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Sample records for surgically high-risk patients

  1. [Anesthesiological management of the high-risk surgical patient].

    PubMed

    Bertoldi, G; Avalle, M

    1980-03-01

    Evaluation of the anaesthesiological risk in surgical patients is described and an account is given of results obtained with an association of ketamin and NLA II in 57 high-risk patients subjected to general surgical management.

  2. Coordinating perioperative care for the 'high risk' general surgical patient using risk prediction scoring.

    PubMed

    Hafiz, Shaziz; Lees, Nicholas Peter

    2016-01-01

    Identifying 'high risk' (> 5% mortality score) emergency general surgical patients early, allows appropriate perioperative care to be allocated by securing critical care beds and ensuring the presence of senior surgeons and senior anesthetists intraoperatively. Scoring systems can be used to predict perioperative risk and coordinate resources perioperatively. Currently it is unclear which estimate of risk correlates with current resource deployment. A retrospective study was undertaken assessing the relationship between deployment of perioperative resources: senior surgeon, senior anesthetist and critical care bed. The study concluded that almost all high risk patients with high POSSUM mortality and morbidity scores had a consultant senior surgeon present intraoperatively. Critically unwell patients with higher operative severity and perioperative morbidity scores received higher care (HDU/ICU) beds postoperatively, ensuring that they received appropriate care if their condition deteriorated. Therefore POSSUM scoring should be used perioperatively in emergency cases to coordinate appropriate perioperative care for high risk general surgical patients. PMID:26901929

  3. Use of a surgical helmet system to minimize splash injury during percutaneous renal surgery in high-risk patients.

    PubMed

    Eandi, Jonathan A; Nanigian, Dana K; Smith, William H; Low, Roger K

    2008-12-01

    The transmission risk to surgeons performing percutaneous renal surgery on patients who are infected with human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B, or hepatitis C is unknown. A recent study found 55% of surgeons' masks contain evidence of blood splash contamination after percutaneous nephrolithotomy. While the risk of infectious disease transmission to the surgeon after mucocutaneous exposure is unknown, the incapacitating disease these pathogens cause can have a devastating and permanent effect on a surgeon's career. We describe our use of a surgical helmet system when performing percutaneous renal surgery on high-risk patients to minimize risk of splash injury and transmission of blood-borne pathogens.

  4. Comparative effectiveness of Mitraclip plus medical therapy versus medical therapy alone in high-risk surgical patients: a comprehensive review.

    PubMed

    Gonzalez, Fernando Matias; Finch, Aureliano Paolo; Armeni, Patrizio; Boscolo, Paola Roberta; Tarricone, Rosanna

    2015-07-01

    In recent years, Mitraclip has become available as a treatment option for mitral regurgitation in high-risk surgical patients. Focusing on the incremental effectiveness of Mitraclip versus the current standard of care, this article provides a comparative review of the evidence on Mitraclip and standard medical therapy (MT) in high-risk mitral regurgitation patients. Evidence was retrieved from seven major databases. Results suggest that Mitraclip presents a high safety profile and a good middle-term effectiveness performance. Evidence on long-term effectiveness is limited both for Mitraclip and MT. Few studies allow a comparison with MT and comparative results on different endpoints are mixed. Therefore, the available evidence does not conclusively inform whether or under which circumstances Mitraclip should be preferred over MT in the treatment of high-risk patients. Head-to-head real-world studies would be needed, as they would provide great and timely insights to support policy decisions when medical devices are at stake. PMID:26051009

  5. Clarification of the circulatory patho-physiology of anaesthesia - implications for high-risk surgical patients.

    PubMed

    Wolff, Christopher B; Green, David W

    2014-12-01

    The paper examines the effects of anaesthesia on circulatory physiology and their implications regarding improvement in perioperative anaesthetic management. Changes to current anaesthetic practice, recommended recently, such as the use of flow monitoring in high risk patients, are already beginning to have an impact in reducing complications but not mortality [1]. Better understanding of the patho-physiology should help improve management even further. Analysis of selected individual clinical trials has been used to illustrate particular areas of patho-physiology and how changes in practice have improved outcome. There is physiological support for the importance of achieving an appropriate rate of oxygen delivery (DO2), particularly following induction of anaesthesia. It is suggested that ensuring adequate DO2 during anaesthesia will avoid development of oxygen debt and hence obviate the need to induce a high, compensatory, DO2 in the post-operative period. In contrast to the usual assumptions underlying strategies requiring a global increase in blood flow [1] by a stroke volume near maximization strategy, blood flow control actually resides entirely at the tissues not at the heart. This is important as the starting point for understanding failed circulatory control as indicated by 'volume dependency'. Local adjustments in blood flow at each individual organ - auto-regulation - normally ensure the appropriate local rate of oxygen supply, i.e. local DO2. Inadequate blood volume leads to impairment of the regulation of blood flow, particularly in the individual tissues with least capable auto-regulatory capability. As demonstrated by many studies, inadequate blood flow first occurs in the gut, brain and kidney. The inadequate blood volume which occurs with induction of anaesthesia is not due to blood volume loss, but probably results from redistribution due to veno-dilation. The increase in venous capacity renders the existing blood volume inadequate to maintain

  6. TIMP2•IGFBP7 biomarker panel accurately predicts acute kidney injury in high-risk surgical patients

    PubMed Central

    Gunnerson, Kyle J.; Shaw, Andrew D.; Chawla, Lakhmir S.; Bihorac, Azra; Al-Khafaji, Ali; Kashani, Kianoush; Lissauer, Matthew; Shi, Jing; Walker, Michael G.; Kellum, John A.

    2016-01-01

    BACKGROUND Acute kidney injury (AKI) is an important complication in surgical patients. Existing biomarkers and clinical prediction models underestimate the risk for developing AKI. We recently reported data from two trials of 728 and 408 critically ill adult patients in whom urinary TIMP2•IGFBP7 (NephroCheck, Astute Medical) was used to identify patients at risk of developing AKI. Here we report a preplanned analysis of surgical patients from both trials to assess whether urinary tissue inhibitor of metalloproteinase 2 (TIMP-2) and insulin-like growth factor–binding protein 7 (IGFBP7) accurately identify surgical patients at risk of developing AKI. STUDY DESIGN We enrolled adult surgical patients at risk for AKI who were admitted to one of 39 intensive care units across Europe and North America. The primary end point was moderate-severe AKI (equivalent to KDIGO [Kidney Disease Improving Global Outcomes] stages 2–3) within 12 hours of enrollment. Biomarker performance was assessed using the area under the receiver operating characteristic curve, integrated discrimination improvement, and category-free net reclassification improvement. RESULTS A total of 375 patients were included in the final analysis of whom 35 (9%) developed moderate-severe AKI within 12 hours. The area under the receiver operating characteristic curve for [TIMP-2]•[IGFBP7] alone was 0.84 (95% confidence interval, 0.76–0.90; p < 0.0001). Biomarker performance was robust in sensitivity analysis across predefined subgroups (urgency and type of surgery). CONCLUSION For postoperative surgical intensive care unit patients, a single urinary TIMP2•IGFBP7 test accurately identified patients at risk for developing AKI within the ensuing 12 hours and its inclusion in clinical risk prediction models significantly enhances their performance. LEVEL OF EVIDENCE Prognostic study, level I. PMID:26816218

  7. Measurement of tissue perfusion by oxygen transport patterns in experimental shock and in high-risk surgical patients.

    PubMed

    Shoemaker, W C; Appel, P L; Kram, H B

    1990-01-01

    Survivors of high-risk general (noncardiac) surgery were observed to have cardiac index (CI) values averaging 4.5 l/min.m2, oxygen delivery (DO2) of greater than 600 ml/min.m2, and oxygen consumption (VO2) of 170 ml/min.m2. In contrast, these values were relatively normal in patients who subsequently died. A very early predictive index based on these observations was found to predict outcome in 94% of high-risk patients. The hypotheses that increased DO2 and VO2 in the survivors represent compensatory physiologic responses and that these values were appropriate therapeutic goals were tested in prospective randomized clinical trials and found to reduce mortality and morbidity significantly. The optimal goals were more easily attained with colloids, red cells, dobutamine, and vasodilators, according to their capacity to improve tissue perfusion, as reflected by increased flow and oxygen transport. The extremely complex interactions between DO2 and VO2 are reviewed.

  8. Extracranial Carotid Artery Stenting in Surgically High-Risk Patients Using the Carotid Wallstent Endoprosthesis:Midterm Clinical and Ultrasound Follow-Up Results

    SciTech Connect

    Maleux, Geert Bernaerts, Pauwel; Thijs, Vincent; Daenens, Kim; Vaninbroukx, Johan; Fourneau, Inge; Nevelsteen, Andre

    2003-08-15

    The purpose of this study was to evaluate the feasibility, safety and midterm outcome of elective implantation of the Carotid Wallstent (registered) in patients considered to be at high surgical risk. In a prospective study, 54 carotid artery stenoses in 51 patients were stented over a 24-month period. Three patients underwent bilateral carotid artery stenting. Institutional inclusion criteria for invasive treatment of carotid occlusive disease (carotid endarterectomy or carotid artery stenting) are patients presenting with a 70% or more symptomatic stenosis and those with an 80% or more asymptomatic stenosis having a life-expectancy of more than 1 year. All patients treated by carotid artery stenting were considered at high risk for carotid endarterectomy because of a hostile neck (17 patients-31.5%) or because of severe comorbidities (37 patients-68.5%). No cerebral protection device was used. Of the 54 lesions, 33 (61.1%) were symptomatic and 21 (38.8%) were asymptomatic. Follow-up was performed by physical examination and by duplex ultrasonography at 1 month, 6 months, 1 year and 2 years after the procedure. All 54 lesions could be stented successfully without periprocedural stroke. Advert events during follow-up (mean 13.9 {+-} 5.7 months) were non-stroke-related death in 6 patients (11.1%), minor stroke in 4 stented hemispheres(7.4%), transient ipsilateral facial pain in 1 patient (1.8%),infection of the stented surgical patch in 1 patient (1.8%) and asymptomatic in stent restenosis in 4 patients (7.4%). The percutaneous implantation of the Carotid Wallstent (registered) , even without cerebral protection device, appears to be a safe procedure with acceptable clinical and ultrasonographic follow-up results in patients at high surgical risk. But some late adverse events such as ipsilateral recurrence of non-disabling (minor) stroke or in stent restenosis still remain real challenging problems.

  9. Length of Stay in Ambulatory Surgical Oncology Patients at High Risk for Sleep Apnea as Predicted by STOP-BANG Questionnaire

    PubMed Central

    Faiz, Saadia A.; Hernandez, Mike; Bashoura, Lara; Cherian, Sujith V.; French, Katy E.

    2016-01-01

    Background. The STOP-BANG questionnaire has been used to identify surgical patients at risk for undiagnosed obstructive sleep apnea (OSA) by classifying patients as low risk (LR) if STOP-BANG score < 3 or high risk (HR) if STOP-BANG score ≥ 3. Few studies have examined whether postoperative complications are increased in HR patients and none have been described in oncologic patients. Objective. This retrospective study examined if HR patients experience increased complications evidenced by an increased length of stay (LOS) in the postanesthesia care unit (PACU). Methods. We retrospectively measured LOS and the frequency of oxygen desaturation (<93%) in cancer patients who were given the STOP-BANG questionnaire prior to cystoscopy for urologic disease in an ambulatory surgery center. Results. The majority of patients in our study were men (77.7%), over the age of 50 (90.1%), and had BMI < 30 kg/m2 (88.4%). STOP-BANG results were obtained on 404 patients. Cumulative incidence of the time to discharge between HR and the LR groups was plotted. By 8 hours, LR patients showed a higher cumulative probability of being discharged early (80% versus 74%, P = 0.008). Conclusions. Urologic oncology patients at HR for OSA based on the STOP-BANG questionnaire were less likely to be discharged early from the PACU compared to LR patients.

  10. Length of Stay in Ambulatory Surgical Oncology Patients at High Risk for Sleep Apnea as Predicted by STOP-BANG Questionnaire.

    PubMed

    Balachandran, Diwakar D; Faiz, Saadia A; Hernandez, Mike; Kowalski, Alicia M; Bashoura, Lara; Goravanchi, Farzin; Cherian, Sujith V; Rebello, Elizabeth; Kee, Spencer S; French, Katy E

    2016-01-01

    Background. The STOP-BANG questionnaire has been used to identify surgical patients at risk for undiagnosed obstructive sleep apnea (OSA) by classifying patients as low risk (LR) if STOP-BANG score < 3 or high risk (HR) if STOP-BANG score ≥ 3. Few studies have examined whether postoperative complications are increased in HR patients and none have been described in oncologic patients. Objective. This retrospective study examined if HR patients experience increased complications evidenced by an increased length of stay (LOS) in the postanesthesia care unit (PACU). Methods. We retrospectively measured LOS and the frequency of oxygen desaturation (<93%) in cancer patients who were given the STOP-BANG questionnaire prior to cystoscopy for urologic disease in an ambulatory surgery center. Results. The majority of patients in our study were men (77.7%), over the age of 50 (90.1%), and had BMI < 30 kg/m(2) (88.4%). STOP-BANG results were obtained on 404 patients. Cumulative incidence of the time to discharge between HR and the LR groups was plotted. By 8 hours, LR patients showed a higher cumulative probability of being discharged early (80% versus 74%, P = 0.008). Conclusions. Urologic oncology patients at HR for OSA based on the STOP-BANG questionnaire were less likely to be discharged early from the PACU compared to LR patients. PMID:27610133

  11. Length of Stay in Ambulatory Surgical Oncology Patients at High Risk for Sleep Apnea as Predicted by STOP-BANG Questionnaire

    PubMed Central

    Faiz, Saadia A.; Hernandez, Mike; Bashoura, Lara; Cherian, Sujith V.; French, Katy E.

    2016-01-01

    Background. The STOP-BANG questionnaire has been used to identify surgical patients at risk for undiagnosed obstructive sleep apnea (OSA) by classifying patients as low risk (LR) if STOP-BANG score < 3 or high risk (HR) if STOP-BANG score ≥ 3. Few studies have examined whether postoperative complications are increased in HR patients and none have been described in oncologic patients. Objective. This retrospective study examined if HR patients experience increased complications evidenced by an increased length of stay (LOS) in the postanesthesia care unit (PACU). Methods. We retrospectively measured LOS and the frequency of oxygen desaturation (<93%) in cancer patients who were given the STOP-BANG questionnaire prior to cystoscopy for urologic disease in an ambulatory surgery center. Results. The majority of patients in our study were men (77.7%), over the age of 50 (90.1%), and had BMI < 30 kg/m2 (88.4%). STOP-BANG results were obtained on 404 patients. Cumulative incidence of the time to discharge between HR and the LR groups was plotted. By 8 hours, LR patients showed a higher cumulative probability of being discharged early (80% versus 74%, P = 0.008). Conclusions. Urologic oncology patients at HR for OSA based on the STOP-BANG questionnaire were less likely to be discharged early from the PACU compared to LR patients. PMID:27610133

  12. Single-port versus conventional multiport access prophylactic laparoscopic bilateral salpingo-oophorectomy in high-risk patients for ovarian cancer: a comparison of surgical outcomes

    PubMed Central

    Angioni, Stefano; Pontis, Alessandro; Sedda, Federica; Zampetoglou, Theodoros; Cela, Vito; Mereu, Liliana; Litta, Pietro

    2015-01-01

    Bilateral salpingo-oophorectomy (BSO) in carriers of BRCA1 and BRCA2 mutations is widely recommended as part of a risk-reduction strategy for ovarian or breast cancer due to an underlying genetic predisposition. BSO is also performed as a therapeutic intervention for patients with hormone-positive premenopausal breast cancer. BSO may be performed via a minimally invasive approach with the use of three to four 5 mm and/or 12 mm ports inserted through a skin incision. To further reduce the morbidity associated with the placement of multiple port sites and to improve cosmetic outcomes, single-port laparoscopy has been developed with a single access point from the umbilicus. The purpose of this study was to evaluate the surgical outcomes associated with reducing the risks of salpingo-oophorectomy performed in a single port, while comparing multiport laparoscopy in women with a high risk for ovarian cancer. Single-port laparoscopy–BSO is feasible and safe, with favorable surgical and cosmetic outcomes when compared to conventional laparoscopy. PMID:26170692

  13. Transcatheter Mitral Valve Repair in Surgical High-Risk Patients: Gender-Specific Acute and Long-Term Outcomes

    PubMed Central

    Tigges, Eike; Kalbacher, Daniel; Thomas, Christina; Appelbaum, Sebastian; Deuschl, Florian; Schofer, Niklas; Schlüter, Michael; Conradi, Lenard; Schirmer, Johannes; Treede, Hendrik; Reichenspurner, Hermann; Blankenberg, Stefan; Schäfer, Ulrich; Lubos, Edith

    2016-01-01

    Background. Analyses emphasizing gender-related differences in acute and long-term outcomes following MitraClip therapy for significant mitral regurgitation (MR) are rare. Methods. 592 consecutive patients (75 ± 8.7 years, 362 men, 230 women) underwent clinical and echocardiographic follow-up for a median of 2.13 (0.99–4.02) years. Results. Significantly higher prevalence of cardiovascular comorbidities, renal failure, and adverse echocardiographic parameters in men resulted in longer device time (p = 0.007) and higher numbers of implanted clips (p = 0.0075), with equal procedural success (p = 1.0). Rehospitalization for heart failure did not differ (p[logrank] = 0.288) while survival was higher in women (p[logrank] = 0.0317). Logarithmic increase of NT-proBNP was a common independent predictor of death. Hypercholesterolemia and peripheral artery disease were predictors of death only in men while ischemic and dilative cardiomyopathy (CM) and age were predictors in women. Independent predictors of rehospitalization for heart failure were severely reduced ejection fraction and success in men while both ischemic and dilative CM, logistic EuroSCORE, and MR severity were predictive in women. Conclusions. Higher numbers of implanted clips and longer device time are likely related to more comorbidities in men. Procedural success and acute and mid-term clinical outcomes were equal. Superior survival for women in long-term analysis is presumably attributable to a comparatively better preprocedural health. PMID:27042662

  14. Using NSQIP to investigate SCIP deficiencies in surgical patients with a high risk of developing hospital-associated urinary tract infections.

    PubMed

    Trickey, Amber W; Crosby, Moira E; Vasaly, Fran; Donovan, Jean; Moynihan, John; Reines, H David

    2014-01-01

    The study objectives were to identify risk factors for surgical patients who develop postoperative urinary tract infections (UTIs) and to characterize urethral catheter practices at the study hospital. Patients from the 2006-2010 institutional National Surgical Quality Improvement Program database were evaluated. Patients with UTIs within 30 postoperative days (n = 116) were compared to patients without UTIs (n = 8685) using multivariable logistic regression. A nested case-control study evaluated the effects of catheter practices on postoperative UTI using conditional logistic regression. Independent predictors of UTI were sex, age, inpatient stay, functional status, renal failure, preoperative transfusion, and preoperative hospital stay. Compared with controls, patients with UTI more often maintained catheters for >2 postoperative days (66% vs 43%, P < .001) and had longer mean catheter duration (11.6 vs 5.1 days, P < .001). Study findings led to institutional recommendations to reduce catheter-associated UTIs. Quality improvement initiatives can increase awareness of performance enhancement opportunities and encourage collaborative, interdisciplinary improvement through shared objectives.

  15. Percutaneous implantation of the CoreValve aortic valve prosthesis in patients at high risk or rejected for surgical valve replacement: Clinical evaluation and feasibility of the procedure in the first 30 patients in the AMC-UvA.

    PubMed

    Baan, J; Yong, Z Y; Koch, K T; Henriques, J P S; Bouma, B J; de Hert, S G; van der Meulen, J; Tijssen, J G P; Piek, J J; de Mol, B A J M

    2010-01-01

    Objective. To report the feasibility, safety and efficacy of percutaneous aortic valve implantation (PAVI) with the CoreValve self-expanding aortic valve bioprosthesis in elderly patients with aortic valve stenosis who are rejected for surgery or have a high surgical risk.Methods. PAVI using the CoreValve ReValving System was performed under general anaesthesia in 30 high-risk (surgical) patients with a symptomatic severe aortic valve stenosis.Results. The patients had a mean age of 80.5+/-7.7 years, a mean aortic valve area of 0.71+/-0.19 cm(2), a peak transvalvular aortic gradient of 79+/-25 mmHg, as measured with echo Doppler, a logistic EuroSCORE of 15+/-10% and a Society of Thoracic Surgeons (STS) score of 5.2+/-2.9%. Device success was achieved in all patients and acute procedural success in 27 patients (90%). In the surviving patients, there was in a reduction of the peak aortic pressure gradient from 76+/-24 mmHg to 22+/-7 mmHg (n=24, p<0.00001) 30 days after successful device implantation. At 30 days, major adverse cardiovascular and cerebral events had occurred in seven patients (23%). This included mortality in six patients (20%), of which one death was cardiovascular. The other five non-cardiovascular deaths involved two patients who died of an exacerbation of severe pre-existent pulmonary disease and three of infectious complications.Conclusions. Percutaneous aortic valve implantation was successfully performed in our centre in highrisk patients, with a 30-day mortality of 20%. When successful, marked haemodynamic improvement and relief of symptoms was achieved. (Neth Heart J 2010;18:18-24.).

  16. Heart calcium sensitizer on morbidity and mortality of high-risk surgical patients with MODS: systematic review and meta-analysis.

    PubMed

    Qiao, Li; Xu, Chengshan; Li, Xinji; Li, Fei; Liu, Wei

    2015-01-01

    A total of 440 patients from 10 studies were included in a systematic review to evaluate the association between improved survivals from multiple organ dysfunction syndromes in patients undergoing surgical operation. Health Inter Network Initiatives (HINARI), MEDLINE and EMBASE were searched. Exclusion criteria were duplicate publications, non-human experimental studies, and no mortality data. The primary endpoint was postoperative mortality. Levosimendan was found to be associated with a reduction in postoperative mortality (11/235 [4.7%] in the levosimendan group v 26/205 [12.7%] in the control, odds ratio of 0.35 [0.18-0.71], P for effect as 0.003, P for heterogeneity 0.22, and I(2) as 27.4% (440 patients included), cardiac troponin release, and atrial fibrillation. No difference was found in terms of myocardial infarction, acute renal failure, time on mechanical ventilation, intensive care unit, and hospital stay. Calcium-sensitizer for congestive heart failure; Levosimendan has cardioprotective effects that could result in a reduced operative mortality. PMID:26770361

  17. Heart calcium sensitizer on morbidity and mortality of high-risk surgical patients with MODS: systematic review and meta-analysis

    PubMed Central

    Qiao, Li; Xu, Chengshan; Li, Xinji; Li, Fei; Liu, Wei

    2015-01-01

    A total of 440 patients from 10 studies were included in a systematic review to evaluate the association between improved survivals from multiple organ dysfunction syndromes in patients undergoing surgical operation. Health Inter Network Initiatives (HINARI), MEDLINE and EMBASE were searched. Exclusion criteria were duplicate publications, non-human experimental studies, and no mortality data. The primary endpoint was postoperative mortality. Levosimendan was found to be associated with a reduction in postoperative mortality (11/235 [4.7%] in the levosimendan group v 26/205 [12.7%] in the control, odds ratio of 0.35 [0.18-0.71], P for effect as 0.003, P for heterogeneity 0.22, and I2 as 27.4% (440 patients included), cardiac troponin release, and atrial fibrillation. No difference was found in terms of myocardial infarction, acute renal failure, time on mechanical ventilation, intensive care unit, and hospital stay. Calcium-sensitizer for congestive heart failure; Levosimendan has cardioprotective effects that could result in a reduced operative mortality. PMID:26770361

  18. Biochemical recurrence risk factors in surgically treated high and very high-risk prostate tumors

    PubMed Central

    Bañuelos, Beatriz; Díez, Jesús; Alonso-Dorrego, Jose María; Cisneros, Jesus; Peña, Javier

    2015-01-01

    Introduction High and very high-risk prostate cancers are tumors that display great variation in their progression, making their behaviour and consequent prognosis difficult to predict. We analyse preoperative and postoperative risk factors that could influence biochemical recurrence of these tumors. Material and methods We carried out univariate and multivariate analyses in an attempt to establish statistically significant preoperative (age, rectal examination, PSA, biopsy Gleason score, uni/bilateral tumor, affected cylinder percentage) and postoperative (pT stage, pN lymph node affectation, Gleason score, positive surgical margins, percentage of tumor affectation, perineural infiltration) risk factors, as well as their relationship with biochemical recurrence (PSA >0.2 ng/mL). Results We analysed 276 patients with high and very high-risk prostate cancer that were treated with laparoscopic radical prostatectomy (LRP) between 2003-2007, with a mean follow-up of 84 months. Incidence of biochemical recurrence is 37.3%. Preoperative factors with the greatest impact on recurrence are suspicious rectal exam (OR 2.2) and the bilateralism of the tumor in the biopsy (OR 1.8). Among the postoperative factors, the presence of a LRP positive surgical margins (OR 3.4) showed the greatest impact, followed by the first grade of the Gleason score (OR 3.3). Conclusions The factor with the greatest influence on biochemical recurrence when it comes to surgery and high and very high-risk prostate cancer is the presence of a positive margin, followed by the Gleason score. Preoperative factors (PSA, biopsy Gleason score, rectal examination, number of affected cylinders) offered no guidance concerning the incidence of BCR. PMID:26568870

  19. Incidence and Sequelae of Prosthesis-Patient Mismatch in Transcatheter Vs Surgical Valve Replacement in High-Risk Patients with Severe Aortic Stenosis – A PARTNER Trial Cohort A Analysis

    PubMed Central

    Pibarot, Philippe; Weissman, Neil J.; Stewart, William J.; Hahn, Rebecca T.; Lindman, Brian R.; McAndrew, Thomas; Kodali, Susheel K.; Mack, Michael J.; Thourani, Vinod H.; Miller, D. Craig; Svensson, Lars G.; Herrmann, Howard C.; Smith, Craig R.; Rodés-Cabau, Josep; Webb, John; Lim, Scott; Xu, Ke; Hueter, Irene; Douglas, Pamela S.; Leon, Martin B.

    2014-01-01

    BACKGROUND Little is known about the incidence of prosthesis-patient mismatch (PPM) and its impact on outcomes after transcatheter aortic valve replacement (TAVR). OBJECTIVES The objectives of this study were: 1) to compare the incidence of PPM in the transcatheter and surgical aortic valve replacement (SAVR) randomized (RCT) arms of the PARTNER-I trial Cohort A; and 2) to assess the impact of PPM on regression of left ventricular (LV) hypertrophy and mortality in these 2 arms and in the TAVR nonrandomized continued access (NRCA) Registry cohort. METHODS The PARTNER trial Cohort A randomized patients 1:1 to TAVR or bioprosthetic SAVR. Postoperative PPM was defined as absent if indexed effective orifice area >0.85, moderate ≥0.65 but ≤0.85, or severe <0.65 cm2/m2. LV mass regression and mortality were analyzed using the SAVR-RCT (n = 270), TAVR-RCT (n = 304) and TAVR-NRCA (n = 1637) cohorts. RESULTS Incidence of PPM was 60.0% (severe: 28.1%) in SAVR-RCT versus 46.4% (severe: 19.7%) in TAVR-RCT (p < 0.001) and 43.8% (severe: 13.6%) in TAVR-NRCA. In patients with aortic annulus diameter < 20 mm, severe PPM developed in 33.7% undergoing SAVR compared to 19.0% undergoing TAVR (p = 0.002). PPM was an independent predictor of less LV mass regression at 1 year in SAVR-RCT (p = 0.017) and TAVR-NRCA (p = 0.012) but not in TAVRRCT (p = 0.35). Severe PPM was an independent predictor of 2-year mortality in SAVR-RCT (hazard ratio [HR]: 1.78; p = 0.041) but not in TAVR-RCT (HR: 0.58; p = 0.11). In the TAVRNRCA, severe PPM was not a predictor of 1-year mortality in the whole cohort (HR: 1.05; p = 0.60) but did independently predict mortality in the subset of patients with no post-procedural aortic regurgitation (HR: 1.88; p = 0.02). CONCLUSIONS In patients with severe aortic stenosis and high surgical risk, PPM is more frequent and more often severe following SAVR than TAVR. Patients with PPM after SAVR have worse survival and less LV mass regression than those without PPM

  20. Treating Patients with High-Risk Smoldering Myeloma

    Cancer.gov

    In this phase III clinical trial, patients with smoldering myeloma classified as high risk for progression will be randomly assigned to undergo standard observation or six 4-week courses of treatment with the drug lenalidomide.

  1. Surgical Delay of the Nipple–Areolar Complex in High-risk Nipple-sparing Mastectomy Reconstruction

    PubMed Central

    Martinovic, Maryann E.; Pellicane, James V.

    2016-01-01

    Summary: As nipple-sparing mastectomy gains increasing popularity, minimizing the risk of nipple necrosis continues to be of critical importance to patients and surgeons. Patients with large or ptotic breasts, scars from previous cosmetic and/or oncologic breast surgery, or previous irradiation have often been denied nipple-sparing mastectomy (NSM) because of increased risk of nipple necrosis. A variety of interventions have been suggested to minimize the ischemic insult to the nipple–areolar complex (NAC). This article presents our experience in 26 high-risk patients with surgical delay of the NAC. PMID:27482499

  2. Dental implants in patients at high risk for infective endocarditis: a preliminary study.

    PubMed

    Findler, M; Chackartchi, T; Regev, E

    2014-10-01

    The safety of dental implant placement in patients at high risk for infective endocarditis (IE) has never been shown. The outcome of osseointegrated implants in patients with artificial heart valves or with a history of an infected valve is not known. In this article we describe our experience of dental implant placement in patients at high risk for IE. A retrospective study was conducted on patients at high risk for IE who underwent dental implant placement. All the patients received prophylactic antibiotic treatment before the surgical procedure, in accordance with the relevant American Heart Association guidelines. A total 13 patients underwent 16 surgical procedures for the placement of 57 dental implants over a period of 17 years. Within the follow-up period, no case of IE was reported. Two implants failed before exposure in one patient, one patient suffered from mitral valve thrombosis 14 days after the dental procedure, and another patient suffered a stroke 6 months following treatment. Despite the limitation of the small group of patients and the known low incidence of IE, dental implants may be regarded as a legitimate procedure for patients at high risk for IE. PMID:24893765

  3. Thromboembolism Prophylaxis in Hip Arthroplasty: Routine and High Risk Patients.

    PubMed

    Nam, Denis; Nunley, Ryan M; Johnson, Staci R; Keeney, James A; Clohisy, John C; Barrack, Robert L

    2015-12-01

    This study's purpose was to present the use of a risk stratification protocol in which "routine" risk patients receive a mobile compression device with aspirin and "high" risk patients receive warfarin for thromboprophylaxis after hip arthroplasty. 1859 hip arthroplasty patients were prospectively enrolled (1402 routine risk--75.4%, 457 high risk--24.6%). The cumulative rate of venous thromboembolism events was 0.5% in the routine versus 0.5% in the high-risk cohort within 6weeks postoperatively (P=1.00). Patients in the routine risk cohort had a lower rate of major bleeding (0.5% versus 2.0%, P=0.006) and wound complications (0.2% versus 1.2%, P=0.01). Use of our risk stratification protocol allowed the avoidance of more aggressive anticoagulation in 75% of patients while achieving a low overall incidence of symptomatic VTE. PMID:26182980

  4. Prospective screening for deep vein thrombosis in high risk patients.

    PubMed

    Barnes, R W

    1977-08-01

    In 257 patients undergoing total hip replacement, gastric bypass for morbid obesity, major abdominal surgery, and major leg amputation, Doppler ultrasonic screening revealed only five instances of deep vein thrombosis. The present study suggests that Doppler screening of high risk patients is a useful alternative to routine anticoagulant prophylaxis of venous thromboembolic disease.

  5. Embedded CMs work with high-risk patients.

    PubMed

    2014-01-01

    Care managers embedded in primary care clinics work with patients with high-risk diagnoses and multiple visits to the emergency department or hospital. Patients are identified though risk assessments, suggestions from inpatient case management, and requests from primary care clinicians. Care managers call patients before their clinic visits, look for gaps in care and find out patients' questions and concerns, sharing the information with the treating clinicians. Care managers follow patients for four weeks after their visit, helping them meet their health care goals and follow their treatment plan.

  6. Transcatheter Aortic Valve Replacement Versus Surgery in Women at High Risk for Surgical Aortic Valve Replacement (from the CoreValve US High Risk Pivotal Trial).

    PubMed

    Skelding, Kimberly A; Yakubov, Steven J; Kleiman, Neal S; Reardon, Michael J; Adams, David H; Huang, Jian; Forrest, John K; Popma, Jeffrey J

    2016-08-15

    The objective of this study was to compare outcomes in women after surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) using a self-expanding prosthesis in patients with severe aortic stenosis who were at high risk for SAVR. Although registries and meta-analyses have suggested that TAVR is of considerable benefit in women, perhaps even more so than in men, a rigorous evaluation of TAVR with a self-expanding valve versus SAVR in women from a randomized trial has not been performed. Patients with severe aortic stenosis were randomized 1:1 to either TAVR or SAVR. Outcomes at 1 year are reported. Treatment was attempted in a total of 353 women (183 TAVR and 170 SAVR). Baseline characteristics and predicted risk of the 2 groups were comparable, although the frequency of diabetes mellitus was lower in patients undergoing TAVR (33.3% vs 45.3%; p = 0.02). TAVR-treated patients experienced a statistically significant 1-year survival advantage compared with SAVR patients (12.7% vs 21.8%; p = 0.03). The composite all-cause mortality or major stroke rate also favored TAVR (14.9% vs 24.2%; p = 0.04). Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire summary score, for both the TAVR and SAVR groups increased significantly from baseline to 1 year. In conclusion, female TAVR patients had lower 1-year mortality and lower 1-year all-cause mortality or major stroke compared with women undergoing SAVR, with both cohorts experiencing improved quality of life. Further studies specifically in women are warranted to validate these findings. PMID:27381665

  7. Prevention of VTE in Nonorthopedic Surgical Patients

    PubMed Central

    Garcia, David A.; Wren, Sherry M.; Karanicolas, Paul J.; Arcelus, Juan I.; Heit, John A.; Samama, Charles M.

    2012-01-01

    Background: VTE is a common cause of preventable death in surgical patients. Methods: We developed recommendations for thromboprophylaxis in nonorthopedic surgical patients by using systematic methods as described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines in this supplement. Results: We describe several alternatives for stratifying the risk of VTE in general and abdominal-pelvic surgical patients. When the risk for VTE is very low (< 0.5%), we recommend that no specific pharmacologic (Grade 1B) or mechanical (Grade 2C) prophylaxis be used other than early ambulation. For patients at low risk for VTE (∼1.5%), we suggest mechanical prophylaxis, preferably with intermittent pneumatic compression (IPC), over no prophylaxis (Grade 2C). For patients at moderate risk for VTE (∼3%) who are not at high risk for major bleeding complications, we suggest low-molecular-weight heparin (LMWH) (Grade 2B), low-dose unfractionated heparin (Grade 2B), or mechanical prophylaxis with IPC (Grade 2C) over no prophylaxis. For patients at high risk for VTE (∼6%) who are not at high risk for major bleeding complications, we recommend pharmacologic prophylaxis with LMWH (Grade 1B) or low-dose unfractionated heparin (Grade 1B) over no prophylaxis. In these patients, we suggest adding mechanical prophylaxis with elastic stockings or IPC to pharmacologic prophylaxis (Grade 2C). For patients at high risk for VTE undergoing abdominal or pelvic surgery for cancer, we recommend extended-duration, postoperative, pharmacologic prophylaxis (4 weeks) with LMWH over limited-duration prophylaxis (Grade 1B). For patients at moderate to high risk for VTE who are at high risk for major bleeding complications or those in whom the consequences of bleeding are believed to be particularly severe, we suggest

  8. “And I think that we can fix it”: Mental Models used in High-Risk Surgical Decision Making

    PubMed Central

    Kruser, Jacqueline M; Pecanac, Kristen E; Brasel, Karen J; Cooper, Zara; Steffens, Nicole; McKneally, Martin; Schwarze, Margaret L

    2014-01-01

    Objective To examine how surgeons use the “fix-it” model to communicate with patients before high-risk operations. Background The “fix-it” model characterizes disease as an isolated abnormality that can be restored to normal form and function through medical intervention. This mental model is familiar to patients and physicians, but it is ineffective for chronic conditions and treatments that cannot achieve normalcy. Overuse may lead to permissive decision making favoring intervention. Efforts to improve surgical decision making will need to consider how mental models function in clinical practice, including “fix-it”. Methods We observed surgeons who routinely perform high-risk surgery during preoperative discussions with patients. We used qualitative content analysis to explore the use of “fix-it” in 48 audio-recorded conversations. Results Surgeons used the “fix-it” model for two separate purposes during preoperative conversations; 1) as an explanatory tool to facilitate patient understanding of disease and surgery and 2) as a deliberation framework to assist in decision making. Although surgeons commonly used “fix-it” as an explanatory model, surgeons explicitly discussed limitations of the “fix-it” model as an independent rationale for operating as they deliberated about the value of surgery. Conclusions While the use of “fix-it” is familiar for explaining medical information to patients, surgeons recognize that the model can be problematic for determining the value of an operation. Whether patients can transition between understanding how their disease is fixed with surgery to a subsequent deliberation about whether they should have surgery is unclear and may have broader implications for surgical decision making. PMID:25749396

  9. Treatment of a High-Risk Diabetic Patient with Peripheral Vascular Disease and Osteomyelitis.

    PubMed

    Allen, Latricia L; Kalmar, Garrett; Driver, Vickie R

    2016-06-01

    We report a case of calcaneal osteomyelitis that was surgically resected from a patient with diabetes and peripheral vascular disease. A 91-year-old male with history of type 2 diabetes, peripheral vascular disease, balloon angioplasty, and recent (2 months ago) stent of the superficial femoral artery presented to the emergency department with a left heel wound infection probed to bone. The patient reported having been on intravenous Zosyn for several months via an outside infectious disease provider for clinical suspicion of osteomyelitis, but noted no improvement. This report includes information regarding the clinical examination and imaging findings, which were used to assess this high-risk patient. Our patient underwent a partial calcanectomy and completed a 6-week course of intravenous antibiotics. The purpose of this case report is to illustrate limb preservation in a high-risk patient with compromised vascular supply who underwent a partial calcanectomy for treatment of calcaneal osteomyelitis. The patient underwent surgical resection of the calcaneus without complications and healed unremarkably with the ability to ambulate while wearing an ankle foot orthosis with a custom shoe. This report was authorized for publication as an educational report to contribute to generalizable knowledge and does not include any patient health information. PMID:27423990

  10. Thromboprophylaxis in non-surgical cancer patients.

    PubMed

    Cohen, Alexander T; Gurwith, Meredith M P; Dobromirski, Mark

    2012-04-01

    Acutely ill medical patients with cancer and cancer patients requiring non-surgical therapy are considered as non-surgical cancer patients and are at moderate to high risk of venous thromboembolism (VTE): approximately 10-30% of these patients may develop asymptomatic or symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE), and the latter is a leading contributor to deaths in hospital. Other medical conditions associated with a high risk of VTE include cardiac disease, respiratory disease, inflammatory bowel disease, rheumatological and infectious diseases. Pre-disposing risk factors in non-surgical cancer patients include a history of VTE, immobilisation, history of metastatic malignancy, complicating infections, increasing age, obesity hormonal or antiangiogenic therapies, thalidomide and lenalidomide therapy. Heparins, both unfractionated (UFH) and low molecular weight heparin (LMWH) and fondaparinux have been shown to be effective agents in prevention of VTE in the medical setting with patients having a history of cancer. UFH and LMWH along with semuloparin also have a role in outpatients with cancer receiving chemotherapy. However, it has not yet been possible to demonstrate a significant effect on mortality rates in this population. UFH has a higher rate of bleeding complications than LMWH. Thromboprophylaxis has been shown to be effective in medical patients with cancer and may have an effect on cancer outcomes. Thromboprophylaxis in patients receiving chemotherapy remains controversial and requires further investigation. There is no evidence for the use of aspirin, warfarin or mechanical methods. We recommend either LMWH, or fondaparinux for the prevention of VTE in cancer patients with acute medical illnesses and UFH for those with significant severe renal impairment. For ambulatory cancer patients undergoing chemotherapy we recommend LMWH or semuloparin. These are safe and effective agents in the thromboprophylaxis of non-surgical cancer

  11. Mid-Term Results After Endovascular Stent-Grafting of Descending Aortic Aneurysms in High-Risk Patients

    SciTech Connect

    Brandt, Michael Walluscheck, Knut P.; Jahnke, Thomas; Attmann, Tim; Heller, Martin; Cremer, Jochen; Mueller-Huelsbeck, Stefan

    2006-10-15

    Purpose. To analyze our experience with endovascular stent-grafting of descending aortic aneurysms in high-risk patients. Methods. Nineteen patients underwent endovascular stent-graft repair of descending aortic aneurysms using the Talent Stent Graft System (Medtronic). All patients were considered high-risk for open surgical repair due to their age, requirement for emergency surgery, and comorbidities. Computed tomography and/or MR tomography were performed at 3, 6 and 12 months postoperatively and thereafter every 12 months. Results. Secondary technical success was 100%. Thirty-day mortality was 5%. Incidence of postoperative stroke and paraplegia were 5% each. One patient required a second stent-graft due to a type I endoleak during the same hospital stay (primary technical success 95%). All patients have been followed for a median of 20 months. No migration, wire fractures or endoleak appeared during follow-up. Conclusion. Endovascular stent-grafting had a low 30-day mortality and morbidity in high-risk patients. One patient developed an aortoesophageal fistula 40 days after stent implantation. Stent-graft repair is a valuable supplement to surgical therapy in high-risk patients.

  12. SUPRAPUR®: Safe and convenient percutaneous suprapubic catheterisation in high-risk patients

    PubMed Central

    Mandel, Philipp; Ritter, Manuel

    2015-01-01

    Introduction Ultrasound-guided percutaneous placement of a suprapubic cystostomy is a common and generally safe procedure in everyday surgery. In case of adverse patient characteristics such as small bladder capacity or high body mass index, however, the procedure carries an increased risk of severe complications, including bowel perforation. The Suprapur® cystostomy set is supposed to enable a safer procedure. The aim of our work was to evaluate the safety and ease of use of the Suprapur® cystostomy set. Material and methods We prospectively evaluated the Suprapur® set in high-risk patients, having either a small bladder capacity below 250 ml or a BMI above 30 kg/m2. Complications and surgical outcome were monitored. In addition, patients’ contentment and pain during the procedure was assessed with a visual analogue scale (VAS). Possible drawbacks and ease of use were evaluated by customized questionnaires for the operating physician. Results In total, 26 cystostomies were performed by 15 different physicians, 40% (n = 6) of whom were inexperienced first or second year residents. No complications occurred. Mild gross haematuria occurred in 11.5% (n = 4) of cases. Average VAS for pain during and two hours after the procedure was 2.1 (±1.2) and 0.3 (±0.5) respectively. In 91%, (n = 20) of the procedures, the physicians claimed to have felt safe using SUPRAPUR® and more comfortable (82%, n = 18) than with a conventional cystostomy set. Conclusions SUPRAPUR® allows a safe and simple placement of a suprapubic cystostomy even in high-risk patients or in inexperienced hands. It might help to reduce the complications of a common and frequent surgical procedure. PMID:26855806

  13. Patient-specific surgical simulation.

    PubMed

    Soler, Luc; Marescaux, Jacques

    2008-02-01

    Technological innovations of the twentieth century have provided medicine and surgery with new tools for education and therapy definition. Thus, by combining Medical Imaging and Virtual Reality, patient-specific applications providing preoperative surgical simulation have become possible.

  14. Associations between Charlson Comorbidity Index and surgical risk severity and the surgical outcomes in advanced-age patients.

    PubMed

    Larson, Kelly J; Hamlin, Ryan J; Sprung, Juraj; Schroeder, Darrell R; Weingarten, Toby N

    2014-06-01

    The Charlson Comorbidity Index (CCI) has not been assessed for elderly (95 years of age or older) surgical patients. We examined the association between the CCI and life-threatening complications and 30-day mortality rate. Medical records of patients 95 years old or older from 2004 through 2008 were reviewed for major postoperative morbidity or death. Logistic regression analyses of age, sex, the CCI, American College of Cardiology/American Heart Association Surgical Risk Stratification, and surgical urgency were performed to identify associations with poor surgical outcome. One hundred eighty-seven patients were identified (mean [standard deviation] age, 96.6 [1.9] years; median [interquartile range] CCI, 4 [2 to 6]). Ninety patients (48.1%) underwent moderate-risk and 20 (10.7%) underwent high-risk surgical procedures. Twenty patients (10.7%) died within 30 postoperative days and 20 others had major morbidity. Only moderate-risk (P = 0.045) and high-risk surgical procedures (P = 0.001) were associated with poor outcome. Patients of advanced age have high rates of morbidity and death after surgical procedures. These events are associated with surgical risk stratification and are independent of patient comorbidities. Risks, benefits, and alternatives must be considered carefully and discussed with patients and their families before deciding to proceed with high-risk surgery.

  15. Outcomes for split-thickness skin transplantation in high-risk patients using octenidine.

    PubMed

    Matiasek, J; Djedovic, G; Unger, L; Beck, H; Mattesich, M; Pierer, G; Koller, R; Rieger, U M

    2015-06-01

    Skin transplantation is a commonly used surgical technique; however, the complication rate, including postoperative infection and delayed wound healing due to inefficient perfusion, is significantly higher in patients suffering from comorbidities. Hence, a subsequent repeat procedure is often necessary. In this report, two case studies are presented in which an octenidine-based antiseptic is used with a tie-over dressing (TOD) instead of povidone iodine (PVP-iodine), following a split-thickness skin graft. The two patients selected were deemed to be at high risk of impaired wound healing due to comorbidities. The first patient, a confirmed smoker with diabetes, presented with a nodular melanoma that was resected and covered with a split-thickness skin graft. After 5 days of negative pressure wound therapy as a TOD, in combination with PVP-iodine, the graft became necrotic. A second split-thickness skin graft was performed and an antiseptic regimen with octenidine in combination with the same TOD resulted in a completely healed transplant. The second patient, also a confirmed smoker with diabetes and receiving oral corticosteroid treatment, was diagnosed with a skin necrosis on her leg. Following the split-thickness skin graft, octenidine and TOD were applied. The patient's skin graft completely healed without any adverse events. These two case studies indicate that the combination of octenidine and TOD following split-thickness skin transplantation is safe, well-tolerated and appears to have positive benefits in the reconstruction of defects in patients with impaired wound healing.

  16. Outcomes for split-thickness skin transplantation in high-risk patients using octenidine.

    PubMed

    Matiasek, J; Djedovic, G; Unger, L; Beck, H; Mattesich, M; Pierer, G; Koller, R; Rieger, U M

    2015-06-01

    Skin transplantation is a commonly used surgical technique; however, the complication rate, including postoperative infection and delayed wound healing due to inefficient perfusion, is significantly higher in patients suffering from comorbidities. Hence, a subsequent repeat procedure is often necessary. In this report, two case studies are presented in which an octenidine-based antiseptic is used with a tie-over dressing (TOD) instead of povidone iodine (PVP-iodine), following a split-thickness skin graft. The two patients selected were deemed to be at high risk of impaired wound healing due to comorbidities. The first patient, a confirmed smoker with diabetes, presented with a nodular melanoma that was resected and covered with a split-thickness skin graft. After 5 days of negative pressure wound therapy as a TOD, in combination with PVP-iodine, the graft became necrotic. A second split-thickness skin graft was performed and an antiseptic regimen with octenidine in combination with the same TOD resulted in a completely healed transplant. The second patient, also a confirmed smoker with diabetes and receiving oral corticosteroid treatment, was diagnosed with a skin necrosis on her leg. Following the split-thickness skin graft, octenidine and TOD were applied. The patient's skin graft completely healed without any adverse events. These two case studies indicate that the combination of octenidine and TOD following split-thickness skin transplantation is safe, well-tolerated and appears to have positive benefits in the reconstruction of defects in patients with impaired wound healing. PMID:26075514

  17. Laparoscopic pyelolithotomy: An emerging tool for complex staghorn nephrolithiasis in high-risk patients

    PubMed Central

    Gandhi, Himesh Ramesh; Thomas, Appu; Nair, Balagopal; Pooleri, Ginilkumar

    2014-01-01

    Objectives To evaluate the effectiveness of laparoscopic pyelolithotomy (LP) for staghorn stones (>3–4 cm) in patients with chronic liver disease or coronary artery disease. Patients and methods In all, 49 patients underwent LP; they were divided into four groups, with stones in group 1 in the renal pelvis only, in group 2 in the renal pelvis and one calyx, in group 3 in the renal pelvis and two calyces, and in group 4, in the renal pelvis and more than two calyces. Patient demography, stone characteristics, surgical outcomes and complications were evaluated. Results The mean stone-free rate in one session was 90% among all groups. The mean (SD) stone size was 4.27 (1.72) cm. The stone-free rate decreased with greater stone burden, but the operative time, estimated blood loss and need for ancillary procedures increased with stone burden. No blood transfusion was required and one patient each in groups 2 and 4 had a urine leak. Conclusion LP provides acceptable results in complex cases for managing renal stone disease with a larger stone burden in high-risk situations. PMID:26413336

  18. Utility of drug-eluting stents in complex lesions and high-risk patients.

    PubMed

    Nikolsky, Eugenia; Stone, Gregg W

    2007-02-01

    Drug-eluting stents represent a breakthrough technology designed to deliver high concentrations of a bioactive agent locally to an atherosclerotic lesion, thereby minimizing systemic side effects of the drug. The safety and efficacy of drug-eluting stents have clearly been demonstrated in noncomplex lesions. This article presents an evidence-based analysis of the current experience with CYPHER sirolimus-eluting stents (Cordis Corp., Miami Lakes, FL) and TAXUS paclitaxel-eluting stents (Boston Scientific, Natick, MA) in a broad spectrum of high-risk and/or complex subsets of patients and lesions, including those with diabetes mellitus, multivessel disease, diffuse disease, very small vessels, lesions in saphenous vein grafts, chronic total occlusions, in-stent restenosis, ostial and bifurcation lesions, unprotected left main disease, and acute myocardial infarction. Emerging data in several of these subsets suggest that drug-eluting stents are safe and effective, and their use may currently be recommended, whereas in other groups of patients and lesions the efficacy and/or safety of drug-eluting stents remains to be determined, thus warranting caution. It is anticipated that penetration of drug-eluting stents will continue to increase, and fewer patients will require surgical revascularization to achieve sustained event-free survival.

  19. Asymptomatic pulmonary embolism: a common event in high risk patients

    SciTech Connect

    Williams, J.W.; Eikman, E.A.; Greenberg, S.

    1982-03-01

    Ventilation and perfusion lung scans were obtained before and at weekly intervals following hip surgery or major amputation in 158 patients. Pulmonary arteriograms were obtained in 21 of 33 patients developing perfusion patterns strongly suggesting embolism; 19 of the 21 arteriograms demonstrated pulmonary embolism. From autopsy and clinical data, 36 patients were diagnosed as having an embolus while under study, and 12 patients were suspected of having had an embolus during their illness but prior to entry into the study. Only four of these 48 patients experienced symptoms suggestive of pulmonary embolism. We conclude that asymptomatic pulmonary embolism is a common event in the populations studied.

  20. Perforated Duodenal Ulcer in High Risk Patients: Is Percutaneous Drainage Justified?

    PubMed Central

    Saber, Aly; Gad, Mohammad A; Ellabban, Gouda M

    2012-01-01

    Background: Conservative treatment was recommended as the treatment of choice in perforated acute peptic ulcer. Here, we adjunct percutaneous peritoneal drainage with nonoperative conservative treatment in high risk elderly patients with perforated duodenal ulcer. Aim: The work was to study the efficacy of percutaneous peritoneal drainage under local anesthesia supported by conservative measures in high risk elderly patients, according to the American Society of Anesthesiologists grading, with perforated duodenal ulcer. Patients and Methods: Twenty four high risk patients with age >65 years having associated medical illness with evidence of perforated duodenal ulcer. Results: The overall morbidity and mortality were comparable with those treated by conservative measures alone. Conclusion: In high risk patients with perforated peptic ulcer and established peritonitis, percutaneous peritoneal drainage under local anesthesia seems to be effective with least operative trauma and mortality rate. PMID:22393546

  1. Usefulness of postoperative hip irradiation in the prevention of heterotopic bone formation in a high risk group of patients

    SciTech Connect

    MacLennan, I.; Keys, H.M.; Evarts, C.M.; Rubin, P.

    1984-01-01

    Heterotopic ossification is a complication of total hip arthroplasty in 14 to 30% of patients. Significant functional impairment will occur in up to 28% of patients with ectopic bone. The high risk group includes those with preexisting heterotopic bone in either hip, those suffering from hypertrophic osteoarthritis or ankylosing spondylitis and patients who have had multiple procedures on the hip. Fifty-eight patients (67 hips) were irradiated after surgical removal of ectopic bone (53 hips) or received radiation prophylaxis of heterotopic ossification (14 hips). Ninety-five percent of patients had either no bone visible or insignificant amounts of ectopic bone visible on postoperative hip X-rays. Only 5% of patients showed significant persistence of ectopic bone. Postoperative hip function was dramatically improved compared to preoperative function in all patients treated. The importance of early commencement of irradiation is emphasized.

  2. [High risk infective endocarditis embolism during pregnancy: Medical or surgical management?].

    PubMed

    Echeverría, Luis Eduardo; Figueredo, Antonio; Gómez, Juan Carlos; Salazar, Leonardo Alberto; Rodriguez, Jaime Alberto; Pizarro, Camilo Ernesto; Riaño, Carlos Eduardo; Perroni, Addy; Cuadros, Alba Lucía; Villamizar, María Cristina; Suárez, Edwin Uriel

    2013-01-01

    A 22-year-old pregnant woman was seen at 14 weeks of pregnancy for infective endocarditis with a vegetation of 15 mm and wide mobility, which affected the native mitral valve accompanied by severe valvular insufficiency. Antibiotic treatment was given for 4 weeks despite the embolism risk. Due to persistence of vegetation size and after considering the fetal and maternal risk, the surgical procedure was favored. We decided to perform valvuloplasty and removal of lesion at 18 weeks of pregnancy. Fetal protection techniques were used and a bioprosthesis was placed before attempting a repair. The postoperative follow-up was satisfactory, achieving a successful birth by cesarean section at 30 weeks. PMID:23896064

  3. Evolving treatment strategies in patients with high-risk acute myeloid leukemia.

    PubMed

    Schiller, Gary J

    2014-11-01

    Acute myeloid leukemia (AML) is defined by a set of biologically distinct diseases characterized by maturation arrest and clonal proliferation of myeloid cells. Recommendations for post-remission therapy depend on assessing the leukemia risk characteristics, such as cytogenetics and molecular features present at diagnosis. Patients with high-risk disease include those whose leukemia is characterized by monosomal karyotype or poor-risk cytogenetic or molecular abnormalities, patients with antecedent hematologic disorders or therapy-related AML, and presence of adverse host factors, such as comorbidities, impaired performance status or older age. Older patients are more likely to have these adverse features. High-risk AML responds poorly to available induction treatment and is likely to relapse despite consolidation therapy. Current data support an increasing understanding of prognosis but have not yet resulted in effective therapies for patients with high-risk disease. This review discusses current therapies and evolving treatment strategies for high-risk AML.

  4. Survival of high-risk pediatric neuroblastoma patients in a developing country.

    PubMed

    Easton, Joseph C; Gomez, Sergio; Asdahl, Peter H; Conner, J Michael; Fynn, Alcira B; Ruiz, Claudia; Ojha, Rohit P

    2016-09-01

    Little information is available about survival of high-risk pediatric neuroblastoma patients in developing countries. We aimed to assess survival among high-risk pediatric neuroblastoma patients in La Plata, Argentina. Individuals eligible for our cohort were aged <20 yr when diagnosed with high-risk neuroblastoma and received cancer-directed therapy including stem cell transplantation at Hospital de Niños Sor Maria Ludovica between February 1999 and February 2015. We estimated overall survival probabilities using an extended Kaplan-Meier approach. Our study population comprised 39 high-risk neuroblastoma patients, of whom 39% were aged >4 yr at diagnosis, 54% were male, and 62% had adrenal neuroblastoma. We observed 18 deaths, and the median survival time of our study population was 1.7 yr. The five-yr overall survival probability was 24% (95% CL: 10%, 41%). In contrast, five-yr survival of high-risk neuroblastoma patients ranges between 23% and 76% in developed countries. Survival among high-risk neuroblastoma patients is generally poor regardless of geographic location, but our results illustrate dramatically worse survival for patients in a developing country. We speculate that the observed survival differences could be attenuated or eliminated with improvements in treatment and supportive care, but addressing these issues will require creative solutions because of resource limitations. PMID:27235336

  5. Survival of high-risk pediatric neuroblastoma patients in a developing country.

    PubMed

    Easton, Joseph C; Gomez, Sergio; Asdahl, Peter H; Conner, J Michael; Fynn, Alcira B; Ruiz, Claudia; Ojha, Rohit P

    2016-09-01

    Little information is available about survival of high-risk pediatric neuroblastoma patients in developing countries. We aimed to assess survival among high-risk pediatric neuroblastoma patients in La Plata, Argentina. Individuals eligible for our cohort were aged <20 yr when diagnosed with high-risk neuroblastoma and received cancer-directed therapy including stem cell transplantation at Hospital de Niños Sor Maria Ludovica between February 1999 and February 2015. We estimated overall survival probabilities using an extended Kaplan-Meier approach. Our study population comprised 39 high-risk neuroblastoma patients, of whom 39% were aged >4 yr at diagnosis, 54% were male, and 62% had adrenal neuroblastoma. We observed 18 deaths, and the median survival time of our study population was 1.7 yr. The five-yr overall survival probability was 24% (95% CL: 10%, 41%). In contrast, five-yr survival of high-risk neuroblastoma patients ranges between 23% and 76% in developed countries. Survival among high-risk neuroblastoma patients is generally poor regardless of geographic location, but our results illustrate dramatically worse survival for patients in a developing country. We speculate that the observed survival differences could be attenuated or eliminated with improvements in treatment and supportive care, but addressing these issues will require creative solutions because of resource limitations.

  6. Percentage of Surgical Patients Receiving Recommended Care

    MedlinePlus

    ... Recommended Care Percentage of Surgical Patients Receiving Recommended Care This is a composite measure based on individual ... Age Group Percentage of Surgical Patients Receiving Recommended Care by Age Group uzrc-9bvr Download these data » ...

  7. Bioengineered Corneas Grafted as Alternatives to Human Donor Corneas in Three High-Risk Patients

    PubMed Central

    Buznyk, Oleksiy; Pasyechnikova, Nataliya; Islam, M Mirazul; Iakymenko, Stanislav; Fagerholm, Per; Griffith, May

    2015-01-01

    Corneas with severe pathologies have a high risk of rejection when conventionally grafted with human donor tissues. In this early observational study, we grafted bioengineered corneal implants made from recombinant human collagen and synthetic phosphorylcholine polymer into three patients for whom donor cornea transplantation carried a high risk of transplant failure. These patients suffered from corneal ulcers and recurrent erosions preoperatively. The implants provided relief from pain and discomfort, restored corneal integrity by promoting endogenous regeneration of corneal tissues, and improved vision in two of three patients. Such implants could in the future be alternatives to donor corneas for high-risk patients, and therefore, merits further testing in a clinical trial. PMID:25996570

  8. Effectiveness of Regional Hyperthermia With Chemotherapy for High-Risk Retroperitoneal and Abdominal Soft-Tissue Sarcoma After Complete Surgical Resection

    PubMed Central

    Angele, Martin K.; Albertsmeier, Markus; Prix, Niclas J.; Hohenberger, Peter; Abdel-Rahman, Sultan; Dieterle, Nelli; Schmidt, Michael; Mansmann, Ulrich; Bruns, Christiane J.; Issels, Rolf D.; Jauch, Karl-Walter; Lindner, Lars H.

    2015-01-01

    Objective To determine whether regional hyperthermia (RHT) in addition to chemotherapy improves local tumor control after macroscopically complete resection of abdominal or retroperitoneal high-risk sarcomas. Background Within the prospectively randomized EORTC 62961 phase- III trial, RHT and systemic chemotherapy significantly improved local progression-free survival (LPFS) and disease-free survival (DFS) in patients with abdominal and extremity sarcomas. That trial included macroscopically complete and R2 resections. Methods A subgroup analysis of the EORTC trial was performed and long-term survival determined. From 341 patients, 149 (median age 52 years, 18–69) were identified with macroscopic complete resection (R0, R1) of abdominal and retroperitoneal soft-tissue sarcomas (median diameter 10 cm, G2 48.3%, G3 51.7%). Seventy-six patients were treated with EIA (etoposide, ifosfamide, doxorubicin) + RHT (≥5 cycles: 69.7%) versus 73 patients receiving EIA alone (≥5 cycles: 52.1%, P = 0.027). LPFS and DFS as well as overall survival were determined. Results RHT and systemic chemotherapy significantly improved LPFS (56% vs 45% after 5 years, P = 0.044) and DFS (34% vs 27% after 5 years, P = 0.040). Overall survival was not significantly improved in the RHT group (57% vs 55% after 5 years, P = 0.82). Perioperative morbidity and mortality were not significantly different between groups. Conclusions In patients with macroscopically complete tumor resection, RHT in addition to chemotherapy resulted in significantly improved local tumor control and DFS without increasing surgical complications. Within a multimodal therapeutic concept for abdominal and retroperitoneal high-risk sarcomas, RHT is a treatment option beside radical surgery and should be further evaluated in future trials. PMID:25379845

  9. Pancreatic Stenting Reduces Post-ERCP Pancreatitis and Biliary Sepsis in High-Risk Patients: A Randomized, Controlled Study

    PubMed Central

    Wu, Hai-En; Li, Qi-Xiang; Wang, Wei; Ou, Wei-Lin; Xia, Harry Hua-Xiang

    2016-01-01

    Background. Endoscopic retrograde cholangiopancreatography (ERCP) is an established treatment modality for bile duct disorders, but patients have a risk of post-ERCP pancreatitis (PEP) and biliary sepsis. Aim. To evaluate the effectiveness and safety of pancreatic stent for prophylaxis of PEP and biliary sepsis in high-risk patients with complicating common bile duct (CBD) disorders. Methods. Two hundred and six patients with complicating confirmed or suspected CBD disorders were randomly assigned to receive ERCP with pancreatic stenting (experimental group) or without stenting (control group). Primary outcome measure was frequency of PEP, and secondary outcome measures included operative time, blood loss, postoperative recovery times, and other ERCP-associated morbidities. Results. Baseline age, sex, CBD etiology, concomitant medical/surgical conditions, cannulation difficulty, and ERCP success were comparable between the two groups (all P > 0.05). Compared to the control group, the experimental group had a significantly lower frequency of PEP (7.7% versus 17.7%, P < 0.05) and positive bile microbial culture (40.4% versus 62.7%, P < 0.05). However, the two groups were similar in operative time, blood loss, postoperative recovery times, and other ERCP-associated morbidities (all P > 0.05). Conclusions. Pancreatic stenting can reduce the occurrence of PEP and biliary sepsis in high-risk patients with complicating CBD disorders but does not increase other ERCP-associated morbidities. This trial is registered with the Chinese Clinical Trial Registry (registration identifier ChiCTR-OCH-14005134). PMID:27057161

  10. Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma

    PubMed Central

    Fonseca, Rafael; Siegel, David; Dimopoulos, Meletios A.; Špička, Ivan; Masszi, Tamás; Hájek, Roman; Rosiñol, Laura; Goranova-Marinova, Vesselina; Mihaylov, Georgi; Maisnar, Vladimír; Mateos, Maria-Victoria; Wang, Michael; Niesvizky, Ruben; Oriol, Albert; Jakubowiak, Andrzej; Minarik, Jiri; Palumbo, Antonio; Bensinger, William; Kukreti, Vishal; Ben-Yehuda, Dina; Stewart, A. Keith; Obreja, Mihaela; Moreau, Philippe

    2016-01-01

    The presence of certain high-risk cytogenetic abnormalities, such as translocations (4;14) and (14;16) and deletion (17p), are known to have a negative impact on survival in multiple myeloma (MM). The phase 3 study ASPIRE (N = 792) demonstrated that progression-free survival (PFS) was significantly improved with carfilzomib, lenalidomide, and dexamethasone (KRd), compared with lenalidomide and dexamethasone (Rd) in relapsed MM. This preplanned subgroup analysis of ASPIRE was conducted to evaluate KRd vs Rd by baseline cytogenetics according to fluorescence in situ hybridization. Of 417 patients with known cytogenetic risk status, 100 patients (24%) were categorized with high-risk cytogenetics (KRd, n = 48; Rd, n = 52) and 317 (76%) were categorized with standard-risk cytogenetics (KRd, n = 147; Rd, n = 170). For patients with high-risk cytogenetics, treatment with KRd resulted in a median PFS of 23.1 months, a 9-month improvement relative to treatment with Rd. For patients with standard-risk cytogenetics, treatment with KRd led to a 10-month improvement in median PFS vs Rd. The overall response rates for KRd vs Rd were 79.2% vs 59.6% (high-risk cytogenetics) and 91.2% vs 73.5% (standard-risk cytogenetics); approximately fivefold as many patients with high- or standard-risk cytogenetics achieved a complete response or better with KRd vs Rd (29.2% vs 5.8% and 38.1% vs 6.5%, respectively). KRd improved but did not abrogate the poor prognosis associated with high-risk cytogenetics. This regimen had a favorable benefit-risk profile in patients with relapsed MM, irrespective of cytogenetic risk status, and should be considered a standard of care in these patients. This trial was registered at www.clinicaltrials.gov as #NCT01080391. PMID:27439911

  11. Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma.

    PubMed

    Avet-Loiseau, Hervé; Fonseca, Rafael; Siegel, David; Dimopoulos, Meletios A; Špička, Ivan; Masszi, Tamás; Hájek, Roman; Rosiñol, Laura; Goranova-Marinova, Vesselina; Mihaylov, Georgi; Maisnar, Vladimír; Mateos, Maria-Victoria; Wang, Michael; Niesvizky, Ruben; Oriol, Albert; Jakubowiak, Andrzej; Minarik, Jiri; Palumbo, Antonio; Bensinger, William; Kukreti, Vishal; Ben-Yehuda, Dina; Stewart, A Keith; Obreja, Mihaela; Moreau, Philippe

    2016-09-01

    The presence of certain high-risk cytogenetic abnormalities, such as translocations (4;14) and (14;16) and deletion (17p), are known to have a negative impact on survival in multiple myeloma (MM). The phase 3 study ASPIRE (N = 792) demonstrated that progression-free survival (PFS) was significantly improved with carfilzomib, lenalidomide, and dexamethasone (KRd), compared with lenalidomide and dexamethasone (Rd) in relapsed MM. This preplanned subgroup analysis of ASPIRE was conducted to evaluate KRd vs Rd by baseline cytogenetics according to fluorescence in situ hybridization. Of 417 patients with known cytogenetic risk status, 100 patients (24%) were categorized with high-risk cytogenetics (KRd, n = 48; Rd, n = 52) and 317 (76%) were categorized with standard-risk cytogenetics (KRd, n = 147; Rd, n = 170). For patients with high-risk cytogenetics, treatment with KRd resulted in a median PFS of 23.1 months, a 9-month improvement relative to treatment with Rd. For patients with standard-risk cytogenetics, treatment with KRd led to a 10-month improvement in median PFS vs Rd. The overall response rates for KRd vs Rd were 79.2% vs 59.6% (high-risk cytogenetics) and 91.2% vs 73.5% (standard-risk cytogenetics); approximately fivefold as many patients with high- or standard-risk cytogenetics achieved a complete response or better with KRd vs Rd (29.2% vs 5.8% and 38.1% vs 6.5%, respectively). KRd improved but did not abrogate the poor prognosis associated with high-risk cytogenetics. This regimen had a favorable benefit-risk profile in patients with relapsed MM, irrespective of cytogenetic risk status, and should be considered a standard of care in these patients. This trial was registered at www.clinicaltrials.gov as #NCT01080391. PMID:27439911

  12. Promising Urinary Protein Biomarkers for the Early Detection of Hepatocellular Carcinoma among High-Risk Hepatitis C Virus Egyptian Patients.

    PubMed

    Abdalla, Moemen Ak; Haj-Ahmad, Yousef

    2012-01-01

    Hepatocellular Carcinoma is a major healthcare problem, representing the third most common cause of cancer-related mortality worldwide. There are 130 million Hepatitis C virus infected patients worldwide who are at a high-risk for developing Hepatocellular Carcinoma. Due to the fact that reliable parameters and/or tools for the early detection of Hepatocellular Carcinoma among high-risk individuals are severely lacking, Hepatocellular Carcinoma patients are always diagnosed at a late stage where surgical solutions or effective treatment are not possible. Urine was collected from 106 Hepatitis C infected patients patients, 32 of whom had already developed Hepatocellular Carcinoma and 74 patients who were diagnosed as Hepatocellular Carcinoma -free at the time of initial sample collection. In addition to these patients, urine samples were also collected from 12 healthy control individuals. Total urinary proteins were isolated from the urine samples and LC-MS/MS was used to identify potential protein HCC biomarker candidates. This was followed by validating relative expression levels of proteins present in urine among all the patients using quantitative real time-PCR. This approach revealed that significant over-expression of three proteins: DJ-1, Chromatin Assembly Factor-1 (CAF-1) and Heat Shock Protein 60 (HSP60), was a characteristic event among Hepatocellular Carcinoma - post Hepatitis C virus infected patients. As a single-based Hepatocellular Carcinoma biomarker, CAF-1 over-expression identified Hepatocellular Carcinoma among Hepatitis C virus infected patients with a specificity of 90%, sensitivity of 66% and with an overall diagnostic accuracy of 78%. Moreover, the CAF-1/HSP60 tandem identified Hepatocellular Carcinoma among Hepatitis C virus infected patients with a specificity of 92%, sensitivity of 61% and with an overall diagnostic accuracy of 77%. PMID:23074380

  13. Immunonutrition in the surgical patient.

    PubMed

    Marik, P E; Flemmer, M

    2012-03-01

    Both malnutrition and the physical injury related to trauma and surgery increase the expression of T-helper 2 (Th2) lymphocytes which cause impaired cell mediated immunity. Activation of the hypothalamic-pituitary-adrenal axis and sympathoadrenal system with the release of cortisol and catecholamines drive the development of Th2 cells. Th2 cytokines result in the accumulation of arginase-1 expressing myeloid-derived suppressor cells in lymphoid tissue. The myeloid-derived suppressor cells cause an arginine deficient state resulting in impaired lymphocyte function. Prostaglandin-E2 released following trauma plays a synergetic role with cortisol and catecholamines in driving these pathways. There is now increasing evidence that immunomodulating enteral formulas supplemented with arginine and omega-3 fatty acids can reverse many of the immune mediated changes and decrease the number of adverse outcomes after major surgery and trauma. These immunomodulating enteral formulas should be strongly considered in surgical patients undergoing major surgery and following severe trauma.

  14. Evaluation and treatment of high-risk patients with early-stage lung cancer.

    PubMed

    Mehta, Hiren J; Ross, Christopher; Silvestri, Gerard A; Decker, Roy H

    2011-12-01

    Standard therapy for early-stage non-small cell lung cancer is lobectomy for patients who are able to tolerate such surgery. However, the risk of postoperative morbidity is not trivial, with a 30% to 40% incidence of postoperative complications and a 1% to 5% incidence of operative mortality. Some patients, though technically resectable, refuse surgery or are considered medically inoperable because of insufficient respiratory reserve, cardiovascular disease, or general frailty. This group is considered either "high risk" or "medically inoperable."

  15. Nonoperative options for management of residual stones after cholecystostomy in high-risk patients

    NASA Astrophysics Data System (ADS)

    Reed, David M.; Daye, S. S.; Lincer, R. M.

    1993-05-01

    Cholecystostomy is frequently performed to obtain control of sepsis in high risk patients with acute cholecystitis. Retained stones in the gallbladder may cause future clinical problems. We present two patients with cholecystostomy tubes managed non-operatively. A review of other reported methods for stone extraction or destruction is also presented. Knowledge of safe and effective techniques for removal of these stones, using minimally invasive techniques is useful to the general surgeon.

  16. Preoperative Evaluation of the Surgical Patient.

    PubMed

    O'Donnell, Frederick T

    2016-01-01

    Primary care physicians and specialists are frequently involved in the care of surgical patients. Changes in reimbursement have prompted re-examination of preoperative testing and health care expenditures. Physicians have additional incentives to improve health care delivery and reduce costs. The perioperative surgical home concept involves coordinating all aspects of patient care, including behavioral modifications, during the perioperative period. Evidence-based guidelines on preoperative evaluation are available to assist practitioners in managing cardiovascular disease, and communicating surgical risks. Shared decision making in the preoperative period can improve surgical outcomes and patient satisfaction. PMID:27443045

  17. Thiazolidinediones and Cardiovascular Events In High-Risk Patients with Type-2 Diabetes Mellitus

    PubMed Central

    Shaya, Fadia T.; Lu, Zhiqiang; Sohn, Kyongsei; Weir, Matthew R.

    2009-01-01

    Context. The use of thiazolidinediones (TZDs) in patients with type-2 diabetes mellitus appears to be associated with an increased risk of myocardial infarction (MI) compared with placebo or other oral antidiabetic drug regimens. Objective. We conducted a study to investigate whether there was a difference in the risk of acute MI and hemorrhagic and non-hemorrhagic stroke between specific TZDs, namely rosiglitazone maleate (Avandia) and pioglitazone (Actos), and other oral antidiabetic agents in a high-risk, largely underrepresented and largely minority Medicaid population. Study Design, Setting, and Patients. We analyzed patient encounter data using propensity-scoring methods and logistic regression to compare the risk of cardiovascular (CV) events in patients with type-2 diabetes in a high-risk population. Main Outcome Measures. Outcomes were identified through International Classification of Disease (ICD-9) codes 410–411 for acute MI; 430–438 for stroke; and revenue (emergency department) codes 450–459 in the case of MI. Results. Using retrospective medical encounter and prescription data analyses, we found that rosiglitazone, compared with other oral antidiabetic agents, was associated with an increased rate of CV events by 20% in a high-risk cohort of diabetic patients. Neither pioglitazone nor the TZD drug class as a whole was associated with an increased CV risk. Conclusion. Rosiglitazone was associated with a significant increase in CV events (MI and stroke) among high-risk patients with type-2 diabetes, whereas pioglitazone was not. We recommend further research to capture risk factors that were not observed in our encounter data. PMID:20140111

  18. [Lipid control in high-risk patients: focus on PCSK9 inhibitors].

    PubMed

    Filardi, Pasquale Perrone; Paolillo, Stefania; Trimarco, Bruno

    2015-01-01

    Low-density lipoprotein (LDL)-cholesterol levels are strictly related to the risk of major cardiovascular events. Statins have been demonstrated to significantly reduce LDL-cholesterol levels, contributing to cardiovascular risk reduction especially in high-risk patients. However, low adherence to statins, due to adverse effects, is often observed and many patients in secondary prevention exhibit LDL-cholesterol levels >70 mg/dl. As a consequence, there is the need for new therapeutic approaches with different mechanisms of action to reach recommended lipid targets in high-risk patients. One potential approach is to inhibit PCSK9, a serum protein with an active role in controlling the expression of LDL receptors, by reducing their recycling and targeting it for lysosomal destruction. Monoclonal antibodies against PCSK9, in particular alirocumab and evolocumab, have been shown to reduce LDL substantially, either with or without concomitant statin therapy with good tolerability. Ongoing trials will further define the efficacy of these drugs as an emerging approach to the treatment of hypercholesterolemia in primary and secondary prevention of high-risk patients.

  19. [Lipid control in high-risk patients: focus on PCSK9 inhibitors].

    PubMed

    Filardi, Pasquale Perrone; Paolillo, Stefania; Trimarco, Bruno

    2015-01-01

    Low-density lipoprotein (LDL)-cholesterol levels are strictly related to the risk of major cardiovascular events. Statins have been demonstrated to significantly reduce LDL-cholesterol levels, contributing to cardiovascular risk reduction especially in high-risk patients. However, low adherence to statins, due to adverse effects, is often observed and many patients in secondary prevention exhibit LDL-cholesterol levels >70 mg/dl. As a consequence, there is the need for new therapeutic approaches with different mechanisms of action to reach recommended lipid targets in high-risk patients. One potential approach is to inhibit PCSK9, a serum protein with an active role in controlling the expression of LDL receptors, by reducing their recycling and targeting it for lysosomal destruction. Monoclonal antibodies against PCSK9, in particular alirocumab and evolocumab, have been shown to reduce LDL substantially, either with or without concomitant statin therapy with good tolerability. Ongoing trials will further define the efficacy of these drugs as an emerging approach to the treatment of hypercholesterolemia in primary and secondary prevention of high-risk patients. PMID:25689751

  20. Effective Dose of Ramosetron for Prophylaxis of Postoperative Nausea and Vomiting in High-Risk Patients

    PubMed Central

    Lee, Seongheon; Jeong, Sinho; Kim, Joungmin; Jeong, Seongwook

    2015-01-01

    Background. Postoperative nausea and vomiting (PONV) are common adverse events with an incidence of up to 80% in high-risk patients. Ramosetron, a selective 5-HT3 receptor antagonist, is widely used to prevent PONV. The purpose of this study was to evaluate the effective dose of ramosetron for the prevention of PONV in high-risk patients. Methods. Fifty-one patients were randomly allocated to 3 groups and were administered ramosetron 0.3 mg (group A), 0.45 mg (group B), or 0.6 mg (group C), at the end of their surgery. The episodes of PONV were assessed 1, 6, 24, and 48 hours after the injection and all the adverse events were observed. Results. The complete response rate in the postoperative period 6–24 hours after the anesthesia was higher in group C than in group A: 93% versus 44%. Group C's experience score of Rhodes index was lower than group A's: 0.81 ± 2.56 versus 3.94 ± 5.25. No adverse drug reaction could be observed in all groups. Conclusions. The effective dose of ramosetron to be injected for the near-complete prophylaxis of PONV 6 to 24 hours after surgery in high-risk patients is a 0.6 mg bolus injection at the end of the surgery. PMID:26258145

  1. Concurrent Androgen Deprivation Therapy During Salvage Prostate Radiotherapy Improves Treatment Outcomes in High-Risk Patients

    SciTech Connect

    Soto, Daniel E.; Passarelli, Michael N.; Daignault, Stephanie; Sandler, Howard M.

    2012-03-01

    Purpose: To determine whether concurrent androgen deprivation therapy (ADT) during salvage radiotherapy (RT) improves prostate cancer treatment outcomes. Methods and Materials: A total of 630 postprostatectomy patients were retrospectively identified who were treated with three-dimensional conformal RT. Of these, 441 were found to be treated for salvage indications. Biochemical failure was defined as prostate-specific antigen (PSA) of 0.2 ng/mL or greater above nadir with another PSA increase or the initiation of salvage ADT. Progression-free survival (PFS) was defined as the absence of biochemical failure, continued PSA rise despite salvage therapy, initiation of systemic therapy, clinical progression, or distant failure. Multivariate-adjusted Cox proportional hazards modeling was performed to determine which factors predict PFS. Results: Low-, intermediate-, and high-risk patients made up 10%, 24%, and 66% of patients, respectively. The mean RT dose was 68 Gy. Twenty-four percent of patients received concurrent ADT (cADT). Regional pelvic nodes were treated in 16% of patients. With a median follow-up of 3 years, the 3-year PFS was 4.0 years for cADT vs. 3.4 years for cADT patients (p = 0.22). Multivariate analysis showed that concurrent ADT (p = 0.05), Gleason score (p < 0.001), and pre-RT PSA (p = 0.03) were independent predictors of PFS. When patients were stratified by risk group, the benefits of cADT (hazard ratio, 0.65; p = 0.046) were significant only for high-risk patients. Conclusions: This retrospective study showed a PFS benefit of concurrent ADT during salvage prostate RT. This benefit was observed only in high-risk patients.

  2. Implementation of a follow-up telephone call process for patients at high risk for readmission.

    PubMed

    Miller, Danielle A; Schaper, Ana M

    2015-01-01

    This project included the development and implementation of a follow-up telephone call within 72 hours of discharge, targeting patients at high risk for readmission. The goal was to improve understanding of aftercare instructions and decrease readmissions. Clinical nurse leaders provided an intervention in 66% of patient contacts. Readmission rate within 7 days of discharge was significantly lower (P < .05), and the rate within 30 days of discharge trended lower (P = .053), in the clinical nurse leader contact group than in patients who were not contacted. PMID:24844916

  3. Predicting patients with high risk of becoming high-cost healthcare users in Ontario (Canada).

    PubMed

    Chechulin, Yuriy; Nazerian, Amir; Rais, Saad; Malikov, Kamil

    2014-02-01

    Literature and original analysis of healthcare costs have shown that a small proportion of patients consume the majority of healthcare resources. A proactive approach is to target interventions towards those patients who are at risk of becoming high-cost users (HCUs). This approach requires identifying high-risk patients accurately before substantial avoidable costs have been incurred and health status has deteriorated further. We developed a predictive model to identify patients at risk of becoming HCUs in Ontario. HCUs were defined as the top 5% of patients incurring the highest costs. Information was collected on various demographic and utilization characteristics. The modelling technique used was logistic regression. If the top 5% of patients at risk of becoming HCUs are followed, the sensitivity is 42.2% and specificity is 97%. Alternatives for implementation of the model include collaboration between different levels of healthcare services for personalized healthcare interventions and interventions addressing needs of patient cohorts with high-cost conditions. PMID:24726075

  4. Lack of GNAQ germline mutations in uveal melanoma patients with high risk for hereditary cancer predisposition.

    PubMed

    Abdel-Rahman, Mohamed H; Pilarski, Robert; Massengill, James B; Christopher, Benjamin B; Davidorf, Frederick H

    2011-06-01

    A high frequency of somatic mutation in GNAQ has been reported in uveal melanoma (UM). GNAQ is located in the chromosomal band 9q21, the same chromosomal band that harbors a putative candidate gene for hereditary UM. We investigated the frequency of germline sequence alterations in the GNAQ gene in UM patients with increased predisposition to hereditary cancer. A total of 44 high risk UM patients were studied including three patients with a family history of UM, 15 patients with a family history of cutaneous melanoma (CM), three patients with early age at onset of their UM (<30 years) and 23 patients with strong family history of cancer and/or personal history of multiple primary tumors. Mutational screening of the seven exons of GNAQ and nearby intronic sequence was carried out by direct sequencing. We identified two deep intronic variants but no potential pathogenic mutations in GNAQ. Our results exclude GNAQ as a candidate gene in UM patients with a high risk for hereditary cancer predisposition.

  5. Audit of co-management and critical care outreach for high risk postoperative patients (The POST audit).

    PubMed

    Story, D A; Shelton, A; Jones, D; Heland, M; Belomo, R

    2013-11-01

    Co-management and critical care outreach for high risk surgical patients have been proposed to decrease postoperative complications and mortality. We proposed that a clinical project with postoperative comanagement and critical care outreach, the Post Operative Surveillance Team: (POST), would be associated with decreased hospital length of stay. We conducted a retrospective before (control group) and after (POST group) audit of this hospital program. POST was staffed for four months in 2010 by two intensive care nurses and two senior registrars who conducted daily ward rounds for the first five postoperative days on high risk patients undergoing inpatient general or urological surgery. The primary endpoint was length of hospital stay and secondary endpoints were Medical Emergency Team (MET) calls, cardiac arrests and in-hospital mortality. There were 194 patients in the POST group and 1,185 in the control group. The length of stay in the POST group, median nine days (Inter-quartile range [IQR]: 5 to 17 days), was longer than the control group, median seven days (IQR: 4 to 13 days): difference two days longer (95.0% confidence interval [95.0% CI]: 1 to 3 days longer, P <0.001). There were no important differences in the proportion of patients having MET calls (16.0% POST versus. 13% control (P=0.25)) or mortality (2.1% POST versus 2.8% Control (P=0.82)). Our audit found that the POST service was not associated with reduced length of stay. Models of co-management, different to POST, or with different performance metrics, could be tested.

  6. Likelihood of Bone Recurrence in Prior Sites of Metastasis in Patients With High-Risk Neuroblastoma

    SciTech Connect

    Polishchuk, Alexei L.; Li, Richard; Little, Anthony; Hawkins, Randall A.; Hamilton, Jeffrey; Lau, Michael; Tran, Hung Chi; Lemons, Richard S.; Matthay, Katherine K.; DuBois, Steven G.; and others

    2014-07-15

    Purpose/Objectives: Despite recent improvements in outcomes, 40% of children with high-risk neuroblastoma will experience relapse, facing a guarded prognosis for long-term cure. Whether recurrences are at new sites or sites of original disease may guide decision making during initial therapy. Methods and Materials: Eligible patients were retrospectively identified from institutional databases at first metastatic relapse of high-risk neuroblastoma. Included patients had disease involving metaiodobenzylguanidine (MIBG)-avid metastatic sites at diagnosis and first relapse, achieved a complete or partial response with no more than one residual MIBG-avid site before first relapse, and received no total body irradiation or therapy with {sup 131}I-MIBG before first relapse. Anatomically defined metastatic sites were tracked from diagnosis through first relapse to determine tendency of disease to recur at previously involved versus uninvolved sites and to assess whether this pattern was influenced by site irradiation. Results: Of 159 MIBG-avid metastatic sites identified among 43 patients at first relapse, 131 (82.4%) overlapped anatomically with the set of 525 sites present at diagnosis. This distribution was similar for bone sites, but patterns of relapse were more varied for the smaller subset of soft tissue metastases. Among all metastatic sites at diagnosis in our subsequently relapsed patient cohort, only 3 of 19 irradiated sites (15.8%) recurred as compared with 128 of 506 (25.3%) unirradiated sites. Conclusions: Metastatic bone relapse in neuroblastoma usually occurs at anatomic sites of previous disease. Metastatic sites identified at diagnosis that did not receive radiation during frontline therapy appeared to have a higher risk of involvement at first relapse relative to previously irradiated metastatic sites. These observations support the current paradigm of irradiating metastases that persist after induction chemotherapy in high-risk patients. Furthermore

  7. Management of a high risk epileptic patient under conscious sedation: A multidisciplinary approach

    PubMed Central

    Chellathurai, Burnice Nalina Kumari; Thiagarajan, Ramakrishnan; Jayakumaran, SelvaKumar; Devadoss, Pradeep; Elavazhagan

    2016-01-01

    Epilepsy, characterized by the risk of recurrent seizures, is a chronic disease that afflicts about 5% of the world's population. The main dental problems associated with epileptic patients include gingival hyperplasia, minor oral injuries, tooth trauma, and prosthodontic problems, which require the dental treatment. Stress and fear are the most common triggering factors for the epilepsy in dental chair. Therefore, a more appropriate method of treating such epileptic patients may be warranted. Conscious sedation is a technique of providing good anesthesia and analgesia to patients, the main advantage of which is the patient's rapid return to presentation levels. Midazolam used as a sedative agent has anticonvulsant properties. This case report highlights a case requiring multiple dental procedures carried out in a high risk epileptic patient under conscious sedation. PMID:27041847

  8. Risk Factors for Urinary Tract Infections in Cardiac Surgical Patients

    PubMed Central

    Gillen, Jacob R.; Isbell, James M.; Michaels, Alex D.; Lau, Christine L.

    2015-01-01

    Abstract Background: Risk factors for catheter-associated urinary tract infections (CAUTIs) in patients undergoing non-cardiac surgical procedures have been well documented. However, the variables associated with CAUTIs in the cardiac surgical population have not been clearly defined. Therefore, the purpose of this study was to investigate risk factors associated with CAUTIs in patients undergoing cardiac procedures. Methods: All patients undergoing cardiac surgery at a single institution from 2006 through 2012 (4,883 patients) were reviewed. Patients with U.S. Centers for Disease Control (CDC) criteria for CAUTI were identified from the hospital's Quality Assessment database. Pre-operative, operative, and post-operative patient factors were evaluated. Univariate and multivariable analyses were used to identify significant correlations between perioperative characteristics and CAUTIs. Results: There were 55 (1.1%) documented CAUTIs in the study population. On univariate analysis, older age, female gender, diabetes mellitus, cardiogenic shock, urgent or emergent operation, packed red blood cell (PRBC) units transfused, and intensive care unit length of stay (ICU LOS) were all significantly associated with CAUTI [p<0.05]. On multivariable logistic regression, older age, female gender, diabetes mellitus, and ICU LOS remained significantly associated with CAUTI. Additionally, there was a significant association between CAUTI and 30-d mortality on univariate analysis. However, when controlling for common predictors of operative mortality on multivariable analysis, CAUTI was no longer associated with mortality. Conclusions: There are several identifiable risk factors for CAUTI in patients undergoing cardiac procedures. CAUTI is not independently associated with increased mortality, but it does serve as a marker of sicker patients more likely to die from other comorbidities or complications. Therefore, awareness of the high-risk nature of these patients should lead to

  9. Perfecting patient flow in the surgical setting.

    PubMed

    Amato-Vealey, Elaine J; Fountain, Patricia; Coppola, Deborah

    2012-07-01

    Reduced surgical efficiency and productivity, delayed patient discharges, and prolonged use of hospital resources are the results of an OR that is unable to move patients to the postanesthesia care unit or other patient units. A primary reason for perioperative patient flow delay is the lack of hospital beds to accommodate surgical patients, which consequently causes backups of patients currently in the surgical suite. In one facility, implementing Six Sigma methodology helped to improve OR patient flow by identifying ways that frontline staff members could work more intelligently and more efficiently, and with less stress to streamline workflow and eliminate redundancy and waste in ways that did not necessitate reducing the number of employees. The results were improved employee morale, job satisfaction and safety, and an enhanced patient experience.

  10. Synthetic ACTH in High Risk Patients with Idiopathic Membranous Nephropathy: A Prospective, Open Label Cohort Study

    PubMed Central

    van de Logt, Anne-Els; Beerenhout, Charles H.; Brink, Hans S.; van de Kerkhof, Jos J.; Wetzels, Jack F.; Hofstra, Julia M.

    2015-01-01

    New therapeutic agents are warranted in idiopathic membranous nephropathy. Synthetic ACTH may be advantageous with reported remission rates up to 85% and few side effects. We conducted a prospective open label cohort study from 2008 till 2010 (NCT00694863). We prospectively selected patients with idiopathic membranous nephropathy and high risk for progression (defined as βeta-2-microglobulin (β2m) excretion of >500 ng/min). For comparison, we selected matched historical controls treated with cyclophosphamide. The prospectively selected patients received intramuscular injections of synthetic ACTH during 9 months (maximal dose 1 mg twice a week). The primary endpoints concerned the feasibility and incidence of remissions as a primary event. Secondary endpoints included side effects of treatment and the incidence of remissions and relapses at long-term follow-up. Twenty patients (15 men) were included (age 54±14 years, serum creatinine 104 μmol/l [IQR 90–113], urine protein:creatinine ratio 8.7 g/10 mmol creatinine [IQR 4.3–11.1]). Seventeen patients (85%) completed treatment. 97% of injections were administered correctly. Cumulative remission rate was 55% (complete remission in 4 patients, partial remission 7 patients). In a group of historical controls treated with cyclophosphamide and steroids, 19 of 20 patients (95%) developed a remission (complete remission in 13 patients, partial remission in 6 patients) (p<0.01). The main limitation of our study is its small size and the use of a historical control group. We show that treatment with intramuscular injections of synthetic ACTH is feasible. Our data suggest that synthetic ACTH is less effective than cyclophosphamide in inducing a remission in high risk patients with idiopathic membranous nephropathy. The use of synthetic ACTH was also associated with many adverse events. Therefore, we advise against synthetic ACTH as standard treatment in membranous nephropathy. Trial Registration ClinicalTrials.gov NCT

  11. Pragmatic fluid optimization in high-risk surgery patients: when pragmatism dilutes the benefits.

    PubMed

    Reuter, Daniel A

    2012-01-31

    There is increasing evidence that hemodynamic optimization by fluid loading, particularly when performed in the early phase of surgery, is beneficial in high-risk surgery patients: it leads to a reduction in postoperative complications and even to improved long-term outcome. However, it is also true that goal- directed strategies of fluid optimization focusing on cardiac output optimization have not been applied in the clinical routine of many institutions. Reasons are manifold: disbelief in the level of evidence and on the accuracy and practicability of the required monitoring systems, and economics. The FOCCUS trial examined perioperative fluid optimization with a very basic approach: a standardized volume load with 25 ml/kg crystalloids over 6 hours immediately prior to scheduled surgery in high-risk patients. The hypothesis was that this intervention would lead to a compensation of preoperative fluid deficit caused by overnight fasting, and would result in improved perioperative fluid homeostasis with less postoperative complications and earlier hospital discharge. However, the primary study endpoints did not improve significantly. This observation points towards the facts that: firstly, the differentiation between interstitial fluid deficit caused by fasting and intravascular volume loss due to acute blood loss must be recognized in treatment strategies; secondly, the type of fluid replacement may play an important role; and thirdly, protocolized treatment strategies should also always be tailored to suit the patients' individual needs in every individual clinical situation.

  12. Nursing Strategies to Support Family Members of ICU Patients at High Risk of Dying

    PubMed Central

    Adams, Judith A.; Anderson, Ruth A.; Docherty, Sharron L.; Tulsky, James A.; Steinhauser, Karen E.; Bailey, Donald E.

    2014-01-01

    Objectives: To explore how family members of ICU patients at high risk of dying respond to nursing communication strategies. Background: Family members of ICU patients may face difficult decisions. Nurses are in a position to provide support. Evidence of specific strategies that nurses use to support decision-making and how family members respond to these strategies is lacking. Methods: This is a prospective, qualitative descriptive study involving the family members of ICU patients identified as being at high risk of dying. Results: Family members described five nursing approaches: Demonstrating concern, building rapport, demonstrating professionalism, providing factual information, and supporting decision-making. This study provides evidence that when using these approaches, nurses helped family members to cope; to have hope, confidence, and trust; to prepare for and accept impending death; and to make decisions. Conclusion: Knowledge lays a foundation for interventions targeting the areas important to family members and most likely to improve their ability to make decisions and their well-being. PMID:24655938

  13. The myocardial protective effect of dexmedetomidine in high-risk patients undergoing aortic vascular surgery

    PubMed Central

    Soliman, Rabie; Zohry, Gomaa

    2016-01-01

    Objective: The aim of the study was to assess the effect of dexmedetomidine in high-risk patients undergoing aortic vascular surgery. Design: A randomized prospective study. Setting: Cairo University, Egypt. Materials and Methods: The study included 150 patients undergoing aortic vascular surgery. Intervention: The patients were classified into two groups (n = 75). Group D: The patients received a loading dose of 1 μg/kg dexmedetomidine over 15 min before induction and maintained as an infusion of 0.3 μg/kg/h to the end of the procedure. Group C: The patients received an equal volume of normal saline. The medication was prepared by the nursing staff and given to anesthetist blindly. Measurements: The monitors included the heart rate, mean arterial blood pressure, central venous pressure, electrocardiogram (ECG), serum troponin I level, end-tidal sevoflurane, and total dose of morphine in addition transthoracic echocardiography to the postoperative in cases with elevated serum troponin I level. Main Results: The dexmedetomidine decreased heart rate and minimized the changes in blood pressure compared to control group (P < 0.05). Furthermore, it decreased the incidence of myocardial ischemia reflected by troponin I level, ECG changes, and the development of new regional wall motion abnormalities (P < 0.05). Dexmedetomidine decreased the requirement for nitroglycerin and norepinephrine compared to control group (P < 0.05). The incidence of hypotension and bradycardia was significantly higher with dexmedetomidine (P < 0.05). Conclusion: The dexmedetomidine is safe and effective in patients undergoing aortic vascular surgery. It decreases the changes in heart rate and blood pressure during the procedures. It provides cardiac protection in high-risk patients reflected by decreasing the incidence of myocardial ischemia and serum level of troponin. The main side effects of dexmedetomidine were hypotension and bradycardia. PMID:27716690

  14. Intertrochanteric fractures in elderly high risk patients treated with Ender nails and compression screw

    PubMed Central

    Gangadharan, Sidhartha; Nambiar, MR

    2010-01-01

    Background: Ender and Simon Weidner popularized the concept of closed condylocephlic nailing for intertrochanteric fractures in 1970. The clinical experience of authors revealed that Ender nailing alone cannot provide secure fixation in elderly patients with osteoporosis. Hence we conducted a study to evaluate the efficacy of a combined fixation procedure using Ender nails and a cannulated compression screw for intertrochanteric fractures. Materials and Methods: 76 patients with intertrochanteric fractures were treated using intramedullary Ender nails and cannulated compression screw from January 2004 to December 2007. The mean age of the patients was 80 years (range 70-105 years).Using the Evan’s system of classification 49 were stable and 27 unstable fractures. Inclusion criteria was high risk elderly patients (age > 70 years) with intertrochanteric fracture. The exclusion criteria included patients with pressure sores over the trochanteric region. Many patients had pre-existing co-morbidities like diabetes mellitus, hypertension, COPD, ischemic heart disease, CVA and coronary artery bypass surgery. The two Ender nails of 4.5mm each were passed across the fracture site into the proximal neck. This was reinforced with a 6.5 mm cannulated compression screw passed from the sub trochanteric region, across the fracture into the head. Results: The mean follow-up was 14 months (range 9-19 months) Average time to fracture union was 10 weeks (range 6-16 weeks). The mean knee ROM was 130° (± 5°). There was no case of nail penetration into hip joint. In five cases with advanced osteoporosis there was minimal migration of Ender nails distally. Conclusions: The Ender nailing combined with compression screw fixation in cases of intertrochanteric fractures in high risk elderly patients could achieve reliable fracture stability with minimal complications. PMID:20697482

  15. A double mobility acetabular implant for primary hip arthroplasty in patients at high risk of dislocation

    PubMed Central

    Middleton, RG; Young, P; Uzoigwe, C; Barkham, B; Yusoff, S; Minhas, THA

    2014-01-01

    Introduction Dislocation following total hip replacement continues to be a problem for which no completely satisfactory solution has been found. Several methods have been proposed to reduce the incidence of hip dislocations with varying degrees of success, including elevated rim liners, constrained liners and large diameter bearings. We present our experience with the double mobility acetabular component in patients at high risk of instability. Methods This was a retrospective review of 65 primary total hip arthroplasties in 55 patients (15 men, 40 women), performed between October 2005 and November 2009. The majority (80%) of patients had at least two and 26% had at least three risk factors for instability. The mean age was 76 years (range: 44–92 years). The patients were followed up for a mean duration of 60 months (range: 36–85 months). Results Fourteen patients died and one was lost to follow-up, leaving fifty hips for final assessment. Until the final follow-up appointment, no patients had dislocation and none required revision surgery. The mean Oxford hip score improved from 45.0 to 26.5 (p<0.0001). The mean Merle d’Aubigné pain score improved from 1.4 to 4.9 (p<0.0001), the walking score from 2.3 to 3.1 (p<0.07) and the absolute hip function score from 5.4 to 10.8 (p<0.0001). There were no clinical or radiographic signs of loosening. Conclusions The double mobility acetabular component was successful at preventing dislocation during early to medium-term follow-up. However, as data are still lacking with regard to polyethylene wear rates at the additional bearing surface, it would be prudent to restrict the use of this implant to selected patients at high risk of instability. PMID:25350182

  16. Retroperitoneal Sarcoma (RPS) High Risk Gross Tumor Volume Boost (HR GTV Boost) Contour Delineation Agreement Among NRG Sarcoma Radiation and Surgical Oncologists

    PubMed Central

    Baldini, Elizabeth H.; Bosch, Walter; Kane, John M.; Abrams, Ross A.; Salerno, Kilian E.; Deville, Curtiland; Raut, Chandrajit P.; Petersen, Ivy A.; Chen, Yen-Lin; Mullen, John T.; Millikan, Keith W.; Karakousis, Giorgos; Kendrick, Michael L.; DeLaney, Thomas F.; Wang, Dian

    2015-01-01

    Purpose Curative intent management of retroperitoneal sarcoma (RPS) requires gross total resection. Preoperative radiotherapy (RT) often is used as an adjuvant to surgery, but recurrence rates remain high. To enhance RT efficacy with acceptable tolerance, there is interest in delivering “boost doses” of RT to high-risk areas of gross tumor volume (HR GTV) judged to be at risk for positive resection margins. We sought to evaluate variability in HR GTV boost target volume delineation among collaborating sarcoma radiation and surgical oncologist teams. Methods Radiation planning CT scans for three cases of RPS were distributed to seven paired radiation and surgical oncologist teams at six institutions. Teams contoured HR GTV boost volumes for each case. Analysis of contour agreement was performed using the simultaneous truth and performance level estimation (STAPLE) algorithm and kappa statistics. Results HRGTV boost volume contour agreement between the seven teams was “substantial” or “moderate” for all cases. Agreement was best on the torso wall posteriorly (abutting posterior chest abdominal wall) and medially (abutting ipsilateral para-vertebral space and great vessels). Contours varied more significantly abutting visceral organs due to differing surgical opinions regarding planned partial organ resection. Conclusions Agreement of RPS HRGTV boost volumes between sarcoma radiation and surgical oncologist teams was substantial to moderate. Differences were most striking in regions abutting visceral organs, highlighting the importance of collaboration between the radiation and surgical oncologist for “individualized” target delineation on the basis of areas deemed at risk and planned resection. PMID:26018727

  17. Rhabdomyolysis in Critically Ill Surgical Patients

    PubMed Central

    Kuzmanovska, Biljana; Cvetkovska, Emilija; Kuzmanovski, Igor; Jankulovski, Nikola; Shosholcheva, Mirjana; Kartalov, Andrijan; Spirovska, Tatjana

    2016-01-01

    Introduction: Rhabdomyolysis is a syndrome of injury of skeletal muscles associated with myoglobinuria, muscle weakness, electrolyte imbalance and often, acute kidney injury as severe complication. The aim: of this study is to detect the incidence of rhabdomyolysis in critically ill patients in the surgical intensive care unit (ICU), and to raise awareness of this medical condition and its treatment among the clinicians. Material and methods: A retrospective review of all surgical and trauma patients admitted to surgical ICU of the University Surgical Clinic “Mother Teresa” in Skopje, Macedonia, from January 1st till December 31st 2015 was performed. Patients medical records were screened for available serum creatine kinase (CK) with levels > 200 U/l, presence of myoglobin in the serum in levels > 80 ng/ml, or if they had a clinical diagnosis of rhabdomyolysis by an attending doctor. Descriptive statistical methods were used to analyze the collected data. Results: Out of totally 1084 patients hospitalized in the ICU, 93 were diagnosed with rhabdomyolysis during the course of one year. 82(88%) patients were trauma patients, while 11(12%) were surgical non trauma patients. 7(7.5%) patients diagnosed with rhabdomyolysis developed acute kidney injury (AKI) that required dialysis. Average values of serum myoglobin levels were 230 ng/ml, with highest values of > 5000 ng/ml. Patients who developed AKI had serum myoglobin levels above 2000 ng/ml. Average values of serum CK levels were 400 U/l, with highest value of 21600 U/l. Patients who developed AKI had serum CK levels above 3000 U/l. Conclusion: Regular monitoring and early detection of elevated serum CK and myoglobin levels in critically ill surgical and trauma patients is recommended in order to recognize and treat rhabdomyolysis in timely manner and thus prevent development of AKI. PMID:27703296

  18. Selective use of post-mastectomy flap irradiation in high-risk breast cancer patients.

    PubMed

    Asgeirsson, Kristjan S; Holroyd, Ben; Morgan, David A L; Robertson, John F R; Blamey, Roger W; Pinder, Sarah E; Macmillan, R Douglas

    2005-08-01

    The incidence of local recurrence after mastectomy can be reduced by chest wall radiotherapy. However, only a minority of patients are at substantial risk. No UK national guidelines exist for the use of mastectomy flap radiotherapy. This study evaluated a protocol, whereby only high-risk patients were treated with post-mastectomy flap radiotherapy; identified histologically by grade, vascular invasion and nodal status. All women treated by simple mastectomy for invasive breast cancer at the Nottingham Breast Unit from January 1993 to December 1995 were studied (n=292). Postoperative flap radiotherapy was given to 147 high-risk women (50.3%). Median follow-up was 76 months. Overall, 12 women (4.1%) developed a chest wall recurrence; six were single spot recurrences and the remaining six were either multiple spot (n=3) or field change (field change dermal invasion, n=3). The chest wall recurrence rate was 2.7% in those treated with radiotherapy. A low rate of local recurrence has been achieved with selective use of mastectomy flap radiotherapy.

  19. Vulnerable Blood in High Risk Vascular Patients: Study Design and Methods

    PubMed Central

    McDermott, Mary M.; Greenland, Philip; Liu, Kiang; Tian, Lu; Green, David; Shah, Sanjiv J.; Huffman, Mark; Wilkins, John; Kibbe, Melina; Liao, Yihua; Huang, Chiang-Ching; Skelly, Christopher; Jacobs, Chad; McCarthy, Walter; Auerbach, Amanda; Lloyd-Jones, Donald

    2014-01-01

    BACKGROUND Basic research suggests that rapid increases in circulating inflammatory and hemostatic blood markers may trigger or indicate impending plaque rupture and coronary thrombosis, resulting in acute ischemic heart disease (IHD) events. However, these associations are not established in humans. METHODS AND RESULTS The Biomarker Risk Assessment in Vulnerable Outpatients (BRAVO) Study will determine whether levels of inflammatory and hemostatic biomarkers rapidly increase during the weeks prior to an acute IHD event in people with lower extremity peripheral artery disease (PAD). The BRAVO Study will determine whether biomarker levels measured immediately prior to an IHD event are higher than levels not preceding an IHD event; whether participants who experience an IHD event (cases) have higher biomarker levels immediately prior to the event and higher biomarker levels at each time point leading up to the IHD event than participants without an IHD event (controls); and whether case participants have greater increases in biomarkers during the months leading up to the event than controls. BRAVO enrolled 595 patients with PAD, a population at high risk for acute IHD events. After a baseline visit, participants returned every two months for blood collection, underwent an electrocardiogram to identify new silent myocardial infarctions, and were queried about new hospitalizations since their prior study visit. Mortality data were also collected. Participants were followed prospectively for up to three years. CONCLUSIONS BRAVO results will provide important information about the pathophysiology of IHD events and may lead to improved therapies for preventing IHD events in high-risk patients. PMID:24721480

  20. Clinical and psychological telemonitoring and telecare of high risk heart failure patients.

    PubMed

    Villani, Alessandra; Malfatto, Gabriella; Compare, Angelo; Della Rosa, Francesco; Bellardita, Lara; Branzi, Giovanna; Molinari, Enrico; Parati, Gianfranco

    2014-12-01

    We conducted a trial of telemonitoring and telecare for patients with chronic heart failure leaving hospital after being treated for clinical instability. Eighty patients were randomized before hospital discharge to a usual care group (n=40: follow-up at the outpatient clinic) or to an integrated management group (n=40: patients learned to use a handheld PDA and kept in touch daily with the monitoring centre). At enrolment, the groups were similar for all clinical variables. At one-year follow-up, integrated management patients showed better adherence, reduced anxiety and depression, and lower NYHA class and plasma levels of BNP with respect to the usual care patients (e.g. NYHA class 2.1 vs 2.4, P<0.02). Mortality and hospital re-admissions for congestive heart failure were also reduced in integrated management patients (P<0.05). Integrated management was more expensive than usual care, although the cost of adverse events was 42% lower. In heart failure patients at high risk of relapse, the regular acquisition of simple clinical information and the possibility for the patient to contact the clinical staff improved drug titration, produced better psychological status and quality of life, and reduced hospitalizations for heart failure. PMID:25339632

  1. Next-generation personalised medicine for high-risk paediatric cancer patients - The INFORM pilot study.

    PubMed

    Worst, Barbara C; van Tilburg, Cornelis M; Balasubramanian, Gnana Prakash; Fiesel, Petra; Witt, Ruth; Freitag, Angelika; Boudalil, Miream; Previti, Christopher; Wolf, Stephan; Schmidt, Sabine; Chotewutmontri, Sasithorn; Bewerunge-Hudler, Melanie; Schick, Matthias; Schlesner, Matthias; Hutter, Barbara; Taylor, Lenka; Borst, Tobias; Sutter, Christian; Bartram, Claus R; Milde, Till; Pfaff, Elke; Kulozik, Andreas E; von Stackelberg, Arend; Meisel, Roland; Borkhardt, Arndt; Reinhardt, Dirk; Klusmann, Jan-Henning; Fleischhack, Gudrun; Tippelt, Stephan; Dirksen, Uta; Jürgens, Heribert; Kramm, Christof M; von Bueren, Andre O; Westermann, Frank; Fischer, Matthias; Burkhardt, Birgit; Wößmann, Wilhelm; Nathrath, Michaela; Bielack, Stefan S; Frühwald, Michael C; Fulda, Simone; Klingebiel, Thomas; Koscielniak, Ewa; Schwab, Matthias; Tremmel, Roman; Driever, Pablo Hernáiz; Schulte, Johannes H; Brors, Benedikt; von Deimling, Andreas; Lichter, Peter; Eggert, Angelika; Capper, David; Pfister, Stefan M; Jones, David T W; Witt, Olaf

    2016-09-01

    The 'Individualized Therapy for Relapsed Malignancies in Childhood' (INFORM) precision medicine study is a nationwide German program for children with high-risk relapsed/refractory malignancies, which aims to identify therapeutic targets on an individualised basis. In a pilot phase, reported here, we developed the logistical and analytical pipelines necessary for rapid and comprehensive molecular profiling in a clinical setting. Fifty-seven patients from 20 centers were prospectively recruited. Malignancies investigated included sarcomas (n = 25), brain tumours (n = 23), and others (n = 9). Whole-exome, low-coverage whole-genome, and RNA sequencing were complemented with methylation and expression microarray analyses. Alterations were assessed for potential targetability according to a customised prioritisation algorithm and subsequently discussed in an interdisciplinary molecular tumour board. Next-generation sequencing data were generated for 52 patients, with the full analysis possible in 46 of 52. Turnaround time from sample receipt until first report averaged 28 d. Twenty-six patients (50%) harbored a potentially druggable alteration with a prioritisation score of 'intermediate' or higher (level 4 of 7). Common targets included receptor tyrosine kinases, phosphoinositide 3-kinase-mammalian target of rapamycin pathway, mitogen-activated protein kinase pathway, and cell cycle control. Ten patients received a targeted therapy based on these findings, with responses observed in some previously treatment-refractory tumours. Comparative primary relapse analysis revealed substantial tumour evolution as well as one case of unsuspected secondary malignancy, highlighting the importance of re-biopsy at relapse. This study demonstrates the feasibility of comprehensive, real-time molecular profiling for high-risk paediatric cancer patients. This extended proof-of-concept, with examples of treatment consequences, expands upon previous personalised oncology endeavors

  2. Next-generation personalised medicine for high-risk paediatric cancer patients - The INFORM pilot study.

    PubMed

    Worst, Barbara C; van Tilburg, Cornelis M; Balasubramanian, Gnana Prakash; Fiesel, Petra; Witt, Ruth; Freitag, Angelika; Boudalil, Miream; Previti, Christopher; Wolf, Stephan; Schmidt, Sabine; Chotewutmontri, Sasithorn; Bewerunge-Hudler, Melanie; Schick, Matthias; Schlesner, Matthias; Hutter, Barbara; Taylor, Lenka; Borst, Tobias; Sutter, Christian; Bartram, Claus R; Milde, Till; Pfaff, Elke; Kulozik, Andreas E; von Stackelberg, Arend; Meisel, Roland; Borkhardt, Arndt; Reinhardt, Dirk; Klusmann, Jan-Henning; Fleischhack, Gudrun; Tippelt, Stephan; Dirksen, Uta; Jürgens, Heribert; Kramm, Christof M; von Bueren, Andre O; Westermann, Frank; Fischer, Matthias; Burkhardt, Birgit; Wößmann, Wilhelm; Nathrath, Michaela; Bielack, Stefan S; Frühwald, Michael C; Fulda, Simone; Klingebiel, Thomas; Koscielniak, Ewa; Schwab, Matthias; Tremmel, Roman; Driever, Pablo Hernáiz; Schulte, Johannes H; Brors, Benedikt; von Deimling, Andreas; Lichter, Peter; Eggert, Angelika; Capper, David; Pfister, Stefan M; Jones, David T W; Witt, Olaf

    2016-09-01

    The 'Individualized Therapy for Relapsed Malignancies in Childhood' (INFORM) precision medicine study is a nationwide German program for children with high-risk relapsed/refractory malignancies, which aims to identify therapeutic targets on an individualised basis. In a pilot phase, reported here, we developed the logistical and analytical pipelines necessary for rapid and comprehensive molecular profiling in a clinical setting. Fifty-seven patients from 20 centers were prospectively recruited. Malignancies investigated included sarcomas (n = 25), brain tumours (n = 23), and others (n = 9). Whole-exome, low-coverage whole-genome, and RNA sequencing were complemented with methylation and expression microarray analyses. Alterations were assessed for potential targetability according to a customised prioritisation algorithm and subsequently discussed in an interdisciplinary molecular tumour board. Next-generation sequencing data were generated for 52 patients, with the full analysis possible in 46 of 52. Turnaround time from sample receipt until first report averaged 28 d. Twenty-six patients (50%) harbored a potentially druggable alteration with a prioritisation score of 'intermediate' or higher (level 4 of 7). Common targets included receptor tyrosine kinases, phosphoinositide 3-kinase-mammalian target of rapamycin pathway, mitogen-activated protein kinase pathway, and cell cycle control. Ten patients received a targeted therapy based on these findings, with responses observed in some previously treatment-refractory tumours. Comparative primary relapse analysis revealed substantial tumour evolution as well as one case of unsuspected secondary malignancy, highlighting the importance of re-biopsy at relapse. This study demonstrates the feasibility of comprehensive, real-time molecular profiling for high-risk paediatric cancer patients. This extended proof-of-concept, with examples of treatment consequences, expands upon previous personalised oncology endeavors

  3. Off-pump myocardial revascularization in a high-risk patient with essential thrombocythemia.

    PubMed

    Darwazah, Ahmad K; Madi, Hamad; Zagha, Rami; Hawash, Yahia

    2014-10-01

    Essential thrombocythemia is a rare type of myeloproliferative disorder. Cerebral, myocardial, and peripheral thrombosis are all frequent complications of the disease. A 71-year-old man presented with severe coronary artery disease, associated with cerebral vascular ischemic changes and erythromelalgia. His platelet count was 1,486 ×10(3)/μL. The patient underwent successful myocardial revascularization by means of an off-pump technique after his platelet count had been reduced by hydroxycarbamide administration. We conclude that the use of off-pump cardiopulmonary bypass in high-risk patients with essential thrombocythemia is safe. Reducing platelet count via the administration of hydroxycarbamide and the careful balancing of antiplatelets and anticoagulants is crucial in determining the outcome of surgery. PMID:25425991

  4. Barotrauma-induced pneumocephalus experienced by a high risk patient after commercial air travel.

    PubMed

    Huh, Jisoon

    2013-08-01

    A 49-year-old female with a history of several neurosurgical and otolaryngologic procedures for occipital meningioma and cerebrospinal fluid leaks was diagnosed with pneumocephalus after a one hour flight on a domestic jet airliner. Despite multiple operations, the air appeared to enter the cranium through a weak portion of the skull base due to the low atmospheric pressure in the cabin. The intracranial air was absorbed with conservative management. The patient was recommended not to fly before a definite diagnostic work up and a sealing procedure for the cerebrospinal fluid leak site had been performed. Recent advances in aviation technology have enabled many people to travel by air, including individuals with medical conditions. Low cabin pressure is not dangerous to healthy individuals; however, practicing consultant neurosurgeons should understand the cabin environment and prepare high risk patients for safe air travel. PMID:24175032

  5. [Surgical infections as patient safety problems].

    PubMed

    Baranyai, Zsolt; Kulin, László; Jósa, Valéria; Mayer, Akos

    2011-06-01

    Surgical infections are severe complications of surgical interventions and one of the most important patient safety issues. These are associated with increased morbidity, mortality, costs and decreased quality of life. Prevention of infections is essential, while one has to consider pre-, intra- and postoperative factors and procedures in the clinical practice. In this article we summarize the latest recommendations for clinicians based on the relevant published literature.

  6. [Oromaxillofacial surgical treatment in aging patients].

    PubMed

    Hausamen, J E; Schliephake, H

    1990-01-01

    The oral and maxillofacial surgical therapy of the elderly patient must include considerations of age-related physiological changes, both of inner organs and oral structures. Decreased hepatic and renal function may lead to delayed elimination of anaesthetic drugs and thereby make dose reductions necessary. Sclerosis or osteoporosis of jaw bones may render the surgical treatment of odontogenic diseases more difficult due to the increased fracture hazard. Painful ankylosis and rheumatic arthritis of the temporo-mandibular joint, tumors and fractures are common diseases of the elderly patient that a maxillofacial surgeon has to deal with. Furthermore, preprosthetic and reconstructive surgery is often required after jaw resections or severe atrophy. Due to the polypathy frequently present in elderly patients maxillofacial surgery requires particular indications, special surgical performance, and extensive postoperative care. By using all possible means, a satisfactory treatment can be achieved even in this age patients, whose quality of life can thus be improved.

  7. Targeting CD20 in Melanoma Patients at High Risk of Disease Recurrence

    PubMed Central

    Pinc, Alice; Somasundaram, Rajasekharan; Wagner, Christine; Hörmann, Marcus; Karanikas, Georgios; Jalili, Ahmad; Bauer, Wolfgang; Brunner, Patrick; Grabmeier-Pfistershammer, Katharina; Gschaider, Melanie; Lai, Chiou-Yan; Hsu, Mei-Yu; Herlyn, Meenhard; Stingl, Georg; Wagner, Stephan N

    2012-01-01

    Melanomas contain distinct cell subpopulations. Several of these subpopulations, including one expressing CD20, may harbor stem cell-like or tumor-initiating characteristics. We hypothesized that patients at high risk of disease recurrence could benefit from an adjuvant anti-CD20 therapy. Therefore, we initiated a small pilot trial to study the effect of the anti-CD20 antibody rituximab in a group of melanoma patients with stage IV metastatic disease who had been rendered without evident disease by way of surgery, chemotherapy and/or radiation therapy. The major objective was safety, while secondary objectives were description of recurrence-free intervals (RFI) and overall survival (OS). Nine patients received rituximab at 375 mg/m2 qw for 4 weeks followed by a maintenance therapy every 8 weeks. Treatment was discontinued after 2 years or with disease recurrence. Treatment was well tolerated. After a median observation of 42 months, the median neither of RFI nor of OS has been reached. Despite therapy that ended after 2 years, six out of nine patients are still alive and five of them are recurrence-free. Though the patient number is too small for definitive conclusions, our data may represent a first example of the potential therapeutic value of targeting CD20+ cell populations—at least for a subset of patients. PMID:22354376

  8. Targeting CD20 in melanoma patients at high risk of disease recurrence.

    PubMed

    Pinc, Alice; Somasundaram, Rajasekharan; Wagner, Christine; Hörmann, Marcus; Karanikas, Georgios; Jalili, Ahmad; Bauer, Wolfgang; Brunner, Patrick; Grabmeier-Pfistershammer, Katharina; Gschaider, Melanie; Lai, Chiou-Yan; Hsu, Mei-Yu; Herlyn, Meenhard; Stingl, Georg; Wagner, Stephan N

    2012-05-01

    Melanomas contain distinct cell subpopulations. Several of these subpopulations, including one expressing CD20, may harbor stem cell-like or tumor-initiating characteristics. We hypothesized that patients at high risk of disease recurrence could benefit from an adjuvant anti-CD20 therapy. Therefore, we initiated a small pilot trial to study the effect of the anti-CD20 antibody rituximab in a group of melanoma patients with stage IV metastatic disease who had been rendered without evident disease by way of surgery, chemotherapy and/or radiation therapy. The major objective was safety, while secondary objectives were description of recurrence-free intervals (RFI) and overall survival (OS). Nine patients received rituximab at 375 mg/m(2) qw for 4 weeks followed by a maintenance therapy every 8 weeks. Treatment was discontinued after 2 years or with disease recurrence. Treatment was well tolerated. After a median observation of 42 months, the median neither of RFI nor of OS has been reached. Despite therapy that ended after 2 years, six out of nine patients are still alive and five of them are recurrence-free. Though the patient number is too small for definitive conclusions, our data may represent a first example of the potential therapeutic value of targeting CD20(+) cell populations-at least for a subset of patients.

  9. Surgical options for patients with Lennox-Gastaut syndrome.

    PubMed

    Douglass, Laurie M; Salpekar, Jay

    2014-09-01

    Despite ongoing investigation into pharmacologic treatments for Lennox-Gastaut syndrome (LGS), outcomes for chronic administration of medications remain disappointing. In many instances LGS is treatment refractory, resulting in poor prognoses that include intellectual disability, persisting seizures, and psychiatric conditions. For patients with treatment resistance to other modalities for LGS, a further option is surgical intervention. Evaluation for surgery should involve interictal electroencephalogram (EEG), magnetic resonance imaging (MRI) analysis, and age-appropriate neuropsychological/developmental assessment. Resective surgery, where seizure foci are removed, successfully controls seizures in many cases, particularly where lesionectomy or lobar resections are appropriate. Recent studies of resective surgery on individuals with LGS show promising results, with a high percentage of patients having improved seizure control. Corpus callosotomy is a palliative surgical approach that aims at controlling potentially injurious seizures, for example, atonic or drop seizures, by preventing the bilateral spread of epileptic activity. Once associated with a high risk for morbidity and mortality, microsurgical techniques and surgery limited to the anterior region of the callosum have greatly diminished complications of corpus callosotomy surgery. Vagus nerve stimulation, another palliative procedure, offers rates of seizure improvement similar to those of corpus callosotomy, with the exception of atonic seizure for which corpus callosotomy may lead to a greater reduction. Recent advances in surgical techniques offer encouraging options for treatment of LGS.

  10. Clinical efficacy and safety of arbekacin for high-risk infections in patients with hematological malignancies.

    PubMed

    Miura, Katsuhiro; Nakagawa, Masaru; Takahashi, Hiromichi; Uchino, Yoshihito; Kodaira, Hitomi; Iriyama, Noriyoshi; Sakagami, Masashi; Ohtake, Shimon; Kobayashi, Sumiko; Hojo, Atsuko; Kurita, Daisuke; Kobayashi, Yujin; Kusuda, Machiko; Hirabayashi, Yukio; Hatta, Yoshihiro; Takei, Masami

    2016-03-01

    We performed a clinical trial to investigate the efficacy and safety of arbekacin (ABK), a unique aminoglycoside with activity against methicillin-resistant Staphylococcus aureus (MRSA), in patients with hematological malignancies complicated by high-risk infections. ABK was administered intravenously at a dose of approximately 5 mg/kg with various broad-spectrum β-lactams, followed by therapeutic drug monitoring (TDM). A total of 54 febrile or infectious episodes were registered, and TDM was performed in 44 (81%) cases. The absolute neutrophil count was below 500/μl in 49 (91%) cases, and cytotoxic chemotherapy was being administered in 47 (87%) cases. Before initiation of ABK, 52 (96%) patients had received fluoroquinolones (n = 37) and/or broad-spectrum β-lactams (n = 34). There were 10 cases of documented infections including one of MRSA pneumonia, and 44 cases of febrile neutropenia. The efficacy at the end of treatment was 80% for all patients, and efficacy was significantly higher in patients attaining maximum concentrations ≥ 16 µg/ml or receiving TDM-guided dose-adjustment of ABK (n = 19, 95 vs. 71%, P = 0.039). Renal toxicity was observed in six cases (11%) but was generally acceptable. This study demonstrated that TDM-guided ABK administration may be applicable under limited conditions for patients with hematological malignancies.

  11. Mechanical circulatory support: balancing bleeding and clotting in high-risk patients.

    PubMed

    Baumann Kreuziger, Lisa; Massicotte, M Patricia

    2015-01-01

    Mechanical circulatory support (MCS) provides a bridge to heart transplant in children and adults with life-threatening heart failure and sustains patients ineligible for transplant. Extracorporeal membrane oxygenation (ECMO) provides temporary support for patients in cardiac or pulmonary failure through external gas exchange and continuous flow of blood. Because the median time to heart transplant exceeds event-free time on ECMO, pulsatile left ventricular assist devices (LVADs) are used to support infants and children. Continuous flow LVADs are preferred in adolescents and adults due to increased pump durability and improved overall survival. The shear stress created by the mechanical pumps cause changes in the hematologic system; acquired von Willebrand syndrome occurs in almost all patients treated with MCS. Despite the improvements in survival, major bleeding occurs in one-third of patients with a LVAD and ischemic stroke and LVAD thrombosis can affect 12% of adults and 29% of children. An antithrombotic strategy to mitigate LVAD bleeding and thrombotic complications has been tested in a randomized trial in children, but intensity of antithrombotic therapy in adults varies widely. Consensus guidelines for antithrombotic therapy during ECMO were created due to significant differences in management across centers. Because of the high risk for both bleeding and thrombotic complications, experts in hemostasis can significantly impact care of patients requiring mechanical circulatory support and are a necessary part of the management team.

  12. Organ Damage in High Risk Patients with Systemic and Incomplete Lupus Syndromes

    PubMed Central

    Olsen, Nancy J.; Yousif, Maha; Mutwally, Azza; Cory, Melinda; Elmagboul, Nada; Karp, David R.

    2013-01-01

    The objective of this study was to characterize organ damage in lupus patients enrolled in the Dallas Regional Autoimmune Disease Registry (DRADR). Retrospective chart review was carried out on 99 patients with 4 or more diagnostic criteria for systemic lupus erythematosus (SLE) and 15 with less than 4 of these criteria, who were designated as having incomplete lupus (ILE). The majority of patients (84%) were African American or Hispanic/Latino; mean disease duration was 9.5 years. The mean damage score was 1.57 (range 0 to 8) and a damage score greater than 0 was present in 64% of the patients. The ILE group had lower mean damage scores (0.67) than the SLE group (1.67; P=0.04), explained in part by the shorter disease duration in the ILE patients (4.33 years vs. 10.24 years; P=0.003). The most prevalent damage category was renal, present in 24% of patients. Malignancies occurred in individuals who were significantly older than those who had renal or peripheral vascular damage (P=0.0007). The findings confirm clinical impressions that the DRADR includes a high-risk lupus population. The ILE patients have less damage but also shorter disease duration, suggesting that this might represent an earlier disease stage. These results are consistent with the hypothesis that ILE patients include a subset that is likely to experience progressive organ damage. Longitudinal study of these patients has significant likelihood of tracking the changes that are correlated with disease progression to SLE. PMID:23715694

  13. [HIGH-RISK CHRONICALLY ILL PATIENTS: DIAGNOSTICS, RESULTS AND NURSING INTERVENTIONS UPON DISCHARGE].

    PubMed

    Martinez López, Constancio; Martinez de Pinillos, Rafael López; Pereira Torres, Ana Isabel; San Pedro, Ana Isabel Castro; Heras Agudo, Dolores; Robledo González, Ascensión; Olmo Alonso, Carmen; Trujillo Orcha, Natalia

    2015-10-01

    It is after the implementation of the new nursing evaluation/ planning care registers (PCE) in the medical record and the updating of the document/circuit of the All-clear Ensuing Care Report (ICCA) with NANDA, NOC, NIC (NNN) in the first months of the year 2013, that we are contemplating the fulfillment of a descriptive/cross-section study so as to know diagnostics, results and nursing interventions upon discharge of high-risk chronically ill patients and qualitatively in medical hospitalization units and in palliative care. The results obtained at a quantitative level, with an implementation degree of 83 and 94 per cent, respectively, are extremely encouraging. Regarding the quality of care planning, we have identified for the first time in our hospital both the NANDA, the NOC and NIC with the prevalence degree in the units studied.

  14. Balloon aortic valvuloplasty as a bridge-to-decision in high risk patients with aortic stenosis: a new paradigm for the heart team decision making

    PubMed Central

    Saia, Francesco; Moretti, Carolina; Dall'Ara, Gianni; Ciuca, Cristina; Taglieri, Nevio; Berardini, Alessandra; Gallo, Pamela; Cannizzo, Marina; Chiarabelli, Matteo; Ramponi, Niccolò; Taffani, Linda; Bacchi-Reggiani, Maria Letizia; Marrozzini, Cinzia; Rapezzi, Claudio; Marzocchi, Antonio

    2016-01-01

    Background Whilst the majority of the patients with severe aortic stenosis can be directly addressed to surgical aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), in some instances additional information may be needed to complete the diagnostic workout. We evaluated the role of balloon aortic valvuloplasty (BAV) as a bridge-to-decision (BTD) in selected high-risk patients. Methods Between 2007 and 2012, the heart team in our Institution required BTD BAV in 202 patients. Very low left ventricular ejection fraction, mitral regurgitation grade ≥ 3, frailty, hemodynamic instability, serious comorbidity, or a combination of these factors were the main drivers for this strategy. We evaluated how BAV influenced the final treatment strategy in the whole patient group and in each specific subgroup. Results Mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 23.5% ± 15.3%, age 81 ± 7 years. In-hospital mortality was 4.5%, cerebrovascular accident 1% and overall vascular complications 4% (0.5% major; 3.5% minor). Of the 193 patients with BTD BAV who survived and received a second heart team evaluation, 72.6% were finally deemed eligible for definitive treatment (25.4% for AVR; 47.2% for TAVI): 96.7% of patients with left ventricular ejection fraction recovery; 70.5% of patients with mitral regurgitation reduction; 75.7% of patients who underwent BAV in clinical hemodynamic instability; 69.2% of frail patients and 68% of patients who presented serious comorbidities. Conclusions Balloon aortic valvuloplasty can be considered as bridge-to-decision in high-risk patients with severe aortic stenosis who cannot be immediate candidates for definitive transcatheter or surgical treatment. PMID:27582761

  15. Identification of high risk DISC1 protein structural variants in patients with bipolar spectrum disorder.

    PubMed

    Song, Wenjia; Li, Wenyan; Noltner, Katie; Yan, Jin; Green, Elaine; Grozeva, Detelina; Jones, Ian R; Craddock, Nick; Longmate, Jeff; Feng, Jinong; Sommer, Steve S

    2010-12-17

    In a large Scottish pedigree, a balanced translocation t (1;11)(q42.1;q14.3) disrupting the DISC1 and DISC2 genes segregates with major mental illness, including schizophrenia and depression. A frame-shift carboxyl-terminal deletion was reported in DISC1 in an American family with schizophrenia, but subsequently found in two controls. Herein, we test one hypothesis utilizing a large scale case-control mutation analysis: uncommon DISC1 variants are associated with high risk for bipolar spectrum disorder. We have analyzed the regions of likely functional significance in the DISC1 gene in 504 patients with bipolar spectrum disorder and 576 ethnically similar controls. Five patients were heterozygous for ultra-rare protein structural variants not found in the 576 controls (p=0.02, one-sided Fisher's exact test) and shown to be ultra-rare by their absence in a pool of 10,000 control alleles. In our sample, ultra-rare (private) protein structural variants in DISC1 are associated with an estimated attributable risk of about 0.5% in bipolar spectrum disorder. These data are consistent with: (i) the high frequency of depression in the large Scottish family with a translocation disrupting DISC1; (ii) linkage disequilibrium analysis demonstrating haplotypes associated with relatively small increases in risk for bipolar disorder (<3-fold odds ratio). The data illustrate how low/moderate risk haplotypes that might be found by the HapMap project can be followed up by resequencing to identify protein structural variants with high risk, low frequency and of potential clinical utility. PMID:20850505

  16. Analyzing treatment aggressiveness and identifying high-risk patients in diabetic foot ulcer return to care.

    PubMed

    Remington, Austin C; Hernandez-Boussard, Tina; Warstadt, Nicholus M; Finnegan, Micaela A; Shaffer, Robyn; Kwong, Jereen Z; Curtin, Catherine

    2016-07-01

    Rates of diabetes and its associated comorbidities have been increasing in the United States, with diabetic foot ulcer treatment representing a large cost to the patient and healthcare system. These ulcers often result in multiple hospital admissions. This study examined readmissions following inpatient care for a diabetic foot ulcer and identified modifiable factors associated with all-cause 30-day readmissions to the inpatient or emergency department (ED) setting. We hypothesized that patients undergoing aggressive treatment would have lower 30-day readmission rates. We identified patient discharge records containing International Classification of Disease ninth revision codes for both diabetes mellitus and distal foot ulcer in the State Inpatient and Emergency Department databases from the Agency for Healthcare Research and Quality, Healthcare Cost and Utilization Project in Florida and New York, 2011-2012. All-cause 30-day return to care visits (ED or inpatient) were analyzed. Patient demographics and treatment characteristics were evaluated using univariate and multivariable regression models. The cohort included 25,911 discharges, having a mean age of 63 and an average of 3.8 comorbidities. The overall rate of return to care was 30%, and 21% of subjects underwent a toe or midfoot amputation during their index stay. The most common diagnosis codes upon readmission were diabetes mellitus (19%) and infection (13%). Patients with a toe or midfoot amputation procedure were less likely to be readmitted within 30 days (odds ratio: 0.78; 95% confidence interval: 0.73, 0.84). Presence of comorbidities, black and Hispanic ethnicities, and Medicare and Medicaid payer status were also associated with higher odds of readmission following initial hospitalization (p < 0.05). The study suggests that there are many factors that affect readmission rates for diabetic foot ulcer patients. Understanding patients at high-risk for readmission can improve counseling and

  17. Dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma.

    PubMed

    Mora, Jaume

    2016-01-01

    Neuroblastoma (NB) is the most common extra cranial solid tumor of childhood, with 60% of patients presenting with high risk (HR) NB by means of clinical, pathological and biological features. The 5-year survival rate for HR-NB remains below 40%, with the majority of patients suffering relapse from chemorefractory tumor. Immunotherapy is the main strategy against minimal residual disease and clinical experience has mostly focused on monoclonal antibodies (MoAb) against the glycolipid disialoganglioside GD2. Three anti-GD2 antibodies have been tested in the clinic including murine 14G2a, human-mouse chimeric ch14.18 and 3F8. Anti-GD2 MoAb induces cellular cytoxicity against NB and is most effective when effector cells like natural killer cells, granulocytes and macrophages are amplified by cytokines. The combination of cytokines IL-2 and GM-CSF with the anti-GD2 MoAb ch14.18 (Dinutuximab) has shown a significant improvement in outcome for HR-NB. The FDA and EMA approved dinutuximab (Unituxin(R)) in 2015 for the treatment of patients with HR-NB who achieved at least a partial response after multimodality therapy.

  18. Targeted sequencing identifies patients with preclinical MDS at high risk of disease progression.

    PubMed

    Cargo, Catherine A; Rowbotham, Nicola; Evans, Paul A; Barrans, Sharon L; Bowen, David T; Crouch, Simon; Jack, Andrew S

    2015-11-19

    The diagnosis of myelodysplastic syndromes (MDS) remains problematic due to the subjective nature of morphologic assessment. The reported high frequency of somatic mutations and increased structural variants by array-based cytogenetics have provided potential objective markers of disease; however, this has been complicated by reports of similar abnormalities in the healthy population. We aimed to identify distinguishing features between those with early MDS and reported healthy individuals by characterizing 69 patients who, following a nondiagnostic marrow, developed progressive dysplasia or acute myeloid leukemia. Targeted sequencing and array-based cytogenetics identified a driver mutation and/or structural variant in 91% (63/69) of prediagnostic samples with the mutational spectrum mirroring that in the MDS population. When compared with the reported healthy population, the mutations detected had significantly greater median variant allele fraction (40% vs 9% to 10%), and occurred more commonly with additional mutations (≥2 mutations, 64% vs 8%). Furthermore, mutational analysis identified a high-risk group of patients with a shorter time to disease progression and poorer overall survival. The mutational features in our cohort are distinct from those seen in the healthy population and, even in the absence of definitive disease, can predict outcome. Early detection may allow consideration of intervention in poor-risk patients. PMID:26392596

  19. Monitoring high-risk patients: minimally invasive and non-invasive possibilities.

    PubMed

    Renner, Jochen; Grünewald, Matthias; Bein, Berthold

    2016-06-01

    Over the past decades, there has been considerable progress in the field of less invasive haemodynamic monitoring technologies. Substantial evidence has accumulated, which supports the continuous measurement and optimization of flow-based variables such as stroke volume, that is, cardiac output, in order to prevent occult hypoperfusion and consequently to improve patients' outcome in the perioperative setting. However, there is a striking gap between the developments in haemodynamic monitoring and the increasing evidence to implement defined treatment protocols based on the measured variables, and daily clinical routine. Recent trials have shown that perioperative morbidity and mortality is higher than anticipated. This emphasizes the need for the anaesthesia community to address this issue and promotes the implementation of proven concepts into clinical practice in order to improve patients' outcome, especially in high-risk patients. The advances in minimally invasive and non-invasive monitoring techniques can be seen as a driving force in this respect, as the degree of invasiveness of any monitoring tool determines the frequency of its application, especially in the operating room (OR). From this point of view, we are very confident that some of these minimally invasive and non-invasive haemodynamic monitoring technologies will become an inherent part of our monitoring armamentarium in the OR and in the intensive care unit (ICU). PMID:27396807

  20. Dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma.

    PubMed

    Mora, Jaume

    2016-01-01

    Neuroblastoma (NB) is the most common extra cranial solid tumor of childhood, with 60% of patients presenting with high risk (HR) NB by means of clinical, pathological and biological features. The 5-year survival rate for HR-NB remains below 40%, with the majority of patients suffering relapse from chemorefractory tumor. Immunotherapy is the main strategy against minimal residual disease and clinical experience has mostly focused on monoclonal antibodies (MoAb) against the glycolipid disialoganglioside GD2. Three anti-GD2 antibodies have been tested in the clinic including murine 14G2a, human-mouse chimeric ch14.18 and 3F8. Anti-GD2 MoAb induces cellular cytoxicity against NB and is most effective when effector cells like natural killer cells, granulocytes and macrophages are amplified by cytokines. The combination of cytokines IL-2 and GM-CSF with the anti-GD2 MoAb ch14.18 (Dinutuximab) has shown a significant improvement in outcome for HR-NB. The FDA and EMA approved dinutuximab (Unituxin(R)) in 2015 for the treatment of patients with HR-NB who achieved at least a partial response after multimodality therapy. PMID:26934530

  1. [Surgical treatment of bronchiectases in elderly patients].

    PubMed

    Danilov, G P; Makeeva, R P; Shornikov, V A; Zil'ber, E K; Akopov, A L

    2010-01-01

    The authors present experiences with surgical treatment of 29 patients (aged 50-64 years) with bronchiectases. Early and late results were analyzed. It was shown that complex approach to the estimation of the findings of radiography, spiral computed tomography, investigation of the external respiration function, fibrobronchoscopy and bronchoscopy, if necessary, allowed operating the patients older than 50 years with local forms of bronchiectases which gave good results. PMID:21137257

  2. Reduced intensity conditioning followed by peripheral blood stem cell transplantation for adult patients with high-risk acute lymphoblastic leukemia

    PubMed Central

    Stein, Anthony S.; Palmer, Joycelynne M.; O'Donnell, Margaret R.; Kogut, Neil M.; Spielberger, Ricardo T.; Slovak, Marilyn L.; Tsai, Ni-Chun; Senitzer, David; Snyder, David S.; Thomas, Sandra H.; J.Forman, Stephen

    2009-01-01

    Acute lymphoblastic leukemia (ALL) with high-risk features has a poor prognosis in adults despite aggressive chemotherapy. Reduced-intensity conditioning (RIC) is a lower toxicity alternative for high-risk patients requiring hematopoietic cell transplantation (HCT), however it has not been widely used for ALL. We conducted a retrospective study of 24 high-risk adult ALL patients who received an RIC regimen of fludarabine/melphalan prior to allogeneic peripheral blood stem cell transplant between 6/14/02 and 6/15/07 at City of Hope. Indications for the RIC regimen were: 1) age 50 or older (42%), 2) compromised organ function (54%), or 3) recipient of a previous HCT (37.5%). Patients had a median age of 47.5 years and the median follow-up was 28.5 months for living patients. Both overall survival and disease-free survival at two years was 61.5%. Relapse incidence was 21.1% and non-relapse mortality was 21.5% at two years. cGVHD developed in 86% of evaluable patients. In this series, no significant correlations were made between outcomes and patient age, presence of Philadelphia chromosome, relatedness of donor source or prior HCT. These high survival rates for high-risk ALL patients following RIC HCT may offer a promising option for patients not eligible for a standard myeloablative transplant. PMID:19822300

  3. Increased Saccadic Rate during Smooth Pursuit Eye Movements in Patients at Ultra High Risk for Developing a Psychosis

    ERIC Educational Resources Information Center

    van Tricht, M. J.; Nieman, D. H.; Bour, L. J.; Boeree, T.; Koelman, J. H. T. M.; de Haan, L.; Linszen, D. H.

    2010-01-01

    Abnormalities in eye tracking are consistently observed in schizophrenia patients and their relatives and have been proposed as an endophenotype of the disease. The aim of this study was to investigate the performance of patients at Ultra High Risk (UHR) for developing psychosis on a task of smooth pursuit eye movement (SPEM). Forty-six UHR…

  4. Psychiatric Symptoms and Community Violence among High-Risk Patients: A Test of the Relationship at the Weekly Level

    ERIC Educational Resources Information Center

    Skeem, Jennifer L.; Schubert, Carol; Odgers, Candice; Mulvey, Edward P.; Gardner, William; Lidz, Charles

    2006-01-01

    Given the availability of violence risk assessment tools, clinicians are now better able to identify high-risk patients. Once these patients have been identified, clinicians must monitor risk state and intervene when necessary to prevent harm. Clinical practice is dominated by the assumption that increases in psychiatric symptoms elevate risk of…

  5. Specificity of Incident Diagnostic Outcomes in Patients at Clinical High Risk for Psychosis

    PubMed Central

    Webb, Jadon R.; Addington, Jean; Perkins, Diana O.; Bearden, Carrie E.; Cadenhead, Kristin S.; Cannon, Tyrone D.; Cornblatt, Barbara A.; Heinssen, Robert K.; Seidman, Larry J.; Tarbox, Sarah I.; Tsuang, Ming T.; Walker, Elaine F.; McGlashan, Thomas H.; Woods, Scott W.

    2015-01-01

    It is not well established whether the incident outcomes of the clinical high-risk (CHR) syndrome for psychosis are diagnostically specific for psychosis or whether CHR patients also are at elevated risk for a variety of nonpsychotic disorders. We collected 2 samples (NAPLS-1, PREDICT) that contained CHR patients and a control group who responded to CHR recruitment efforts but did not meet CHR criteria on interview (help-seeking comparison patients [HSC]). Incident diagnostic outcomes were defined as the occurrence of a SIPS-defined psychosis or a structured interview diagnosis from 1 of 3 nonpsychotic Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) groups (anxiety, bipolar, or nonbipolar mood disorder), when no diagnosis in that group was present at baseline. Logistic regression revealed that the CHR vs HSC effect did not vary significantly across study for any emergent diagnostic outcome; data from the 2 studies were therefore combined. CHR (n = 271) vs HSC (n = 171) emergent outcomes were: psychosis 19.6% vs 1.8%, bipolar disorders 1.1% vs 1.2%, nonbipolar mood disorders 4.4% vs 5.3%, and anxiety disorders 5.2% vs 5.3%. The main effect of CHR vs HSC was statistically significant (OR = 13.8, 95% CI 4.2–45.0, df = 1, P < .001) for emergent psychosis but not for any emergent nonpsychotic disorder. Sensitivity analyses confirmed these findings. Within the CHR group emergent psychosis was significantly more likely than each nonpsychotic DSM-IV emergent disorder, and within the HSC group emergent psychosis was significantly less likely than most emergent nonpsychotic disorders. The CHR syndrome is specific as a marker for research on predictors and mechanisms of developing psychosis. PMID:26272875

  6. [SURGICAL TREATMENT OF PATIENTS WITH URETERAL RUPTURES].

    PubMed

    Komjakov, B K; Guliev, B G

    2015-01-01

    The aim of the study was to analyze the causes of ureteral ruptures and the types surgical procedures used for their management. Over the period from 2006 to 2014, 7 patients with ureteral ruptures underwent surgical treatment in the Mechnikov N-WSMU clinic. All of them were males aged 50 to 71 years. In all cases, the ureter was injured during ureteroscopy and contact lithotripsy. In two patients the right ureter was cut off at the border of the upper and middle third, in four--at 3-4 cm below pyeloureteral segment, one patient diagnosed with a complete separation of the ureter from the kidney pelvis. Patients, who have suffered a detachment of the ureter in other hospitals, previously underwent surgical exploration of the retroperitoneal space, drainage of the kidney by pyelonephrostomy (5) and ureterocutaneostomy (1). In a case of a patient with an injury that occurred in our clinic, laparoscopic nephrectomy with autologous renal transplantation was carried out. Five patients with extended ureter defects underwent ileo-ureteroplasty. The patient with left ureterocutaneostomy underwent nephrovesical bypass. Patency of the upper urinary tract and kidney function were restored in all patients, all of them were relieved from external drains. The duration of the intestinal plastic averaged 160 minutes, laparoscopic nephrectomy with autologous transplantation--210 min and nephrovesical bypass--110 min. Blood transfusion was required only in autologous graft patient. The ureteral rupture is a serious complication of ureteral endourological procedures in upper urinary tract. It requires such complicated reconstructive operations as autologous transplantation of the kidney or intestinal ureteroplasty. PMID:26390553

  7. Pilot Clinical Trial of Indocyanine Green Fluorescence-Augmented Colonoscopy in High Risk Patients.

    PubMed

    Sheth, Rahul A; Heidari, Pedram; Woods, Kevin; Chung, Daniel; Chan, Andrew T; Mahmood, Umar

    2016-01-01

    White light colonoscopy is the current gold standard for early detection and treatment of colorectal cancer, but emerging data suggest that this approach is inherently limited. Even the most experienced colonoscopists, under optimal conditions, miss at least 15-25% of adenomas. There is an unmet clinical need for an adjunctive modality to white light colonoscopy with improved lesion detection and characterization. Optical molecular imaging with exogenously administered organic fluorochromes is a burgeoning imaging modality poised to advance the capabilities of colonoscopy. In this proof-of-principle clinical trial, we investigated the ability of a custom-designed fluorescent colonoscope and indocyanine green, a clinically approved fluorescent blood pool imaging agent, to visualize polyps in high risk patients with polyposis syndromes or known distal colonic masses. We demonstrate (1) the successful performance of real-time, wide-field fluorescence endoscopy using off-the-shelf equipment, (2) the ability of this system to identify polyps as small as 1 mm, and (3) the potential for fluorescence imaging signal intensity to differentiate between neoplastic and benign polyps. PMID:26989406

  8. Immunomodulation by imiquimod in patients with high-risk primary melanoma

    PubMed Central

    Narayan, Rupa; Nguyen, Hong; Bentow, Jason J.; Moy, Lauren; Lee, Diana K.; Greger, Stephanie; Haskell, Jacquelyn; Vanchinathan, Veena; Chang, Pei-Lin; Tsui, Shanli; Konishi, Tamiko; Comin-Anduix, Begonya; Dauphine, Christine; Vargas, Hernan I.; Economou, James S.; Ribas, Antoni; Bruhn, Kevin W.; Craft, Noah

    2011-01-01

    Imiquimod is a synthetic Toll-like receptor 7 (TLR7) agonist approved for the topical treatment of actinic keratoses, superficial basal cell carcinoma, and genital warts. Imiquimod leads to an 80–100% cure rate of lentigo maligna, but studies of invasive melanoma are lacking. We conducted a pilot study to characterize the local, regional, and systemic immune responses induced by imiquimod in patients with high-risk melanoma. After treatment of the primary melanoma biopsy site with placebo or imiquimod cream, we measured immune responses in the treated skin, sentinel lymph nodes (SLN), and peripheral blood. Treatment of primary melanomas with 5% imiquimod cream was associated with an increase in both CD4+ and CD8+ T cells in the skin, and CD4+ T cells in the SLN. Most of the CD8+ T cells in the skin were CD25 negative. We could not detect any increases in CD8+ T cells specifically recognizing HLA-A*0201-restricted melanoma epitopes in the peripheral blood. The findings from this small pilot study demonstrate that topical imiquimod treatment results in enhanced local and regional T cell numbers in both the skin and SLN. Further research into TLR7 immunomodulating pathways as a basis for effective immunotherapy against melanoma in conjunction with surgery is warranted. PMID:21850019

  9. Thermal imaging evaluation of paravertebral block for mastectomy in high risk patient: case report.

    PubMed

    Możański, Marcin; Rustecki, Bartosz; Kalicki, Bolesław; Jung, Anna

    2015-04-01

    Thoracic paravertebral block is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina. It is effective in treating acute and chronic pain of unilateral origin from the chest and abdomen. This technique causes pain relief with pulmonary function preservation and great hemodynamic stability. 66 year old woman (156 cm, 80 kg, BMI 32) with chronic right heart failure, hypertension and obesity, on chronic oxygen therapy was presented for elective mastectomy due to breast cancer. She suffered from severe COPD and also bullous emphysema. FVC 1.59 l; FEV1 0.55 l; FEV1%FVC 34.6. The paravertebral block was performed using the multi-shot percutaneous technique with additional light general anesthesia. For confirmation, of proper analgesia range, control of temperature changes, using FLIR i7 infrared camera, was performed. Control photos were made 20 min after the blockade and then 10 min later. Infrared photo showed rise of temperature reading in every marked region. There were no hemodynamic and pulmonary complications postoperatively. Paravertebral block in combination with sedation creates excellent conditions for breast surgery procedures. Additional temperature changes monitoring performed with infrared camera may confirm proper range of analgesia needed to perform surgery. Great cardiovascular stability and very good pulmonary function preservation make this method excellent for high risk patients. Low complication rate is additional advantage. In our opinion this method is recommendable.

  10. Assessing, Counseling, and Treating Patients at High Risk for Breast Cancer.

    PubMed

    Clifford, Edward; Hughes, Kevin S; Roberts, Maegan; Pirzadeh-Miller, Sara; McLaughlin, Sarah A

    2016-10-01

    Identifying patients at high risk of carrying pathogenic variants in genes is a crucial part of providing both accurate counseling and evidence-based treatment recommendations. Current risk assessment models have strengths and weaknesses that may limit their applicability to specific clinical circumstances. Clinicians must have knowledge regarding variations in available models, how they should be used, and what data they can expect from specific models. In addition, indications for genetic testing are expanding, and the adoption of next-generation sequencing has allowed the creation of multigene testing panels. Complex consequences of panel testing have included an increase in the incidence of identifying variants of uncertain significance and the identification of pathogenic variants in genes for which treatment guidelines are not available. Women diagnosed with breast cancer who carry pathogenic variants in genes with proven associations with breast cancer (BRCA1/2) or highly likely associations (PTEN, PALB2) require additional risk assessment to facilitate treatment decisions that will limit in-breast tumor recurrence and contralateral breast cancer. PMID:27401444

  11. Medical costs associated with cardiovascular events among high-risk patients with hyperlipidemia

    PubMed Central

    Bonafede, Machaon M; Johnson, Barbara H; Richhariya, Akshara; Gandra, Shravanthi R

    2015-01-01

    Objectives This study descriptively examined acute and longer term direct medical costs associated with a major cardiovascular (CV) event among high-risk coronary heart disease risk-equivalent (CHD-RE) patients. It also gives a firsthand look at fatal versus nonfatal CV events. Methods The MarketScan® Commercial Claims and Encounters Database was used to identify adults with a CV event in 2006–2012 with hyperlipidemia or lipid-lowering therapy use in the 18 months prior to one of the following inpatient CV events: myocardial infarction, ischemic stroke, unstable angina, transient ischemic attack, percutaneous coronary intervention, or coronary artery bypass graft (CABG). Patients were required to have a preindex diagnosis of at least one of the following: peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, or diabetes. A subset analysis was conducted with patients with data linkable to the Social Security Administration Master Death File. Direct medical costs were reported for each quarter following a CV event, for up to 36 months after the first CV event. Results In total, 38,609 CHD-RE patients were included, mean age 57 years, 31% female. CABG, myocardial infarction, and percutaneous coronary intervention were the most frequent and most expensive first CV events, accounting for >75% of all first CV events with mean first quarter costs ranging from $17,454 (nonfatal transient ischemic attack) to $125,690 (fatal CABG). Overall, 15% of those with a first CV event went on to have a second event during the 36-month study period with mean first quarter nonfatal and fatal costs similar to first event levels. Third CV events were rare, happening in less than 3% of patients. Conclusion CV events among CHD-RE patients were costly regardless of sequence, averaging $47,433 in the first 90 days following an event and remaining high, never returning to preevent levels. When fatal, first CV event costs were 1.2 to 2.9 times higher than when

  12. Perioperative preparation of the adolescent surgical patient.

    PubMed

    Busen, N H

    2001-02-01

    The perioperative preparation of adolescents for surgery provides a challenge to nurses and other health care providers because of the wide diversity in adolescents' age, physical maturation, and cognitive and psychosocial development. Perioperative issues, informed consent, and assent differ considerably depending on the age and developmental level of each adolescent. This article provides information about adolescent growth and development and approaches to managing adolescent surgical patients.

  13. Hospital transfer for primary coronary angioplasty in high risk patients with acute myocardial infarction

    PubMed Central

    Straumann, E; Yoon, S; Naegeli, B; Frielingsdorf, J; Gerber, A; Schuiki, E; Bertel, O

    1999-01-01

    , respectively. Only one hospital survivor (group A) died during follow up.
CONCLUSION—Interhospital transport for primary PTCA in high risk patients with acute myocardial infarction is safe and feasible within a reasonable period of time. Short and medium term outcome is favourable. Optimising the decision process and transport logistics may further improve outcome by reducing the total time of ischaemia.


Keywords: acute myocardial infarction; primary percutaneous transluminal coronary angioplasty; hospital transfer; time delay PMID:10490552

  14. Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer | Division of Cancer Prevention

    Cancer.gov

    This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer. |

  15. Thermal imaging evaluation of paravertebral block for mastectomy in high risk patient: case report.

    PubMed

    Możański, Marcin; Rustecki, Bartosz; Kalicki, Bolesław; Jung, Anna

    2015-04-01

    Thoracic paravertebral block is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina. It is effective in treating acute and chronic pain of unilateral origin from the chest and abdomen. This technique causes pain relief with pulmonary function preservation and great hemodynamic stability. 66 year old woman (156 cm, 80 kg, BMI 32) with chronic right heart failure, hypertension and obesity, on chronic oxygen therapy was presented for elective mastectomy due to breast cancer. She suffered from severe COPD and also bullous emphysema. FVC 1.59 l; FEV1 0.55 l; FEV1%FVC 34.6. The paravertebral block was performed using the multi-shot percutaneous technique with additional light general anesthesia. For confirmation, of proper analgesia range, control of temperature changes, using FLIR i7 infrared camera, was performed. Control photos were made 20 min after the blockade and then 10 min later. Infrared photo showed rise of temperature reading in every marked region. There were no hemodynamic and pulmonary complications postoperatively. Paravertebral block in combination with sedation creates excellent conditions for breast surgery procedures. Additional temperature changes monitoring performed with infrared camera may confirm proper range of analgesia needed to perform surgery. Great cardiovascular stability and very good pulmonary function preservation make this method excellent for high risk patients. Low complication rate is additional advantage. In our opinion this method is recommendable. PMID:25059839

  16. High-risk patients following hospitalisation for an acute exacerbation of COPD.

    PubMed

    Piquet, Jacques; Chavaillon, Jean-Michel; David, Philippe; Martin, Francis; Blanchon, François; Roche, Nicolas

    2013-10-01

    The aim of this study was to assess long-term mortality and predictive factors of death after hospital admission for acute exacerbation of chronic obstructive pulmonary disease (COPD). 1824 patients (23.2% female; mean age 70.3±11.3 years) consecutively admitted for acute exacerbation of COPD in the respiratory medicine departments of 68 general hospitals between October 2006 and June 2007 were prospectively enrolled in a follow-up cohort. Their vital status was documented between October 2010 and April 2011. Vital status was available for 1750 patients (95.9%), among whom 787 (45%) died during follow-up. Multivariate analysis found that age (60-80 years and ≥80 years versus <60 years, relative risk 2.99, 95% CI 2.31-3.89), lower body mass index (25-30 kg·m(-2) versus ≤20 kg·m(-2), relative risk 0.80, 95% CI 0.66-0.97), lung cancer (relative risk 2.08, 95% CI 1.43-3.01), cardiovascular comorbidity (relative risk 1.35, 95% CI 1.16-1.58), previous hospital admissions for acute exacerbation of COPD (four or more versus none, relative risk 1.91, 95% CI 1.44-2.53), use of accessory respiratory muscles (relative risk 1.19, 95% CI 1.01-1.40) or lower-limb oedema (relative risk 1.74, 95% CI (1.44-2.12)) at admission and treatment by long-term oxygen therapy at discharge (relative risk 2.09, 95% CI 1.79-2.45) were independent risk factors of death. Mortality rate during the 4 years following hospital admission for acute exacerbation of COPD was high (45%). Simple clinical information relating to respiratory and general status can help in identifying high-risk patients and targeting more intensive follow-up and care. Interestingly, cardiovascular comorbidities and past hospitalisations for acute exacerbation of COPD, but not forced expiratory volume in 1 s, independently predicted the risk of death.

  17. Endovascular Stenting of Peripheral Infected Aneurysms: A Temporary Measure or a Definitive Solution in High-Risk Patients

    SciTech Connect

    Riga, Celia; Bicknell, Colin; Jindal, Ravul; Cheshire, Nicholas; Hamady, Mohamad

    2008-11-15

    The purpose of this study was to demonstrate the use of endovascular technology in the management of peripheral infected aneurysms in high-risk patients as a temporary measure or definitive solution. Five cases underwent successful endovascular stenting of infected aneurysms of the subclavian, femoral, and carotid arteries. All these patients were at high risk for open surgery. Covered stents were placed by percutaneous approach under local anesthesia in all patients. Postoperatively, antibiotics were continued for 3 months. A literature review using the Medline database was also undertaken, and all the relevant papers on endovascular management of peripheral infected aneurysms were taken into account. Stent deployment was successful in all patients. One patient died of mediastinal sepsis and another from type A aortic dissection 5 weeks later. Two patients required drainage of the infected hematoma. Three patients did well at a median follow-up of 1 year, with no evidence of sepsis. A review of the literature shows promising early and midterm results. Most early reports were of single cases, reflecting the low incidence of peripheral infected aneurysms. We conclude that further development of endoluminal techniques and long-term follow-up to establish the durability of stenting could potentially lead to a decrease in the high morbidity and mortality rates associated with infected aneurysmal disease in this high-risk group of patients.

  18. Strategies for screening for pancreatic adenocarcinoma in high-risk patients.

    PubMed

    Canto, Marcia Irene

    2007-08-01

    Identification of high-risk individuals, genetic counseling, and informed consent are important components of a screening program for familial pancreatic cancer. Screening high-risk individuals with imaging tests, such endoscopic ultrasound (EUS) and computed tomography (CT), can lead to the detection and treatment of predominantly asymptomatic early pancreatic neoplasms, as well as extra-pancreatic tumors. These pancreatic neoplasms consist of resectable, mostly branch-type non-invasive intraductal papillary mucinous neoplasms (IPMNs). EUS can visualize these very early IPMNs as focal duct ectasias or cysts. EUS features of chronic pancreatitis are highly prevalent in high-risk individuals and these directly correlate with multifocal lobulocentric parenchymal atrophy due to multifocal pancreatic intraepithelial neoplasia (PanIN). No one molecular marker is ready for "prime time" screening of high-risk individuals. Translational studies are underway to discover novel biomarkers for IPMNs, PanIN-3 lesions, or microinvasive adenocarcinoma, which are likely to be cured by timely intervention. Long-term, multi-prospective studies are needed to determine if screening for early pancreatic neoplasia and timely intervention results in decreased pancreatic cancer incidence and mortality in high-risk individuals.

  19. The incidence of deep venous thrombosis in high-risk Indian neurosurgical patients: Need for early chemoprophylaxis?

    PubMed Central

    George, Ajith John; Nair, Shalini; Karthic, Jayanthi Chinnaiya; Joseph, Mathew

    2016-01-01

    Introduction: Deep venous thrombosis (DVT) is thought to be less common in Asians than in Caucasian population. The incidence of DVT in high-risk groups, especially the neurosurgical (NS) patients, has not been well studied. This leaves no firm basis for the start of early prophylactic anticoagulation within first 5 postoperative days in Indian NS patients. This is a prospective observational study to determine the early occurrence of DVT in the NS patients. Patients and Methods: We screened 137 consecutive high-risk NS patients based on inclusion and exclusion criteria. The femoral veins were screened using Doppler ultrasound on day 1, 3, and 5 of admission into the NS Intensive Care Unit (ICU) at tertiary center from South India. Results: Among 2887 admissions to NICU 147 patients met inclusion criteria. One hundred thirty seven were screened for DVT. There was a 4.3% (6/137) incidence of DVT with none of the six patients having signs or symptoms of pulmonary embolism. Among the risk factors studied, there was a significant association with femoral catheterization and a probable association with weakness/paraparesis/paraplegia. The mortality in the study group was 10.8% with none attributable to DVT or pulmonary embolism. Conclusion: There is a low incidence of DVT among the high risk neurosurgical population evaluated within the first 5 days of admission to NICU, limiting the need for early chemical thrombo-prophylaxis in these patients. With strict protocols for mechanical prophylaxis with passive leg exercise, early mobilization and serial femoral Doppler screening, heparin anticoagulation can be restricted within the first 5 days of ICU admission in high risk patients. PMID:27555696

  20. Enteral nutrition in hypermetabolic surgical patients.

    PubMed

    Cerra, F B; Shronts, E P; Raup, S; Konstantinides, N

    1989-07-01

    Enteral nutrition is usually administered with premixed formulas and in a volume determined by the estimated total caloric need of the patient. The present study was undertaken to evaluate the nutritional outcome when isocaloric amounts of three commercial products were given as enteral nutrition in hypermetabolic surgical ICU patients. To qualify for the study, the patients had to be hypermetabolic and must have received and retained the volume of enteral formula estimated to meet energy and nutritional requirements for at least eight consecutive days. Caloric needs were defined as 30 to 35 total cal/kg.day. All data were prospectively collected; all patients had moderate to high-level metabolic stress after surgical intervention. Thirty-five patients participated in the study: 18 received a formula that was 23% amino acids, 20% fat, and had a nonprotein calorie/nitrogen (NPC/N) ratio of 97:1; ten patients received a formula with NPC/N 125:1 that was 17.5% protein and 35% fat; and seven patients received a formula with an NPC/N of 149:1 that was 15.3% amino acids and 2.5% fat. All formulas were given via nasoduodenal tube by continuous pump technique. Patients who received the low NPC/N had significantly greater N retention (p less than .05), increased plasma transferrin levels (p less than .05), and a lower RQ (p less than .05). There was a strong correlation between NPC/N and N retention and the increase in plasma transferrin levels. Thus, dosing enteral nutrition by total estimated caloric need does not presume optimal nutritional outcome. Formula composition is an important determinant of nutritional effect; formulas that have a lower NPC/N with more N and reduced calories as glucose demonstrate better nutritional results.

  1. Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules | Division of Cancer Prevention

    Cancer.gov

    This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in patients with subsolid lung nodules. |

  2. Blockade of BCL-2 proteins efficiently induces apoptosis in progenitor cells of high-risk myelodysplastic syndromes patients.

    PubMed

    Jilg, S; Reidel, V; Müller-Thomas, C; König, J; Schauwecker, J; Höckendorf, U; Huberle, C; Gorka, O; Schmidt, B; Burgkart, R; Ruland, J; Kolb, H-J; Peschel, C; Oostendorp, R A J; Götze, K S; Jost, P J

    2016-01-01

    Deregulated apoptosis is an identifying feature of myelodysplastic syndromes (MDS). Whereas apoptosis is increased in the bone marrow (BM) of low-risk MDS patients, progression to high-risk MDS correlates with an acquired resistance to apoptosis and an aberrant expression of BCL-2 proteins. To overcome the acquired apoptotic resistance in high-risk MDS, we investigated the induction of apoptosis by inhibition of pro-survival BCL-2 proteins using the BCL-2/-XL/-W inhibitor ABT-737 or the BCL-2-selective inhibitor ABT-199. We characterized a cohort of 124 primary human BM samples from MDS/secondary acute myeloid leukemia (sAML) patients and 57 healthy, age-matched controls. Inhibition of anti-apoptotic BCL-2 proteins was specifically toxic for BM cells from high-risk MDS and sAML patients, whereas low-risk MDS or healthy controls remained unaffected. Notably, ABT-737 or ABT-199 treatment was capable of targeting the MDS stem/progenitor compartment in high-risk MDS/sAML samples as shown by the reduction in CD34(+) cells and the decreased colony-forming capacity. Elevated expression of MCL-1 conveyed resistance against both compounds. Protection by stromal cells only partially inhibited induction of apoptosis. Collectively, our data show that the apoptotic resistance observed in high-risk MDS/sAML cells can be overcome by the ABT-737 or ABT-199 treatment and implies that BH3 mimetics might delay disease progression in higher-risk MDS or sAML patients.

  3. Phase II Study of Vinorelbine and Estramustine in Combination With Conformational Radiotherapy for Patients With High-Risk Prostate Cancer

    SciTech Connect

    Carles, Joan; Nogue, Miguel; Sole, Josep M.; Foro, Palmira; Domenech, Montserrat; Suarez, Marta; Gallardo, Enrique; Garcia, Dario; Ferrer, Ferran; Gelabert-Mas, Antoni; Gayo, Javier; Fabregat, Xavier

    2010-03-15

    Purpose: To evaluate the efficacy and safety profile of vinorelbine and estramustine in combination with three-dimensional conformational radiotherapy (3D-CRT) in patients with localized high-risk prostate cancer. Methods and Materials: Fifty patients received estramustine, 600 mg/m{sup 2} daily, and vinorelbine, 25 mg/m{sup 2}, on days 1 and 8 of a 21-day cycle for three cycles in combination with 8 weeks of 3D-CRT (total dose of 70.2 gray [Gy] at 1.8-Gy fractions or 70 Gy at 2.0-Gy fractions). Additionally, patients received luteinizing hormone-releasing hormone analogs for 3 years. Results: All patients were evaluated for response and toxicity. Progression-free survival at 5 years was 72% (95% confidence interval [CI]: 52-86). All patients who relapsed had only biochemical relapse. The most frequent severe toxicities were cystitis (16% of patients), leucopenia (10% of patients), diarrhea (10% of patients), neutropenia (8% of patients), and proctitis (8% of patients). Six patients (12%) did not complete study treatment due to the patient's decision (n = 1) and to adverse events such as hepatotoxicity, proctitis, paralytic ileus, and acute myocardial infarction. Conclusions: Vinorelbine and estramustine in combination with 3D-CRT is a safe and effective regimen for patients with localized high-risk prostate cancer. A randomized trial is needed to determine whether the results of this regimen are an improvement over the results obtained with radiotherapy and androgen ablation.

  4. Early detection of tumor relapse/regrowth by consecutive minimal residual disease monitoring in high-risk neuroblastoma patients

    PubMed Central

    Hirase, Satoshi; Saitoh, Atsuro; Hartomo, Tri Budi; Kozaki, Aiko; Yanai, Tomoko; Hasegawa, Daiichiro; Kawasaki, Keiichiro; Kosaka, Yoshiyuki; Matsuo, Masafumi; Yamamoto, Nobuyuki; Mori, Takeshi; Hayakawa, Akira; Iijima, Kazumoto; Nishio, Hisahide; Nishimura, Noriyuki

    2016-01-01

    Neuroblastoma is an aggressive pediatric tumor accounting for ~15% of cancer-associated mortalities in children. Despite the current intensive therapy, >50% of high-risk patients experience tumor relapse or regrowth caused by the activation of minimal residual disease (MRD). Although several MRD detection protocols using various reverse transcription-quantitative polymerase chain reaction (RT-qPCR) markers have been reported to evaluate the therapeutic response and disease status of neuroblastoma patients, their clinical significance remains elusive. The present study reports two high-risk neuroblastoma patients, whose MRD was consecutively monitored using 11 RT-qPCR markers (CHRNA3, CRMP1, DBH, DCX, DDC, GABRB3, GAP43, ISL1, KIF1A, PHOX2B and TH) during their course of treatment. The two patients initially responded to the induction therapy and reached MRD-negative status. The patients' MRD subsequently became positive with no elevation of their urinary homovanillic acid, urinary vanillylmandelic acid and serum neuron-specific enolase levels at 13 or 19 weeks prior to the clinical diagnosis of tumor relapse or regrowth. The present cases highlight the possibility of consecutive MRD monitoring using 11 markers to enable an early detection of tumor relapse or regrowth in high-risk neuroblastoma patients. PMID:27446404

  5. An intervention to improve care and reduce costs for high-risk patients with frequent hospital admissions: a pilot study

    PubMed Central

    2011-01-01

    Background A small percentage of high-risk patients accounts for a large proportion of Medicaid spending in the United States, which has become an urgent policy issue. Our objective was to pilot a novel patient-centered intervention for high-risk patients with frequent hospital admissions to determine its potential to improve care and reduce costs. Methods Community and hospital-based care management and coordination intervention with pre-post analysis of health care utilization. We enrolled Medicaid fee-for-service patients aged 18-64 who were admitted to an urban public hospital and identified as being at high risk for hospital readmission by a validated predictive algorithm. Enrolled patients were evaluated using qualitative and quantitative interview techniques to identify needs such as transportation to/advocacy during medical appointments, mental health/substance use treatment, and home visits. A community housing partner initiated housing applications in-hospital for homeless patients. Care managers facilitated appropriate discharge plans then worked closely with patients in the community using a harm reduction approach. Results Nineteen patients were enrolled; all were male, 18/19 were substance users, and 17/19 were homeless. Patients had a total of 64 inpatient admissions in the 12 months before the intervention, versus 40 in the following 12 months, a 37.5% reduction. Most patients (73.3%) had fewer inpatient admissions in the year after the intervention compared to the prior year. Overall ED visits also decreased after study enrollment, while outpatient clinic visits increased. Yearly study hospital Medicaid reimbursements fell an average of $16,383 per patient. Conclusions A pilot intervention for high-cost patients shows promising results for health services usage. We are currently expanding our model to serve more patients at additional hospitals to see if the pilot's success can be replicated. Trial registration Clinicaltrials.gov Identifier: NCT

  6. Evaluation of a Pharmacist-Specific Intervention on 30-Day Readmission Rates for High-Risk Patients with Pneumonia

    PubMed Central

    Carroll, Douglas N.; Pinner, Nathan A.

    2015-01-01

    Background: Pharmacist interventions have been shown to have an impact on reducing readmission rates, however further research is necessary to target resources to high-risk populations and determine the most effective bundle of interventions. Objective: To evaluate the effect of a pharmacist-bundled intervention on 30-day readmission rates for high-risk patients with pneumonia. Methods: A pilot study with a historical control conducted at a community, teaching-affiliated medical center. Up to 65 selected subjects were included if they had pneumonia and any of the following high-risk criteria: admission within 6 months, at least 5 scheduled home medications, chronic obstructive pulmonary disease (COPD), or heart failure. A retrospective chart review was conducted to compile the historical control group that received usual care between June and November 2013. Patients admitted from December 2013 through March 2014 were reviewed to receive a bundled intervention. The primary outcome was 30-day readmission rates. Risk factors and reasons for readmission, pharmacist clinical interventions, and the time interval between discharge and readmission were also evaluated. Results: A trend toward a reduced 30-day readmission rate was observed in the intervention group (n = 43) compared to those who received usual care (n = 65) (27.9% vs 40.0%; relative risk [RR], 0.6977; 95% CI, 0.3965–1.2278; P = .2119). The most commonly identified high-risk inclusion criteria were having at least 5 scheduled home medications and COPD. The time interval between discharge and readmission did not considerably differ between groups (10.8 vs 10.6 days). Conclusions: The pharmacist-bundled intervention was associated with a reduced 30-day readmission rate for high-risk patients with pneumonia. PMID:26823619

  7. Coronectomy versus surgical removal of the lower third molars with a high risk of injury to the inferior alveolar nerve. A bibliographical review

    PubMed Central

    Moreno-Vicente, Javier; Schiavone-Mussano, Rocío; Clemente-Salas, Enrique; Marí-Roig, Antoni; Jané-Salas, Enric

    2015-01-01

    Background Coronectomy is the surgical removal of the crown of the tooth deliberately leaving part of its roots. This is done with the hope of eliminating the pathology caused, and since the roots are still intact, the integrity of the inferior alveolar nerve is preserved. Objectives The aim is to carry out a systematic review in order to be able to provide results and conclusions with the greatest scientific evidence possible. Material and Methods A literature review is carried out through the following search engines: Pubmed MEDLINE, Scielo, Cochrane library and EMI. The level of evidence criteria from the Agency for Healthcare Research and Quality was applied, and the clinical trials’ level of quality was analyzed by means of the JADAD criteria. Results The following articles were obtained which represents a total of 17: 1 systematic review, 2 randomized clinical trials and 2 non-randomized clinical trials, 3 cohort studies, 2 retrospective studies, 3 case studies and 4 literature reviews. Conclusions Coronectomy is an adequate preventative technique in protecting the inferior alveolar nerve, which is an alternative to the conventional extraction of third molars, which unlike the former technique, presents a high risk of injury to the inferior alveolar nerve. However, there is a need for new clinical studies, with a greater number of samples and with a longer follow-up period in order to detect potential adverse effects of the retained roots. Key words: Coronectomy, inferior alveolar nerve, nerve injury, wisdom tooth removal, paresthesia, and systematic review. PMID:25858081

  8. [Assessment of surgical risk in patients with lower limb chronic critical ischaemia].

    PubMed

    Kazakov, Iu I; Lukin, I B; Sokolova, N Iu; Strakhov, M A

    2016-01-01

    Analysed herein are both immediate and remote results of surgical treatment of 93 patients presenting with chronic atherosclerotic occlusion of the femoral-popliteal-tibial segment in the stage of critical ischaemia. The patients were subjected to autovenous femoropopliteal bypass grafting to the isolated arterial segment or balloon angioplasty with stenting of the superficial femoral artery. While choosing the method of arterial reconstruction we assessed concomitant diseases, primarily lesions of the coronary and cerebral circulation. In order to objectively evaluate the patient state, we worked out a scale for assessing surgical risk. Survival rate without amputation after three years in patients with low risk amounted to 71.4%, in those with moderate risk to 60.0%, and in high-risk patients to 43.3%. Patients with initially high risk were found to have a high incidence rate of cardiac and cerebrovascular complications, exceeding 40%. It was shown that the worked out system of assessing the level of surgical risk objectively reflects the prognosis of patient survival following a reconstructive operation. This system of assessment may be appropriate while choosing an optimal method of arterial reconstruction (bypassing operation or endovascular intervention) in patients with atherosclerotic lesions of arteries of the femoropopliteal-tibial segment and critical ischaemia accompanied by severe concomitant pathology. Patients with high surgical risk should preferably be subjected to endovascular reconstruction, while those with low surgical risk should better undergo open shunting bypassing operation, and for those with moderate risk it is acceptable to perform both methods of arterial reconstruction. PMID:27626262

  9. The influence of number of high risk factors on clinical outcomes in patients with early-stage cervical cancer after radical hysterectomy and adjuvant chemoradiation

    PubMed Central

    Lim, Soyi; Lee, Seok-Ho; Park, Chan-Yong

    2016-01-01

    Objective The purpose of this study was to evaluate the prognosis according to the number of high risk factors in patients with high risk factors after radical hysterectomy and adjuvant chemoradiation therapy for early stage cervical cancer. Methods Clinicopathological variables and clinical outcomes of patients with FIGO (International Federation of Gynecology and Obstetrics) stage IB1 to IIA cervical cancer who had one or more high risk factors after radical hysterectomy and adjuvant chemoradiation therapy were retrospectively analyzed. Patients were divided into two groups according to the number of high risk factors (group 1, single high risk factor; group 2, two or more high risk factors). Results A total of 93 patients were enrolled in the present study. Forty nine out of 93 (52.7%) patients had a single high risk factor, and 44 (47.3%) had two or more high risk factors. Statistically significant differences in stage and stromal invasion were observed between group 1 and group 2. However, age, histology, tumor size, and lymphovascular space invasion did not differ significantly between the groups. Distant recurrence occurred more frequently in group 2, and the probability of recurrence and death was higher in group 2. Conclusion Patients with two or more high risk factors had worse prognosis in early stage cervical cancer. For these patients, consideration of new strategies to improve survival may be worthwhile. Conduct of further clinical trials is warranted for development of adjuvant treatment strategies individualized to each risk group. PMID:27200308

  10. 10-Year Survival and Quality of Life in Patients With High-Risk {sub P}N{sub 0} Prostate Cancer Following Definitive Radiotherapy

    SciTech Connect

    Berg, Arne Lilleby, Wolfgang; Bruland, Oyvind Sverre; Fossa, Sophie Dorothea

    2007-11-15

    Purpose: To evaluate long-term overall survival (OS), cancer-specific survival (CSS), clinical progression-free survival (cPFS), and health-related quality of life (HRQoL) following definitive radiotherapy (RT) given to T{sub 1-4p}N{sub 0}M{sub 0} prostate cancer patients provided by a single institution between 1989 and 1996. Methods and Materials: We assessed outcome among 203 patients who had completed three-dimensional conformal RT (66 Gy) without hormone treatment and in whom staging by lymphadenectomy had been performed. OS was compared with an age-matched control group from the general population. A cross-sectional, self-report survey of HRQoL was performed among surviving patients. Results: Median observation time was 10 years (range, 1-16 years). Eighty-one percent had high-risk tumors defined as T{sub 3-4} or Gleason score (GS) {>=}7B (4+3). Among these, 10-year OS, CSS, and cPFS rates were 52%, 66%, and 39%, respectively. The corresponding fractions in low-risk patients (T{sub 1-2} and GS {<=}7A [3+4]) were 79%, 95%, and 73%, respectively. Both CSS and cPFS were predicted by GS and T-classification; OS was associated with GS only. High-risk, but not low-risk, patients had reduced OS compared with the general population (p < 0.0005). When pelvis-related side effects were included in multivariate analyzes together with physical function and pain, sexual, urinary, and bowel function were not independently associated with self-reported global quality of life. Conclusions: Despite surgically proven {sub p}N{sub 0}, RT with dosage <70 Gy as monotherapy does not give satisfactory CSS rates after 10 years in patients with T{sub 3-4} or GS {>=}7B.

  11. Monitoring the critically ill surgical patient.

    PubMed Central

    Holliday, R L; Doris, P J

    1979-01-01

    Critically ill surgical patients account for approximately half the patients in an active multidisciplinary critical care unit. Hypovolemia and sepsis are common in such patients and affect a number of organ systems. Monitoring these systems provides therapeutically relevant information that may decrease morbidity and improve patient survival. Circulatory hemodynamics may be assessed by direct measurement of the arterial blood pressure, central venous and pulmonary artery pressure monitoring and cardiac output determination; the data thus obtained are valuable in guiding fluid replacement in the hypovolemic individual. The respiratory status may be assessed by bedside spirometry and measurement of arterial blood gas tensions to gauge pulmonary function and the need for assisted ventilation. Renal dysfunction is common in such patients; careful analysis of both urine and blood may identify prerenal as opposed to renal and postrenal factors. Monitoring of the gastrointestinal tract, especially for hemorrhage, is important. Finally, careful attention to nutritional status and provision of adequate protein and energy intake by mouth or by vein is a vital component of the optimal care of these patients. PMID:115566

  12. Stent-graft and multilayer stent for treatment of type II thoracoabdominal aortic aneurysm in a high-risk patient.

    PubMed

    Pane, B; Spinella, G; Salcuni, M; Palombo, D

    2013-08-01

    The aim of the present article was to present an alternative endovascular treatment for type II thoracoabdominal aortic aneurysm that would have the advantage of limiting the duration of the procedure and the use of contrast. A high-risk patient was admitted to our Vascular Unit for type II thoracoabdominal aneurysm according to Crawford's classification. Two thoracic stent-grafts (Valiant Captivia, Medtronic, Pewaukee, WI, USA), a bifurcated stent-graft (Endurant Medtronic) and two multilayer stents (Cardiatis SA, Isnes, Belgium) were deployed. No postoperative major complications were observed. Operative time and use of contrast material were 45 min and 80 mL, respectively. Computed angiography tomography at 1 and 6 months showed patency of visceral and renal arteries and progressive thrombosis of the aneurysmal sac. This stent-graft treatment in combination with multilayer stent could be an alternative treatment for thoracoabdominal aneurysm in high-risk patients. PMID:24013540

  13. The meaning of anti-Müllerian hormone levels in patients at a high risk of poor ovarian response.

    PubMed

    Park, Hyun Jong; Lee, Geun Ho; Gong, Du Sik; Yoon, Tae Ki; Lee, Woo Sik

    2016-09-01

    Measurements of ovarian reserve play an important role in predicting the clinical results of assisted reproductive technology (ART). The ideal markers of ovarian reserve for clinical applications should have high specificity in order to determine genuine poor responders. Basal follicle-stimulating hormone levels, antral follicle count, and serum anti-Müllerian hormone (AMH) levels have been suggested as ovarian reserve tests that may fulfill this requirement, with serum AMH levels being the most promising parameter. Serum AMH levels have been suggested to be a predictor of clinical pregnancy in ART for older women, who are at a high risk for decreased ovarian response. We reviewed the prognostic significance of ovarian reserve tests for patients undergoing ART treatment, with a particular focus on the significance of serum AMH levels in patients at a high risk of poor ovarian response. PMID:27689035

  14. The meaning of anti-Müllerian hormone levels in patients at a high risk of poor ovarian response

    PubMed Central

    Park, Hyun Jong; Lee, Geun Ho; Gong, Du Sik; Yoon, Tae Ki

    2016-01-01

    Measurements of ovarian reserve play an important role in predicting the clinical results of assisted reproductive technology (ART). The ideal markers of ovarian reserve for clinical applications should have high specificity in order to determine genuine poor responders. Basal follicle-stimulating hormone levels, antral follicle count, and serum anti-Müllerian hormone (AMH) levels have been suggested as ovarian reserve tests that may fulfill this requirement, with serum AMH levels being the most promising parameter. Serum AMH levels have been suggested to be a predictor of clinical pregnancy in ART for older women, who are at a high risk for decreased ovarian response. We reviewed the prognostic significance of ovarian reserve tests for patients undergoing ART treatment, with a particular focus on the significance of serum AMH levels in patients at a high risk of poor ovarian response. PMID:27689035

  15. The meaning of anti-Müllerian hormone levels in patients at a high risk of poor ovarian response

    PubMed Central

    Park, Hyun Jong; Lee, Geun Ho; Gong, Du Sik; Yoon, Tae Ki

    2016-01-01

    Measurements of ovarian reserve play an important role in predicting the clinical results of assisted reproductive technology (ART). The ideal markers of ovarian reserve for clinical applications should have high specificity in order to determine genuine poor responders. Basal follicle-stimulating hormone levels, antral follicle count, and serum anti-Müllerian hormone (AMH) levels have been suggested as ovarian reserve tests that may fulfill this requirement, with serum AMH levels being the most promising parameter. Serum AMH levels have been suggested to be a predictor of clinical pregnancy in ART for older women, who are at a high risk for decreased ovarian response. We reviewed the prognostic significance of ovarian reserve tests for patients undergoing ART treatment, with a particular focus on the significance of serum AMH levels in patients at a high risk of poor ovarian response.

  16. High-risk angina patient. Identification by clinical features, hospital course, electrocardiography and technetium-99m stannous pyrophosphate scintigraphy

    SciTech Connect

    Olson, H.G.; Lyons, K.P.; Aronow, W.S.; Stinson, P.J.; Kuperus, J.; Waters, H.J.

    1981-10-01

    We evaluated 193 consecutive unstable angina patients by clinical features, hospital course and electrocardiography. All patients were managed medically. Of the 193 patients, 150 (78%) had a technetium-99m pyrophosphate (Tc-PYP) myocardial scintigram after hospitalization. Of these, 49 (33%) had positive scintigrams. At a follow-up of 24.9 +/- 10.8 months after hospitalization, 16 of 49 patients (33%) with positive scintigrams died from cardiac causes, compared with six of 101 patients (6%) with negative scintigrams (p less than 0.001). Of 49 patients with positive scintigrams, 11 (22%) had had nonfatal myocardial infarction at follow-up, compared with seven of 101 patients (7%) with negative scintigrams (p less than 0.01). Age, duration of clinical coronary artery disease, continuing angina during hospitalization, ischemic ECG, cardiomegaly and a history of heart failure also correlated with cardiac death at follow-up. Ischemic ECG and a history of angina with a crescendo pattern also correlated with nonfatal infarction at follow-up. Patients with continuing angina, an ischemic ECG and a positive scintigram constituted a high-risk unstable angina subgroup with a survival rate of 58% at 6 months, 47% at 12 months and 42% at 24 and 36 months. We conclude that the assessment of clinical features, hospital course, ECG and Tc-PYP scintigraphy may be useful in identifying high-risk unstable angina patients.

  17. High-risk angina patient: identification by clinical features, hospital course, electrocardiography, and technetium-99m stannous pyrophosphate scintigraphy

    SciTech Connect

    Olson, H.G.; Lyons, K.P.; Aronow, W.S.; Stinson, P.J.; Kuperus, J.; Waters, H.J.

    1981-10-01

    We evaluated 193 consecutive unstable angina patients by clinical features, hospital course and electrocardiography. All patients were managed medically. Of the 193 patients, 150 (78%) had a technetium-99m pyrophosphate (Tc-PYP) myocardial scintigram after hospitalization. Of these, 49 (33%) had positive scintigrams. At a follow-up of 24.9 +- 10.8 months after hospitalization, 16 of 49 patients (33%) with positive scintigrams died from cardiac causes, compared with six of 101 patients (6%) with negative scintigrams (p < 0.001). Of 49 patients with positive scintigrams, 11 (22%) had had nonfatal myocardial infarction at follow-up, compared with seven of 101 patients (7%) with negative scintigrams (p < 0.01). Age, duration of clinical coronary artery disease, continuing angina during hospitalization, ischemic ECG, cardiomegaly and a history of heart failure also correlated with cardiac death at follow-up. Ischemic ECG and a history of angina with a crescendo pattern also correlated with nonfatal infarction at follow-up. Patients with continuing angina, an ischemic ECG and a positive scintigram constituted a high-risk unstable angina subgroup, with a survival rate of 58% at 6 months, 47% at 12 months and 42% at 24 and 36 months. We conclude that the assessment of clinical features, hospital course, ECG and Tc-PYP scintigraphy may be useful in identifying high-risk unstable angina patients.

  18. Bevacizumab for Ovarian Cancer at High Risk of Progression: Reproducibility of Trial Results in 'Real-world' Patients.

    PubMed

    Bertelli, Gianfilippo; Drews, Florian; Lutchman-Singh, Kerryn

    2016-09-01

    Bevacizumab has become a 'community standard' at many UK centres as part of first-line treatment of patients with ovarian cancer at high risk of progression [International Federation of Gynecology and Obstetrics (FIGO) stage IV, or suboptimally debulked stage III] based on the results of phase III trials such as ICON-7. Its impact in patients treated outside clinical trials is, however, still unknown. In this study, we investigated patient characteristics, treatment patterns, adverse events and progression-free survival in 'real-world' patients in South West Wales. A total of 60 patients, treated between 2012 and 2015, were included in the study. Patient characteristics were less favourable compared to the bevacizumab-treated high-risk group in the ICON-7 trial (median age: 66 vs. 60 years; stage IV: 58% vs. 42%; performance status 0: 18% vs. 41%); 75% had received neoadjuvant chemotherapy before starting bevacizumab. After a median treatment duration of 8 months (range=0-34 months), 45 patients (75%) had experienced disease progression and 34 (56.7%) had died. Median progression-free survival was 16 months (95% confidence interval=14.4-17.6 months). The most common toxicities consisted of proteinuria (66.7%, all grade 1) and grade 1-2 hypertension (15%). Cardiovascular incidents, two of which were fatal, occurred in 6.7% of patients. In conclusion, our study provides encouraging evidence that the routine use of bevacizumab as part of first-line treatment of patients with ovarian cancer at high risk of progression may be associated with outcomes comparable with those obtained in clinical trials. PMID:27630353

  19. Comorbidity and Inflammatory Markers May Contribute to Predict Mortality of High-Risk Patients With Chronic Obstructive Pulmonary Disease Exacerbation

    PubMed Central

    Kim, Yu Jin; Lim, Byeongwoo; Kyung, Sun Young; Park, Jeong-woong; Jeong, Sung Hwan

    2016-01-01

    Background Acute exacerbation of chronic obstructive pulmonary disease (COPD) causes not only an accelerated disease progression, but also an increased mortality rate. The purpose of this study was to analyze the factors associated with clinical features, comorbidities and mortality in patients at high risk for acute COPD exacerbation who had been hospitalized at least once in a year. Methods The study enrolled 606 patients who had been diagnosed with and were being treated for COPD at university affiliated hospital. Among them, there were 61 patients at high risk for acute exacerbation of COPD who had been hospitalized at least once in a year. A retrospective analysis was conducted to examine the factors affecting mortality. The analysis divided the patients into non-survivor and survivor groups, and reviewed their medical records for clinical aspects, comorbidities, pulmonary function tests and blood tests. Results In the high-risk group, the number of comorbidities at diagnosis (P = 0.020) and the Charlson comorbidity index value (P = 0.018) were higher in the non-survivor group than in the survivor group. During hospitalization, the non-survivor group had a significantly higher neutrophil (%) and a significantly lower lymphocyte (%) in complete blood count. Under stable conditions, the high-sensitivity C-reactive protein (hsCRP) concentration in blood plasma and neutrophil (%) were significantly higher (P = 0.025 and P = 0.036), while the lymphocyte (%) was significantly lower (P = 0.005) in the non-survivor group. A pulmonary function test revealed no statistically significant differences between the two groups. Conclusion The number of comorbidities, neutrophil (%), lymphocyte (%) in complete blood cell (CBC) and hsCRP in blood plasma concentration among the groups at high risk for COPD exacerbation are associated with increased mortality. PMID:27298662

  20. Differential expression of minimal residual disease markers in peripheral blood and bone marrow samples from high-risk neuroblastoma patients

    PubMed Central

    YAMAMOTO, NOBUYUKI; KOZAKI, AIKO; HARTOMO, TRI BUDI; YANAI, TOMOKO; HASEGAWA, DAIICHIRO; KAWASAKI, KEIICHIRO; KOSAKA, YOSHIYUKI; MATSUO, MASAFUMI; HIRASE, SATOSHI; MORI, TAKESHI; HAYAKAWA, AKIRA; IIJIMA, KAZUMOTO; NISHIO, HISAHIDE; NISHIMURA, NORIYUKI

    2015-01-01

    Neuroblastoma is an aggressive solid tumor that leads to tumor relapse in more than half of high-risk patients. Minimal residual disease (MRD) is primarily responsible for tumor relapses and may be detected in peripheral blood (PB) and bone marrow (BM) samples. To evaluate the disease status and treatment response, a number of MRD detection protocols based on either common or distinct markers for PB and BM samples have been reported. However, the correlation between the expression of MRD markers in PB and BM samples remains elusive in the clinical samples. In the present study, the expression of 11 previously validated MRD markers (CHRNA3, CRMP1, DBH, DCX, DDC, GABRB3, GAP43, ISL1, KIF1A, PHOX2B and TH) was determined in 23 pairs of PB and BM samples collected from seven high-risk neuroblastoma patients at the same time point, and the sample was scored as MRD-positive if one of the MRD markers exceeded the normal range. Although the number of MRD-positive samples was not significantly different between PB and BM samples, the two most sensitive markers for PB samples (CRMP1 and KIF1A) were different from those for BM samples (PHOX2B and DBH). There was no statistically significant correlation between the expression of MRD markers in the PB and BM samples. These results suggest that MRD markers were differentially expressed in PB and BM samples from high-risk neuroblastoma patients. PMID:26722317

  1. Detection of lower limb deep venous thrombosis in asymptomatic high risk patients using a new radiolabelled thrombus specific agent

    SciTech Connect

    Butler, S.P.; Rahman, T.; Boyd S.J.

    1995-05-01

    Deep venous thrombosis is a serious consequence of major orthopaedic surgery and non invasive screening with either venous ultrasound or impedance plethysmography is unreliable for detecting or excluding DVT in this group. A new method of thrombus detection has been devised using Tc-99m labelled inhibited recombinant tissue plasminogen activator. The accuracy of scanning with this new radiopharmaceutical in asymptomatic high risk patients was evaluated using venography as the gold standard. 36 consecutive asymptomatic high risk patients (17 total hip, 19 total knee replacements) underwent both a contrast venogram on the operated leg and scintigraphic scan 7 days following operation. Scintigraphic imaging was performed at 4 hours post injection. For the purpose of this analysis, each venogram was divided into a proximal and a distal segment. Venograms were interpreted as being positive, negative or uninterpretable in each segment. Similar analysis of the scintigraphic scans was performed except that all segments were considered to be of diagnostic quality. 57 segments were able to be analysed. Of the 13 thrombosed segments (1 proximal, 12 calf), 12 had positive scans; in the 44 non thrombosed segments, 40 had negative scans. Thus in detecting lower limb thrombosis, scanning had a sensitivity of 92% and a specificity of 91%. Scintigraphic scanning with this new radiopharmaceutical permits accurate detection of thrombus in high risk patients.

  2. Diagnostic accuracy of myocardial deformation indices for detecting high risk coronary artery disease in patients without regional wall motion abnormality

    PubMed Central

    Rostamzadeh, Alireza; Shojaeifard, Maryam; Rezaei, Yousef; Dehghan, Kasra

    2015-01-01

    Background: The prediction of coronary artery disease (CAD) by conventional echocardiographic measurements is principally based on the estimation of ejection fraction and regional wall motion abnormality (RWMA). This study aimed to determine whether strain echocardiography of left ventricle measured by velocity vector imaging (VVI) method could detect patients with a high-risk CAD. Methods: In a prospective study, a total of 119 consecutive patients who were assessed for eligibility were categorized into three groups: (1) without CAD as normal (n=59), (2) 1- or 2-vessel disease as low-risk (n=29), and (3) left main and/or 3-vessel disease as high-risk (n=31). The peaks of systolic strain and strain rate from 18 curves of apical views were averaged as global longitudinal strain and strain rate (GLS and GLSR), respectively; the 6 systolic peaks of strain and strain rate at base- and mid-ventricular of short axis views were averaged as mean radial strain rate (MRSR). Results: GLS, GLSR, and basal MRSR of left ventricle were significantly lower in the high-risk group (P=0.047, P=0.004 and P=0.030, respectively). Receiver operating characteristics curve showed that the optimal values of GLS, GLSR, and basal MRSR for detecting the severe CAD were -17%, -1 s-1, and 1.45 s-1 with the sensitivities of 77%, 71%, and 71% and the specificities of 63%, 67%, and 62%, respectively. Conclusion: Decrements in the GLS, GLSR, and basal MRSR of the left ventricle can detect the high-risk CAD cases among patients without RWMA at rest. PMID:26309603

  3. [When the conservative treatment in high-risk non-muscle invasive bladder cancer patients should be abandoned].

    PubMed

    Colombo, Renzo; Maccagnano, Carmen; Rocchini, Lorenzo; Pellucchi, Federico

    2013-01-01

    Despite the good quality of treatment expected with optimized transurethral resection (TUR) and adjuvant Bacillus Calmette-Guérin (BCG) regimen, many high-risk non-muscle invasive bladder cancer (NMIBC) patients recur and progress. According to the EORTC Tables of risk, cases with a score of 10-17 and those with a score of 7-23 should be considered as being at high risk of recurrence and progression, respectively. AUA and NCCN consider all T1 stage tumors, high grade Ta and CIS at high risk of recurrence and progression. Long-term follow-up shows that T1,G3 patients treated with BCG will suffer from up to 45% and 17% rate of recurrence and progression, respectively. Consequently, EAU, AUA and NCCN Guidelines for bladder cancer recommend radical cystectomy as a first treatment option for those patients who failed after two cycles of adjuvant BCG. However, to date, there is no definitive evidence that in this special subgroup of patients an early radical cystectomy is better than any additional salvage strategy, in terms of oncologic outcome. On the other hand, it is well accepted that radical cystectomy is burdened with consistent reduction of overall post-operative quality of life. The reluctance of patient to accept (and of surgeon to recommend) this major extirpative surgery may explain the reduced disease-free survival rate, well documented when radical cystectomy has been extremely delayed. Defining the criteria for the selection of BCG-failure patients for whom any conservative procedure should be definitively abandoned in favor of a timely radical cystectomy has become of critical importance. Recently, clinical, laboratory and pathologic acquisitions allowed the development of more accurate predictive factors for tumor progression in NMIBC. Among these factors, clinical type of BCG-failure, morphology and tumor growth patterns, pathologic sub-staging and immunohistochemistry will play a paramount role in decision-making with these patients in routine

  4. Prediction of positron emission tomography/computed tomography (PET/CT) positivity in patients with high-risk primary melanoma

    PubMed Central

    Danielsen, Maria; Kjaer, Andreas; Wu, Max; Martineau, Lea; Nosrati, Mehdi; Leong, Stanley PL; Sagebiel, Richard W; III, James R Miller; Kashani-Sabet, Mohammed

    2016-01-01

    Positron emission tomography/computed tomography (PET/CT) is an important tool to identify occult melanoma metastasis. To date, it is controversial which patients with primary cutaneous melanoma should have staging PET/CT. In this retrospective analysis of more than 800 consecutive patients with cutaneous melanoma, we sought to identify factors predictive of PET/CT positivity in the setting of newly-diagnosed high-risk primary melanoma to determine those patients most appropriate to undergo a PET/CT scan as part of their diagnostic work up. 167 patients with newly-diagnosed high-risk primary cutaneous melanoma underwent a PET/CT scan performed as part of their initial staging. Clinical and histologic factors were evaluated as possible predictors of melanoma metastasis identified on PET/CT scanning using both univariate and multivariate logistic regression. In all, 32 patients (19.2%) had a positive PET/CT finding of metastatic melanoma. In more than half of these patients (56.3%), PET/CT scanning identified disease that was not detectable on clinical examination. Mitotic rate, tumor thickness, lymphadenopathy, and bleeding were significantly predictive of PET/CT positivity. A combinatorial index constructed from these factors revealed a significant association between number of high-risk factors observed and prevalence of PET/CT positivity, which increased from 5.8% (with the presence of 0-2 factors) to 100.0%, when all four factors were present. These results indicate that combining clinical and histologic prognostic factors enables the identification of patients with a higher likelihood of a positive PET/CT scan. PMID:27766186

  5. Switching patients at high risk of PML from natalizumab to another disease-modifying therapy.

    PubMed

    Giovannoni, Gavin; Marta, Monica; Davis, Angharad; Turner, Benjamin; Gnanapavan, Sharmilee; Schmierer, Klaus

    2016-10-01

    There are several options for switching people with multiple sclerosis (MS) who are at high risk of developing progressive multifocal leukoencephalopathy (PML) from natalizumab to alemtuzumab. However, some of these have risks that need to be managed, for example, the risks of carrying over asymptomatic PML from natalizumab on to the new therapy, and the risk of rebound disease activity associated with a prolonged washout after starting natalizumab. We propose a pragmatic bridging strategy, using another disease-modifying therapy (DMT), to reduce the risk of switching from natalizumab to alemtuzumab. We also discuss the caveats and subtleties associated with sequencing DMTs in MS and the complex decision making involved. PMID:27114560

  6. Prophylactic Subclavian Artery Intraaortic Balloon Counter-Pulsation is Safe in High-Risk Cardiac Surgery Patients.

    PubMed

    Russo, Mark J; Jeevanandam, Valluvan; Hur, Michael J; Johnson, Elizabeth M; Siffring, Travis; Shah, Atman P; Raman, Jaishankar

    2015-01-01

    The objective of this study was to determine the safety of prophylactic subclavian artery intraaortic balloon pumps (SCA-IABP) in high-risk cardiac surgery patients as a bridge to recovery (BTR). From November 2011 to January 2013, 11 consecutive patients at three institutions underwent prophylactic insertion of a SCA-IABP as a BTR. All patients (n = 11) had preoperative ejection fractions of 30% or less. Patients concurrently underwent one or a combination of the following procedures: coronary artery bypass grafting, mitral valve surgery, aortic valve replacement, left ventricular aneurysm resection, and ventricular/atrial septal defect closure. The primary outcome measure was a composite endpoint of device-related complications (including limb ischemia, stroke, device failure, bleeding requiring reoperation, brachial plexus injury, device-related infection, and vascular complications) and in-hospital mortality. Secondary outcome measures included interval to patient ambulation and postoperative length of stay. There were no device-related complications or in-hospital mortalities in this cohort of 11 consecutive patients. Mean time to ambulation, balloon pump support, and postoperative length of stay were 3.70 ± 2.50 days, 8.50 ± 7.00 days, and 15.9 ± 8.25 days, respectively. Prophylactic SCA-IABPs appear to be safe in high-risk cardiac surgery patients as a BTR. PMID:26313557

  7. The role of upfront autologous stem cell transplantation in high-risk younger patients with primary central nervous system lymphoma.

    PubMed

    Cho, Hyunsoo; Chang, Jong Hee; Kim, Yu Ri; Kim, Soo-Jeong; Chung, Haerim; Park, Hyunsung; Lee, Jung Yeon; Jang, Ji Eun; Kim, Yundeok; Kim, Se Hoon; Yang, Woo Ick; Suh, Chang-Ok; Cheong, June-Won; Min, Yoo Hong; Kim, Jin Seok

    2016-08-01

    Upfront autologous stem cell transplantation (ASCT) has shown favourable outcome in patients with primary central nervous system lymphoma (PCNSL), but the role of risk-adapted upfront ASCT consolidation has not been evaluated in PCNSL. As PCNSL patients with the International Extranodal Lymphoma Study Group (IELSG) prognostic score ≥2 or those who did not achieve complete response after two courses of induction chemotherapy (non-CR1) have shown inferior outcomes, we retrospectively analysed the role of upfront ASCT in 66 high-risk (IELSG ≥2 and/or non-CR1) younger (age <65 years) immunocompetent PCNSL patients who achieved at least partial response after initial high-dose methotrexate-based chemotherapy. Nineteen patients who received upfront ASCT exhibited significantly better overall survival (OS, P = 0·021) and progression-free survival (PFS, P = 0·005) compared to 47 patients who did not. In univariate and multivariate analyses, upfront ASCT was associated with better OS (P = 0·037 and P = 0·025, respectively) and PFS (P = 0·009 and P = 0·007, respectively). In a propensity score-matched cohort (n = 36), patients who received upfront ASCT also showed better outcome (P = 0·037 for OS, P = 0·001 for PFS). Our results suggest that upfront ASCT consolidation might be especially beneficial for high-risk PCNSL patients.

  8. Effect of hypertension on outcomes of high-risk patients after BCG-treated bladder cancer: a single-institution long follow-up cohort study.

    PubMed

    Dal Moro, Fabrizio; Bovo, Alberto; Crestani, Alessandro; Vettor, Roberto; Gardiman, Marina P; Zattoni, Filiberto

    2015-03-01

    Immunotherapy with Bacillus Calmette-Guérin (BCG) is the most efficacious treatment for high-risk bladder cancer (BC) (Ta/T1 or carcinoma in situ) to reduce the risk of recurrence. Our aim was to evaluate whether hypertension and diabetes influence the outcome of patients with noninvasive BC treated with BCG instillations.In order to collect homogeneous data, we considered as "hypertensive" only those patients who had previous diagnosed hypertension and a history of taking medical therapy with antihypertensive drugs (AHT), and as "diabetic" only those prescribed oral antidiabetics or insulin (ADT).We analyzed 343 high-risk BC patients undergoing BCG (1995-2010) with a median follow-up of 116 months (range 48-238). The distribution of various kinds of AHT and antidiabetic drugs was homogeneous, with no significant differences (p > 0.05).In both univariate and multivariate analyses, the only statistically significant parameter prognostic for recurrence after BCG treatment was AHT. Recurrence-free survival curves showed a significant correlation with AHT (p = 0.0168, hazards ratio [HR] 1.45, 95% confidence interval [CI] 1.0692-1.9619); there was no correlation (p = 0.9040) with ADT (HR 0.9750, 95% CI 0.6457-1.4721). After stratification of AHT and ADT according to drug(s) prescribed, there were no significant differences in the BC recurrence rate (p > 0.05).In this study with a very long-term follow-up, hypertension alone (evaluated by AHT) revealed the increased risk of BC recurrence after BCG treatment.Several hypotheses have been formulated to support these findings, but further prospective studies are needed to both evaluate the real influence of hypertension and identify a possible prognostic factor to be used in selecting poor-prognosis BC patients as early candidates for surgical treatment.

  9. Endoscopic hemostasis by injection therapy and electro-hydro-coagulation in high-risk patients with active gastroduodenal bleeding ulcer.

    PubMed

    Boix, J; Planas, R; Humbert, P; Fabrega, C; Villagrasa, M

    1987-11-01

    For the purpose of arresting hemorrhage from bleeding gastric or duodenal ulcers we developed, in 28 high-risk patients, a new method of endoscopic local injection of epinephrine (1:10,000) followed by electro-hydro monopolar coagulation and injection of Polidocanol (1%). Nine patients had signs of shock at the time of admission. The average blood requirements were 3.9 units in the first 24 hours. All patients had important factors militating against surgery, namely age and serious primary disease. In 26 out of 28 patients (92.8%) hemostasis was accomplished during endoscopy. Three patients (10.7%) rebled within the first 36 hours, requiring emergency surgery. Thus definitive hemostasis was achieved in 23 patients (82.1%). There were no complications as a result of endoscopic treatment.

  10. Tension-free Polypropylene Mesh-related Surgical Repair for Pelvic Organ Prolapse has a Good Anatomic Success Rate but a High Risk of Complications

    PubMed Central

    Zhang, Lei; Zhu, Lan; Chen, Juan; Xu, Tao; Lang, Jing-He

    2015-01-01

    Background: Food and Drug Administration announcements have highlighted the standard rate of mesh-related complications. We aimed to report the short-term results and complications of tension-free polypropylene mesh (PROSIMA™) surgical repair of pelvic organ prolapse (POP) using the standard category (C), timing (T), and site (S) classification system. Methods: A prospective cohort study of 48 patients who underwent PROSIMA™ mesh kit-related surgical repairs were followed for two years at Peking Union Medical College Hospital. Recurrence was defined as symptomatic POP quantification (POP-Q) Stage II or higher (leading edge ≥ −1 cm). The Patient Global Impression of Change Questionnaire, the Chinese version of the Pelvic Floor Impact Questionnaire short-form-7 and POP/Urinary Incontinence Sexual Questionnaire short-form-12 were used to evaluate the self-perception and sexual function of each patient. Mesh-related complications conformed to the International Urogynecological Association/International Continence Society joint terminology. The paired-sample t-test, one-way analysis of variance, Fisher's exact test, Kaplan-Meier survival analysis and log-rank test were used to analyze data. Results: All patients were followed up for ≥12 months; 30 (62.5%) patients completed the 24 months study. We observed a 93.8% (45/48) positive anatomical outcome rate at 12 months and 90.0% (27/30) at 24 months. Recurrence most frequently involved the anterior compartment (P < 0.05). Pelvic symptoms improved significantly from baseline (P < 0.05), although the patients’ impressions of change and sexual function were not satisfying. Vaginal complication was the main complication observed (35.4%, 17/48). The survival analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse (POP-Q ≥ Stage II) (P = 0.653). Conclusions: Tension-free polypropylene mesh (PROSIMA™)-related surgical repair of POP has better short-term anatomical

  11. High-risk human papillomavirus in non-melanoma skin lesions from renal allograft recipients and immunocompetent patients

    PubMed Central

    Reuschenbach, M; Tran, T; Faulstich, F; Hartschuh, W; Vinokurova, S; Kloor, M; Krautkrämer, E; Zeier, M; von Knebel Doeberitz, M; Sommerer, C

    2011-01-01

    Background: High-risk human papillomaviruses (HR-HPVs) can be detected in a proportion of non-melanoma skin cancers. Data on prevalence are inconclusive, but are essential to estimate the relevance of HR-HPV, particularly with regard to prophylactic HPV vaccines for skin cancer prevention. Methods: High-risk human papillomavirus DNA was investigated in 140 non-melanoma skin lesions from 54 immunocompetent patients and 33 immunosuppressed renal allograft recipients. Expression of p16INK4a, a marker for HR-HPV oncogene expression in the uterine cervix, and of p53 and pRB was evaluated immunohistochemically. Results: The highest prevalence of HR-HPV was found in squamous cell cancer (SCC) (46.2% (6 out of 13) in immunosuppressed and 23.5% (4 out of 17) in immunocompetent patients). High-risk human papillomavirus positivity was accompanied by diffuse p16INK4a expression in most SCC (P<0.001) and basal cell cancers (P=0.02), while almost all SCC in situ were p16INK4a positive irrespective of HR-HPV presence (P=0.66). Diffuse p16INK4a expression was associated with lack of pRB expression (P=0.001). p53 was strongly expressed in 40.0% (56 out of 140) of the lesions irrespective of HR-HPV presence. Conclusion: High-risk human papillomavirus can be detected in lesions of keratinised squamous epithelia. The association of HR-HPV with diffuse p16INK4a expression might indicate HR-HPV oncogene expression in a proportion of lesions. Overexpression of p53 suggests p53 pathway alterations in HR-HPV-positive and -negative lesions. PMID:21427726

  12. Mapping Patterns of Ipsilateral Supraclavicular Nodal Metastases in Breast Cancer: Rethinking the Clinical Target Volume for High-risk Patients

    SciTech Connect

    Jing, Hao; Wang, Shu-Lian; Li, Jing; Xue, Mei; Xiong, Zu-Kun; Jin, Jing; Wang, Wei-Hu; Song, Yong-Wen; Liu, Yue-Ping; Ren, Hua; Fang, Hui; Yu, Zi-Hao; Liu, Xin-Fan; Li, Ye-Xiong

    2015-10-01

    Purpose: To map the location of metastatic supraclavicular (SCV) lymph nodes (LNMs) in breast cancer patients with SCV node involvement and determine whether and where the radiation therapy clinical target volume (CTV) of this region could be modified in high-risk subsets. Methods and Materials: Fifty-five patients with metastatic SCV LNMs were eligible for geographic mapping and atlas coverage analysis. All LNMs and their epicenters were registered proportionally by referencing the surrounding landmarks onto simulation computed tomography images of a standard patient. CTVs based on selected SCV atlases, including the one by the Radiation Therapy Oncology Group (RTOG) were contoured. A modified SCV CTV was tried and shown to have better involved-node coverage and thus theoretically improved prophylaxis in this setting. Results: A total of 50 (91%) and 45 (81.8%) patients had LNMs in the medial and lateral SCV subregions, respectively. Also, 36 patients (65.5%) had LNMs located at the junction of the jugular-subclavian veins. All nodes were covered in only 25.5% to 41.8% of patients by different atlases. The RTOG atlas covered all nodes in 25.5% of patients. Stratified by the nodes in all the patients as a whole, 49.2% to 81.3% were covered, and the RTOG atlas covered 62.6%. The lateral and posterior borders were the most overlooked locations. Modification by extending the borders to natural anatomic barriers allowed the new CTV to cover all the nodes in 81.8% of patients and encompass 96.1% of all the nodes. Conclusions: According to the distribution of SCV LNMs, the extent of existing atlases might not be adequate for potential metastatic sites in certain groups of patients. The extension of the lateral and posterior CTV borders in high-risk or recurrent patients might be a reasonable approach for increasing coverage. However, additional data in more homogeneous populations with localized disease are needed before routine application.

  13. [Coronary surgery on the beating heart under extracorporeal circulation in high-risk patients. An acceptable compromise?].

    PubMed

    Bel, A; Menasché, P; Faris, B; Perrault, L P; Peynet, J; de Chaumaray, T; Gatecel, C; Touchot, B; Moalic, J M; Bloch, G

    1998-07-01

    Coronary artery surgery with cardioplegia in high risk patients carries a risk of myocardial ischaemia and, without cardiopulmonary bypass, is not always technically feasible. The authors assessed an alternative, surgery on the beating heart with haemodynamic assist by cardiopulmonary bypass in 43 consecutive patients with poor left ventricular function (mean ejection fraction: 0.26), evolving myocardial ischaemia or acute myocardial infarction, old age (mean: 79.5 years) and comorbid conditions. Results were assessed mainly on clinical criteria. In addition, 9 patients had pre- and post-cardiopulmonary bypass measurements of markers of myocardial ischaemia (troponine Ic) and systemic inflammation (interleukines 6 and 10, elastase). In 6 cases, right atrial biopsy was analysed for expression of messenger ribonucleic acid coding for heat shock protein (HSP) 70; the data were compared with those of patients operated under warm blood cardioplegia. There was one cardiac death and one myocardial infarction. Myocardial conservation was confirmed by the minimal increase in troponine Ic levels and the significant increase in HSP 70 in RNA suggesting myocardial adaptation to stress. On the other hand, the minimal concentrations of mediators of inflammation were not significantly changed. In selected high risk patients, coronary revascularisation on the beating heart under cardiopulmonary bypass could be a valuable alternative. It conserves the potentially deleterious effects of cardiopulmonary bypass but peroperative global myocardial ischaemia, an important factor in the aggressivity of cardiac surgery, is eliminated.

  14. Improved Survival Endpoints With Adjuvant Radiation Treatment in Patients With High-Risk Early-Stage Endometrial Carcinoma

    SciTech Connect

    Elshaikh, Mohamed A.; Vance, Sean; Suri, Jaipreet S.; Mahan, Meredith; Munkarah, Adnan

    2014-02-01

    Purpose/Objective(s): To determine the impact of adjuvant radiation treatment (RT) on recurrence-free survival (RFS), disease-specific survival (DSS), and overall survival (OS) in patients with high-risk 2009 International Federation of Gynecology and Obstetrics stage I-II endometrial carcinoma. Methods and Materials: We identified 382 patients with high-risk EC who underwent hysterectomy. RFS, DSS, and OS were calculated from the date of hysterectomy by use of the Kaplan-Meier method. Cox regression modeling was used to explore the risks associated with various factors on survival endpoints. Results: The median follow-up time for the study cohort was 5.4 years. The median age was 71 years. All patients underwent hysterectomy and salpingo-oophorectomy, 93% had peritoneal cytology, and 85% underwent lymphadenectomy. Patients with endometrioid histology constituted 72% of the study cohort, serous in 16%, clear cell in 7%, and mixed histology in 4%. Twenty-three percent of patients had stage II disease. Adjuvant management included RT alone in 220 patients (57%), chemotherapy alone in 25 patients (7%), and chemoradiation therapy in 27 patients (7%); 110 patients (29%) were treated with close surveillance. The 5-year RFS, DSS, and OS were 76%, 88%, and 73%, respectively. On multivariate analysis, adjuvant RT was a significant predictor of RFS (P<.001) DSS (P<.001), and OS (P=.017). Lymphovascular space involvement was a significant predictor of RFS and DSS (P<.001). High tumor grade was a significant predictor for RFS (P=.038) and DSS (P=.025). Involvement of the lower uterine segment was also a predictor of RFS (P=.049). Age at diagnosis and lymphovascular space involvement were significant predictors of OS: P<.001 and P=.002, respectively. Conclusion: In the treatment of patients with high-risk features, our study suggests that adjuvant RT significantly improves recurrence-free, disease-specific, and overall survival in patients with early-stage endometrial carcinoma

  15. Improving the quality of patient handover on a surgical ward.

    PubMed

    Bradley, Alison

    2014-01-01

    The European Working Time Directive means safe patient hand over is imperative. It is the responsibility of every doctor and an issue of patient safety and clinical governance [1]. The aims of this project were to improve the quality of patient handover between combined assessment unit (CAU) and surgical ward FY1 doctors. The Royal College of Surgeons England (RCSEng) guidelines on surgical patient handover [1] were used as the standard. Data was collected throughout November 2013. A handover tool was then introduced and attached to the front of patient notes when a patient was transferred from CAU to the surgical ward. The doctor handing over the patient and the ward doctor receiving the handover signed this document. Policy was also changed so that handover should take place once the patient had received senior review on the CAU and was deemed appropriate for transfer to the surgical ward. Data from the handover tool was collated and checked against the list of surgical admission for February 2014. The number of patients handed over improved from 15 % to 45%. The quality of patient handover also improved. 0 patient handovers in November 2013 included all of the information recommended by the RCSEng guidelines. 100% of the patient handovers in February 2014 contained all the recommended information. Introduction of a handover tool and formalisation of timing of patient handover helped to improve quality and number of patients being handed over. Further work needs to be done to improve safe handover of surgical patients, particularly out of hours.

  16. Prognostic Value of Coronary Computed Tomography Imaging in Patients at High Risk Without Symptoms of Coronary Artery Disease.

    PubMed

    Dedic, Admir; Ten Kate, Gert-Jan R; Roos, Cornelis J; Neefjes, Lisan A; de Graaf, Michiel A; Spronk, Angela; Delgado, Victoria; van Lennep, Jeanine E Roeters; Moelker, Adriaan; Ouhlous, Mohamed; Scholte, Arthur J H A; Boersma, Eric; Sijbrands, Eric J G; Nieman, Koen; Bax, Jeroen J; de Feijter, Pim J

    2016-03-01

    At present, traditional risk factors are used to guide cardiovascular management of asymptomatic subjects. Intensified surveillance may be warranted in those identified as high risk of developing cardiovascular disease (CVD). This study aims to determine the prognostic value of coronary computed tomography (CT) angiography (CCTA) next to the coronary artery calcium score (CACS) in patients at high CVD risk without symptoms suspect for coronary artery disease (CAD). A total of 665 patients at high risk (mean age 56 ± 9 years, 417 men), having at least one important CVD risk factor (diabetes mellitus, familial hypercholesterolemia, peripheral artery disease, or severe hypertension) or a calculated European systematic coronary risk evaluation of >10% were included from outpatient clinics at 2 academic centers. Follow-up was performed for the occurrence of adverse events including all-cause mortality, nonfatal myocardial infarction, unstable angina, or coronary revascularization. During a median follow-up of 3.0 (interquartile range 1.3 to 4.1) years, adverse events occurred in 40 subjects (6.0%). By multivariate analysis, adjusted for age, gender, and CACS, obstructive CAD on CCTA (≥50% luminal stenosis) was a significant predictor of adverse events (hazard ratio 5.9 [CI 1.3 to 26.1]). Addition of CCTA to age, gender, plus CACS, increased the C statistic from 0.81 to 0.84 and resulted in a total net reclassification index of 0.19 (p <0.01). In conclusion, CCTA has incremental prognostic value and risk reclassification benefit beyond CACS in patients without CAD symptoms but with high risk of developing CVD.

  17. Prognostic Value of Coronary Computed Tomography Imaging in Patients at High Risk Without Symptoms of Coronary Artery Disease.

    PubMed

    Dedic, Admir; Ten Kate, Gert-Jan R; Roos, Cornelis J; Neefjes, Lisan A; de Graaf, Michiel A; Spronk, Angela; Delgado, Victoria; van Lennep, Jeanine E Roeters; Moelker, Adriaan; Ouhlous, Mohamed; Scholte, Arthur J H A; Boersma, Eric; Sijbrands, Eric J G; Nieman, Koen; Bax, Jeroen J; de Feijter, Pim J

    2016-03-01

    At present, traditional risk factors are used to guide cardiovascular management of asymptomatic subjects. Intensified surveillance may be warranted in those identified as high risk of developing cardiovascular disease (CVD). This study aims to determine the prognostic value of coronary computed tomography (CT) angiography (CCTA) next to the coronary artery calcium score (CACS) in patients at high CVD risk without symptoms suspect for coronary artery disease (CAD). A total of 665 patients at high risk (mean age 56 ± 9 years, 417 men), having at least one important CVD risk factor (diabetes mellitus, familial hypercholesterolemia, peripheral artery disease, or severe hypertension) or a calculated European systematic coronary risk evaluation of >10% were included from outpatient clinics at 2 academic centers. Follow-up was performed for the occurrence of adverse events including all-cause mortality, nonfatal myocardial infarction, unstable angina, or coronary revascularization. During a median follow-up of 3.0 (interquartile range 1.3 to 4.1) years, adverse events occurred in 40 subjects (6.0%). By multivariate analysis, adjusted for age, gender, and CACS, obstructive CAD on CCTA (≥50% luminal stenosis) was a significant predictor of adverse events (hazard ratio 5.9 [CI 1.3 to 26.1]). Addition of CCTA to age, gender, plus CACS, increased the C statistic from 0.81 to 0.84 and resulted in a total net reclassification index of 0.19 (p <0.01). In conclusion, CCTA has incremental prognostic value and risk reclassification benefit beyond CACS in patients without CAD symptoms but with high risk of developing CVD. PMID:26754124

  18. Acute Toxicity in High-Risk Prostate Cancer Patients Treated With Androgen Suppression and Hypofractionated Intensity-Modulated Radiotherapy

    SciTech Connect

    Pervez, Nadeem; Small, Cormac; MacKenzie, Marc; Yee, Don; Parliament, Matthew; Ghosh, Sunita; Mihai, Alina; Amanie, John; Murtha, Albert; Field, Colin; Murray, David; Fallone, Gino; Pearcey, Robert

    2010-01-15

    Purpose: To report acute toxicity resulting from radiotherapy (RT) dose escalation and hypofractionation using intensity-modulated RT (IMRT) treatment combined with androgen suppression in high-risk prostate cancer patients. Methods and Materials: Sixty patients with a histological diagnosis of high-risk prostatic adenocarcinoma (having either a clinical Stage of >=T3a or an initial prostate-specific antigen [PSA] level of >=20 ng/ml or a Gleason score of 8 to 10 or a combination of a PSA concentration of >15 ng/ml and a Gleason score of 7) were enrolled. RT prescription was 68 Gy in 25 fractions (2.72 Gy/fraction) over 5 weeks to the prostate and proximal seminal vesicles. The pelvic lymph nodes and distal seminal vesicles concurrently received 45 Gy in 25 fractions. The patients were treated with helical TomoTherapy-based IMRT and underwent daily megavoltage CT image-guided verification prior to each treatment. Acute toxicity scores were recorded weekly during RT and at 3 months post-RT, using Radiation Therapy Oncology Group acute toxicity scales. Results: All patients completed RT and follow up for 3 months. The maximum acute toxicity scores were as follows: 21 (35%) patients had Grade 2 gastrointestinal (GI) toxicity; 4 (6.67%) patients had Grade 3 genitourinary (GU) toxicity; and 30 (33.33%) patients had Grade 2 GU toxicity. These toxicity scores were reduced after RT; there were only 8 (13.6%) patients with Grade 1 GI toxicity, 11 (18.97%) with Grade 1 GU toxicity, and 5 (8.62%) with Grade 2 GU toxicity at 3 months follow up. Only the V60 to the rectum correlated with the GI toxicity. Conclusion: Dose escalation using a hypofractionated schedule to the prostate with concurrent pelvic lymph node RT and long-term androgen suppression therapy is well tolerated acutely. Longer follow up for outcome and late toxicity is required.

  19. HLA-DR expression on myeloid cells is a potential prognostic factor in patients with high-risk neuroblastoma.

    PubMed

    Gowda, Madhu; Payne, Kyle K; Godder, Kamar; Manjili, Masoud H

    2013-10-01

    The adaptive immune system has been reported to play a dual role in many cancers, on one hand inhibiting tumor growth and, on the other hand, promoting disease progression, escape from cancer immunosurveillance and relapse. We have previously reported that the suppression of the adaptive immune response associated with high levels of myeloid-derived suppressor cells (MDSC) was evident in patients with low-risk neuroblastoma. Here, we report the results of a pilot study demonstrating that the amounts of HLA-DR-positive or negative myeloid cells in the peripheral blood might predict disease outcome among individuals affected by high-risk neuroblastoma.

  20. Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease

    PubMed Central

    Huang, Hsuan-Li; Juang, Jyh-Ming Jimmy; Chou, Hsin-Hua; Tsao, Chueh-Yung; Wu, Tien-Yu; Ko, Yu-Lin

    2015-01-01

    Background Clinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently. Methods This retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up. Results Most of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50–782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis. Conclusions Despite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment. PMID:26599128

  1. Efficacy and adverse events of azacitidine in the treatment of hemodialysis patients with high-risk myelodysplastic syndrome.

    PubMed

    Yoshihiro, Tomoyasu; Muta, Tsuyoshi; Aoki, Kenichi; Shimamoto, Syo; Tamura, Yasuhisa; Ogawa, Ryosuke

    2016-08-01

    We describe two hemodialysis patients with high-risk myelodysplastic syndrome (MDS) treated with azacitidine. A 65-year-old woman (case 1) received azacitidine at 75 mg/m(2) for 7 days, and a 52-year-old man (case 2) with liver cirrhosis received a 70% dose of azacitidine. Both cases developed grade 4 cytopenia, but they achieved transfusion independence after 3 and 2 courses, and the durations of remission were 10 and 11 months, respectively. Case 1 had the complication of febrile neutropenia (FN) twice during the 1(st) and 2(nd) courses, but continued to receive azacitidine treatment thereafter. Case 2 developed infectious peritonitis during the sixth course, and azacitidine treatment was thus discontinued. After a 4-month treatment interruption, he became transfusion-dependent, and re-induction of azacitidine was successful. Of note, the course of case 1 was complicated by erythema nodosum on admission, which then disappeared after one course of azacitidine treatment. The mean durations of hospitalization were 17.5 and 23 days per course of azacitidine treatment, respectively. Though there are few reports of azacitidine treatment for hemodialysis patients with high-risk MDS, we advocate administering azacitidine to such patients, while paying close attention to the dose intensity of azacitidine and taking prompt action to manage infectious complications. PMID:27599416

  2. hERG1 positivity and Glut-1 negativity identifies high-risk TNM stage I and II colorectal cancer patients, regardless of adjuvant chemotherapy

    PubMed Central

    Muratori, Leonardo; Petroni, Giulia; Antonuzzo, Lorenzo; Boni, Luca; Iorio, Jessica; Lastraioli, Elena; Bartoli, Gianluca; Messerini, Luca; Di Costanzo, Francesco; Arcangeli, Annarosa

    2016-01-01

    Background The identification of early-stage colorectal cancer (CRC) with high risk of progression is one major clinical challenge, mainly due to lack of validated biomarkers. The aims of the present study were to analyze the prognostic impact of three molecular markers belonging to the ion channels and transporters family: the ether-à-go-go-related gene 1 (hERG1) and the calcium-activated KCa3.1 potassium channels, as well as the glucose transporter 1 (Glut-1); and to define the impact of adjuvant chemotherapy in conjunction with the abovementioned biomarkers, in a cohort of radically resected stage I–III CRC patients. Patients and methods The expressions of hERG1, KCa3.1, and Glut-1 were tested by immunohistochemistry on 162 surgical samples of nonmetastatic, stage I–III CRC patients. The median follow-up was 32 months. The association between biological markers, clinicopathological features, and survival outcomes was investigated by evaluating both disease-free survival and overall survival. Results Although no prognostic valence emerged for KCa3.1, evidence of a negative impact of hERG1 expression on survival outcomes was provided. On the contrary, Glut-1 expression had a positive impact. According to the results of the multivariate analysis, patients were stratified in four risk groups, based on TNM stage and hERG1/Glut-1 expression. After adjusting for adjuvant therapy, stage I and II, Glut-1-negative, and hERG1-positive patients showed the worst survival experience. Conclusion This study strongly indicates that the combination of hERG1 positivity and Glut-1 negativity behaves as a prognostic biomarker in radically resected CRC patients. This combination identifies a group of stage I and II CRC patients with a bad prognosis, even worse than that of stage III patients, regardless of adjuvant therapy accomplishment.

  3. Levetiracetam seizure prophylaxis in craniotomy patients at high risk for postoperative seizures

    PubMed Central

    Gokhale, Sankalp; Khan, Shariq Ali; Agrawal, Abhishek; Friedman, Allan H.; McDonagh, David L.

    2013-01-01

    Background: The risk of developing immediate postoperative seizures in patients undergoing supratentorial brain tumor surgery without anti-epileptic drug (AED) prophylaxis is 15-20%. Patients who present with pre-operative seizures and patients with supratentorial meningioma or supratentorial low grade gliomas are at significantly higher risk. There is little data on the efficacy of levetiracetam as a prophylactic AED in the immediate postoperative period (within 7 days of surgery) in these patients. Methods: We conducted a retrospective chart review of 165 adult patients classified as higher risk for postoperative seizures who underwent brain tumor resection at Duke University Hospital between time May 2010 and December 2011. All patients had received levetiracetam monotherapy in doses of 1000-3000 mg/day in the immediate postoperative period. Results: We identified 165 patients with following tumor locations: Frontal 83 (50.3%), Temporal 37 (22.4%), Parietal 30 (18.2%), Occipital 2 (1.2%) and 13 (7.8%) with single lesions involving more than one lobe. Histology revealed: Glioma 98 (59.4%), Meningioma 57 (34.5%) and Brain Metastases 6 (3.6%). Preoperatively, 88/165 (53.3%) patients had presented with seizures. 12/165 patients (7.3%) developed clinical seizures (generalized 10, partial 2) in the immediate post-operative period. Other than somnolence in 7 patients (4.2%), no major side-effects were noted. Conclusions: The incidence of seizures was significantly lower in patients treated with levetiracetam (7.3%) when compared with the expected (15-20%) rate without AED prophylaxis based on the previous literature. Levetiracetam appears effective and safe for seizure prevention in patients undergoing brain tumor resection and who are at significantly higher risk of developing post-operative seizures. These findings warrant confirmation in a prospective randomized trial. PMID:24550999

  4. Experience With the Wearable Cardioverter-Defibrillator in Patients at High Risk for Sudden Cardiac Death

    PubMed Central

    Günther, Michael; Quick, Silvio; Pfluecke, Christian; Rottstädt, Fabian; Szymkiewicz, Steven J.; Ringquist, Steven; Strasser, Ruth H.; Speiser, Uwe

    2016-01-01

    Background: This study evaluated the wearable cardioverter-defibrillator (WCD) for use and effectiveness in preventing sudden death caused by ventricular tachyarrhythmia or fibrillation. Methods: From April 2010 through October 2013, 6043 German WCD patients (median age, 57 years; male, 78.5%) were recruited from 404 German centers. Deidentified German patient data were used for a retrospective, nonrandomized analysis. Results: Ninety-four patients (1.6%) were treated by the WCD in response to ventricular tachyarrhythmia/fibrillation. The incidence rate was 8.4 (95% confidence interval, 6.8–10.2) per 100 patient-years. Patients with implantable cardioverter-defibrillator explantation had an incidence rate of 19.3 (95% confidence interval, 12.2–29.0) per 100 patient-years. In contrast, an incidence rate of 8.2 (95% confidence interval, 6.4–10.3) was observed in the remaining cardiac diagnosis groups, including dilated cardiomyopathy, myocarditis, and ischemic and nonischemic cardiomyopathies. Among 120 shocked patients, 112 (93%) survived 24 hours after treatment, whereas asystole was observed in 2 patients (0.03%) with 1 resulting death. ConclusionS: This large cohort represents the first nationwide evaluation of WCD use in patients outside the US healthcare system and confirms the overall value of the WCD in German treatment pathways. PMID:27458236

  5. Improved Biochemical Outcomes With Statin Use in Patients With High-Risk Localized Prostate Cancer Treated With Radiotherapy

    SciTech Connect

    Kollmeier, Marisa A.; Katz, Matthew S.; Mak, Kimberley; Yamada, Yoshiya; Feder, David J.; Zhang Zhigang; Jia Xiaoyu; Shi Weiji; Zelefsky, Michael J.

    2011-03-01

    Purpose: To investigate the association between 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) and biochemical and survival outcomes after high-dose radiotherapy (RT) for prostate cancer. Methods and Materials: A total of 1711 men with clinical stage T1-T3 prostate cancer were treated with conformal RT to a median dose of 81 Gy during 1995-2007. Preradiotherapy medication data were available for 1681 patients. Three hundred eighty-two patients (23%) were taking a statin medication at diagnosis and throughout RT. Nine hundred forty-seven patients received a short-course of neoadjuvant and concurrent androgen-deprivation therapy (ADT) with RT. The median follow-up was 5.9 years. Results: The 5- and 8-year PSA relapse-free survival (PRFS) rates for statin patients were 89% and 80%, compared with 83% and 74% for those not taking statins (p = 0.002). In a multivariate analysis, statin use (hazard ratio [HR]0.69, p = 0.03), National Comprehensive Cancer Network (NCCN) low-risk group, and ADT use were associated with improved PRFS. Only high-risk patients in the statin group demonstrated improvement in PRFS (HR 0.52, p = 0.02). Across all groups, statin use was not associated with improved distant metastasis-free survival (DMFS) (p = 0.51). On multivariate analysis, lower NCCN risk group (p = 0.01) and ADT use (p = 0.005) predicted improved DMFS. Conclusions: Statin use during high-dose RT for clinically localized prostate cancer was associated with a significant improvement in PRFS in high-risk patients. These data suggest that statins have anticancer activity and possibly provide radiosensitization when used in conjunction with RT in the treatment of prostate cancer.

  6. Expressive writing for high-risk drug dependent patients in a primary care clinic: A pilot study

    PubMed Central

    Baikie, Karen A; Wilhelm, Kay; Johnson, Beverley; Boskovic, Mary; Wedgwood, Lucinda; Finch, Adam; Huon, Gail

    2006-01-01

    Background Previous research has shown that expressive writing is beneficial in terms of both physical and emotional health outcomes. This study aimed to investigate the effectiveness and acceptability of a brief expressive writing intervention for high-risk drug dependent patients in a primary care clinic, and to determine the relationship between linguistic features of writing and health outcomes. Methods Participants completed four 15-minute expressive writing tasks over a week, in which they described their thoughts and feelings about a recent stressful event. Self-report measures of physical (SF-12) and psychological health (DASS-21) were administered at baseline and at a two-week follow-up. Fifty-three participants were recruited and 14 (26%) completed all measures. Results No statistically significant benefits in physical or psychological health were found, although all outcomes changed in the direction of improvement. The intervention was well-received and was rated as beneficial by participants. The use of more positive emotion words in writing was associated with improvements in depression and stress, and flexibility in first person pronoun use was associated with improvements in anxiety. Increasing use of cognitive process words was associated with worsening depressive mood. Conclusion Although no significant benefits in physical and psychological health were found, improvements in psychological wellbeing were associated with certain writing styles and expressive writing was deemed acceptable by high-risk drug dependent patients. Given the difficulties in implementing psychosocial interventions in this population, further research using a larger sample is warranted. PMID:17112389

  7. [Substantiation of active surgical tactics for patients with puerperal endometritis].

    PubMed

    Nikonov, A P; Ankirskaia, A S

    1991-01-01

    An active surgical tactics for managing patients (uterine wash and its cavity content vacuum aspiration) was applied in 34 patients with postnatal endometritis. Echography and hysteroscopy demonstrated that in 28 of 34 patients, the endometritis developed in the presence of pathological involvements into the uterine cavity, which made the use of surgical endometrial treatment justifiable. In addition, the surgical treatment substantially decreased the bacterial dissemination of the content in the uterine cavity. The proposed procedure enabled uterine extirpation to be avoided in 5 of 6 patients with partial suture inadequacy. PMID:2042714

  8. Increased IL6 plasma levels in indolent systemic mastocytosis patients are associated with high risk of disease progression.

    PubMed

    Mayado, A; Teodosio, C; Garcia-Montero, A C; Matito, A; Rodriguez-Caballero, A; Morgado, J M; Muñiz, C; Jara-Acevedo, M; Álvarez-Twose, I; Sanchez-Muñoz, L; Matarraz, S; Caldas, C; Muñoz-González, J I; Escribano, L; Orfao, A

    2016-01-01

    Systemic mastocytosis (SM) is a heterogeneous disease with altered interleukin (IL)-6 and IL13 plasma levels. However, no study has simultaneously investigated the plasma levels of IL1β, IL6, IL13, CCL23 and clusterin in SM at diagnosis and correlated them with disease outcome. Here we investigated IL1β, IL6, IL13, CCL23 and clusterin plasma levels in 75 SM patients--66 indolent SM (ISM) and 9 aggressive SM--and analyzed their prognostic impact among ISM cases grouped according to the extent of hematopoietic involvement of the bone marrow cells by the KIT D816V mutation. Although increased IL1β, IL6 and CCL23 levels were detected in SM patients versus healthy controls, only IL6 and CCL23 levels gradually increased with disease severity. Moreover, increased IL6 plasma levels were associated with ISM progression to more aggressive disease, in particular among ISM patients with multilineal KIT mutation (ISM-ML), these patients also showing a higher frequency of organomegalies, versus other ISM-ML patients. Of note, all ISM patients who progressed had increased IL6 plasma levels already at diagnosis. Our results indicate that SM patients display an altered plasma cytokine profile already at diagnosis, increased IL6 plasma levels emerging as an early marker for disease progression among ISM cases, in particular among high-risk ISM patients who carry multilineage KIT mutation. PMID:26153655

  9. Herbo-mineral ayurvedic treatment in a high risk acute promyelocytic leukemia patient with second relapse: 12 years follow up

    PubMed Central

    Prakash, Balendu; Parikh, Purvish M.; Pal, Sanjoy K.

    2010-01-01

    A 47 year old diabetic male patient was diagnosed and treated for high risk AML-M3 at Tata Memorial Hospital (BJ 17572), Mumbai in September 1995. His bone marrow aspiration cytology indicated 96% promyelocytes with abnormal forms, absence of lymphocytic series and myeloperoxide test 100% positive. Initially treated with ATRA, he achieved hematological remission on day 60, but cytogenetically the disease persisted. The patient received induction and consolidated chemotherapy with Daunorubicin and Cytarabine combination from 12.01.96 to 14.05.96, following which he achieved remission. However, his disease relapsed in February 97. The patient was given two cycles of chemotherapy with Idarubicine and Etoposide, after which he achieved remission. His disease again relapsed in December 97. The patient then refused more chemotherapy and volunteered for a pilot Ayurvedic study conducted by the Central Council for Research in Ayurveda and Siddha, New Delhi. The patient was treated with a proprietary Ayurvedic medicine Navajeevan, Kamadudha Rasa and Keharuba Pisti for one year. For the subsequent 5 years the patient received three months of intermittent Ayurvedic treatment every year. The patient achieved complete disease remission with the alternative treatment without any adverse side effects. The patient has so far completed 13 years of survival after the start of Ayurvedic therapy. PMID:21547051

  10. Herbo-mineral ayurvedic treatment in a high risk acute promyelocytic leukemia patient with second relapse: 12 years follow up.

    PubMed

    Prakash, Balendu; Parikh, Purvish M; Pal, Sanjoy K

    2010-07-01

    A 47 year old diabetic male patient was diagnosed and treated for high risk AML-M3 at Tata Memorial Hospital (BJ 17572), Mumbai in September 1995. His bone marrow aspiration cytology indicated 96% promyelocytes with abnormal forms, absence of lymphocytic series and myeloperoxide test 100% positive. Initially treated with ATRA, he achieved hematological remission on day 60, but cytogenetically the disease persisted. The patient received induction and consolidated chemotherapy with Daunorubicin and Cytarabine combination from 12.01.96 to 14.05.96, following which he achieved remission. However, his disease relapsed in February 97. The patient was given two cycles of chemotherapy with Idarubicine and Etoposide, after which he achieved remission. His disease again relapsed in December 97. The patient then refused more chemotherapy and volunteered for a pilot Ayurvedic study conducted by the Central Council for Research in Ayurveda and Siddha, New Delhi. The patient was treated with a proprietary Ayurvedic medicine Navajeevan, Kamadudha Rasa and Keharuba Pisti for one year. For the subsequent 5 years the patient received three months of intermittent Ayurvedic treatment every year. The patient achieved complete disease remission with the alternative treatment without any adverse side effects. The patient has so far completed 13 years of survival after the start of Ayurvedic therapy. PMID:21547051

  11. Old age, high risk medication, polypharmacy: a ‘trilogy’ of risks in older patients with atrial fibrillation

    PubMed Central

    2015-01-01

    Background: The safety of pharmacotherapy in atrial fibrillation (AF) is compounded by a trilogy of risks old age, high-risk medications (e.g., antithrombotics, antiarrhythmics), polypharmacy due to multiple patient comorbidities. However, to date, scarce study has investigated the use of polypharmacy (including potentially inappropriate medication (PIM)) in AF patients, and how this may contribute to their overall risk of medication misadventure. Objectives: To review the extent of polypharmacy and PIM use in older patients (65 years or older) with AF. Methods: Information was extracted from a database characterising a cohort of older AF patients treated in general practice in New South Wales, Australia. Patient characteristics, number and types of drugs, the degree of PIM use were recorded. The predictors for the use of polypharmacy in older AF patients were identified. Results: Overall, 367 patients (mean age 77.8 years) were reviewed, among which 94.8% used 5 medications or more and over half used 10 medications or more. Cardiovascular agents were most commonly used (98.9%), followed by antithrombotics (90.7%). Among agents deemed PIMs, digoxin (30.2%) was the most frequently used, followed by benzodiazepines (19.6%), and sotalol (9.8%). AF patients using polypharmacy were more likely to have low bleeding risk (OR=10.97), representing those patients in whom high-risk antithrombotics are mostly indicated. Patients with major-polypharmacy (5-9 medications) are more likely to have obstructive pulmonary diseases (OR=2.32), upper gastrointestinal diseases (OR=2.02) and poor physical function (OR=1.04), but less likely to have cognitive impairment (OR=0.27). Conclusion: Polypharmacy affects oldest AF patients, comprising medications that are indicated for AF, yet regarded as PIMs. Patients with lower risk of bleeding, obstructive pulmonary diseases, upper gastrointestinal diseases and poor physical function are also at higher risk of using higher number of

  12. Innovations at Miami practice show promise for treating high-risk Medicare patients.

    PubMed

    Tanio, Craig; Chen, Christopher

    2013-06-01

    Patients with five or more chronic conditions drive most Medicare costs. Our organization, ChenMed, developed a scalable primary care-led delivery model that focuses on this population while getting reimbursed through full-risk capitation by Medicare Advantage plans. ChenMed is a primary care-led group practice based in Florida that serves low-to-moderate-income elderly patients, largely through the Medicare Advantage program. Our model includes a number of innovations: a one-stop-shop approach for delivering multispecialty services in the community, smaller physician panel sizes of 350-450 patients that allow for intensive health coaching and preventive care, on-site physician pharmacy dispensing, a collaborative physician culture with peer review, and customized information technology. These innovations have improved patient medication adherence, increased the time doctors and patients spend together, and led to high rates of patient satisfaction. Additionally, our Medicare patients have substantially lower rates of hospital use than their peers in the Miami Medicare market. Creating chronic disease centers focused on seniors with multiple chronic conditions is a promising delivery system innovation with major potential to improve the cost and quality of care.

  13. Screening Magnetic Resonance Imaging Recommendations and Outcomes in Patients at High Risk for Breast Cancer

    PubMed Central

    Ehsani, Sima; Strigel, Roberta M; Pettke, Erica; Wilke, Lee; Tevaarwerk, Amye J; DeMartini, Wendy; Wisinski, Kari B

    2014-01-01

    Objective The purpose of this study was to determine MRI screening recommendations and the subsequent outcomes in women with increased risk for breast cancer evaluated by oncology subspecialists at an academic center. Patients and Methods Patients evaluated between 1/1/2007– 3/1/2011 under diagnosis codes for family history of breast or ovarian cancer, genetic syndromes, lobular carcinoma in situ or atypical hyperplasia were included. Patients with a history of breast cancer were excluded. Retrospective review of prospectively acquired demographics, lifetime risk of breast cancer and screening recommendations were obtained from the medical record. Retrospective review of the results of prospectively interpreted breast imaging examinations and image-guided biopsies were analyzed. Results 282 women were included. The majority of patients were premenopausal with a median age of 43. Most (69%) were referred due to a family history of breast or ovarian cancers. MRI was recommended for 84% of patients based on a documented lifetime risk > 20%. Most women referred for MRI screening (88%) were compliant with this recommendation. A total of 299 breast MRI examinations were performed in 146 patients. Biopsy was performed for 32 (11%) exams and 10 cancers were detected for a PPV of 31% (based on biopsy performed) and an overall per exam cancer yield of 3.3%. Three cancers were detected in patients who did not undergo screening MRI. The 13 cancers were Stage 0-II; all patients were without evidence of disease with a median follow-up of 22 months. Conclusion In a cohort of women seen by breast subspecialty providers, screening breast MRI was recommended according to guidelines, and used primarily premenopausal women with a family history or genetic predisposition to breast cancer. Adherence to MRI screening recommendations was high and cancer yield from breast MRI was similar to that in clinical trials. PMID:25789917

  14. Local anaesthetic thoracoscopy for intractable pneumothorax in a high-risk patient.

    PubMed

    Yutaka, Yojiro; Katakura, Hiromichi; Kaneda, Shohei; Yamanaka, Akira

    2012-08-01

    The management of high-operative-risk patients with a pneumothorax is complicated. The case of a 79-year old man with an intractable secondary pneumothorax, who had taken oral steroids to control asthma, is presented. Since the patient could not tolerate general anaesthesia because of poor cardiac function, thoracoscopic surgery was performed under local anaesthesia. A successful lung fistula closure was achieved and the continuous air leakage disappeared immediately after the surgery. PMID:22527089

  15. [APOPTOSIS AND NECROSIS OF CIRCULATING NEUTROPHILS IN PATIENTS WHILE HIGH RISK OF POSTOPERAIVE PERITONITIS OCCURRENCE].

    PubMed

    Sheyko, V D; Sytnik, D A; Shkurupiy, O O

    2015-11-01

    Processes of apoptosis and necrosis of peripheral neutrophils were investigated in 43 patients, operated on for an acute abdominal organs diseases on the first and fourth postoperative days. Changes of apoptosis and necrosis processes in peripheral neutrophils in dynamics were established. Unfavorable course of early postoperative period in patients with initial high and average risk of postoperative peritonitis occurrence was accompanied by shift in necrosis/apoptosis ratio towards necrosis of peripheral neutrophils.

  16. Management of vitiligo patients with surgical interventions.

    PubMed

    Shokeen, Divya

    2016-05-01

    Vitiligo is an acquired depigmentation disorder of unknown etiology. Medical treatments are usually reasonably effective for nonstable vitiligo patches; however, for vitiligo patches that have been stable for a substantial period of time, surgical intervention should be considered. In this article, surgical interventions for vitiligo are reviewed, including split-thickness skin grafting, suction blister grafting, miniature punch grafting, and cultured melanocyte transplantation. PMID:27274556

  17. High Risk of Depressive Disorders in Patients With Gout: A Nationwide Population-Based Cohort Study.

    PubMed

    Changchien, Te-Chang; Yen, Yung-Chieh; Lin, Cheng-Li; Lin, Ming-Chia; Liang, Ji-An; Kao, Chia-Hung

    2015-12-01

    Metabolic abnormalities are common in patients with depressive disorders. However, the relationship between gout and depression is unclear. We explored the causal relationship among gout, antigout medication, and the associated risk of incidental depressive disorders.In this nationwide cohort study, we sampled data from the National Health Insurance Research Database to recruit 34,050 patients with gout as the gout cohort and 68,100 controls (without gout) as the nongout cohort. Our primary endpoint was the diagnosis of depressive disorders during follow-up. The overall study population was followed up until depression diagnosis, withdrawal from the NHI program, or the end of the study. The differences in demographic and clinical characteristics between both cohorts were determined using the Chi-square test for categorical variables and the t-test for continuous variables. Cox proportional hazard regression models were used to examine the effect of gout on the risk of depression, represented using the hazard ratio with the 95% confidence interval.Patients with gout exhibited a higher risk of depressive disorders than controls did. The risk of depressive disorders increased with age and was higher in female patients and those with hypertension, stroke, and coronary artery disease. Nonsteroidal antiinflammatory drug and prednisolone use was associated with a reduced risk of depression. Patients with gout who had received antigout medication exhibited a reduced risk of depressive disorders compared with nongout patients.Our findings support that gout increases the risk of depressive disorders, and that antigout medication use reduces the risk.

  18. Management of Stroke Prevention in Canadian Patients with Atrial Fibrillation at Moderate to High Risk of Stroke

    PubMed Central

    Semchuk, William M; Levac, Brandon; Lara, Muria; Shakespeare, Annabelle; Evers, Thomas; Bolt, Jennifer

    2013-01-01

    Background Many patients with atrial fibrillation who are at moderate to high risk of stroke do not receive anticoagulation with vitamin K antagonists (VKAs) in accordance with recommendations. Objective: To determine (1) why Canadian patients with atrial fibrillation who are potentially eligible for VKA do not receive this therapy, (2) why Canadian primary care physicians discontinue VKA therapy, and (3) why VKA therapy is perceived as difficult to manage. Methods: The study involved a chart review of 3 cohorts of patients with nonvalvular atrial fibrillation at moderate to high risk of stroke: patients who had never received VKA treatment (VKA-naive), those whose treatment had been discontinued, and those whose VKA treatment was considered difficult to manage. Results: Charts for 187 patients (mean age 78.4 years, standard deviation 8.9 years) treated at 39 primary care sites were reviewed (62 treatment-naive, 42 with therapy discontinued, and 83 whose therapy was considered difficult to manage). Atrial fibrillation was paroxysmal in 82 (44%) of the patients, persistent in 47 patients (25%), and permanent in 58 (31%). One patient in each of the 3 cohorts had experienced a stroke during the 6 months before study participation. Bleeding events were more frequent among patients who had discontinued VKA therapy than in the other 2 groups. Among those whose therapy was discontinued and those whose therapy was difficult to manage, the mean time in the therapeutic range was 46.3% and 56.4%, respectively. The most common reason for not initiating VKA therapy in treatment-naive patients was the transient nature of atrial fibrillation (25/62 [40%]). The most common reason for discontinuation of VKA therapy was a bleeding event (10/42 [24%]). The presence of a concomitant chronic disease was the most common reason that a patient’s therapy was considered difficult to manage (46/83 [55%]). Conclusions: VKA therapy was not initiated or was discontinued for various reasons

  19. Phase II Trial of Radiosurgery to Magnetic Resonance Spectroscopy–Defined High-Risk Tumor Volumes in Patients With Glioblastoma Multiforme

    PubMed Central

    Einstein, Douglas B.; Wessels, Barry; Bangert, Barbara; Fu, Pingfu; Nelson, A. Dennis; Cohen, Mark; Sagar, Stephen; Lewin, Jonathan; Sloan, Andrew; Zheng, Yiran; Williams, Jordonna; Colussi, Valdir; Vinkler, Robert; Maciunas, Robert

    2015-01-01

    Purpose To determine the efficacy of a Gamma Knife stereotactic radiosurgery (SRS) boost to areas of high risk determined by magnetic resonance spectroscopy (MRS) functional imaging in addition to standard radiotherapy for patients with glioblastoma (GBM). Methods and Materials Thirty-five patients in this prospective Phase II trial underwent surgical resection or biopsy for a GBM followed by SRS directed toward areas of MRS-determined high biological activity within 2 cm of the postoperative enhancing surgical bed. The MRS regions were determined by identifying those voxels within the postoperative T2 magnetic resonance imaging volume that contained an elevated choline/N-acetylaspartate ratio in excess of 2:1. These voxels were marked, digitally fused with the SRS planning magnetic resonance image, targeted with an 8-mm isocenter per voxel, and treated using Radiation Therapy Oncology Group SRS dose guidelines. All patients then received conformal radiotherapy to a total dose of 60 Gy in 2-Gy daily fractions. The primary endpoint was overall survival. Results The median survival for the entire cohort was 15.8 months. With 75% of recursive partitioning analysis (RPA) Class 3 patients still alive 18 months after treatment, the median survival for RPA Class 3 has not yet been reached. The median survivals for RPA Class 4, 5, and 6 patients were 18.7, 12.5, and 3.9 months, respectively, compared with Radiation Therapy Oncology Group radiotherapy-alone historical control survivals of 11.1, 8.9, and 4.6 months. For the 16 of 35 patients who received concurrent temozolomide in addition to protocol radiotherapeutic treatment, the median survival was 20.8 months, compared with European Organization for Research and Treatment of Cancer historical controls of 14.6 months using radiotherapy and temozolomide. Grade 3/4 toxicities possibly attributable to treatment were 11%. Conclusions This represents the first prospective trial using selective MRS-targeted functional SRS

  20. Phase II Trial of Radiosurgery to Magnetic Resonance Spectroscopy-Defined High-Risk Tumor Volumes in Patients With Glioblastoma Multiforme

    SciTech Connect

    Einstein, Douglas B.; Wessels, Barry; Bangert, Barbara; Fu, Pingfu; Nelson, A. Dennis; Cohen, Mark; Sagar, Stephen; Lewin, Jonathan; Sloan, Andrew; Zheng Yiran; Williams, Jordonna; Colussi, Valdir; Vinkler, Robert; Maciunas, Robert

    2012-11-01

    Purpose: To determine the efficacy of a Gamma Knife stereotactic radiosurgery (SRS) boost to areas of high risk determined by magnetic resonance spectroscopy (MRS) functional imaging in addition to standard radiotherapy for patients with glioblastoma (GBM). Methods and Materials: Thirty-five patients in this prospective Phase II trial underwent surgical resection or biopsy for a GBM followed by SRS directed toward areas of MRS-determined high biological activity within 2 cm of the postoperative enhancing surgical bed. The MRS regions were determined by identifying those voxels within the postoperative T2 magnetic resonance imaging volume that contained an elevated choline/N-acetylaspartate ratio in excess of 2:1. These voxels were marked, digitally fused with the SRS planning magnetic resonance image, targeted with an 8-mm isocenter per voxel, and treated using Radiation Therapy Oncology Group SRS dose guidelines. All patients then received conformal radiotherapy to a total dose of 60 Gy in 2-Gy daily fractions. The primary endpoint was overall survival. Results: The median survival for the entire cohort was 15.8 months. With 75% of recursive partitioning analysis (RPA) Class 3 patients still alive 18 months after treatment, the median survival for RPA Class 3 has not yet been reached. The median survivals for RPA Class 4, 5, and 6 patients were 18.7, 12.5, and 3.9 months, respectively, compared with Radiation Therapy Oncology Group radiotherapy-alone historical control survivals of 11.1, 8.9, and 4.6 months. For the 16 of 35 patients who received concurrent temozolomide in addition to protocol radiotherapeutic treatment, the median survival was 20.8 months, compared with European Organization for Research and Treatment of Cancer historical controls of 14.6 months using radiotherapy and temozolomide. Grade 3/4 toxicities possibly attributable to treatment were 11%. Conclusions: This represents the first prospective trial using selective MRS-targeted functional SRS

  1. A case report of cognitive behavioural therapy for social anxiety in an ultra-high risk patient

    PubMed Central

    Haglund, Margaret; Cabaniss, Deborah; Kimhy, David; Corcoran, Cheryl M.

    2013-01-01

    Aim Psychological treatments such as cognitive behavioural therapy (CBT) may have efficacy in young people at ultra-high risk (UHR) for psychosis. Case reports can illuminate the obstacles and challenges, and potential trajectory of symptom changes, observed with this treatment. Methods This is a detailed case report of a young adult at UHR for psychosis who received manualized CBT for accompanying social anxiety. Results Cognitive deficits and suspiciousness created initial challenges for successful implementation of CBT. Engagement in treatment occurred with slowing of pace and simplification of material, and modelling of social interaction. Treatment of social anxiety was accompanied by decreases in suspiciousness, conceptual disorganization, and social anhedonia, and increase in range of affect. Conclusions Adaptation of manualized CBT to accommodate cognitive deficits and suspiciousness in UHR patients may improve engagement. CBT focused on social anxiety can lead to improvement across symptom domains in UHR patients. PMID:23734668

  2. Seroepidemiologic study of giardiasis patients and high-risk groups in a midwestern city in the United States.

    PubMed

    Sullivan, R; Linneman, C C; Clark, C S; Walzer, P D

    1987-08-01

    Serum antibodies to Giardia lamblia were measured in giardiasis patients, in groups at high risk for intestinal parasite infection, and in controls by an indirect fluorescent antibody (IFA) technique. Symptomatic patients had the highest antibody titers, and antibodies remained present for up to 18 months in persons with chronic infection. Indochinese refugees and male homosexuals with the acquired immunodeficiency syndrome (AIDS) and pre-AIDS had higher mean antibody levels than did healthy controls, whereas sewer and highway maintenance workers had levels similar to those of controls. Serum antibodies to Entamoeba histolytica measured by an indirect hemagglutination antibody technique were detected in only a few Indochinese refugees. We conclude that serology is a promising tool in G. lamblia epidemiology and that further population studies would be of interest. PMID:2886069

  3. Improving osteoporosis care in high-risk home health patients through a high intensity intervention

    PubMed Central

    Outman, Ryan C.; Curtis, Jeffrey R.; Locher, Julie L.; Allison, Jeroan J.; Saag, Kenneth G.; Kilgore, Meredith L.

    2014-01-01

    Purpose We developed and tested a multi-modal intervention, delivered in the home health care setting, aimed at increasing osteoporosis treatment rates to prevent fractures. Material and Methods The intervention focused on home health nurses. Key components included: nursing education; development of a nursing care plan; patient teaching materials and creation of physician materials. Nursing education consisted of a lecture covering osteoporosis, fracture risks and prevention, and the effectiveness of anti-osteoporosis treatment options. Patients received education materials concerning osteoporosis and anti-osteoporosis medications. A pocket-sized treatment algorithm card and standardized order sets were prepared for physicians. Focus groups of physicians and nurses were conducted to obtain feedback on the materials and methods to facilitate effective nurse-physician communication. Successful application required nurses to identify patients with a fracture history, initiate the care plan, prompt physicians on risk status, and provide patient education. The intervention was piloted in one field office. Results In the year prior to the intervention, home health patients (n=92) with a fracture history were identified in the pilot field office and only 20 (22%) received osteoporosis prescription therapy. In the three months following the intervention, 21 newly enrolled patients were identified and 9 (43%) had received osteoporosis prescription medications. Conclusions Home health care provides a venue where patients and physicians can be informed by nurses about osteoporosis and fracture risks and, consequently, initiate appropriate therapy. This multi-modal intervention is easily transportable to other home health agencies and adaptable to other medical conditions and settings. PMID:22005175

  4. Hyperfractionated Low-Dose (21 Gy) Radiotherapy for Cranial Skeletal Metastases in Patients With High-Risk Neuroblastoma

    SciTech Connect

    Kushner, Brian H.; Cheung, Nai-Kong V.; Barker, Christopher A.; Kramer, Kim; Modak, Shakeel; Yataghene, Karima; Wolden, Suzanne L.

    2009-11-15

    Purpose: To present a large experience (73 patients) using a standard radiotherapy (RT) protocol to prevent relapse in cranial sites where measurable metastatic neuroblastoma (NB), an adverse prognostic marker, is common. Methods and Materials: High-risk NB patients with measurable cranial disease at diagnosis or residual cranial disease after induction therapy had those sites irradiated with hyperfractionated 21 Gy; a brain-sparing technique was used for an extensive field. The patients were grouped according to the response to systemic therapy. Thus, when irradiated, Group 1 patients were in complete remission and Group 2 patients had primary refractory disease. Follow-up was from the start of cranial RT. Results: At 3 years, the 39 Group 1 patients had a progression-free survival rate of 51%; control of cranial disease was 79%. Two relapses involved irradiated cranial sites. Two other patients relapsed in the irradiated cranial sites 6 and 12 months after a systemic relapse. At 3 years, the 34 Group 2 patients had a progression-free survival rate of 33%; control of cranial disease was 52%. Group 2 included 19 patients who had residual cranial (with or without extracranial) disease. The cranial sites showed major (n = 13), minor (n = 2), or no response (n = 4) to RT. Five patients had progression in the cranial RT field at 10-27 months. Group 2 also included 15 patients who had persistent NB in extracranial, but not cranial, sites. Of these 15 patients, 2 relapsed in the irradiated cranial sites and elsewhere at 8 and 14 months. Cranial RT was well tolerated, with no Grade 2 or greater toxicity. Conclusion: Hyperfractionated 21-Gy cranial RT might help control NB and is feasible without significant toxicity in children.

  5. Dipeptidyl Peptidase-4 Inhibitor Use Is Not Associated With Acute Pancreatitis in High-Risk Type 2 Diabetic Patients

    PubMed Central

    Chang, Chia-Hsuin; Lin, Jou-Wei; Chen, Shu-Ting; Lai, Mei-Shu; Chuang, Lee-Ming; Chang, Yi-Cheng

    2016-01-01

    Abstract To analyze the association between use of DPP-4 inhibitors and acute pancreatitis in high-risk type 2 diabetic patients. A retrospective nationwide cohort study was conducted using the Taiwan National Health Insurance claim database. The risk associated with sitagliptin was compared to that with acarbose, a second-line antidiabetic drug prescribed for patients with similar diabetes severity and with a known neutral effect on pancreatitis. Between January 1, 2009 and December 31, 2010, a total of 8526 sitagliptin initiators and 8055 acarbose initiators who had hypertriglyceridemia or prior hospitalization history for acute pancreatitis were analyzed for the risk of hospitalization due to acute pancreatitis stratified for baseline propensity score. In the crude analysis, sitagliptin was associated with a decreased risk of acute pancreatitis (hazard ratio [HR] 0.74; 95% confidence interval [CI]: 0.62–0.88) compared to acarbose in diabetic patients with prior history of hospitalization for pancreatitis or hypertriglyceridemia. The association was abolished after stratification for propensity score quintiles (adjusted HR 0.95; 95% CI: 0.79–1.16). Similar results were found separately in both patients’ histories of prior hospitalization of acute pancreatitis (adjusted HR 0.97; 95% CI: 0.76–1.24) and those with hypertriglyceridemia (adjusted HR 0.86; 95% CI: 0.65–1.13). No significant association was found for different durations or accumulative doses of sitagliptin. In the stratified analysis, no significant effect modification was found in relation to patients’ characteristics. Use of sitagliptin was not associated with an increased risk of acute pancreatitis in high-risk diabetic patients with hypertriglyceridemia or with history of acute pancreatitis. PMID:26886601

  6. Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial

    PubMed Central

    O’Cathain, Alicia; Thomas, Clare; Edwards, Louisa; Gaunt, Daisy; Dixon, Padraig; Hollinghurst, Sandra; Nicholl, Jon; Large, Shirley; Yardley, Lucy; Fahey, Tom; Foster, Alexis; Garner, Katy; Horspool, Kimberley; Man, Mei-See; Rogers, Anne; Pope, Catherine; Montgomery, Alan A

    2016-01-01

    Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design Pragmatic, multicentre, randomised controlled trial. Setting 42 general practices in three areas of England. Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. Interventions Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. Main outcome measures The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. Results 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic −2.7 mm Hg (95% confidence interval −4.7 to −0.6 mm Hg

  7. High Risk of Under-Grading and -Staging in Prostate Cancer Patients Eligible for Active Surveillance

    PubMed Central

    Heidegger, Isabel; Skradski, Viktor; Steiner, Eberhard; Klocker, Helmut; Pichler, Renate; Pircher, Andreas; Horninger, Wolfgang; Bektic, Jasmin

    2015-01-01

    Background Active surveillance (AS) is increasingly offered to patients with low risk prostate cancer. The present study was conducted to evaluate the risk of tumor under-grading and -staging for AS eligibility. Moreover, we analyzed possible biomarkers for predicting more unfavorable final tumor histology. Methods 197 patients who underwent radical prostatectomy (RPE) but would have met the EAU (European Association of Urology) criteria for AS (PSA<10 ng/ml, biopsy GS ≤6, ≤2 cancer-positive biopsy cores with ≤50% of tumor in any core and clinical stage ≤T2a) were included in the study. These AS inclusion parameters were correlated to the final histology of the RPE specimens. The impact of preoperative PSA level (low PSA ≤4 ng/ml vs. intermediate PSA of >4–10 ng/ml), PSA density (<15 vs. ≥ 15 ng/ml) and the number of positive biopsy cores (1 vs. 2 positive cores) on predicting upgrading and final adverse histology of the RPE specimens was analyzed in uni- and multivariate analyses. Moreover, clinical courses of undergraded patients were assessed. Results In our patient cohort 41.1% were found under-graded in the biopsy (final histology 40.1% GS7, 1% GS8). Preoperative PSA levels, PSA density or the number of positive cores were not predictive for worse final pathological findings including GS >6, extraprostatic extension and positive resection margin (R1) or correlated significantly with up-grading and/or extraprostatic extension in a multivariate model. Only R1 resections were predictable by combining intermediate PSA levels with two positive biopsy cores (p = 0.004). Sub-analyses showed that the number of biopsy cores (10 vs. 15 biopsy cores) had no influence on above mentioned results on predicting biopsy undergrading. Clinical courses of patients showed that 19.9% of patients had a biochemical relapse after RPE, among all of them were undergraded in the initial biopsy. Conclusion In summary, this study shows that a multitude of patients fulfilling

  8. Haploidentical, G-CSF-primed, unmanipulated bone marrow transplantation for patients with high-risk hematological malignancies: an update.

    PubMed

    Arcese, W; Picardi, A; Santarone, S; De Angelis, G; Cerretti, R; Cudillo, L; Pennese, E; Bavaro, P; Olioso, P; Dentamaro, T; Cupelli, L; Chierichini, A; Ferrari, A; Mengarelli, A; Tirindelli, M C; Testi, M; Di Piazza, F; Di Bartolomeo, P

    2015-06-01

    Ninety-seven patients affected by high-risk hematological malignancies underwent G-CSF primed, unmanipulated bone marrow (BM) transplantation from a related, haploidentical donor. All patients were prepared with an identical conditioning regimen including Thiotepa, Busilvex, Fludarabine (TBF) and antithymocyte globulin given at myeloablative (MAC = 68) or reduced (reduced intensity conditioning (RIC) = 29) dose intensity and received the same GvHD prophylaxis consisting of the combination of methotrexate, cyclosporine, mycofenolate-mofetil and basiliximab. Patients were transplanted in 1st or 2nd CR (early phase: n = 60) or in > 2nd CR or active disease (advanced phase: n = 37). With a median time of 21 days (range 12-38 days), the cumulative incidence (CI) of neutrophil engraftment was 94 ± 3%. The 100-day CI of III-IV grade acute GvHD and the 2-year CI of extensive chronic GvHD were 9 ± 3% and 12 ± 4%, respectively. Overall, at a median follow-up of 2.2 years (range 0.3-5.6), 44 out of 97 (45%) patients are alive in CR. The 5-year probability of overall survival (OS) and disease-free survival (DFS) for patients in early and advanced phase was 53 ± 7 vs 24 ± 8% (P = 0.006) and 48 ± 7 vs 22 ± 8% (P = 0.01), respectively. By comparing MAC with RIC patient groups, the transplant-related mortality was equivalent (36 ± 6 vs 28 ± 9%) while the relapse risk was lower for the MAC patients (22 ± 6 vs 45 ± 11%), who showed higher OS (48 ± 7 vs 29 ± 10%) and DFS (43 ± 7 vs 26 ± 10%). However, all these differences did not reach a statistical significance. In multivariate analysis, diagnosis and recipient age were significant factors for OS and DFS. In conclusion, this analysis confirms, on a longer follow-up and higher number of patients, our previous encouraging results obtained by using MAC and RIC TBF regimen as conditioning for G-CSF primed, unmanipulated BM transplantation from related, haploidentical donor in patients with high-risk hematological

  9. Management of chronic empyema with unexpandable lung in poor surgical risk patients using an empyema tube

    PubMed Central

    Biswas, Abhishek; Jantz, Michael A; Penley, Andrea M; Mehta, Hiren J

    2016-01-01

    Objectives: High preoperative risk precludes decortication and other surgical interventions in some patients with chronic empyema. We manage such patients by converting the chest tube into an “empyema tube,” cutting the tube near the skin and securing the end with a sterile clip to allow for open pleural drainage. The patient is followed serially, and the tube gradually withdrawn based on radiological resolution and amount of drainage. Methods: Between 2010 and 2014, patients with chronic empyema and unexpandable lung, deemed high-risk surgical candidates, had staged chest tube removal, and were included for the study. The volume of fluid drained, culture results, duration of drainage, functional status, and comorbidities were recorded. Measurements and Results: Eight patients qualified. All had resolution of infection. The tube was removed after an average of 73.6 ± 49.73 (95% confidence interval [CI]) days. The mean duration of antibiotic treatment was 5.37 ± 1.04 (95% CI) weeks. None required surgery or experienced complications from an empyema tube. Conclusion: A strategy of empyema tube drainage with staged removal is an option in appropriately selected patients with chronic empyema, unexpandable lung, and poor surgical candidacy. PMID:27185989

  10. The patients with cariogenic high-risk after the cervico-facial radiotherapy and their management.

    PubMed

    Lăcătuşu, S; Frâncu, D; Frâncu, L

    1996-01-01

    Studying through clinical and laboratory means the bucco-dental status of the 28 patients who followed radiotherapeutical cures in the cervico-facial territory, the authors establish the apparition, at different periods of time, of the rampant caries. The rampant caries have been found in 46.42 percent of the cases, especially in patients exposed to prolonged or repeated cures of cervico-facial radiotherapy (88.88 percent) and concern the cervical zones, incisal edges and cusps, zones that are usually resistant at caries. The appearance and the severity of these types of caries are correlated with: a) the degree of reduction of the repose and stimulated salivary flow; b) the maintaining time of the low salivary flow that is dependent on the received X-ray dose and the number of cures; c) the association with sweet-drinks intake; d) the manner of effectuation of the bucco-dental hygiene; e) the setting-up or not of the some prevention measures. There are presented some preventive measures that must be set-up in this category of patients and treatment-protocols, that can be applied in the clinical situations of appearance of rampant caries after the irradiant treatment of the head and neck. The authors recommend the compulsory use of the prophylactic treatment and suggest a suitable plan of treatment that includes the reduction of microbial flora, the change of the alimentary diet, and salivary stimulates and substitutes. These measures can avoid the apparition of rampant caries, which will require ample restoration. The conclusions emphasize the fact that exists real possibilities of protection and treatment for these types of caries, depending on the clinical status of patient and the disease prognosis, when exists a tight collaboration between the radiotherapist, patients, and dentist.

  11. Patients infected with HIV are at high-risk for hepatitis E virus infection in Spain.

    PubMed

    Mateos-Lindemann, Maria Luisa; Diez-Aguilar, María; Galdamez, Ana L Gonzalez; Galán, Juan Carlos; Moreno, Ana; Pérez-Gracia, María Teresa

    2014-01-01

    Hepatitis E virus is responsible for sporadic cases of acute, self-limited viral hepatitis not only in endemic but also in industrialized countries. In addition, some reports confirm that it can cause chronic infection and even cirrhosis in immunosuppressed and also in patients infected with HIV. There are few data about prevalence and incidence of HEV chronic infection in HIV-HEV coinfected individuals in Spain. The aim of this study is to investigate the prevalence of anti-HEV IgG in a representative sample of 448 patients infected with HIV and determine the role of age, gender, and CD4 counts in the detection of anti-HEV IgG antibodies in blood. In addition, the clinical features and ALT levels in relation to the presence of anti-HEV IgM and/or HEV-RNA in the blood of these patients were investigated. Anti-HEV IgG antibodies were detected in serum using a commercial enzyme immunoassay. All positive samples were studied further for the presence of anti-HEV IgM antibodies. In addition, HEV RNA was amplified by reverse transcriptase (RT)-nested PCR in all serum samples with IgM anti-HEV. The overall prevalence of anti-HEV IgG was 10.4% (45/448, 95% C.I. 7.2-12.8%). HEV-RNA was found in only one patient out of the 45 anti-HEV IgG positive samples studied. Regarding to gender and CD4 count, no difference in seroprevalence could be observed. This prevalence data suggest that patients infected with HIV can be considered a risk group for HEV infection and that chronic coinfection HEV-HIV seems to be a very rare event. PMID:24136591

  12. Tolerability and feasibility of eptifibatide in acute coronary syndrome in patients at high risk for cardiovascular disease: A retrospective analysis*

    PubMed Central

    Azzam, Zaher S.; Sa'ad, Elias; Jabareen, Amal; Eilam, Oron; Bartha, Petru; Hadad, Salim; Krivoy, Norberto

    2005-01-01

    Background: Despite the beneficial effects of glycoprotein (GP) IIb/IIIa antagonists in patients with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), GP IIb/IIIa antagonists are rarely administered in general internal medicine wards in Israel, where most patients with UA/ NSTEMI are admitted, due to lack of adequate monitoring and safety concerns. Objective: The aims of this study were to compare the prevalence of bleeding complications in patients with UA/NSTEMI receiving combination treatment with eptifibatide (a GP IIb/IIIa antagonist), the low-molecular-weight heparin enoxaparin, and acetylsalicylic acid (ASA) versus that in patients receiving enoxaparin and ASA in internal medicine wards in Israel, and to identify risk factors for bleeding complications. Methods: This retrospective analysis included information from the database at Rambam Medical Center, Haifa, Israel. The database provided information from 4 of the 5 wards (the ward from which data were unavailable did not routinely use eptifibatide). Data were included from patients aged ≥l.8 years who were admitted to the center with a diagnosis of UA/NSTEMI, were at high risk for death and/or nonfatal ischemic events based on American College of Cardiology/American Heart Association guidelines, were to undergo coronary intervention, and who had a Thrombosis in Myocardial Infarction risk score ≥3 (moderate to high risk). Patients in the eptifibatide group received eptifibatide IV (180-μg/kg bolus followed by a continuous infusion of 2 μg/kg · min up to 72 hours), enoxaparin SC (2 mg/kg · d), and ASA (100 mg/d). Patients in the control group received enoxaparin SC (2 mg/kg - d up to 96 hours) and ASA (100 mg/d). The prevalence of bleeding events was assessed using data up to 24 hours after the end of study drug administration. Major bleeding was defined as life-threatening bleeding at any site, intracranial hemorrhage, or bleeding accompanied by a decrease in plasma

  13. Detection of candidaemia in high risk patients: can yield of blood cultures be improved by blind subculture?

    PubMed

    Søgaard, Mette; Hjort, Ulla; Højbjerg, Tove; Schønheyder, Henrik Carl

    2006-01-01

    Rapid detection of candidaemia is crucial for timely antifungal chemotherapy. However, the sensitivity of automated blood culture (BC) systems has been questioned. Blind subculture might increase detection rate and possibly also reduce time to detection of candidaemia. This retrospective study aimed to evaluate the efficacy of blind subcultures in patients deemed at high risk of candidaemia. BCs were processed by the BacT/Alert BC system, and during a 5-y period (1998-2003) subculture on the third d of incubation was performed for patients selected by clinical and microbiological assessment. A total of 79,165 BCs were drawn during the study period. 2154 BCs from 285 patients were selected for subculture. 103 (4.8%) BCs from 52 patients were yeast positive; 71 were detected positive prior to the planned subculture, 25 were positive on subculture, and 7 were negative on subculture, but became positive during further incubation. The 25 BCs positive on subculture originated from 14 patients, 11 of whom had already been diagnosed with candidaemia during the previous 14 d. Thus, a primary diagnosis of candidaemia was obtained by subculture in only 3 (1.1%) of the 285 patients selected. In conclusion, in our clinical setting blind subculture did not materially increase the detection of candidaemia, but helped to document persistent infection in a subset of cases.

  14. Surgical Management of the Pediatric Cochlear Implant Patient.

    ERIC Educational Resources Information Center

    Cohen, Seth M.; Haynes, David S.

    2003-01-01

    This article discusses the surgical management of children receiving cochlear implants. It identifies preoperative considerations to select patients likely to benefit, contraindications, some new surgical techniques, complications, special considerations (otitis media, meningitis, head growth, inner ear malformations, and cochlear obstruction).…

  15. Managing hypertension in high-risk patients: lessons and promises from the STRATHE and ADVANCE trials.

    PubMed

    Waeber, Bernard

    2006-05-01

    Pharmacological treatment of hypertension represents a cost-effective way of preventing cardiovascular and renal complications. To benefit maximally from antihypertensive treatment, blood pressure should be brought to below 140/90 mmHg in every hypertensive patient, and even lower (< 130/80 mmHg) if diabetes or renal disease co-exists. Such targets cannot usually be reached using monotherapies. This is especially true in patients who present with a high cardiovascular risk. The co-administration of two agents acting by different mechanisms considerably increases the blood pressure control rate. Such combinations are not only efficacious, but are also well tolerated, and some fixed low-dose combinations even have a placebo-like tolerability. This is the case for the preparation containing the angiotensin-converting enzyme inhibitor perindopril (2 mg) and the diuretic indapamide (0.625 mg), a fixed low-dose combination that has been shown in controlled trials to be more effective than monotherapies in reducing albuminuria, regressing cardiac hypertrophy and improving the stiffness of large arteries. Using this combination to initiate antihypertensive therapy has been shown in a double-blind trial (Strategies of Treatment in Hypertension: Evaluation; STRATHE) to normalize blood pressure (< 140/90 mmHg) in significantly more patients (62%) than a sequential monotherapy approach based on atenolol, losartan and amlodipine (49%) and a stepped-care strategy based on valsartan and hydrochlorothiazide (47%), with no difference between the three arm groups in terms of tolerability. An ongoing randomized trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation; ADVANCE) is a study with a 2 x 2 factorial design assessing the effects of the fixed-dose perindopril-indapamide combination and of the intensive gliclazide modified release-based glucose control regimen in type 2 diabetic patients, with or without hypertension. A

  16. Blood transfusion after total shoulder arthroplasty: Which patients are at high risk?

    PubMed Central

    Kandil, Abdurrahman; Griffin, Justin W.; Novicoff, Wendy M.; Brockmeier, Stephen F.

    2016-01-01

    Purpose: There are multiple reported risk factors and a wide range of reported blood transfusion rates for total shoulder arthroplasty (TSA). There are no evidence-based guidelines for blood transfusions in TSA patients. Materials and Methods: We utilized the Nationwide Inpatient Sample to analyze 51,191 patients undergoing TSA between 1998 and 2011. The purpose was to describe the incidence and identify the preoperative factors that are independently associated with blood transfusion after TSA. In addition, we studied the association of blood transfusions with certain variables such as length of stay (LOS), total charges, and payer status. Results: The blood transfusion rate in our study was 6.1%. There was no difference in the rate of blood transfusions over the study period (P < 0.001). In our logistic regression model, significant associations were found with increased age (odds ratio [OR] =1.03), white race (OR = 1.05), higher Charlson-Deyo score (OR = 1.12), presence of ischemic heart disease (OR = 1.24), blood loss anemia (OR = 1.65), female gender (OR = 1.94), presence of coagulation disorders (OR = 2.25), and presence of deficiency anemia (OR = 3.5). Patients receiving a blood transfusion had higher total charges, a longer hospital LOS, and were more likely to be Medicare payers (P < 0.001). Conclusions: Our study found five clinically significant risk factors for blood transfusions for TSA: female gender, ischemic heart disease, deficiency anemia, coagulation disorder, and blood loss anemia. Patients with these risk factors should be considered higher risk for requiring a blood transfusion after TSA and counseled appropriately. Level of Evidence: Level II, retrospective cohort study, prognostic study. PMID:27186059

  17. New oral anticoagulants: their role in stroke prevention in high-risk patients with atrial fibrillation.

    PubMed

    Ferns, Sunita J; Naccarelli, Gerald V

    2015-07-01

    Based on efficacy, safety, and ease of use, novel oral anticoagulants will likely replace VKAs for many if not most patients with atrial fibrillation. Novel anticoagulants have a lower rate of intracranial hemorrhage compared with vitamin K antagonists. The incidence of other life-threatening bleeds is similar if not lower. Dose adjustments need to be made based on renal function and advanced age. There is at present a need for an antidote for these new drugs.

  18. Haptoglobin phenotype is not a predictor of recurrence free survival in high-risk primary breast cancer patients

    PubMed Central

    Gast, Marie-Christine W; van Tinteren, Harm; Bontenbal, Marijke; van Hoesel, René QGCM; Nooij, Marianne A; Rodenhuis, Sjoerd; Span, Paul N; Tjan-Heijnen, Vivianne CG; de Vries, Elisabeth GE; Harris, Nathan; Twisk, Jos WR; Schellens, Jan HM; Beijnen, Jos H

    2008-01-01

    Background Better breast cancer prognostication may improve selection of patients for adjuvant therapy. We conducted a retrospective follow-up study in which we investigated sera of high-risk primary breast cancer patients, to search for proteins predictive of recurrence free survival. Methods Two sample sets of high-risk primary breast cancer patients participating in a randomised national trial investigating the effectiveness of high-dose chemotherapy were analysed. Sera in set I (n = 63) were analysed by surface enhanced laser desorption ionisation time-of-flight mass spectrometry (SELDI-TOF MS) for biomarker finding. Initial results were validated by analysis of sample set II (n = 371), using one-dimensional gel-electrophoresis. Results In sample set I, the expression of a peak at mass-to-charge ratio 9198 (relative intensity ≤ 20 or > 20), identified as haptoglobin (Hp) alpha-1 chain, was strongly associated with recurrence free survival (global Log-rank test; p = 0.0014). Haptoglobin is present in three distinct phenotypes (Hp 1-1, Hp 2-1, and Hp 2-2), of which only individuals with phenotype Hp 1-1 or Hp 2-1 express the haptoglobin alpha-1 chain. As the expression of the haptoglobin alpha-1 chain, determined by SELDI-TOF MS, corresponds to the phenotype, initial results were validated by haptoglobin phenotyping of the independent sample set II by native one-dimensional gel-electrophoresis. With the Hp 1-1 phenotype as the reference category, the univariate hazard ratio for recurrence was 0.87 (95% CI: 0.56 – 1.34, p = 0.5221) and 1.03 (95% CI: 0.65 – 1.64, p = 0.8966) for the Hp 2-1 and Hp 2-2 phenotypes, respectively, in sample set II. Conclusion In contrast to our initial results, the haptoglobin phenotype was not identified as a predictor of recurrence free survival in high-risk primary breast cancer in our validation set. Our initial observation in the discovery set was probably the result of a type I error (i.e. false positive). This study

  19. Short-term clinicopathological outcome of neoadjuvant chemohormonal therapy comprising complete androgen blockade, followed by treatment with docetaxel and estramustine phosphate before radical prostatectomy in Japanese patients with high-risk localized prostate cancer

    PubMed Central

    2012-01-01

    Background To assess the outcome of neoadjuvant chemohormonal therapy comprising complete androgen blockade followed by treatment with docetaxel and estramustine phosphate before radical prostatectomy in Japanese patients with a high risk of localized prostate cancer (PCa). Methods Complete androgen blockade followed by 6 cycles of docetaxel (30 mg/m2) with estramustine phosphate (560 mg) were given to 18 PCa patients before radical prostatectomy. Subsequently, the clinical and pathological outcomes were analyzed. Results No patients had severe adverse events during chemohormonal therapy, and hence they were treated with radical prostatectomy. Two patients (11.1%) achieved pathological complete response. Surgical margins were negative in all patients. At a median follow-up of 18 months, 14 patients (77.8%) were disease-free without PSA recurrence. All 4 patients with PSA recurrence had pathologic T3b or T4 disease and 3 of these 4 patients had pathologic N1 disease. Conclusion We found that neoadjuvant chemohormonal therapy with complete androgen blockade followed by treatment with docetaxel and estramustine phosphate before radical prostatectomy was safe, feasible, and associated with favorable pathological outcomes in patients with a high risk of localized PCa. PMID:22214417

  20. Patients' Perspectives of Surgical Safety: Do They Feel Safe?

    PubMed Central

    Dixon, Jennifer L.; Tillman, Matthew M.; Wehbe-Janek, Hania; Song, Juhee; Papaconstantinou, Harry T.

    2015-01-01

    Background Increased focus on reducing patient harm has led to surgical safety initiatives, including time-out, surgical safety checklists, and debriefings. The perception of the lay public of the surgical safety process is largely unknown. Methods A 20-question survey focused on perceptions of surgical safety practice was distributed to a random sample of patients following elective operations requiring hospitalization. Responses were measured by a 7-point Likert scale. Qualitative feedback was obtained through nonphysician-moderated sessions. Participation was voluntary and anonymous. Results Surveys were distributed to 345 patients of whom 102 (29.5%) responded. Overall, patients felt safe as evidenced by scores for the questions “I felt safe the day of my surgery” (6.53 ± 0.72) and “Mistakes rarely happen during surgery” (5.39 ± 1.51). Patients undergoing their first surgery and patients with higher income levels were associated with a significant decrease in specific safety perceptions. Qualitative feedback sessions identified the physician-patient relationship as the most important factor positively influencing patient safety perceptions. Conclusion Current surgical safety practice is perceived positively by our patients; however, patients still identify physician-patient interactions, relationships, and trust as the most positive factors influencing their perception of the safety environment. PMID:26130976

  1. Next-generation-sequencing of recurrent childhood high hyperdiploid acute lymphoblastic leukemia reveals mutations typically associated with high risk patients.

    PubMed

    Chen, Cai; Bartenhagen, Christoph; Gombert, Michael; Okpanyi, Vera; Binder, Vera; Röttgers, Silja; Bradtke, Jutta; Teigler-Schlegel, Andrea; Harbott, Jochen; Ginzel, Sebastian; Thiele, Ralf; Husemann, Peter; Krell, Pina F I; Borkhardt, Arndt; Dugas, Martin; Hu, Jianda; Fischer, Ute

    2015-09-01

    20% of children suffering from high hyperdiploid acute lymphoblastic leukemia develop recurrent disease. The molecular mechanisms are largely unknown. Here, we analyzed the genetic landscape of five patients at relapse, who developed recurrent disease without prior high-risk indication using whole-exome- and whole-genome-sequencing. Oncogenic mutations of RAS pathway genes (NRAS, KRAS, FLT3, n=4) and deactivating mutations of major epigenetic regulators (CREBBP, EP300, each n=2 and ARID4B, EZH2, MACROD2, MLL2, each n=1) were prominent in these cases and virtually absent in non-recurrent cases (n=6) or other pediatric acute lymphoblastic leukemia cases (n=18). In relapse nucleotide variations were detected in cell fate determining transcription factors (GLIS1, AKNA). Structural genomic alterations affected genes regulating B-cell development (IKZF1, PBX1, RUNX1). Eleven novel translocations involved the genes ART4, C12orf60, MACROD2, TBL1XR1, LRRN4, KIAA1467, and ELMO1/MIR1200. Typically, patients harbored only single structural variations, except for one patient who displayed massive rearrangements in the context of a germline tumor suppressor TP53 mutation and a Li-Fraumeni syndrome-like family history. Another patient harbored a germline mutation in the DNA repair factor ATM. In summary, the relapse patients of our cohort were characterized by somatic mutations affecting the RAS pathway, epigenetic and developmental programs and germline mutations in DNA repair pathways. PMID:26189108

  2. Identification of high-risk patients by human epididymis protein 4 levels during follow-up of ovarian cancer

    PubMed Central

    STEFFENSEN, KARINA DAHL; WALDSTRØM, MARIANNE; BRANDSLUND, IVAN; LUND, BENTE; SØRENSEN, SARAH MEJER; PETZOLD, MAX; JAKOBSEN, ANDERS

    2016-01-01

    The majority of ovarian cancer patients with advanced disease at diagnosis will relapse following primary treatment, with a dismal prognosis. Monitoring the levels of serum markers in patients under follow-up may be essential for the early detection of relapse, and for distinguishing high-risk patients from those with less aggressive disease. The aim of the present study was to investigate the possible predictive value of human epididymis protein 4 (HE4) and carbohydrate antigen 125 (CA125) in relation to recurrence of epithelial ovarian cancer by measuring the two markers during follow-up subsequent to surgery and adjuvant first-line carboplatin/paclitaxel chemotherapy. Serum HE4 and CA125 were analyzed in 88 epithelial ovarian cancer patients at the end of treatment and consecutively during follow-up. The patients were divided into a high-risk and a low-risk group based on having an increase in HE4 and CA125 levels above or below 50% during follow-up, relative to the baseline (end-of-treatment) level. Disease recurrence was detected in 55 patients during follow-up. Patients with an increase in HE4 of >50% at 3- and 6-month follow-up compared to the end-of-treatment sample had significantly poorer progression-free survival (PFS) [hazard ratio (HR), 2.82 (95% CI, 0.91–8.79; P=0.0052) and HR, 7.71 (95% CI, 3.03–19.58; P<0.0001), respectively]. The corresponding 3- and 6-month biomarker assessments for increased CA125 levels (>50%) showed HRs of 1.86 (95% CI, 0.90–3.80; P=0.0512) and 2.55 (95% CI, 1.39–4.68; P=0.0011), respectively. Multivariate analysis confirmed HE4 as a predictor of short PFS, with an HR of 8.23 (95% CI, 3.28–20.9; P<0.0001) at 6-month follow-up. The increase of CA125 was not a significant prognostic factor in multivariate analysis for PFS. In conclusion, HE4 appears to be a sensitive marker of recurrence and instrumental in risk assessment during the first 6 months of follow-up. PMID:27313725

  3. Evaluation of the Potential Role of Alirocumab in the Management of Hypercholesterolemia in Patients with High-Risk Cardiovascular Disease.

    PubMed

    Okere, Arinze Nkemdirim; Serra, Courtney

    2015-08-01

    A high level of low-density lipoprotein cholesterol (LDL-C) has proved to have a positive correlation with mortality from cardiovascular disease, and it is the key modifiable risk factor for cardiovascular disease. Lowering levels of LDL-C with statins reduces both vascular morbidity and mortality; however, myalgias occur in 10% to 15% of patients, and many patients managed with statins achieve suboptimal levels of LDL-C. The injectable drug alirocumab-the first of a new class of drugs called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors-is a monoclonal antibody to the PCSK9 gene, which regulates LDL receptor expression and circulating levels of LDL-C. In this review, we evaluated the efficacy and safety of alirocumab and its potential role in the management of patients with high-risk cardiovascular disease. Data were gathered from articles indexed in the PubMed database (2006-April 2015). All English-language, prospective, randomized, double-blinded trials evaluating the efficacy of alirocumab, as a monotherapy or in combination with statins, for treatment of hypercholesterolemia were identified. Five clinical trials were evaluated, and the results from these studies revealed that the use of alirocumab, both as monotherapy or in combination with statins, significantly reduced LDL-C levels. Patients treated with alirocumab, with or without statins, were more likely to achieve LDL-C goals of less than 100 or 70 mg/dl compared with placebo. Despite its ability to lower LDL-C level, one study did not show any antiinflammatory activity (i.e., reduced C-reactive protein level) among patients who received alirocumab; however, more clinical trials will be needed to further assess this effect. Alirocumab also appears to cause regression of plaque. The most commonly reported adverse effect was mild injection-site reaction. With increased odds of statin discontinuation among patients taking high-intensity statins, alirocumab will contribute to

  4. Evaluation of the Potential Role of Alirocumab in the Management of Hypercholesterolemia in Patients with High-Risk Cardiovascular Disease.

    PubMed

    Okere, Arinze Nkemdirim; Serra, Courtney

    2015-08-01

    A high level of low-density lipoprotein cholesterol (LDL-C) has proved to have a positive correlation with mortality from cardiovascular disease, and it is the key modifiable risk factor for cardiovascular disease. Lowering levels of LDL-C with statins reduces both vascular morbidity and mortality; however, myalgias occur in 10% to 15% of patients, and many patients managed with statins achieve suboptimal levels of LDL-C. The injectable drug alirocumab-the first of a new class of drugs called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors-is a monoclonal antibody to the PCSK9 gene, which regulates LDL receptor expression and circulating levels of LDL-C. In this review, we evaluated the efficacy and safety of alirocumab and its potential role in the management of patients with high-risk cardiovascular disease. Data were gathered from articles indexed in the PubMed database (2006-April 2015). All English-language, prospective, randomized, double-blinded trials evaluating the efficacy of alirocumab, as a monotherapy or in combination with statins, for treatment of hypercholesterolemia were identified. Five clinical trials were evaluated, and the results from these studies revealed that the use of alirocumab, both as monotherapy or in combination with statins, significantly reduced LDL-C levels. Patients treated with alirocumab, with or without statins, were more likely to achieve LDL-C goals of less than 100 or 70 mg/dl compared with placebo. Despite its ability to lower LDL-C level, one study did not show any antiinflammatory activity (i.e., reduced C-reactive protein level) among patients who received alirocumab; however, more clinical trials will be needed to further assess this effect. Alirocumab also appears to cause regression of plaque. The most commonly reported adverse effect was mild injection-site reaction. With increased odds of statin discontinuation among patients taking high-intensity statins, alirocumab will contribute to

  5. Solitary pulmonary metastases in high-risk melanoma patients: a prospective comparison of conventional and computed tomography

    SciTech Connect

    Heaston, D.K.; Putman, C.E.; Rodan, B.A.; Nicholson, E.; Ravin, C.E.; Korobkin, M.; Chen, J.T.; Seigler, H.F.

    1983-07-01

    A prospective comparison of chest radiography, conventional tomography, and computed tomography (CT) in the detection or confirmation of solitary pulmonary nodules was made in 42 patients with high propensity for pulmonary metastases due to advanced local (Clark level IV or V) or regional malignant melanoma. Unequivocal nodules were revealed by chest radiography in 11 patients, conventional tomograhy in 16, and computed tomography in 20 patients. Both plain films and tomography in three of these 20 were normal, but follow-up verified pulmonary metastases. Computed tomography detected more pulmonary nodules than conventional tomography in 11 patients in addition to identifying lesions in extrapulmonary sites. Therefore, chest CT is recommended before institution of immunotherapy or surgical removal of a solitary pulmonary melanoma metastasis. Once chemotherapy had been instituted for bulky regional or cutaneous involvement, however, the findings of either conventional or computed tomography were comparable in this study.

  6. Defensive Projection, Superimposed on Simplistic Object Relations, Erodes Patient-Provider Relationships in High-Risk Pregnancy: An Empirical Investigation

    PubMed Central

    Shahar, Golan; Porcerelli, John H.; Kamoo, Ray; Epperson, C. Neill; Czarkowski, Kathryn A.; Magriples, Urania; Mayes, Linda C.

    2014-01-01

    In an attempt to illustrate the relevance of psychoanalytic theory and research to behavior medicine, an empirical investigation was conducted of females treated at a high-risk pregnancy specialty clinic (N = 58). Drawing from psychoanalytic object relations theory, it was hypothesized and confirmed that use of projection as a defense mechanism during pregnancy, superimposed on simplistic object relations, predicted an erosion of patient-provider relationships during the pregnancy/postdelivery period. Findings are interpreted through the perspective of mentalization, pertaining to individuals' ability to understand the mental states of self and others, specifically under significant stress. Implications for psychoanalytically oriented assessment and treatment, and for the rift between psychoanalysis and research, are discussed. PMID:21156840

  7. High-Risk Cardiovascular Patients: Clinical Features, Comorbidities, and Interconnecting Mechanisms

    PubMed Central

    Schuett, Katharina Andrea; Lehrke, Michael; Marx, Nikolaus; Burgmaier, Mathias

    2015-01-01

    Cardiovascular disease is the leading cause of death in the Western world with an increase over the last few decades. Atherosclerosis with its different manifestations in the coronary artery tree, the cerebral, as well as peripheral arteries is the basis for cardiovascular events, such as myocardial infarction, stroke, and cardiovascular death. The pathophysiological understanding of the mechanisms that promote the development of vascular disease has changed over the last few decades, leading to the recognition that inflammation and inflammatory processes in the vessel wall are major contributors in atherogenesis. In addition, a subclinical inflammatory status, e.g., in patients with diabetes or the presence of a chronic inflammatory disease, such as rheumatoid arthritis, have been recognized as strong risk factors for cardiovascular disease. The present review will summarize the different inflammatory processes in the vessel wall leading to atherosclerosis and highlight the role of inflammation in diabetes and chronic inflammatory diseases for cardiovascular morbidity and mortality. PMID:26635805

  8. High-Risk Cardiovascular Patients: Clinical Features, Comorbidities, and Interconnecting Mechanisms.

    PubMed

    Schuett, Katharina Andrea; Lehrke, Michael; Marx, Nikolaus; Burgmaier, Mathias

    2015-01-01

    Cardiovascular disease is the leading cause of death in the Western world with an increase over the last few decades. Atherosclerosis with its different manifestations in the coronary artery tree, the cerebral, as well as peripheral arteries is the basis for cardiovascular events, such as myocardial infarction, stroke, and cardiovascular death. The pathophysiological understanding of the mechanisms that promote the development of vascular disease has changed over the last few decades, leading to the recognition that inflammation and inflammatory processes in the vessel wall are major contributors in atherogenesis. In addition, a subclinical inflammatory status, e.g., in patients with diabetes or the presence of a chronic inflammatory disease, such as rheumatoid arthritis, have been recognized as strong risk factors for cardiovascular disease. The present review will summarize the different inflammatory processes in the vessel wall leading to atherosclerosis and highlight the role of inflammation in diabetes and chronic inflammatory diseases for cardiovascular morbidity and mortality. PMID:26635805

  9. Managing high-risk patients: the Mass General care management programme.

    PubMed

    Kodner, Dennis L

    2015-01-01

    The Massachusetts General Care Management Program (Mass General CMP or CMP) was designed as a federally supported demonstration to test the impact of intensive, practice-based care management on high-cost Medicare fee-for-service (FFS) beneficiaries-primarily older persons-with multiple hospitalisations and multiple chronic conditions. The Massachusetts General Care Management Program operated over a 6-year period in two phases (3 years each). It started during the first phase at Massachusetts General Hospital, a major academic medical centre in Boston, Massachusetts in collaboration with Massachusetts General Physicians Organisation. During the second phase, the programme expanded to two more affiliated sites in and around the Boston area, including a community hospital, as well as incorporated several modifications primarily focused on the management of transitions to post-acute care in skilled nursing facilities. At the close of the demonstration in July 2012, Mass General Massachusetts General Care Management Program became a component of a new Pioneer accountable care organisation (ACO). The Massachusetts General Care Management Program is focused on individuals meeting defined eligibility criteria who are offered care that is integrated by a case manager embedded in a primary care practice. The demonstration project showed substantial cost savings compared to fee-for-service patients served in the traditional Medicare system but no impact on hospital readmissions. The Massachusetts General Care Management Program does not rest upon a "whole systems" approach to integrated care. It is an excellent example of how an innovative care co-ordination programme can be implemented in an existing health-care organisation without making fundamental changes in its underlying structure or the way in which direct patient care services are paid for. The accountable care organisation version of the Massachusetts General Care Management Program includes the staffing structure

  10. Ex Vivo Expanded Natural Killer Cells Demonstrate Robust Proliferation In Vivo In High-Risk Relapsed Multiple Myeloma Patients

    PubMed Central

    Szmania, Susann; Lapteva, Natalia; Garg, Tarun; Greenway, Amy; Lingo, Joshuah; Nair, Bijay; Stone, Katie; Woods, Emily; Khan, Junaid; Stivers, Justin; Panozzo, Susan; Campana, Dario; Bellamy, William T.; Robbins, Molly; Epstein, Joshua; Yaccoby, Shmuel; Waheed, Sarah; Gee, Adrian; Cottler-Fox, Michele; Rooney, Cliona; Barlogie, Bart; van Rhee, Frits

    2015-01-01

    Highly activated/expanded natural killer (NK) cells can be generated via stimulation with the HLA-deficient cell line K562 genetically modified to express 41BB-ligand and membrane-bound interleukin (IL)15. We tested the safety, persistence and activity of expanded NK cells generated from myeloma patients (auto-NK) or haplo-identical family donors (allo-NK) in heavily pretreated patients with high-risk relapsing myeloma. The preparative regimen comprised bortezomib only or bortezomib and immunosuppression with cyclophosphamide, dexamethasone and fludarabine. NK cells were shipped overnight either cryopreserved or fresh. In 8 patients, up to 1×108 NK cells/kg were infused on day 0 and followed by daily administrations of IL2. Significant in vivo expansion was observed only in the 5 patients receiving fresh products, peaking at or near day 7, with the highest NK cell counts in 2 subjects who received cells produced in a high concentration of IL2 (500 units/mL). Seven days after infusion, donor NK cells comprised > 90% of circulating leukocytes in fresh allo-NK cell recipients, and cytolytic activity against allogeneic myeloma targets was retained in vitro. Among the 7 evaluable patients, there were no serious adverse events that could be related to NK cell infusion. One patient had a partial response and in another the tempo of disease progression decreased; neither patient required further therapy for 6 months. In the 5 remaining patients, disease progression was not affected by NK cell infusion. In conclusion, infusion of large numbers of expanded NK cells was feasible and safe; infusing fresh cells was critical to their expansion in vivo. PMID:25415285

  11. Altered depth of the olfactory sulcus in ultra high-risk individuals and patients with psychotic disorders.

    PubMed

    Takahashi, Tsutomu; Wood, Stephen J; Yung, Alison R; Nelson, Barnaby; Lin, Ashleigh; Yücel, Murat; Phillips, Lisa J; Nakamura, Yumiko; Suzuki, Michio; Brewer, Warrick J; Proffitt, Tina M; McGorry, Patrick D; Velakoulis, Dennis; Pantelis, Christos

    2014-03-01

    A shallow olfactory sulcus has been reported in schizophrenia, possibly reflecting abnormal forebrain development during early gestation. However, it remains unclear whether this anomaly exists prior to the onset of psychosis and/or differs according to illness stage. In the current study, magnetic resonance imaging was used to investigate the length and depth of the olfactory sulcus in 135 ultra high-risk (UHR) individuals [of whom 52 later developed psychosis (UHR-P) and 83 did not (UHR-NP)], 162 patients with first-episode psychosis (FEP), 89 patients with chronic schizophrenia, and 87 healthy controls. While there was no group difference in the length of the sulcus, UHR-P subjects had significantly shallower olfactory sulcus at baseline as compared with UHR-NP and control subjects. The depth of this sulcus became increasingly more superficial as one moved from UHR-P subjects to FEP patients to chronic schizophrenia patients. Finally, the depth of the olfactory sulcus in the UHR-P subjects was negatively correlated with the severity of negative symptoms. These findings suggest that the altered depth of the olfactory sulcus, which exists before psychosis onset, could be predictive of transition to psychosis, but also suggest ongoing changes of the sulcus morphology during the course of the illness.

  12. Clinical significance of CD81 expression by clonal plasma cells in high-risk smoldering and symptomatic multiple myeloma patients.

    PubMed

    Paiva, B; Gutiérrez, N-C; Chen, X; Vídriales, M-B; Montalbán, M-Á; Rosiñol, L; Oriol, A; Martínez-López, J; Mateos, M-V; López-Corral, L; Díaz-Rodríguez, E; Pérez, J-J; Fernández-Redondo, E; de Arriba, F; Palomera, L; Bengoechea, E; Terol, M-J; de Paz, R; Martin, A; Hernández, J; Orfao, A; Lahuerta, J-J; Bladé, J; Pandiella, A; Miguel, J-F San

    2012-08-01

    The presence of CD19 in myelomatous plasma cells (MM-PCs) correlates with adverse prognosis in multiple myeloma (MM). Although CD19 expression is upregulated by CD81, this marker has been poorly investigated and its prognostic value in MM remains unknown. We have analyzed CD81 expression by multiparameter flow cytometry in MM-PCs from 230 MM patients at diagnosis included in the Grupo Español de Mieloma (GEM)05>65 years trial as well as 56 high-risk smoldering MM (SMM). CD81 expression was detected in 45% (103/230) MM patients, and the detection of CD81(+) MM-PC was an independent prognostic factor for progression-free (hazard ratio=1.9; P=0.003) and overall survival (hazard ratio=2.0; P=0.02); this adverse impact was validated in an additional series of 325 transplant-candidate MM patients included in the GEM05 <65 years trial. Moreover, CD81(+) SMM (n=34/56, 57%) patients had a shorter time to progression to MM (P=0.02). Overall, our results show that CD81 may have a relevant role in MM pathogenesis and represent a novel adverse prognostic marker in myeloma. PMID:22333880

  13. Occult gastrointestinal bleeding in high-risk intensive care unit patients receiving antacid prophylaxis: frequency and significance.

    PubMed

    Derrida, S; Nury, B; Slama, R; Marois, F; Moreau, R; Soupison, T; Sicot, C

    1989-02-01

    Gastroccult reagent was used every 4 h to detect blood in gastric juice in 41 ICU patients at risk of GI bleeding (GB) and receiving antacid prophylaxis (gastric pH greater than 3.5). Of the present patients, 27% (11/41) had at least one episode of occult GB (three consecutive positive determinations; a total of 14 episodes). Endoscopy identified acute gastroduodenal mucosal lesions (stress ulcers) as the most frequent lesion in this group (eight patients). Sepsis was the most frequent underlying condition associated with occult GB due to stress ulcer. Hematemesis occurred in 36% (4/11) of patients with occult GB and was due to stress ulcer in three patients and to benign gastric tumor in one. No overt GB occurred in the absence of previous occult GB. We conclude that: a) risk of GB persists in critically ill ICU patients in spite of antacid prophylaxis (gastric pH greater than 3.5); b) high-risk patients can be identified through periodic testing for the presence of blood in gastric juice using the reagent; c) when occult GB occurs, treatment should be based on the endoscopy results. In the absence of acute gastroduodenal mucosal lesions, antacid prophylaxis should not be modified, and specific treatment of the identified lesion(s) should be initiated. In the presence of stress lesions, antacid prophylaxis should be reinforced if the pH of the gastric content is less than 3.5 and a septic complication should be actively sought if the pH is greater than 3.5. PMID:2783669

  14. Perioperative utility of goal-directed therapy in high-risk cardiac patients undergoing coronary artery bypass grafting: “A clinical outcome and biomarker-based study”

    PubMed Central

    Kapoor, Poonam Malhotra; Magoon, Rohan; Rawat, Rajinder; Mehta, Yatin

    2016-01-01

    Goal-directed therapy (GDT) encompasses guidance of intravenous (IV) fluid and vasopressor/inotropic therapy by cardiac output or similar parameters to help in early recognition and management of high-risk cardiac surgical patients. With the aim of establishing the utility of perioperative GDT using robust clinical and biochemical outcomes, we conducted the present study. This multicenter randomized controlled study included 130 patients of either sex, with European system for cardiac operative risk evaluation ≥3 undergoing coronary artery bypass grafting on cardiopulmonary bypass. The patients were randomly divided into the control and GDT group. All the participants received standardized care; arterial pressure monitored through radial artery, central venous pressure (CVP) through a triple lumen in the right internal jugular vein, electrocardiogram, oxygen saturation, temperature, urine output per hour, and frequent arterial blood gas (ABG) analysis. In addition, cardiac index (CI) monitoring using FloTrac™ and continuous central venous oxygen saturation (ScVO2) using PreSep™ were used in patients in the GDT group. Our aim was to maintain the CI at 2.5–4.2 L/min/m2, stroke volume index 30–65 ml/beat/m2, systemic vascular resistance index 1500–2500 dynes/s/cm5/m2, oxygen delivery index 450–600 ml/min/m2, continuous ScVO2 >70%, and stroke volume variation <10%; in addition to the control group parameters such as CVP 6–8 mmHg, mean arterial pressure 90–105 mmHg, normal ABG values, oxygen saturation, hematocrit value >30%, and urine output >1 ml/kg/h. The aims were achieved by altering the administration of IV fluids and doses of inotropes or vasodilators. The data of sixty patients in each group were analyzed in view of ten exclusions. The average duration of ventilation (19.89 ± 3.96 vs. 18.05 ± 4.53 h, P = 0.025), hospital stay (7.94 ± 1.64 vs. 7.17 ± 1.93 days, P = 0.025), and Intensive Care Unit (ICU) stay (3.74 ± 0.59 vs. 3.41 ± 0

  15. Effects of ulinastatin on coagulation in high-risk patients undergoing off-pump coronary artery bypass graft surgery

    PubMed Central

    Kim, Na-Young; Shim, Jae-Kwang; Bang, Seo-Ouk; Sim, Jee-Suk; Kwak, Young-Lan

    2013-01-01

    Background Both systemic inflammatory reaction and regional myocardial ischemia/reperfusion injury may elicit hypercoagulability after off-pump coronary artery bypass grafting (OPCAB). We investigated the influence of ulinastatin, which suppresses the activity of polymorphonuclear leukocyte elastase and production of pro-inflammatory cytokines, on coagulation in patients with elevated high-sensitivity C-reactive protein (hsCRP) undergoing OPCAB. Methods Fifty patients whose preoperative hsCRP > 3.0 mg/L were randomly allocated into the ulinastatin (600,000 U) or control group. Serum concentrations of thrombin-antithrombin complex (TAT) and prothrombin fragment 1+2 (F1+2) were measured preoperatively, immediately after surgery, and at 24 h after surgery, respectively. Secondary endpoints included platelet factor (PF)-4, amount of blood loss, and transfusion requirement. Results All baseline values of TAT, F1+2, and PF-4 were higher than the normal range in both groups. F1+2 was elevated in both groups at immediate, and at 24 h after surgery as compared to baseline value, without any significant intergroup differences. Remaining coagulation parameters, transfusion requirement and blood loss during operation and postoperative 24 h were not different between the two groups. Conclusions Intraoperative administration of ulinastatin did not convey beneficial influence in terms of coagulation and blood loss in high-risk patients with elevated hsCRP undergoing multivessel OPCAB, who already exhibited hypercoagulability before surgery. PMID:23459312

  16. Toxoplasma gondii Seropositivity and Co-Infection with TORCH Pathogens in High-Risk Patients from Qatar

    PubMed Central

    Abu-Madi, Marawan A.; Behnke, Jerzy M.; Dabritz, Haydee A.

    2010-01-01

    Testing of patients who are deemed to be at high risk for TORCH pathogens, e.g., pregnant women, their fetuses, neonates, and acquired immunodeficiency syndrome (AIDS) patients, is important so that specific treatment can be initiated. This study included 1,857 such patients between 2005 and 2008. Logistic regression was used to evaluate factors associated with Toxoplasma gondii seropositivity. Among 823 women of childbearing age, 35.1% and 5.2% tested positive for T. gondii IgG and IgM, respectively. Three infants ≤ 6 months of age (0.8% of 353) were congenitally infected. Factors associated with T. gondii IgG seropositivity included older age, East Mediterranean or African nationality, positive cytomegalovirus (CMV) and herpes simplex virus (HSV)-1 serostatus, and negative rubella IgG results. The decreasing prevalence of IgM antibodies between 2005 and 2008 suggested that exposure to T. gondii from food or environmental sources declined over this period in Qatar. Population-based studies of newborns would be helpful to accurately estimate incidence of congenital toxoplasmosis. PMID:20348511

  17. Successful implementation of a telemedicine-based counseling program for high-risk patients with breast cancer.

    PubMed

    Pruthi, Sandhya; Stange, Kevin J; Malagrino, Gerald D; Chawla, Kashmira S; LaRusso, Nicholas F; Kaur, Judith S

    2013-01-01

    An interactive audio and video telemedicine feasibility program was established to provide counseling on breast cancer risk-reducing strategies for underserved, high-risk Alaskan native women through a collaboration among the Alaska Native Medical Center, the Mayo Clinic Breast Clinic, Mayo's Center for Innovation, and the Alaska Federal Health Care Access Network. The telemedicine model included a navigator to facilitate patient encounters (referrals, electronic records, and scheduling) and a subscription billing contract. Between January 1 and December 31, 2011, 60 consultations were provided to the Alaska Native Medical Center. A survey of a sample of 15 women demonstrated overall patient satisfaction of 98% pertaining to the experience, technology, and medical consultation. The referring physician satisfaction, from 11 visit surveys and 8 referring physicians, revealed 99% satisfaction with the service. In this telemedicine pilot study, we demonstrated the feasibility of a telemedicine program to provide integrated specialty care that resulted in a positive effect on patient satisfaction. This program has a sustainable business model, thus creating a new modality for health care delivery.

  18. Results of high-risk neutropenia therapy of hematology–oncology patients in a university hospital in Uruguay

    PubMed Central

    Boada Burutaran, Matilde; Guadagna, Regina; Grille, Sofia; Stevenazzi, Mariana; Guillermo, Cecilia; Diaz, Lilian

    2014-01-01

    Background Febrile neutropenia is an important cause of mortality and morbidity in hematology–oncology patients undergoing chemotherapy. The management of febrile neutropenia is typically algorithm-driven. The aim of this study was to assess the results of a standardized protocol for the treatment of febrile neutropenia. Methods A retrospective cohort study (2011–2012) was conducted of patients with high-risk neutropenia in a hematology–oncology service. Results Forty-four episodes of 17 patients with a median age of 48 years (range: 18–78 years) were included. The incidence of febrile neutropenia was 61.4%. The presence of febrile neutropenia was associated with both the duration and severity of neutropenia. Microbiological agents were isolated from different sources in 59.3% of the episodes with bacteremia isolated from blood being the most prevalent (81.3%). Multiple drug-resistant gram-negative bacilli were isolated in 62.5% of all microbiologically documented infections. Treatment of 63% of the episodes in which the initial treatment was piperacillin/tazobactam needed to be escalated to meropenem. The mortality rate due to febrile neutropenia episodes was 18.5%. Conclusion The high rate of gram-negative bacilli resistant to piperacillin/tazobactam (front-line antibiotics in our protocol) and the early need to escalate to carbapenems raises the question as to whether it is necessary to change the current protocol. PMID:25638764

  19. Less invasive surgery using external fixator for the treatment of subtrochanteric femur fracture in a high-risk geriatric patient.

    PubMed

    Atik, O Şahap; Can, Fatih I; Şenol, M Selçuk; Eren, Toygun K

    2016-08-01

    A 90-year-old female patient was admitted to our clinic complaining of pain in her left hip which occurred due to fall from a chair. Her medical history included memory loss and mental changes associated with Alzheimer's disease and depression. Patient's cooperation and orientation were weak. Range of motion of the left hip was restricted and painful. Radiographs of the left hip demonstrated subtrochanteric comminuted fracture of femur. Laboratory tests revealed anemia and liver insufficiency. Departments of internal medicine and anesthesiology reported high risk for surgery. Surgery was performed under spinal anesthesia on radiolucent table and in supine position. Using fluoroscopy, subtrochanteric comminuted fracture of femur was reduced. Proximally, two Schanz screws were placed through femoral neck and head in axial plane, and distally, three Schanz screws were placed through femoral shaft in coronal plane. Finally, fixation of the screws was achieved with an external fixator which was made of carbon fiber rods. Patient was allowed to sit in the bed and move around with a wheelchair as of the day of surgery. No infection or loosening of fixator occurred. PMID:27499322

  20. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions.

    PubMed

    Cheng, A L; Hsu, C H; Lin, J K; Hsu, M M; Ho, Y F; Shen, T S; Ko, J Y; Lin, J T; Lin, B R; Ming-Shiang, W; Yu, H S; Jee, S H; Chen, G S; Chen, T M; Chen, C A; Lai, M K; Pu, Y S; Pan, M H; Wang, Y J; Tsai, C C; Hsieh, C Y

    2001-01-01

    Curcumin (diferuloylmethane), a yellow substance from the root of the plant Curcuma longa Linn., has been demonstrated to inhibit carcinogenesis of murine skin, stomach, intestine and liver. However, the toxicology, pharmacokinetics and biologically effective dose of curcumin in humans have not been reported. This prospective phase-I study evaluated these issues of curcumin in patients with one of the following five high-risk conditions: 1) recently resected urinary bladder cancer; 2) arsenic Bowen's disease of the skin; 3) uterine cervical intraepithelial neoplasm (CIN); 4) oral leucoplakia; and 5) intestinal metaplasia of the stomach. Curcumin was taken orally for 3 months. Biopsy of the lesion sites was done immediately before and 3 months after starting curcumin treament. The starting dose was 500 mg/day. If no toxicity > or = grade II was noted in at least 3 successive patients, the dose was then escalated to another level in the order of 1,000, 2,000, 4,000, 8,000, and 12,000 mg/day. The concentration of curcumin in serum and urine was determined by high pressure liquid chromatography (HPLC). A total of 25 patients were enrolled in this study. There was no treatment-related toxicity up to 8,000 mg/day. Beyond 8,000 mg/day, the bulky volume of the drug was unacceptable to the patients. The serum concentration of curcumin usually peaked at 1 to 2 hours after oral intake of crucumin and gradually declined within 12 hours. The average peak serum concentrations after taking 4,000 mg, 6,000 mg and 8,000 mg of curcumin were 0.51 +/- 0.11 microM, 0.63 +/- 0.06 microM and 1.77 +/- 1.87 microM, respectively. Urinary excretion of curcumin was undetectable. One of 4 patients with CIN and 1 of 7 patients with oral leucoplakia proceeded to develop frank malignancies in spite of curcumin treatment. In contrast, histologic improvement of precancerous lesions was seen in 1 out of 2 patients with recently resected bladder cancer, 2 out of 7 patients of oral leucoplakia, 1 out

  1. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions.

    PubMed

    Cheng, A L; Hsu, C H; Lin, J K; Hsu, M M; Ho, Y F; Shen, T S; Ko, J Y; Lin, J T; Lin, B R; Ming-Shiang, W; Yu, H S; Jee, S H; Chen, G S; Chen, T M; Chen, C A; Lai, M K; Pu, Y S; Pan, M H; Wang, Y J; Tsai, C C; Hsieh, C Y

    2001-01-01

    Curcumin (diferuloylmethane), a yellow substance from the root of the plant Curcuma longa Linn., has been demonstrated to inhibit carcinogenesis of murine skin, stomach, intestine and liver. However, the toxicology, pharmacokinetics and biologically effective dose of curcumin in humans have not been reported. This prospective phase-I study evaluated these issues of curcumin in patients with one of the following five high-risk conditions: 1) recently resected urinary bladder cancer; 2) arsenic Bowen's disease of the skin; 3) uterine cervical intraepithelial neoplasm (CIN); 4) oral leucoplakia; and 5) intestinal metaplasia of the stomach. Curcumin was taken orally for 3 months. Biopsy of the lesion sites was done immediately before and 3 months after starting curcumin treament. The starting dose was 500 mg/day. If no toxicity > or = grade II was noted in at least 3 successive patients, the dose was then escalated to another level in the order of 1,000, 2,000, 4,000, 8,000, and 12,000 mg/day. The concentration of curcumin in serum and urine was determined by high pressure liquid chromatography (HPLC). A total of 25 patients were enrolled in this study. There was no treatment-related toxicity up to 8,000 mg/day. Beyond 8,000 mg/day, the bulky volume of the drug was unacceptable to the patients. The serum concentration of curcumin usually peaked at 1 to 2 hours after oral intake of crucumin and gradually declined within 12 hours. The average peak serum concentrations after taking 4,000 mg, 6,000 mg and 8,000 mg of curcumin were 0.51 +/- 0.11 microM, 0.63 +/- 0.06 microM and 1.77 +/- 1.87 microM, respectively. Urinary excretion of curcumin was undetectable. One of 4 patients with CIN and 1 of 7 patients with oral leucoplakia proceeded to develop frank malignancies in spite of curcumin treatment. In contrast, histologic improvement of precancerous lesions was seen in 1 out of 2 patients with recently resected bladder cancer, 2 out of 7 patients of oral leucoplakia, 1 out

  2. Risk Assessment of Postoperative Nausea and Vomiting in the Intravenous Patient-Controlled Analgesia Environment: Predictive Values of the Apfel's Simplified Risk Score for Identification of High-Risk Patients

    PubMed Central

    Kim, Shin Hyung; Shin, Yang-Sik; Oh, Young Jun; Lee, Jeong Rim; Chung, Sung Chan

    2013-01-01

    Purpose Opioid-based intravenous patient-controlled analgesia (IV PCA) is popular method of postoperative pain control, but many patients suffer from IV PCA-related postoperative nausea and vomiting (PONV). In this retrospective observational study, we have determined independent predictors of IV PCA-related PONV and predictive values of the Apfel's simplified risk score in pursuance of identifying high-risk patients. Materials and Methods We analyzed 7000 patients who received IV PCA with background infusion after elective surgery. Patients who maintained IV PCA for a postoperative period of 48 hr (completion group, n=6128) were compared with those who have discontinued IV PCA within 48 hr of surgery due to intractable PONV (cessation group, n=872). Patients, anesthetics, and surgical factors known for predicting PONV were evaluated by logistic regression analysis to identify independent predictors of IV PCA related intractable PONV. Results In a stepwise multivariate analysis, weight, background infusion dose of fentanyl, addition of ketolorac to PCA, duration of anesthesia, general anesthesia, head and neck surgery, and Apfel's simplified risk score were revealed as independent risk factors for intractable PONV followed by the cessation of IV PCA. In addition, Apfel's simplified risk score, which demonstrated the highest odds ratio among the predictors, was strongly correlated with the cessation rate of IV PCA. Conclusion Multimodal prophylactic antiemetic strategies and dose reduction of opioids may be considered as strategies for the prevention of PONV with the use of IV PCA, especially in patients with high Apfel's simplified risk scores. PMID:23918581

  3. Transcatheter Aortic Valve Replacement in Lower Surgical Risk Patients: Review of Major Trials and Future Perspectives.

    PubMed

    Saji, Mike; Lim, D Scott

    2016-10-01

    Following the first successful transcatheter aortic valve replacement (TAVR) in 2002, TAVR has globally evolved to become a standard procedure in high-risk patients. Surgical aortic valve replacement in non-high-risk patients remains the gold standard for treatment of severe aortic stenosis. However, a paradigm shift appears to be occurring in the direction of treating lower-risk patients, and several studies have suggested its impact on clinical outcomes. In this review, we highlight the current status of TAVR in intermediate-risk patients and review major trials including Placement of AoRTic TraNscathetER (PARTNER) 2A randomized intermediate-risk trial using SAPIEN XT (Edwards Lifesciences Corp, Irvine, CA) recently presented with excellent outcomes and the lowest major complications rate at the American College of Cardiology's 65th Annual Scientific Session in Chicago. Clinical trials in low-risk patients using SAPIEN 3 and CoreValve Evolut R have just been launched, and they are going to be important milestones in the TAVR field.

  4. Transcatheter Aortic Valve Replacement in Lower Surgical Risk Patients: Review of Major Trials and Future Perspectives.

    PubMed

    Saji, Mike; Lim, D Scott

    2016-10-01

    Following the first successful transcatheter aortic valve replacement (TAVR) in 2002, TAVR has globally evolved to become a standard procedure in high-risk patients. Surgical aortic valve replacement in non-high-risk patients remains the gold standard for treatment of severe aortic stenosis. However, a paradigm shift appears to be occurring in the direction of treating lower-risk patients, and several studies have suggested its impact on clinical outcomes. In this review, we highlight the current status of TAVR in intermediate-risk patients and review major trials including Placement of AoRTic TraNscathetER (PARTNER) 2A randomized intermediate-risk trial using SAPIEN XT (Edwards Lifesciences Corp, Irvine, CA) recently presented with excellent outcomes and the lowest major complications rate at the American College of Cardiology's 65th Annual Scientific Session in Chicago. Clinical trials in low-risk patients using SAPIEN 3 and CoreValve Evolut R have just been launched, and they are going to be important milestones in the TAVR field. PMID:27600519

  5. Role of random biopsies in surveillance of dysplasia in ulcerative colitis patients with high risk of colorectal cancer

    PubMed Central

    Bopanna, Sawan; Roy, Maitreyee; Das, Prasenjit; Dattagupta, S; Sreenivas, V; Mouli, V Pratap; Kedia, Saurabh; Dhingra, Rajan; Pradhan, Rajesh; Kumar, N Suraj; Yadav, Dawesh P; Makharia, Govind

    2016-01-01

    Background/Aims Recent data suggest that the incidence of ulcerative colitis (UC) related colorectal cancer (CRC) in India is similar to that of West. The optimum method for surveillance is still a debate. Surveillance with random biopsies has been the standard of care, but is a tedious process. We therefore undertook this study to assess the yield of random biopsy in dysplasia surveillance. Methods Between March 2014 and July 2015, patients of UC attending the Inflammatory Bowel Disease clinic at the All India Institute of Medical Sciences with high risk factors for CRC like duration of disease >15 years and pancolitis, family history of CRC, primary sclerosing cholangitis underwent surveillance colonoscopy for dysplasia. Four quadrant random biopsies at 10 cm intervals were taken (33 biopsies). Two pathologists examined specimens for dysplasia, and the yield of dysplasia was calculated. Results Twenty-eight patients were included. Twenty-six of these had pancolitis with a duration of disease greater than 15 years, and two patients had associated primary sclerosing cholangis. No patient had a family history of CRC. The mean age at onset of disease was 28.89±8.73 years and the duration of disease was 19.00±8.78 years. Eighteen patients (64.28%) were males. A total of 924 biopsies were taken. None of the biopsies revealed any evidence of dysplasia, and 7/924 (0.7%) were indefinite for dysplasia. Conclusions Random biopsy for surveillance in longstanding extensive colitis has a low yield for dysplasia and does not suffice for screening. Newer techniques such as chromoendoscopy-guided biopsies need greater adoption. PMID:27433149

  6. Maternal autoantibody profiles at risk for autoimmune congenital heart block: a prospective study in high-risk patients

    PubMed Central

    Tonello, Marta; Ruffatti, Amelia; Favaro, Maria; Tison, Tiziana; del Ross, Teresa; Calligaro, Antonia; Hoxha, Ariela; Mattia, Elena; Punzi, Leonardo

    2016-01-01

    Objective This prospective study aimed to identify antibody profiles characterising mothers with fetuses developing congenital heart block (CHB) by comparing their antibody frequencies and levels with those in unaffected mothers. Methods Eighty-one consecutive pregnant patients positive to anti-Ro±anti-La antibodies, at high risk of developing fetal CHB were prospectively studied. The 16 patients with fetal CHB outcome were considered the study population and the 65 patients with normal pregnancy outcomes were considered the control cohort. Anti-Ro52, anti-Ro60, anti-p200 and anti-La antibodies were assayed using home-made ELISA assays. Results The prevalence of anti-p200 antibodies was significantly higher in the fetal CHB affected patients than in the controls (p=0.03). Combinations of anti-p200 with anti-Ro52 and anti-Ro60 antibodies were significantly more frequent in the women with fetuses developing CHB than in the controls (p=0.03 for all combinations). The women with fetal CHB had significantly higher mean anti-Ro52, anti-Ro60 and anti-p200 levels than the controls (p=0.003, p=0.0001 and p=0.04, respectively); mean anti-La/SSB level was not significantly different in the two cohorts (p=0.25). Conclusions Since anti-p200, anti-Ro52 and anti-Ro60 antibodies, especially at high level, seem to identify patients at increased risk of developing fetal CHB, their detection could recognise anti-Ro/La positive women at risk for having an infant with this rare, potentially dangerous disorder. PMID:27026811

  7. Clinical impact of the NKp30/B7-H6 axis in high-risk neuroblastoma patients.

    PubMed

    Semeraro, Michaela; Rusakiewicz, Sylvie; Minard-Colin, Véronique; Delahaye, Nicolas F; Enot, David; Vély, Frédéric; Marabelle, Aurélien; Papoular, Benjamin; Piperoglou, Christelle; Ponzoni, Mirco; Perri, Patrizia; Tchirkov, Andrei; Matta, Jessica; Lapierre, Valérie; Shekarian, Tala; Valsesia-Wittmann, Sandrine; Commo, Frédéric; Prada, Nicole; Poirier-Colame, Vichnou; Bressac, Brigitte; Cotteret, Sophie; Brugieres, Laurence; Farace, Françoise; Chaput, Nathalie; Kroemer, Guido; Valteau-Couanet, Dominique; Zitvogel, Laurence

    2015-04-15

    The immunosurveillance mechanisms governing high-risk neuroblastoma (HR-NB), a major pediatric malignancy, have been elusive. We identify a potential role for natural killer (NK) cells, in particular the interaction between the NK receptor NKp30 and its ligand, B7-H6, in the metastatic progression and survival of HR-NB after myeloablative multimodal chemotherapy and stem cell transplantation. NB cells expressing the NKp30 ligand B7-H6 stimulated NK cells in an NKp30-dependent manner. Serum concentration of soluble B7-H6 correlated with the down-regulation of NKp30, bone marrow metastases, and chemoresistance, and soluble B7-H6 contained in the serum of HR-NB patients inhibited NK cell functions in vitro. The expression of distinct NKp30 isoforms affecting the polarization of NK cell functions correlated with 10-year event-free survival in three independent cohorts of HR-NB in remission from metastases after induction chemotherapy (n = 196, P < 0.001), adding prognostic value to known risk factors such as N-Myc amplification and age >18 months. We conclude that the interaction between NKp30 and B7-H6 may contribute to the fate of NB patients and that both the expression of NKp30 isoforms on circulating NK cells and the concentration of soluble B7-H6 in the serum may be clinically useful as biomarkers for risk stratification. PMID:25877893

  8. Predicting the onset of psychosis in patients at clinical high risk: practical guide to probabilistic prognostic reasoning.

    PubMed

    Fusar-Poli, P; Schultze-Lutter, F

    2016-02-01

    Prediction of psychosis in patients at clinical high risk (CHR) has become a mainstream focus of clinical and research interest worldwide. When using CHR instruments for clinical purposes, the predicted outcome is but only a probability; and, consequently, any therapeutic action following the assessment is based on probabilistic prognostic reasoning. Yet, probabilistic reasoning makes considerable demands on the clinicians. We provide here a scholarly practical guide summarising the key concepts to support clinicians with probabilistic prognostic reasoning in the CHR state. We review risk or cumulative incidence of psychosis in, person-time rate of psychosis, Kaplan-Meier estimates of psychosis risk, measures of prognostic accuracy, sensitivity and specificity in receiver operator characteristic curves, positive and negative predictive values, Bayes' theorem, likelihood ratios, potentials and limits of real-life applications of prognostic probabilistic reasoning in the CHR state. Understanding basic measures used for prognostic probabilistic reasoning is a prerequisite for successfully implementing the early detection and prevention of psychosis in clinical practice. Future refinement of these measures for CHR patients may actually influence risk management, especially as regards initiating or withholding treatment.

  9. Can Saliva Proteins Be Used to Predict the Onset of Acute Myocardial Infarction among High-Risk Patients?

    PubMed

    Rahim, Mohd Aizat Abdul; Rahim, Zubaidah Haji Abdul; Ahmad, Wan Azman Wan; Hashim, Onn Haji

    2015-01-01

    Human saliva plays a pivotal role in digesting food and maintaining oral hygiene. The presence of electrolytes, mucus, glycoproteins, enzymes, antibacterial compounds, and gingival crevicular fluid in saliva ensures the optimum condition of oral cavity and general health condition. Saliva collection has been proven non-invasive, convenient, and inexpensive compared to conventional venipuncture procedure. These distinctive advantages provide a promising potential of saliva as a diagnostic fluid. Through comprehensive analysis, an array of salivary proteins and peptides may be beneficial as biomarkers in oral and systemic diseases. In this review, we discuss the utility of human salivary proteomes and tabulate the recent salivary biomarkers found in subjects with acute myocardial infarction as well as respective methods employed. In a clinical setting, since acute myocardial infarction contributes to large cases of mortality worldwide, an early intervention using these biomarkers will provide an effective solution to reduce global heart attack incidence particularly among its high-risk group of type-2 diabetes mellitus patients. The utility of salivary biomarkers will make the prediction of this cardiac event possible due to its reliability hence improve the quality of life of the patients. Current challenges in saliva collection are also addressed to improve the quality of saliva samples and produce robust biomarkers for future use in clinical applications.

  10. Toward strategies for cost containment in surgical patients.

    PubMed Central

    Drucker, W R; Gavett, J W; Kirshner, R; Messick, W J; Ingersoll, G

    1983-01-01

    The University of Rochester, Department of Surgery, in response to an experimental community-wide limit on hospital budgets, studied high-cost general surgical patients as a potential source of leverage for containment of hospital costs. It was found that a small number of patients impact significantly on hospital costs. In 1980, 3935 patients at Strong Memorial Hospital (SMH) had at least one contact with a general surgical patient care or intensive care unit; 261 patients (6.6%) had total 1980 charges of more than $20,000 each. They contributed 32% of the total of both general surgical charges and patient days. A subset of 2021 patients was selected to represent more precisely the general surgical patient. The 85 high-cost patients (4.2%) of this subset were chosen for intensive study. These patients generated a significant and disproportionate per cent of total (2021) general surgical charges (26.8%) and hospital days (27.6%). Average total charges were more than 8 times those of the complementary general surgical subset (1936). Nineteen of the 85 patients (22.3%) died in the hospital and 42 patients (49.4%) were dead within 2 1/2 years. Forty patients (of the 85) were then further identified as "complex", based on multiple, usually unrelated, illnesses and multiple annual admissions. Tending to be elderly with poor prognoses, 60% of them had died by April 1983. The major criterion of complexity was the lack of a well-focused medical problem; the cure for one problem simply relinquished primacy to another. A parallel study of hospital ancillary procedures disclosed a similar high-cost pattern. Of approximately 4000 ancillary procedures, 100 (2.5%) had annual charges of $100,000 or over, accounting for two-thirds of total 1980 ancillary charges. Roughly 20% of a single patient's ordered procedures accounted for 80% of the patient's ancillary charges, thus allowing concentrated study of a relatively small number of charges. Means for cost containment may be

  11. Toward strategies for cost containment in surgical patients.

    PubMed

    Drucker, W R; Gavett, J W; Kirshner, R; Messick, W J; Ingersoll, G

    1983-09-01

    The University of Rochester, Department of Surgery, in response to an experimental community-wide limit on hospital budgets, studied high-cost general surgical patients as a potential source of leverage for containment of hospital costs. It was found that a small number of patients impact significantly on hospital costs. In 1980, 3935 patients at Strong Memorial Hospital (SMH) had at least one contact with a general surgical patient care or intensive care unit; 261 patients (6.6%) had total 1980 charges of more than $20,000 each. They contributed 32% of the total of both general surgical charges and patient days. A subset of 2021 patients was selected to represent more precisely the general surgical patient. The 85 high-cost patients (4.2%) of this subset were chosen for intensive study. These patients generated a significant and disproportionate per cent of total (2021) general surgical charges (26.8%) and hospital days (27.6%). Average total charges were more than 8 times those of the complementary general surgical subset (1936). Nineteen of the 85 patients (22.3%) died in the hospital and 42 patients (49.4%) were dead within 2 1/2 years. Forty patients (of the 85) were then further identified as "complex", based on multiple, usually unrelated, illnesses and multiple annual admissions. Tending to be elderly with poor prognoses, 60% of them had died by April 1983. The major criterion of complexity was the lack of a well-focused medical problem; the cure for one problem simply relinquished primacy to another. A parallel study of hospital ancillary procedures disclosed a similar high-cost pattern. Of approximately 4000 ancillary procedures, 100 (2.5%) had annual charges of $100,000 or over, accounting for two-thirds of total 1980 ancillary charges. Roughly 20% of a single patient's ordered procedures accounted for 80% of the patient's ancillary charges, thus allowing concentrated study of a relatively small number of charges. Means for cost containment may be

  12. Regression of Some High-risk Features of Age-related Macular Degeneration (AMD) in Patients Receiving Intensive Statin Treatment

    PubMed Central

    Vavvas, Demetrios G.; Daniels, Anthony B.; Kapsala, Zoi G.; Goldfarb, Jeremy W.; Ganotakis, Emmanuel; Loewenstein, John I.; Young, Lucy H.; Gragoudas, Evangelos S.; Eliott, Dean; Kim, Ivana K.; Tsilimbaris, Miltiadis K.; Miller, Joan W.

    2016-01-01

    Importance Age-related macular degeneration (AMD) remains the leading cause of blindness in developed countries, and affects more than 150 million worldwide. Despite effective anti-angiogenic therapies for the less prevalent neovascular form of AMD, treatments are lacking for the more prevalent dry form. Similarities in risk factors and pathogenesis between AMD and atherosclerosis have led investigators to study the effects of statins on AMD incidence and progression with mixed results. A limitation of these studies has been the heterogeneity of AMD disease and the lack of standardization in statin dosage. Objective We were interested in studying the effects of high-dose statins, similar to those showing regression of atherosclerotic plaques, in AMD. Design Pilot multicenter open-label prospective clinical study of 26 patients with diagnosis of AMD and the presence of many large, soft drusenoid deposits. Patients received 80 mg of atorvastatin daily and were monitored at baseline and every 3 months with complete ophthalmologic exam, best corrected visual acuity (VA), fundus photographs, optical coherence tomography (OCT), and blood work (AST, ALT, CPK, total cholesterol, TSH, creatinine, as well as a pregnancy test for premenopausal women). Results Twenty-three subjects completed a minimum follow-up of 12 months. High-dose atorvastatin resulted in regression of drusen deposits associated with vision gain (+ 3.3 letters, p = 0.06) in 10 patients. No subjects progressed to advanced neovascular AMD. Conclusions High-dose statins may result in resolution of drusenoid pigment epithelial detachments (PEDs) and improvement in VA, without atrophy or neovascularization in a high-risk subgroup of AMD patients. Confirmation from larger studies is warranted. PMID:27077128

  13. Resiquimod as an immunologic adjuvant for NY-ESO-1 protein vaccination in patients with high-risk melanoma.

    PubMed

    Sabado, Rachel Lubong; Pavlick, Anna; Gnjatic, Sacha; Cruz, Crystal M; Vengco, Isabelita; Hasan, Farah; Spadaccia, Meredith; Darvishian, Farbod; Chiriboga, Luis; Holman, Rose Marie; Escalon, Juliet; Muren, Caroline; Escano, Crystal; Yepes, Ethel; Sharpe, Dunbar; Vasilakos, John P; Rolnitzsky, Linda; Goldberg, Judith D; Mandeli, John; Adams, Sylvia; Jungbluth, Achim; Pan, Linda; Venhaus, Ralph; Ott, Patrick A; Bhardwaj, Nina

    2015-03-01

    The Toll-like receptor (TLR) 7/8 agonist resiquimod has been used as an immune adjuvant in cancer vaccines. We evaluated the safety and immunogenicity of the cancer testis antigen NY-ESO-1 given in combination with Montanide (Seppic) with or without resiquimod in patients with high-risk melanoma. In part I of the study, patients received 100 μg of full-length NY-ESO-1 protein emulsified in 1.25 mL of Montanide (day 1) followed by topical application of 1,000 mg of 0.2% resiquimod gel on days 1 and 3 (cohort 1) versus days 1, 3, and 5 (cohort 2) of a 21-day cycle. In part II, patients were randomized to receive 100-μg NY-ESO-1 protein plus Montanide (day 1) followed by topical application of placebo gel [(arm A; n = 8) or 1,000 mg of 0.2% resiquimod gel (arm B; n = 12)] using the dosing regimen established in part I. The vaccine regimens were generally well tolerated. NY-ESO-1-specific humoral responses were induced or boosted in all patients, many of whom had high titer antibodies. In part II, 16 of 20 patients in both arms had NY-ESO-1-specific CD4⁺ T-cell responses. CD8⁺ T-cell responses were only seen in 3 of 12 patients in arm B. Patients with TLR7 SNP rs179008 had a greater likelihood of developing NY-ESO-1-specific CD8⁺ responses. In conclusion, NY-ESO-1 protein in combination with Montanide with or without topical resiquimod is safe and induces both antibody and CD4⁺ T-cell responses in the majority of patients; the small proportion of CD8⁺ T-cell responses suggests that the addition of topical resiquimod to Montanide is not sufficient to induce consistent NY-ESO-1-specific CD8⁺ T-cell responses.

  14. Therapeutic benefit of decitabine, a hypomethylating agent, in patients with high-risk primary myelofibrosis and myeloproliferative neoplasm in accelerated or blastic/acute myeloid leukemia phase.

    PubMed

    Badar, Talha; Kantarjian, Hagop M; Ravandi, Farhad; Jabbour, Elias; Borthakur, Gautam; Cortes, Jorge E; Pemmaraju, Naveen; Pierce, Sherry R; Newberry, Kate J; Daver, Naval; Verstovsek, Srdan

    2015-09-01

    Myeloproliferative neoplasm (MPN) transformed to acute myeloid leukemia (MPN-AML), MPN in accelerated phase (MPN-AP), and high-risk primary myelofibrosis (PMF) are associated with a poor response to therapy and very short survival. Several reports have suggested clinical activity of hypomethylating agents in these patients. We conducted a retrospective study of 21 patients with MPN-AML, 13 with MPN-AP and 11 with DIPSS-plus high-risk PMF treated with decitabine at our institution over the last 7 years and evaluated their clinical outcomes. Six patients (29%) with MPN-AML responded to decitabine (3 CR, 2 CRi, and 1 PR); median response duration was 7 months. The median overall survival (OS) was significantly higher in those who responded (10.5 vs 4 months). Among patients with MPN-AP, 8 patients (62%) benefited; the median response duration was 6.5 months. The median OS was 11.8 months in responders vs 4.7 months in non-responders. Among patients with DIPSS-plus high-risk PMF, 9 (82%) benefited; the median response duration was 9 months. The median OS was 32 months in responders vs 16.3 months in non-responders. Decitabine is a viable therapeutic option for patients with MPN-AML, MP-AP and high-risk PMF. Prospective clinical studies combining decitabine with other clinically active agents are needed to improve overall outcome.

  15. Therapeutic benefit of decitabine, a hypomethylating agent, in patients with high-risk primary myelofibrosis and myeloproliferative neoplasm in accelerated or blastic/acute myeloid leukemia phase

    PubMed Central

    Badar, Talha; Kantarjian, Hagop M.; Ravandi, Farhad; Jabbour, Elias; Borthakur, Gautam; Cortes, Jorge E.; Pemmaraju, Naveen; Pierce, Sherry R.; Newberry, Kate J.; Daver, Naval; Verstovsek, Srdan

    2015-01-01

    Myeloproliferative neoplasm (MPN) transformed to acute myeloid leukemia (MPN-AML), MPN in accelerated phase (MPN-AP), and high-risk primary myelofibrosis (PMF) are associated with a poor response to therapy and very short survival. Several reports have suggested clinical activity of hypomethylating agents in these patients. We conducted a retrospective study of 21 patients with MPN-AML, 13 with MPN-AP and 11 with DIPSS-plus high-risk PMF treated with decitabine at our institution over the last 7 years and evaluated their clinical outcomes. Six patients (29%) with MPN-AML responded to decitabine (3 CR, 2 CRi, and 1 PR); median response duration was 7 months. The median overall survival (OS) was significantly higher in those who responded (10.5 vs 4 months). Among patients with MPN-AP, 8 patients (62%) benefited; median response duration was 6.5 months. The median OS was 11.8 months in responders vs 4.7 months in non-responders. Among patients with DIPSS-plus high-risk PMF, 9 (82%) benefited; median response duration was 9 months. The median OS was 32 months in responders vs 16.3 months in non-responders. Decitabine is a viable therapeutic option for patients with MPN-AML, MP-AP and high-risk PMF. Prospective clinical studies combining decitabine with other clinically active agents are needed to improve overall outcome. PMID:26183878

  16. The fetus as a patient. Surgical considerations.

    PubMed Central

    Harrison, M R; Adzick, N S

    1991-01-01

    The diagnosis and treatment of human fetal defects has evolved rapidly over the past decade due to improved fetal imaging techniques and better understanding of fetal pathophysiology derived from animal models. The detection of a fetal anomaly may now lead to a change in the timing of delivery, a change in the mode of delivery, or prenatal treatment. Because most therapeutic maneuvers involve some risk to the fetus and mother, there must be a reasonable expectation that the procedure is feasible, safe, and effective before it can be attempted in humans. This requires reliable information about the pathophysiology and natural history of the disease process, the efficacy of fetal surgical intervention in ameliorating the disease, and the feasibility and safety of the proposed intervention. This paper focuses on the rationale and initial clinical experience with fetal surgery for a variety of life-threatening fetal anatomic defects. PMID:2009009

  17. Surgical resection for gastrointestinal stromal tumors (GIST): experience on 25 patients

    PubMed Central

    Boni, Luigi; Benevento, Angelo; Dionigi, Gianlorenzo; Rovera, Francesca; Dionigi, Renzo

    2005-01-01

    Background Gastrointestinal stromal tumors (GIST) are infrequent and diagnosis and prognosis could be troublesome. We present short and long term results of surgical resection for GIST at the Department of Surgery, University of Insubria, during a period of 17 years. Materials and methods All patients' data, tumor characteristics, surgical procedure and survival data were analyzed retrospectively. Tumors were divided in risk classes using the classification proposed by Fletcher, based on tumor size and number of mitosis. Results Between 1987 and 2004, 25 patients underwent surgical resection for GIST. Stomach was the most common site of localization. Complete resection was achieved in 88% cases, while in 12% radical resection was not possible. The mean tumor size was 9.2 cm (1.2 – 30 cm): <5 cm diameter in 14/25 cases (56%), 5–10 cm in 5/25 (20%) and >10 cm in 6/25 (24%). Mitotic count was <10/50 HPF in 68% (17/25) and >10/50 in 32% (8/25). Using Fletcher's classification, tumors were divided in very low (11/25, 44%), low (4/25, 16%), intermediate (6/25, 24%) and high-risk (4/25, 16%) groups. The 5-year overall survival was 65% and 34% respectively with a statistically significant difference between tumors <5 cm and >10 cm in diameter and between complete and incomplete resection. High-risk tumors had a significantly shorter survival than low or very low risk. Conclusion Our experience confirms that GIST's are uncommon and aggressive cancers. The prognosis is strictly related to tumor size and number of mitosis. Although significant advances on new chemotherapeutic regimes have been made, to date, only radical surgery offers the chance of long-term survival. PMID:16384538

  18. Extremity gunshot wounds: Part one--Identification and treatment of patients at high risk of vascular injury.

    PubMed

    Ordog, G J; Balasubramanium, S; Wasserberger, J; Kram, H; Bishop, M; Shoemaker, W

    1994-03-01

    Cost containment is important in this time of inner-city economic and health-care crisis. This paper examines patients who were treated for gunshot wounds (GSWs) of the extremities. During the study period 1978 through 1992, 16,316 patients (18,349 extremities) were treated for extremity GSWs. Nine patients with asymptomatic injuries in proximity to vascular structures who were treated before the use of duplex Doppler ultrasonography (DDU) were later found to have surgically treatable vascular injuries. These were identified and treated on an outpatient basis with no long-term morbidity or mortality. With the advent of DDU, asymptomatic vascular injuries were no longer missed. A conservative estimate of the cost savings from this study is more than $47,000,000.00. The use of DDU and the enclosed protocols for treating asymptomatic extremity wounds prevented 16,450 needless angiograms, with an additional savings of $32,900,000.00, for a total savings of more than $79,900,000.00. With a more liberal use of DDU and angiography to eliminate the rare missed vascular injuries (0.09%), and the use of protocols to analyze patients with asymptomatic injuries, many extremity GSW victims (79% in this study) can be safely treated as outpatients, eliminating the need for expensive in-hospital observation.

  19. Quality of life of patients surgically treated for ameloblastoma

    PubMed Central

    Lawal, Hammed Sikiru; Adebola, Rafel Adetokunbo; Arotiba, Juwon Tunde; Amole, Ibiyinka Olushola; Efunkoya, Akinwale Adeyemi; Omeje, Uchenna Kelvin; Amole, Taiwo Gboluwaga; Adeoye, Joshua Biodun

    2016-01-01

    Background: The surgical management of ameloblastoma can have a profound functional and psychological effect on a patient's quality of life (QoL). The aim of this study was to compare the pre- and post-operative QoL outcomes of patients requiring surgical treatment for ameloblastoma. Patients and Methods: A total number of 30 patients were identified as fulfilling the criteria for this study. They included 18 males and 12 females, aged between 14 and 47 years with a mean of 27.3 years (standard deviation 10.2). Each patient completed a modified version of the University of Washington QoL questionnaire version 4, a day to surgery and postoperatively on the 7th day, 3 months, and 6 months. Results: Following surgical treatment of patients for ameloblastoma, the QoL decreased immediately after surgery. It then gradually improved over time and exceeded the preoperative value at 6 months postoperatively. When analyzed with respect to location, posteriorly placed tumors had the best postoperative QoL outcome. Patients expressed concern more about their appearance preoperatively while postoperative concerns were mostly focused on their ability to chew. Conclusion: Significant improvement occurred in QoL scores following surgical management of ameloblastoma. The small sample size utilized in this study limits a definitive conclusion. A larger multicenter study is therefore recommended. PMID:27226682

  20. The diagnostic and prognostic value of coronary CT angiography in asymptomatic high-risk patients: a cohort study

    PubMed Central

    Plank, Fabian; Friedrich, Guy; Dichtl, Wolfgang; Klauser, Andrea; Jaschke, Werner; Franz, Wolfgang-Michael; Feuchtner, Gudrun

    2014-01-01

    Objective To prospectively assess the value of coronary CT angiography (CTA) in asymptomatic patients with high ‘a priori’ risk of coronary artery disease (CAD). Methods 711 consecutive asymptomatic patients (61.8 years; 40.1% female) with high ‘a priori’ risk of CAD were prospectively examined with a coronary calcium score (CCS) and CTA. Coronary arteries were evaluated for atherosclerotic plaque (non-calcified and calcified) and stenosis (mild <50%, intermediate 50–70% or high-grade >70%). Coronary Segment Involvement Score (SIS, total number of segments with plaque) and nc (non-calcified) SIS were calculated. Primary end points were major adverse cardiac events (ST-elevation MI, non-ST-elevation MI and cardiac death); secondary end points were coronary revascularisation and >50% stenosis by invasive angiography. Results Of 711 patients, 28.3% were negative for CAD and 71.7% positive (CAD+) by CTA (15.6% had plaques without stenosis, 23.9% mild, 10.7% intermediate and 21.5% high-grade stenosis). CCS zero prevalence was 306 (43%), out of those 100 (32.7%) had non-calcified plaque only. Mean follow-up period was 2.65 years. MACE rate was 0% in CAD negative and higher (1.2%) in CAD positive by CTA. Coronary revascularisation rate was 5.5%. Patients with SIS ≥5 had an HR of 6.5 (95% CI 1.6 to 25.8, p<0.013) for MACE, patients with ncSIS ≥1 had an HR of 2.4 (95% CI 1.2 to 4.6, p<0.01) for secondary end point. The sensitivity of CTA for stenosis >50% compared with invasive angiography was 92.9% (95% CI 83.0% to 98.1%). Negative predictive value of CTA was 99.4% (95% CI 98.3% to 99.8%) for combined end points. Conclusions CAD prevalence by CTA in asymptomatic high-risk patients is high. CCS zero does not exclude CAD. CTA is highly accurate to exclude CAD. Total coronary plaque burden and nc plaques, even if only one segment is involved, are associated with an increased risk of adverse outcome. PMID:25332810

  1. Brain structure in people at ultra-high risk of psychosis, patients with first-episode schizophrenia, and healthy controls: a VBM study.

    PubMed

    Nenadic, Igor; Dietzek, Maren; Schönfeld, Nils; Lorenz, Carsten; Gussew, Alexander; Reichenbach, Jürgen R; Sauer, Heinrich; Gaser, Christian; Smesny, Stefan

    2015-02-01

    Early intervention research in schizophrenia has suggested that brain structural alterations might be present in subjects at high risk of developing psychosis. The heterogeneity of regional effects of these changes, which is established in schizophrenia, however, has not been explored in prodromal or high-risk populations. We used high-resolution MRI and voxel-based morphometry (VBM8) to analyze grey matter differences in 43 ultra high-risk subjects for psychosis (meeting ARMS criteria, identified through CAARMS interviews), 24 antipsychotic-naïve first-episode schizophrenia patients and 49 healthy controls (groups matched for age and gender). Compared to healthy controls, resp., first-episode schizophrenia patients had reduced regional grey matter in left prefrontal, insula, right parietal and left temporal cortices, while the high-risk group showed reductions in right middle temporal and left anterior frontal cortices. When dividing the ultra-high-risk group in those with a genetic risk vs. those with attenuated psychotic symptoms, the former showed left anterior frontal, right caudate, as well as a smaller right hippocampus, and amygdala reduction, while the latter subgroup showed right middle temporal cortical reductions (each compared to healthy controls). Our findings in a clinical psychosis high-risk cohort demonstrate variability of brain structural changes according to subgroup and background of elevated risk, suggesting frontal and possibly also hippocampal/amygdala changes in individuals with genetic susceptibility. Heterogeneity of structural brain changes (as seen in schizophrenia) appears evident even at high-risk stage, prior to potential onset of psychosis.

  2. Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients

    PubMed Central

    Tehranian, Afsaneh; Esfehani-Mehr, Bahareh; Pirjani, Reihaneh; Rezaei, Negar; Sadat Heidary, Somaye; Sepidarkish, Mahdi

    2016-01-01

    Background Platelet-rich plasma (PRP) is a human plasma product enriched by platelets, growth factors, and fibrinogen with high hemostatic and healing properties. Objectives The aim of this study was to evaluate the effect of autologous PRP on wound healing in high-risk women undergoing cesarean sections. Patients and Methods In this balanced, randomized, and controlled trial, 140 patients were admitted to Arash women’s hospital, Tehran, Iran from May of 2013 to November of 2014 for elective cesarean surgery. The patients were randomly assigned into two groups. The intervention group received PRP after surgery, whereas the control group received the usual care. All patients were evaluated at baseline, five days, and eight weeks after the cesarean section. The primary endpoint used the REEDA scale for assessing the changes in wound healing. The secondary outcome measures used were the Vancouver scar scale (VSS) and the visual analog scale (VAS). All scale scores were analyzed using a repeated measures test for variance. Results At the end of study, the PRP group showed a greater reduction in the edema ecchymosed discharge approximation (REEDA) score compared to the control group (85.5% reduction in the PRP group; 72% in the control group) (P < 0.001). Compared with the control group, the PRP group had a significantly greater reduction in the VAN score, beginning on the fifth day after the cesarean section (-0.7, 38% reduction in PRP group; -0.8, 33% in control group) (P < 0.001), and this trend was stable at the end of the eighth week (-0.6, 54% reduction in PRP group; -0.3, 18% in control group). Furthermore, patients treated with PRP experienced a 93% reduction in the VAS score at the end of follow-up, but the control group only observed a 79% reduction (P < 0.001). Conclusions It seems that applying PRP is an effective therapeutic approach for wound healing, and faster wound healing is expected due to the presence of more platelets and growth factors.

  3. Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients

    PubMed Central

    Tehranian, Afsaneh; Esfehani-Mehr, Bahareh; Pirjani, Reihaneh; Rezaei, Negar; Sadat Heidary, Somaye; Sepidarkish, Mahdi

    2016-01-01

    Background Platelet-rich plasma (PRP) is a human plasma product enriched by platelets, growth factors, and fibrinogen with high hemostatic and healing properties. Objectives The aim of this study was to evaluate the effect of autologous PRP on wound healing in high-risk women undergoing cesarean sections. Patients and Methods In this balanced, randomized, and controlled trial, 140 patients were admitted to Arash women’s hospital, Tehran, Iran from May of 2013 to November of 2014 for elective cesarean surgery. The patients were randomly assigned into two groups. The intervention group received PRP after surgery, whereas the control group received the usual care. All patients were evaluated at baseline, five days, and eight weeks after the cesarean section. The primary endpoint used the REEDA scale for assessing the changes in wound healing. The secondary outcome measures used were the Vancouver scar scale (VSS) and the visual analog scale (VAS). All scale scores were analyzed using a repeated measures test for variance. Results At the end of study, the PRP group showed a greater reduction in the edema ecchymosed discharge approximation (REEDA) score compared to the control group (85.5% reduction in the PRP group; 72% in the control group) (P < 0.001). Compared with the control group, the PRP group had a significantly greater reduction in the VAN score, beginning on the fifth day after the cesarean section (-0.7, 38% reduction in PRP group; -0.8, 33% in control group) (P < 0.001), and this trend was stable at the end of the eighth week (-0.6, 54% reduction in PRP group; -0.3, 18% in control group). Furthermore, patients treated with PRP experienced a 93% reduction in the VAS score at the end of follow-up, but the control group only observed a 79% reduction (P < 0.001). Conclusions It seems that applying PRP is an effective therapeutic approach for wound healing, and faster wound healing is expected due to the presence of more platelets and growth factors. PMID

  4. Surgical site infection in patients submitted to heart transplantation

    PubMed Central

    Rodrigues, Jussara Aparecida Souza do Nascimento; Ferretti-Rebustini, Renata Eloah de Lucena; Poveda, Vanessa de Brito

    2016-01-01

    Abstract Objectives: to analyze the occurrence and predisposing factors for surgical site infection in patients submitted to heart transplantation, evaluating the relationship between cases of infections and the variables related to the patient and the surgical procedure. Method: retrospective cohort study, with review of the medical records of patients older than 18 years submitted to heart transplantation. The correlation between variables was evaluated by using Fisher's exact test and Mann-Whitney-Wilcoxon test. Results: the sample consisted of 86 patients, predominantly men, with severe systemic disease, submitted to extensive preoperative hospitalizations. Signs of surgical site infection were observed in 9.3% of transplanted patients, with five (62.5%) superficial incisional, two (25%) deep and one (12.5%) case of organ/space infection. There was no statistically significant association between the variables related to the patient and the surgery. Conclusion: there was no association between the studied variables and the cases of surgical site infection, possibly due to the small number of cases of infection observed in the sample investigated. PMID:27579924

  5. Patient Safety Events and Harms During Medical and Surgical Hospitalizations for Persons With Serious Mental Illness

    PubMed Central

    Daumit, Gail L.; McGinty, Emma E.; Pronovost, Peter; Dixon, Lisa B.; Guallar, Eliseo; Ford, Daniel E.; Cahoon, Elizabeth K.; Boonyasai, Romsai T.; Thompson, David

    2016-01-01

    Objective This study explored the risk of patient safety events and associated nonfatal physical harms and mortality in a cohort of persons with serious mental illness. This group experiences high rates of medical comorbidity and premature mortality and may be at high risk of adverse patient safety events. Methods Medical record review was conducted for medical-surgical hospitalizations occurring during 1994–2004 in a community-based cohort of Maryland adults with serious mental illness. Individuals were eligible if they died within 30 days of a medical-surgical hospitalization and if they also had at least one prior medical-surgical hospitalization within five years of death. All admissions took place at Maryland general hospitals. A case-crossover analysis examined the relationships among patient safety events, physical harms, and elevated likelihood of death within 30 days of hospitalization. Results A total of 790 hospitalizations among 253 adults were reviewed. The mean number of patient safety events per hospitalization was 5.8, and the rate of physical harms was 142 per 100 hospitalizations. The odds of physical harm were elevated in hospitalizations in which 22 of the 34 patient safety events occurred (p<.05), including medical events (odds ratio [OR]=1.5, 95% confidence interval [CI]=1.3–1.7) and procedure-related events (OR=1.6, CI=1.2–2.0). Adjusted odds of death within 30 days of hospitalization were elevated for individuals with any patient safety event, compared with those with no event (OR=3.7, CI=1.4–10.3). Conclusions Patient safety events were positively associated with physical harm and 30-day mortality in nonpsychiatric hospitalizations for persons with serious mental illness. PMID:27181736

  6. Caring for Surgical Patients With Piercings.

    PubMed

    Smith, Francis Duval

    2016-06-01

    Body piercing, a type of body modification that is practiced in many cultures, creates an unnatural tract through tissue that is then held open by artificial means. Today, professional body piercing is often performed in piercing establishments that are subject to dissimilar forms of regulation. The most frequently reported medical complication of body piercing and similar body modifications, such as dermal implantation, is infection. Patients with piercings who undergo surgery may have additional risks for infection, electrical burns, trauma, or airway obstruction. The published research literature on piercing prevalence, complications, regulations, education, and nursing care is outdated. The purpose of this article is to educate nurses on topics related to nursing care for patients with piercings and similar body modifications, including the history, prevalence, motivations for, and perceptions of body piercings as well as possible complications, devices used, locations, healing times, regulations, patient education, and other health concerns. PMID:27234793

  7. Methicillin-resistant Staphylococcus aureus infection in vascular surgical patients.

    PubMed Central

    Murphy, G. J.; Pararajasingam, R.; Nasim, A.; Dennis, M. J.; Sayers, R. D.

    2001-01-01

    BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) infection is emerging as a major problem in vascular surgical practice. The aim of this study was to review the management of patients with MRSA infection complicating vascular surgical operations. METHODS: Data were obtained from the vascular audit, case notes, intensive therapy unit (ITU) notes, high dependency unit (HDU) notes and microbiological records of patients who underwent either arterial reconstruction (n = 464) or limb amputation (n = 110) between April 1994 and October 1998. RESULTS: Forty-nine vascular surgical patients developed clinical MRSA infection (9%). Clinical MRSA infection in patients who had undergone aorto-iliac reconstruction (n = 18) was associated with a 56% mortality (n = 10) and the most common infections were bacteraemia (55%) and pneumonia (50%). MRSA infection occurred in 17 patients who had undergone infra-inguinal bypass and was associated with a 29% mortality (n = 5). The most common site of MRSA infection was the groin wound (76%) leading to anastomotic dehiscence and death in one patient (11%) and necessitating wound debridement in 4 patients (22%). MRSA infection of the groin wound in the presence of a prosthetic graft (n = 3) led to anastomotic dehiscence in 2 patients, and graft excision in 2 patients. Similar complications were not observed in the presence of an underlying autogeneous long saphenous vein graft (n = 16). MRSA infection following major lower limb amputation (n = 14) was associated with death in 5 patients (36%). Wound infection in 10 amputees (71%) led to revision of the amputation to a higher level in 2 (14%) and wound debridement in 2 (14%). CONCLUSIONS: MRSA infection has a high mortality in vascular surgical patients in general, and following aorto-iliac reconstruction in particular. Autogeneous vein may confer some protection against local complications following groin wound infection. Strategies aimed at reducing the incidence of infection

  8. [Meaning of premature discharge in surgical patients].

    PubMed

    Lacambra Montanuy, Lucía; Carrasco Aranda, M Teresa; Castro Milán, Patricia; Melchor Gómez, Magdalena

    2013-12-01

    In the last years, there have been some changes in our society related to the organization of the health system to optimize resources and serve the population. Because of the gradual aging of the population and increasing chronic pluripathologies, there is an increased health care demand, leading to the introduction of new technologies and minimally invasive surgery, helping quick reintegration of the patient in their daily activity. There is no agreed definition of early discharge but the patient is discharged from hospital sooner than indicated by the standards, provided that the medical condition, personal, social and family allows. The aim of our work is to know in depth the meaning of the experience of patients in relation to early discharge and home care associated and, knowing the deficiencies and needs perceived by patients during recovery in their midst. This will allow us to have a realistic and humanist view that will help us understand and improve the processes of care, planning and evaluation of different health complex situations.

  9. Pain management in the pediatric surgical patient.

    PubMed

    Sohn, Vance Y; Zenger, David; Steele, Scott R

    2012-06-01

    Surgeons performing painful, invasive procedures in pediatric patients must be cognizant of both the potential short- and long-term detrimental effects of inadequate analgesia. This article reviews the available tools, sedation procedures, the management of intraoperative, postoperative, and postprocedural pain, and the issues surrounding neonatal addiction.

  10. Pain management in the pediatric surgical patient.

    PubMed

    Sohn, Vance Y; Zenger, David; Steele, Scott R

    2012-06-01

    Surgeons performing painful, invasive procedures in pediatric patients must be cognizant of both the potential short- and long-term detrimental effects of inadequate analgesia. This article reviews the available tools, sedation procedures, the management of intraoperative, postoperative, and postprocedural pain, and the issues surrounding neonatal addiction. PMID:22595704

  11. Involvement of a Surgical Service Improves Patient Satisfaction in Patients Admitted with Small Bowel Obstruction

    PubMed Central

    Schmocker, Ryan K.; Vang, Xia; Cherney Stafford, Linda M.; Leverson, Glen E.; Winslow, Emily R.

    2015-01-01

    Background For patients with small bowel obstruction (SBO), surgical care has been associated with improved outcomes; however it remains unknown how it impacts satisfaction. Methods Patients admitted for SBO who completed the hospital satisfaction survey were eligible. Only those with adhesions or hernias were included. Chart review extracted structural characteristics and outcomes. Results 47 patients were included; 74% (n=35) were admitted to a surgical service. 26% (n=12) were admitted to medicine, and 50% of those (n=6) had surgical consultation. Patients with surgical involvement as the consulting or primary service (SURG) had higher satisfaction with the hospital than those cared for by the medical service (80% SURG; 33% MED, p=0.015). SURG patients also had higher satisfaction with physicians (74% SURG; 44% MED; p=0.015). Conclusions Surgical involvement during SBO admissions is associated with increased patient satisfaction, and adds further weight to the recommendation that these patients be cared for by surgeons. PMID:25886702

  12. Surgical management of bilateral bronchiectases: results in 29 patients.

    PubMed

    Aghajanzadeh, Manucher; Sarshad, Ali; Amani, Hosin; Alavy, Ali

    2006-06-01

    Bronchiectasis is a major cause of morbidity and mortality in developing countries. Staged bilateral segmental resection of the lungs is performed in selected patients. Our experience of surgical removal of 87 bilateral bronchiectases in 29 patients during an 11-year period was reviewed retrospectively. High-resolution computed tomography was performed preoperatively in all patients to locate the anatomic sites of bronchiectasis. The mortality and morbidity of the surgical procedure, clinical symptoms, age distribution, etiology, bacteriology, and operative procedures were analyzed. There were 22 males (76%) and 7 females (24%), aged 5 to 60 years, with a mean age of 30 years. Complications developed in 11 patients (38%); atelectasia was the most common (14%). There was one hospital death. Clinical symptoms disappeared in 19 (66%) patients, improved in 5 (17%), and were unchanged in 4 (14%). Staged bilateral resection for bronchiectases can be performed at any age with acceptable morbidity and mortality. PMID:16714699

  13. Role of peripheral blood minimum residual disease at day 8 of induction therapy in high-risk pediatric patients with acute lymphocytic leukemia

    PubMed Central

    Salina, Thais Ditolvo da Costa; Ferreira, Yvelise Antunes; Alves, Eliana Brasil; Ferreira, Cristina Motta; De Paula, Erich Vinícius; Mira, Marcelo Távora; Passos, Leny da Mota

    2016-01-01

    Risk stratification and treatment intensification, based on minimal residual disease (MRD) mensurement, changed the prognosis of pediatric patients with acute lymphocytic leukemia (ALL). The main aim of this study was to investigate whether peripheral blood (PB) MRD measurement at day 8 (D8) could predict the risk stratification category determined by bone marrow (BM) MRD at day 15 (D15). The study was performed prospectively, in a cohort of 40 children with B-lineage ALL, adopting the protocol of the Brazilian Cooperative Group of the Treatment Childhood Leukemia (GBTLI-2009). MRD was detected by flow cytometry (FC) using a simplifed panel that can reliably identify MRD at early phases of induction therapy. Upon diagnosis, the proportion of low and high-risk patients, was 24:16 (60%:40%). The main result of our study demonstrated the potential of D8 MRD in anticipating of week the risk stratification of high-risk patients as determined by D15 BM MRD. In these patients D8 MRD level of 1% was able to segregate high risk fast responders from high risk slow responders (p = 0.0097). This result could represent an opportunity for early treatment intensification, as already performed in some protocols. PMID:27526794

  14. Role of peripheral blood minimum residual disease at day 8 of induction therapy in high-risk pediatric patients with acute lymphocytic leukemia.

    PubMed

    Salina, Thais Ditolvo da Costa; Ferreira, Yvelise Antunes; Alves, Eliana Brasil; Ferreira, Cristina Motta; De Paula, Erich Vinícius; Mira, Marcelo Távora; Passos, Leny da Mota

    2016-08-16

    Risk stratification and treatment intensification, based on minimal residual disease (MRD) mensurement, changed the prognosis of pediatric patients with acute lymphocytic leukemia (ALL). The main aim of this study was to investigate whether peripheral blood (PB) MRD measurement at day 8 (D8) could predict the risk stratification category determined by bone marrow (BM) MRD at day 15 (D15). The study was performed prospectively, in a cohort of 40 children with B-lineage ALL, adopting the protocol of the Brazilian Cooperative Group of the Treatment Childhood Leukemia (GBTLI-2009). MRD was detected by flow cytometry (FC) using a simplifed panel that can reliably identify MRD at early phases of induction therapy. Upon diagnosis, the proportion of low and high-risk patients, was 24:16 (60%:40%). The main result of our study demonstrated the potential of D8 MRD in anticipating of week the risk stratification of high-risk patients as determined by D15 BM MRD. In these patients D8 MRD level of 1% was able to segregate high risk fast responders from high risk slow responders (p = 0.0097). This result could represent an opportunity for early treatment intensification, as already performed in some protocols.

  15. Role of peripheral blood minimum residual disease at day 8 of induction therapy in high-risk pediatric patients with acute lymphocytic leukemia.

    PubMed

    Salina, Thais Ditolvo da Costa; Ferreira, Yvelise Antunes; Alves, Eliana Brasil; Ferreira, Cristina Motta; De Paula, Erich Vinícius; Mira, Marcelo Távora; Passos, Leny da Mota

    2016-01-01

    Risk stratification and treatment intensification, based on minimal residual disease (MRD) mensurement, changed the prognosis of pediatric patients with acute lymphocytic leukemia (ALL). The main aim of this study was to investigate whether peripheral blood (PB) MRD measurement at day 8 (D8) could predict the risk stratification category determined by bone marrow (BM) MRD at day 15 (D15). The study was performed prospectively, in a cohort of 40 children with B-lineage ALL, adopting the protocol of the Brazilian Cooperative Group of the Treatment Childhood Leukemia (GBTLI-2009). MRD was detected by flow cytometry (FC) using a simplifed panel that can reliably identify MRD at early phases of induction therapy. Upon diagnosis, the proportion of low and high-risk patients, was 24:16 (60%:40%). The main result of our study demonstrated the potential of D8 MRD in anticipating of week the risk stratification of high-risk patients as determined by D15 BM MRD. In these patients D8 MRD level of 1% was able to segregate high risk fast responders from high risk slow responders (p = 0.0097). This result could represent an opportunity for early treatment intensification, as already performed in some protocols. PMID:27526794

  16. A Focus Group Exploration of Automated Case-Finders to Identify High-Risk Heart Failure Patients Within an Urban Safety Net Hospital

    PubMed Central

    Patterson, Mark E.; Miranda, Derick; Schuman, Greg; Eaton, Christopher; Smith, Andrew; Silver, Brad

    2016-01-01

    Background: Leveraging “big data” as a means of informing cost-effective care holds potential in triaging high-risk heart failure (HF) patients for interventions within hospitals seeking to reduce 30-day readmissions. Objective: Explore provider’s beliefs and perceptions about using an electronic health record (EHR)-based tool that uses unstructured clinical notes to risk-stratify high-risk heart failure patients. Methods: Six providers from an inpatient HF clinic within an urban safety net hospital were recruited to participate in a semistructured focus group. A facilitator led a discussion on the feasibility and value of using an EHR tool driven by unstructured clinical notes to help identify high-risk patients. Data collected from transcripts were analyzed using a thematic analysis that facilitated drawing conclusions clustered around categories and themes. Results: From six categories emerged two themes: (1) challenges of finding valid and accurate results, and (2) strategies used to overcome these challenges. Although employing a tool that uses electronic medical record (EMR) unstructured text as the benchmark by which to identify high-risk patients is efficient, choosing appropriate benchmark groups could be challenging given the multiple causes of readmission. Strategies to mitigate these challenges include establishing clear selection criteria to guide benchmark group composition, and quality outcome goals for the hospital. Conclusion: Prior to implementing into practice an innovative EMR-based case-finder driven by unstructured clinical notes, providers are advised to do the following: (1) define patient quality outcome goals, (2) establish criteria by which to guide benchmark selection, and (3) verify the tool’s validity and reliability. Achieving consensus on these issues would be necessary for this innovative EHR-based tool to effectively improve clinical decision-making and in turn, decrease readmissions for high-risk patients. PMID:27683666

  17. A Focus Group Exploration of Automated Case-Finders to Identify High-Risk Heart Failure Patients Within an Urban Safety Net Hospital

    PubMed Central

    Patterson, Mark E.; Miranda, Derick; Schuman, Greg; Eaton, Christopher; Smith, Andrew; Silver, Brad

    2016-01-01

    Background: Leveraging “big data” as a means of informing cost-effective care holds potential in triaging high-risk heart failure (HF) patients for interventions within hospitals seeking to reduce 30-day readmissions. Objective: Explore provider’s beliefs and perceptions about using an electronic health record (EHR)-based tool that uses unstructured clinical notes to risk-stratify high-risk heart failure patients. Methods: Six providers from an inpatient HF clinic within an urban safety net hospital were recruited to participate in a semistructured focus group. A facilitator led a discussion on the feasibility and value of using an EHR tool driven by unstructured clinical notes to help identify high-risk patients. Data collected from transcripts were analyzed using a thematic analysis that facilitated drawing conclusions clustered around categories and themes. Results: From six categories emerged two themes: (1) challenges of finding valid and accurate results, and (2) strategies used to overcome these challenges. Although employing a tool that uses electronic medical record (EMR) unstructured text as the benchmark by which to identify high-risk patients is efficient, choosing appropriate benchmark groups could be challenging given the multiple causes of readmission. Strategies to mitigate these challenges include establishing clear selection criteria to guide benchmark group composition, and quality outcome goals for the hospital. Conclusion: Prior to implementing into practice an innovative EMR-based case-finder driven by unstructured clinical notes, providers are advised to do the following: (1) define patient quality outcome goals, (2) establish criteria by which to guide benchmark selection, and (3) verify the tool’s validity and reliability. Achieving consensus on these issues would be necessary for this innovative EHR-based tool to effectively improve clinical decision-making and in turn, decrease readmissions for high-risk patients.

  18. The assessment of the role of baseline low-dose CT scan in patients at high risk of lung cancer

    PubMed Central

    Kołaczyk, Katarzyna; Walecka, Anna; Grodzki, Tomasz; Alchimowicz, Jacek; Smereczyński, Andrzej; Kiedrowicz, Radosław

    2014-01-01

    Summary Background Despite the progress in contemporary medicine comprising diagnostic and therapeutic methods, lung cancer is still one of the biggest health concerns in many countries of the world. The main purpose of the study was to evaluate the detection rate of pulmonary nodules and lung cancer in the initial, helical low-dose CT of the chest as well as the analysis of the relationship between the size and the histopathological character of the detected nodules. Material/Methods We retrospectively evaluated 1999 initial, consecutive results of the CT examinations performed within the framework of early lung cancer detection program initiated in Szczecin. The project enrolled persons of both sexes, aged 55–65 years, with at least 20 pack-years of cigarette smoking or current smokers. The analysis included assessment of the number of positive results and the evaluation of the detected nodules in relationship to their size. All of the nodules were classified into I of VI groups and subsequently compared with histopathological type of the neoplastic and nonneoplastic pulmonary lesions. Results Pulmonary nodules were detected in 921 (46%) subjects. What is more, malignant lesions as well as lung cancer were significantly, more frequently discovered in the group of asymptomatic nodules of the largest dimension exceeding 15 mm. Conclusions The initial, low-dose helical CT of the lungs performed in high risk individuals enables detection of appreciable number of indeterminate pulmonary nodules. In most of the asymptomatic patients with histopathologically proven pulmonary nodules greater than 15 mm, the mentioned lesions are malignant, what warrants further, intensified diagnostics. PMID:25057333

  19. Post-marketing safety evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir: A drug-use investigation in patients with high risk factors.

    PubMed

    Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

    2016-10-01

    Peramivir, the only injectable anti-influenza neuraminidase inhibitor medically available in Japan at present, is considered first-line treatment in patients with high risk factors for influenza exacerbation. We conducted a drug-use investigation of peramivir in inpatients with high risk factors (old age, pregnancy, and underlying disease such as chronic respiratory disease) from January 2010 to March 2013. Data of 772 patients from 124 facilities across Japan were collected; peramivir's safety in 770 patients and effectiveness in 688 patients were examined. In total, 412 adverse events were observed in 219 patients (28.4%). Of these, 155 events were adverse drug reactions (ADRs) observed in 98 patients (12.7%). Major ADRs (≥2%) were increased aspartate aminotransferase (5.1%), increased alanine aminotransferase (3.8%) and decreased white blood cell count (2.5%). Fourteen serious ADRs were observed in 12 patients (1.6%). All serious ADRs were resolved or improved except for two events for which outcomes were unknown. Multivariate analyses revealed that ADR incidences were significantly associated with these four backgrounds of patients: medical history, no influenza vaccination, renal impairment and other infection(s). With regard to its effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration, which was the same as in other previous surveillance studies. This surveillance study indicated the safety of peramivir in the treatment of influenza inpatients with high risk factors under routine clinical settings. PMID:27497712

  20. Patient outcomes following surgical management of multinodular goiter

    PubMed Central

    Lin, Yann-Sheng; Wu, Hsin-Yi; Yu, Ming-Chin; Hsu, Chih-Chieh; Chao, Tzu-Chieh

    2016-01-01

    Abstract Background: the difference in the risk of thyroid malignancy for patients with multinodular goiter (MNG) and solitary nodular goiter (SNG) remains controversial. Although total thyroidectomy (TT) is the current preferred surgical option for MNG, permanent hypothyroidism in these patients may be a concern. Therefore, we discuss whether nontotal thyroidectomy is a reasonable alternative surgical option. Methods: A retrospective cohort study was performed for 1598 consecutive patients who underwent thyroid surgery for nodular goiter between January 2007 and December 2012. Numerous clinical parameters were collected and analyzed. Results: We reviewed 795 patients with MNG and 803 patients with SNG. The prevalence of malignancy on final pathology was significantly higher in the patients with MNG than in the patients with SNG (15.6% vs 10.1%, P = 0.001). However, a multivariate analysis revealed that this difference was insignificant (P = 0.50). Papillary carcinoma was the predominant type in both groups, but papillary microcarcinoma was more frequently found (41.1%) in the patients with MNG. The only multifocal cancers were of the papillary carcinoma histologic type, and the incidence of multifocal papillary carcinoma was significantly higher in the patients with MNG (23.4% vs 7.4%, P = 0.005). Reoperation was not required for the patients who underwent TT for goiter recurrence or incidental carcinoma. The overall rate of recurrence following nontotal thyroidectomy was 12.2%. Among the patients who underwent reoperation for goiter recurrence, 2 (20.0%) were complicated with permanent hypoparathyroidism. Among the patients who underwent a nontotal bilateral thyroidectomy, an average of 56.5% had permanent hypothyroidism. Conclusions: Multinodularity does not increase the risk of thyroid malignancy. However, patients with MNG who develop papillary carcinoma are at an increased risk of cancer multifocality. If a patient can tolerate lifelong thyroid hormone

  1. Encouraging Surgical ICU Patients to Get Moving Pays Off

    MedlinePlus

    ... FAQs Contact Us Health Topics Drugs & Supplements Videos & Tools Español You Are Here: Home → Latest Health News → Article URL of this page: https://medlineplus.gov/news/fullstory_161258.html Encouraging Surgical ICU Patients to Get Moving Pays Off They' ...

  2. [Croatian guidelines for perioperative enteral nutrition of surgical patients].

    PubMed

    Zelić, Marko; Bender, Darija Vranesić; Kelecić, Dina Ljubas; Zupan, Zeljko; Cicvarić, Tedi; Maldini, Branka; Durut, Iva; Rahelić, Velimir; Skegro, Mate; Majerović, Mate; Perko, Zdravko; Sustić, Alan; Madzar, Tomislav; Kovacić, Borna; Kekez, Tihomir; Krznarić, Zeljko

    2014-01-01

    Nutritional status of patients significantly affects the outcome of surgical treatment, whether it's about being obese or malnutrition with loss of muscle mass. Inadequate nutritional support in the perioperative period compromises surgical procedures even in patients who are adequately nourished. In this paper, particular attention was paid to malnourished patients, and their incidence in population hospitalized in surgical wards can be high up to 30%. Special emphasis was paid to the appropriateness of preoperative fasting and to the acceptance of new knowledge in this area of treatment. The aim of this working group was to make guidelines for perioperative nutritional support with different modalities of enteral nutrition. The development of these guidelines was attended by representatives of Croatian Medical Association: Croatian Society for Digestive Surgery, Croatian Society for Clinical Nutrition, Croatian Society of Surgery, Croatian Society for Endoscopic Surgery, Croatian Trauma Society and the Croatian Society of Anesthesiology and Intensive Care. The guidelines are designed as a set of questions that arise daily in clinical practice when preparing patients for surgery and after the surgical treatment, which relate to the assessment of nutritional status, perioperative nutritional support, duration of preoperative fasting period and the selection of food intake route. Assessment of nutritional status and the use of different modes of enteral nutrition should enter into standard protocols of diagnosis and treatment in the Croatian hospitals.

  3. Washed cell salvage in surgical patients

    PubMed Central

    Meybohm, Patrick; Choorapoikayil, Suma; Wessels, Anke; Herrmann, Eva; Zacharowski, Kai; Spahn, Donat R.

    2016-01-01

    Abstract Background: Cell salvage is commonly used as part of a blood conservation strategy. However concerns among clinicians exist about the efficacy of transfusion of washed cell salvage. Methods: We performed a meta-analysis of randomized controlled trials in which patients, scheduled for all types of surgery, were randomized to washed cell salvage or to a control group with no cell salvage. Data were independently extracted, risk ratio (RR), and weighted mean differences (WMD) with 95% confidence intervals (CIs) were calculated. Data were pooled using a random effects model. The primary endpoint was the number of patients exposed to allogeneic red blood cell (RBC) transfusion. Results: Out of 1140 search results, a total of 47 trials were included. Overall, the use of washed cell salvage reduced the rate of exposure to allogeneic RBC transfusion by a relative 39% (RR = 0.61; 95% CI 0.57 to 0.65; P < 0.001), resulting in an average saving of 0.20 units of allogeneic RBC per patient (weighted mean differences [WMD] = −0.20; 95% CI −0.22 to −0.18; P < 0.001), reduced risk of infection by 28% (RR = 0.72; 95% CI 0.54 to 0.97; P = 0.03), reduced length of hospital stay by 2.31 days (WMD = −2.31; 95% CI −2.50 to −2.11; P < 0.001), but did not significantly affect risk of mortality (RR = 0.92; 95% CI 0.63 to 1.34; P = 0.66). No statistical difference could be observed in the number of patients exposed to re-operation, plasma, platelets, or rate of myocardial infarction and stroke. Conclusions: Washed cell salvage is efficacious in reducing the need for allogeneic RBC transfusion and risk of infection in surgery. PMID:27495095

  4. [Cervical spine instability in the surgical patient].

    PubMed

    Barbeito, A; Guerri-Guttenberg, R A

    2014-03-01

    Many congenital and acquired diseases, including trauma, may result in cervical spine instability. Given that airway management is closely related to the movement of the cervical spine, it is important that the anesthesiologist has detailed knowledge of the anatomy, the mechanisms of cervical spine instability, and of the effects that the different airway maneuvers have on the cervical spine. We first review the normal anatomy and biomechanics of the cervical spine in the context of airway management and the concept of cervical spine instability. In the second part, we review the protocols for the management of cervical spine instability in trauma victims and some of the airway management options for these patients.

  5. Principles of thromboprophylaxis in surgical patients.

    PubMed

    Husted, S E

    1991-01-01

    Thromboprophylactic treatment during surgery reduces mortality and morbidity. The type of prophylaxis may be individualized according to type of operation and presence of major risk factors, such as prior thromboembolism, malignancy, long duration of immobilization, and medical conditions. All patients over the age of 40, or even younger, who have major risk factors, and whose operations will last for more than 1 hour, may benefit from thromboprophylaxis. Available prophylactic methods allow for treatment with an acceptably low level of side effects and economic cost, when compared with the cost of diagnostics and treatment of thromboembolism.

  6. Predictive Factor of Surgical Efficacy in Male Patients with Prolactinoma.

    PubMed

    Chen, Mei-Ting; Lian, Wei; Xing, Bing; Yao, Yong; Feng, Ming; Wang, Ren-Zhi

    2016-08-01

    Objective To analyze the predictive factor of surgical efficacy in male patients with prolactinoma. Method The clinical data of 184 male patients with prolactinoma who had undergone surgery were retrospectively analyzed.Results Before the surgery,the serum prolactin level from 150 to 204 952 ng/ml,the tumors sized 6 to 70 mm. Macroadenoma was seen in 152 cases (82.6%) and suprasellar adenoma with visual deficitsin 75 cases (40.7%). Complete resection was achieved in 149 patients. After surgical therapy,postoperative immediate prolactin level declined in 182 patients (98.4%);57 patients (31.0%)achieved initial remission,while the disease recurred in 26 patients (45.6%).Larger tumor had significantly lower rate of complete resection (P<0.05). The recurrence rate was significantly higher in the group with higher Ki-67 index (P<0.001). The recurrence rate was significantly lower in patients with intrasellar adenoma (P<0.001).No significant relationship was found between preoperative prolactin level and complete resection (P=0.306). Conclusions Tumor size can predictthe degree of surgical resection. The prognostic factors include tumor size,preoperative growth pattern of prolactinoma,and Ki-67 index.

  7. The utility of the surgical safety checklist for wound patients.

    PubMed

    Myers, Joseph W; Gilmore, Brent A; Powers, Kelly A; Kim, Paul J; Attinger, Christopher E

    2016-10-01

    The purpose of this study was to determine the frequency of changes in patient care resulting from the use of a surgical safety checklist. Data were retrospectively obtained from 233 patients. The number and types of changes made to the patients' intra-operative management, based on the use of the checklist, were recorded. The number of patients whose management was modified as a result of the checklist was 113 (48%) out of 233. The total number of changes made was 132, and 18 patients had more than one modification made to their care plan. Further stratification was identified: among the 132 changes made, antibiotics were held or administered in 73 (55%), changes related to anaemia involving type and screen or transfusion occurred in 27 (20%), modifications made regarding anti-coagulation occurred in 8 (7%), beta-blockers were held in 2 (2%), an allergy was identified in 7 (5%), modifications made to the surgical procedure were 3 (2%) and a category labelled 'other' encompassed 9 (7%) changes. The surgical safety checklist is a standardised form of team communication that leads to modifications of the patient care plan in a large percentage of cases. The ever-increasing complexity of medicine means that patients are at greater risk of oversight and harm without the use of a checklist. PMID:25585543

  8. Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study).

    PubMed

    Ballantyne, Christie M; Weiss, Robert; Moccetti, Tiziano; Vogt, Anja; Eber, Bernd; Sosef, Froukje; Duffield, Emma

    2007-03-01

    Patients at risk of coronary heart disease may not achieve recommended low-density lipoprotein (LDL) cholesterol goals on statin monotherapy. This study was designed to investigate the efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe 10 mg in patients at high risk of coronary heart disease. Four hundred sixty-nine patients were randomly assigned to rosuvastatin alone or in combination with ezetimibe for 6 weeks. The primary end point was the percentage of patients achieving the Adult Treatment Panel III (ATP III) LDL cholesterol goal (<100 mg/dl) at week 6. Secondary end points included the percentage of patients achieving other ATP III and 2003 European lipid goals, changes from baseline in lipid, lipoprotein, and inflammatory parameters, and safety and tolerability. Significantly more patients receiving rosuvastatin/ezetimibe than rosuvastatin alone achieved their ATP III LDL cholesterol goal (<100 mg/dl, 94.0% vs 79.1%, p <0.001) and the optional LDL cholesterol goal (<70 mg/dl) for very high-risk patients (79.6% vs 35.0%, p <0.001). The combination of rosuvastatin/ezetimibe reduced LDL cholesterol significantly more than rosuvastatin (-69.8% vs -57.1%, p <0.001). Other components of the lipid/lipoprotein profile were also significantly (p <0.001) improved with rosuvastatin/ezetimibe. Both treatments generally were well tolerated. Rosuvastatin 40 mg was effective at improving the atherogenic lipid profile in this high-risk population. Combination rosuvastatin with ezetimibe 10 mg enabled greater decreases in LDL cholesterol and allowed more patients to achieve LDL cholesterol goals. In conclusion, rosuvastatin plus ezetimibe may improve the management of high-risk patients who cannot achieve goal on maximal statin monotherapy.

  9. Whole-Pelvic Nodal Radiation Therapy in the Context of Hypofractionation for High-Risk Prostate Cancer Patients: A Step Forward

    SciTech Connect

    Kaidar-Person, Orit; Roach, Mack; Créhange, Gilles

    2013-07-15

    Given the low α/β ratio of prostate cancer, prostate hypofractionation has been tested through numerous clinical studies. There is a growing body of literature suggesting that with high conformal radiation therapy and even with more sophisticated radiation techniques, such as high-dose-rate brachytherapy or image-guided intensity modulated radiation therapy, morbidity associated with shortening overall treatment time with higher doses per fraction remains low when compared with protracted conventional radiation therapy to the prostate only. In high-risk prostate cancer patients, there is accumulating evidence that either dose escalation to the prostate or hypofractionation may improve outcome. Nevertheless, selected patients who have a high risk of lymph node involvement may benefit from whole-pelvic radiation therapy (WPRT). Although combining WPRT with hypofractionated prostate radiation therapy is feasible, it remains investigational. By combining modern advances in radiation oncology (high-dose-rate prostate brachytherapy, intensity modulated radiation therapy with an improved image guidance for soft-tissue sparing), it is hypothesized that WPRT could take advantage of recent results from hypofractionation trials. Moreover, the results from hypofractionation trials raise questions as to whether hypofractionation to pelvic lymph nodes with a high risk of occult involvement might improve the outcomes in WPRT. Although investigational, this review discusses the challenging idea of WPRT in the context of hypofractionation for patients with high-risk prostate cancer.

  10. Self-destructive behavior in hospitalized medical and surgical patients.

    PubMed

    Kellner, C H; Best, C L; Roberts, J M; Bjorksten, O

    1985-06-01

    This article reviews the literature and presents data from the Psychiatric Consultation Service of the Medical University of South Carolina on self-destructive behavior in hospitalized medical and surgical patients. Fatal suicide attempts are rare and usually occur in patients with severe, painful chronic illnesses, psychosis, or dementia. Less overt forms of self-destructive behavior include refusal of medical treatment and uncooperative behavior.

  11. Umbilical hernia in patients with liver cirrhosis: A surgical challenge

    PubMed Central

    Coelho, Julio C U; Claus, Christiano M P; Campos, Antonio C L; Costa, Marco A R; Blum, Caroline

    2016-01-01

    Umbilical hernia occurs in 20% of the patients with liver cirrhosis complicated with ascites. Due to the enormous intraabdominal pressure secondary to the ascites, umbilical hernia in these patients has a tendency to enlarge rapidly and to complicate. The treatment of umbilical hernia in these patients is a surgical challenge. Ascites control is the mainstay to reduce hernia recurrence and postoperative complications, such as wound infection, evisceration, ascites drainage, and peritonitis. Intermittent paracentesis, temporary peritoneal dialysis catheter or transjugular intrahepatic portosystemic shunt may be necessary to control ascites. Hernia repair is indicated in patients in whom medical treatment is effective in controlling ascites. Patients who have a good perspective to be transplanted within 3-6 mo, herniorrhaphy should be performed during transplantation. Hernia repair with mesh is associated with lower recurrence rate, but with higher surgical site infection when compared to hernia correction with conventional fascial suture. There is no consensus on the best abdominal wall layer in which the mesh should be placed: Onlay, sublay, or underlay. Many studies have demonstrated several advantages of the laparoscopic umbilical herniorrhaphy in cirrhotic patients compared with open surgical treatment. PMID:27462389

  12. Effectiveness of Surgical Safety Checklists in Improving Patient Safety.

    PubMed

    Ragusa, Paul S; Bitterman, Adam; Auerbach, Brett; Healy, William A

    2016-01-01

    Wrong-site surgery is all too common. Despite more than a decade of campaigns by major organizations to prevent these events, there are still reports of such mistakes. This article reviews the recent literature on surgical safety checklists and other tools designed to prevent wrong-site surgery and improve patient safety in the operating room. Emphasis is placed on how well institutions comply with these guidelines, the perceptions and attitudes of those who are asked to implement them, and their effectiveness. The literature shows that the implementation of such protocols has improved patient safety. In general, these efforts are viewed favorably by operating room personnel. However, the role of these checklists and other tools in reducing wrong-sided surgeries has not been proven. The goal of the health care profession should be to continue to improve on the advances that have been made in implementing surgical checklists and preventing wrong-site surgery. Practitioners at the authors' institution are continuously searching for ways to improve on the current protocols to prevent wrong-site surgeries. The authors recently employed a protocol in which surgical instruments are kept in the back of the room, away from the patient, until completion of the surgical time-out. This practice helps to ensure that team members are not distracted or preoccupied with setting up equipment during the time-out. This approach also helps to mitigate the hierarchal style in the operating room. PMID:26942472

  13. Assessment of Telemedicine in Surgical Education and Patient Care

    PubMed Central

    Demartines, Nicolas; Mutter, Didier; Vix, Michel; Leroy, Joël; Glatz, Dieter; Rösel, Fritz; Harder, Felix; Marescaux, Jacques

    2000-01-01

    Objective To analyze the value of teleconferencing for patient care and surgical education by assessing the activity of an international academic network. Summary Background Data The uses of telemedicine include teleeducation, training, and consulting, and surgical teams are now involved, sharing diagnostic information and opinions without the need for travel. However, the value of telematics in surgery remains to be assessed. Methods During a 2-year period, weekly surgical teleconferences were held among six university hospitals in four European countries. To assess the accuracy of telediagnosis for surgical cases, 60 randomly selected cases were analyzed by a panel of surgeons. Participants’ opinions were analyzed by questionnaire. Results Seventy teleconferences (50 lectures and 271 case presentations) were held. Ninety-five of the 114 participants (83.3%) completed the final questionnaire. Eighty-six percent rated the surgical activity as good or excellent, 75.7% rated the scientific level as good or excellent, 55.8% rated the daily clinical activity as good or excellent, and 28.4% rated the manual surgical technique as good or excellent. The target organ was identified in all the cases; the organ structure and pathology were considered well defined in 93.3%, and the fine structure was considered well defined in 58.3%. Diagnosis was accurate in 17 cases (28.3%), probable in 25 (41.7%), possible but uncertain in 16 (26.7%), and not possible in 2 cases (3.3%). Discussion among the remote sites increased the rate of valuable therapeutic advice from 55% of cases before the discussion to 95% after the discussion. Eighty-six percent of the surgeons expressed satisfaction with telematics for medical education and patient care. Conclusions Participant satisfaction was high, transmission of clinical documents was accurate, and the opportunity to discuss case documentation and management significantly improved diagnostic potential, resulting in an accuracy rate of up

  14. STD care: variations in clinical care associated with provider sex, patient sex, patients' self-reported symptoms or high-risk behaviors, partner STD history.

    PubMed

    St Lawrence, Janet S; Kuo, Wen-Hung; Hogben, Matthew; Montaño, Daniel E; Kasprzyk, Danuta; Phillips, William R

    2004-09-01

    Sexually transmitted diseases in the United States are frequently diagnosed by private, as well as public, physicians. However, we know little about the decision processes that physicians employ when faced with people who may or may not be infected. To address this gap, we compared physicians' responses to different patient vignettes to assess how variations in patients' presentations affect physicians' clinical behavior. We systematically varied reported symptoms, behavioral risk, partner STD, and sex of patients in 16 different vignettes, with one vignette randomly presented to each physician in a national survey. Physicians rated the likelihood of 12 clinical management actions they might take with the patient vignette presented. Responses varied with self-reported symptoms, high-risk behavior, and report of an STD infected partner such that female physicians were more attentive to sexual health, and all physicians were more likely to treat female patients aggressively, relative to their male patients. Overall behavior was broadly congruent with sound medical practice, although we discuss several caveats to this general statement.

  15. Constitutive Function of the Ikaros Transcription Factor in Primary Leukemia Cells from Pediatric Newly Diagnosed High-Risk and Relapsed B-precursor ALL Patients

    PubMed Central

    Uckun, Fatih M.; Ma, Hong; Ishkhanian, Rita; Arellano, Martha; Shahidzadeh, Anoush; Termuhlen, Amanda; Gaynon, Paul S.; Qazi, Sanjive

    2013-01-01

    We examined the constitutive function of the Ikaros (IK) transcription factor in blast cells from pediatric B-precursor acute lymphoblastic leukemia (BPL) patients using multiple assay platforms and bioinformatics tools. We found no evidence of diminished IK expression or function for primary cells from high-risk BPL patients including a Philadelphia chromosome (Ph)+ subset. Relapse clones as well as very aggressive in vivo clonogenic leukemic B-cell precursors isolated from spleens of xenografted NOD/SCID mice that developed overt leukemia after inoculation with primary leukemic cells of patients with BPL invariably and abundantly expressed intact IK protein. These results demonstrate that a lost or diminished IK function is not a characteristic feature of leukemic cells in Ph+ or Ph- high-risk BPL. PMID:24278314

  16. Role of Rectal Diclofenac Suppository for Prevention and Its Impact on Severity of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-Risk Patients

    PubMed Central

    Patil, Sandeep; Pandey, Vikas; Pandav, Nilesh; Ingle, Meghraj; Phadke, Aniruddha; Sawant, Prabha

    2016-01-01

    Background The aim was to study the role of rectal diclofenac in prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis and its impact on severity of post-ERCP pancreatitis. Methods We conducted a single-center, prospective, open-labeled, randomized trial for evaluating the use of rectal diclofenac in prevention of post-ERCP pancreatitis in high-risk patients. We assessed 526 patients coming for ERCP for different indications. Four hundred patients were eligible for the study. Those not fitting the high-risk criteria and with acute pancreatitis were excluded. These patients were randomized in two groups: 200 patients received rectal diclofenac prior to or during the procedure, while 200 patients received placebos. Serum amylase was measured at 2 and 36 hours. Post-ERCP pancreatitis was defined as serum amylase > 3 times upper limit of normal with associated severe abdominal pain. Severity was graded according to days of hospitalization and complications. Results Twenty-nine out of 400 (7.2%) patients developed post-ERCP pancreatitis. Six out of 200 (3%) patients in rectal diclofenac group developed post-ERCP pancreatitis compared to 23 out of 200 (11.5%) patients in placebo group. The difference was statistically significant (P = 0.001). All patients (six) in rectal diclofenac group developed mild pancreatitis as compared to severe pancreatitis in four and moderate pancreatitis in five patients in the placebo group. Conclusion Rectal diclofenac prior to or during ERCP in high-risk patients reduces the incidence as well as severity of post-ERCP pancreatitis compared to placebo.

  17. Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) - DEVOTE 1.

    PubMed

    Marso, Steven P; McGuire, Darren K; Zinman, Bernard; Poulter, Neil R; Emerson, Scott S; Pieber, Thomas R; Pratley, Richard E; Haahr, Poul-Martin; Lange, Martin; Frandsen, Kirstine Brown; Rabøl, Rasmus; Buse, John B

    2016-09-01

    DEVOTE was designed to evaluate the cardiovascular safety of insulin degludec (IDeg) vs insulin glargine U100 (IGlar) in patients with T2D at high risk of cardiovascular events. DEVOTE is a phase 3b, multicenter, international, randomized, double-blind, active comparator-controlled trial, designed as an event-driven trial that would continue until 633 positively adjudicated primary events were accrued. The primary end point was the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Patients with T2D at high risk of cardiovascular complications were randomized 1:1 to receive either IDeg or IGlar, each added to background therapies. This trial was designed to demonstrate statistical noninferiority of IDeg vs IGlar for the primary end point. DEVOTE enrolled 7,637 patients between October 2013 and November 2014 at 436 sites in 20 countries. Of these, 6,506 patients had prior cardiovascular disease or chronic kidney disease, and the remainder had multiple cardiovascular risk factors. DEVOTE was designed to provide conclusive evidence regarding the cardiovascular safety of IDeg relative to IGlar in a high-risk population of patients with T2D. PMID:27595693

  18. [Comparison of clinical efficacy between decitabine combined with CAG regimen and CAG regimen alone in patients with intermediate to high-risk myelodysplastic syndromes].

    PubMed

    Zhang, Yun-Ping; Wu, Wen-Zhong; Cui, Guo-Xing

    2014-10-01

    This study was purposed to compare the clinical efficacy and adverse reactions of low-dose decitabine combined with CAG regimen (aclarubicin, Ara-C, and G-CSF) and CAG regimen alone in intermediate to high-risk myelodysplastic syndromes (MDS), and evaluate the validity and efficacy of the former regimen as new treatment method of intermediate to high-risk myelodysplastic syndromes. A total of 12 patients with intermediate (IR) to high-risk (HR) MDS treated by low-dose decitabine combined with CAG regimen and 10 patients with IR to HR MDS treated by CAG regimen alone were evaluated after treatment of 1 cycle and at least after 2 cycles. The complete remission (CR) after 1 cycle, overall remission rate (ORR), progression free survival (PFS) and overall survival (OS) between them were analyzed. The results showed that 9 patients treated by low-dose decitabine combined with CAG regimen achieved complete remission after 1 cycle, 2 patients achieved partial remission, 1 patient did not show reaction. The complete remission rate was 75.0% and overall response rate was 91.7%. The median time of disease free survival was 9 months (0-27 months). The median overall survival time was 16 months (3-28 months). 4 patients suffered from pulmonary infection after treatment and then were all cured after treatment with anti-infective therapy. The 5 patients treated by CAG regimen alone achieved complete remission,3 patients achieved partial remission, 2 patients showed non-reaction. The complete remission rate was 50.0% and overall response rate was 80.0%. The median time of disease free survival was 6 months(0-18 months). The median overall survival time was 13 months(3-31 months), 4 patients suffered from pulmonary infection, 1 patient suffered from enteric infection and 1 patient suffered from Escherichia coli septicemia after treatment, all of them becomed better after active treatment. Two groups of patients all had no serious adverse reactions, All patients could tolerate, no

  19. DOC-2/DAB2 Interacting Protein Status in High-Risk Prostate Cancer Correlates With Outcome for Patients Treated With Radiation Therapy

    SciTech Connect

    Jacobs, Corbin; Tumati, Vasu; Kapur, Payal; Yan, Jingsheng; Hong, David; Bhuiyan, Manzerul; Xie, Xian-Jin; Pistenmaa, David; Yu, Lan; Hsieh, Jer-Tsong; Saha, Debabrata; Kim, D. W. Nathan

    2014-07-15

    Purpose: This pilot study investigates the role of DOC-2/DAB2 Interacting Protein (DAB2IP) and enhancer of zeste homolog 2 (EZH2) as prognostic biomarkers in high-risk prostate cancer patients receiving definitive radiation therapy. Methods and Materials: Immunohistochemistry was performed and scored by an expert genitourinary pathologist. Clinical endpoints evaluated were freedom from biochemical failure (FFBF), castration resistance–free survival (CRFS), and distant metastasis–free survival (DMFS). Log-rank test and Cox regression were used to determine significance of biomarker levels with clinical outcome. Results: Fifty-four patients with high-risk prostate cancer (stage ≥T3a, or Gleason score ≥8, or prostate-specific antigen level ≥20 ng/mL) treated with radiation therapy from 2005 to 2012 at our institution were evaluated. Nearly all patients expressed EZH2 (98%), whereas 28% of patients revealed DAB2IP reduction and 72% retained DAB2IP. Median follow-up was 34.0 months for DAB2IP-reduced patients, 29.9 months for DAB2IP-retained patients, and 32.6 months in the EZH2 study. Reduction in DAB2IP portended worse outcome compared with DAB2IP-retained patients, including FFBF (4-year: 37% vs 89%, P=.04), CRFS (4-year: 50% vs 90%, P=.02), and DMFS (4-year: 36% vs 97%, P=.05). Stratified EZH2 expression trended toward significance for worse FFBF and CRFS (P=.07). Patients with reduced DAB2IP or highest-intensity EZH2 expression exhibited worse FFBF (4-year: 32% vs 95%, P=.02), CRFS (4-year: 28% vs 100%, P<.01), and DMFS (4-year: 39% vs 100%, P=.04) compared with the control group. Conclusion: Loss of DAB2IP is a potent biomarker that portends worse outcome despite definitive radiation therapy for patients with high-risk prostate cancer. Enhancer of zeste homolog 2 is expressed in most high-risk tumors and is a less potent discriminator of outcome in this study. The DAB2IP status in combination with degree of EZH2 expression may be useful for

  20. Hypercapnia Improves Tissue Oxygenation in Morbidly Obese Surgical Patients

    PubMed Central

    Hager, Helmut; Reddy, Dayakar; Mandadi, Goutham; Pulley, Debra; Eagon, J Chris; Sessler, Daniel I; Kurz, Andrea

    2006-01-01

    Risk of wound infection is increased in morbidly obese surgical patients, in part because a major determinant of wound infection risk, tissue oxygenation, is marginal. Unlike in lean patients, supplemental inspired oxygen (FIO2) only slightly improves tissue oxygenation in obese patients. Mild hypercapnia improves tissue oxygenation in lean, but has not been evaluated in obese patients. We thus tested the hypothesis that mild hypercapnia markedly improves tissue oxygenation in morbidly obese patients given FIO2 80% during major abdominal surgery. Thirty obese patients (body mass index 61.5±17 kg/m2) scheduled for open gastric bypass were randomly assigned to normocapnia (n=15, end-tidal PCO2 35 mmHg) or hypercapnia (n=15, end-tidal PCO2 50 mmHg); FIO2 was 80%. Anesthetic management and other confounding factors were controlled. Tissue oxygen tension was measured subcutaneously at the upper arm using a polarographic probe in a silastic tonometer. Demographic characteristics, cardiovascular measurements, and PaO2 (222±48 versus 230±68 mmHg in normocapnic versus hypercapnic; mean±SD, P=0.705) were comparable in the groups. Tissue oxygen tension, however, was greater in hypercapnic than in normocapnic patients (78±31 versus 56±13 mmHg, P=0.029). Mild hypercapnia increased tissue oxygenation by an amount believed to be clinically important and could potentially reduce the risk of surgical wound infection in morbidly obese patients. PMID:16931680

  1. Surgical Options for Drug-Refractory Overactive Bladder Patients

    PubMed Central

    Starkman, Jonathan S; Smith, Christopher P; Staskin, David R

    2010-01-01

    Overactive bladder (OAB) is a symptom complex of urinary frequency, urinary urgency, and nocturia, with or without urgency incontinence. This syndrome is idiopathic in most instances without clearly defined pathophysiology. Studies clearly show that OAB negatively impacts health-related quality of life and impairs daily functioning in a large proportion of patients. Despite recent advances in drug delivery and improved tolerability of antimuscarinic drug class, a large percentage of patients remain refractory to conventional pharmacological therapy for this chronic condition. There are several unique and effective treatments that are available for this difficult population. We review the various surgical options within the urological armamentarium to treat patients with refractory OAB. PMID:20811558

  2. Effect of intensive nursing education on the prevention of diabetic foot ulceration among patients with high-risk diabetic foot: a follow-up analysis.

    PubMed

    Ren, Meng; Yang, Chuan; Lin, Diao Zhu; Xiao, Hui Sheng; Mai, Li Fang; Guo, Yi Chen; Yan, Li

    2014-09-01

    The aim of the study was to discuss the effect of intensive nursing education on the prevention of diabetic foot ulceration among patients at high risk for diabetic foot. One hundred eighty-five diabetes patients at high risk for foot diseases were enrolled in this study and provided with intensive nursing education, including individualized education about diabetes mellitus and diabetic foot diseases, instruction in podiatric care (the right way of washing the foot, the care of foot skin, appropriate choice of shoes and socks, intense examinations and records of feet by patients themselves every day, and the assistant management of calluses). Study subjects were followed up for 2 years. Once the foot ulceration developed, the inducing factors of foot ulceration were inquired about, the ulcers were evaluated, and the incidence of foot ulceration was analyzed before and after the intensive nursing education according to self-paired data. Results showed there were highly statistically significant improvements in the intensive treatment group compared with the control group in plasma glucose, blood pressure, and high-density lipoprotein cholesterol levels. More important is that intensive nursing education helps to prevent diabetic foot ulceration and to decrease the rate of amputation among patients at high risk for diabetic foot.

  3. Long-Term Outcomes for Patients with Prostate Cancer Having Intermediate and High-Risk Disease, Treated with Combination External Beam Irradiation and Brachytherapy

    PubMed Central

    Dattoli, Michael; Wallner, Kent; True, Lawrence; Bostwick, David; Cash, Jennifer; Sorace, Richard

    2010-01-01

    Background. Perception remains that brachytherapy-based regimens are inappropriate for patients having increased risk of extracapsular extension (ECE). Methods. 321 consecutive intermediate and high-risk disease patients were treated between 1/92 and 2/97 by one author (M. Dattoli) and stratified by NCCN guidelines. 157 had intermediate-risk; 164 had high-risk disease. All were treated using the combination EBRT/brachytherapy ± hormones. Biochemical failure was defined using PSA >0.2 and nadir +2 at last followup. Nonfailing patients followup was median 10.5 years. Both biochemical data and original biopsy slides were independently rereviewed at an outside institution. Results. Overall actuarial freedom from biochemical progression at 16 years was 82% (89% intermediate, 74% high-risk) with failure predictors: Gleason score (P = .01) and PSA (P = .03). Hormonal therapy did not affect failure rates (P = .14). Conclusion. This study helps to strengthen the rationale for brachytherapy-based regimens as being both durable and desirable treatment options for such patients. Prospective studies are justified to confirm these positive results. PMID:20847945

  4. Long-term outcomes for patients with prostate cancer having intermediate and high-risk disease, treated with combination external beam irradiation and brachytherapy.

    PubMed

    Dattoli, Michael; Wallner, Kent; True, Lawrence; Bostwick, David; Cash, Jennifer; Sorace, Richard

    2010-01-01

    Background. Perception remains that brachytherapy-based regimens are inappropriate for patients having increased risk of extracapsular extension (ECE). Methods. 321 consecutive intermediate and high-risk disease patients were treated between 1/92 and 2/97 by one author (M. Dattoli) and stratified by NCCN guidelines. 157 had intermediate-risk; 164 had high-risk disease. All were treated using the combination EBRT/brachytherapy ± hormones. Biochemical failure was defined using PSA >0.2 and nadir +2 at last followup. Nonfailing patients followup was median 10.5 years. Both biochemical data and original biopsy slides were independently rereviewed at an outside institution. Results. Overall actuarial freedom from biochemical progression at 16 years was 82% (89% intermediate, 74% high-risk) with failure predictors: Gleason score (P = .01) and PSA (P = .03). Hormonal therapy did not affect failure rates (P = .14). Conclusion. This study helps to strengthen the rationale for brachytherapy-based regimens as being both durable and desirable treatment options for such patients. Prospective studies are justified to confirm these positive results. PMID:20847945

  5. Different surgical strategies of patients with intravenous leiomyomatosis.

    PubMed

    Ma, Guotao; Miao, Qi; Liu, Xingrong; Zhang, Chaoji; Liu, Jianzhou; Zheng, Yuehong; Shao, Jiang; Cheng, Ninghai; Du, Shunda; Hu, Zhan; Ren, Zhinan; Sun, Luxi

    2016-09-01

    Intravenous leiomyomatosis (IVL) is a rare benign tumor. The study aimed to assess outcomes of patients treated surgically for IVL.Between November 2002 and January 2015, 76 patients were treated for IVL. The stage of IVL was evaluated preoperatively by echocardiography and enhanced computerized tomography (CT) scan, and graded into 4 stages according to intravascular tumor progression. We recorded age, lower limb edema before surgery, surgical parameters, and hospitalization expenses. Patients were followed up every 6 months and tumor recurrence was assessed by CT and ultrasound. Patients were followed up for a mean of 4.5 ± 2.5 years (range 1-13 years) and there was no operative, hospital, or long-term mortality or were lost to follow-up.The rate of lower extremity edema, amount of blood loss, postoperative transfusion, length of intensive care unit (ICU) stay, postoperative hospitalization, and hospitalization expenses differed significantly between patients at different presurgery stages. Tumors recurred in 4 of 7 patients with stage I IVL that opted for surgery that preserved the ovaries and uterus. No recurrence was observed in patients graded stage II or more, in all of which the uterus and ovaries were removed. Recurrence was observed in only 4 of 76 cases of IVL, all of whom opted for surgery that spared the ovaries and uterus.Different surgical strategies should be decided based on the staging to completely remove the tumor and ensure the safety of patients. Removal of both ovaries is necessary for inhibiting tumor growth and avoiding recurrence. PMID:27631266

  6. Cell of origin predicts outcome to treatment with etoposide-containing chemotherapy in young patients with high-risk diffuse large B-cell lymphoma.

    PubMed

    Gang, Anne O; Pedersen, Mette Ø; Knudsen, Helle; Lauritzen, Anne F; Pedersen, Michael; Nielsen, Signe L; Brown, Peter; Høgdall, Estrid; Klausen, Tobias W; Nørgaard, Peter

    2015-07-01

    Addition of etoposide to the R-CHOP chemotherapy regimen with cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab (R-CHOEP) has resulted in improved survival in young patients with high-risk diffuse large B-cell lymphoma (DLBCL). It is not known whether biological factors can predict this effect. In this study, 245 patients representing all young patients with high-risk DLBCL treated with R-CHOP or R-CHOEP in 2004-2012 in Denmark were extracted from the Danish lymphoma database. Patients were stratified according to cell of origin (COO) into germinal-center B-cell-like (GCB) or non-GCB by Hans' algorithm. Only in patients with the GCB phenotype was treatment with R-CHOEP associated with improved progression-free survival (PFS) and overall survival (OS) compared with R-CHOP. Patients with GCB phenotype treated with R-CHOEP also had superior OS compared with patients with non-GCB phenotype treated with R-CHOEP. This was not seen in R-CHOP treated patients. This could suggest that R-CHOEP should be restricted to patients with GCB phenotype.

  7. Chemoradiation With Paclitaxel and Carboplatin in High-Risk Cervical Cancer Patients After Radical Hysterectomy: A Korean Gynecologic Oncology Group Study

    SciTech Connect

    Lee, Taek Sang; Kang, Soon Beom; Kim, Young Tak; Park, Byung Joo; Kim, Yong Man; Lee, Jong Min; Kim, Seok Mo; Kim, Young Tae; Kim, Jae Hoon; Kim, Kyung Tai

    2013-06-01

    Purpose: To evaluate the efficacy and toxicity of concurrent chemoradiation with paclitaxel and carboplatin in patients with high-risk cervical cancer. Methods and Materials: Patients after radical hysterectomy for cervical cancer, with at least 1 high-risk characteristic, were administered paclitaxel 135 mg/m{sup 2}, carboplatin area under the curve = 5 every 3 weeks for 3 cycles concomitant with radiation therapy as adjuvant treatment. Results: This prospective study enrolled 71 consecutive patients. Sixty-six patients (93%) completed the planned treatment. The majority of grade 3/4 neutropenia or nonhematologic toxicities were usually self-limited. Diarrhea grades 3/4 were observed in 4 patients (5.6%). One patient developed anaphylactic shock after infusion of paclitaxel. With a median follow-up of 57 months, recurrences occurred in 16 patients. Multivariable analysis indicated that common iliac lymph node involvement is an independent risk factor for disease recurrence (odds ratio 13.48; 95% confidence interval 2.93-62.03). In the intent-to-treat population (n=71), the estimated 5-year disease-free survival and overall survival rates were 77.3% and 80.3% respectively. In the per-protocol population (n=62), disease-free survival was 78.9% and overall survival was 83.9%. Conclusions: Concurrent chemoradiation with paclitaxel/carboplatin is well tolerated and seems to be effective for patients who undergo radical hysterectomy. Therefore, a prospective, randomized controlled study should be designed to evaluate efficacy of this approach for patients with high-risk cervical cancer.

  8. Magnetic resonance imaging of patients wearing a surgical traction halo.

    PubMed

    Hua, J; Fox, R A

    1996-01-01

    Magnetic resonance images of patients wearing a surgical halo may have unacceptable artifacts if the halo has a conductive loop structure. This study shows that the observed artifacts are predominantly due to eddy currents generated in the halo by switching field gradients, and that these artifacts can be substantially reduced by adjusting the phase encoding direction in MRI sequences so that it is parallel to the axis of the halo. PMID:8851441

  9. Pilot study evaluating the safety of a combined central venous catheter and inferior vena cava filter in critically ill patients at high risk of pulmonary embolism.

    PubMed

    Cadavid, Carlos A; Gil, Bladimir; Restrepo, Alvaro; Alvarez, Sergio; Echeverry, Santiago; Angel, Luis F; Tapson, Victor; Kaufman, John

    2013-04-01

    The objectives of this pilot trial were to assess the safety of a new device for pulmonary embolism (PE) prophylaxis. The device, the Angel Catheter, was placed in eight patients who were in the intensive care unit and were at high risk of PE. The device was inserted at the bedside without fluoroscopic guidance via a femoral venous approach. All eight devices were inserted and subsequently retrieved without complications (follow-up, 33-36 d). One filter trapped a large clot.

  10. Quality of life in patients with ulcerative colitis treated surgically

    PubMed Central

    Kozłowska, Katarzyna A.; Krokowicz, Piotr

    2014-01-01

    Introduction Ulcerative colitis belongs to the group of inflammatory bowel diseases. The specific symptoms and chronic nature of the disease significantly affect the quality of patients’ lives. Quality-of-life assessment helps to define its determining factors as well as the efficiency of surgical procedures. Aim Quality-of-life evaluation of patients with ulcerative colitis treated surgically. Material and methods A retrospective review was carried out on 35 patients with ulcerative colitis, who were treated surgically in the Clinic of General and Colorectal Surgery, University of Medical Sciences in Poznan. The research tools used to assess the quality of life consisted of: the Inflammatory Bowel Disease Questionnaire, a Polish version of the Short Form Health Survey-36, and a questionnaire. Results The mean of the IBDQ scale was 152.51, and the median was 161. In this scale, a higher score indicates better quality of life. The situation in the subjective SF-36 scale is reversed: a lower score indicates better quality of life. The mean of the SF-36 was 115.94, and the median was 58. Many discrepancies in the field (e.g. the influence of determining factors) create a niche for further studies. Conclusions Moreover, quality-of-life evaluation may lead to better patient care, understanding their problems or treatment modifications, and finally may become a kind of therapy efficiency parameter. PMID:25276253

  11. VTE primary prevention, including hospitalised medical and orthopaedic surgical patients.

    PubMed

    Granziera, Serena; Cohen, Alexander T

    2015-06-01

    Primary prevention is the key to managing a significant proportion of the burden of venous thromboembolism (VTE), defined as deep venous thrombosis (DVT) or pulmonary embolism (PE). This is because VTE may lead to sudden death or are often misdiagnosed and therefore treatment is not feasible. Primary prevention usually commences in hospital as VTE following hospitalisation adds to the significant disease burden worldwide. Numerous medical, surgical and other risk factors have been recognised and studied as indications for prophylaxis. The risk of VTE continues following admission to hospital with a medical or surgical condition, usually long after discharge and therefore prolonged primary prophylaxis is often recommended. Clinical and observational studies in surgical patients show this risk extends for months and perhaps more than one year, for medical patients the risk extends for at least several weeks. For the specific groups of patients at higher risk of developing VTE primary prevention, either pharmaceutical or mechanical, is recommended. The aim of this review is to describe the population at risk, the main related risk factors and the approach to thromboprophylaxis in different populations.

  12. Tumor size and T stage correlate independently with recurrence and progression in high-risk non-muscle-invasive bladder cancer patients treated with adjuvant BCG.

    PubMed

    Zachos, Ioannis; Tzortzis, Vasileios; Mitrakas, Lampros; Samarinas, Michael; Karatzas, Anastasios; Gravas, Stavros; Vandoros, Gerasimos P; Melekos, Michael D; Papavassiliou, Athanasios G

    2014-05-01

    We conducted a retrospective study to determine the prognostic significance of age, gender, associated carcinoma in situ, stage, number of tumors, and tumor size for patients with high-risk non-muscle-invasive bladder tumors treated with bacillus Calmette-Guérin (BCG). Data were evaluated on 144 high-risk patients with non-muscle-invasive bladder cancer treated with BCG immunotherapy after the initial treatment with transurethral resection. According to their response to BCG, patients were divided into groups, and the differences in factors, associated with recurrence and progression, were evaluated. Patients were categorized into two groups: group A, complete responders without recurrence and without progression, and group B, patients with recurrence and with progression. Furthermore, group B was divided into two subgroups: group B1, patients with recurrence, and group B2, patients with progression. Univariate analysis of group B showed that only tumor size of >3 cm diameter (hazard ratio (HR) 11.99; 95% confidence interval (CI) range 5.69-25.3; p < 0.001) is associated with recurrence. After multivariate analysis, the same factor appeared to be prognostic for recurrence as well. In addition, group B2 was statistically correlated with group B1. Univariate analysis proved that tumor stage (Ta or T1) is the unique factor associated with progression (HR 6.4; 95% CI 1.29-31.9; p = 0.02). Tumor stage seems to be associated with disease's progression after the multivariate analysis too. Tumor size and stage may serve as prognostic factors, because of its independent correlation with recurrence and progression for patients with high-risk non-muscle-invasive bladder tumors treated with BCG.

  13. Surgical Treatment in Patients with Cervical Osteomyelitis: Single Institute's Experiences

    PubMed Central

    Hahn, Bang Sang; Kim, Kyung-Hyun; Park, Jung Yoon; Chin, Dong-Kyu; Kim, Keun-Su; Cho, Yong-Eun

    2014-01-01

    Objective To study practical guidelines and strategies in the treatment of cervical osteomyelitis. Methods We retrospectively reviewed 14 patients who underwent surgical treatment for cervical osteomyelitis from May 2000 to July 2008. We investigated their clinical course, antibiotic regimen, surgical methods, and laboratory and radiologic findings including X-ray, CT and MRI. Results 5 patients had primary spondylodiscitis, 5 patients had post operative spondylodiscitis and 4 patients had tuberculosis in cervical spine. The causative microorganisms were MRSA (5), P. aeruginosa (1), Methicillin resistant coagulase negative streptococcus (1), P. aeruginosa changed to MRSA (1), and 2 patients showed no growth on culture studies. Patients were treated 13.8 weeks (range, 5.4-25.8) with IV antibiotics and then treated for 58.2 days (range, 13-106) with oral antibiotics. Antituberculotic medications were used for a mean of 383.8 days. Patients were treated with anterior debridement and fusion (5), irrigation and debridement (5), simultaneous cervical anterior interbody and transthoracic thoracic interbody fusion (1). 3 patients underwent the planned 2-staged operation, which included an anterior debridement with or without fusion for the 1st operation and posterior instrumentation for 2nd operation. 10 patients (71.4%) had neurologic deficits at the time of diagnosis and 7 patients (70%) among them improved post-operatively. Conclusion Anterior cervical spine surgery is the preferable treatment option in patients with neurological deterioration, extensive bony destruction with expected kyphotic deformity, and uncontrolled infection being managed only with antibiotics. Antibiotics are also important for thorough treatment. PMID:25346763

  14. Generating patient-specific pulmonary vascular models for surgical planning

    NASA Astrophysics Data System (ADS)

    Murff, Daniel; Co-Vu, Jennifer; O'Dell, Walter G.

    2015-03-01

    Each year in the U.S., 7.4 million surgical procedures involving the major vessels are performed. Many of our patients require multiple surgeries, and many of the procedures include "surgical exploration". Procedures of this kind come with a significant amount of risk, carrying up to a 17.4% predicted mortality rate. This is especially concerning for our target population of pediatric patients with congenital abnormalities of the heart and major pulmonary vessels. This paper offers a novel approach to surgical planning which includes studying virtual and physical models of pulmonary vasculature of an individual patient before operation obtained from conventional 3D X-ray computed tomography (CT) scans of the chest. These models would provide clinicians with a non-invasive, intricately detailed representation of patient anatomy, and could reduce the need for invasive planning procedures such as exploratory surgery. Researchers involved in the AirPROM project have already demonstrated the utility of virtual and physical models in treatment planning of the airways of the chest. Clinicians have acknowledged the potential benefit from such a technology. A method for creating patient-derived physical models is demonstrated on pulmonary vasculature extracted from a CT scan with contrast of an adult human. Using a modified version of the NIH ImageJ program, a series of image processing functions are used to extract and mathematically reconstruct the vasculature tree structures of interest. An auto-generated STL file is sent to a 3D printer to create a physical model of the major pulmonary vasculature generated from 3D CT scans of patients.

  15. AB174. Clinical analysis of transurethral end-fire greenlight PVRP-ST for the treatment of elderly and high-risk patients with

    PubMed Central

    Yang, Guosheng; Qiu, Xiaofo

    2016-01-01

    intraoperative complication rate, surgical risk and higher security for elderly patients at high risk; (V) compared with TURP, the patients underwent PVRP-ST can recovery quicker and the hospital stay days are shorter. There is lower incidence of postoperative hematuria. But there was no significant difference between the other complications.

  16. Results of Surgical Therapy in Patients with Medullary Thyroid Carcinoma.

    PubMed

    Vlad, Mihaela; Zosin, Ioana; Timar, Bogdan; Lazar, Fulger; Vlad, Adrian; Timar, Romulus; Cornianu, Marioara

    2016-08-01

    Medullary thyroid carcinoma (MTC) is a rare form of malignancy, having an intermediate prognosis. Controversies exist regarding the best surgical approach. The aim of the study was to analyze the outcome in a group of patients with MTC, diagnosed and followed up in a single care center. We performed a retrospective analysis of all the patients diagnosed with MTC in the Department of Endocrinology from the County Emergency Hospital Timisoara between 1992 and 2012. The study group included 19 patients, 6 men (31.6 %), mean age 41.2 ± 12.5 years (20-72 years). The preoperative diagnosis was based on the protocol for nodular thyroid disease. Total or near-total thyroidectomy was performed in 10 out of 16 patients who could be operated. Postoperative follow-up included repeated measurements of serum calcitonin and imaging investigations. Nine out of the total of 19 (47.3 %) patients had hereditary forms of MTC. Most of the cases (84.2 %) were submitted to surgery. The median duration of follow-up was 84 months. The pTNM staging indicated that the majority of the patients with hereditary MTC were diagnosed in an earlier stage. Disease remission was achieved in 7 cases (43.8 %). Four patients, all with sporadic forms, died. Survival rates at 1, 5 and 10 years were significantly higher (p = 0.048) in patients with hereditary MTC. An early diagnosis of MTC allows a better surgical approach and an improved survival rate. We support the general recommendation that modified radical neck dissection is not necessary for all the patients with MTC. PMID:27574350

  17. A phase I study of adjuvant intensity-modulated radiotherapy with concurrent paclitaxel and cisplatin for cervical cancer patients with high risk factors.

    PubMed

    Shu, Pei; Shen, Yali; Zhao, Yaqin; Xu, Feng; Qiu, Meng; Li, Qiu; Gou, Hongfeng; Cao, Dan; Yang, Yu; Liu, Jiyan; Yi, Cheng; Liao, Zhengyin; Luo, Deyun; Bi, Feng; Wang, Xin; Li, Zhiping

    2015-11-01

    The aim of the study is to determine the maximum tolerated dose (MTD) and acute dose-limiting toxicities (DLTs) of adjuvant concurrent paclitaxel and cisplatin (TP) with pelvic intensity-modulated radiotherapy (IMRT) for early-stage cervical cancer patients with high risk factors. Women who underwent radical hysterectomy and pelvic lymphadenectomy for stages IB-IIA cervical cancer and had high risk factors were enrolled. One cycle of TP was delivered before and after concurrent chemoradiotherapy, respectively. Then 3 weeks after the start of the initial cycle of the chemotherapy, patients received IMRT in a total dose of 50-50.4 Gy in 25-28 fractions with two cycles of concurrent TP, which was administered with escalating doses. Eighteen patients were enrolled at three dose levels. At dose level 1 (paclitaxel 90 mg/m(2), cisplatin 40 mg/m(2)) and level 2 (paclitaxel 90 mg/m(2), cisplatin 50 mg/m(2)), DLT (grade 3 leukopenia) was observed in one patient, respectively. At level 3 (paclitaxel 105 mg/m(2), cisplatin 50 mg/m(2)), two DLTs (grade 3 leukopenia) were observed in two patients. The MTD of paclitaxel and cisplatin was then defined as 90 and 50 mg/m(2), respectively. Pelvic IMRT and concurrent TP is a safe and tolerable adjuvant treatment regimen for cervical cancer patients with high risk factors. The MTD of concurrent chemotherapy is paclitaxel 90 mg/m(2) and cisplatin 50 mg/m(2). Trial registration Current controlled trials ChiECRCT-2014025.

  18. Patients treated in a coronary care unit without acute myocardial infarction: identification of high risk subgroup for subsequent myocardial infarction and/or cardiovascular death.

    PubMed Central

    Nordlander, R; Nyquist, O

    1979-01-01

    Consecutive patients admitted to a coronary care unit (CCU) during one year were studied. The diagnosis of acute myocardial infarction was not substantiated by our criteria in 206 of the patients discharged from the CCU. Of these, 193 were retrospectively followed up during one year. Seventeen of the patients (9%) died from cardiovascular causes during the 1-year period. Another 14 patients (7%) had a subsequent non-fatal acute myocardial infarction during the same period. The majority of the patients had coronary artery disease. Only 32 (17%) could be classified as non-coronary cases, and these had an excellent prognosis without any subsequent acute myocardial infarctions or deaths. The occurrence of transient ST-T shifts in serial electrocardiograms obtained during the first 3 days in hospital selected a subgroup of patients who had a high risk for subsequent non-fatal acute myocardial infarction and/or cardiovascular death. This high risk subgroup provides a basis for more aggressive diagnostic and therapeutic intervention. Images PMID:465239

  19. Intraoperative Frozen Section of the Prostate Reduces the Risk of Positive Margin Whilst Ensuring Nerve Sparing in Patients with Intermediate and High-Risk Prostate Cancer Undergoing Robotic Radical Prostatectomy: First Reported UK Series

    PubMed Central

    Vasdev, Nikhil; Agarwal, Samita; Rai, Bhavan P.; Soosainathan, Arany; Shaw, Gregory; Chang, Sebastian; Prasad, Venkat; Mohan-S, Gowrie; Adshead, James M.

    2016-01-01

    Introduction Nerve sparing during robotic radical prostatectomy (RRP) considerably improves post-operative potency and urinary continence as long as it does not compromise oncological outcome. Excision of the neurovascular bundle (NVB) is often performed in patients with intermediate and high risk prostate cancer to reduce the risk of positive surgical margin raising the risk of urinary incontinence and impotence. We present the first UK series outcomes of such patients who underwent an intra-operative frozen section (IOFS) analysis of the prostate during RRP allowing nerve sparing. Patients and Methods We prospectively analysed the data of 40 patients who underwent an IOFS during RRP at our centre from November 2012 until November 2014. Our IOFS technique involved whole lateral circumferential analysis of the prostate during RRP with the corresponding neurovascular tissue. An intrafascial nerve spare was performed and the specimen was removed intra-operatively via an extension of the 12 mm Autosuture™ camera port without undocking robotic arms. It was then painted by the surgeon and sprayed with “Ink Aid” prior to frozen section analysis. The corresponding NVB was excised if the histopathologist found a positive surgical margin on frozen section. Results Median time to extract the specimen, wound closure and re-establishment of pneumoperitoneum increased the operative time by 8 min. Median blood loss for IOFS was 130 ± 97 ml vs. 90 ± 72 ml (p = NS). IOFS was not associated with major complications or with blood transfusion. PSM decreased significantly from non-IOFS RRP series of 28.7 to 7.8% (p < 0.05). Intra-operative PSM on the prostate specimen was seen in 8/40 margin analysis (20%) leading to an excision of the contra-lateral nerve bundle. On analysis of the nerve bundle on a paraffin embedded block, 6 nerve bundle matched tumor on the specimen whereas 2 NVB were retrospectively removed unnecessarily in our series. All 40 patients have undetectable PSA

  20. A Phase II Multi-institutional Trial of Chemoradiation Using Weekly Docetaxel and Erythropoietin for High-Risk Postoperative Head and Neck Cancer Patients

    SciTech Connect

    Willey, Christopher D.; Murphy, Barbara A.; Netterville, James L.; Burkey, Brian B.; Shyr, Yu; Shakhtour, Bashar; Kish, Bonnie; Raben, David; Chen Changhu; Song, John I.; Kane, Madeleine A.; Cmelak, Anthony J. . E-mail: anthony.cmelak@vanderbilt.edu

    2007-04-01

    Purpose: To determine efficacy and toxicities of postoperative concurrent chemoradiation using docetaxel in high-risk head and neck cancer. Methods and Materials: High-risk patients were enrolled 2-8 weeks after surgery. Treatment included 60 Gy for 6 weeks with weekly docetaxel 25 mg/m{sup 2} and erythropoietin alpha 40,000 U for hemoglobin {<=}12 g/dL. Primary endpoints included locoregional control (LC), disease-free survival (DFS), and patterns of failure (POF). Secondary endpoints were toxicity and quality of life. Results: Eighteen patients were enrolled (14 male, 4 female), aged 24-70 years (median, 55 years). Primary site included oropharynx = 7, oral cavity 8, hypopharynx = 1, and larynx = 2. Pathologic American Joint Committee on Cancer Stage was III = 3 patients, IV = 15 patients. High-risk eligibility included {>=}2 positive lymph nodes = 13, extracapsular extension = 10, positive margins = 8 (11 patients with two or more risk factors). Docetaxel was reduced to 20 mg/m{sup 2}/week after 5 patients had prolonged Grade 3 or higher mucositis. Overall, number of doses delivered was 2 of 6 = 1, 3 of 6 2, 4 of 6 = 2, 5 of 6 = 4, 6 of 6 = 9 patients. With median follow-up of 30 months (range, 5-66), 10 (56%) patients are alive and have no evidence of disease (NED); POF: three local recurrences (two with distant) and 1 distant only. One-year survival was 76%, median PFS and DFS had not been reached. Three-year LC was 82%. No Grade 3 or higher late toxicities were observed, although a few cases of prolonged mucositis and taste loss (>3 months) were seen, particularly at 25 mg/m{sup 2}/week. Conclusion: Postoperative radiation therapy with weekly docetaxel 20 or 25 mg/m{sup 2}/week for high-risk postoperative head and neck cancer caused intolerable mucosal toxicity, prompting early study termination. Further studies should consider 15 mg/m{sup 2}. Actuarial 3-year LC is 82%, similar to cisplatin-based chemoradiation regimens. Distant metastasis remains an

  1. Assessment of surgical wounds in the home health patient: definitions and accuracy with OASIS-C.

    PubMed

    Trexler, Rhonda A

    2011-10-01

    The number of surgical patients receiving home care continues to grow as hospitals discharge patients sooner. Home health clinicians must gain knowledge of the wound healing stages and surgical wound classification to collect accurate data in the Outcome and Assessment Information Set-C (OASIS-C). This article provides the information clinicians need to accurately assess surgical wounds and implement best practices for improving surgical wounds in the home health patient.

  2. Perioperative cardiovascular care for patients undergoing noncardiac surgical intervention.

    PubMed

    Eagle, Kim A; Vaishnava, Prashant; Froehlich, James B

    2015-05-01

    The field of perioperative medicine has garnered legitimacy during the past 3 decades. Adverse cardiovascular events in the perioperative period account for significant morbidity and mortality. Although testing patients preoperatively to detect ischemia and identify those who may benefit from modifications in care is a tempting strategy, risk assessment should account for posterior probability. Validated risk stratification tools, such as the Revised Cardiac Risk Index or the National Surgical Quality Improvement Program risk calculator, can assist in the identification of patients for whom preoperative noninvasive testing is justified and may change the plan of care. Furthermore, current guidelines emphasize that prophylactic coronary revascularization should not be performed exclusively for the purposes of reducing the risk of perioperative events. There has been enthusiasm for medical therapies that may reduce the risk of adverse cardiovascular events in the perioperative period. Current guidelines encourage the perioperative use of β-blockade in patients already receiving such therapy and caution against initiating such therapy on the day of the surgical procedure. Reduction of morbidity and mortality in the perioperative period relies on an understanding of the myriad physiological perturbations in this period and thoughtful selection of patients for further testing and treatment.

  3. Preventing Paradoxical Tuberculosis-Associated Immune Reconstitution Inflammatory Syndrome in High-Risk Patients: Protocol of a Randomized Placebo-Controlled Trial of Prednisone (PredART Trial)

    PubMed Central

    Schutz, Charlotte; Blumenthal, Lisette; Thienemann, Friedrich; Buyze, Jozefien; Nöstlinger, Christiana; Ravinetto, Raffaella; Wouters, Edwin; Colebunders, Robert; Maartens, Gary; Wilkinson, Robert J; Lynen, Lutgarde; Meintjes, Graeme

    2016-01-01

    Background Early antiretroviral therapy (ART) initiation in patients diagnosed with HIV-associated tuberculosis (TB) reduces mortality among those with the lowest CD4 counts. At the same time, both early ART and a low CD4 count heighten the risk of paradoxical TB-associated immune reconstitution inflammatory syndrome (TB-IRIS). TB is common in patients starting ART in sub-Saharan Africa. Safe interventions that reduce the incidence or severity of TB-IRIS are needed. Prednisone has been shown to reduce symptoms and markers of inflammation when used to treat TB-IRIS. Objective To determine whether prophylactic prednisone in patients at high risk for paradoxical TB-IRIS initiating ART reduces the incidence of TB-IRIS. Methods We are conducting a randomized, double-blind, placebo-controlled trial of prophylactic prednisone (40 mg/day for 2 weeks, followed by 20 mg/day for 2 weeks) initiated at the same time as ART in patients at high risk for TB-IRIS (starting ART within 30 days of TB treatment and CD4 count ≤100/μL). The primary endpoint is development of TB-IRIS, defined using an international consensus case definition. Secondary endpoints include time to TB-IRIS event, severity of TB-IRIS, quality of life, mortality, hospitalization, other infections and malignancies, and adverse events including corticosteroid adverse effects. Results Enrollment for the trial began in August 2013. All 240 participants have been enrolled, and safety follow-up will be completed in March 2017. Conclusion No preventive strategies for TB-IRIS currently exist. If results of this trial demonstrate the efficacy and safety of prednisone, this will provide clinicians with an evidence-based preventive strategy in patients at high risk for paradoxical TB-IRIS when initiating ART. PMID:27571786

  4. Diagnostic Potential of Cell-Free and Exosomal MicroRNAs in the Identification of Patients with High-Risk Colorectal Adenomas

    PubMed Central

    Kitajima, Takahito; Kawamura, Mikio; Hiro, Junichiro; Kobayashi, Minako; Tanaka, Koji; Inoue, Yasuhiro; Mohri, Yasuhiko; Mori, Takao; Kato, Toshio; Goel, Ajay; Kusunoki, Masato

    2016-01-01

    Background Although there is a growing interest in developing circulating microRNA (miRNA) as noninvasive diagnostic biomarkers for the detection of high-risk colorectal adenomas and early-stage CRCs, but the comparative diagnostic significance of serum vs. exosomal miRNAs remains unexplored. Methods Based upon published literature, we performed an initial discovery step by investigating the expression of a miRNA panel in 20 normal colonic mucosa, 27 adenomas, and 19 CRC tissues. We performed subsequent validation by quantifying expression of candidate miRNAs in total serum and in exosomes from 26 adenoma patients and 47 healthy controls, and evaluated their clinical significance and potential diagnostic value in colorectal adenomas. Results We observed that the expression of four miRNAs, miR-21, miR-29a, miR-92a, and miR-135b, was significantly higher in colorectal adenomas vs. normal colonic mucosa. During validation, expression of miR-21, miR-29a and miR-92a in serum was significantly higher in adenomas vs. healthy controls, significantly correlated with adenoma size and total adenoma number within the colorectum, and significantly discriminated patients with advanced adenomas. In contrast, although exosomal miR-21 and miR-29a levels in adenoma patients were significantly higher than those of healthy volunteers, only exosomal miR-21 significantly correlated with adenoma size and total adenoma number, and could discriminate patients with high-risk adenomas. Conclusion Compared to exosomal miRNAs, serum levels of miR-21, miR-29a and miR-92a are superior diagnostic biomarkers in patients with high-risk adenomatous polyps. PMID:27760147

  5. Effectiveness of ezetimibe alone or in combination with twice a week Atorvastatin (10 mg) for statin intolerant high-risk patients.

    PubMed

    Athyros, Vasilios G; Tziomalos, Konstantinos; Kakafika, Anna I; Koumaras, Haralambos; Karagiannis, Asterios; Mikhailidis, Dimitri P

    2008-02-15

    This study was undertaken to investigate the effect of ezetimibe (10 mg/day) alone or in combination with atorvastatin (10 mg twice a week) on hypercholesterolemia in 56 high-risk patients intolerant to daily statin use. Ezetimibe monotherapy was well tolerated (2 withdrawals) and induced a mean reduction in low-density lipoprotein (LDL) cholesterol of 20% (p <0.05) at the third month. However, of the 54 patients still taking ezetimibe, only 5 (9%) were at their LDL cholesterol targets. Atorvastatin 10 mg twice a week was then added to ezetimibe and was well tolerated (3 withdrawals). This combination reduced LDL cholesterol (in a treatment-based analysis) by 37% compared with baseline (p <0.001), with 43 (84%) patients reaching their LDL cholesterol goals. When patients (n = 34, 25 men) with baseline serum creatinine values in the upper 2 tertiles were analyzed separately, there was a significant (p = 0.041) decrease in serum creatinine levels after 6 months of treatment. In conclusion, the combination of ezetimibe plus atorvastatin 10 mg twice a week might be a therapeutic option for high-risk patients intolerant to daily statin monotherapy.

  6. Examining Noncardiac Surgical Procedures in Patients on Extracorporeal Membrane Oxygenation.

    PubMed

    Taghavi, Sharven; Jayarajan, Senthil N; Mangi, Abeel A; Hollenbach, Kathryn; Dauer, Elizabeth; Sjoholm, Lars O; Pathak, Abhijit; Santora, Thomas A; Goldberg, Amy J; Rappold, Joseph F

    2015-01-01

    As extracorporeal membrane oxygenation (ECMO) is increasingly used for patients with cardiac and/or pulmonary failure, the need for noncardiac surgical procedures (NCSPs) in these patients will continue to increase. This study examined the NCSP required in patients supported with ECMO and determined which variables affect outcomes. The National Inpatient Sample Database was examined for patients supported with ECMO from 2007 to 2010. There were 563 patients requiring ECMO during the study period. Of these, 269 (47.8%) required 380 NCSPs. There were 149 (39.2%) general surgical procedures, with abdominal exploration/bowel resection (18.2%) being most common. Vascular (29.5%) and thoracic procedures (23.4%) were also common. Patients requiring NCSP had longer median length of stay (15.5 vs. 9.2 days, p = 0.001), more wound infections (7.4% vs. 3.7%, p = 0.02), and more bleeding complications (27.9% vs. 17.3%, p = 0.01). The incidences of other complications and inpatient mortality (54.3% vs. 58.2%, p = 0.54) were similar. On logistic regression, the requirement of NCSPs was not associated with mortality (odds ratio [OR]: 0.91, 95% confidence interval [CI]: 0.68-1.23, p = 0.17). However, requirement of blood transfusion was associated with mortality (OR: 1.70, 95% CI: 1.06-2.74, p = 0.03). Although NCSPs in patients supported with ECMO does not increase mortality, it results in increased morbidity and longer hospital stay.

  7. Prevalence of high risk Tl-201 scintigraphic findings in patients with coronary artery disease: Relation to coronary anatomy and ECG stress test findings

    SciTech Connect

    Ryan, J.M.; Nygaard, T.W.; Gibson, R.S.; Gascho, J.A.; Watson, D.D.; Beller, G.A.

    1984-01-01

    The prevalence of a high risk exercise (Ex) Tl-201 (Tl) scintigram (scint) was determined in 295 consecutive patients (pts) with angiographic (angio) (>50% stenosis) coronary artery disease (CAD) and correlated with extent of CAD and Ex stress test findings. A high risk scint by quantitative criteria was defined as either: 1) a typical left main (LM) CAD pattern showing greater than or equal to 25% homogenous disease in Tl activity in septal and posterolateral walls; 2) a multivessel disease (MVD) pattern showing abnormal Tl uptake and/or washout in multiple vascular scan segments; 3) increased lung Tl uptake. The typical LMCAD pattern was observed in 6 of 43 pts (14%) with LMCAD compared to 2% of 53 pts with 3VD (p=0.03), 3% of 99 pts with 2VD (p=0.02) and 2% of 100 pts with 1VD (p-0.01). The MVD scint pattern was seen in 67% of pts with LMCAD compared to 49% (p=0.05) in 3VD pts, 41% (p=0.004) in 2VD pts and 24% (p=<0.0001) in 1VD pts. Prevalence of abnormal lung Tl was comparable in LMCAD (42%), 3VD (38%) and 2VD (34%) pts, but greater than observed in 1VD pts (26%; p=0.05). High risk ECG stress test was defined as 2 or more of: 1) >2.0 mm of ST decreasing; 2) greater than or equal to1.0 mm ST decreasing persisting >5 min post-EX; 3) ST decreasing at less than or equal to5 METS; 4) greater than or equal to10 mm Hg decreasing in Ex blood pressure. A high risk ECG stress test was observed in 58% of LMCAD pts compared to 32% of 3VD pts (p=0.009), 31% of 2VD pts (p=0.003) and 16% of 1VD pts (p<0.0001). Eighty-six % of LMCAD and 70% of 2 and 3VD pts had either a high risk Ex scint or stress test. Thus, EX Tl-201 scint appears useful in identifying high risk CAD pts.

  8. A high-risk patient with long-QT syndrome with no response to cardioselective beta-blockers.

    PubMed

    Toyota, Naoki; Miyazaki, Aya; Sakaguchi, Heima; Shimizu, Wataru; Ohuchi, Hideo

    2015-09-01

    We present a case of a high-risk 19-year-old female with long-QT syndrome (LQTS) with compound mutations. She had a history of aborted cardiac arrest and syncope and had received treatment with propranolol for 15 years. However, because she developed adult-onset asthma we tried to switch propranolol, a nonselective beta-blocker, to beta-1-cardioselective agents, bisoprolol and metoprolol. These resulted in both a markedly prolonged corrected QT interval and the development of LQTS-associated arrhythmias. Eventually, propranolol was reinitiated at a higher dose with the addition of verapamil, and she has had no further cardiac or asthmatic events for 5 years.

  9. Discharge planning for the elderly ambulatory surgical patient.

    PubMed

    Burden, Nancy

    2004-12-01

    Discharge planning for the elderly ambulatory surgery patient should begin as soon as the patient's procedure is booked. Successful discharge planning relies on 1) comprehensive preoperative assessment; 2) effective communication among the surgical facility's caregivers, the physician's office, the patient, and the family; 3) consideration of the patient's preoperative status; and 4) a strong patient and family education plan. The challenges of planning the aftercare are compounded by the physical, social, financial, cognitive, and sensory changes related to the normal aging process as well as to systemic diseases, which are more prevalent in the older population than in younger patients. The elderly patient's discharge plan should identify and address age-related barriers to communication, incorporate the patient's existing physical and medical condition, diminish the negative effects of social support challenges, and address environmental issues that can be improved to support recovery. The elderly population often deals with the imperfect: isolation from family or friends, aging bodies, hearing and visual loss, financial limitations, and emotional challenges. Although the nurse cannot reverse these challenges of old age, he or she can still make a difference by providing guidance and resources to blunt the potential complications of surgery and anesthesia. PMID:15801349

  10. Evaluation of a Progressive Mobility Protocol in Postoperative Cardiothoracic Surgical Patients.

    PubMed

    Floyd, Shawn; Craig, Sarah W; Topley, Darla; Tullmann, Dorothy

    2016-01-01

    Cardiothoracic surgical patients are at high risk for complications related to immobility, such as increased intensive care and hospital length of stay, intensive care unit readmission, pressure ulcer development, and deep vein thrombosis/pulmonary embolus. A progressive mobility protocol was started in the thoracic cardiovascular intensive care unit in a rural academic medical center. The purpose of the progressive mobility protocol was to increase mobilization of postoperative patients and decrease complications related to immobility in this unique patient population. A matched-pairs design was used to compare a randomly selected sample of the preintervention group (n = 30) to a matched postintervention group (n = 30). The analysis compared outcomes including intensive care unit and hospital length of stay, intensive care unit readmission occurrence, pressure ulcer prevalence, and deep vein thrombosis/pulmonary embolism prevalence between the 2 groups. Although this comparison does not achieve statistical significance (P < .05) for any of the outcomes measured, it does show clinical significance in a reduction in hospital length of stay, intensive care unit days, in intensive care unit readmission rate, and a decline in pressure ulcer prevalence, which is the overall goal of progressive mobility. This study has implications for nursing, hospital administration, and therapy services with regard to staffing and cost savings related to fewer complications of immobility. Future studies with a larger sample size and other populations are warranted. PMID:27487753

  11. A comparative study-efficacy and safety of combined spinal epidural anesthesia versus spinal anesthesia in high-risk geriatric patients for surgeries around the hip joint

    PubMed Central

    Tummala, Vengamamba; Rao, Lella Nageswara; Vallury, Manoj Kumar; Sanapala, Anitha

    2015-01-01

    Context: Combined spinal epidural anesthesia (CSEA) has a significant advantage by enabling the use of low dose intrathecal local anesthetic, with knowledge that the epidural catheter may be used to extend the block as necessary. CSEA is useful in high-risk geriatric patients by providing greater hemodynamic stability. Aim: This study is designed to compare the clinical effects of CSEA versus spinal anesthesia in high-risk geriatric patients undergoing surgeries around the hip joint. Materials and Methods: Sixty patients aged >65 years, American Society of Anaesthesiology III and IV were randomly allocated into two equal groups. Group A (n = 30) received CSEA with 1 ml (5 mg) of 0.5% hyperbaric bupivacaine with 25 μg fentanyl through spinal route, and the expected incompleteness of spinal block was managed with small incremental dose of 0.5% isobaric bupivacaine through epidural catheter, 1–1.5 ml for every unblocked segment to achieve T10 sensory level. Group B (n = 30) received spinal anesthesia with 2.5 ml (12.5 mg) of 0.5% hyperbaric bupivacaine and 25 μg fentanyl. Result: Both the groups showed rapid onset, excellent analgesia and good quality motor block. Group A showed a significantly less incidence of hypotension (P < 0.01) along with the provision of prolonging analgesia as compared to Group B. Conclusion: CSEA is a safe, effective, reliable technique with better hemodynamic stability along with the provision of prolonging analgesia compared to spinal anesthesia for high-risk geriatric patients undergoing surgeries around the hip joint. PMID:26417125

  12. Surgical management of cleft lip in pedo-patients.

    PubMed

    Taware, C P; Kulkarni, S R

    1991-01-01

    The Present article describes in short etiology of cleft lip and cleft palate. With this in-born defect, patient develops crucial problems with feeding, phonation, overall growth and development of affected and allied soft and hard tissue structures. This in turn results in deformity and asymmetry which is going to affect functional requirements as well as aesthetic outlook. Hence it really becomes mandatory to correct this defect surgically as early as possible, at stipulated timings so as to avoid present and future anticipated problems. PMID:1820390

  13. Surgical management of cleft lip in pedo-patients.

    PubMed

    Taware, C P; Kulkarni, S R

    1991-01-01

    The Present article describes in short etiology of cleft lip and cleft palate. With this in-born defect, patient develops crucial problems with feeding, phonation, overall growth and development of affected and allied soft and hard tissue structures. This in turn results in deformity and asymmetry which is going to affect functional requirements as well as aesthetic outlook. Hence it really becomes mandatory to correct this defect surgically as early as possible, at stipulated timings so as to avoid present and future anticipated problems.

  14. Surgical strategy: matching the patient with the procedure.

    PubMed

    Hentz, Vincent R

    2002-08-01

    The general indications, timing, and choice of procedure can be determined by asking and answering the following questions appropriately: 1. Has the patient achieved neurologic, emotional, and social stability? 2. What is the patient's current level of motor and sensory resources and function? The number and strength of muscles remaining under good voluntary control are the most important variables. 3. Are the patient's expectations realistic? 4. Does the patient possess the necessary intelligence and motivation? Some procedures, such as arthrodesis of a specific joint, require little motivation to succeed; however, a complex set of muscle-tendon transfers requires a great deal of motor reeducation for the patient to achieve an optimal result. 5. Does the patient have the necessary time to invest in achieving a good result? The patient must be able to set aside the time necessary for postoperative immobilization in a cast or splint and for therapy and reeducation. 6. Are the necessary support services and personnel available and committed? 7. Have all preoperative obstacles to success been considered and has a plan developed to overcome any remaining obstacles? 8. Does the patient understand the potential complications and benefits? 9. Can the patient and professional team tolerate a complication, failure, or suboptimal result? Both the medical staff and the patient must be prepared for complications that may lead to a suboptimal outcome or frank failure. 10. Are the patient's current health and well-being ideal? 11. Is the surgical plan consistent with the patient's physical resources, goals, and expectations? 12. Does an alternate plan exist? 13. Does the surgeon understand the scope of the complications and how to salvage an acceptable result should a complication occur? PMID:12474600

  15. Outcome of patients with high risk Myelodysplastic Syndrome (MDS) and advanced Chronic Myelomonocytic Leukemia (CMML) treated with decitabine after azacitidine failure.

    PubMed

    Harel, Stéphanie; Cherait, Amina; Berthon, Céline; Willekens, Christophe; Park, Sophie; Rigal, Marthe; Brechignac, Sabine; Thépot, Sylvain; Quesnel, Bruno; Gardin, Claude; Adès, Lionel; Fenaux, Pierre; Braun, Thorsten

    2015-05-01

    Outcome of patients with high risk MDS and CMML who failed treatment with azacitidine remains poor with a median survival of 6 months, without established therapy available except allogeneic hematopoietic stem cell transplantation. The objective of our study was to evaluate efficacy of decitabine after azacitidine failure in a relatively large patient cohort based on conflicting results with 0-28% response rates (RR) in this setting in small patient series. Thirty-six consecutive high risk MDS and CMML patients who received decitabine after azacitidine failure were retrospectively reviewed. Response was based on IWG 2006 criteria for MDS and CMML with WBC<13G/l and also included for proliferative CMML the evolution of WBC, splenomegaly (SMG) and extramedullary disease (EMD). Patients received a median number of 3 (range 1-27) cycles of decitabine and 12 patients received at least 6 cycles. Seven (19.4%) patients were responders including 3 marrow CR (mCR), 2 stable disease (SD) with HI-E, 1 SD with HI-N and HI-P and 1 SD with HI-N. In a CMML patient with SD, specific skin lesions resolved with decitabine. Responses were generally short lived (2-5 months) except 1 responder currently ongoing with +11 months follow up. Two non-responders had prolonged SD (without HI) of 21 and 27 months duration respectively. Median OS from onset of decitabine was 7.3 months, without significant difference between responders and non-responders. Treatment with decitabine after azacitidine failure yielded modest ORR (19.4%) with short response duration and poor OS. Thus, use of decitabine in such patients who failed or progressed after azacitidine cannot be recommended, underscoring the need for novel strategies in this setting.

  16. The Effect of Radiation Timing on Patients With High-Risk Features of Parameningeal Rhabdomyosarcoma: An Analysis of IRS-IV and D9803

    SciTech Connect

    Spalding, Aaron C.; Hawkins, Douglas S.; Anderson, James R.; Lyden, Elizabeth; Laurie, Fran; Wolden, Suzanne L.; Arndt, Carola A.S.; Michalski, Jeff M.

    2013-11-01

    Purpose: Radiation therapy remains an essential treatment for patients with parameningeal rhabdomyosarcoma (PMRMS), and early radiation therapy may improve local control for patients with intracranial extension (ICE). Methods and Materials: To address the role of radiation therapy timing in PMRMS in the current era, we reviewed the outcome from 2 recent clinical trials for intermediate-risk RMS: Intergroup Rhabdomyosarcoma Study (IRS)-IV and Children's Oncology Group (COG) D9803. The PMRMS patients on IRS-IV with any high-risk features (cranial nerve palsy [CNP], cranial base bony erosion [CBBE], or ICE) were treated immediately at day 0, and PMRMS patients without any of these 3 features received week 6-9 radiation therapy. The D9803 PMRMS patients with ICE received day 0 X-Ray Therapy (XRT) as well; however, those with either CNP or CBBE had XRT at week 12. Results: Compared with the 198 PMRMS patients from IRS-IV, the 192 PMRMS patients from D9803 had no difference (P<.05) in 5-year local failure (19% vs 19%), failure-free-survival (70% vs 67%), or overall survival (75% vs 73%) in aggregate. The 5-year local failure rates by subset did not differ when patients were classified as having no risk features (None, 15% vs 19%, P=.25), cranial nerve palsy/cranial base of skull erosion (CNP/CBBE, 15% vs 28%, P=.22), or intracranial extension (ICE, 21% vs 15%, P=.27). The D9083 patients were more likely to have received initial staging by magnetic resonance imaging (71% vs 53%). Conclusions: These data support that a delay in radiation therapy for high-risk PMRMS features of CNP/CBBE does not compromise clinical outcomes.

  17. The effectiveness of one-on-one nurse education on the outcomes of high-risk adult and pediatric patients with asthma.

    PubMed

    Forshee, J D; Whalen, E B; Hackel, R; Butt, L T; Smeltzer, P A; Martin, J; Lavin, P T; Buchner, D A

    1998-12-01

    The effects of an asthma self-management program on asthma outcomes were evaluated in adult and pediatric patients with asthma who were considered at high risk (i.e., those who were not in control of their disease as determined by resource utilization, medication use, or lack of use). The program consisted of one-on-one nurse-to-patient ("nurse champion") education and subsequent assessment of asthma outcomes using the Asthma Quality Assessment System (AQAS) questionnaire, which measured asthma severity, patient quality of life, asthma awareness and knowledge, confidence in managing asthma, use of peak flow meters, asthma symptoms, medication use, lost work or school days, and affect of asthma. Over the course of six months, nurse champions educated 201 patients from four managed care plans and collected data at baseline and during four follow-up sessions. Adult patients and pediatric patient caregivers reported significant improvements in quality of life, and clinical and process measures. Significant increases in asthma knowledge were observed immediately after patient education, including greater than 89% increase in the proportion of patients who reported that they know "a lot" about the "things that cause asthma symptoms." Significant decreases were also found in work or school days missed, urgent care utilization, and hospital admission rates. Appropriate preventive care visits increased by more than 40%. These results indicate that the nurse champion program was associated with an improvement in asthma outcomes in high-risk adult and pediatric patients and warrant further evaluation in controlled studies. Incorporating one-on-one education programs into asthma management is an effective and rapid means of improving asthma outcomes.

  18. Cilostazol Enhances Mobilization of Circulating Endothelial Progenitor Cells and Improves Endothelium-Dependent Function in Patients at High Risk of Cardiovascular Disease.

    PubMed

    Chao, Ting-Hsing; Chen, I-Chih; Lee, Cheng-Han; Chen, Ju-Yi; Tsai, Wei-Chuan; Li, Yi-Heng; Tseng, Shih-Ya; Tsai, Liang-Miin; Tseng, Wei-Kung

    2016-08-01

    This is the first study to investigate the vasculoangiogenic effects of cilostazol on endothelial progenitor cells (EPCs) and flow-mediated dilatation (FMD) in patients at high risk of cardiovascular disease (CVD). This double-blind, placebo-controlled study included 71 patients (37 received 200 mg/d cilostazol and 34 received placebo for 12 weeks). Use of cilostazol, but not placebo, significantly increased circulating EPC (kinase insert domain receptor(+)CD34(+)) counts (percentage changes: 149.0% [67.9%-497.8%] vs 71.9% [-31.8% to 236.5%], P = .024) and improved triglyceride and high-density lipoprotein cholesterol levels (P = .002 and P = .003, respectively). Plasma levels of vascular endothelial growth factor (VEGF)-A165 and FMD significantly increased (72.5% [32.9%-120.4%] vs -5.8% [-46.0% to 57.6%], P = .001; 232.8% ± 83.1% vs -46.9% ± 21.5%, P = .003, respectively) in cilostazol-treated patients. Changes in the plasma triglyceride levels significantly inversely correlated with the changes in the VEGF-A165 levels and FMD. Cilostazol significantly enhanced the mobilization of EPCs and improved endothelium-dependent function by modifying some metabolic and angiogenic markers in patients at high risk of CVD.

  19. The Management of Patients after Surgical Treatment of Maxillofacial Tumors

    PubMed Central

    Rolski, D.; Zawadzki, P.; Życińska, K.; Mierzwińska-Nastalska, E.

    2016-01-01

    Morphological and functional disturbances induced by postsurgical defects and loss of tissues in the stomatognathic system due to the treatment of tumors in the maxillofacial region determine the therapeutic needs of patients. The study aimed at clinical and epidemiological evaluation of patients under prosthetic treatment in order to establish the algorithm for rehabilitation. The study group was composed of the patients after midface surgery (45.74%); surgery in a lower part of the face (47.38%); mixed postoperative losses (3.44%); loss of face tissues and surgery in other locations in the head and neck region (3.44%). The supplementary treatment was applied in 69.63% of patients. Clinical and additional examinations were performed to obtain the picture of postoperative loss, its magnitude, and location to plan the strategy of prosthetic rehabilitation. The management algorithm for prosthetic rehabilitation in patients after surgical treatment of maxillofacial neoplasms was based on its division in stages. The location and magnitude of postoperative losses, as well as the implementation of supplementary treatment of the patients after treatment of maxillofacial tumors, influence the planning of prosthetic rehabilitation that plays a key role and facilitates the patients' return to their prior living situation, occupational and family lives. PMID:27747229

  20. A Prospective Follow-up of Patients Treated Surgically or Non-Surgically for Full-thickness Rotator Cuff Tears

    PubMed Central

    Gagnier, Joel Joseph; Oltean, Hanna N.; Bedi, Asheesh; Carpenter, James E.; Miller, Bruce S.

    2013-01-01

    Objectives: The objectives of this project are: (1) to compare the efficacy of surgical versus non-surgical management of full-thickness rotator cuff tears, and (2) to detect variables that predict success within each treatment group. Methods: Patients who presented to our care for management of symptomatic full-thickness rotator cuff tears were enrolled in our Shoulder Registry and clinical data were collected prospectively. In addition to baseline demographic information, the following outcome measures were collected at baseline, 6 months, 1 year and annually up to 3 years: Western Ontario Rotator Cuff (WORC) Index, American Shoulder and Elbow Surgeons (ASES) score, Modified Marx Shoulder Activity Level Scale, VR-12, 100-point Single Assessment Numeric Evaluation (SANE) rating, 100-point visual analog scale (VAS) for pain, and a patient satisfaction scale. All patients were allocated treatment as recommended by the attending surgeon. We described all patient demographic characteristics, and performed linear and logistic regression for variables associated with treatment allocation and with treatment effects. We also used Student’ t-tests and Wilcoxon rank-sum tests where appropriate, to explore differences in treatment effects between the groups for all outcome measures at all time points. Results: A total of 292 patients were included with 155 allocated to surgery and 137 to non-surgical treatment. Those allocated to surgery were younger (58.6 years vs 65.2 years; P<.0001), less likely to have diabetes (12% vs 21%; P=0.05), more likely to have a known traumatic injury (71% vs 55%; P=0.002), and tended to be worse off on all outcome measures at baseline then the non-surgical group. Both the surgical group and non-surgical group improved on all outcome measures across the follow up period with several variables predicting changes at each time point. Table 1 contains the list of specific variables that predicted improved outcomes separately for both treatment

  1. The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications.

    PubMed

    Raskob, Gary E; Spyropoulos, Alex C; Zrubek, Julie; Ageno, Walter; Albers, Gregory; Elliott, C Gregory; Halperin, Jonathan; Haskell, Lloyd; Hiatt, William R; Maynard, Gregory A; Peters, Gary; Spiro, Theodore; Steg, Philippe Gabriel; Suh, Eun Young; Weitz, Jeffrey I

    2016-06-01

    Hospital-associated venous thromboembolism (VTE) is a leading cause of premature death and disability worldwide. Evidence-based guidelines recommend that anticoagulant thromboprophylaxis be given to hospitalised medical patients at risk of VTE, but suggest against routine use of thromboprophylaxis beyond the hospital stay. The MARINER study is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of thromboprophylaxis using rivaroxaban, begun at hospital discharge and continued for 45 days, for preventing symptomatic VTE in high-risk medical patients. Eligible patients are identified using the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE VTE) risk score, combined with a laboratory test, D-dimer. The rivaroxaban regimen is 10 mg once daily for patients with CrCl ≥ 50 ml/min, or 7.5 mg once daily for patients with CrCl ≥ 30 ml/min and < 50 ml/min. The primary efficacy outcome is the composite of symptomatic VTE (lower extremity deep-vein thrombosis and non-fatal pulmonary embolism) and VTE-related death. The principal safety outcome is major bleeding. A blinded clinical events committee adjudicates all suspected outcome events. The sample size is event-driven with an estimated total of 8,000 patients to acquire 161 primary outcome events. Study design features that distinguish MARINER from previous and ongoing thromboprophylaxis trials in medically ill patients are: (i) use of a validated risk assessment model (IMPROVE VTE) and D-dimer determination for identifying eligible patients at high risk of VTE, (ii) randomisation at the time of hospital discharge, (iii) a 45-day treatment period and (iv) restriction of the primary efficacy outcome to symptomatic VTE events.

  2. Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report.

    PubMed

    Nishikawa, Atsushi; Ishida, Takehiro; Taketsuna, Masanori; Yoshiki, Fumito; Enomoto, Hiroyuki

    2016-01-01

    This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan. The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months. Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years. A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness. Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%). Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively. There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study. These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures. Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey). The results of this 24-month postmarketing surveillance study imply that teriparatide has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture in Japan. Teriparatide may also be a useful treatment for osteoporosis in other societies with aging populations. PMID:27462147

  3. Safety and effectiveness of daily teriparatide in a prospective observational study in patients with osteoporosis at high risk of fracture in Japan: final report

    PubMed Central

    Nishikawa, Atsushi; Ishida, Takehiro; Taketsuna, Masanori; Yoshiki, Fumito; Enomoto, Hiroyuki

    2016-01-01

    This postmarketing surveillance study assessed the safety and effectiveness of teriparatide in patients with osteoporosis at high risk of fracture in Japan. The patients received teriparatide 20 μg daily by subcutaneous injection, for a maximum of 24 months. Safety and effectiveness analyses were based on data from 1,847 patients who were predominantly female (92.6%) with a mean age of 75.4 years. A total of 157 adverse drug reactions (ADRs) were reported in 140 (7.58%) patients; the most common ADRs were hyperuricemia, nausea, and dizziness. Only six (0.32%) patients reported serious ADRs, the most common being nausea (two patients; 0.1%). Persistence with teriparatide treatment was 60.8% and 39.1% at 18 and 24 months, respectively. There were significant increases in biomarkers for bone formation (procollagen type I N-terminal propeptide and bone-specific alkaline phosphatase) and bone resorption (collagen type I cross-linked C telopeptide and tartrate-resistant acid phosphatase 5b) throughout the study. These were accompanied by significant increases in bone mineral density and low incidences of new vertebral and nonvertebral fractures. Patient-reported measurements for health-related quality of life revealed significant improvements from baseline in back pain and overall health-related quality of life (Short Form-8™ health survey). The results of this 24-month postmarketing surveillance study imply that teriparatide has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture in Japan. Teriparatide may also be a useful treatment for osteoporosis in other societies with aging populations. PMID:27462147

  4. The Prevalence of Malnutrition and Effectiveness of STRONGkids Tool in the Identification of Malnutrition Risks among Pediatric Surgical Patients

    PubMed Central

    Durakbaşa, Çiğdem Ulukaya; Fettahoğlu, Selma; Bayar, Ahu; Mutus, Murat; Okur, Hamit

    2014-01-01

    Background: High prevalence of malnutrition along with the risk for the development of malnutrition in hospitalised children has been reported. However, this problem remains largely unrecognised by healthcare workers. Aims: To determine the prevalence of malnutrition and effectiveness of STRONGkids nutritional risk screening (NRS) tool in the identification of malnutrition risk among pediatric surgical patients. Study Design: Cross-sectional study. Methods: A total of 494 pediatric surgical patients (median age 59 months, 75.8% males) were included in this prospective study conducted over 3 months. SD-scores <−2 for Body Mass Index (BMI) for age or weight-for-height (WFH) and height-for-age (HFA) were considered to indicate acute and chronic malnutrition, respectively. The STRONGkids NRS tool was used to determine risk for malnutrition. Results: Malnutrition was detected in 13.4% in this group of pediatric surgical patients. Acute malnutrition was identified in 10.1% of patients and more commonly in patients aged ≤60 months than aged >60 months (13.4 vs. 6.6%, p=0.012). Chronic malnutrition was identified in 23 (4.6%) of patients with no significant difference between age groups. There were 7 (1.4%) children with coexistent acute and chronic malnutrition. The STRONGkids tool revealed that 35.7% of patients were either in the moderate or high risk group for malnutrition. Malnutrition, as revealed by anthropometric measurements, was more likely in the presence of gastrointestinal (26.9%, p=0.004) and inguinoscrotal/penile surgery (4.0%, p=0.031), co-morbidities affecting nutritional status (p<0.001) and inpatient admissions (p=0.014). Among patients categorized as low risk for malnutrition, there were more outpatients than inpatients (89.3 vs. 10.7%, p<0.001) and more elective surgery cases than emergency surgery cases (93.4 vs. 6.6%, p<0.001). Conclusion: Providing data on the prevalence of malnutrition and risk of malnutrition in a prospectively recruited group

  5. [Management of High-Risk Prostate Cancer and Left Ectopic Ureter Inserting into Seminal Vesicle with Ipsilateral Hypoplastic Kidney of a Young Patient : A Case Report].

    PubMed

    Matsumoto, Teppei; Koie, Takuya; Soma, Osamu; Kusaka, Ayumu; Hosogoe, Shogo; Hamano, Itsuto; Imai, Atsushi; Hatakeyama, Shingo; Yoneyama, Takahiro; Hashimoto, Yasuhiro; Ohyama, Chikara

    2016-06-01

    A 44-year-old male patient visited our hospital with a chief complaint of macroscopic hematuria. Prostate biopsies were performed due to prostate specific antigen (PSA) 11.6 ng/ml, and he was diagnosed with Gleason score 5+4 prostate cancer. Computed tomography showed a left hypoplastic kidney. T2- weighted magnetic resonance imaging showed the left ureter stump with ectopic insertion into the dilated left seminal vesicle. He was diagnosed with high-risk prostate cancer and left ectopic ureter inserting into the seminal vesicle with ipsilateral hypoplastic kidney. Laparoscopic left nephroureterectomy and open radical prostatectomy were performed. PMID:27452497

  6. Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial

    SciTech Connect

    Bosiers, Marc; Scheinert, Dierk; Mathias, Klaus; Langhoff, Ralf; Mudra, Harald; Diaz-Cartelle, Juan

    2015-04-15

    PurposeThis prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).Materials and MethodsThe study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis.ResultsOf the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31–365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.ConclusionResults through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.

  7. Quality of sleep in postoperative surgical oncologic patients.

    PubMed

    Barichello, Elizabeth; Sawada, Namie Okino; Sonobe, Helena Megumi; Zago, Márcia Maria Fontão

    2009-01-01

    This study aimed to evaluate surgical-oncologic patients' quality of sleep through the Pittsburgh Sleep Quality Index (PSQI) questionnaire. It is an exploratory study with transversal-observational design, in 46 postoperative head & neck and urology cancer patients. The PSQI questionnaire was used to evaluate the subjective quality of sleep and the occurrence of sleep disorders. Six PSQI components were statistically significant and 78.3% of the interviewees had impaired subjective quality of sleep. Among factors leading to sleep disorders we point out: taking too long to fall asleep; waking up in the middle of the night; getting up to go to the bathroom and napping during the day. This study is expected to sensitize the nursing team regarding the need to investigate quality of sleep and causes of its disorders in cancer survivors for an effective course of action. PMID:19820854

  8. The HAS-BLED Score Identifies Patients with Acute Venous Thromboembolism at High Risk of Major Bleeding Complications during the First Six Months of Anticoagulant Treatment

    PubMed Central

    Kooiman, Judith; van Hagen, Nadja; Iglesias del Sol, Antonio; Planken, Erwin V.; Lip, Gregory Y. H.; van der Meer, Felix J. M.; Cannegieter, Suzanne C.; Klok, Frederikus A.; Huisman, Menno V.

    2015-01-01

    Objective The HAS-BLED score enables a risk estimate of major bleeds in patients with atrial fibrillation on vitamin K-antagonists (VKA) treatment, but has not been validated for patients with venous thromboembolism (VTE). We analyzed whether the HAS-BLED score accurately identifies patients at high risk of major bleeds during VKA treatment for acute VTE. Methods Medical records of 537 patients with acute VTE (primary diagnosis pulmonary embolism in 223, deep vein thrombosis in 314) starting VKA treatment between 2006-2007 were searched for items on the HAS-BLED score and the occurrence of major bleeds during the first 180 days of follow-up. The hazard ratio (HR) for the occurrence of major bleeds comparing non-high with high-risk patients as defined by a HAS-BLED score ≥ 3 points was calculated using Cox-regression analysis. Results Major bleeds occurred in 11/537 patients (2.0%, 5.2/100 person years, 95% CI 2.8-9.2). Cumulative incidences of major bleeds were 1.3% (95% CI 0.1-2.5) in the non-high (HAS-BLED < 3) and 9.6% (95%CI 2.2-17.0) in the high-risk group (HAS-BLED ≥ 3), (p <0.0001 by Log-Rank test), with a HR of 8.7 (95% CI 2.7-28.4). Of the items in the HAS-BLED score, abnormal renal function (HR 10.8, 95% CI 1.9-61.7) and a history of bleeding events (HR 10.4, 95% CI 2.5-42.5) were independent predictors of major bleeds during follow-up. Conclusion Acute VTE patients with a HAS-BLED score ≥ 3 points are at increased risk of major bleeding. These results warrant for correction of the potentially reversible risk factors for major bleeding and careful International Normalized Ratio monitoring in acute VTE patients with a high HAS-BLED score. PMID:25905638

  9. Radiotherapy After Prostatectomy: Improved Biochemical Relapse-Free Survival With Whole Pelvic Compared With Prostate Bed Only for High-Risk Patients

    SciTech Connect

    Spiotto, Michael T.; Hancock, Steven L.; King, Christopher R.

    2007-09-01

    Purpose: To compare the biochemical relapse-free survival (bRFS) among patients receiving whole pelvic radiotherapy (WPRT) vs. prostate bed RT (PBRT) after radical prostatectomy. Methods and Materials: Between 1985 and 2005, 160 patients underwent adjuvant or salvage RT after radical prostatectomy. A short course of total androgen suppression was also given concurrently to 87 patients. Of the 160 patients, 114 were considered at high risk of lymph node involvement because they had a pathologic Gleason score of {>=}8, a preoperative prostate-specific antigen level >20 ng/mL, seminal vesicle or prostate capsule involvement, or pathologic lymph node involvement. Of this group, 72 underwent WPRT and 42 underwent PBRT. The median follow-up was >5 years for all patient subsets. Kaplan-Meier and Cox proportional hazards multivariate analyses were performed for all clinical, pathologic, and treatment factors predicting for bRFS. Results: Whole pelvic RT resulted in superior bRFS compared with PBRT (p = 0.03). The advantage of WPRT was limited to high-risk patients, with a 5-year bRFS rate of 47% (95% confidence interval, 35-59%) after WPRT vs. 21% (95% confidence interval, 8-35%) after PBRT (p = 0.008). For low-risk patients, no difference (p = 0.9) was found. On multivariate analysis, only WPRT (p = 0.02) and a preoperative prostate-specific antigen level <1.0 ng/mL (p = 0.002) were significantly associated with bRFS. The benefit from total androgen suppression with postoperative RT was only observed when given concurrently with WPRT (p 0.04) and not with PBRT (p = 0.4). Conclusion: The results of our study have indicated that WPRT confers superior bRFS compared with PBRT for high-risk patients receiving adjuvant or salvage RT after radical prostatectomy. This advantage was observed only with concurrent TAS. These results are analogous to the benefit from WPRT seen in the Radiation Therapy Oncology Group 94-13 study.

  10. Successful management of grade III coronary perforation after percutaneous angioplasty in a high-risk patient: a case report.

    PubMed

    Coloma Araniya, Ricardo; Beas, Renato; Maticorena-Quevedo, Jesús; Anduaga-Beramendi, Alexander; Pastrana Castillo, Marco Antonio

    2016-01-01

    Coronary perforation is a rare complication in patients undergoing percutaneous coronary angioplasty. The mortality of this complication varies depending on factors related to the patient and the procedure performed, reaching 44% in patients with Ellis type III perforation. We report the case of an 81 year old male with multiple cardiovascular risk factors, who underwent percutaneous angioplasty for unstable angina management. The patient developed grade III coronary perforation in the anterior descending artery, which was successfully managed with balloon inflation to 6 atmospheres for 10 minutes twice in the affected area, with an interval of 5 minutes between each dilatation. The patient improved and was discharged. PMID:26938857

  11. High-dose busulfan and melphalan as conditioning regimen for autologous peripheral blood progenitor cell transplantation in high-risk neuroblastoma patients.

    PubMed

    Molina, Blanca; Alonso, Laura; Gonzalez-Vicent, Marta; Andion, Maitane; Hernandez, Carmen; Lassaletta, Alvaro; Cormenzana, Maria; Lopez-Ibor, Blanca; Villa, Marta; Molina, Javier; Diaz, Miguel A

    2011-03-01

    The aim of this retrospective study was to analyze the outcome and identify risk factors associated with progression-free survival (PFS) in 36 children with high-risk neuroblastoma who underwent autologous peripheral blood progenitor cell (PBPC) transplantation between 1994 and 2010. The conditioning regimen used in all cases consisted of high-dose of busulfan and melphalan. Median age at transplantation was 3 years (range: 0.7-14 years). The median times to neutrophil and platelet engraftment were 11 days (range: 9.16 days) and 13 days (range: 9.33), respectively. Twenty-one patients developed nonhematologic toxicity: 15 patients had mucositis, 4 patients developed an engraftment syndrome, and there were 2 cases of liver toxicity. No toxic deaths were observed. There were 15 patients who relapsed. The median time to relapse was 6 months after the transplant (range: 3-13 months). With a median follow-up of 55 months (range: 4-180 months), the PFS was 57% ± 8.5% for the whole group. In multivariate analysis, age below 3 years (P < .005), complete remission (CR) pretransplantation (P < .07) and 1p germline status (P < .01) were variables associated with better outcomes. Patients who were or achieved early CR following transplantation (3 months posttransplantation) had a probability of PFS of 91% ± 6% as compared to patients who did not (PFS 9% ± 8%) (P < .0001). This retrospective study shows that high dose of busulfan and melphalan as conditioning regimen in children with high-risk neuroblastoma is associated with very low morbidity and no mortality in the authors' hands. Younger patients with no 1p deletions and in first CR at transplantation had the better outcome.

  12. Are there a guidelines for implantable spinal cord stimulator therapy in patients using chronic anticoagulation therapy? - A review of decision-making in the high-risk patient

    PubMed Central

    Ghaly, Ramsis F.; Lissounov, Alexei; Candido, Kenneth D.; Knezevic, Nebojsa Nick

    2016-01-01

    Background: Spinal cord stimulators (SCSs) are gaining increasing indications and utility in an expanding variety of clinical conditions. Complications and initial expenses have historically prevented the early use of SCS therapy despite ongoing efforts to educate and promote its utilization. At present, there exists no literature evidence of SCS implantation in a chronically anticoagulated patient, and neuromodulation manufacturers are conspicuously silent in providing warnings or recommendations in the face of anticoagulant use chronically. It would appear as through these issues demand scrutiny and industry as well as neuromodulation society advocacy and support in terms of the provision of coherent guidelines on how to proceed. Case Description: A 79-year-old male returned to the neurosurgical clinic with persistent low back pain and leg heaviness due to adjacent level degenerative spondylosis and severe thoracic spinal stenosis. The patient had a notable history of multiple comorbidities along with atrial fibrillation requiring chronic anticoagulation. On initial presentation, he was educated with three choice of conservative medical therapy, intrathecal drug delivery system implantation, or additional lumbar decompression laminectomy with instrumented fusion of T10-L3 and a palliative surgical lead SCS implantation. Description: A 79-year-old male returned to the neurosurgical clinic with persistent low back pain and leg heaviness due to adjacent level degenerative spondylosis and severe thoracic spinal stenosis. The patient had a notable history of multiple comorbidities along with atrial fibrillation requiring chronic anticoagulation. On initial presentation, he was educated with three choice of conservative medical therapy, intrathecal drug delivery system implantation, or additional lumbar decompression laminectomy with instrumented fusion of T10-L3 and a palliative surgical lead SCS implantation. Conclusion: Our literature search did not reveal any

  13. The combination of amlodipine and angiotensin receptor blocker or diuretics in high-risk hypertensive patients: rationale, design and baseline characteristics

    PubMed Central

    Wang, W; Ma, L; Zhang, Y; Deng, Q; Liu, M; Liu, L

    2011-01-01

    The Chinese Hypertension Intervention Efficacy Study (CHIEF) is a multi-centre randomized controlled clinical trial comparing the effects of amlodipine+angiotensin II receptor blocker and amlodipine+diuretics on the incidence of cardiovascular events, represented as a composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death events in high-risk Chinese hypertensive patients. The study also evaluates the long-term effects of lipid-lowering treatment and lifestyle modification. From October 2007 to October 2008, 13 542 patients were enrolled into the study in 180 centres in China. Patients will be followed up for 4 years. There was no difference in baseline characteristics between the two blood pressure arms. PMID:20445570

  14. Tandem high-dose chemotherapy and autologous stem cell transplantation in patients with high-risk neuroblastoma: results of SMC NB-2004 study.

    PubMed

    Sung, K W; Son, M H; Lee, S H; Yoo, K H; Koo, H H; Kim, J Y; Cho, E J; Lee, S K; Choi, Y S; Lim, D H; Kim, J-S; Kim, D W

    2013-01-01

    From January 2004 to December 2008, 50 consecutive patients with high-risk neuroblastoma were assigned to receive tandem HDCT (high-dose chemotherapy)/auto-SCT after nine cycles of induction chemotherapy. CEC (carboplatin + etoposide + cyclophosphamide) regimen and TM (thiotepa + melphalan)-TBI regimen (or TM regimen for stage 3 patients) were the first and second HDCT regimens. Local radiotherapy, differentiation therapy with 13-cis-retinoid acid and immunotherapy with interleukin-2 were given after tandem HDCT/auto-SCT. Of the 50 patients, 49 underwent a first HDCT/auto-SCT and 47 underwent a second HDCT/auto-SCT. The tumor relapsed or progressed in 14 patients, secondary malignancy developed in one patient and one patient died from chronic lung disease. Therefore, 34 patients remained event free with a median follow-up of 54.5 months (range, 14-94 months) from diagnosis. The probabilities of 5-year OS and EFS for all 50 patients were 77.0% (95% confidence interval (CI), 63.7-90.3) and 71.4% (95% CI, 58.7-84.1), respectively. However, all patients who remained event free for >3 years after tandem HDCT/auto-SCT experienced late adverse effects. Chemotherapeutic dose-escalation strategy using tandem HDCT/auto-SCT was very encouraging for survival. However, further studies incorporating newer treatment modalities are needed to reduce late adverse effects without jeopardizing the survival rate.

  15. [Interest of cervical epidural anesthesia in perioperative management of thyroidectomy with the high-risk anesthetic patient].

    PubMed

    Mahoungou Guimbi, K C; Itiere Odzili, F A; Soussa, G R

    2014-03-01

    Cervical epidural anesthesia is an anesthetic technique that can be useful in patients with high perioperative risk undergoing to cervical surgery. We report the case of a patient of 49 years old with hypertension, diabetes mellitus, epilepsy, left hemiparesis sequelae of stroke and congestive left ventricular failure. The patient underwent total thyroidectomy under cervical epidural anesthesia. No difficulty breathing or decompensation of chronic underlying diseases were noted in the postoperative.

  16. Perioperative challenges in management of a deaf and dumb patient posted for high-risk cardiac surgery.

    PubMed

    Chowdhry, Vivek; Padhi, Manoranjan; Mohanty, B B; Biswal, Suvakanta

    2016-01-01

    Perioperative management of deaf and dumb patients can be a challenging task. For smooth postoperative recovery, proper care should begin in the preoperative period. Understanding the patients' needs and training him to follow the instructions requires to involve a communication specialist. Judicious use of sedatives and analgesics is essential to keep the patient pain-free and comfortable. Postoperatively, the patient should be kept awake, enough to understand the internal need of the body and to make a meaningful response to external stimuli. Adequate preoperative planning and coordinated team efforts with involvement of specialists can help in delivering better postoperative care. PMID:27397473

  17. Dipeptidyl Peptidase-4 Inhibitor Use Is Not Associated With Acute Pancreatitis in High-Risk Type 2 Diabetic Patients: A Nationwide Cohort Study.

    PubMed

    Chang, Chia-Hsuin; Lin, Jou-Wei; Chen, Shu-Ting; Lai, Mei-Shu; Chuang, Lee-Ming; Chang, Yi-Cheng

    2016-02-01

    To analyze the association between use of DPP-4 inhibitors and acute pancreatitis in high-risk type 2 diabetic patients. A retrospective nationwide cohort study was conducted using the Taiwan National Health Insurance claim database. The risk associated with sitagliptin was compared to that with acarbose, a second-line antidiabetic drug prescribed for patients with similar diabetes severity and with a known neutral effect on pancreatitis. Between January 1, 2009 and December 31, 2010, a total of 8526 sitagliptin initiators and 8055 acarbose initiators who had hypertriglyceridemia or prior hospitalization history for acute pancreatitis were analyzed for the risk of hospitalization due to acute pancreatitis stratified for baseline propensity score. In the crude analysis, sitagliptin was associated with a decreased risk of acute pancreatitis (hazard ratio [HR] 0.74; 95% confidence interval [CI]: 0.62-0.88) compared to acarbose in diabetic patients with prior history of hospitalization for pancreatitis or hypertriglyceridemia. The association was abolished after stratification for propensity score quintiles (adjusted HR 0.95; 95% CI: 0.79-1.16). Similar results were found separately in both patients' histories of prior hospitalization of acute pancreatitis (adjusted HR 0.97; 95% CI: 0.76-1.24) and those with hypertriglyceridemia (adjusted HR 0.86; 95% CI: 0.65-1.13). No significant association was found for different durations or accumulative doses of sitagliptin. In the stratified analysis, no significant effect modification was found in relation to patients' characteristics. Use of sitagliptin was not associated with an increased risk of acute pancreatitis in high-risk diabetic patients with hypertriglyceridemia or with history of acute pancreatitis.

  18. Dipeptidyl Peptidase-4 Inhibitor Use Is Not Associated With Acute Pancreatitis in High-Risk Type 2 Diabetic Patients: A Nationwide Cohort Study.

    PubMed

    Chang, Chia-Hsuin; Lin, Jou-Wei; Chen, Shu-Ting; Lai, Mei-Shu; Chuang, Lee-Ming; Chang, Yi-Cheng

    2016-02-01

    To analyze the association between use of DPP-4 inhibitors and acute pancreatitis in high-risk type 2 diabetic patients. A retrospective nationwide cohort study was conducted using the Taiwan National Health Insurance claim database. The risk associated with sitagliptin was compared to that with acarbose, a second-line antidiabetic drug prescribed for patients with similar diabetes severity and with a known neutral effect on pancreatitis. Between January 1, 2009 and December 31, 2010, a total of 8526 sitagliptin initiators and 8055 acarbose initiators who had hypertriglyceridemia or prior hospitalization history for acute pancreatitis were analyzed for the risk of hospitalization due to acute pancreatitis stratified for baseline propensity score. In the crude analysis, sitagliptin was associated with a decreased risk of acute pancreatitis (hazard ratio [HR] 0.74; 95% confidence interval [CI]: 0.62-0.88) compared to acarbose in diabetic patients with prior history of hospitalization for pancreatitis or hypertriglyceridemia. The association was abolished after stratification for propensity score quintiles (adjusted HR 0.95; 95% CI: 0.79-1.16). Similar results were found separately in both patients' histories of prior hospitalization of acute pancreatitis (adjusted HR 0.97; 95% CI: 0.76-1.24) and those with hypertriglyceridemia (adjusted HR 0.86; 95% CI: 0.65-1.13). No significant association was found for different durations or accumulative doses of sitagliptin. In the stratified analysis, no significant effect modification was found in relation to patients' characteristics. Use of sitagliptin was not associated with an increased risk of acute pancreatitis in high-risk diabetic patients with hypertriglyceridemia or with history of acute pancreatitis. PMID:26886601

  19. The rise of ampicillin-resistant Enterococcus faecium high-risk clones as a frequent intestinal colonizer in oncohaematological neutropenic patients on levofloxacin prophylaxis: a risk for bacteraemia?

    PubMed

    Sánchez-Díaz, A M; Cuartero, C; Rodríguez, J D; Lozano, S; Alonso, J M; Rodríguez-Domínguez, M; Tedim, A P; Del Campo, R; López, J; Cantón, R; Ruiz-Garbajosa, P

    2016-01-01

    Levofloxacin extended prophylaxis (LEP), recommended in oncohaematological neutropenic patients to reduce infections, might select resistant bacteria in the intestine acting as a source of endogenous infection. In a prospective observational study we evaluated intestinal emergence and persistence of ampicillin-resistant Enterococcus faecium (AREfm), a marker of hospital adapted high-risk clones. AREfm was recovered from the faeces of 52 patients with prolonged neutropenia after chemotherapy, at admission (Basal), during LEP, and twice weekly until discharge (Pos-LEP). Antibiotic susceptibility, virulence traits and population structure (pulsed-field gel electrophoresis and multilocus sequence typing) were determined and compared with bacteraemic isolates. Gut enterococcal population was monitored using a quantitative PCR quantification approach. AREfm colonized 61.4% of patients (194/482 faecal samples). Sequential AREfm acquisition (25% Basal, 36.5% LEP, 50% Pos-LEP) and high persistent colonization rates (76.9-89.5%) associated with a decrease in clonal diversity were demonstrated. Isolates were clustered into 24 PFGE-patterns within 13 sequence types, 95.8% of them belonging to hospital-associated Bayesian analysis of population structure subgroups 2.1a and 3.3a. Levofloxacin resistance and high-level streptomycin resistance were a common trait of these high-risk clones. AREfm-ST117, the most persistent clone, was dominant (60.0% isolates, 32.6% patients). It presented esp gene and caused 18.2% of all bacteraemia episodes in 21% of patients previously colonized by this clone. In AREfm-colonized patients, intestinal enrichment in the E. faecium population with a decline in total bacterial load was observed. AREfm intestinal colonization increases during hospital stay and coincides with enterococci population enrichment in the gut. Dominance and intestinal persistence of the ST117 clone might increase the risk of bacteraemia.

  20. Comparison of the Ability of Different Clinical Treatment Scores to Estimate Prognosis in High-Risk Early Breast Cancer Patients: A Hellenic Cooperative Oncology Group Study

    PubMed Central

    Pliarchopoulou, Kyriaki; Wirtz, Ralph M.; Alexopoulou, Zoi; Zagouri, Flora; Veltrup, Elke; Timotheadou, Eleni; Gogas, Helen; Koutras, Angelos; Lazaridis, Georgios; Christodoulou, Christos; Pentheroudakis, George; Laskarakis, Apostolos; Arapantoni-Dadioti, Petroula; Batistatou, Anna; Sotiropoulou, Maria; Aravantinos, Gerasimos; Papakostas, Pavlos; Kosmidis, Paris; Pectasides, Dimitrios; Fountzilas, George

    2016-01-01

    Background-Aim Early breast cancer is a heterogeneous disease, and, therefore, prognostic tools have been developed to evaluate the risk for distant recurrence. In the present study, we sought to develop a risk for recurrence score (RRS) based on mRNA expression of three proliferation markers in high-risk early breast cancer patients and evaluate its ability to predict risk for relapse and death. In addition the Adjuvant! Online score (AOS) was also determined for each patient, providing a 10-year estimate of relapse and mortality risk. We then evaluated whether RRS or AOS might possibly improve the prognostic information of the clinical treatment score (CTS), a model derived from clinicopathological variables. Methods A total of 1,681 patients, enrolled in two prospective phase III trials, were treated with anthracycline-based adjuvant chemotherapy. Sufficient RNA was extracted from 875 samples followed by multiplex quantitative reverse transcription-polymerase chain reaction for assessing RACGAP1, TOP2A and Ki67 mRNA expression. The CTS, slightly modified to fit our cohort, integrated the prognostic information from age, nodal status, tumor size, histological grade and treatment. Patients were also classified to breast cancer subtypes defined by immunohistochemistry. Likelihood ratio (LR) tests and concordance indices were used to estimate the relative increase in the amount of information provided when either RRS or AOS is added to CTS. Results The optimal RRS, in terms of disease-free survival (DFS) and overall survival (OS), was based on the co-expression of two of the three evaluated genes (RACGAP1 and TOP2A). CTS was prognostic for DFS (p<0.001), while CTS, AOS and RRS were all prognostic for OS (p<0.001, p<0.001 and p = 0.036, respectively). The use of AOS in addition to CTS added prognostic information regarding DFS (LR-Δχ2 8.7, p = 0.003), however the use of RRS in addition to CTS did not. For estimating OS, the use of either AOS or RRS in addition to

  1. Evaluation of six CTLA-4 polymorphisms in high-risk melanoma patients receiving adjuvant interferon therapy in the He13A/98 multicenter trial

    PubMed Central

    2010-01-01

    Purpose Interferon is approved for adjuvant treatment of patients with stage IIb/III melanoma. The toxicity and uncertainty regarding survival benefits of interferon have qualified its acceptance, despite significant durable relapse prevention in a fraction of patients. Predictive biomarkers that would enable selection of patients for therapy would have a large impact upon clinical practice. Specific CTLA-4 polymorphisms have previously shown an association with response to CTLA-4 blockade in patients with metastatic melanoma and the development of autoimmunity. Experimental design 286 melanoma patients and 288 healthy controls were genotyped for six CTLA-4 polymorphisms previously suggested to be important (AG 49, CT 318, CT 60, JO 27, JO30 and JO 31). Specific allele frequencies were compared between the healthy and patient populations, as well as presence or absence of these in relation to recurrence. Alleles related to autoimmune disease were also investigated. Results No significant differences were found between the distributions of CTLA-4 polymorphisms in the melanoma population compared with healthy controls. Relapse free survival (RFS) and overall survival (OS) did not differ significantly between patients with the alleles represented by these polymorphisms. No correlation between autoimmunity and specific alleles was shown. The six polymorphisms evaluated where strongly associated (Fisher's exact p-values < 0.001 for all associations) and significant linkage disequilibrium among these was indicated. Conclusion No polymorphisms of CTLA-4 defined by the SNPs studied were correlated with improved RFS, OS, or autoimmunity in this high-risk group of melanoma patients. PMID:21044351

  2. 3D surgical planning in patients affected by lipodystrophy.

    PubMed

    Pérez-Carrasco, J A; Acha, B; Gómez-Cia, T; Lopez-Garcia, R A; Delgado, Carlos; Serrano, C

    2015-03-01

    Lipodystrophy is a pathological condition characterized by the focal or general absence of adipose tissue. Surgeons reset the patient's surface contours using injectable materials to recreate a normal physical appearance. However, due to difficulties in preoperative planning and intraoperative assessment, about 15% of the surgical procedures involved are reinterventions to improve volume or symmetry. This increases the need for an available, efficient tool capable of providing the surgeon with a good estimation of the volumes to be injected before the intervention proper begins. This work describes a virtual reality-based application for the surgical planning of facial lipodystrophy correction (FLIC). The tool uses points selected interactively by the surgeon to compute a curve that delimits the surface area to be operated on. It then automatically computes an estimated natural reconstructed surface and the quantity of volume that needs to be implanted during the intervention. Experiments have been carried out in which the filling volumes estimated using FLIC and ZBrush software were compared with the real volumes injected by the surgeon. ICCs higher than 0.97 indicate that there were no significant differences between the respective measurements, thus validating the tool proposed in this paper.

  3. Absolute monocyte count trichotomizes chronic lymphocytic leukemia into high risk patients with immune dysregulation, disease progression and poor survival.

    PubMed

    Herishanu, Yair; Kay, Sigi; Sarid, Nadav; Kohan, Pedram; Braunstein, Rony; Rotman, Rachel; Deutsch, Varda; Ben-Ezra, Jonathan; Naparstek, Elizabeth; Perry, Chava; Katz, Ben-Zion

    2013-10-01

    Peripheral absolute monocyte count (AMC) has been reported to correlate with clinical outcome in different types of cancers. This association may relate to alteration in circulating monocytic subpopulations and tumor infiltrating macrophages. In this study we evaluated the clinical significance of peripheral AMC in 80 treatment naive patients with CLL. Measurement of AMC was based on direct morphological enumeration, due to our findings that complete blood count data may yield incorrect monocytes enumeration values in CLL. The median AMC in patients with CLL was within normal limits, however the AMC range exceeded the values of healthy individuals. The AMC trichotomized patients into 3 distinct sub-groups with different characteristics and outcomes. High AMC patients were younger and had higher absolute lymphocytes count, while patients with low AMC had prominent immune dysregulation (lower serum IgA levels, susceptibility to infections and a tendency for positive direct anti-globulin test). The low and high AMC patients had a shorter time to treatment compared to the intermediates AMC subgroups, whereas low AMC was associated with increased mortality caused by infectious complications. In conclusion, AMC quantification during the disease course classifies CLL patients into subgroups with unique clinical features and outcomes.

  4. Patrilineal Background of Esophageal Cancer and Gastric Cardia Cancer Patients in a Chaoshan High-Risk Area in China

    PubMed Central

    Huang, Haihua; Li, Xiaoyun; Chen, Guangcan; Zhang, Guohong; Lin, Wengting; Guo, Dan; Wang, Jie; Yu, Zefeng; Liu, Xi; Su, Min

    2013-01-01

    The Taihang Mountain range of north-central China, the Southern region area of Fujian province, and the Chaoshan plain of Guangdong province are 3 major regions in China well known for their high incidence of esophageal cancer (EC). These areas also exhibit high incidences of gastric cardia cancer (GCC). The ancestors of the Chaoshanese, now the major inhabitants in the Chaoshan plain, were from north-central China. We hypothesized that EC and GCC patients in Chaoshan areas share a common ancestry with Taihang Mountain patients. We analyzed 16 East Asian-specific Y-chromosome biallelic markers (single nucleotide polymorphisms; Y-SNPs) and 6 Y-chromosome short tandem repeat (Y-STR) loci in 72 EC and 48 GCC patients from Chaoshan and 49 EC and 63 GCC patients from the Taihang Mountain range. We also compared data for 32 Chaoshan Hakka people and 24 members of the aboriginal She minority who live near the Chaoshan area. Analysis was by frequency distribution and principal component, correlation and hierarchical cluster analysis of Y-SNP. Chaoshan patients were closely related to Taihang Mountain patients, even though they are geographically distant. Y-STR analysis revealed that the 4 patient groups were more closely related with each other than with other groups. Network analysis of the haplogroup O3a3c1-M117 showed a high degree of patient-specific substructure. We suggest that EC and GCC patients from these 2 areas share a similar patrilineal genetic background, which may play an important role in the genetic factor of EC and GCC in these populations. PMID:24339953

  5. Clinical studies of combined photodynamic therapy using 5-fluorouracil and methyl-aminolevulinate in patients at high risk for squamous cell carcinoma

    NASA Astrophysics Data System (ADS)

    Maytin, Edward V.; Lohser, Sara; Tellez, Alejandra; Wene, Lauren; Ishak, Rim; Anand, Sanjay

    2013-03-01

    Photodynamic therapy (PDT) using aminolevulinic acid or its methyl ester, methyl-aminolevulinate (MAL), is an increasingly recognized approach for treating squamous neoplasia of the skin. Advantages of MAL-PDT include its ability to cover broad diseased areas (field treatment), and to do multiple sessions with little-to-no risk of scarring or mutagenesis. MAL-PDT is especially valuable in certain populations at high risk for skin cancer, including Caucasian patients with extensive solar damage, and organ transplant recipients (OTR) who take immunosuppressive drugs to prevent graft rejection. The latter group has a 65-200 fold increased risk of developing squamous cell carcinoma (SCC), a major cause of mortality. Therapeutic options for those patients, other than frequent surgeries, are very limited. Topical 5-Fluorouracil (5-FU), frequently prescribed in normal patients for pre-SCC of the skin, is only minimally effective in the OTR group. MAL-PDT, however, has ~40% efficacy for pre-SCC in OTR patients. Based upon our preclinical studies in mouse tumor models, which showed that preconditioning with 5-FU can drive higher accumulation of target protoporphyins (PpIX), we proposed a rational combination regimen of 5-FU and MAL-PDT in humans. A clinical trial was designed to test the hypothesis that a combination of 5-FU followed by MAL-PDT will elevate PpIX levels and achieve better clinical outcomes in high-risk OTR patients. Primary endpoints include PpIX levels and biochemical markers (p53) measured noninvasively and in skin biopsies. Lesion clearance and recurrence (via photographs and clinical exam) are secondary endpoints. Ongoing results of this clinical trial are presented.

  6. Phase I adaptive dose-finding study of neoadjuvant gemcitabine combined with radiation therapy for patients with high-risk extremity and trunk soft tissue sarcoma

    PubMed Central

    Tseng, William W.; Zhou, Shouhao; To, Christina A.; Thall, Peter F.; Lazar, Alexander J.; Pollock, Raphael E.; Lin, Patrick P.; Cormier, Janice N.; Lewis, Valerae O.; Feig, Barry W.; Hunt, Kelly K.; Ballo, Matthew T.; Patel, Shreyaskumar; Pisters, Peter W.T.

    2016-01-01

    BACKGROUND We sought to determine the maximum tolerated dose (MTD) of gemcitabine given concurrently with preoperative, fixed-dose external-beam radiation therapy (EBRT) for patients with resectable, high-risk extremity and trunk soft tissue sarcomas (STS). METHODS Gemcitabine was administered on days 1, 8, 22, 29, 43, and 50 with EBRT (50 Gy, 25 fractions over 5 weeks). The gemcitabine MTD was determined using a toxicity severity weight method (TSWM), incorporating 6 toxicity types. The TSWM is a Bayesian procedure that chooses each cohort’s dose to have posterior mean total toxicity burden closest to a predetermined clinician-defined target. Clinicopathologic and outcome data were also collected. RESULTS Thirty-six patients completed the study. Using the TSWM, the gemcitabine MTD was 700 mg/m2. At this dose level, 4 patients (24%) experienced grade 4 toxicity; no toxicity-related deaths occurred. All tumors were resected with microscopically negative margins. Pathologic responses of >90% tumor necrosis were achieved in 17 patients (47%); 14 (39%) had complete responses. With a median follow-up of 6.2 years, the 5-year locoregional recurrence-free survival, distant metastasis-free survival, and overall survival rates were 85%, 80%, and 86%, respectively. CONCLUSIONS The TSWM combines data from qualitatively different toxicities and can be used to determine the MTD for a drug given as part of multimodality treatment. Neoadjuvant gemcitabine plus radiation therapy is feasible and safe in patients with high-risk extremity and trunk STS. Major pathologic responses can be achieved and after complete resection, long-term clinical outcomes are encouraging. PMID:26177983

  7. Prostate Stem Cell Antigen Expression in Radical Prostatectomy Specimens Predicts Early Biochemical Recurrence in Patients with High Risk Prostate Cancer Receiving Neoadjuvant Hormonal Therapy

    PubMed Central

    Kim, Sung Han; Park, Weon Seo; Kim, Sun Ho; Park, Boram; Joo, Jungnam; Lee, Geon Kook; Joung, Jae Young; Seo, Ho Kyung; Chung, Jinsoo; Lee, Kang Hyun

    2016-01-01

    We aimed to identify tissue biomarkers that predict early biochemical recurrence (BCR) in patients with high-risk prostate cancer (PC), toward the goal of increasing the benefits of neoadjuvant hormonal therapy (NHT). In 2005–2012, prostatectomy specimens were collected from 134 PC patients who had received NHT and radical prostatectomy. The expression of 13 tissue biomarkers was assessed in the specimens via immunohistochemistry. Time to BCR and factors predictive of BCR were determined by using the Cox proportional hazards model. During the follow-up period (median, 57.5 months), 67 (50.0%) patients experienced BCR. Four (3.0%) patients were tumor-free in the final pathology assessment, and 101 (75.4%) had negative resection margins. Prostate stem cell antigen (PSCA) was the only significant prognostic tissue biomarker of BCR [hazard ratio (HR), 2.58; 95% confidence interval (CI), 1.06–6.27; p = 0.037] in a multivariable analysis adjusted by the clinicopathological variables that also significantly predicted BCR; these were seminal vesicle invasion (HR, 2.39; 95% CI, 1.32–4.34), initial prostate serum antigen level (HR 1.01; 95% CI, 1.001–1.020), prostate size (HR, 0.93; 95% CI, 0.90–0.97), and the Gleason score of preoperative biopsies (HR, 1.34; 95% CI, 1.01–1.79). We suggest that PSCA is a useful tissue marker for predicting BCR in patients with high risk PC receiving NHT and radical prostatectomy. PMID:26982980

  8. Prostate Stem Cell Antigen Expression in Radical Prostatectomy Specimens Predicts Early Biochemical Recurrence in Patients with High Risk Prostate Cancer Receiving Neoadjuvant Hormonal Therapy.

    PubMed

    Kim, Sung Han; Park, Weon Seo; Kim, Sun Ho; Park, Boram; Joo, Jungnam; Lee, Geon Kook; Joung, Jae Young; Seo, Ho Kyung; Chung, Jinsoo; Lee, Kang Hyun

    2016-01-01

    We aimed to identify tissue biomarkers that predict early biochemical recurrence (BCR) in patients with high-risk prostate cancer (PC), toward the goal of increasing the benefits of neoadjuvant hormonal therapy (NHT). In 2005-2012, prostatectomy specimens were collected from 134 PC patients who had received NHT and radical prostatectomy. The expression of 13 tissue biomarkers was assessed in the specimens via immunohistochemistry. Time to BCR and factors predictive of BCR were determined by using the Cox proportional hazards model. During the follow-up period (median, 57.5 months), 67 (50.0%) patients experienced BCR. Four (3.0%) patients were tumor-free in the final pathology assessment, and 101 (75.4%) had negative resection margins. Prostate stem cell antigen (PSCA) was the only significant prognostic tissue biomarker of BCR [hazard ratio (HR), 2.58; 95% confidence interval (CI), 1.06-6.27; p = 0.037] in a multivariable analysis adjusted by the clinicopathological variables that also significantly predicted BCR; these were seminal vesicle invasion (HR, 2.39; 95% CI, 1.32-4.34), initial prostate serum antigen level (HR 1.01; 95% CI, 1.001-1.020), prostate size (HR, 0.93; 95% CI, 0.90-0.97), and the Gleason score of preoperative biopsies (HR, 1.34; 95% CI, 1.01-1.79). We suggest that PSCA is a useful tissue marker for predicting BCR in patients with high risk PC receiving NHT and radical prostatectomy. PMID:26982980

  9. Perioperative challenges in management of a deaf and dumb patient posted for high-risk cardiac surgery

    PubMed Central

    Chowdhry, Vivek; Padhi, Manoranjan; Mohanty, B. B.; Biswal, Suvakanta

    2016-01-01

    Perioperative management of deaf and dumb patients can be a challenging task. For smooth postoperative recovery, proper care should begin in the preoperative period. Understanding the patients’ needs and training him to follow the instructions requires to involve a communication specialist. Judicious use of sedatives and analgesics is essential to keep the patient pain-free and comfortable. Postoperatively, the patient should be kept awake, enough to understand the internal need of the body and to make a meaningful response to external stimuli. Adequate preoperative planning and coordinated team efforts with involvement of specialists can help in delivering better postoperative care. PMID:27397473

  10. Futility and the care of surgical patients: ethical dilemmas.

    PubMed

    Grant, Scott B; Modi, Parth K; Singer, Eric A

    2014-07-01

    Futility has been a contentious topic in medicine for several decades. Surgery in critical or end-of-life situations often raises difficult questions about futility. In this article, we discuss the definition of futility, methods for resolving futility disputes, and some ways to reframe the futility debate to a more fruitful discussion about the goals of care, better communication between surgeon and patient/surrogate, and palliative surgical care. Many definitions of futile therapy have been discussed. The most controversial of these is "qualitative futility" which describes a situation in which the treatment provided is likely to result in an unacceptable quality of life. This is an area of continued controversy because it has been impossible to identify universally held beliefs about acceptable quality of life. Many authors have described methods for resolving futility disputes, including community standards and legalistic multi-step due process protocols. Others, however, have abandoned the concept of futility altogether as an unhelpful term. Reframing the issue of futility as one of inadequate physician-patient communication, these authors have advocated for methods of improving communication and strengthening the patient-physician relationship. Finally, we discuss the utilization of consultants who may be of use in resolving futility disputes: ethics committees, palliative care specialists, pastoral care teams, and dedicated patient advocates. Involving these specialists in a futility conflict can help improve communication and provide invaluable assistance in arriving at the appropriate treatment decision.

  11. Basal Tumor Cell Isolation and Patient-Derived Xenograft Engraftment Identify High-Risk Clinical Bladder Cancers

    PubMed Central

    Skowron, K. B.; Pitroda, S. P.; Namm, J. P.; Balogun, O.; Beckett, M. A.; Zenner, M. L.; Fayanju, O.; Huang, X.; Fernandez, C.; Zheng, W.; Qiao, G.; Chin, R.; Kron, S. J.; Khodarev, N. N.; Posner, M. C.; Steinberg, G. D.; Weichselbaum, R. R.

    2016-01-01

    Strategies to identify tumors at highest risk for treatment failure are currently under investigation for patients with bladder cancer. We demonstrate that flow cytometric detection of poorly differentiated basal tumor cells (BTCs), as defined by the co-expression of CD90, CD44 and CD49f, directly from patients with early stage tumors (T1-T2 and N0) and patient-derived xenograft (PDX) engraftment in locally advanced tumors (T3-T4 or N+) predict poor prognosis in patients with bladder cancer. Comparative transcriptomic analysis of bladder tumor cells isolated from PDXs indicates unique patterns of gene expression during bladder tumor cell differentiation. We found cell division cycle 25C (CDC25C) overexpression in poorly differentiated BTCs and determined that CDC25C expression predicts adverse survival independent of standard clinical and pathologic features in bladder cancer patients. Taken together, our findings support the utility of BTCs and bladder cancer PDX models in the discovery of novel molecular targets and predictive biomarkers for personalizing oncology care for patients. PMID:27775025

  12. TP53 mutation in patients with high-risk acute myeloid leukaemia treated with allogeneic haematopoietic stem cell transplantation.

    PubMed

    Middeke, Jan M; Herold, Sylvia; Rücker-Braun, Elke; Berdel, Wolfgang E; Stelljes, Matthias; Kaufmann, Martin; Schäfer-Eckart, Kerstin; Baldus, Claudia D; Stuhlmann, Reingard; Ho, Anthony D; Einsele, Hermann; Rösler, Wolf; Serve, Hubert; Hänel, Mathias; Sohlbach, Kristina; Klesse, Christian; Mohr, Brigitte; Heidenreich, Falk; Stölzel, Friedrich; Röllig, Christoph; Platzbecker, Uwe; Ehninger, Gerhard; Bornhäuser, Martin; Thiede, Christian; Schetelig, Johannes

    2016-03-01

    Treatment success in patients with acute myeloid leukaemia (AML) is heterogeneous. Cytogenetic and molecular alterations are strong prognostic factors, which have been used to individualize treatment. Here, we studied the impact of TP53 mutations on the outcome of AML patients with adverse cytogenetic risk treated with allogeneic haematopoietic stem cell transplantation (HSCT). Samples of 97 patients with AML and adverse-risk cytogenetics who had received a HSCT within three randomized trials were analysed. Complete sequencing of the TP53 coding region was performed using next generation sequencing. The median age was 51 years. Overall, TP53 mutations were found in 40 patients (41%). With a median follow up of 67 months, the three-year probabilities of overall survival (OS) and event-free survival for patients with TP53 wild type were 33% [95% confidence interval (CI), 21% to 45%] and 24% (95% CI, 13% to 35%) compared to 10% (95% CI, 0% to 19%) and 8% (95% CI, 0% to 16%) (P = 0·002 and P = 0·007) for those with mutated TP53, respectively. In multivariate analysis, the TP53-mutation status had a negative impact on OS (Hazard Ratio = 1·7; P = 0·066). Mutational analysis of TP53 might be an important additional tool to predict outcome after HSCT in patients with adverse karyotype AML.

  13. Bimatoprost/timolol fixed combination versus latanoprost in treatment-naïve glaucoma patients at high risk of progression: a pilot study

    PubMed Central

    Gutierrez-Diaz, Esperanza; Silva Cotta, Jose; Muñoz-Negrete, Francisco J; Gutierrez-Ortiz, Consuelo; Morgan-Warren, Robert J; Maltman, John

    2014-01-01

    Objective To compare a fixed combination of 0.03% bimatoprost and 0.5% timolol (BTFC) with latanoprost monotherapy (LM) in treatment-naïve patients with open-angle glaucoma (OAG) and risk factors for glaucomatous progression. Methods Patients were enrolled at 15 sites in Spain and Portugal, and were randomized 1:1 to BTFC or LM. Patients instilled one drop of medication once per day at 8 pm for 12 weeks. The primary outcome was change in intraocular pressure (IOP) at 12 weeks. Results Of 81 patients enrolled, 43 were randomized to BTFC and 38 to LM. Mean (SD) change in IOP from baseline to 12 weeks was significantly greater for BTFC than for LM: −13.5 mmHg (4.48) versus −11.4 mmHg (3.19), respectively (P=0.003). Similarly, at 12 weeks, significantly more BTFC patients than LM patients had IOP reductions of ≥40% (74.4% versus 47.4%, P=0.015) or ≥50% (46.5% versus 15.8%, P=0.003). Adverse events were more frequent with BTFC than with LM (33 versus 13 events), but most were mild in severity. The only serious adverse event (colon cancer) was adjudged unrelated to the study medication. Conclusion BTFC was effective and well tolerated in treatment-naïve patients with OAG at high risk of progression. PMID:24748767

  14. The characteristics of sleep in patients with manifest bipolar disorder, subjects at high risk of developing the disease and healthy controls.

    PubMed

    Ritter, Philipp S; Marx, Carolin; Lewtschenko, Natalia; Pfeiffer, Steffi; Leopold, Karolina; Bauer, Michael; Pfennig, Andrea

    2012-10-01

    Sleep is highly altered during affective episodes in patients with bipolar disorder. There is accumulating evidence that sleep is also altered in euthymic states. A deficit in sleep regulation may be a vulnerability factor with aetiological relevance in the development of the disease. This study aims to explore the objective, subjective and lifetime sleep characteristics of patients with manifest bipolar disorder and persons with an elevated risk of developing the disease. Twenty-two patients with bipolar I and II disorder, nine persons with an elevated risk of developing the disorder and 28 healthy controls were evaluated with a structured interview to characterize subjective and lifetime sleeping habits. In addition, participants wore an actimeter for six nights. Patients with bipolar disorder had longer sleep latency and duration compared with healthy controls as determined by actigraphy. The subjective and lifetime sleep characteristics of bipolar patients differed significantly from healthy controls. The results of participants with an elevated risk of developing the disorder had subjective and lifetime characteristics that were largely analogous to those of patients with manifest bipolar disorder. In particular, both groups described recurring insomnia and hypersomnia, sensitivity to shifts in circadian rhythm, difficulties awakening and prolonged sleep latency. This study provides further evidence that sleep and circadian timing are profoundly altered in patients with bipolar disorder. It may also tentatively suggest that sleep may be altered prior to the first manic episode in subjects at high risk.

  15. Comparable outcomes between unrelated and related donors after reduced-intensity conditioning allogeneic hematopoietic stem cell transplantation in patients with high-risk multiple myeloma.

    PubMed

    El-Cheikh, Jean; Crocchiolo, Roberto; Boher, Jean-Marie; Furst, Sabine; Stoppa, Anne-Marie; Ladaique, Patrick; Faucher, Catherine; Calmels, Boris; Castagna, Luca; Lemarie, Claude; De Colella, Jean-Marc Schiano; Coso, Diane; Bouabdallah, Reda; Chabannon, Christian; Blaise, Didier

    2012-06-01

    The purpose of this study was to assess the results of allogeneic stem cell transplantation (allo-SCT) after reduced-intensity conditioning (RIC) from matched related donors (MRD) and unrelated donors (URD) in 40 patients with high-risk multiple myeloma (MM) in a single centre. Seventeen (43%) (Group 1) and 23 patients (57%) (Group 2) had URD and MRD, respectively. Thirty-nine patients (98%) received one or more autologous transplantation. The median follow-up was 22 months (1-49). None of our patient experienced a graft rejection. The cumulative incidence of grade II-IV acute GVHD was higher (47%) for the URD vs. (17%) for the MRD (P = 0.092). The cumulative incidence of chronic GVHD was no different between the two groups (24% vs. 30%, respectively). At 2 yr, the TRM probabilities were lower in the unrelated group 12% vs. 22% in the related group (P = 0.4). Also at 2 yrs, for patients receiving unrelated transplantation overall and progression-free survivals, 59% and 42%, respectively compared to patients with related donor transplantation, 66% and 44% (P = 0.241). In conclusion, these results suggest that URD in MM is feasible. The small number of patients with URD emphasizes the need to delineate indications and perform prospective protocols.

  16. Treatment of High-risk Venous Thrombosis Patients Using Low-dose Intraclot Injections of Recombinant Tissue Plasminogen Activator and Regional Anticoagulation

    PubMed Central

    Chang, Richard; Butman, John A.; Lonser, Russell R.; Sherry, Richard M.; Pandalai, Prakash K.; Horne, McDonald K.; Lozier, Jay N.

    2013-01-01

    Seven patients with venous thrombosis and contraindications to traditional thrombolytic therapy, consisting of recent intracranial surgery, recent pineal or retroperitoneal hemorrhage, active genitourinary or gastrointestinal bleeding, epidural procedures, and impending surgery, were successfully treated with a modified thrombolytic regimen. To improve safety, prolonged continuous infusions of tissue plasminogen activator (tPA) was eliminated in favor of once-daily low-dose intraclot injections of tPA to minimize the amount and duration of tPA in the systemic circulation, and low-therapeutic or regional anticoagulation was used to reduce anticoagulant risks. These modifications may allow thrombolytic treatment for selected patients with severe venous thrombosis who are deemed to be at high risk. PMID:23273695

  17. A phase II study of AZD2171 (cediranib) in the treatment of patients with acute myeloid leukemia or high-risk myelodysplastic syndrome

    PubMed Central

    Mattison, Ryan; Jumonville, Alcee; Flynn, Patrick James; Moreno-Aspitia, Alvaro; Erlichman, Charles; Laplant, Betsy; Juckett, Mark B.

    2015-01-01

    Patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) not fit for intensive treatment need novel therapy options. Vascular endothelial growth factor (VEGF) receptor inhibition is one potential mechanism by which AML and MDS could be treated. The receptor tyrosine kinase inhibitor AZD2171 (cediranib) has activity against VEGF receptors KDR and FLT-1. This multicenter phase II study was designed to test cediranib's activity in patients with AML or high-risk MDS. The primary endpoint was confirmed disease response defined as a composite of complete remission, partial remission or hematologic improvement. The study enrolled 23 subjects in the AML cohort and 16 subjects in the MDS cohort. There were no confirmed responses in either group. Since the study met the stopping rule after the first stage of enrollment, the trial was closed to further accrual. Common adverse events in both cohorts included thrombocytopenia, neutropenia, anemia, fatigue, dyspnea, diarrhea, nausea and dehydration. PMID:25329007

  18. Association between cholesterol synthesis/absorption markers and effects of cholesterol lowering by atorvastatin among patients with high risk of coronary heart disease.

    PubMed

    Qi, Yue; Liu, Jing; Ma, Changsheng; Wang, Wei; Liu, Xiaohui; Wang, Miao; Lv, Qiang; Sun, Jiayi; Liu, Jun; Li, Yan; Zhao, Dong

    2013-11-01

    No indices are currently available to facilitate clinicians to identify patients who need either statin monotherapy or statin-ezetimibe combined treatment. We aimed to investigate whether cholesterol synthesis and absorption markers can predict the cholesterol-lowering response to statin. Total 306 statin-naïve patients with high risk of coronary heart disease (CHD) were treated with atorvastatin 20 mg/day for 1 month. Cholesterol synthesis and absorption markers and LDL cholesterol (LDL-C) levels were measured before and after treatment. Atorvastatin decreased LDL-C by 36.8% (range: decrease of 74.5% to increase of 31.9%). Baseline cholesterol synthesis marker lathosterol and cholesterol absorption marker campesterol codetermined the effect of atorvastatin treatment. The effect of cholesterol lowering by atorvastatin was significantly associated with baseline lathosterol levels but modified bidirectionally by baseline campesterol levels. In patients with the highest baseline campesterol levels, atorvastatin treatment decreased cholesterol absorption by 46.1%, which enhanced the effect of LDL-C lowering. Atorvastatin treatment increased cholesterol absorption by 52.3% in those with the lowest baseline campesterol levels, which attenuated the effect of LDL-C reduction. Especially those with the highest lathosterol but the lowest campesterol levels at baseline had significantly less LDL-C reduction than those with the same baseline lathosterol levels but the highest campesterol levels (27.3% versus 42.4%, P = 0.002). These results suggest that combined patterns of cholesterol synthesis/absorption markers, rather than each single marker, are potential predictors of the LDL-C-lowering effects of atorvastatin in high-risk CHD patients.

  19. Pretreatment biopsy analysis of DAB2IP identifies subpopulation of high-risk prostate cancer patients with worse survival following radiation therapy.

    PubMed

    Jacobs, Corbin; Tumati, Vasu; Kapur, Payal; Yan, Jingsheng; Xie, Xian-Jin; Hannan, Raquibul; Hsieh, Jer-Tsong; Kim, Dong Wook Nathan; Saha, Debabrata

    2015-12-01

    Decreased expression of tumor suppressor DAB2IP is linked to aggressive cancer and radiation resistance in several malignancies, but clinical survival data is largely unknown. We hypothesized that pretreatment DAB2IP reduction would predict worse prostate cancer-specific survival (PCSS). Immunohistochemistry of pretreatment biopsies was scored by an expert genitourinary pathologist. Other endpoints analyzed include freedom from biochemical failure (FFBF), castration resistance-free survival (CRFS), and distant metastasis-free survival (DMFS). Seventy-nine patients with NCCN-defined high-risk prostate cancer treated with radiotherapy from 2005 to 2012 at our institution were evaluated. Twenty-eight percent (22/79) of pretreatment biopsies revealed DAB2IP-reduction. The median follow up times were 4.8 years and 5.3 years for patients in the DAB2IP-reduced group and DAB2IP-retained group, respectively. Patients with reduced DAB2IP demonstrated worse outcome compared to patients retaining DAB2IP, including FFBF (4-year: 34 vs. 92%; P < 0.0001), CRFS (4-year: 58 vs. 96%; P = 0.0039), DMFS (4-year: 58 vs. 100%; P = 0.0006), and PCSS (5-year: 83 vs. 100%; P = 0.0102). Univariate analysis showed T stage, N stage, and Gleason score were statistically significant variables. Pretreatment tumor DAB2IP status remained significant in multivariable analyses. This study suggests that about one-fourth of men with high-risk prostate cancer have decreased tumor expression of DAB2IP. This subpopulation with reduced DAB2IP has a suboptimal response and worse malignancy-specific survival following radiation therapy and androgen deprivation. DAB2IP loss may be a genetic explanation for the observed differences in aggressive tumor characteristics and radiation resistance. Further study into improving treatment response and survival in this subpopulation is warranted.

  20. [Prophylaxis of complications after radical surgical intervention for mammary gland cancer in elderly patients].

    PubMed

    Hrybach, S M; Borodaĭ, N V

    2014-10-01

    Surgical treatment of 80 patients, suffering mammary gland cancer (MGC), was conducted. The complications rate in elderly and young patients after radical surgical treatment was analyzed. There was established, that while preparation Traumastem P application in elderly patients, suffering MGC, the lymphorrhea volume and duration are reducing, what prevents complications in postoperative period.

  1. The kSORT Assay to Detect Renal Transplant Patients at High Risk for Acute Rejection: Results of the Multicenter AART Study

    PubMed Central

    Hsieh, Sue; Dai, Hong; Bestard, Oriol; Metes, Diana; Zeevi, Andrea; Gritsch, Albin; Cheeseman, Jennifer; Macedo, Camila; Peddy, Ram; Medeiros, Mara; Vincenti, Flavio; Asher, Nancy; Salvatierra, Oscar; Shapiro, Ron; Kirk, Allan; Reed, Elaine; Sarwal, Minnie M.

    2014-01-01

    Background Development of noninvasive molecular assays to improve disease diagnosis and patient monitoring is a critical need. In renal transplantation, acute rejection (AR) increases the risk for chronic graft injury and failure. Noninvasive diagnostic assays to improve current late and nonspecific diagnosis of rejection are needed. We sought to develop a test using a simple blood gene expression assay to detect patients at high risk for AR. Methods and Findings We developed a novel correlation-based algorithm by step-wise analysis of gene expression data in 558 blood samples from 436 renal transplant patients collected across eight transplant centers in the US, Mexico, and Spain between 5 February 2005 and 15 December 2012 in the Assessment of Acute Rejection in Renal Transplantation (AART) study. Gene expression was assessed by quantitative real-time PCR (QPCR) in one center. A 17-gene set—the Kidney Solid Organ Response Test (kSORT)—was selected in 143 samples for AR classification using discriminant analysis (area under the receiver operating characteristic curve [AUC] = 0.94; 95% CI 0.91–0.98), validated in 124 independent samples (AUC = 0.95; 95% CI 0.88–1.0) and evaluated for AR prediction in 191 serial samples, where it predicted AR up to 3 mo prior to detection by the current gold standard (biopsy). A novel reference-based algorithm (using 13 12-gene models) was developed in 100 independent samples to provide a numerical AR risk score, to classify patients as high risk versus low risk for AR. kSORT was able to detect AR in blood independent of age, time post-transplantation, and sample source without additional data normalization; AUC = 0.93 (95% CI 0.86–0.99). Further validation of kSORT is planned in prospective clinical observational and interventional trials. Conclusions The kSORT blood QPCR assay is a noninvasive tool to detect high risk of AR of renal transplants. Please see later in the article for the Editors' Summary PMID

  2. [Treatment of acute coronary syndrome in older adults and high-risk patients."When the going gets tough…"].

    PubMed

    Bassanelli, Giorgio; Morici, Nuccia; De Luca, Leonardo; De Servi, Stefano; Savonitto, Stefano

    2015-10-01

    The increasing life expectancy in older adults and the better survival of patients with multiple pathologies require the capability to treat complex clinical conditions with an increased risk of iatrogenic complications. Nevertheless, recent improvements in the pharmacological and interventional treatment of acute coronary syndrome (ACS) have promoted a shift from therapeutic nihilism to a more active management of complex ACS cases. Despite the paucity of specific randomized clinical trials, observational studies seem to show benefit of an early invasive treatment in these patients. This approach requires close cooperation of clinical intensivists, interventional cardiologists and cardiovascular surgeons either in a specialized heart center or in a network of hospitals. PMID:26442976

  3. Laparoscopic colostomy for acute left colon obstruction caused by diverticular disease in high risk patient: A case report

    PubMed Central

    Palladino, Elisa; Cappiello, Antonio; Guarino, Vincenzo; Perrotta, Nicola; Loffredo, Domenico

    2015-01-01

    Introduction The colostomy is often necessary in complicated divertcular disease. The laparoscopic colostomy is not widely used for the treatment of complicated diverticular disease. Its use in patients with high operative risk is still on debate. The aim of this case report was to present the benefits of laparoscopic colostomy in patients with high peri-and postoperative risk factors. Presentation of case We present a case of 76-year-old female admitted to emergency unit for left colonic obstruction. The patient had a past history of liver cirrhosis HCV-related with a severe malnutrition, hypertrophic cardiomyopathy, diverticular disease, hiatal ernia, previous appendectomy. Patient was classified according to their preoperative risk ASA 3 (classification of the American society of Anestesia-ASA score). Contrast-enhanced abdominal CT revealed a marked thickening in the sigmoid colon and a marked circumferential stenosis in the sigmoid colon in absence of neoplasm, and/or abscess. The laparoscopic procedure is proposed as first intention. Discussion The operation time was 50 min, and the hospital stay was 4 days. Post operative complications grade I according to the Clavien Dindo Classification. Conclusions Laparoscopic colostomy is safe and feasible procedure in experienced hands. It is associated with low morbidity and short stay in hospital and should be considered a good alternative to a laparotomy. PMID:26036456

  4. Attributable Hospital Cost and Antifungal Treatment of Invasive Fungal Diseases in High-Risk Hematology Patients: an Economic Modeling Approach▿

    PubMed Central

    Ananda-Rajah, Michelle R.; Cheng, Allen; Morrissey, C. Orla; Spelman, Tim; Dooley, Michael; Neville, A. Munro; Slavin, Monica

    2011-01-01

    Studies using patient-level data to determine the attributable cost of invasive fungal diseases (IFDs) are few. Using a case-control study with activity-based costing of patients admitted to a quaternary hospital from 2002 to 2007, we determined attributable hospitalization cost (and 12 weeks thereafter), length of stay (LOS), and costly antifungal treatment (C-AT; liposomal amphotericin B, voriconazole, posaconazole, caspofungin), expressed as defined daily doses (DDDs) per IFD episode, in patients with hematological malignancies and hematopoietic stem cell recipients. Matching criteria and median regression modeling controlled for confounding variables, including LOS prior to IFD onset. Multiple mycoses were identified in 43 matched case-control pairs (n = 86). A separate sensitivity analysis included 22 unmatched patients. IFD status was associated with a median excess cost of AU$30,957 (95% confidence interval [CI] = AU$2,368 to AU$59,546; P = 0.034), approximating at purchasing power parity US$21,203 (95% CI = US$1,622 to US$40,784) and €15,788 (95% CI = €1,208 to €30,368), increasing to AU$80,291 (95% CI = AU$33,636 to AU$126,946; P = 0.001), i.e., US$54,993 (95% CI = US$23,038 to US$86,948) and €40,948 (95% CI = €17,154 to €64,742), with intensive care unit (ICU) requirement. Cost determinants were pharmacy costs (64%; P < 0.001) inclusive of antifungal treatment (27%; P < 0.001) and ward costs (27%; P = 0.091), with proportions persisting through 12 weeks for 25 surviving matched pairs (pharmacy, 60% [P = 0.12]; ward, 31% [P = 0.21]). Median LOS was not significantly increased unless unmatched patients were included (8 days, 95% CI = 1.8 to 14 days; P = 0.012). Excess C-ATs were 17 DDDs (95% CI = 15 to 19 DDDs; P < 0.001) per case patient and 19 DDDs (95% CI = 16 to 22 DDDs; P < 0.001) per ICU patient. The sensitivity analysis was confirmatory (for median cost, AU$29,441, 95% CI = AU$5,571 to AU$53,310, P = 0.016; for C-AT, 17 DDDs, 95% CI = 16

  5. Nonsteroidal anti-inflammatory drugs: add an anti-ulcer drug for patients at high risk only. Always limit the dose and duration of treatment with NSAIDs.

    PubMed

    2011-09-01

    In addition to their cardiac, renal, hepatic, cutaneous and neuropsychological adverse effects, nonsteroidal anti-inflammatory drugs (NSAIDs) can have severe effects on the entire gastrointestinal tract, including bleeding, perforation and occlusion. Which anti-ulcer drugs reduce the risk of the severe gastrointestinal adverse effects of NSAIDs, and which patients should receive them? To answer these questions, we conducted a review of the literature, using the standard Prescrire methodology. The main risk factors for severe gastrointestinal adverse effects during NSAID therapy are: a high dose regimen; age over 65 years; a history of gastric or duodenal ulcer or gastrointestinal bleeding; heavy use of both alcohol and tobacco; and concomitant treatment with a corticosteroid, antiplatelet drug, anticoagulant, or selective serotonin reuptake inhibitor (SSRI) antidepressant. Gastrointestinal symptoms and ulceration (on endoscopy) are poor predictors of severe gastrointestinal reactions. A meta-analysis examined randomised placebo-controlled trials of misoprostol in more than 11 000 patients. The results were mainly based on a large trial including about 9000 rheumatoid arthritis patients with an average age of 68 years. Misoprostol (400 microg to 800 microg/day, in 4 doses) prevented about 4 severe gastroduodenal events when 1000 patients over 60 years of age were treated for 6 months. Diarrhoea and other mild gastrointestinal disorders were frequent. There are no randomised trials comparing proton pump inhibitors (PPIs) and histamine H2 receptor antagonists versus misoprostol or versus placebo therapy for the prevention of severe adverse effects associated with NSAIDs. PPIs and H2 antagonists both reduce the incidence of gastric or duodenal ulceration detected by routine endoscopy. A randomised trial compared an H2 antagonist (famotidine) versus a PPI (pantoprazole) in 128 patients with an average age of 69 years who had a very high risk of serious gastrointestinal

  6. Second generation tyrosine kinase inhibitors prevent disease progression in high-risk (high CIP2A) chronic myeloid leukaemia patients.

    PubMed

    Lucas, C M; Harris, R J; Holcroft, A K; Scott, L J; Carmell, N; McDonald, E; Polydoros, F; Clark, R E

    2015-07-01

    High cancerous inhibitor of PP2A (CIP2A) protein levels at diagnosis of chronic myeloid leukaemia (CML) are predictive of disease progression in imatinib-treated patients. It is not known whether this is true in patients treated with second generation tyrosine kinase inhibitors (2G TKI) from diagnosis, and whether 2G TKIs modulate the CIP2A pathway. Here, we show that patients with high diagnostic CIP2A levels who receive a 2G TKI do not progress, unlike those treated with imatinib (P=<0.0001). 2G TKIs induce more potent suppression of CIP2A and c-Myc than imatinib. The transcription factor E2F1 is elevated in high CIP2A patients and following 1 month of in vivo treatment 2G TKIs suppress E2F1 and reduce CIP2A; these effects are not seen with imatinib. Silencing of CIP2A, c-Myc or E2F1 in K562 cells or CML CD34+ cells reactivates PP2A leading to BCR-ABL suppression. CIP2A increases proliferation and this is only reduced by 2G TKIs. Patients with high CIP2A levels should be offered 2G TKI treatment in preference to imatinib. 2G TKIs disrupt the CIP2A/c-Myc/E2F1 positive feedback loop, leading to lower disease progression risk. The data supports the view that CIP2A inhibits PP2Ac, stabilising E2F1, creating a CIP2A/c-Myc/E2F1 positive feedback loop, which imatinib cannot overcome.

  7. A qualitative assessment of psychosocial impact, coping and adjustment in high-risk melanoma patients and caregivers.

    PubMed

    Tan, Jason D; Butow, Phyllis N; Boyle, Frances M; Saw, Robyn P M; O'Reilly, Amanda J

    2014-06-01

    The present study qualitatively assessed the psychosocial impacts experienced by stage III melanoma patients and caregivers throughout the course of the disease, and the coping responses they utilized in an attempt to promote psychosocial adjustment. The purpose of the study was to inform the development of a supportive care strategy for this population. Nineteen stage III melanoma patients and 14 of their caregivers were recruited from the clinical research database of the Melanoma Institute Australia. Data were collected using semistructured telephone interviews and analysed using thematic analysis. Participants reported psychosocial impacts related to diagnosis (shock, panic and devastation), treatment (challenges and unsatisfactory care, pain and limitation, practical impacts, new roles and responsibilities for the caregiver, caregiver inadequacy) and survivorship (ongoing physical problems, watchful waiting, feeling abandoned). They also reported global themes relevant to multiple phases of the disease (emotional distress, disfigurement, injustice, caregiver devaluation). Coping responses were identified related to diagnosis (avoidance), treatment (confidence in the treatment team, taking action) and survivorship (finding a positive meaning, acceptance and moving on) as well as global themes pertaining to multiple disease phases (receiving support, helpful thinking, putting on a brave face, redirecting attention, religion). The current findings support routine screening for the presence of symptoms and psychological distress and appropriate referral when necessary, and for provision of psychosocial interventions to provide information and support to stage III melanoma patients and caregivers. In addition, provision of communication skills training to all health professionals treating melanoma, use of evidence-based strategies for improving patient/caregiver understanding and recall, and routine assessment of patient-reported outcomes to inform clinical

  8. Derivation of Urine Output Thresholds That Identify a Very High Risk of AKI in Patients with Septic Shock

    PubMed Central

    Leedahl, David D.; Schramm, Garrett E.; Dierkhising, Ross A.; Bergstralh, Eric J.; Chawla, Lakhmir S.; Kashani, Kianoush B.

    2014-01-01

    Background and objectives To promote early detection of AKI, recently proposed pretest probability models combine sub–Kidney Disease Improving Global Outcomes (KDIGO) AKI criteria with baseline AKI risk. The primary objective of this study was to determine sub-KDIGO thresholds that identify patients with septic shock at highest risk for AKI. Design, setting, participants, & measurements This was a retrospective analysis of 390 adult patients admitted to the medical intensive care unit (ICU) of a tertiary, academic medical center with septic shock between January 2008 and December 2010. Hourly urine output was collected from the time of septic shock recognition (hour 0) to hour 96, urine catheter removal, or ICU discharge (whichever occurred first). All available serum creatinine (SCr) measurements were collected until hour 96. The AKI pretest probability model was assessed during the first 12 hours of resuscitation and included the initial episode of oliguria, increase from baseline to peak SCr level, and Acute Physiology and Chronic Health Evaluation (APACHE) III score in a multivariable receiver-operator characteristic (ROC) analysis. The primary outcome was the incidence of stage II or III (stage II+) AKI defined by KDIGO criteria. Secondary outcomes included the need for RRT and 28-day mortality. Results Ninety-eight (25%) patients developed stage II+ AKI after septic shock recognition. APACHE III score and increase in SCr level in the first 12 hours were not statistically associated with stage II+ AKI in multivariable ROC analysis. Consecutive oliguria for 3 hours had fair predictive ability for achieving stage II+ AKI criteria (area under ROC curve, 0.73; 95% confidence interval [95% CI], 0.68 to 0.78), and oliguria for 5 hours demonstrated optimal accuracy (82%; 95% CI, 79% to 86%). Conclusions Three to 5 hours of consecutive oliguria in patients with septic shock may provide a valuable measure of AKI risk. Further validation to support this finding is

  9. High Risk of Herpes Zoster among Patients with Advance Acute Kidney Injury--A Population-Based Study.

    PubMed

    Yang, Wei-Shun; Hu, Fu-Chang; Chen, Meng-Kan; Ko, Wen-Je; Chen, Likwang; Wu, Kwan-Dun; Wu, Vin-Cent

    2015-09-03

    The risk for herpes zoster (HZ) in acute kidney injury (AKI) survivors was never explored. We identified 2,387 adults in the Taiwan National Health Insurance Research Database who recovered from dialysis-requiring AKI and matched them with non-recovery and non-AKI patients by propensity score. During a mean follow-up of 2.7 years, the incidences of HZ were 6.9, 8.2 and 4.8 episodes per 1,000 person-years in AKI-non-recovery, AKI-recovery and non-AKI group, respectively. The recovery group was more likely to develop herpes zoster than those without acute kidney injury [incidence-rate ratios 1.71, 95% confidence interval 1.16-2.52; p = 0.007]. Patients without acute kidney injury were less likely to develop herpes zoster than those AKI, recovered from dialysis or not (hazard ratio HR 0.66, 95% CI 0.46-0.95). Dialysis-requiring acute kidney injury poses a long-term risk of herpes zoster after hospital discharge. Even patients who have recovered from dialysis still carry a significantly higher risk of developing herpes zoster.

  10. Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance

    PubMed Central

    2014-01-01

    Background Image-guided radiotherapy (IGRT) facilitates the delivery of a very precise radiation dose. In this study we compare the toxicity and biochemical progression-free survival between patients treated with daily image-guided intensity-modulated radiotherapy (IG-IMRT) and 3D conformal radiotherapy (3DCRT) without daily image guidance for high risk prostate cancer (PCa). Methods A total of 503 high risk PCa patients treated with radiotherapy (RT) and endocrine treatment between 2000 and 2010 were retrospectively reviewed. 115 patients were treated with 3DCRT, and 388 patients were treated with IG-IMRT. 3DCRT patients were treated to 76 Gy and without daily image guidance and with 1–2 cm PTV margins. IG-IMRT patients were treated to 78 Gy based on daily image guidance of fiducial markers, and the PTV margins were 5–7 mm. Furthermore, the dose-volume constraints to both the rectum and bladder were changed with the introduction of IG-IMRT. Results The 2-year actuarial likelihood of developing grade > = 2 GI toxicity following RT was 57.3% in 3DCRT patients and 5.8% in IG-IMRT patients (p < 0.001). For GU toxicity the numbers were 41.8% and 29.7%, respectively (p = 0.011). On multivariate analysis, 3DCRT was associated with a significantly increased risk of developing grade > = 2 GI toxicity compared to IG-IMRT (p < 0.001, HR = 11.59 [CI: 6.67-20.14]). 3DCRT was also associated with an increased risk of developing GU toxicity compared to IG-IMRT. The 3-year actuarial biochemical progression-free survival probability was 86.0% for 3DCRT and 90.3% for IG-IMRT (p = 0.386). On multivariate analysis there was no difference in biochemical progression-free survival between 3DCRT and IG-IMRT. Conclusion The difference in toxicity can be attributed to the combination of the IMRT technique with reduced dose to organs-at-risk, daily image guidance and margin reduction. PMID:24495815

  11. 3-D Storybook: Effects on Surgical Knowledge and Anxiety Among Four- to Six-Year-Old Surgical Patients.

    PubMed

    Macindo, John Rey B; Macabuag, Katherine R; Macadangdang, Carlo Miguel P; Macaranas, Margaux Valerie S; Macarilay, Marianne Jezelle Jem T; Madriñan, Natasha Nikki M; Villarama, Rouena S

    2015-07-01

    Inadequate surgical knowledge potentiates anxiety; however, no methodology simultaneously addresses anxiety and surgical knowledge. Our quasi-experimental study determined the effectiveness of a three-dimensional (3-D) storybook in increasing surgical knowledge and decreasing anxiety among young children scheduled for planned or required major surgeries. We studied 20 randomly assigned participants who received either the 3-D storybook or traditional health teaching. A presurgical knowledge questionnaire and modified Yale Preoperative Anxiety Scale assessed surgical knowledge and anxiety. Data were analyzed with one-way and repeated-measures multivariate analysis of variance. Results showed that both groups had higher knowledge scores (F = 8.94; P = .008) and lower anxiety scores (F = 5.13; P = .036) after the intervention. The children who received information from the 3-D storybook exhibited a significantly higher posttest knowledge score (F = 11.71; P = .003) and lower anxiety score (F = 10.05; P = .005) than the traditionally educated group of children. The 3-D storybook effectively increased surgical knowledge and decreased anxiety and could be used as an alternative method to prepare pediatric surgical patients.

  12. Preoperative intra-aortic counterpulsation in high-risk patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials†.

    PubMed

    Pilarczyk, Kevin; Boening, Andreas; Jakob, Heinz; Langebartels, Georg; Markewitz, Andreas; Haake, Nils; Heringlake, Matthias; Trummer, Georg

    2016-01-01

    In contrast to the results of previous studies, recent randomized controlled trials (RCTs) failed to show a benefit of prophylactic aortic counterpulsation in high-risk patients undergoing cardiac surgery. The present analysis aims to redefine the effects of this treatment modality in the light of this new evidence. MEDLINE, EMBASE, CENTRAL/CCTR, Google Scholar and reference lists of relevant articles were searched for full-text articles of RCTs in English or German. Assessments for eligibility, relevance, study validity and data extraction were performed by two reviewers independently using prespecified criteria. The primary outcome was hospital mortality. A total of nine eligible RCTs with 1171 patients were identified: 577 patients were treated preoperatively with intra-aortic balloon pump (IABP) and 594 patients served as controls. The pooled odds ratio (OR) for hospital mortality (22 hospital deaths in the intervention arm, 54 in the control group) was 0.381 (95% CI 0.230-0.629; P < 0.001). The pooled analyses of five RCTs including only patients undergoing isolated on-pump coronary artery bypass grafting (n[IABP] = 348, n[control] = 347) also showed a statistically significant improvement in mortality for preoperative IABP implantation (fixed-effects model: OR 0.267, 95% CI 0.129-0.552, P < 0.001). The pooled OR for hospital mortality from two randomized off-pump trials was 0.556 (fixed-effects model, 95% CI 0.207-1.493, P = 0.226). Preoperative aortic counterpulsation was associated with a significant reduction in low cardiac output syndrome (LCOS) in the total population (fixed-effects model: OR 0.330, 95% CI 0.214-0.508, P < 0.001) as well as in the subgroup of CAGB patients (fixed-effects model: OR 0.113, 95% CI 0.056-0.226, P < 0.001), whereas there was no benefit in the off-pump population (fixed-effects model: OR 0.555, 95% CI 0.209-1.474, P = 0.238). Preoperative IABP implantation was associated with a reduction of intensive care unit (ICU) stay in

  13. Evidence of anaerobic metabolism during low-level exercise testing in high-risk postmyocardial infarction patients.

    PubMed

    Hossack, K F; Wolfel, E

    1988-03-01

    Low-level exercise testing was performed on 31 patients 7.4 +/- 2.7 days following an acute myocardial infarction. Measurements of oxygen consumption (VO2) and arterial serum lactate were made at rest and during exercise in these patients and 15 normal subjects. The patients were subdivided into finishers (F) and nonfinishers (NF) of the low-level protocol. The NF group had 2.5 +/- 6 stenosed vessels and an ejection fraction of 44 +/- 11% compared to F subjects, who had 1.4 +/- 1 vessels stenosed (p less than .001) and an ejection fraction of 54 +/- 14% (p less than .05). Finishers had significantly higher VO2 than the nonfinishers (14.5 +/- 2.5 ml/kg/min vs. 11.2 +/- 3.5 ml/kg/min p less than .01). At the end of exercise serum lactate level was 1.18 +/- .59 mM in normals, 1.43 +/- .52 mM in finishers, and 2.15 +/- .9 mM in nonfinishers. The change in serum lactate from rest to end exercise divided by the change in VO2 from rest to end exercise was .039 +/- .038 mM/ml kg per min in normals, .075 +/- .045 mM/ml kg per min in finishers (p less than .03 vs. normal), and .210 +/- .189 mM/ml kg per min for nonfinishers (p less than .001 vs. normal). These results indicate that nonfinishers produce more lactate and use less oxygen during low-level exercise, suggesting that working muscles are deriving energy by anaerobic metabolism.(ABSTRACT TRUNCATED AT 250 WORDS)

  14. PCSK9 inhibitors and their role in high-risk patients in reducing LDL cholesterol levels: evolocumab.

    PubMed

    Dahagam, Chanukya; Goud, Aditya; Abdelqader, Abdelhai; Hendrani, Aditya; Feinstein, Matthew J; Qamar, Arman; Joshi, Parag H; Swiger, Kristopher J; Byrne, Kathleen; Quispe, Renato; Jones, Steven R; Blumenthal, Roger S; Martin, Seth S

    2016-03-01

    Patients with familial hypercholesterolemia or statin intolerance are especially challenging to manage since LDL cholesterol levels often remain considerably elevated despite clinicians' best efforts. With statins regarded as first-line pharmacologic therapy by the current American College of Cardiology/American Heart Association guidelines to reduce LDL cholesterol and cardiovascular risk, there is now a critical need to determine when other agents will play a role beyond maximally tolerated statin therapy and lifestyle changes. In this review, we take a closer look at evolocumab (Repatha(®)), one of the new injectable human monoclonal antibodies to PCSK9 and its efficacy and safety properties from the results of various trials.

  15. PCSK9 inhibitors and their role in high-risk patients in reducing LDL cholesterol levels: evolocumab.

    PubMed

    Dahagam, Chanukya; Goud, Aditya; Abdelqader, Abdelhai; Hendrani, Aditya; Feinstein, Matthew J; Qamar, Arman; Joshi, Parag H; Swiger, Kristopher J; Byrne, Kathleen; Quispe, Renato; Jones, Steven R; Blumenthal, Roger S; Martin, Seth S

    2016-03-01

    Patients with familial hypercholesterolemia or statin intolerance are especially challenging to manage since LDL cholesterol levels often remain considerably elevated despite clinicians' best efforts. With statins regarded as first-line pharmacologic therapy by the current American College of Cardiology/American Heart Association guidelines to reduce LDL cholesterol and cardiovascular risk, there is now a critical need to determine when other agents will play a role beyond maximally tolerated statin therapy and lifestyle changes. In this review, we take a closer look at evolocumab (Repatha(®)), one of the new injectable human monoclonal antibodies to PCSK9 and its efficacy and safety properties from the results of various trials. PMID:26911578

  16. Fecal bile acid excretion and messenger RNA expression levels of ileal transporters in high risk gallstone patients

    PubMed Central

    2009-01-01

    Background Cholesterol gallstone disease (GS) is highly prevalent among Hispanics and American Indians. In GS, the pool of bile acids (BA) is decreased, suggesting that BA absorption is impaired. In Caucasian GS patients, mRNA levels for ileal BA transporters are decreased. We aimed to determine fecal BA excretion rates, mRNA levels for ileal BA transporter genes and of regulatory genes of BA synthesis in Hispanic GS patients. Results Excretion of fecal BA was measured in seven GS females and in ten GS-free individuals, all with a body mass index < 29. Participants ingested the stool marker Cr2O3 (300 mg/day) for 10 days, and fecal specimens were collected on the last 3 days. Chromium was measured by a colorimetric method, and BA was quantitated by gas chromatography/mass spectroscopy. Intake of calories, nutrients, fiber and cholesterol were similar in the GS and GS-free subjects. Mean BA excretion levels were 520 ± 80 mg/day for the GS-free group, and 461 ± 105 mg/day for the GS group. Messenger RNA expression levels were determined by RT-PCR on biopsy samples obtained from ileum during diagnostic colonoscopy (14 GS-free controls and 16 GS patients) and from liver during surgery performed at 8 and 10 AM (12 GS and 10 GS-free patients operated on for gastrointestinal malignancies), all with a body mass index < 29. Messenger RNA level of the BA transporter genes for ileal lipid binding protein, multidrug resistance-associated protein 3, organic solute transporter alpha, and organic solute transporter beta were similar in GS and GS-free subjects. Messenger RNA level of Cyp27A1, encoding the enzyme 27α-hydroxylase, the short heterodimer partner and farnesoid X receptor remained unchanged, whereas the mRNA level of Cyp7A1, the rate limiting step of BA synthesis, was increased more than 400% (p < 0.01) in the liver of GS compared to GS-free subjects. Conclusion Hispanics with GS have fecal BA excretion rates and mRNA levels of genes for ileal BA transporters that

  17. U.S. survey of surgical capabilities and experience with surgical procedures in patients with congenital haemophilia with inhibitors.

    PubMed

    Shapiro, A; Cooper, D L

    2012-05-01

    General guidelines exist for the use of recombinant activated factor VII (rFVIIa) to maintain haemostasis during surgery in congenital haemophilia A and B patients with high responding inhibitors (CHwI). Individual surgical plans are required and based upon historical therapy response, adverse events and anticipated procedure. Surgical interventions are feasible, yet it remains unclear how many US hemophilia treatment centres (HTCs) perform procedures in this fragile population. To better understand the US HTC surgical experience in CHwI patients and the number/types of procedures performed, a 21-question survey was sent to 133 US HTCs, with follow-up for response clarification and to non-responders. 98/133 HTCs (74%) responded, with 87 currently treating CHwI patients. In the last decade, 76/85 HTCs performed 994 surgeries on CHwI patients. Sites were experienced in the following procedures: central line insertion/removal (73 HTCs), dental (58), orthopaedic (52), abdominal (23), cardiovascular (14) and otolaryngologic (11). Experience with orthopaedic surgeries included synovectomies - arthroscopic (23 HTCs), radioisotopic (22), and open (7); joint replacement (18); fracture repair (14); and arthrodesis (8). Treatment modalities included rFVIIa bolus (83 HTCs) or continuous infusions (9), plasma-derived activated prothrombin complex concentrate (pd-aPCC) (55), antifibrinolytics (51), topical haemostatic agents (29), factor VIII (16) and fibrin sealants (14). Protocols for bypassing agents were used by 31/92 (33%) HTCs. Most US HTCs surveyed care for CHwI patients (74%) and have experience in minor surgery; fewer HTCs reported complex orthopaedic surgical experience. Identification of best practices and surgical barriers is required to guide future initiatives to support these patients.

  18. The safety and effectiveness profile of daily teriparatide in a prospective observational study in Japanese patients with osteoporosis at high risk for fracture: interim report.

    PubMed

    Yamamoto, Takanori; Taketsuna, Masanori; Guo, Xiaoyan; Sato, Masayo; Sowa, Hideaki

    2014-11-01

    This postmarketing surveillance study assessed the safety and effectiveness of daily teriparatide treatment in patients with osteoporosis in a Japanese clinical setting. In this prospective, multicenter, observational study, patients with osteoporosis at high risk for fracture received subcutaneous injections of teriparatide (20 μg/day) for a maximum of 24 months. For this interim report, data from 1,671 patients were eligible for analysis at the cutoff date. The mean age was 75.3 years; 93% of patients (1,552/1,671 patients) were women. There were 117 adverse drug reactions (ADRs) reported in 101 of 1,671 patients (6.04%); the most common reported ADRs were nausea, dizziness, headache, and palpitations. No clinically significant safety issues were identified, although 5 serious ADRs were reported in 4/1,671 (0.24 %) patients. At 12 months, 71.9% of patients remained on teriparatide treatment. From 1 month, there were rapid increases in the biomarkers of bone formation P1NP and, to a lesser extent, BAP. In contrast, increases in the biomarkers of bone resorption, serum NTX, urinary NTX, and TRACP5b, were smaller. After 12 months of treatment, there was an increase in bone mineral density at the lumbar spine, femoral neck, and total hip, and a decrease in the Visual Analog Scale score for back pain. The incidence of new vertebral and nonvertebral fractures was 1.21% and 3.18%, respectively. In conclusion, the favorable safety profile and effectiveness of teriparatide observed in this population of Japanese patients with osteoporosis were accompanied by relatively high persistence with treatment, which is a key factor in the success of osteoporosis treatment. PMID:24368586

  19. The link between heightened thrombogenicity and inflammation: pre-procedure characterization of the patient at high risk for recurrent events after stenting.

    PubMed

    Gurbel, Paul A; Bliden, Kevin P; Kreutz, Rolf P; Dichiara, Joseph; Antonino, Mark J; Tantry, Udaya S

    2009-03-01

    Heightened thrombogenicity and biomarker evidence of inflammation have been independently associated with ischemic risk in patients with coronary artery disease. However, a study examining their relation has not been reported. We analysed the relation between measurements of thrombogenicity and biomarkers in patients undergoing stenting and followed for 24 months recurrent ischemic events. In 84 consecutive patients undergoing stenting, pre-procedure thrombogenicity was measured by thrombelastography (TEG) and conventional aggregometry whereas biomarkers were measured by fluorokine multi-analyte profiling. Patients were stratified into quartiles based on platelet-fibrin clot strength (MA) by TEG and correlated with ischemic event occurrence. Patients in the highest MA quartile (high MA) had greater ADP-induced platelet aggregation (57.5 +/- 15.0% vs. 47.9 +/- 17.6%, p = 0.05), C-reactive protein (25.0 +/- 5.6 vs. 4.2 +/- 1.0 microg/mL, p = 0.006) and interleukin-8 (23.8 +/- 2.8 vs. 14.1 +/- 1.6 pg/mL, p < 0.001) than patients within the lowest MA quartile (low MA). Epidermal growth factor (7.7 +/- 2.2 vs. 1.2 +/- 0.3 pg/mL, p = 0.006) and vascular endothelial growth factor (296 +/- 35 vs. 190 +/- 10 pg/mL, p = 0.05) were also higher. Patients with high-MA had an ischemic event more often than patients with low-MA (48% vs. 13%, p = 0.02). Our study suggests that a link is present between inflammation and heightened thrombogenicity measured pre-procedurally in the patient at high risk for recurrent ischemic events after stenting. Larger studies are required to solidify these observations and their clinical relevance.

  20. Big data in health care: using analytics to identify and manage high-risk and high-cost patients.

    PubMed

    Bates, David W; Saria, Suchi; Ohno-Machado, Lucila; Shah, Anand; Escobar, Gabriel

    2014-07-01

    The US health care system is rapidly adopting electronic health records, which will dramatically increase the quantity of clinical data that are available electronically. Simultaneously, rapid progress has been made in clinical analytics--techniques for analyzing large quantities of data and gleaning new insights from that analysis--which is part of what is known as big data. As a result, there are unprecedented opportunities to use big data to reduce the costs of health care in the United States. We present six use cases--that is, key examples--where some of the clearest opportunities exist to reduce costs through the use of big data: high-cost patients, readmissions, triage, decompensation (when a patient's condition worsens), adverse events, and treatment optimization for diseases affecting multiple organ systems. We discuss the types of insights that are likely to emerge from clinical analytics, the types of data needed to obtain such insights, and the infrastructure--analytics, algorithms, registries, assessment scores, monitoring devices, and so forth--that organizations will need to perform the necessary analyses and to implement changes that will improve care while reducing costs. Our findings have policy implications for regulatory oversight, ways to address privacy concerns, and the support of research on analytics. PMID:25006137

  1. Big data in health care: using analytics to identify and manage high-risk and high-cost patients.

    PubMed

    Bates, David W; Saria, Suchi; Ohno-Machado, Lucila; Shah, Anand; Escobar, Gabriel

    2014-07-01

    The US health care system is rapidly adopting electronic health records, which will dramatically increase the quantity of clinical data that are available electronically. Simultaneously, rapid progress has been made in clinical analytics--techniques for analyzing large quantities of data and gleaning new insights from that analysis--which is part of what is known as big data. As a result, there are unprecedented opportunities to use big data to reduce the costs of health care in the United States. We present six use cases--that is, key examples--where some of the clearest opportunities exist to reduce costs through the use of big data: high-cost patients, readmissions, triage, decompensation (when a patient's condition worsens), adverse events, and treatment optimization for diseases affecting multiple organ systems. We discuss the types of insights that are likely to emerge from clinical analytics, the types of data needed to obtain such insights, and the infrastructure--analytics, algorithms, registries, assessment scores, monitoring devices, and so forth--that organizations will need to perform the necessary analyses and to implement changes that will improve care while reducing costs. Our findings have policy implications for regulatory oversight, ways to address privacy concerns, and the support of research on analytics.

  2. Surgical innovation-enhanced quality and the processes that assure patient/provider safety: A surgical conundrum.

    PubMed

    Bruny, Jennifer; Ziegler, Moritz

    2015-12-01

    Innovation is a crucial part of surgical history that has led to enhancements in the quality of surgical care. This comprises both changes which are incremental and those which are frankly disruptive in nature. There are situations where innovation is absolutely required in order to achieve quality improvement or process improvement. Alternatively, there are innovations that do not necessarily arise from some need, but simply are a new idea that might be better. All change must assure a significant commitment to patient safety and beneficence. Innovation would ideally enhance patient care quality and disease outcomes, as well stimulate and facilitate further innovation. The tensions between innovative advancement and patient safety, risk and reward, and demonstrated effectiveness versus speculative added value have created a contemporary "surgical conundrum" that must be resolved by a delicate balance assuring optimal patient/provider outcomes. This article will explore this delicate balance and the rules that govern it. Recommendations are made to facilitate surgical innovation through clinical research. In addition, we propose options that investigators and institutions may use to address competing priorities.

  3. Surgical complications associated with primary closure in patients with diabetic foot osteomyelitis

    PubMed Central

    García-Morales, Esther; Lázaro-Martínez, José Luis; Aragón-Sánchez, Javier; Cecilia-Matilla, Almudena; García-Álvarez, Yolanda; Beneit-Montesinos, Juan Vicente

    2012-01-01

    Background The aim of this study was to determine the incidence of complications associated with primary closure in surgical procedures performed for diabetic foot osteomyelitis compared to those healed by secondary intention. In addition, further evaluation of the surgical digital debridement for osteomyelitis with primary closure as an alternative to patients with digital amputation was also examined in our study. Methods Comparative study that included 46 patients with diabetic foot ulcerations. Surgical debridement of the infected bone was performed on all patients. Depending on the surgical technique used, primary surgical closure was performed on 34 patients (73.9%, Group 1) while the rest of the 12 patients were allowed to heal by secondary intention (26.1%, Group 2). During surgical intervention, bone samples were collected for both microbiological and histopathological analyses. Post-surgical complications were recorded in both groups during the recovery period. Results The average healing time was 9.9±SD 8.4 weeks in Group 1 and 19.1±SD 16.9 weeks in Group 2 (p=0.008). The percentage of complications was 61.8% in Group 1 and 58.3% in Group 2 (p=0.834). In all patients with digital ulcerations that were necessary for an amputation, a primary surgical closure was performed with successful outcomes. Discussion Primary surgical closure was not associated with a greater number of complications. Patients who received primary surgical closure had faster healing rates and experienced a lower percentage of exudation (p=0.05), edema (p<0.001) and reinfection, factors that determine the delay in wound healing and affect the prognosis of the surgical outcome. Further research with a greater number of patients is required to better define the cases for which primary surgical closure may be indicated at different levels of the diabetic foot. PMID:23050062

  4. [Surgical intervention in severe acute pancreatitis--retrospective study of 79 patients of the RWTH Aachen Surgical Clinic].

    PubMed

    Lohmann, A; Kasperk, R; Schumpelick, V

    1998-01-01

    This is a report on the surgical intervention in 79 patients with acute pancreatitis, who were operated in the Department of Surgery of the University Clinic RWTH Aachen in the period from 1986 to 1993. The main objective was the stratification of pancreatitis according to the Ranson-Score, the analysis of the surgical treatment and the timing of operation depending on the clinical condition. The average Ranson-score was 3.3 (median 3). 56 patients had necroses, which were removed because of the deteriorating clinical condition. In these cases the average Ranson-score was 4.2 (median 4). Seven patients (8.9% of the total number and 12.5% of the patients with necroses of the pancreas) died. This small number is the result of a severity-adapted management in a modern intensive care-unit and the good cooperation with the Department of Internal Medicine.

  5. Factors that are associated with injury to the inferior alveolar nerve in high-risk patients after removal of third molars.

    PubMed

    Selvi, Firat; Dodson, Thomas B; Nattestad, Anders; Robertson, Kevin; Tolstunov, Len

    2013-12-01

    Our aim was to answer the question: "Among patients at high risk of injury to the inferior alveolar nerve (IAN) after removal of 3rd molars, what factors are associated with postoperative neurosensory deficits?" We organized a retrospective, two-center study and enrolled a group of subjects who were at increased risk of injury to the IAN after removal of 3rd molars because radiographic findings indicated a risk on panoramic radiography that was high enough to warrant preoperative computed tomography (CT). The primary outcome variable was postoperative injury to the IAN. We used descriptive, bivariate, and multivariate analyses to assess the significance of differences, and probabilities of less than 0.05 were accepted as significant. We studied 149 subjects who had 235 3rd molars removed. Their mean (SD) age was 31 (11) years and 25/235 (11%) of 3rd molars were associated with injury to the IAN. In the multiple logistic regression model, increasing age (odds ratio (OR) 1.05, 95% CI 1.01-1.1, p=0.04), female sex (OR 5.3, 95% CI 1.6-16.9, p=0.005), and the size (mm) of the cortical perforation in the inferior alveolar canal (IAC) viewed on the coronal CT cut (OR 1.3; 95% CI 1.0-1.6, p=0.03) were associated with an increased risk of postoperative injury to the IAN. Age, sex, and the size of the perforation in the IAC on the coronal CT were associated with an increased risk of injury to the IAN. These findings may help to guide recommendations for treatment of patients at high risk of injury to the IAN during removal of 3rd molars. PMID:24012054

  6. Prevention strategies differentially modulate the impact of cytomegalovirus replication on CD8(+) T-cell differentiation in high-risk solid organ transplant patients.

    PubMed

    Cantisán, Sara; Páez-Vega, Aurora; Pérez-Romero, Pilar; Montejo, Miguel; Cordero, Elisa; Gracia-Ahufinger, Irene; Martín-Gandul, Cecilia; Maruri, Naroa; Aguado, Rocío; Solana, Rafael; Torre-Cisneros, Julián

    2016-08-01

    The present study aimed to determine whether antiviral prevention strategies against cytomegalovirus (CMV) infection used in high-risk D+R- solid organ transplanted patients can modulate the impact of CMV replication on CD8(+) T-cell differentiation. The different CD8(+) T-cell subpopulations were measured at a single point when at least one year had elapsed since transplantation. A total of 68 D+R- patients were included, of which 33 underwent pre-emptive therapy and 35 received prophylaxis. Multivariate analysis showed that CMV replication was associated with the expansion of CD28־ EMRA CD8(+) T cells in patients managed pre-emptively but not in patients under prophylaxis (21.4% vs. 3.6%). This finding is likely related to the higher frequency of CMV recurrence observed in patients under pre-emptive therapy compared to those under prophylaxis (75% vs. 14.3%; p < 0.001). In fact, multivariate analysis showed that having more than one replication episode was associated with a 17.2% increase (p = 0.001) in the percentage of CD28־ EMRA CD8(+) T cells compared to "no episode" and with a 10.9% increase with respect to "single episodes" (p = 0.025). Additionally, patients with IFNγ response to CMV (QuantiFERON-CMV Reactive) had a higher percentage of late-differentiated CD8(+) T cells than patients lacking this response. In summary, recurrent CMV replication in D+R- patients under pre-emptive therapy was associated with the expansion of CD28־ EMRA CD8(+) T cells, which might have a short-term beneficial effect related to the high functionality of this T-cell subpopulation. Nevertheless, we cannot rule out that this accumulation might have a long-term detrimental effect related to immunosenescence and inflammation.

  7. Patients with first-episode, drug-naive schizophrenia and subjects at ultra-high risk of psychosis shared increased cerebellar-default mode network connectivity at rest

    PubMed Central

    Wang, Houliang; Guo, Wenbin; Liu, Feng; Wang, Guodong; Lyu, Hailong; Wu, Renrong; Chen, Jindong; Wang, Shuai; Li, Lehua; Zhao, Jingping

    2016-01-01

    Increased cerebellar-default mode network (DMN) connectivity has been observed in first-episode, drug-naive patients with schizophrenia. However, it remains unclear whether increased cerebellar-DMN connectivity starts earlier than disease onset. Thirty-four ultra-high risk (UHR) subjects, 31 first-episode, drug-naive patients with schizophrenia and 37 healthy controls were enrolled for a resting-state scan. The imaging data were analyzed using the seed-based functional connectivity (FC) method. Compared with the controls, UHR subjects and patients with schizophrenia shared increased connectivity between the right Crus I and bilateral posterior cingulate cortex/precuneus and between Lobule IX and the left superior medial prefrontal cortex. There are positive correlations between the right Crus I-bilateral precuneus connectivity and clinical variables (Structured Interview for Prodromal Syndromes/Positive and Negative Symptom Scale negative symptoms/total scores) in the UHR subjects. Increased cerebellar-DMN connectivity shared by the UHR subjects and the patients not only highlights the importance of the DMN in the pathophysiology of psychosis but also may be a trait alteration for psychosis. PMID:27188233

  8. Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204.

    PubMed

    Hojo, Takashi; Masuda, Norikazu; Mizutani, Tomonori; Shibata, Taro; Kinoshita, Takayuki; Tamura, Kenji; Hara, Fumikata; Fujisawa, Tomomi; Inoue, Kenichi; Saji, Shigehira; Nakamura, Kenichi; Fukuda, Haruhiko; Iwata, Hiroji

    2015-10-01

    This Phase III trial aims to determine the superiority of intensive follow-up to standard follow-up in terms of overall survival in high-risk breast cancer patients, who are expected to have recurrence rates of over 30% within 5 years after surgery. Eligible patients are randomized either to the intensive follow-up group or to the standard follow-up group; the former will undergo physical examination, bone scintigraphy, chest computed tomography, abdominal computed tomography, brain magnetic resonance imaging/computed tomography and frequent tumor marker evaluations, whereas the latter will undergo physical examination at the same frequency and tumor markers will be evaluated once a year. Mammography once a year is planned for both groups. The primary endpoint is overall survival. Patient accrual was started in November 2013. A total of 1700 patients will be enrolled for 3 years and followed up for 7 years after closure of accrual. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000012429.

  9. Antiseptic effect of a novel alcohol-free mouthwash: a convenient prophylactic alternative for high-risk patients.

    PubMed

    Bahna, Paul; Hanna, Hend A; Dvorak, Tanya; Vaporciyan, Ara; Chambers, Mark; Raad, Issam

    2007-02-01

    We developed an efficacious and non-irritant mouthwash that is alcohol-free and that has a low concentration of chlorhexidine, in order to be used for preventing oral cavity infections in immunocompromised and cancer patients. The novel mouthwash solution was tested for its antimicrobial efficacy against both free floating (planktonic) and the biofilm forms of Candida albicans. The solution was also tested against Klebsiella pneumoniae, Pseudomonas aeruginosa, and methicillin-resistant Staphylococcus aureus (MRSA), using a modification of a previously published method. The activity of the novel mouthwash was also compared with that of three commercially available mouthwashes. The experimental mouthwash showed efficacy against C. albicans, both in free-floating form and in biofilm. With higher concentration of chlorhexidine, the solution was also efficacious in inhibiting the growth of K. pneumoniae, P. aeruginosa, and MRSA. The antiseptic activity of the alcohol-free mouthwash against other bacterial organisms and C. albicans was comparable to other commercially available alcohol-based mouthwash solutions. A novel alcohol-free mouthwash solution, that has low concentration of chlorhexidine, showed antiseptic effect against planktonic and biofilm forms of C. albicans and against K. pneumoniae, P. aeruginosa, and MRSA.

  10. Predictive Score Card in Lumbar Disc Herniation: Is It Reflective of Patient Surgical Success after Discectomy?

    PubMed

    Azimi, Parisa; Benzel, Edward C; Montazeri, Ali

    2016-01-01

    Does the Finneson-Cooper score reflect the true value of predicting surgical success before discectomy? The aim of this study was to identify reliable predictors for surgical success two year after surgery for patients with LDH. Prospective analysis of 154 patients with LDH who underwent single-level lumbar discectomy was performed. Pre- and post-surgical success was assessed by the Oswestry Disability Index (ODI) over a 2-year period. The Finneson-Cooper score also was used for evaluation of the clinical results. Using the ODI, surgical success was defined as a 30% (or more) improvement on the ODI score from the baseline. The ODI was considered the gold standard in this study. Finally, the sensitivity, specificity, and positive and negative predictive power of the Finneson-Cooper score in predicting surgical success were calculated. The mean age of the patients was 49.6 (SD = 9.3) years and 47.4% were male. Significant improvement from the pre- to post-operative ODI scores was observed (P < 0.001). Post-surgical success was 76.0% (n = 117). The patients' rating on surgical success assessments by the ODI discriminated well between sub-groups of patients who differed with respect to the Finneson-Cooper score. Regarding patients' surgical success, the sensitivity, specificity, and accuracy of the Finneson-Cooper ratings correlated with success rate. The findings indicated that the Finneson-Cooper score was reflective of surgical success before discectomy.

  11. Predictive Score Card in Lumbar Disc Herniation: Is It Reflective of Patient Surgical Success after Discectomy?

    PubMed

    Azimi, Parisa; Benzel, Edward C; Montazeri, Ali

    2016-01-01

    Does the Finneson-Cooper score reflect the true value of predicting surgical success before discectomy? The aim of this study was to identify reliable predictors for surgical success two year after surgery for patients with LDH. Prospective analysis of 154 patients with LDH who underwent single-level lumbar discectomy was performed. Pre- and post-surgical success was assessed by the Oswestry Disability Index (ODI) over a 2-year period. The Finneson-Cooper score also was used for evaluation of the clinical results. Using the ODI, surgical success was defined as a 30% (or more) improvement on the ODI score from the baseline. The ODI was considered the gold standard in this study. Finally, the sensitivity, specificity, and positive and negative predictive power of the Finneson-Cooper score in predicting surgical success were calculated. The mean age of the patients was 49.6 (SD = 9.3) years and 47.4% were male. Significant improvement from the pre- to post-operative ODI scores was observed (P < 0.001). Post-surgical success was 76.0% (n = 117). The patients' rating on surgical success assessments by the ODI discriminated well between sub-groups of patients who differed with respect to the Finneson-Cooper score. Regarding patients' surgical success, the sensitivity, specificity, and accuracy of the Finneson-Cooper ratings correlated with success rate. The findings indicated that the Finneson-Cooper score was reflective of surgical success before discectomy. PMID:27100287

  12. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial

    PubMed Central

    Derdeyn, Colin P; Chimowitz, Marc I; Lynn, Michael J; Fiorella, David; Turan, Tanya N; Janis, L Scott; Montgomery, Jean; Nizam, Azhar; Lane, Bethany F; Lutsep, Helmi L; Barnwell, Stanley L; Waters, Michael F; Hoh, Brian L; Hourihane, J Maurice; Levy, Elad I; Alexandrov, Andrei V; Harrigan, Mark R; Chiu, David; Klucznik, Richard P; Clark, Joni M; McDougall, Cameron G; Johnson, Mark D; Pride, G Lee; Lynch, John R; Zaidat, Osama O; Rumboldt, Zoran; Cloft, Harry J

    2014-01-01

    13·8%; p=0·0428), 6·5% at year 2 (−0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 [26%] of 224 patients vs 42 [19%] of 227 patients; p=0·0468) and major haemorrhage (29 [13%] of 224 patients vs 10 [4%] of 227 patients; p=0·0009). Interpretation The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up. Our findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis. PMID:24168957

  13. Daily Co-Occurrence of Alcohol Use and High-Risk Sexual Behavior among Heterosexual, Heavy Drinking Emergency Department Patients

    PubMed Central

    Wray, Tyler B.; Celio, Mark A.; Kahler, Christopher W.; Barnett, Nancy P.; Mastroleo, Nadine R.; Operario, Don; Monti, Peter M.

    2015-01-01

    Background Global association and experimental studies suggest that alcohol use may increase sexual behavior that poses risk for exposure to sexually-transmitted infections (STI) among heterosexual men and women. However, results from longitudinal and daily recall studies exploring the co-occurrence of alcohol use with various sexual risk outcomes in more naturalistic contexts have been mixed, and the bulk of this research has focused on college students. Methods The current study enrolled heavy-drinking emergency department (ED) patients and used a cross-sectional, 30-day Timeline Followback (TLFB) method to examine the daily co-occurrence between alcohol use and three sexual behavior outcomes: Any sex, unprotected intercourse (UI), and UI with casual partners (vs. protected intercourse [PI] with casual partners, or UI/PI with steady partners). Results Results indicated that increasing levels of alcohol use on a given day increased the odds of engaging in any sexual activity and that heavy drinking (but not very heavy drinking) on a given day was associated with an increased odds of engaging in UI with either steady or casual partners. However, day-level alcohol use was not associated with an increased odds of UI with casual partners. Conclusions These findings suggest that alcohol may play an important role in increasing risk for HIV/STIs among heterosexuals, and support the continued need to target heavy drinking in sex risk reduction interventions. However, our results also suggest that alcohol may not universally result in unprotected sex with casual partners, a behavior posing perhaps the highest risk for HIV/STI transmission. PMID:25962789

  14. Meta-Analysis and Cost Comparison of Empirical versus Pre-Emptive Antifungal Strategies in Hematologic Malignancy Patients with High-Risk Febrile Neutropenia

    PubMed Central

    Kim, Jane; Marty, Francisco M.; Schwarzinger, Michaël

    2015-01-01

    Background Invasive fungal disease (IFD) causes significant morbidity and mortality in hematologic malignancy patients with high-risk febrile neutropenia (FN). These patients therefore often receive empirical antifungal therapy. Diagnostic test-guided pre-emptive antifungal therapy has been evaluated as an alternative treatment strategy in these patients. Methods We conducted an electronic search for literature comparing empirical versus pre-emptive antifungal strategies in FN among adult hematologic malignancy patients. We systematically reviewed 9 studies, including randomized-controlled trials, cohort studies, and feasibility studies. Random and fixed-effect models were used to generate pooled relative risk estimates of IFD detection, IFD-related mortality, overall mortality, and rates and duration of antifungal therapy. Heterogeneity was measured via Cochran’s Q test, I2 statistic, and between study τ2. Incorporating these parameters and direct costs of drugs and diagnostic testing, we constructed a comparative costing model for the two strategies. We conducted probabilistic sensitivity analysis on pooled estimates and one-way sensitivity analyses on other key parameters with uncertain estimates. Results Nine published studies met inclusion criteria. Compared to empirical antifungal therapy, pre-emptive strategies were associated with significantly lower antifungal exposure (RR 0.48, 95% CI 0.27–0.85) and duration without an increase in IFD-related mortality (RR 0.82, 95% CI 0.36–1.87) or overall mortality (RR 0.95, 95% CI 0.46–1.99). The pre-emptive strategy cost $324 less (95% credible interval -$291.88 to $418.65 pre-emptive compared to empirical) than the empirical approach per FN episode. However, the cost difference was influenced by relatively small changes in costs of antifungal therapy and diagnostic testing. Conclusions Compared to empirical antifungal therapy, pre-emptive antifungal therapy in patients with high-risk FN may decrease

  15. Duration of eptifibatide infusion after percutaneous coronary intervention and outcomes among high-risk patients with non-ST-segment elevation acute coronary syndrome: insights from EARLY ACS

    PubMed Central

    Hess, Connie N; Schulte, Phillip J; Steg, Philippe Gabriel; Dalby, Anthony J; Schweiger, Marc J; Lewis, Basil S; Armstrong, Paul W; Califf, Robert M; van de Werf, Frans; Harrington, Robert A

    2013-01-01

    Background and Objectives: Eptifibatide is indicated during percutaneous coronary intervention (PCI) with continuation for 18–24 hours post procedure but is associated with bleeding. We examined the efficacy and safety of shorter post-PCI eptifibatide infusions in high-risk non-ST-segment elevation acute coronary syndrome (NSTE ACS) patients. Methods: EARLY ACS patients treated with PCI and eptifibatide were grouped by post-procedure infusion duration: <10, 10–13, 13–17, and 17–25 (per protocol) hours. Adjusted estimated event rates for 96-hour death/myocardial infarction (MI)/recurrent ischaemia requiring urgent revascularization (RIUR), 30-day death/MI, post-PCI packed red blood cell (PRBC) transfusion, and GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) moderate/severe bleeding were obtained using inverse-propensity weighting to account for informative censoring of infusions. Results: Among 3271 eptifibatide-treated PCI patients, there were 66 96-hour death/MI/RIUR events, 94 30-day death/MI events, 127 PRBC transfusions, and 115 GUSTO moderate/severe bleeds. Compared with per protocol, patients receiving post-PCI infusions <10 hours had similar adjusted estimated rates of 96-hour death/MI/RIUR (absolute difference 0.021 higher; 0.040 vs. 0.019, 95% CI −0.023 to 0.064; p=0.35) and 30-day death/MI (0.020 higher; 0.046 vs. 0.026, 95% CI −0.021 to 0.062; p=0.34). There were also no differences in ischaemic outcomes between infusions of 10–17 hours and per-protocol infusions. Adjusted estimated rates of PRBC transfusion were higher for the <10-hour infusion group compared with per protocol (0.048 higher; 0.079 vs. 0.031, 95% CI 0.005 to 0.091, p=0.03) but were similar for other groups. Adjusted GUSTO moderate/severe bleeding rates were similar to per-protocol rates for all groups. Conclusions: In high-risk NSTE ACS patients, post-PCI eptifibatide infusions <18 hours were not associated with

  16. Phase II study of tosedostat with cytarabine or decitabine in newly diagnosed older patients with acute myeloid leukaemia or high-risk MDS.

    PubMed

    Mawad, Raya; Becker, Pamela S; Hendrie, Paul; Scott, Bart; Wood, Brent L; Dean, Carol; Sandhu, Vicky; Deeg, Hans Joachim; Walter, Roland; Wang, Lixia; Myint, Han; Singer, Jack W; Estey, Elihu; Pagel, John M

    2016-01-01

    Tosedostat, an oral aminopeptidase inhibitor, has synergy with cytarabine and hypomethylating agents. We performed a Phase II trial to determine rates of complete remission (CR) and survival using tosedostat with cytarabine or decitabine in older patients with untreated acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (MDS). Thirty-four patients ≥60 years old (median age 70 years; range, 60-83) were randomized to receive tosedostat (120 mg on days 1-21 or 180 mg continuously) with 5 d of either cytarabine (1 g/m2 /d) or decitabine (20 mg/m2 /d) every 35 d. Twenty-nine patients (85%) had AML, including 15 (44%) with secondary AML/MDS, and 5 (15%) had MDS-refractory anaemia with excess blasts type 2. The CR/CR with incomplete count recovery (CRi) rate was 53% [9 in each arm; 14 CR (41%) and 4 CRi (12%)], attained in 6 of 14 patients with adverse cytogenetics and 4 of 7 with FLT3-internal tandem duplication mutations. Median follow-up was 11.2 months (range, 0.5-22.3), and median survival was 11.5 months (95% confidence interval, 5.2-16.7). Twenty-three patients (67.6%) were treated as outpatients and 10 of these patients required hospitalization for febrile neutropenia. No Grade 3-4 non-haematological toxicities required withdrawal from study. Tosedostat with cytarabine or decitabine is tolerated in older patients with untreated AML/MDS, results in a CR/CRi rate of >50%, and warrants further study in larger trials.

  17. [Surgical correction of dislipodemia in patients with obesity].

    PubMed

    Fishman, M B; Mirchuk, K K; Chie, Ma; Muzhikov, S P

    2014-01-01

    The results of surgical treatment of 139 patients with metabolic syndrome, obesity and dislipodemia were analyzed. Modern bariatric operations (4 types) were performed by using laparoscopic method. There were regulated bandages of the stomach (RBS), lengthwise gastric resections (LGR), biliopancreatic and stomach bypass surgeries (BBS, SBS). Results of five-year follow-up indicated that restrictive operations on the stomach (RBS, LGR) aimed to correct overweight and dislipodemia had some limitations to application in a varying degree. The RBS operation should be appropriate to use for women of the young age group, when an initial body-weight index wasn't more than 43 kg/m2. The LGR operation was effective for men of the young age group and women in case of moderately expressed dislipodemia and in case when the initial body-weight index didn't exceed more than 45 kg/m2. Combined bariatric operations (BBS, SBS) were most likely effective on body weight and dislipodemia.

  18. Effectiveness of an Interventional Program to Improve Blood Pressure Control in Hypertensive Patients at High Risk for Developing Heart Failure: HEROIC study.

    PubMed

    De Rivas, Beatriz; Barrios, Vivencio; Redón, Josep; Calderón, Alberto

    2010-05-01

    The Efectividad de un Programa de Intervención en el Control de la Presión Arterial de los Hipertensos en Riesgo de Desarrollar Insuficiencia Cardiaca (HEROIC) study was designed to assess whether an educational program for primary care physicians could improve blood pressure (BP) control in hypertensive patients at high risk for developing heart failure. The program contained a combination of educational training (live group sessions or online training) and information feedback. Two hundred twenty-six physicians completed the program and provided valid data in 2489 patients before and 2168 after 1 year. There was a small but significant reduction of -1.1 mm Hg (P=.009) in systolic BP and a higher proportion of patients achieved their BP target (13.6% vs 15.6%, P=.055). Thus, the authors concluded that there was a slight improvement in BP control after the educational program, but this change was not sufficient to avoid development of heart failure. More complex and intensive programs are needed for this type of prevention.

  19. Study to Improve Cardiovascular Outcomes in high-risk older patieNts (ICON1) with acute coronary syndrome: study design and protocol of a prospective observational study

    PubMed Central

    Kunadian, Vijay; Neely, R Dermot G; Sinclair, Hannah; Batty, Jonathan A; Veerasamy, Murugapathy; Ford, Gary A; Qiu, Weiliang

    2016-01-01

    Introduction The ICON1 study (a study to Improve Cardiovascular Outcomes in high-risk older patieNts with acute coronary syndrome) is a prospective observational study of older patients (≥75 years old) with non-ST-elevation acute coronary syndrome managed by contemporary treatment (pharmacological and invasive). The aim of the study was to determine the predictors of poor cardiovascular outcomes in this age group and to generate a risk prediction tool. Methods and analysis Participants are recruited from 2 tertiary hospitals in the UK. Baseline evaluation includes frailty, comorbidity, cognition and quality-of-life measures, inflammatory status assessed by a biomarker panel, including microRNAs, senescence assessed by telomere length and telomerase activity, cardiovascular status assessed by arterial stiffness, endothelial function, carotid intima media thickness and left ventricular systolic and diastolic function, and coronary plaque assessed by virtual histology intravascular ultrasound and optical coherence tomography. The patients are followed-up at 30 days and at 1 year for primary outcome measures of death, myocardial infarction, stroke, unplanned revascularisation, bleeding and rehospitalisation. Ethics and dissemination The study has been approved by the regional ethics committee (REC 12/NE/016). Findings of the study will be presented in scientific sessions and will be published in peer-reviewed journals. Trial registration number NCT01933581: Pre-results. PMID:27554105

  20. Molecular response assessment by quantitative real-time polymerase chain reaction after induction therapy in NPM1-mutated patients identifies those at high risk of relapse

    PubMed Central

    Hubmann, Max; Köhnke, Thomas; Hoster, Eva; Schneider, Stephanie; Dufour, Annika; Zellmeier, Evelyn; Fiegl, Michael; Braess, Jan; Bohlander, Stefan K.; Subklewe, Marion; Sauerland, Maria-Cristina; Berdel, Wolfgang E.; Büchner, Thomas; Wörmann, Bernhard; Hiddemann, Wolfgang; Spiekermann, Karsten

    2014-01-01

    Monitoring minimal residual disease is an important way to identify patients with acute myeloid leukemia at high risk of relapse. In this study we investigated the prognostic potential of minimal residual disease monitoring by quantitative real-time polymerase chain reaction analysis of NPM1 mutations in patients treated in the AMLCG 1999, 2004 and 2008 trials. Minimal residual disease was monitored - in aplasia, after induction therapy, after consolidation therapy, and during follow-up - in 588 samples from 158 patients positive for NPM1 mutations A, B and D (with a sensitivity of 10−6). One hundred and twenty-seven patients (80.4%) achieved complete remission after induction therapy and, of these, 56 patients (44.1%) relapsed. At each checkpoint, minimal residual disease cut-offs were calculated. After induction therapy a cut-off NPM1 mutation ratio of 0.01 was associated with a high hazard ratio of 4.26 and the highest sensitivity of 76% for the prediction of relapse. This was reflected in a cumulative incidence of relapse after 2 years of 77.8% for patients with ratios above the cut-off versus 26.4% for those with ratios below the cut-off. In the favorable subgroup according to European LeukemiaNet, the cut-off after induction therapy also separated the cohort into two prognostic groups with a cumulative incidence of relapse of 76% versus 6% after 2 years. Our data demonstrate that in addition to pre-therapeutic factors, the course of minimal residual disease in an individual is an important prognostic factor and could be included in clinical trials for the guidance of post-remission therapy. The trials from which data were obtained were registered at www.clinicaltrials.gov (#NCT01382147, #NCT00266136) and at the European Leukemia Trial Registry (#LN_AMLINT2004_230). PMID:24816240

  1. Need for High Radiation Dose (>=70 Gy) in Early Postoperative Irradiation After Radical Prostatectomy: A Single-Institution Analysis of 334 High-Risk, Node-Negative Patients

    SciTech Connect

    Cozzarini, Cesare; Montorsi, Francesco; Fiorino, Claudio; Alongi, Filippo; Bolognesi, Angelo; Da Pozzo, Luigi Filippo; Guazzoni, Giorgio; Freschi, Massimo; Roscigno, Marco; Scattoni, Vincenzo; Rigatti, Patrizio; Di Muzio, Nadia

    2009-11-15

    Purpose: To determine the clinical benefit of high-dose early adjuvant radiotherapy (EART) in high-risk prostate cancer (hrCaP) patients submitted to radical retropubic prostatectomy plus pelvic lymphadenectomy. Patients and Methods: The clinical outcome of 334 hrCaP (pT3-4 and/or positive resection margins) node-negative patients submitted to radical retropubic prostatectomy plus pelvic lymphadenectomy before 2004 was analyzed according to the EART dose delivered to the prostatic bed, <70.2 Gy (lower dose, median 66.6 Gy, n = 153) or >=70.2 Gy (median 70.2 Gy, n = 181). Results: The two groups were comparable except for a significant difference in terms of median follow-up (10 vs. 7 years, respectively) owing to the gradual increase of EART doses over time. Nevertheless, median time to prostate-specific antigen (PSA) failure was almost identical, 38 and 36 months, respectively. At univariate analysis, both 5-year biochemical relapse-free survival (bRFS) and disease-free survival (DFS) were significantly higher (83% vs. 71% [p = 0.001] and 94% vs. 88% [p = 0.005], respectively) in the HD group. Multivariate analysis confirmed EART dose >=70 Gy to be independently related to both bRFS (hazard ratio 2.5, p = 0.04) and DFS (hazard ratio 3.6, p = 0.004). Similar results were obtained after the exclusion of patients receiving any androgen deprivation. After grouping the hormone-naive patients by postoperative PSA level the statistically significant impact of high-dose EART on both 5-year bRFS and DFS was maintained only for those with undetectable values, possibly owing to micrometastatic disease outside the irradiated area in case of detectable postoperative PSA values. Conclusion: This series provides strong support for the use of EART doses >=70 Gy after radical retropubic prostatectomy in hrCaP patients with undetectable postoperative PSA levels.

  2. IgH-V(D)J NGS-MRD measurement pre- and early post-allotransplant defines very low- and very high-risk ALL patients.

    PubMed

    Pulsipher, Michael A; Carlson, Chris; Langholz, Bryan; Wall, Donna A; Schultz, Kirk R; Bunin, Nancy; Kirsch, Ilan; Gastier-Foster, Julie M; Borowitz, Michael; Desmarais, Cindy; Williamson, David; Kalos, Michael; Grupp, Stephan A

    2015-05-28

    Positive detection of minimal residual disease (MRD) by multichannel flow cytometry (MFC) prior to hematopoietic cell transplantation (HCT) of patients with acute lymphoblastic leukemia (ALL) identifies patients at high risk for relapse, but many pre-HCT MFC-MRD negative patients also relapse, and the predictive power MFC-MRD early post-HCT is poor. To test whether the increased sensitivity of next-generation sequencing (NGS)-MRD better identifies pre- and post-HCT relapse risk, we performed immunoglobulin heavy chain (IgH) variable, diversity, and joining (V[D]J) DNA sequences J NGS-MRD on 56 patients with B-cell ALL enrolled in Children's Oncology Group trial ASCT0431. NGS-MRD predicted relapse and survival more accurately than MFC-MRD (P < .0001), especially in the MRD negative cohort (relapse, 0% vs 16%; P = .02; 2-year overall survival, 96% vs 77%; P = .003). Post-HCT NGS-MRD detection was better at predicting relapse than MFC-MRD (P < .0001), especially early after HCT (day 30 MFC-MRD positive relapse rate, 35%; NGS-MRD positive relapse rate, 67%; P = .004). Any post-HCT NGS positivity resulted in an increase in relapse risk by multivariate analysis (hazard ratio, 7.7; P = .05). Absence of detectable IgH-V(D)J NGS-MRD pre-HCT defines good-risk patients potentially eligible for less intense treatment approaches. Post-HCT NGS-MRD is highly predictive of relapse and survival, suggesting a role for this technique in defining patients early who would be eligible for post-HCT interventions. The trial was registered at www.clinicaltrials.gov as #NCT00382109.

  3. Sunitinib Plus Androgen Deprivation and Radiation Therapy for Patients With Localized High-Risk Prostate Cancer: Results From a Multi-institutional Phase 1 Study

    SciTech Connect

    Corn, Paul G.; Song, Danny Y.; Heath, Elisabeth; Maier, Jordan; Meyn, Raymond; Kuban, Deborah; DePetrillo, Thomas A.; Mathew, Paul

    2013-07-01

    Purpose: To evaluate the feasibility of administering sunitinib in combination with androgen deprivation therapy and external-beam intensity modulated radiation therapy (XRT) in patients with localized high-risk prostate cancer. Methods and Materials: Seventeen men with localized adenocarcinoma of the prostate with cT2c-cT4 or Gleason 8-10 or prostate-specific antigen >20 ng/mL received initial androgen deprivation (leuprolide 22.5 mg every 12 weeks plus oral bicalutamide 50 mg daily) for 4-8 weeks before oral sunitinib 12.5, 25, or 37.5 mg daily for 4 weeks as lead-in, then concurrently with and 4 weeks after XRT (75.6 Gy in 42 fractions to prostate and seminal vesicles). A 3+3 sequential dose-escalation design was used to assess the frequency of dose-limiting toxicity (DLT) and establish a maximal tolerated dose of sunitinib. Results: Sunitinib at 12.5- and 25-mg dose levels was well tolerated. The first 4 patients enrolled at 37.5 mg experienced a DLT during lead-in, and a drug interaction between sunitinib and bicalutamide was suspected. The protocol was revised and concurrent bicalutamide omitted. Of the next 3 patients enrolled at 37.5 mg, 2 of 3 receiving concurrent therapy experienced DLTs during radiation: grade 3 diarrhea and grade 3 proctitis, respectively. Only 1 of 7 patients completed sunitinib at 37.5 mg daily, whereas 3 of 3 patients (25 mg as starting dose) and 3 of 4 patients (25 mg as reduced dose) completed therapy. Conclusions: The feasibility of combined vascular endothelial growth factor receptor (VEGFR)/platelet-derived growth factor receptor (PDGFR) inhibitor therapy, androgen deprivation, and radiation therapy for prostate cancer was established. Using a daily dosing regimen with lead-in, concurrent, and post-XRT therapy, the recommended phase 2 dose of sunitinib is 25 mg daily.

  4. Biochemical Control With Radiotherapy Improves Overall Survival in Intermediate and High-Risk Prostate Cancer Patients Who Have an Estimated 10-Year Overall Survival of >90%

    SciTech Connect

    Herbert, Christopher; Liu, Mitchell; Tyldesley, Scott; Morris, W. James; Joffres, Michel; Khaira, Mandip; Kwan, Winkle; Moiseenko, Vitali; Pickles, Thomas

    2012-05-01

    Purpose: To identify subgroups of patients with carcinoma of the prostate treated with radical radiotherapy that have improved overall survival when disease is biochemically controlled. Methods and Materials: A cohort of 1,060 prostate cancer patients treated with radical radiotherapy was divided into nine subgroups based on National Comprehensive Cancer Network risk category and estimated 10-year overall survival (eOS 10y) derived from the age adjusted Charlson Comorbidity Index. Patients with and without biochemical control were compared with respect to overall survival. Actuarial estimates of overall survival were calculated using the Kaplan-Meier method. Univariate and multivariate Cox proportional hazards models were used for analysis of overall survival. Results: Median follow-up was 125 months (range, 51-176 months). Only the subgroups with high or intermediate risk disease and an eOS 10y of >90% had a statistically significantly improved overall survival when prostate cancer was biochemically controlled. In all other groups, biochemical control made no significant difference to overall survival. In the subgroup with high-risk disease and eOS 10y >90%, actuarial overall survival was 86.3% (95% confidence interval [CI] 78.5%-94.1%) and 62.1% (95% CI 52.9%-71.3%) for patients with biochemical control and biochemical relapse respectively (p = 0.002). In the intermediate risk group with eOS >90%, actuarial overall survival was 95.3% (95% CI 89.0%-100%) and 79.8% (95% CI 68.0%-91.6%) for biochemically controlled and biochemically relapsed patients (p = 0.033). On multivariate analysis, National Comprehensive Cancer Network risk group (p = 0.005), biochemical control (p = 0.033) and eOS 10y (p < 0.001) were statistically significant. Conclusion: Biochemical control translates into improved overall survival in patients with high or intermediate risk disease and an estimated 10-year overall survival of >90%.

  5. Intravenous injection of low-dose flurbiprofen axetil for preventing post-ERCP pancreatitis in high-risk patients: An interim analysis of the trial

    PubMed Central

    Fujita, Yuji; Hasegawa, Sho; Kato, Yuri; Ishii, Ken; Iwasaki, Akito; Sato, Takamitsu; Sekino, Yusuke; Hosono, Kunihiro; Nakajima, Atsushi; Kubota, Kensuke

    2016-01-01

    Background and study aims: Several meta-analyses and randomized control trials have demonstrated the efficacy of rectal nonsteroidal anti-inflammatory drugs for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Diclofenac or indomethacin was administered at a dose of 100 mg in those studies, which may be too high for Asian population. In addition, rectal administration can be considered complicated. Patients and methods: This study was a prospective, randomized, placebo-controlled trial. Patients with a PEP risk score ≥ 1 were randomly assigned to receive intravenous injection of 50 mg flurbiprofen axetil (flurbiprofen group) or saline only (placebo group). The primary outcome was reduced PEP. The secondary outcome was amylase level after 2 hours of ERCP as a predictor of PEP. (Clinical Trials.gov, ID UMIN000011322) Results: In total, 144 patients were enrolled from August 2013 to March 2015. We performed an interim analysis of the first 100 patients: 47 received flurbiprofen axetil and 53 received placebo. PEP occurred in 11 patients (11 %): 2 of 47 (4.3 %) in the flurbiprofen group and 9 of 53 (17 %) in the placebo group (P = 0.042). Relative risk reduction was 62.4 %. Hyperamylasemia did not differ significantly (17.0 % vs. 26.4 %, P = 0.109). This analysis resulted in early termination of the study for ethical reasons. Conclusions: Intravenous injection of low-dose flurbiprofen axetil after ERCP can reduce the incidence of PEP in high-risk patients PMID:27747282

  6. Multiscale modeling and surgical planning for single ventricle heart patients

    NASA Astrophysics Data System (ADS)

    Marsden, Alison

    2011-11-01

    Single ventricle heart patients are among the most challenging for pediatric cardiologists to treat, and typically undergo a palliative course of three open-heart surgeries starting immediately after birth. We will present recent tools for modeling blood flow in single ventricle heart patients using a multiscale approach that couples a 3D Navier-Stokes domain to a 0D closed loop lumped parameter network comprised of circuit elements. This coupling allows us to capture the effect of changes in local geometry, such as shunt sizes, on global circulatory dynamics, such as cardiac output. A semi-implicit numerical method is formulated to solve the coupled system in which flow and pressure information is passed between the two domains at the inlets and outlets of the model. A finite element method with outflow stabilization is applied in the 3D Navier-Stokes domain, and the LPN system of ordinary differential equations is solved numerically using a Runge-Kutta method. These tools are coupled via automated scripts to a derivative-free optimization method. Optimization is used to systematically explore surgical designs using clinically relevant cost functions for two stages of single ventricle repair. First, we will present results from optimization of the first stage Blalock Taussig Shunt. Second, we will present results from optimization of a new Y-graft design for the third stage of single ventricle repair called the Fontan surgery. The Y-graft is shown, in simulations, to successfully improve hepatic flow distribution, a known clinical problem. Preliminary clinical experience with the Y-graft will be discussed.

  7. Management of high-risk gestational trophoblastic disease.

    PubMed

    Lurain, J R

    1998-01-01

    Multimodality therapy with combination chemotherapy employing etoposide, high-dose methotrexate, actinomycin D, cyclophosphamide and vincristine (EMA-CO), and adjuvant radiotherapy and surgery, when indicated, has resulted in cure rates of 80-90% in patients with high-risk metastatic gestational trophoblastic tumors. However, approximately 25-30% of high-risk patients will have an incomplete response to first-time chemotherapy or will relapse from remission. Most of these patients will have a clinicopathologic diagnosis of choriocarcinoma, metastases to sites other than the lung and vagina, more than eight metastases and/or failed inappropriate previous chemotherapy, resulting in very high World Health Organization scores. Salvage chemotherapy with cisplatin/etoposide, usually in conjunction with bleomycin or ifosfamide, as well as surgical resection of sites of resistant disease in selected patients, will result in a cure in most patients. New technology, such as the use of colony-stimulating factors to prevent treatment delays and dose reductions or high-dose chemotherapy with or without autologous bone marrow transplantation or peripheral blood stem cell support, may play an important role in the future management of patients who develop drug resistance. PMID:9475149

  8. Predictive Score Card in Lumbar Disc Herniation: Is It Reflective of Patient Surgical Success after Discectomy?

    PubMed Central

    Azimi, Parisa; Benzel, Edward C.; Montazeri, Ali

    2016-01-01

    Does the Finneson–Cooper score reflect the true value of predicting surgical success before discectomy? The aim of this study was to identify reliable predictors for surgical success two year after surgery for patients with LDH. Prospective analysis of 154 patients with LDH who underwent single-level lumbar discectomy was performed. Pre- and post-surgical success was assessed by the Oswestry Disability Index (ODI) over a 2-year period. The Finneson-Cooper score also was used for evaluation of the clinical results. Using the ODI, surgical success was defined as a 30% (or more) improvement on the ODI score from the baseline. The ODI was considered the gold standard in this study. Finally, the sensitivity, specificity, and positive and negative predictive power of the Finneson–Cooper score in predicting surgical success were calculated. The mean age of the patients was 49.6 (SD = 9.3) years and 47.4% were male. Significant improvement from the pre- to post-operative ODI scores was observed (P < 0.001). Post-surgical success was 76.0% (n = 117). The patients’ rating on surgical success assessments by the ODI discriminated well between sub-groups of patients who differed with respect to the Finneson–Cooper score. Regarding patients’ surgical success, the sensitivity, specificity, and accuracy of the Finneson-Cooper ratings correlated with success rate. The findings indicated that the Finneson–Cooper score was reflective of surgical success before discectomy. PMID:27100287

  9. Feasibility of radiotherapy after high-dose dense chemotherapy with epirubicin, preceded by dexrazoxane, and paclitaxel for patients with high-risk Stage II-III breast cancer

    SciTech Connect

    De Giorgi, Ugo . E-mail: ugo_degiorgi@yahoo.com; Giannini, Massimo; Frassineti, Luca; Kopf, Barbara; Palazzi, Silvia; Giovannini, Noemi; Zumaglini, Federica; Rosti, Giovanni; Emiliani, Ermanno; Marangolo, Maurizio

    2006-07-15

    Purpose: To verify the feasibility of, and quantify the risk of, pneumonitis from locoregional radiotherapy (RT) after high-dose dense chemotherapy with epirubicin and paclitaxel with peripheral blood progenitor cell support in patients with high-risk Stage II-III breast cancer. Methods and Materials: Treatment consisted of a mobilizing course of epirubicin 150 mg/m{sup 2}, preceded by dexrazoxane (Day 1), paclitaxel 175 mg/m{sup 2} (Day 2), and filgrastim; followed by three courses of epirubicin 150 mg/m{sup 2}, preceded by dexrazoxane (Day 1), paclitaxel 400 mg/m{sup 2} (Day 2), and peripheral blood progenitor cell support and filgrastim, every 16-19 days. After chemotherapy, patients were treated with locoregional RT, which included the whole breast or the chest wall, axilla, and supraclavicular area. Results: Overall, 64 of 69 patients were evaluable. The interval between the end of chemotherapy and the initiation of RT was at least 1.5-2 months (mean 2). No treatment-related death was reported. After a median follow-up of 27 months from RT (range 5-77 months), neither clinically relevant radiation pneumonitis nor congestive heart failure had been reported. Minor and transitory lung and cardiac toxicities were observed. Conclusion: Sequential high doses of epirubicin, preceded by dexrazoxane, and paclitaxel did not adversely affect the tolerability of locoregional RT in breast cancer patients. The risk of pneumonitis was not affected by the use of sequential paclitaxel with an interval of at least 1.5-2 months between the end of chemotherapy and the initiation of RT. Long-term follow-up is needed to define the risk of cardiotoxicity in these patients.

  10. Tyrosinase-related protein 1 mRNA expression in lymph node metastases predicts overall survival in high-risk melanoma patients

    PubMed Central

    El Hajj, P; Journe, F; Wiedig, M; Laios, I; Salès, F; Galibert, M-D; Van Kempen, L C; Spatz, A; Badran, B; Larsimont, D; Awada, A; Ghanem, G

    2013-01-01

    Background: Clinical outcome of high-risk melanoma patients is not reliably predicted from histopathological analyses of primary tumours and is often adjusted during disease progression. Our study aimed at extending our previous findings in skin metastases to evaluate the prognostic value of tyrosinase-related protein 1 (TYRP1) in lymph node metastases of stages III and IV melanoma patients. Methods: TYRP1 mRNA expression in 104 lymph node metastases was quantified by real-time PCR and normalised to S100 calcium-binding protein B (S100B) mRNA expression to correct for tumour load. TYRP1/S100B ratios were calculated and median was used as cutoff value. TYRP1/S100B mRNA values were correlated to clinical follow-up and histopathological characteristics of the primary lesion. Results: A high TYRP1/S100B mRNA ratio significantly correlated with reduced disease-free (DFS) and overall survival (OS; Cox regression analysis, P=0.005 and 0.01, respectively), increased Breslow thickness (Spearman's rho test, P<0.001) and the presence of ulceration (Mann–Whitney test, P=0.02) of the primaries. Moreover, high TYRP1/S100B was of better prognostic value (lower P-value) for OS than Breslow thickness and ulceration. Finally, it was well conserved during disease progression with respect to high/low TYRP1 groups. Conclusion: High TYRP1/S100B mRNA expression in lymph node metastases from melanoma patients is associated with unfavourable clinical outcome. Its evaluation in lymph node metastases may refine initial prognosis for metastatic patients, may define prognosis for those with unknown or non-evaluable primary lesions and may allow different management of the two groups of patients. PMID:23519055

  11. Results of the Chronic Heart Failure Intervention to Improve MEdication Adherence (CHIME) Study: A Randomized Intervention in High-Risk Patients

    PubMed Central

    Granger, Bradi B.; Ekman, Inger; Hernandez, Adrian F.; Sawyer, Tenita; Bowers, Margaret; DeWald, Tracy; Zhao, Yanfang; Levy, Janet; Bosworth, Hayden B.

    2015-01-01

    Background Poor adherence to evidence-based medications in heart failure (HF) is a major cause of avoidable hospitalizations, disability, and death. To test the feasibility of improving medication adherence, we performed a randomized proof-of-concept study of a self-management intervention in high-risk patients with HF. Methods Patients with HF who screened positively for poor adherence (<6 Morisky Medication Adherence Scale 8-item) were randomized to either the intervention or attention control group. In the intervention group (n=44), a nurse conducted self-management training prior to discharge that focused on identification of medication goals, facilitation of medication-symptom associations, and use of a symptom-response plan. The attention control group (n=42) received usual care; both groups received follow-up calls at 1 week. However, the content of follow-up calls for the attention control group was unrelated to HF medications or symptoms. General linear mixed models were used to evaluate the magnitude of change in adherence and symptom-related events at 3-, 6-, and 12-month follow-up clinic visits. Efficacy was measured as improved medication adherence using nurse-assessed pill counts at each time point. Results Pooled over all time points, patients in the intervention group were more likely to be adherent to medications compared with patients in the attention control group (odds ratio [OR] 3.92, t=3.51, p=0.0007). Conclusions A nurse-delivered, self-care intervention improved medication adherence in patients with advanced HF. Further work is needed to examine whether this intervention can be sustained to improve clinical outcomes. PMID:25819861

  12. KRAS and GNAS Mutations in Pancreatic Juice Collected From the Duodenum of Patients at High Risk for Neoplasia Undergoing Endoscopic Ultrasound

    PubMed Central

    Eshleman, James R.; Norris, Alexis L.; Sadakari, Yoshihiko; Debeljak, Marija; Borges, Michael; Harrington, Colleen; Lin, Elaine; Brant, Aaron; Barkley, Thomas; Almario, J. Alejandro; Topazian, Mark; Farrell, James; Syngal, Sapna; Lee, Jeffrey H.; Yu, Jun; Hruban, Ralph H.; Kanda, Mitsuro; Canto, Marcia Irene; Goggins, Michael

    2014-01-01

    BACKGROUND & AIMS Pancreatic imaging can identify neoplastic cysts but not microscopic neoplasms. Mutation analysis of pancreatic fluid following secretin stimulation might identify microscopic neoplasias in the pancreatic duct system. We determined the prevalence of mutations in KRAS and GNAS genes in pancreatic juice from subjects undergoing endoscopic ultrasound for suspected pancreatic intraepithelial neoplasia (PanIN), intraductal papillary mucinous neoplasms, or pancreatic adenocarcinoma. METHODS Secretin-stimulated juice samples were collected from the duodenum of 272 subjects enrolled in Cancer of the Pancreas Screening studies; 194 subjects were screened because of a family history of, or genetic predisposition to, pancreatic cancer and 78 were evaluated for pancreatic cancer (n=30) or other disorders (controls: pancreatic cysts, pancreatitis, or normal pancreata, n=48). Mutations were detected by digital high-resolution melt-curve analysis and pyrosequencing. The number of replicates containing a mutation determined the mutation score. RESULTS KRAS mutations were detected in pancreatic juice from larger percentages of subjects with pancreatic cancer (73%) or undergoing cancer screening (50%) than controls (19%) (P=.0005). A greater proportion of patients with pancreatic cancer had at least 1 KRAS mutation detected 3 or more times (47%) than screened subjects (21%) or controls (6%, P=.002). Among screened subjects, mutations in KRAS (but not GNAS) were found in similar percentages of patients with or without pancreatic cysts. However, a greater proportion of patients over 50 ys old had KRAS mutations (54.6%) than younger patients (36.3%) (P=.032); the older subjects also more mutations in KRAS (P=.02). CONCLUSIONS Mutations in KRAS are detected in pancreatic juice from the duodenum of 73% of patients with pancreatic cancer, and 50% of asymptomatic individuals with a high risk for pancreatic cancer. However, KRAS mutations are detected in pancreatic juice

  13. Functional Bioassays for Immune Monitoring of High-Risk Neuroblastoma Patients Treated with ch14.18/CHO Anti-GD2 Antibody

    PubMed Central

    Siebert, Nikolai; Seidel, Diana; Eger, Christin; Jüttner, Madlen; Lode, Holger N.

    2014-01-01

    Effective treatment of high-risk neuroblastoma (NB) remains a major challenge in pediatric oncology. Human/mouse chimeric monoclonal anti-GD2 antibody (mAb) ch14.18 is emerging as a treatment option to improve outcome. After establishing a production process in Chinese hamster ovary (CHO) cells, ch14.18/CHO was made available in Europe for clinical trials. Here, we describe validated functional bioassays for the purpose of immune monitoring of these trials and demonstrate GD2-specific immune effector functions of ch14.18/CHO in treated patients. Two calcein-based bioassays for complement-dependent- (CDC) and antibody-dependent cellular cytotoxicity (ADCC) were set up based on patient serum and immune cells tested against NB cells. For this purpose, we identified LA-N-1 NB cells as best suited within a panel of cell lines. Assay conditions were first established using serum and cells of healthy donors. We found an effector-to-target (E:T) cell ratio of 20∶1 for PBMC preparations as best suited for GD2-specific ADCC analysis. A simplified method of effector cell preparation by lysis of erythrocytes was evaluated revealing equivalent results at an E:T ratio of 40∶1. Optimal results for CDC were found with a serum dilution at 1∶8. For validation, both within-assay and inter-assay precision were determined and coefficients of variation (CV) were below 20%. Sample quality following storage at room temperature (RT) showed that sodium-heparin-anticoagulated blood and serum are stable for 48 h and 96 h, respectively. Application of these bioassays to blood samples of three selected high-risk NB patients treated with ch14.18/CHO (100 mg/m2) revealed GD2-specific increases in CDC (4.5–9.4 fold) and ADCC (4.6–6.0 fold) on day 8 compared to baseline, indicating assay applicability for the monitoring of multicenter clinical trials requiring sample shipment at RT for central lab analysis. PMID:25226154

  14. Five year follow up of biocolonisable microporous fluorocarbon haptic (BIOKOP) keratoprosthesis implantation in patients with high risk of corneal graft failure

    PubMed Central

    Alió, J L; Mulet, M E; Haroun, H; Merayo, J; Moreno, J M Ruiz

    2004-01-01

    Aim: To study the anatomical and visual performance following implantation of a model of artificial cornea and to evaluate the postoperative long term complications. Methods: 11 eyes of 11 patients with bilateral corneal blindness considered as potentially having high risk of failure of penetrating corneal keratoplasty were implanted with biocolonisable Kpro keratoprosthesis (BIOKOP I, FCI, Rantigny, France) in the period between January 1996 and May 1998. Only one eye was implanted in all patients and followed up for a period of 60 months. The visual outcome, anatomical and functional stability, complications, and the general performance of the keratoprosthesis were evaluated. Results: The keratoprosthesis (BIOKOP I) only 36.3% remained in position to date. In the patients’ last visit five eyes (45.4%) were blind and one (9.0%) showed a slight improvement in the best corrected visual acuity (BCVA) in comparison to preoperative tests. Six eyes (54.5%) showed improved BCVA before having postoperative complications. Four eyes underwent replacement of a BIOKOP I Kpro with a BIOKOP II as a result of extrusion. The keratoprostheses remained anatomically in situ for a mean of 25.5 months and their functional performance period was limited to a mean of 22 months. Conclusion: Corneal keratoprosthesis (BIOKOP I, II) does not provide a stable anatomical relation with the surrounding ocular structures. Its ability to restore vision is limited to a short postoperative period in eyes implanted with severe ocular surface disease. PMID:15550368

  15. Long term outcome of high-risk neuroblastoma patients after immunotherapy with antibody ch14.18 or oral metronomic chemotherapy

    PubMed Central

    2011-01-01

    Background The treatment of high-risk neuroblastoma patients consists of multimodal induction therapy to achieve remission followed by consolidation therapy to prevent relapses. However, the type of consolidation therapy is still discussed controversial. We applied metronomic chemotherapy in the prospective NB90 trial and monoclonal anti-GD2-antibody (MAB) ch14.18 in the NB97 trial. Here, we present the long term outcome data of the patient cohort. Methods A total of 334 stage 4 neuroblastoma patients one year or older were included. All patients successfully completed the induction therapy. In the NB90 trial, 99 patients received at least one cycle of the oral maintenance chemotherapy (NB90 MT, 12 alternating cycles of oral melphalan/etoposide and vincristine/cyclophosphamide). In the NB97 trial, 166 patients commenced the MAB ch14.18 consolidation therapy (six cycles over 12 months). Patients who received no maintenance therapy according to the NB90 protocol or by refusal in NB97 (n = 69) served as controls. Results The median observation time was 11.11 years. The nine-year event-free survival rates were 41 ± 4%, 31 ± 5%, and 32 ± 6% for MAB ch14.18, NB90 MT, and no consolidation, respectively (p = 0.098). In contrast to earlier reports, MAB ch14.18 treatment improved the long-term outcome compared to no additional therapy (p = 0.038). The overall survival was better in the MAB ch14.18-treated group (9-y-OS 46 ± 4%) compared to NB90 MT (34 ± 5%, p = 0.026) and to no consolidation (35 ± 6%, p = 0.019). Multivariable Cox regression analysis revealed ch14.18 consolidation to improve outcome compared to no consolidation, however, no difference between NB90 MT and MAB ch14.18-treated patients was found. Conclusions Follow-up analysis of the patient cohort indicated that immunotherapy with MAB ch14.18 may prevent late relapses. Finally, metronomic oral maintenance chemotherapy also appeared effective. PMID:21244693

  16. Oncologic Outcome of Radical Prostatectomy as Monotherapy for Men with High-risk Prostate Cancer

    PubMed Central

    Furukawa, Junya; Miyake, Hideaki; Inoue, Taka-aki; Ogawa, Takayoshi; Tanaka, Hirokazu; Fujisawa, Masato

    2016-01-01

    Background The objective of this study was to review our experience with radical prostatectomy (RP) as monotherapy for men with high-risk prostate cancer (PCa). Patients and Methods This study included 382 consecutive patients who were diagnosed with high-risk PCa according to the D'Amico definition and subsequently underwent RP without neoadjuvant therapy. Biochemical recurrence (BR) was defined as a serum prostate-specific antigen (PSA) level ≥ 0.2 ng/ml on two consecutive measurements, and none of the patients received any adjuvant therapies until their serum PSA levels reached ≥ 0.4 ng/ml. Results The median preoperative serum PSA level in these 382 patients was 15.9 ng/ml. Pathological stages ≥ pT2c and Gleason scores ≥ 8 were observed in 288 and 194 patients, respectively. During the observation period (median, 48.0 months), BR occurred in 134 patients, and the 5-year BR-free survival rate was 60.1%; however, no patient died of cancer progression. Multivariate analysis identified capsular invasion, seminal vesicle invasion, and surgical margin status as independent predictors of BR. Conclusions Comparatively favorable cancer control could be achieved using RP as monotherapy for men with high-risk PCa; however, RP alone may be insufficient for patients with capsular invasion, seminal vesicle invasion, and/or surgical margin positivity. PMID:27390578

  17. Optimization of care for the pediatric surgical patient: Why now?

    PubMed

    Arca, Marjorie J; Goldin, Adam B; Oldham, Keith T

    2015-12-01

    In 2015, the American College of Surgeons (ACS) has begun to verify hospitals and ambulatory centers which meet consensus based optimal resource standards as "Children׳s Surgical Centers." The intent is to identify children-specific resources available within an institution and using a stratification system similar to the ACS Trauma Program match these to the needs of infants and children with surgical problems. This review briefly summarizes the history, supporting data and processes which drove this initiative.

  18. [Anxiolytic effect of preoperative showing of "anesthesia video" for surgical patients].

    PubMed

    Hashimoto, Y; Baba, S; Koh, H; Takagi, H; Ishihara, H; Matsuki, A

    1993-04-01

    Over 60% of preoperative surgical patients are reported to suffer from preoperative anxiety. Since 1986, an anesthesia video, explaining our routine anesthesia procedures has been shown to elective surgical patients preoperatively at our clinic. In 1990, as our anesthesia method was modified, we revised this video and evaluated the effect of this video on their preoperative anxiety. Female patients, in general, have much more anxiety than male patients, and the female patients of 30-59 years of age were the most anxious about their surgical operations not about anesthesia per se. The patients who were to undergo a major surgery, such as gynecological patients also belonged to the most anxious patient group. After demonstrating the video any patient group including gynecological patients of 30-59 years of age was less anxious about the upcoming anesthesia and surgery.

  19. Identification of High-Risk Patients with Non-ST Segment Elevation Myocardial Infarction using Strain Doppler Echocardiography: Correlation with Cardiac Magnetic Resonance Imaging

    PubMed Central

    Loutfi, Mohamed; Ashour, Sanaa; El-Sharkawy, Eman; El-Fawal, Sara; El-Touny, Karim

    2016-01-01

    size ≥12%. CONCLUSION GLS is a good predictor of infarct size in NSTEMI, and it may serve as a tool in conjunction with risk stratification scores for the selection of high-risk NSTEMI patients. PMID:27199575

  20. Development of a patient-specific surgical simulator for pediatric laparoscopic procedures.

    PubMed

    Saber, Nikoo R; Menon, Vinay; St-Pierre, Jean C; Looi, Thomas; Drake, James M; Cyril, Xavier

    2014-01-01

    The purpose of this study is to develop and evaluate a pediatric patient-specific surgical simulator for the planning, practice, and validation of laparoscopic surgical procedures prior to intervention, initially focusing on the choledochal cyst resection and reconstruction scenario. The simulator is comprised of software elements including a deformable body physics engine, virtual surgical tools, and abdominal organs. Hardware components such as haptics-enabled hand controllers and a representative endoscopic tool have also been integrated. The prototype is able to perform a number of surgical tasks and further development work is under way to simulate the complete procedure with acceptable fidelity and accuracy. PMID:24732536

  1. Multidisciplinary case management for patients at high risk of hospitalization: comparison of virtual ward models in the United kingdom, United States, and Canada.

    PubMed

    Lewis, Geraint; Wright, Lorraine; Vaithianathan, Rhema

    2012-10-01

    Virtual wards are a model for delivering multidisciplinary case management to people who are at high predicted risk of unplanned acute care hospitalization. First introduced in Croydon, England, in 2006, this concept has since been adopted and adapted by health care organizations in other parts of the United Kingdom and internationally. In this article, the authors review the model of virtual wards as originally described-with its twin pillars of (1) using a predictive model to identify people who are at high risk of future emergency hospitalization, and (2) offering these individuals a period of intensive, multidisciplinary preventive care at home using the systems, staffing, and daily routines of a hospital ward. The authors then describe how virtual wards have been modified and implemented in 6 sites in the United Kingdom, United States, and Canada where they are subject to formal evaluation. Like hospital wards, virtual wards vary in terms of patient selection, ward configuration, staff composition, and ward processes. Policy makers and researchers should be aware of these differences when considering the evaluation results of studies investigating the cost-effectiveness of virtual wards.

  2. Clinical Factors Associated with High-risk Carotid Plaque Features as Assessed by Magnetic Resonance Imaging in Patients with Established Vascular Disease (From the AIM-HIGH Study)

    PubMed Central

    Zhao, Xue-Qiao; Hatsukami, Thomas S.; Hippe, Daniel S.; Sun, Jie; Balu, Niranjan; Isquith, Daniel A.; Crouse, John R.; Anderson, Todd; Huston, John; Polissar, Nayak; O’Brien, Kevin; Yuan, Chun

    2014-01-01

    Association between clinical factors and high-risk plaque features such as thin or ruptured cap, intra-plaque hemorrhage (IPH), presence of Lipid Rich Necrotic Core (LRNC) and increased LRNC volume as assessed by Magnetic Resonance Imaging (MRI) was examined in patients with established vascular disease in AIM-HIGH. A total of 214 subjects underwent carotid MRI and had acceptable image quality for assessment of plaque burden, tissue contents and MRI-modified AHA lesion type by a Core Lab. We found that 77% of subjects had carotid plaques, 52% had lipid-containing plaques, and 11% had advanced, AHA type-VI lesions with possible surface defect, IPH or mural thrombus. Type-VI lesions were associated with older age (OR=2.6 per 5 years increase, p<0.001). After adjusting for age, these lesions were associated with history of cerebrovascular disease (OR=4.1, p=0.01), higher levels of Lipoprotein(a) (OR=2.0 per 1 SD increase, p=0.02) and larger %wall volume (%WV; OR=4.6 per 1 SD increase, p<0.001), but, were negatively associated with metabolic syndrome (OR=0.2, p=0.02). Presence of LRNC was associated with male gender (OR=3.2, p=0.02) and %WV (OR=3.8 per 1 SD, p<0.001), but, was negatively associated with diabetes (OR=0.4, p=0.02) and HDL-C levels (OR=0.7 per 1 SD, p=0.02). Increased %LRNC was associated with %WV (regression coefficient=0.36, p<0.001) and negatively associated with ApoA1 levels (regression coefficient=−0.20, p=0.03). In conclusions, older age, male gender, history of cerebrovascular disease, larger plaque burden, higher Lp(a), and lower HDL-C or ApoA1 have statistically significant associations with high-risk plaque features. Metabolic syndrome and diabetes showed negative associations in this population. PMID:25245415

  3. Pelvic Nodal Dosing With Registration to the Prostate: Implications for High-Risk Prostate Cancer Patients Receiving Stereotactic Body Radiation Therapy

    SciTech Connect

    Kishan, Amar U. Lamb, James M.; Jani, Shyam S.; Kang, Jung J.; Steinberg, Michael L.; King, Christopher R.

    2015-03-15

    Purpose: To determine whether image guidance with rigid registration (RR) to intraprostatic markers (IPMs) yields acceptable coverage of the pelvic lymph nodes in the context of a stereotactic body radiation therapy (SBRT) regimen. Methods and Materials: Four to seven kilovoltage cone-beam CTs (CBCTs) from 12 patients with high-risk prostate cancer were analyzed, allowing approximation of an SBRT regimen. The nodal clinical target volume (CTV{sub N}) and bladder were contoured on all kilovoltage CBCTs. The V{sub 100} CTV{sub N}, expressed as a ratio to the same parameter on the initial plan, and the magnitude of translational shift between RR to the IPMs versus RR to the pelvic bones, were computed. The ability of a multimodality bladder filling protocol to minimize bladder height variation was assessed in a separate cohort of 4 patients. Results: Sixty-five CBCTs were assessed. The average V{sub 100} CTV{sub N} was 92.6%, but for a subset of 3 patients the average was 80.0%, compared with 97.8% for the others (P<.0001). The average overall and superior–inferior axis magnitudes of the bony-to-fiducial translations were significantly larger in the subgroup with suboptimal nodal coverage (8.1 vs 3.9 mm and 5.8 vs 2.4 mm, respectively; P<.0001). Relative bladder height changes were also significantly larger in the subgroup with suboptimal nodal coverage (42.9% vs 18.5%; P<.05). Use of a multimodality bladder-filling protocol minimized bladder height variation (P<.001). Conclusion: A majority of patients had acceptable nodal coverage after RR to IPMs, even when approximating SBRT. However, a subset of patients had suboptimal nodal coverage. These patients had large bony-to-fiducial translations and large variations in bladder height. Nodal coverage should be excellent if the superior–inferior axis bony-to-fiducial translation and the relative bladder height change (both easily measured on CBCT) are kept to a minimum. Implementation of a strict bladder filling

  4. Immune-enhancing nutrition in surgical critical care.

    PubMed

    Pollock, Graham R Y; Van Way, Charles W

    2012-01-01

    Immune-enhancing nutrition, or "immunonutrition," refers to the use of specialized nutrients, including glutamine, alanine, omega-3 fatty acids, and others, that help regulate the body's response to illness and injury. Clinical studies have demonstrated some very specific benefits, including fewer infectious complications and shorter length of hospitalization, in certain populations including high-risk surgical patients, trauma victims, and the critically-ill. Nationally recognized guidelines support the use of immune-enhancing nutrition in high-risk patients.

  5. Interval to Biochemical Failure Predicts Clinical Outcomes in Patients With High-Risk Prostate Cancer Treated by Combined-Modality Radiation Therapy

    SciTech Connect

    Shilkrut, Mark; McLaughlin, P. William; Merrick, Gregory S.; Vainshtein, Jeffrey M.; Feng, Felix Y.; Hamstra, Daniel A.

    2013-07-15

    Purpose: To validate the prognostic value of interval to biochemical failure (IBF) in patients with high-risk prostate cancer (HiRPCa) treated with combined-modality radiation therapy (CMRT) with or without androgen deprivation therapy (ADT). Methods and Materials: We conducted a retrospective review of HiRPCa (prostate-specific antigen >20 ng/mL, Gleason score [GS] 8-10, or clinical T stage T3-T4) treated with either dose-escalated external beam radiation therapy (EBRT) or CMRT. Interval to biochemical failure was classified as ≤18 or >18 months from the end of all therapy to the date of biochemical failure (BF). Kaplan-Meier methods and Cox proportional hazards regression were used to evaluate the prognostic value of IBF ≤18 months for distant metastasis (DM) and prostate cancer-specific mortality (PCSM). Results: Of 958 patients with a median follow-up of 63.2 months, 175 patients experienced BF. In those with BF, there were no differences in pretreatment clinical characteristics between the EBRT and CMRT groups, except for a higher proportion of patients with GS 8-10 in the CMRT group (70% vs 52%, P=.02). Median IBF after all therapy was 24.0 months (interquartile range 9.6-46.0) in the EBRT group and 18.9 months (interquartile range 9.2-34.5) in the CMRT group (P=.055). On univariate analysis, IBF ≤18 months was associated with increased risk of DM and PCSM in the entire cohort and the individual EBRT and CMRT groups. On multivariate analysis, only GS 9-10 and IBF ≤18 months, but not the radiation therapy regimen or ADT use, predicted DM (hazard ratio [HR] 3.7, P<.01, 95% confidence interval [CI] 1.4-10.3 for GS 9-10; HR 3.9, P<.0001, 95% CI 2.4-6.5 for IBF ≤18 months) and PCSM (HR 14.8, P<.009, 95% CI 2.0-110 for GS 9-10; HR 4.4, P<.0001, 95% CI 2.4-8.1 for IBF ≤18 months). Conclusions: Short IBF was highly prognostic for higher DM and PCSM in patients with HiRPCa. The prognostic value of IBF for DM and PCSM was not affected by the radiation

  6. Triglyceride-rich lipoproteins and high-density lipoprotein cholesterol in patients at high risk of cardiovascular disease: evidence and guidance for management.

    PubMed

    Chapman, M John; Ginsberg, Henry N; Amarenco, Pierre; Andreotti, Felicita; Borén, Jan; Catapano, Alberico L; Descamps, Olivier S; Fisher, Edward; Kovanen, Petri T; Kuivenhoven, Jan Albert; Lesnik, Philippe; Masana, Luis; Nordestgaard, Børge G; Ray, Kausik K; Reiner, Zeljko; Taskinen, Marja-Riitta; Tokgözoglu, Lale; Tybjærg-Hansen, Anne; Watts, Gerald F

    2011-06-01

    Even at low-density lipoprotein cholesterol (LDL-C) goal, patients with cardiometabolic abnormalities remain at high risk of cardiovascular events. This paper aims (i) to critically appraise evidence for elevated levels of triglyceride-rich lipoproteins (TRLs) and low levels of high-density lipoprotein cholesterol (HDL-C) as cardiovascular risk factors, and (ii) to advise on therapeutic strategies for management. Current evidence supports a causal association between elevated TRL and their remnants, low HDL-C, and cardiovascular risk. This interpretation is based on mechanistic and genetic studies for TRL and remnants, together with the epidemiological data suggestive of the association for circulating triglycerides and cardiovascular disease. For HDL, epidemiological, mechanistic, and clinical intervention data are consistent with the view that low HDL-C contributes to elevated cardiovascular risk; genetic evidence is unclear however, potentially reflecting the complexity of HDL metabolism. The Panel believes that therapeutic targeting of elevated triglycerides (≥ 1.7 mmol/L or 150 mg/dL), a marker of TRL and their remnants, and/or low HDL-C (<1.0 mmol/L or 40 mg/dL) may provide further benefit. The first step should be lifestyle interventions together with consideration of compliance with pharmacotherapy and secondary causes of dyslipidaemia. If inadequately corrected, adding niacin or a fibrate, or intensifying LDL-C lowering therapy may be considered. Treatment decisions regarding statin combination therapy should take into account relevant safety concerns, i.e. the risk of elevation of blood glucose, uric acid or liver enzymes with niacin, and myopathy, increased serum creatinine and cholelithiasis with fibrates. These recommendations will facilitate reduction in the substantial cardiovascular risk that persists in patients with cardiometabolic abnormalities at LDL-C goal. PMID:21531743

  7. Treatment Results of PDR Brachytherapy Combined With External Beam Radiotherapy in 106 Patients With Intermediate- to High-Risk Prostate Cancer

    SciTech Connect

    Pieters, Bradley R.

    2011-03-15

    Purpose: To evaluate treatment outcome of pulsed dose-rate brachytherapy (PDR) combined with external-beam radiotherapy (EBRT) for the treatment of prostate cancer. Methods and Materials: Between 2002 and 2007, 106 patients were treated by EBRT combined with PDR and followed prospectively. Two, 38, and 66 patients were classified as low-, intermediate-, and high-risk disease respectively according to the National Comprehensive Cancer Network criteria. EBRT dose was 46 Gy in 2.0-Gy fractions. PDR dose was increased stepwise from 24.96 to 28.80 Gy. Biochemical disease free survival and overall survival were determined by the Kaplan-Meier method. Cumulative incidence of late gastrointestinal (GI) and genitourinary (GU) toxicity were scored, according to the Common Terminology Criteria for Adverse Events. Results: The 3- and 5-year biochemical nonevidence of disease (bNED) were 92.8% (95% confidence interval [CI], 87.1-98.5) and 89.5% (95% CI, 85.2-93.8), respectively. Overall survival at 3 and 5 years was 99% (95% CI, 96-100) and 96% (95% CI, 90-100), respectively. The 3- and 5-year Grade 2 GI toxicity was 5.3% (95% CI, 0-10.6) and 12.0% (95% CI, 1.4-22.6), respectively. No Grade 3 or higher GI toxicity was observed. The 3- and 5-year Grade 2 or higher GU toxicity was 18.7% (95% CI, 10.3-27.1) and 26.9% (95% CI, 15.1-38.7), respectively. Conclusion: Results on tumor control and late toxicity of EBRT combined with PDR are good and comparable to results obtained with EBRT combined with high-dose-rate brachytherapy for the treatment of prostate cancer.

  8. Dietary patterns and the risk of major adverse cardiovascular events in a global study of high-risk patients with stable coronary heart disease

    PubMed Central

    Stewart, Ralph A. H.; Wallentin, Lars; Benatar, Jocelyne; Danchin, Nicolas; Hagström, Emil; Held, Claes; Husted, Steen; Lonn, Eva; Stebbins, Amanda; Chiswell, Karen; Vedin, Ola; Watson, David; White, Harvey D.

    2016-01-01

    Objectives To determine whether dietary pattern assessed by a simple self-administered food frequency questionnaire is associated with major adverse cardiovascular events (MACE) in high-risk patients with stable coronary artery disease. Background A Mediterranean dietary pattern has been associated with lower cardiovascular (CV) mortality. It is less certain whether foods common in western diets are associated with CV risk. Methods At baseline, 15 482 (97.8%) patients (mean age 67 ± 9 years) with stable coronary heart disease from 39 countries who participated in the Stabilisation of atherosclerotic plaque by initiation of darapladib therapy (STABILITY) trial completed a life style questionnaire which included questions on common foods. A Mediterranean diet score (MDS) was calculated for increasing consumption of whole grains, fruits, vegetables, legumes, fish, and alcohol, and for less meat, and a ‘Western diet score’ (WDS) for increasing consumption of refined grains, sweets and deserts, sugared drinks, and deep fried foods. A multi-variable Cox proportional hazards models assessed associations between MDS or WDS and MACE, defined as CV death, non-fatal myocardial infarction, or non-fatal stroke. Results After a median follow-up of 3.7 years MACE occurred in 7.3% of 2885 subjects with an MDS ≥15, 10.5% of 4018 subjects with an MDS of 13–14, and 10.8% of 8579 subjects with an MDS ≤12. A one unit increase in MDS >12 was associated with lower MACE after adjusting for all covariates (+1 category HR 0.95, 95% CI 0.91, 0.98, P = 0.002). There was no association between WDS (adjusted model +1 category HR 0.99, 95% CI 0.97, 1.01) and MACE. Conclusion Greater consumption of healthy foods may be more important for secondary prevention of coronary artery disease than avoidance of less healthy foods typical of Western diets. PMID:27109584

  9. Right Heart Transvalvular Embolus with High Risk Pulmonary Embolism in a Recently Hospitalized Patient: A Case Report of a Therapeutic Challenge

    PubMed Central

    Acharya, Gyanendra Kumar; Adedayo, Ajibola Monsur; Prabhu, Hejmadi; Brinster, Derek R.; Mir, Parvez

    2015-01-01

    Thrombus-in-transit is not uncommon in pulmonary embolism but Right Heart Transvalvular Embolus (RHTVE) complicating this is rare. A 54-year-old obese male with recent hospitalization presented with severe dyspnea and collapse. Initial investigations revealed elevated d-dimer and troponin. CTA showed saddle pulmonary embolus and bedside echocardiogram revealed right ventricular (RV) pressure overload and dilatation (RV > 41 mm), McConnell's sign, and mobile echodensity attached to tricuspid valve. Patient was immediately resuscitated and promptly transferred for surgical embolectomy under cardiopulmonary bypass. A long segment of embolus traversing through the tricuspid valve and extensive bilateral pulmonary artery embolus were removed. IVC filter was placed for a persistent right lower extremity DVT. Hypercoagulable work-up was negative. Patient continued to do well after discharge on Coumadin. Open embolectomy offers great promises where there is no consensus in optimal management approach in such patients. Bedside echocardiogram is vital in risk stratification and deciding choice of advanced PE treatment. PMID:26417470

  10. Descriptive summary of patients seen at the surgical companies during Operation Iraqi Freedom-1.

    PubMed

    Walker, G Jay; Zouris, James; Galarneau, Michael F; Dye, Judy

    2007-01-01

    The Navy-Marine Corps Combat Trauma Registry is a data repository summarizing information from data sets describing injuries sustained and treatments administered to casualties from the point of injury to rehabilitation. Among the medical facilities contributing data to the Combat Trauma Registry during Operation Iraqi Freedom were the Marine Corps forward surgical companies. The surgical companies offer resuscitative surgery, medical treatment, and temporary holding facilities, in addition to preparing patients for evacuation. This article reviews the types of patients admitted and treatments provided at the surgical companies during the major combat period of Operation Iraqi Freedom. The surgical companies saw an average of 15 to 17 patients per day during this period. Less than 20% of the U.S. casualties seen were wounded in action. In contrast, >75% of the enemy prisoner of war presentations were for battle injuries. Less than 15% of the patients were held at the facilities for >24 hours.

  11. A retrospective study of risk factors for poor outcomes in methicillin-resistant staphylococcus aureus (MRSA) infection in surgical patients

    PubMed Central

    2011-01-01

    Background Since its isolation, Methicillin-resistant Staphlococcus aureus (MRSA) has become a major cause of hospital acquired infection (HAI), adverse patient outcome and overall resource utilisation. It is endemic in Scotland and widespread in Western hospitals. MRSA has been the subject of widespread media interest- a manifestation of concerns about sterile surgical techniques and hospital cleanliness. This study aimed to investigate patient outcome of MRSA infections over the last decade at a major orthopaedic trauma centre. The objective was to establish the association of variables, such as patient age and inpatient residence, against patient outcome, in order to quantify significant relationships; facilitating the evaluation of management strategies with an aim to improving patient outcomes and targeting high-risk procedures. Methods This is a retrospective study of the rates and outcomes of MRSA infection in orthopaedic trauma at the Royal Infirmary of Edinburgh. Data was collated using SPSS 14.0 for Windows(R). Shapiro-Wilkes testing was performed to investigate the normality of continuous data sets (e.g: age). Data was analysed using both Chi-Squared and Fisher's exact tests (in cases of expected values under 5) Results This study found significant associations between adverse patient outcome (persistent deep infection, osteomyelitis, the necessity for revision surgery, amputation and mortality) and the following patient variables: Length of inpatient stay, immuno-compromise, pre-admission residence in an institutional setting (such as a residential nursing home) and the number of antibiotics used in patient care. Despite 63% of all infections sampled resulting from proximal femoral fractures, no association between patient outcome and site of infection or diagnosis was found. Somewhat surprisingly, the relationship between age and outcome of infection was not proved to be significant, contradicting previous studies suggesting a statistical association

  12. TextWithSurgeryPatients - A Research Hypothesis in Enhancing Education and Physical Assessment for Abdominal Surgical Patients.

    PubMed

    Hansen, Margaret

    2016-01-01

    Medical surgical nurses may not have the time or resources to provide effective pre- and post-operative instructions for patients in today's healthcare system. And, making timely physical assessments following discharge from the hospital is not always straightforward. Therefore, the risk for readmission associated with post-surgical complications is a concern. At present, mobile healthcare technologies and patient care are precipitously evolving and may serve as a resource to enhance communication between the healthcare provider and patient. A mobile telephone text message (short message service [SMS]) intervention for abdominal surgical patients may foster effective education (communication) and timely self-reported physical assessment in the home environment hence preventing deleterious outcomes. The aim of this research proposal is to identify the feasibility of using a SMS intervention via smart phones to improve health outcomes via timely communication, reach large numbers of at-risk surgical patients and, establish and sustain uniform protocols in a cost-efficient manner. PMID:27332251

  13. [Intraoperative anaphylaxis caused by latex surgical gloves].

    PubMed

    Tomita, S; Sugawara, K; Tamakawa, S; Saitoh, Y

    1998-02-01

    A 17-year-old male encountered anaphylaxis caused by latex surgical gloves during emergency surgery under general anesthesia. He had undergone multiple surgical procedures, bladder catheterization and was suffering from atopic dermatitis. The patient developed bronchospasm and circulatory collapse 20 minutes after the start of surgery. Administration of dopamine, aminophylline and methylprednisolone helped to normalize airway pressure and blood pressure. Latex allergy occurs in persons considered at high risk including patient with spina bifida, urogenital abnormalities, atopic dermatitis, health care workers and rubber industry workers. These persons may develop hypersensitivity to latex products. If patients