed the prognostic value of traditional CVD risk factors in individuals with severely decreased GFR, although the risk estimates vary for kidney and CVD outcomes. A 2- and 4-year model of the probability and timing of kidney failure requiring KRT was also developed. The implications of these findings for patient management were discussed in the context of published evidence under 4 key themes: management of CKD G4+, diagnostic and therapeutic challenges of heart failure, shared decision-making, and optimization of clinical trials in CKD G4+ patients. Participants concluded that variable prognosis of patients with advanced CKD mandates individualized, risk-based management, factoring in competing risks and patient preferences. Copyright © 2018 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

Hospital delivery volume, severe obstetrical morbidity, and failure to rescue.

PubMed

Friedman, Alexander M; Ananth, Cande V; Huang, Yongmei; D'Alton, Mary E; Wright, Jason D

2016-12-01

In the setting of persistently high risk for maternal death and severe obstetric morbidity, little is known about the relationship between hospital delivery volume and maternal outcomes. The objectives of this analysis were (1) to determine maternal risk for severe morbidity during delivery hospitalizations by hospital delivery volume in the United States and (2) to characterize, by hospital volume, the risk for death in the setting of severe obstetric morbidity, a concept known as failure to rescue. This cohort study evaluated 50,433,539 delivery hospitalizations across the United States from 1998-2010. The main outcome measures were (1) severe morbidity that was defined as a composite of any 1 of 15 diagnoses that are representative of acute organ injury and critical illness and (2) failure to rescue that was defined as death in the setting of severe morbidity. The prevalence of severe morbidity rose from 471.2-751.5 cases per 100,000 deliveries from 1998-2010, which was an increase of 59.5%. Failure to rescue was highest in 1998 (1.5%), decreased to 0.6% in 2007, and rose to 0.9% in 2010. In models that were adjusted for comorbid risk and hospital factors, both low and high annualized delivery volume were associated with increased risk for failure to rescue and severe morbidity. However, the relative importance of hospital volume for both outcomes compared with other factors was relatively small. Although low-and high-delivery volume are associated with increased risk for both failure to rescue and severe maternal morbidity, other factors, in particular characteristics of individual centers, may be more important in the determination of outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Outcome of High-Risk Myelodysplastic Syndrome After Azacitidine Treatment Failure

PubMed Central

Prébet, Thomas; Gore, Steven D.; Esterni, Benjamin; Gardin, Claude; Itzykson, Raphael; Thepot, Sylvain; Dreyfus, François; Rauzy, Odile Beyne; Recher, Christian; Adès, Lionel; Quesnel, Bruno; Beach, C.L.; Fenaux, Pierre; Vey, Norbert

2011-01-01

Purpose Azacitidine (AZA) is the current standard of care for high-risk (ie, International Prognostic Scoring System high or intermediate 2) myelodysplastic syndrome (MDS), but most patients will experience primary or secondary treatment failure. The outcome of these patients has not yet been described. Patients and Methods Overall, 435 patients with high-risk MDS and former refractory anemia with excess blasts in transformation (RAEB-T) were evaluated for outcome after AZA failure. The cohort of patients included four data sets (ie, AZA001, J9950, and J0443 trials and the French compassionate use program). Results The median follow-up after AZA failure was 15 months. The median overall survival was 5.6 months, and the 2-year survival probability was 15%. Increasing age, male sex, high-risk cytogenetics, higher bone marrow blast count, and the absence of prior hematologic response to AZA were associated with significantly worse survival in multivariate analysis. Data on treatment administered after AZA failure were available for 270 patients. Allogeneic stem-cell transplantation and investigational agents were associated with a better outcome when compared with conventional clinical care. Conclusion Outcome after AZA failure is poor. Our results should serve as a basis for designing second-line clinical trials in this population. PMID:21788559

A single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure.

PubMed

Wu, Jia-Rong; DeWalt, Darren A; Baker, David W; Schillinger, Dean; Ruo, Bernice; Bibbins-Domingo, Kristen; Macabasco-O'Connell, Aurelia; Holmes, George M; Broucksou, Kimberly A; Erman, Brian; Hawk, Victoria; Cene, Crystal W; Jones, Christine DeLong; Pignone, Michael

2014-09-01

To determine whether a single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure. Poor medication adherence is associated with increased morbidity and mortality. Having a simple means of identifying suboptimal medication adherence could help identify at-risk patients for interventions. We performed a prospective cohort study in 592 participants with heart failure within a four-site randomised trial. Self-report medication adherence was assessed at baseline using a single-item question: 'Over the past seven days, how many times did you miss a dose of any of your heart medication?' Participants who reported no missing doses were defined as fully adherent, and those missing more than one dose were considered less than fully adherent. The primary outcome was combined all-cause hospitalisation or death over one year and the secondary endpoint was heart failure hospitalisation. Outcomes were assessed with blinded chart reviews, and heart failure outcomes were determined by a blinded adjudication committee. We used negative binomial regression to examine the relationship between medication adherence and outcomes. Fifty-two percent of participants were 52% male, mean age was 61 years, and 31% were of New York Heart Association class III/IV at enrolment; 72% of participants reported full adherence to their heart medicine at baseline. Participants with full medication adherence had a lower rate of all-cause hospitalisation and death (0·71 events/year) compared with those with any nonadherence (0·86 events/year): adjusted-for-site incidence rate ratio was 0·83, fully adjusted incidence rate ratio 0·68. Incidence rate ratios were similar for heart failure hospitalisations. A single medication adherence question at baseline predicts hospitalisation and death over one year in heart failure patients. Medication adherence is associated with all-cause and heart failure-related hospitalisation and death in heart failure. It is important for clinicians to assess patients' medication adherence on a regular basis at their clinical follow-ups. © 2013 John Wiley & Sons Ltd.

Salvage Surgery after Radiation Failure in T1/T2 Larynx Cancer: Outcomes following Total versus Conservation Surgery.

PubMed

Cheraghlou, Shayan; Kuo, Phoebe; Mehra, Saral; Yarbrough, Wendell G; Judson, Benjamin L

2018-03-01

Objective After radiation failure for early T-stage larynx cancer, national guidelines recommend salvage surgery. Total laryngectomy and conservation laryngeal surgery with an open or endoscopic approach are both used. Beyond single-institution studies, there is a lack of evidence concerning the outcomes of these procedures. We aim to study whether treatment with conservation laryngeal surgery is associated with poorer outcomes than treatment with total laryngectomy as salvage surgery after radiation failure for T1/T2 larynx cancers. Study Design A retrospective study was conducted of adult squamous cell larynx cancer cases in the National Cancer Database diagnosed from 2004 to 2012. Setting Commission on Cancer cancer programs in the United States. Methods Demographic, facility, tumor, and survival variables were included in the analyses. Multivariate survival regressions as well as univariate Kaplan-Meier analyses were conducted. Results Slightly more than 7% of patients receiving radiotherapy for T1/T2 larynx cancers later received salvage surgery. Salvage with partial laryngectomy was not associated with diminished survival as compared with total laryngectomy. However, positive surgical margins were associated with worse outcomes (hazard ratio, 1.782; P = .001), and a larger percentage of patients receiving partial laryngectomy had positive margins than those receiving total laryngectomy. Facility characteristics were not associated with differences in salvage surgery type or outcomes. Conclusion In recognition of the inherent selection bias, patients who experienced recurrences after radiation for T1/T2 larynx cancer and underwent conservation salvage laryngeal surgery demonstrated clinical outcomes similar to those of patients undergoing salvage total laryngectomy. Increased rates of positive surgical margins were observed among patients undergoing salvage conservation surgery.

Effect of Fish Oil Supplementation and Aspirin Use on Arteriovenous Fistula Failure in Patients Requiring Hemodialysis: A Randomized Clinical Trial.

PubMed

Irish, Ashley B; Viecelli, Andrea K; Hawley, Carmel M; Hooi, Lai-Seong; Pascoe, Elaine M; Paul-Brent, Peta-Anne; Badve, Sunil V; Mori, Trevor A; Cass, Alan; Kerr, Peter G; Voss, David; Ong, Loke-Meng; Polkinghorne, Kevan R

2017-02-01

Vascular access dysfunction is a leading cause of morbidity and mortality in patients requiring hemodialysis. Arteriovenous fistulae are preferred over synthetic grafts and central venous catheters due to superior long-term outcomes and lower health care costs, but increasing their use is limited by early thrombosis and maturation failure. ω-3 Polyunsaturated fatty acids (fish oils) have pleiotropic effects on vascular biology and inflammation and aspirin impairs platelet aggregation, which may reduce access failure. To determine whether fish oil supplementation (primary objective) or aspirin use (secondary objective) is effective in reducing arteriovenous fistula failure. The Omega-3 Fatty Acids (Fish Oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) study was a randomized, double-blind, controlled clinical trial that recruited participants with stage 4 or 5 chronic kidney disease from 2008 to 2014 at 35 dialysis centers in Australia, Malaysia, New Zealand, and the United Kingdom. Participants were observed for 12 months after arteriovenous fistula creation. Participants were randomly allocated to receive fish oil (4 g/d) or matching placebo. A subset (n = 406) was also randomized to receive aspirin (100 mg/d) or matching placebo. Treatment started 1 day prior to surgery and continued for 12 weeks. The primary outcome was fistula failure, a composite of fistula thrombosis and/or abandonment and/or cannulation failure, at 12 months. Secondary outcomes included the individual components of the primary outcome. Of 1415 eligible participants, 567 were randomized (359 [63%] male, 298 [53%] white, 264 [47%] with diabetes; mean [SD] age, 54.8 [14.3] y). The same proportion of fistula failures occurred in the fish oil and placebo arms (128 of 270 [47%] vs 125 of 266 [47%]; relative risk [RR] adjusted for aspirin use, 1.03; 95% CI, 0.86-1.23; P = .78). Fish oil did not reduce fistula thrombosis (60 [22%] vs 61 [23%]; RR, 0.98; 95% CI, 0.72-1.34; P = .90), abandonment (51 [19%] vs 58 [22%]; RR, 0.87; 95% CI, 0.62-1.22; P = .43), or cannulation failure (108 [40%] vs 104 [39%]; RR, 1.03; 95% CI, 0.83-1.26; P = .81). The risk of fistula failure was similar between the aspirin and placebo arms (87 of 194 [45%] vs 83 of 194 [43%]; RR, 1.05; 95% CI, 0.84-1.31; P = .68). Neither fish oil supplementation nor aspirin use reduced failure of new arteriovenous fistulae within 12 months of surgery. anzctr.org.au Identifier: CTRN12607000569404.

Positive and negative volume-outcome relationships in the geriatric trauma population.

PubMed

Matsushima, Kazuhide; Schaefer, Eric W; Won, Eugene J; Armen, Scott B; Indeck, Matthew C; Soybel, David I

2014-04-01

In trauma populations, improvements in outcome are documented in institutions with higher case volumes. However, it is not known whether improved outcomes are attributable to the case volume within specific higher-risk groups, such as the elderly, or to the case volume among all trauma patients treated by an institution. To test the hypothesis that outcomes of trauma care for geriatric patients are affected differently by the volume of geriatric cases and nongeriatric cases of an institution. This retrospective cohort study using a statewide trauma registry was set in state-designated levels 1 and 2 trauma centers in Pennsylvania. It included 39 431 eligible geriatric trauma patients (aged >65 years) in the Pennsylvania Trauma Outcomes Study. In-hospital mortality, major complications, and mortality after major complications (failure to rescue). Between 2001 and 2010, 39 431 geriatric trauma patients and 105 046 nongeriatric patients were captured in a review of outcomes in 20 state-designated levels 1 and 2 trauma centers. Larger volumes of geriatric trauma patients were significantly associated with lower odds of in-hospital mortality, major complications, and failure to rescue. In contrast, larger nongeriatric trauma volumes were significantly associated with higher odds of major complications in geriatric patients. Higher rates of in-hospital mortality, major complications, and failure to rescue were associated with lower volumes of geriatric trauma care and paradoxically with higher volumes of trauma care for younger patients. These findings offer the possibility that outcomes might be improved with differentiated pathways of care for geriatric trauma patients.

Gastroschisis: one year outcomes from national cohort study.

PubMed

Bradnock, Timothy J; Marven, Sean; Owen, Anthony; Johnson, Paul; Kurinczuk, Jennifer J; Spark, Patsy; Draper, Elizabeth S; Knight, Marian

2011-11-15

To describe one year outcomes for a national cohort of infants with gastroschisis. Population based cohort study of all liveborn infants with gastroschisis born in the United Kingdom and Ireland from October 2006 to March 2008. All 28 paediatric surgical centres in the UK and Ireland. 301 infants (77%) from an original cohort of 393. Duration of parenteral nutrition and stay in hospital; time to establish full enteral feeding; rates of intestinal failure, liver disease associated with intestinal failure, unplanned reoperation; case fatality. Compared with infants with simple gastroschisis (intact, uncompromised, continuous bowel), those with complex gastroschisis (bowel perforation, necrosis, or atresia) took longer to reach full enteral feeding (median difference 21 days, 95% confidence interval 9 to 39 days); required a longer duration of parenteral nutrition (median difference 25 days, 9 to 46 days) and a longer stay in hospital (median difference 57 days, 29 to 95 days); were more likely to develop intestinal failure (81% (25 infants) v 41% (102); relative risk 1.96, 1.56 to 2.46) and liver disease associated with intestinal failure (23% (7) v 4% (11); 5.13, 2.15 to 12.3); and were more likely to require unplanned reoperation (42% (13) v 10% (24); 4.39, 2.50 to 7.70). Compared with infants managed with primary fascial closure, those managed with preformed silos took longer to reach full enteral feeding (median difference 5 days, 1 to 9) and had an increased risk of intestinal failure (52% (50) v 32% (38); 1.61, 1.17 to 2.24). Event rates for the other outcomes were low, and there were no other significant differences between these management groups. Twelve infants died (4%). This nationally representative study provides a benchmark against which individual centres can measure outcome and performance. Stratifying neonates with gastroschisis into simple and complex groups reliably predicts outcome at one year. There is sufficient clinical equipoise concerning the initial management strategy to embark on a multicentre randomised controlled trial comparing primary fascial closure with preformed silos in infants suitable at presentation for either treatment to determine the optimal initial management strategy and define algorithms of care.

Impact of the pretransplant dialysis modality on kidney transplantation outcomes: a nationwide cohort study.

PubMed

Lin, Huan-Tang; Liu, Fu-Chao; Lin, Jr-Rung; Pang, See-Tong; Yu, Huang-Ping

2018-06-04

Most patients with uraemia must undergo chronic dialysis while awaiting kidney transplantation; however, the role of the pretransplant dialysis modality on the outcomes of kidney transplantation remains obscure. The objective of this study was to clarify the associations between the pretransplant dialysis modality, namely haemodialysis (HD) or peritoneal dialysis (PD), and the development of post-transplant de novo diseases, allograft failure and all-cause mortality for kidney-transplant recipients. Retrospective nationwide cohort study. Data retrieved from the Taiwan National Health Insurance Research Database. The National Health Insurance database was explored for patients who received kidney transplantation in Taiwan during 1998-2011 and underwent dialysis >90 days before transplantation. The pretransplant characteristics, complications during kidney transplantation and post-transplant outcomes were statistically analysed and compared between the HD and PD groups. Cox regression analysis was used to evaluate the HR of the dialysis modality on graft failure and all-cause mortality. The primary outcomes were long-term post-transplant death-censored allograft failure and all-cause mortality started after 90 days of kidney transplantation until the end of follow-up. The secondary outcomes were events during kidney transplantation and post-transplant de novo diseases adjusted by propensity score in log-binomial model. There were 1812 patients included in our cohort, among which 1209 (66.7%) and 603 (33.3%) recipients received pretransplant HD and PD, respectively. Recipients with chronic HD were generally older and male, had higher risks of developing post-transplant de novo ischaemic heart disease, tuberculosis and hepatitis C after adjustment. Pretransplant HD contributed to higher graft failure in the multivariate analysis (HR 1.38, p<0.05) after adjustment for the recipient age, sex, duration of dialysis and pretransplant diseases. There was no significant between-group difference in overall survival. Pretransplant HD contributed to higher risks of death-censored allograft failure after kidney transplantation when compared with PD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Outcomes of Children With and Without Hepatic Encephalopathy From the Pediatric Acute Liver Failure Study Group.

PubMed

Ng, Vicky L; Li, Ruosha; Loomes, Kathleen M; Leonis, Mike A; Rudnick, David A; Belle, Steven H; Squires, Robert H

2016-09-01

Hepatic encephalopathy (HE) is challenging to identify in children with acute liver failure and was not a requirement for enrollment into the Pediatric Acute Liver Failure Study Group (PALFSG). The outcomes of PALFSG participants presenting with and without HE are presented. PALFSG participants were classified based on daily assessment of HE during the first 7 days following study enrollment: group 1-never developed HE; group 2-no HE at enrollment with subsequent HE development; and group 3-HE at study enrollment. Clinical and biochemical parameters and outcomes of death, spontaneous recovery, or liver transplantation were compared between groups. Data from 769 PALFSG (54% boys; median age 4.2 years; range 0-17.9 years) participants were analyzed, with 277 in group 1 (36%), 83 in group 2 (11%), and 409 in group 3 (53%). Mortality occurred in 11% of all participants and was highest among group 3 participants who demonstrated persistent grade III-IV HE (55%) or showed progression of HE (26%). Eleven (4%) group 1 participants died within 21 days of enrollment. Spontaneous recovery was highest in group 1 (79%) and lowest in group 2 (25%; P < 0.001). Mortality 21 days after enrollment was highest in participants enrolled with severe HE (grades III or IV) or demonstrating HE progression. Four percent of participants without recorded clinical HE in the 7 days after enrollment, however, died within 21 days. Improved assessment of neurological injury and pediatric acute liver failure prognostication schema are needed.

Does high-flow nasal cannula oxygen improve outcome in acute hypoxemic respiratory failure? A systematic review and meta-analysis.

PubMed

Lin, Si-Ming; Liu, Kai-Xiong; Lin, Zhi-Hong; Lin, Pei-Hong

2017-10-01

To evaluate the efficacy of high-flow nasal cannula (HFNC) in the rate of intubation and mortality for patients with acute hypoxemic respiratory failure. We searched Pubmed, EMBASE, and the Cochrane Library for relevant studies. Two reviewers extracted data and reviewed the quality of the studies independently. The primary outcome was the rate of intubation; secondary outcome was mortality in the hospital. Study-level data were pooled using a random-effects model when I2 was >50% or a fixed-effects model when I2 was <50%. Eight randomized controlled studies with a total of 1,818patients were considered. Pooled analysis showed that no statistically significant difference was found between groups regarding the rate of intubation (odds ratio [OR] = 0.79; 95% confidence interval [CI]: 0.60-1.04; P = 0.09; I2 = 36%) and no statistically significant difference was found between groups regarding hospital mortality (OR = 0.89; 95% CI: 0.62-127; P = 0.51; I2 = 47%). The use of HFNC showed a trend toward reduction in the intubation rate, which did not meet statistical significance, in patients with acute respiratory failure compared with conventional oxygen therapy (COT) and noninvasive ventilation (NIV). Moreover no difference in mortality. So, Large, well-designed, randomized, multi-center trials are needed to confirm the effects of HFNC in acute hypoxemic respiratory failure patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Chest Wall Thickness and Decompression Failure: A Systematic Review and Meta-analysis Comparing Anatomic Locations in Needle Thoracostomy

PubMed Central

Laan, Danuel V.; Vu, Trang Diem N.; Thiels, Cornelius A.; Pandian, T. K.; Schiller, Henry J.; Murad, M. Hassan; Aho, Johnathon M.

2015-01-01

Introduction Current Advanced Trauma Life Support guidelines recommend decompression for thoracic tension physiology using a 5-cm angiocatheter at the second intercostal space (ICS) on the midclavicular line (MCL). High failure rates occur. Through systematic review and meta-analysis, we aimed to determine the chest wall thickness (CWT) of the 2nd ICS-MCL, the 4th/5th ICS at the anterior axillary line (AAL), the 4th/5th ICS mid axillary line (MAL) and needle thoracostomy failure rates using the currently recommended 5-cm angiocatheter. Methods A comprehensive search of several databases from their inception to July 24, 2014 was conducted. The search was limited to the English language, and all study populations were included. Studies were appraised by two independent reviewers according to a priori defined PRISMA inclusion and exclusion criteria. Continuous outcomes (CWT) were evaluated using weighted mean difference and binary outcomes (failure with 5-cm needle) were assessed using incidence rate. Outcomes were pooled using the random-effects model. Results The search resulted in 34,652 studies of which 15 were included for CWT analysis, 13 for NT effectiveness. Mean CWT was 42.79 mm (95% CI, 38.78–46.81) at 2nd ICS-MCL, 39.85 mm (95% CI, 28.70–51.00) at MAL, and 34.33 mm (95% CI, 28.20–40.47) at AAL (P=0.08). Mean failure rate was 38% (95% CI, 24–54) at 2nd ICS-MCL, 31% (95% CI, 10–64) at MAL, and 13% (95% CI, 8–22) at AAL (P=0.01). Conclusion Evidence from observational studies suggests that the 4th/5th ICS-AAL has the lowest predicted failure rate of needle decompression in multiple populations. PMID:26724173

Chest wall thickness and decompression failure: A systematic review and meta-analysis comparing anatomic locations in needle thoracostomy.

PubMed

Laan, Danuel V; Vu, Trang Diem N; Thiels, Cornelius A; Pandian, T K; Schiller, Henry J; Murad, M Hassan; Aho, Johnathon M

2016-04-01

Current Advanced Trauma Life Support guidelines recommend decompression for thoracic tension physiology using a 5-cm angiocatheter at the second intercostal space (ICS) on the midclavicular line (MCL). High failure rates occur. Through systematic review and meta-analysis, we aimed to determine the chest wall thickness (CWT) of the 2nd ICS-MCL, the 4th/5th ICS at the anterior axillary line (AAL), the 4th/5th ICS mid axillary line (MAL) and needle thoracostomy failure rates using the currently recommended 5-cm angiocatheter. A comprehensive search of several databases from their inception to July 24, 2014 was conducted. The search was limited to the English language, and all study populations were included. Studies were appraised by two independent reviewers according to a priori defined PRISMA inclusion and exclusion criteria. Continuous outcomes (CWT) were evaluated using weighted mean difference and binary outcomes (failure with 5-cm needle) were assessed using incidence rate. Outcomes were pooled using the random-effects model. The search resulted in 34,652 studies of which 15 were included for CWT analysis, 13 for NT effectiveness. Mean CWT was 42.79 mm (95% CI, 38.78-46.81) at 2nd ICS-MCL, 39.85 mm (95% CI, 28.70-51.00) at MAL, and 34.33 mm (95% CI, 28.20-40.47) at AAL (P=.08). Mean failure rate was 38% (95% CI, 24-54) at 2nd ICS-MCL, 31% (95% CI, 10-64) at MAL, and 13% (95% CI, 8-22) at AAL (P=.01). Evidence from observational studies suggests that the 4th/5th ICS-AAL has the lowest predicted failure rate of needle decompression in multiple populations. Level 3 SR/MA with up to two negative criteria. Therapeutic. Copyright © 2015 Elsevier Ltd. All rights reserved.

Cellulitis in Obesity: Adverse Outcomes Affected by Increases in Body Mass Index.

PubMed

Theofiles, Meghan; Maxson, Julie; Herges, Lori; Marcelin, Alberto; Angstman, Kurt B

2015-10-01

Cellulitis in obese patients is associated with increased rates of treatment failure compared to those with normal body mass index (BMI); however, patients have not been extensively studied in the outpatient environment or stratified based on range of obesity and associated risk factors. This study looked at antibiotic dosing and treatment failure in the obese population from the primary care perspective and accounts for BMI range, weight, comorbid diabetes, and tobacco use. This study was a retrospective chart review of 637 adult primary care patients designed to evaluate rates of treatment failure of outpatient cellulitis among patients of varying BMI. Treatment failure was defined as (a) hospital admission for intravenous antibiotics, (b) prolonged antibiotic course, or (c) requiring a different antibiotic after initial course. Adverse outcomes were not statistically significant between normal BMI and those with BMI ≥40 kg/m(2). A subset of patients with a BMI ≥50 kg/m(2) was noted to have approximately twice the rate of adverse outcomes as the normal BMI group. While controlling for age, gender, race, diagnosis of diabetes mellitus, and tobacco use, a BMI of ≥50 kg/m(2) and a weight ≥120 kg was associated with adverse outcomes with an odds ratio of 2.440 (95% CI, 1.260-4.724; P = .008) and 2.246 (95% CI, 1.154-4.369; P = .017), respectively. Patients with cellulitis weighing >120kg or with a BMI ≥50 kg/m(2) were at greatest risk for treatment failure in the outpatient setting, even when controlling for comorbid diabetes and tobacco use. As morbid obesity continues to become more prevalent, it becomes imperative that primary care physicians have better antibiotic dosing guidelines to account for the physiologic effects of obesity to minimize the risk of increased morbidity, health care costs, and antibiotic resistance. © The Author(s) 2015.

Prosthetic valve endocarditis: who needs surgery? A multicentre study of 104 cases

PubMed Central

Habib, G; Tribouilloy, C; Thuny, F; Giorgi, R; Brahim, A; Amazouz, M; Remadi, J-P; Nadji, G; Casalta, J-P; Coviaux, F; Avierinos, J-F; Lescure, X; Riberi, A; Weiller, P-J; Metras, D; Raoult, D

2005-01-01

Objectives: To identify the prognostic markers of a bad outcome in a large population of 104 patients with prosthetic valve endocarditis (PVE), and to study the influence of medical versus surgical strategy on outcome in PVE and thus to identify patients for whom surgery may be beneficial. Design: Multicentre study. Methods and results: Among 104 patients, 22 (21%) died in hospital. Factors associated with in-hospital death were severe co-morbidity (6% of survivors v 41% of those who died, p  =  0.05), renal failure (28% v 45%, p  =  0.05), moderate to severe regurgitation (22% v 54%, p  =  0.006), staphylococcal infection (16% v 54%, p  =  0.001), severe heart failure (22% v 64%, p  =  0.001), and occurrence of any complication (60% v 90%, p  =  0.05). By multivariate analysis, severe heart failure (odds ratio 5.5) and Staphylococcus aureus infection (odds ratio 6.1) were the only independent predictors of in-hospital death. Among 82 in-hospital survivors, 21 (26%) died during a 32 month follow up. A Cox proportional hazards model identified early PVE, co-morbidity, severe heart failure, staphylococcus infection, and new prosthetic dehiscence as independent predictors of long term mortality. Mortality was not significantly different between surgical and non-surgical patients (17% v 25%, respectively, not significant). However, both in-hospital and long term mortality were reduced by a surgical approach in high risk subgroups of patients with staphylococcal PVE and complicated PVE. Conclusions: Firstly, PVE not only carries a high in-hospital mortality risk but also is associated with high long term mortality and needs close follow up after the initial episode. Secondly, congestive heart failure, early PVE, staphylococcal infection, and complicated PVE are associated with a bad outcome. Thirdly, subgroups of patients could be identified for whom surgery is associated with a better outcome: patients with staphylococcal and complicated PVE. Early surgery is strongly recommended for these patients. PMID:15958370

The Advanced Glaucoma Intervention Study (AGIS): 9. Comparison of glaucoma outcomes in black and white patients within treatment groups.

PubMed

2001-09-01

To compare in eyes of black and white patients the progression of glaucoma after failure of medical therapy and upon start of surgical intervention. Cohort study analysis of data from a randomized clinical trial. This multicenter study included open-angle glaucoma patients who had failed medical therapy: 451 eyes of 332 black patients, 325 eyes of 249 white patients. Eyes were randomly assigned to an argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) sequence or a trabeculectomy-ALT-trabeculectomy (TAT) sequence; they had been followed for 7 to 11 years at database closure. Main outcome measures were decrease of visual field (DVF), sustained decrease of visual field (SDVF), decrease of visual acuity (DVA), sustained decrease of visual acuity (SDVA), and failure of first surgical glaucoma intervention. Statistical methods included logistic regression to obtain average adjusted black-white odds ratios for binary outcomes, and Cox regression to estimate adjusted black-white risk ratios for time-to-event outcomes. In the ATT sequence blacks were at lower risk than whites of failure of first intervention (ALT, RR = 0.68, P = 0.040). In the TAT sequence blacks were at higher risk than whites of failure of the first intervention (trabeculectomy, RR = 1.79, P = 0.033), of intraocular pressure > or =18 mm Hg (average OR = 1.41, P = 0.026), and of DVF (average OR = 1.78, P = 0.007). In both treatment sequences, the average number of prescribed medications was greater for blacks than whites (P < or = 0.002). The results support the hypothesis that after failure of medical therapy and upon initiation of surgical intervention, an initial intervention with trabeculectomy retards the progression of glaucoma more effectively in white than in black patients. The data provide a weak suggestion that an initial surgical intervention with ALT retards the progression of glaucoma more effectively in black than in white patients.

Rationale and design of the Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure (AVOID-HF) trial.

PubMed

Costanzo, Maria Rosa; Negoianu, Daniel; Fonarow, Gregg C; Jaski, Brian E; Bart, Bradley A; Heywood, J Thomas; Nabut, Jose L; Schollmeyer, Michael P

2015-09-01

In patients hospitalized with acutely decompensated heart failure, unresolved signs and symptoms of fluid overload have been consistently associated with poor outcomes. Regardless of dosing and type of administration, intravenous loop diuretics have not reduced heart failure events or mortality in patients with acutely decompensated heart failure. The results of trials comparing intravenous loop diuretics to mechanical fluid removal by isolated venovenous ultrafiltration have yielded conflicting results. Studies evaluating early decongestive strategies have shown that ultrafiltration removed more fluid and was associated with fewer heart failure-related rehospitalization than intravenous loop diuretics. In contrast, when used in the setting of worsening renal function, ultrafiltration was associated with poorer renal outcomes and no reduction in heart failure events. The AVOID-HF trial seeks to determine if an early strategy of ultrafiltration in patients with acutely decompensated heart failure is associated with fewer heart failure events at 90 days compared with a strategy based on intravenous loop diuretics. Study subjects from 40 highly experienced institutions are randomized to either early ultrafiltration or intravenous loop diuretics. In both treatment arms, fluid removal therapies are adjusted according to the patients' hemodynamic condition and renal function. The study was unilaterally terminated by the sponsor in the absence of futility and safety concerns after the enrollment of 221 subjects, or 27% of the originally planned sample size of 810 patients. The AVOID-HF trial's principal aim is to compare the safety and efficacy of ultrafiltration vs that of intravenous loop diuretics in patients hospitalized with acutely decompensated heart failure. Because stepped treatment approaches are applied in both ultrafiltration and intravenous loop diuretics groups and the primary end point is time to first heart failure event within 90 days, it is hoped that the AVOID-HF trial, despite its untimely termination by the sponsor, will provide further insight on how to optimally decongest patients with fluid-overloaded heart failure. Copyright © 2015. Published by Elsevier Inc.

Both in- and out-hospital worsening of renal function predict outcome in patients with heart failure: results from the Coordinating Study Evaluating Outcome of Advising and Counseling in Heart Failure (COACH).

PubMed

Damman, Kevin; Jaarsma, Tiny; Voors, Adriaan A; Navis, Gerjan; Hillege, Hans L; van Veldhuisen, Dirk J

2009-09-01

The effect of worsening renal function (WRF) after discharge on outcome in patients with heart failure is unknown. We assessed estimated glomerular filtration rate (eGFR) and serum creatinine at admission, discharge, and 6 and 12 months after discharge, in 1023 heart failure patients. Worsening renal function was defined as an increase in serum creatinine of >26.5 micromol/L and >25%. The primary endpoint was a composite of all-cause mortality and heart failure admissions. The mean age of patients was 71 +/- 11 years, and 62% was male. Mean eGFR at admission was 55 +/- 21 mL/min/1.73 m(2). In-hospital WRF occurred in 11% of patients, while 16 and 9% experienced WRF from 0 to 6, and 6 to 12 months after discharge, respectively. In multivariate landmark analysis, WRF at any point in time was associated with a higher incidence of the primary endpoint: hazard ratio (HR) 1.63 (1.10-2.40), P = 0.014 for in-hospital WRF, HR 2.06 (1.13-3.74), P = 0.018 for WRF between 0-6 months, and HR 5.03 (2.13-11.88), P < 0.001 for WRF between 6-12 months. Both in- and out-hospital worsening of renal function are independently related to poor prognosis in patients with heart failure, suggesting that renal function in heart failure patients should be monitored long after discharge.

A Systematic Review of Relaxation, Meditation, and Guided Imagery Strategies for Symptom Management in Heart Failure.

PubMed

Kwekkeboom, Kristine L; Bratzke, Lisa C

2016-01-01

Pain, dyspnea, fatigue, and sleep disturbance are prevalent and distressing symptoms in persons with advanced heart failure. Although many lifestyle and self-care interventions have been developed to control heart failure progression, very few studies have explored treatments exclusively for symptom palliation. Cognitive-behavioral strategies may be effective treatment for these symptoms in advanced heart failure. A systemic review was conducted to describe the effect of cognitive-behavioral strategies on pain, dyspnea, fatigue, and sleep disturbance in patients with heart failure. CINAHL, Medline, and PsychINFO were searched from inception through December 2014. Articles were selected for inclusion if they tested a cognitive-behavioral strategy using a quasi-experimental or experimental design, involved a sample of adults with heart failure, and measured pain, dyspnea, fatigue, sleep disturbance, or symptom-related quality of life. The 2 authors evaluated study quality, abstracted data elements from each study, and synthesized findings. Thirteen articles describing 9 unique studies met criteria and were included in the review. Five studies tested relaxation strategies, 3 tested meditation strategies, and 1 tested a guided imagery strategy. Of the 9 studies, 7 demonstrated some improvement in symptom outcomes. Relaxation, meditation, guided imagery, or combinations of these strategies resulted in less dyspnea and better sleep compared with attention control or usual care conditions and reduced pain, dyspnea, fatigue, and sleep disturbance within treatment groups (pretreatment to posttreatment). Symptom-related quality of life was improved with meditation compared with attention control and usual care conditions and improved pre- to post-guided imagery. Studies exploring cognitive-behavioral symptom management strategies in heart failure vary in quality and report mixed findings but indicate potential beneficial effects of relaxation, meditation, and guided imagery on heart failure-related symptoms. Future research should test cognitive-behavioral strategies in rigorously designed efficacy trials, using samples selected for their symptom experience, and measure pain, dyspnea, fatigue, and sleep disturbance outcomes with targeted symptom measures.

A Systematic Review of Relaxation, Meditation, and Guided Imagery Strategies for Symptom Management in Heart Failure

PubMed Central

Kwekkeboom, Kristine L.; Bratzke, Lisa C.

2015-01-01

Background Pain, dyspnea, fatigue, and sleep disturbance are prevalent and distressing symptoms in persons with advanced heart failure. Although many lifestyle and self-care interventions have been developed to control heart failure progression, very few studies have explored treatments exclusively for symptom palliation. Cognitive-behavioral strategies may be effective treatment for these symptoms in advanced heart failure. Objective A systemic review was conducted to describe the effect of cognitive-behavioral strategies on pain, dyspnea, fatigue, and sleep disturbance in patients with heart failure. Methods CINAHL, Medline, and PsychINFO were searched from inception through December 2014. Articles were selected for inclusion if they tested a cognitive-behavioral strategy using a quasi-experimental or experimental design, involved a sample of adults with heart failure, and measured pain, dyspnea, fatigue, sleep disturbance, or symptom-related quality of life (QoL). The two authors evaluated study quality, abstracted data elements from each study, and synthesized findings. Results Thirteen articles describing nine unique studies met criteria and were included in the review. Five studies tested relaxation strategies, three tested meditation strategies, and one tested a guided imagery strategy. Seven of the nine studies demonstrated some improvement in symptom outcomes. Relaxation, meditation, guided imagery, or combinations of these strategies resulted in less dyspnea and better sleep compared to attention control or usual care conditions, and reduced pain, dyspnea, fatigue and sleep disturbance within treatment groups (pre- to post-treatment). Symptom-related QoL was improved with meditation compared to attention control and usual care conditions, and improved pre- to post-guided imagery. Conclusions Studies exploring cognitive-behavioral symptom management strategies in heart failure vary in quality and report mixed findings, but indicate potential beneficial effects of relaxation, meditation, and guided imagery on heart failure-related symptoms. Future research should test cognitive-behavioral strategies in rigorously designed efficacy trials, using samples selected for their symptom experience, and measure pain, dyspnea, fatigue, and sleep disturbance outcomes with targeted symptom measures. PMID:26065388

Risk factors for unsuccessful tuberculosis treatment outcome (failure, default and death) in public health institutions, Eastern Ethiopia.

PubMed

Amante, Tariku Dingeta; Ahemed, Tekabe Abdosh

2015-01-01

Unsuccessful TB treatment outcome is a serious public health concern. It is compelling to identify, and deal with factors determining unsuccessful treatment outcome. Therefore, study was aimed to determine pattern of unsuccessful TB treatment outcome and associated factors in eastern Ethiopia. A case control study was used. Cases were records of TB patients registered as defaulter, dead and/or treatment failure where as controls were those cured or treatment complete. Multivariate logistic regression models were used to derive adjusted odds ratios (OR) at 95% CI to examine the relationship between the unsuccessful TB treatment outcome and patients' characteristics. A total of 990 sample size (330 cases and 660 controls) were included. Among cases (n = 330), majority 212(64.2%) were because of death, 100(30.3%) defaulters and 18(5.5%) were treatment failure. Lack of contact person(OR = 1.37; 95% CI 1.14-2.9, P, .024), sputum smear negative treatment category at initiation of treatment (OR = 1.8; 95% CI 1.3-5.5,P, .028), smear positive sputum test result at 2(nd) month after initiation treatment (OR = 14; 95% CI 5.5-36, P,0.001) and HIV positive status (OR = 2.5; 95% CI 1.34-5.7, P, 0.01) were independently associated with increased risk of unsuccessful TB treatment outcome. Death was the major cause of unsuccessful TB treatment outcome. TB patients do not have contact person, sputum smear negative treatment category at initiation of treatment, smear positive on 2(nd) month after treatment initiation and HIV positive were factors significantly associated unsuccessful treatment outcome. TB patients with sputum smear negative treatment category, HIV positive and smear positive on 2(nd) nd month of treatment initiation need strict follow up throughout DOTs period.

Effects of hospital care environment on patient mortality and nurse outcomes.

PubMed

Aiken, Linda H; Clarke, Sean P; Sloane, Douglas M; Lake, Eileen T; Cheney, Timothy

2009-01-01

The objective of this study was to analyze the net effects of nurse practice environments on nurse and patient outcomes after accounting for nurse staffing and education. Staffing and education have well-documented associations with patient outcomes, but evidence on the effect of care environments on outcomes has been more limited. Data from 10,184 nurses and 232,342 surgical patients in 168 Pennsylvania hospitals were analyzed. Care environments were measured using the practice environment scales of the Nursing Work Index. Outcomes included nurse job satisfaction, burnout, intent to leave, and reports of quality of care, as well as mortality and failure to rescue in patients. Nurses reported more positive job experiences and fewer concerns with care quality, and patients had significantly lower risks of death and failure to rescue in hospitals with better care environments. Care environment elements must be optimized alongside nurse staffing and education to achieve high quality of care.

Effects of hospital care environment on patient mortality and nurse outcomes.

PubMed

Aiken, Linda H; Clarke, Sean P; Sloane, Douglas M; Lake, Eileen T; Cheney, Timothy

2008-05-01

The objective of this study was to analyze the net effects of nurse practice environments on nurse and patient outcomes after accounting for nurse staffing and education. Staffing and education have well-documented associations with patient outcomes, but evidence on the effect of care environments on outcomes has been more limited. Data from 10,184 nurses and 232,342 surgical patients in 168 Pennsylvania hospitals were analyzed. Care environments were measured using the practice environment scales of the Nursing Work Index. Outcomes included nurse job satisfaction, burnout, intent to leave, and reports of quality of care, as well as mortality and failure to rescue in patients. Nurses reported more positive job experiences and fewer concerns with care quality, and patients had significantly lower risks of death and failure to rescue in hospitals with better care environments. Care environment elements must be optimized alongside nurse staffing and education to achieve high quality of care.

[Consensus on nursing diagnoses, interventions and outcomes for home care of patients with heart failure].

PubMed

Azzolin, Karina; de Souza, Emiliane Nogueira; Ruschel, Karen Brasil; Mussi, Cláudia Motta; de Lucena, Amália Fátima; Rabelo, Eneida Rejane

2012-12-01

This was a consensus study with six cardiology nurses with the objective of selecting nursing diagnoses, outcomes and interventions described by NANDA International (NANDA-I), Nursing Outcomes Classification (NOC), Nursing Intervention Classification (NIC), for home care of patients with heart failure (HF). Eight nursing diagnoses (NDs) were pre-selected and a consensus was achieved in three stages, during which interventions/activities and outcomes/indicators of each NDs were validated and those considered valid obtained 70% to 100% consensus. From the eight pre-selected NDs, two were excluded due to the lack of consensus on appropriate interventions for the clinical home care scenario. Eleven interventions were selected from a total of 96 pre-selected ones and seven outcomes were validated out of 71. The practice of consensus among expert nurses provides assistance to the qualifications of the care process and deepens the knowledge about the use of tazonomies in nursing clinical practice.

Outcomes and predictors of failure of thrombolysis for iliofemoral deep venous thrombosis.

PubMed

Avgerinos, Efthymios D; Hager, Eric S; Naddaf, Abdallah; Dillavou, Ellen; Singh, Michael; Chaer, Rabih A

2015-01-01

Catheter-directed thrombolysis (CDT) with adjunctive mechanical techniques, when successful, is reported to alleviate symptoms of acute iliofemoral deep venous thrombosis (IFDVT) and to lower the occurrence of the post-thrombotic syndrome (PTS). This study aimed to determine longer term outcomes of catheter-based interventions for IFDVT and to identify predictors of immediate and mid-long-term failures that would guide optimal patient selection. Consecutive patients who underwent CDT or pharmacomechanical thrombolysis for IFDVT between May 2007 and March 2013 were identified from a prospectively maintained database. Assessment of predictors of immediate periprocedural failure was based on the degree of clot lysis (≤ 50% vs >50%) and 30-day recurrence of DVT. Long-term anatomic and clinical failures and outcomes were assessed by ultrasound imaging of the lysed segments and Villalta score (≥ 5 vs <5). Survival analysis was used to assess primary patency and PTS morbidity. Multivariate binary logistic and Cox regression models were used to determine predictors of anatomic and clinical failures. During the study period, 93 patients (118 limbs; mean age, 49.4 ± 16.2 years; 47 women) with symptoms averaging 11.1 ± 9.6 days in duration were treated with various combinations of CDT or pharmacomechanical thrombolysis; in 52 (56%), at least one iliocaval stent was deployed. Immediate treatment failure was seen in 11 patients (12%) predicted by the preoperative indication "phlegmasia" (odds ratio, 3.12; P = .042) and recent surgery (odds ratio, 19.6; P = .018). At a mean ultrasonographic follow-up of 16 ± 14 months (range, 1-65 months), six more patients sustained a rethrombosis, accounting for an overall 3-year primary patency of 72.1%. In the long-term model, loss of primary patency was associated with recent surgery (hazard ratio [HR], 4.04; P = .023), malignant disease (HR, 6.75; P = .016), and incomplete thrombolysis (≤ 50%) (HR, 5.83; P < .001). By stratification of PTS on the basis of postprocedure failures, at 2 years PTS occurred in 50.6% of patients and in 16.3% of patients without failure (P < .001). Thrombolysis for symptomatic IFDVT can achieve high rates of thrombus resolution and reduce long-term PTS morbidity on careful patient selection. Improved anatomic and clinical outcomes are associated with the completeness of thrombolysis. Copyright © 2015. Published by Elsevier Inc.

Heart Failure in Women

PubMed Central

Bozkurt, Biykem; Khalaf, Shaden

2017-01-01

Heart failure is an important cause of morbidity and mortality in women, and they tend to develop it at an older age compared to men. Heart failure with preserved ejection fraction is more common in women than in men and accounts for at least half the cases of heart failure in women. When comparing men and women who have heart failure and a low left ventricular ejection fraction, the women are more symptomatic and have a similarly poor outcome. Overall recommendations for guideline-directed medical therapies show no differences in treatment approaches between men and women. Overall, women are generally underrepresented in clinical trials for heart failure. Further studies are needed to shed light into different mechanisms, causes, and targeted therapies of heart failure in women. PMID:29744014

Association between copayment, medication adherence and outcomes in the management of patients with diabetes and heart failure.

PubMed

Gourzoulidis, George; Kourlaba, Georgia; Stafylas, Panagiotis; Giamouzis, Gregory; Parissis, John; Maniadakis, Nikolaos

2017-04-01

To determine the association between copayment, medication adherence and outcomes in patients with Heart failure (HF) and Diabetes Mellitus (DM). PubMed, Scopus and Cochrane databases were searched using combinations of four sets of key words for: drug cost sharing; resource use, health and economic outcomes; medication adherence; and chronic disease. Thirty eight studies were included in the review. Concerning the direct effect of copayment changes on outcomes, the scarcity and diversity of data, does not allow us to reach a clear conclusion, although there is some evidence indicating that higher copayments may result in poorer health and economic outcomes. Seven and one studies evaluating the relationship between copayment and medication adherence in DM and HF population, respectively, demonstrated an inverse statistically significant association. All studies (29) examining the relationship between medication adherence and outcomes, revealed that increased adherence is associated with health benefits in both DM and HF patients. Finally, the majority of studies in both populations, showed that medication adherence was related to lower resource utilization which in turn may lead to lower total healthcare cost. The results of our systematic review imply that lower copayments may result in higher medication adherence, which in turn may lead to better health outcomes and lower total healthcare expenses. Future studies are recommended to reinforce these findings. Copyright © 2017 Elsevier B.V. All rights reserved.

Risk factors for tuberculosis treatment failure, default, or relapse and outcomes of retreatment in Morocco

PubMed Central

2011-01-01

Background Patients with tuberculosis require retreatment if they fail or default from initial treatment or if they relapse following initial treatment success. Outcomes among patients receiving a standard World Health Organization Category II retreatment regimen are suboptimal, resulting in increased risk of morbidity, drug resistance, and transmission.. In this study, we evaluated the risk factors for initial treatment failure, default, or early relapse leading to the need for tuberculosis retreatment in Morocco. We also assessed retreatment outcomes and drug susceptibility testing use for retreatment patients in urban centers in Morocco, where tuberculosis incidence is stubbornly high. Methods Patients with smear- or culture-positive pulmonary tuberculosis presenting for retreatment were identified using clinic registries in nine urban public clinics in Morocco. Demographic and outcomes data were collected from clinical charts and reference laboratories. To identify factors that had put these individuals at risk for failure, default, or early relapse in the first place, initial treatment records were also abstracted (if retreatment began within two years of initial treatment), and patient characteristics were compared with controls who successfully completed initial treatment without early relapse. Results 291 patients presenting for retreatment were included; 93% received a standard Category II regimen. Retreatment was successful in 74% of relapse patients, 48% of failure patients, and 41% of default patients. 25% of retreatment patients defaulted, higher than previous estimates. Retreatment failure was most common among patients who had failed initial treatment (24%), and default from retreatment was most frequent among patients with initial treatment default (57%). Drug susceptibility testing was performed in only 10% of retreatment patients. Independent risk factors for failure, default, or early relapse after initial treatment included male gender (aOR = 2.29, 95% CI 1.10-4.77), positive sputum smear after 3 months of treatment (OR 7.14, 95% CI 4.04-13.2), and hospitalization (OR 2.09, 95% CI 1.01-4.34). Higher weight at treatment initiation was protective. Male sex, substance use, missed doses, and hospitalization appeared to be risk factors for default, but subgroup analyses were limited by small numbers. Conclusions Outcomes of retreatment with a Category II regimen are suboptimal and vary by subgroup. Default among patients receiving tuberculosis retreatment is unacceptably high in urban areas in Morocco, and patients who fail initial tuberculosis treatment are at especially high risk of retreatment failure. Strategies to address risk factors for initial treatment default and to identify patients at risk for failure (including expanded use of drug susceptibility testing) are important given suboptimal retreatment outcomes in these groups. PMID:21356062

Risk factors for tuberculosis treatment failure, default, or relapse and outcomes of retreatment in Morocco.

PubMed

Dooley, Kelly E; Lahlou, Ouafae; Ghali, Iraqi; Knudsen, Janine; Elmessaoudi, My Driss; Cherkaoui, Imad; El Aouad, Rajae

2011-02-28

Patients with tuberculosis require retreatment if they fail or default from initial treatment or if they relapse following initial treatment success. Outcomes among patients receiving a standard World Health Organization Category II retreatment regimen are suboptimal, resulting in increased risk of morbidity, drug resistance, and transmission.. In this study, we evaluated the risk factors for initial treatment failure, default, or early relapse leading to the need for tuberculosis retreatment in Morocco. We also assessed retreatment outcomes and drug susceptibility testing use for retreatment patients in urban centers in Morocco, where tuberculosis incidence is stubbornly high. Patients with smear- or culture-positive pulmonary tuberculosis presenting for retreatment were identified using clinic registries in nine urban public clinics in Morocco. Demographic and outcomes data were collected from clinical charts and reference laboratories. To identify factors that had put these individuals at risk for failure, default, or early relapse in the first place, initial treatment records were also abstracted (if retreatment began within two years of initial treatment), and patient characteristics were compared with controls who successfully completed initial treatment without early relapse. 291 patients presenting for retreatment were included; 93% received a standard Category II regimen. Retreatment was successful in 74% of relapse patients, 48% of failure patients, and 41% of default patients. 25% of retreatment patients defaulted, higher than previous estimates. Retreatment failure was most common among patients who had failed initial treatment (24%), and default from retreatment was most frequent among patients with initial treatment default (57%). Drug susceptibility testing was performed in only 10% of retreatment patients. Independent risk factors for failure, default, or early relapse after initial treatment included male gender (aOR = 2.29, 95% CI 1.10-4.77), positive sputum smear after 3 months of treatment (OR 7.14, 95% CI 4.04-13.2), and hospitalization (OR 2.09, 95% CI 1.01-4.34). Higher weight at treatment initiation was protective. Male sex, substance use, missed doses, and hospitalization appeared to be risk factors for default, but subgroup analyses were limited by small numbers. Outcomes of retreatment with a Category II regimen are suboptimal and vary by subgroup. Default among patients receiving tuberculosis retreatment is unacceptably high in urban areas in Morocco, and patients who fail initial tuberculosis treatment are at especially high risk of retreatment failure. Strategies to address risk factors for initial treatment default and to identify patients at risk for failure (including expanded use of drug susceptibility testing) are important given suboptimal retreatment outcomes in these groups.

The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications.

PubMed

Viecelli, Andrea K; Pascoe, Elaine; Polkinghorne, Kevan R; Hawley, Carmel; Paul-Brent, Peta-Anne; Badve, Sunil V; Cass, Alan; Heritier, Stephane; Kerr, Peter G; Mori, Trevor A; Robertson, Amanda; Seong, Hooi L; Irish, Ashley B

2015-06-27

The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design. The original trial protocol published in 2009 has undergone two major amendments, which were implemented in 2011. Firstly, the primary outcome 'early thrombosis' at 3 months following AVF creation was broadened to a more clinically relevant outcome of 'AVF access failure'; a composite of thrombosis, AVF abandonment and cannulation failure at 12 months. Secondly, participants unable to cease using aspirin were allowed to be enrolled and randomised to omega-3 PUFAs or placebo. The revised primary aim of the FAVOURED study is to test the hypothesis that omega-3 PUFAs will reduce rates of AVF access failure within 12 months following AVF surgery. The secondary aims are to examine the effect of omega-3 PUFAs and aspirin on the individual components of the primary end-point, to examine the safety of study interventions and assess central venous catheter requirement as a result of access failure. This multicentre international clinical trial was amended to address the clinically relevant question of whether the usability of de novo AVF at 12 months can be improved by the early use of omega-3 PUFAs and to a lesser extent aspirin. This study protocol amendment was made in response to a large trial demonstrating that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Secondly, including patients taking aspirin will enroll a more representative cohort of haemodialysis patients, who are significantly older with a higher prevalence of cardiovascular disease and diabetes which may increase event rates and the power of the study. Australia & New Zealand Clinical Trial Register (ACTRN12607000569404).

Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) Trial: Design and Rationale

PubMed Central

Reeves, Gordon R.; Whellan, David J.; Duncan, Pamela; O’Connor, Christopher M.; Pastva, Amy M.; Eggebeen, Joel D; Hewston, Leigh Ann; Morgan, Timothy M.; Reed, Shelby D.; Rejeski, W. Jack; Mentz, Robert J.; Rosenberg, Paul B.; Kitzman, Dalane W.

2017-01-01

Background Acute decompensated heart failure (ADHF) is a leading cause of hospitalization in older persons in the United States. Reduced physical function and frailty are major determinants of adverse outcomes in older patients with hospitalized ADHF. However, these are not addressed by current heart failure (HF) management strategies and there has been little study of exercise training in older, frail HF patients with recent ADHF. Hypothesis Targeting physical frailty with a multi-domain structured physical rehabilitation intervention will improve physical function and reduce adverse outcomes among older patients experiencing a HF hospitalization. Study Design Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) is a multi-center clinical trial in which 360 patients ≥ 60 years hospitalized with ADHF will be randomized either to a novel 12-week multi-domain physical rehabilitation intervention or to attention control. The goal of the intervention is to improve balance, mobility, strength and endurance utilizing reproducible, targeted exercises administered by a multi-disciplinary team with specific milestones for progression. The primary study aim is to assess the efficacy of the REHAB-HF intervention on physical function measured by total Short Physical Performance Battery score. The secondary outcome is 6-month all-cause rehospitalization. Additional outcome measures include quality of life and costs. Conclusions REHAB-HF is the first randomized trial of a physical function intervention in older patients with hospitalized ADHF designed to determine if addressing deficits in balance, mobility, strength and endurance improves physical function and reduces rehospitalizations. It will address key evidence gaps concerning the role of physical rehabilitation in the care of older patients, those with ADHF, frailty, and multiple comorbidities. PMID:28267466

Predictive Validity of Sepsis-3 Definitions and Sepsis Outcomes in Critically Ill Patients: A Cohort Study in 49 ICUs in Argentina.

PubMed

Estenssoro, Elisa; Kanoore Edul, Vanina S; Loudet, Cecilia I; Osatnik, Javier; Ríos, Fernando G; Vázquez, Daniela N; Pozo, Mario O; Lattanzio, Bernardo; Pálizas, Fernando; Klein, Francisco; Piezny, Damián; Rubatto Birri, Paolo N; Tuhay, Graciela; Díaz, Anatilde; Santamaría, Analía; Zakalik, Graciela; Dubin, Arnaldo

2018-05-08

The new Sepsis-3 definitions have been scarcely assessed in low- and middle-income countries; besides, regional information of sepsis outcomes is sparse. Our objective was to evaluate Sepsis-3 definition performance in Argentina. Cohort study of 3-month duration beginning on July 1, 2016. Forty-nine ICUs. Consecutive patients admitted to the ICU with suspected infection that triggered blood cultures and antibiotic administration. None. Patients were classified as having infection, sepsis (infection + change in Sequential Organ Failure Assessment ≥ 2 points), and septic shock (vasopressors + lactate > 2 mmol/L). Patients on vasopressors and lactate less than or equal to 2 mmol/L (cardiovascular dysfunction) were analyzed separately, as those on vasopressors without serum lactate measurement. Systemic inflammatory response syndrome was also recorded. Main outcome was hospital mortality. Of 809 patients, 6% had infection, 29% sepsis, 20% cardiovascular dysfunction, 40% septic shock, and 3% received vasopressors with lactate unmeasured. Hospital mortality was 13%, 20%, 39%, 51%, and 41%, respectively (p = 0.000). Independent predictors of outcome were lactate, Sequential Organ Failure Assessment score, comorbidities, prior duration of symptoms (hr), mechanical ventilation requirement, and infection by highly resistant microorganisms. Area under the receiver operating characteristic curves for mortality for systemic inflammatory response syndrome and Sequential Organ Failure Assessment were 0.53 (0.48-0.55) and 0.74 (0.69-0.77), respectively (p = 0.000). Increasing severity of Sepsis-3 categories adequately tracks mortality; cardiovascular dysfunction subgroup, not included in Sepsis-3, has distinct characteristics. Sequential Organ Failure Assessment score shows adequate prognosis accuracy-contrary to systemic inflammatory response syndrome. This study supports the predictive validity of Sepsis-3 definitions.

Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation: A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A; Arima, Hisatomi; Wang, Dao Wen

2016-06-01

Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin-angiotensin-aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin-angiotensin-aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive.A pooled study of 6 randomized controlled trials assessing the efficacy of renin-angiotensin-aldosterone blockers on subjects with atrial fibrillation was performed.A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76- 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70-0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2-2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0-6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0-0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: -0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction.This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation.

Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation

PubMed Central

Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A.; Arima, Hisatomi; Wang, Dao Wen

2016-01-01

Abstract Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin–angiotensin–aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin–angiotensin–aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive. A pooled study of 6 randomized controlled trials assessing the efficacy of renin–angiotensin–aldosterone blockers on subjects with atrial fibrillation was performed. A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76– 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70–0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2–2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0–6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0–0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: –0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction. This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation. PMID:27368043

Induction of labor in elderly nulliparous women.

PubMed

Hadar, Eran; Hiersch, Liran; Ashwal, Eran; Chen, Rony; Wiznitzer, Arnon; Gabbay-Benziv, Rinat

2017-09-01

Maternal age is an important consideration for antenatal care, labor and delivery. We aimed to evaluate the induction of labor (IoL) failure rates among elderly nulliparous women. We conducted a retrospective analysis of all nulliparous women at 34 + 0 to 41 + 6 weeks, undergoing cervical ripening by prostaglandin E2 (PGE2) vaginal insert. Study group included elderly (≥35 years) nulliparous and control group included non-elderly (<35 years) nulliparous women. Primary outcome was IoL failure rate and secondary outcome was cesarean delivery rate. Outcomes were compared between the groups by univariate analysis followed by regression analysis to adjust results to potential confounders. Of 537 women undergoing IoL, 69 (12.8%) were elderly. The univariate analysis demonstrated no difference in IoL failure rate (26.5% versus 34.8%, p = 0.502) between groups. However, elderly nulliparous women had higher rates of cesarean delivery (36.2% versus 21.4%, p = 0.009). This difference was no longer significant after adjustment for maternal body mass index, indication for delivery, birth weight and gestational age at delivery. Among nulliparous women, older maternal age is not associated with higher rates of IoL failure or cesarean deliveries.

Factors Contributing to Failure of Rotator Cuff Surgery in Persons with Work-Related Injuries

PubMed Central

Lincoln, Sandra; Axelrod, Terry; Holtby, Richard

2008-01-01

Purpose: Shoulder pain is a major musculoskeletal and economic concern in industrialized countries, with the rate of surgical failure reportedly higher in patients injured at work. The purposes of this study were (1) to examine the prevalence of identifiable causes of rotator cuff surgery failure and (2) to examine the relationship among the existence of these causes and outcome scores, patient expectations, and overall satisfaction. Methods: This was a cross-sectional study of patients who experienced continued impairments following surgical treatment for work-related injuries. The primary outcome was a disease-specific measure, the Western Ontario Rotator Cuff (WORC) index. Patients were categorized into two groups based on the existence of an identifiable reason for surgical failure vs. no reason for failure, as demonstrated by clinical and radiologic investigations and decided upon by a shoulder surgeon and a physical therapist. Analyses included a t-test for independent sample means, linear regression, non-parametric Wilcoxon test, and Fisher's exact test. Results: Thirty-eight consecutive patients were included in the study, and 24 causes of surgical failure were identified in 19 patients (50%). Overall, patients with findings of failure were more disabled according to the total WORC index and had higher levels of symptoms, emotional difficulties, and limitations in sports and recreational activities. Expectations and satisfaction levels were not significantly different between groups. Conclusion: Our results indicate that 50% of patients who reported failed surgery had at least one reason to explain their ongoing symptoms, emotional difficulties, and functional limitations. PMID:20145776

The Thompson Encephalopathy Score and Short-Term Outcomes in Asphyxiated Newborns Treated With Therapeutic Hypothermia.

PubMed

Thorsen, Patricia; Jansen-van der Weide, Martine C; Groenendaal, Floris; Onland, Wes; van Straaten, Henrika L M; Zonnenberg, Inge; Vermeulen, Jeroen R; Dijk, Peter H; Dudink, Jeroen; Rijken, Monique; van Heijst, Arno; Dijkman, Koen P; Cools, Filip; Zecic, Alexandra; van Kaam, Anton H; de Haan, Timo R

2016-07-01

The Thompson encephalopathy score is a clinical score to assess newborns suffering from perinatal asphyxia. Previous studies revealed a high sensitivity and specificity of the Thompson encephalopathy score for adverse outcomes (death or severe disability). Because the Thompson encephalopathy score was developed before the use of therapeutic hypothermia, its value was reassessed. The purpose of this study was to assess the association of the Thompson encephalopathy score with adverse short-term outcomes, defined as death before discharge, development of severe epilepsy, or the presence of multiple organ failure in asphyxiated newborns undergoing therapeutic hypothermia. The study period ranged from November 2010 to October 2014. A total of 12 tertiary neonatal intensive care units participated. Demographic and clinical data were collected from the "PharmaCool" multicenter study, an observational cohort study analyzing pharmacokinetics of medication during therapeutic hypothermia. With multiple logistic regression analyses the association of the Thompson encephalopathy scores with outcomes was studied. Data of 142 newborns were analyzed (male: 86; female: 56). Median Thompson score was 9 (interquartile range: 8 to 12). Median gestational age was 40 weeks (interquartile range 38 to 41), mean birth weight was 3362 grams (standard deviation: 605). All newborns manifested perinatal asphyxia and underwent therapeutic hypothermia. Death before discharge occurred in 23.9% and severe epilepsy in 21.1% of the cases. In total, 59.2% of the patients had multiple organ failure. The Thompson encephalopathy score was not associated with multiple organ failure, but a Thompson encephalopathy score ≥12 was associated with death before discharge (odds ratio: 3.9; confidence interval: 1.3 to 11.2) and with development of severe epilepsy (odds ratio: 8.4; confidence interval: 2.5 to 27.8). The Thompson encephalopathy score is a useful clinical tool, even in cooled asphyxiated newborns. A score ≥12 is associated with adverse outcomes (death before discharge and development of severe epilepsy). The Thompson encephalopathy score is not associated with the development of multiple organ failure. Copyright © 2016 Elsevier Inc. All rights reserved.

Association of hospice utilization and publicly reported outcomes following hospitalization for pneumonia or heart failure: a retrospective cohort study.

PubMed

Lah, Soowhan; Wilson, Emily L; Beesley, Sarah; Sagy, Iftach; Orme, James; Novack, Victor; Brown, Samuel M

2018-01-09

The Center for Medicare and Medicaid Services (CMS) and the Hospital Quality Alliance began collecting and reporting United States hospital performance in the treatment of pneumonia and heart failure in 2008. Whether the utilization of hospice might affect CMS-reported mortality and readmission rates is not known. Hospice utilization (mean days on hospice per decedent) for 2012 from the Dartmouth Atlas (a project of the Dartmouth Institute that reports a variety of public health and policy-related statistics) was merged with hospital-level 30-day mortality and readmission rates for pneumonia and heart failure from CMS. The association between hospice use and outcomes was analyzed with multivariate quantile regression controlling for quality of care metrics, acute care bed availability, regional variability and other measures. 2196 hospitals reported data to both CMS and the Dartmouth Atlas in 2012. Higher rates of hospice utilization were associated with lower rates of 30-day mortality and readmission for pneumonia but not for heart failure. Higher quality of care was associated with lower rates of mortality for both pneumonia and heart failure. Greater acute care bed availability was associated with increased readmission rates for both conditions (p < 0.05 for all). Higher rates of hospice utilization were associated with lower rates of 30-day mortality and readmission for pneumonia as reported by CMS. While causality is not established, it is possible that hospice referrals might directly affect CMS outcome metrics. Further clarification of the relationship between hospice referral patterns and publicly reported CMS outcomes appears warranted.

The association between social capital and HIV treatment outcomes in South Africa.

PubMed

Mukoswa, Grace Musanse; Charalambous, Salome; Nelson, Gill

2017-01-01

HIV treatment has reduced morbidity and mortality. By 2012, it was estimated that 60.4% of eligible South Africans accessed antiretroviral treatment; however, treatment adherence and retention remain the greatest challenges. There is a growing belief that social capital, seen as "the features of social organization that facilitate cooperation for mutual benefit", is important in promoting HIV treatment retention. The aim of this study was to establish whether social capital is associated with HIV treatment outcomes. This was a cross-sectional analysis of data from a cohort study that investigated how patient outcomes were linked to clinical characteristics, and included exploratory factor and logistic regression analysis. Data from 943 patients were analyzed. Outcomes for the analysis were visit non-adherence, unsuppressed viral load, and treatment failure. Sixteen percent of patients (n = 118) had unsuppressed viral loads; 19% (n = 179) were non-adherent; and 32% (n = 302) experienced treatment failure. Social capital had two dimensions that were described by two factors. There was no association between either factor and visit non-adherence. Social capital factor 1 was marginally associated with lower risks of unsuppressed viral load and treatment failure at 12 months (OR = 0.78; 95% CI = 0.58-1.03 and OR = 0.76; 95% CI = 0.62-0.93, respectively); but not with visit non-adherence (OR = 0.93; 95% CI = 0.71-1.22). After controlling for confounders, the odds of both unsuppressed viral load and treatment failure decreased with an increase in social capital factor 1. This study suggests that social capital, in terms of the number of groups to which an HIV-infected person belongs, the diversity of the groups, availability of child support, and time available for community projects, is protective against poor HIV treatment outcomes. Implementers and policy makers in the areas of HIV treatment and prevention need to consider the inclusion of social capital in the design of HIV/AIDS treatment program.

The influence of deficient retro-aortic rim on technical success and early adverse events following device closure of secundum atrial septal defects: An Analysis of the IMPACT Registry®.

PubMed

O'Byrne, Michael L; Gillespie, Matthew J; Kennedy, Kevin F; Dori, Yoav; Rome, Jonathan J; Glatz, Andrew C

2017-01-01

Concern regarding aortic erosion has focused attention on the retro-aortic rim in patients undergoing device closure of atrial septal defects (ASD), but its effect on early outcomes is not well studied. A multicenter retrospective cohort study of patients undergoing device occlusion of ASD between 1/2011-10/2014 was performed, using data from the IMproving Pediatric and Adult Congenital Treatment Registry. Subjects were divided between those with retro-aortic rim <5 and ≥5 mm. Primary outcomes were technical failure and major early adverse events. Case times were measured as surrogates of technical complexity. The effect of deficient retro-aortic rim on primary outcomes was assessed using hierarchical logistic regression, adjusting for other suspected covariates and assessing whether they represent independent risk factors RESULTS: 1,564 subjects (from 77 centers) were included, with deficient retro-aortic rim present in 40%. Technical failure occurred in 91 subjects (5.8%) and a major early adverse event in 64 subjects (4.1%). Adjusting for known covariates, the presence of a deficient retro-aortic rim was not significantly associated with technical failure (OR: 1.3, 95% CI: 0.9-2.1) or major early adverse event (OR: 0.7, 95% CI: 0.4-1. 2). Total case (P = 0.01) and fluoroscopy time (P = 0.02) were greater in subjects with deficient rim, but sheath time was not significantly different (P = 0.07). Additional covariates independently associated with these outcomes were identified. Deficient retro-aortic rim was highly prevalent but not associated with increased risk of technical failure or early adverse events. Studies with longer follow-up are necessary to assess other outcomes, including device erosion. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Obstetric hemorrhage and shock management: using the low technology Non-pneumatic Anti-Shock Garment in Nigerian and Egyptian tertiary care facilities.

PubMed

Miller, Suellen; Fathalla, Mohamed M F; Ojengbede, Oladosu A; Camlin, Carol; Mourad-Youssif, Mohammed; Morhason-Bello, Imran O; Galadanci, Hadiza; Nsima, David; Butrick, Elizabeth; Al Hussaini, Tarek; Turan, Janet; Meyer, Carinne; Martin, Hilarie; Mohammed, Aminu I

2010-10-18

Obstetric hemorrhage is the leading cause of maternal mortality globally. The Non-pneumatic Anti-Shock Garment (NASG) is a low-technology, first-aid compression device which, when added to standard hypovolemic shock protocols, may improve outcomes for women with hypovolemic shock secondary to obstetric hemorrhage in tertiary facilities in low-resource settings. This study employed a pre-intervention/intervention design in four facilities in Nigeria and two in Egypt. Primary outcomes were measured mean and median blood loss, severe end-organ failure morbidity (renal failure, pulmonary failure, cardiac failure, or CNS dysfunctions), mortality, and emergency hysterectomy for 1442 women with ≥750 mL blood loss and at least one sign of hemodynamic instability. Comparisons of outcomes by study phase were assessed with rank sum tests, relative risks (RR), number needed to treat for benefit (NNTb), and multiple logistic regression. Women in the NASG phase (n = 835) were in worse condition on study entry, 38.5% with mean arterial pressure <60 mmHg vs. 29.9% in the pre-intervention phase (p = 0.001). Despite this, negative outcomes were significantly reduced in the NASG phase: mean measured blood loss decreased from 444 mL to 240 mL (p < 0.001), maternal mortality decreased from 6.3% to 3.5% (RR 0.56, 95% CI 0.35-0.89), severe morbidities from 3.7% to 0.7% (RR 0.20, 95% CI 0.08-0.50), and emergency hysterectomy from 8.9% to 4.0% (RR 0.44, 0.23-0.86). In multiple logistic regression, there was a 55% reduced odds of mortality during the NASG phase (aOR 0.45, 0.27-0.77). The NNTb to prevent either mortality or severe morbidity was 18 (12-36). Adding the NASG to standard shock and hemorrhage management may significantly improve maternal outcomes from hypovolemic shock secondary to obstetric hemorrhage at tertiary care facilities in low-resource settings.

The fate of sulfate in chronic heart failure

PubMed Central

Koning, Anne M.; Meijers, Wouter C.; Minović, Isidor; Post, Adrian; Feelisch, Martin; Pasch, Andreas; Leuvenink, Henri G. D.; de Boer, Rudolf A.; Bakker, Stephan J. L.

2017-01-01

New leads to advance our understanding of heart failure (HF) pathophysiology are urgently needed. Previous studies have linked urinary sulfate excretion to a favorable cardiovascular risk profile. Sulfate is not only the end product of hydrogen sulfide metabolism but is also directly involved in various (patho)physiological processes, provoking scientific interest in its renal handling. This study investigates sulfate clearance in chronic HF (CHF) patients and healthy individuals and considers its relationship with disease outcome. Parameters related to renal sulfate handling were determined in and compared between 96 previously characterized CHF patients and sex-matched healthy individuals. Among patients, sulfate clearance was analyzed for associations with clinical and outcome parameters. In CHF patients, plasma sulfate concentrations are significantly higher, whereas 24-h urinary excretion, fractional excretion, and clearance of sulfate are significantly lower, compared with healthy individuals. Among patients, sulfate clearance is independently associated with diuretics use, creatinine clearance and 24-h urinary sodium excretion. Sulfate clearance is associated with favorable disease outcome [hazard ratio per SD increase 0.38 (95% confidence interval 0.23–0.63), P < 0.001]. Although significance was lost after adjustment for creatinine clearance, the decrease of sulfate clearance in patients is independent of this parameter, indicating that sulfate clearance is not merely a reflection of renal function. This exploratory study reveals aberrant sulfate clearance as a potential contributor to CHF pathophysiology, with reduced levels in patients and a positive association with favorable disease outcome. Further research is needed to unravel the nature of its involvement and to determine its potential as a biomarker and target for therapy. NEW & NOTEWORTHY Sulfate clearance is decreased in chronic heart failure patients compared with healthy individuals. Among patients, sulfate clearance is positively associated with favorable disease outcome, i.e., a decreased rehospitalization rate and increased patient survival. Hence, decreased sulfate clearance may be involved in the pathophysiology of heart failure. PMID:27923792

Preimplant Histologic Acute Tubular Necrosis and Allograft Outcomes

PubMed Central

Hall, Isaac E.; Reese, Peter P.; Weng, Francis L.; Schröppel, Bernd; Doshi, Mona D.; Hasz, Rick D.; Reitsma, William; Goldstein, Michael J.; Hong, Kwangik

2014-01-01

Background and objectives The influence of deceased-donor AKI on post-transplant outcomes is poorly understood. The few published studies about deceased-donor preimplant biopsy have reported conflicting results regarding associations between AKI and recipient outcomes. Design, setting, participants, & measurements This multicenter study aimed to evaluate associations between deceased-donor biopsy reports of acute tubular necrosis (ATN) and delayed graft function (DGF), and secondarily for death-censored graft failure, first adjusting for the kidney donor risk index and then stratifying by donation after cardiac death (DCD) status. Results Between March 2010 and April 2012, 651 kidneys (369 donors, 4 organ procurement organizations) were biopsied and subsequently transplanted, with ATN reported in 110 (17%). There were 262 recipients (40%) who experienced DGF and 38 (6%) who experienced graft failure. DGF occurred in 45% of kidneys with reported ATN compared with 39% without ATN (P=0.31) resulting in a relative risk (RR) of 1.13 (95% confidence interval [95% CI], 0.9 to 1.43) and a kidney donor risk index–adjusted RR of 1.11 (95% CI, 0.88 to 1.41). There was no significant difference in graft failure for kidneys with versus without ATN (8% versus 5%). In stratified analyses, the adjusted RR for DGF with ATN was 0.97 (95% CI, 0.7 to 1.34) for non-DCD kidneys and 1.59 (95% CI, 1.23 to 2.06) for DCD kidneys (P=0.02 for the interaction between ATN and DCD on the development of DGF). Conclusions Despite a modest association with DGF for DCD kidneys, this study reveals no significant associations overall between preimplant biopsy-reported ATN and the outcomes of DGF or graft failure. The potential benefit of more rigorous ATN reporting is unclear, but these findings provide little evidence to suggest that current ATN reports are useful for predicting graft outcomes or deciding to accept or reject allograft offers. PMID:24558049

Video-enabled cue-exposure-based intervention improves postdischarge drinking outcomes among alcohol-dependent men: A prospective study at a government addiction treatment setting in India.

PubMed

Nattala, Prasanthi; Murthy, Pratima; Leung, Kit Sang; Rentala, Sreevani; Ramakrishna, Jayashree

2017-04-25

Returning to alcohol use following inpatient treatment occurs due to various real life cues/triggers. It is a challenge to demonstrate to patients how to deal with these triggers during inpatient treatment. Aims of the current study were (a) to evaluate the effectiveness of video-enabled cue-exposure-based intervention (VE-CEI) in influencing treatment outcomes in alcohol dependence, (b) to identify postdischarge predictors of intervention failure (returning to ≥50% of baseline alcohol consumption quantity/day). The VE-CEI comprises live action videos in which human characters model various alcohol use cues and strategies to deal with them effectively. The VE-CEI was administered to an inpatient alcohol-dependent sample (n = 43) and compared with treatment as usual (TAU) (n = 42) at a government addiction treatment setting in India. Patients were followed up over 6 months postdischarge to evaluate effectiveness of the VE-CEI on specific drinking outcomes. Over 6-month follow-up, VE-CEI group (vs. TAU) reported significantly lesser alcohol consumption quantity, fewer drinking days, and lower intervention failure rates. Results of multivariate Cox regression showed that participants who did not receive VE-CEI had an elevated risk of intervention failure (hazards ratio: 11.14; 95% confidence interval [4.93, 25.15]), other intervention failure predictors being early-onset dependence and increased baseline drinking. Findings provide evidence from India for effectiveness of cue-exposure-based intervention delivered using video technology in improving postdischarge treatment outcomes.

Rehabilitation Enablement in Chronic Heart Failure-a facilitated self-care rehabilitation intervention in patients with heart failure with preserved ejection fraction (REACH-HFpEF) and their caregivers: rationale and protocol for a single-centre pilot randomised controlled trial.

PubMed

Eyre, V; Lang, C C; Smith, K; Jolly, K; Davis, R; Hayward, C; Wingham, J; Abraham, C; Green, C; Warren, F C; Britten, N; Greaves, C J; Doherty, P; Austin, J; Van Lingen, R; Singh, S; Buckingham, S; Paul, K; Taylor, R S; Dalal, H M

2016-10-25

The Rehabilitation EnAblement in CHronic Heart Failure in patients with Heart Failure (HF) with preserved ejection fraction (REACH-HFpEF) pilot trial is part of a research programme designed to develop and evaluate a facilitated, home-based, self-help rehabilitation intervention to improve self-care and quality of life (QoL) in heart failure patients and their caregivers. We will assess the feasibility of a definitive trial of the REACH-HF intervention in patients with HFpEF and their caregivers. The impact of the REACH-HF intervention on echocardiographic outcomes and bloodborne biomarkers will also be assessed. A single-centre parallel two-group randomised controlled trial (RCT) with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention) or usual care alone (control) in 50 HFpEF patients and their caregivers. The REACH-HF intervention comprises a REACH-HF manual with supplementary tools, delivered by trained facilitators over 12 weeks. A mixed methods approach will be used to assess estimation of recruitment and retention rates; fidelity of REACH-HF manual delivery; identification of barriers to participation and adherence to the intervention and study protocol; feasibility of data collection and outcome burden. We will assess the variance in study outcomes to inform a definitive study sample size and assess methods for the collection of resource use and intervention delivery cost data to develop the cost-effectiveness analyses framework for any future trial. Patient outcomes collected at baseline, 4 and 6 months include QoL, psychological well-being, exercise capacity, physical activity and HF-related hospitalisation. Caregiver outcomes will also be assessed, and a substudy will evaluate impact of the REACH-HF manual on resting global cardiovascular function and bloodborne biomarkers in HFpEF patients. The study is approved by the East of Scotland Research Ethics Service (Ref: 15/ES/0036). Findings will be disseminated via journals and presentations to clinicians, commissioners and service users. ISRCTN78539530; Pre-results . Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Outcomes and complications of intracranial pressure monitoring in acute liver failure: a retrospective cohort study.

PubMed

Karvellas, Constantine J; Fix, Oren K; Battenhouse, Holly; Durkalski, Valerie; Sanders, Corron; Lee, William M

2014-05-01

To determine if intracranial pressure monitor placement in patients with acute liver failure is associated with significant clinical outcomes. Retrospective multicenter cohort study. Academic liver transplant centers comprising the U.S. Acute Liver Failure Study Group. Adult critically ill patients with acute liver failure presenting with grade III/IV hepatic encephalopathy (n = 629) prospectively enrolled between March 2004 and August 2011. Intracranial pressure monitored (n = 140) versus nonmonitored controls (n = 489). Intracranial pressure monitored patients were younger than controls (35 vs 43 yr, p < 0.001) and more likely to be on renal replacement therapy (52% vs 38%, p = 0.003). Of 87 intracranial pressure monitored patients with detailed information, 44 (51%) had evidence of intracranial hypertension (intracranial pressure > 25 mm Hg) and overall 21-day mortality was higher in patients with intracranial hypertension (43% vs 23%, p = 0.05). During the first 7 days, intracranial pressure monitored patients received more intracranial hypertension-directed therapies (mannitol, 56% vs 21%; hypertonic saline, 14% vs 7%; hypothermia, 24% vs 10%; p < 0.03 for each). Forty-one percent of intracranial pressure monitored patients received liver transplant (vs 18% controls; p < 0.001). Overall 21-day mortality was similar (intracranial pressure monitored 33% vs controls 38%, p = 0.24). Where data were available, hemorrhagic complications were rare in intracranial pressure monitored patients (4 of 56 [7%]; three died). When stratifying by acetaminophen status and adjusting for confounders, intracranial pressure monitor placement did not impact 21-day mortality in acetaminophen patients (p = 0.89). However, intracranial pressure monitor was associated with increased 21-day mortality in nonacetaminophen patients (odds ratio, ~ 3.04; p = 0.014). In intracranial pressure monitored patients with acute liver failure, intracranial hypertension is commonly observed. The use of intracranial pressure monitor in acetaminophen acute liver failure did not confer a significant 21-day mortality benefit, whereas in nonacetaminophen acute liver failure, it may be associated with worse outcomes. Hemorrhagic complications from intracranial pressure monitor placement were uncommon and cannot account for mortality trends. Although our results cannot conclusively confirm or refute the utility of intracranial pressure monitoring in patients with acute liver failure, patient selection and ancillary assessments of cerebral blood flow likely have a significant role. Prospective studies would be required to conclusively account for confounding by illness severity and transplant.

Etiology, clinical features and outcome of fulminant hepatic failure in pregnancy.

PubMed

Brohi, Zahida Parveen; Sadaf, Aneela; Perveen, Uzma

2013-09-01

To determine the etiology, clinical features and outcome of fulminant hepatic failure in pregnancy. An observational hospital based study was conducted at Isra University hospital Hyderabad from 1st March 2009 to 28th February 2010. Total 1192 obstetric patients were admitted in obstetrics & gynaecology department during this period, of whom 52 were with Fulminant hepatic failure in pregnancy and were included in this study. A pre-designed structured proforma was used. All patients had clinical history and underwent a physical examination. Routine laboratory tests, liver function tests and viral serology were performed in all cases. All results were analyzed on statistical software SPSS version 11. Frequencies and percentages were calculated, the final outcome was recorded. Out of 52, 6 (11.5%) presented in the first trimester, 4 (7.6%) in the second trimester and 42 (80.7%) were in their 3rd trimester of pregnancy. Etiology of the disease was Hepatitis E in 28 (53.8%), Hepatitis B in 9 (17.3%), Hepatitis C in 7 (13.5%) HELLP syndrome in 7 (13.5%) and acute fatty liver of pregnancy in 1 (3.57%) case. Maternal mortality was 15 (28.8%) and foetal mortality was 40 (77%). Only 12 (23.1%) new born remained alive. Fulminant hepatic failure in pregnancy has very high foetal and maternal mortality which is mostly due to viral hepatitis E.

Does improvement in self-management skills predict improvement in quality of life and depressive symptoms? A prospective study in patients with heart failure up to one year after self-management education.

PubMed

Musekamp, Gunda; Schuler, Michael; Seekatz, Bettina; Bengel, Jürgen; Faller, Hermann; Meng, Karin

2017-02-15

Heart failure (HF) patient education aims to foster patients' self-management skills. These are assumed to bring about, in turn, improvements in distal outcomes such as quality of life. The purpose of this study was to test the hypothesis that change in self-reported self-management skills observed after participation in self-management education predicts changes in physical and mental quality of life and depressive symptoms up to one year thereafter. The sample comprised 342 patients with chronic heart failure, treated in inpatient rehabilitation clinics, who received a heart failure self-management education program. Latent change modelling was used to analyze relationships between both short-term (during inpatient rehabilitation) and intermediate-term (after six months) changes in self-reported self-management skills and both intermediate-term and long-term (after twelve months) changes in physical and mental quality of life and depressive symptoms. Short-term changes in self-reported self-management skills predicted intermediate-term changes in mental quality of life and long-term changes in physical quality of life. Intermediate-term changes in self-reported self-management skills predicted long-term changes in all outcomes. These findings support the assumption that improvements in self-management skills may foster improvements in distal outcomes.

Epidemiology of invasive pulmonary aspergillosis in patients with liver failure: Clinical presentation, risk factors, and outcomes.

PubMed

Zhang, Xuan; Yang, Meifang; Hu, Jianhua; Zhao, Hong; Li, Lanjuan

2018-02-01

Objective Invasive pulmonary aspergillosis (IPA) is a severe and often lethal infection. The possible risk factors, clinical presentation, and treatment of patients with simultaneous liver failure and IPA have received little attention in previous studies. The aim of this study was to investigate the epidemiology of IPA in patients with liver failure in an effort to reduce patient mortality. Methods The patients with liver failure (including acute liver failure , sub-acute liver failure , acute-on-chronic liver failure and chronic liver failure) were recruited from 2011 to 2016. The clinical data of these patients were retrieved for the study. Results In total, 1077 patients with liver failure were included in this study. Of the 1077 patients, 53 (4.9%) had IPA. Forty-four (83%) patients with IPA died. Independent risk factors for IPA were male sex (hazard ratio [HR] = 2.542), hepatorenal syndrome (HR = 2.463), antibiotic use (HR = 4.631), and steroid exposure (HR = 18.615). Conclusions IPA is a fatal complication in patients with liver failure. Male sex, hepatorenal syndrome, antibiotic use, and steroid exposure were independent risk factors for IPA. When patients with liver failure have these risk factors and symptoms of pneumonia such as cough or hemoptysis, clinicians should be cautious about the possibility of IPA.

Fatigue failure of the cephalomedullary nail: revision options, outcomes and review of the literature.

PubMed

Tucker, Adam; Warnock, Michael; McDonald, Sinead; Cusick, Laurence; Foster, Andrew P

2018-04-01

Cephalomedullary nail (CMN) failure is a rare entity following hip fracture treatment. However, it poses significant challenges for revision surgery, both mechanically and biologically. Nail failure rates have been reported at < 2%; however, no published studies have reported revision surgery procedures and their respective outcomes. We present a regional experience, with outcomes, of the revision options. We identified 20 fatigued CMNs that underwent four different revision procedures. Mean age was 73 ± 15.24 years, with a 3:1 female preponderance, and a median ASA grade of 3. Post-operative CMN radiographs demonstrated a significant number of fractures were fixed in varus, with reductions in neck-shaft angles post-operatively. A "poor" quality of reduction resulted in significantly earlier nail failure, compared to "adequate" and "good" (p = 0.027). Tip-Apex Distance (TAD) mean was 23.2 ± 8.3 mm, and an adequate TAD with three-point fixation was seen in only 35% of cases. Mean time to failure was 401.0 ± 237.2 days, with mean age at failure of 74.0 ± 14.8 years. Options after failure included revision CMN nail, proximal femoral locking plate (PFLP), long-stem or restoration arthroplasty, or femoral endoprosthesis. Barthel Functional Index scores showed no significant difference at 3 and 12 months post-operatively, nor any difference between treatment groups. Mean 12-month mortality was 30%, akin to a primary hip fracture mortality risk according to NICE guidelines. Mortality rates were lowest in revision nails. Subsequent revision rates were higher in the PFLP group. There is no reported evidence on the best surgical technique for managing the failed CMN, with no clear functional benefit in the options above. Good surgical technique at the time of primary CMN surgery is critical in minimising fatigue failure. After revision, overall mortality rates were equivalent to reported primary hip fracture mortality rates. Further multicentre evaluations are required to assess which technique convey the best functional outcomes without compromising 12-month mortality rates.

Association between Vancomycin Day 1 Exposure Profile and Outcomes among Patients with Methicillin-Resistant Staphylococcus aureus Infective Endocarditis

PubMed Central

Casapao, Anthony M.; Lodise, Thomas P.; Davis, Susan L.; Claeys, Kimberly C.; Kullar, Ravina; Levine, Donald P.

2015-01-01

Given the critical importance of early appropriate therapy, a retrospective cohort (2002 to 2013) was performed at the Detroit Medical Center to evaluate the association between the day 1 vancomycin exposure profile and outcomes among patients with MRSA infective endocarditis (IE). The day 1 vancomycin area under the concentration-time curve (AUC0–24) and the minimum concentration at 24 h (Cmin 24) was estimated for each patient using the Bayesian procedure in ADAPT 5, an approach shown to accurately predict the vancomycin exposure with low bias and high precision with limited pharmacokinetic sampling. Initial MRSA isolates were collected and vancomycin MIC was determined by broth microdilution (BMD) and Etest. The primary outcome was failure, defined as persistent bacteremia (≥7 days) or 30-day attributable mortality. Classification and regression tree analysis (CART) was used to determine the vancomycin exposure variables associated with an increased probability of failure. In total, 139 patients met study criteria; 76.3% had right-sided IE, 16.5% had left-sided IE, and 7.2% had both left and right-sided IE. A total of 89/139 (64%) experienced failure by composite definition. In the CART analysis, failure was more pronounced in patients with an AUC0–24/MIC as determined by BMD of ≤600 relative to those with AUC0–24/MIC as determined by BMD of >600 (69.8% versus 54.7%, respectively, P = 0.073). In the logistic regression analysis, an AUC/MIC as determined by BMD of ≤600 (adjusted odds ratio, 2.3; 95% confidence interval, 1.01 to 5.37; P = 0.047) was independently associated with failure. Given the retrospective nature of the present study, further prospective studies are required but these data suggest that patients with an AUC0–24/MIC as determined by BMD of ≤600 present an increased risk of failure. PMID:25753631

Chronic obstructive airway disease among patients hospitalized with acute heart failure; clinical characteristics, precipitating factors, management and outcome: Observational report from the Middle East.

PubMed

Khafaji, Hadi A R; Sulaiman, Kadhim; Singh, Rajvir; Alhabib, Khalid F; Asaad, Nidal; Alsheikh-Ali, Alawi; Al-Jarallah, Mohammed; Bulbanat, Bassam; Almahmeed, Wael; Ridha, Mustafa; Bazargani, Nooshin; Amin, Haitham; Al-Motarreb, Ahmed; Faleh, Husam Al; Elasfar, Abdelfatah; Panduranga, Prashanth; Suwaidi, Jassim Al

2015-12-01

The purpose of this study was to report the prevalence, clinical characteristics, contributing factors, management and outcome of patients with chronic obstructive pulmonary disease (COPD) among patients hospitalized with heart failure (HF). Data were derived from Gulf Care (Gulf acute heart failure registry), a prospective multicenter study of 5005 consecutive patients hospitalized with acute heart failure during February to November 2012 in seven Middle Eastern countries. Data were described and compared for demographics, management and outcomes. The prevalence of COPD among HF patients was 10%. COPD patients were older, more likely to be female and to have diabetes, hypertension, chronic kidney disease and sleep apnea (P = 0.001 for all) when compared to non-COPD patients. Contributing factors for hospitalization were systemic infection and atrial arrhythmias in COPD patients compared to acute coronary syndrome, uncontrolled hypertension and anemia in the non-COPD patients. Left-ventricular ejection fraction was higher in COPD patients; while BNP levels were comparable between the two groups. Non-invasive ventilation was used more frequently among COPD patients compared to non-COPD patients (P = 0.001). On multivariate logistic regression analysis, COPD was not associated with increased risk in-hospital and one-year death among acute heart failure (AHF) population and β blockers treatment appear to have neutral mortality effect in COPD patients with HF. COPD have distinct cardiovascular risk profile and precipitating factors for hospitalization with HF when compared to non-COPD patients. COPD history had no impact on the short-term and one-year mortality.

Low diastolic blood pressure and adverse outcomes in heart failure with preserved ejection fraction.

PubMed

Tsujimoto, Tetsuro; Kajio, Hiroshi

2018-07-15

It remains unknown whether a low diastolic blood pressure (DBP) increases the risks of cardiovascular events and death in patients with heart failure with preserved ejection fraction (HFpEF). We used data from the TOPCAT trial. The primary outcome was a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure. Hazard ratios (HRs) were analyzed for DBPs of <60, 60-69, 70-79, and ≥90 mm Hg in comparison with a DBP of 80-89 mm Hg using multivariable Cox proportional hazard models. This study included 3417 patients with HFpEF who had a controlled blood pressure. In the mean follow-up period of 3.0 years, 881 patients experienced at least one confirmed primary outcome event. Compared with patients with a DBP of 80-89 mm Hg, the adjusted HRs for primary outcome events were significantly higher in those with DBPs of <60 mm Hg (HR: 2.19 [95% confidence interval,1.72-2.78]) and 60-69 mm Hg (HR: 1.52 [1.23-1.87]). Similarly, the adjusted HRs for all-cause death, major cardiovascular events, and hospitalization for heart failure, but not stroke, were significantly higher in patients with a DBP of <70 mm Hg. A relationship between a low DBP and adverse outcomes was found in HFpEF patients with a systolic blood pressure of ≥120 mm Hg; however, a low systolic blood pressure with a DBP of ≥70 mm Hg was not associated with these event risks. A low DBP increased the risks of adverse outcomes in patients with HFpEF. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Iron deficiency and anemia in heart failure.

PubMed

Çavuşoğlu, Yüksel; Altay, Hakan; Çetiner, Mustafa; Güvenç, Tolga Sinan; Temizhan, Ahmet; Ural, Dilek; Yeşilbursa, Dilek; Yıldırım, Nesligül; Yılmaz, Mehmet Birhan

2017-03-01

Heart failure is an important community health problem. Prevalence and incidence of heart failure have continued to rise over the years. Despite recent advances in heart failure therapy, prognosis is still poor, rehospitalization rate is very high, and quality of life is worse. Co-morbidities in heart failure have negative impact on clinical course of the disease, further impair prognosis, and add difficulties to treatment of clinical picture. Therefore, successful management of co-morbidities is strongly recommended in addition to conventional therapy for heart failure. One of the most common co-morbidities in heart failure is presence of iron deficiency and anemia. Current evidence suggests that iron deficiency and anemia are more prevalent in patients with heart failure and reduced ejection fraction, as well as those with heart failure and preserved ejection fraction. Moreover, iron deficiency and anemia are referred to as independent predictors for poor prognosis in heart failure. There is strong relationship between iron deficiency or anemia and severity of clinical status of heart failure. Over the last two decades, many clinical investigations have been conducted on clinical effectiveness of treatment of iron deficiency or anemia with oral iron, intravenous iron, and erythropoietin therapies. Studies with oral iron and erythropoietin therapies did not provide any clinical benefit and, in fact, these therapies have been shown to be associated with increase in adverse clinical outcomes. However, clinical trials in patients with iron deficiency in the presence or absence of anemia have demonstrated considerable clinical benefits of intravenous iron therapy, and based on these positive outcomes, iron deficiency has become target of therapy in management of heart failure. The present report assesses current approaches to iron deficiency and anemia in heart failure in light of recent evidence.

The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis

PubMed Central

Perl, Jeffrey; Davies, Simon J.; Lambie, Mark; Pisoni, Ronald L.; McCullough, Keith; Johnson, David W.; Sloand, James A.; Prichard, Sarah; Kawanishi, Hideki; Tentori, Francesca; Robinson, Bruce M.

2016-01-01

♦ Background: Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD. ♦ Methods: The PDOPPS is an international prospective cohort study in Australia, Canada, Japan, the United Kingdom (UK), and the United States (US). Each country is enrolling a random sample of incident and prevalent patients from national samples of 20 to 80 sites with at least 20 patients on PD. Enrolled patients will be followed over an initial 3-year study period. Demographic, comorbidity, and treatment-related variables, and patient-reported data, will be collected over the study course. The primary outcome will be all-cause PD technique failure or death; other outcomes will include cause-specific technique failure, hospitalizations, and patient-reported outcomes. ♦ Results: A high proportion of the targeted number of study sites has been recruited to date in each country. Several ancillary studies have been funded with high momentum toward expansion to new countries and additional participation. ♦ Conclusion: The PDOPPS is the first large, international study to follow PD patients longitudinally to capture clinical practice. With data collected, the study will serve as an invaluable resource and research platform for the international PD community, and provide a means to understand variation in PD practices and outcomes, to identify optimal practices, and to ultimately improve outcomes for PD patients. PMID:26526049

The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis.

PubMed

Perl, Jeffrey; Davies, Simon J; Lambie, Mark; Pisoni, Ronald L; McCullough, Keith; Johnson, David W; Sloand, James A; Prichard, Sarah; Kawanishi, Hideki; Tentori, Francesca; Robinson, Bruce M

2016-01-01

♦ Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD. ♦ The PDOPPS is an international prospective cohort study in Australia, Canada, Japan, the United Kingdom (UK), and the United States (US). Each country is enrolling a random sample of incident and prevalent patients from national samples of 20 to 80 sites with at least 20 patients on PD. Enrolled patients will be followed over an initial 3-year study period. Demographic, comorbidity, and treatment-related variables, and patient-reported data, will be collected over the study course. The primary outcome will be all-cause PD technique failure or death; other outcomes will include cause-specific technique failure, hospitalizations, and patient-reported outcomes. ♦ A high proportion of the targeted number of study sites has been recruited to date in each country. Several ancillary studies have been funded with high momentum toward expansion to new countries and additional participation. ♦ The PDOPPS is the first large, international study to follow PD patients longitudinally to capture clinical practice. With data collected, the study will serve as an invaluable resource and research platform for the international PD community, and provide a means to understand variation in PD practices and outcomes, to identify optimal practices, and to ultimately improve outcomes for PD patients. Copyright © 2016 International Society for Peritoneal Dialysis.

Transitional care programs improve outcomes for heart failure patients: an integrative review.

PubMed

Stamp, Kelly D; Machado, Monique A; Allen, Nancy A

2014-01-01

Individuals with heart failure are frequently rehospitalized owing to a lack of knowledge concerning how to perform their self-care and when to inform their healthcare provider of worsening symptoms. Because there are an overwhelming number of hospital readmissions for individuals with heart failure, efforts are underway to discover how they can be supported and educated during their hospitalization and subsequently followed by a nurse after discharge for continued education and support. The purpose of this integrative review was to critically examine the interventions, quality of life, and readmission rates of individuals with heart failure who are enrolled in a transitional care program. The second aim was to examine the cost-effectiveness of nurse-led transitional care programs. The results of this integrative review (n = 20) showed that transitional care programs for individuals with heart failure can increase a patient's quality of life and decrease the number of readmissions and the overall cost of care. The types of interventions that were most successful in decreasing readmissions used home visits alone or in combination with telephone calls. There is a need for nurse researchers to address gaps in transitional care for heart failure patients by performing studies with larger randomized clinical trials and measuring outcomes such as readmissions at regular intervals over the study period. The Patient Protection and Affordable Care Act will change reimbursement for heart failure readmissions and presents opportunities for healthcare teams to build transitional care programs for patients with conditions such as heart failure. This integrative review can be used to determine effective intervention strategies for transitional care programs and highlights the gaps in research. Healthcare teams that use these programs within their practice may increase continuity of care and quality of life and decrease readmissions and healthcare costs for individuals with heart failure.

Results of revision anterior shoulder stabilization surgery in adolescent athletes.

PubMed

Blackman, Andrew J; Krych, Aaron J; Kuzma, Scott A; Chow, Roxanne M; Camp, Christopher; Dahm, Diane L

2014-11-01

The purpose of this study was to determine failure rates, functional outcomes, and risk factors for failure after revision anterior shoulder stabilization surgery in high-risk adolescent athletes. Adolescent athletes who underwent primary anterior shoulder stabilization were reviewed. Patients undergoing subsequent revision stabilization surgery were identified and analyzed. Failure rates after revision surgery were assessed by Kaplan-Meier analysis. Failure was defined as recurrent instability requiring reoperation. Functional outcomes included the Marx activity score; American Shoulder and Elbow Surgeons score; and University of California, Los Angeles score. The characteristics of patients who required reoperation for recurrent instability after revision surgery were compared with those of patients who required only a single revision to identify potential risk factors for failure. Of 90 patients who underwent primary anterior stabilization surgery, 15 (17%) had failure and underwent revision surgery (mean age, 16.6 years; age range, 14 to 18 years). The mean follow-up period was 5.5 years (range, 2 to 12 years). Of the 15 revision patients, 5 (33%) had recurrent dislocations and required repeat revision stabilization surgery at a mean of 50 months (range, 22 to 102 months) after initial revision. No risk factors for failure were identified. The Kaplan-Meier reoperation-free estimates were 86% (95% confidence interval, 67% to 100%) at 24 months and 78% (95% confidence interval, 56% to 100%) at 48 months after revision surgery. The mean final Marx activity score was 14.8 (range, 5 to 20); American Shoulder and Elbow Surgeons score, 82.1 (range, 33 to 100); and University of California, Los Angeles score, 30.8 (range, 16 to 35). At 5.5 years' follow-up, adolescent athletes had a high failure rate of revision stabilization surgery and modest functional outcomes. We were unable to convincingly identify specific risk factors for failure of revision surgery. Level IV, retrospective therapeutic case series. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Why do some therapists not deal with outcome monitoring feedback? A feasibility study on the effect of regulatory focus and person-organization fit on attitude and outcome.

PubMed

de Jong, Kim; de Goede, Marije

2015-01-01

Despite research on its effectiveness, many therapists still have negative attitudes toward using outcome monitoring feedback. The current study aims to investigate how the perceived match between values of an individual and those of the organization (Person-Organization fit; PO fit), and motivation to prevent failure or to achieve success (regulatory focus) are related to therapists' attitude, attitude changes over time, and outcomes. Therapists (n = 20) filled out a feedback attitude questionnaire at two points in time: before the start of outcome monitoring, and after six months. In addition, they completed measures on PO fit and regulatory focus. PO fit was predictive of outcomes, when feedback was provided, but did not predict therapists' attitude. Therapists with a strong prevention focus (prevent failures), had a more positive attitude toward feedback, but achieved slower symptom reduction in their at risk cases. A strong promotion focus (achieve success) was not predictive of attitude, but did result in faster symptom reduction in at risk patients when feedback was provided. Therapists motivational approach to work and the perceived match with the organization they work for, can influence both their attitude toward outcome monitoring and their outcomes.

Effect of spironolactone on 30-day death and heart failure rehospitalization (from the COACH Study).

PubMed

Maisel, Alan; Xue, Yang; van Veldhuisen, Dirk J; Voors, Adriaan A; Jaarsma, Tiny; Pang, Peter S; Butler, Javed; Pitt, Bertram; Clopton, Paul; de Boer, Rudolf A

2014-09-01

The aim of our study is to investigate the effect of spironolactone on 30-day outcomes in patients with acute heart failure (AHF) and the association between treatment and outcomes stratified by biomarkers. We conducted a secondary analysis of the biomarker substudy of the multicenter COACH (Co-ordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure) trial involving 534 AHF patients for 30-day mortality and HF rehospitalizations. Spironolactone therapy was initiated and terminated at the discretion of the treating physician; 30-day outcomes were compared between patients who were treated with spironolactone and those who were not. Outcomes with spironolactone therapy were explored based on N-terminal pro-B-type natriuretic peptide, ST2, galectin-3, and creatinine levels. Spironolactone was prescribed to 297 (55.6%) patients at discharge (158 new and 139 continued). There were 19 deaths and 30 HF rehospitalizations among 46 patients by 30 days. Patients discharged on spironolactone had significantly less 30-day event (hazard ratio 0.538, p = 0.039) after adjustment for multiple risk factors. Initiation of spironolactone in patients who were not on spironolactone before admission was associated with a significant reduction in event rate (hazard ratio 0.362, p = 0.027). The survival benefit of spironolactone was more prominent in patient groups with elevations of creatinine, N-terminal pro-B-type natriuretic peptide, ST2, or galectin-3. In conclusion, AHF patients who received spironolactone during hospitalization had significantly fewer 30-day mortality and HF rehospitalizations, especially in high-risk patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Baccalaureate education in nursing and patient outcomes.

PubMed

Blegen, Mary A; Goode, Colleen J; Park, Shin Hye; Vaughn, Thomas; Spetz, Joanne

2013-02-01

The aim of this study was to examine the effects of registered nurse (RN) education by determining whether nurse-sensitive patient outcomes were better in hospitals with a higher proportion of RNs with baccalaureate degrees. The Future of Nursing report recommends increasing the percentage of RNs with baccalaureate degrees from 50% to 80% by 2020. Research has linked RN education levels to hospital mortality rates but not with other nurse-sensitive outcomes. This was a cross-sectional study that, with the use of data from 21 University HealthSystem Consortium hospitals, analyzed the association between RN education and patient outcomes (risk-adjusted patient safety and quality of care indicators), controlling for nurse staffing and hospital characteristics. Hospitals with a higher percentage of RNs with baccalaureate or higher degrees had lower congestive heart failure mortality, decubitus ulcers, failure to rescue, and postoperative deep vein thrombosis or pulmonary embolism and shorter length of stay. The recommendation of the Future of Nursing report to increase RN education levels is supported by these findings.

Nutritional Deficiency in Patients with Heart Failure.

PubMed

Sciatti, Edoardo; Lombardi, Carlo; Ravera, Alice; Vizzardi, Enrico; Bonadei, Ivano; Carubelli, Valentina; Gorga, Elio; Metra, Marco

2016-07-22

Heart failure (HF) is the main cause of mortality and morbidity in Western countries. Although evidence-based treatments have substantially improved outcomes, prognosis remains poor with high costs for health care systems. In patients with HF, poor dietary behaviors are associated with unsatisfactory quality of life and adverse outcome. The HF guidelines have not recommended a specific nutritional strategy. Despite the role of micronutrient deficiency, it has been extensively studied, and data about the efficacy of supplementation therapy in HF are not supported by large randomized trials and there is limited evidence regarding the outcomes. The aim of the present review is to analyze the state-of-the-art of nutritional deficiencies in HF, focusing on the physiological role and the prognostic impact of micronutrient supplementation.

Novel Predictors of Peritonitis-Related Outcomes in the BRAZPD Cohort

PubMed Central

de Moraes, Thyago Proença; Olandoski, Marcia; Caramori, Jaqueline C.T.; Martin, Luis C.; Fernandes, Natália; Divino-Filho, José Carolino; Pecoits-Filho, Roberto; Barretti, Pasqual

2014-01-01

♦ Introduction: Peritonitis remains the main cause of peritoneal dialysis (PD) technique failure worldwide, despite significant reductions in infection rates observed over the past decades. Several studies have described risk factors for peritonitis, technique failure and mortality. However, there are scarce data regarding predictors of complications during and after a peritonitis episode. The aim of our study was to analyze predictors of peritonitis-related outcome in the Brazilian Peritoneal Dialysis study (BRAZPD) cohort. ♦ Methods: All adult incident patients recruited in the BRAZPD Study between December 2004 and October 2007, who remained at least 90 days on PD and presented their first peritonitis episode (n = 474 patients) were included in the study. The endpoints analyzed were non-resolution, death due to a peritonitis episode and long-term technique survival after a peritonitis episode. ♦ Results: In the multivariable regression, non-resolution was independently associated with older age (odds ratio (OR) 1.02; p < 0.01), collagenosis as the primary renal disease (OR 4.6; p < 0.05) and Pseudomonas spp as etiological agent (OR 2.9; p < 0.05). Patients who were transferred from APD to CAPD during peritonitis therapy presented a higher risk of non-response (OR 2.5; p < 0.05). The only factor associated with death during a peritonitis episode was older age (OR 1.04; p < 0.05). Exposure to vancomycin and male gender were the independent predictors of long-term technique failure (OR 2.2; p < 0.01). ♦ Conclusion: Apart from confirming previous observations of the negative impact of older age and Pseudomonas spp peritonitis on outcomes, we observed that collagenosis may negatively impact response to treatment and exposure to vancomycin may possibly reduce long-term technique survival. It is important to emphasize that the association of vancomycin with technique failure does not prove causality. These findings shed light on new factors predicting outcome when peritonitis is diagnosed. PMID:24385333

A Systematic Review of Outcome Measurements and Quality of Studies Evaluating Fixed Tooth-Supported Restorations

PubMed Central

Patel, Devangkumar Rajnikant; O'Brien, Tim; Petrie, Aviva; Petridis, Haralampos

2014-01-01

Purpose The purpose of this systematic review was to review clinical studies of fixed tooth-supported prostheses, and to assess the quality of evidence with an emphasis on the assessment of the reporting of outcome measurements. Multiple hypotheses were generated to compare the effect of study type on different outcome modifiers and to compare the quality of publications before and after January 2005. Materials and Methods An electronic search was conducted using specific databases (MEDLINE via Ovid, EMBASE via Ovid, Cochrane Library) through July 2012. This was complemented by hand searching the past 10 years of issues of the Journal of Oral Rehabilitation, Journal of Prosthetic Dentistry, Journal of Prosthodontics, and the International Journal of Prosthodontics. All experimental and observational clinical studies evaluating survival, success, failure, and complications of tooth-supported extracoronal fixed partial dentures, crowns, and onlays were included. No restrictions on age or follow-up time were placed. Results The electronic search generated 14,869 papers, of which 206 papers were included for full-text review. Hand-searching added 23 papers. Inclusion criteria were met by 182 papers and were included for the review. The majority were retrospective studies. Only 8 (4.4%) were randomized controlled trials. The majority of the studies measured survival and failure, and few studies recorded data on success; however, more than 60% of the studies failed to define survival, success, and failure. Many studies did not use any standardized criteria for assessment of the quality of the restorations and, when standardized criteria were used, they were modified, thereby not allowing for comparisons with other studies. There was an increase of 21.8% in the number of studies evaluating outcome measurements of all-ceramic restorations in past 8 years. Conclusions Prosthodontic literature presents with a reduced percentage of RCTs compared to other disciplines in dentistry. The overall quality of recording prosthodontic outcome measurements has not improved greatly in the past 8 years. PMID:24947268

Change the management of patients with heart failure: Rationale and design of the CHAMP-HF registry.

PubMed

DeVore, Adam D; Thomas, Laine; Albert, Nancy M; Butler, Javed; Hernandez, Adrian F; Patterson, J Herbert; Spertus, John A; Williams, Fredonia B; Turner, Stuart J; Chan, Wing W; Duffy, Carol I; McCague, Kevin; Mi, Xiaojuan; Fonarow, Gregg C

2017-07-01

Heart failure (HF) with reduced ejection fraction (HFrEF) is a common and costly condition that diminishes patients' health status and confers a poor prognosis. Despite the availability of multiple guideline-recommended pharmacologic and cardiac device therapies for patients with chronic HFrEF, outcomes remain suboptimal. Currently, there is limited insight into the rationale underlying clinical decisions by health care providers and patient factors that guide the use and intensity of outpatient HF treatments. A better understanding of current practice patterns has the potential to improve patients' outcomes. The CHAnge the Management of Patients with Heart Failure (CHAMP-HF) registry will evaluate the care and outcomes of patients with chronic HFrEF by assessing real-world treatment patterns, as well as the reasons for and barriers to medication treatment changes. CHAMP-HF will enroll approximately 5,000 patients with chronic HFrEF (left ventricular ejection fraction ≤40%) at approximately 150 US sites, and patients will be followed for a maximum duration of 24 months. Participating sites will collect data from both providers (HF history, examination findings, results of diagnostic studies, pharmacotherapy treatment patterns, decision-making factors, and clinical outcomes) and patients (medication adherence and patient-reported outcomes). The CHAMP-HF registry will provide a unique opportunity to study practice patterns and the adoption of new HF therapies across a diverse mix of health care providers and outpatient practices in the United States that care for HFrEF patients. Copyright © 2017 Elsevier Inc. All rights reserved.

The evolving landscape of quality measurement for heart failure

PubMed Central

Fitzgerald, Ashley A.; Allen, Larry A.; Masoudi, Frederick A.

2013-01-01

Heart failure (HF) is a major cause of mortality and morbidity, representing a leading cause of death and hospitalization among U.S. Medicare beneficiaries. Advances in science have generated effective interventions to reduce adverse outcomes in HF, particularly in patients with reduced left ventricular ejection fraction. Unfortunately, effective therapies for heart failure are often not utilized in an effective, safe, timely, equitable, patient-centered, and efficient manner. Further, the risk of adverse outcomes for HF remains high. The last decades have witnessed the growth of efforts to measure and improve the care and outcomes of patients with HF. This paper will review the evolution of quality measurement for HF, including a brief history of quality measurement in medicine; the measures that have been employed to characterize quality in heart failure; how the measures are obtained; how measures are employed; and present and future challenges surrounding quality measurement in heart failure. PMID:22548579

Echinocandins Compared to Fluconazole for Candidemia of a Urinary Tract Source: A Propensity Score Analysis.

PubMed

Cuervo, Guillermo; Garcia-Vidal, Carolina; Puig-Asensio, Mireia; Vena, Antonio; Meije, Yolanda; Fernández-Ruiz, Mario; González-Barberá, Eva; Blanco-Vidal, María José; Manzur, Adriana; Cardozo, Celia; Gudiol, Carlota; Montejo, José Miguel; Pemán, Javier; Ayats, Josefina; Aguado, Jose María; Muñoz, Patricia; Marco, Francesc; Almirante, Benito; Carratalà, Jordi

2017-05-15

Whether echinocandins could be used to treat candidemia of a urinary tract source (CUTS) is unknown. We aimed to provide current epidemiological information of CUTS and to compare echinocandin to fluconazole treatment on CUTS outcomes. A multicenter study of adult patients with candidemia was conducted in 9 hospitals. CUTS was defined as a candidemia with concomitant candiduria by the same organism associated with significant urological comorbidity. The primary outcome assessed was clinical failure (defined by 7-day mortality or persistent candidemia) in patients treated with either an echinocandin or fluconazole. A propensity score was calculated and then entered into a regression model. Of 2176 episodes of candidemia, 128 were CUTS (5.88%). Most CUTS cases were caused by Candida albicans (52.7%), followed by Candida glabrata (25.6%) and Candida tropicalis (16.3%). Clinical failure occurred in 7 patients (20%) treated with an echinocandin and in 15 (17.1%) treated with fluconazole (P = .730). Acute renal failure (adjusted odds ratio [AOR], 3.01; 95% confidence interval [CI], 1.01-8.91; P = .047) was the only independent factor associated with clinical failure, whereas early urinary tract drainage procedures (surgical, percutaneous, or endoscopic) were identified as protective (AOR, 0.08; 95% CI, .02-.31; P < .001). Neither univariate nor multivariate analysis showed that echinocandin therapy altered the risk of clinical failure. Initial echinocandin therapy was not associated with clinical failure in patients with CUTS. Notably, acute renal failure predicted worse outcomes and performing an early urologic procedure was a protective measure. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com

Urgent Chemotherapy in Sepsis-Like Shock Related to Hematologic Malignancies.

PubMed

Cherruault, Marlène; Le Goff, Marielle; Tamburini, Jérôme; Pène, Frédéric

2018-05-01

Hematologic malignancies may result in multiple organ involvement including pulmonary and renal dysfunctions, and the less common acute circulatory failure. We herein addressed the outcome of patients with sepsis-like shock related to aggressive hematologic malignancies. A 10-year (2007-2016) monocenter retrospective study. A medical ICU in a tertiary care center. Patients with circulatory shock requiring vasopressors and who subsequently received chemotherapy. Shock was presumably related to the underlying malignancy after ruling out an ongoing or new-onset infectious process. The extent and time course of organ failures was assessed by a modified Sequential Organ Failure Assessment score devoid of the platelet component. None. Seventeen patients were included, including 13 with non-Hodgkin lymphoma, two with hyperleukocytic acute myeloid leukemia, and two with "Human Herpes virus 8"-associated multicentric Castleman's disease. The following associated conditions prompted urgent administration of chemotherapy: tumor lysis syndrome (n = 10), hemophagocytic lymphohistiocytosis (n = 3), compressive bulky tumor (n = 3), pulmonary involvement (n = 3), and disseminated intravascular coagulation (n = 1). Following the initiation of chemotherapy, a number of patients died rapidly from untractable multiple organ failure. In contrast, chemotherapy led to a fast and dramatic improvement in organ failures in early survivors, as shown by the decrease in the modified Sequential Organ Failure Assessment score. However, the overall outcome was poor since only four and three patients could be discharged alive from the ICU and the hospital, and three and two patients remained alive at 6 months and 1 year. Multiple organ dysfunction syndrome related to hematologic malignancies is associated with a dismal outcome. A chemotherapy trial may provide a fast prognostic assessment of the reversibility of organ failure.

Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial.

PubMed

Jelovsek, J Eric; Barber, Matthew D; Brubaker, Linda; Norton, Peggy; Gantz, Marie; Richter, Holly E; Weidner, Alison; Menefee, Shawn; Schaffer, Joseph; Pugh, Norma; Meikle, Susan

2018-04-17

Uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) are commonly performed pelvic organ prolapse procedures despite a lack of long-term efficacy data. To compare outcomes in women randomized to (1) ULS or SSLF and (2) usual care or perioperative behavioral therapy and pelvic floor muscle training (BPMT) for vaginal apical prolapse. This 2 × 2 factorial randomized clinical trial was conducted at 9 US medical centers. Eligible participants who completed the Operations and Pelvic Muscle Training in the Management of Apical Support Loss Trial enrolled between January 2008 and March 2011 and were followed up 5 years after their index surgery from April 2011 through June 2016. Two randomizations: (1) BPMT (n = 186) or usual care (n = 188) and (2) surgical intervention (ULS: n = 188 or SSLF: n = 186). The primary surgical outcome was time to surgical failure. Surgical failure was defined as (1) apical descent greater than one-third of total vaginal length or anterior or posterior vaginal wall beyond the hymen or retreatment for prolapse (anatomic failure), or (2) bothersome bulge symptoms. The primary behavioral outcomes were time to anatomic failure and Pelvic Organ Prolapse Distress Inventory scores (range, 0-300). The original study randomized 374 patients, of whom 309 were eligible for this extended trial. For this study, 285 enrolled (mean age, 57.2 years), of whom 244 (86%) completed the extended trial. By year 5, the estimated surgical failure rate was 61.5% in the ULS group and 70.3% in the SSLF group (adjusted difference, -8.8% [95% CI, -24.2 to 6.6]). The estimated anatomic failure rate was 45.6% in the BPMT group and 47.2% in the usual care group (adjusted difference, -1.6% [95% CI, -21.2 to 17.9]). Improvements in Pelvic Organ Prolapse Distress Inventory scores were -59.4 in the BPMT group and -61.8 in the usual care group (adjusted mean difference, 2.4 [95% CI, -13.7 to 18.4]). Among women who had undergone vaginal surgery for apical pelvic organ vaginal prolapse, there was no significant difference between ULS and SSLF in rates of surgical failure and no significant difference between perioperative behavioral muscle training and usual care on rates of anatomic success and symptom scores at 5 years. Compared with outcomes at 2 years, rates of surgical failure increased during the follow-up period, although prolapse symptom scores remained improved. clinicaltrials.gov Identifier: NCT01166373.

New echocardiographic predictors of clinical outcome in patients presenting with heart failure and a preserved left ventricular ejection fraction: a subanalysis of the Ka (Karolinska) Ren (Rennes) Study.

PubMed

Donal, Erwan; Lund, Lars H; Oger, Emmanuel; Hage, Camilla; Persson, Hans; Reynaud, Amélie; Ennezat, Pierre-Vladimir; Bauer, Fabrice; Drouet, Elodie; Linde, Cecilia; Daubert, Claude

2015-07-01

To identify electrocardiographic and echocardiographic predictors of mortality and hospitalizations for heart failure (HF) in the KaRen study. KaRen is a prospective, observational study of the long-term outcomes of patients presenting with heart failure and a preserved ejection fraction (HFpEF). We identified 538 patients who presented with acute cardiac decompensation, a >100 pg/mL serum b-type natriuretic peptide (BNP) or >300 pg/mL N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration and a left ventricular ejection fraction (LVEF) >45%. After 4-8 weeks of standard treatment, 413 patients (mean age = 76 ± 9 years, 55.9% women) returned for analyses of their clinical status, laboratory screen, and detailed electrocardiographic and Doppler echocardiographic recordings. They were followed for a mean of 28 months thereafter. The primary study endpoint was time to death from all causes or first hospitalization for heart failure. Mean LVEF was 62.4 ± 6.9% and median NT-proBNP 1410 pmol/L. PR interval >200 ms was present in 11.2% of patients and 14.9% had a >120 ms QRS duration, with left bundle branch block in only 6.3%. Over a mean follow-up of 28 months, 177 patients (42.9%) reached a primary study endpoint, including 61 deaths and 116 hospitalizations for heart failure. After adjustment for age, gender, New York Heart Association class, atrial fibrillation history, creatinine, sodium, BNP, ejection fraction, and right ventricular fractional shortening, only E/e' remained as a predictor, with a hazard ratio = 1.49 and P = 0.0012. The incidence of hospitalizations for HF and deaths in KaRen was high and E/e' predicted adverse clinical outcomes. These observations should help in the risk stratification and therapy of HFpEF. © 2015 The Authors. European Journal of Heart Failure © 2015 European Society of Cardiology.

Serum Phosphorus and Risk of Cardiovascular Disease, All-Cause Mortality, or Graft Failure in Kidney Transplant Recipients: An Ancillary Study of the FAVORIT Trial Cohort

PubMed Central

Merhi, Basma; Shireman, Theresa; Carpenter, Myra A.; Kusek, John W.; Jacques, Paul; Pfeffer, Marc; Rao, Madhumathi; Foster, Meredith C.; Kim, S. Joseph; Pesavento, Todd E.; Smith, Stephen R.; Kew, Clifton E.; House, Andrew A.; Gohh, Reginald; Weiner, Daniel E.; Levey, Andrew S.; Ix, Joachim H.; Bostom, Andrew

2017-01-01

Background Mild hyperphosphatemia is a putative risk factor for cardiovascular disease [CVD], loss of kidney function, and mortality. Very limited data are available from sizable multicenter kidney transplant recipient (KTR) cohorts assessing the potential relationships between serum phosphorus levels and the development of CVD outcomes, transplant failure, or all-cause mortality. Study Design Cohort study. Setting & Participants The Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial, a large, multicenter, multiethnic, controlled clinical trial that provided definitive evidence that high-dose vitamin B–based lowering of plasma homocysteine levels did not reduce CVD events, transplant failure, or total mortality in stable KTRs. Predictor Serum phosphorus levels were determined in 3,138 FAVORIT trial participants at randomization. Results During a median follow-up of 4.0 years, the cohort had 436 CVD events, 238 transplant failures, and 348 deaths. Proportional hazards modeling revealed that each 1-mg/dL higher serum phosphorus level was not associated with a significant increase in CVD risk (HR, 1.06; 95% CI, 0.92–1.22), but increased transplant failure (HR, 1.36; 95% CI, 1.15–1.62) and total mortality risk associations (HR, 1.21; 95% CI, 1.04–1.40) when adjusted for treatment allocation, traditional CVD risk factors, kidney measures, type of kidney transplant, transplant vintage, and use of calcineurin inhibitors, steroids, or lipid-lowering drugs. These associations were strengthened in models without kidney measures: CVD (HR, 1.14; 95% CI, 1.00–1.31), transplant failure (HR, 1.72; 95% CI, 1.46–2.01), and mortality (HR, 1.34; 95% CI, 1.15–1.54). Limitations We lacked data for concentrations of parathyroid hormone, fibroblast growth factor 23, or vitamin D metabolites. Conclusions Serum phosphorus level is marginally associated with CVD and more strongly associated with transplant failure and total mortality in long-term KTRs. A randomized controlled clinical trial in KTRs that assesses the potential impact of phosphorus-lowering therapy on these hard outcomes may be warranted. PMID:28579423

Baseline severity but not gender modulates quantified Crataegus extract effects in early heart failure--a pooled analysis of clinical trials.

PubMed

Eggeling, Thomas; Regitz-Zagrosek, Vera; Zimmermann, Andrea; Burkart, Martin

2011-11-15

The efficacy of quantified Crataegus extract in chronic heart failure (CHF) has been assessed in numerous clinical studies. The present pooled analysis evaluates the impact of baseline severity and gender on objective and patient-reported endpoints and associations between both types of outcomes in patients with early CHF. Available data from 687 individual patients treated with quantified Crataegus extract or placebo in ten studies were pooled. Treatment effects on physiologic outcome parameters and on symptoms were analysed for their association with baseline severity and gender. Changes in symptom scores were investigated with respect to their relation to physiologic outcome parameters. Results were compared with observations in a 3-year cohort study. Physiologic outcome parameters maximal workload (MWL), left ventricular ejection fraction (LVEF) and pressure-heart rate product increase (PHRPI) at 50 W ergometric exercise improved more in active treatment than in placebo patients. Magnitude of improvement was independent from baseline for LVEF but increased for MWL and PHRPI with baseline severity. Improvement of typical symptoms like reduced exercise tolerance, exertional dyspnea, weakness, fatigue, and palpitations improved more with active treatment and in patients with more severe symptoms. A weak association between improvements in MWL, PRHP, and symptoms could be demonstrated. Gender differences in treatment effects could be explained by baseline differences. Results of the pooled analysis are in agreement with observations in the cohort study. Crataegus extract treatment effects on physiologic outcomes and typical symptoms were modulated by baseline severity. Taking baseline differences into account, benefits were comparable in male and female patients with impaired exercise-tolerance in early chronic heart-failure. Copyright © 2011 Elsevier GmbH. All rights reserved.

Rearrest and Probation Violation Outcomes among Probationers Participating in a Jail-Based Substance-Abuse Treatment Used as an Intermediate Sanction

ERIC Educational Resources Information Center

Linhorst, Donald M.; Dirks-Linhorst, P. Ann; Groom, Ralph

2012-01-01

This study compares the characteristics of two groups of probationers ordered to jail-based substance-abuse treatment as an intermediate sanction. It further reviews rearrest and probation failure outcomes of the two groups, along with the demographic, clinical, and criminal factors associated with those outcomes. Probationers jailed for probation…

Limited experience, high body mass index and previous urethral surgery are risk factors for failure in open urethroplasty due to penile strictures.

PubMed

Ekerhult, Teresa O; Lindqvist, Klas; Peeker, Ralph; Grenabo, Lars

2015-01-01

The aim of this study was to evaluate outcomes and possible risk factors for failure of open urethroplasty due to penile urethral strictures. A retrospective chart review was undertaken of 90 patients with penile stricture undergoing 109 open urethroplasties between 2000 and 2011. In 80 urethroplasties, a one-stage procedure was performed: 68 of these had a pediculated penile skin flap, nine had a free buccal mucosal graft and three had a free skin graft. A two-stage procedure using buccal mucosa was performed in 29 urethroplasties. Failure was defined as when further urethral instrumentation was needed. The mean age in the one-stage and two-stage groups were 50 and 54 years, respectively. The success rates in the corresponding groups were 65% and 72%, with follow-up times of 63 and 40 months, respectively. Multivariable analyses disclosed body mass index (BMI) and previous urethral surgery to be significant risk factors for failure in the one-stage group. Failure over time significantly decreased during the study period. Both one- and two-stage penile urethroplasty demonstrated success rates in line with previous reports. Limited experience, high BMI and previous urethral surgery appear to be associated with less favourable outcome.

A matched-cohort study of health services utilization and financial outcomes for a heart failure disease-management program in elderly patients.

PubMed

Berg, Gregory D; Wadhwa, Sandeep; Johnson, Alan E

2004-10-01

To investigate the utilization and financial outcomes of a telephonic nursing disease-management program for elderly patients with heart failure. A 1-year concurrent matched-cohort study employing propensity score matching. Medicare+Choice recipients residing in Ohio, Kentucky, and Indiana. A total of 533 program participants aged 65 and older matched to nonparticipants. Disease-management heart failure program employing a structured, evidence-based, telephonic nursing intervention designed to provide patient education, counseling, and monitoring services. Medical service utilization, including hospitalizations, emergency department visits, medical doctor visits, skilled nursing facility (SNF) days, selected clinical indicators, and financial effect. The intervention group had considerably and significantly lower rates of acute service utilization than the control group, including 23% fewer hospitalizations, 26% fewer inpatient bed days, 22% fewer emergency department visits, 44% fewer heart failure hospitalizations, 70% fewer 30-day readmissions, and 45% fewer SNF bed days. Claims costs were 1,792 dollars per person lower in the intervention group than in the control group (inclusive of intervention costs), and the return on investment was calculated to be 2.31. The study demonstrates that a commercially delivered heart failure disease-management program significantly reduced hospitalizations, emergency department visits, and SNF days. The intervention group had 17% lower costs than the control group; when intervention costs were included, the intervention group had 10% lower costs.

Aldosterone blockade and left ventricular dysfunction: a systematic review of randomized clinical trials.

PubMed

Ezekowitz, Justin A; McAlister, Finlay A

2009-02-01

Aldosterone blockade has been used to treat acute myocardial infarction (MI) and chronic heart failure. The aim of this study is to summarize the evidence on the efficacy of spironolactone (SP), eplerenone (EP), or canrenoate (CAN) in patients with left ventricular dysfunction. A search of multiple electronic databases until June 2008 was supplemented by hand searches of reference lists of included studies and review articles, meeting abstracts, FDA reports, and contact with study authors and drug manufacturers. Studies were eligible for inclusion if they included patients with left ventricular systolic or diastolic dysfunction, treatment with SP, EP, or CAN vs. control, and reported clinical outcomes. Nineteen randomized controlled trials (four in acute MI and 15 in heart failure, n = 10 807 patients) were included -- 14 of SP, three of EP, and three of CAN. Analysis was performed using relative risks (RRs) with 95% confidence intervals (CIs) and a random effects model with statistical heterogeneity assessed by I(2). Aldosterone blockade reduced all-cause mortality by 20% (RR 0.80, 95% CI 0.74-0.87). All-cause mortality was reduced in both heart failure (RR = 0.75, 95% CI 0.67-0.84) and post-MI (RR 0.85, 95% CI 0.76-0.95) patients. Only nine trials reported hospitalizations, and the RR reduction was 23% (RR 0.77, 95% CI 0.68-0.87), although 98% of the outcomes came from two trials. Ejection fraction (EF) improved in the seven heart failure trials, which assessed this outcome (weighted mean difference 3.1%, 95% CI 1.6-4.5). We demonstrated a 20% reduction in all-cause mortality with the use of aldosterone blockade in a clinically heterogeneous group of clinical trial participants with heart failure and post-MI. In addition, we found a 3.1% improvement in EF. Further study in those with less severe symptoms or preserved systolic function is warranted.

Uncontrolled diabetes as a potential risk factor in tibiotalocalcaneal fusion using a retrograde intramedullary nail.

PubMed

Lee, Moses; Choi, Woo Jin; Han, Seung Hwan; Jang, Jinyoung; Lee, Jin Woo

2017-07-22

Tibiotalocalcaneal (TTC) fusion using a retrograde intramedullary (IM) nail is an effective salvage option for terminal-stage hindfoot problems. However, as many patients who receive TTC fusion bear unfavorable medical comorbidities, the risk of nonunion, infection and other complications increases. This study was performed to identify the factors influencing outcomes after TTC fusion using a retrograde IM nail. Between September 2008 and February 2012, 34 consecutive patients received TTC fusion using a retrograde IM nail for limb salvage. All patients had a minimum follow-up of two years. Throughout follow-up, standard ankle radiography was performed along with clinical outcome assessment using a visual analog scale (VAS) for pain, the American Orthopaedic Foot and Ankle Society Ankle-Hind Foot Scale (AOFAS A/H scale) and the Foot and Ankle Outcome Score (FAOS). For the retrospective analysis, demographic factors, preoperative medical status, laboratory markers, and etiology were comprehensively reviewed using medical records. The success of the index operation was determined using clinical and radiological outcomes. Finally, the effect of each factor on failure after the operation was analyzed using univariate logistic regression. In a mean of seven months, 82% (28/34) achieved union, as evaluated by standard radiography. All clinical outcome parameters improved significantly after the operation, including VAS, AOFAS A/H scale, and FAOS (P<0.001). At the last follow-up, five cases of nonunion with less than AOFAS A/H scale of 80 and two cases of below knee amputation due to uncontrolled infection were determined to be failures. None of the factors (etiology, demographics, laboratory markers and medical status) significantly influenced failures. However, uncontrolled DM significantly increased the failure rate with an odds ratio of 10 (P=0.029). TTC fusion with a retrograde intramedullary nail is a successful treatment for complicated hindfoot problems such as traumatic osteoarthritis, Charcot arthropathy and failed TAA. However, it should be used judiciously in patients with uncontrolled DM, as the risk of failure increases. Retrospective cohort study. Copyright © 2017 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

Recent trauma is associated with antiretroviral failure and HIV transmission risk behavior among HIV-positive women and female-identified transgenders.

PubMed

Machtinger, E L; Haberer, J E; Wilson, T C; Weiss, D S

2012-11-01

Trauma and posttraumatic stress disorder disproportionally affect HIV-positive women. Studies increasingly demonstrate that both conditions may predict poor HIV-related health outcomes and transmission-risk behaviors. This study analyzed data from a prevention-with-positives program to understand if socio-economic, behavioral, and health-related factors are associated with antiretroviral failure and HIV transmission-risk behaviors among 113 HIV-positive biological and transgender women. An affirmative answer to a simple screening question for recent trauma was significantly associated with both outcomes. Compared to participants without recent trauma, participants reporting recent trauma had over four-times the odds of antiretroviral failure (AOR 4.3; 95% CI 1.1-16.6; p = 0.04), and over three-times the odds of reporting sex with an HIV-negative or unknown serostatus partner (AOR 3.9; 95% CI 1.3-11.9; p = 0.02) and <100% condom use with these partners (AOR 4.5; 95% CI 1.5-13.3; p = 0.007). Screening for recent trauma in HIV-positive biological and transgender women identifies patients at high risk for poor health outcomes and HIV transmission-risk behavior.

Development of Decision Making in School-Aged Children and Adolescents: Evidence from Heart Rate and Skin Conductance Analysis

ERIC Educational Resources Information Center

Crone, Eveline A.; van der Molen, Maurits W.

2007-01-01

Age differences in decision making indicate that children fail to anticipate outcomes of their decisions. Using heart rate and skin conductance analyses, we tested whether developmental changes in decision making are associated with (a) a failure to process outcomes of decisions, or (b) a failure to anticipate future outcomes of decisions.…

Heart Failure with Recovered EF and Heart Failure with Mid-Range EF: Current Recommendations and Controversies.

PubMed

Unkovic, Peter; Basuray, Anupam

2018-04-03

This review explores key features and potential management controversies in two emerging populations in heart failure: heart failure with recovered ejection fraction (HF-recovered EF) and heart failure with mid-range ejection fraction (HFmrEF). While HF-recovered EF patients have better outcomes than heart failure with reduced ejection fraction (HFrEF), they continue to have symptoms, persistent biomarker elevations, and abnormal outcomes suggesting a continued disease process. HFmrEF patients appear to have features of HFrEF and heart failure with preserved ejection fraction (HFpEF), but have a high prevalence of ischemic heart disease and may represent a transitory phase between the HFrEF and HFpEF. Management strategies have insufficient data to warrant standardization at this time. HF-recovered EF and HFmrEF represent new populations with unmet needs and expose the pitfalls of an EF basis for heart failure classification.

Failure to activate the in-hospital emergency team: causes and outcomes.

PubMed

Barbosa, Vera; Gomes, Ernestina; Vaz, Senio; Azevedo, Gustavo; Fernandes, Gonçalo; Ferreira, Amélia; Araujo, Rui

2016-01-01

To determine the incidence of afferent limb failure of the in-hospital Medical Emergency Team, characterizing it and comparing the mortality between the population experiencing afferent limb failure and the population not experiencing afferent limb failure. A total of 478 activations of the Medical Emergency Team of Hospital Pedro Hispano occurred from January 2013 to July 2015. A sample of 285 activations was obtained after excluding incomplete records and activations for patients with less than 6 hours of hospitalization. The sample was divided into two groups: the group experiencing afferent limb failure and the group not experiencing afferent limb failure of the Medical Emergency Team. Both populations were characterized and compared. Statistical significance was set at p ≤ 0.05. Afferent limb failure was observed in 22.1% of activations. The causal analysis revealed significant differences in Medical Emergency Team activation criteria (p = 0.003) in the group experiencing afferent limb failure, with higher rates of Medical Emergency Team activation for cardiac arrest and cardiovascular dysfunction. Regarding patient outcomes, the group experiencing afferent limb failure had higher immediate mortality rates and higher mortality rates at hospital discharge, with no significant differences. No significant differences were found for the other parameters. The incidence of cardiac arrest and the mortality rate were higher in patients experiencing failure of the afferent limb of the Medical Emergency Team. This study highlights the need for health units to invest in the training of all healthcare professionals regarding the Medical Emergency Team activation criteria and emergency medical response system operations.

Differential influence of distinct components of increased blood pressure on cardiovascular outcomes: from the atherosclerosis risk in communities study.

PubMed

Cheng, Susan; Gupta, Deepak K; Claggett, Brian; Sharrett, A Richey; Shah, Amil M; Skali, Hicham; Takeuchi, Madoka; Ni, Hanyu; Solomon, Scott D

2013-09-01

Elevation in blood pressure (BP) increases risk for all cardiovascular events. Nevertheless, the extent to which different indices of BP elevation may be associated to varying degrees with different cardiovascular outcomes remains unclear. We studied 13340 participants (aged 54 ± 6 years, 56% women and 27% black) of the Atherosclerosis Risk in Communities Study who were free of baseline cardiovascular disease. We used Cox proportional hazards models to compare the relative contributions of systolic BP, diastolic BP, pulse pressure, and mean arterial pressure to risk for coronary heart disease, heart failure, stroke, and all-cause mortality. For each multivariable-adjusted model, the largest area under the receiver-operating curve (AUC) and smallest -2 log-likelihood values were used to identify BP measures with the greatest contribution to risk prediction for each outcome. A total of 2095 coronary heart disease events, 1669 heart failure events, 771 stroke events, and 3016 deaths occurred during 18 ± 5 years of follow-up. In multivariable analyses adjusting for traditional cardiovascular risk factors, the BP measures with the greatest risk contributions were the following: systolic BP for coronary heart disease (AUC=0.74); pulse pressure for heart failure (AUC=0.79); systolic BP for stroke (AUC=0.74); and pulse pressure for all-cause mortality (AUC=0.74). With few exceptions, results were similar in analyses stratified by age, sex, and race. Our data indicate that distinct BP components contribute variably to risk for different cardiovascular outcomes.

Defining and predicting 'intrauterine fetal renal failure' in congenital lower urinary tract obstruction.

PubMed

Ruano, Rodrigo; Safdar, Adnan; Au, Jason; Koh, Chester J; Gargollo, Patricio; Shamshirsaz, Alireza A; Espinoza, Jimmy; Cass, Darrell L; Olutoye, Oluyinka O; Olutoye, Olutoyin A; Welty, Stephen; Roth, David R; Belfort, Michael A; Braun, Michael C

2016-04-01

The aim of this study was to identify predictors of 'intrauterine fetal renal failure' in fetuses with severe congenital lower urinary tract obstruction (LUTO). We undertook a retrospective study of 31 consecutive fetuses with a diagnosis of LUTO in a tertiary Fetal Center between April 2013 and April 2015. Predictors of 'intrauterine fetal renal failure' were evaluated in those infants with severe LUTO who had either a primary composite outcome measure of neonatal death in the first 24 h of life due to severe pulmonary hypoplasia or a need for renal replacement therapy within 7 days of life. The following variables were analyzed: fetal bladder re-expansion 48 h after vesicocentesis, fetal renal ultrasound characteristics, fetal urinary indices, and amniotic fluid volume. Of the 31 fetuses included in the study, eight met the criteria for 'intrauterine fetal renal failure'. All of the latter had composite poor postnatal outcomes based on death within 24 h of life (n = 6) or need for dialysis within 1 week of life (n = 2). The percentage of fetal bladder refilling after vesicocentesis at time of initial evaluation was the only predictor of 'intrauterine fetal renal failure' (cut-off <27 %, area under the time-concentration curve 0.86, 95 % confidence interval 0.68-0.99; p = 0.009). We propose the concept of 'intrauterine fetal renal failure' in fetuses with the most severe forms of LUTO. Fetal bladder refilling can be used to reliably predict 'intrauterine fetal renal failure', which is associated with severe pulmonary hypoplasia or the need for dialysis within a few days of life.

Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial.

PubMed

Dauriz, Marco; Targher, Giovanni; Temporelli, Pier Luigi; Lucci, Donata; Gonzini, Lucio; Nicolosi, Gian Luigi; Marchioli, Roberto; Tognoni, Gianni; Latini, Roberto; Cosmi, Franco; Tavazzi, Luigi; Maggioni, Aldo Pietro

2017-07-05

The independent prognostic impact of diabetes mellitus (DM) and prediabetes mellitus (pre-DM) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre-DM on survival outcomes in the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) trial. We assessed the risk of all-cause death and the composite of all-cause death or cardiovascular hospitalization over a median follow-up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI-HF trial, who were stratified by presence of DM (n=2852), pre-DM (n=2013), and non-DM (n=2070) at baseline. Compared with non-DM patients, those with DM had remarkably higher incidence rates of all-cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non-DM patients and those with pre-DM. Cox regression analysis showed that DM, but not pre-DM, was associated with an increased risk of all-cause death (adjusted hazard ratio, 1.43; 95% CI, 1.28-1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI, 1.13-1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all-cause death: adjusted hazard ratio, 1.21; 95% CI, 1.02-1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI, 1.01-1.29, respectively). Presence of DM was independently associated with poor long-term survival outcomes in patients with chronic heart failure. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00336336. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Heart failure care in low- and middle-income countries: a systematic review and meta-analysis.

PubMed

Callender, Thomas; Woodward, Mark; Roth, Gregory; Farzadfar, Farshad; Lemarie, Jean-Christophe; Gicquel, Stéphanie; Atherton, John; Rahimzadeh, Shadi; Ghaziani, Mehdi; Shaikh, Maaz; Bennett, Derrick; Patel, Anushka; Lam, Carolyn S P; Sliwa, Karen; Barretto, Antonio; Siswanto, Bambang Budi; Diaz, Alejandro; Herpin, Daniel; Krum, Henry; Eliasz, Thomas; Forbes, Anna; Kiszely, Alastair; Khosla, Rajit; Petrinic, Tatjana; Praveen, Devarsetty; Shrivastava, Roohi; Xin, Du; MacMahon, Stephen; McMurray, John; Rahimi, Kazem

2014-08-01

Heart failure places a significant burden on patients and health systems in high-income countries. However, information about its burden in low- and middle-income countries (LMICs) is scant. We thus set out to review both published and unpublished information on the presentation, causes, management, and outcomes of heart failure in LMICs. Medline, Embase, Global Health Database, and World Health Organization regional databases were searched for studies from LMICs published between 1 January 1995 and 30 March 2014. Additional unpublished data were requested from investigators and international heart failure experts. We identified 42 studies that provided relevant information on acute hospital care (25 LMICs; 232,550 patients) and 11 studies on the management of chronic heart failure in primary care or outpatient settings (14 LMICs; 5,358 patients). The mean age of patients studied ranged from 42 y in Cameroon and Ghana to 75 y in Argentina, and mean age in studies largely correlated with the human development index of the country in which they were conducted (r = 0.71, p<0.001). Overall, ischaemic heart disease was the main reported cause of heart failure in all regions except Africa and the Americas, where hypertension was predominant. Taking both those managed acutely in hospital and those in non-acute outpatient or community settings together, 57% (95% confidence interval [CI]: 49%-64%) of patients were treated with angiotensin-converting enzyme inhibitors, 34% (95% CI: 28%-41%) with beta-blockers, and 32% (95% CI: 25%-39%) with mineralocorticoid receptor antagonists. Mean inpatient stay was 10 d, ranging from 3 d in India to 23 d in China. Acute heart failure accounted for 2.2% (range: 0.3%-7.7%) of total hospital admissions, and mean in-hospital mortality was 8% (95% CI: 6%-10%). There was substantial variation between studies (p<0.001 across all variables), and most data were from urban tertiary referral centres. Only one population-based study assessing incidence and/or prevalence of heart failure was identified. The presentation, underlying causes, management, and outcomes of heart failure vary substantially across LMICs. On average, the use of evidence-based medications tends to be suboptimal. Better strategies for heart failure surveillance and management in LMICs are needed. Please see later in the article for the Editors' Summary.

Heart Failure Care in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis

PubMed Central

Callender, Thomas; Woodward, Mark; Roth, Gregory; Farzadfar, Farshad; Lemarie, Jean-Christophe; Gicquel, Stéphanie; Atherton, John; Rahimzadeh, Shadi; Ghaziani, Mehdi; Shaikh, Maaz; Bennett, Derrick; Patel, Anushka; Lam, Carolyn S. P.; Sliwa, Karen; Barretto, Antonio; Siswanto, Bambang Budi; Diaz, Alejandro; Herpin, Daniel; Krum, Henry; Eliasz, Thomas; Forbes, Anna; Kiszely, Alastair; Khosla, Rajit; Petrinic, Tatjana; Praveen, Devarsetty; Shrivastava, Roohi; Xin, Du; MacMahon, Stephen; McMurray, John; Rahimi, Kazem

2014-01-01

Background Heart failure places a significant burden on patients and health systems in high-income countries. However, information about its burden in low- and middle-income countries (LMICs) is scant. We thus set out to review both published and unpublished information on the presentation, causes, management, and outcomes of heart failure in LMICs. Methods and Findings Medline, Embase, Global Health Database, and World Health Organization regional databases were searched for studies from LMICs published between 1 January 1995 and 30 March 2014. Additional unpublished data were requested from investigators and international heart failure experts. We identified 42 studies that provided relevant information on acute hospital care (25 LMICs; 232,550 patients) and 11 studies on the management of chronic heart failure in primary care or outpatient settings (14 LMICs; 5,358 patients). The mean age of patients studied ranged from 42 y in Cameroon and Ghana to 75 y in Argentina, and mean age in studies largely correlated with the human development index of the country in which they were conducted (r = 0.71, p<0.001). Overall, ischaemic heart disease was the main reported cause of heart failure in all regions except Africa and the Americas, where hypertension was predominant. Taking both those managed acutely in hospital and those in non-acute outpatient or community settings together, 57% (95% confidence interval [CI]: 49%–64%) of patients were treated with angiotensin-converting enzyme inhibitors, 34% (95% CI: 28%–41%) with beta-blockers, and 32% (95% CI: 25%–39%) with mineralocorticoid receptor antagonists. Mean inpatient stay was 10 d, ranging from 3 d in India to 23 d in China. Acute heart failure accounted for 2.2% (range: 0.3%–7.7%) of total hospital admissions, and mean in-hospital mortality was 8% (95% CI: 6%–10%). There was substantial variation between studies (p<0.001 across all variables), and most data were from urban tertiary referral centres. Only one population-based study assessing incidence and/or prevalence of heart failure was identified. Conclusions The presentation, underlying causes, management, and outcomes of heart failure vary substantially across LMICs. On average, the use of evidence-based medications tends to be suboptimal. Better strategies for heart failure surveillance and management in LMICs are needed. Please see later in the article for the Editors' Summary PMID:25117081

Prediction and Outcome of Intensive Care Unit-Acquired Paresis.

PubMed

Peñuelas, Oscar; Muriel, Alfonso; Frutos-Vivar, Fernando; Fan, Eddy; Raymondos, Konstantinos; Rios, Fernando; Nin, Nicolás; Thille, Arnaud W; González, Marco; Villagomez, Asisclo J; Davies, Andrew R; Du, Bin; Maggiore, Salvatore M; Matamis, Dimitrios; Abroug, Fekri; Moreno, Rui P; Kuiper, Michael A; Anzueto, Antonio; Ferguson, Niall D; Esteban, Andrés

2018-01-01

Intensive care unit-acquired paresis (ICUAP) is associated with poor outcomes. Our objective was to evaluate predictors for ICUAP and the short-term outcomes associated with this condition. A secondary analysis of a prospective study including 4157 mechanically ventilated adults in 494 intensive care units from 39 countries. After sedative interruption, patients were screened for ICUAP daily, which was defined as the presence of symmetric and flaccid quadriparesis associated with decreased or absent deep tendon reflexes. A multinomial logistic regression was used to create a predictive model for ICUAP. Propensity score matching was used to estimate the relationship between ICUAP and short-term outcomes (ie, weaning failure and intensive care unit [ICU] mortality). Overall, 114 (3%) patients had ICUAP. Variables associated with ICUAP were duration of mechanical ventilation (relative risk ratio [RRR] per day, 1.10; 95% confidence interval [CI] 1.08-1.12), steroid therapy (RRR 1.8; 95% CI, 1.2-2.8), insulin therapy (RRR 1.8; 95% CI 1.2-2.7), sepsis (RRR 1.9; 95% CI: 1.2 to 2.9), acute renal failure (RRR 2.2; 95% CI 1.5-3.3), and hematological failure (RRR 1.9; 95% CI: 1.2-2.9). Coefficients were used to generate a weighted scoring system to predict ICUAP. ICUAP was significantly associated with both weaning failure (paired rate difference of 22.1%; 95% CI 9.8-31.6%) and ICU mortality (paired rate difference 10.5%; 95% CI 0.1-24.0%). Intensive care unit-acquired paresis is relatively uncommon but is significantly associated with weaning failure and ICU mortality. We constructed a weighted scoring system, with good discrimination, to predict ICUAP in mechanically ventilated patients at the time of awakening.

Natural History and Treatment Outcomes of Severe Autoimmune Hepatitis.

PubMed

Sonthalia, Nikhil; Rathi, Pravin M; Jain, Samit S; Surude, Ravindra G; Mohite, Ashok R; Pawar, Sunil V; Contractor, Qais

2017-07-01

The aim of this study was to analyze the natural history and treatment outcomes of autoimmune hepatitis (AIH) variants presenting with severe-AIH. Severe acute presentation is an uncommon manifestation of AIH, and it remains poorly characterized. We included 101 patients with AIH from January 2011 to December 2015. Patients were classified as seropositive-AIH and seronegative-AIH. Patients with acute liver failure, acute-on-chronic liver failure, and severe acute hepatitis were defined as severe-AIH patients. Patient characteristics and treatment outcomes with follow-up until 12 months were analyzed between the different groups. Out of 101 cases, 24 (23.76%) had severe AIH. Of them 9 (37.5%) had severe acute hepatitis, 3 (12.5%) had acute liver failure, and 12 (50%) had acute-on-chronic liver failure. Seronegative-AIH patients presented with severe-AIH significantly more frequently compared with seropositive-AIH patients (50% vs. 20.27%, P=0.022). Severe-AIH had 50% complete responders, 25% partial responders, and 25% treatment failures. Jaundice (88.88% vs. 68.7%, P=0.048), encephalopathy (55.55% vs. 6.66%, P=0.014), and higher international normalized ratio values (2.17±0.60 vs. 1.82±0.14, P=0.038) were factors associated with nonresponse rather than the presence or absence of autoantibodies in severe-AIH. The hazard ratio for predicting remission in the non-severe AIH group as compared with the severe-AIH group was 1.502, which was statistically not significant (95% CI, 0.799-2.827; P=0.205). Approximately 24% of patients with AIH have severe-AIH. Conventional autoantibodies are often absent in severe-AIH; however, it does not alter the outcome. Immunosuppressants should be given expediently in patients with severe-AIH.

Physiologic Preoperative Knee Hyperextension Is a Predictor of Failure in an Anterior Cruciate Ligament Revision Cohort: A Report From the MARS Group.

PubMed

Cooper, Daniel E; Dunn, Warren R; Huston, Laura J; Haas, Amanda K; Spindler, Kurt P; Allen, Christina R; Anderson, Allen F; DeBerardino, Thomas M; Lantz, Brett Brick A; Mann, Barton; Stuart, Michael J; Albright, John P; Amendola, Annunziato Ned; Andrish, Jack T; Annunziata, Christopher C; Arciero, Robert A; Bach, Bernard R; Baker, Champ L; Bartolozzi, Arthur R; Baumgarten, Keith M; Bechler, Jeffery R; Berg, Jeffrey H; Bernas, Geoffrey A; Brockmeier, Stephen F; Brophy, Robert H; Bush-Joseph, Charles A; Butler V, J Brad; Campbell, John D; Carey, James L; Carpenter, James E; Cole, Brian J; Cooper, Jonathan M; Cox, Charles L; Creighton, R Alexander; Dahm, Diane L; David, Tal S; Flanigan, David C; Frederick, Robert W; Ganley, Theodore J; Garofoli, Elizabeth A; Gatt, Charles J; Gecha, Steven R; Giffin, James Robert; Hame, Sharon L; Hannafin, Jo A; Harner, Christopher D; Harris, Norman Lindsay; Hechtman, Keith S; Hershman, Elliott B; Hoellrich, Rudolf G; Hosea, Timothy M; Johnson, David C; Johnson, Timothy S; Jones, Morgan H; Kaeding, Christopher C; Kamath, Ganesh V; Klootwyk, Thomas E; Levy, Bruce A; Ma, C Benjamin; Maiers, G Peter; Marx, Robert G; Matava, Matthew J; Mathien, Gregory M; McAllister, David R; McCarty, Eric C; McCormack, Robert G; Miller, Bruce S; Nissen, Carl W; O'Neill, Daniel F; Owens, Brett D; Parker, Richard D; Purnell, Mark L; Ramappa, Arun J; Rauh, Michael A; Rettig, Arthur C; Sekiya, Jon K; Shea, Kevin G; Sherman, Orrin H; Slauterbeck, James R; Smith, Matthew V; Spang, Jeffrey T; Svoboda, Steven J; Taft, Timothy N; Tenuta, Joachim J; Tingstad, Edwin M; Vidal, Armando F; Viskontas, Darius G; White, Richard A; Williams, James S; Wolcott, Michelle L; Wolf, Brian R; York, James J; Wright, Rick W

2018-06-01

The occurrence of physiologic knee hyperextension (HE) in the revision anterior cruciate ligament reconstruction (ACLR) population and its effect on outcomes have yet to be reported. Hypothesis/Purpose: The prevalence of knee HE in revision ACLR and its effect on 2-year outcome were studied with the hypothesis that preoperative physiologic knee HE ≥5° is a risk factor for anterior cruciate ligament (ACL) graft rupture. Cohort study; Level of evidence, 2. Patients undergoing revision ACLR were identified and prospectively enrolled between 2006 and 2011. Study inclusion criteria were patients undergoing single-bundle graft reconstructions. Patients were followed up at 2 years and asked to complete an identical set of outcome instruments (International Knee Documentation Committee, Knee injury and Osteoarthritis Outcome Score, WOMAC, and Marx Activity Rating Scale) as well as provide information regarding revision ACL graft failure. A regression model with graft failure as the dependent variable included age, sex, graft type at the time of the revision ACL surgery, and physiologic preoperative passive HE ≥5° (yes/no) to assess these as potential risk factors for clinical outcomes 2 years after revision ACLR. Analyses included 1145 patients, for whom 2-year follow-up was attained for 91%. The median age was 26 years, with age being a continuous variable. Those below the median were grouped as "younger" and those above as "older" (age: interquartile range = 20, 35 years), and 42% of patients were female. There were 50% autografts, 48% allografts, and 2% that had a combination of autograft plus allograft. Passive knee HE ≥5° was present in 374 (33%) patients in the revision cohort, with 52% being female. Graft rupture at 2-year follow-up occurred in 34 cases in the entire cohort, of which 12 were in the HE ≥5° group (3.2% failure rate) and 22 in the non-HE group (2.9% failure rate). The median age of patients who failed was 19 years, as opposed to 26 years for those with intact grafts. Three variables in the regression model were significant predictors of graft failure: younger age (odds ratio [OR] = 3.6; 95% CI, 1.6-7.9; P = .002), use of allograft (OR = 3.3; 95% CI, 1.5-7.4; P = .003), and HE ≥5° (OR = 2.12; 95% CI, 1.1-4.7; P = .03). This study revealed that preoperative physiologic passive knee HE ≥5° is present in one-third of patients who undergo revision ACLR. HE ≥5° was an independent significant predictor of graft failure after revision ACLR with a >2-fold OR of subsequent graft rupture in revision ACL surgery. Registration: NCT00625885 ( ClinicalTrials.gov identifier).

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vlies, C. H. van der, E-mail: c.h.vandervlies@amc.uva.nl; Hoekstra, J.; Ponsen, K. J.

Introduction: Nonoperative management (NOM) has become the treatment of choice for hemodynamically stable patients with blunt splenic injury. Results of outcome after NOM are predominantly based on large-volume studies from level 1 trauma centers in the United States. This study was designed to assess the results of NOM in a relatively low-volume Dutch level 1 trauma center. Methods: An analysis of a prospective trauma registry was performed for a 6-year period before (period 1) and after the introduction and implementation of splenic artery embolization (SAE) (period 2). Primary outcome was the failure rate of initial treatment. Results: A total ofmore » 151 patients were reviewed. An increased use of SAE and a reduction of splenic operations during the second period was observed. Compared with period 1, the failure rate after observation in period 2 decreased from 25% to 10%. The failure rate after SAE in period 2 was 18%. The splenic salvage rate (SSR) after observation increased from 79% in the first period to 100% in the second period. During the second period, all patients with failure after observation were successfully treated with SAE. The SSR after SAE in periods 1 and 2 was respectively 100% and 86%. Conclusions: SAE of patients with blunt splenic injuries is associated with a reduction in splenic operations. The failure and splenic salvage rates in this current study were comparable with the results from large-volume studies of level 1 trauma centers. Nonoperative management also is feasible in a relatively low-volume level 1 trauma center outside the United States.« less

The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled Trial (VeRDiCT Trial)

PubMed Central

Clout, Madeleine; Harris, Tracy; Rogers, Chris; Culliford, Lucy; Taylor, Jodi; Angelini, Gianni; Narayan, Pradeep; Reeves, Barnaby; Hillier, James; Ashton, Kate; Sarkar, Kunal

2017-01-01

Background Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients. Objective The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to “fit for discharge”, incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated. Methods In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann’s solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were “fit for discharge”, which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources. Results Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017. Conclusions VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol will increase scientific and clinical knowledge of VRT in diabetic patients undergoing elective or urgent CABG surgery. Findings supporting the efficacy of this intervention could easily be implemented in the health care system. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 02159606; http://www.controlled-trials.com/ISRCTN02159606 (Archived by WebCite at http://www.webcitation.org/6rDkSSkkK) PMID:28630035

In-Hospital Diuretic Agent Use and Post-Discharge Clinical Outcomes in Patients Hospitalized for Worsening Heart Failure: Insights From the EVEREST Trial.

PubMed

Mecklai, Alicia; Subačius, Haris; Konstam, Marvin A; Gheorghiade, Mihai; Butler, Javed; Ambrosy, Andrew P; Katz, Stuart D

2016-07-01

The aim of this study was to characterize the association between decongestion therapy and 30-day outcomes in patients hospitalized for heart failure (HF). Loop diuretic agents are commonly prescribed for the treatment of symptomatic congestion in patients hospitalized for HF, but the association between loop diuretic agent dose response and post-discharge outcomes has not been well characterized. Cox proportional hazards models were used to estimate the association among average loop diuretic agent dose, congestion status at discharge, and 30-day post-discharge all-cause mortality and HF rehospitalization in 3,037 subjects hospitalized with worsening HF enrolled in the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study With Tolvaptan) study. In univariate analysis, subjects exposed to high-dose diuretic agents (≥160 mg/day) had greater risk for the combined outcome than subjects exposed to low-dose diuretic agents (18.9% vs. 10.0%; hazard ratio: 2.00; 95% confidence interval: 1.64 to 2.46; p < 0.0001). After adjustment for pre-specified covariates of disease severity, the association between diuretic agent dose and outcomes was not significant (hazard ratio: 1.11; 95% confidence interval: 0.89 to 1.38; p = 0.35). Of the 3,011 subjects with clinical assessments of volume status, 2,063 (69%) had little or no congestion at hospital discharge. Congestion status at hospital discharge did not modify the association between diuretic agent exposure and the combined endpoint (p for interaction = 0.84). Short-term diuretic agent exposure during hospital treatment for worsening HF was not an independent predictor of 30-day all-cause mortality and HF rehospitalization in multivariate analysis. Congestion status at discharge did not modify the association between diuretic agent dose and clinical outcomes. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Comparison of fertilization outcome between microdrop and open insemination methods in non-male factor IVF patients.

PubMed

Li, Yubin; Li, Tao; Mai, Qingyun; Long, Lingli; Ou, Jianping

2014-06-01

Both microdrop and open methods are commonly used for in vitro fertilization (IVF) protocols for embryo culture as well as oocyte insemination. However, few comparative studies evaluating the microdrop or open method of insemination on the fertilization outcome and subsequent embryo development have been performed. A randomized study was conducted to compare microdrop and open fertilization with respect to fertilization rate and embryo development among non-male factor patients undergoing in vitro fertilization and embryo transfer (IVF-ET). The results presented in this study demonstrate that the fertilization failure rate [total fertilization failure rate (TFF) plus low fertilization rate (<25% oocytes fertilized)] in the microdrop insemination group was higher than in the open insemination group (11.9% versus 3.3%, p < 0.001), while the good quality embryo rate and pregnancy rate did not differ significantly between the groups. As a highly complicated process involving many extrinsic and intrinsic factors, further studies are needed to confirm the effects of these insemination methods on the rate of fertilization failure.

Worsening renal function and outcome in heart failure patients with preserved ejection fraction and the impact of angiotensin receptor blocker treatment.

PubMed

Damman, Kevin; Perez, Ana C; Anand, Inder S; Komajda, Michel; McKelvie, Robert S; Zile, Michael R; Massie, Barrie; Carson, Peter E; McMurray, John J V

2014-09-16

Worsening renal function (WRF) associated with renin-angiotensin-aldosterone system (RAAS) inhibition does not confer excess risk in heart failure patients with reduced ejection fraction (HFrEF). The goal of this study was to investigate the relationship between WRF and outcomes in heart failure patients with preserved ejection fraction (HFpEF) and the interaction with RAAS blockade. In 3,595 patients included in the I-PRESERVE (Irbesartan in Heart Failure With Preserved Ejection Fraction) trial, change in estimated glomerular filtration rate (eGFR) and development of WRF after initiation of irbesartan or placebo were examined. We examined the association between WRF and the first occurrence of cardiovascular death or heart failure hospitalization (primary outcome in this analysis) and the interaction with randomized treatment. Estimated GFR decreased early with irbesartan treatment and remained significantly lower than in the placebo group. WRF developed in 229 (6.4%) patients and occurred more frequently with irbesartan treatment (8% vs. 4%). Overall, WRF was associated with an increased risk of the primary outcome (adjusted hazard ratio [HR]: 1.43; 95% confidence interval [CI]: 1.10 to 1.85; p = 0.008). Although the risk related to WRF was greater in the irbesartan group (HR: 1.66; 95% CI: 1.21 to 2.28; p = 0.002) than with placebo (HR: 1.09; 95% CI: 0.66 to 1.79; p = 0.73), the interaction between treatment and WRF on outcome was not significant in an adjusted analysis. The incidence of WRF in HFpEF was similar to that previously reported in HFrEF but more frequent with irbesartan than with placebo. WRF after initiation of irbesartan treatment in HFpEF was associated with excess risk, in contrast to WRF occurring with RAAS blockade in HFrEF. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Outcomes and Pharmacoeconomic Analysis of a Home Intravenous Antibiotic Infusion Program in Veterans.

PubMed

Ruh, Christine A; Parameswaran, Ganapathi I; Wojciechowski, Amy L; Mergenhagen, Kari A

2015-11-01

The use of outpatient parenteral antibiotic therapy (OPAT) programs has become more frequent because of benefits in costs with equivalent clinical outcomes compared with inpatient care. The purpose of this study was to evaluate the outcomes of our program. A modified pharmacoeconomic analysis was performed to compare costs of our program with hospital or rehabilitation facility care. This was a retrospective chart review of 96 courses of OPAT between April 1, 2011, and July 31, 2013. Clinical failures were defined as readmission or death due to worsening infection or readmission secondary to adverse drug event (ADE) to antibiotic therapy. This does not include those patients readmitted for reasons not associated with OPAT therapy, including comorbidities or elective procedures. Baseline characteristics and program-specific data were analyzed. Statistically significant variables were built into a multivariate logistic regression model to determine predictors of failure. A pharmacoeconomic analysis was performed with the use of billing records. Of the total episodes evaluated, 17 (17.71%) clinically failed therapy, and 79 (82.29%) were considered a success. In the multivariate analysis, number of laboratory draws (P = 0.02) and occurrence of drug reaction were significant in the final model, P = 0.02 and P = 0.001, respectively. The presence an adverse drug reaction increases the odds of failure (OR = 10.10; 95% CI, 2.69-44.90). Compared with inpatient or rehabilitation care, the cost savings was $6,932,552.03 or $2,649,870.68, respectively. In our study, patients tolerated OPAT well, with a low number of failures due to ADE. The clinical outcomes and cost savings of our program indicate that OPAT can be a viable alternative to long-term inpatient antimicrobial therapy. Published by Elsevier Inc.

A Systematic Review of Randomized Controlled Trials Comparing Hypertonic Sodium Solutions and Mannitol for Traumatic Brain Injury: Implications for Emergency Department Management.

PubMed

Burgess, Sarah; Abu-Laban, Riyad B; Slavik, Richard S; Vu, Erik N; Zed, Peter J

2016-04-01

To comparatively evaluate hypertonic sodium (HTS) and mannitol in patients following acute traumatic brain injury (TBI) on the outcomes of all-cause mortality, neurological disability, intracranial pressure (ICP) change from baseline, ICP treatment failure, and serious adverse events. PubMed, EMBASE, CENTRAL, Cochrane Database of Systematic Reviews, ClinicalTrials.gov, and WHO ICTRP (World Health Organization International Clinical Trials Registry Platform) were searched (inception to November 2015) using hypertonic saline solutions, sodium chloride, mannitol, osmotic diuretic, traumatic brain injury, brain injuries, and head injury. Searches were limited to humans. Clinical practice guidelines and bibliographies were reviewed. Prospective, randomized trials comparing HTS and mannitol in adults (≥16 years) with severe TBI (Glasgow Coma Scale score ≤8) and elevated ICP were included. ICP elevation, ICP reduction, and treatment failure were defined using study definitions. Of 326 articles screened, 7 trials enrolling a total of 191 patients met inclusion criteria. Studies were underpowered to detect a significant difference in mortality or neurological outcomes. Due to significant heterogeneity and differences in reporting ICP change from baseline, this outcome was not meta-analyzed. No difference between HTS and mannitol was observed for mean ICP reduction; however, risk of ICP treatment failure favored HTS (risk ratio [RR] = 0.39; 95% CI = 0.18-0.81). Serious adverse events were not reported. Based on limited data, clinically important differences in mortality, neurological outcomes, and ICP reduction were not observed between HTS or mannitol in the management of severe TBI. HTS appears to lead to fewer ICP treatment failures. © The Author(s) 2016.

Academic Remediation-Focused Alternative Schools: Impact on Student Outcomes

ERIC Educational Resources Information Center

Wilkerson, Kimber L.; Afacan, Kemal; Yan, Min-Chi; Justin, Whitney; Datar, Sujata D.

2016-01-01

School districts offer specialized programming for secondary students who experience high rates of course failure or low credit accumulation. While these alternative programs are meant to increase student success, little research evaluates outcomes for students attending them. In this study, we used propensity score matching (PSM) to investigate…

Predictors of Outcome in Modern Surgery for Lung Abscess.

PubMed

Schweigert, Michael; Solymosi, Norbert; Dubecz, Attila; John, Joseph; West, Doug; Boenisch, Paul Leonhard; Karmy-Jones, Riyad; Ospina, Carlos F Giraldo; Almeida, Ana Beatriz; Witzigmann, Helmut; Stein, Hubert J

2017-10-01

Background  Surgery for lung abscess is a challenging task. Timing and indications for surgery are not well established. Identification of predictors of outcome could help to clarify the role of surgery. Methods  Patients who underwent major thoracic surgery for infectious lung abscess were identified at six centers for general thoracic surgery in Germany, Spain, the United Kingdom, and the United States. Study period was 2000 to 2016. Results  There were 91 patients. Pulmonary sepsis (48), pleural empyema (43), persistent air leakage (25), acute renal failure (12), and respiratory failure with mechanical ventilation (25) were already preoperatively present. The mean Charlson index of comorbidity was 3.0 (median: 2.0; interquartile range: 3). Procedures were segmentectomy (18), lobectomy (58), and pneumonectomy (15). The 30-day mortality following surgery was 13/91.Preoperative sepsis (odds ratio [OR]: 13.69; 95% confidence interval [CI]: 1.86-610.53; p  < 0.01), preoperative persistent air leak (OR: 13.46, 95% CI: 3.00-85.37, p  < 0.01), respiratory failure (OR: 5.60; 95% CI: 1.41-24.84; p  < 0.01), acute renal failure (OR: 6.15 ; 95% CI: 1.24-29.56 ; p  = 0.01), and Charlson index of comorbidity ≥ 3 (OR: 7.19 ; 95% CI: 1.43-71.21 ; p  < 0.01) are associated with higher mortality, whereas age > 70 years ( p  = 0.46) and the extent of pulmonary resection (segmentectomy, lobectomy, pneumonectomy) have no significant influence on mortality. Patients with fatal outcome have significantly higher Charlson index of comorbidity ( p  < 0.01). Conclusions  Delayed referral for surgery is common. Significant predictors for fatal outcome are pulmonary sepsis, septic complications (air leak, pleural empyema), septic organ failure (respiratory, acute renal failure), and preexisting comorbidity (Charlson index of comorbidity ≥ 3). The extent of surgical resection shows no significant influence. Georg Thieme Verlag KG Stuttgart · New York.

Investigating the health profile of patients with end-stage renal failure receiving peritoneal dialysis: a cluster analysis.

PubMed

Chan, M F; Wong, Frances K Y; Chow, Susan K Y

2010-03-01

To determine whether the patients with end stage renal failure can be differentiated into several subtypes based on five main variables. There is a lack of interventional research linking to clinical outcomes among the patients with end stage renal failure in Hong Kong and with no clear evidence of differences in terms of their clinical/health outcomes and characteristics. A cross-sectional survey. Data were collected using a structured questionnaire. One hundred and fifty-three patients with end stage renal failure were recruited during 2007 at three renal centres in Hong Kong. Five main variables were employed: predisposing characteristic, enabling resources, quality of life, symptom control and self-care adherence. A cluster analysis yielded two clusters. Each cluster represented a different profile of patients with end stage renal failure. Cluster A consisted of 49.7% (n = 76) and Cluster B consisted of 50.3% (n = 77) of the patients. Cluster A patients, more of whom were women, were older, less educated, had higher quality of life scores, a better adherence rate and more had received nursing care supports than patients in Cluster B. We have identified two groupings of patients with end stage renal failure who were experiencing unique health profile. Nursing support services may have an effect on patient health outcomes but only on a group of patients whose profile is similar to the patients in Cluster A and not for patients in Cluster B. A clear profile may help health care professional make appropriate strategies to target a specific group of patients to improve patient outcomes. The identification of risk for future health-care use could enable better targeting of interventional strategies in these groups. The results of this study might provide health care professionals with a model to design specified interventions to improve life quality for each profile group.

Dipeptidyl Peptidase-4 Inhibitors and Heart Failure Exacerbation in the Veteran Population: An Observational Study.

PubMed

Cobretti, Michael R; Bowman, Benjamin; Grabarczyk, Ted; Potter, Emily

2018-03-01

The dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) are effective modulators of fasting and postprandial hyperglycemia in patients with type 2 diabetes mellitus (T2DM). In 2013 the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) clinical trial found an increased risk of heart failure exacerbation, as a secondary outcome, among patients treated with saxagliptin. This study examines the safety of DPP-4 inhibitors as a class in T2DM in relation to risk of heart failure exacerbations. Retrospective cohort study of two groups of patients using data from the national Department of Veteran's Affairs (VA) Health Care System: patients initially prescribed DPP-4 inhibitors with or without second-generation sulfonylureas and/or metformin (exposed group) compared with patients initially prescribed only second-generation sulfonylureas and/or metformin (unexposed group) between August 1, 2013, and August 30, 2016. The primary aim of this study was to determine the difference in 1-year heart failure exacerbation rate in patients with T2DM between the exposed and unexposed groups. Data were analyzed using the χ 2 Student t test and Kaplan-Meier analysis. Significance was set at p<0.05. The study evaluated 672,265 patients: 33,614 patients in the exposed group and 638,651 patients in the unexposed group. Overall, 130 (0.38%) heart failure exacerbations were documented in the exposed group, and 2222 (0.34%) heart failure exacerbations were documented in the unexposed group; the difference in exacerbation rate was nonsignificant between groups (p=0.24). In a subgroup analysis of patients with a baseline diagnosis of heart failure, the difference in rate of heart failure exacerbations remained nonsignificant (p=0.334). Patients in the veteran population with T2DM treated with DPP-4 inhibitors did not demonstrate a significant increase in risk for heart failure exacerbation, regardless of whether a patient had been previously diagnosed with heart failure. This finding potentially supports safe usage of DPP-4 inhibitors in this patient population regardless of heart failure diagnosis. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

Tumor Necrosis Factor Inhibitor Primary Failure Predicts Decreased Ustekinumab Efficacy in Psoriasis Patients.

PubMed

Sorensen, Eric P; Fanucci, Kristina A; Saraiya, Ami; Volf, Eva; Au, Shiu-chung; Argobi, Yahya; Mansfield, Ryan; Gottlieb, Alice B

2015-08-01

Additional studies are needed to examine the efficacy of ustekinumab in psoriasis patients who have previously been exposed to tumor necrosis factor inhibitors (TNFi). To examine the predictive effect of TNFi primary failure and the number of TNFi exposures on the efficacy of ustekinumab in psoriasis treatment. This retrospective study examined 44 psoriasis patients treated at the Tufts Medical Center Department of Dermatology between January 2008 and July 2014. Patients were selected if they were treated with ustekinumab and had ≥ 1 previous TNFi exposure. The following subgroups were compared: patients with vs without a previous TNFi primary failure, and patients with one vs multiple previous TNFi exposures. The efficacy measure used was the previously validated Simple Measure for Assessing Psoriasis Activity (S-MAPA), which is calculated by the product of the body surface area and physician global assessment. The primary outcome was the percentage improvement S-MAPA from course baseline at week 12 of ustekinumab treatment. Secondary outcomes were the psoriasis clearance, primary failure, and secondary failure rates with ustekinumab treatment. Patients with a previous TNFi primary failure had a significantly lower percentage improvement in S-MAPA score at week 12 of ustekinumab treatment compared with patients without TNFi primary failure (36.2% vs 61.1%, P=.027). Multivariate analysis demonstrated that this relationship was independent of patient demographics and medical comorbidities. Patients with multiple TNFi exposures had a non-statistically significant lower percentage S-MAPA improvement at week 12 (40.5% vs 52.9%, P=.294) of ustekinumab treatment compared with patients with a single TNFi exposure. Among psoriasis patients previously exposed to TNFi, a history of a previous TNFi primary failure predicts a decreased response to ustekinumab independent of patient demographics and medical comorbidities.

[Reliability of nursing outcomes classification label "Knowledge: cardiac disease management (1830)" in outpatients with heart failure].

PubMed

Cañón-Montañez, Wilson; Oróstegui-Arenas, Myriam

2015-01-01

To determine the reliability (internal consistency, inter-rater reproducibility and level of agreement) of nursing outcome: "Knowledge: cardiac disease management (1830)" of the version published in Spanish, in outpatients with heart failure. A reliability study was conducted on 116 outpatients with heart failure. Six indicators of nursing outcome were operationalized. All participants were assessed simultaneously by two evaluators. Three evaluation periods were defined: initial (at baseline), final (a month later), and follow-up (two months later). Internal consistency by Cronbach alpha coefficient, inter-rater reproducibility with intraclass correlation coefficient of reproducibility or agreement and level agreement using the 95% limits of Bland and Altman. Cronbach's alpha was 0.83 (95% CI: 0.77 - 0.89) in the final evaluation, and follow-up values of 0.85 (95% CI: 0.82-0.89) and 0.83 (95% CI: 0.78 - 0.88) were found for the first and second evaluator, respectively. The intraclass correlation coefficient showed values greater 0.9 in the three evaluation periods in both the random and mixed model. The Bland-Altman 95% limits of agreement were close to zero in the three evaluations performed. The questionnaire operationalized to assess the nursing outcome: "Knowledge: cardiac disease management (1830)" in its Spanish version, is a reliable method to measure skills and knowledge in outpatients with heart failure in the Colombian context. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Machine-Learning Algorithms Predict Graft Failure After Liver Transplantation.

PubMed

Lau, Lawrence; Kankanige, Yamuna; Rubinstein, Benjamin; Jones, Robert; Christophi, Christopher; Muralidharan, Vijayaragavan; Bailey, James

2017-04-01

The ability to predict graft failure or primary nonfunction at liver transplant decision time assists utilization of scarce resource of donor livers, while ensuring that patients who are urgently requiring a liver transplant are prioritized. An index that is derived to predict graft failure using donor and recipient factors, based on local data sets, will be more beneficial in the Australian context. Liver transplant data from the Austin Hospital, Melbourne, Australia, from 2010 to 2013 has been included in the study. The top 15 donor, recipient, and transplant factors influencing the outcome of graft failure within 30 days were selected using a machine learning methodology. An algorithm predicting the outcome of interest was developed using those factors. Donor Risk Index predicts the outcome with an area under the receiver operating characteristic curve (AUC-ROC) value of 0.680 (95% confidence interval [CI], 0.669-0.690). The combination of the factors used in Donor Risk Index with the model for end-stage liver disease score yields an AUC-ROC of 0.764 (95% CI, 0.756-0.771), whereas survival outcomes after liver transplantation score obtains an AUC-ROC of 0.638 (95% CI, 0.632-0.645). The top 15 donor and recipient characteristics within random forests results in an AUC-ROC of 0.818 (95% CI, 0.812-0.824). Using donor, transplant, and recipient characteristics known at the decision time of a transplant, high accuracy in matching donors and recipients can be achieved, potentially providing assistance with clinical decision making.

Treatment outcomes in patients with third-generation cephalosporin-resistant Enterobacter bacteremia.

PubMed

O'Neal, Catherine S; O'Neal, Hollis R; Daniels, Titus L; Talbot, Thomas R

2012-10-01

Infections with resistant Enterobacter spp. are increasingly described, yet data on outcomes associated with these infections are limited. A retrospective cohort study was conducted to investigate outcomes of hospitalized patients with third-generation cephalosporin-resistant (CR) Enterobacter bacteremia. Cephalosporin resistance was detected using cefotaxime and cefpodoxime. Patients with Enterobacter spp. bacteremia from January 2006 through February 2008 defined the population. We defined cases as those with CR isolates; controls were patients with bacteremia due to non-CR isolates. Treatment failure was defined as persistence of the presenting signs of infection 72 h after initial culture collection. Of the 95 Enterobacter cases identified, 31 (33%) were CR. CR cases were significantly associated with treatment failure (odds ratio (OR) 2.81, 95% confidence interval (CI) 1.14-6.94). This association was not seen after adjustment for age, simplified acute physiology score (SAPS II), and inappropriate empiric antibiotic therapy. Inappropriate empiric therapy (adjusted OR 3.86, 95% CI 1.32-11.31) and SAPS II score (adjusted OR 1.09, 95% CI 1.02-1.16) were significantly associated with treatment failure in the multivariate analysis. Third-generation cephalosporin-resistant Enterobacter bacteremia is associated with treatment failure due to receipt of inappropriate empiric antibiotic therapy and severity of illness.

Persistent high serum bicarbonate and the risk of heart failure in patients with chronic kidney disease (CKD): A report from the Chronic Renal Insufficiency Cohort (CRIC) study.

PubMed

Dobre, Mirela; Yang, Wei; Pan, Qiang; Appel, Lawrence; Bellovich, Keith; Chen, Jing; Feldman, Harold; Fischer, Michael J; Ham, L L; Hostetter, Thomas; Jaar, Bernard G; Kallem, Radhakrishna R; Rosas, Sylvia E; Scialla, Julia J; Wolf, Myles; Rahman, Mahboob

2015-04-20

Serum bicarbonate varies over time in chronic kidney disease (CKD) patients, and this variability may portend poor cardiovascular outcomes. The aim of this study was to conduct a time-updated longitudinal analysis to evaluate the association of serum bicarbonate with long-term clinical outcomes: heart failure, atherosclerotic events, renal events (halving of estimated glomerular filtration rate [eGFR] or end-stage renal disease), and mortality. Serum bicarbonate was measured annually, in 3586 participants with CKD, enrolled in the Chronic Renal Insufficiency Cohort (CRIC) study. Marginal structural models were created to allow for integration of all available bicarbonate measurements and proper adjustment for time-dependent confounding. During the 6 years follow-up, 512 participants developed congestive heart failure (26/1000 person-years) and 749 developed renal events (37/1000 person-years). The risk of heart failure and death was significantly higher for participants who maintained serum bicarbonate >26 mmol/L for the entire duration of follow-up (hazard ratio [HR] 1.66; 95% confidence interval [CI], 1.23 to 2.23, and HR 1.36, 95% CI 1.02 to 1.82, respectively) compared with participants who kept their bicarbonate 22 to 26 mmol/L, after adjusting for demographics, co-morbidities, medications including diuretics, eGFR, and proteinuria. Participants who maintained serum bicarbonate <22 mmol/L had almost a 2-fold increased risk of renal disease progression (HR 1.97; 95% CI, 1.50 to 2.57) compared with participants with bicarbonate 22 to 26 mmol/L. In this large CKD cohort, persistent serum bicarbonate >26 mmol/L was associated with increased risk of heart failure events and mortality. Further studies are needed to determine the optimal range of serum bicarbonate in CKD to prevent adverse clinical outcomes. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Persistent High Serum Bicarbonate and the Risk of Heart Failure in Patients With Chronic Kidney Disease (CKD): A Report From the Chronic Renal Insufficiency Cohort (CRIC) Study

PubMed Central

Dobre, Mirela; Yang, Wei; Pan, Qiang; Appel, Lawrence; Bellovich, Keith; Chen, Jing; Feldman, Harold; Fischer, Michael J.; Ham, L. L.; Hostetter, Thomas; Jaar, Bernard G.; Kallem, Radhakrishna R.; Rosas, Sylvia E.; Scialla, Julia J.; Wolf, Myles; Rahman, Mahboob

2015-01-01

Background Serum bicarbonate varies over time in chronic kidney disease (CKD) patients, and this variability may portend poor cardiovascular outcomes. The aim of this study was to conduct a time‐updated longitudinal analysis to evaluate the association of serum bicarbonate with long‐term clinical outcomes: heart failure, atherosclerotic events, renal events (halving of estimated glomerular filtration rate [eGFR] or end‐stage renal disease), and mortality. Methods and Results Serum bicarbonate was measured annually, in 3586 participants with CKD, enrolled in the Chronic Renal Insufficiency Cohort (CRIC) study. Marginal structural models were created to allow for integration of all available bicarbonate measurements and proper adjustment for time‐dependent confounding. During the 6 years follow‐up, 512 participants developed congestive heart failure (26/1000 person‐years) and 749 developed renal events (37/1000 person‐years). The risk of heart failure and death was significantly higher for participants who maintained serum bicarbonate >26 mmol/L for the entire duration of follow‐up (hazard ratio [HR] 1.66; 95% confidence interval [CI], 1.23 to 2.23, and HR 1.36, 95% CI 1.02 to 1.82, respectively) compared with participants who kept their bicarbonate 22 to 26 mmol/L, after adjusting for demographics, co‐morbidities, medications including diuretics, eGFR, and proteinuria. Participants who maintained serum bicarbonate <22 mmol/L had almost a 2‐fold increased risk of renal disease progression (HR 1.97; 95% CI, 1.50 to 2.57) compared with participants with bicarbonate 22 to 26 mmol/L. Conclusion In this large CKD cohort, persistent serum bicarbonate >26 mmol/L was associated with increased risk of heart failure events and mortality. Further studies are needed to determine the optimal range of serum bicarbonate in CKD to prevent adverse clinical outcomes. PMID:25896890

An early, novel illness severity score to predict outcome after cardiac arrest.

PubMed

Rittenberger, Jon C; Tisherman, Samuel A; Holm, Margo B; Guyette, Francis X; Callaway, Clifton W

2011-11-01

Illness severity scores are commonly employed in critically ill patients to predict outcome. To date, prior scores for post-cardiac arrest patients rely on some event-related data. We developed an early, novel post-arrest illness severity score to predict survival, good outcome and development of multiple organ failure (MOF) after cardiac arrest. Retrospective review of data from adults treated after in-hospital or out-of-hospital cardiac arrest in a single tertiary care facility between 1/1/2005 and 12/31/2009. In addition to clinical data, initial illness severity was measured using serial organ function assessment (SOFA) scores and full outline of unresponsiveness (FOUR) scores at hospital or intensive care unit arrival. Outcomes were hospital mortality, good outcome (discharge to home or rehabilitation) and development of multiple organ failure (MOF). Single-variable logistic regression followed by Chi-squared automatic interaction detector (CHAID) was used to determine predictors of outcome. Stepwise multivariate logistic regression was used to determine the independent association between predictors and each outcome. The Hosmer-Lemeshow test was used to evaluate goodness of fit. The n-fold method was used to cross-validate each CHAID analysis and the difference between the misclassification risk estimates was used to determine model fit. Complete data from 457/495 (92%) subjects identified distinct categories of illness severity using combined FOUR motor and brainstem subscales, and combined SOFA cardiovascular and respiratory subscales: I. Awake; II. Moderate coma without cardiorespiratory failure; III. Moderate coma with cardiorespiratory failure; and IV. Severe coma. Survival was independently associated with category (I: OR 58.65; 95% CI 27.78, 123.82; II: OR 14.60; 95% CI 7.34, 29.02; III: OR 10.58; 95% CI 4.86, 23.00). Category was also similarly associated with good outcome and development of MOF. The proportion of subjects in each category changed over time. Initial illness severity explains much of the variation in cardiac arrest outcome. This model provides prognostic information at hospital arrival and may be used to stratify patients in future studies. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The Relationship between Body Mass Index and Risk of Failure following Meniscus Repair.

PubMed

Sommerfeldt, Mark F; Magnussen, Robert A; Randall, Kyle L; Tompkins, Marc; Perkins, Bryan; Sharma, Avijit; Blackwell, Ryan; Flanigan, David C

2016-11-01

It is unknown whether body mass index (BMI) influences outcomes of meniscus repair. We hypothesized that increased BMI would be associated with increased risk of failure. A retrospective study was performed involving patients who had undergone meniscus repair between 2008 and 2012. Chart review and phone interviews were conducted to determine which patients required additional surgery. Patients were categorized as normal BMI (<25) or increased BMI (≥25). Of the 305 patients who met study criteria, 216 (70.8%) were available for follow-up at a mean of 19 months postoperatively. A total of 100 patients (46.3%) had a BMI <25 and 116 (53.7%) patients had a BMI ≥25. BMI was less than 35 in 90% of patients. Thirty-four patients (15.7%) required further surgery for a repair failure. Failure occurred in 20 patients (20%) in the normal BMI group and 14 patients (12%) in the increased BMI group ( p  = 0.14). Logistic regression revealed a trend toward decreased odds of repair failure in the increased BMI group (odds ratio: 0.46; 95% confidence interval: 0.20-1.05; p  = 0.065). Patients with a BMI ≥25 did not have a higher risk of meniscus repair failure relative to those with a BMI <25. Given these findings, surgeons should not consider moderately increased BMI as a contraindication to meniscal repair. The effect of BMI greater than 35 on outcomes of meniscal repair remains unclear and warrants further study. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Effects of carvedilol therapy in patients with heart failure with preserved ejection fraction - Results from the Croatian heart failure (CRO-HF) registry.

PubMed

Domagoj, Markovic; Branka, Jurcevic Zidar; Jelena, Macanovic; Davor, Milicic; Duska, Glavas

2018-04-17

According to recent guidelines, the best approach for treatment of heart failure patients with preserved ejection function is still not defined. The aim of this study was to investigate how carvedilol therapy influences the survival rate, ejection fraction and NYHA class in these patients. We conducted study on heart failure patients with preserved systolic function from the Croatian heart failure registry who were hospitalized in the period between 2005 and 2010. We enrolled patients with carvedilol listed as treatment on their discharge letters and patients who had been using carvedilol for at least 4 years, while for the control group we selected patients with no beta-blockers on their discharge letters (113 vs 204 respectively). The primary outcome was the overall survival rate and the secondary outcome was the change in ejection fraction of the left ventricle and NYHA class during the study. Patients in the carvedilol group had a higher overall survival rate compared to patients in the control group (chi-square=14.1, P<0.001). Patients in the carvedilol group in two measurements had a significantly higher ejection fraction compared to the control group (F=148.04, P<0.001). Also, patients in the carvedilol group showed improvement in NYHA class (chi-square=29.768, P<0.001). Long term carvedilol therapy appears to be associated with a higher overall survival rate, improvement in ejection fraction and NYHA class in heart failure patients with preserved ejection fraction. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Outcome of Hip Impingement Surgery: Does Generalized Joint Hypermobility Matter?

PubMed

Naal, Florian D; Müller, Aileen; Varghese, Viju D; Wellauer, Vanessa; Impellizzeri, Franco M; Leunig, Michael

2017-05-01

Generalized joint hypermobility (JH) might negatively influence the results of surgical femoroacetabular impingement (FAI) treatment, as JH has been linked to musculoskeletal pain and injury incidence in athletes. JH may also be associated with worse outcomes of FAI surgery in thin females. To (1) determine the results of FAI surgery at a minimum 2-year follow-up by means of patient-reported outcome measures (PROMs) and failure rates, (2) assess the prevalence of JH in FAI patients and its effect on outcomes, and (3) identify other risk factors associated with treatment failure. Cohort study; Level of evidence, 3. We included 232 consecutive patients (118 females; mean age, 36 years) with 244 hips surgically treated for symptomatic FAI between 2010 and 2012. All patients completed different PROMs preoperatively and at a mean follow-up of 3.7 years. Satisfaction questions were used to define subjective failure (answering any of the 2 subjective questions with dissatisfied/ very dissatisfied and/or didn't help/ made things worse). Conversion to total hip replacement (THR) was defined as objective failure. JH was assessed using the Beighton score. All PROM values significantly ( P < .001) improved from preoperative measurement to follow-up (Oxford Hip Score: 33.8 to 42.4; University of California at Los Angeles Activity Scale: 6.3 to 7.3; EuroQol-5 Dimension Index: 0.58 to 0.80). Overall, 34% of patients scored ≥4 on the Beighton score, and 18% scored ≥6, indicating generalized JH. Eleven hips (4.7%) objectively failed and were converted to THR. Twenty-four patients (10.3%) were considered as subjective failures. No predictive risk factors were identified for subjective failure. Tönnis grade significantly ( P < .001) predicted objective failure (odds ratio, 13; 95% CI, 4-45). There was a weak inverse association ( r = -0.16 to -0.30) between Beighton scores and preoperative PROM values. There were no significant associations between Beighton scores and postoperative PROM values or subjective failure rates, but patients who objectively failed had lower Beighton scores than did nonfailures (1.6 vs 2.6; P = .049). FAI surgery yielded favorable outcomes at short- to midterm follow-up. JH as assessed by the Beighton score was not consistently associated with subjective and objective results. Joint degeneration was the most important risk factor for conversion to THR. Although statistical significance was not reached, female patients with no joint degeneration, only mild FAI deformity, and higher Oxford scores at the time of surgery seemed to be at increased risk for subjective dissatisfaction.

Interaction of Body Mass Index on the Association Between N-Terminal-Pro-b-Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure).

PubMed

Bhatt, Ankeet S; Cooper, Lauren B; Ambrosy, Andrew P; Clare, Robert M; Coles, Adrian; Joyce, Emer; Krishnamoorthy, Arun; Butler, Javed; Felker, G Michael; Ezekowitz, Justin A; Armstrong, Paul W; Hernandez, Adrian F; O'Connor, Christopher M; Mentz, Robert J

2018-02-03

Higher body mass index (BMI) is associated with lower circulating levels of N-terminal-pro-b-type natriuretic peptide (NT-proBNP). The Interaction between BMI and NT-proBNP with respect to clinical outcomes is not well characterized in patients with acute heart failure. A total of 686 patients from the biomarker substudy of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated HF ) clinical trial with documented NT-proBNP levels at baseline were included in the present analysis. Patients were classified by the World Health Organization obesity classification (nonobese: BMI <30 kg/m 2 , Class I obesity: BMI 30-34.9 kg/m 2 , Class II obesity BMI 35-39.9 kg/m 2 , and Class III obesity BMI ≥40 kg/m 2 ). We assessed baseline characteristics and 30- and 180-day outcomes by BMI class and explored the interaction between BMI and NT-proBNP for these outcomes. Study participants had a median age of 67 years (55, 78) and 71% were female. NT-proBNP levels were inversely correlated with BMI ( P <0.001). Higher NT-proBNP levels were associated with higher 180-day mortality (adjusted hazard ratio for each doubling of NT-proBNP, 1.40; 95% confidence interval, 1.16, 1.71; P <0.001), but not 30-day outcomes. The effect of NT-proBNP on 180-day death was not modified by BMI class (interaction P =0.24). The prognostic value of NT-proBNP was not modified by BMI in this acute heart failure population. NT-proBNP remains a useful prognostic indicator of long-term mortality in acute heart failure even in the obese patient. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Foley catheter placement for induction of labor with or without stylette: a randomized clinical trial.

PubMed

Forgie, Marie M; Greer, Danielle M; Kram, Jessica J F; Vander Wyst, Kiley B; Salvo, Nicole P; Siddiqui, Danish S

2016-03-01

Foley catheters are used for cervical ripening during induction of labor. Previous studies suggest that use of a stylette (a thin, rigid wire) to guide catheter insertion decreases insertion failure. However, stylette effects on insertion outcomes have been sparsely studied. The purpose of this study was to compare catheter insertion times, patient-assessed pain levels, and insertion failure rates between women who received a digitally placed Foley catheter for cervical ripening with the aid of a stylette and women who received the catheter without a stylette. We conducted a randomized clinical trial of women aged ≥ 18 years who presented for induction of labor. Inclusion criteria were singletons with intact membranes and cephalic presentation. Women received a computer-generated random assignment of a Foley catheter insertion with a stylette (treatment group, n = 62) or without a stylette (control group, n = 61). For all women, a standard insertion technique protocol was used. Three primary outcomes were of interest, including the following: (1) insertion time (total minutes to successful catheter placement), (2) patient-assessed pain level (0-10), and (3) failure rate of the randomly assigned insertion method. Treatment control differences were first examined using the Pearson's test of independence and the Student t test. Per outcome, we also constructed 4 regression models, each including the random effect of physician and fixed effects of stylette use with patient nulliparity, a history of vaginal delivery, cervical dilation at presentation, or postgraduate year of the performing resident physician. Women who received the Foley catheter with the stylette vs without the stylette did not differ by age, race/ethnicity, body mass index, or any of several other characteristics. Regression models revealed that insertion time, patient pain, and insertion failure were unrelated to stylette use, nulliparity, and history of vaginal delivery. However, overall insertion time and failure were significantly influenced by cervical dilation, with insertion time decreasing by 21% (95% confidence interval [CI], 5-34%) and odds of failure decreasing by 71% (odds ratio, 0.29; 95% CI, 0.10-0.86) per 1 cm dilation. Resident postgraduate year also significantly influenced insertion time, with greater time required of physicians with less experience. Mean insertion time was 51% (95% CI, 23-69%) shorter for fourth-year than second-year residents. Statistically nonsignificant but prominent patterns in outcomes were also observed, suggesting stylette use may lengthen the overall insertion procedure but minimize variability in pain levels and decrease insertion failure. The randomized trial suggests that, even after accounting for nulliparity, history of vaginal delivery, cervical dilation, and physician experience, Foley catheter insertions with and without a stylette are equivalent in insertion times, patient pain levels, and failure of catheter placement. Copyright © 2016 Elsevier Inc. All rights reserved.

Risk factors and outcomes of acute kidney injury in patients with acute liver failure.

PubMed

Tujios, Shannan R; Hynan, Linda S; Vazquez, Miguel A; Larson, Anne M; Seremba, Emmanuel; Sanders, Corron M; Lee, William M

2015-02-01

Patients with acute liver failure (ALF) frequently develop renal dysfunction, yet its overall incidence and outcomes have not been fully assessed. We investigated the incidence of acute kidney injury (AKI) among patients with ALF, using defined criteria to identify risk factors and to evaluate its effect on overall outcomes. We performed a retrospective review of data from 1604 patients enrolled in the Acute Liver Failure Study Group, from 1998 through 2010. Patients were classified by the Acute Kidney Injury Network criteria, as well as for etiology of liver failure (acetaminophen-based, ischemic, and all others). Seventy percent of patients with ALF developed AKI, and 30% received renal replacement therapy (RRT). Patients with severe AKI had higher international normalized ratio values than those without renal dysfunction (P < .001), and a higher proportion had advanced-grade coma (coma grades 3 or 4; P < .001) or presented with hypotension requiring vasopressor therapy (P < .001). A greater proportion of patients with acetaminophen-induced ALF had severe kidney injury than of patients with other etiologies of ALF; 34% required RRT, compared with 25% of patients with ALF not associated with acetaminophen or ischemia (P < .002). Of the patients with ALF who were alive at 3 weeks after study entry, significantly fewer with AKI survived for 1 year. Although AKI reduced the overall survival time, more than 50% of patients with acetaminophen-associated or ischemic ALF survived without liver transplantation (even with RRT), compared with 19% of patients with ALF attribute to other causes (P < .001). Only 4% of patients requiring RRT became dependent on dialysis. Based on a retrospective analysis of data from more than 1600 patients, AKI is common in patients with ALF and affects short- and long-term outcomes, but rarely results in chronic kidney disease. Acetaminophen-induced kidney injury is frequent, but patients have better outcomes than those with other forms of ALF. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Comparison of Predictors of Heart Failure-related Hospitalization or Death in Patients with versus without Preserved Left Ventricular Ejection Fraction

PubMed Central

Mangla, Ashvarya; Kane, John; Beaty, Elijah; Richardson, DeJuran; Powell, Lynda H.; Calvin, James E.

2013-01-01

Heart failure with preserved ejection fraction (HFpEF) is recognized as a major cause of cardiovascular morbidity and mortality. An ability to identify patients with HFpEF who are at increased risk for adverse outcome can facilitate their more careful management. We studied the patients having heart failure (HF) using data from the Heart Failure Adherence and Retention Trial (HART). HART enrolled 902 NYHA Class II or III patients who had been recently hospitalized for HF to study the impact of self-management counseling on the primary outcome of death or HF hospitalization. In HART 208 patients had HFpEF and 692 had HFrEF (heart failure with reduced ejection fraction), and were followed for median of 1080 days. Two final multivariate models were developed. In patients having HFpEF, predictors of primary outcome were: male sex (OR 3.45, p=0.004), NYHA class III (OR 3.05, p=0.008), distance covered on 6-minute walk test (6-MWT) of< 620 feet (OR 2.81, p=0.013), and <80% adherence to prescribed medications (OR 2.61, p=0.018). In patients having HFrEF, the predictors were: being on diuretics (OR 3.06, p=0.001), having ≥ 3 comorbidities (OR 2.11, p=0.0001), distance covered on 6-MWT of < 620 feet (OR 1.94, p=0.001), NYHA class III (OR 1.90, p=0.001) and age > 65 years (OR 1.63, p=0.01). In conclusion, indicators of functional status(6-MWT and NYHA class) were common to both HFpEF and HFrEF patients while gender and adherence to prescribed therapy were unique to patients having HFpEF in predicting death or HF hospitalization. PMID:24063842

Does short-term virologic failure translate to clinical events in antiretroviral-naïve patients initiating antiretroviral therapy in clinical practice?

PubMed

Mugavero, Michael J; May, Margaret; Harris, Ross; Saag, Michael S; Costagliola, Dominique; Egger, Matthias; Phillips, Andrew; Günthard, Huldrych F; Dabis, Francois; Hogg, Robert; de Wolf, Frank; Fatkenheuer, Gerd; Gill, M John; Justice, Amy; D'Arminio Monforte, Antonella; Lampe, Fiona; Miró, Jose M; Staszewski, Schlomo; Sterne, Jonathan A C

2008-11-30

To determine whether differences in short-term virologic failure among commonly used antiretroviral therapy (ART) regimens translate to differences in clinical events in antiretroviral-naïve patients initiating ART. Observational cohort study of patients initiating ART between January 2000 and December 2005. The Antiretroviral Therapy Cohort Collaboration (ART-CC) is a collaboration of 15 HIV cohort studies from Canada, Europe, and the United States. A total of 13 546 antiretroviral-naïve HIV-positive patients initiating ART with efavirenz, nevirapine, lopinavir/ritonavir, nelfinavir, or abacavir as third drugs in combination with a zidovudine and lamivudine nucleoside reverse transcriptase inhibitor backbone. Short-term (24-week) virologic failure (>500 copies/ml) and clinical events within 2 years of ART initiation (incident AIDS-defining event, death, and a composite measure of these two outcomes). Compared with efavirenz as initial third drug, short-term virologic failure was more common with all other third drugs evaluated; nevirapine (adjusted odds ratio = 1.87, 95% confidence interval (CI) = 1.58-2.22), lopinavir/ritonavir (1.32, 95% CI = 1.12-1.57), nelfinavir (3.20, 95% CI = 2.74-3.74), and abacavir (2.13, 95% CI = 1.82-2.50). However, the rate of clinical events within 2 years of ART initiation appeared higher only with nevirapine (adjusted hazard ratio for composite outcome measure 1.27, 95% CI = 1.04-1.56) and abacavir (1.22, 95% CI = 1.00-1.48). Among antiretroviral-naïve patients initiating therapy, between-ART regimen, differences in short-term virologic failure do not necessarily translate to differences in clinical outcomes. Our results should be interpreted with caution because of the possibility of residual confounding by indication.

[Frequency, etiology, and outcomes of acute renal failure (data of Kaunas University of Medicine Hospital in 1995-2006)].

PubMed

Skarupskiene, Inga; Kuzminskis, Vytautas; Ziginskiene, Edita

2007-01-01

The aim of this study was to determine the frequency, etiology, and outcomes of acute renal failure. We retrospectively collected data on all patients (n=1653) who received renal replacement therapy for acute renal failure at the Kaunas University of Medicine Hospital during 1995-2006. The number of patients with acute renal failure increased nine times during the 11-year period. The mean age of patients was 59.76+/-17.52 years and increased from 44.97+/-17.1 years in 1995 to 62.84+/-16.49 years in 2006. The most common causes of acute renal failure were renal (n=646, 39%), prerenal (n=380, 23%), and obstructive (n=145, 9%). The renal replacement therapy was discontinued because of recovery of renal function in 49.9% of cases. The overall hospital mortality rate was 45.1%. Renal function did not recover in 6.7% of patients. The mortality rate over the 11-year period varied from 37.8 to 57.5%. The highest mortality rate was in the neurosurgical (62.3%) and cardiac surgical (61.8%) intensive care units. High mortality rate (more than 50%) was in the groups of patients with acute renal failure that was caused by hepatorenal syndrome, shock, sepsis, and reduced cardiac output.

Causal attribution of success and failure as a function or authoritarianism and sex.

PubMed

Goldberg, C; Evenbeck, S

1976-04-01

We predicted that authoritarian actors would engage in defensive attribution, and authoritarian observers would derogate the other, to a greater extent than egalitarian perceivers. 48 male and 48 female college students were run in pairs of same sex and authoritarianism. A set of easy anagrams was given to subjects in success conditions and difficult anagrams to those in failure conditions. Each subject rated own outcome and other outcome in terms of internal factors of ability and effort, and external factors of task and luck. We found that authoritarian actors were more internal than egalitarian actors only in the condition own success-other's failure. Authoritarian observers, as compared to egalitarians, were more external for other's success and more internal for other's failure only when own outcome was successful. It seems that authoritarian perceivers exaggerate their abilities and derogate the other only when they are clearly in a superior position vis-a-vis the other. There were no sex differences as a function of outcome and authoritarianism.

Relationship of left ventricular hypertrophy and diastolic function with cardiovascular and renal outcomes in African Americans with hypertensive chronic kidney disease.

PubMed

Peterson, Gail E; de Backer, Tine; Contreras, Gabriel; Wang, Xuelei; Kendrick, Cynthia; Greene, Tom; Appel, Lawrence J; Randall, Otelio S; Lea, Janice; Smogorzewski, Miroslaw; Vagaonescu, Tudor; Phillips, Robert A

2013-09-01

African Americans with hypertension are at high risk for adverse outcomes from cardiovascular and renal disease. Patients with stage 3 or greater chronic kidney disease have a high prevalence of left ventricular (LV) hypertrophy and diastolic dysfunction. Our goal was to study prospectively the relationships of LV mass and diastolic function with subsequent cardiovascular and renal outcomes in the African American Study of Kidney Disease and Hypertension cohort study. Of 691 patients enrolled in the cohort, 578 had interpretable echocardiograms and complete relevant clinical data. Exposures were LV hypertrophy and diastolic parameters. Outcomes were cardiovascular events requiring hospitalization or causing death; a renal composite outcome of doubling of serum creatinine or end-stage renal disease (censoring death); and heart failure. We found strong independent relationships between LV hypertrophy and subsequent cardiovascular (hazard ratio, 1.16; 95% confidence interval, 1.05-1.27) events, but not renal outcomes. After adjustment for LV mass and clinical variables, lower systolic tissue Doppler velocities and diastolic parameters reflecting a less compliant LV (shorter deceleration time and abnormal E/A ratio) were significantly (P<0.05) associated with future heart failure events. This is the first study to show a strong relationship among LV hypertrophy, diastolic parameters, and adverse cardiac outcomes in African Americans with hypertension and chronic kidney disease. These echocardiographic risk factors may help identify high-risk patients with chronic kidney disease for aggressive therapeutic intervention.

Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial.

PubMed

Konstam, Marvin A; Neaton, James D; Dickstein, Kenneth; Drexler, Helmut; Komajda, Michel; Martinez, Felipe A; Riegger, Gunter A J; Malbecq, William; Smith, Ronald D; Guptha, Soneil; Poole-Wilson, Philip A

2009-11-28

Angiotensin-receptor blockers (ARBs) are effective treatments for patients with heart failure, but the relation between dose and clinical outcomes has not been explored. We compared the effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure. This double-blind trial was undertaken in 255 sites in 30 countries. 3846 patients with heart failure of New York Heart Association class II-IV, left-ventricular ejection fraction 40% or less, and intolerance to angiotensin-converting-enzyme (ACE) inhibitors were randomly assigned to losartan 150 mg (n=1927) or 50 mg daily (n=1919). Allocation was by block randomisation stratified by centre and presence or absence of beta-blocker therapy, and all patients and investigators were masked to assignment. The primary endpoint was death or admission for heart failure. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00090259. Six patients in each group were excluded because of poor data quality. With 4.7-year median follow-up in each group (IQR 3.7-5.5 for losartan 150 mg; 3.4-5.5 for losartan 50 mg), 828 (43%) patients in the 150 mg group versus 889 (46%) in the 50 mg group died or were admitted for heart failure (hazard ratio [HR] 0.90, 95% CI 0.82-0.99; p=0.027). For the two primary endpoint components, 635 patients in the 150 mg group versus 665 in the 50 mg group died (HR 0.94, 95% CI 0.84-1.04; p=0.24), and 450 versus 503 patients were admitted for heart failure (0.87, 0.76-0.98; p=0.025). Renal impairment (n=454 vs 317), hypotension (203 vs 145), and hyperkalaemia (195 vs 131) were more common in the 150 mg group than in the 50 mg group, but these adverse events did not lead to significantly more treatment discontinuations in the 150 mg group. Losartan 150 mg daily reduced the rate of death or admission for heart failure in patients with heart failure, reduced left-ventricular ejection fraction, and intolerance to ACE inhibitors compared with losartan 50 mg daily. These findings show the value of up-titrating ARB doses to confer clinical benefit. Merck (USA).

A retrospective study of a modified 1-minute formocresol pulpotomy technique part 1: clinical and radiographic findings.

PubMed

Kurji, Zahra A; Sigal, Michael J; Andrews, Paul; Titley, Keith

2011-01-01

The purpose of this study was to assess the clinical and radiographic outcomes of a 1-minute application of full-strength Buckley's formocresol with concurrent hemostasis using the medicated cotton pledget in human primary teeth. Using a retrospective chart review, clinical and radiographic data were available for 557 primary molars in 320 patients. Descriptive statistics and survival analysis were used to assess outcomes. Overall clinical success, radiographic success, and cumulative 5-year survival rates were approximately 99%, 90%, and 87%, respectively. Internal root resorption (∼5%) and pulp canal obliteration (∼2%) were the most frequently observed radiographic failures. Thirty-nine teeth were extracted due to clinical and or radiographic failure. Mandibular molars were 6 times more prone to radiographic failure than maxillary molars. Success rates for the modified technique are comparable to techniques that use the 5-minute diluted or full-strength solutions reported in the literature. This 1-minute full-strength formocresol technique is an acceptable alternative to published traditional techniques.

Understanding the disparity: predictors of virologic failure in women using highly active antiretroviral therapy vary by race and/or ethnicity.

PubMed

McFall, Allison M; Dowdy, David W; Zelaya, Carla E; Murphy, Kerry; Wilson, Tracey E; Young, Mary A; Gandhi, Monica; Cohen, Mardge H; Golub, Elizabeth T; Althoff, Keri N

2013-11-01

Stark racial/ethnic disparities in health outcomes exist among those living with HIV in the United States. One of 3 primary goals of the National HIV/AIDS Strategy is to reduce HIV-related disparities and health inequities. Using data from HIV-infected women participating in the Women's Interagency HIV Study from April 2006 to March 2011, we measured virologic failure (HIV RNA >200 copies/mL) after suppression (HIV RNA < 80 copies/mL) on highly active antiretroviral therapy. We identified predictors of virologic failure using discrete time survival analysis and calculated racial/ethnic-specific population-attributable fractions (PAFs). Of 887 eligible women, 408 (46%) experienced virologic failure during the study period. Hispanic and white women had significantly lower hazards of virologic failure than African American women [Hispanic hazard ratio, (HR) = 0.8, 95% confidence interval: (0.6 to 0.9); white HR = 0.7 (0.5 to 0.9)]. The PAF of virologic failure associated with low income was higher in Hispanic [adjusted hazard ratios (aHR) = 2.2 (0.7 to 6.5), PAF = 49%] and African American women [aHR = 1.8 (1.1 to 3.2), PAF = 38%] than among white women [aHR = 1.4 (0.6 to 3.4), PAF = 16%]. Lack of health insurance compared with public health insurance was associated with virologic failure only among Hispanic [aHR = 2.0 (0.9 to 4.6), PAF = 22%] and white women [aHR = 1.9 (0.7 to 5.1), PAF = 13%]. By contrast, depressive symptoms were associated with virologic failure only among African-American women [aHR = 1.6 (1.2 to 2.2), PAF = 17%]. In this population of treated HIV-infected women, virologic failure was common, and correlates of virologic failure varied by race/ethnicity. Strategies to reduce disparities in HIV treatment outcomes by race/ethnicity should address racial/ethnic-specific barriers including depression and low income to sustain virologic suppression.

A meta-analysis of the association between diabetic patients and AVF failure in dialysis.

PubMed

Yan, Yan; Ye, Dan; Yang, Liu; Ye, Wen; Zhan, Dandan; Zhang, Li; Xiao, Jun; Zeng, Yan; Chen, Qinkai

2018-11-01

The most preferable vascular access for patients with end-stage renal failure needing hemodialysis is native arteriovenous fistula (AVF) on account of its access longevity, patient morbidity, hospitalization costs, lower risks of infection and fewer incidence of thrombotic complications. Meanwhile, according to National Kidney Foundation (NKF)̸Dialysis Out-comes Quality Initiative (DOQI) guidelines, AVF is more used than before. However, a significant percentage of AVF fails to support dialysis therapy due to lack of adequate maturity. Among all factors, the presence of diabetes mellitus was shown to be one of the risk factors for the development of vascular access failure by some authors. Therefore, this review evaluates the current evidence concerning the correlation of diabetes and AVF failure. A search was conducted using MEDLINE, SCIENCE DIRECT, SPRINGER, WILEY-BLACKWELL, KARGER, EMbase, CNKI and WanFang Data from the establishment time of databases to January 2016. The analysis involved studies that contained subgroups of diabetic patients and compared their outcomes with those of non-diabetic adults. In total, 23 articles were retrieved and included in the review. The meta-analysis revealed a statistically significantly higher rate of AVF failure in diabetic patients compared with non-diabetic patients (OR = 1.682; 95% CI, 1.429-1.981, Test of OR = 1: z = 6.25, p <.001). This review found an increased risk of AVF failure in diabetes patients. If confirmed by further prospective studies, preventive measure should be considered when planning AVF in diabetic patients.

Heart failure disease management: implementation and outcomes.

PubMed

Whellan, David J

2005-01-01

Millions of dollars are being spent to identify new therapies to improve mortality and morbidity for the growing epidemic of patients sustaining heart failure. However, in clinical practice, these therapies are currently underused. To bridge the gap between proven therapies and clinical practice, the medical community has turned to disease management. Heart failure disease management interventions vary from vital-sign monitoring to multidisciplinary approaches involving a pharmacist, nutritionist, nurse practitioner, and physician. This review attempts to categorize these inventions based on location. We compared the published results from randomized, controlled trials of the following types of heart failure disease management interventions: inpatient, clinic visits, home visits, and telephone follow up. Although research shows an improvement in the quality of care and a decrease in hospitalizations for patients sustaining heart failure, the economic impact of disease management is still unclear. The current reimbursement structure is a disincentive to providers wanting to offer disease management services to patients sustaining heart failure. Additionally, the cost of providing disease management services such as additional clinical visits, patient education materials, or additional personnel time has not been well documented. Most heart failure disease management studies do confirm the concept that providing increased access to healthcare providers for an at-risk group of patients sustaining heart failure does improve outcomes. However, a large-scale randomized, controlled clinical trial based in the United States is needed to prove that this concept can be implemented beyond a single center and to determine how much it will cost patients, providers, healthcare systems, and payers.

The outcomes and prognostic factors of acute respiratory failure in the patients 90 years old and over.

PubMed

Chen, Wan-Ling; Chen, Chin-Ming; Kung, Shu-Chen; Wang, Ching-Min; Lai, Chih-Cheng; Chao, Chien-Ming

2018-01-23

This retrospective cohort study investigated the outcomes and prognostic factors in nonagenarians (patients 90 years old or older) with acute respiratory failure. Between 2006 and 2016, all nonagenarians with acute respiratory failure requiring invasive mechanical ventilation (MV) were enrolled. Outcomes including in-hospital mortality and ventilator dependency were measured. A total of 173 nonagenarians with acute respiratory failure were admitted to the intensive care unit (ICU). A total of 56 patients died during the hospital stay and the rate of in-hospital mortality was 32.4%. Patients with higher APACHE (Acute Physiology and Chronic Health Evaluation) II scores (adjusted odds ratio [OR], 5.91; 95 % CI, 1.55-22.45; p = 0.009, APACHE II scores ≥ 25 vs APACHE II scores < 15), use of vasoactive agent (adjust OR, 2.67; 95% CI, 1.12-6.37; p = 0.03) and more organ dysfunction (adjusted OR, 11.13; 95% CI, 3.38-36.36, p < 0.001; ≥ 3 organ dysfunction vs ≤ 1 organ dysfunction) were more likely to die. Among the 117 survivors, 25 (21.4%) patients became dependent on MV. Female gender (adjusted OR, 3.53; 95% CI, 1.16-10.76, p = 0.027) and poor consciousness level (adjusted OR, 4.98; 95% CI, 1.41-17.58, p = 0.013) were associated with MV dependency. In conclusion, the mortality rate of nonagenarians with acute respiratory failure was high, especially for those with higher APACHE II scores or more organ dysfunction.

Preoperative radiation and free flap outcomes for head and neck reconstruction: a systematic review and meta-analysis.

PubMed

Herle, Pradyumna; Shukla, Lipi; Morrison, Wayne A; Shayan, Ramin

2015-03-01

There is a general consensus among reconstructive surgeons that preoperative radiotherapy is associated with a higher risk of flap failure and complications in head and neck surgery. Opinion is also divided regarding the effects of radiation dose on free flap outcomes and timing of preoperative radiation to minimize adverse outcomes. Our meta-analysis will attempt to address these issues. A systematic review of the literature was conducted in concordance to PRISMA protocol. Data were combined using STATA 12 and Open Meta-Analyst software programmes. Twenty-four studies were included comparing 2842 flaps performed in irradiated fields and 3491 flaps performed in non-irradiated fields. Meta-analysis yielded statistically significant risk ratios for flap failure (RR 1.48, P = 0.004), complications (RR 1.84, P < 0.001), reoperation (RR 2.06, P < 0.001) and fistula (RR 2.05, P < 0.001). Mean radiation dose demonstrated a trend towards increased risk of flap failure, but this was not statistically significant. On subgroup analysis, flaps with >60 Gy radiation had a non-statistically significant higher risk of flap failure (RR 1.61, P = 0.145). Preoperative radiation is associated with a statistically significant increased risk of flap complications, failure and fistula. Preoperative radiation in excess of 60 Gy after radiotherapy represents a potential risk factor for increased flap loss and should be avoided where possible. © 2014 Royal Australasian College of Surgeons.

Influence of implant location on the clinical outcomes of implant abutments: a systematic review and meta-analysis

PubMed Central

ElHoussiney, Amr G; Zhang, He; Song, Jinlin; Ji, Ping; Wang, Lu; Yang, Sheng

2018-01-01

Purpose To compare the failure events and incidence of complications of different abutment materials in anterior and posterior regions. Failure was defined as complete loss of the abutment requiring replacement by a new abutment. Materials and methods Electronic searches using PubMed/Medline and Google Scholar complemented with manual searches were performed with specific search terms. Searches were restricted to publications in English between January 2006 and March 2016. Results A total of 863 and 1,264 implants were inserted in the anterior and posterior regions, respectively, in a total of 1,529 patients. No titanium abutments failed in anterior or posterior regions. On the other hand, 1.6% of zirconia abutments failed in the anterior region and 1.5% failed in the posterior region. Technical complications occurred mostly in the posterior region and mostly involved zirconia abutment. Meta-analysis was possible only for zirconia-abutment failure, due to considerable heterogeneity of studies and outcome variables. No significant difference in failure rate was found between anterior and posterior zirconia abutments (risk ratio 1.53, 95% CI 0.49–4.77; P=0.47). Conclusion This systematic review and meta-analysis showed similar outcomes of different abutment materials when used in anterior and posterior regions in terms of failure events and biological and aesthetic complications. The only significant finding was the increased incidence of technical complications in the posterior region, mostly involving zirconia abutments. Abutment-screw loosening was the most common technical complication. PMID:29520162

Maternal and neonatal outcomes of respiratory failure during pregnancy.

PubMed

Hung, Chen-Yiu; Hu, Han-Chung; Chiu, Li-Chung; Chang, Chih-Hao; Li, Li-Fu; Huang, Chung-Chi; Kao, Chuan-Chi; Cheng, Po-Jen; Kao, Kuo-Chin

2018-05-01

Obstetric patients comprise a limited portion of intensive care unit patients, but they often present with unfamiliar conditions and exhibit the potential for catastrophic deterioration. This study evaluated the maternal and neonatal outcomes of respiratory failure during pregnancy. Information on 71 patients at >25 weeks gestation in the ICU with respiratory failure was recorded between 2009 and 2013. The characteristics and outcomes of mothers and fetuses were determined through a retrospective chart review and evaluated using Student's t test, chi-square test, and Fisher's exact test. The leading causes of respiratory failure were postpartum hemorrhage and severe preeclampsia in the obstetric causes group and pneumonia in the nonobstetric causes group during pregnancy and the peripartum period. The non-obstetric causes group exhibited a higher incidence of acute respiratory distress syndrome and renal replacement therapy as well as requiring more ventilator days. The patients in the obstetric causes group showed significant improvement after delivery in the partial pressure of arterial oxygen to the fraction of inspired oxygen and peak inspiratory pressure decrease. Both groups exhibited high incidences of neonatal respiratory distress syndrome. Neonatal complications resulting from meconium aspiration syndrome (MAS) and sepsis were more common in the non-obstetric causes group; however, neurological development impairment was more common in the obstetric causes group. Obstetric cause was associated with longer ventilator free days and fewer episodes of ARDS after delivery. Neonatal complications resulting from different etiologies of respiratory failure were found to differ. Copyright © 2017. Published by Elsevier B.V.

The impact of extracerebral organ failure on outcome of patients after cardiac arrest: an observational study from the ICON database.

PubMed

Nobile, Leda; Taccone, Fabio S; Szakmany, Tamas; Sakr, Yasser; Jakob, Stephan M; Pellis, Tommaso; Antonelli, Massimo; Leone, Marc; Wittebole, Xavier; Pickkers, Peter; Vincent, Jean-Louis

2016-11-14

We used data from a large international database to assess the incidence and impact of extracerebral organ dysfunction on prognosis of patients admitted after cardiac arrest (CA). This was a sub-analysis of the Intensive Care Over Nations (ICON) database, which contains data from all adult patients admitted to one of 730 participating intensive care units (ICUs) in 84 countries from 8-18 May 2012, except admissions for routine postoperative surveillance. For this analysis, patients admitted after CA (defined as those with "post-anoxic coma" or "cardiac arrest" as the reason for ICU admission) were included. Data were collected daily in the ICU for a maximum of 28 days; patients were followed up for outcome data until death, hospital discharge, or a maximum of 60 days in-hospital. Favorable neurological outcome was defined as alive at hospital discharge with a last available neurological Sequential Organ Failure Assessment (SOFA) subscore of 0-2. Among the 469 patients admitted after CA, 250 (53 %) had had out-of-hospital CA; 210 (45 %) patients died in the ICU and 357 (76 %) had an unfavorable neurological outcome. Non-survivors had a higher incidence of renal (43 vs. 16 %), cardiovascular (56 vs. 45 %), and respiratory (62 vs. 48 %) failure on admission and during the ICU stay than survivors (all p < 0.05). Similar results were found for patients with unfavorable vs. favorable neurological outcomes. In multivariable analysis, independent predictors of ICU mortality were renal failure on admission, high admission Simplified Acute Physiology Score (SAPS) II, high maximum serum lactate levels within the first 24 h after ICU admission, and development of sepsis. Independent predictors of unfavorable neurological outcome were mechanical ventilation on admission, high admission SAPS II score, and neurological dysfunction on admission. In this multicenter cohort, extracerebral organ dysfunction was common in CA patients. Renal failure on admission was the only extracerebral organ dysfunction independently associated with higher ICU mortality.

Two-year outcomes in initial survivors with acute liver failure: results from a prospective, multicentre study.

PubMed

Fontana, Robert J; Ellerbe, Caitlyn; Durkalski, Valerie E; Rangnekar, Amol; Reddy, Rajender K; Stravitz, Todd; McGuire, Brendan; Davern, Timothy; Reuben, Adrian; Liou, Iris; Fix, Oren; Ganger, Daniel R; Chung, Raymond T; Schilsky, Mike; Han, Steven; Hynan, Linda S; Sanders, Corron; Lee, William M

2015-02-01

The long-term clinical outcomes in initial survivors with acute liver failure (ALF) are not well known. The aim of this study was to provide an overview of the 2-year clinical outcomes among initial survivors and liver transplant (LT) recipients that were alive 3 weeks after enrolment in the Acute Liver Failure Study Group (ALFSG). Outcomes in adult ALFSG patients that were enrolled between 1998 and 2010 were reviewed. Two-year patient survival was significantly higher in the 262 LT recipients (92.4%) compared to the 306 acetaminophen (APAP) spontaneous survivors (SS) (89.5%) and 200 non-APAP SS (75.5%) (P < 0.0001). The causes of death were similar in the three groups but the time to death was significantly longer in the LT recipients (P < 0.0001). Independent predictors of 2-year mortality in the APAP group were a high serum phosphate level and patient age (c-statistic = 0.65 (0.54, 0.76)), patient age and days from jaundice to ALF onset in the non-APAP group (c-statistic = 0.69 (0.60, 0.78)), and patient age, days from jaundice, and higher coma grade in the LT recipients (c-statistic = 0.74 (0.61, 0.87)). The LT recipients were significantly more likely to be employed and have a higher educational level (P < 0.05). Two-year outcomes in initial survivors of ALF are generally good but non-APAP patients have a significantly lower survival which may relate to pre-existing medical comorbidities. Spontaneous survivors with APAP overdose experience substantial morbidity during follow-up from ongoing psychiatric and substance abuse issues. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES).

PubMed

Pieske, Burkert; Butler, Javed; Filippatos, Gerasimos; Lam, Carolyn; Maggioni, Aldo Pietro; Ponikowski, Piotr; Shah, Sanjiv; Solomon, Scott; Kraigher-Krainer, Elisabeth; Samano, Eliana Tibana; Scalise, Andrea Viviana; Müller, Katharina; Roessig, Lothar; Gheorghiade, Mihai

2014-09-01

The clinical outcomes for patients with worsening chronic heart failure (WCHF) remain exceedingly poor despite contemporary evidence-based therapies, and effective therapies are urgently needed. Accumulating evidence supports augmentation of cyclic guanosine monophosphate (cGMP) signalling as a potential therapeutic strategy for HF with reduced or preserved ejection fraction (HFrEF and HFpEF, respectively). Direct soluble guanylate cyclase (sGC) stimulators target reduced cGMP generation due to insufficient sGC stimulation and represent a promising method for cGMP enhancement. The phase II SOluble guanylate Cyclase stimulatoR in heArT failurE Study (SOCRATES) programme consists of two randomized, parallel-group, placebo-controlled, double-blind, multicentre studies, SOCRATES-REDUCED (in patients with LVEF <45%) and SOCRATES-PRESERVED (in those with LVEF ≥ 45%), that will explore the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the once-daily oral sGC stimulator vericiguat (BAY 1021189) over 12 weeks compared with placebo. These studies will enrol patients stabilized during hospitalization for HF at the time of discharge or within 4 weeks thereafter. The primary endpoint in SOCRATES-REDUCED is change in NT-proBNP at 12 weeks. The primary endpoints in SOCRATES-PRESERVED are change in NT-proBNP and left atrial volume at 12 weeks. SOCRATES will be the first programme to enrol specifically both inpatients and outpatients with WCHF and patients with reduced or preserved ejection fraction. Results will inform the benefits of pursuing subsequent event-driven clinical outcome trials with sGC stimulators in this patient population. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

Treatment outcomes of multidrug-resistant tuberculosis patients in Zhejiang, China, 2009-2013.

PubMed

Zhang, L; Meng, Q; Chen, S; Zhang, M; Chen, B; Wu, B; Yan, G; Wang, X; Jia, Z

2018-04-01

To examine treatment outcomes and factors associated with poor outcome of multidrug-resistant (MDR) tuberculosis (TB) in China. We conducted a prospective observational cohort study including consecutive patients with MDR-TB between 2009 and 2013 in six regions of Zhejiang province. Patients were prescribed treatments by infectious disease specialists, and treatment outcomes were recorded. Sociodemographic characteristics were obtained through a structured questionnaire. The primary endpoint was poor treatment outcomes, defined as treatment failure based on microbiologic persistence, default (lost to follow-up) or death at 24 months. We assessed risk factors for poor treatment outcomes using a Cox proportional hazards model. A total of 820 MDR-TB patients were observed, and 537 with known treatment outcomes were included in our study. Overall, the treatment success rate was 40.2 per 100 years (374/537 participants, 69.6%), while treatment failure, death and default rates were 10.0 per 100 years (101 participants, 18.8%), 3.4 per 100 years (36 participants, 6.7%) and 2.7 per 100 years (26 participants, 4.8%) respectively. Independent predictors of poor treatment outcomes included age >60 years (hazard ratio (HR) 2.3, 95% confidence interval (CI) 1.2-4.2), patients registered as experiencing relapse (HR 2.2, 95% CI 1.1-4.4), patients registered as receiving treatment after failure (HR 2.4, 95% CI 1.2-4.9), use of standardized MDR-TB regimens (HR 0.6, 95% CI 0.4-1.0), cavitary disease (HR 4.9, 95% CI 2.8-8.6) and adverse events (HR 2.5, 95% CI 1.2-5.5). Under well-designed treatment and management scheme, high treatment success rates were achieved in a high-MDR-TB-burden country. Antimicrobial susceptibility testing for all second-line drugs should be conducted to further assist in the treatment of MDR-TB. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Intestinal Failure: The Evolving Demographic and Patient Outcomes on Home Parenteral Nutrition.

PubMed

Brown, Sarah Kate; Davies, Natalie; Smyth, Enda; Heather, Nicky; Cole, Caroline; Keys, Simon Charles; Beattie, Robert Mark; Batra, Akshay

2018-05-13

We performed this study to examine and understand the evolving demographics and changing outcomes of intestinal failure, and its implications for healthcare delivery. We conducted a retrospective analysis of outcome data of children on home Parenteral Nutrition (HPN), over a 15 year period. 31 patients received HPN, 15 for short bowel syndrome (SBS), 8 neuromuscular disease (NMD) and 8 for other causes. The HPN prevalence increased from 1.54 per million children in 2000, to 21.5 in 2016. The outcomes over last 5 years were better than previous 10. The rate of Catheter-Related bloodstream infection (CRBSI) had fallen from 4 to 1.3 and intestinal failure liver disease (IFALD) from 20% to 7.7%. The aetiology changed over years from SBS being the main cause, to NMD contributing 43% to the total in 2016. This was especially relevant as NMD was associated with greater numbers of IFALD (38% vs 6.7%), CRBSI (1.51 vs 0.64/1000 PN days) and mortality. The outcome of long-term Parenteral Nutrition (PN) has improved. The increasing number of patients with NMD, coupled with their higher burden of care, results in an increasing health care burden, and the planning of intestinal rehabilitation services needs to reflect this. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Impact of tricuspid valve surgery at the time of left ventricular assist device insertion on postoperative outcomes.

PubMed

Dunlay, Shannon M; Deo, Salil V; Park, Soon J

2015-01-01

Tricuspid regurgitation (TR) is common in patients with heart failure undergoing left ventricular assist device (LVAD) implantation. Whether the TR should be surgically managed at the time of LVAD surgery is controversial. We searched SCOPUS, Web of Science, Ovid EMBASE, and Ovid MEDLINE (through May 10, 2014) for randomized controlled trials and observational studies comparing postoperative outcomes in patients treated with LVAD with concomitant tricuspid valve surgery (TVS) compared with LVAD alone. Six observational studies including 3,249 patients compared outcomes following LVAD + TVS versus LVAD. Four studies were single-center and most did not adjust for potential confounders. Addition of TVS prolonged cardiopulmonary bypass times by an average of 31 minutes (three studies, 95% CI 20-42). There was no difference in need for right ventricular assist device (six studies, HR 1.42, 95% CI 0.54-3.76), acute renal failure (four studies, HR 1.07, 95% CI 0.55-2.10), or early mortality (six studies, HR 1.28, 95% CI 0.78-2.08) in patients treated with LVAD + TVS versus LVAD alone. TVS prolongs cardiopulmonary bypass times, but available data demonstrate no significant association with early postoperative outcomes. However, differences in baseline risk of patients treated with TVS versus not limit our ability to draw conclusions.

The effect of endometrial scratch injury on pregnancy outcome in women with previous intrauterine insemination failure: A randomized clinical trial.

PubMed

Ashrafi, Mahnaz; Tehraninejad, Ensieh Shahrokh; Haghiri, Mansooreh; Masomi, Masoumeh; Sadatmahalleh, Shahideh Jahanian; Arabipoor, Arezoo

2017-09-01

Endometrial scratch injury (ESI) has been recently proposed to enhance the implantation rate in assisted reproductive technology cycles. The present study was conducted to determine the effect of ESI on pregnancy rate in women with intrauterine insemination (IUI) failure. This prospective randomized controlled study was carried out in Imam-Khomeini Hospital and Royan Institute, Tehran, during a 12-month period from January 2013 to January 2014. After assessment, 169 patients who had IUI failure twice or more (no chemical or clinical pregnancy) with normal uterine anatomy and hysterosalpingography, were enrolled. They were randomly assigned into two groups. In the experimental group, all patients underwent ESI at day 8 or 9 of stimulation phase in the present IUI cycle, whereas no intervention was performed on the control group. IUI outcome was then compared between the two groups. A total of 150 patients completed the IUI cycle during the study. The chemical pregnancy rate was 10.7% and 2.7% in the experimental and control groups, respectively, without significant difference (P = 0.09). Also no significant differences were detected in terms of clinical pregnancy and miscarriage rates between the two groups (P > 0.05). No significant beneficial effect of ESI on fertility outcome in patients with repeated IUI failure was detected when it was carried out on day 8 or 9 of the same IUI stimulation cycle. Also, however, no negative impact secondary to ESI was observed. Therefore, confirmation or refutation of this hypothesis requires further studies with a larger sample size. IRCT201507271141N19. © 2017 Japan Society of Obstetrics and Gynecology.

Transposed brachial-basilic arteriovenous fistulas versus prosthetic upper limb grafts: a meta-analysis.

PubMed

Lazarides, M K; Georgiadis, G S; Papasideris, C P; Trellopoulos, G; Tzilalis, V D

2008-11-01

Controversy exists regarding the best type of arteriovenous (AV) fistula to be formed in secondary and tertiary access procedures when primary fistulas have failed. This meta-analysis aimed to compare transposed brachial-basilic AV fistulas (BBAVFs) with upper limb AV prosthetic grafts. A literature search of the MEDLINE and SCOPUS databases was performed to identify comparative studies reporting outcomes for both BBAVFs with upper limb AV prosthetic grafts. Meta-analysis techniques were applied to identify differences in outcomes between the two groups regarding primary and secondary 1-year failure rates. Eleven relevant studies, involving 1509 patients, met the inclusion criteria and were incorporated in the final analysis; however, only one was randomised controlled trial. The pooled odds' ratio (OR) estimate for the primary and secondary failure rates at 1 year was 0.67 (CI 0.41-1.09) and 0.88 (CI 0.69-1.12), respectively, showing no difference in the outcome between the two groups. The re-intervention rate was higher for prosthetic grafts (0.54 per BBAVF versus 1.32 per graft). In a small subgroup of two studies comparing BBAVFs with forearm grafts the pooled estimate for 1-year primary failure rate was in favour of the BBAVF group (OR 0.3, CI 0.15-0.58, p=0.0004) suggesting that forearm grafts were inferior having a 3-fold risk of failure at 1 year. This analysis supports the use of BBAVF early in difficult access cases prior to the use of prosthetic grafts. However, the latter conclusion is debatable due to heterogeneity, small size and non-randomised design of the included studies.

Stunting is associated with poor outcomes in childhood pneumonia.

PubMed

Moschovis, Peter P; Addo-Yobo, Emmanuel O D; Banajeh, Salem; Chisaka, Noel; Christiani, David C; Hayden, Douglas; Jeena, Prakash; MacLeod, William B; Mino, Greta; Patel, Archana; Qazi, Shamim; Santosham, Mathuram; Thea, Donald M; Hibberd, Patricia L

2015-10-01

Stunting affects 26.7% of children worldwide, and little is known about its effects on the outcomes of childhood pneumonia. We evaluated the effect of stunting on the outcomes of pneumonia among children enrolled in two large clinical trials. We analysed data from two WHO and USAID-sponsored inpatient treatment trials, the Severe Pneumonia Evaluation Antimicrobial Research study (n = 958) and the Amoxicillin Penicillin Pneumonia International Study (n = 1702), which enrolled children aged 2-59 months across 16 sites in LMICs. We assessed the effect of stunting (height-for-age Z score < -2) on treatment outcome and time to resolution of hypoxaemic pneumonia. Among 2542 (96%) children with valid data for height, 28% were stunted and 12.8% failed treatment by 5 days. The failure rate among stunted patients was 16.0% vs. 11.5% among non-stunted patients [unadjusted RR = 1.24 (95% CI 1.08, 1.41); adjusted RR = 1.28 (95% CI 1.10, 1.48)]. An inverse relationship was observed between height and failure rates, even among non-stunted children. Among 845 patients with hypoxaemic pneumonia, stunting was associated with a lower probability of normalisation of respiratory rate [HR = 0.63 (95% CI 0.52, 0.75)] and oxygen saturation [HR = 0.74 (95% CI 0.61, 0.89)]. Stunting increases the risk of treatment failure and is associated with a longer course of recovery in children with pneumonia. Strategies to decrease stunting may decrease the burden of adverse outcomes in childhood pneumonia in low-resource settings. © 2015 John Wiley & Sons Ltd.

Day-to-day measurement of patient-reported outcomes in exacerbations of chronic obstructive pulmonary disease

PubMed Central

Kocks, Jan Willem H; van den Berg, Jan Willem K; Kerstjens, Huib AM; Uil, Steven M; Vonk, Judith M; de Jong, Ynze P; Tsiligianni, Ioanna G; van der Molen, Thys

2013-01-01

Background Exacerbations of chronic obstructive pulmonary disease (COPD) are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes. Methods Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients) were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ), and the St George’s Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study. Results All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found to be less impaired than in hospitalized patients, while the rate and pattern of recovery was remarkably similar. Conclusion Daily health status measurements were found to predict treatment failure, which could help decision-making for patients hospitalized due to an exacerbation of COPD. PMID:23766644

Clinical and microbiological characteristics of peritoneal dialysis-related peritonitis caused by Escherichia coli in southern Taiwan.

PubMed

Lin, Wei-Hung; Tseng, Chin-Chung; Wu, An-Bang; Chang, Yu-Tzu; Kuo, Te-Hui; Chao, Jo-Yen; Wang, Ming-Cheng; Wu, Jiunn-Jong

2018-06-21

Peritonitis is a serious complication and major cause of treatment failure in patients undergoing peritoneal dialysis (PD). Escherichia coli is the major pathogen in extraintestinal Gram-negative infections, including PD-related peritonitis. The outcomes of E. coli peritonitis in PD varied from relatively favorable outcomes to a higher incidence of treatment failure. The aim of this study was to investigate the impact of bacterial virulence and host characteristics on the outcomes of PD-related peritonitis caused by E. coli. From January 2000 to June 2016, a total of 47 episodes of monomicrobial and 10 episodes of polymicrobial E. coli PD-related peritonitis, as well as 89 episodes of monomicrobial Gram-positive (56 Staphylococcus spp. and 33 Streptococcus spp.) PD-related peritonitis cases, were retrospectively enrolled. Clinical features, E. coli bacterial virulence, and outcomes were analyzed. Compared to Streptococcus spp. peritonitis, E. coli peritonitis had a higher peritoneal catheter removal rate (38 versus 12%; P = 0.0115). Compared to the monomicrobial group, patients in polymicrobial group were older and had higher peritoneal catheter removal rate (80 versus 38%; P = 0.0324). Treatment failure of E. coli peritonitis was associated with more polymicrobial peritonitis and immunocompromised comorbidity, longer duration of PD therapy, and more antimicrobial resistance. E. coli isolates with more iron-related genes had higher prevalence of phylogenetic group B2 and papG II, iha, ompT, and usp genes. This study demonstrates the important roles of clinical and bacterial characteristics in the outcomes of monomicrobial and polymicrobial E. coli PD-related peritonitis.

Stunting is associated with poor outcomes in childhood pneumonia

PubMed Central

Moschovis, Peter P.; Addo-Yobo, Emmanuel O. D.; Banajeh, Salem; Chisaka, Noel; Christiani, David C.; Hayden, Douglas; Jeena, Prakash; MacLeod, William B.; Mino, Greta; Patel, Archana; Qazi, Shamim; Santosham, Mathuram; Thea, Donald M.; Hibberd, Patricia L.

2015-01-01

Objective Stunting affects 26.7% of children worldwide, and little is known about its effects on the outcomes of childhood pneumonia. We evaluated the effect of stunting on the outcomes of pneumonia among children enrolled in two large clinical trials. Methods We analyzed data from two WHO and USAID-sponsored inpatient treatment trials, the Severe Pneumonia Evaluation Antimicrobial Research study (n=958) and the Amoxicillin Penicillin Pneumonia International Study (n=1702), which enrolled children aged 2–59 months across 16 sites in LMICs. We assessed the effect of stunting (height-for-age Z score < −2) on treatment outcome and time to resolution of hypoxemic pneumonia. Results Among 2542 (96%) children with valid data for height, 28% were stunted and 12.8% failed treatment by 5 days. The failure rate among stunted patients was 16.0% vs. 11.5% among non-stunted patients (unadjusted RR = 1.24 [95% CI 1.08, 1.41]; adjusted RR = 1.28 [95% CI 1.10, 1.48]). An inverse relationship was observed between height and failure rates, even among non-stunted children. Among 845 patients with hypoxemic pneumonia, stunting was associated with a lower probability of normalization of respiratory rate (HR = 0.63 [95% CI 0.52, 0.75]) and oxygen saturation (HR = 0.74 [95% CI 0.61, 0.89]). Conclusions Stunting increases the risk of treatment failure and is associated with a longer course of recovery in children with pneumonia. Strategies to decrease stunting may decrease the burden of adverse outcomes in childhood pneumonia in low-resource settings. PMID:26083963

Testosterone therapy during exercise rehabilitation in male patients with chronic heart failure who have low testosterone status: a double-blind randomized controlled feasibility study.

PubMed

Stout, Martin; Tew, Garry A; Doll, Helen; Zwierska, Irena; Woodroofe, Nicola; Channer, Kevin S; Saxton, John M

2012-12-01

This study assessed the feasibility of a 12-week program of exercise, with and without intramuscular testosterone supplementation, in male patients with chronic heart failure (CHF) and low testosterone status and collected preliminary data for key health outcomes. Male patients with CHF (n = 41, age 67.2 years, range 51-84 years) with mean ± SD testosterone levels of 10.7 ± 2.6 nmol/L (309 ± 76 ng/dL) were randomly allocated to exercise with testosterone or placebo groups. Feasibility was assessed in terms of recruitment, intervention compliance, and attrition. Outcomes included an incremental shuttle walk test, peak oxygen uptake, muscular strength, echocardiographic measures, N-terminal pro-brain natriuretic peptide, inflammatory markers, depression (Beck Depression Inventory), and health-related quality of life (Minnesota Living with Heart Failure Questionnaire and Medical Outcomes Study Short-Form). Attrition was 30% but with 100% compliance to exercise and injections in patients who completed the study. Similar improvements in shuttle walk test (18% vs 19%), body mass (-1.3 kg vs -1.0 kg), and hand grip strength (2.1 kg vs 2.5 kg) from baseline were observed in both groups. The exercise with testosterone group showed improvements from baseline in peak oxygen uptake (P < .01), Beck Depression Inventory (P < .05), leg strength (P < .05), and several Medical Outcomes Study Short-Form quality of life domains (P < .05), which were generally not apparent in the exercise with placebo group. Echocardiographic measures, N-terminal pro-brain natriuretic peptide, and inflammatory markers were mostly unchanged. This study shows for the first time that testosterone supplementation during a program of exercise rehabilitation is feasible and can positively impact on a range of key health outcomes in elderly male patients with CHF who have a low testosterone status. Copyright © 2012 Mosby, Inc. All rights reserved.

Surgical Adverse Events, Risk Management, and Malpractice Outcome: Morbidity and Mortality Review Is Not Enough

PubMed Central

Morris, John A.; Carrillo, Ysela; Jenkins, Judith M.; Smith, Philip W.; Bledsoe, Sandy; Pichert, James; White, Andrew

2003-01-01

Objective To review all admissions (age > 13) to three surgical patient care centers at a single academic medical center between January 1, 1995, and December 6, 1999, for significant surgical adverse events. Summary Background Data Little data exist on the interrelationships between surgical adverse events, risk management, malpractice claims, and resulting indemnity payments to plaintiffs. The authors hypothesized that examination of this process would identify performance improvement opportunities overlooked by standard medical peer review; the risk of litigation would be constant across the three homogeneous patient care centers; and the risk management process would exceed the performance improvement process. Methods Data collected included patient demographics (age, gender, and employment status), hospital financials (hospital charges, costs, and financial class), and outcome. Outcome categories were medical (disability: <1 month, 1–6 months, permanent/death), legal (no legal action, settlement, summary judgment), financial (indemnity payments, legal fees, write-offs), and cause and effect analysis. Cause and effect analysis attempts to identify system failures contributing to adverse outcomes. This was determined by two independent analysts using the 17 Harvard criteria and subdividing these into subsystem causative factors. Results The study group consisted of 130 patients with surgical adverse events resulting in total liabilities of $8.2 million. The incidence of adverse events per 1,000 admissions across the three patient care centers was similar, but indemnity payments per 1,000 admissions varied (cardiothoracic = $30, women’s health = $90, trauma = $520). Patient demographics were not predictive of high-risk subgroups for adverse events or litigation. In terms of medical outcome, 51 patients had permanent disability or death, accounting for 98% of the indemnity payments. In terms of legal outcome, 103 patients received no indemnity payments, 15 patients received indemnity payments, four suits remain open, and in eight cases charges were written off ($0.121 million). To date, no cases have been adjudicated in court. Cause and effect analysis identified 390 system failures contributing to the adverse events (mean 3.0 failures per adverse event); there were 4.7 failures per adverse event in the 15 indemnity cases. Five categories of causes accounted for 75% of the failures (patient management, n = 104; communication, n = 89; administration, n = 33; documentation, n = 32; behavior, n = 23). The current medical review process would have identified 104 of 390 systems failures (37%). Conclusions This study demonstrates no rational link between the tort system and the reduction of adverse events. Sixty-three percent of contributing causes to adverse events were undetected by current medical review processes. Adverse events occur at the interface between different systems or disciplines and result from multiple failures. Indemnity costs per hospital day vary dramatically by patient care center (range $3.60–97.60 a day). The regionalization of healthcare is in jeopardy from the burden of high indemnity payments. PMID:12796581

Drug treatment effects on outcomes in heart failure with preserved ejection fraction: a systematic review and meta-analysis

PubMed Central

Zheng, Sean Lee; Chan, Fiona T; Nabeebaccus, Adam A; Shah, Ajay M; McDonagh, Theresa; Okonko, Darlington O; Ayis, Salma

2018-01-01

Background Clinical drug trials in patients with heart failure and preserved ejection fraction have failed to demonstrate improvements in mortality. Methods We systematically searched Medline, Embase and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCT) assessing pharmacological treatments in patients with heart failure with left ventricular (LV) ejection fraction≥40% from January 1996 to May 2016. The primary efficacy outcome was all-cause mortality. Secondary outcomes were cardiovascular mortality, heart failure hospitalisation, exercise capacity (6-min walk distance, exercise duration, VO2 max), quality of life and biomarkers (B-type natriuretic peptide, N-terminal pro-B-type natriuretic peptide). Random-effects models were used to estimate pooled relative risks (RR) for the binary outcomes, and weighted mean differences for continuous outcomes, with 95% CI. Results We included data from 25 RCTs comprising data for 18101 patients. All-cause mortality was reduced with beta-blocker therapy compared with placebo (RR: 0.78, 95%CI 0.65 to 0.94, p=0.008). There was no effect seen with ACE inhibitors, aldosterone receptor blockers, mineralocorticoid receptor antagonists and other drug classes, compared with placebo. Similar results were observed for cardiovascular mortality. No single drug class reduced heart failure hospitalisation compared with placebo. Conclusion The efficacy of treatments in patients with heart failure and an LV ejection fraction≥40% differ depending on the type of therapy, with beta-blockers demonstrating reductions in all-cause and cardiovascular mortality. Further trials are warranted to confirm treatment effects of beta-blockers in this patient group. PMID:28780577

A Systematic Review of the Outcomes of Posterolateral Corner Knee Injuries, Part 2: Surgical Treatment of Chronic Injuries.

PubMed

Moulton, Samuel G; Geeslin, Andrew G; LaPrade, Robert F

2016-06-01

There are a variety of reported surgical techniques outcomes of chronic grade III posterolateral corner (PLC) knee injuries. It is unknown if outcomes differ among the various surgical treatments. To systematically review the literature and report subjective and objective outcomes for surgical treatment strategies for chronic grade III PLC injuries to determine the optimal surgical technique. Systematic review; Level of evidence, 4. A systematic review of the literature including Cochrane, PubMed, Medline, and Embase was performed. The following search terms were used: posterolateral corner knee, posterolateral knee, posterolateral instability, multiligament knee, and knee dislocation. Inclusion criteria were outcome studies of surgical treatment for chronic PLC knee injuries with a minimum 2-year follow-up, subjective outcomes, objective outcomes including varus stability, and subgroup data on PLC injuries. Two investigators independently reviewed all abstracts. Accepted definitions of varus stability on examination or stress radiographs, and the need for revision surgery, were used to categorically define success and failure. Fifteen studies with a total of 456 patients were included in this study. The 15 studies included 5 with level 3 evidence and 10 with level 4 evidence. The mean age of the patients in each study ranged from 25.2 to 40 years, the reported mean time to surgery ranged from 5.5 to 52.8 months, and the mean follow-up duration ranged from 2 to 16.3 years. Mean postoperative Lysholm scores ranged from 65.5 to 91.8; mean postoperative International Knee Documentation Committee (IKDC) scores ranged from 62.6 to 86.0. Based on objective stability, there was an overall success rate of 90% and a 10% failure rate of PLC reconstruction. A variety of surgical techniques were reported. Chronic PLC injuries were reconstructed in all studies, and while techniques varied, the surgical management of chronic PLC injuries had a 90% success rate and a 10% failure rate according to the individual investigators' examination or stress radiographic assessment of objective outcomes. More than half of the 456 patients had a combined posterior cruciate ligament-PLC injury. Surgical techniques included variations of fibular slings, capsular shifts, and anatomic-based techniques (fibular tunnel and tibial tunnel). Further research is needed to determine the optimal surgical technique for treating chronic grade III PLC injuries. © 2015 The Author(s).

Comparative Effectiveness of Vancomycin Versus Daptomycin for MRSA Bacteremia With Vancomycin MIC >1 mg/L: A Multicenter Evaluation.

PubMed

Moise, Pamela A; Culshaw, Darren L; Wong-Beringer, Annie; Bensman, Joyce; Lamp, Kenneth C; Smith, Winter J; Bauer, Karri; Goff, Debra A; Adamson, Robert; Leuthner, Kimberly; Virata, Michael D; McKinnell, James A; Chaudhry, Saira B; Eskandarian, Romic; Lodise, Thomas; Reyes, Katherine; Zervos, Marcus J

2016-01-01

Clinical studies comparing vancomycin with alternative therapy for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia are limited. The objective of this study was to compare outcomes of early daptomycin versus vancomycin treatment for MRSA bacteremia with high vancomycin MICs in a geographically diverse multicenter evaluation. This nationwide, retrospective, multicenter (N = 11), matched, cohort study compared outcomes of early daptomycin with vancomycin for MRSA bloodstream infection (BSI) with vancomycin MICs 1.5 to 2 µg/mL. Matching variables, based on propensity regression analysis, included age, intensive care unit (ICU), and type of BSI. Outcomes were as follows: (1) composite failure (60-day all-cause mortality, 7-day clinical or microbiologic failure, 30-day BSI relapse, or end-of-treatment failure (EOT; discontinue/change daptomycin or vancomycin because of treatment failure or adverse event]); (2) nephrotoxicity; and (2) day 4 BSI clearance. A total of 170 patients were included. The median (interquartile range) age was 60 years (50-74); the median (range) Acute Physiology and Chronic Health Evaluation II score was 15 (10-18); 31% were in an ICU; and 92% had an infectious disease consultation. BSI types included endocarditis/endovascular (39%), extravascular (55%), and central catheter (6%). The median daptomycin dose was 6 mg/kg, and the vancomycin trough level was 17 mg/L. Overall composite failure was 35% (59 of 170): 15% due to 60-day all-cause mortality, 14% for lack of clinical or microbiologic response by 7 days, and 17% due to failure at end of therapy (discontinue/change because of treatment failure or adverse event). Predictors of composite failure according to multivariate analysis were age >60 years (odds ratio, 3.7; P < 0.01) and ICU stay (odds ratio, 2.64; P = 0.03). Notable differences between treatment groups were seen with: (1) end of therapy failure rates (11% vs 24% for daptomycin vs vancomycin; P = 0.025); (2) acute kidney injury rates (9% vs 23% for daptomycin vs vancomycin; P = 0.043); and (3) day 4 bacteremia clearance rates for immunocompromised patients (n = 26) (94% vs 56% for daptomycin vs vancomycin; P = 0.035). Results from this multicenter study provide, for the first time, a geographically diverse evaluation of daptomycin versus vancomycin for patients with vancomycin-susceptible MRSA bacteremia with vancomycin MIC values >1 µg/mL. Although the overall composite failure rates did not differ between the vancomycin and daptomycin groups when intensively matched according to risks for failure, the rates of acute kidney injury were significantly lower in the daptomycin group. These findings suggest that daptomycin is a useful therapy for clinicians treating patients who have MRSA bacteremia. Prospective, randomized trials should be conducted to better assess the potential significance of elevated vancomycin MIC. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

A clinical study of pattern and factors affecting outcome in Nigerian patients with advanced heart failure.

PubMed

Familoni, O B; Olunuga, T O; Olufemi, B W

2007-01-01

Advanced heart failure (AHF) accounts for about 25% of all cases of heart failure in Nigeria and is associated with a high mortality rate. To undertake a clinical study of the pattern and outcome of AHF in our hospitalised patients and to determine the parameters associated with mortality and survival in these patients. Eighty-two patients with AHF were studied between January 2003 and December 2005. Baseline blood chemistry and haemodynamics were determined. A congestion score, including orthopnoea, elevated jugular venous pressure, oedema, ascites and loud P2, was derived as well as a low perfusion score. Mortality was computed and risk estimated using the Pearson coefficient and log-ranking test. Cox regression analysis was used to identify the predictors of survival. AHF accounted for 43.6% of all hospitalised heart failure patients, with a total mortality of 67.1%. Hypertension was the commonest cause of AHF. The parameters associated with increased mortality rates included age (r = 0.671; p = 0.02), presence of atrial fibrillation (r = 0.532; p = 0.045) and estimated glomerular filtration rate (r = -0.486, p = 0.04). The majority of patients (54.8%) were in the 'wet and cold' congestion category. The congestion score correlated with mortality. The indices of survival included lower age, lower systolic blood pressure, being literate and lower congestion score. AHF was common in our cohorts of hospitalised heart failure patients and it was associated with a high mortality rate.

Factors Associated with Mortality and Graft Failure in Liver Transplants: A Hierarchical Approach

PubMed Central

Andraus, Wellington; de Martino, Rodrigo Bronze; Ortega, Neli Regina de Siqueira; Abe, Jair Minoro; D’Albuquerque, Luiz Augusto Carneiro

2015-01-01

Background Liver transplantation has received increased attention in the medical field since the 1980s following the introduction of new immunosuppressants and improved surgical techniques. Currently, transplantation is the treatment of choice for patients with end-stage liver disease, and it has been expanded for other indications. Liver transplantation outcomes depend on donor factors, operating conditions, and the disease stage of the recipient. A retrospective cohort was studied to identify mortality and graft failure rates and their associated factors. All adult liver transplants performed in the state of São Paulo, Brazil, between 2006 and 2012 were studied. Methods and Findings A hierarchical Poisson multiple regression model was used to analyze factors related to mortality and graft failure in liver transplants. A total of 2,666 patients, 18 years or older, (1,482 males; 1,184 females) were investigated. Outcome variables included mortality and graft failure rates, which were grouped into a single binary variable called negative outcome rate. Additionally, donor clinical, laboratory, intensive care, and organ characteristics and recipient clinical data were analyzed. The mortality rate was 16.2 per 100 person-years (py) (95% CI: 15.1–17.3), and the graft failure rate was 1.8 per 100 py (95% CI: 1.5–2.2). Thus, the negative outcome rate was 18.0 per 100 py (95% CI: 16.9–19.2). The best risk model demonstrated that recipient creatinine ≥ 2.11 mg/dl [RR = 1.80 (95% CI: 1.56–2.08)], total bilirubin ≥ 2.11 mg/dl [RR = 1.48 (95% CI: 1.27–1.72)], Na+ ≥ 141.01 mg/dl [RR = 1.70 (95% CI: 1.47–1.97)], RNI ≥ 2.71 [RR = 1.64 (95% CI: 1.41–1.90)], body surface ≥ 1.98 [RR = 0.81 (95% CI: 0.68–0.97)] and donor age ≥ 54 years [RR = 1.28 (95% CI: 1.11–1.48)], male gender [RR = 1.19(95% CI: 1.03–1.37)], dobutamine use [RR = 0.54 (95% CI: 0.36–0.82)] and intubation ≥ 6 days [RR = 1.16 (95% CI: 1.10–1.34)] affected the negative outcome rate. Conclusions The current study confirms that both donor and recipient characteristics must be considered in post-transplant outcomes and prognostic scores. Our data demonstrated that recipient characteristics have a greater impact on post-transplant outcomes than donor characteristics. This new concept makes liver transplant teams to rethink about the limits in a MELD allocation system, with many teams competing with each other. The results suggest that although we have some concerns about the donors features, the recipient factors were heaviest predictors for bad outcomes. PMID:26274497

Disease management produces limited quality-of-life improvements in patients with congestive heart failure: evidence from a randomized trial in community-dwelling patients.

PubMed

Smith, Brad; Forkner, Emma; Zaslow, Barbara; Krasuski, Richard A; Stajduhar, Karl; Kwan, Michael; Ellis, Robert; Galbreath, Autumn Dawn; Freeman, Gregory L

2005-11-01

Disease management programs are reported to improve clinical and quality-of-life outcomes while simultaneously lowering healthcare costs. To examine the effectiveness of disease management in improving health-related quality of life (HRQL) among patients with heart failure beyond 12 months. A total of 1069 community-dwelling patients 18 years and older in South Texas with echocardiographic evidence of congestive heart failure were randomly assigned to disease management, augmented disease management, and control groups. They were followed up 18 months. Patients in the control group received usual care. Patients in the intervention groups were assigned a registered nurse as a disease manager who performed telephonic patient education and medication management. Health-related quality-of-life data (based on the Medical Outcomes Study 36-Item Short-Form Health Survey [SF-36]) were collected 4 times, at 6-month intervals. Disease management has a limited effect on HRQL. Analysis of the SF-36 health transition measure showed a positive effect of the intervention on self-reported improvement in health at 6 months and at 12 months (P = .04 and P = .004, respectively). However, no effect of disease management was observed across any of the SF-36 components. Women and patients with diastolic heart failure had poorer HRQL scores. Participation in disease management has little effect on HRQL outcomes in congestive heart failure. Beneficial effects on the SF-36 scale scores seen at 6 and 12 months were not sustained. Therefore, it is unclear whether disease management can provide long-term improvement in HRQL for patients with congestive heart failure.

Long-term survival and vitality outcomes of permanent teeth following deep caries treatment with step-wise and partial-caries-removal: A Systematic Review.

PubMed

Hoefler, Vaughan; Nagaoka, Hiroko; Miller, Craig S

2016-11-01

A systematic review was performed to compare the long-term survival of deep dentine caries-affected permanent teeth treated with partial-caries-removal (PCR) versus similar teeth treated with stepwise-caries-removal techniques (SWT). Clinical studies investigating long-term PCR and SWT outcomes in unrestored permanent teeth with deep dentine caries were evaluated. Failures were defined as loss of pulp vitality or restorative failures following treatment. PubMed, Web of Science, Dentistry and Oral Sciences Source, and Central databases were systematically searched. From 136 potentially relevant articles, 9 publications utilizing data from 5 studies (2 RCTs, and 3 observational case-series) reporting outcomes for 426 permanent teeth over two to ten years were analyzed. Regarding restorative failures, >88% success at two years for both techniques was reported. For loss of pulp vitality, observational studies reported >96% vitality at two years for each technique, while one RCT reported significantly higher vitality (p<0.05) at three years for PCR (96%) compared to SWT (83%). Risk of bias was high in all studies. Successful vitality and restorative outcomes for both PCR and SWT have been demonstrated at two years and beyond in permanent teeth with deep dentine caries. Partial-caries-removal may result in fewer pulpal complications over a three year period than SWT, although claims of a therapeutic advantage are based on very few, limited-quality studies. Partial-caries-removal and SWT are deep caries management techniques that reduce pulp exposure risk. Permanent teeth with deep dentine caries treated with either technique have a high likelihood for survival beyond two years. Copyright © 2016 Elsevier Ltd. All rights reserved.

Shunting for hydrocephalus: analysis of techniques and failure patterns.

PubMed

Nigim, Fares; Critchlow, Jonathan F; Schneider, Benjamin E; Chen, Clark; Kasper, Ekkehard M

2014-09-01

Hydrocephalus is characterized by ventricular dilatation because of progressive accumulation of cerebrospinal fluid. Normal pressure hydrocephalus (NPH) affects a subset of patients representing a reversible clinical triad of gait disturbance, urinary incontinence, and dementia with normal cerebrospinal fluid pressure and composition. Various shunting procedures have been used for treatment, but techniques and outcomes remain under debate. The objective of this study was to evaluate the clinical outcomes of 232 patients with and without NPH after the first-time Ventriculoperitoneal shunt placement and assessed patterns of failure between December 2004 and December 2012. Mean age was 54.7 y in non-NPH and 71.9 y in NPH patients. We used open technique in 34.3% and laparoscopic technique in 65.7% of NPH patients and 32.7% and 67.3% of the non-NPH patients, respectively. A total of 36 of 232 patients displayed shunt failure, 16.4% in NPH and 15.2% in non-NPH patients. Twenty-three of 155 patients failed after laparoscopic and 13 of 77 failed after open placement. Proximal shunt failure was more frequent in the non-NPH cohort. Distal failures accounted for 13 of 232 cases, and the difference between laparoscopic (six of 155) and open failures (seven of 77) was profound, but not between NPH- and non-NPH patients. Shunt failures are related to the placement method. Non-NPH patients showed more proximal failures. NPH patients showed fewer proximal failures. Less distal failures were observed after laparoscopic ventriculoperitoneal shunt placement without significant differences between NPH and non-NPH patients. Beyond this, laparoscopic surgery carries distinct advantages such as shorter operating room times and hospital stays, which should translate into less use of pain medications, earlier mobilization, and a lower incidence of ileus. Copyright © 2014 Elsevier Inc. All rights reserved.

Noninvasive ventilation in the event of acute respiratory failure in patients with idiopathic pulmonary fibrosis.

PubMed

Vianello, Andrea; Arcaro, Giovanna; Battistella, Laura; Pipitone, Emanuela; Vio, Stefania; Concas, Alessandra; Paladini, Luciana; Gallan, Federico; Marchi, Maria Rita; Tona, Francesco; Iliceto, Sabino

2014-08-01

Some patients with idiopathic pulmonary fibrosis (IPF) develop severe acute respiratory failure (ARF) requiring admission to an intensive care unit (ICU) and ventilatory support. A limited number of observational studies have reported that noninvasive ventilation (NIV) can be an effective treatment to support breathing and to prevent use of invasive mechanical ventilation in these patients. This study aimed to retrospectively investigate the clinical status and outcomes in IPF patients receiving NIV for ARF and to identify those clinical and laboratory characteristics, which could be considered risk factors for its failure. This is a retrospective analysis of short-term outcomes in 18 IPF patients being administered NIV for ARF. This study was conducted in a 4-bed respiratory ICU (RICU) in a university hospital. Eighteen IPF patients who were administered NIV between January 1, 2005, and April 30, 2013, were included. The outcome measures are the need for endotracheal intubation despite NIV treatment and mortality rate during their RICU stay. The length of the patients' stay in the RICU and their survival rate following RICU admission were also evaluated. Noninvasive ventilation was successful in 8 patients and unsuccessful in 10 who required endotracheal intubation. All the patients in the NIV failure group died within 20.2±15.3 days of intubation. The patients in the NIV success group spent fewer days in the RICU (11.6±4.5 vs 24.6±13.7; P=.0146). The median survival time was significantly shorter for the patients in the NIV failure with respect to the success group (18.0 [95% confidence interval {CI}, 9.0-25.0] vs 90.0 [95% CI, 65.0-305.0] days; P<.0001); the survival rate at 90 days was, likewise, lower in the NIV failure group (0% vs 34%±19.5%). At admission, the patients in the failure group had significantly higher respiratory rate values (36.9±7.8 vs 30.5±3.3 breaths/min; P=.036), plasma N-terminal fragment of the prohormone of B-type natriuretic peptide (NT-proBNP) levels (4528.8±4012.8 vs 634.6±808.0 pg/mL; P=.023) and serum C-reactive protein values (72.0±50.0 vs 20.7±24.0 μg/mL; P=.0289) with respect to those in the success group. Noninvasive ventilation failure was correlated to the plasma NT-proBNP levels at RICU admission (P=.0326) with an odds ratio of 12.2 (95% CI, 1.2 to infinity) in the patients with abnormally high values (>900 pg/mL). The outcome of IPF patients who were administered NIV was quite poor. The use of NIV was, nevertheless, found to be associated with clinical benefits in selected IPF patients, preventing the need for intubation and reducing the rate of complications/death. Elevated plasma NT-proBNP levels at the time of ICU admission is a simple clinical marker for poor NIV outcome. Copyright © 2014 Elsevier Inc. All rights reserved.

The School Experiences of Rural Youths: A Study in Appalachian Ohio

ERIC Educational Resources Information Center

Hoffman, Jill A.; Anderson-Butcher, Dawn; Fuller, Michael; Bates, Samantha

2017-01-01

Rural schools face unique challenges that affect student academic success or failure. Youths served in rural settings experience barriers to learning that negatively influence their achievement and developmental outcomes. To improve outcomes for rural youths, it is important for schools to understand overall school experiences so that school-wide…

Comparative evaluation of continuous intercostal nerve block or epidural analgesia on the rate of respiratory complications, intensive care unit, and hospital stay following traumatic rib fractures: a retrospective review.

PubMed

Britt, Todd; Sturm, Ryan; Ricardi, Rick; Labond, Virginia

2015-01-01

Thoracic trauma accounts for 10%-15% of all trauma admissions. Rib fractures are the most common injury following blunt thoracic trauma. Epidural analgesia improves patient outcomes but is not without problems. The use of continuous intercostal nerve blockade (CINB) may offer superior pain control with fewer side effects. This study's objective was to compare the rate of pulmonary complications when traumatic rib fractures were treated with CINB vs epidurals. A hospital trauma registry provided retrospective data from 2008 to 2013 for patients with 2 or more traumatic rib fractures. All subjects were admitted and were treated with either an epidural or a subcutaneously placed catheter for continuous intercostal nerve blockade. Our primary outcome was a composite of either pneumonia or respiratory failure. Secondary outcomes included total hospital days, total ICU days, and days on the ventilator. 12.5% (N=8) of the CINB group developed pneumonia or had respiratory failure compared to 16.3% (N=7) in the epidural group. No statistical difference (P=0.58) in the incidence of pneumonia or vent dependent respiratory failure was observed. There was a significant reduction (P=0.05) in hospital days from 9.72 (SD 9.98) in the epidural compared to 6.98 (SD 4.67) in the CINB group. The rest of our secondary outcomes showed no significant difference. This study did not show a difference in the rate of pneumonia or ventilator-dependent respiratory failure in the CINB vs epidural groups. It was not sufficiently powered. Our data supports a reduction in hospital days when CINB is used vs epidural. CINB may have advantages over epidurals such as fewer complications, fewer contraindications, and a shorter time to placement. Further studies are needed to confirm these statements.

Serum Phosphorus and Risk of Cardiovascular Disease, All-Cause Mortality, or Graft Failure in Kidney Transplant Recipients: An Ancillary Study of the FAVORIT Trial Cohort.

PubMed

Merhi, Basma; Shireman, Theresa; Carpenter, Myra A; Kusek, John W; Jacques, Paul; Pfeffer, Marc; Rao, Madhumathi; Foster, Meredith C; Kim, S Joseph; Pesavento, Todd E; Smith, Stephen R; Kew, Clifton E; House, Andrew A; Gohh, Reginald; Weiner, Daniel E; Levey, Andrew S; Ix, Joachim H; Bostom, Andrew

2017-09-01

Mild hyperphosphatemia is a putative risk factor for cardiovascular disease [CVD], loss of kidney function, and mortality. Very limited data are available from sizable multicenter kidney transplant recipient (KTR) cohorts assessing the potential relationships between serum phosphorus levels and the development of CVD outcomes, transplant failure, or all-cause mortality. Cohort study. The Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial, a large, multicenter, multiethnic, controlled clinical trial that provided definitive evidence that high-dose vitamin B-based lowering of plasma homocysteine levels did not reduce CVD events, transplant failure, or total mortality in stable KTRs. Serum phosphorus levels were determined in 3,138 FAVORIT trial participants at randomization. During a median follow-up of 4.0 years, the cohort had 436 CVD events, 238 transplant failures, and 348 deaths. Proportional hazards modeling revealed that each 1-mg/dL higher serum phosphorus level was not associated with a significant increase in CVD risk (HR, 1.06; 95% CI, 0.92-1.22), but increased transplant failure (HR, 1.36; 95% CI, 1.15-1.62) and total mortality risk associations (HR, 1.21; 95% CI, 1.04-1.40) when adjusted for treatment allocation, traditional CVD risk factors, kidney measures, type of kidney transplant, transplant vintage, and use of calcineurin inhibitors, steroids, or lipid-lowering drugs. These associations were strengthened in models without kidney measures: CVD (HR, 1.14; 95% CI, 1.00-1.31), transplant failure (HR, 1.72; 95% CI, 1.46-2.01), and mortality (HR, 1.34; 95% CI, 1.15-1.54). We lacked data for concentrations of parathyroid hormone, fibroblast growth factor 23, or vitamin D metabolites. Serum phosphorus level is marginally associated with CVD and more strongly associated with transplant failure and total mortality in long-term KTRs. A randomized controlled clinical trial in KTRs that assesses the potential impact of phosphorus-lowering therapy on these hard outcomes may be warranted. Copyright © 2017 National Kidney Foundation, Inc. All rights reserved.

Revision Distal Femoral Arthroplasty With the Compress(®) Prosthesis Has a Low Rate of Mechanical Failure at 10 Years.

PubMed

Zimel, Melissa N; Farfalli, German L; Zindman, Alexandra M; Riedel, Elyn R; Morris, Carol D; Boland, Patrick J; Healey, John H

2016-02-01

Patients with failed distal femoral megaprostheses often have bone loss that limits reconstructive options and contributes to the high failure rate of revision surgery. The Compress(®) Compliant Pre-stress (CPS) implant can reconstruct the femur even when there is little remaining bone. It differs from traditional stemmed prostheses because it requires only 4 to 8 cm of residual bone for fixation. Given the poor long-term results of stemmed revision constructs, we sought to determine the failure rate and functional outcomes of the CPS implant in revision surgery. (1) What is the cumulative incidence of mechanical and other types of implant failure when used to revise failed distal femoral arthroplasties placed after oncologic resection? (2) What complications are characteristic of this prosthesis? (3) What function do patients achieve after receiving this prosthesis? We retrospectively reviewed 27 patients who experienced failure of a distal femoral prosthesis and were revised to a CPS implant from April 2000 to February 2013. Indications for use included a minimum 2.5 mm cortical thickness of the remaining proximal femur, no prior radiation, life expectancy > 10 years, and compliance with protected weightbearing for 3 months. The cumulative incidence of failure was calculated for both mechanical (loss of compression between the implant anchor plug and spindle) and other failure modes using a competing risk analysis. Failure was defined as removal of the CPS implant. Followup was a minimum of 2 years or until implant removal. Median followup for patients with successful revision arthroplasty was 90 months (range, 24-181 months). Functional outcomes were measured with the Musculoskeletal Tumor Society (MSTS) functional assessment score. The cumulative incidence of mechanical failure was 11% (95% confidence interval [CI], 4%-33%) at both 5 and 10 years. These failures occurred early at a median of 5 months. The cumulative incidence of other failures was 18% (95% CI, 7%-45%) at 5 and 10 years, all of which were deep infection. Three patients required secondary operations for cortical insufficiency proximal to the anchor plug in bone not spanned by the CPS implant and unrelated to the prosthesis. Median MSTS score was 27 (range, 24-30). Revision distal femoral replacement arthroplasty after a failed megaprosthesis is often difficult as a result of a lack of adequate bone. Reconstruction with the CPS implant has an 11% failure rate at 10 years. Our results are promising and demonstrate the durable fixation provided by the CPS implant. Further studies to compare the CPS prosthesis and other reconstruction options with respect to survival and functional outcomes are warranted. Level IV, therapeutic study.

Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry): Observational and Retrospective Study.

PubMed

Tehrani, Behnam; Truesdell, Alexander; Singh, Ramesh; Murphy, Charles; Saulino, Patricia

2018-06-28

The development and implementation of a Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided management and improvement of outcomes in cardiogenic shock. The objectives of this study are (1) to collect retrospective clinical outcomes for acute decompensated heart failure cardiogenic shock and acute myocardial infarction cardiogenic shock, and compare current versus historical survival rates and clinical outcomes; (2) to evaluate Inova Heart and Vascular Institute site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017; (3) to compare outcomes related to early implementation of mechanical circulatory support and hemodynamic-guided management versus historical controls; (4) to assess survival to discharge rate in patients receiving intervention from the designated shock team and (5) create a clinical archive of Cardiogenic Shock patient characteristics for future analysis and the support of translational research studies. This is an observational, retrospective, single center study. Retrospective and prospective data will be collected in patients treated at the Inova Heart and Vascular Institute with documented cardiogenic shock as a result of acute decompensated heart failure or acute myocardial infarction. This registry will include data from patients prior to and after the initiation of the multidisciplinary Cardiogenic Shock team on January 1, 2017. Clinical outcomes associated with early multidisciplinary team intervention will be analyzed. In the study group, all patients evaluated for documented cardiogenic shock (acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock) treated at the Inova Heart and Vascular Institute by the Cardiogenic Shock team will be included. An additional historical Inova Heart and Vascular Institute control group will be analyzed as a comparator. Means with standard deviations will be reported for outcomes. For categorical variables, frequencies and percentages will be presented. For continuous variables, the number of subjects, mean, standard deviation, minimum, 25th percentile, median, 75th percentile and maximum will be reported. Reported differences will include standard errors and 95% CI. Preliminary data analysis for the year 2017 has been completed. Compared to a baseline 2016 survival rate of 47.0%, from 2017 to 2018, CS survival rates were increased to 57.9% (58/110) and 81.3% (81/140), respectively (P=.01 for both). Study data will continue to be collected until December 31, 2018. The preliminary results of this study demonstrate that the INOVA SHOCK team approach to the treatment of Cardiogenic Shock with early team activation, rapid initiation of mechanical circulatory support, hemodynamic-guided management, and strict protocol adherence is associated with superior clinical outcomes: survival to discharge and overall survival when compared to 2015 and 2016 outcomes prior to Shock team initiation. What may limit the generalization of these results of this study to other populations are site specific; expertise of the team, strict algorithm adherence based on the INOVA SHOCK protocol, and staff commitment to timely team activation. Retrospective clinical outcomes (acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock) demonstrated an increase in current survival rates when compared to pre-Cardiogenic Shock team initiation, rapid team activation and diagnosis and timely utilization of mechanical circulatory support. ClinicalTrials.gov NCT03378739; https://clinicaltrials.gov/ct2/show/NCT03378739 (Archived by WebCite at http://www.webcitation.org/701vstDGd). ©Behnam Tehrani, Alexander Truesdell, Ramesh Singh, Charles Murphy, Patricia Saulino. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.06.2018.

An exploratory study on the efficacy and safety of a BCAA preparation used in combination with cardiac rehabilitation for patients with chronic heart failure.

PubMed

Takata, Munenori; Amiya, Eisuke; Watanabe, Masafumi; Hosoya, Yumiko; Nakayama, Atsuko; Fujiwara, Takayuki; Taya, Masanobu; Oguri, Gaku; Hyodo, Kanako; Takayama, Naoko; Takano, Nami; Mashiko, Tomoe; Uemura, Yukari; Komuro, Issei

2017-07-27

Sarcopenia is generally complicated with patients with chronic heart failure (CHF) and its presence negatively affects the course of heart failure, however effective nutritional intervention had not been elucidated yet. The primary objective of this study is to explore whether the addition of a branched-chain amino acid (BCAA) preparation for cardiac rehabilitation (CR) of patients with CHF further improves cardiopulmonary functions, skeletal muscle functions, and metabolism in comparison with conventional CR. This is a randomized, parallel-group comparative study. The elderly patients that were participated in CR and complicated with left ventricular systolic or diastolic dysfunction are randomized into two groups, CR + BCAA and CR. 20 weeks later, the second randomization is performed, which divide subjects into two groups with and without BCAA intervention without CR. Primary outcome measure is the rate of change of the anaerobic threshold workload from baseline to post-intervention. Secondary outcome include parameters of exercise capacity, cardiac function and psychological status. In the current study the effect of a promising new intervention, BCAA, will be assessed to determine whether its addition to CR improve exercise capacity in patients with heart failure, who are generally complicated with sarcopenia. This clinical trial was registered with the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR; JPRN-UMIN R000022440 ).

Early prognostic markers for fatal fulminant hepatic failure cases with viral hepatitis: proton nuclear magnetic resonance spectroscopic studies of serum.

PubMed

Bala, Lakshmi; Mehrotra, Mayank; Mohindra, Samir; Saxena, Rajan; Khetrapal, Chunni Lal

2013-02-01

Fulminant hepatic failure is associated with liver metabolic derangements which could have fatal consequences. The aim of the present study is to identify serum markers for early prediction of the outcome. Proton nuclear magnetic resonance spectroscopic studies of serum of fulminant hepatic failure patients due to viral hepatitis with grade II/III of encephalopathy (twenty-four: ten prospective and fourteen retrospective) and twenty-five controls were undertaken. Of the twenty-four patients, fifteen survived with medical management alone while nine had fatal outcome. The results demonstrated significantly elevated indices of amino acids (alanine, lysine, glutamine, histidine, tyrosine, phenylalanine and 1,2-propanediol) in fatal cases compared to survivors and controls. Principal component analysis showed clear separation of fatal and surviving cases. Liver function parameters were significantly deranged in patients but they failed to provide early significant differences between surviving and fatal cases. Compared to model for end-stage liver disease scores, principal component analysis appear to be better as an early prognostic indicator. Biochemical mapping of pathways suggested interruptions in amino acid metabolism and urea cycle. Proton nuclear magnetic resonance studies of serum have the potential of rapidly identifying patients with irreversible fulminant hepatic failure requiring liver transplantation as life saving option. Copyright © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Comparison of a therapeutic-only versus prophylactic platelet transfusion policy for people with congenital or acquired bone marrow failure disorders.

PubMed

Malouf, Reem; Ashraf, Asma; Hadjinicolaou, Andreas V; Doree, Carolyn; Hopewell, Sally; Estcourt, Lise J

2018-05-14

Bone marrow disorders encompass a group of diseases characterised by reduced production of red cells, white cells, and platelets, or defects in their function, or both. The most common bone marrow disorder is myelodysplastic syndrome. Thrombocytopenia, a low platelet count, commonly occurs in people with bone marrow failure. Platetet transfusions are routinely used in people with thrombocytopenia secondary to bone marrow failure disorders to treat or prevent bleeding. Myelodysplastic syndrome is currently the most common reason for receiving a platelet transfusion in some Western countries. To determine whether a therapeutic-only platelet transfusion policy (transfusion given when patient is bleeding) is as effective and safe as a prophylactic platelet transfusion policy (transfusion given to prevent bleeding according to a prespecified platelet threshold) in people with congenital or acquired bone marrow failure disorders. We searched for randomised controlled trials (RCTs), non-RCTs, and controlled before-after studies (CBAs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2017, Issue 9), Ovid MEDLINE (from 1946), Ovid Embase (from 1974), PubMed (e-publications only), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 12 October 2017. We included RCTs, non-RCTs, and CBAs that involved the transfusion of platelet concentrates (prepared either from individual units of whole blood or by apheresis any dose, frequency, or transfusion trigger) and given to treat or prevent bleeding among people with congenital or acquired bone marrow failure disorders.We excluded uncontrolled studies, cross-sectional studies, and case-control studies. We excluded cluster-RCTs, non-randomised cluster trials, and CBAs with fewer than two intervention sites and two control sites due to the risk of confounding. We included all people with long-term bone marrow failure disorders that require platelet transfusions, including neonates. We excluded studies of alternatives to platelet transfusion, or studies of people receiving intensive chemotherapy or a stem cell transplant. We used the standard methodological procedures outlined by Cochrane. Due to the absence of evidence we were unable to report on any of the review outcomes. We identified one RCT that met the inclusion criteria for this review. The study enrolled only nine adults with MDS over a three-year study duration period. The trial was terminated due to poor recruitment rate (planned recruitment 60 participants over two years). Assessment of the risk of bias was not possible for all domains. The trial was a single-centre, single-blind trial. The clinical and demographic characteristics of the participants were never disclosed. The trial outcomes relevant to this review were bleeding assessments, mortality, quality of life, and length of hospital stay, but no data were available to report on any of these outcomes.We identified no completed non-RCTs or CBAs.We identified no ongoing RCTs, non-RCTs, or CBAs. We found no evidence to determine the safety and efficacy of therapeutic platelet transfusion compared with prophylactic platelet transfusion for people with long-term bone marrow failure disorders. This review underscores the urgency of prioritising research in this area. People with bone marrow failure depend on long-term platelet transfusion support, but the only trial that assessed a therapeutic strategy was halted. There is a need for good-quality studies comparing a therapeutic platelet transfusion strategy with a prophylactic platelet transfusion strategy; such trials should include outcomes that are important to patients, such as quality of life, length of hospital admission, and risk of bleeding.

When pupils do not understand the determinants of their success and failure in school: relations between internal, teacher and unknown perceptions of control and school achievement.

PubMed

Butler, R; Orion, R

1990-02-01

Both dispositional and attributional perspectives on perceptions of control assume that people have some idea of outcome determinants. This, however, may not always be so. This study tested the hypothesis that pupils do not always understand the determinants of their learning outcomes, and that such a sense of unknown control will be associated with poor achievement in school. The study was unusual in that it tapped both dispositional control perceptions, using the new MMPCC, and causal attributions for success and failure in a school examination. Subjects were 186 10-year-old Israeli pupils of heterogeneous SES. Results confirmed that unknown control emerged as a distinct dimension of perceived control in both dispositional and attributional measures, and was consistently associated with poor achievement in school. Attributions of test outcomes to unknown causes were strongly related to dispositional unknown control, and were not affected by success or failure. In contrast, dispositional and attributional internality were unrelated, and did not predict achievement. It is argued that internal beliefs reflect internalised social-educational norms, and as a result have less impact on motivation than perceptions of unknown control. The implications of these findings for educational practice and motivational interventions are discussed.

Vasodilators in Acute Heart Failure: Review of the Latest Studies.

PubMed

Levy, Phillip D; Laribi, Said; Mebazaa, Alexandre

2014-06-01

Vasodilators play an important role in the management of acute heart failure, particularly when increased afterload is the precipitating cause of decompensation. The time-honored approach to afterload reduction has been largely focused on use of intravenous nitrovasodilators and, when properly dosed, this class of agents does provide substantial symptom relief for patients with acute hypertensive heart failure. Despite this, nitrovasodilators have never been shown to diminish mortality or provide any post-discharge outcome benefit leading to an on-going search for viable and more effective alternatives. While no new vasodilators have been approved for use in acute heart failure since nesiritide more than a decade ago, a number of novel agents have been developed, with some showing significant promise in recent clinical trials. In this review, we summarize the latest study data as it relates to vasodilator therapy and provide a glimpse into the not too distant future state of acute heart failure care.

Variation in Dialysis Exposure Prior to Nonpreemptive Living Donor Kidney Transplantation in the United States and Its Association With Allograft Outcomes.

PubMed

Gill, John S; Rose, Caren; Joffres, Yayuk; Landsberg, David; Gill, Jagbir

2018-05-01

The impact of dialysis exposure before nonpreemptive living donor kidney transplantation on allograft outcomes is uncertain. Retrospective cohort study. Adult first-time recipients of kidney-only living donor transplants in the United States who were recorded within the Scientific Registry of Transplant Recipients for 2000 to 2016. Duration of pretransplantation dialysis exposure. Kidney transplant failure from any cause including death, death-censored transplant failure, and death with allograft function. Among the 77,607 living donor transplant recipients studied, longer pretransplantation dialysis exposure was independently associated with progressively higher risk for transplant failure from any cause, including death beginning 6 months after transplantation. Compared with patients with 0.1 to 3.0 months of dialysis exposure, the HR for transplant failure from any cause including death increased from 1.16 (95% CI, 1.07-1.31) among patients with 6.1 to 9.0 months of dialysis exposure to 1.60 (95% CI, 1.43-1.79) among patients with more than 60.0 months of dialysis exposure. Pretransplantation dialysis exposure varied markedly among centers; median exposures were 11.0 and 18.9 months for centers in the 10th and 90th percentiles of dialysis exposure, respectively. Centers with the highest proportions of living donor transplantations had the shortest pretransplantation dialysis exposures. In multivariable analysis, patients of black race, with low income, with nonprivate insurance, with less than high school education, and not working for income had longer pretransplantation dialysis exposures. Dialysis exposure in patients with these characteristics also varied 2-fold between transplantation centers. Why longer dialysis exposure is associated with transplant failure could not be determined. Longer pretransplantation dialysis exposure in nonpreemptive living donor kidney transplantation is associated with increased risk for allograft failure. Pretransplantation dialysis exposure is associated with recipients' sociodemographic and transplantation centers' characteristics. Understanding whether limiting pretransplantation dialysis exposure could improve living donor transplant outcomes will require further study. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Estimating effect of environmental contaminants on women's subfecundity for the MoBa study data with an outcome-dependent sampling scheme

PubMed Central

Ding, Jieli; Zhou, Haibo; Liu, Yanyan; Cai, Jianwen; Longnecker, Matthew P.

2014-01-01

Motivated by the need from our on-going environmental study in the Norwegian Mother and Child Cohort (MoBa) study, we consider an outcome-dependent sampling (ODS) scheme for failure-time data with censoring. Like the case-cohort design, the ODS design enriches the observed sample by selectively including certain failure subjects. We present an estimated maximum semiparametric empirical likelihood estimation (EMSELE) under the proportional hazards model framework. The asymptotic properties of the proposed estimator were derived. Simulation studies were conducted to evaluate the small-sample performance of our proposed method. Our analyses show that the proposed estimator and design is more efficient than the current default approach and other competing approaches. Applying the proposed approach with the data set from the MoBa study, we found a significant effect of an environmental contaminant on fecundability. PMID:24812419

Survival and prognosis: investigation of Crataegus extract WS 1442 in congestive heart failure (SPICE)--rationale, study design and study protocol.

PubMed

Holubarsch, C J; Colucci, W S; Meinertz, T; Gaus, W; Tendera, M

2000-12-01

SPICE is the first, international, randomized, placebo-controlled, double-blind study to investigate the influence of the herbal drug Crataegus Special Extract WS 1442 (hawthorn leaves with flowers) on mortality of patients suffering from congestive heart failure. In vitro and experimental animal studies have suggested the following pharmacological modes of action of standardized Crataegus extracts: (1) cAMP-independent positive inotropy; (2) peripheral and coronary vasodilation; (3) protection against ischemia-induced ventricular arrhythmias; (4) antioxidative properties; and (5) anti-inflammatory effects. In this randomized, placebo-controlled, double-blind, international trial (approximately 120 investigational centers in seven European countries), up to 2300 patients with congestive heart failure, New York Heart Association class II and III and markedly impaired left ventricular function, will be enrolled and treated over a period of 24 months. During this time patients receive either two film-coated tablets of 450 mg of the Special Extract WS 1442 standardized to 84.3 mg of oligomeric procyanidines or matched placebo per day in addition to standard therapy for congestive heart failure, such as diuretics, digoxin or digitoxin, beta-adrenoceptor blockers and angiotensin-converting-enzyme inhibitors. The primary outcome variable is the combined endpoint of cardiac death, non-lethal myocardial infarction, and hospitalization due to progression of heart failure. Secondary outcome variables are total mortality, exercise duration, echocardiographic parameters, quality of life as well as pharmacoeconomic parameters. The first patient was included in October 1998. The trial is expected to be completed at the end of 2002.

Improved outcomes in the non-operative management of liver injuries

PubMed Central

Saltzherr, Teun Peter; van der Vlies, Cees H; van Lienden, Krijn P; Beenen, Ludo F M; Ponsen, Kees Jan; van Gulik, Thomas M; Goslings, J Carel

2011-01-01

Objectives Non-operative management has become the treatment of choice in the majority of liver injuries. The aim of this study was to assess the changes in primary treatment and outcomes in a single Dutch Level 1 trauma centre with wide experience in angio-embolisation (AE). Methods The prospective trauma registry was retrospectively analysed for 7-year periods before (Period 1) and after (Period 2) the introduction of AE. The primary outcome was the failure rate of primary treatment defined as liver injury-related death or re-bleeding requiring radiologic or operative (re)interventions. Secondary outcomes were liver injury-related intra-abdominal complications. Results Despite an increase in high-grade liver injuries, the incidence of primary non-operative management more than doubled over the two periods, from 33% (20 of 61 cases) in Period 1 to 72% (84 of 116 cases) in Period 2 (P < 0.001). The failure rate of primary treatment in Period 1 was 18% (11/61), compared with 11% (13/116) in Period 2 (P = 0.21). Complication rates were 23% (14/61) and 16% (18/116) in Periods 1 and 2, respectively (P = 0.22). Liver-related mortality rates were 10% (6/61) and 3% (4/116) in Periods 1 and 2, respectively (P = 0.095). The increase in the frequency of non-operative management was even higher in high-grade injuries, in which outcomes were improved. In high-grade injuries in Periods 1 and 2, failure rates decreased from 45% (9/20) to 20% (11/55) (P = 0.041), liver-related mortality decreased from 30% (6/20) to 7% (4/55) (P = 0.019) and complication rates fell from 60% (12/20) to 27% (15/55) (P = 0.014). Liver infarction or necrosis and abscess formation seemed to occur more frequently with AE. Conclusions Overall, liver-related mortality, treatment failure and complication rates remained constant despite an increase in non-operative management. However, in high-grade injuries outcomes improved after the introduction of AE. PMID:21492335

Outcome of Early Initiation of Peritoneal Dialysis in Patients with End-Stage Renal Failure

PubMed Central

Oh, Kook-Hwan; Hwang, Young-Hwan; Cho, Jung-Hwa; Kim, Mira; Ju, Kyung Don; Joo, Kwon Wook; Kim, Dong Ki; Kim, Yon Su; Ahn, Curie

2012-01-01

Recent studies reported that early initiation of hemodialysis may increase mortality. However, studies that assessed the influence of early initiation of peritoneal dialysis (PD) yielded controversial results. In the present study, we evaluated the prognosis of early initiation of PD on the various outcomes of end stage renal failure patients by using propensity-score matching methods. Incident PD patients (n = 491) who started PD at SNU Hospital were enrolled. The patients were divided into 'early starters (n = 244)' and 'late starters (n = 247)' on the basis of the estimated glomerular filtration rate (eGFR) at the start of dialysis. The calculated propensity-score was used for one-to-one matching. After propensity-score-based matching (n = 136, for each group), no significant differences were observed in terms of all-cause mortality (P = 0.17), technique failure (P = 0.62), cardiovascular event (P = 0.96) and composite event (P = 0.86) between the early and late starters. Stratification analysis in the propensity-score quartiles (n = 491) exhibited no trend toward better or poorer survival in terms of all-cause mortality. In conclusion, early commencement of PD does not reduce the mortality risk and other outcomes. Although the recent guidelines suggest that initiation of dialysis at higher eGFR, physicians should not determine the time to initiate PD therapy simply rely on the eGFR alone. PMID:22323864

A comparison of graft and patient outcomes following kidney transplantation in extended hour and conventional haemodialysis patients.

PubMed

See, Emily J; Hawley, Carmel M; Cho, Yeoungjee; Toussaint, Nigel D; Agar, John Wm; Pascoe, Elaine M; Lim, Wai H; Francis, Ross S; Collins, Michael G; Johnson, David W

2018-01-08

Differences in early graft function between kidney transplant recipients previously managed with either haemodialysis (HD) or peritoneal dialysis are well described. However, only two single-centre studies have compared graft and patient outcomes between extended hour and conventional HD patients, with conflicting results. This study compared the outcomes of all extended hour (≥24 hours/week) and conventional HD patients transplanted in Australia and New Zealand between 2000 and 2014. The primary outcome was delayed graft function (DGF), defined in an ordinal manner as either a spontaneous fall in serum creatinine of less than 10% within 24 hours, or the need for dialysis within 72 hours following transplantation. Secondary outcomes included the requirement for dialysis within 72 hours post-transplant, acute rejection, estimated glomerular filtration rate at 12 months, death-censored graft failure, all-cause and cardiovascular mortality, and a composite of graft failure and mortality. A total of 4,935 HD patients (378 extended hour HD, 4,557 conventional HD) received a kidney transplant during the study period. Extended hour HD was associated with an increased likelihood of DGF compared with conventional HD (adjusted proportional odds ratio 1.33; 95% confidence interval 1.06-1.67). There was no significant difference between extended hour and conventional HD in terms of any of the secondary outcomes. Compared to conventional HD, extended hour HD was associated with DGF, although long-term graft and patient outcomes were not different. This article is protected by copyright. All rights reserved.

Efficacy and safety of deep anterior lamellar keratoplasty vs. penetrating keratoplasty for keratoconus: a meta-analysis.

PubMed

Liu, Hao; Chen, Yihui; Wang, Peng; Li, Bing; Wang, Weifang; Su, Yan; Sheng, Minjie

2015-01-01

To evaluate difference in therapeutic outcomes between deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty (PKP) for the clinical treatment of keratoconus. A comprehensive search was conducted in Pubmed, EMBASE, Cochrane Library, and Web of science. Eligible studies should include at least one of the following factors: best corrected visual acuity (BCVA), postoperative spherical equivalent (SE), postoperative astigmatism and endothelial cell count (ECC), central corneal thickness (CCT), graft rejection and graft failure, of which BCVA, graft rejection and graft failure were used as the primary outcome measures, and postoperative SE, astigmatism, CCT and ECC as the secondary outcome measures. Given the lack of randomized clinical trials (RCTs), cohort studies and prospective studies were considered eligible. Sixteen clinical trials involving 6625 eyes were included in this review, including 1185 eyes in DALK group, and 5440 eyes in PKP group. The outcomes were analyzed using Cochrane Review Manager (RevMan) version 5.0 software. The postoperative BCVA in DALK group was significantly better than that in PKP group (OR = 0.48; 95%CI 0.39 to 0.60; p<0.001). There were fewer cases of graft rejection in DALK group than those in PKP group (OR = 0.28; 95%CI 0.15 to 0.50; p<0.001). Nevertheless the rate of graft failure was similar between DALK and PKP groups (OR = 1.05; 95%CI 0.81 to 1.36; p = 0.73). There were no significant differences in the secondary outcomes of SE (p = 0.70), astigmatism (p = 0.14) and CCT (p = 0.58) between DALK and PKP groups. And ECC in DALK group was significantly higher than PKP group (p<0.001). The postoperative complications, high intraocular pressure (high-IOP) and cataract were analyzed, fewer cases of complications occurred in DALK group than those in PKP group (high-IOP, OR 0.22, 95% CI 0.11-0.44, P<0.001) (cataract, OR 0.22; 95% CI 0.08-0.61, P = 0.004). And no cases of expulsive hemorrhage and endophthalmitis were reported. The visual outcomes for DALK were not equivalent to PKP. The rate of graft failure was similar between DALK and PKP. Fewer postoperative complications occurred in DALK group, indicating that compared with PKP, DALK has lower efficacy but higher safety.

Clinical outcomes in heart failure: report from a community hospital-based registry.

PubMed

Philbin, E F; Rocco, T A; Lindenmuth, N W; Ulrich, K; Jenkins, P L

1999-12-01

Most of the recent information on the prognosis of patients with heart failure has come from large clinical trials or tertiary care centers. This study reports current information from a community hospital-based heart failure registry. We compiled data from 2,906 unselected consecutive patients with heart failure who were admitted to 10 acute care community hospitals in New York State between 1995 and 1997. Patients were followed prospectively for 6 months after hospital discharge or until their death. The mean (+/- SI)) age of the sample was 76 +/- 11 years. The majority of the patients were women (56%) and most were white (95%). Hospital length of stay averaged 7.4 +/- 7.6 days; hospital charges averaged $7,460 +/- $6,114. Mortality during the index admission was 5%. Among the 2,508 patients for whom mortality or follow-up data were available, an additional 411 died during follow-up, for a cumulative 6-month mortality of 23%. Progressive pump failure was the predominant cause of death in the hospital and after discharge. Although mean functional class (on a 1 to 4 scale) improved from 3.4 +/- 0.7 at hospital admission to 2.3 +/- 0.9 at 1 month after discharge, 43% of patients had at least one hospital readmission during follow-up and 25% had at least one recurrent admission for heart failure. The mean time from index discharge to first rehospitalization was 60 +/- 56 days. In all, 55% of patients (1,370 of 2,508) were rehospitalized or died during the study period. Despite advances in the management of heart failure, patients recently hospitalized for this disorder remain at high risk of death, hospital readmission, and poor clinical outcome. Discovery or implementation of new or existing methods of prevention and treatment remain a high priority.

Inhibitors of cyclic nucleotide phosphodiesterase 3 and 5 as therapeutic agents in heart failure.

PubMed

Stehlik, Josef; Movsesian, Matthew A

2006-07-01

Cyclic nucleotide phosphodiesterases (PDE) 3 and 5 regulate cAMP and cGMP signalling in cardiac and smooth muscle myocytes. Important advances in the understanding of the roles of these enzymes have recently been made. PDE3 inhibitors have inotropic and vasodilatory properties, and although they acutely improve haemodynamics in patients with heart failure, they do not improve long-term morbidity and mortality. Although combination therapy with beta-adrenergic receptor antagonists or selective inhibition of specific PDE3 isoforms might result in a more favourable long-term outcome, more clinical data are needed to test this proposition. The role of PDE5 inhibitors in the treatment of cardiac disease is evolving. PDE5 inhibitors cause pulmonary and systemic vasodilation. How these drugs will compare with other vasodilators in terms of long-term outcomes in patients with heart failure is unknown. Recent studies also suggest that PDE5 inhibitors may have antihypertropic effects, exerted through increased myocardial cGMP signalling, that could be of additional benefit in patients with heart failure.

Factors related to outcome in heart failure with a preserved (or normal) left ventricular ejection fraction.

PubMed

Sanderson, John E

2016-07-01

Heart failure with a preserved ejection faction (HFpEF) is a growing and expensive cause of heart failure (HF) affecting particularly the elderly. It differs in substantial ways in addition to the normal left ventricular ejection fraction, from the more easily recognized form of heart failure with a reduced ejection fraction (HFrEF or 'systolic heart failure') and unlike HFrEF there have been little advances in treatment. In part, this relates to the complexity of the pathophysiology and identifying the correct targets. In HFpEF, there appears to be widespread stiffening of the vasculature and the myocardium affecting ventricular function (both systolic and diastolic), impeding ventricular suction, and thus early diastolic filling leading to breathlessness on exertion and later atrial failure and fibrillation. Left ventricular ejection fraction tends to gradually decline and some evolve into HFrEF. Most patients also have a mixture of several co-morbidities including hypertension, diabetes, obesity, poor renal function, lack of fitness, and often poor social conditions. Therefore, many factors may influence outcome in an individual patient. In this review, the epidemiology, possible causation, pathophysiology, the influence of co-morbidities and some of the many potential predictors of outcome will be considered.

Severe acute haemorrhagic liver failure in a neonate with a favourable spontaneous outcome.

PubMed

Cavet, Madeleine; Balu, Marie; Garel, Catherine; Mitanchez, Delphine; Renolleau, Sylvain; Alexandre, Marie; Pariente, Danièle; Ducou le Pointe, Hubert

2008-10-01

Acute liver failure in neonates is rare and is frequently associated with an unfavourable outcome. There is no curative treatment other than liver transplantation. Screening for viral, metabolic, toxic or vascular disease is essential to assess the prognosis and to guide specific treatment. Hepatic haemorrhage in neonates is often associated with bacterial infection, trauma and coagulopathies. We present a unique case of neonatal acute liver failure and multifocal massive haemorrhagic intrahepatic lesions of traumatic origin, documented by US and MRI. The patient made a spontaneous recovery. Clinical, biological and imaging outcome was excellent despite the apparent severity of the initial features. The only possible aetiology was a difficult caesarean delivery for mild fetal macrosomia.

Vital Signs: How Early Can Resident Evaluation Predict Acquisition of Competency in Surgical Pathology?

PubMed Central

Ducatman, Barbara S.; Williams, H. James; Hobbs, Gerald; Gyure, Kymberly A.

2009-01-01

Objectives To determine whether a longitudinal, case-based evaluation system can predict acquisition of competency in surgical pathology and how trainees at risk can be identified early. Design Data were collected for trainee performance on surgical pathology cases (how well their diagnosis agreed with the faculty diagnosis) and compared with training outcomes. Negative training outcomes included failure to complete the residency, failure to pass the anatomic pathology component of the American Board of Pathology examination, and/or failure to obtain or hold a position immediately following training. Findings Thirty-three trainees recorded diagnoses for 54 326 surgical pathology cases, with outcome data available for 15 residents. Mean case-based performance was significantly higher for those with positive outcomes, and outcome status could be predicted as early as postgraduate year-1 (P  =  .0001). Performance on the first postgraduate year-1 rotation was significantly associated with the outcome (P  =  .02). Although trainees with unsuccessful outcomes improved their performance more rapidly, they started below residents with successful outcomes and did not make up the difference during training. There was no significant difference in Step 1 or 2 United States Medical Licensing Examination (USMLE) scores when compared with performance or final outcomes (P  =  .43 and P  =  .68, respectively) and the resident in-service examination (RISE) had limited predictive ability. Discussion Differences between successful- and unsuccessful-outcome residents were most evident in early residency, ideal for designing interventions or counseling residents to consider another specialty. Conclusion Our longitudinal case-based system successfully identified trainees at risk for failure to acquire critical competencies for surgical pathology early in the program. PMID:21975705

Mid-range Ejection Fraction Does Not Permit Risk Stratification Among Patients Hospitalized for Heart Failure.

PubMed

Gómez-Otero, Inés; Ferrero-Gregori, Andreu; Varela Román, Alfonso; Seijas Amigo, José; Pascual-Figal, Domingo A; Delgado Jiménez, Juan; Álvarez-García, Jesús; Fernández-Avilés, Francisco; Worner Diz, Fernando; Alonso-Pulpón, Luis; Cinca, Juan; Gónzalez-Juanatey, José Ramón

2017-05-01

European Society of Cardiology heart failure guidelines include a new patient category with mid-range (40%-49%) left ventricular ejection fraction (HFmrEF). HFmrEF patient characteristics and prognosis are poorly defined. The aim of this study was to analyze the HFmrEF category in a cohort of hospitalized heart failure patients (REDINSCOR II Registry). A prospective observational study was conducted with 1420 patients classified according to ejection fraction as follows: HFrEF, < 40%; HFmrEF, 40%-49%; and HFpEF, ≥ 50%. Baseline patient characteristics were examined, and outcome measures were mortality and readmission for heart failure at 1-, 6-, and 12-month follow-up. Propensity score matching was used to compare the HFmrEF group with the other ejection fraction groups. Among the study participants, 583 (41%) had HFrEF, 227 (16%) HFmrEF, and 610 (43%) HFpEF. HFmrEF patients had a clinical profile similar to that of HFpEF patients in terms of age, blood pressure, and atrial fibrillation prevalence, but shared with HFrEF patients a higher proportion of male participants and ischemic etiology, and use of class I drugs targeting HFrEF. All other features were intermediate, and comorbidities were similar among the 3 groups. There were no significant differences in all-cause mortality, cause of death, or heart failure readmission. The similar outcomes were confirmed in the propensity score matched cohorts. The HFmrEF patient group has characteristics between the HFrEF and HFpEF groups, with more similarities to the HFpEF group. No between-group differences were observed in total mortality, cause of death, or heart failure readmission. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Two-year outcome of a prospective, controlled study of a disease management programme for elderly patients with heart failure.

PubMed

Del Sindaco, Donatella; Pulignano, Giovanni; Minardi, Giovanni; Apostoli, Antonella; Guerrieri, Luca; Rotoloni, Marina; Petri, Gabriella; Fabrizi, Lino; Caroselli, Attilia; Venusti, Rita; Chiantera, Angelo; Giulivi, Alessia; Giovannini, Ezio; Leggio, Francesco

2007-05-01

Elderly heart failure patients are at high risk of events. Available studies and systematic reviews suggest that elderly patients benefit from disease management programmes (DMPs). However, important questions remain open, including the optimal follow-up intensity and duration and whether such interventions are cost-effective during long-term follow-up and in different healthcare systems. The aim of this study was to determine the long-term efficacy of a hybrid DMP in consecutive older outpatients. Intervention consisted in combined hospital-based (cardiologists and nurse-coordinators from two heart failure clinics) and home-based (patient's general practitioner visits) care. The components of the DMP were the following: discharge planning, education, therapy optimisation, improved communication, early attention to signs and symptoms. Intensive follow-up was based on scheduled hospital visits (starting within 14 days of discharge), nurse's phone call and home general practitioner visits. A group of 173 patients aged > or =70 years (mean age 77 +/- 6 years, 48% women) was randomly assigned to DMP (n = 86) or usual care (n = 87). At 2-year follow-up, a 36% reduction in all-cause death and heart failure hospital admissions was observed in DMP vs. usual care. All-cause and heart failure admissions as well as the length of hospital stay were also reduced. DMP patients reported, compared to baseline, significant improvements in functional status, quality of life and beta-blocker prescription rate. The intervention was cost-effective with a mean saving of euro 982.04 per patient enrolled. A hybrid DMP for elderly heart failure patients improves outcomes and is cost-effective over a long-term follow-up.

Acute Kidney Injury Predicts Major Adverse Outcomes in Diabetes: Synergic Impact With Low Glomerular Filtration Rate and Albuminuria.

PubMed

Monseu, Mathilde; Gand, Elise; Saulnier, Pierre-Jean; Ragot, Stéphanie; Piguel, Xavier; Zaoui, Philippe; Rigalleau, Vincent; Marechaud, Richard; Roussel, Ronan; Hadjadj, Samy; Halimi, Jean-Michel

2015-12-01

Subjects with diabetes are prone to the development of cardiovascular and noncardiovascular complications. In separate studies, acute kidney injury (AKI), albuminuria, and low estimated glomerular filtration rate (eGFR) were shown to predict adverse outcomes, but, when considered together, their respective prognostic value is unknown. Patients with type 2 diabetes consecutively recruited in the SURDIAGENE cohort were prospectively followed up for major diabetes-related events, as adjudicated by an independent committee: death (with cause), major cardiovascular events (myocardial infarction, stroke, congestive heart failure, amputation, and arterial revascularization), and renal failure (i.e., sustained doubling of serum creatinine level or end-stage renal disease). Intrahospital AKI occurred in 411 of 1,371 patients during the median follow-up period of 69 months. In multivariate analyses, AKI was significantly associated with cardiovascular and noncardiovascular death, including cancer-related death. In multivariate analyses, AKI was a powerful predictor of major adverse cardiovascular events, heart failure requiring hospitalization, myocardial infarction, stroke, lower-limb amputation or revascularization, and carotid artery revascularization. AKI, eGFR, and albuminuria, even when simultaneously considered in multivariate models, predicted all-cause and cardiovascular deaths. All three renal biomarkers were also prognostic of most adverse outcomes and of the risk of renal failure. AKI, low eGFR, and elevated albuminuria, separately or together, are compelling biomarkers of major adverse outcomes and death in diabetes. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

B-type natriuretic peptide-guided treatment for heart failure.

PubMed

McLellan, Julie; Heneghan, Carl J; Perera, Rafael; Clements, Alison M; Glasziou, Paul P; Kearley, Karen E; Pidduck, Nicola; Roberts, Nia W; Tyndel, Sally; Wright, F Lucy; Bankhead, Clare

2016-12-22

Heart failure is a condition in which the heart does not pump enough blood to meet all the needs of the body. Symptoms of heart failure include breathlessness, fatigue and fluid retention. Outcomes for patients with heart failure are highly variable; however on average, these patients have a poor prognosis. Prognosis can be improved with early diagnosis and appropriate use of medical treatment, use of devices and transplantation. Patients with heart failure are high users of healthcare resources, not only due to drug and device treatments, but due to high costs of hospitalisation care. B-type natriuretic peptide levels are already used as biomarkers for diagnosis and prognosis of heart failure, but could offer to clinicians a possible tool to guide drug treatment. This could optimise drug management in heart failure patients whilst allaying concerns over potential side effects due to drug intolerance. To assess whether treatment guided by serial BNP or NT-proBNP (collectively referred to as NP) monitoring improves outcomes compared with treatment guided by clinical assessment alone. Searches were conducted up to 15 March 2016 in the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library; MEDLINE (OVID), Embase (OVID), the Database of Abstracts of Reviews of Effects (DARE) and the NHS Economic Evaluation Database in the Cochrane Library. Searches were also conducted in the Science Citation Index Expanded, the Conference Proceedings Citation Index on Web of Science (Thomson Reuters), World Health Organization International Clinical Trials Registry and ClinicalTrials.gov. We applied no date or language restrictions. We included randomised controlled trials of NP-guided treatment of heart failure versus treatment guided by clinical assessment alone with no restriction on follow-up. Adults treated for heart failure, in both in-hospital and out-of-hospital settings, and trials reporting a clinical outcome were included. Two review authors independently selected studies for inclusion, extracted data and evaluated risk of bias. Risk ratios (RR) were calculated for dichotomous data, and pooled mean differences (MD) (with 95% confidence intervals (CI)) were calculated for continuous data. We contacted trial authors to obtain missing data. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, we assessed the quality of the evidence and GRADE profiler (GRADEPRO) was used to import data from Review Manager to create a 'Summary of findings' table. We included 18 randomised controlled trials with 3660 participants (range of mean age: 57 to 80 years) comparing NP-guided treatment with clinical assessment alone. The evidence for all-cause mortality using NP-guided treatment showed uncertainty (RR 0.87, 95% CI 0.76 to 1.01; patients = 3169; studies = 15; low quality of the evidence), and for heart failure mortality (RR 0.84, 95% CI 0.54 to 1.30; patients = 853; studies = 6; low quality of evidence).The evidence suggested heart failure admission was reduced by NP-guided treatment (38% versus 26%, RR 0.70, 95% CI 0.61 to 0.80; patients = 1928; studies = 10; low quality of evidence), but the evidence showed uncertainty for all-cause admission (57% versus 53%, RR 0.93, 95% CI 0.84 to 1.03; patients = 1142; studies = 6; low quality of evidence).Six studies reported on adverse events, however the results could not be pooled (patients = 1144; low quality of evidence). Only four studies provided cost of treatment results, three of these studies reported a lower cost for NP-guided treatment, whilst one reported a higher cost (results were not pooled; patients = 931, low quality of evidence). The evidence showed uncertainty for quality of life data (MD -0.03, 95% CI -1.18 to 1.13; patients = 1812; studies = 8; very low quality of evidence).We completed a 'Risk of bias' assessment for all studies. The impact of risk of bias from lack of blinding of outcome assessment and high attrition levels was examined by restricting analyses to only low 'Risk of bias' studies. In patients with heart failure low-quality evidence showed a reduction in heart failure admission with NP-guided treatment while low-quality evidence showed uncertainty in the effect of NP-guided treatment for all-cause mortality, heart failure mortality, and all-cause admission. Uncertainty in the effect was further shown by very low-quality evidence for patient's quality of life. The evidence for adverse events and cost of treatment was low quality and we were unable to pool results.

Acute Kidney Injury Enhances Outcome Prediction Ability of Sequential Organ Failure Assessment Score in Critically Ill Patients

PubMed Central

Chang, Chih-Hsiang; Fan, Pei-Chun; Chang, Ming-Yang; Tian, Ya-Chung; Hung, Cheng-Chieh; Fang, Ji-Tseng; Yang, Chih-Wei; Chen, Yung-Chang

2014-01-01

Introduction Acute kidney injury (AKI) is a common and serious complication in intensive care unit (ICU) patients and also often part of a multiple organ failure syndrome. The sequential organ failure assessment (SOFA) score is an excellent tool for assessing the extent of organ dysfunction in critically ill patients. This study aimed to evaluate the outcome prediction ability of SOFA and Acute Physiology and Chronic Health Evaluation (APACHE) III score in ICU patients with AKI. Methods A total of 543 critically ill patients were admitted to the medical ICU of a tertiary-care hospital from July 2007 to June 2008. Demographic, clinical and laboratory variables were prospectively recorded for post hoc analysis as predictors of survival on the first day of ICU admission. Results One hundred and eighty-seven (34.4%) patients presented with AKI on the first day of ICU admission based on the risk of renal failure, injury to kidney, failure of kidney function, loss of kidney function, and end-stage renal failure (RIFLE) classification. Major causes of the ICU admissions involved respiratory failure (58%). Overall in-ICU mortality was 37.9% and the hospital mortality was 44.7%. The predictive accuracy for ICU mortality of SOFA (areas under the receiver operating characteristic curves: 0.815±0.032) was as good as APACHE III in the AKI group. However, cumulative survival rates at 6-month follow-up following hospital discharge differed significantly (p<0.001) for SOFA score ≤10 vs. ≥11 in these ICU patients with AKI. Conclusions For patients coexisting with AKI admitted to ICU, this work recommends application of SOFA by physicians to assess ICU mortality because of its practicality and low cost. A SOFA score of ≥ “11” on ICU day 1 should be considered an indicator of negative short-term outcome. PMID:25279844

Application of a marketing concept to patient-centered care: co-producing health with heart failure patients.

PubMed

Leone, Robert P; Walker, Charles A; Curry, Linda Cox; Agee, Elizabeth J

2012-04-03

Increasing numbers of patients are being treated for heart failure each year. One out of four of the heart failure patients who receives care in a hospital is readmitted to the hospital within 30 days of discharge. Effective discharge instruction is critical to prevent these patient readmissions. Co-production is a marketing concept whereby the customer is a partner in the delivery of a good or service. For example, a patient and nurse may partner to co-produce a patient-centered health regimen to improve patient outcomes. In this article we review the cost of treating heart failure patients and current strategies to decrease hospital readmissions for these patients along with the role of the nurse and the concept of co-producing health as related to heart failure patients. Next we describe our study assessing the degree to which discharge processes were co-produced on two hospital units having a preponderance of heart failure patients, and present our findings indicating minimal evidence of co-production. A discussion of our findings, along with clinical implications of these findings, recommendations for change, and suggestions for future research are offered. We conclude that standardized discharge plans lead to a mindset of 'one size fits all,' a mindset inconsistent with the recent call for patient-centered care. We offer co-production as a patient-centered strategy for customizing discharge teaching and improving health outcomes for heart failure patients.

Design and Rationale of the Cognitive Intervention to Improve Memory in Heart Failure Patients Study.

PubMed

Pressler, Susan J; Giordani, Bruno; Titler, Marita; Gradus-Pizlo, Irmina; Smith, Dean; Dorsey, Susan G; Gao, Sujuan; Jung, Miyeon

Memory loss is an independent predictor of mortality among heart failure patients. Twenty-three percent to 50% of heart failure patients have comorbid memory loss, but few interventions are available to treat the memory loss. The aims of this 3-arm randomized controlled trial were to (1) evaluate efficacy of computerized cognitive training intervention using BrainHQ to improve primary outcomes of memory and serum brain-derived neurotrophic factor levels and secondary outcomes of working memory, instrumental activities of daily living, and health-related quality of life among heart failure patients; (2) evaluate incremental cost-effectiveness of BrainHQ; and (3) examine depressive symptoms and genomic moderators of BrainHQ effect. A sample of 264 heart failure patients within 4 equal-sized blocks (normal/low baseline cognitive function and gender) will be randomly assigned to (1) BrainHQ, (2) active control computer-based crossword puzzles, and (3) usual care control groups. BrainHQ is an 8-week, 40-hour program individualized to each patient's performance. Data collection will be completed at baseline and at 10 weeks and 4 and 8 months. Descriptive statistics, mixed model analyses, and cost-utility analysis using intent-to-treat approach will be computed. This research will provide new knowledge about the efficacy of BrainHQ to improve memory and increase serum brain-derived neurotrophic factor levels in heart failure. If efficacious, the intervention will provide a new therapeutic approach that is easy to disseminate to treat a serious comorbid condition of heart failure.

Predictive value of daily living score in acute respiratory failure of COPD patients requiring invasive mechanical ventilation pilot study.

PubMed

Langlet, Ketty; Van Der Linden, Thierry; Launois, Claire; Fourdin, Caroline; Cabaret, Philippe; Kerkeni, Nadia; Barbe, Coralie; Lebargy, François; Deslée, Gaetan

2012-10-18

Mechanical ventilation (MV) is imperative in many forms of acute respiratory failure (ARF) in COPD patients. Previous studies have shown the difficulty to identify parameters predicting the outcome of COPD patients treated by invasive MV. Our hypothesis was that a non specialized score as the activities daily living (ADL) score may help to predict the outcome of these patients. We studied the outcome of 25 COPD patients admitted to the intensive care unit for ARF requiring invasive MV. The patients were divided into those weaning success (group A n = 17, 68%) or failure (group B n = 8, 32%). We investigated the correlation between the ADL score and the outcome and mortality. The ADL score was higher in group A (5.1 ±1.1 vs 3.7 ± 0.7 in group B, p < 0.01). Weaning was achieved in 76.5% of the cases with an ADL score ≥ 4 and in 23.5% of the cases with an ADL score < 4 (p < 0.05). Pulmonary function test, arterial blood gases collected during period of clinical stability and at admission and nutritional status were similar in both groups. The mortality, at six months, was 36%. The ADL score was a significant predictor of 6-month mortality (80 with an ADL score <4, 20 with an ADL score ≥4, p < 0.01). Our pilot study demonstrates that the ADL score is predictive of weaning success and mortality at 6 months, suggesting that the assessment of daily activities should be an important component of ARF management in COPD patients.

Home inotropic therapy in advanced heart failure: cost analysis and clinical outcomes.

PubMed

Harjai, K J; Mehra, M R; Ventura, H O; Lapeyre, Y M; Murgo, J P; Stapleton, D D; Smart, F W

1997-11-05

This study was conducted to assess cost savings and clinical outcomes associated with the use of home i.v. inotropic therapy in patients with advanced (New York Heart Association [NYHA] class IV) heart failure. Retrospective analysis. Tertiary care referral center. Twenty-four patients (13 men, 11 women; age, 61+/-12 years) with left ventricular ejection fraction <30% and heart failure refractory to oral agents required home i.v. inotropic therapy for at least 4 consecutive weeks between May 1994 and April 1996. Inotropic agents used included dobutamine (n=20; dose, 5.0+/-2.2 microg/kg/min) or milrinone (n=7; dose, 0.53+/-0.05 microg/kg/min). Cost of care and clinical outcomes (hospital admissions, length of hospital stay, NYHA functional class) were compared during the period of inotropic therapy (study period) and the immediate preceding period of equal duration (control period). In comparison to the control period, the study period (3.9+/-2.7 months) was associated with a 16% reduction in cost, amounting to a calculated savings of $5,700 per patient or $1,465 per patient per month. Concomitantly, a decrease in the number of hospital admissions from 2.7+/-2.6 to 1.3+/-1.3 (p=0.056) and length of hospital stay from 20.9+/-12.7 to 5.5+/-5.4 days (p=0.0004) was observed with improvement in NYHA functional class from 4.0+/-0.0 to 2.7+/-0.9 (p<0.0001). Eight patients (38%) died after 2.8+/-1.7 months of home i.v. inotropic therapy. Home i.v. inotropic therapy reduces hospital admissions, length of stay, and cost of care and improves functional class in patients with advanced (NYHA class IV) heart failure.

Nationwide Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS): first analysis on survival.

PubMed

Ito, Kazuto; Saito, Shiro; Yorozu, Atsunori; Kojima, Shinsuke; Kikuchi, Takashi; Higashide, Satoshi; Aoki, Manabu; Koga, Hirofumi; Satoh, Takefumi; Ohashi, Toshio; Nakamura, Katsumasa; Katayama, Norihisa; Tanaka, Nobumichi; Nakano, Masahiro; Shigematsu, Naoyuki; Dokiya, Takushi; Fukushima, Masanori

2018-06-22

Investigating oncological outcomes in patients registered in the Japanese Prostate Cancer Outcome Study of Permanent Iodine-125 Seed Implantation (J-POPS) in terms of biochemical relapse-free survival (bRFS) by the Phoenix and the newly developed J-POPS definitions, exploration of predictive factors for bRFS, and preliminary verification of pitfalls of prostate-specific antigen (PSA) failure definitions. Between July 2005 and June 2007, 2316 clinically localized patients underwent permanent seed implantation. The primary endpoint was bRFS. One of the secondary endpoints was overall survival (OS). The median age was 69 and performance status was 0 in 99.1% of participants. The median biologically effective dose (BED) was about 180 Gy 2 . During a median follow-up of 60.0 months, 8.4 and 5.9% had PSA failure by the Phoenix and the J-POPS definitions, respectively. The 5-year bRFSs based on the Phoenix and the J-POPS definitions were 89.1 and 91.6%, respectively. The 5-year OS was 97.3%. According to multivariate analyses, only age affected bRFS based on the Phoenix definition, whereas the risk group and BED independently affected bRFS based on the J-POPS definition. A spontaneous PSA decrease was seen in 91.1% of participants after PSA failure based on the Phoenix definition alone, but in only 22.2% after PSA failure based on the J-POPS definition alone. The world's largest registration study, J-POPS, consisted of patients with longevity, and a highly quality-controlled BED resulted in excellent bRFS and OS. The high likelihood of PSA bounce by the Phoenix definition should be taken into account, especially in younger patients. NCT00534196.

Elevated troponin I levels in acute liver failure: is myocardial injury an integral part of acute liver failure?

PubMed

Parekh, Nimisha K; Hynan, Linda S; De Lemos, James; Lee, William M

2007-06-01

Although rare instances of cardiac injury or arrhythmias have been reported in acute liver failure (ALF), overall, the heart is considered to be spared in this condition. Troponin I, a sensitive and specific marker of myocardial injury, may be elevated in patients with sepsis and acute stroke without underlying acute coronary syndrome, indicating unrecognized cardiac injury in these settings. We sought to determine whether subclinical cardiac injury might also occur in acute liver failure. Serum troponin I levels were measured in 187 patients enrolled in the US Acute Liver Failure Study Group registry, and correlated with clinical variables and outcomes. Diagnoses were representative of the larger group of >1000 patients thus far enrolled and included 80 with acetaminophen-related injury, 26 with viral hepatitis, 19 with ischemic injury, and 62 others. Overall, 74% of patients had elevated troponin I levels (>0.1 ng/ml). Patients with elevated troponin I levels were more likely to have advanced hepatic coma (grades III or IV) or to die (for troponin I levels >0.1 ng/ml, odds ratio 3.88 and 4.69 for advanced coma or death, respectively). In acute liver failure, subclinical myocardial injury appears to occur more commonly than has been recognized, and its pathogenesis in the context of acute liver failure is unclear. Elevated troponin levels are associated with a significant increase in morbidity and mortality. Measurement of troponin I levels may be helpful in patients with acute liver failure, to detect unrecognized myocardial damage and as a marker of unfavorable outcome.

Clinical outcomes of isolated renal failure compared to other forms of organ failure in patients with severe acute pancreatitis.

PubMed

Gougol, Amir; Dugum, Mohannad; Dudekula, Anwar; Greer, Phil; Slivka, Adam; Whitcomb, David C; Yadav, Dhiraj; Papachristou, Georgios I

2017-08-07

To assess differences in clinical outcomes of isolated renal failure (RF) compared to other forms of organ failure (OF) in patients with severe acute pancreatitis (SAP). Using a prospectively maintained database of patients with acute pancreatitis admitted to a tertiary medical center between 2003 and 2016, those with evidence of persistent OF were classified to renal, respiratory, cardiovascular, or multi-organ (2 or more organs). Data regarding demographics, comorbidities, etiology of acute pancreatitis, and clinical outcomes were prospectively recorded. Differences in clinical outcomes after development of isolated RF in comparison to other forms of OF were determined using independent t and Mann-Whitney U tests for continues variables, and χ 2 test for discrete variables. Among 500 patients with acute pancreatitis, 111 patients developed persistent OF: mean age was 54 years, and 75 (67.6%) were male. Forty-three patients had isolated OF: 17 (15.3%) renal, 25 (21.6%) respiratory, and 1 (0.9%) patient with cardiovascular failure. No differences in demographics, etiology of acute pancreatitis, systemic inflammatory response syndrome scores, or development of pancreatic necrosis were seen between patients with isolated RF vs isolated respiratory failure. Patients with isolated RF were less likely to require nutritional support (76.5% vs 96%, P = 0.001), ICU admission (58.8% vs 100%, P = 0.001), and had shorter mean ICU stay (2.4 d vs 15.7 d, P < 0.001), compared to isolated respiratory failure. None of the patients with isolated RF or isolated respiratory failure died. Among patients with SAP per the Revised Atlanta Classification, approximately 15% develop isolated RF. This subgroup seems to have a less protracted clinical course compared to other forms of OF. Isolated RF might be weighed less than isolated respiratory failure in risk predictive modeling of acute pancreatitis.

Proactive Approaches to Improving Outcomes for At-Risk Students.

ERIC Educational Resources Information Center

Freeman, G.; Gum, M.; Blackbourn, J. M.

This paper outlines two approaches for improving outcomes for students at risk for academic failure. Both take a systemic approach to the problem by focusing on how specific circumstances create a reality of failure for many students. One school analyzed factors related to retention/promotion decisions and determined that four factors directly…

Quality of Life for Saudi Patients With Heart Failure: A Cross-Sectional Correlational Study.

PubMed

AbuRuz, Mohannad Eid; Alaloul, Fawwaz; Saifan, Ahmed; Masa'deh, Rami; Abusalem, Said

2015-06-25

Heart failure is a major public health issue and a growing concern in developing countries, including Saudi Arabia. Most related research was conducted in Western cultures and may have limited applicability for individuals in Saudi Arabia. Thus, this study assesses the quality of life of Saudi patients with heart failure. A cross-sectional correlational design was used on a convenient sample of 103 patients with heart failure. Data were collected using the Short Form-36 and the Medical Outcomes Study-Social Support Survey. Overall, the patients' scores were low for all domains of Quality of Life. The Physical Component Summary and Mental Component Summary mean scores and SDs were (36.7±12.4, 48.8±6.5) respectively, indicating poor Quality of Life. Left ventricular ejection fraction was the strongest predictor of both physical and mental summaries. Identifying factors that impact quality of life for Saudi heart failure patients is important in identifying and meeting their physical and psychosocial needs.

Outcomes of reintervention after failed urethroplasty.

PubMed

Ekerhult, Teresa Olsen; Lindqvist, Klas; Peeker, Ralph; Grenabo, Lars

2017-02-01

Urethroplasty is a procedure that has a high success rate. However, there exists a small subgroup of patients who require multiple procedures to achieve an acceptable result. This study analyses the outcomes of a series of patients with failed urethroplasty. This is a retrospective review of 82 failures out of 407 patients who underwent urethroplasty due to urethral stricture during the period 1999-2013. Failure was defined as the need for an additional surgical procedure. Of the failures, 26 patients had penile strictures and 56 had bulbar strictures. Meatal strictures were not included. The redo procedures included one or multiple direct vision internal urethrotomies, dilatations or new urethroplasties, all with a long follow-up time. The patients underwent one to seven redo surgeries (mean 2.4 procedures per patient). In the present series of patients, endourological procedures cured 34% (28/82) of the patients. Ten patients underwent multiple redo urethroplasties until a satisfactory outcome was achieved; the penile strictures were the most difficult to cure. In patients with bulbar strictures, excision with anastomosis and substitution urethroplasty were equally successful. Nevertheless, 18 patients were defined as treatment failures. Of these patients, nine ended up with clean intermittent self-dilatation as a final solution, five had perineal urethrostomy and four are awaiting a new reintervention. Complicated cases need centralized professional care. Despite the possibility of needing multiple reinterventions, the majority of patients undergoing urethroplasty have a good chance of successful treatment.

Treatment preferences and outcome in male hypogonadotropic hypogonadism: an Indian perspective.

PubMed

Sanyal, D; Chatterjee, S

2016-06-01

This retrospective study assessed treatment preferences and outcome with testosterone or HCG / HCG-FSH combination in Indian male idiopathic hypogonadotropic hypogonadism (IHH) subjects (n = 31) above 18 years of age. 38.7% of IHH study subjects had no fertility plans and chose 3 monthly intramuscular testosterone undecanoate. 73.7% of subjects with fertility plans chose human chorionic gonadotropin (HCG) alone due to cost considerations. Spermatogenesis occurred in 21.4% on HCG alone and 60% of subjects on HCG with follicle-stimulating hormone (FSH) combination. Treatment failure is higher than published Western rates. FSH and HCG combination regimen is costly but superior to HCG alone. However, treatment failure still persists, suggesting unknown testicular defect in IHH. © 2015 Blackwell Verlag GmbH.

B-type natriuretic peptide-guided treatment for heart failure

PubMed Central

McLellan, Julie; Heneghan, Carl J; Perera, Rafael; Clements, Alison M; Glasziou, Paul P; Kearley, Karen E; Pidduck, Nicola; Roberts, Nia W; Tyndel, Sally; Wright, F Lucy; Bankhead, Clare

2016-01-01

Background Heart failure is a condition in which the heart does not pump enough blood to meet all the needs of the body. Symptoms of heart failure include breathlessness, fatigue and fluid retention. Outcomes for patients with heart failure are highly variable; however on average, these patients have a poor prognosis. Prognosis can be improved with early diagnosis and appropriate use of medical treatment, use of devices and transplantation. Patients with heart failure are high users of healthcare resources, not only due to drug and device treatments, but due to high costs of hospitalisation care. B-type natriuretic peptide levels are already used as biomarkers for diagnosis and prognosis of heart failure, but could offer to clinicians a possible tool to guide drug treatment. This could optimise drug management in heart failure patients whilst allaying concerns over potential side effects due to drug intolerance. Objectives To assess whether treatment guided by serial BNP or NT-proBNP (collectively referred to as NP) monitoring improves outcomes compared with treatment guided by clinical assessment alone. Search methods Searches were conducted up to 15 March 2016 in the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library; MEDLINE (OVID), Embase (OVID), the Database of Abstracts of Reviews of Effects (DARE) and the NHS Economic Evaluation Database in the Cochrane Library. Searches were also conducted in the Science Citation Index Expanded, the Conference Proceedings Citation Index on Web of Science (Thomson Reuters), World Health Organization International Clinical Trials Registry and ClinicalTrials.gov. We applied no date or language restrictions. Selection criteria We included randomised controlled trials of NP-guided treatment of heart failure versus treatment guided by clinical assessment alone with no restriction on follow-up. Adults treated for heart failure, in both in-hospital and out-of-hospital settings, and trials reporting a clinical outcome were included. Data collection and analysis Two review authors independently selected studies for inclusion, extracted data and evaluated risk of bias. Risk ratios (RR) were calculated for dichotomous data, and pooled mean differences (MD) (with 95% confidence intervals (CI)) were calculated for continuous data. We contacted trial authors to obtain missing data. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, we assessed the quality of the evidence and GRADE profiler (GRADEPRO) was used to import data from Review Manager to create a 'Summary of findings' table. Main results We included 18 randomised controlled trials with 3660 participants (range of mean age: 57 to 80 years) comparing NP-guided treatment with clinical assessment alone. The evidence for all-cause mortality using NP-guided treatment showed uncertainty (RR 0.87, 95% CI 0.76 to 1.01; patients = 3169; studies = 15; low quality of the evidence), and for heart failure mortality (RR 0.84, 95% CI 0.54 to 1.30; patients = 853; studies = 6; low quality of evidence). The evidence suggested heart failure admission was reduced by NP-guided treatment (38% versus 26%, RR 0.70, 95% CI 0.61 to 0.80; patients = 1928; studies = 10; low quality of evidence), but the evidence showed uncertainty for all-cause admission (57% versus 53%, RR 0.93, 95% CI 0.84 to 1.03; patients = 1142; studies = 6; low quality of evidence). Six studies reported on adverse events, however the results could not be pooled (patients = 1144; low quality of evidence). Only four studies provided cost of treatment results, three of these studies reported a lower cost for NP-guided treatment, whilst one reported a higher cost (results were not pooled; patients = 931, low quality of evidence). The evidence showed uncertainty for quality of life data (MD -0.03, 95% CI -1.18 to 1.13; patients = 1812; studies = 8; very low quality of evidence). We completed a 'Risk of bias' assessment for all studies. The impact of risk of bias from lack of blinding of outcome assessment and high attrition levels was examined by restricting analyses to only low 'Risk of bias' studies. Authors' conclusions In patients with heart failure low-quality evidence showed a reduction in heart failure admission with NP-guided treatment while low-quality evidence showed uncertainty in the effect of NP-guided treatment for all-cause mortality, heart failure mortality, and all-cause admission. Uncertainty in the effect was further shown by very low-quality evidence for patient's quality of life. The evidence for adverse events and cost of treatment was low quality and we were unable to pool results. B-type natriuretic peptide-guided treatment for heart failure patients Review question We aimed to discover whether using B-type natriuretic-guided treatment or a health plan alone is more effective for managing patients with heart failure. Background Heart failure is a complex condition that occurs when the heart does not pump blood effectively enough to meet the needs of the body. It is caused by a range of diseases that impair the structure and function of the heart and may result in breathlessness, fatigue and fluid retention. People with heart failure are frequently users of general practice and hospitals, particularly as inpatients. Furthermore, they have reduced life expectancy, although medicines and other treatments can improve the chance of survival. B-type natriuretic peptide (NP) is a substance produced in the heart. The measurement of NP can be used to indicate the condition of the heart. For some time, NP has been used for diagnosing heart failure and predicting what is likely to happen. We wanted to discover if NP may also offer a way to manage and make the best use of medicines. Study selection and characteristics We carried out a review of all studies and the evidence is current to 15 March 2016. We found 18 studies of NP-guided treatment in which 3660 patients with heart failure took part. Patients were between 62 to 80 years old at the start of the studies. The duration of each study ranged from one to 54 months. Eight out of the 18 studies were part or fully funded by pharmaceutical companies, one was funded by a national research body, five were partially funded either by national research grants, lotteries, hospital funds and/or pharmaceutical companies and four studies did not report the funding source. Key results The evidence was unclear as to whether number of deaths from any cause varied between patients with heart failure using NP-guided treatment compared with those using a health plan alone. Nor was it clear as to whether there were less deaths when the results were separated into patients older or younger than 75 years old (age results only included three studies). Furthermore, we found that the evidence was unclear whether the number of deaths from heart failure alone varied between the NP-guided treatment or health plan alone groups. We found that hospital admission due to heart failure may be reduced in the patients using NP-guided treatment compared with a health plan alone. Based on these results we would expect that out of 1000 patients with heart failure who are guided by a health plan alone, 377 would experience an admission to hospital due to heart failure. Whereas, between 230 and 301 patients would experience an admission to hospital due to heart failure if they received NP-guided treatment. However, the evidence was unclear as to whether the numbers of hospital admission from any cause were affected. There was limited information about either harms to patients, or the cost of the treatment. It was not possible to combine the results from these studies for these outcomes. However, four of the six studies commented that they found no difference in harms or less difference in harms between the patients using NP-guided treatment compared with a health plan alone, the other two studies did not comment. Four studies reported results on costs, three of these reported there may be lower costs in the NP-guided treatment groups compared with health plan groups. Lower costs appeared to be due to less cost for hospital stays. However, one study reported that NP-guided treatment was unlikely to be cost-effective. The evidence was unclear as to if a benefit was shown in the replies to quality-of-life surveys when comparing between NP-guided treatment and health plan only groups. Quality of evidence Overall evidence for death from all causes, from heart failure alone and for hospital admission was of low quality. For harm to patients and cost outcomes the quality of evidence was low, whilst evidence for patients' quality of life surveys was very low. For all outcomes there was little evidence due to the way the studies were conducted. In addition, for harm to patients and cost of treatment there were differences in the type of information available. PMID:28102899

Drug Concentration Thresholds Predictive of Therapy Failure and Death in Children With Tuberculosis: Bread Crumb Trails in Random Forests

PubMed Central

Swaminathan, Soumya; Pasipanodya, Jotam G.; Ramachandran, Geetha; Hemanth Kumar, A. K.; Srivastava, Shashikant; Deshpande, Devyani; Nuermberger, Eric; Gumbo, Tawanda

2016-01-01

Background. The role of drug concentrations in clinical outcomes in children with tuberculosis is unclear. Target concentrations for dose optimization are unknown. Methods. Plasma drug concentrations measured in Indian children with tuberculosis were modeled using compartmental pharmacokinetic analyses. The children were followed until end of therapy to ascertain therapy failure or death. An ensemble of artificial intelligence algorithms, including random forests, was used to identify predictors of clinical outcome from among 30 clinical, laboratory, and pharmacokinetic variables. Results. Among the 143 children with known outcomes, there was high between-child variability of isoniazid, rifampin, and pyrazinamide concentrations: 110 (77%) completed therapy, 24 (17%) failed therapy, and 9 (6%) died. The main predictors of therapy failure or death were a pyrazinamide peak concentration <38.10 mg/L and rifampin peak concentration <3.01 mg/L. The relative risk of these poor outcomes below these peak concentration thresholds was 3.64 (95% confidence interval [CI], 2.28–5.83). Isoniazid had concentration-dependent antagonism with rifampin and pyrazinamide, with an adjusted odds ratio for therapy failure of 3.00 (95% CI, 2.08–4.33) in antagonism concentration range. In regard to death alone as an outcome, the same drug concentrations, plus z scores (indicators of malnutrition), and age <3 years, were highly ranked predictors. In children <3 years old, isoniazid 0- to 24-hour area under the concentration-time curve <11.95 mg/L × hour and/or rifampin peak <3.10 mg/L were the best predictors of therapy failure, with relative risk of 3.43 (95% CI, .99–11.82). Conclusions. We have identified new antibiotic target concentrations, which are potential biomarkers associated with treatment failure and death in children with tuberculosis. PMID:27742636

Drug treatment effects on outcomes in heart failure with preserved ejection fraction: a systematic review and meta-analysis.

PubMed

Zheng, Sean Lee; Chan, Fiona T; Nabeebaccus, Adam A; Shah, Ajay M; McDonagh, Theresa; Okonko, Darlington O; Ayis, Salma

2018-03-01

Clinical drug trials in patients with heart failure and preserved ejection fraction have failed to demonstrate improvements in mortality. We systematically searched Medline, Embase and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCT) assessing pharmacological treatments in patients with heart failure with left ventricular (LV) ejection fraction≥40% from January 1996 to May 2016. The primary efficacy outcome was all-cause mortality. Secondary outcomes were cardiovascular mortality, heart failure hospitalisation, exercise capacity (6-min walk distance, exercise duration, VO 2 max), quality of life and biomarkers (B-type natriuretic peptide, N-terminal pro-B-type natriuretic peptide). Random-effects models were used to estimate pooled relative risks (RR) for the binary outcomes, and weighted mean differences for continuous outcomes, with 95% CI. We included data from 25 RCTs comprising data for 18101 patients. All-cause mortality was reduced with beta-blocker therapy compared with placebo (RR: 0.78, 95%CI 0.65 to 0.94, p=0.008). There was no effect seen with ACE inhibitors, aldosterone receptor blockers, mineralocorticoid receptor antagonists and other drug classes, compared with placebo. Similar results were observed for cardiovascular mortality. No single drug class reduced heart failure hospitalisation compared with placebo. The efficacy of treatments in patients with heart failure and an LV ejection fraction≥40% differ depending on the type of therapy, with beta-blockers demonstrating reductions in all-cause and cardiovascular mortality. Further trials are warranted to confirm treatment effects of beta-blockers in this patient group. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The outcomes and prognostic factors of acute respiratory failure in the patients 90 years old and over

PubMed Central

Kung, Shu-Chen; Wang, Ching-Min; Lai, Chih-Cheng; Chao, Chien-Ming

2018-01-01

This retrospective cohort study investigated the outcomes and prognostic factors in nonagenarians (patients 90 years old or older) with acute respiratory failure. Between 2006 and 2016, all nonagenarians with acute respiratory failure requiring invasive mechanical ventilation (MV) were enrolled. Outcomes including in-hospital mortality and ventilator dependency were measured. A total of 173 nonagenarians with acute respiratory failure were admitted to the intensive care unit (ICU). A total of 56 patients died during the hospital stay and the rate of in-hospital mortality was 32.4%. Patients with higher APACHE (Acute Physiology and Chronic Health Evaluation) II scores (adjusted odds ratio [OR], 5.91; 95 % CI, 1.55-22.45; p = 0.009, APACHE II scores ≥ 25 vs APACHE II scores < 15), use of vasoactive agent (adjust OR, 2.67; 95% CI, 1.12-6.37; p = 0.03) and more organ dysfunction (adjusted OR, 11.13; 95% CI, 3.38-36.36, p < 0.001; ≥ 3 organ dysfunction vs ≤ 1 organ dysfunction) were more likely to die. Among the 117 survivors, 25 (21.4%) patients became dependent on MV. Female gender (adjusted OR, 3.53; 95% CI, 1.16-10.76, p = 0.027) and poor consciousness level (adjusted OR, 4.98; 95% CI, 1.41-17.58, p = 0.013) were associated with MV dependency. In conclusion, the mortality rate of nonagenarians with acute respiratory failure was high, especially for those with higher APACHE II scores or more organ dysfunction. PMID:29467961

Joint statement of the European Association for the Study of Obesity and the European Society of Hypertension: obesity and heart failure.

PubMed

Jordan, Jens; Toplak, Hermann; Grassi, Guido; Yumuk, Volkan; Kotsis, Vasilios; Engeli, Stefan; Cuspidi, Cesare; Nilsson, Peter M; Finer, Nick; Doehner, Wolfram

2016-09-01

Obese individuals are more likely to develop heart failure. Yet, once heart failure is established, the impact of overweight and obesity on prognosis and survival is unclear. The purpose of this joint scientific statement of the European Association for the Study of Obesity and the European Society of Hypertension is to provide an overview on the current scientific literature on obesity and heart failure in terms of prognosis, mechanisms, and clinical management implications. Moreover, the document identifies open questions that ought to be addressed. The need for more tailored weight management recommendations in heart failure will be emphasized and, in line with the emerging evidence, aims to distinguish between primary disease and secondary outcome prevention. In the primary prevention of heart failure, it appears prudent advising obese individuals to lose or achieve a healthy body weight, especially in those with risk factors such as hypertension or type 2 diabetes. However, there is no evidence from clinical trials to guide weight management in overweight or obese patients with established heart failure. Prospective clinical trials are strongly encouraged.

Is Diabetes Mellitus a Risk Factor for Poor Outcomes after Left Ventricular Assist Device Placement?

PubMed

Mohamedali, Burhan; Yost, Gardner; Bhat, Geetha

2017-04-01

Diabetes mellitus is associated with adverse outcomes in patients with cardiovascular diseases, including heart failure. Left ventricular assist devices (LVADs) are increasingly used as life-saving therapy for advanced heart failure. The effects of pre-LVAD diabetes on long-term outcomes after LVAD implantation are not well understood. In this study, we retrospectively evaluated the effect of existing diabetes on post-LVAD outcomes. Data on 288 LVAD recipients from 2006 through 2013 were reviewed. Patients were stratified in accordance with their histories of diabetes. Baseline demographic, laboratory, hemodynamic, and echocardiographic information before LVAD placement were reviewed, together with the post-LVAD incidence of major adverse outcomes. Kaplan-Meier analysis and Cox regression analysis were performed. Our cohort comprised 122 patients with diabetes and 166 patients without. The mean glycosylated hemoglobin A 1c level in the diabetes group was 7.4% ± 1.6%. Diabetic patients at baseline had a more adverse medical profile than did nondiabetic patients. There were no differences in major outcomes between the 2 groups other than a higher incidence of hemolysis in the diabetes group: 12 (10%) vs 5 (3%); P =0.02. There was no difference in survival outcomes between the groups. Diabetic patients did not have worse survival or more adverse outcomes than did nondiabetic patients in this study, perhaps because of improved diabetes control, or improvement in biochemical derangements after normalization of cardiac output with LVAD therapy. A diagnosis of diabetes was an independent predictor of hemolysis. Further studies to evaluate the link between hemolysis and diabetes are indicated.

A collaborative comparison of objective structured clinical examination (OSCE) standard setting methods at Australian medical schools.

PubMed

Malau-Aduli, Bunmi Sherifat; Teague, Peta-Ann; D'Souza, Karen; Heal, Clare; Turner, Richard; Garne, David L; van der Vleuten, Cees

2017-12-01

A key issue underpinning the usefulness of the OSCE assessment to medical education is standard setting, but the majority of standard-setting methods remain challenging for performance assessment because they produce varying passing marks. Several studies have compared standard-setting methods; however, most of these studies are limited by their experimental scope, or use data on examinee performance at a single OSCE station or from a single medical school. This collaborative study between 10 Australian medical schools investigated the effect of standard-setting methods on OSCE cut scores and failure rates. This research used 5256 examinee scores from seven shared OSCE stations to calculate cut scores and failure rates using two different compromise standard-setting methods, namely the Borderline Regression and Cohen's methods. The results of this study indicate that Cohen's method yields similar outcomes to the Borderline Regression method, particularly for large examinee cohort sizes. However, with lower examinee numbers on a station, the Borderline Regression method resulted in higher cut scores and larger difference margins in the failure rates. Cohen's method yields similar outcomes as the Borderline Regression method and its application for benchmarking purposes and in resource-limited settings is justifiable, particularly with large examinee numbers.

What Factors Influence the Biomechanical Properties of Allograft Tissue for ACL Reconstruction? A Systematic Review.

PubMed

Lansdown, Drew A; Riff, Andrew J; Meadows, Molly; Yanke, Adam B; Bach, Bernard R

2017-10-01

Allograft tissue is used in 22% to 42% of anterior cruciate ligament (ACL) reconstructions. Clinical outcomes have been inconsistent with allograft tissue, with some series reporting no differences in outcomes and others reporting increased risk of failure. There are numerous variations in processing and preparation that may influence the eventual performance of allograft tissue in ACL reconstruction. We sought to perform a systematic review to summarize the factors that affect the biomechanical properties of allograft tissue for use in ACL reconstruction. Many factors might impact the biomechanical properties of allograft tissue, and these should be understood when considering using allograft tissue or when reporting outcomes from allograft reconstruction. What factors affect the biomechanical properties of allograft tissue used for ACL reconstruction? We performed a systematic review to identify studies on factors that influence the biomechanical properties of allograft tissue through PubMed and SCOPUS databases. We included cadaveric and animal studies that reported on results of biomechanical testing, whereas studies on fixation, histologic evaluation, and clinical outcomes were excluded. There were 319 unique publications identified through the search with 48 identified as relevant to answering the study question. For each study, we recorded the type of tissue tested, parameters investigated, and the effects on biomechanical behavior, including load to failure and stiffness. Primary factors identified to influence allograft tissue properties were graft tissue type, sterilization methods (irradiation and chemical processing), graft preparation, donor parameters, and biologic adjuncts. Load to failure and graft stiffness varied across different tissue types, with nonlooped tibialis grafts exhibiting the lowest values. Studies on low-dose irradiation showed variable effects, whereas high-dose irradiation consistently produced decreased load to failure and stiffness values. Various chemical sterilization measures were also associated with negative effects on biomechanical properties. Prolonged freezing decreased load to failure, ultimate stress, and ultimate strain. Up to eight freeze-thaw cycles did not lead to differences in biomechanical properties of cadaveric grafts. Regional differences were noted in patellar tendon grafts, with the central third showing the highest load to failure and stiffness. Graft diameter strongly contributed to load-to-failure measurements. Age older than 40 years, and especially older than 65 years, negatively impacted biomechanical properties, whereas gender had minimal effect on the properties of allograft tissue. Biologic adjuncts show potential for improving in vivo properties of allograft tissue. Future clinical studies on allograft ACL reconstruction should investigate in vivo graft performance with standardized allograft processing and preparation methods that limit the negative effects on the biomechanical properties of tissue. Additionally, biologic adjuncts may improve the biomechanical properties of allograft tissue, although future preclinical and clinical studies are necessary to clarify the role of these treatments. Based on the findings of this systematic review that emphasize biomechanical properties of ACL allografts, surgeons should favor the use of central third patellar tendon or looped soft tissue grafts, maximize graft cross-sectional area, and favor grafts from donors younger than 40 years of age while avoiding grafts subjected to radiation doses > 20 kGy, chemical processing, or greater than eight freeze-thaw cycles.

Alpha-fetoprotein as a prognostic marker in acute liver failure: a pilot study.

PubMed

Varshney, Anshul; Gupta, Rohit; Verma, Sanjiv K; Ahmad, Sohaib

2017-07-01

Prognostic markers of acute liver failure (ALF) are based on clinical, laboratory or radiological parameters. Most of the biochemical markers are based on hepatic degeneration. We studied the impact of serial serum alpha-fetoprotein (AFP) levels, a marker of liver regeneration, on the outcome of the patients with ALF. AFP levels were estimated on days 1 and 3 of hospitalisation of 32 patients with ALF and the ratio (AFP day3/day1) was calculated. All subjects were categorised as group A (expired) or group B (survived). The AFP ratio was 0.84  +  0.15 in group A (n = 20) versus 1.55  +  0.70 in group B (n = 10); P < 0.001. However, the absolute initial AFP values were not associated with the outcome, favourable or unfavourable. We conclude that AFP levels change dynamically during ALF and have the potential to be used as a predictor of outcome in isolation or in combination with well-established prognostic markers.

A risk-adjusted O-E CUSUM with monitoring bands for monitoring medical outcomes.

PubMed

Sun, Rena Jie; Kalbfleisch, John D

2013-03-01

In order to monitor a medical center's survival outcomes using simple plots, we introduce a risk-adjusted Observed-Expected (O-E) Cumulative SUM (CUSUM) along with monitoring bands as decision criterion.The proposed monitoring bands can be used in place of a more traditional but complicated V-shaped mask or the simultaneous use of two one-sided CUSUMs. The resulting plot is designed to simultaneously monitor for failure time outcomes that are "worse than expected" or "better than expected." The slopes of the O-E CUSUM provide direct estimates of the relative risk (as compared to a standard or expected failure rate) for the data being monitored. Appropriate rejection regions are obtained by controlling the false alarm rate (type I error) over a period of given length. Simulation studies are conducted to illustrate the performance of the proposed method. A case study is carried out for 58 liver transplant centers. The use of CUSUM methods for quality improvement is stressed. Copyright © 2013, The International Biometric Society.

Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model: A Web-based program designed to evaluate the cost-effectiveness of disease management programs in heart failure.

PubMed

Reed, Shelby D; Neilson, Matthew P; Gardner, Matthew; Li, Yanhong; Briggs, Andrew H; Polsky, Daniel E; Graham, Felicia L; Bowers, Margaret T; Paul, Sara C; Granger, Bradi B; Schulman, Kevin A; Whellan, David J; Riegel, Barbara; Levy, Wayne C

2015-11-01

Heart failure disease management programs can influence medical resource use and quality-adjusted survival. Because projecting long-term costs and survival is challenging, a consistent and valid approach to extrapolating short-term outcomes would be valuable. We developed the Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, a Web-based simulation tool designed to integrate data on demographic, clinical, and laboratory characteristics; use of evidence-based medications; and costs to generate predicted outcomes. Survival projections are based on a modified Seattle Heart Failure Model. Projections of resource use and quality of life are modeled using relationships with time-varying Seattle Heart Failure Model scores. The model can be used to evaluate parallel-group and single-cohort study designs and hypothetical programs. Simulations consist of 10,000 pairs of virtual cohorts used to generate estimates of resource use, costs, survival, and incremental cost-effectiveness ratios from user inputs. The model demonstrated acceptable internal and external validity in replicating resource use, costs, and survival estimates from 3 clinical trials. Simulations to evaluate the cost-effectiveness of heart failure disease management programs across 3 scenarios demonstrate how the model can be used to design a program in which short-term improvements in functioning and use of evidence-based treatments are sufficient to demonstrate good long-term value to the health care system. The Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model provides researchers and providers with a tool for conducting long-term cost-effectiveness analyses of disease management programs in heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

Isolating the Role of Psychological Dysfunction in Smoking Cessation Failure: Relations of Personality and Psychopathology to Attaining Smoking Cessation Milestones

PubMed Central

Leventhal, Adam M.; Japuntich, Sandra J.; Piper, Megan E.; Jorenby, Douglas E.; Schlam, Tanya R.; Baker, Timothy B.

2012-01-01

Research exploring psychological dysfunction as a predictor of smoking cessation success may be limited by nonoptimal predictor variables (i.e., categorical psychodiagnostic measures vs. continuous personality-based manifestations of dysfunction) and imprecise outcomes (i.e., summative point prevalence abstinence vs. constituent cessation milestone measures). Accordingly, this study evaluated the unique and overlapping relations of broad-spectrum personality traits (positive emotionality, negative emotionality, and constraint) and past-year psychopathology (anxiety, mood, and substance use disorder) to point prevalence abstinence and three smoking cessation milestones: (1) initiating abstinence; (2) first lapse; and (3) transition from lapse to relapse. Participants were daily smokers (N=1365) enrolled in a smoking cessation treatment study. In single predictor regression models, each manifestation of internalizing dysfunction (lower positive emotionality, higher negative emotionality, and anxiety and mood disorder) predicted failure at one or more cessation milestone. In simultaneous predictor models, lower positive and higher negative emotionality significantly predicted failure to achieve milestones after controlling for psychopathology. Psychopathology did not predict any outcome when controlling for personality. Negative emotionality showed the most robust and consistent effects, significantly predicting failure to initiate abstinence, earlier lapse, and lower point prevalence abstinence rates. Substance use disorder and constraint did not predict cessation outcomes, and no single variable predicted lapse-to-relapse transition. These findings suggest that personality-related manifestations of internalizing dysfunction are more accurate markers of affective sources of relapse risk than mood and anxiety disorders. Further, individuals with high trait negative emotionality may require intensive intervention to promote the initiation and early maintenance of abstinence. PMID:22642858

The Effects of Nurse Staffing and Nurse Education on Patient Deaths in Hospitals With Different Nurse Work Environments

PubMed Central

Aiken, Linda H.; Cimiotti, Jeannie P.; Sloane, Douglas M.; Smith, Herbert L.; Flynn, Linda; Neff, Donna F.

2011-01-01

Context Better hospital nurse staffing, more educated nurses, and improved nurse work environments have been shown to be associated with lower hospital mortality. Little is known about whether and under what conditions each type of investment works better to improve outcomes. Objective To determine the conditions under which the impact of hospital nurse staffing, nurse education, and work environment are associated with patient outcomes. Design, Setting, and Participants Outcomes of 665 hospitals in four large states were studied through linked data from hospital discharge abstracts for 1,262,120 general, orthopedic, and vascular surgery patients, a random sample of 39,038 hospital staff nurses, and American Hospital Association data. Main outcome measures 30-day inpatient mortality and failure-to-rescue. Results The effect of decreasing workloads by one patient/nurse on deaths and failure-to-rescue is virtually nil in hospitals with poor work environments, but decreases the odds on both deaths and failures in hospitals with average environments by 4%, and in hospitals with the best environments by 9 and 10% respectively. The effect of 10% more BSN nurses decreases the odds on both outcomes in all hospitals, regardless of their work environment, by roughly 4%. Conclusions While the positive effect of increasing percentages of BSN nurses is consistent across all hospitals, lowering the patient-to-nurse ratios markedly improves patient outcomes in hospitals with good work environments, slightly improves them in hospitals with average environments, and has no effect in hospitals with poor environments. PMID:21945978

Machine learning in heart failure: ready for prime time.

PubMed

Awan, Saqib Ejaz; Sohel, Ferdous; Sanfilippo, Frank Mario; Bennamoun, Mohammed; Dwivedi, Girish

2018-03-01

The aim of this review is to present an up-to-date overview of the application of machine learning methods in heart failure including diagnosis, classification, readmissions and medication adherence. Recent studies have shown that the application of machine learning techniques may have the potential to improve heart failure outcomes and management, including cost savings by improving existing diagnostic and treatment support systems. Recently developed deep learning methods are expected to yield even better performance than traditional machine learning techniques in performing complex tasks by learning the intricate patterns hidden in big medical data. The review summarizes the recent developments in the application of machine and deep learning methods in heart failure management.

PREDICE score as a predictor of 90 days mortality in patients with heart failure

NASA Astrophysics Data System (ADS)

Purba, D. P. S.; Hasan, R.

2018-03-01

Hospitalization in chronic heart failure patients associated with high mortality and morbidity rate. The 90 days post-discharge period following hospitalization in heart failure patients is known as the vulnerable phase, it carries the high risk of poor outcomes. Identification of high-risk individuals by using prognostic evaluation was intended to do a closer follow up and more intensive to decreasing the morbidity and mortality rate of heart failure.To determine whether PREDICE score could predict mortality within 90 days in patients with heart failure, an observational cohort study in patients with heart failure who were hospitalized due to worsening chronic heart failure. Patients were in following-up for up to 90 days after initial evaluation with the primary endpoint is death.We found a difference of the significantstatistical between PREDICE score in survival and mortality group (p=0.001) of 84% (95% CI: 60.9% - 97.4%).In conclusion, PREDICE score has a good ability to predict mortality within 90 days in patients with heart failure.

Failure to Rescue, Rescue Surgery and Centralization of Postoperative Complications: A Challenge for General and Acute Care Surgeons.

PubMed

Zago, Mauro; Bozzo, Samantha; Carrara, Giulia; Mariani, Diego

2017-01-01

To explore the current literature on the failure to rescue and rescue surgery concepts, to identify the key items for decreasing the failure to rescue rate and improve outcome, to verify if there is a rationale for centralization of patients suffering postoperative complications. There is a growing awareness about the need to assess and measure the failure to rescue rate, on institutional, regional and national basis. Many factors affect failure to rescue, and all should be individually analyzed and considered. Rescue surgery is one of these factors. Rescue surgery assumes an acute care surgery background. Measurement of failure to rescue rate should become a standard for quality improvement programs. Implementation of all clinical and organizational items involved is the key for better outcomes. Preparedness for rescue surgery is a main pillar in this process. Centralization of management, audit, and communication are important as much as patient centralization. Celsius.

Serum Bicarbonate Is Associated with Heart Failure in the Multi-Ethnic Study of Atherosclerosis.

PubMed

Kendrick, Jessica B; Zelnick, Leila; Chonchol, Michel B; Siscovick, David; Hoofnagle, Andrew N; Ix, Joachim H; Sarnak, Mark; Shlipak, Michael G; Kestenbaum, Bryan; de Boer, Ian H

2017-01-01

Low serum bicarbonate concentrations are associated with mortality and kidney disease progression. Data regarding associations between bicarbonate and cardiovascular disease (CVD) are scarce. We performed a cohort study of 6,229 adult participants from the Multi-Ethnic Study of Atherosclerosis, a community-based cohort free of CVD at baseline. Serum bicarbonate was measured at baseline. Cardiovascular outcomes were defined as: (1) subclinical CVD (left ventricular mass [LVM] and aortic pulse pressure [PP] measured at baseline), (2) incident atherosclerotic cardiovascular events (CVE; composite of myocardial infarction, resuscitated cardiac arrest, stroke, coronary heart disease death, and stroke death), and (3) incident heart failure. During a median (interquartile range) follow-up of 8.5 (7.7-8.6) years, 331 (5.3%) participants had an incident CVE and 174 (2.8%) developed incident heart failure. We stratified analyses by use of diuretics because we observed a significant interaction between diuretic use and bicarbonate with study outcomes. Among diuretic nonusers, with adjustment, bicarbonate ≥25 mEq/L was associated with an estimated 3.0 g greater LVM (95% CI 0.5-5.0) and 1.0 mm Hg higher aortic PP (95% CI 0.4-2.0) compared to bicarbonate 23-24 mEq/L. Each 1 mEq/L of bicarbonate increase was associated with a 13% higher risk of incident heart failure (hazards ratio 1.13, 95% CI 1.01-2.11). Among diuretic users, higher bicarbonate was not associated with CVD. Bicarbonate was not associated with incident atherosclerotic CVE irrespective of diuretic use. Among nonusers of diuretics in a large community-based study, higher serum bicarbonate concentrations are associated with subclinical CVD and new heart failure. © 2016 S. Karger AG, Basel.

Serum Bicarbonate is Associated with Heart Failure in the Multi-Ethnic Study of Atherosclerosis (MESA)

PubMed Central

Kendrick, Jessica; Zelnick, Leila; Chonchol, Michel; Siscovick, David; Hoofnagle, Andrew N.; Ix, Joachim H.; Sarnak, Mark; Shlipak, Michael; Kestenbaum, Bryan; de Boer, Ian H.

2016-01-01

Background Low serum bicarbonate concentrations are associated with mortality and kidney disease progression. Data regarding associations between bicarbonate and cardiovascular disease (CVD) are scarce. Methods We performed a cohort study of 6229 adult participants from MESA (Multi-Ethnic Study of Atherosclerosis), a community-based cohort free of CVD at baseline. Serum bicarbonate was measured at baseline. Cardiovascular outcomes were defined as: 1) subclinical CVD (left ventricular mass (LVM) and aortic pulse pressure (PP) measured at baseline), 2) incident atherosclerotic cardiovascular events (CVE) (composite of myocardial infarction, resuscitated cardiac arrest, stroke, coronary heart disease death and stroke death), and 3) incident heart failure. Results During a median (IQR) follow-up of 8.5 (7.7–8.6) years, 331 (5.3%) participants had an incident CVE and 174 (2.8%) developed incident heart failure. We stratified analyses by use of diuretics because we observed a significant interaction between diuretic use and bicarbonate with study outcomes. Among diuretic nonusers, with adjustment, bicarbonate ≥25 mEq/L was associated with an estimated 3.0 gram greater LVM (95% CI 0.5 to 5.0) and 1.0 mmHg higher aortic PP (95% CI 0.4 to 2.0) compared to bicarbonate 23–24 mEq/L. Each 1mEq/L higher bicarbonate was associated with a 13% higher risk of incident heart failure (HR 1.13, 95% CI 1.01 to 2.11). Among diuretic users, higher bicarbonate was not associated with CVD. Bicarbonate was not associated with incident atherosclerotic CVE irrespective of diuretic use. Conclusion Among nonusers of diuretics in a large community-based study, higher serum bicarbonate concentrations are associated with subclinical CVD and new heart failure. PMID:27941322

The use of pharmacokinetic/pharmacodynamic principles to predict clinical outcome in paediatric acute otitis media.

PubMed

Dagan, Ron

2007-12-01

Double tympanocentesis studies of children with acute otitis media, carried out over an 11-year period, were used to confirm that pharmacokinetic (PK) and pharmacodynamic (PD) parameters can be used as predictors of the bacteriological and clinical efficacy of antimicrobial agents. Predicted susceptibilities of common respiratory pathogens, such as Streptococcus pneumoniae and Haemophilus influenzae, were compared with the bacteriological outcome of treatment in which the high-dose formulation of amoxicillin/clavulanate (90mg/kg/day) given twice daily achieved the greatest bacteriological eradication rates for an oral agent. Further analysis of the data has indicated that failure to eradicate bacteria from the middle ear fluid is strongly correlated with clinical failure.

Combination Vancomycin/Cefazolin (VAN/CFZ) for Methicillin-Resistant Staphylococcus aureus (MRSA) Bloodstream Infections (BSI)

PubMed Central

Trinh, Trang D; Zasowski, Evan J; Lagnf, Abdalhamid M; Bhatia, Sahil; Dhar, Sorabh; Mynatt, Ryan; Pogue, Jason M; Rybak, Michael J

2017-01-01

Abstract Background VAN remains the standard for MRSA BSI but has been associated with treatment failures and resulted in prolonged BSI durations and recurrences. In vitro studies of VAN/CFZ against MRSA demonstrated synergy and prevention of VAN resistance. However, clinical use of VAN/CFZ has not been reported. The objective of this study was to compare patient outcomes treated with VAN/CFZ vs. VAN for MRSA BSI. Methods This was a retrospective, cohort, comparative-effectiveness study of hospitalized adults ≥18y with ≥1 MRSA blood culture and received VAN/CFZ combination for ≥24h or VAN alone initiated within 72h of index infection between 1/1/08 and 5/1/17. Patients who received >24h β-lactams other than CFZ, MRSA-active antibiotics other than VAN, with polymicrobial BSI, or had a second MRSA BSI episode during the study period were excluded. The primary composite failure outcome included: 30d mortality, MRSA BSI ≥7d, and 60d recurrence. Demographics were compared by Χ2, Fisher’s exact, Student’s t, or Mann–Whitney U tests. Multivariable regression models compared outcomes between the two treatment groups. Covariates with p-values ≤0.2 in bivariate analyses were included in the model. Results A total of 101 patients were included (CFZ/VAN = 41, VAN = 60). Demographics were similar except VAN patients were older (mean (±SD) age 58 (±14) v. 51 (±18) y, P = 0.04), had higher median (IQR) Charlson Comorbidity Index (3 (2-5) v. 1 (0–4), P < 0.01), APACHE II scores (13 (8-18) v. 11 (8-18), P = 0.2), and more endocarditis BSI source (37% v. 20%, P = 0.06). After accounting for BSI source, VAN/CFZ (adjusted odds ratio [aOR], 95% confidence intervals [CI], 0.33, 0.13-0.83) and low APACHE II scores (aOR 1.07, 95% CI 1–1.15) were independently associated with fewer failures. Bivariate outcomes are in table below: Variable, n (%) VAN/CFZ VAN P value Composite failure 10 (24) 31 (52) 0.006 30d mortality 3 (7.3) 5 (8.3) 1 BSI ≥7d 6 (15) 21 (35) 0.023 60d recurrence 3 (7.3) 9 (15) 0.351 Failure switch 1 (2.4) 10 (17) 0.026 Conclusion In this cohort of MRSA BSI, patients treated with VAN/CFZ experienced fewer failures than with VAN alone, with shorter BSI durations. Additional studies are needed to confirm the role of VAN/CFZ combination treatment for MRSA BSI. Disclosures J. M. Pogue, Achaogen, Inc.: Consultant, Consulting fee. M. J. Rybak, Allergen: Scientific Advisor, Consulting fee.

A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial.

PubMed

Black, Jeanne T; Romano, Patrick S; Sadeghi, Banafsheh; Auerbach, Andrew D; Ganiats, Theodore G; Greenfield, Sheldon; Kaplan, Sherrie H; Ong, Michael K

2014-04-13

Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure. A multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the 'teach-back' method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life. BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure. ClinicalTrials.gov # NCT01360203.

The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled Trial (VeRDiCT Trial).

PubMed

Clout, Madeleine; Harris, Tracy; Rogers, Chris; Culliford, Lucy; Taylor, Jodi; Angelini, Gianni; Narayan, Pradeep; Reeves, Barnaby; Hillier, James; Ashton, Kate; Sarkar, Kunal; Ascione, Raimondo

2017-06-19

Diabetes mellitus is a major risk factor for prolonged hospital stays, renal failure, and mortality in patients having coronary artery bypass grafting (CABG). Complications pose a serious threat to patients and prolong intensive care and hospital stays. Low glomerular filtration rate (GFR) due to existing renal impairment or volume depletion may exacerbate acute renal impairment/failure in these patients. Preoperative volume replacement therapy (VRT) is reported to increase the GFR and we hypothesize that VRT will reduce renal impairment and related complications in diabetic patients. The objective of this study is to establish the efficacy of preoperative VRT in reducing postoperative complications in diabetic patients undergoing CABG surgery. Time to "fit for discharge", incidence of postoperative renal failure, cardiac injury, inflammation, and other health outcomes will be investigated. In this open parallel group randomized controlled trial, 170 diabetic patients undergoing elective or urgent CABG surgery received 1 mL/kg/hour of Hartmann's solution for 12 consecutive hours prior to surgery, versus routine care. The primary outcome was time until participants were "fit for discharge", which is defined as presence of: normal temperature, pulse, and respiration; normal oxygen saturation on air; normal bowel function; and physical mobility. Secondary outcomes included: incidence of renal failure; markers of renal function, inflammation, and cardiac damage; operative morbidity; intensive care stay; patient-assessed outcome, including the Coronary Revascularization Outcome Questionnaire; and use of hospital resources. Recruitment started in July 2010. Enrolment for the study was completed in July 2014. Data analysis commenced in December 2016. Study results will be submitted for publication in the summer of 2017. VRT is a relatively easy treatment to administer in patients undergoing surgical procedures who are at risk of renal failure. This experimental protocol will increase scientific and clinical knowledge of VRT in diabetic patients undergoing elective or urgent CABG surgery. Findings supporting the efficacy of this intervention could easily be implemented in the health care system. International Standard Randomized Controlled Trial Number (ISRCTN): 02159606; http://www.controlled-trials.com/ISRCTN02159606 (Archived by WebCite at http://www.webcitation.org/6rDkSSkkK). ©Madeleine Clout, Tracy Harris, Chris Rogers, Lucy Culliford, Jodi Taylor, Gianni Angelini, Pradeep Narayan, Barnaby Reeves, James Hillier, Kate Ashton, Kunal Sarkar, Raimondo Ascione. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.06.2017.

The preoperative manometric pattern predicts the outcome of surgical treatment for esophageal achalasia.

PubMed

Salvador, Renato; Costantini, Mario; Zaninotto, Giovanni; Morbin, Tiziana; Rizzetto, Christian; Zanatta, Lisa; Ceolin, Martina; Finotti, Elena; Nicoletti, Loredana; Da Dalt, Gianfranco; Cavallin, Francesco; Ancona, Ermanno

2010-11-01

A new manometric classification of esophageal achalasia has recently been proposed that also suggests a correlation with the final outcome of treatment. The aim of this study was to investigate this hypothesis in a large group of achalasia patients undergoing laparoscopic Heller-Dor myotomy. We evaluated 246 consecutive achalasia patients who underwent surgery as their first treatment from 2001 to 2009. Patients with sigmoid-shaped esophagus were excluded. Symptoms were scored and barium swallow X-ray, endoscopy, and esophageal manometry were performed before and again at 6 months after surgery. Patients were divided into three groups: (I) no distal esophageal pressurization (contraction wave amplitude <30 mmHg); (II) rapidly propagating compartmentalized pressurization (panesophageal pressurization >30 mmHg); and (III) rapidly propagating pressurization attributable to spastic contractions. Treatment failure was defined as a postoperative symptom score greater than the 10th percentile of the preoperative score (i.e., >7). Type III achalasia coincided with a longer overall lower esophageal sphincter (LES) length, a lower symptom score, and a smaller esophageal diameter. Treatment failure rates differed significantly in the three groups: I = 14.6% (14/96), II = 4.7% (6/127), and III = 30.4% (7/23; p = 0.0007). At univariate analysis, the manometric pattern, a low LES resting pressure, and a high chest pain score were the only factors predicting treatment failure. At multivariate analysis, the manometric pattern and a LES resting pressure <30 mmHg predicted a negative outcome. This is the first study by a surgical group to assess the outcome of surgery in 3 manometric achalasia subtypes: patients with panesophageal pressurization have the best outcome after laparoscopic Heller-Dor myotomy.

Fistula and Survival Outcomes after Fistula Creation among Predialysis Chronic Kidney Disease Stage 5 Patients.

PubMed

Miyamoto, Masahito; Kurita, Noriaki; Suemitsu, Kotaro; Murakami, Masaaki

2017-01-01

Most guidelines recommend the creation of arteriovenous fistula (AVF) in patients with chronic kidney disease (CKD) stage 4. However, an increasing number of studies suggest that early AVF creation leads to high rates of AVF failure and death before dialysis commencement. Only the Japanese guideline recommends AVF creation at CKD stage 5; however, no data are available regarding access-related outcomes at this stage. This was a multicenter cohort study involving Japanese CKD stage 5 patients who underwent preemptive AVF creation from 2009 to 2013. The primary outcome was unnecessary AVF creation, defined as death before requiring dialysis or AVF failure before dialysis commencement. The secondary outcome was dialysis commencement. The associations with candidate predictors and the outcomes were examined. A total of 303 patients were registered. Four cases of death before dialysis and 13 cases of AVF failure before dialysis commencement were observed. A total of 283 patients who advanced to dialysis were found to have functional AVFs. The cumulative incidences of unnecessary AVF creation and dialysis commencement at 1 year were 4.8 and 89.3%, respectively. Competing risk regression analyses showed that age ≥75 years (subhazard ratio [SHR] 3.12, 95% CI 1.20-8.09) and female gender (SHR 3.31, 95% CI 1.20-9.09) were associated with unnecessary AVF creation. A low incidence of unnecessary AVF creation was revealed among Japanese patients who received AVF at CKD stage 5. These results may help clarify the natural history of unnecessary AVF creation for other countries reformatting their guidelines regarding late vascular access creation. © 2017 S. Karger AG, Basel.

Association of Serum Bicarbonate With Risk of Renal and Cardiovascular Outcomes in CKD: A Report From the Chronic Renal Insufficiency Cohort (CRIC) Study

PubMed Central

Dobre, Mirela; Yang, Wei; Chen, Jing; Drawz, Paul; Hamm, L. Lee; Horwitz, Edward; Hostetter, Thomas; Jaar, Bernard; Lora, Claudia M; Nessel, Lisa; Ojo, Akinlolu; Scialla, Julia; Steigerwalt, Susan; Teal, Valerie; Wolf, Myles; Rahman, Mahboob

2013-01-01

Background The purpose of this study is to evaluate serum bicarbonate as a risk factor for renal outcomes, cardiovascular events and mortality in patients with chronic kidney disease (CKD). Study Design Observational cohort study. Setting & Participants 3939 participants with CKD stages 2-4 who enrolled in the Chronic Renal Insufficiency Cohort (CRIC) between June 2003 - December 2008. Predictor Serum bicarbonate. Outcomes Renal outcomes, defined as end-stage renal disease (either initiation of dialysis or kidney transplantation) or 50% reduction in eGFR; atherosclerotic events (myocardial infarction, stroke, peripheral arterial disease); congestive heart failure events; and death. Measurements Time to event. Results The mean eGFR was 44.8 ± 16.8 (SD) mL/min/1.73 m2, and the median serum bicarbonate was 24 (IQR, 22-26) mEq/L. During a median follow-up of 3.9 years, 374 participants died, 767 had a renal outcome, and 332 experienced an atherosclerotic event and 391 had a congestive heart failure event. In adjusted analyses, the risk of developing a renal endpoint was 3% lower per mEq/L increase in serum bicarbonate (HR, 0.97; 95% CI, 0.94-0.99; p=0.01). The association was stronger for participants with eGFR> 45ml/min/1.73m2 (HR, 0.91; 95%CI, 0.85-0.97; p=0.004). The risk of heart failure increased by 14% (HR, 1.14; 95%CI, 1.03-1.26; p=0.02) per mEq/L increase in serum bicarbonate over 24 mEq/L. Serum bicarbonate was not independently associated with atherosclerotic events (HR, 0.99; 95%CI, 0.95-1.03; p=0.6) and all-cause mortality (HR, 0.98; 95%CI, 0.95-1.02; p=0.3). Limitations Single measurement of sodium bicarbonate. Conclusions In a cohort of participants with CKD, low serum bicarbonate was an independent risk factor for kidney disease progression, particularly for participants with preserved kidney function. The risk of heart failure was higher at the upper extreme of serum bicarbonate. There was no association between serum bicarbonate and all-cause mortality or atherosclerotic events. PMID:23489677

Emergent literacy intervention for prekindergarteners at risk for reading failure.

PubMed

Bailet, Laura L; Repper, Karla K; Piasta, Shayne B; Murphy, Suzanne P

2009-01-01

This study examined the effectiveness of an assessment and intervention study targeting prekindergarten children at risk for reading failure. Across 38 child care sites, 220 children were identified as "at risk" for reading failure due to their performance on a screening measure of early literacy skills and randomly assigned to receive immediate or delayed intervention. The intervention consisted of eighteen 30-minute lessons delivered twice weekly for 9 weeks and focused on teaching critical emergent literacy skills within small groups. Hierarchical linear models were used to nest children within center and measure treatment and dosage effects for students' residualized gains in rhyming, alliteration, picture naming, and print and letter knowledge skills. Results indicated significant treatment effects on two of four outcome variables (rhyming and alliteration) and significant dosage effects on all four variables. The study demonstrated a significant positive impact of this intervention for prekindergartners at risk for reading failure.

Validated surrogate endpoints needed for peri-implantitis.

PubMed

Lee, Dong Won

2011-01-01

Pubmed, Cochrane and Lilac databases, Google, Google Scholar, hand searching of websites of major dental journals. The reference list of five recently published systematic reviews on peri-implantitis treatment were also screened for potential studies. Randomised controlled trials and non-randomised studies in English, German, French, Spanish and Italian on peri-implantitis treatment in humans were included. Case series, case reports and cross sectional or non-therapy studies were excluded from the assessment of endpoints. No minimum follow up time was set for studies that were included. Data were extracted in duplicate by two reviewers and disagreements were resolved by consensus. True endpoints for peri-implantitis treatment were considered only if they provided evidence of tangible benefit to the patient. The outcome variables regarded as true endpoints were implant failure, aesthetic assessment and variables related to quality of life, but these were only considered if they were clearly identified as an objective of the research, not as an outcome of treatment. Surrogate endpoints were considered as those measurements of clinical outcomes such as probing pocket depth and clinical attachment level. Fourteen studies were included in this review with data on implant failure presented solely as consequence of peri-implantitis therapy. No true endpoint was described for any study on peri-implantitis. Mean pocket probing depth, clinical attachment level and bleeding on probing were the three surrogate endpoints cited most often in the literature. All endpoints used in the trials reviewed are surrogates of clinical events, such as implant failure. Clinical surrogate endpoints should be validated to assess the real effect of these measures on true endpoints.

Skin grafts: a rural general surgical perspective.

PubMed

Henderson, Nigel J; Fancourt, Michael; Gilkison, William; Kyle, Stephen; Mosquera, Damien

2009-05-01

Skin grafts are a common method of closing skin defects. The literature comparing methods of graft application and subsequent outcomes is poor, but reports indicate a graft failure rate between 2 and 30%. The aim of this study was to audit our current skin graft practice. Data were collected prospectively on all skin grafts performed by the general surgical department between 1st December 2005 and 1st December 2006. A standardized proforma on each patient included data on age, gender, graft indication, application method, comorbidities, length of stay, and graft outcomes including graft take at 1, 2 and 6 weeks post-operatively. There were 85 grafts performed on 74 patients, median age 72 years (9-102 years), with 10 (12%) acute admissions. Prophylactic antibiotics were given to 50% (38 of 74) of patients. Successful grafts (>80% take) were performed in 68 (80%) patients. The overall graft complication rate was 24.7% (22 of 85 grafts). Infection occurred in 13 of 17 graft failures. No patients underwent re-operation for graft failure. Patients who received prophylactic antibiotics had a reduced risk of graft failure (Fisher's exact test, P = 0.016). Skin grafts were performed successfully in the majority of patients. Graft complication and failure rates compare well with the world literature. The use of prophylactic antibiotics was the only predictor of successful graft take.

Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: design and rationale of the ROADMAP clinical trial.

PubMed

Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C

2015-02-01

Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

Risk factors for the treatment outcome of retreated pulmonary tuberculosis patients in China: an optimized prediction model.

PubMed

Wang, X-M; Yin, S-H; Du, J; Du, M-L; Wang, P-Y; Wu, J; Horbinski, C M; Wu, M-J; Zheng, H-Q; Xu, X-Q; Shu, W; Zhang, Y-J

2017-07-01

Retreatment of tuberculosis (TB) often fails in China, yet the risk factors associated with the failure remain unclear. To identify risk factors for the treatment failure of retreated pulmonary tuberculosis (PTB) patients, we analyzed the data of 395 retreated PTB patients who received retreatment between July 2009 and July 2011 in China. PTB patients were categorized into 'success' and 'failure' groups by their treatment outcome. Univariable and multivariable logistic regression were used to evaluate the association between treatment outcome and socio-demographic as well as clinical factors. We also created an optimized risk score model to evaluate the predictive values of these risk factors on treatment failure. Of 395 patients, 99 (25·1%) were diagnosed as retreatment failure. Our results showed that risk factors associated with treatment failure included drug resistance, low education level, low body mass index (6 months), standard treatment regimen, retreatment type, positive culture result after 2 months of treatment, and the place where the first medicine was taken. An Optimized Framingham risk model was then used to calculate the risk scores of these factors. Place where first medicine was taken (temporary living places) received a score of 6, which was highest among all the factors. The predicted probability of treatment failure increases as risk score increases. Ten out of 359 patients had a risk score >9, which corresponded to an estimated probability of treatment failure >70%. In conclusion, we have identified multiple clinical and socio-demographic factors that are associated with treatment failure of retreated PTB patients. We also created an optimized risk score model that was effective in predicting the retreatment failure. These results provide novel insights for the prognosis and improvement of treatment for retreated PTB patients.

Spectral Electroencephalogram Analysis for the Evaluation of Encephalopathy Grade in Children With Acute Liver Failure.

PubMed

Press, Craig A; Morgan, Lindsey; Mills, Michele; Stack, Cynthia V; Goldstein, Joshua L; Alonso, Estella M; Wainwright, Mark S

2017-01-01

Spectral electroencephalogram analysis is a method for automated analysis of electroencephalogram patterns, which can be performed at the bedside. We sought to determine the utility of spectral electroencephalogram for grading hepatic encephalopathy in children with acute liver failure. Retrospective cohort study. Tertiary care pediatric hospital. Patients between 0 and 18 years old who presented with acute liver failure and were admitted to the PICU. None. Electroencephalograms were analyzed by spectral analysis including total power, relative δ, relative θ, relative α, relative β, θ-to-Δ ratio, and α-to-Δ ratio. Normal values and ranges were first derived using normal electroencephalograms from 70 children of 0-18 years old. Age had a significant effect on each variable measured (p < 0.03). Electroencephalograms from 33 patients with acute liver failure were available for spectral analysis. The median age was 4.3 years, 14 of 33 were male, and the majority had an indeterminate etiology of acute liver failure. Neuroimaging was performed in 26 cases and was normal in 20 cases (77%). The majority (64%) survived, and 82% had a good outcome with a score of 1-3 on the Pediatric Glasgow Outcome Scale-Extended at the time of discharge. Hepatic encephalopathy grade correlated with the qualitative visual electroencephalogram scores assigned by blinded neurophysiologists (rs = 0.493; p < 0.006). Spectral electroencephalogram characteristics varied significantly with the qualitative electroencephalogram classification (p < 0.05). Spectral electroencephalogram variables including relative Δ, relative θ, relative α, θ-to-Δ ratio, and α-to-Δ ratio all significantly varied with the qualitative electroencephalogram (p < 0.025). Moderate to severe hepatic encephalopathy was correlated with a total power of less than or equal to 50% of normal for children 0-3 years old, and with a relative θ of less than or equal to 50% normal for children more than 3 years old (p > 0.05). Spectral electroencephalogram classification correlated with outcome (p < 0.05). Spectral electroencephalogram analysis can be used to evaluate even young patients for hepatic encephalopathy and correlates with outcome. Spectral electroencephalogram may allow improved quantitative and reproducible assessment of hepatic encephalopathy grade in children with acute liver failure.

Acute heart failure: perspectives from a randomized trial and a simultaneous registry.

PubMed

Ezekowitz, Justin A; Hu, Jia; Delgado, Diego; Hernandez, Adrian F; Kaul, Padma; Leader, Rolland; Proulx, Guy; Virani, Sean; White, Michel; Zieroth, Shelley; O'Connor, Christopher; Westerhout, Cynthia M; Armstrong, Paul W

2012-11-01

Randomized controlled trials (RCT) are limited by their generalizability to the broader nontrial population. To provide a context for Acute Study of Nesiritide in Decompensated Heart Failure (ASCEND-HF) trial, we designed a complementary registry to characterize clinical characteristics, practice patterns, and in-hospital outcomes of acute heart failure patients. Eligible patients for the registry included those with a principal diagnosis of acute heart failure (ICD-9-CM 402 and 428; ICD-10 I50.x, I11.0, I13.0, I13.2) from 8 sites participating in ASCEND-HF (n=697 patients, 2007-2010). Baseline characteristics, treatments, and hospital outcomes from the registy were compared with ASCEND-HF RCT patients from 31 Canadian sites (n=465, 2007-2010). Patients in the registry were older, more likely to be female, and have chronic respiratory disease, less likely to have diabetes mellitus: they had a similar incidence of ischemic HF, atrial fibrillation, and similar B-type natriuretic peptide levels. Registry patients had higher systolic blood pressure (registry: median 132 mm Hg [interquartile range 115-151 mm Hg]; RCT: median 120 mm Hg [interquartile range 110-135 mm Hg]) and ejection fraction (registry: median 40% [interquartile range 27-58%]; RCT: median 29% [interquartile range 20-40 mm Hg]) than RCT patients. Registry patients presented more often via ambulance and had a similar total length of stay as RCT patients. In-hospital mortality was significantly higher in the registry compared with the RCT patients (9.3% versus 1.3%,P<0.001), and this remained after multivariable adjustment (odds ratio 6.6, 95% CI 2.6-16.8, P<0.001). Patients enrolled in a large RCT of acute heart failure differed significantly based on clinical characteristics, treatments, and inpatient outcomes from contemporaneous patients participating in a registry. These results highlight the need for context of RCTs to evaluate generalizability of results and especially the need to improve clinical outcomes in acute heart failure. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852.

An intervention to promote physical activity and self-management in people with stable chronic heart failure The Home-Heart-Walk study: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Chronic heart failure (CHF) is a chronic debilitating condition with economic consequences, mostly because of frequent hospitalisations. Physical activity and adequate self-management capacity are important risk reduction strategies in the management of CHF. The Home-Heart-Walk is a self-monitoring intervention. This model of intervention has adapted the 6-minute walk test as a home-based activity that is self-administered and can be used for monitoring physical functional capacity in people with CHF. The aim of the Home-Heart-Walk program is to promote adherence to physical activity recommendations and improving self-management in people with CHF. Methods/Design A randomised controlled trial is being conducted in English speaking people with CHF in four hospitals in Sydney, Australia. Individuals diagnosed with CHF, in New York Heart Association Functional Class II or III, with a previous admission to hospital for CHF are eligible to participate. Based on a previous CHF study and a loss to follow-up of 10%, 166 participants are required to be able to detect a 12-point difference in the study primary endpoint (SF-36 physical function domain). All enrolled participant receive an information session with a cardiovascular nurse. This information session covers key self-management components of CHF: daily weight; diet (salt reduction); medication adherence; and physical activity. Participants are randomised to either intervention or control group through the study randomisation centre after baseline questionnaires and assessment are completed. For people in the intervention group, the research nurse also explains the weekly Home-Heart-Walk protocol. All participants receive monthly phone calls from a research coordinator for six months, and outcome measures are conducted at one, three and six months. The primary outcome of the trial is the physical functioning domain of quality of life, measured by the physical functioning subscale of the Medical Outcome Study Short Form -36. Secondary outcomes include physical functional capacity measured by the standard six minute walk test, self-management capacity, health related quality of life measured by Medical Outcome Study Short Form -36 and Minnesota Living With Heart Failure Questionnaire, self-efficacy and self-care behaviour. Discussion A self-monitoring intervention that can improve individual's exercise self-efficacy, self-management capacity could have potential significance in improving the management of people with chronic heart failure in community settings. Trial Registration Australian New Zealand Clinical Trial Registry 12609000437268 PMID:21366927

An intervention to promote physical activity and self-management in people with stable chronic heart failure The Home-Heart-Walk study: study protocol for a randomized controlled trial.

PubMed

Du, Hui Y; Newton, Phillip J; Zecchin, Robert; Denniss, Robert; Salamonson, Yenna; Everett, Bronwyn; Currow, David C; Macdonald, Peter S; Davidson, Patricia M

2011-03-02

Chronic heart failure (CHF) is a chronic debilitating condition with economic consequences, mostly because of frequent hospitalisations. Physical activity and adequate self-management capacity are important risk reduction strategies in the management of CHF. The Home-Heart-Walk is a self-monitoring intervention. This model of intervention has adapted the 6-minute walk test as a home-based activity that is self-administered and can be used for monitoring physical functional capacity in people with CHF. The aim of the Home-Heart-Walk program is to promote adherence to physical activity recommendations and improving self-management in people with CHF. A randomised controlled trial is being conducted in English speaking people with CHF in four hospitals in Sydney, Australia. Individuals diagnosed with CHF, in New York Heart Association Functional Class II or III, with a previous admission to hospital for CHF are eligible to participate. Based on a previous CHF study and a loss to follow-up of 10%, 166 participants are required to be able to detect a 12-point difference in the study primary endpoint (SF-36 physical function domain).All enrolled participant receive an information session with a cardiovascular nurse. This information session covers key self-management components of CHF: daily weight; diet (salt reduction); medication adherence; and physical activity. Participants are randomised to either intervention or control group through the study randomisation centre after baseline questionnaires and assessment are completed. For people in the intervention group, the research nurse also explains the weekly Home-Heart-Walk protocol. All participants receive monthly phone calls from a research coordinator for six months, and outcome measures are conducted at one, three and six months. The primary outcome of the trial is the physical functioning domain of quality of life, measured by the physical functioning subscale of the Medical Outcome Study Short Form -36. Secondary outcomes include physical functional capacity measured by the standard six minute walk test, self-management capacity, health related quality of life measured by Medical Outcome Study Short Form -36 and Minnesota Living With Heart Failure Questionnaire, self-efficacy and self-care behaviour. A self-monitoring intervention that can improve individual's exercise self-efficacy, self-management capacity could have potential significance in improving the management of people with chronic heart failure in community settings. Australian New Zealand Clinical Trial Registry 12609000437268.

Solving Tomorrow's Problems Today? Daily Anticipatory Coping and Reactivity to Daily Stressors.

PubMed

Neupert, Shevaun D; Ennis, Gilda E; Ramsey, Jennifer L; Gall, Agnes A

2016-07-01

The present study examined the day-to-day fluctuation of state-like anticipatory coping (coping employed prior to stressors) and how these coping processes relate to important outcomes for older adults (i.e., physical health, affect, memory failures). Forty-three older adults aged 60-96 (M = 74.65, SD = 8.19) participated in an 8-day daily diary study of anticipatory coping, stressors, health, affect, and memory failures. Participants reported anticipatory coping behaviors on one day with respect to 6 distinct stressor domains that could occur the following day. Multilevel models indicated that anticipatory coping changes from day to day and within stressor domains. Lagged associations suggested that yesterday's anticipatory coping for potential upcoming arguments is related to today's physical health and affect. Increased stagnant deliberation is associated with reduced cognitive reactivity (i.e., fewer memory failures) to arguments the next day. Taken together, these findings suggest that anticipatory coping is dynamic and associated with important daily outcomes. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Significance of change in serum bilirubin in predicting left ventricular reverse remodeling and outcomes in heart failure patients with cardiac resynchronization therapy.

PubMed

Hosoda, Junya; Ishikawa, Toshiyuki; Matsumoto, Katsumi; Iguchi, Kohei; Matsushita, Hirooki; Ogino, Yutaka; Taguchi, Yuka; Sugano, Teruyasu; Ishigami, Tomoaki; Kimura, Kazuo; Tamura, Kouichi

2017-11-01

Research on the correlation of serum bilirubin level with cardiac function as well as outcomes in heart failure patients with cardiac resynchronization therapy (CRT) has not yet been reported. The aim of this study was to analyze the relationship between change in serum bilirubin level and left ventricular reverse remodeling, and also to clarify the impact of bilirubin change on clinical outcomes in CRT patients. We evaluated 105 consecutive patients who underwent CRT. Patients who had no serum total-bilirubin data at both baseline and 3-9 months' follow-up or had died less than 3 months after CRT implantation were excluded. Accordingly, a total of 69 patients were included in the present analysis. The patients were divided into two groups: decreased bilirubin group (serum total-bilirubin level at follow-up≤that at baseline; n=48) and increased bilirubin group (serum total-bilirubin level at follow-up>that at baseline; n=21). Mean follow-up period was 39.3 months. In the decreased bilirubin group, mean left ventricular end-systolic diameter decreased from 54.5mm to 50.2mm (p=0.001) and mean left ventricular ejection fraction increased significantly from 29.8% to 37.0% (p=0.001). In the increased bilirubin group, there was no significant change in echocardiographic parameters from baseline to follow-up. In Kaplan-Meyer analysis, cardiac mortality combined with heart failure hospitalization in the increased bilirubin group was significantly higher than that in the decreased bilirubin group (log-rank p=0.018). Multivariate Cox regression analysis revealed that increased bilirubin was an independent predictor of cardiac mortality combined with heart failure hospitalization (OR=2.66, p=0.023). The change in serum bilirubin is useful for assessment of left ventricular reverse remodeling and prediction of outcomes in heart failure patients with CRT. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Multicentre analysis of second-line antiretroviral treatment in HIV-infected children: adolescents at high risk of failure.

PubMed

Boerma, Ragna S; Bunupuradah, Torsak; Dow, Dorothy; Fokam, Joseph; Kariminia, Azar; Lehman, Dara; Kityo, Cissy; Musiime, Victor; Palumbo, Paul; Schoffelen, Annelot; Sophan, Sam; Zanoni, Brian; Rinke de Wit, Tobias F; Calis, Job C J; Sigaloff, Kim C E

2017-09-15

The number of HIV-infected children and adolescents requiring second-line antiretroviral treatment (ART) is increasing in low- and middle-income countries (LMIC). However, the effectiveness of paediatric second-line ART and potential risk factors for virologic failure are poorly characterized. We performed an aggregate analysis of second-line ART outcomes for children and assessed the need for paediatric third-line ART. We performed a multicentre analysis by systematically reviewing the literature to identify cohorts of children and adolescents receiving second-line ART in LMIC, contacting the corresponding study groups and including patient-level data on virologic and clinical outcomes. Kaplan-Meier survival estimates and Cox proportional hazard models were used to describe cumulative rates and predictors of virologic failure. Virologic failure was defined as two consecutive viral load measurements >1000 copies/ml after at least six months of second-line treatment. We included 12 cohorts representing 928 children on second-line protease inhibitor (PI)-based ART in 14 countries in Asia and sub-Saharan Africa. After 24 months, 16.4% (95% confidence interval (CI): 13.9-19.4) of children experienced virologic failure. Adolescents (10-18 years) had failure rates of 14.5 (95% CI 11.9-17.6) per 100 person-years compared to 4.5 (95% CI 3.4-5.8) for younger children (3-9 years). Risk factors for virologic failure were adolescence (adjusted hazard ratio [aHR] 3.93, p  < 0.001) and short duration of first-line ART before treatment switch (aHR 0.64 and 0.53, p  = 0.008, for 24-48 months and >48 months, respectively, compared to <24 months). In LMIC, paediatric PI-based second-line ART was associated with relatively low virologic failure rates. However, adolescents showed exceptionally poor virologic outcomes in LMIC, and optimizing their HIV care requires urgent attention. In addition, 16% of children and adolescents failed PI-based treatment and will require integrase inhibitors to construct salvage regimens. These drugs are currently not available in LMIC.

Status epilepticus in the elderly patients: A national data study in Thailand.

PubMed

Tiamkao, Somsak; Pranboon, Sineenard; Thepsuthammarat, Kaewjai; Sawanyawisuth, Kittisak

2017-01-15

There are limited data in terms of incidence, clinical features, and outcomes in elderly patients with status epilepticus (SE) in national level. We retrospectively explored national data in Thailand for reimbursement of all SE in elderly patients admitted in the fiscal year 2004-2012. SE in elderly patients (age>60years old) were diagnosed and searched based on ICD 10 (G41) from the national database of from the National Health and Security Office. There were 3326 SE in elderly patients. The national incidence of SE was highest at 8.78patients/100,000/year in 2012. The average age was 72.02years and most were males (1379 patients; 58.8%). At discharge, 66% of patients had improved and in-hospital mortality rate was 14.5%. Predictors of poor outcomes were older age≥80years, being female, hospital levels, chronic renal failure, central nervous system infection, respiratory failure, pneumonia, septicemia, shock, acute renal failure, and hyperkalemia. In conclusion, the number of cases of SE in elderly patients in Thailand has been increasing annually. Increasing age was associated with poor outcome in admitted elderly SE patients. Copyright © 2016 Elsevier B.V. All rights reserved.

Type 2 Diabetes and Heart Failure: Challenges and Solutions

PubMed Central

Thomas, Merlin C.

2016-01-01

Increasing numbers of older patients with type 2 diabetes, and their improved survival from cardiovascular events is seeing a massive increase in patients with both diabetes and heart failure. Already, at least a third of all patients with heart failure have diabetes. This close association is partly because all the major risk factors for heart failure also cluster in patients with type 2 diabetes, including obesity, hypertension, advanced age, sleep apnoea, dyslipidaemia, anaemia, chronic kidney disease, and coronary heart disease. However, diabetes may also cause cardiac dysfunction in the absence of overt macrovascular disease, as well as complicate the response to therapy. Current management is focused on targeting modifiable risk factors for heart failure including hyperglycaemia, dyslipidaemia, hypertension, obesity and anemia. But although these are important risk markers, none of these interventions substantially prevents heart failure or improves its outcomes. Much more needs to be done to focus on this issue, including the inclusion of hospital admission for heart failure as a pre-specified component of the primary composite cardiovascular outcomes and new trials in heart failure management specifically in the context of diabetes. PMID:27280301

Peritonitis outcomes in patients with HIV and end-stage renal failure on peritoneal dialysis: a prospective cohort study.

PubMed

Ndlovu, Kwazi C Z; Sibanda, Wilbert; Assounga, Alain

2017-02-03

Few studies have investigated the management of human immunodeficiency virus (HIV)-associated end-stage renal failure particularly in low-resource settings with limited access to renal replacement therapy. We aimed to evaluate the effects of HIV infection on continuous ambulatory peritoneal dialysis (CAPD)-associated peritonitis outcomes and technique failure in highly active antiretroviral therapy (HAART)-treated HIV-positive CAPD populations. We conducted a single-center prospective cohort study of consecutive incident CAPD patients recruited from two hospitals in Durban, South Africa from September 2012-February 2015. Seventy HIV-negative and 70 HIV-positive end-stage renal failure patients were followed monthly for 18 months at a central renal clinic. Primary outcomes of peritonitis and catheter failure were assessed for the first 18 months of CAPD therapy. We assessed risk factors for peritonitis and catheter failure using Cox regression survival analysis. The HIV-positive cohort had a significantly increased rate of peritonitis compared to the HIV-negative cohort (1.86 vs. 0.76 episodes/person-years, respectively; hazard ratio [HR], 2.41; 95% confidence interval [CI], 1.69-3.45, P < 0.001). When the baseline CD4 count was below 200 cells/μL, the peritonitis rate rose to 3.69 episodes/person-years (HR 4.54, 95% CI 2.35-8.76, P < 0.001), while a baseline CD4 count above 350 cells/μL was associated with a peritonitis rate of 1.60 episodes/person-years (HR 2.10, CI 1.39-3.15, P = 0.001). HIV was associated with increased hazards of peritonitis relapse (HR, 3.88; CI, 1.37-10.94; P = 0.010). Independent predictors associated with increased peritonitis risk were HIV (HR, 1.84; CI, 1.07-3.16; P = 0.027), diabetes (HR, 2.09; CI, 1.09-4.03; P = 0.027) and a baseline CD4 count < 200 cells/μL (HR, 3.28; CI, 1.42-7.61; P = 0.006). Catheter failure rates were 0.34 (HIV-positive cohort) and 0.24 (HIV-negative cohort) episodes/person-years (HR, 1.42; 95% CI, 0.73-2.73; P = 0.299). Peritonitis (HR, 14.47; CI, 2.79-75.00; P = 0.001), average hemoglobin concentrations (HR, 0.75; CI, 0.59-0.95; P = 0.016), and average serum C-reactive protein levels were independent predictors of catheter failure. HIV infection in end-stage renal disease patients managed by CAPD was associated with increased peritonitis risk; however, HIV infection did not increase the risk for CAPD catheter failure rate at 18 months.

Follow-up of the original cohort with the Ahmed glaucoma valve implant.

PubMed

Topouzis, F; Coleman, A L; Choplin, N; Bethlem, M M; Hill, R; Yu, F; Panek, W C; Wilson, M R

1999-08-01

To study the long-term results of the Ahmed glaucoma valve implant in patients with complicated glaucoma in whom short-term results have been reported. In this multicenter study, we analyzed the long-term outcome of a cohort of 60 eyes from 60 patients in whom the Ahmed glaucoma valve was implanted. Failure was characterized by at least one of the following: intraocular pressure greater than 21 mm Hg at both of the last two visits less than 6 mm Hg at both of the last two visits, loss of light perception, additional glaucoma surgery, devastating complications, and removal or replacement of the Ahmed glaucoma valve implant. Devastating complications included chronic hypotony, retinal detachment, malignant glaucoma, endophthalmitis, and phthisis bulbi; we also report results that add corneal complications (corneal decompensation or edema, corneal graft failure) as defining a devastating complication. The mean follow-up time for the 60 eyes was 30.5 months (range, 2.1 to 63.5). When corneal complications were included in the definition of failure, 26 eyes (43%) were considered failures. Cumulative probabilities of success at 1, 2, 3, and 4 years were 76%, 68%, 54%, and 45%, respectively. When corneal complications were excluded from the definition of failure, 13 eyes (21.5%) were considered failures. Cumulative probabilities of success at 1, 2, 3, and 4 years were 87%, 82%, 76%, and 76%, respectively. Most of the failures after 12 months of postoperative follow-up were because of corneal complications. The long-term performance of the Ahmed glaucoma valve implant is comparable to other drainage devices. More than 12 months after the implantation of the Ahmed glaucoma valve implant, the most frequent adverse outcome was corneal decompensation or corneal graft failure. These corneal problems may be secondary to the type of eyes that have drainage devices or to the drainage device itself. Further investigation is needed to identify the reasons that corneal problems follow drainage device implantation.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dinshaw, Ketayun A.; Budrukkar, Ashwini N.; Chinoy, Roshan F.

Purpose: The outcome of breast cancer treatment can vary in different geographic and ethnic groups. A multivariate analysis was performed for various prognostic factors in 1022 Indian women with pathologic Stage I-II breast cancer treated between 1980 and 2000 with standard breast-conserving therapy with or without systemic adjuvant therapy. Methods and Materials: At a mean follow-up of 53 months, the outcomes studied were local failure, locoregional failure, and distant failure, overall survival (OS), and disease-free survival (DFS). Results: The median pathologic tumor size was 3 cm (range, 1-5 cm), and axillary lymph node metastasis was present in 39% of women.more » The actuarial 5- and 10-year OS and DFS rate was 87% and 77% and 76% and 68%, respectively. Lymphovascular emboli or invasion (LVI) was the strongest independent adverse factor for all failure and survival (local failure, hazard ratio 2.85; 95% confidence interval, 1.68-4.83; OS; hazard ratio, 2.01, 95% confidence interval, 1.35-2.99). Lymph node metastasis was also an independent adverse factor for local failure, locoregional failure, distant failure, DFS, and OS (hazard ratio, 1.55, 95% confidence interval, 1.04-2.30). Age {<=}40 years increased the incidence of local recurrence, and patients with inner quadrant tumors had inferior DFS. The incidence of LVI was significantly greater in women with lymph node metastases than in node-negative women (p < 0.001) and in women with Grade 3 tumors than in those with Grade 1 or 2 tumors (p = 0.001). Conclusion: In Indian women, LVI was the strongest independent prognostic factor for OS, DFS, and local recurrence, irrespective of nodal status and systemic adjuvant treatment. Although LVI may not be a contraindication for BCT, as has been proposed by certain groups, it is necessary to define its role in prospective studies in determining local and systemic treatment.« less

Hyporesponsiveness to Darbepoetin Alfa in Patients With Heart Failure and Anemia in the RED-HF Study (Reduction of Events by Darbepoetin Alfa in Heart Failure): Clinical and Prognostic Associations.

PubMed

van der Meer, Peter; Grote Beverborg, Niels; Pfeffer, Marc A; Olson, Kurt; Anand, Inder S; Westenbrink, B Daan; McMurray, John J V; Swedberg, Karl; Young, James B; Solomon, Scott D; van Veldhuisen, Dirk J

2018-02-01

A poor response to erythropoiesis-stimulating agents such as darbepoetin alfa has been associated with adverse outcomes in patients with diabetes mellitus, chronic kidney disease, and anemia; whether this is also true in heart failure is unclear. We performed a post hoc analysis of the RED-HF trial (Reduction of Events by Darbepoetin Alfa in Heart Failure), in which 1008 patients with systolic heart failure and anemia (hemoglobin level, 9.0-12.0 g/dL) were randomized to darbepoetin alfa. We examined the relationship between the hematopoietic response to darbepoetin alfa and the incidence of all-cause death or first heart failure hospitalization during a follow-up of 28 months. For the purposes of the present study, patients in the lowest quartile of hemoglobin change after 4 weeks were considered nonresponders. The median initial hemoglobin change in nonresponders (n=252) was -0.25 g/dL and +1.00 g/dL in the remainder of patients (n=756). Worse renal function, lower sodium levels, and less use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers were independently associated with nonresponse. Although a low endogenous erythropoietin level helped to differentiate responders from nonresponders, its predictive value in a multivariable model was poor (C statistic=0.69). Nonresponders had a higher rate of all-cause death or first heart failure hospitalization (hazard ratio, 1.25; 95% confidence interval, 1.02-1.54) and a higher risk of all-cause mortality (hazard ratio, 1.30; 95% confidence interval, 1.04-1.63) than responders. A poor response to darbepoetin alfa was associated with worse outcomes in heart failure patients with anemia. Patients with a poor response were difficult to identify using clinical and biochemical biomarkers. URL: https://www.clinicaltrials.gov. Unique identifier: NCT00358215. © 2018 American Heart Association, Inc.

Gender differences in health care utilization and outcome of respiratory tuberculosis in Alexandria.

PubMed

Kamel, M I; Rashed, S; Foda, N; Mohie, A; Loutfy, M

2003-07-01

A study of gender differences in health care utilization and outcome of respiratory tuberculosis was carried out in Alexandria, Egypt. A cohort of 334 patients was followed-up for 8 months; 69.2% of cases were males. The pattern of tuberculosis symptoms was similar for both sexes. Women started treatment earlier than men. Women had significantly lower scores in knowledge, beliefs and attitudes about tuberculosis than men. Compliance was unsatisfactory for both sexes. Men tended to be more adherent to drugs and to sputum and X-ray examinations but there were no sex differences in compliance with health education and medical examinations. No significant sex differences in treatment outcome were found: the overall cure rate was 60.5% and treatment failure was 4.8%. Multiple regression analysis showed satisfaction with medical care was the only significant predictor of treatment failure.

Renin-angiotensin-aldosterone system (RAAS) pharmacogenomics: implications in heart failure management.

PubMed

Beitelshees, Amber L; Zineh, Issam

2010-05-01

Blockade of the renin-angiotensin-aldosterone system (RAAS) with ACE inhibitors has been a cornerstone of heart failure therapy for over 15 years. More recently, further blockade of RAAS with aldosterone antagonists and angiotensin receptor blockers (ARBs) has been studied. While these therapies have certainly improved outcomes in the treatment of heart failure, morbidity and mortality remain extremely high. Furthermore, polypharmacy and complex regimens of seven medications on average is the norm for management of heart failure. This results in increased costs, patient burden, and uncertainty as to the best course of therapy. The ability to personalize patients' therapeutic regimens using pharmacogenomics has the potential of providing more effective and efficient use of RAAS-modulating medications. This review highlights the implications of major RAAS pharmacogenetic studies, while outlining future directions for translation to practice.

Character and temporal evolution of apoptosis in acetaminophen-induced acute liver failure*.

PubMed

Possamai, Lucia A; McPhail, Mark J W; Quaglia, Alberto; Zingarelli, Valentina; Abeles, R Daniel; Tidswell, Robert; Puthucheary, Zudin; Rawal, Jakirty; Karvellas, Constantine J; Leslie, Elaine M; Hughes, Robin D; Ma, Yun; Jassem, Wayel; Shawcross, Debbie L; Bernal, William; Dharwan, Anil; Heaton, Nigel D; Thursz, Mark; Wendon, Julia A; Mitry, Ragai R; Antoniades, Charalambos G

2013-11-01

To evaluate the role of hepatocellular and extrahepatic apoptosis during the evolution of acetaminophen-induced acute liver failure. A prospective observational study in two tertiary liver transplant units. Eighty-eight patients with acetaminophen-induced acute liver failure were recruited. Control groups included patients with nonacetaminophen-induced acute liver failure (n = 13), nonhepatic multiple organ failure (n = 28), chronic liver disease (n = 19), and healthy controls (n = 11). Total and caspase-cleaved cytokeratin-18 (M65 and M30) measured at admission and sequentially on days 3, 7, and 10 following admission. Levels were also determined from hepatic vein, portal vein, and systemic arterial blood in seven patients undergoing transplantation. Protein arrays of liver homogenates from patients with acetaminophen-induced acute liver failure were assessed for apoptosis-associated proteins, and histological assessment of liver tissue was performed. Admission M30 levels were significantly elevated in acetaminophen-induced acute liver failure and non-acetaminophen induced acute liver failure patients compared with multiple organ failure, chronic liver disease, and healthy controls. Admission M30 levels correlated with outcome with area under receiver operating characteristic of 0.755 (0.639-0.885, p < 0.001). Peak levels in patients with acute liver failure were seen at admission then fell significantly but did not normalize over 10 days. A negative gradient of M30 from the portal to hepatic vein was demonstrated in patients with acetaminophen-induced acute liver failure (p = 0.042) at the time of liver transplant. Analysis of protein array data demonstrated lower apoptosis-associated protein and higher catalase concentrations in acetaminophen-induced acute liver failure compared with controls (p < 0.05). Explant histological analysis revealed evidence of cellular proliferation with an absence of histological evidence of apoptosis. Hepatocellular apoptosis occurs in the early phases of human acetaminophen-induced acute liver failure, peaking on day 1 of hospital admission, and correlates strongly with poor outcome. Hepatic regenerative/tissue repair responses prevail during the later stages of acute liver failure where elevated levels of M30 are likely to reflect epithelial cell death in extrahepatic organs.

Bacterial meningitis in alcoholic patients: A population-based prospective study.

PubMed

van Veen, Kiril E B; Brouwer, Matthijs C; van der Ende, Arie; van de Beek, Diederik

2017-04-01

To study clinical features and outcome of community-acquired bacterial meningitis in alcoholic patients. Patients with a history of alcoholism were selected from our nationwide, prospective cohort on community-acquired bacterial meningitis performed from March 2006 to October 2014. Data on patient history, symptoms and signs on admission, treatment, and outcome were prospectively collected. Of 1359 included episodes, 88 episodes (6%) occurred in 88 alcoholic patients. Seizures as presenting symptom were present in 18% alcoholic patients, and 23% presented with co-existing pneumonia. Causative organisms were Streptococcus pneumoniae in 76%, Listeria monocytogenes in 8%, and Neisseria meningitidis in 6% of patients. A high rate of systemic complications occurred with respiratory failure in 40% and endocarditis in 9% of patients. Outcome was unfavorable in 58% of alcoholic patients, and 25% died. Alcoholism was associated with unfavorable outcome in a multivariate analysis (OR 1.96; 95% CI 1.12-3.46; P = 0.019), but not with death (OR 0.76; 95% CI 0.35-1.68; P = 0.762). Alcoholic bacterial meningitis patients often have an unfavorable outcome, which appears to result from a high rate of systemic complications, mainly respiratory failure. Seizures are common in alcoholic patients and warrant caution of development of an alcohol withdrawal syndrome. Copyright © 2017. Published by Elsevier Ltd.

Gender-related differences in clinical characteristics and outcomes in patients with diabetic ketoacidosis.

PubMed

Barski, Leonid; Harman-Boehm, Ilana; Nevzorov, Roman; Rabaev, Elena; Zektser, Miri; Jotkowitz, Alan B; Zeller, Lior; Shleyfer, Elena; Almog, Yaniv

2011-12-01

Diabetic ketoacidosis (DKA) is 1 of the most common and serious complications of diabetes, and is a significant cause of morbidity and mortality. There is a paucity of data regarding gender-related differences in clinical characteristics and outcomes of patients hospitalized for DKA. The purpose of this study was to assess whether gender plays a role in clinical characteristics and outcome of DKA. We performed a retrospective cohort study of patients hospitalized with DKA between January 1, 2003 and January 1, 2010. The outcomes of male and female patients were compared. The primary outcome was in-hospital all-cause mortality. The secondary outcomes were 30-day all-cause mortality and rate of complications: sepsis, respiratory failure, multiple organ failure, stroke, and myocardial infarction. Eighty-nine men and 131 women with DKA were included in the study. Male patients had higher rates of chronic renal failure compared with women (16.9% vs 3.1%; P = 0.001), whereas more women than men received oral hypoglycemic therapy (19.8% vs 9.0%; P = 0.046); women also had higher glycosated hemoglobin levels before admission (11.9% [1.7%] vs 9.9% [2.2%]; P = 0.025). The in-hospital mortality rate was not significantly different for both genders (4.5% in the male group vs 3.8% in the female group; P = 1.0). We did not find significant differences between the 2 groups in the 30-day mortality rate (4.5% vs 6.1%; P = 0.7) or the rate of complications (5.6% vs 6.9%; P = 0.9). Advanced age, mechanical ventilation, and bedridden state were independent predictors of 30-day mortality. In our study we did not find statistically significant differences in the in-hospital mortality, 30-day all-cause mortality, or rate of complications between men and women hospitalized with DKA. However, women with poorly controlled type 2 diabetes mellitus receiving oral hypoglycemic therapy required particular attention and might benefit from earlier introduction and intensification of insulin therapy to avoid DKA. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

Donor hypernatremia before procurement and early outcomes following pediatric liver transplantation.

PubMed

Kaseje, Neema; McLin, Valerie; Toso, Christian; Poncet, Antoine; Wildhaber, Barbara E

2015-08-01

The demand for transplantable organs far outweighs the supply. Recently, efforts have been made to increase the donor pool by adopting extended criteria for livers, including those from hypernatremic donors. Currently, there is no clear evidence that the use of organs from hypernatremic donors has detrimental effects on pediatric liver transplantation (LT) recipients. Our aim was to use the Scientific Registry of Transplant Recipients database to evaluate the effects of donor hypernatremia on 30-day outcomes in pediatric LT recipients. We performed an analysis of 2325 children who underwent whole or partial LT between 2005 and 2010. First, we sought to determine a donor sodium threshold for increased mortality following pediatric LT. Second, we examined rates of mortality and graft failure at 30 days after LT in patients receiving grafts from hypernatremic donors compared to patients receiving grafts from normonatremic donors. Hypernatremia was defined as a donor sodium level of ≥160 µmol/L. The primary outcome measure was mortality at 30 days after transplant. The secondary outcome measure was graft failure at 30 days after transplant. There was no threshold sodium level for increased 30-day mortality following pediatric LT. Mean recipient ages/weights, Pediatric End-Stage Liver Disease/Model for End-Stage Liver Disease scores, and mean cold and warm ischemia times were similar between the 2 study groups. There were no significant differences in mortality rates (3.9% versus 4.5%; P = 0.87) and graft failure rates (2.2% versus 1.9%; P = 1.00) in patients receiving grafts from hypernatremic donors compared to patients receiving grafts from normonatremic donors at 30 days after LT. In conclusion, donor hypernatremia just before procurement does not appear to have negative effects on mortality and graft failure rates at 30 days following pediatric LT. © 2015 American Association for the Study of Liver Diseases.

Heart Rate at Hospital Discharge in Patients With Heart Failure Is Associated With Mortality and Rehospitalization

PubMed Central

Laskey, Warren K.; Alomari, Ihab; Cox, Margueritte; Schulte, Phillip J.; Zhao, Xin; Hernandez, Adrian F.; Heidenreich, Paul A.; Eapen, Zubin J.; Yancy, Clyde; Bhatt, Deepak L.; Fonarow, Gregg C.

2015-01-01

Background Whether heart rate upon discharge following hospitalization for heart failure is associated with long‐term adverse outcomes and whether this association differs between patients with sinus rhythm (SR) and atrial fibrillation (AF) have not been well studied. Methods and Results We conducted a retrospective cohort study from clinical registry data linked to Medicare claims for 46 217 patients participating in Get With The Guidelines®–Heart Failure. Cox proportional‐hazards models were used to estimate the association between discharge heart rate and all‐cause mortality, all‐cause readmission, and the composite outcome of mortality/readmission through 1 year. For SR and AF patients with heart rate ≥75, the association between heart rate and mortality (expressed as hazard ratio [HR] per 10 beats‐per‐minute increment) was significant at 0 to 30 days (SR: HR 1.30, 95% CI 1.22 to 1.39; AF: HR 1.23, 95% CI 1.16 to 1.29) and 31 to 365 days (SR: HR 1.15, 95% CI 1.12 to 1.20; AF: HR 1.05, 95% CI 1.01 to 1.08). Similar associations between heart rate and all‐cause readmission and the composite outcome were obtained for SR and AF patients from 0 to 30 days but only in the composite outcome for SR patients over the longer term. The HR from 0 to 30 days exceeded that from 31 to 365 days for both SR and AF patients. At heart rates <75, an association was significant for mortality only for both SR and AF patients. Conclusions Among older patients hospitalized with heart failure, higher discharge heart rate was associated with increased risks of death and rehospitalization, with higher risk in the first 30 days and for SR compared with AF. PMID:25904590

Fluid removal in acute heart failure: diuretics versus devices.

PubMed

Krishnamoorthy, Arun; Felker, G Michael

2014-10-01

Fluid removal and relief of congestion are central to treatment of acute heart failure. Diuretics have been the decongestive mainstay but their known limitations have led to the exploration of alternative strategies. This review compares diuretics with ultrafiltration and examines the recent evidence evaluating their use. Relevant recent studies are the Diuretic Optimization Strategies Evaluation trial (of diuretics) and the Cardiorenal Rescue Study in Acute Decompensated Heart Failure (of ultrafiltration). The Diuretic Optimization Strategies Evaluation study evaluated strategies of loop diuretic use during acute heart failure (continuous infusion versus intermittent bolus and high dose versus low dose). After 72  h, there was no significant difference with either comparison for the coprimary end points. Patients treated with a high-dose strategy tended to have greater diuresis and more decongestion compared with low-dose therapy, at the cost of transient changes in renal function. The Cardiorenal Rescue Study in Acute Decompensated Heart Failure study showed that in acute heart failure patients with persistent congestion and worsening renal function, ultrafiltration, as compared with a medical therapy, was associated with similar weight loss but greater increase in serum creatinine and more adverse events. Decongestion remains a major challenge in acute heart failure. Although recent studies provide useful data to guide practice, the relatively poor outcomes point to the continued need to identify better strategies for safe and effective decongestion.

Risk of heart failure and edema associated with the use of pregabalin: a systematic review.

PubMed

Ho, Joanne M; Tricco, Andrea C; Perrier, Laure; Chen, Maggie; Juurlink, David N; Straus, Sharon E

2013-05-04

Pregabalin is used in the treatment of postherpetic neuralgia, diabetic neuropathic pain, partial seizures, anxiety disorders and fibromyalgia. Recognized adverse effects associated with its use include cognitive impairment, somnolence and dizziness. Heart failure associated with pregabalin has been described, however the strength of this association has not been well characterized. To examine this further, we will conduct a systematic review of the risk of heart failure and edema associated with use of pregabalin. We will include all studies (experimental, quasi-experimental, observational, case series/reports, drug regulatory reports) that examine the use of pregabalin compared to placebo, gabapentin or conventional care. Our primary outcome is heart failure and the secondary outcomes include edema and weight gain. We will search electronic databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials), and grey literature sources (trial registries, conference abstracts) to identify relevant studies. To ensure literature saturation, we will contact drug manufacturers, conduct forward citation searching, and scan the reference lists of key articles and included studies. We will not restrict inclusion by language or publication status.Two reviewers will screen citations (titles and abstracts) and full-text articles, conduct data abstraction, and appraise risk of bias. Random-effects meta-analysis will be conducted if the studies are deemed heterogeneous in terms of clinical, statistical and methodological factors but still suitable for meta-analysis. The results of this review will assist physicians to better appreciate pregabalin's risk for edema or congestive heart failure and will be pertinent to the thousands of patients worldwide who are administered this medication.Our protocol was registered in the PROSPERO database (CRD42012002948).

Toward phase 4 trials in heart failure: A social and corporate responsibility of the medical profession.

PubMed

Iyngkaran, Pupalan; Beneby, Glen S

2015-12-26

Congestive heart failure (CHF) is a chronic condition, requiring polypharmacy, allied health supports and regular monitoring. All these factors are needed to ensure compliance and to deliver the positive outcomes demonstrated from randomized controlled trials. Unfortunately many centers around the world are unable to match trial level support. The outcomes for many communities are thus unclear. Research design factors in post-marketing surveillance to address this issue. Phase 4 studies is the name given to trials designed to obtain such community level data and thus address issues of external validity. CHF phase 4 studies are relatively underutilized. We feel the onus for this research lies with the health profession. In this commentary we provide arguments as to why phase 4 studies should be viewed as a social and corporate responsibility of health professional that care for clients with CHF.

Toward phase 4 trials in heart failure: A social and corporate responsibility of the medical profession

PubMed Central

Iyngkaran, Pupalan; Beneby, Glen S

2015-01-01

Congestive heart failure (CHF) is a chronic condition, requiring polypharmacy, allied health supports and regular monitoring. All these factors are needed to ensure compliance and to deliver the positive outcomes demonstrated from randomized controlled trials. Unfortunately many centers around the world are unable to match trial level support. The outcomes for many communities are thus unclear. Research design factors in post-marketing surveillance to address this issue. Phase 4 studies is the name given to trials designed to obtain such community level data and thus address issues of external validity. CHF phase 4 studies are relatively underutilized. We feel the onus for this research lies with the health profession. In this commentary we provide arguments as to why phase 4 studies should be viewed as a social and corporate responsibility of health professional that care for clients with CHF. PMID:26713277

Benchmarking outcomes in the critically injured trauma patient and the effect of implementing standard operating procedures.

PubMed

Cuschieri, Joseph; Johnson, Jeffrey L; Sperry, Jason; West, Michael A; Moore, Ernest E; Minei, Joseph P; Bankey, Paul E; Nathens, Avery B; Cuenca, Alex G; Efron, Philip A; Hennessy, Laura; Xiao, Wenzhong; Mindrinos, Michael N; McDonald-Smith, Grace P; Mason, Philip H; Billiar, Timothy R; Schoenfeld, David A; Warren, H Shaw; Cobb, J Perren; Moldawer, Lyle L; Davis, Ronald W; Maier, Ronald V; Tompkins, Ronald G

2012-05-01

To determine and compare outcomes with accepted benchmarks in trauma care at 7 academic level I trauma centers in which patients were treated on the basis of a series of standard operating procedures (SOPs). Injury remains the leading cause of death for those younger than 45 years. This study describes the baseline patient characteristics and well-defined outcomes of persons hospitalized in the United States for severe blunt trauma. We followed 1637 trauma patients from 2003 to 2009 up to 28 hospital days using SOPs developed at the onset of the study. An extensive database on patient and injury characteristics, clinical treatment, and outcomes was created. These data were compared with existing trauma benchmarks. The study patients were critically injured and were in shock. SOP compliance improved 10% to 40% during the study period. Multiple organ failure and mortality rates were 34.8% and 16.7%, respectively. Time to recovery, defined as the time until the patient was free of organ failure for at least 2 consecutive days, was developed as a new outcome measure. There was a reduction in mortality rate in the cohort during the study that cannot be explained by changes in the patient population. This study provides the current benchmark and the overall positive effect of implementing SOPs for severely injured patients. Over the course of the study, there were improvements in morbidity and mortality rates and increasing compliance with SOPs. Mortality was surprisingly low, given the degree of injury, and improved over the duration of the study, which correlated with improved SOP compliance.

A systematic review of mHealth-based heart failure interventions

PubMed Central

Cajita, Maan Isabella; Gleason, Kelly T.; Han, Hae-Ra

2015-01-01

Background The popularity of mobile phones and similar mobile devices makes it an ideal medium for delivering interventions. This is especially true with heart failure (HF) interventions, in which mHealth-based HF interventions are rapidly replacing their telephone-based predecessors. Purpose This systematic review examined the impact of mHealth-based HF management interventions on HF outcomes. The specific aims of the systematic review are to: (1) describe current mHealth-based HF interventions and (2) discuss the impact of these interventions on HF outcomes. Methods PubMed, CINAHL Plus, Embase, PsycINFO, and Scopus were systematically searched for randomized controlled trials or quasi-experimental studies that tested mHealth interventions in people with HF using the terms Heart Failure, Mobile Health, mHealth, Telemedicine, Text Messaging, Texting, Short Message Service, Mobile Applications, and Mobile Apps. Conclusions Ten articles, representing nine studies, were included in this review. Majority of the studies utilized mobile health technology as part of a HF monitoring system, which typically included a blood pressure measuring device, weighing scale, and an ECG recorder. The impact of the mHealth interventions on all-cause mortality, cardiovascular mortality, HF-related hospitalizations, length of stay, NYHA functional class, LVEF, quality of life, and self-care were inconsistent at best. Implications Further research is needed to conclusively determine the impact of mHealth interventions on HF outcomes. The limitations of the current studies (e.g. inadequate sample size, quasi-experimental design, use of older mobile phone models, etc.) should be taken into account when designing future studies. PMID:26544175

A Systematic Review of mHealth-Based Heart Failure Interventions.

PubMed

Cajita, Maan Isabella; Gleason, Kelly T; Han, Hae-Ra

2016-01-01

The popularity of mobile phones and similar mobile devices makes it an ideal medium for delivering interventions. This is especially true with heart failure (HF) interventions, in which mHealth-based HF interventions are rapidly replacing their telephone-based predecessors. This systematic review examined the impact of mHealth-based HF management interventions on HF outcomes. The specific aims of the systematic review are to (1) describe current mHealth-based HF interventions and (2) discuss the impact of these interventions on HF outcomes. PubMed, CINAHL Plus, EMBASE, PsycINFO, and Scopus were systematically searched for randomized controlled trials or quasi-experimental studies that tested mHealth interventions in people with HF using the terms Heart Failure, Mobile Health, mHealth, Telemedicine, Text Messaging, Texting, Short Message Service, Mobile Applications, and Mobile Apps. Ten articles, representing 9 studies, were included in this review. The majority of the studies utilized mobile health technology as part of an HF monitoring system, which typically included a blood pressure-measuring device, weighing scale, and an electrocardiogram recorder. The impact of the mHealth interventions on all-cause mortality, cardiovascular mortality, HF-related hospitalizations, length of stay, New York Heart Association functional class, left ventricular ejection fraction, quality of life, and self-care were inconsistent at best. Further research is needed to conclusively determine the impact of mHealth interventions on HF outcomes. The limitations of the current studies (eg, inadequate sample size, quasi-experimental design, use of older mobile phone models, etc) should be taken into account when designing future studies.

Real world heart failure epidemiology and outcome: A population-based analysis of 88,195 patients

PubMed Central

Vela, Emili; Clèries, Montse; Bustins, Montse; Cainzos-Achirica, Miguel; Enjuanes, Cristina; Moliner, Pedro; Ruiz, Sonia; Verdú-Rotellar, José María; Comín-Colet, Josep

2017-01-01

Background Heart failure (HF) is frequent and its prevalence is increasing. We aimed to evaluate the epidemiologic features of HF patients, the 1-year follow-up outcomes and the independent predictors of those outcomes at a population level. Methods and results Population-based longitudinal study including all prevalent HF cases in Catalonia (Spain) on December 31st, 2012. Patients were divided in 3 groups: patients without a previous HF hospitalization, patients with a remote (>1 year) HF hospitalization and patients with a recent (<1 year) HF admission. We analyzed 1year all-cause and HF hospitalizations, and all-cause mortality. Logistic regression was used to identify the independent predictors of each of those outcomes. A total of 88,195 patients were included. Mean age was 77 years, 55% were women. Comorbidities were frequent. Fourteen percent of patients had never been hospitalized, 71% had a remote HF hospitalization and 15% a recent hospitalization. At 1-year follow-up, all-cause and HF hospitalization were 53% and 8.8%, respectively. One-year all-cause mortality rate was 14%, and was higher in patients with a recent HF hospitalization (24%). The presence of diabetes mellitus, atrial fibrillation or chronic kidney disease was independently associated with all-cause and HF hospitalization and all-cause mortality. Hospital admissions and emergency department visits the previous year were also found to be independently associated with the three study outcomes. Conclusions Outcomes are different depending on the HF population studied. Some comorbidity, an all-cause hospitalization or emergency department visit the previous year were associated with a worse outcome. PMID:28235067

Real world heart failure epidemiology and outcome: A population-based analysis of 88,195 patients.

PubMed

Farré, Núria; Vela, Emili; Clèries, Montse; Bustins, Montse; Cainzos-Achirica, Miguel; Enjuanes, Cristina; Moliner, Pedro; Ruiz, Sonia; Verdú-Rotellar, José María; Comín-Colet, Josep

2017-01-01

Heart failure (HF) is frequent and its prevalence is increasing. We aimed to evaluate the epidemiologic features of HF patients, the 1-year follow-up outcomes and the independent predictors of those outcomes at a population level. Population-based longitudinal study including all prevalent HF cases in Catalonia (Spain) on December 31st, 2012. Patients were divided in 3 groups: patients without a previous HF hospitalization, patients with a remote (>1 year) HF hospitalization and patients with a recent (<1 year) HF admission. We analyzed 1year all-cause and HF hospitalizations, and all-cause mortality. Logistic regression was used to identify the independent predictors of each of those outcomes. A total of 88,195 patients were included. Mean age was 77 years, 55% were women. Comorbidities were frequent. Fourteen percent of patients had never been hospitalized, 71% had a remote HF hospitalization and 15% a recent hospitalization. At 1-year follow-up, all-cause and HF hospitalization were 53% and 8.8%, respectively. One-year all-cause mortality rate was 14%, and was higher in patients with a recent HF hospitalization (24%). The presence of diabetes mellitus, atrial fibrillation or chronic kidney disease was independently associated with all-cause and HF hospitalization and all-cause mortality. Hospital admissions and emergency department visits the previous year were also found to be independently associated with the three study outcomes. Outcomes are different depending on the HF population studied. Some comorbidity, an all-cause hospitalization or emergency department visit the previous year were associated with a worse outcome.

Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study).

PubMed

Rådholm, Karin; Figtree, Gemma; Perkovic, Vlado; Solomon, Scott D; Mahaffey, Kenneth W; de Zeeuw, Dick; Fulcher, Greg; Barrett, Terrance D; Shaw, Wayne; Desai, Mehul; Matthews, David R; Neal, Bruce

2018-03-11

BACKGROUND : Canagliflozin is a sodium glucose cotransporter 2 inhibitor that reduces the risk of cardiovascular events. We report the effects on heart failure and cardiovascular death overall, in those with and without a baseline history of heart failure, and in other participant subgroups. METHODS : The CANVAS Program (Canagliflozin Cardiovascular Assessment Study) enrolled 10 142 participants with type 2 diabetes mellitus and high cardiovascular risk. Participants were randomly assigned to canagliflozin or placebo and followed for a mean of 188 weeks. The primary end point for these analyses was adjudicated cardiovascular death or hospitalized heart failure. RESULTS : Participants with a history of heart failure at baseline (14.4%) were more frequently women, white, and hypertensive and had a history of prior cardiovascular disease (all P <0.001). Greater proportions of these patients were using therapies such as blockers of the renin angiotensin aldosterone system, diuretics, and β-blockers at baseline (all P <0.001). Overall, cardiovascular death or hospitalized heart failure was reduced in those treated with canagliflozin compared with placebo (16.3 versus 20.8 per 1000 patient-years; hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.67-0.91), as was fatal or hospitalized heart failure (HR, 0.70; 95% CI, 0.55-0.89) and hospitalized heart failure alone (HR, 0.67; 95% CI, 0.52-0.87). The benefit on cardiovascular death or hospitalized heart failure may be greater in patients with a prior history of heart failure (HR, 0.61; 95% CI, 0.46-0.80) compared with those without heart failure at baseline (HR, 0.87; 95% CI, 0.72-1.06; P interaction =0.021). The effects of canagliflozin compared with placebo on other cardiovascular outcomes and key safety outcomes were similar in participants with and without heart failure at baseline (all interaction P values >0.130), except for a possibly reduced absolute rate of events attributable to osmotic diuresis among those with a prior history of heart failure ( P =0.03). CONCLUSIONS : In patients with type 2 diabetes mellitus and an elevated risk of cardiovascular disease, canagliflozin reduced the risk of cardiovascular death or hospitalized heart failure across a broad range of different patient subgroups. Benefits may be greater in those with a history of heart failure at baseline. CLINICAL TRIAL REGISTRATION : URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01032629 and NCT01989754.

[Long-term outcomes of children treated with continuous renal replacement therapy].

PubMed

Almarza, S; Bialobrzeska, K; Casellas, M M; Santiago, M J; López-Herce, J; Toledo, B; Carrillo, Á

2015-12-01

The objective of this study is to analyze long-term outcomes and kidney function in children requiring continuous renal replacement therapy (CRRT) after an acute kidney injury episode. A retrospective observational study was performed using a prospective database of 128 patients who required CRRT admitted to the pediatric intensive care unit between years 2006 and 2012. The subsequent outcomes were assessed in those surviving at hospital discharge. Of the 128 children who required RRT in the pediatric intensive care unit, 71 survived at hospital discharge (54.4%), of whom 66 (92.9%) were followed up. Three patients had chronic renal failure prior to admission to the NICU. Of the 63 remaining patients, 6 had prolonged or relapses of renal function disturbances, but only one patient with atypical Hemolytic Uremic Syndrome developed end-stage renal failure. The rest had normal kidney function at the last check-up. Most of surviving children that required CRRT have a positive outcome later on, presenting low mortality rates and recovery of kidney function in the medium term. Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

Spironolactone for heart failure with preserved ejection fraction.

PubMed

Pitt, Bertram; Pfeffer, Marc A; Assmann, Susan F; Boineau, Robin; Anand, Inder S; Claggett, Brian; Clausell, Nadine; Desai, Akshay S; Diaz, Rafael; Fleg, Jerome L; Gordeev, Ivan; Harty, Brian; Heitner, John F; Kenwood, Christopher T; Lewis, Eldrin F; O'Meara, Eileen; Probstfield, Jeffrey L; Shaburishvili, Tamaz; Shah, Sanjiv J; Solomon, Scott D; Sweitzer, Nancy K; Yang, Song; McKinlay, Sonja M

2014-04-10

Mineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction. In this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. With a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P=0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P=0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter) or higher, or dialysis. In patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. (Funded by the National Heart, Lung, and Blood Institute; TOPCAT ClinicalTrials.gov number, NCT00094302.).

Influence of TVT properties on outcomes of midurethral sling procedures: high-stiffness versus low-stiffness tape.

PubMed

Prien-Larsen, Jens Christian; Prien-Larsen, Thomas; Cieslak, Lars; Dessau, Ram B

2016-07-01

Although there is clear consensus on the use of monofilament polypropylene tapes for treating stress urinary incontinence (SUI), tapes differ in weight, stiffness, and elasticity. In this study, we compared outcomes of two tape types: high-stiffness Intramesh SOFT L.I.F.T versus low-stiffness Intramesh L.I.F.T. tape. Our null hypothesis was that in terms of performance, SOFT tape equaled L.I.F.T. tape. Six hundred and sixty women underwent prospective transvaginal tape (TVT) surgery for SUI: 210 had the SOFT tape placed and 450 the L.I.F.T. tape. Follow-ups were scheduled at 3 and 12 months. Objective cure at 3-months' follow-up was 87 % in the SOFT group vs 94 % in the L.I.F.T. group (p = 0.003) and at 12 months 86 vs 96 % (p = 0.0004), respectively. Subjective outcomes were equal. For SOFT tape, the objective failure rate at 3 months was especially pronounced in women older than 70 years: 31 vs 10 % (p = 0.008), and subjective failure was 24 vs 7 % (p = 0.01). At 12 months, objective failure for the SOFT tape was significantly higher in both age groups compared with L.I.F.T. [odds ratio (OR) 2.17]. Multivariate analysis showed that body mass index (BMI) ≥30 (OR 2.41), mixed incontinence (MUI) (OR 2.24), use of SOFT tape (OR 2.17), and age ≥ 70 years are significant independent risk factors for surgical failure. Outcomes with SOFT tape are significantly inferior than with L.I.F.T. tape, especially among elderly women. Therefore, the two variants of monofilament polypropylene tape are not interchangeable.

Systolic blood pressure reduction during the first 24 h in acute heart failure admission: friend or foe?

PubMed

Cotter, Gad; Metra, Marco; Davison, Beth A; Jondeau, Guillaume; Cleland, John G F; Bourge, Robert C; Milo, Olga; O'Connor, Christopher M; Parker, John D; Torre-Amione, Guillermo; van Veldhuisen, Dirk J; Kobrin, Isaac; Rainisio, Maurizio; Senger, Stefanie; Edwards, Christopher; McMurray, John J V; Teerlink, John R

2018-02-01

Changes in systolic blood pressure (SBP) during an admission for acute heart failure (AHF), especially those leading to hypotension, have been suggested to increase the risk for adverse outcomes. We analysed associations of SBP decrease during the first 24 h from randomization with serum creatinine changes at the last time-point available (72 h), using linear regression, and with 30- and 180-day outcomes, using Cox regression, in 1257 patients in the VERITAS study. After multivariable adjustment for baseline SBP, greater SBP decrease at 24 h from randomization was associated with greater creatinine increase at 72 h and greater risk for 30-day all-cause death, worsening heart failure (HF) or HF readmission. The hazard ratio (HR) for each 1 mmHg decrease in SBP at 24 h for 30-day death, worsening HF or HF rehospitalization was 1.01 [95% confidence interval (CI) 1.00-1.02; P = 0.021]. Similarly, the HR for each 1 mmHg decrease in SBP at 24 h for 180-day all-cause mortality was 1.01 (95% CI 1.00-1.03; P = 0.038). The associations between SBP decrease and outcomes did not differ by tezosentan treatment group, although tezosentan treatment was associated with a greater SBP decrease at 24 h. In the current post hoc analysis, SBP decrease during the first 24 h was associated with increased renal impairment and adverse outcomes at 30 and 180 days. Caution, with special attention to blood pressure monitoring, should be exercised when vasodilating agents are given to AHF patients. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

A randomized trial of heart failure disease management in skilled nursing facilities: design and rationale.

PubMed

Boxer, Rebecca S; Dolansky, Mary A; Bodnar, Christine A; Singer, Mendel E; Albert, Jeffery M; Gravenstein, Stefan

2013-09-01

Heart failure (HF) disease management can improve health outcomes for older community dwelling patients with heart failure. HF disease management has not been studied in skilled nursing facilities, a major site of transitional care for older adults. The objective of this trial is to investigate if a HF- disease management program (HF-DMP) in skilled nursing facilities (SNF)s will decrease all-cause rehospitalizations for the first 60 days post-SNF admission. The trial is a randomized cluster trial to be conducted in 12 for-profit SNF in the greater Cleveland area. The study population is inclusive of patients with HF regardless of ejection fraction but excludes those patients on dialysis and with a life expectancy of 6 months or less. The HF-DMP includes 7 elements considered standard of care for patients with HF documentation of left ventricular function, tracking of weight and symptoms, medication titration, discharge instructions, 7-day follow-up appointment post-SNF discharge, and patient education. The HF-DMP is conducted by a research nurse tasked with adhering to each element of the program and regularly audited to maintain fidelity of the program. Additional outcomes include health status, self-care management, and discharge destination. The SNF-Connect Trial is the first trial of its kind to assess if a HF-DMP will improve outcomes for patients in SNFs. This trial will provide evidence on the effectiveness of HF-DMP to improve outcomes for older frail HF patients undergoing postacute rehabilitation. Copyright © 2013 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF).

PubMed

Rossignol, Patrick; Dobre, Daniela; McMurray, John J V; Swedberg, Karl; Krum, Henry; van Veldhuisen, Dirk J; Shi, Harry; Messig, Michael; Vincent, John; Girerd, Nicolas; Bakris, George; Pitt, Bertram; Zannad, Faiez

2014-01-01

Mineralocorticoid receptor antagonists improve outcomes in patients with systolic heart failure but may induce worsening of renal function (WRF) and hyperkalemia (HK). We assessed the risk factors for mineralocorticoid receptor antagonist-related WRF and for HK, as well as the association between HK and WRF with clinical outcomes in the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Serial changes in estimated glomerular filtration rate and in serum potassium were available in 2737 patients during a median 21-month follow-up. HK variably defined as serum K>4.5, 5, or 5.5 mmol/L occurred in 74.7%, 32.5%, and 8.9% patients enrolled in EMPHASIS-HF, respectively. WRF defined as a decrease in estimated glomerular filtration rate>20% or >30% from baseline occurred in 27% and 14% of patients, respectively. Patients assigned eplerenone displayed modest and early but significant and persistent (1) rise in serum potassium and (2) reduction in estimated glomerular filtration rate when compared with those assigned placebo. In multivariate analyses, eplerenone was associated with a higher incidence of WRF and HK, which were interrelated and also associated with baseline patient characteristics (eg, age≥75 years, hypertension, diabetes mellitus, nonwhite race, ejection fraction<30%, and treatment with an antiarrythmics drug or loop diuretic). Eplerenone retained its survival benefits without any significant interaction with the association between HK>5.5 mmol/L only and WRF and worse outcomes. In patients with heart failure receiving optimal therapy, WRF and HK were more frequent when eplerenone was added, but their occurrence did not eliminate the survival benefit of eplerenone. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00232180.

Smoking and morphology of calcific deposits affect the outcome of needle aspiration of calcific deposits (NACD) for calcific tendinitis of the rotator cuff.

PubMed

Oudelaar, Bart W; Ooms, Edwin M; Huis In 't Veld, Rianne M H A; Schepers-Bok, Relinde; Vochteloo, Anne J

2015-11-01

Although NACD has proven to be an effective minimal invasive treatment for calcific tendinitis of the rotator cuff, little is known about the factors associated with treatment failure or the need for multiple procedures. Patients with symptomatic calcific tendinitis who were treated by NACD were evaluated in a retrospective cohort study. Demographic details, medical history, sonographic and radiographic findings were collected from patient files. Failure of NACD was defined as the persistence of symptoms after a follow-up of at least six months. NACD procedures performed within six months after a previous NACD procedure were considered repeated procedures. Multivariate logistic regression analysis was used to determine factors associated with treatment failure and multiple procedures. 431 patients (277 female; mean age 51.4±9.9 years) were included. Smoking (adjusted odds ratio (AOR): 1.7, 95% CI 1.0-2.7, p=0.04) was significantly associated with failure of NACD. Patients with Gärtner and Heyer (GH) type I calcific deposits were more likely to need multiple NACD procedures (AOR: 3.4, 95% CI 1.6-7.5, p<0.01) compared to patients with type III calcific deposits. Partial thickness rotator cuff tears were of no influence on the outcome of NACD or the number of treatments necessary. Smoking almost doubled the chance of failure of NACD and the presence of GH type I calcific deposits significantly increased the chance of multiple procedures. Partial thickness rotator cuff tears did not seem to affect the outcome of NACD. Based on the findings in this study, the importance of quitting smoking should be emphasized prior to NACD and partial thickness rotator cuff tears should not be a reason to withhold patients NACD. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Observational longitudinal cohort study to determine progression to heart failure in a screened community population: the Echocardiographic Heart of England Screening Extension (ECHOES-X) study

PubMed Central

Taylor, Clare J; Roalfe, Andrea K; Tait, Lynda; Davis, Russell C; Iles, Rachel; Derit, Marites; Hobbs, F D Richard

2014-01-01

Objectives Rescreen a large community cohort to examine the progression to heart failure over time and the role of natriuretic peptide testing in screening. Design Observational longitudinal cohort study. Setting 16 socioeconomically diverse practices in central England. Participants Participants from the original Echocardiographic Heart of England Screening (ECHOES) study were invited to attend for rescreening. Outcome measures Prevalence of heart failure at rescreening overall and for each original ECHOES subgroup. Test performance of N Terminal pro-B-type Natriuretic Peptide (NT-proBNP) levels at different thresholds for screening. Results 1618 of 3408 participants underwent screening which represented 47% of survivors and 26% of the original ECHOES cohort. A total of 176 (11%, 95% CI 9.4% to 12.5%) participants were classified as having heart failure at rescreening; 103 had heart failure with reduced ejection fraction (HFREF) and 73 had heart failure with preserved ejection fraction (HFPEF). Sixty-eight out of 1232 (5.5%, 95% CI 4.3% to 6.9%) participants who were recruited from the general population over the age of 45 and did not have heart failure in the original study, had heart failure on rescreening. An NT-proBNP cut-off of 400 pg/mL had sensitivity for a diagnosis of heart failure of 79.5% (95% CI 72.4% to 85.5%) and specificity of 87% (95% CI 85.1% to 88.8%). Conclusions Rescreening identified new cases of HFREF and HFPEF. Progression to heart failure poses a significant threat over time. The natriuretic peptide cut-off level for ruling out heart failure must be low enough to ensure cases are not missed at screening. PMID:25015472

Clinical Trials Update: CAPRICORN, COPERNICUS, MIRACLE, STAF, RITZ-2, RECOVER and RENAISSANCE and cachexia and cholesterol in heart failure. Highlights of the Scientific Sessions of the American College of Cardiology, 2001.

PubMed

Louis, A; Cleland, J G; Crabbe, S; Ford, S; Thackray, S; Houghton, T; Clark, A

2001-06-01

This is a synopsis of presentations made at the American College of Cardiology (ACC) in 2001 summarising recent research developments relating to heart failure. Clinical studies of particular interest to physicians with an interest in heart failure and its prevention are reviewed. The COPERNICUS trial lends further support to the use of the beta-blocker, carvedilol, in severe heart failure and the CAPRICORN trial to its use in patients with post-infarction left ventricular systolic dysfunction. The MIRACLE study reinforces the evidence from three smaller trials that cardiac resynchronisation therapy is an effective treatment for the relief of symptoms in patients with severe heart failure and cardiac dyssynchrony. The STAF trial casts further doubt on the wisdom of cardioversion as a routine strategy for the management of chronic atrial fibrillation. The RITZ-2 trial suggests that an intravenous, non-selective endothelin antagonist is effective in improving haemodynamics and symptoms and possibly in reducing morbidity in severe heart failure. Observational studies in heart failure suggest that a moderate excess of body fat and elevated blood cholesterol may be desirable in patients with heart failure, challenging the current non-evidenced-based vogue for cholesterol lowering therapy in heart failure. The RENAISSANCE and RECOVER outcome studies of etanercept, a tumour necrosis factor (TNF) receptor analogue that blocks the effect of TNF, were stopped because of lack of evidence of benefit shortly after the ACC.

Background and design of the profiling biobehavioral responses to mechanical support in advanced heart failure study.

PubMed

Lee, Christopher S; Mudd, James O; Gelow, Jill M; Nguyen, Thuan; Hiatt, Shirin O; Green, Jennifer K; Denfeld, Quin E; Bidwell, Julie T; Grady, Kathleen L

2014-01-01

Unexplained heterogeneity in response to ventricular assist device (VAD) implantation for the management of advanced heart failure impedes our ability to predict favorable outcomes, provide adequate patient and family education, and personalize monitoring and symptom management strategies. The purpose of this article was to describe the background and the design of a study entitled "Profiling Biobehavioral Responses to Mechanical Support in Advanced Heart Failure" (PREMISE). PREMISE is a prospective cohort study designed to (1) identify common and distinct trajectories of change in physical and psychological symptom burden; (2) characterize common trajectories of change in serum biomarkers of myocardial stress, systemic inflammation, and endothelial dysfunction; and (3) quantify associations between symptoms and biomarkers of pathogenesis in adults undergoing VAD implantation. Latent growth mixture modeling, including parallel process and cross-classification modeling, will be used to address the study aims and will entail identifying trajectories, quantifying associations between trajectories and both clinical and quality-of-life outcomes, and identifying predictors of favorable symptom and biomarker responses to VAD implantation. Research findings from the PREMISE study will be used to enhance shared patient and provider decision making and to shape a much-needed new breed of interventions and clinical management strategies that are tailored to differential symptom and pathogenic responses to VAD implantation.

Biomechanical Comparison of Single- Versus Double-Row Capsulolabral Repair for Shoulder Instability: A Review.

PubMed

Yousif, Matthew John; Bicos, James

2017-12-01

The glenohumeral joint is the most commonly dislocated joint in the body. Failure rates of capsulolabral repair have been reported to be approximately 8%. Recent focus has been on restoration of the capsulolabral complex by a double-row capsulolabral repair technique in an effort to decrease redislocation rates after arthroscopic capsulolabral repair. To present a review of the biomechanical literature comparing single- versus double-row capsulolabral repairs and discuss the previous case series of double-row fixation. Narrative review. A simple review of the literature was performed by PubMed search. Only biomechanical studies comparing single- versus double-row capsulolabral repair were included for review. Only those case series and descriptive techniques with clinical results for double-row repair were included in the discussion. Biomechanical comparisons evaluating the native footprint of the labrum demonstrated significantly superior restoration of the footprint through double-row capsulolabral repair compared with single-row repair. Biomechanical comparisons of contact pressure at the repair interface, fracture displacement in bony Bankart lesion, load to failure, and decreased external rotation (suggestive of increased load to failure) were also significantly in favor of double- versus single-row repair. Recent descriptive techniques and case series of double-row fixation have demonstrated good clinical outcomes; however, no comparative clinical studies between single- and double-row repair have assessed functional outcomes. The superiority of double-row capsulolabral repair versus single-row repair remains uncertain because comparative studies assessing clinical outcomes have yet to be performed.

Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study.

PubMed

Jacobs, Cheryl L; Gross, Cynthia R; Messersmith, Emily E; Hong, Barry A; Gillespie, Brenda W; Hill-Callahan, Peg; Taler, Sandra J; Jowsey, Sheila G; Beebe, Tim J; Matas, Arthur J; Odim, Jonah; Ibrahim, Hassan N

2015-12-07

Most kidney donors view their experience positively, but some may experience psychosocial and financial burdens. We hypothesized that certain donor characteristics, poor outcome of the recipient, negative perceptions of care, and lack of support may be associated with poor psychosocial outcomes for donors. The Renal and Lung Living Donors Evaluation Study (RELIVE) examined long-term medical and psychosocial outcomes for kidney donors (at three U.S. transplant centers) who donated between 1963 and 2005. Standardized questionnaires evaluated donor perspectives, recovery time, social support, motivation, financial impact, insurability after donation, and current psychological status. Questionnaires were mailed to 6909 donors. Questionnaires were returned by 2455 donors, who had donated 17 ± 10 years earlier (range, 5-48 years), a response rate of 36%. Most (95%) rated their overall donation experience as good to excellent. Rating the overall donor experience more negatively was associated with donor complications, psychological difficulties, recipient graft failure, and longer time since donation. Nine percent (n=231) reported one or more of the following poor psychosocial outcomes: fair or poor overall donor experience, financial burden, regret or discomfort with decision to donate, or psychological difficulties since donation. Recipient graft failure was the only predictor for reporting one or more of these poor psychosocial outcomes (odds ratio, 1.77; 95% confidence interval, 1.33 to 2.34). Donors with lower educational attainment experienced greater financial burden. One of five employed donors took unpaid leave; 2% reported health and life insurability concerns. Although the majority of donors viewed their overall donation experience positively, almost 1 in 10 donors reported at least one negative consequence related to donation. Recipient graft failure was associated with poor psychosocial outcome, defined as one or more of these negative consequences. Some donors were financially disadvantaged, and some experienced insurance difficulties. Interventions to avoid negative psychosocial and financial consequences are warranted. Copyright © 2015 by the American Society of Nephrology.

Soluble ST2 in ambulatory patients with heart failure: Association with functional capacity and long-term outcomes.

PubMed

Felker, G Michael; Fiuzat, Mona; Thompson, Vivian; Shaw, Linda K; Neely, Megan L; Adams, Kirkwood F; Whellan, David J; Donahue, Mark P; Ahmad, Tariq; Kitzman, Dalane W; Piña, Ileana L; Zannad, Faiez; Kraus, William E; O'Connor, Christopher M

2013-11-01

ST2 is involved in cardioprotective signaling in the myocardium and has been identified as a potentially promising biomarker in heart failure (HF). We evaluated ST2 levels and their association with functional capacity and long-term clinical outcomes in a cohort of ambulatory patients with HF enrolled in the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study-a multicenter, randomized study of exercise training in HF. HF-ACTION randomized 2331 patients with left ventricular ejection fraction <0.35 and New York Heart Association class II to IV HF to either exercise training or usual care. ST2 was analyzed in a subset of 910 patients with evaluable plasma samples. Correlations and Cox models were used to assess the relationship among ST2, functional capacity, and long-term outcomes. The median baseline ST2 level was 23.7 ng/mL (interquartile range, 18.6-31.8). ST2 was modestly associated with measures of functional capacity. In univariable analysis, ST2 was significantly associated with death or hospitalization (hazard ratio, 1.48; P<0.0001), cardiovascular death or HF hospitalization (hazard ratio, 2.14; P<0.0001), and all-cause mortality (hazard ratio, 2.33; P<0.0001; all hazard ratios for log2 ng/mL). In multivariable models, ST2 remained independently associated with outcomes after adjustment for clinical variables and amino-terminal pro-B-type natriuretic peptide. However, ST2 did not add significantly to reclassification of risk as assessed by changes in the C statistic, net reclassification improvement, and integrated discrimination improvement. ST2 was modestly associated with functional capacity and was significantly associated with outcomes in a well-treated cohort of ambulatory patients with HF although it did not significantly affect reclassification of risk. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00047437.

Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study

PubMed Central

Gross, Cynthia R.; Messersmith, Emily E.; Hong, Barry A.; Gillespie, Brenda W.; Hill-Callahan, Peg; Taler, Sandra J.; Jowsey, Sheila G.; Beebe, Tim J.; Matas, Arthur J.; Odim, Jonah; Ibrahim, Hassan N.

2015-01-01

Background and objectives Most kidney donors view their experience positively, but some may experience psychosocial and financial burdens. We hypothesized that certain donor characteristics, poor outcome of the recipient, negative perceptions of care, and lack of support may be associated with poor psychosocial outcomes for donors. Design, setting, participants, & measurements The Renal and Lung Living Donors Evaluation Study (RELIVE) examined long-term medical and psychosocial outcomes for kidney donors (at three U.S. transplant centers) who donated between 1963 and 2005. Standardized questionnaires evaluated donor perspectives, recovery time, social support, motivation, financial impact, insurability after donation, and current psychological status. Questionnaires were mailed to 6909 donors. Results Questionnaires were returned by 2455 donors, who had donated 17±10 years earlier (range, 5–48 years), a response rate of 36%. Most (95%) rated their overall donation experience as good to excellent. Rating the overall donor experience more negatively was associated with donor complications, psychological difficulties, recipient graft failure, and longer time since donation. Nine percent (n=231) reported one or more of the following poor psychosocial outcomes: fair or poor overall donor experience, financial burden, regret or discomfort with decision to donate, or psychological difficulties since donation. Recipient graft failure was the only predictor for reporting one or more of these poor psychosocial outcomes (odds ratio, 1.77; 95% confidence interval, 1.33 to 2.34). Donors with lower educational attainment experienced greater financial burden. One of five employed donors took unpaid leave; 2% reported health and life insurability concerns. Conclusions Although the majority of donors viewed their overall donation experience positively, almost 1 in 10 donors reported at least one negative consequence related to donation. Recipient graft failure was associated with poor psychosocial outcome, defined as one or more of these negative consequences. Some donors were financially disadvantaged, and some experienced insurance difficulties. Interventions to avoid negative psychosocial and financial consequences are warranted. PMID:26463883

Economic impact of heart failure according to the effects of kidney failure.

PubMed

Sicras Mainar, Antoni; Navarro Artieda, Ruth; Ibáñez Nolla, Jordi

2015-01-01

To evaluate the use of health care resources and their cost according to the effects of kidney failure in heart failure patients during 2-year follow-up in a population setting. Observational retrospective study based on a review of medical records. The study included patients ≥ 45 years treated for heart failure from 2008 to 2010. The patients were divided into 2 groups according to the presence/absence of KF. Main outcome variables were comorbidity, clinical status (functional class, etiology), metabolic syndrome, costs, and new cases of cardiovascular events and kidney failure. The cost model included direct and indirect health care costs. Statistical analysis included multiple regression models. The study recruited 1600 patients (prevalence, 4.0%; mean age 72.4 years; women, 59.7%). Of these patients, 70.1% had hypertension, 47.1% had dyslipidemia, and 36.2% had diabetes mellitus. We analyzed 433 patients (27.1%) with kidney failure and 1167 (72.9%) without kidney failure. Patients with kidney failure were associated with functional class III-IV (54.1% vs 40.8%) and metabolic syndrome (65.3% vs 51.9%, P<.01). The average unit cost was €10,711.40. The corrected cost in the presence of kidney failure was €14,868.20 vs €9,364.50 (P=.001). During follow-up, 11.7% patients developed ischemic heart disease, 18.8% developed kidney failure, and 36.1% developed heart failure exacerbation. Comorbidity associated with heart failure is high. The presence of kidney failure increases the use of health resources and leads to higher costs within the National Health System. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

rhBMP-2 protects against reoperation for pseudoarthrosis and/or instrumentation failure: A matched case-control study of 448 patients.

PubMed

Macki, Mohamed; Syeda, Sbaa; Kerezoudis, Panagiotis; Bydon, Ali; Witham, Timothy F; Sciubba, Daniel M; Wolinsky, Jean-Paul; Bydon, Mohamad; Gokaslan, Ziya

2016-10-01

The objective of this independent study is to determine the impact of recombinant human bone morphogenetic protein 2 (rhBMP-2) on reoperation for pseudarthrosis and/or instrumentation failure. A nested case-control study of first-time posterolateral, instrumented fusion of the lumbar spine for degenerative spinal disease was undertaken. Cases of reoperation for pseudoarthrosis and/or instrumentation failure were assigned to controls, who did not experience the primary outcome measure at the time of reoperation. Cases and controls were matched on number of interspaces fused and inclusion of interbody. Predictors of reoperation for pseudoarthrosis and/or instrumentation failure were assessed with a conditional logistical regression controlling for rhBMP-2, age, obesity, and smoking. Of the 448 patients, 155 cases of reoperation for pseudoarthrosis and/or instrumentation were matched with 293 controls. Twenty-six percent of first-time surgeries included rhBMP-2, which was statistically more commonly used in the control cohort (33.11%) versus the case cohort (12.90%) (Unadjusted odds ratio [ORunadj]=0.28) (95% confidence interval [CI]: 0.16-0.49). Following a multivariate analysis controlling for age, obesity, and smoking, the rhBMP-2 recipients incurred a 73% lower odds of reoperation for pseudoarthrosis and/or instrumentation failure (95% CI, 0.15-0.48). Neither sarcomatous nor osseous neoplasm was detected in the study population. Mean follow up did not differ between the cases (81.57±standard deviation [SD] 4.98months) versus controls (74.75±2.49month) (ORunadj=1.01) (95% CI: 1.00-1.01). rhBMP-2 in lumbar fusion constructs protects against reoperation for pseudoarthrosis and/or instrumentation failure. However, the decision to include fusion supplements should be weighted between surgical determinants and clinical outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

Haemodialysis-membrane biocompatibility and mortality of patients with dialysis-dependent acute renal failure: a prospective randomised multicentre trial. International Multicentre Study Group.

PubMed

Jörres, A; Gahl, G M; Dobis, C; Polenakovic, M H; Cakalaroski, K; Rutkowski, B; Kisielnicka, E; Krieter, D H; Rumpf, K W; Guenther, C; Gaus, W; Hoegel, J

1999-10-16

There is controversy as to whether haemodialysis-membrane biocompatibility (ie, the potential to activate complement and neutrophils) influences mortality of patients with acute renal failure. We did a prospective randomised multicentre trial in patients with dialysis-dependent acute renal failure treated with two different types of low-flux membrane. 180 patients with acute renal failure were randomly assigned bioincompatible Cuprophan (n=90) or polymethyl-methacrylate (n=90) membranes. The main outcome was survival 14 days after the end of therapy (treatment success). Odds ratios for survival were calculated and the two groups were compared by Fisher's exact test. Analyses were based on patients treated according to protocol (76 Cuprophan, 84 polymethyl methacrylate). At the start of dialysis, the groups did not differ significantly in age, sex, severity of illness (as calculated by APACHE II scores), prevalence of oliguria, or biochemical measures of acute renal failure. 44 patients (58% [95% CI 46-69]) assigned Cuprophan membranes and 50 patients (60% [48-70]) assigned polymethyl-methacrylate membranes survived. The odds ratio for treatment failure on Cuprophan compared with polymethyl-methacrylate membranes was 1.07 (0.54-2.11; p=0.87). No difference between Cuprophan and polymethyl-methacrylate membranes was detected when the analysis was adjusted for age and APACHE II score. 18 patients in the Cuprophan group and 20 in the polymethyl-methacrylate group had clinical complications of therapy (mainly hypotension). There were no differences in outcome for patients with dialysis-dependent acute renal failure between those treated with Cuprophan membranes and those treated with polymethyl-methacrylate membranes.

Benchmarking Outcomes in the Critically Injured Trauma Patient and the Effect of Implementing Standard Operating Procedures

PubMed Central

Cuschieri, Joseph; Johnson, Jeffrey L.; Sperry, Jason; West, Michael A.; Moore, Ernest E.; Minei, Joseph P.; Bankey, Paul E.; Nathens, Avery B.; Cuenca, Alex G.; Efron, Philip A.; Hennessy, Laura; Xiao, Wenzhong; Mindrinos, Michael N.; McDonald-Smith, Grace P.; Mason, Philip H.; Billiar, Timothy R.; Schoenfeld, David A.; Warren, H. Shaw; Cobb, J. Perren; Moldawer, Lyle L.; Davis, Ronald W.; Maier, Ronald V.; Tompkins, Ronald G.

2012-01-01

Objective To determine and compare outcomes with accepted benchmarks in trauma care at seven academic Level I trauma centers in which patients were treated based on a series of standard operating procedures (SOPs). Background Injury remains the leading cause of death for those under 45 years of age. We describe the baseline patient characteristics and well-defined outcomes of persons hospitalized in the United States for severe blunt trauma. Methods We followed 1,637 trauma patients from 2003–2009 up to 28 hospital days using SOPs developed at the onset of the study. An extensive database on patient and injury characteristics, clinical treatment, and outcomes was created. These data were compared with existing trauma benchmarks. Results The study patients were critically injured and in shock. SOP compliance improved 10–40% during the study period. Multiple organ failure and mortality rates were 34.8% and 16.7% respectively. Time to recovery, defined as the time until the patient was free of organ failure for at least two consecutive days, was developed as a new outcome measure. There was a reduction in mortality rate in the cohort during the study that cannot be explained by changes in the patient population. Conclusions This study provides the current benchmark and the overall positive effect of implementing SOPs for severely injured patients. Over the course of the study, there were improvements in morbidity and mortality and increasing compliance with SOPs. Mortality was surprisingly low, given the degree of injury, and improved over the duration of the study, which correlated with improved SOP compliance. PMID:22470077

Heart failure and the discrepancy between trials of intensive blood pressure management: an analysis of individual patient data.

PubMed

Aggarwal, Rahul; Mirzan, Haares; Chiu, Nicholas; Steinkamp, Jackson

2018-02-26

ACCORD and SPRINT are the best randomized controlled trial data evaluating the effects of blood pressure targets below 140 mmHg. These trials had contradictory results regarding the benefits of intensive antihypertensive therapy. We investigate if this discordance was driven by SPRINT's inclusion of Heart Failure in its primary outcome, as this is a parameter not included in ACCORD's original primary outcome. This analysis helps to resolve a significant area of contention. Individual patient data from 4733 participants in ACCORD were analyzed from time of randomization. All participants were diabetic and at increased cardiovascular risk. Participants were assigned to their original intervention, a standard blood pressure target of less than 140 mmHg or an intensive target of less than 120 mmHg. Primary composite outcome was defined as in SPRINT: a composite of first occurrence of myocardial infarction, stroke, heart failure, death from cardiovascular causes, and other acute coronary syndromes. Primary outcome was not significantly different between standard and intensive groups [HR: 0.89; 95% CI: (0.76-1.03); p = 0.108]. The primary composite outcome occurred in 370 participants in the standard group (15.6%) and 324 participants in the intensive group (13.7%), with an event rate of 3.38% per year for the standard group and 3.01% per year for the intensive group. Differing results between ACCORD and SPRINT are not attributable to ACCORD's exclusion of Heart Failure from its original primary outcome measurement. No significant differences in primary outcome were observed between intensive and standard blood pressure groups in the ACCORD patients under the SPRINT primary outcome definition. Caution should be taken in extrapolating the intensive blood pressure control benefits of SPRINT to the diabetic population.

Risk factors for early failure after peripheral endovascular intervention: application of a reliability engineering approach.

PubMed

Meltzer, Andrew J; Graham, Ashley; Connolly, Peter H; Karwowski, John K; Bush, Harry L; Frazier, Peter I; Schneider, Darren B

2013-01-01

We apply an innovative and novel analytic approach, based on reliability engineering (RE) principles frequently used to characterize the behavior of manufactured products, to examine outcomes after peripheral endovascular intervention. We hypothesized that this would allow for improved prediction of outcome after peripheral endovascular intervention, specifically with regard to identification of risk factors for early failure. Patients undergoing infrainguinal endovascular intervention for chronic lower-extremity ischemia from 2005 to 2010 were identified in a prospectively maintained database. The primary outcome of failure was defined as patency loss detected by duplex ultrasonography, with or without clinical failure. Analysis included univariate and multivariate Cox regression models, as well as RE-based analysis including product life-cycle models and Weibull failure plots. Early failures were distinguished using the RE principle of "basic rating life," and multivariate models identified independent risk factors for early failure. From 2005 to 2010, 434 primary endovascular peripheral interventions were performed for claudication (51.8%), rest pain (16.8%), or tissue loss (31.3%). Fifty-five percent of patients were aged ≥75 years; 57% were men. Failure was noted after 159 (36.6%) interventions during a mean follow-up of 18 months (range, 0-71 months). Using multivariate (Cox) regression analysis, rest pain and tissue loss were independent predictors of patency loss, with hazard ratios of 2.5 (95% confidence interval, 1.6-4.1; P < 0.001) and 3.2 (95% confidence interval, 2.0-5.2, P < 0.001), respectively. The distribution of failure times for both claudication and critical limb ischemia fit distinct Weibull plots, with different characteristics: interventions for claudication demonstrated an increasing failure rate (β = 1.22, θ = 13.46, mean time to failure = 12.603 months, index of fit = 0.99037, R(2) = 0.98084), whereas interventions for critical limb ischemia demonstrated a decreasing failure rate, suggesting the predominance of early failures (β = 0.7395, θ = 6.8, mean time to failure = 8.2, index of fit = 0.99391, R(2) = 0.98786). By 3.1 months, 10% of interventions failed. This point (90% reliability) was identified as the basic rating life. Using multivariate analysis of failure data, independent predictors of early failure (before 3.1 months) included tissue loss, long lesion length, chronic total occlusions, heart failure, and end-stage renal disease. Application of a RE framework to the assessment of clinical outcomes after peripheral interventions is feasible, and potentially more informative than traditional techniques. Conceptualization of interventions as "products" permits application of product life-cycle models that allow for empiric definition of "early failure" may facilitate comparative effectiveness analysis and enable the development of individualized surveillance programs after endovascular interventions. Copyright © 2013 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.

Clinical characteristics, precipitating factors, management and outcome of patients with prior stroke hospitalised with heart failure: an observational report from the Middle East

PubMed Central

Khafaji, Hadi A R; Sulaiman, Kadhim; Singh, Rajvir; AlHabib, Khalid F; Asaad, Nidal; Alsheikh-Ali, Alawi; Al-Jarallah, Mohammed; Bulbanat, Bassam; AlMahmeed, Wael; Ridha, Mustafa; Bazargani, Nooshin; Amin, Haitham; Al-Motarreb, Ahmed; AlFaleh, Hussam; Elasfar, Abdelfatah; Panduranga, Prashanth; Al Suwaidi, Jassim

2015-01-01

Objectives The purpose of this study is to report the prevalence, clinical characteristics, precipitating factors, management and outcome of patients with prior stroke hospitalised with acute heart failure (HF). Design Retrospective analysis of prospectively collected data. Setting Data were derived from Gulf CARE (Gulf aCute heArt failuRe rEgistry), a prospective multicentre study of consecutive patients hospitalised with acute HF in 2012 in seven Middle Eastern countries and analysed according to the presence or absence of prior stroke; demographics, management and outcomes were compared. Participants A total of 5005 patients with HF. Outcome measures In-hospital and 1-year outcome. Results The prevalence of prior stroke in patients with HF was 8.1%. Patients with stroke with HF were more likely to be admitted under the care of internists rather than cardiologists. When compared with patients without stroke, patients with stroke were more likely to be older and to have diabetes mellitus, hypertension, atrial fibrillation, hyperlipidaemia, chronic kidney disease, ischaemic heart disease, peripheral arterial disease and left ventricular dysfunction (p=0.001 for all). Patients with stroke were less likely to be smokers (0.003). There were no significant differences in terms of precipitating risk factors for HF hospitalisation between the two groups. Patients with stroke with HF had a longer hospital stay (mean±SD days; 11±14 vs 9±13, p=0.03), higher risk of recurrent strokes and 1-year mortality rates (32.7% vs 23.2%, p=0.001). Multivariate logistic regression analysis showed that stroke is an independent predictor of in-hospital and 1-year mortality. Conclusions This observational study reports high prevalence of prior stroke in patients hospitalised with HF. Internists rather than cardiologists were the predominant caregivers in this high-risk group. Patients with stroke had higher risk of in-hospital recurrent strokes and long-term mortality rates. Trial registration number NCT01467973. PMID:25908674

Association of chronic kidney disease with abnormal cardiac mechanics and adverse outcomes in patients with heart failure and preserved ejection fraction.

PubMed

Unger, Erin D; Dubin, Ruth F; Deo, Rajat; Daruwalla, Vistasp; Friedman, Julie L; Medina, Crystal; Beussink, Lauren; Freed, Benjamin H; Shah, Sanjiv J

2016-01-01

Chronic kidney disease (CKD) is associated with worse outcomes in heart failure with preserved ejection fraction (HFpEF). Whether this association is due the effect of CKD on intrinsic abnormalities in cardiac function is unknown. We hypothesized that CKD is independently associated with worse cardiac mechanics in HFpEF. We prospectively studied 299 patients enrolled in the Northwestern University HFpEF Program. Using the creatinine-based CKD-Epi equation to calculate estimated glomerular filtration rate (eGFR), study participants were analysed by CKD status (using eGFR <60 mL/min/1.73 m(2) to denote CKD). Indices of cardiac mechanics (longitudinal strain parameters) were measured using speckle-tracking echocardiography. Using multivariable-adjusted linear and Cox regression analyses, we determined the association between CKD and echocardiographic parameters and clinical outcomes (cardiovascular hospitalization or death). Of 299 study participants, 48% had CKD. CKD (dichotomous variable) and reduced eGFR (continuous variable) were both associated with worse cardiac mechanics indices including left atrial (LA) reservoir strain, LV longitudinal strain, and right ventricular free wall strain even after adjusting for potential confounders, including co-morbidities, EF, and volume status. For example, for each 1-SD decrease in eGFR, LA reservoir strain was 3.52% units lower (P < 0.0001) after multivariable adjustment. Reduced eGFR was also associated with worse outcomes [adjusted hazard ratio (HR) 1.28, 95% confidence interval (CI) 1.01-1.61 per 1-SD decrease in eGFR; P = 0.039]. The association was attenuated after adjustment for indices of cardiac mechanics (P = 0.064). In HFpEF, CKD is independently associated with worse cardiac mechanics, which may explain why HFpEF patients with CKD have worse outcomes. NCT01030991. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial

PubMed Central

Fitchett, David; Zinman, Bernard; Wanner, Christoph; Lachin, John M.; Hantel, Stefan; Salsali, Afshin; Johansen, Odd Erik; Woerle, Hans J.; Broedl, Uli C.; Inzucchi, Silvio E.

2016-01-01

Abstract Aims We previously reported that in the EMPA-REG OUTCOME® trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure outcomes in all patients and in subgroups, including patients with or without baseline heart failure. Methods and results Patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Seven thousand and twenty patients were treated; 706 (10.1%) had heart failure at baseline. Heart failure hospitalization or cardiovascular death occurred in a significantly lower percentage of patients treated with empagliflozin [265/4687 patients (5.7%)] than with placebo [198/2333 patients (8.5%)] [hazard ratio, HR: 0.66 (95% confidence interval: 0.55–0.79); P < 0.001], corresponding to a number needed to treat to prevent one heart failure hospitalization or cardiovascular death of 35 over 3 years. Consistent effects of empagliflozin were observed across subgroups defined by baseline characteristics, including patients with vs. without heart failure, and across categories of medications to treat diabetes and/or heart failure. Empagliflozin improved other heart failure outcomes, including hospitalization for or death from heart failure [2.8 vs. 4.5%; HR: 0.61 (0.47–0.79); P < 0.001] and was associated with a reduction in all-cause hospitalization [36.8 vs. 39.6%; HR: 0.89 (0.82–0.96); P = 0.003]. Serious adverse events and adverse events leading to discontinuation were reported by a higher proportion of patients with vs. without heart failure at baseline in both treatment groups, but were no more common with empagliflozin than with placebo. Conclusion In patients with type 2 diabetes and high cardiovascular risk, empagliflozin reduced heart failure hospitalization and cardiovascular death, with a consistent benefit in patients with and without baseline heart failure. PMID:26819227

Failure of Anterior Cruciate Ligament Reconstruction

PubMed Central

Samitier, Gonzalo; Marcano, Alejandro I.; Alentorn-Geli, Eduard; Cugat, Ramon; Farmer, Kevin W; Moser, Michael W

2015-01-01

The present review classifies and describes the multifactorial causes of anterior cruciate ligament (ACL) surgery failure, concentrating on preventing and resolving such situations. The article particularly focuses on those causes that require ACL revision due to recurrent instability, without neglecting those that affect function or produce persistent pain. Although primary ACL reconstruction has satisfactory outcome rates as high as 97%, it is important to identify the causes of failure, because satisfactory outcomes in revision surgery can drop to as much as 76%. It is often possible to identify a primary or secondary cause of ACL surgery failure; even the most meticulous planning can give rise to unexpected findings during the intervention. The adopted protocol should therefore be sufficiently flexible to adapt to the course of surgery. Preoperative patient counseling is essential. The surgeon should limit the patient’s expectations for the outcome by explaining the complexity of this kind of procedure. With adequate preoperative planning, close attention to details and realistic patient expectations, ACL revision surgery may offer beneficial and satisfactory results for the patient. PMID:26550585

A self-controlled case series to assess the effectiveness of beta blockers for heart failure in reducing hospitalisations in the elderly.

PubMed

Ramsay, Emmae N; Roughead, Elizabeth E; Ewald, Ben; Pratt, Nicole L; Ryan, Philip

2011-07-18

To determine the suitability of using the self-controlled case series design to assess improvements in health outcomes using the effectiveness of beta blockers for heart failure in reducing hospitalisations as the example. The Australian Government Department of Veterans' Affairs administrative claims database was used to undertake a self-controlled case-series in elderly patients aged 65 years or over to compare the risk of a heart failure hospitalisation during periods of being exposed and unexposed to a beta blocker. Two studies, the first using a one year period and the second using a four year period were undertaken to determine if the estimates varied due to changes in severity of heart failure over time. In the one year period, 3,450 patients and in the four year period, 12, 682 patients had at least one hospitalisation for heart failure. The one year period showed a non-significant decrease in hospitalisations for heart failure 4-8 months after starting beta-blockers, (RR, 0.76; 95% CI (0.57-1.02)) and a significant decrease in the 8-12 months post-initiation of a beta blocker for heart failure (RR, 0.62; 95% CI (0.39, 0.99)). For the four year study there was an increased risk of hospitalisation less than eight months post-initiation and significant but smaller decrease in the 8-12 month window (RR, 0.90; 95% CI (0.82, 0.98)). The results of the one year observation period are similar to those observed in randomised clinical trials indicating that the self-controlled case-series method can be successfully applied to assess health outcomes. However, the result appears sensitive to the study periods used and further research to understand the appropriate applications of this method in pharmacoepidemiology is still required. The results also illustrate the benefits of extending beta blocker utilisation to the older age group of heart failure patients in which their use is common but the evidence is sparse.

Cardiac-resynchronization therapy in heart failure with a narrow QRS complex.

PubMed

Ruschitzka, Frank; Abraham, William T; Singh, Jagmeet P; Bax, Jeroen J; Borer, Jeffrey S; Brugada, Josep; Dickstein, Kenneth; Ford, Ian; Gorcsan, John; Gras, Daniel; Krum, Henry; Sogaard, Peter; Holzmeister, Johannes

2013-10-10

Cardiac-resynchronization therapy (CRT) reduces morbidity and mortality in chronic systolic heart failure with a wide QRS complex. Mechanical dyssynchrony also occurs in patients with a narrow QRS complex, which suggests the potential usefulness of CRT in such patients. We conducted a randomized trial involving 115 centers to evaluate the effect of CRT in patients with New York Heart Association class III or IV heart failure, a left ventricular ejection fraction of 35% or less, a QRS duration of less than 130 msec, and echocardiographic evidence of left ventricular dyssynchrony. All patients underwent device implantation and were randomly assigned to have CRT capability turned on or off. The primary efficacy outcome was the composite of death from any cause or first hospitalization for worsening heart failure. On March 13, 2013, the study was stopped for futility on the recommendation of the data and safety monitoring board. At study closure, the 809 patients who had undergone randomization had been followed for a mean of 19.4 months. The primary outcome occurred in 116 of 404 patients in the CRT group, as compared with 102 of 405 in the control group (28.7% vs. 25.2%; hazard ratio, 1.20; 95% confidence interval [CI], 0.92 to 1.57; P=0.15). There were 45 deaths in the CRT group and 26 in the control group (11.1% vs. 6.4%; hazard ratio, 1.81; 95% CI, 1.11 to 2.93; P=0.02). In patients with systolic heart failure and a QRS duration of less than 130 msec, CRT does not reduce the rate of death or hospitalization for heart failure and may increase mortality. (Funded by Biotronik and GE Healthcare; EchoCRT ClinicalTrials.gov number, NCT00683696.).

Remote Monitoring of Patients With Heart Failure: An Overview of Systematic Reviews

PubMed Central

Karunanithi, Mohanraj; Fatehi, Farhad; Ding, Hang; Walters, Darren

2017-01-01

Background Many systematic reviews exist on the use of remote patient monitoring (RPM) interventions to improve clinical outcomes and psychological well-being of patients with heart failure. However, research is broadly distributed from simple telephone-based to complex technology-based interventions. The scope and focus of such evidence also vary widely, creating challenges for clinicians who seek information on the effect of RPM interventions. Objective The aim of this study was to investigate the effects of RPM interventions on the health outcomes of patients with heart failure by synthesizing review-level evidence. Methods We searched PubMed, EMBASE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library from 2005 to 2015. We screened reviews based on relevance to RPM interventions using criteria developed for this overview. Independent authors screened, selected, and extracted information from systematic reviews. AMSTAR (Assessment of Multiple Systematic Reviews) was used to assess the methodological quality of individual reviews. We used standardized language to summarize results across reviews and to provide final statements about intervention effectiveness. Results A total of 19 systematic reviews met our inclusion criteria. Reviews consisted of RPM with diverse interventions such as telemonitoring, home telehealth, mobile phone–based monitoring, and videoconferencing. All-cause mortality and heart failure mortality were the most frequently reported outcomes, but others such as quality of life, rehospitalization, emergency department visits, and length of stay were also reported. Self-care and knowledge were less commonly identified. Conclusions Telemonitoring and home telehealth appear generally effective in reducing heart failure rehospitalization and mortality. Other interventions, including the use of mobile phone–based monitoring and videoconferencing, require further investigation. PMID:28108430

Remote Monitoring of Patients With Heart Failure: An Overview of Systematic Reviews.

PubMed

Bashi, Nazli; Karunanithi, Mohanraj; Fatehi, Farhad; Ding, Hang; Walters, Darren

2017-01-20

Many systematic reviews exist on the use of remote patient monitoring (RPM) interventions to improve clinical outcomes and psychological well-being of patients with heart failure. However, research is broadly distributed from simple telephone-based to complex technology-based interventions. The scope and focus of such evidence also vary widely, creating challenges for clinicians who seek information on the effect of RPM interventions. The aim of this study was to investigate the effects of RPM interventions on the health outcomes of patients with heart failure by synthesizing review-level evidence. We searched PubMed, EMBASE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the Cochrane Library from 2005 to 2015. We screened reviews based on relevance to RPM interventions using criteria developed for this overview. Independent authors screened, selected, and extracted information from systematic reviews. AMSTAR (Assessment of Multiple Systematic Reviews) was used to assess the methodological quality of individual reviews. We used standardized language to summarize results across reviews and to provide final statements about intervention effectiveness. A total of 19 systematic reviews met our inclusion criteria. Reviews consisted of RPM with diverse interventions such as telemonitoring, home telehealth, mobile phone-based monitoring, and videoconferencing. All-cause mortality and heart failure mortality were the most frequently reported outcomes, but others such as quality of life, rehospitalization, emergency department visits, and length of stay were also reported. Self-care and knowledge were less commonly identified. Telemonitoring and home telehealth appear generally effective in reducing heart failure rehospitalization and mortality. Other interventions, including the use of mobile phone-based monitoring and videoconferencing, require further investigation. ©Nazli Bashi, Mohanraj Karunanithi, Farhad Fatehi, Hang Ding, Darren Walters. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 20.01.2017.

Poor short term outcome with a metal-on-metal total hip arthroplasty.

PubMed

Levy, Yadin D; Ezzet, Kace A

2013-08-01

Metal-on-metal (MoM) bearings for total hip arthroplasty (THA) have come under scrutiny with reports of high failure rates. Clinical outcome studies with several commercially available MoM THA bearings remain unreported. We evaluated 78 consecutive MoM THAs from a single manufacturer in 68 patients. Sixty-six received cobalt-chrome (CoCr) monoblock and 12 received modular titanium acetabular cups with internal CoCr liners. Femoral components were titanium with modular necks. At average 2.1 years postoperatively, 12 THAs (15.4%) demonstrated aseptic failure (10 revisions, 2 revision recommended). All revised hips demonstrated capsular necrosis with positive histology reaction for aseptic lymphocytic vasculitis-associated lesions/adverse local tissue reactions. Prosthetic instability following revision surgery was relatively common. Female gender was a strong risk factor for failure, though smaller cups were not. Both monoblock and modular components fared poorly. Corrosion was frequently observed around the proximal and distal end of the modular femoral necks. Copyright © 2013 Elsevier Inc. All rights reserved.

Failure mechanisms of fibrin-based surgical tissue adhesives

NASA Astrophysics Data System (ADS)

Sierra, David Hugh

A series of studies was performed to investigate the potential impact of heterogeneity in the matrix of multiple-component fibrin-based tissue adhesives upon their mechanical and biomechanical properties both in vivo and in vitro. Investigations into the failure mechanisms by stereological techniques demonstrated that heterogeneity could be measured quantitatively and that the variation in heterogeneity could be altered both by the means of component mixing and delivery and by the formulation of the sealant. Ex vivo tensile adhesive strength was found to be inversely proportional to the amount of heterogeneity. In contrast, in vivo tensile wound-closure strength was found to be relatively unaffected by the degree of heterogeneity, while in vivo parenchymal organ hemostasis in rabbits was found to be affected: greater heterogeneity appeared to correlate with an increase in hemostasis time and amount of sealant necessary to effect hemostasis. Tensile testing of the bulk sealant showed that mechanical parameters were proportional to fibrin concentration and that the physical characteristics of the failure supported a ductile mechanism. Strain hardening as a function of percentage of strain, and strain rate was observed for both concentrations, and syneresis was observed at low strain rates for the lower fibrin concentration. Blister testing demonstrated that burst pressure and failure energy were proportional to fibrin concentration and decreased with increasing flow rate. Higher fibrin concentration demonstrated predominately compact morphology debonds with cohesive failure loci, demonstrating shear or viscous failure in a viscoelastic rubbery adhesive. The lower fibrin concentration sealant exhibited predominately fractal morphology debonds with cohesive failure loci, supporting an elastoviscous material condition. The failure mechanism for these was hypothesized and shown to be flow-induced ductile fracture. Based on these findings, the failure mechanism was stochastic in nature because the mean failure energy and burst pressure values were not predictive of locus and morphology. Instead, flow rate and fibrin concentration showed the most predictive value, with the outcome best described as a probability distribution rather than a specific deterministic outcome.

Heart rate at first postdischarge visit and outcomes in patients with heart failure.

PubMed

Kim, Tae-Hun; Kim, Hyungseop; Kim, In-Cheol; Yoon, Hyuck-Jun; Park, Hyoung-Seob; Cho, Yun-Kyeong; Nam, Chang-Wook; Han, Seongwook; Hur, Seung-Ho; Kim, Yoon-Nyun

2018-07-01

Heart rate control is important to prevent adverse outcomes in patients with heart failure (HF). However, postdischarge activity may worsen heart rate control, resulting in readmission. This study aimed to explore the implications of the heart rate differences between discharge and the first outpatient visit (D-O diff). We retrospectively identified 458 patients (male: 46%; mean age: 72 years) discharged after HF. The heart rates at admission, discharge and first outpatient visit were analysed. The primary outcome was a composite of cardiovascular (CV) death and readmission of non-fatal myocardial infarction (MI), non-fatal stroke or non-fatal HF over a mean follow-up of 16 months. During follow-up, the clinical outcomes were noted in 223 patients (49%): HF, 199; stroke, 9; MI, 6; CV death, 9. The heart rate at the first outpatient visit (r=-0.311, P<0.001) and D-O diff (r=0.416, P<0.001) showed a better correlation with the time-to-clinical event than the heart rate at admission or discharge. The events group displayed a pronounced heart rate increase (13 beats/min) from discharge to the first outpatient visit compared with the event-free group (a decrease of 2 beats/min). A decrease less than -15 in the D-O diff showed a 4.5-fold risk of clinical outcomes during follow-up (P<0.001). A decreased D-O diff was related to the adverse outcomes of HF. The failure of heart rate control within more than 15 beats/min at the first outpatient visit was an independent factor for CV events. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Sacubitril/valsartan, a new and effective treatment for heart failure with reduced ejection fraction].

PubMed

Senni, Michele; Trimarco, Bruno; Emdin, Michele; De Biase, Luciano

2017-01-01

Despite significant therapeutic advances, patients with chronic heart failure and reduced ejection fraction (HFrEF) remain at high risk for heart failure progression and death. The PARADIGM-HF study, the largest outcome trial in HFrEF, has shown improved cardiovascular outcomes with sacubitril/valsartan (Entresto®, Novartis), previously known as LCZ696, compared with angiotensin-converting enzyme (ACE) inhibitor therapy, possibly leading us to a new era for heart failure treatment. Sacubitril/valsartan represents a first-in-class drug acting through inhibition of angiotensin receptor and neprilysin, thus modulating the renin-angiotensin-aldosterone system and vasoactive substances such as natriuretic peptides. This approach can be considered a "paradigm shift" from neurohumoral inhibition to neurohumoral modulation. Based on the PARADIGM-HF results, the European Society of Cardiology and the American Heart Association/American College of Cardiology guidelines proposed a substitution of ACE-inhibitor/angiotensin receptor blocker therapy rather than an "add-on" strategy in HFrEF. Sacubitril/valsartan can be considered a milestone in cardiovascular therapy, like aspirin, statins, beta-blockers. Of course there are many questions that arise spontaneously from this trial, three recognized experts can help us to answer them.

Parenteral Nutrition and Intestinal Failure

PubMed Central

Bielawska, Barbara; Allard, Johane P.

2017-01-01

Severe short bowel syndrome (SBS) is a major cause of chronic (Type 3) intestinal failure (IF) where structural and functional changes contribute to malabsorption and risk of micronutrient deficiencies. Chronic IF may be reversible, depending on anatomy and intestinal adaptation, but most patients require long-term nutritional support, generally in the form of parenteral nutrition (PN). SBS management begins with dietary changes and pharmacologic therapies taking into account individual anatomy and physiology, but these are rarely sufficient to avoid PN. New hormonal therapies targeting intestinal adaptation hold promise. Surgical options for SBS including intestinal transplant are available, but have significant limitations. Home PN (HPN) is therefore the mainstay of treatment for severe SBS. HPN involves chronic administration of macronutrients, micronutrients, fluid, and electrolytes via central venous access in the patient’s home. HPN requires careful clinical and biochemical monitoring. Main complications of HPN are related to venous access (infection, thrombosis) and metabolic complications including intestinal failure associated liver disease (IFALD). Although HPN significantly impacts quality of life, outcomes are generally good and survival is mostly determined by the underlying disease. As chronic intestinal failure is a rare disease, registries are a promising strategy for studying HPN patients to improve outcomes. PMID:28481229

Parenteral Nutrition and Intestinal Failure.

PubMed

Bielawska, Barbara; Allard, Johane P

2017-05-06

Severe short bowel syndrome (SBS) is a major cause of chronic (Type 3) intestinal failure (IF) where structural and functional changes contribute to malabsorption and risk of micronutrient deficiencies. Chronic IF may be reversible, depending on anatomy and intestinal adaptation, but most patients require long-term nutritional support, generally in the form of parenteral nutrition (PN). SBS management begins with dietary changes and pharmacologic therapies taking into account individual anatomy and physiology, but these are rarely sufficient to avoid PN. New hormonal therapies targeting intestinal adaptation hold promise. Surgical options for SBS including intestinal transplant are available, but have significant limitations. Home PN (HPN) is therefore the mainstay of treatment for severe SBS. HPN involves chronic administration of macronutrients, micronutrients, fluid, and electrolytes via central venous access in the patient's home. HPN requires careful clinical and biochemical monitoring. Main complications of HPN are related to venous access (infection, thrombosis) and metabolic complications including intestinal failure associated liver disease (IFALD). Although HPN significantly impacts quality of life, outcomes are generally good and survival is mostly determined by the underlying disease. As chronic intestinal failure is a rare disease, registries are a promising strategy for studying HPN patients to improve outcomes.

Donor age and early graft failure after lung transplantation: a cohort study.

PubMed

Baldwin, M R; Peterson, E R; Easthausen, I; Quintanilla, I; Colago, E; Sonett, J R; D'Ovidio, F; Costa, J; Diamond, J M; Christie, J D; Arcasoy, S M; Lederer, D J

2013-10-01

Lungs from older adult organ donors are often unused because of concerns for increased mortality. We examined associations between donor age and transplant outcomes among 8860 adult lung transplant recipients using Organ Procurement and Transplantation Network and Lung Transplant Outcomes Group data. We used stratified Cox proportional hazard models and generalized linear mixed models to examine associations between donor age and both 1-year graft failure and primary graft dysfunction (PGD). The rate of 1-year graft failure was similar among recipients of lungs from donors age 18-64 years, but severely ill recipients (Lung Allocation Score [LAS] >47.7 or use of mechanical ventilation) of lungs from donors age 56-64 years had increased rates of 1-year graft failure (p-values for interaction = 0.04 and 0.02, respectively). Recipients of lungs from donors <18 and ≥65 years had increased rates of 1-year graft failure (adjusted hazard ratio [HR] 1.23, 95% CI 1.01-1.50 and adjusted HR 2.15, 95% CI 1.47-3.15, respectively). Donor age was not associated with the risk of PGD. In summary, the use of lungs from donors age 56 to 64 years may be safe for adult candidates without a high LAS and the use of lungs from pediatric donors is associated with a small increase in early graft failure. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.

Long-term outcome of patients with multiple [corrected] myeloma-related advanced renal failure following auto-SCT.

PubMed

Glavey, S V; Gertz, M A; Dispenzieri, A; Kumar, S; Buadi, F; Lacy, M; Hayman, S R; Kapoor, P; Dingli, D; McCurdy, A; Hogan, W J; Gastineau, D A; Leung, N

2013-11-01

Renal failure commonly complicates multiple myeloma (MM) and is associated with reduced survival. It is not clear whether auto-SCT results in improved renal function or attainment of independence from dialysis in patients with advanced renal impairment due to MM. We conducted a retrospective cohort study of all patients who underwent auto-SCT for MM complicated by advanced renal failure at our institution over a 10-year period (2000-2010). We aimed to assess the association between auto-SCT and renal outcome in patients with serum creatinine (SCr) over 3 mg/dL, attributable to MM, including those who were dialysis dependent. Thirty patients (2.8% of all auto-SCT patients) met inclusion criteria. Fourteen of 15 patients who were dialysis dependent before auto-SCT remained dialysis dependent in the long term despite hematological response (HR). Of the remaining 15 patients with SCr >3 mg/dL, an improvement in glomerular filtration rate (GFR) from 15 to 19.4 mL/min/1.73 m(2) was noted post auto-SCT (P=0.035); however, neither HR post auto-SCT or pre-existing renal function were independently associated with renal outcome. Auto-SCT was not associated with independence from dialysis in patients with renal failure due to MM at our institution. Although auto-SCT was associated with an improvement in GFR in patients with SCr >3 mg/dL, this improvement was not related to HR.

Prediction of postoperative outcome after hepatectomy with a new bedside test for maximal liver function capacity.

PubMed

Stockmann, Martin; Lock, Johan F; Riecke, Björn; Heyne, Karsten; Martus, Peter; Fricke, Michael; Lehmann, Sina; Niehues, Stefan M; Schwabe, Michael; Lemke, Arne-Jörn; Neuhaus, Peter

2009-07-01

To validate the LiMAx test, a new bedside test for the determination of maximal liver function capacity based on C-methacetin kinetics. To investigate the diagnostic performance of different liver function tests and scores including the LiMAx test for the prediction of postoperative outcome after hepatectomy. Liver failure is a major cause of mortality after hepatectomy. Preoperative prediction of residual liver function has been limited so far. Sixty-four patients undergoing hepatectomy were analyzed in a prospective observational study. Volumetric analysis of the liver was carried out using preoperative computed tomography and intraoperative measurements. Perioperative factors associated with morbidity and mortality were analyzed. Cutoff values of the LiMAx test were evaluated by receiver operating characteristic. Residual LiMAx demonstrated an excellent linear correlation with residual liver volume (r = 0.94, P < 0.001) after hepatectomy. The multivariate analysis revealed LiMAx on postoperative day 1 as the only predictor of liver failure (P = 0.003) and mortality (P = 0.004). AUROC for the prediction of liver failure and liver failure related death by the LiMAx test was both 0.99. Preoperative volume/function analysis combining CT volumetry and LiMAx allowed an accurate calculation of the remnant liver function capacity prior to surgery (r = 0.85, P < 0.001). Residual liver function is the major factor influencing the outcome of patients after hepatectomy and can be predicted preoperatively by a combination of LiMAx and CT volumetry.

Circulating intestinal fatty acid-binding protein (I-FABP) levels in acute decompensated heart failure.

PubMed

Kitai, Takeshi; Kim, Yong-Hyun; Kiefer, Kathryn; Morales, Rommel; Borowski, Allen G; Grodin, Justin L; Tang, W H Wilson

2017-06-01

Venous congestion has become increasingly recognized as a potential contributor to end-organ dysfunction in heart failure. Elevated I-FABP, which is excreted specifically from damaged intestinal epithelial cells, has been found in patients with abdominal hypertension and intestinal ischemia. We hypothesize that elevated intestinal fatty acid-binding protein (I-FABP) levels would identify patients with more advanced heart failure who have venous and intestinal congestion. Baseline serum I-FABP levels were measured in 69 acute decompensated heart failure (ADHF) patients admitted to the intensive care unit for invasive hemodynamic monitoring and tailored medical therapy. Comprehensive echocardiography examinations were performed in all study patients, and clinical outcomes (death, cardiac transplant or left ventricular assist device placement) were assessed. The median circulating I-FABP level was 853pg/ml (interquartile range: 533 to 1448pg/ml). Age, gender, race, and baseline comorbidities were comparable between patients with low and high I-FABP levels. Although there were no significant correlations between I-FABP levels and invasively-measured hemodynamic parameters nor echocardiographic parameters, patients with higher I-FABP levels (≥853g/ml) had significantly worse clinical outcomes compared to those with lower I-FABP levels (<853pg/ml, P=0.025). Circulating I-FABP levels had no association with invasively-measured hemodynamic parameters, but were associated with adverse clinical outcomes in patients with ADHF with systolic dysfunction. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Postdischarge growth failure among extremely low birth weight infants: Correlates and consequences

PubMed Central

Sices, Laura; Wilson-Costello, Deanne; Minich, Nori; Friedman, Harriet; Hack, Maureen

2007-01-01

OBJECTIVE To describe the prevalence and correlates of postdis-charge growth failure among extremely low birth weight (ELBW) infants (weighing less than 1 kg) and its impact on growth and development. METHODS One hundred fifty-four ELBW infants were followed to 20 months corrected age. Growth failure was defined as a decrease in weight z score (standard deviation score) of over 0.67 during one of three periods: between 40 weeks and four months (period I), between four and eight months (period II), and between eight and 20 months corrected age (period III). A decrease in weight z score of this magnitude is comparable to crossing major growth percentiles (eg, from 25th to 10th percentile). Developmental outcomes were assessed at 20 months. RESULTS Growth failure occurred in 8% of infants during period I, 28% during period II and 12% during period III. This resulted in poorer growth attainment and motor function at 20 months. Significant predictors of growth failure included chronic lung disease during periods I and III, and cerebral palsy during period III. Growth failure during period II, while more common, was not associated with specific sequelae of prematurity. It may represent a physiological process comparable to shifts in weight percentiles in term-born infants. CONCLUSIONS Postdischarge growth failure is common among ELBW infants and contributes to poorer growth outcomes. It is associated with poorer motor outcomes when it occurs early after discharge or later in infancy. A decrease in weight z score of over 0.67 can serve as a useful indicator of growth failure in ELBW infants. PMID:19030335

Incidence and Outcome of CPAP Failure in Preterm Infants.

PubMed

Dargaville, Peter A; Gerber, Angela; Johansson, Stefan; De Paoli, Antonio G; Kamlin, C Omar F; Orsini, Francesca; Davis, Peter G

2016-07-01

Data from clinical trials support the use of continuous positive airway pressure (CPAP) for initial respiratory management in preterm infants, but there is concern regarding the potential failure of CPAP support. We aimed to examine the incidence and explore the outcomes of CPAP failure in Australian and New Zealand Neonatal Network data from 2007 to 2013. Data from inborn preterm infants managed on CPAP from the outset were analyzed in 2 gestational age ranges (25-28 and 29-32 completed weeks). Outcomes after CPAP failure (need for intubation <72 hours) were compared with those succeeding on CPAP using adjusted odds ratios (AORs). Within the cohort of 19 103 infants, 11 684 were initially managed on CPAP. Failure of CPAP occurred in 863 (43%) of 1989 infants commencing on CPAP at 25-28 weeks' gestation and 2061 (21%) of 9695 at 29-32 weeks. CPAP failure was associated with a substantially higher rate of pneumothorax, and a heightened risk of death, bronchopulmonary dysplasia (BPD) and other morbidities compared with those managed successfully on CPAP. The incidence of death or BPD was also increased: (25-28 weeks: 39% vs 20%, AOR 2.30, 99% confidence interval 1.71-3.10; 29-32 weeks: 12% vs 3.1%, AOR 3.62 [2.76-4.74]). The CPAP failure group had longer durations of respiratory support and hospitalization. CPAP failure in preterm infants is associated with increased risk of mortality and major morbidities, including BPD. Strategies to promote successful CPAP application should be pursued vigorously. Copyright © 2016 by the American Academy of Pediatrics.

Impact of the timing of hepatitis B virus identification and anti-hepatitis B virus therapy initiation on the risk of adverse liver outcomes for patients receiving cancer therapy.

PubMed

Hwang, Jessica P; Suarez-Almazor, Maria E; Cantor, Scott B; Barbo, Andrea; Lin, Heather Y; Ahmed, Sairah; Chavez-MacGregor, Mariana; Donato-Santana, Christian; Eng, Cathy; Ferrajoli, Alessandra; Fisch, Michael J; McLaughlin, Peter; Simon, George R; Rondon, Gabriela; Shpall, Elizabeth J; Lok, Anna S

2017-09-01

Data on the incidence of adverse liver outcomes are limited for cancer patients with chronic (hepatitis B surface antigen [HBsAg]-positive/hepatitis B core antibody [anti-HBc]-positive) or past (HBsAg-negative/anti-HBc-positive) hepatitis B virus (HBV) after chemotherapy. This study was aimed at determining the impact of test timing and anti-HBV therapy on adverse liver outcomes in these patients. Patients with solid or hematologic malignancies who received chemotherapy between 2004 and 2011 were retrospectively studied. HBV testing and anti-HBV therapy were defined as early at the initiation of cancer therapy and as late after initiation. Outcomes included hepatitis flares, hepatic impairment, liver failure, and death. Time-to-event analysis was used to determine incidence, and multivariate hazard models were used to determine predictors of outcomes. There were 18,688 study patients (80.4% with solid tumors). The prevalence of chronic HBV was 1.1% (52 of 4905), and the prevalence of past HBV was 7.1% (350 of 4905). Among patients with solid tumors, late identification of chronic HBV was associated with a higher risk of hepatitis flare (hazard ratio [HR], 4.02; 95% confidence interval [CI], 1.26-12.86), hepatic impairment (HR, 8.48; 95% CI, 1.86-38.66), liver failure (HR, 9.38; 95% CI, 1.50-58.86), and death (HR, 3.90; 95% CI, 1.19-12.83) in comparison with early identification. Among patients with hematologic malignancies and chronic HBV, the risk of death was 7.8 (95% CI, 1.73-35.27) times higher for persons with late initiation of anti-HBV therapy versus early initiation. Patients with late identification of chronic HBV had late or no anti-HBV therapy. Chronic HBV predicted liver failure in patients with solid or hematologic malignancies, whereas male sex and late identification were predictors for patients with solid tumors. Early identification correlates with early anti-HBV therapy and reduces the risk of liver failure and death in chronic HBV patients receiving chemotherapy. Cancer 2017;123:3367-76. © 2017 American Cancer Society. © 2017 American Cancer Society.

Effect of a multidisciplinary supportive program for family caregivers of patients with heart failure on caregiver burden, quality of life, and depression: A randomized controlled study.

PubMed

Hu, Xiaolin; Dolansky, Mary A; Su, Yonglin; Hu, Xiuying; Qu, Moying; Zhou, Lingjuan

2016-10-01

Caregivers of patients with heart failure experience burden and negative health outcomes. Adequate support for family caregivers improves their well-being and the quality of care provided to the patients. However, little is known about the benefits of interventions for caregivers of patients with heart failure in China. To test the effects of a multidisciplinary supportive program for family caregivers on caregiver burden, quality of life, and depression. A randomized controlled design with repeated measures was used in this study. A total of 118 participants were randomized into experimental (n=59) and control groups (n=59) from May to December 2014 in one hospital in Chengdu, People's Republic of China. Participants in the experimental group received a 3-month multidisciplinary supportive program, consisting of three 60-min sessions of group classes, three 30-min peer support groups, and regular telephone follow-ups and consultations, while participants in the control group received usual care only. Outcomes were caregiver burden, quality of life, and depression. Data were collected at baseline, post-test (3 months after discharge), and 3 months after post-test (6 months after discharge). The repeated measures analysis of variance was used to examine the effects of groups, changes over time, and time-group interaction on outcome variables. There were significant improvements in caregiver burden, mental health, and depression after post-test and 3 months after post-test in the experimental group. However, there was no significant improvement in caregivers' physical health at either 3 or 6 months following discharge. A multidisciplinary supportive program for caregivers of heart failure patients had positive effects and provides a unique perspective of an intervention considering Chinese culture and customs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Clinical Outcomes of Golimumab as First, Second or Third Anti-TNF Agent in Patients with Moderate-to-Severe Ulcerative Colitis.

PubMed

Taxonera, Carlos; Rodríguez, Cristina; Bertoletti, Federico; Menchén, Luís; Arribas, Julia; Sierra, Mónica; Arias, Lara; Martínez-Montiel, Pilar; Juan, Alba; Iglesias, Eva; Algaba, Alicia; Manceñido, Noemí; Rivero, Montserrat; Barreiro-de Acosta, Manuel; López-Serrano, Pilar; Argüelles-Arias, Federico; Gutierrez, Ana; Busquets, David; Gisbert, Javier P; Olivares, David; Calvo, Marta; Alba, Cristina

2017-08-01

Golimumab efficacy data in ulcerative colitis (UC) are limited to anti-tumor necrosis factor α (TNF)-naive patients. The aim of this study was to assess the short-term and long-term efficacy of golimumab used as first, second, or third anti-TNF in UC in a real-life clinical setting. This retrospective multicenter cohort study included patients with moderate-to-severe UC treated with golimumab. The primary efficacy endpoints were short-term partial Mayo score response, long-term golimumab failure-free survival, and colectomy-free survival. In 142 patients with UC, golimumab was administered as first (40%), second (23%), or third anti-TNF (37%). Ninety-two patients (65%, 95% confidence interval 56.6-73) achieved short-term clinical response. Forty-five patients (32%, 95% confidence interval 23.7-39.7) achieved clinical remission. Response rates for golimumab were 75% as first anti-TNF, 70% as second anti-TNF (ns versus first anti-TNF), and 50% as third anti-TNF (P = 0.007 versus first anti-TNF). After 12 months median follow-up (interquartile range 6-18), 60 patients (42%, 95% confidence interval 34-51) had golimumab failure, and 15 patients (11%) needed colectomy. Thirty-one patients (22%) needed golimumab dose escalation, and 71% of these regained response after escalation. Starting maintenance with 100 mg golimumab doses and short-term nonresponse were independent predictors of golimumab failure. In this real-life cohort of patients with UC, golimumab therapy was effective for inducing and maintaining clinical response. Although anti-TNF-naive patients had better outcomes, golimumab was also effective in anti-TNF-experienced patients. Only the patients given golimumab after previous failure of 2 anti-TNF agents had significantly worse outcomes. Golimumab dose escalation was beneficial and safe.

Role of ventricular assist therapy for patients with heart failure and restrictive physiology: Improving outcomes for a lethal disease.

PubMed

Grupper, Avishay; Park, Soon J; Pereira, Naveen L; Schettle, Sarah D; Gerber, Yariv; Topilsky, Yan; Edwards, Brooks S; Daly, Richard C; Stulak, John M; Joyce, Lyle D; Kushwaha, Sudhir S

2015-08-01

Restrictive cardiomyopathy (RCM) patients have poor prognosis due to progressive heart failure characterized by impaired ventricular filling of either or both ventricles. The goal of this study was to evaluate the outcome of end-stage RCM patients after left ventricular assist device (LVAD) implantation and to determine factors that may be associated with improved survival. This investigation is a retrospective study of prospectively collected data that include 28 consecutive patients with end-stage RCM who received continuous-flow LVADs at the Mayo Clinic, Rochester, Minnesota. Outcome was assessed by survival with LVAD support until heart transplantation or all-cause mortality. The mean follow-up time post-LVAD implantation was 448 ± 425 days. The mean hospitalization time was 29 ± 19 days and was complicated mainly by post-operative right ventricular (RV) failure requiring short-term medical support. The short-term in-hospital mortality was 14%. Ten patients underwent heart transplantation with 100% survival post-transplant during the follow-up period. One-year survival for patients with LVADs without transplantation was 64%, and was not significantly different between amyloidosis and non-amyloidosis patients. Larger left ventricle (LV) end-diastolic and end-systolic dimensions were significantly associated with improved survival rates (RR = 0.94 and 0.95, p < 0.05, respectively), and left ventricular end-diastolic diameter (LVEDD) ≤46 mm was associated with increased mortality post-LVAD implantation. LVAD is a feasible, life-saving therapy for end-stage heart failure related to RCM, especially as a bridge to transplant and in patients with larger LV dimensions. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Visit-to-visit variability of blood pressure and coronary heart disease, stroke, heart failure and mortality: A cohort study

PubMed Central

Muntner, Paul; Whittle, Jeff; Lynch, Amy I.; Colantonio, Lisandro D.; Simpson, Lara M.; Einhorn, Paula T.; Levitan, Emily B.; Whelton, Paul K; Cushman, William C.; Louis, Gail T.; Davis, Barry R.; Oparil, Suzanne

2016-01-01

Background Variability of blood pressure (BP) across outpatient visits is frequently dismissed as random fluctuation around a patient’s underlying BP. Objective: Examine the association between visit-to-visit variability (VVV) of systolic and diastolic BP (SBP and DBP) on cardiovascular disease and mortality outcomes. Design Prospective cohort study Setting Post-hoc analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Participants 25,814 ALLHAT participants. Measurements VVV of SBP was defined as the standard deviation (SD) across BP measurements obtained at 7 visits conducted from 6 to 28 months following ALLHAT enrollment. Participants free of cardiovascular disease events during the first 28 months of follow-up were followed from the month 28 study visit through the end of active ALLHAT follow-up. Outcomes included fatal coronary heart disease or non-fatal myocardial infarction, all-cause mortality, stroke and heart failure. Results There were 1194 cases of fatal CHD or non-fatal MI, 1948 deaths, 606 cases of stroke and 921 cases of heart failure during follow-up. After multivariable adjustment including mean SBP, the hazard ratio comparing participants in the highest versus lowest quintile of SD of SBP (≥14.4 mmHg versus <6.5 mmHg) was 1.30 (1.06–1.59) for fatal coronary heart disease or non-fatal myocardial infarction, 1.58 (1.32–1.90) for all-cause mortality, 1.46 (1.06–2.01) for stroke, and 1.25 (0.97–1.61) for heart failure. Higher VVV of DBP was also associated with cardiovascular disease events and mortality. Limitations Long-term outcomes were not available. Conclusions Higher VVV of SBP is associated with increased cardiovascular disease and mortality risk. Future studies should examine whether reducing VVV of BP lowers this risk. Primary funding source National Institutes of Health PMID:26215765

Rheumatic Mitral Valve Disease Is Associated With Worse Outcomes in Stroke: A Thailand National Database Study.

PubMed

Wood, Adrian D; Mannu, Gurdeep S; Clark, Allan B; Tiamkao, Somsak; Kongbunkiat, Kannikar; Bettencourt-Silva, Joao H; Sawanyawisuth, Kittisak; Kasemsap, Narongrit; Barlas, Raphae S; Mamas, Mamas; Myint, Phyo Kyaw

2016-11-01

Rheumatic valvular heart disease is associated with the increased risk of cerebrovascular events, although there are limited data on the prognosis of patients with rheumatic mitral valve disease (RMVD) after stroke. We examined the association between RMVD and both serious and common cardiovascular and noncardiovascular (respiratory and infective) complications in a cohort of hospitalized stroke patients based in Thailand. Factors associated with in-hospital mortality were also explored. Data were obtained from a National Insurance Database. All hospitalized strokes between October 1, 2004, and January 31, 2013, were included in the current study. Characteristics and outcomes were compared for RMVD and non-RMVD patients. Logistic regression, propensity score matching, and multivariate models were used to assess study outcomes. In total, 594 681 patients (mean [SD] age=64 [14.5] years) with a diagnosis of stroke (ischemic=306 154; hemorrhagic=195 392; undetermined=93 135) were included in this study, of whom 5461 had RMVD. Results from primary analyses showed that after ischemic stroke, and controlling for potential confounding covariates, RMVD was associated (P<0.001) with increased odds for cardiac arrest (odds ratio [95% confidence interval]=2.13 [1.68-2.70]), shock (2.13 [1.64-2.77]), arrhythmias (1.70 [1.21-2.39]), respiratory failure (2.09 [1.87-2.33]), pneumonia (2.00 [1.81-2.20]), and sepsis (1.39 [1.19-1.63]). In hemorrhagic stroke patients, RMVD was associated with increased odds (fully adjusted model) for respiratory failure (1.26 [1.01-1.57]), and in patients with undetermined stroke, RMVD was associated with increased odds (fully adjusted analyses) for shock (3.00 [1.46-6.14]), respiratory failure (2.70 [1.91-3.79]), and pneumonia (2.42 [1.88-3.11]). RMVD is associated with the development of cardiac arrest, shock, arrhythmias, respiratory failure, pneumonia, and sepsis after acute stroke. © 2016 American Heart Association, Inc.

Salvage Radiation Therapy Dose Response for Biochemical Failure of Prostate Cancer After Prostatectomy—A Multi-Institutional Observational Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pisansky, Thomas M., E-mail: pisansky.thomas@mayo.edu; Agrawal, Shree; Hamstra, Daniel A.

Purpose: To determine whether a dose-response relationship exists for salvage radiation therapy (RT) of biochemical failure after prostatectomy for prostate cancer. Methods and Materials: Individual data from 1108 patients who underwent salvage RT at 10 academic centers were pooled. The cohort was enriched for selection criteria more likely associated with tumor recurrence in the prostate bed (margin positive and pre-RT prostate-specific antigen [PSA] level of ≤2.0 ng/mL) and without the confounding of planned androgen suppression. The cumulative incidence of biochemical failure and distant metastasis over time was computed, and competing risks hazard regression models were used to investigate the association betweenmore » potential predictors and these outcomes. The association of radiation dose with outcomes was the primary focus. Results: With a 65.2-month follow-up duration, the 5- and 10-year estimates of freedom from post-RT biochemical failure (PSA level >0.2 ng/mL and rising) was 63.5% and 49.8%, respectively, and the cumulative incidence of distant metastasis was 12.4% by 10 years. A Gleason score of ≥7, higher pre-RT PSA level, extraprostatic tumor extension, and seminal vesicle invasion were associated with worse biochemical failure and distant metastasis outcomes. A salvage radiation dose of ≥66.0 Gy was associated with a reduced cumulative incidence of biochemical failure, but not of distant metastasis. Conclusions: The use of salvage radiation doses of ≥66.0 Gy are supported by evidence presented in the present multicenter pooled analysis of individual patient data. The observational reporting method, limited sample size, few distant metastasis events, modest follow-up duration, and elective use of salvage therapy might have diminished the opportunity to identify an association between the radiation dose and this endpoint.« less

Switch to maraviroc with darunavir/r, both QD, in patients with suppressed HIV-1 was well tolerated but virologically inferior to standard antiretroviral therapy: 48-week results of a randomized trial

PubMed Central

Gagliardini, Roberta; Meini, Genny; Sterrantino, Gaetana; Colangeli, Vincenzo; Re, Maria Carla; Latini, Alessandra; Colafigli, Manuela; Vignale, Francesca; Rusconi, Stefano; Micheli, Valeria; Di Biagio, Antonio; Orofino, Giancarlo; Ghisetti, Valeria; Fantauzzi, Alessandra; Vullo, Vincenzo; Grima, Pierfrancesco; Francisci, Daniela; Mastroianni, Claudio; Antinori, Andrea; Trezzi, Michele; Lisi, Lucia; Navarra, Pierluigi; Canovari, Benedetta; D’Arminio Monforte, Antonella; Lamonica, Silvia; D’Avino, Alessandro; Zazzi, Maurizio; Di Giambenedetto, Simona; De Luca, Andrea

2017-01-01

Objectives Primary study outcome was absence of treatment failure (virological failure, VF, or treatment interruption) per protocol at week 48. Methods Patients on 3-drug ART with stable HIV-1 RNA <50 copies/mL and CCR5-tropic virus were randomized 1:1 to maraviroc with darunavir/ritonavir qd (study arm) or continue current ART (continuation arm). Results In June 2015, 115 patients were evaluable for the primary outcome (56 study, 59 continuation arm). The study was discontinued due to excess of VF in the study arm (7 cases, 12.5%, vs 0 in the continuation arm, p = 0.005). The proportion free of treatment failure was 73.2% in the study and 59.3% in the continuation arm. Two participants in the study and 10 in the continuation arm discontinued therapy due to adverse events (p = 0.030). At VF, no emergent drug resistance was detected. Co-receptor tropism switched to non-R5 in one patient. Patients with VF reported lower adherence and had lower plasma drug levels. Femoral bone mineral density was significantly improved in the study arm. Conclusion Switching to maraviroc with darunavir/ritonavir qd in virologically suppressed patients was associated with improved tolerability but was virologically inferior to 3-drug therapy. PMID:29161288

Renal Function and Outcomes With Use of Left Ventricular Assist Device Implantation and Inotropes in End-Stage Heart Failure: A Retrospective Single Center Study.

PubMed

Verma, Sean; Bassily, Emmanuel; Leighton, Shane; Mhaskar, Rahul; Sunjic, Igor; Martin, Angel; Rihana, Nancy; Jarmi, Tambi; Bassil, Claude

2017-07-01

Left ventricular assist device (LVAD) and inotrope therapy serve as a bridge to transplant (BTT) or as destination therapy in patients who are not heart transplant candidates. End-stage heart failure patients often have impaired renal function, and renal outcomes after LVAD therapy versus inotrope therapy have not been evaluated. In this study, 169 patients with continuous flow LVAD therapy and 20 patients with continuous intravenous inotrope therapy were analyzed. The two groups were evaluated at baseline and at 3 and 6 months after LVAD or inotrope therapy was started. The incidence of acute kidney injury (AKI), need for renal replacement therapy (RRT), BTT rate, and mortality for 6 months following LVAD or inotrope therapy were studied. Results between the groups were compared using Mann-Whitney U test and Chi-square with continuity correction or Fischer's exact at the significance level of 0.05. Mean glomerular filtration rate (GFR) was not statistically different between the two groups, with P = 0.471, 0.429, and 0.847 at baseline, 3 and 6 months, respectively. The incidence of AKI, RRT, and BTT was not statistically different. Mortality was less in the inotrope group (P < 0.001). Intravenous inotrope therapy in end-stage heart failure patients is non-inferior for mortality, incidence of AKI, need for RRT, and renal function for 6-month follow-up when compared to LVAD therapy. Further studies are needed to compare the effectiveness of inotropes versus LVAD implantation on renal function and outcomes over a longer time period.

Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study

PubMed Central

Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

2017-01-01

Objectives We aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE. Methods A cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification. Results At baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score. Conclusions Our study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF. Trial registration number NCT01794715; Results PMID:28320791

Biomechanical Comparison of Single- Versus Double-Row Capsulolabral Repair for Shoulder Instability: A Review

PubMed Central

Yousif, Matthew John; Bicos, James

2017-01-01

Background: The glenohumeral joint is the most commonly dislocated joint in the body. Failure rates of capsulolabral repair have been reported to be approximately 8%. Recent focus has been on restoration of the capsulolabral complex by a double-row capsulolabral repair technique in an effort to decrease redislocation rates after arthroscopic capsulolabral repair. Purpose: To present a review of the biomechanical literature comparing single- versus double-row capsulolabral repairs and discuss the previous case series of double-row fixation. Study Design: Narrative review. Methods: A simple review of the literature was performed by PubMed search. Only biomechanical studies comparing single- versus double-row capsulolabral repair were included for review. Only those case series and descriptive techniques with clinical results for double-row repair were included in the discussion. Results: Biomechanical comparisons evaluating the native footprint of the labrum demonstrated significantly superior restoration of the footprint through double-row capsulolabral repair compared with single-row repair. Biomechanical comparisons of contact pressure at the repair interface, fracture displacement in bony Bankart lesion, load to failure, and decreased external rotation (suggestive of increased load to failure) were also significantly in favor of double- versus single-row repair. Recent descriptive techniques and case series of double-row fixation have demonstrated good clinical outcomes; however, no comparative clinical studies between single- and double-row repair have assessed functional outcomes. Conclusion: The superiority of double-row capsulolabral repair versus single-row repair remains uncertain because comparative studies assessing clinical outcomes have yet to be performed. PMID:29230427

Acute Cardiopulmonary Failure From Sleep-Disordered Breathing

PubMed Central

Carr, Gordon E.; Mokhlesi, Babak

2012-01-01

Sleep-disordered breathing (SDB) comprises a diverse set of disorders marked by abnormal respiration during sleep. Clinicians should realize that SDB may present as acute cardiopulmonary failure in susceptible patients. In this review, we discuss three clinical phenotypes of acute cardiopulmonary failure from SDB: acute ventilatory failure, acute congestive heart failure, and sudden death. We review the pathophysiologic mechanisms and recommend general principles for management. Timely recognition of, and therapy for, SDB in the setting of acute cardiopulmonary failure may improve short- and long-term outcomes. PMID:22396567

Probabilistic metrology or how some measurement outcomes render ultra-precise estimates

NASA Astrophysics Data System (ADS)

Calsamiglia, J.; Gendra, B.; Muñoz-Tapia, R.; Bagan, E.

2016-10-01

We show on theoretical grounds that, even in the presence of noise, probabilistic measurement strategies (which have a certain probability of failure or abstention) can provide, upon a heralded successful outcome, estimates with a precision that exceeds the deterministic bounds for the average precision. This establishes a new ultimate bound on the phase estimation precision of particular measurement outcomes (or sequence of outcomes). For probe systems subject to local dephasing, we quantify such precision limit as a function of the probability of failure that can be tolerated. Our results show that the possibility of abstaining can set back the detrimental effects of noise.

Quality of Life for Saudi Patients With Heart Failure: A Cross-Sectional Correlational Study

PubMed Central

AbuRuz, Mohannad Eid; Alaloul, Fawwaz; Saifan, Ahmed; Masa’Deh, Rami; Abusalem, Said

2016-01-01

Introduction: Heart failure is a major public health issue and a growing concern in developing countries, including Saudi Arabia. Most related research was conducted in Western cultures and may have limited applicability for individuals in Saudi Arabia. Thus, this study assesses the quality of life of Saudi patients with heart failure. Materials and Methods: A cross-sectional correlational design was used on a convenient sample of 103 patients with heart failure. Data were collected using the Short Form-36 and the Medical Outcomes Study-Social Support Survey. Results: Overall, the patients’ scores were low for all domains of Quality of Life. The Physical Component Summary and Mental Component Summary mean scores and SDs were (36.7±12.4, 48.8±6.5) respectively, indicating poor Quality of Life. Left ventricular ejection fraction was the strongest predictor of both physical and mental summaries. Conclusion: Identifying factors that impact quality of life for Saudi heart failure patients is important in identifying and meeting their physical and psychosocial needs. PMID:26493415

Early neurodevelopmental outcomes of infants with intestinal failure.

PubMed

So, Stephanie; Patterson, Catherine; Gold, Anna; Rogers, Alaine; Kosar, Christina; de Silva, Nicole; Burghardt, Karolina Maria; Avitzur, Yaron; Wales, Paul W

2016-10-01

The survival rate of infants and children with intestinal failure is increasing, necessitating a greater focus on their developmental trajectory. To evaluate neurodevelopmental outcomes in children with intestinal failure at 0-15months corrected age. Analysis of clinical, demographic and developmental assessment results of 33 children followed in an intestinal rehabilitation program between 2011 and 2014. Outcome measures included: Prechtl's Assessment of General Movements, Movement Assessment of Infants, Alberta Infant Motor Scale and Mullen Scales of Early Learning. Clinical factors were correlated with poorer developmental outcomes at 12-15months corrected age. Thirty-three infants (17 males), median gestational age 34weeks (interquartile range 29.5-36.0) with birth weight 1.98kg (interquartile range 1.17-2.50). Twenty-nine (88%) infants had abnormal General Movements. More than half had suspect or abnormal scores on the Alberta Infant Motor Scale and medium to high-risk scores for future neuromotor delay on the Movement Assessment of Infants. Delays were seen across all Mullen subscales, most notably in gross motor skills. Factors significantly associated with poorer outcomes at 12-15months included: prematurity, low birth weight, central nervous system co-morbidity, longer neonatal intensive care admission, necrotizing enterocolitis diagnosis, number of operations and conjugated hyperbilirubinemia. Multiple risk factors contribute to early developmental delay in children with intestinal failure, highlighting the importance of close developmental follow-up. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Central hypothyroidism and its role for cardiovascular risk factors in hypopituitary patients.

PubMed

Feldt-Rasmussen, Ulla; Klose, Marianne

2016-10-01

Hypothyroidism is characterized by hypometabolism, and may be seen as a part of secondary failure due to pituitary insufficiency or tertiary due to hypothalamic disease. Secondary and tertiary failures are also referred to as central hypothyroidism. Whereas overt primary hypothyroidism has a well-known affection on the heart and cardiovascular system, and may result in cardiac failure, cardiovascular affection is less well recognized in central hypothyroidism. Studies on central hypothyroidism and cardiovascular outcome are few and given the rarity of the diseases often small. Further, there are several limitations given vast difficulties in diagnosing the condition correctly biochemically, and difficulties monitoring the treatment because normal thyroid-pituitary feedback interrelationships are disrupted. The present review summarizes available studies of central adult hypothyroidism and its possible influence on the cardiovascular system, describe differences from primary thyroid failure and seek evidence for performing guidelines for clinical management of this particular thyroid and hypothalamo-pituitary disorder.

Descriptive Epidemiology of the Multicenter ACL Revision Study (MARS) Cohort

PubMed Central

2013-01-01

Background Revision anterior cruciate ligament (ACL) reconstruction has worse outcomes than primary reconstructions. Predictors for these worse outcomes are not known. The Multicenter ACL Revision Study (MARS) Group was developed to perform a multisurgeon, multicenter prospective longitudinal study to obtain sufficient subjects to allow multivariable analysis to determine predictors of clinical outcome. Purpose To describe the formation of MARS and provide descriptive analysis of patient demographics and clinical features for the initial 460 enrolled patients to date in this prospective cohort. Study Design Cross-sectional study; Level of evidence, 2. Methods After training and institutional review board approval, surgeons began enrolling patients undergoing revision ACL reconstruction, recording patient demographics, previous ACL reconstruction methods, intra-articular injuries, and current revision techniques. Enrolled subjects completed a questionnaire consisting of validated patient-based outcome measures. Results As of April 1, 2009, 87 surgeons have enrolled a total of 460 patients (57% men; median age, 26 years). For 89%, the reconstruction was the first revision. Mode of failure as deemed by the revising surgeon was traumatic (32%), technical (24%), biologic (7%), combination (37%), infection (<1%), and no response (<1%). Previous graft present at the time of injury was 70% autograft, 27% allograft, 2% combination, and 1% unknown. Sixty-two percent were more than 2 years removed from their last reconstruction. Graft choice for revision ACL reconstruction was 45% autograft, 54% allograft, and more than 1% both allograft and autograft. Meniscus and/or chondral damage was found in 90% of patients. Conclusion The MARS Group has been able to quickly accumulate the largest revision ACL reconstruction cohort reported to date. Traumatic reinjury is deemed by surgeons to be the most common single mode of failure, but a combination of factors represents the most common mode of failure. Allograft graft choice is more common in the revision setting than autograft. Concomitant knee injury is extremely common in this population. PMID:20889962

Sports Participation, Functional Outcome, and Complications After Ankle Arthrodesis: Midterm Follow-up.

PubMed

Kerkhoff, Yvonne R A; Keijsers, Noël L W; Louwerens, Jan Willem K

2017-10-01

Ankle arthrodesis provides satisfactory functional outcome based on basic daily activities, but information regarding more demanding tasks is limited. Also, studies reporting longer term survival and complication rates are sparse and concern small study populations. This study reports functional outcome with more focus on demanding tasks and sports and reports the mid- to long-term union and complication rates in a large study population. Between 2005 and 2010, an ankle arthrodesis was performed on 185 ankles. Clinical results were retrospectively assessed with the Foot Function Index (FFI), visual analog scale (VAS) for pain, and the Foot and Ankle Ability Measure (FAAM). Information regarding sports pre- and postoperatively was obtained through a questionnaire. In addition, postoperative complications, reoperations, and failures (defined as nonunion of the ankle arthrodesis) were determined. Mean follow-up time was 8 years. FFI scores significantly improved, the FAAM ADL score was 70%, and the mean VAS for pain at the ankle/hindfoot at follow-up was 20. Sports participation slightly diminished from 79.5% prior to the onset of disabling complaints to 68.9% postoperatively. Of the patients, 73.1% were able to hike with a median hiking time of 40 minutes (range, 2-600 minutes). Kneeling could be performed on average 10 minutes (range, 2-60 minutes) in 39.8% and jumping down from steps by 23.5% of the patients. A small selection of patients was able to sprint (14%), and 16.8% of the patients were able to run a median distance of 60 meters (range, 3-1000 meters). Failure occurred in 9.2% and other postoperative complications were present in 21.6%, requiring reoperation in 8.6% of the cases. Ankle arthrodesis led to satisfactory functional outcome and pain reduction. Most patients remained active in sports, but a transition to less demanding sporting activities was seen. The complication and failure rates were similar with previous literature, and the incidence of nonrevision secondary surgery was relatively low. Level III, retrospective comparative study.

Heart failure services in the United Kingdom: rethinking the machine bureaucracy.

PubMed

Hawkins, Nathaniel M; Wright, David J; Capewell, Simon

2013-01-20

Poor outcomes and poor uptake of evidence based therapies persist for patients with heart failure in the United Kingdom. We offer a strategic analysis of services, defining the context, organization and objectives of the service, before focusing on implementation and performance. Critical flaws in past service development and performance are apparent, a consequence of failed performance management, policy and political initiative. The barriers to change and potential solutions are common to many health care systems. Integration, information, financing, incentives, innovation and values: all must be challenged and improved if heart failure services are to succeed. Modern healthcare requires open adaptive systems, continually learning and improving. The system also needs controls. Performance indicators should be simple, clinically relevant, and outcome focused. Heart failure presents one of the greatest opportunities to improve symptoms and survival with existing technology. To do so, heart failure services require radical reorganization. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Posterior Meniscal Root Repairs: Outcomes of an Anatomic Transtibial Pull-Out Technique.

PubMed

LaPrade, Robert F; Matheny, Lauren M; Moulton, Samuel G; James, Evan W; Dean, Chase S

2017-03-01

Outcomes after transtibial pull-out repair for posterior meniscal root tears remain underreported, and factors that may affect outcomes are unknown. Purpose/Hypothesis: The purpose of this study was to compare patient-centered outcomes after transtibial pull-out repair for posterior root tears in patients <50 and ≥50 years of age. We hypothesized that improvement in function and activity level at minimum 2-year follow-up would be similar among patients <50 years of age compared with patients ≥50 years and among patients undergoing medial versus lateral root repairs. Cohort study; Level of evidence, 3. Inclusion criteria were patients aged 18 years or older who underwent anatomic transtibial pull-out repair of the medial or lateral posterior meniscus root by a single surgeon. All patients were identified from a data registry consisting of prospectively collected data in a consecutive series. Cohorts were analyzed by age (<50 years [n = 35] vs ≥50 years [n = 15]) and laterality (lateral [n = 15] vs medial [n = 35]). Patients completed a subjective questionnaire preoperatively and at minimum of 2 years postoperatively (Lysholm, Tegner, Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC], 12-Item Short Form Health Survey [SF-12], and patient satisfaction with outcome). Failure was defined as revision meniscal root repair or partial meniscectomy. The analysis included 50 knees in 49 patients (16 females, 33 males; mean age, 38.3 years; mean body mass index, 26.6). Of the 50 knees, 45 were available for analysis. Three of 45 (6.7%) required revision surgery. All failures were in patients <50 years old, and all failures underwent medial root repair. No significant difference in failure was found based on age ( P=.541) or laterality ( P = .544). For age cohorts, Lysholm and WOMAC scores demonstrated significant postoperative improvement. For laterality cohorts, all functional scores significantly improved postoperatively. No significant difference was noted in postoperative Lysholm, WOMAC, SF-12, Tegner, or patient satisfaction scores for the age cohort or the laterality cohort. Outcomes after posterior meniscal root repair significantly improved postoperatively and patient satisfaction was high, regardless of age or meniscal laterality. Patients <50 years had outcomes similar to those of patients ≥50 years, as did patients who underwent medial versus lateral root repair. Transtibial double-tunnel pull-out meniscal root repair provided improvement in function, pain, and activity level, which may aid in delayed progression of knee osteoarthritis.

Impact of Cardiac Progenitor Cells on Heart Failure and Survival in Single Ventricle Congenital Heart Disease.

PubMed

Sano, Toshikazu; Ousaka, Daiki; Goto, Takuya; Ishigami, Shuta; Hirai, Kenta; Kasahara, Shingo; Ohtsuki, Shinichi; Sano, Shunji; Oh, Hidemasa

2018-03-30

Intracoronary administration of cardiosphere-derived cells (CDCs) in patients with single ventricles resulted in a short-term improvement in cardiac function. To test the hypothesis that CDC infusion is associated with improved cardiac function and reduced mortality in patients with heart failure. We evaluated the effectiveness of CDCs using an integrated cohort study in 101 patients with single ventricles, including 41 patients who received CDC infusion and 60 controls treated with staged palliation alone. Heart failure with preserved ejection fraction (EF) or reduced EF was stratified by the cardiac function after surgical reconstruction. The main outcome measure was to evaluate the magnitude of improvement in cardiac function and all-cause mortality at 2 years. Animal studies were conducted to clarify the underlying mechanisms of heart failure with preserved EF and heart failure with reduced EF phenotypes. At 2 years, CDC infusion increased ventricular function (stage 2: +8.4±10.0% versus +1.6±6.4%, P =0.03; stage 3: +7.9±7.5% versus -1.1±5.5%, P <0.001) compared with controls. In all available follow-up data, survival did not differ between the 2 groups (log-rank P =0.225), whereas overall patients treated by CDCs had lower incidences of late failure ( P =0.022), adverse events ( P =0.013), and catheter intervention ( P =0.005) compared with controls. CDC infusion was associated with a lower risk of adverse events (hazard ratio, 0.411; 95% CI, 0.179-0.942; P =0.036). Notably, CDC infusion reduced mortality ( P =0.038) and late complications ( P <0.05) in patients with heart failure with reduced EF but not with heart failure with preserved EF. CDC-treated rats significantly reversed myocardial fibrosis with differential collagen deposition and inflammatory responses between the heart failure phenotypes. CDC administration in patients with single ventricles showed favorable effects on ventricular function and was associated with reduced late complications except for all-cause mortality after staged procedures. Patients with heart failure with reduced EF but not heart failure with preserved EF treated by CDCs resulted in significant improvement in clinical outcome. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01273857 and NCT01829750. © 2018 American Heart Association, Inc.

New Medications for Heart Failure

PubMed Central

Gordin, Jonathan S.; Fonarow, Gregg C.

2016-01-01

Heart failure is common and results in substantial morbidity and mortality. Current guideline-based therapies for heart failure with reduced ejection fraction, including beta-blockers, angiotensin converting enzyme (ACE) inhibitors, and aldosterone antagonists aim to interrupt deleterious neurohormonal pathways and have shown significant success in reducing morbidity and mortality associated with heart failure. Continued efforts to further improve outcomes in patients with heart failure with reduced ejection fraction have led to the first new-in-class medications approved for heart failure since 2005, ivabradine and sacubitril/valsartan. Ivabradine targets the If channels in the sinoatrial node of the heart, decreasing heart rate. Sacubitril/valsartan combines a neprilysin inhibitor that increases levels of beneficial vasodilatory peptides with an angiotensin receptor antagonist. On a background of previously approved, guideline-directed medical therapies for heart failure, these medications have shown improved clinical outcomes ranging from decreased hospitalizations in a select group of patients to a reduction in all-cause mortality across all pre-specified subgroups. In this review, we will discuss the previously established guideline-directed medical therapies for heart failure with reduced ejection fraction, the translational research that led to the development of these new therapies, and the results from the major clinical trials of ivabradine and sacubitril/valsartan. PMID:27038558

All-on-4® Treatment Concept for the Rehabilitation of the Completely Edentulous Mandible: A 7-Year Clinical and 5-Year Radiographic Retrospective Case Series with Risk Assessment for Implant Failure and Marginal Bone Level.

PubMed

Maló, Paulo; de Araújo Nobre, Miguel; Lopes, Armando; Ferro, Ana; Gravito, Inês

2015-10-01

Studies are needed to evaluate long-term outcomes of the All-on-4® treatment concept (Nobel Biocare AB) for rehabilitation of edentulous mandibles by assessing marginal bone levels and risk indicators for implant failure. To evaluate 7-year clinical outcomes and 5-year radiographic outcomes of the All-on-4 treatment concept. This retrospective case series included patients admitted for implant rehabilitations in the mandible, who were followed for 7 years clinically and 5 years radiographically. Primary outcome measures were cumulative prosthetic and implant survival using patient as the unit of analysis (Kaplan-Meier product limit estimator). Secondary outcome measure was marginal bone level (MBL) at 5 years. Variables associated with implant failure were analyzed using the Cox proportional hazards regression model to calculate hazard ratios (HRs) with 95% confidence intervals (CIs). Binary logistic regression was used to compute odds ratio (OR) with 95% CIs for variables associated with MBL ≥2.8 mm at 5 years. A total of 324 patients (194 women, 130 men, average age = 58.9 years) were rehabilitated with 1,296 implants supporting 324 full-arch fixed immediately loaded mandibular prostheses. Sixty-four patients (19.8%) were lost to follow-up. Prosthetic survival was 323/324 (99.7%), and 14 patients lost 18 implants, with an estimated cumulative survival rate of 95.4% at 7 years. Variables associated with implant failure were smoking (HR = 5.28; 95% CI: 1.33, 20.91]) and the learning curve effect (0.69 < HR < 0.33 for more experienced levels). Mean MBL at 5 years was 1.81 mm (95% CI: 1.70, 1.92), and smoking was associated with MBL ≥2.8 mm (OR = 2.4; 95% CI: 1.02, 5.62). The high implant and prosthetic survival rates and excellent MBL outcome confirm the predictability and safety of the All-on-4 treatment concept over a longer term than previously reported. © 2014 Wiley Periodicals, Inc.

Drug Concentration Thresholds Predictive of Therapy Failure and Death in Children With Tuberculosis: Bread Crumb Trails in Random Forests.

PubMed

Swaminathan, Soumya; Pasipanodya, Jotam G; Ramachandran, Geetha; Hemanth Kumar, A K; Srivastava, Shashikant; Deshpande, Devyani; Nuermberger, Eric; Gumbo, Tawanda

2016-11-01

 The role of drug concentrations in clinical outcomes in children with tuberculosis is unclear. Target concentrations for dose optimization are unknown.  Plasma drug concentrations measured in Indian children with tuberculosis were modeled using compartmental pharmacokinetic analyses. The children were followed until end of therapy to ascertain therapy failure or death. An ensemble of artificial intelligence algorithms, including random forests, was used to identify predictors of clinical outcome from among 30 clinical, laboratory, and pharmacokinetic variables.  Among the 143 children with known outcomes, there was high between-child variability of isoniazid, rifampin, and pyrazinamide concentrations: 110 (77%) completed therapy, 24 (17%) failed therapy, and 9 (6%) died. The main predictors of therapy failure or death were a pyrazinamide peak concentration <38.10 mg/L and rifampin peak concentration <3.01 mg/L. The relative risk of these poor outcomes below these peak concentration thresholds was 3.64 (95% confidence interval [CI], 2.28-5.83). Isoniazid had concentration-dependent antagonism with rifampin and pyrazinamide, with an adjusted odds ratio for therapy failure of 3.00 (95% CI, 2.08-4.33) in antagonism concentration range. In regard to death alone as an outcome, the same drug concentrations, plus z scores (indicators of malnutrition), and age <3 years, were highly ranked predictors. In children <3 years old, isoniazid 0- to 24-hour area under the concentration-time curve <11.95 mg/L × hour and/or rifampin peak <3.10 mg/L were the best predictors of therapy failure, with relative risk of 3.43 (95% CI, .99-11.82).  We have identified new antibiotic target concentrations, which are potential biomarkers associated with treatment failure and death in children with tuberculosis. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

Psychological Aspects of Heart Failure.

PubMed

Moser, Debra K; Arslanian-Engoren, Cynthia; Biddle, Martha J; Chung, Misook Lee; Dekker, Rebecca L; Hammash, Muna H; Mudd-Martin, Gia; Alhurani, Abdullah S; Lennie, Terry A

2016-12-01

Psychological conditions such as depression can have a greater impact on morbidity and mortality outcomes than traditional risk factors for these outcomes. Despite their importance, it is rare for clinicians to assess patients for these conditions and rarer still for them to consistently and adequately manage them. Illumination of the phenomena of comorbid psychological conditions in heart failure may increase awareness of the problem, resulting in improved assessment and management.

The Effect of Age upon Care and Outcomes in Patients Hospitalized for Congestive Heart Failure in Alberta, Canada

ERIC Educational Resources Information Center

Cujec, Bibiana; Quan, Hude; Jin, Yan; Johnson, David

2004-01-01

We describe the age-specific outcomes for patients hospitalized with newly diagnosed congestive heart failure using administrative hospital abstracts from Alberta, Canada, from April 1, 1994, to March 31, 2000. Seniors (aged 65 years and older) constituted about 85 per cent of the 16,162 patients. Both co-morbidity and severity of illness tended…

Temporal Trends and Factors Associated with Home Hemodialysis Technique Survival in Canada.

PubMed

Perl, Jeffrey; Na, Yingbo; Tennankore, Karthik K; Chan, Christopher T

2017-07-24

The last 15 years has seen growth in home hemodialysis (HD) utilization in Canada owing to reports of improved outcomes relative to patients on conventional in-center HD. What effect growth has had on home HD technique and patient survival during this period is not known. We compared the risk of home HD technique failure, mortality, and the composite outcome among three incident cohorts of patients on home HD in Canada: 1996-2002, 2003-2007, and 2008-2012. A multivariable piece-wise exponential model was used to evaluate all outcomes using inverse probability of treatment and censoring weights. A total of 1869 incident patients on home HD were identified from the Canadian Organ Replacement Register. Relative to those treated between 2003 and 2007 ( n =568), the risk of home HD technique failure was similar between patients treated between 1996 and 2002 ( n =233; adjusted hazard ratio [AHR], 1.39; 95% confidence interval [95% CI], 0.78 to 2.46) but higher among incident patients on home HD treated between 2008 and 2012 ( n =1068; AHR, 1.51; 95% CI, 1.06 to 2.15). Relative to patients treated between 2003 and 2007, adjusted mortality was similar among those treated between 2008 and 2012 (AHR, 0.83; 95% CI, 0.58 to 1.19) and those treated between 1996 and 2002 (AHR, 0.67; 95% CI, 0.38 to 1.21). The risk of the composite outcome of death and technique failure was similar across cohorts, as was the risk of receiving a kidney transplant. Increasing age, diabetes as a comorbidity, and smoking status were associated with an increased risk of death as well as the composite outcome. Medium-sized facilities had a lower risk of death, technique failure, and the composite outcome compared with larger facilities. A higher risk of technique failure was seen in the most contemporary era. Further characterization of the risk factors for, and causes of technique failure is needed to develop strategies to improve patient retention on home HD. Copyright © 2017 by the American Society of Nephrology.

When Project Commitment Leads to Learning from Failure: The Roles of Perceived Shame and Personal Control

PubMed Central

Wang, Wenzhou; Wang, Bin; Yang, Ke; Yang, Chong; Yuan, Wenlong; Song, Shanghao

2018-01-01

Facing a remarkably changing world, researchers have gradually shifted emphasis from successful experiences to failures. In the current study, we build a model to explore the relationship between project commitment and learning from failure, and test how emotion (i.e., perceived shame after failure) and cognition (i.e., attribution for failure) affect this process. After randomly selecting 400 firms from the list of high-tech firms reported by the Beijing Municipal Science and Technology Commission, we use a two-wave investigation of the employees, and the final sample consists of 140 teams from 58 companies in the technology industry in mainland China. The results provide evidence for the positive role of personal control attribution in the relationship between project commitment and learning from failure. However, in contrast to previous studies, perceived shame, as the negative emotion after failed events, could bring desirable outcomes during this process. Based on the results, we further expand a model to explain the behavioral responses after failure, and the implications of our findings for research and practice are discussed. The failures and reverses which await men - and one after another sadden the brow of youth - add a dignity to the prospect of human life, which no Arcadian success would do. —Henry David Thoreau PMID:29467699

When Project Commitment Leads to Learning from Failure: The Roles of Perceived Shame and Personal Control.

PubMed

Wang, Wenzhou; Wang, Bin; Yang, Ke; Yang, Chong; Yuan, Wenlong; Song, Shanghao

2018-01-01

Facing a remarkably changing world, researchers have gradually shifted emphasis from successful experiences to failures. In the current study, we build a model to explore the relationship between project commitment and learning from failure, and test how emotion (i.e., perceived shame after failure) and cognition (i.e., attribution for failure) affect this process. After randomly selecting 400 firms from the list of high-tech firms reported by the Beijing Municipal Science and Technology Commission, we use a two-wave investigation of the employees, and the final sample consists of 140 teams from 58 companies in the technology industry in mainland China. The results provide evidence for the positive role of personal control attribution in the relationship between project commitment and learning from failure. However, in contrast to previous studies, perceived shame, as the negative emotion after failed events, could bring desirable outcomes during this process. Based on the results, we further expand a model to explain the behavioral responses after failure, and the implications of our findings for research and practice are discussed. The failures and reverses which await men - and one after another sadden the brow of youth - add a dignity to the prospect of human life, which no Arcadian success would do. -Henry David Thoreau.

Curved-stem Hip Resurfacing

PubMed Central

2008-01-01

Hip resurfacing is an attractive concept because it preserves rather than removes the femoral head and neck. Most early designs had high failure rates, but one unique design had a femoral stem. Because that particular device appeared to have better implant survival, this study assessed the clinical outcome and long-term survivorship of a hip resurfacing prosthesis. Four hundred forty-five patients (561 hips) were retrospectively reviewed after a minimum of 20 years’ followup or until death; 23 additional patients were lost to followup. Patients received a metal femoral prosthesis with a small curved stem. Three types of acetabular reconstructions were used: (1) cemented polyurethane; (2) metal-on-metal; and (3) polyethylene secured with cement or used as the liner of a two-piece porous-coated implant. Long-term results were favorable with the metal-on-metal combination only. The mean overall Harris hip score was 92 at 2 years of followup. None of the 121 patients (133 hips) who received metal-on-metal articulation experienced failure. The failure rate with polyurethane was 100%, and the failure rate with cemented polyethylene was 41%. Hip resurfacing with a curved-stem femoral component had a durable clinical outcome when a metal-on-metal articulation was used. Level of Evidence: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18338217

The Influence of a High Salt Diet on a Rat Model of Isoproterenol-Induced Heart Failure

EPA Science Inventory

Rat models of heart failure (HF) show varied pathology and time to disease outcome, dependent on induction method. We found that subchronic (4 weeks) isoproterenol (ISO) infusion exacerbated cardiomyopathy in Spontaneously Hypertensive Heart Failure (SHHF) rats. Others have shown...

A RAT MODEL OF HEART FAILURE INDUCED BY ISOPROTERENOL AND A HIGH SALT DIET

EPA Science Inventory

Rat models of heart failure (HF) show varied pathology and time to disease outcome, dependent on induction method. We found that subchronic (4wk) isoproterenol (ISO) infusion in Spontaneously Hypertensive Heart Failure (SHHF) rats caused cardiac injury with minimal hypertrophy. O...

Failure rate of single-unit restorations on posterior vital teeth: A systematic review.

PubMed

Afrashtehfar, Kelvin I; Emami, Elham; Ahmadi, Motahareh; Eilayyan, Owis; Abi-Nader, Samer; Tamimi, Faleh

2017-03-01

No knowledge synthesis exists concerning when to use a direct restoration versus a complete-coverage indirect restoration in posterior vital teeth. The purpose of this systematic review was to identify the failure rate of conventional single-unit tooth-supported restorations in posterior permanent vital teeth as a function of remaining tooth structure. Four databases were searched electronically, and 8 selected journals were searched manually up to February 2015. Clinical studies of tooth-supported single-unit restorative treatments with a mean follow-up period of at least 3 years were selected. The outcome measured was the restorations' clinical or radiological failure. Following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines, the Cochrane Collaboration procedures for randomized control trials, the Strengthening the Reporting of Observational Studies in Epidemiology criteria for observational studies, 2 reviewers independently applied eligibility criteria, extracted data, and assessed the quality of the evidence of the included studies using the American Association of Critical Care Nurses' system. The weighted-mean group 5-year failure rates of the restorations were reported according to the type of treatment and remaining tooth structure. A metaregression model was used to assess the correlation between the number of remaining tooth walls and the weighted-mean 5-year failure rates. Five randomized controlled trials and 9 observational studies were included and their quality ranged from low to moderate. These studies included a total of 358 crowns, 4804 composite resins, and 303582 amalgams. Data obtained from the randomized controlled trials showed that, regardless of the amount of remaining tooth structure, amalgams presented better outcomes than composite resins. Furthermore, in teeth with fewer than 2 remaining walls, high-quality observational studies demonstrated that crowns were better than amalgams. A clear inverse correlation was found between the amount of remaining tooth structure and restoration failure. Insufficient high-quality data are available to support one restorative treatment or material over another for the restoration of vital posterior teeth. However, the current evidence suggests that the failure rates of treatments may depend on the amount of remaining tooth structure and types of treatment. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home)

PubMed Central

2016-01-01

Background Seniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department. Objective The aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context. Methods This 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to detect patient deterioration sooner. Results It is hypothesized that TEC4Home will be a cost-effective strategy to decrease 90-day emergency department revisits and hospital admission rates and improve comfort and quality of life for seniors with heart failure. The results from this project will also help establish an innovation pathway for rapid and rigorous introduction of innovation into the health system. Conclusions While there is some evidence about the effectiveness of home telemonitoring for some patients and conditions, the TEC4Home project will be one of the first protocols that implements and evaluates the technology for patients with heart failure as they transition from the emergency department to home care. The results from this research are expected to inform the full scale and spread of the home monitoring approach throughout British Columbia and Canada and to other chronic diseases. ClinicalTrial ClinicalTrials.gov NCT02821065; https://clinicaltrials.gov/ct2/show/NCT02821065 (Archived by WebCite at http://www.webcitation.org/6ml2iwKax) PMID:27977002

Defective support network: a major obstacle to coping for patients with heart failure: a qualitative study

PubMed Central

Shahrbabaki, Parvin Mangolian; Nouhi, Esmat; Kazemi, Majid; Ahmadi, Fazlollah

2016-01-01

Background Heart failure as a chronic disease poses many challenges for a patient in his or her everyday life. Support in various aspects of life positively affects coping strategies and influences the well-being and health outcomes of heart failure patients. Inadequate support may lead to a worsening of symptoms, increased hospital readmissions, psychological disorders, and a reduced quality of life. Objective This study explored obstacles to coping related to support for heart failure patients as viewed by the patients themselves and their family members and caregivers. Design This qualitative study was conducted using content analysis. The 20 Iranian participants included 11 patients with heart failure, three cardiologists, three nurses, and three family members of heart failure patients selected through purposive sampling. Data were collected through semi-structured interviews and analyzed using the Lundman and Graneheim qualitative content analysis method. Results During data analysis, ‘defective support network’ developed as the main theme along with four other categories of ‘inadequate family performance’, ‘inadequate support by the healthcare team’, ‘distorted societal social support’, and ‘inadequate welfare support’. Conclusion The findings of the current study can assist health authorities and planners in identifying the needs of patients with heart failure so as to focus and plan on facilitating their coping as much as possible by obviating the existing obstacles. PMID:27041539

Multivariate analysis of risk factors for long-term urethroplasty outcome.

PubMed

Breyer, Benjamin N; McAninch, Jack W; Whitson, Jared M; Eisenberg, Michael L; Mehdizadeh, Jennifer F; Myers, Jeremy B; Voelzke, Bryan B

2010-02-01

We studied the patient risk factors that promote urethroplasty failure. Records of patients who underwent urethroplasty at the University of California, San Francisco Medical Center between 1995 and 2004 were reviewed. Cox proportional hazards regression analysis was used to identify multivariate predictors of urethroplasty outcome. Between 1995 and 2004, 443 patients of 495 who underwent urethroplasty had complete comorbidity data and were included in analysis. Median patient age was 41 years (range 18 to 90). Median followup was 5.8 years (range 1 month to 10 years). Stricture recurred in 93 patients (21%). Primary estimated stricture-free survival at 1, 3 and 5 years was 88%, 82% and 79%. After multivariate analysis smoking (HR 1.8, 95% CI 1.0-3.1, p = 0.05), prior direct vision internal urethrotomy (HR 1.7, 95% CI 1.0-3.0, p = 0.04) and prior urethroplasty (HR 1.8, 95% CI 1.1-3.1, p = 0.03) were predictive of treatment failure. On multivariate analysis diabetes mellitus showed a trend toward prediction of urethroplasty failure (HR 2.0, 95% CI 0.8-4.9, p = 0.14). Length of urethral stricture (greater than 4 cm), prior urethroplasty and failed endoscopic therapy are predictive of failure after urethroplasty. Smoking and diabetes mellitus also may predict failure potentially secondary to microvascular damage. Copyright 2010 American Urological Association. Published by Elsevier Inc. All rights reserved.

Clinical and radiological outcomes after reverse shoulder arthroplasty in patients with failed deltoid or latissimus dorsi transfers. A review of ten cases.

PubMed

Valenti, Philippe; Maqdes, Ali; Werthel, Jean-David

2017-10-01

The purpose of this study was to report clinical and radiological results of reverse shoulder arthroplasty (RSA) after failure of either a deltoid and/or a latissimus dorsi transfer. Between 2001 and 2011, ten patients (average age, 61 years) underwent primary RSA after a failed tendon transfer for irreparable postero-superior rotator cuff tear (five deltoid muscle transfers, four latissimus dorsi transfers and one both). Average follow-up was 48 months. Outcome measures included pain, range of motion and postoperative Constant-Murley score. Pain score improved significantly from a mean 8.3 to a mean 0.3. Mean shoulder elevation improved from 66 to 134°, and absolute Constant-Murley scores increased from 25.8 to 62.8 The mean improvement in external rotation was limited to 7.5°. Subjectively, six patients rated the result as much better and three rated it as better than before surgery. Failure of the tendon transfer with deterioration of the functional outcomes can be salvaged with a RSA with no impact on the expected outcome.

Role of First-Line Noninvasive Ventilation in Non-COPD Subjects With Pneumonia.

PubMed

Rialp, Gemma; Forteza, Catalina; Muñiz, Daniel; Romero, Maria

2017-09-01

The use of noninvasive ventilation (NIV) in non-COPD patients with pneumonia is controversial due to its high rate of failure and the potentially harmful effects when NIV fails. The purpose of the study was to evaluate outcomes of the first ventilatory treatment applied, NIV or invasive mechanical ventilation (MV), and to identify predictors of NIV failure. Historical cohort study of 159 non-COPD patients with pneumonia admitted to the ICU with ventilatory support. Subjects were divided into 2 groups: invasive MV or NIV. Univariate and multivariate analyses with demographic and clinical data were performed. Analysis of mortality was adjusted for the propensity of receiving first-line invasive MV. One hundred and thirteen subjects received first-line invasive MV and 46 received first-line NIV, of which 27 needed intubation. Hospital mortality was 35, 37 and 56%, respectively, with no significant differences among groups. In the propensity-adjusted analysis (expressed as OR [95% CI]), hospital mortality was associated with age (1.05 [1.02-1.08]), SAPS3 (1.03 [1.00-1.07]), immunosuppression (2.52 [1.02-6.27]) and NIV failure compared to first-line invasive MV (4.3 [1.33-13.94]). Compared with invasive MV, NIV failure delayed intubation (p=.004), and prolonged the length of invasive MV (p=.007) and ICU stay (p=.001). NIV failure was associated with need for vasoactive drugs (OR 7.8 [95% CI, 1.8-33.2], p=.006). In non-COPD subjects with pneumonia, first-line NIV was not associated with better outcome compared with first-line invasive MV. NIV failure was associated with longer duration of MV and hospital stay, and with increased hospital mortality. The use of vasoactive drugs predicted NIV failure. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

Prognostic Significance of Baseline Serum Sodium in Heart Failure With Preserved Ejection Fraction.

PubMed

Patel, Yash R; Kurgansky, Katherine E; Imran, Tasnim F; Orkaby, Ariela R; McLean, Robert R; Ho, Yuk-Lam; Cho, Kelly; Gaziano, J Michael; Djousse, Luc; Gagnon, David R; Joseph, Jacob

2018-06-13

The purpose of this study was to evaluate the relationship between serum sodium at the time of diagnosis and long term clinical outcomes in a large national cohort of patients with heart failure with preserved ejection fraction. We studied 25 440 patients with heart failure with preserved ejection fraction treated at Veterans Affairs medical centers across the United States between 2002 and 2012. Serum sodium at the time of heart failure diagnosis was analyzed as a continuous variable and in categories as follows: low (115.00-134.99 mmol/L), low-normal (135.00-137.99 mmol/L), referent group (138.00-140.99 mmol/L), high normal (141.00-143.99 mmol/L), and high (144.00-160.00 mmol/L). Multivariable Cox regression and negative binomial regression were performed to estimate hazard ratios (95% confidence interval [CI]) and incidence density ratios (95% CI) for the associations of serum sodium with mortality and hospitalizations (heart failure and all-cause), respectively. The average age of patients was 70.8 years, 96.2% were male, and 14% were black. Compared with the referent group, low, low-normal, and high sodium values were associated with 36% (95% CI, 28%-44%), 6% (95% CI, 1%-12%), and 9% (95% CI, 1%-17%) higher risk of all-cause mortality, respectively. Low and low-normal serum sodium were associated with 48% (95% CI, 10%-100%) and 38% (95% CI, 8%-77%) higher risk of number of days of heart failure hospitalizations per year, and with 44% (95% CI, 32%-56%) and 18% (95% CI, 10%-27%) higher risk of number of days of all-cause hospitalizations per year, respectively. Both elevated and reduced serum sodium, including values currently considered within normal range, are associated with adverse outcomes in patients with heart failure with preserved ejection fraction. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Clinical outcomes of osteomyelitis patients infected with methicillin-resistant Staphylococcus aureus USA-300 strains.

PubMed

Peyrani, P; Allen, M; Seligson, D; Roberts, C; Chen, A; Haque, N; Zervos, M; Wiemken, T; Harting, J; Christensen, D; Ramirez, R

2012-03-01

Methicillin-resistant Staphylococcus aureus (MRSA) USA-300 strains have emerged as an important cause of community-acquired infections. These strains have been recognized as an etiology of osteomyelitis but data on their incidence and outcomes are limited. We retrospectively studied the incidence and clinical outcomes of MRSA USA-300 osteomyelitis in patients at the University of Louisville Hospital and the Henry Ford Health System between January 2007 and March 2008. Pulsed-field gel electrophoresis was used to determine USA type. Clinical outcomes were defined as management success versus failure at 12 months. Chi-square tests, Fisher exact tests, and Mann-Whitney tests were used to compare patient characteristics on the basis of clinical outcomes and USA type. Of the 50 patients with MRSA osteomyelitis, 27 (54%) had the USA-300 strain. Clinical failure was identified in 22% (6/27) of the patients with MRSA USA-300 and in 30% (7/23) of the patients with MRSA non-USA-300 osteomyelitis (P = .509). Our results showed that MRSA USA-300 is a significant etiology of MRSA osteomyelitis. With current surgical and medical management, outcomes of patients with MRSA USA-300 osteomyelitis are similar to those of patients with MRSA non-USA-300 osteomyelitis.

Stress and reproductive failure: past notions, present insights and future directions

PubMed Central

Sheps, Sam; Clara Arck, Petra

2008-01-01

Problem Maternal stress perception is frequently alleged as a cause of infertility, miscarriages, late pregnancy complications or impaired fetal development. The purpose of the present review is to critically assess the biological and epidemiological evidence that considers the plausibility of a stress link to human reproductive failure. Methods All epidemiological studies published between 1980 and 2007 that tested the link between stress exposure and impaired reproductive success in humans were identified. Study outcomes were evaluated on the basis of how associations were predicted, tested and integrated with theories of etiology arising from recent scientific developments in the basic sciences. Further, published evidence arising from basic science research has been assessed in order to provide a mechanistic concept and biological evidence for the link between stress perception and reproductive success. Results Biological evidence points to an immune–endocrine disequilibrium in response to stress and describes a hierarchy of biological mediators involved in a stress trigger to reproductive failure. Epidemiological evidence presents positive correlations between various pregnancy failure outcomes with pre-conception negative life events and elevated daily urinary cortisol. Strikingly, a relatively new conceptual approach integrating the two strands of evidence suggests the programming of stress susceptibility in mother and fetus via a so-called pregnancy stress syndrome. Conclusions An increasing specificity of knowledge is available about the types and impact of biological and social pathways involved in maternal stress responses. The present evidence is sufficient to warrant a reconsideration of conventional views on the etiology of reproductive failure. Physicians and patients will benefit from the adaptation of this integrated evidence to daily clinical practice. PMID:18274890

Results of lateral ankle ligament repair surgery in one hundred and nineteen patients: do surgical method and arthroscopy timing matter?

PubMed

Araoye, Ibukunoluwa; De Cesar Netto, Cesar; Cone, Brent; Hudson, Parke; Sahranavard, Bahman; Shah, Ashish

2017-11-01

Ankle sprains are the most common athletic injury. One of five chronic lateral ankle instability patients will require surgery, making operative outcomes crucial. The purpose of this study is to determine if operative method influences failure and complication rates in chronic lateral ankle ligament repair surgery. We retrospectively reviewed 119 cases (118 patients) of lateral ankle ligament surgery between 2006 and 2016. Patient charts and operative reports were examined for demographics, use and timing of ankle arthroscopy, ligament fixation method, type of surgical incision, presence of calcaneofibular ligament repair, and operative technique. Impact of operative methods on failure (one-year minimum follow-up) and complication outcomes was explored using Chi-square test of independence (or Fisher's exact test). Statistical significance was set at p less than .05. Mean age at surgery was 40 (range, 18-73) years. Mean follow-up was 51 (range, 12-260) weeks. Failure rate was 8.4% (10/89 cases) while complication rate was 17.6% (21/119). Failure rate did not differ significantly between any data subgroups (p > .05). Single stage arthroscopy was associated with a significantly lower complication rate (11%, 4/37) than double-stage arthroscopy (47%, 9/19) (p < .01) as was suture anchor ligament fixation (9%, 6/67) compared to direct suture ligament fixation (29%, 15/52) (p < .01). Failure rate was not impacted by any of the studied variables. Use of suture anchors and concurrent ankle arthroscopy may be favourable options to achieve fewer complications in chronic lateral ankle instability repair surgery.

Post-discharge body weight and neurodevelopmental outcomes among very low birth weight infants in Taiwan: A nationwide cohort study.

PubMed

Hsu, Chung-Ting; Chen, Chao-Huei; Lin, Ming-Chih; Wang, Teh-Ming; Hsu, Ya-Chi

2018-01-01

Premature infants are at high risk for developmental delay and cognitive dysfunction. Besides medical conditions, growth restriction is regarded as an important risk factor for cognitive and neurodevelopmental dysfunction throughout childhood and adolescence and even into adulthood. In this study, we analyzed the relationship between post-discharge body weight and psychomotor development using a nationwide dataset. This was a nationwide cohort study conducted in Taiwan. Total of 1791 premature infants born between 2007 and 2011 with a birth weight of less than 1500 g were enrolled into this multi-center study. The data were obtained from the Taiwan Premature Infant Developmental Collaborative Study Group. The growth and neurodevelopmental evaluations were performed at corrected ages of 6, 12 and 24 months. Post-discharge failure to thrive was defined as a body weight below the 3rd percentile of the standard growth curve for Taiwanese children by the corrected age. The prevalence of failure to thrive was 15.8%, 16.9%, and 12.0% at corrected ages of 6, 12, and 24 months, respectively. At corrected ages of 24 months, 12.9% had low Mental Developmental Index (MDI) scores (MDI<70), 17.8% had low Psychomotor Developmental Index (PDI) scores (PDI<70), 12.7% had cerebral palsy, and 29.5% had neurodevelopmental impairment. Post-discharge failure to thrive was significantly associated with poor neurodevelopmental outcomes. After controlling for potential confounding factors (small for gestational age, extra-uterine growth retardation at discharge, cerebral palsy, gender, mild intraventricular hemorrhage, persistent pulmonary hypertension of newborn, respiratory distress syndrome, chronic lung disease, hemodynamic significant patent ductus arteriosus, necrotizing enterocolitis, surfactant use and indomethacin use), post-discharge failure to thrive remained a risk factor. This observational study observed the association between lower body weight at corrected age of 6, 12, and 24 months and poor neurodevelopmental outcomes among VLBW premature infants. There are many adverse factors which can influence the neurodevelopment in NICU care. More studies are needed to elucidate the causal relationship.

Post-discharge body weight and neurodevelopmental outcomes among very low birth weight infants in Taiwan: A nationwide cohort study

PubMed Central

Hsu, Chung-Ting; Chen, Chao-Huei; Wang, Teh-Ming; Hsu, Ya-Chi

2018-01-01

Background Premature infants are at high risk for developmental delay and cognitive dysfunction. Besides medical conditions, growth restriction is regarded as an important risk factor for cognitive and neurodevelopmental dysfunction throughout childhood and adolescence and even into adulthood. In this study, we analyzed the relationship between post-discharge body weight and psychomotor development using a nationwide dataset. Materials and methods This was a nationwide cohort study conducted in Taiwan. Total of 1791 premature infants born between 2007 and 2011 with a birth weight of less than 1500 g were enrolled into this multi-center study. The data were obtained from the Taiwan Premature Infant Developmental Collaborative Study Group. The growth and neurodevelopmental evaluations were performed at corrected ages of 6, 12 and 24 months. Post-discharge failure to thrive was defined as a body weight below the 3rd percentile of the standard growth curve for Taiwanese children by the corrected age. Results The prevalence of failure to thrive was 15.8%, 16.9%, and 12.0% at corrected ages of 6, 12, and 24 months, respectively. At corrected ages of 24 months, 12.9% had low Mental Developmental Index (MDI) scores (MDI<70), 17.8% had low Psychomotor Developmental Index (PDI) scores (PDI<70), 12.7% had cerebral palsy, and 29.5% had neurodevelopmental impairment. Post-discharge failure to thrive was significantly associated with poor neurodevelopmental outcomes. After controlling for potential confounding factors (small for gestational age, extra-uterine growth retardation at discharge, cerebral palsy, gender, mild intraventricular hemorrhage, persistent pulmonary hypertension of newborn, respiratory distress syndrome, chronic lung disease, hemodynamic significant patent ductus arteriosus, necrotizing enterocolitis, surfactant use and indomethacin use), post-discharge failure to thrive remained a risk factor. Conclusion This observational study observed the association between lower body weight at corrected age of 6, 12, and 24 months and poor neurodevelopmental outcomes among VLBW premature infants. There are many adverse factors which can influence the neurodevelopment in NICU care. More studies are needed to elucidate the causal relationship. PMID:29444139

Outcomes and xerostomia after postoperative radiotherapy for oral and oropharyngeal carcinoma.

PubMed

Wang, Zhong-He; Yan, Chao; Zhang, Zhi-Yuan; Zhang, Chen-Ping; Hu, Hai-Sheng; Tu, Wen-Yong; Kirwan, Jessica; Mendenhall, William M

2014-10-01

We compared outcomes and xerostomia grade after postoperative intensity-modulated radiation therapy (IMRT) and conventional radiotherapy (RT) in patients with oral and oropharyngeal carcinoma. Eighty-eight patients with oral cavity (n = 77) and oropharyngeal (n = 11) carcinoma underwent postoperative IMRT (n = 44) or conventional RT (n = 44). Outcomes, failure patterns, volume, doses, salivary gland V30, and xerostomia grade were evaluated. The median follow-up was 53 months (range, 48-58 months). The median interval from surgery to RT was 4 weeks (range, 3-6 weeks). Twenty-one patients (7 and 14 for the IMRT and conventional RT groups, respectively) experienced local-regional failure. For the IMRT group, all 7 local-regional failures occurred in the high-dose target volumes. For the conventional RT group, there were 12 in-field failures, 1 at the margin, and 1 out-of-field. Nine patients experienced distant failure (5 and 4 for the IMRT and conventional RT groups, respectively). The 4-year local-regional control, disease-free survival (DFS), overall survival (OS), and distant-metastasis rates for the IMRT and conventional RT groups were 84.1% versus 68.2% (p = .055), 68.2% versus 52.3% (p = .091), 70.5% versus 56.8% (p = .124), and 11.4% versus 9.1% (p = .927), respectively. Xerostomia grade after RT was lower for IMRT compared to conventional RT (p < .001). Postoperative IMRT for oral and oropharyngeal carcinoma significantly improves mean dose, salivary gland V30, and xerostomia grade when compared to conventional RT. The predominant failure pattern was local. No differences were found in survival outcomes between both groups. There was a marginal difference in local-regional control. © 2014 Wiley Periodicals, Inc.

Concurrent Anemia and Elevated C-Reactive Protein Predicts HIV Clinical Treatment Failure, Including Tuberculosis, After Antiretroviral Therapy Initiation

PubMed Central

Shivakoti, Rupak; Yang, Wei-Teng; Gupte, Nikhil; Berendes, Sima; Rosa, Alberto La; Cardoso, Sandra W.; Mwelase, Noluthando; Kanyama, Cecilia; Pillay, Sandy; Samaneka, Wadzanai; Riviere, Cynthia; Sugandhavesa, Patcharaphan; Santos, Brento; Poongulali, Selvamuthu; Tripathy, Srikanth; Bollinger, Robert C.; Currier, Judith S.; Tang, Alice M.; Semba, Richard D.; Christian, Parul; Campbell, Thomas B.; Gupta, Amita

2015-01-01

Background. Anemia is a known risk factor for clinical failure following antiretroviral therapy (ART). Notably, anemia and inflammation are interrelated, and recent studies have associated elevated C-reactive protein (CRP), an inflammation marker, with adverse human immunodeficiency virus (HIV) treatment outcomes, yet their joint effect is not known. The objective of this study was to assess prevalence and risk factors of anemia in HIV infection and to determine whether anemia and elevated CRP jointly predict clinical failure post-ART. Methods. A case-cohort study (N = 470 [236 cases, 234 controls]) was nested within a multinational randomized trial of ART efficacy (Prospective Evaluation of Antiretrovirals in Resource Limited Settings [PEARLS]). Cases were incident World Health Organization stage 3, 4, or death by 96 weeks of ART treatment (clinical failure). Multivariable logistic regression was used to determine risk factors for pre-ART (baseline) anemia (females: hemoglobin <12.0 g/dL; males: hemoglobin <13.0 g/dL). Association of anemia as well as concurrent baseline anemia and inflammation (CRP ≥10 mg/L) with clinical failure were assessed using multivariable Cox models. Results. Baseline anemia prevalence was 51% with 15% prevalence of concurrent anemia and inflammation. In analysis of clinical failure, multivariate-adjusted hazard ratios were 6.41 (95% confidence interval [CI], 2.82–14.57) for concurrent anemia and inflammation, 0.77 (95% CI, .37–1.58) for anemia without inflammation, and 0.45 (95% CI, .11–1.80) for inflammation without anemia compared to those without anemia and inflammation. Conclusions. ART-naive, HIV-infected individuals with concurrent anemia and inflammation are at particularly high risk of failing treatment, and understanding the pathogenesis could lead to new interventions. Reducing inflammation and anemia will likely improve HIV disease outcomes. Alternatively, concurrent anemia and inflammation could represent individuals with occult opportunistic infections in need of additional screening. PMID:25828994

Nonrhabdomyosarcoma soft tissue sarcoma (NRSTS) in pediatric and young adult patients: Results from a prospective study using limited-margin radiotherapy.

PubMed

Tinkle, Christopher L; Fernandez-Pineda, Israel; Sykes, April; Lu, Zhaohua; Hua, Chia-Ho; Neel, Michael D; Bahrami, Armita; Shulkin, Barry L; Kaste, Sue C; Pappo, Alberto; Spunt, Sheri L; Krasin, Matthew J

2017-11-15

Indications for and delivery of adjuvant therapies for pediatric nonrhabdomyosarcoma soft tissue sarcoma (NRSTS) have been derived largely from adult studies; therefore, significant concern remains regarding radiation exposure to normal tissue. The authors report long-term treatment outcomes and toxicities for pediatric and young adult patients with high-grade NRSTS who were treated on a prospective trial using limited-margin radiotherapy. Sixty-two patients (ages 3-22 years) with predominantly high-grade NRSTS requiring radiation were treated on a phase 2 institutional study of conformal external-beam radiotherapy and/or brachytherapy using a 1.5-cm to 2-cm anatomically constrained margin. The estimated cumulative incidence of local failure, Gray's method estimated cumulative incidence of local failure, Kaplan-Meier method estimated survival, competing-risk regression model determined predictors of disease outcome, and toxicity was reported according to CTCAE v2.0. At a median follow-up of 5.1 years (range, 0.2-10.9 years), 9 patients had experienced local failure. The 5-year overall cumulative incidence of local failure was 14.8% (95% confidence interval [CI], 7.2%-25%), and all but 1 local failure occurred outside the highest-dose irradiation volume. The 5-year Kaplan-Meier estimates for event-free and overall survival were 49.3% (95% CI, 36.3%-61.1%) and 67.9% (95% CI, 54.2%-78.3%), respectively. Multivariable analysis indicated that younger age was the only independent predictor of local recurrence (P = .004). The 5-year cumulative incidence of grade 3 or 4 late toxicity was 15% (95% CI, 7.2%-25.3%). The delivery of limited-margin radiotherapy using conformal external-beam radiotherapy or brachytherapy provides a high rate of local tumor control without an increase in marginal failures and with acceptable treatment-related morbidity. Cancer 2017;123:4419-29. © 2017 American Cancer Society. © 2017 American Cancer Society.

Critical evaluation of challenges and future use of animals in experimentation for biomedical research.

PubMed

Singh, Vijay Pal; Pratap, Kunal; Sinha, Juhi; Desiraju, Koundinya; Bahal, Devika; Kukreti, Ritushree

2016-12-01

Animal experiments that are conducted worldwide contribute to significant findings and breakthroughs in the understanding of the underlying mechanisms of various diseases, bringing up appropriate clinical interventions. However, their predictive value is often low, leading to translational failure. Problems like translational failure of animal studies and poorly designed animal experiments lead to loss of animal lives and less translatable data which affect research outcomes ethically and economically. Due to increasing complexities in animal usage with changes in public perception and stringent guidelines, it is becoming difficult to use animals for conducting studies. This review deals with challenges like poor experimental design and ethical concerns and discusses key concepts like sample size, statistics in experimental design, humane endpoints, economic assessment, species difference, housing conditions, and systematic reviews and meta-analyses that are often neglected. If practiced, these strategies can refine the procedures effectively and help translate the outcomes efficiently. © The Author(s) 2016.

Critical evaluation of challenges and future use of animals in experimentation for biomedical research

PubMed Central

Singh, Vijay Pal; Pratap, Kunal; Sinha, Juhi; Desiraju, Koundinya; Bahal, Devika; Kukreti, Ritushree

2016-01-01

Animal experiments that are conducted worldwide contribute to significant findings and breakthroughs in the understanding of the underlying mechanisms of various diseases, bringing up appropriate clinical interventions. However, their predictive value is often low, leading to translational failure. Problems like translational failure of animal studies and poorly designed animal experiments lead to loss of animal lives and less translatable data which affect research outcomes ethically and economically. Due to increasing complexities in animal usage with changes in public perception and stringent guidelines, it is becoming difficult to use animals for conducting studies. This review deals with challenges like poor experimental design and ethical concerns and discusses key concepts like sample size, statistics in experimental design, humane endpoints, economic assessment, species difference, housing conditions, and systematic reviews and meta-analyses that are often neglected. If practiced, these strategies can refine the procedures effectively and help translate the outcomes efficiently. PMID:27694614

Systolic blood pressure, cardiovascular outcomes and efficacy and safety of sacubitril/valsartan (LCZ696) in patients with chronic heart failure and reduced ejection fraction: results from PARADIGM-HF.

PubMed

Böhm, Michael; Young, Robin; Jhund, Pardeep S; Solomon, Scott D; Gong, Jianjian; Lefkowitz, Martin P; Rizkala, Adel R; Rouleau, Jean L; Shi, Victor C; Swedberg, Karl; Zile, Michael R; Packer, Milton; McMurray, John J V

2017-04-14

Compared to heart failure patients with higher systolic blood pressure (SBP), those with lower SBP have a worse prognosis. To make matters worse, the latter patients often do not receive treatment with life-saving therapies that might lower blood pressure further. We examined the association between SBP and outcomes in the Prospective Comparison of angiotensin receptor-neprilysin inhibitor (ARNI) with an angiotensin-converting enzyme (ACE) inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure trial (PARADIGM-HF), as well as the effect of sacubitril/valsartan, compared with enalapril, according to baseline SBP. We analysed the effect of treatment on SBP and on the primary composite outcome (cardiovascular death or heart failure hospitalization), its components and all-cause death. We examined baseline SBP as a categorical (<110, 110 to < 120, 120 to < 130, 130 to < 140 and ≥140 mmHg) and continuous variable, as well as average in-trial SBP and time-updated SBP. All-cause and cardiovascular mortality rates were highest in patients with the lowest SBP whereas there was a U-shaped relationship between SBP and the rate of heart failure hospitalization. The benefit of sacubitril/valsartan over enalapril was consistent across all baseline SBP categories for all outcomes. For example, the sacubitril/valsartan versus enalapril hazard ratio for the primary endpoint was 0.88 (95%CI 0.74-1.06) in patients with a baseline SBP <110 mmHg and 0.81 (0.65-1.02) for those with a SBP ≥140 mmHg (P for interaction = 0.55). Symptomatic hypotension, study drug dose-reduction and discontinuation were more frequent in patients with a lower SBP. In PARADIGM-HF, patients with lower SBP at randomization, notably after tolerating full doses of both study drugs during a run-in period, were at higher risk but generally tolerated sacubitril/valsartan and had the same relative benefit over enalapril as patients with higher baseline SBP. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For Permissions, please email: journals.permissions@oup.com.

Instrument Failures for the da Vinci Surgical System: a Food and Drug Administration MAUDE Database Study.

PubMed

Friedman, Diana C W; Lendvay, Thomas S; Hannaford, Blake

2013-05-01

Our goal was to analyze reported instances of the da Vinci robotic surgical system instrument failures using the FDA's MAUDE (Manufacturer and User Facility Device Experience) database. From these data we identified some root causes of failures as well as trends that may assist surgeons and users of the robotic technology. We conducted a survey of the MAUDE database and tallied robotic instrument failures that occurred between January 2009 and December 2010. We categorized failures into five main groups (cautery, shaft, wrist or tool tip, cable, and control housing) based on technical differences in instrument design and function. A total of 565 instrument failures were documented through 528 reports. The majority of failures (285) were of the instrument's wrist or tool tip. Cautery problems comprised 174 failures, 76 were shaft failures, 29 were cable failures, and 7 were control housing failures. Of the reports, 10 had no discernible failure mode and 49 exhibited multiple failures. The data show that a number of robotic instrument failures occurred in a short period of time. In reality, many instrument failures may go unreported, thus a true failure rate cannot be determined from these data. However, education of hospital administrators, operating room staff, surgeons, and patients should be incorporated into discussions regarding the introduction and utilization of robotic technology. We recommend institutions incorporate standard failure reporting policies so that the community of robotic surgery companies and surgeons can improve on existing technologies for optimal patient safety and outcomes.

Factors predicting mortality in severe acute pancreatitis.

PubMed

Compañy, L; Sáez, J; Martínez, J; Aparicio, J R; Laveda, R; Griñó, P; Pérez-Mateo, M

2003-01-01

Acute pancreatitis (AP) is a common disorder in which ensuing serious complications may lead to a fatal outcome in patients. To describe a large series of patients with severe AP (SAP) who were admitted to our hospital and to identify factors predicting mortality. In a retrospective study, all patients with SAP diagnosed between February 1996 and October 2000 according to the Atlanta criteria were studied. Out of a total of 363 AP patients, 67 developed SAP. The mean age of the patients was 69; the commonest etiology was biliary; 55.2% developed necrosis; the commonest systemic complication was respiratory failure (44.7%), followed by acute renal failure (35.8%) and shock (20.9%). A total of 31.3% of the patients died. Factors significantly related to mortality were age, upper digestive tract bleeding, acute renal failure, respiratory failure and shock by univariate analysis. However, pseudocysts seemed to have a protective effect. By multivariate analysis, independent prognostic factors were age, acute renal failure and respiratory failure. Patients with SAP mainly died due to systemic complications, especially acute renal failure and respiratory failure. Necrosis (in the absence or presence of infection) was not correlated with increased mortality. A pseudocyst was found to be a protective factor, probably because the definition itself led to the selection of patients who had survived multiorgan failure. Copyright 2003 S. Karger AG, Basel and IAP

Academic and Demographic Predictors of NCLEX-RN Pass Rates in First- and Second-Degree Accelerated BSN Programs.

PubMed

Kaddoura, Mahmoud A; Flint, Elizabeth P; Van Dyke, Olga; Yang, Qing; Chiang, Li-Chi

Relatively few studies have addressed predictors of first-attempt outcomes (pass-fail) on the National Council Licensure Examination-Registered Nurses (NCLEX-RN) for accelerated BSN programs. The purpose of this study was to compare potential predictors of NCLEX outcomes in graduates of first-degree accelerated (FDA; n=62) and second-degree accelerated (SDA; n=173) BSN programs sharing a common nursing curriculum. In this retrospective study, bivariate analyses and multiple logistic regression assessed significance of selected demographic and academic characteristics as predictors of NCLEX-RN outcomes. FDA graduates were more likely than SDA graduates to fail the NCLEX-RN (P=.0013). FDA graduates were more likely to speak English as a second or additional language (P<.0001), have lower end-of-program GPA and HESI Exit Exam scores (both P<.0001), and have a higher proportions of grades ≤ C (P=.0023). All four variables were significant predictors of NCLEX-RN outcomes within both FDA and SDA programs. The only significant predictors in adjusted logistic regression of NCLEX-RN outcome for the pooled FDA+SDA graduate sample were proportion of grades ≤ C (a predictor of NCLEX-RN failure) and HESI Exit Exam score (a predictor of passing NCLEX-RN). Grades of C or lower on any course may indicate inadequate mastery of critical NCLEX-RN content and increased risk of NCLEX-RN failure. Copyright © 2016 Elsevier Inc. All rights reserved.

Rate of change of heart size before congestive heart failure in dogs with mitral regurgitation.

PubMed

Lord, P; Hansson, K; Kvart, C; Häggström, J

2010-04-01

The objective of the study was to examine the changes in vertebral heart scale, and left atrial and ventricular dimensions before and at onset of congestive heart failure in cavalier King Charles spaniels with mitral regurgitation. Records and radiographs from 24 cavalier King Charles spaniels with mitral regurgitation were used. Vertebral heart scale (24 dogs), and left atrial dimension and left ventricular end diastolic and end systolic diameters (18 dogs) and their rate of increase were measured at intervals over years to the onset of congestive heart failure. They were plotted against time to onset of congestive heart failure. Dimensions and rates of change of all parameters were highest at onset of congestive heart failure, the difference between observed and chance outcome being highly significant using a two-tailed chi-square test (P<0.001). The left heart chambers increase in size rapidly only in the last year before the onset of congestive heart failure. Increasing left ventricular end systolic dimension is suggestive of myocardial failure before the onset of congestive heart failure. Rate of increase of heart dimensions may be a useful indicator of impending congestive heart failure.

Modelling of Safety Instrumented Systems by using Bernoulli trials: towards the notion of odds on for SIS failures analysis

NASA Astrophysics Data System (ADS)

Cauffriez, Laurent

2017-01-01

This paper deals with the modeling of a random failures process of a Safety Instrumented System (SIS). It aims to identify the expected number of failures for a SIS during its lifecycle. Indeed, the fact that the SIS is a system being tested periodically gives the idea to apply Bernoulli trials to characterize the random failure process of a SIS and thus to verify if the PFD (Probability of Failing Dangerously) experimentally obtained agrees with the theoretical one. Moreover, the notion of "odds on" found in Bernoulli theory allows engineers and scientists determining easily the ratio between “outcomes with success: failure of SIS” and “outcomes with unsuccess: no failure of SIS” and to confirm that SIS failures occur sporadically. A Stochastic P-temporised Petri net is proposed and serves as a reference model for describing the failure process of a 1oo1 SIS architecture. Simulations of this stochastic Petri net demonstrate that, during its lifecycle, the SIS is rarely in a state in which it cannot perform its mission. Experimental results are compared to Bernoulli trials in order to validate the powerfulness of Bernoulli trials for the modeling of the failures process of a SIS. The determination of the expected number of failures for a SIS during its lifecycle opens interesting research perspectives for engineers and scientists by completing the notion of PFD.

Heart Failure Virtual Consultation: bridging the gap of heart failure care in the community - A mixed-methods evaluation.

PubMed

Gallagher, Joseph; James, Stephanie; Keane, Ciara; Fitzgerald, Annie; Travers, Bronagh; Quigley, Etain; Hecht, Christina; Zhou, Shuaiwei; Watson, Chris; Ledwidge, Mark; McDonald, Kenneth

2017-08-01

We undertook a mixed-methods evaluation of a Web-based conferencing service (virtual consult) between general practitioners (GPs) and cardiologists in managing patients with heart failure in the community to determine its effect on use of specialist heart failure services and acceptability to GPs. All cases from June 2015 to October 2016 were recorded using a standardized recording template, which recorded patient demographics, medical history, medications, and outcome of the virtual consult for each case. Quantitative surveys and qualitative interviewing of 17 participating GPs were also undertaken. During this time, 142 cases were discussed-68 relating to a new diagnosis of heart failure, 53 relating to emerging deterioration in a known heart failure patient, and 21 relating to therapeutic issues. Only 17% required review in outpatient department following the virtual consultation. GPs reported increased confidence in heart failure management, a broadening of their knowledge base, and a perception of overall better patient outcomes. These data from an initial experience with Heart Failure Virtual Consultation present a very positive impact of this strategy on the provision of heart failure care in the community and acceptability to users. Further research on the implementation and expansion of this strategy is warranted. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

[The Predictive Factors of Stent Failure in the Treatment of Malignant Extrinsc Ureteral Obstruction Using Internal Ureteral Stents].

PubMed

Matsuura, Hiroshi; Arase, Shigeki; Hori, Yasuhide; Tochigi, Hiromi

2017-12-01

In this study, we retrospectively reviewed the experiences at our single institute in the treatment of malignant extrinsic ureteral obstruction (MUO) using ureteral stents to investigate the clinical outcomes and the predictive factors of stent failure. In 52 ureters of 38 patients who had radiologically significant hydronephrosis due to MUO, internal ureteral stents (The BARD(R) INLAY(TM) ureteral stent set) were inserted. The median follow-up interval after the initial stent insertion was 124.5 days (4-1,120). Stent failure occurred in 8 ureters (15.4%) of the 7 patients. The median interval from the first stent insertion to stent failure was 88 days (1-468). A Cox regression multivariate analysis showed that the significant predictors of stent failure were bladder invasion. Based on the possibility of stent failure, the adaptation of the internal ureteral stent placement should be considered especially in a patient with MUO combined with bladder invasion.

PRETREATMENT NUTRITIONAL STATUS AND LOCOREGIONAL FAILURE IN PATIENTS WITH HEAD AND NECK CANCER UNDERGOING DEFINITIVE CONCURRENT CHEMORADIATION THERAPY

PubMed Central

Platek, Mary E.; Reid, Mary E.; Wilding, Gregory E.; Jaggernauth, Wainwright; Rigual, Nestor R.; Hicks, Wesley L.; Popat, Saurin R.; Warren, Graham W.; Sullivan, Maureen; Thorstad, Wade L.; Khan, Mohamed K.; Loree, Thom R.; Singh, Anurag K.

2015-01-01

Background This study was carried out to determine if markers of nutritional status predict for locoregional failure following intensity-modulated radiation therapy (IMRT) with concurrent chemoradiotherapy (CCRT) for squamous cell carcinoma of the head and neck (SCCHN). Methods We performed a retrospective chart review of 78 patients with SCCHN who received definitive CCRT. We compared patient factors, tumor characteristics, and nutritional status indicators between patients with and without locoregional failure. Results Fifteen of 78 patients (19%) experienced locoregional failure. Median follow-up for live patients was 38 months. On univariate analysis, pretreatment percentage of ideal body weight (%IBW) (p < .01), pretreatment hemoglobin (p = .04), and treatment duration (p < .01) were significant predictors of failure. On multivariate analysis, pretreatment %IBW (p = .04) and treatment time (p < .01) remained statistically significant. Conclusions Although treatment time is an accepted risk factor for failure, differences in outcome for patients with head and neck cancer undergoing definitive CCRT based on pre-treatment %IBW should be examined further. PMID:21990220

Disease management 360 degrees: a scorecard approach to evaluating TRICARE's programs for asthma, congestive heart failure, and diabetes.

PubMed

Yang, Wenya; Dall, Timothy M; Zhang, Yiduo; Hogan, Paul F; Arday, David R; Gantt, Cynthia J

2010-08-01

To assess the effect of TRICARE's asthma, congestive heart failure, and diabetes disease management programs using a scorecard approach. EVALUATION MEASURES: Patient healthcare utilization, financial, clinical, and humanistic outcomes. Absolute measures were translated into effect size and incorporated into a scorecard. Actual outcomes for program participants were compared with outcomes predicted in the absence of disease management. The predictive equations were established from regression models based on historical control groups (n = 39,217). Z scores were calculated for the humanistic measures obtained through a mailed survey. Administrative records containing medical claims, patient demographics and characteristics, and program participation status were linked using an encrypted patient identifier (n = 57,489). The study time frame is 1 year prior to program inception through 2 years afterward (October 2005-September 2008). A historical control group was identified with the baseline year starting October 2003 and a 1-year follow-up period starting October 2004. A survey was administered to a subset of participants 6 months after baseline assessment (39% response rate). Within the observation window--24 months for asthma and congestive heart failure, and 15 months for the diabetes program--we observed modest reductions in hospital days and healthcare cost for all 3 programs and reductions in emergency visits for 2 programs. Most clinical outcomes moved in the direction anticipated. The scorecard provided a useful tool to track performance of 3 regional contractors for each of 3 diseases and over time.

Liver Transplantation for Fulminant Hepatic Failure

PubMed Central

Farmer, Douglas G.; Anselmo, Dean M.; Ghobrial, R. Mark; Yersiz, Hasan; McDiarmid, Suzanne V.; Cao, Carlos; Weaver, Michael; Figueroa, Jesus; Khan, Khurram; Vargas, Jorge; Saab, Sammy; Han, Steven; Durazo, Francisco; Goldstein, Leonard; Holt, Curtis; Busuttil, Ronald W.

2003-01-01

Objective To analyze outcomes after liver transplantation (LT) in patients with fulminant hepatic failure (FHF) with emphasis on pretransplant variables that can potentially help predict posttransplant outcome. Summary Background Data FHF is a formidable clinical problem associated with a high mortality rate. While LT is the treatment of choice for irreversible FHF, few investigations have examined pretransplant variables that can potentially predict outcome after LT. Methods A retrospective review was undertaken of all patients undergoing LT for FHF at a single transplant center. The median follow-up was 41 months. Thirty-five variables were analyzed by univariate and multivariate analysis to determine their impact on patient and graft survival. Results Two hundred four patients (60% female, median age 20.2 years) required urgent LT for FHF. Before LT, the majority of patients were comatose (76%), on hemodialysis (16%), and ICU-bound. The 1- and 5-year survival rates were 73% and 67% (patient) and 63% and 57% (graft). The primary cause of patient death was sepsis, and the primary cause of graft failure was primary graft nonfunction. Univariate analysis of pre-LT variables revealed that 19 variables predicted survival. From these results, multivariate analysis determined that the serum creatinine was the single most important prognosticator of patient survival. Conclusions This study, representing one of the largest published series on LT for FHF, demonstrates a long-term survival of nearly 70% and develops a clinically applicable and readily measurable set of pretransplant factors that determine posttransplant outcome. PMID:12724633

Retrospective Analysis of Factors Leading to Pediatric Tracheostomy Decannulation Failure. A Single-Institution Experience

PubMed Central

Cristea, A. Ioana; Davis, Stephanie D.; Ackerman, Veda L.; Slaven, James E.; Jalou, Hasnaa E.; Givan, Deborah C.; Daftary, Ameet

2017-01-01

Rationale: There is a lack of evidence regarding factors associated with failure of tracheostomy decannulation. Objectives: We aimed to identify characteristics of pediatric patients who fail a tracheostomy decannulation challenge Methods: A retrospective review was performed on all patients who had a decannulation challenge at a tertiary care center from June 2006 to October 2013. Tracheostomy decannulation failure was defined as reinsertion of the tracheostomy tube within 6 months of the challenge. Data on demographics, indications for tracheostomy, home mechanical ventilation, and comorbidities were collected. Data were also collected on specific airway endoscopic findings during the predecannulation bronchoscopy and airway surgical procedures before decannulation. We attempted to predict the decannulation outcome by analyzing associations. Measurements and Main Results: 147 of 189 (77.8%) patients were successfully decannulated on the first attempt. Tracheostomy performed due to chronic respiratory failure decreased odds for decannulation failure (odds ratio = 0.34, 95% confidence interval = 0.15–0.77). Genetic abnormalities (45%) and feeding dysfunction (93%) were increased in the population of patients failing their first attempt. The presence of one comorbidity increased the odds of failure by 68% (odds ratio = 1.68, 95% confidence interval = 1.23–2.29). Decannulation pursuit based on parental expectation of success, rather than medically determined readiness, was associated with a higher chance of failure (P = 0.01). Conclusions: Our study highlights the role of genetic abnormalities, feeding dysfunction, and multiple comorbidities in patients who fail decannulation. Our findings also demonstrate that the outcome of decannulation may be predicted by the indication for tracheostomy. Patients who had tracheostomy placed for chronic respiratory support had a higher likelihood of success. Absence of a surgically treatable airway obstruction abnormality on the predecannulation bronchoscopy increased the chances of success. PMID:27768853

Virologic outcomes in early antiretroviral treatment: HPTN 052.

PubMed

Eshleman, Susan H; Wilson, Ethan A; Zhang, Xinyi C; Ou, San-San; Piwowar-Manning, Estelle; Eron, Joseph J; McCauley, Marybeth; Gamble, Theresa; Gallant, Joel E; Hosseinipour, Mina C; Kumarasamy, Nagalingeswaran; Hakim, James G; Kalonga, Ben; Pilotto, Jose H; Grinsztejn, Beatriz; Godbole, Sheela V; Chotirosniramit, Nuntisa; Santos, Breno Riegel; Shava, Emily; Mills, Lisa A; Panchia, Ravindre; Mwelase, Noluthando; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Fogel, Jessica M

2017-05-01

The HIV Prevention Trials Network (HPTN) 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure. To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052. 1566 participants who had a viral load (VL) > 400 copies/mL at enrollment were included in the analyses. This included 832 in the early ART arm (CD4 350-550 cells/mm 3 at ART initiation) and 734 in the delayed ART arm (204 with a CD4 < 250 cells/mm 3 at ART initiation; 530 with any CD4 at ART initiation). Viral suppression was defined as two consecutive VLs ≤ 400 copies/mL after ART initiation; virologic failure was defined as two consecutive VLs > 1000 copies/mL > 24 weeks after ART initiation. Overall, 93% of participants achieved viral suppression by 12 months. The annual incidence of virologic failure was 3.6%. Virologic outcomes were similar in the two study arms. Longer time to viral suppression was associated with younger age, higher VL at ART initiation, and region (Africa vs. Asia). Virologic failure was strongly associated with younger age, lower educational level, and lack of suppression by three months; lower VL and higher CD4 at ART initiation were also associated with virologic failure. Several clinical and demographic factors were identified that were associated with longer time to viral suppression and virologic failure. Recognition of these factors may help optimize ART for HIV treatment and prevention.

The high failure rate of biologic resurfacing of the glenoid in young patients with glenohumeral arthritis.

PubMed

Strauss, Eric J; Verma, Nikhil N; Salata, Michael J; McGill, Kevin C; Klifto, Christopher; Nicholson, Gregory P; Cole, Brian J; Romeo, Anthony A

2014-03-01

The current study evaluated the outcomes of biologic resurfacing of the glenoid using a lateral meniscus allograft or human acellular dermal tissue matrix at intermediate-term follow-up. Forty-five patients (mean age, 42.2 years) underwent biologic resurfacing of the glenoid, and 41 were available for follow-up at a mean of 2.8 years. Lateral meniscal allograft resurfacing was used in 31 patients and human acellular dermal tissue matrix interposition in 10. Postoperative range of motion and clinical outcomes were assessed at the final follow-up. The overall clinical failure rate was 51.2%. The lateral meniscal allograft cohort had a failure rate of 45.2%, with a mean time to failure of 3.4 years. Human acellular dermal tissue matrix interposition had a failure rate of 70.0%, with a mean time to failure of 2.2 years. Overall, significant improvements were seen compared with baseline with respect to the visual analog pain score (3.0 vs. 6.3), American Shoulder and Elbow Surgeons score (62.0 vs. 36.8), and Simple Shoulder Test score (7.0 vs. 4.0). Significant improvements were seen for forward elevation (106° to 138°) and external rotation (31° to 51°). Despite significant improvements compared with baseline values, biologic resurfacing of the glenoid resulted in a high rate of clinical failure at intermediate follow-up. Our results suggest that biologic resurfacing of the glenoid may have a minimal and as yet undefined role in the management of glenohumeral arthritis in the young active patient over more traditional methods of hemiarthroplasty or total shoulder arthroplasty. Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

Virologic outcomes in early antiretroviral treatment: HPTN 052

PubMed Central

Eshleman, Susan H.; Wilson, Ethan A.; Zhang, Xinyi C.; Ou, San-San; Piwowar-Manning, Estelle; Eron, Joseph J.; McCauley, Marybeth; Gamble, Theresa; Gallant, Joel E.; Hosseinipour, Mina C.; Kumarasamy, Nagalingeswaran; Hakim, James G.; Kalonga, Ben; Pilotto, Jose H.; Grinsztejn, Beatriz; Godbole, Sheela V.; Chotirosniramit, Nuntisa; Santos, Breno Riegel; Shava, Emily; Mills, Lisa A.; Panchia, Ravindre; Mwelase, Noluthando; Mayer, Kenneth H.; Chen, Ying Q.; Cohen, Myron S.; Fogel, Jessica M.

2017-01-01

INTRODUCTION The HPTN 052 trial demonstrated that early antiretroviral therapy (ART) prevented 93% of HIV transmission events in serodiscordant couples. Some linked infections were observed shortly after ART initiation or after virologic failure. OBJECTIVE To evaluate factors associated with time to viral suppression and virologic failure in participants who initiated ART in HPTN 052. METHODS 1,566 participants who had a viral load (VL) >400 copies/mL at enrollment were included in the analyses. This included 832 in the early ART arm (CD4 350–550 cells/mm3 at ART initiation) and 734 in the delayed ART arm (204 with a CD4 <250 cells/mm3 at ART initiation; 530 with any CD4 at ART initiation). Viral suppression was defined as two consecutive VLs ≤400 copies/mL after ART initiation; virologic failure was defined as two consecutive VLs >1,000 copies/mL >24 weeks after ART initiation. RESULTS Overall, 93% of participants achieved viral suppression by 12 months. The annual incidence of virologic failure was 3.6%. Virologic outcomes were similar in the two study arms. Longer time to viral suppression was associated with younger age, higher VL at ART initiation, and region (Africa vs. Asia). Virologic failure was strongly associated with younger age, lower educational level, and lack of suppression by 3 months; lower VL and higher CD4 at ART initiation were also associated with virologic failure. CONCLUSIONS Several clinical and demographic factors were identified that were associated with longer time to viral suppression and virologic failure. Recognition of these factors may help optimize ART for HIV treatment and prevention. PMID:28385131

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial.

PubMed

Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

2009-08-13

Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2-13; p = 0.02). The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care. ISRCTN08601529.

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial

PubMed Central

Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

2009-01-01

Background Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. Methods This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. Results There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2–13; p = 0.02). Conclusion The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care. Trial registration ISRCTN08601529. PMID:19678944

[Refusal of initiation of dialysis by elderly patients with chronic renal failure].

PubMed

Fujimaki, Hiroshi; Kasuya, Yutaka; Kawaguchi, Sachiko; Hara, Shino; Koga, Shiro; Takahashi, Tadao; Mizuno, Shoichi

2005-07-01

Refusal of dialysis is not uncommon in elderly patients with chronic renal failure. In this study, we retrospectively inspected our dealings with patients who refused our offer to initiate dialysis. In addition, we discussed how to grasp the meaning of this phenomenon. We treated 152 patients with advanced chronic renal failure aged 60 years and over at Tokyo Metropolitan Geriatric Hospital. The patients fulfilling the following two criteria were considered to be refusal cases. The first criterion was that an acceptance of the initiation of dialysis could not be obtained in spite of repeated counseling. The second criterion was that a definite outcome was precipitated by the development of severe uremic symptoms. In every refusal case, clinical characteristics and household members were surveyed. Verbal expressions of the reasons for refusal were retrieved from medical charts. The outcome was also studied. The two criteria were fulfilled in 7 cases. The male/female ratio was 5:2. The age was 78 +/- 7 years (mean +/- standard deviation). All but one cases were ambulatory, and all cases had normal cognitive function. Four cases were married, and the other cases had lost their partners. The number of household members was 3.9 +/- 1.8. We speculated that every case could maintain a good quality of life even after the initiation of dialysis. Representative expressions of the reasons for refusal were "I have already lived fully" and "I would prefer to accept death rather than dialysis". The outcome was urgent initiation of dialysis (five cases) and death (two cases). The time between initial counseling and the outcome was 115 +/- 37 days. Accepting or refusing dialysis therapy is a selection related to life or death. We must make an effort to obtain consent to initiating dialysis if patients are assessed as suitable for dialysis.

Cardiac acute care nurse practitioner and 30-day readmission.

PubMed

David, Daniel; Britting, Lorraine; Dalton, Joanne

2015-01-01

The utilization outcomes of nurse practitioners (NPs) in the acute care setting have not been widely studied. The purpose of this study was to determine the impact on utilization outcomes of NPs on medical teams who take care of patients admitted to a cardiovascular intensive care unit. A retrospective 2-group comparative design was used to evaluate the outcomes of 185 patients with ST- or non ST-segment elevation myocardial infarction or heart failure who were admitted to a cardiovascular intensive care unit in an urban medical center. Patients received care from a medical team that included a cardiac acute care NP (n = 109) or medical team alone (n = 76). Patient history, cardiac assessment, medical interventions, discharge disposition, discharge time, and 3 utilization outcomes (ie, length of stay, 30-day readmission, and time of discharge) were compared between the 2 treatment groups. Logistic regression was used to identify predictors of 30-day readmission. Patients receiving care from a medical team that included an NP were rehospitalized approximately 50% less often compared with those receiving care from a medical team without an NP. Thirty-day hospital readmission (P = .011) and 30-day return rates to the emergency department (P = .021) were significantly lower in the intervention group. Significant predictors for rehospitalization included diagnosis of heart failure versus myocardial infarction (odds ratio [OR], 3.153, P = 0.005), treatment by a medical team without NP involvement (OR, 2.905, P = 0.008), and history of diabetes (OR, 2.310, P = 0.032). The addition of a cardiac acute care NP to medical teams caring for myocardial infarction and heart failure patients had a positive impact on 30-day emergency department return and hospital readmission rates.

Defining Long-term Outcomes with Living Donor Liver Transplantation in North America

PubMed Central

Olthoff, Kim M.; Smith, Abigail R.; Abecassis, Michael; Baker, Talia; Emond, Jean C.; Berg, Carl L.; Beil, Charlotte A.; Burton, James R.; Fisher, Robert A.; Freise, Christopher E.; Gillespie, Brenda W.; Grant, David R.; Humar, Abhi; Kam, Igal; Merion, Robert M.; Pomfret, Elizabeth A.; Samstein, Benjamin; Shaked, Abraham

2015-01-01

Objective To compare long-term survival of living donor liver transplant (LDLT) at experienced transplant centers to outcomes of deceased donor liver transplant (DDLT) and identify key variables impacting patient and graft survival. Summary Background Data The Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) is a prospective multicenter NIH study comparing outcomes of LDLT and DDLT and associated risks. Methods Mortality and graft failure for 1427 liver recipients (963 LDLT) enrolled in A2ALL transplanted between 1/1/1998 and 1/31/2014 at 12 North American centers with median follow-up 6.7 years were analyzed using Kaplan-Meier and multivariable Cox models. Results Survival probability at 10 years was 70% for LDLT and 64% for DDLT. Unadjusted survival was higher with LDLT (HR=0.76, p=0.02) but attenuated after adjustment (HR=0.98, p=0.90) as LDLT recipients had lower mean MELD (15.5 vs 20.4) and fewer were transplanted from ICU, inpatient, on dialysis, ventilated, or with ascites. Post-transplant ICU days were less for LDLT. For all recipients female gender and primary sclerosing cholangitis were associated with improved survival, while dialysis and older recipient/donor age were associated with worse survival. Higher MELD score was associated with increased graft failure. Era of transplantation and type of donated lobe did not impact survival in LDLT. Conclusions LDLT provides significant long-term transplant benefit resulting in transplantation at a lower MELD score, decreased death on waitlist, and excellent post-transplant outcomes. Recipient diagnosis, disease severity, renal failure, and ages of recipient and donor should be considered in decision-making regarding timing of transplant and donor options. Clinical Trials ID NCT00096733. PMID:26258315

Outcomes of Basic Versus Advanced Life Support for Out-of-Hospital Medical Emergencies.

PubMed

Sanghavi, Prachi; Jena, Anupam B; Newhouse, Joseph P; Zaslavsky, Alan M

2015-11-03

Most Medicare patients seeking emergency medical transport are treated by ambulance providers trained in advanced life support (ALS). Evidence supporting the superiority of ALS over basic life support (BLS) is limited, but some studies suggest ALS may harm patients. To compare outcomes after ALS and BLS in out-of-hospital medical emergencies. Observational study with adjustment for propensity score weights and instrumental variable analyses based on county-level variations in ALS use. Traditional Medicare. 20% random sample of Medicare beneficiaries from nonrural counties between 2006 and 2011 with major trauma, stroke, acute myocardial infarction (AMI), or respiratory failure. Neurologic functioning and survival to 30 days, 90 days, 1 year, and 2 years. Except in cases of AMI, patients showed superior unadjusted outcomes with BLS despite being older and having more comorbidities. In propensity score analyses, survival to 90 days among patients with trauma, stroke, and respiratory failure was higher with BLS than ALS (6.1 percentage points [95% CI, 5.4 to 6.8 percentage points] for trauma; 7.0 percentage points [CI, 6.2 to 7.7 percentage points] for stroke; and 3.7 percentage points [CI, 2.5 to 4.8 percentage points] for respiratory failure). Patients with AMI did not exhibit differences in survival at 30 days but had better survival at 90 days with ALS (1.0 percentage point [CI, 0.1 to 1.9 percentage points]). Neurologic functioning favored BLS for all diagnoses. Results from instrumental variable analyses were broadly consistent with propensity score analyses for trauma and stroke, showed no survival differences between BLS and ALS for respiratory failure, and showed better survival at all time points with BLS than ALS for patients with AMI. Only Medicare beneficiaries from nonrural counties were studied. Advanced life support is associated with substantially higher mortality for several acute medical emergencies than BLS. National Science Foundation, Agency for Healthcare Research and Quality, and National Institutes of Health.

Retrospectively Estimating Prevalence of Peanut Allergy Genetic Markers in an Air Force Population

DTIC Science & Technology

2018-01-25

operational success. Latent food allergies could manifest catastrophic outcomes during missions, resulting in potential failure and loss of life ...Understanding an individual’s risk of developing severe allergies is one of many components that can make up a high- quality surveillance and public health...food allergies could manifest catastrophic outcomes during missions, resulting in potential failure and loss of life . Understanding an individual’s

Primary Trabeculectomy Outcomes by Glaucoma Fellows in a Tertiary Hospital in Brazil.

PubMed

Abe, Ricardo Y; Shigueoka, Leonardo S; Vasconcellos, José P C; Costa, Vital P

2017-11-01

To examine outcomes of trabeculectomy with mitomycin C for uncontrolled glaucoma when performed by glaucoma trainee surgeons. Retrospective case series of patients who underwent trabeculectomy with mitomycin C. Primary outcome was to assess the rate of failure, which was defined as intraocular pressure in 2 consecutive visits >18 or <5 mm Hg or intraocular pressure reduction <30% from baseline, additional glaucoma surgery, or loss of light perception. The secondary outcome was to investigate risk factors for failure and surgical complications. One hundred forty-three eyes from 126 glaucoma patients underwent primary trabeculectomy between 2013 and 2014 at University of Campinas. Mean follow-up time was 1.47±0.96 years. Kaplan-Meier analysis showed cumulative survival rates of 70.1%, 62.5%, and 57.8%, after 1, 2, and 3 years, respectively. Multivariate analysis with generalized estimating equations revealed that neovascular glaucoma [odd ratios (OR): 5.05, P=0.043], suture lysis (OR: 8.89, P=0.011), and early bleb leak (OR: 4.63, P=0.011) were risk factors for failure. A success rate of approximately 60% was obtained 3 years after primary trabeculectomy performed by trainees. Patients with neovascular glaucoma, who underwent suture lysis and who presented an early bleb leak had an increased risk for failure during follow-up.

Outcomes of Patients Implanted Using a Left Thoracotomy Technique for a Miniaturized Centrifugal Continuous-Flow Pump.

PubMed

Sileshi, Bantayehu; O'Hara, Brian K; Davis, Mary E; Haglund, Nicholas A; Meng, Xu; Deegan, Robert; Stulak, John M; Kushwaha, Sudhir S; Shaw, Andrew; Maltais, Simon

2016-01-01

As ventricular-assist devices (VADs) are increasingly employed in heart failure management, a leading cause of mortality, new literature is consistently published on less-invasive implantation techniques. Although early perioperative outcomes have been shown to be favorable with minimally invasive left thoracotomy (LT) approaches compared with conventional sternotomy (CS), studies comparing long-term outcomes are lacking. We set out to evaluate long-term follow up between LT and CS approach. In a single center, retrospective review, data on patients with similar demographic profiles were collected. HeartWare (HVAD) implantation was performed by either CS or LT. Analysis was performed on perioperative adverse outcomes, and 6 month postoperative adverse events. Primary objectives of the study included comparative outcomes of morbidity and mortality between both groups at 180 days postimplantation. Eighty-one (n = 81) bridge to transplant (BTT) patients underwent CS or LT HVAD implantation. Perioperative transfusion (p = 0.04) favored the LT cohort compared with CS, with a median of 6 units and 8 units transfused for each group, respectively. No survival difference was observed between both groups at 6 months postimplantation (p = 0.52). Clinical outcomes at an average of 6 month follow up showed no difference in adverse events, including common postoperative VAD complications such as infection and right heart failure. Miniaturization of LVAD size and improvement in technology has allowed expansion of interest in alternative surgical approaches for HVAD implantation. For BTT patients, no difference in early outcome was observed 6 months after implantation using a left LT versus CS technique.

Evaluation of a nurse-led disease management programme for chronic kidney disease: a randomized controlled trial.

PubMed

Wong, Frances Kam Yuet; Chow, Susan Ka Yee; Chan, Tony Moon Fai

2010-03-01

Patients with end stage renal failure require dialysis and strict adherence to treatment plans to sustain life. However, non-adherence is a common and serious problem among patients with chronic kidney disease. There is a scarcity of studies in examining the effects of disease management programmes on patients with chronic kidney disease. This paper examines whether the study group receiving the disease management programme have better improvement than the control group, comparing outcomes at baseline (O1), at 7 weeks at the completion of the programme (O2) and at 13 weeks (O3). This is a randomized controlled trial. The outcome measures were non-adherence in diet, fluid, dialysis and medication, quality of life, satisfaction, symptom control, complication control and health service utilisation. There was no significant difference between the control and study group for the baseline measures, except for sleep. Significant differences (p<0.05) were found between the control and study group at O2 in the outcome measures of diet degree non-adherence, sleep, symptom, staff encouragement, overall health and satisfaction. Sustained effects at O3 were noted in the outcome measures of continuous ambulatory peritoneal dialysis (CAPD) non-adherence degree, sleep, symptom, and effect of kidney disease. Many studies exploring chronic disease management have neglected the group with end stage renal failure and this study fills this gap. This study has employed an innovative model of skill mix using specialist and general nurses and demonstrated patient improvement in diet non-adherence, CAPD non-adherence, aspects of quality of life and satisfaction with care. Redesigning chronic disease management programmes helps to optimize the use of different levels of skills and resources to bring about positive outcomes. Copyright 2009 Elsevier Ltd. All rights reserved.

Similar Outcomes After Osteochondral Allograft Transplantation in Anterior Cruciate Ligament-Intact and -Reconstructed Knees: A Comparative Matched-Group Analysis With Minimum 2-Year Follow-Up.

PubMed

Wang, Dean; Eliasberg, Claire D; Wang, Tim; Fader, Ryan R; Coxe, Francesca R; Pais, Mollyann D; Williams, Riley J

2017-12-01

To compare failure rates and clinical outcomes of osteochondral allograft transplantation (OCA) in anterior cruciate ligament (ACL)-intact versus ACL-reconstructed knees at midterm follow-up. After a priori power analysis, a prospective registry of patients treated with OCA for focal chondral lesions ≥2 cm 2 in size with minimum 2-year follow-up was used to match ACL-reconstructed knees with ACL-intact knees by age, sex, and primary chondral defect location. Exclusion criteria included meniscus transplantation, realignment osteotomy, or other ligamentous injury. Complications, reoperations, and patient responses to validated outcome measures were reviewed. Failure was defined by any procedure involving allograft removal/revision or conversion to arthroplasty. Kaplan-Meier analysis and multivariate Cox regression were performed to evaluate the association of ACL reconstruction (ACLR) with failure. A total of 50 ACL-intact and 25 ACL-reconstructed (18 prior, 7 concomitant) OCA patients were analyzed. The mean age was 36.2 years (range, 14-62 years). Mean follow-up was 3.9 years (range, 2-14 years). Patient demographics and chondral lesion characteristics were similar between groups. ACL-reconstructed patients averaged 2.2 ± 1.9 prior surgeries on the ipsilateral knee compared with 1.4 ± 1.4 surgeries for ACL-intact patients (P = .014). Grafts used for the last ACLR included bone-patellar tendon-bone autograft, hamstring autograft, Achilles tendon allograft, and tibialis allograft (data available for only 11 of 25 patients). At final follow-up, 22% of ACL-intact and 32% of ACL-reconstructed patients had undergone reoperation. OCA survivorship was 90% and 96% at 2 years and 79% and 85% at 5 years in ACL-intact and ACL-reconstructed patients, respectively (P = .774). ACLR was not independently associated with failure. Both groups demonstrated clinically significant improvements in the Short Form-36 pain and physical functioning, International Knee Documentation Committee subjective, and Knee Outcome Survey-Activities of Daily Living scores at final follow-up (P < .001), with no significant differences in preoperative, postoperative, and change scores between groups. OCA in the setting of prior or concomitant ACLR does not portend higher failure rates or compromise clinical outcomes. Level III, retrospective comparative study. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Specialized Community-Based Care: An Evidence-Based Analysis

PubMed Central

2012-01-01

Background Specialized community-based care (SCBC) refers to services that manage chronic illness through formalized links between primary and specialized care. Objectives The objectives of this evidence-based analysis (EBA) were as follows: to summarize the literature on SCBC, also known as intermediate care to synthesize the evidence from previous Medical Advisory Secretariat (now Health Quality Ontario) EBAs on SCBC for heart failure, diabetes, chronic obstructive pulmonary disease (COPD), and chronic wounds to examine the role of SCBC in family practice Results Part 1: Systematic Review of Intermediate Care Seven systematic reviews on intermediate care since 2008 were identified. The literature base is complex and difficult to define. There is evidence to suggest that intermediate care is effective in improving outcomes; however, the effective interventions are still uncertain. Part 2: Synthesis of Evidence in Intermediate Care Mortality • Heart failure Significant reduction in patients receiving SCBC • COPD Nonsignificant reduction in patients receiving SCBC Hospitalization • Heart failure Nonsignificant reduction in patients receiving SCBC • COPD Significant reduction in patients receiving SCBC Emergency Department Visits • Heart failure Nonsignificant reduction in patients receiving SCBC • COPD Significant reduction in patients receiving SCBC Disease-Specific Patient Outcomes • COPD Nonsignificant improvement in lung function in patients receiving SCBC • Diabetes Significant reduction in hemoglobin A1c (HbA1c) and systolic blood pressure in patients receiving SCBC • Chronic wounds Significant increase in the proportion of healed wounds in patients receiving SCBC Quality of Life • Heart failure Trend toward improvement in patients receiving SCBC • COPD Significant improvement in patients receiving SCBC Part 3: Intermediate Care in Family Practice—Evidence-Based Analysis Five randomized controlled trials were identified comparing SCBC to usual care in family practice. Inclusion criteria were 1) the presence of multiple chronic conditions, and 2) interventions that included 2 or more health care professions. The GRADE quality of the evidence was assessed as low for all outcomes due to the inconsistency and indirectness of the results. Limitations This review did not look at disease-specific studies on intermediate care in family practice. Conclusions Specialized community-based care effectively improves outcomes in patients with heart failure, COPD, and diabetes. The effectiveness of SCBC in family practice is unclear. PMID:23226812

A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure

PubMed Central

McMurray, John; Packer, Milton; Desai, Akshay; Gong, Jianjian; Greenlaw, Nicola; Lefkowitz, Martin; Rizkala, Adel; Shi, Victor; Rouleau, Jean; Solomon, Scott; Swedberg, Karl; Zile, Michael R.; Andersen, Karl; Arango, Juan Luis; Arnold, Malcolm; Be˘lohlávek, Jan; Böhm, Michael; Boytsov, Sergey; Burgess, Lesley; Cabrera, Walter; Chen, Chen-Huan; Erglis, Andrejs; Fu, Michael; Gomez, Efrain; Gonzalez, Angel; Hagege, Albert-Alain; Katova, Tzvetana; Kiatchoosakun, Songsak; Kim, Kee-Sik; Bayram, Edmundo; Martinez, Felipe; Merkely, Bela; Mendoza, Iván; Mosterd, Arend; Negrusz-Kawecka, Marta; Peuhkurinen, Keijo; Ramires, Felix; Refsgaard, Jens; Senni, Michele; Sibulo, Antonio S.; Silva-Cardoso, José; Squire, Iain; Starling, Randall C.; Vinereanu, Dragos; Teerlink, John R.; Wong, Raymond

2015-01-01

Aims Although active-controlled trials with renin–angiotensin inhibitors are ethically mandated in heart failure with reduced ejection fraction, clinicians and regulators often want to know how the experimental therapy would perform compared with placebo. The angiotensin receptor-neprilysin inhibitor LCZ696 was compared with enalapril in PARADIGM-HF. We made indirect comparisons of the effects of LCZ696 with putative placebos. Methods and results We used the treatment-arm of the Studies Of Left Ventricular Dysfunction (SOLVD-T) as the reference trial for comparison of an ACE inhibitor to placebo and the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity-Alternative trial (CHARM-Alternative) as the reference trial for comparison of an ARB to placebo. The hazard ratio of LCZ696 vs. a putative placebo was estimated through the product of the hazard ratio of LCZ696 vs. enalapril (active-control) and that of the historical active-control (enalapril or candesartan) vs. placebo. For the primary composite outcome of cardiovascular death or heart failure hospitalization in PARADIGM-HF, the relative risk reduction with LCZ696 vs. a putative placebo from SOLVD-T was 43% (95%CI 34–50%; P < 0.0001) with similarly large effects on cardiovascular death (34%, 21–44%; P < 0.0001) and heart failure hospitalization (49%, 39–58%; P < 0.0001). For all-cause mortality, the reduction compared with a putative placebo was 28% (95%CI 15–39%; P < 0.0001). Putative placebo analyses based on CHARM-Alternative gave relative risk reductions of 39% (95%CI 27–48%; P < 0.0001) for the composite outcome of cardiovascular death or heart failure hospitalization, 32% (95%CI 16–45%; P < 0.0001) for cardiovascular death, 46% (33–56%; P < 0.0001) for heart failure hospitalization, and 26% (95%CI 11–39%; P < 0.0001) for all-cause mortality. Conclusion These indirect comparisons of LCZ696 with a putative placebo show that the strategy of combined angiotensin receptor blockade and neprilysin inhibition led to striking reductions in cardiovascular and all-cause mortality, as well as heart failure hospitalization. These benefits were obtained even though LCZ696 was added to comprehensive background beta-blocker and mineralocorticoid receptor antagonist therapy. PMID:25416329

Worsening renal function and outcome in heart failure patients with reduced and preserved ejection fraction and the impact of angiotensin receptor blocker treatment: data from the CHARM-study programme.

PubMed

Damman, Kevin; Solomon, Scott D; Pfeffer, Marc A; Swedberg, Karl; Yusuf, Salim; Young, James B; Rouleau, Jean L; Granger, Christopher B; McMurray, John J V

2016-12-01

We investigated the association between worsening renal function (WRF) that occurs during renin-angiotensin-aldosterone system inhibition initation and outcome in heart failure (HF) patients with preserved ejection fraction (HFPEF) and compared this with HF patients with reduced ejection fraction (HFREF). We examined changes in estimated glomerular filtration rate (GFR) and the relationship between WRF (defined as ≥26.5 µmol/L and ≥25% increase in serum creatinine from baseline to 6 weeks) and outcome, according to randomized treatment, in patients with HFREF (EF <45%; n = 1569) and HFPEF (EF ≥45%; n = 836) in the CHARM programme. The primary outcome was cardiovascular death or HF hospitalization. Estimated GFR decreased 9.0 ± 21 vs. 4.0 ± 21 mL/min/1.73 m 2 with candesartan and placebo, respectively, and this was similar in HFREF and HFPEF. WRF developed more frequently with candesartan, 16% vs. 7%, P < 0.001, with similar findings in patients with HFREF and HFPEF. WRF was associated with a higher risk of the primary outcome: multivariable hazard ratio (HR) 1.26, 95% confidence interval 1.03-1.54, P = 0.022, in both treatment groups, and in both HFREF and HFPEF (P for interaction 0.98). In HFREF, WRF was mostly related to HF hospitalization, while in HFPEF, WRF seemed more associated with mortality. GFR decreased more and WRF was more common with candesartan compared with placebo, and this was similar in HFREF and HFPEF. WRF was associated with worse outcomes in HFREF and HFPEF. Although no formal interaction was present, the association between candesartan treatment, WRF, and type of clinical outcome was slightly different between HFREF and HFPEF. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

Outcomes of implants and restorations placed in general dental practices: a retrospective study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network.

PubMed

Da Silva, John D; Kazimiroff, Julie; Papas, Athena; Curro, Frederick A; Thompson, Van P; Vena, Donald A; Wu, Hongyu; Collie, Damon; Craig, Ronald G

2014-07-01

The authors conducted a study to determine the types, outcomes, risk factors and esthetic assessment of implants and their restorations placed in the general practices of a practice-based research network. All patients who visited network practices three to five years previously and underwent placement of an implant and restoration within the practice were invited to enroll. Practitioner-investigators (P-Is) recorded the status of the implant and restoration, characteristics of the implant site and restoration, presence of peri-implant pathology and an esthetic assessment by the P-I and patient. The P-Is classified implants as failures if the original implant was missing or had been replaced, the implant was mobile or elicited pain on percussion, there was overt clinical or radiographic evidence of pathology or excessive bone loss (> 0.2 millimeter per year after an initial bone loss of 2 mm). They classified restorations as failures if they had been replaced or if there was abutment or restoration fracture. The authors enrolled 922 implants and patients from 87 practices, with a mean (standard deviation) follow-up of 4.2 (0.6) years. Of the 920 implants for which complete data records were available, 64 (7.0 percent) were classified as failures when excessive bone loss was excluded from the analysis. When excessive bone loss was included, 172 implants (18.7 percent) were classified as failures. According to the results of univariate analysis, a history of severe periodontitis, sites with preexisting inflammation or type IV bone, cases of immediate implant placement and placement in the incisor or canine region were associated with implant failure. According to the results of multivariate analysis, sites with preexisting inflammation (odds ratio [OR] = 2.17; 95 percent confidence interval [CI], 1.41-3.34]) or type IV bone (OR = 1.99; 95 percent CI, 1.12-3.55) were associated with a greater risk of implant failure. Of the 908 surviving implants, 20 (2.2 percent) had restorations replaced or judged as needing to be replaced. The majority of P-Is and patients were satisfied with the esthetic outcomes for both the implant and restoration. These results suggest that implant survival and success rates in general dental practices may be lower than those reported in studies conducted in academic or specialty settings. The results of this study, generated in the private general practice setting, add to the evidence base to facilitate implant treatment planning.

Factors Determining the Success and Failure of eHealth Interventions: Systematic Review of the Literature.

PubMed

Granja, Conceição; Janssen, Wouter; Johansen, Monika Alise

2018-05-01

eHealth has an enormous potential to improve healthcare cost, effectiveness, and quality of care. However, there seems to be a gap between the foreseen benefits of research and clinical reality. Our objective was to systematically review the factors influencing the outcome of eHealth interventions in terms of success and failure. We searched the PubMed database for original peer-reviewed studies on implemented eHealth tools that reported on the factors for the success or failure, or both, of the intervention. We conducted the systematic review by following the patient, intervention, comparison, and outcome framework, with 2 of the authors independently reviewing the abstract and full text of the articles. We collected data using standardized forms that reflected the categorization model used in the qualitative analysis of the outcomes reported in the included articles. Among the 903 identified articles, a total of 221 studies complied with the inclusion criteria. The studies were heterogeneous by country, type of eHealth intervention, method of implementation, and reporting perspectives. The article frequency analysis did not show a significant discrepancy between the number of reports on failure (392/844, 46.5%) and on success (452/844, 53.6%). The qualitative analysis identified 27 categories that represented the factors for success or failure of eHealth interventions. A quantitative analysis of the results revealed the category quality of healthcare (n=55) as the most mentioned as contributing to the success of eHealth interventions, and the category costs (n=42) as the most mentioned as contributing to failure. For the category with the highest unique article frequency, workflow (n=51), we conducted a full-text review. The analysis of the 23 articles that met the inclusion criteria identified 6 barriers related to workflow: workload (n=12), role definition (n=7), undermining of face-to-face communication (n=6), workflow disruption (n=6), alignment with clinical processes (n=2), and staff turnover (n=1). The reviewed literature suggested that, to increase the likelihood of success of eHealth interventions, future research must ensure a positive impact in the quality of care, with particular attention given to improved diagnosis, clinical management, and patient-centered care. There is a critical need to perform in-depth studies of the workflow(s) that the intervention will support and to perceive the clinical processes involved. ©Conceição Granja, Wouter Janssen, Monika Alise Johansen. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 01.05.2018.

Factors Determining the Success and Failure of eHealth Interventions: Systematic Review of the Literature

PubMed Central

Janssen, Wouter; Johansen, Monika Alise

2018-01-01

Background eHealth has an enormous potential to improve healthcare cost, effectiveness, and quality of care. However, there seems to be a gap between the foreseen benefits of research and clinical reality. Objective Our objective was to systematically review the factors influencing the outcome of eHealth interventions in terms of success and failure. Methods We searched the PubMed database for original peer-reviewed studies on implemented eHealth tools that reported on the factors for the success or failure, or both, of the intervention. We conducted the systematic review by following the patient, intervention, comparison, and outcome framework, with 2 of the authors independently reviewing the abstract and full text of the articles. We collected data using standardized forms that reflected the categorization model used in the qualitative analysis of the outcomes reported in the included articles. Results Among the 903 identified articles, a total of 221 studies complied with the inclusion criteria. The studies were heterogeneous by country, type of eHealth intervention, method of implementation, and reporting perspectives. The article frequency analysis did not show a significant discrepancy between the number of reports on failure (392/844, 46.5%) and on success (452/844, 53.6%). The qualitative analysis identified 27 categories that represented the factors for success or failure of eHealth interventions. A quantitative analysis of the results revealed the category quality of healthcare (n=55) as the most mentioned as contributing to the success of eHealth interventions, and the category costs (n=42) as the most mentioned as contributing to failure. For the category with the highest unique article frequency, workflow (n=51), we conducted a full-text review. The analysis of the 23 articles that met the inclusion criteria identified 6 barriers related to workflow: workload (n=12), role definition (n=7), undermining of face-to-face communication (n=6), workflow disruption (n=6), alignment with clinical processes (n=2), and staff turnover (n=1). Conclusions The reviewed literature suggested that, to increase the likelihood of success of eHealth interventions, future research must ensure a positive impact in the quality of care, with particular attention given to improved diagnosis, clinical management, and patient-centered care. There is a critical need to perform in-depth studies of the workflow(s) that the intervention will support and to perceive the clinical processes involved. PMID:29716883

Motivational Interviewing Tailored Interventions for Heart Failure (MITI-HF): study design and methods.

PubMed

Masterson Creber, Ruth; Patey, Megan; Dickson, Victoria Vaughan; DeCesaris, Marissa; Riegel, Barbara

2015-03-01

Lack of engagement in self-care is common among patients needing to follow a complex treatment regimen, especially patients with heart failure who are affected by comorbidity, disability and side effects of poly-pharmacy. The purpose of Motivational Interviewing Tailored Interventions for Heart Failure (MITI-HF) is to test the feasibility and comparative efficacy of an MI intervention on self-care, acute heart failure physical symptoms and quality of life. We are conducting a brief, nurse-led motivational interviewing randomized controlled trial to address behavioral and motivational issues related to heart failure self-care. Participants in the intervention group receive home and phone-based motivational interviewing sessions over 90-days and those in the control group receive care as usual. Participants in both groups receive patient education materials. The primary study outcome is change in self-care maintenance from baseline to 90-days. This article presents the study design, methods, plans for statistical analysis and descriptive characteristics of the study sample for MITI-HF. Study findings will contribute to the literature on the efficacy of motivational interviewing to promote heart failure self-care. We anticipate that using an MI approach can help patients with heart failure focus on their internal motivation to change in a non-confrontational, patient-centered and collaborative way. It also affirms their ability to practice competent self-care relevant to their personal health goals. Copyright © 2015 Elsevier Inc. All rights reserved.