Long-Term Results of Laparoscopic Sleeve Gastrectomy for Morbid Obesity: 5 to 8-Year Results.

PubMed

Gadiot, Ralph P M; Biter, L Ulas; van Mil, Stefanie; Zengerink, Hans F; Apers, J; Mannaerts, Guido H H

2017-01-01

Although long-term results of sleeve gastrectomy (LSG) remain scarce in the literature, its popularity as a stand-alone procedure has accounted for a global increase in LSG performance. In this retrospective study, the authors present 5 to 8-year follow-up results in terms of weight loss, failure/revision rate, and comorbidity resolution from a single center. A prospectively maintained database was reviewed for patients who underwent LSG between 2007 and 2010. Data analysis on weight loss, comorbid conditions, revision surgery, and mortality was conducted. Median percentage excess BMI loss (%EBMIL) was 59.0, and 53.9 %, and median percentage total weight loss (%TWL) was 25.1, and 22.9 % at 5 and 8 years, respectively. Revision to gastric bypass due to insufficient weight loss or gastroesophageal reflux disease (GERD) was performed in 42 patients (15.2 %). Resolution of comorbid condition was achieved in 91 % of patients with obstructive sleep apnea syndrome (OSAS), 68 % of patients with type 2 diabetes (T2DM), 53 % of patients with hypertension, and 25 % of patients with dyslipedemia. Loss to follow-up rate was 45 % at 5 years, 28 % at 6 years, 23 % at 7 years, and 13 % at 8 years. This study adds to the currently available data confirming the LSG to be a safe and effective procedure at long term. Data from high-volume studies are needed to establish the definite role of the LSG in the spectrum of bariatric procedures.

Fisics-Incor bovine pericardial bioprostheses: 15 year results.

PubMed

Pomerantzeff, P M; Brandao, C M; Cauduro, P; Puig, L B; Grinberg, M; Tarasoutchi, F; Cardoso, L F; Lerner, A; Stolf, N A; Verginelli, G; Jatene, A D

1998-01-01

From March 1982 to December 1995, 2,607 Fisics-Incor bovine pericardial bioprostheses were implanted in 2,259 patients. Mean age was 47.2 +/- 17.5 years, and 55% were male. Rheumatic fever was present in 1,301 (45.7%) patients. One thousand and seventy-three aortic valve replacements, 1,085 mitral replacements, 27 tricuspid replacements, 195 mitral-aortic replacements, and 16 other combined valve replacements were carried out. Combined procedures were performed in 788 (32.9%) patients, the most frequent being tricuspid valve repair (9.2%) and coronary artery bypass grafting (7.7%). Hospital mortality was 8.6% (194 patients), 8.6% for the mitral group, 4.7% for the aortic group, and 12.8% for double-valve replacements. The linear rates for calcification, thromboembolism, rupture, leak and endocarditis were, respectively, 1.1%, 0.2%, 0.9%, 0.1% and 0.5% patient-year. The actuarial survival curve was 56.7 +/- 5.4% in 15 years. Survival free from endocarditis was 91.92%, survival free from thromboembolism was 95 +/- 1.7%, survival free from rupture was 43.7 +/- 9.8%, survival free from leak was 98.9 +/- 4.5%, and survival free from calcification was 48.8 +/- 7.9% in 15 years. In the late postoperative period, 1,614 (80.6%) patients were in New York Heart Association functional Class I. We conclude that the results with the Fisics-Incor bovine pericardial prostheses were satisfactory in our group of patients.

[Clinical Trial to Test the iFuse Implant System® in Patients with Sacroiliac Joint Syndrome: One Year Results].

PubMed

Bornemann, R; Pflugmacher, R; Webler, M; Koch, E M W; Dengler, J; Wirtz, D C; Frey, S P

2016-12-01

Background: This study reports one year post-operative monitoring of the efficacy and safety of iFuse Implant System® in patients with sacroiliac joint syndrome. Material and Methods: After 6 months of inadequate conservative treatment, patients with properly proven ISG syndrome were selected for surgery. The iFuse implants had a triangular profile and coating of porous titanium plasma spray and were used in the minimally invasive procedures. The procedure was performed under general anaesthesia and fluoroscopic control. In each case, three implants were placed. Results: 24 patients (22 f; 92 %; 54.9 ± 14 years) participated in the study. The operations were performed in 11 patients (46 %) on the left and in 13 patients (54 %) on the right. The mean operative time was 42.4 minutes (95 % CI: 35.6-49.3). The reduction in pain intensity on the VAS scale was 58 ± 11 mm (68 ± 7 %). The Oswestry score showed a median decrease of 44 percentage points (57 %). After 12 months, 15 patients (63 %) reported that they were taking no more painkillers. Conclusion: The minimally invasive treatment of patients with sacroiliac joint syndrome using the iFuse Implant System leads to significant analgesic effects over the period of one year; it also contributes significantly to improving the functioning of the patient. Georg Thieme Verlag KG Stuttgart · New York.

Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a Medicare claims analysis.

PubMed

Clark, Mary Ann; Arnold, Suzanne V; Duhay, Francis G; Thompson, Ann K; Keyes, Michelle J; Svensson, Lars G; Bonow, Robert O; Stockwell, Benjamin T; Cohen, David J

2012-09-01

Patients with severe, symptomatic aortic stenosis, who do not undergo valve replacement surgery have a poor long-term prognosis. Limited data exist on the medical resource utilization and costs during the final stages of the disease. We used data from the 2003 Medicare 5% standard analytic files to identify patients with aortic stenosis and a recent hospitalization for heart failure, who did not undergo valve replacement surgery within the ensuing 2 calendar quarters. These patients (n=2150) were considered to have medically managed severe aortic stenosis and were tracked over 5 years to measure clinical outcomes, medical resource use, and costs (from the perspective of the Medicare Program). The mean age of the cohort was 82 years, 64% were female, and the estimated logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (a measure of predicted mortality with cardiac surgery) was 17%. During 5 years of follow-up, overall mortality was 88.4% with a mean survival duration of 1.8 years. During this time period, patients experienced an average of 4.4 hospital admissions, 52% were admitted to skilled nursing care, and 28% were admitted to hospice care. The total 5-year costs were $63 844 per patient, whereas mean annual follow-up costs (excluding the index quarter) per year alive were $29 278. Elderly patients with severe aortic stenosis undergoing medical management have limited long-term survival and incur substantial costs to the Medicare Program. These results have important implications for policy makers interested in better understanding the cost-effectiveness of emerging treatment options such as transcatheter aortic valve replacement.

How healthy are chronically ill patients after eight years of homeopathic treatment? – Results from a long term observational study

PubMed Central

Witt, Claudia M; Lüdtke, Rainer; Mengler, Nils; Willich, Stefan N

2008-01-01

Background Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up. Methods In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years. Results A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 ± 12.3; 819 children, 48.4% female, age 6.5 ± 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 ± 1.7 to 2.9 ± 2.2 and 2.7 ± 2.1; children from 6.1 ± 1.8 to 2.1 ± 2.0 and 1.7 ± 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success. Conclusion Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years. PMID:19091085

Four-Year Evolution of a Thrombophylaxis Protocol in an Enhanced Recovery After Surgery (ERAS) Program: Recent Results in 485 Patients.

PubMed

Blanchet, Marie-Cécile; Frering, Vincent; Gignoux, Benoît; Matussière, Yann; Oudar, Philippe; Noël, Romain; Mirabaud, Alban

2018-05-12

"Enhanced recovery after surgery" (ERAS) protocols may reduce morbidity, length of hospital stay (LOS), and costs. During the 4-year evolution of a bariatric ERAS protocol, we found that administration of thrombophylaxis selectively to high-risk morbidly obese patients (assessed postoperatively by Caprini score ≥ 3) undergoing omega loop gastric bypass ("mini" gastric bypass) or sleeve gastrectomy resulted in safe outcomes. Both procedures proved equally effective with this protocol. The vast majority of rapidly mobilized, low-risk patients did not appear to require antithrombotic heparin. Similar to other reported ERAS outcomes, our recent year's results in 485 patients included a mean LOS of 1.08 ± 0.64 days (range 1-14), with 460 (95.0%) discharged on day 1 and 99.6% by day 2. There were 13 30-day complications (2.7%), two reinterventions (0.4%), and no hemorrhages.

Valvular replacement for aortic stenosis in patients over 70 years: immediate risk and long-term results (from a consecutive series of 355 patients).

PubMed

Rioux, C; Logeais, Y; Leguerrier, A; Langanay, T; Delambre, J F; Le Couls, H; Le Normand, J P; Boulvard, J

1988-04-01

From 1971 to 1985, 355 patients over 70 years of age (mean age 73.7) underwent isolated aortic valve replacement, most of them for pure calcified stenosis (78.6%). Mechanical valves (group A) were used in 112 cases (109 Bjork-Shiley; 3 SJM) and bioprostheses (group B) exclusively implanted since 1981 (192 Edwards-Carpentier; 51 Ionescu-Shiley). Thirty-six patients died post-operatively (10.1%). 36% of the deaths were related to cardiac causes, and 14% to cerebral damage. The follow-up involved 100% of the 319 survivors and spanned 12 years (1 month to 11.8 years), with an average of 3.2 years. The follow-up was almost equally distributed between groups A and B: 474 and 453 patient-years, respectively. Sixty late deaths (18.8%) occurred: 26.7% of them related to cardiac causes, and 20% to cerebral accidents. Twenty-nine cases were in group A (6.1% patient-years), and 31 in group B (5.7% patient-years). Acturial analysis shows that, at five years, 94.1% of patients in group A and 96% in group B were free of valve-related complications, and that 88.9% in group A and 89% in group B were free of valve-related non-lethal complications. Actuarial calculation of survival rates shows that, at five years, the probability of survival was 70.8% for the entire series, including the operative deaths. This curve of survival is similar to that of the normal population of the same age. Moreover, the functional status is dramatically improved by surgery: 99.6% of patients are in the NYHA classes I or II.

Three-year follow-up results of a residential community reintegration program for patients with chronic acquired brain injury.

PubMed

Geurtsen, Gert J; van Heugten, Caroline M; Martina, Juan D; Rietveld, Antonius C; Meijer, Ron; Geurts, Alexander C

2012-05-01

To evaluate outcomes of a residential community reintegration program 3 years after treatment on independent living, societal participation, emotional well-being, and quality of life in patients with chronic acquired brain injury and psychosocial problems hampering societal participation. A follow-up assessment 3 years after treatment was compared with the 1-year follow-up assessment in a prospective cohort study. A tertiary rehabilitation center for acquired brain injury. Of the 67 patients assessed at the 1-year follow-up, 63 subjects (94%; 42 men; mean age at admission to treatment 24.7y; mean time postonset 5.1y) were available at the 3-year follow-up and taken into account in the analyses. A structured residential treatment program directed at improving independence in domestic life, work, leisure time, and social interactions. Community Integration Questionnaire, Employability Rating Scale, living situation, school, work situation, work hours, Center for Epidemiological Studies-Depression scale, and the World Health Organization Quality of Life Scale Abbreviated (5 scales). There were no significant differences for any of the outcome measures between the 1-year and 3-year follow-up assessment. These results indicate that the established significant and clinically relevant improvements after a residential community reintegration program remain stable in the long term. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

How healthy are chronically ill patients after eight years of homeopathic treatment?--Results from a long term observational study.

PubMed

Witt, Claudia M; Lüdtke, Rainer; Mengler, Nils; Willich, Stefan N

2008-12-17

Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up. In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years. A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 +/- 12.3; 819 children, 48.4% female, age 6.5 +/- 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 +/- 1.7 to 2.9 +/- 2.2 and 2.7 +/- 2.1; children from 6.1 +/- 1.8 to 2.1 +/- 2.0 and 1.7 +/- 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success. Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years.

Preoperative Chemoradiotherapy for Rectal Cancer in Patients Aged 75 Years and Older: Acute Toxicity, Compliance with Treatment, and Early Results.

PubMed

Guimas, Valentine; Boustani, Jihane; Schipman, Benjamin; Lescut, Nicolas; Puyraveau, Marc; Bosset, Jean François; Servagi-Vernat, Stéphanie

2016-06-01

Treatment of locally advanced rectal cancer (T3-T4 or N+) is based on short-course radiotherapy (RT) or chemoradiotherapy (CRT) followed by surgery. It is estimated that 30-40 % of rectal cancer occurs in patients aged 75 years or more. Data on adherence to neoadjuvant CRT and its safety remain poor owing to the under-representation of older patients in randomized clinical trials and the discordance in the results from retrospective studies. The aim of this study was to assess adherence with preoperative CRT and tolerability in older patients with a stage II/III unresectable rectal cancer. Patients aged 75 years or more with stage II/III rectal cancer treated with preoperative CRT at the University Hospital of Besancon from 1993 to 2011 were included. Feasibility, toxicities, overall survival, and local recurrence rates were studied. Fifty-six patients with a Charlson score from 2 to 6 were included. The mean age was 78 years. The compliance rates for RT and chemotherapy were 91 and 41.1 %, respectively. Two patients stopped CRT; one for hemostatic surgery, and one for severe sepsis. For CRT, the rate of grade ≥3 toxicity was 14.29 %, mainly the digestive type. Fifty-two patients underwent tumor resection, including 76.79 % total mesorectal excision resection with 84.6 % complete resection, and a rate of postoperative complications of 39.6 %. At 2 years, the overall survival and local recurrences rates were 87.3 and 7.8 %, respectively. In older patients, selected preoperative CRT, with an adapted chemotherapy dose, is well tolerated. The main toxicity was gastrointestinal. Adherence to RT is comparable to that of younger patients.

Clinical course after five years of insulin therapy in patients with type 2 diabetes in Spain: results of the EDIN study.

PubMed

Rodríguez, Angel; Tofe, Santiago; Reviriego, Jesus

2014-01-01

The primary study objective was to assess the proportion of patients with type 2 diabetes and an HbA1c value ≤ 6.5% from the start of insulin therapy to five years later in the outpatient setting in Spain. This was an observational, multicenter, naturalistic study with retrospective collection of clinical data. Investigators were endocrinologists or internal medicine specialists from all over Spain. During standard clinical care, patients started insulin therapy, which was continued for at least 5 years. The clinical records of 405 patients were reviewed. The final analysis set included records from 346 patients. At baseline (start of insulin therapy), 51.2% of patients were female; mean (SD) age was 64.6 (9.0) years; body mass index, 29.8 (4-5) kg/m(2); time since diagnosis, 8.8 (6.8) years; HbA1c, 9.4% (1.5); fasting glucose, 223.7 (55.9) mg/dL; and mean 2-hour postprandial glucose, 293.6 (71.0) mg/dL. When insulin therapy was started, <1.0% of patients had an HbA1c value ≤ 6.5%. At 5 years, 10.3% of patients achieved the HbA1c goal of ≤ 6.5% (mean, 7.72%). All glucose parameters (HbA1c, fasting glucose, and 2-hour postprandial glucose) improved at 5 years as compared to values at the start of insulin therapy. Glucose parameters improved over time in patients with type 2 diabetes in this naturalistic study. However, blood glucose control exceeded the internationally recommended target values. These results therefore suggest that there is still some margin for improvement in outpatient care in Spain. Copyright © 2013 SEEN. Published by Elsevier Espana. All rights reserved.

Food and Drug Administration study update. One-year results from 671 patients with the 3M multifocal intraocular lens.

PubMed

Lindstrom, R L

1993-01-01

The clinical evaluation of the Food and Drug Administration study of the 3M diffractive multifocal intraocular lens (IOL) is presented here to demonstrate the results of 1-year postoperative data accumulated for 671 patients, the first of whom received the implant in 1987. Patients were selected for study if they had absence of preoperative pathology, were at least 60 years of age, and had a reasonable postoperative prognosis. Extensive evaluations took place at 4 to 6 months and 12 to 14 months after surgery, including five different visual acuity measurements and contrast sensitivity. All testing was completed on both eyes. Data from the fellow eye served as a control when implanted with a monofocal IOL. Overall uncorrected distance visual acuity at 1 year after surgery shows 57% patients with 20/40 or better acuity. In this same group, 78% achieved J3 or better near vision, which improved to 82% in the best case group. Uncorrected visual acuity of 20/40 or better and J3 or better was achieved by 50% of best case multifocal IOL patients, compared with 26% of the monofocal best case comparison group. Measurements of contrast sensitivity consistently document a small loss, which is considered clinically insignificant. Statistical analysis of satisfaction ratings shows that predictors of satisfaction include uncorrected distance acuity, final near acuity, and fellow eye spherical equivalent. This multifocal lens appears to work very well for most patients, with more than half having functional uncorrected distance and near vision. The study showed several considerations that are important for optimizing clinical performance and patient satisfaction: patient selection, realistic expectations, accurate biometry, and adequate control of surgical procedures.

[Fall events in geriatric hospital in-patients. Results of prospective recording over a 3 year period].

PubMed

von Renteln-Kruse, W; Krause, T

2004-02-01

For a period of 3 consecutive years, all fall events were prospectively recorded in geriatric hospital in-patients by using a standardized protocol. The incidence was 9.1 fall events/1000 hospital days in 5946 patients, and 41.0/1000 hospital days in 1015 patients (17.0%) who actually had falls. The fall rate varied between 35.0-57.0/1000 hospital days according to the main diagnostic group. Fall events were more often recorded in men than women. Recurrent falls (> or =3 falls) which contributed 13% to the 1596 falls were recorded more frequently in male patients. The majority of fall events (73.5%) occurred in patient rooms, another 20% on the floor between the patient's bedroom and toilet/bath, or in the toilet/bath, respectively. The absolute numbers of falls during night and day were not different. However, there were different patterns in the time distribution of high fall frequencies according to the main diagnostic groups. Confusion and dehydration were recorded more frequently with fall events in patients 80 years and older, and more often in fall events during the night. Injuries due to falls which had to be treated were rare, and fall-related fractures were very rare. The average duration of in-hospital stay was longer for patients with than without falls.

[Old and new long stay patients in French psychiatric institutions: results from a national random survey with two-year follow-up].

PubMed

Chapireau, F

2005-01-01

, specialised wards for children were very poorly staffed and received patients with most severe problems. Some of these patients have now become adults and live in the hospital where they were admitted as children. Another question is about how services should be organised so that patients will be able to stay out of hospital despite their severe problems in daily life. A third question is about institutions for disabled persons, who are supposed to provide shelter for patients with disabilities, yet fail to do so for a number of them, so that these persons are admitted to a psychiatric hospital, then cannot leave it. This first French national random survey in psychiatric institutions, with two-year follow up, shows that old and new long stay patients are found in French psychiatric institutions. The results provide information about the patients; they can also help planners in order to improve appropriate services.

Reverse shoulder arthroplasty in 3 and 4 part proximal humeral fractures in patients aged more than 65 years: Results and complications.

PubMed

Villodre-Jiménez, J; Estrems-Díaz, V; Diranzo-García, J; Bru-Pomer, A

The treatment of 3and 4 part proximal humeral fractures in elderly patients is still controversial. The frequent co-existence of poor quality bone and rotator cuff abnormalities in patients with multiple clinical conditions and with difficulties for physical rehabilitation leads to disappointing clinical results, even when the radiological images are acceptable. To evaluate the clinical, radiological, and functional results in patients over 65 years old with complex proximal humerus fractures treated with reverse shoulder arthroplasty. A prospective review was carried out on 30 patients (26 women and 4 men) with proximal humeral fractures treated with reverse shoulder arthroplasty in our department. The mean age was 74.9 years (SD=6.3), and the mean follow-up was 34.5 months (SD=19.3). Clinical and functional results were acceptable, with a mean forward flexion of 124° and a mean external rotation of 13°. The mean abbreviated Constant abbreviated score was 49.1 (SD=14.1), 27 (SD=6.3) in the UCLA scale, and 32.2 (SD=19.2) in the QuickDASH questionnaire. The large majority (80%) of the patients are pain free, and they do not need medication to do daily activities. The complication rate was 13.3%. We consider that reverse shoulder arthroplasty is a valid option to treat 3and 4 part proximal humeral fractures in elderly patients. The surgical goals should include the anatomical reconstruction of the tuberosities, avoiding enlargement of the operated arm greater than 2cm. Copyright © 2016 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Multi-disciplinary management for patients with oligometastases to the brain: results of a 5 year cohort study.

PubMed

Maclean, Jillian; Fersht, Naomi; Singhera, Mausam; Mulholland, Paul; McKee, Orla; Kitchen, Neil; Short, Susan C

2013-06-27

The incidence of oligometastases to the brain in good performance status patients is increasing due to improvements in systemic therapy and MRI screening, but specific management pathways are often lacking. We established a multi-disciplinary brain metastases clinic with specific referral guidelines and standard follow-up for good prognosis patients with the view that improving the process of care may improve outcomes. We evaluated patient demographic and outcome data for patients first seen between February 2007 and November 2011. The clinic was feasible to run and referrals were appropriate. 87% of patients referred received a localised therapy during their treatment course. 114 patients were seen and patient numbers increased during the 5 years that the clinic has been running as relationships between clinicians were developed. Median follow-up for those still alive was 23.1 months (6.1-79.1 months). Primary treatments were: surgery alone 52%, surgery plus whole brain radiotherapy (WBRT) 9%, radiosurgery 14%, WBRT alone 23%, supportive care 2%. 43% received subsequent treatment for brain metastases. 25%, 11% and 15% respectively developed local neurological progression only, new brain metastases only or both. Median overall survival following brain metastases diagnosis was 16.0 months (range 1-79.1 months). Breast (32%) and NSCLC (26%) were the most common primary tumours with median survivals of 26 and 16.9 months respectively (HR 0.6, p=0.07). Overall one year survival was 55% and two year survival 31.5%. 85 patients died of whom 37 (44%) had a neurological death. Careful patient selection and multi-disciplinary management identifies a subset of patients with oligometastatic brain disease who benefit from aggressive local treatment. A dedicated joint neurosurgical/ neuro-oncology clinic for such patients is feasible and effective. It also offers the opportunity to better define management strategies and further research in this field. Consideration should be

Variation in Results Release and Patient Portal Access to Diagnostic Test Results at an Academic Medical Center

PubMed Central

Krasowski, Matthew D.; Grieme, Caleb V.; Cassady, Brian; Dreyer, Nicholas R.; Wanat, Karolyn A.; Hightower, Maia; Nepple, Kenneth G.

2017-01-01

Background: Electronic health records (EHRs) are commonplace in industrialized countries. Many hospitals are granting their patients access to their medical information through online patient portals. In this report, we describe a retrospective analysis of patient access to diagnostic test results released through the patient portal (MyChart; Epic, Inc.) at a state academic medical center. Methods: We analyzed 6 months of data for anatomic pathology, clinical laboratory, and radiology test results to evaluate variations in results release (automated vs. manual) and subsequent patient access to the institutional patient portal. During this period, diagnostic test results were released for all patient encounters including inpatient units, outpatient clinics, and the emergency department. Results: Manual results release by providers before automated release time occurred most commonly in the outpatient setting. The highest rates of access of diagnostic test results occurred for outpatients (about 30% overall view rate), females (two times or more compared to males in nearly every age bracket), and 20–45-year-old. Access rates of diagnostic tests in the emergency department or inpatient units were <10% across all populations. Access of diagnostic test results was very low for 12–17-year-old, likely influenced by institutional policies limiting parental proxy access within this pediatric age range. Approximately 20% of outpatient laboratory results were viewed by patients within 8 h of release from the EHR to the patient portal and 10% within 2 h of release. Conclusions: Patient accessing of diagnostic test results were generally higher for females, outpatients, and 20–45-year-old. Approximately, 20% of outpatient results were viewed quickly by patients after release to the EHR. PMID:29226008

Arthroplasty for cervical spondylotic myelopathy: similar results to patients with only radiculopathy at 3 years' follow-up.

PubMed

Fay, Li-Yu; Huang, Wen-Cheng; Wu, Jau-Ching; Chang, Hsuan-Kan; Tsai, Tzu-Yun; Ko, Chin-Chu; Tu, Tsung-Hsi; Wu, Ching-Lan; Cheng, Henrich

2014-09-01

Cervical arthroplasty has been accepted as a viable option for surgical management of cervical spondylosis or degenerative disc disease (DDD). The best candidates for cervical arthroplasty are young patients who have radiculopathy caused by herniated disc with competent facet joints. However, it remains uncertain whether arthroplasty is equally effective for patients who have cervical myelopathy caused by DDD. The aim of this study was to compare the outcomes of arthroplasty for patients with cervical spondylotic myelopathy (CSM) and patients with radiculopathy without CSM. A total of 151 consecutive cases involving patients with CSM or radiculopathy caused by DDD and who underwent one- or two-level cervical arthroplasty were included in this study. Clinical outcome evaluations and radiographic studies were reviewed. Clinical outcome measurements included the Visual Analog Scale (VAS) of neck and arm pain, Japanese Orthopaedic Association (JOA) scores, and the Neck Disability Index (NDI) in every patient. For patients with CSM, Nurick scores were recorded for evaluation of cervical myelopathy. Radiographic studies included lateral dynamic radiographs and CT for detection of the formation of heterotopic ossification . Of the 151 consecutive patients with cervical DDD, 125 (82.8%; 72 patients in the myelopathy group and 53 in the radiculopathy group) had at least 24 months of clinical and radiographic follow-up. The mean duration of follow-up in these patients was 36.4 months (range 24-56 months). There was no difference in sex distribution between the 2 groups. However, the mean age of the patients in the myelopathy group was approximately 6 years greater than that of the radiculopathy group (53.1 vs 47.2 years, p < 0.001). The mean operation time, mean estimated blood loss, and the percentage of patients prescribed perioperative analgesic agents were similar in both groups (p = 0.754, 0.652, and 0.113, respectively). There were significant improvements in VAS neck

Results of Medium Seventeen Years' Follow-Up after Laparoscopic Choledochotomy for Ductal Stones.

PubMed

Quaresima, Silvia; Balla, Andrea; Guerrieri, Mario; Lezoche, Giovanni; Campagnacci, Roberto; D'Ambrosio, Giancarlo; Lezoche, Emanuele; Paganini, Alessandro M

2016-01-01

Introduction. In a previously published article the authors reported the long-term follow-up results in 138 consecutive patients with gallstones and common bile duct (CBD) stones who underwent laparoscopic transverse choledochotomy (TC) with T-tube biliary drainage and laparoscopic cholecystectomy (LC). Aim of this study is to evaluate the results at up to 23 years of follow-up in the same series. Methods. One hundred twenty-one patients are the object of the present study. Patients were evaluated by clinical visit, blood assay, and abdominal ultrasound. Symptomatic patients underwent cholangio-MRI, followed by endoscopic retrograde cholangiopancreatography (ERCP) as required. Results. Out of 121 patients, 61 elderly patients died from unrelated causes. Fourteen patients were lost to follow-up. In the 46 remaining patients, ductal stone recurrence occurred in one case (2,1%) successfully managed by ERCP with endoscopic sphincterotomy. At a mean follow-up of 17.1 years no other patients showed signs of bile stasis and no patient showed any imaging evidence of CBD stricture at the site of choledochotomy. Conclusions. Laparoscopic transverse choledochotomy with routine T-tube biliary drainage during LC has proven to be safe and effective at up to 23 years of follow-up, with no evidence of CBD stricture when the procedure is performed with a correct technique.

Variation in Results Release and Patient Portal Access to Diagnostic Test Results at an Academic Medical Center.

PubMed

Krasowski, Matthew D; Grieme, Caleb V; Cassady, Brian; Dreyer, Nicholas R; Wanat, Karolyn A; Hightower, Maia; Nepple, Kenneth G

2017-01-01

Electronic health records (EHRs) are commonplace in industrialized countries. Many hospitals are granting their patients access to their medical information through online patient portals. In this report, we describe a retrospective analysis of patient access to diagnostic test results released through the patient portal (MyChart; Epic, Inc.) at a state academic medical center. We analyzed 6 months of data for anatomic pathology, clinical laboratory, and radiology test results to evaluate variations in results release (automated vs. manual) and subsequent patient access to the institutional patient portal. During this period, diagnostic test results were released for all patient encounters including inpatient units, outpatient clinics, and the emergency department. Manual results release by providers before automated release time occurred most commonly in the outpatient setting. The highest rates of access of diagnostic test results occurred for outpatients (about 30% overall view rate), females (two times or more compared to males in nearly every age bracket), and 20-45-year-old. Access rates of diagnostic tests in the emergency department or inpatient units were <10% across all populations. Access of diagnostic test results was very low for 12-17-year-old, likely influenced by institutional policies limiting parental proxy access within this pediatric age range. Approximately 20% of outpatient laboratory results were viewed by patients within 8 h of release from the EHR to the patient portal and 10% within 2 h of release. Patient accessing of diagnostic test results were generally higher for females, outpatients, and 20-45-year-old. Approximately, 20% of outpatient results were viewed quickly by patients after release to the EHR.

Male-to-female transsexualism: technique, results and 3-year follow-up in 50 patients.

PubMed

Wagner, Sigrid; Greco, F; Hoda, M R; Inferrera, A; Lupo, A; Hamza, A; Fornara, P

2010-01-01

To evaluate the functional and cosmetic results of male-to-female gender-transforming surgery. Between May 2001 and April 2008 we performed 50 male-to-female gender-transforming surgeries. All patients had been cross-dressing, living as women, and receiving estrogen and progesterone for at least 12 months, which was sufficient for breast development and atrophy of the testes and prostate to occur. This hormonal therapy was suspended 1 month before the operation. The mean operative time was 190 min and the mean depth of the vagina was 10 cm. On follow-up, the most common complication (10%) was shrinkage of the neovagina, which could be corrected by a second surgical intervention. Of the 50 patients, 45 (90%) were satisfied with the esthetic results; 42 patients (84%) reported having regular sexual intercourse, 2 of whom had pain during intercourse. Of the 50 patients, 35 (70%) reported achieving clitoral orgasm. Male-to-female gender-transforming surgery can assure satisfactory cosmetic and functional results, with a reduced intra- and postoperative morbidity. Nevertheless the experience of the surgeon and the center remains central to obtaining optimal results. Copyright 2010 S. Karger AG, Basel.

Effectiveness of the Medtep Hemophilia online platform for adherence to prophylactic treatment in haemophilia patients: Results from a 1-year observational study.

PubMed

Cuesta-Barriuso, R; López-Pina, J A; Nieto-Munuera, J; Sagarra-Valls, G; Panisello-Royo, J M; Torres-Ortuño, A

2018-03-01

Medtep Hemophilia platform is an online tool that allows patients with congenital coagulopathies to keep track of their daily condition-related events with the objective of ensuring successful adherence to therapy. To assess the effectiveness of Medtep Hemophilia in improving adherence to prophylactic treatment in haemophilia A and B patients in a 1-year prospective observational study, as well as its impact on the patient's disease status. Patients (>13 years old) received support material to familiarize themselves with Medtep Hemophilia. Adherence to treatment, quality of life (QoL) and illness perception were assessed. Values at baseline, 1, 6 and 12 months, and changes from baseline value were analysed. The Hemophilia Joint Health Score (HJHS) test was applied at baseline and study completion. Forty-six patients were enrolled (43 evaluable). After 1 year, 56.4% patients showed continued use of the platform (100% compliance) whereas 25.6% were inactive. Treatment adherence increased both significantly (P < .001) and progressively during the study. Similarly, improved QoL and illness perception were observed with respect to baseline in most of the questionnaire components (P < .05 after 12 months). A patient's age had no influence on the results, whereas compliant patients (>80% of platform use) tended to score better than noncompliant. The HJHS test values remained similar during the study. The Medtep Hemophilia online platform helped the studied patients with haemophilia to improve their adherence to prophylactic treatment, while increasing their QoL and illness perception, as well as joint arthropathies stabilization. © 2018 John Wiley & Sons Ltd.

Ten-year results of thoracoscopic unilateral extended thymectomy performed in nonthymomatous myasthenia gravis.

PubMed

Tomulescu, Victor; Sgarbura, Olivia; Stanescu, Codrut; Valciu, Crisanda; Campeanu, Ana; Herlea, Vlad; Popescu, Irinel

2011-11-01

The aim of this study was to analyze the 10-year results of thoracoscopic unilateral extended thymectomy (TUET) performed in nontumoral myasthenia gravis according to the Myasthenia Gravis Foundation of America recommendations. Thoracoscopic unilateral extended thymectomy has the benefits of a minimally invasive approach. Previous data have shown promising midterm results but long-term results were lacking. Two hundred forty patients with nontumoral myasthenia gravis who underwent surgery between 1999 and 2009 were eligible for the study. The mean follow-up was of 67 months (range: 12-125), 134 patients completed follow-up assessments more than 60 months after TUET. There were 39 males (16.3%) and 201 females (83.7%), with an age range from 8 to 60 years. The mean preoperative disease duration was 21.5 months. All patients underwent preoperative steroid therapy. Anticholinesterase drugs were required for 123 patients (51.3%), and immunosuppressive drugs were required for 87 (36.3%) patients. The pathologic findings were as follows: normal thymus in 13 patients (5.5%), involuted thymus in 65 patients (27%), and hyperplastic thymus in 162 patients (67.5%). The average weight of the thymus was 110 ± 45 g. Ectopic thymic tissue was found in 147 patients (61.3%). There was no mortality, and morbidity consisted of 12 patients (5%). Complete stable remission was achieved in 61% of the patients, and the cumulative probability of achieving complete stable remission was 0.88 at 10 years. With zero mortality, low morbidity, and comparable long-term results to open surgery, TUET can be regarded as the best treatment option for patients undergoing surgery for myasthenia gravis.

Long-term liver stiffness assessment in hepatitis C virus patients undergoing antiviral therapy: Results from a 5-year cohort study.

PubMed

Facciorusso, Antonio; Del Prete, Valentina; Turco, Antonio; Buccino, Rosario Vincenzo; Nacchiero, Maurizio Cosimo; Muscatiello, Nicola

2018-04-01

Observational studies showed significant liver stiffness regression after sustained virological response, but long-term effects of antiviral therapy are still unknown. The aim of this study was to assess the magnitude of change in stiffness up to 5 years after therapy in hepatitis C patients undergoing antiviral treatment. Data of 153 patients were retrieved. Stiffness was assessed by Fibroscan at baseline, end of treatment, 6 months after treatment, and every year hereafter up to 5 years. Seventy patients were treated with interferon-based regimens and 83 with direct antiviral agents. Baseline cirrhosis was diagnosed in 53 (34.6%) patients. Sustained virological response was achieved in 112 patients, whereas 41 were non-responders. In responders, stiffness decreased from 12.3 kPa (9-17.8) to 6.6 kPa (5.3-7.4) at 5 years. A sharper decline was observed immediately after treatment (-2.5 kPa at the end of treatment and -3.7 kPa at 6 months), while from 1 year onwards, the magnitude of stiffness decrease was progressively lower. In non-responders, stiffness showed a slight decrease at the end of treatment (from 19.2 to 18.1 kPa), then returned to baseline levels at 6 months (19.4 kPa), and finally increased over time up to 23.7 kPa (15-32.5) at 5 years. The proportion of cirrhotic patients decreased by 50% at 6 months and finally fell < 5% at 4 years after treatment. Stiffness declines significantly after achieving response, and the magnitude of decline is greater in the first year after treatment, while it tends to plateau from 1 year onwards. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Tolerability and efficacy of deferasirox in patients with transfusional iron overload: results from a German 2-year non-interventional study.

PubMed

Nolte, Florian; Nückel, Holger; Schmidt, Burkhard; Geer, Thomas; Rubanov, Oleg; Hebart, Holger; Jarisch, Andrea; Albrecht, Stefan; Johr, Christiane; Schumann, Christiane; Hofmann, Wolf-Karsten

2018-05-14

Iron overload (IOL) due to repetitive transfusions of packed red blood cells (pRBC) has a major impact on morbidity and mortality in patients with inherited bone marrow failure syndromes and hemoglobinopathies such as thalassemia and sickle cell disease. However, whether IOL influences the outcome of elderly patients with myeloid malignancies is not yet clear. Moreover, clinical trials have reported high drop-out rates during treatment with the oral iron chelator deferasirox (DFX). Here we report the results of a 2-year prospective observational study that aimed at describing the routine use of DFX in patients with hematological malignancies with regard to safety, efficacy and handling of the drug in a routine setting. A total of 406 patients were included. 58% of the patients were male. Most of the patients had myelodysplastic syndromes (MDS) (68%) and myeloproliferative neoplasms (MPN) (14%). Median time from first transfusion to study enrollment was 1.1 years (0-25.5 years) and most patients were chelation naive (91%) at enrollment. With regard to transfusion burden, most of the patients were moderately or mildly transfusion-dependent with 53% receiving 2-4 and 27% receiving less than 2 units of pRBC per month. Serum ferritin decreased from a mean of 2305 μg/l (± 1449 μg/l) to a mean of 1910 μg/l (± 1529 μg/l) at 24 months. There was no substantial change in transfusion-dependence during the observation period. Dose adjustments were reported in 48% of the patients with dose-escalation strategies being the most frequent reason for dosage increases (49%). The median observation time was 355 days (5-1080 days). Median duration of exposure to DFX was 322 days (2-1078 days). Two-hundred and ninety (72%) patients discontinued the trial prematurely after a median time of 235 days (1-808 days). Death (29%) and adverse events (23%) were the main reasons for discontinuation. Eleven percent of the patients discontinued treatment due to sufficient decrease in

Cutting Balloon Angioplasty (CBA) for the Treatment of Renal Artery Fibromuscular Dysplasia (FMD) in Six Patients: 5-Year Long-Term Results

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

Cotroneo, Antonio Raffaele; Amoroso, Luigi; Giammarino, Alberto

PurposeTo evaluate long-term outcomes in terms of hypertension control, recurrent stenosis, and reinterventions from patients who underwent cutting balloon angioplasty (CBA) for symptomatic renal artery fibromuscular dysplasia (FMD).Materials and MethodsFrom 2011, six consecutive renal artery FMD women underwent CBA for poorly controlled hypertension, despite antihypertensive therapy. Follow-up consisted of blood pressure monitoring and duplex ultrasonography at 1, 6, and 12 months and thereafter annually for 5 years.ResultsAll treatments were technically successful. Recurrence of hypertension was found in two patients within 12 months, and reinterventions were performed using CBA.ConclusionResults show the efficacy of CBA for renal artery FMD.

[Operative treatment and remote results in patients with bronchoalveolar lung cancer].

PubMed

Uchikov, A; Batashki, I; Dimitrov, I; Uchikova, E; Belovezhdov, V; Bonev, P

2008-01-01

Bronchoalveolar pulmonary carcinoma (BAC) is a type of adenocarcinoma with an increasing frequency. Because BAC rarely metastasize outside the thorax, the postoperative results are good. We present 28 patients with BAC, operated in the clinic for a period of 7 years--12 patients with an infiltrative form of BAC, 16 patients with nodular form 12 patients underwent lobectomy, 15 patients--pneumonectomy, and 1 patient--bilobectomy. The 5-years-survival rate is 50%. We found a better 5-years survival rate for the patients with BAC in comparison with the other histological types of non-small cell pulmonary carcinoma

[Atherosclerotic renovascular hypertension: clinical findings and results of treatment over 15 years].

PubMed

Alfonzo, J P; Rosario, M N; Ugarte, C; Banasco, J; Fraxedas, R; Lahera, J

2003-01-01

The aim of this study was to present our clinical experience and results of different treatments in 83 atherosclerotic renovascular hypertensive patients treated in the last 15 years in the Instituto de nefrologia in Havana. Regardless of the type of treatment the patients were divided in two groups. Group I: 52 (62.3%) cases with standard oral hypotensive drugs alone and control of other cardiovascular risk factors (mean age 53 years old, sex m/f 50/50%, race white/no-white 75/25%, mean known hypertension follow-up 10.2 +/- 10 years, mean SBP 208 +/- 30 mmHg, mean DBP 123 +/- 17 mmHg, mean serum creatinina 1.62 mg/dl and increase peripheral plasma renin value in 61.6% of patients) and group II: 31 (37.7%) cases treated with revascularización procedures (PTA or surgery) or nephrectomy in selected patients (mean age 50 years old, sex m/f 68/32%, race white/no-white 16/84%, mean known hypertension follow-up 8.5 +/- 8.6 years, mean SBP 214 +/- 32 mmHg, mean DBP 1.31 +/- 16 mmHg, mean serum creatinina 1.85 mg/dl and increase peripheral plasma renin value 78.3% of patients). As end point for treatment results we selected: 1) hypertension cure or control, 2) evolution of the serum creatinine value and 3) kidney and patients survival. In those cases with a follow up for more than one year, in 82.9% the blood pressure was cure (21.4%) or controlled (61.4%). The proportion of failed was superior in group I (20.9%) than in group II (11.1%). All 18 cases treated by PTA with a follow up period longer than a year, blood pressure cure in 10 (55.6%), ameliorate in 5 (27.8%) and in 3 (16.6%) was unchanged (one patient lost of follow up). Nine patients were treated by surgery (3 revascularization and 6 nephrectomy), 5 (55.5%) cases cured and 4 (44.5%) ameliorate his blood pressure. Patients in group II maintain normal renal function in more cases than in group I (48.4% vs 30.8%). Both group had similar percentage of normal-normal + pathology-normal renal function (G I: 65.4% vs G

Analysis of oxybutynin treatment for hyperhidrosis in patients aged over 40 years

PubMed Central

Wolosker, Nelson; Krutman, Mariana; Teivelis, Marcelo Passos; de Paula, Rafael Pessanha; Kauffman, Paulo; de Campos, Jose Ribas Milanez; Puech-Leão, Pedro

2014-01-01

ABSTRACT Objective: Our aim was to analyze the effectiveness of oxybutynin for hyperhidrosis treatment in patients over 40 years. Methods: Eighty-seven patients aged over 40 years were divided into two groups. One group consisted of 48 (55.2%) patients aged between 40 and 49 years, and another was composed of 39 (44.8%) patients aged over 50 years (50 to 74 years). A comparative analysis of Quality of Life and level of hyperhidrosis between the groups was carried out 6 weeks after a protocol treatment with oxybutynin. A validated clinical questionnaire was used for evaluation. Results: In the younger age group, 75% of patients referred a “partial” or “great” improvement in level of hyperhidrosis after treatment. This number was particularly impressive in patients over 50 years, in which 87.2% of the cases demonstrated similar levels of improvement. Over 77% of patients in both groups demonstrated improvement in Quality of Life. Excellent outcomes were observed in older patients, in which 87.1% of patients presented “slightly better” (41%) or “much better” (46.1%) improvement. Conclusion: Patients aged over 40 years with hyperhidrosis presented excellent results after oxybutynin treatment. These outcomes were particularly impressive in the age group over 50 years, in which most patients had significant improvement in Quality of Life and in level of hyperhidrosis. PMID:24728245

Belgian Schizophrenia Outcome Survey - results of a 2-year naturalistic study in patients stabilised on monotherapy with olanzapine, risperidone or haloperidol.

PubMed

Peuskens, J; Gillain, B; De Graeve, D; Van Vleymen, B; Albert, A

2009-04-01

This Schizophrenia Outcome Survey compared medical costs, psychopathology and adverse events in outpatients for 2 years following hospitalisation for an acute schizophrenic episode. Adults stabilised with haloperidol, olanzapine or risperidone entered this observational study patients (haloperidol 32, olanzapine 149, risperidone 142), baseline characteristics were similar in the olanzapine and risperidone groups, except for more first episodes in the risperidone group (p=0.01). Haloperidol patients were more often single and institutionalised, less educated, had more residual schizophrenia, were longer hospitalised in the previous year, took more corrective and psychotropic drugs and had more extrapyramidal symptoms (EPS) and gynaecomastia (all significantly). Sixty-eight percent of patients completed a 2-year follow-up. In all groups, CGI and GAF improved during the first 3 months (both p<0.0001) while BPRS deteriorated in the first year (all within group changes p<0.05, between group changes NS) before it stabilised. There were no significant differences in hospitalisations and no change in social profile. At the last visit, 66% of haloperidol (p<0.01), 35% of olanzapine (NS) and 39% (NS) of risperidone patients had >or=1 EPS; 69% (p<0.013), 40 and 44%, respectively, had >or=1 sexual problem (NS). Mean weight gain was 0.4 (NS), 2.6 (p<0.05) and 2.6 kg (p<0.05), respectively. In this naturalistic study, treatment allocation might have introduced a bias in the interpretation of efficiency results, but olanzapine and risperidone caused less EPS than haloperidol during 2 years of outpatient follow-up.

Long-Term Results of Total Hip Arthroplasty with 28 millimeter Cobalt-Chromium Femoral Heads on Highly Cross-linked Polyethylene in Patients 50 years and Less

PubMed Central

Stambough, Jeffrey B.; Pashos, Gail; Bohnenkamp, Frank C.; Maloney, William J.; Martell, John M.; Clohisy, John C.

2016-01-01

Highly cross-linked polyethylene (HXLPE) is the most commonly used bearing surface in total hip arthroplasty (THA) because of its superior wear properties, but long-term results in young patients are limited. We report on the clinical outcome, radiographic wear patterns and survivorship of 72 patients ≤50 years old who had a 28-millimeter cobalt-chromium femoral head on HXLPE acetabular liner. Mean and median true linear wear rates at average ten-year follow-up were 0.0104 and 0.016 mm per year +/− 0.07 mm. Mean and median two-dimensional volumetric wear rates were 12.79 mm3 and 5.834 mm3 per year +/− 26.1mm3 as determined by Martell analysis. As a result of the minimal wear profile, there was no evidence of radiographic osteolysis and no wear-related revisions. PMID:26260785

Final 5-Year Study Results of DASISION: The Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients Trial.

PubMed

Cortes, Jorge E; Saglio, Giuseppe; Kantarjian, Hagop M; Baccarani, Michele; Mayer, Jiří; Boqué, Concepción; Shah, Neil P; Chuah, Charles; Casanova, Luis; Bradley-Garelik, Brigid; Manos, George; Hochhaus, Andreas

2016-07-10

We report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients (DASISION) trial, evaluating long-term efficacy and safety outcomes of patients with chronic myeloid leukemia (CML) in chronic phase (CP) treated with dasatinib or imatinib. Patients with newly diagnosed CML-CP were randomly assigned to receive dasatinib 100 mg once daily (n = 259) or imatinib 400 mg once daily (n = 260). At the time of study closure, 61% and 63% of dasatinib- and imatinib-treated patients remained on initial therapy, respectively. Cumulative rates of major molecular response and molecular responses with a 4.0- or 4.5-log reduction in BCR-ABL1 transcripts from baseline by 5 years remained statistically significantly higher for dasatinib compared with imatinib. Rates for progression-free and overall survival at 5 years remained high and similar across treatment arms. In patients who achieved BCR-ABL1 ≤ 10% at 3 months (dasatinib, 84%; imatinib, 64%), improvements in progression-free and overall survival and lower rates of transformation to accelerated/blast phase were reported compared with patients with BCR-ABL1 greater than 10% at 3 months. Transformation to accelerated/blast phase occurred in 5% and 7% of patients in the dasatinib and imatinib arms, respectively. Fifteen dasatinib-treated and 19 imatinib-treated patients had BCR-ABL1 mutations identified at discontinuation. There were no new or unexpected adverse events identified in either treatment arm, and pleural effusion was the only drug-related, nonhematologic adverse event reported more frequently with dasatinib (28% v 0.8% with imatinib). First occurrences of pleural effusion were reported with dasatinib, with the highest incidence in year 1. Arterial ischemic events were uncommon in both treatment arms. These final results from the DASISION trial continue to support dasatinib 100 mg once daily as a safe and effective first-line therapy for the long

Total knee replacement-cementless tibial fixation with screws: 10-year results.

PubMed

Ersan, Önder; Öztürk, Alper; Çatma, Mehmet Faruk; Ünlü, Serhan; Akdoğan, Mutlu; Ateş, Yalım

2017-12-01

The aim of this study was to evaluate the long term clinical and radiological results of cementless total knee replacement. A total of 51 knees of 49 patients (33 female and 16 male; mean age: 61.6 years (range, 29-66 years)) who underwent TKR surgery with a posterior stabilized hydroxyapatite coated knee implant were included in this study. All of the tibial components were fixed with screws. The HSS scores were examined preoperatively and at the final follow-up. Radiological assessment was performed with Knee Society evaluating and scoring system. Kaplan-Meier survival analysis was performed to rule out the survival of the tibial component. The mean HSS scores were 45.8 (range 38-60) and 88.1 (range 61-93), preoperatively and at the final follow-up respectively. Complete radiological assessment was performed for 48 knees. Lucent lines at the tibial component were observed in 4 patients; one of these patients underwent a revision surgery due to the loosening of the tibial component. The 10-year survival rate of a tibial component was 98%. Cementless total knee replacement has satisfactory long term clinical results. Primary fixation of the tibial component with screws provides adequate stability even in elderly patients with good bone quality. Level IV, Therapeutic study. Copyright © 2017 Turkish Association of Orthopaedics and Traumatology. Production and hosting by Elsevier B.V. All rights reserved.

Clinical results of Hi-tech Knee II total knee arthroplasty in patients with rheumatoid athritis: 5- to 12-year follow-up

PubMed Central

2012-01-01

Background Total knee arthroplasty (TKA) is a common form of treatment to relieve pain and improve function in cases of rheumatoid arthritis (RA). Good clinical outcomes have been reported with a variety of TKA prostheses. The cementless Hi-Tech Knee II cruciate-retaining (CR)-type prosthesis, which has 6 fins at the anterior of the femoral component, posterior cruciate ligament (PCL) retention, flat-on-flat surface component geometry, all-polyethylene patella, strong initial fixation by the center screw of the tibial base plate, 10 layers of titanium alloy fiber mesh, and direct compression molded ultra high molecular weight polyethylene (UHMWPE), is appropriate for TKA in the Japanese knee. The present study was performed to evaluate the clinical results of primary TKA in RA using the cementless Hi-Tech Knee II CR-type prosthesis. Materials and methods We performed 32 consecutive primary TKAs using cementless Hi-Tech Knee II CR-type prosthesis in 31 RA patients. The average follow-up period was 8 years 3 months. Clinical evaluations were performed according to the American Knee Society (KS) system, knee score, function score, radiographic evaluation, and complications. Results The mean postoperative maximum flexion angle was 115.6°, and the KS knee score and function score improved to 88 and 70 after surgery, respectively. Complications, such as infection, occurred in 1 patient and revision surgery was performed. There were no cases of loosening in this cohort, and prosthesis survival rate was 96.9% at 12 years postoperatively. Conclusion These results suggest that TKA using the cementless Hi-Tech Knee II CR-type prosthesis is a very effective form of treatment in RA patients at 5 to 12 years postoperatively. Further long-term follow-up studies are required to determine the ultimate utility of this type of prosthesis. PMID:22356935

BARIATRIC SURGERY IN THE ELDERLY: RESULTS OF A MEAN FOLLOW-UP OF FIVE YEARS

PubMed Central

PAJECKI, Denis; SANTO, Marco Aurelio; JOAQUIM, Henrique Dametto Giroud; MORITA, Flavio; RICCIOPPO, Daniel; de CLEVA, Roberto; CECCONELLO, Ivan

2015-01-01

Background : Surgical treatment of obesity in the elderly, particularly over 65, remains controversial; it is explained by the increased surgical risk or the lack of data demonstrating its long-term benefit. Few studies have evaluated the clinical effects of bariatric surgery in this population. Aim : To evaluate the results of surgical treatment of obesity in patients over 60 years, followed for an average period of five years. Method : This was a retrospective study evaluating 46 patients, 60 years or older, who underwent surgical treatment of obesity, by conventional gastric bypass technique (laparotomy). The average age was 64 years (60-71), mean BMI of 49.6 kg/m2 (38-66), mean follow-up of 5.9 years; 91% of patients were hypertensive, 56% diabetics and 39% had dyslipidemia. Results : The incidence of complications (major and minor) in patients under 65 years was 26% and over 65 years 37% (p=0.002). There were no deaths in the group with less than 65 years and there were two deaths (12.5%) over 65 years. The average loss of overweight over 65 years or less was 72% vs 68% (p=0.56). There was total control of the diabetes mellitus in 77% and partial in 23%, with no difference between groups. There was improvement in arterial hypertension in 56% of patients, also no difference between groups. The average LDL levels did not differ between the pre and postoperative (106 mg/dl to 102 mg/dl), an increase of HDL (56 mg/dl to 68 mg/dL) and reduced triglyceride levels (136 mg/dl to 109 mg/dl). There was no statistical difference in the variation of the cholesterol fractions and triglycerides between the groups. Two patients in the group with less than 65 years died in late follow-up, of brain tumor and pneumonia, three and five years after bariatric surgery, respectively. Conclusions : Surgical morbidity and mortality were higher in patients over 65 years, and this group had the same benefits observed in patients lower 65 years for weight loss and comorbidities control

7-year follow-up after stereotactic ablative radiotherapy for patients with stage I non-small cell lung cancer: Results of a phase 2 clinical trial.

PubMed

Sun, Bing; Brooks, Eric D; Komaki, Ritsuko U; Liao, Zhongxing; Jeter, Melenda D; McAleer, Mary F; Allen, Pamela K; Balter, Peter A; Welsh, James D; O'Reilly, Michael S; Gomez, Daniel; Hahn, Stephen M; Roth, Jack A; Mehran, Reza J; Heymach, John V; Chang, Joe Y

2017-08-15

The authors evaluated the efficacy, patterns of failure, and toxicity of stereotactic ablative radiotherapy (SABR) for patients with medically inoperable, clinical stage I non-small cell lung cancer (NSCLC) in a prospective clinical trial with 7 years of follow-up. Clinical staging was performed according to the seventh edition of the American Joint Committee on Cancer TNM staging system. Eligible patients with histologically confirmed NSCLC of clinical stage I as determined using positron emission tomography staging were treated with SABR (50 grays in 4 fractions). The primary endpoint was progression-free survival. Patients were followed with computed tomography and/or positron emission tomography/computed tomography every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually thereafter. A total of 65 patients were eligible for analysis. The median age of the patients was 71 years, and the median follow-up was 7.2 years. A total of 18 patients (27.7%) developed disease recurrence at a median of 14.5 months (range, 4.3-71.5 months) after SABR. Estimated incidences of local, regional, and distant disease recurrence using competing risk analysis were 8.1%, 10.9%, and 11.0%, respectively, at 5 years and 8.1%, 13.6%, and 13.8%, respectively, at 7 years. A second primary lung carcinoma developed in 12 patients (18.5%) at a median of 35 months (range, 5-67 months) after SABR. Estimated 5-year and 7-year progression-free survival rates were 49.5% and 38.2%, respectively; the corresponding overall survival rates were 55.7% and 47.5%, respectively. Three patients (4.6%) experienced grade 3 treatment-related adverse events. No patients developed grade 4 or 5 adverse events (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]). With long-term follow-up, the results of the current prospective study demonstrated outstanding local control and low toxicity after SABR in

Five-Year Biochemical Results, Toxicity, and Patient-Reported Quality of Life After Delivery of Dose-Escalated Image Guided Proton Therapy for Prostate Cancer

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

Bryant, Curtis, E-mail: cbryant@floridaproton.org; Smith, Tamara L.; Henderson, Randal H.

Purpose: To report clinical outcomes in patients treated with image guided proton therapy (PT) for localized prostate cancer. Methods and Materials: The medical records of 1327 men were reviewed. Each man was enrolled on an outcomes tracking study. Dual enrollment on a prospective clinical trial was allowed. Each patient was treated for localized prostate cancer with PT at our institution between 2006 and 2010. Ninety-eight percent of patients received 78 Gy (radiobiological equivalent [RBE]) or higher; 18% received androgen deprivation therapy (ADT). The 5-year freedom from biochemical progression (FFBP), distant metastasis-free survival, and cause-specific survival rates are reported for each risk group. Datamore » on patient-reported quality of life and high-grade toxicities were prospectively collected and reported. A multivariate analysis was performed to identify clinical predictors of biochemical failure and urologic toxicity. Results: The median follow-up time was 5.5 years. The 5-year FFBP rates were 99%, 94%, and 74% in low-risk, intermediate-risk, and high-risk patients, respectively. The actuarial 5-year rates of late grade 3+ Common Terminology Criteria for Adverse Events, version 4.0, gastrointestinal (GI) and genitourinary (GU) toxicity were 0.6% and 2.9%, respectively. Multivariate analysis showed a significant correlation between grade 3+ GU toxicity and pretreatment prostate reductive procedures (P<.0001), prostate volume (P=.0085), pretreatment α-blockers (P=.0067), diabetes (P=.0195), and dose–volume histogram parameters (P=.0208). The median International Prostate Symptom Scores pretreatment scores and scores at 5 years after treatment were 7 and 7, respectively. The mean Expanded Prostate Cancer Index Composite (EPIC) scores significantly declined for sexual summary for patients not receiving ADT (from 67 to 53) between baseline and 5 years. Conclusions: Image guided PT provided excellent biochemical control rates for patients

Ticagrelor versus clopidogrel in real-world patients with ST elevation myocardial infarction: 1-year results by propensity score analysis.

PubMed

Vercellino, Matteo; Sànchez, Federico Ariel; Boasi, Valentina; Perri, Dino; Tacchi, Chiara; Secco, Gioel Gabrio; Cattunar, Stefano; Pistis, Gianfranco; Mascelli, Giovanni

2017-04-05

European guidelines recommend the use of ticagrelor versus clopidogrel in patients with ST elevation myocardial infarction (STEMI). This recommendation is based on inconclusive results and subanalyses from clinical trials. Few data are available on the effects of ticagrelor in a real-world population. To compare the effects of ticagrelor and clopidogrel in a real-world STEMI population, we conducted a pre-post case-control study examining all patients with STEMI included in the Cardio-STEMI Sanremo registry between February 2011 and June 2013. Cases and controls were defined according to P2Y 12 inhibitors, correcting the bias due to lack of randomization by propensity score analysis. Ticagrelor was introduced in 2012 in both in-hospital and pre-hospital settings independently of this study. Of the 416 patients enrolled in the Cardio-STEMI registry, 401 with a definite diagnosis of STEMI were included in this study. One hundred forty-two patients received ticagrelor and 259 received clopidogrel. Regarding clinical presentation and procedural data, those in the ticagrelor group had lower CRUSADE scores (23 [14-36] vs 27 [18-38]; p = 0.015] but a higher proportion of radial access (33% vs 14%; p < 0.001), percutaneous coronary intervention (PCI; 92% vs 81 %; p = 0.002) and primary PCI ≤ 12 h (82% vs 66%; p = 0.001). The patients in the ticagrelor group had a higher procedural success rate (100% vs. 96%; p = 0.044). There was no difference in Bleeding Academic Research Consortium bleeding and in unadjusted incidence of hospital major adverse cardiovascular events (MACE; cardiac death, myocardial infarction, or stroke) but there was a significant reduction in unadjusted cardiac hospital death in the ticagrelor group (0.7% vs 5.4%; p = 0.024). After correcting for propensity score, hospital death (p = 0.22) and hospital MACE (p = 0.96) did not differ in both groups. The unadjusted survival at 1 year after STEMI was higher in the ticagrelor group (97

Long-Term Results of Total Hip Arthroplasty with 28-Millimeter Cobalt-Chromium Femoral Heads on Highly Cross-Linked Polyethylene in Patients 50 Years and Less.

PubMed

Stambough, Jeffrey B; Pashos, Gail; Bohnenkamp, Frank C; Maloney, William J; Martell, John M; Clohisy, John C

2016-01-01

Highly cross-linked polyethylene (HXLPE) is the most commonly used bearing surface in total hip arthroplasty (THA) because of its superior wear properties, but long-term results in young patients are limited. We report on the clinical outcome, radiographic wear patterns and survivorship of 72 patients ≤50 years old who had a 28-millimeter cobalt-chromium femoral head on HXLPE acetabular liner. Mean and median true linear wear rates at average ten-year follow-up were 0.0104 and 0.01 mm per year ± 0.07 mm. Mean and median two-dimensional volumetric wear rates were 12.79 mm(3) and 5.834 mm(3) per year ± 26.1mm(3) as determined by Martell analysis. As a result of the minimal wear profile, there was no evidence of radiographic osteolysis and no wear-related revisions. Copyright © 2016 Elsevier Inc. All rights reserved.

Percutaneous laser disc decompression versus conventional microdiscectomy for patients with sciatica: Two-year results of a randomised controlled trial.

PubMed

Brouwer, Patrick A; Brand, Ronald; van den Akker-van Marle, M Elske; Jacobs, Wilco Ch; Schenk, Barry; van den Berg-Huijsmans, Annette A; Koes, Bart W; Arts, Mark A; van Buchem, M A; Peul, Wilco C

2017-06-01

Background Percutaneous laser disc decompression is a minimally invasive treatment, for lumbar disc herniation and might serve as an alternative to surgical management of sciatica. In a randomised trial with two-year follow-up we assessed the clinical effectiveness of percutaneous laser disc decompression compared to conventional surgery. Materials and methods This multicentre randomised prospective trial with a non-inferiority design, was carried out according to an intent-to-treat protocol with full institutional review board approval. One hundred and fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were randomly allocated to percutaneous laser disc decompression ( n = 55) or conventional surgery ( n = 57). The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analogue scores for back and leg pain and the patient's report of perceived recovery. Results The primary outcome measures showed no significant difference or clinically relevant difference between the two groups at two-year follow-up. The re-operation rate was 21% in the surgery group, which is relatively high, and with an even higher 52% in the percutaneous laser disc decompression group. Conclusion At two-year follow-up, a strategy of percutaneous laser disc decompression, followed by surgery if needed, resulted in non-inferior outcomes compared to a strategy of microdiscectomy. Although the rate of reoperation in the percutaneous laser disc decompression group was higher than expected, surgery could be avoided in 48% of those patients that were originally candidates for surgery. Percutaneous laser disc decompression, as a non-surgical method, could have a place in the treatment arsenal of sciatica caused by contained herniated discs.

Financial impact of allogeneic hematopoietic cell transplantation on patients and families over 2 years: results from a multicenter pilot study.

PubMed

Denzen, E M; Thao, V; Hahn, T; Lee, S J; McCarthy, P L; Rizzo, J D; Ammi, M; Drexler, R; Flesch, S; James, H; Omondi, N; Murphy, E; Pederson, K; Majhail, N S

2016-09-01

Hematopoietic cell transplantation (HCT) is a procedure that can significantly influence the socioeconomic wellbeing of patients, caregivers and their families. Among 30 allogeneic HCT recipients and their caregivers enrolled on a pilot study evaluating the feasibility of studying financial impact of HCT, 16 agreed to participate in the long-term phase, completed a baseline questionnaire and received phone interviews at 6, 12, 18 and 24 months post HCT. Analyses showed that by 2 years post HCT, 54% of patients who previously contributed to household earnings had not returned to work and 80% of patients/caregivers reported transplant as having moderate to great impact on household income. However, patients' levels of confidence in their abilities to meet household financial obligations increased from baseline to 2 years. A relatively large proportion of patients reported inability to pay for medical care through this time period. Case studies demonstrated that patients' individual perceptions of the financial impact of HCT varies considerably, regardless of actual income. We demonstrate the feasibility of conducting a study to evaluate the financial impact of allogeneic HCT through 2 years post transplantation. Some patients/caregivers continue to experience a significant long-term financial burden after this procedure. Our study lays the foundation for a larger evaluation of patient/caregiver financial burden associated with HCT.

Hip arthroplasty with the thrust plate prosthesis in patients of 65 years of age or older: 67 patients followed 2-7 years.

PubMed

Karatosun, Vasfi; Unver, Bayram; Gunal, Izge

2008-04-01

Thrust plate prosthesis (TPP) is a relatively new concept in total hip arthroplasty and advocated to be used in young patients. We retrospectively evaluated the results of 67 patients (71 hips) who were older than 65 years of age and underwent hip arthroplasty using the TPP. There were 50 female and 17 male patients with a mean age 71 (range 65-89) years. All patients received accelerated rehabilitation program either with full weight bearing in the second postoperative day or at 6 weeks. All patients were followed-up for at least 2 years (range 28-87 months). The average Harris hip score improved from 43 (range 8-72) to 93 (range 64-100) at the latest follow-up (p < 0.001). The overall revision rate was 8.4%. However, when the patients with definitive history of trauma were excluded the rate for loosening and technical errors decreased to 4.2%. There was no significant difference between the Harris hip score of patients with full weight bearing in the second postoperative day or 6 weeks (p = 0.57). We conclude that the TPP could be indicated for older patients without age limit and that an accelerated rehabilitation program with early weight bearing can be applied to these patients.

Disappointing mid-term results after laparoscopic gastric banding in young patients.

PubMed

Lanthaler, Monika; Sieb, Michael; Strasser, Stefan; Weiss, Helmut; Aigner, Franz; Nehoda, Hermann

2009-01-01

When gastric banding was introduced as a bariatric operation about 12 years previously, its early results were promising, with a low complication rate. Only a few long-term studies on this subject have been published. This study was performed to assess our results with laparoscopic gastric banding in young patients afteryears of follow-up. From January 1996 to December 2000, a total of 41 patients (83% female, 17% male)<25 years old underwent laparoscopic gastric banding at our institution. The patient data were derived from the electronic patient data system, paper charts, and a telephone interview. Psychosocial changes were analyzed using the Moorehead-Ardelt/Bariatric Analysis and Reporting Outcome System questionnaire. The mean preoperative body mass index was 44.26+/-6.53 kg/m2, with a mean excess weight of 65.22+/-20.48 kg. The body mass index after 1, 5, and 7 years was 31.50+/-7.38 kg/m2, 31.12+/-7.10 kg/m2, and 32.88+/-5.68 kg/m2, respectively. The mean excess weight loss after 1 year was 60.07%+/-25.33%, and after 5 and 7 years, it was 64.84%+/-27.45% and 57.48%+/-28.07%, respectively. An improvement in obesity-related co-morbidities was observed in nearly all patients. Of our patients, 52% had complications requiring reoperation (27% pouch dilation, 10% band leakage, 5% intragastral band migration, 5% perforation of either the esophagus or the stomach, and 5% port disconnection). According to Bariatric Analysis and Reporting Outcome System, the long-term outcome was regarded as a failure in 40%, fair in 4%, good in 28%, very good in 20%, and excellent in 8% of patients. Our mid-term results were disappointing, with a high complication rate and many dissatisfied patients.

Three-year outcome of shunted idiopathic NPH patients.

PubMed

Aygok, G; Marmarou, A; Young, H F

2005-01-01

The incidence of idiopathic normal pressure hydrocephalus (iNPH) has increased as a result of improved longevity. This report describes the 3-year outcome of shunted iNPH patients compared to three-month outcome after shunting. Patients (n = 50) (Age 70.4 +/- 8.9) admitted to our service were diagnosed and treated according to a fixed protocol for management of iNPH and after shunting were followed at least three times per year in clinic. The outcome of 50 patients was graded according to the level of improvement in symptoms as Excellent/Good, Partial or None in each category of Gait, Incontinence and Dementia. If we lump favorable (excellent, good, partial recovery) vs poor recovery (none), we found from 3 months to 3 years, a moderate decline in gait performance (91% to 75%), a retention of memory improvement (80%-80%) and an improvement in incontinence occurred over time (70%-82.5%). With proper diagnosis and management of iNPH, shunting of patients is associated with a favorable risk/benefit ratio that is reasonably long lasting.

Levels of mania and cognitive performance two years after ECT in patients with bipolar I disorder - results from a follow-up study.

PubMed

Haghighi, Mohammad; Barikani, Reza; Jahangard, Leila; Ahmadpanah, Mohammad; Bajoghli, Hafez; Sadeghi Bahmani, Dena; Holsboer-Trachsler, Edith; Brand, Serge

2016-08-01

There is limited evidence on the long-term outcomes for patients with bipolar I disorder (BP-I-D) and treated with ECT. Therefore, we asked whether mania scores and cognitive performance at the end of ECT treatment (baseline/BL) predicted mania scores, cognitive performance, recurrence, treatment adherence, and mood (depression; hypomania) two years later (follow-up/FU). 38 patients with BP-I-D undergoing ECT at baseline were followed up two years later. A brief psychiatric and cognitive assessment (Mini Mental State Examination; short-term verbal memory test) was performed; patients completed questionnaires covering recurrence, treatment adherence, and mood (depression; hypomania). High cognitive performance at BL predicted high cognitive performance at FU; low mania scores at BL predicted low mania scores at FU. By FU, cognitive performance had increased and mania scores decreased. Mania scores and cognitive performance at BL did not predict recurrence, or adherence to medication, or mood (depression; hypomania). The pattern of results suggests that after two years of successful treatment of acute mania with ECT, cognitive impairment, measured by MMSE and a short-term verbal memory test, is not impaired and mood symptom recurrence seems to be improved. Mania scores and cognitive performance at the end of ECT treatment predicted neither mood (depression; hypomania), nor recurrence, or adherence to medication two years later. Copyright © 2016 Elsevier Inc. All rights reserved.

Longterm Safety and Efficacy of Subcutaneous Abatacept in Patients with Rheumatoid Arthritis: 5-year Results from a Phase IIIb Trial.

PubMed

Genovese, Mark C; Pacheco-Tena, César; Covarrubias, Arturo; Leon, Gustavo; Mysler, Eduardo; Keiserman, Mauro; Valente, Robert M; Nash, Peter; Simon-Campos, J Abraham; Box, Jane; Legerton, Clarence W; Nasonov, Evgeny; Durez, Patrick; Elegbe, Ayanbola; Wong, Robert; Li, Xiaohui; Banerjee, Subhashis; Alten, Rieke

2018-04-15

To assess 5-year safety, tolerability, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate (MTX)-refractory patients with rheumatoid arthritis (RA). The Abatacept Comparison of sub[QU]cutaneous versus intravenous in Inadequate Responders to methotrexatE (ACQUIRE) phase IIIb, randomized, double-dummy, multinational trial compared efficacy and safety of SC and intravenous (IV) ABA in patients with RA. In the initial 6-month double-blind (DB) period, patients received IV or SC ABA, plus MTX, and in the subsequent open-label longterm extension (LTE) period, all patients received SC ABA (125 mg/wk). The final 5-year safety, tolerability, and efficacy analyses are reported. Of 1385 patients who completed the DB period, 1372 entered LTE and 945 (68.8%) completed ≥ 5 years of treatment. During LTE, 97 (7.1%) patients discontinued treatment because of an adverse event (AE). Incidence rate (IR; event/100 patient-yrs of exposure; based on LTE data, 95% CI) for AE of interest were the following: serious AE 7.73 (6.96-8.58), infection 38.60 (36.24-41.12), serious infection 1.68 (1.35-2.07), malignancies 1.09 (0.84-1.42), and autoimmune disorders 1.33 (1.05-1.69), and were stable over time. No association between immunogenicity and either worsening of ABA safety or loss of efficacy was noted. Efficacy in the LTE was consistent with the DB period and was maintained to the end of the study. These 5-year data establish that SC ABA (125 mg/wk) has a consistent safety profile and durable efficacy for longterm treatment of patients with RA who had an inadequate response to MTX.

Financial Impact of Allogeneic Hematopoietic Cell Transplantation on Patients and Families over 2-years: Results from a Multicenter Pilot Study

PubMed Central

Denzen, Ellen M.; Thao, Viengneesee; Hahn, Theresa; Lee, Stephanie J.; McCarthy, Philip L.; Rizzo, J. Douglas; Ammi, Monique; Drexler, Rebecca; Flesch, Susan; James, Heather; Omondi, Nancy; Murphy, Elizabeth; Pederson, Kate; Majhail, Navneet S.

2016-01-01

Hematopoietic cell transplantation (HCT) is a procedure that can significantly influence the socioeconomic wellbeing of patients, caregivers and their families. Among 30 allogeneic HCT recipients and their caregivers enrolled on a pilot study evaluating the feasibility of studying financial impact of HCT, 16 agreed to participate in the long-term phase, completed a baseline questionnaire and received phone interviews at 6, 12, 18 and 24 months post-HCT. Analyses showed that by 2-years post-HCT, 54% of patients who previously contributed to household earnings had not returned to work and 80% of patients/caregivers reported transplant as having moderate to great impact on household income. However, patients’ level of confidence in their ability to meet household financial obligations increased from baseline to 2-years. A relatively large proportion of patients reported inability to pay for medical care through this time period. Case studies demonstrated patient individual perception of financial impact of HCT varies considerably, regardless of actual income. We demonstrate the feasibility of conducting a study to evaluate financial impact of allogeneic HCT through 2-years post-transplantation. Some patients/caregivers continue to experience significant long-term financial burden after this procedure. Our study lays the foundation for a larger evaluation of patient/caregiver financial burden associated with HCT. PMID:27088381

Self-awareness four years after severe traumatic brain injury: discordance between the patient's and relative's complaints. Results from the PariS-TBI study.

PubMed

Chesnel, Camille; Jourdan, Claire; Bayen, Eleonore; Ghout, Idir; Darnoux, Emmanuelle; Azerad, Sylvie; Charanton, James; Aegerter, Philippe; Pradat-Diehl, Pascale; Ruet, Alexis; Azouvi, Philippe; Vallat-Azouvi, Claire

2018-05-01

To evaluate the patient's awareness of his or her difficulties in the chronic phase of severe traumatic brain injury (TBI) and to determine the factors related to poor awareness. This study was part of a larger prospective inception cohort study of patients with severe TBI in the Parisian region (PariS-TBI study). Intervention/Main measures: Evaluation was carried out at four years and included the Brain Injury Complaint Questionnaire (BICoQ) completed by the patient and his or her relative as well as the evaluation of impairments, disability and quality of life. A total of 90 patient-relative pairs were included. Lack of awareness was measured using the unawareness index that corresponded to the number of discordant results between the patient and relative in the direction of under evaluation of difficulties by the patient. The only significant relationship found with lack of awareness was the subjective burden perceived by the relative (Zarit Burden Inventory) ( r = 0.5; P < 0.00001). There was no significant relationship between lack of awareness and injury severity, pre-injury socio-demographic data, cognitive impairments, mood disorders, functional independence (Barthel index), global disability (Glasgow Outcome Scale), return to work at four years or quality of life (Quality Of Life after Brain Injury scale (QOLIBRI)). Lack of awareness four years post severe TBI was not related to the severity of the initial trauma, sociodemographic data, the severity of impairments, limitations of activity and participation, or the patient's quality of life. However, poor awareness did significantly influence the weight of the burden perceived by the relative.

Actual 5-Year Nutritional Outcomes of Patients with Gastric Cancer.

PubMed

Kim, Ki Hyun; Park, Dong Jin; Park, Young Suk; Ahn, Sang Hoon; Park, Do Joong; Kim, Hyung Ho

2017-06-01

In this study, we aimed to evaluate the rarely reported long-term nutritional results of patients with gastric cancer after curative gastrectomy. We retrospectively reviewed the prospectively collected medical records of 658 patients who underwent radical gastrectomy with curative intent for gastric cancer from January 2008 to December 2009 and had no recurrences. All patients were followed for 5 years. Nutritional statuses were assessed using measurements of body weight, serum hemoglobin, total lymphocyte count (TLC), protein, albumin, cholesterol, and nutritional risk index (NRI). Patients who underwent total gastrectomy had lower body weights, hemoglobin, protein, albumin, and cholesterol levels. TLC and NRI valued after the first postoperative year (P<0.05), and lower hemoglobin and NRI valued during the fifth postoperative year than patients who underwent distal gastrectomy (P<0.05). Patients who received adjuvant chemotherapy after gastrectomy had lower hemoglobin, protein, albumin, and cholesterol levels. TLC and NRI valued during the first postoperative year, than those who underwent gastrectomy only (P<0.05). Regarding post-distal gastrectomy reconstruction, those who underwent Roux-en-Y had lower cholesterol levels than did those who underwent Billroth-I and Billroth-II reconstruction at the first and fifth years after gastrectomy, respectively (P<0.05). Patients undergoing total or distal gastrectomy with Roux-en-Y anastomosis or adjuvant chemotherapy after surgery should be monitored carefully for malnutrition during the first postoperative year, and patients undergoing total gastrectomy should be monitored for malnutrition and anemia for 5 years.

Decreased Time from 9-1-1 Call to PCI among Patients Experiencing STEMI Results in a Decreased One Year Mortality.

PubMed

Studnek, Jonathan R; Infinger, Allison; Wilson, Hadley; Niess, Gary; Jackson, Patrick; Swanson, Doug

2018-03-29

The impact on mortality due to prompt recognition of ST-segment Elevation Myocardial Infarction (STEMI) patients by EMS has not been well described. The objective of this study was to describe the association between the time interval, 9-1-1 call to percutaneous intervention (PCI), and mortality at one year. This retrospective analysis included patients that were transported by EMS as a "code STEMI" and underwent PCI.  Total time from 9-1-1 call to PCI was calculated for each patient and was the independent variable of interest. Each patient's mortality status at one year was the outcome variable, collected by querying medical records and the national death index. Confounding variables were abstracted from hospital records. Logistic regression was conducted to determine the likelihood of survival given differences in time to PCI. A total of 550 patients were included in the analyses of which 68% were male with an average age 59.8 (SD 12.8). Mean reperfusion time was 81.8 min (SD 20.0) and was significantly lower in patients alive at one year (80.8 min, SD 19.7) vs. deceased at one year (93.9 min, SD 19.6), respectively. Odds of survival at one year decreased by 3% (OR 0.97; 95% CI 0.96-0.99) for every one minute increase in time to PCI. This relationship practically represents a 30% increase in mortality for every 10 minute delay from 9-1-1 call to PCI. The model produced suggests that a linear relationship exists between time to PCI and mortality in the prehospital environment with the probability of survival decreasing significantly as time to PCI increases.

Rationale for a 'Male Lumpectomy,' a Prostate Cancer Targeted Approach Using Cryoablation: Results in 21 Patients with at Least 2 Years of Follow-Up

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

Onik, Gary

2008-01-15

Background. Prostate cancer in men raises many of the same issues that breast cancer does in women. Complications of prostate cancer treatment, including impotence and incontinence, affect the self-image and psyche of a man no less than does the loss of a breast in a woman. We present a pilot study in which 21 patients were treated with a focal cryoablation procedure. Methods. Focal cryoablation was performed using biplane transrectal ultrasound if the tumor was confined to only one prostate lobe. Preoperative PSA values were recorded. Cryoablation was planned to encompass the area of known tumor. PSA values were obtainedmore » every 3 months for 2 years and every 6 months thereafter. Potency and continence status was obtained at the same intervals. Routine biopsy was obtained at 1 year. Results. Twenty-one patients had focal cryoablation. Follow-up ranged from 24 to 105 months with a mean of 50 months. Twenty of 21 (95%) patients have stable PSA values with no evidence for cancer, despite 10 patients being at medium to high risk for recurrence. All patients biopsied (n = 19) were negative for tumor. Potency was maintained in 17 of 21 patients (80%). No other complications, including incontinence or fistula formation, were noted. Conclusion. These preliminary results indicate a 'male lumpectomy,' in which the prostate tumor region itself is destroyed, appears to preserve potency in a majority of patients and limits other complications, without compromising cancer control. If these results are confirmed by further studies and long-term follow-up, this treatment approach could have a profound effect on prostate cancer management.« less

Surgical Treatment in Active Infective Endocarditis: Results of a Four-Year Experience

PubMed Central

Rostagno, Carlo; Carone, Enrico; Rossi, Alessandra; Gensini, Gian Franco; Stefano, Pier Luigi

2011-01-01

Background. Aim of present investigation was to analyze survival and recurrence rate in patients with active endocarditis referred to our centre for surgical treatment. Methods. 80 consecutive patients with active infective endocarditis (52 males, 28 females, mean age 59.2 years) were referred to our institution for surgical treatment. 78 patients underwent surgery, and 2 patients died before intervention. Results. Fifty patients had native valve endocarditis, 30 prosthetic valve involvement. Hospital mortality has been 10.2%. Three discharged patients (4.9%) died at an average 18-month followup. Endocarditis recurred in 4 (2 being S. aureus prosthetic tricuspid endocarditis in drug addicts). All patients who underwent valve repair or homograft implant were alive and free of recurrence. Conclusions. Our results suggest that with proper surgical treatment patients with active endocarditis discharged alive from hospital have a survival >90% at 18 months with a low recurrence rate. PMID:22347645

Prognosis of patients after open mitral commissurotomy. Actuarial analysis of late results in 100 patients.

PubMed

Housman, L B; Bonchek, L; Lambert, L; Grunkemeier, G; Starr, A

1977-05-01

The continuing controversy between proponents of open and closed commissurotomy might be clarified by analysis of late follow-up with modern actuarial techniques that provide a true perspective of patient risk. We have used open mitral commissurotomy exclusively for 15 years in 100 patients. There was one operative death from pancreatitis and one late death from cancer; the actuarially projected survival rate (+/- the standard error) at 10 years is 97 per cent (+/- 2). Thirteen patients had preoperative emboli, 6 of whom were in sinus rhythm and 7 in atrial fibrillation. Two patients had postoperative emboli, both in sinus rhythm. The actuarial chance of remaining free of embolism at 10 years is 97 per cent (+/- 2). Sixteen patients required reoperation on the mitral valve for functional deterioration. The remaining survivors were in Class I or II when last seen. The actuarial chance of not requiring a reoperation after 5 years is 91 per cent (+/- 4) and at 10 years, 38 per cent(+/- 16). Results in different centers are difficult to compare for many reasons, but imprecise statistical methods further obscure such comparisons. The use of actuarial techniques may help to define the role of open mitral commissurotomy.

Clinical results of Hi-tech Knee II total knee arthroplasty in patients with rheumatoid athritis: 5- to 12-year follow-up.

PubMed

Yamanaka, Hajime; Goto, Ken-ichiro; Suzuki, Munetaka

2012-02-22

Total knee arthroplasty (TKA) is a common form of treatment to relieve pain and improve function in cases of rheumatoid arthritis (RA). Good clinical outcomes have been reported with a variety of TKA prostheses. The cementless Hi-Tech Knee II cruciate-retaining (CR)-type prosthesis, which has 6 fins at the anterior of the femoral component, posterior cruciate ligament (PCL) retention, flat-on-flat surface component geometry, all-polyethylene patella, strong initial fixation by the center screw of the tibial base plate, 10 layers of titanium alloy fiber mesh, and direct compression molded ultra high molecular weight polyethylene (UHMWPE), is appropriate for TKA in the Japanese knee.The present study was performed to evaluate the clinical results of primary TKA in RA using the cementless Hi-Tech Knee II CR-type prosthesis. We performed 32 consecutive primary TKAs using cementless Hi-Tech Knee II CR-type prosthesis in 31 RA patients. The average follow-up period was 8 years 3 months. Clinical evaluations were performed according to the American Knee Society (KS) system, knee score, function score, radiographic evaluation, and complications. The mean postoperative maximum flexion angle was 115.6°, and the KS knee score and function score improved to 88 and 70 after surgery, respectively. Complications, such as infection, occurred in 1 patient and revision surgery was performed. There were no cases of loosening in this cohort, and prosthesis survival rate was 96.9% at 12 years postoperatively. These results suggest that TKA using the cementless Hi-Tech Knee II CR-type prosthesis is a very effective form of treatment in RA patients at 5 to 12 years postoperatively. Further long-term follow-up studies are required to determine the ultimate utility of this type of prosthesis.

Audiophonological results after cochlear implantation in 40 congenitally deaf patients: preliminary results.

PubMed

Loundon, N; Busquet, D; Roger, G; Moatti, L; Garabedian, E N

2000-11-30

The aim of this study is to evaluate the prognostic factors of audiophonological results in cochlear implant in congenitally deaf patients. Between 1991 and 1996. 40 congenitally deaf children underwent cochlear implantation in our department, at an average age of 7 years (median: 5 years). The results of speech therapy were evaluated with a mean follow-up of 2 years and were classified according to four criteria: perception of sound, speech perception, speech production and the level of oral language. For each criterion, a score was established ranging from zero to four. These scores were weighted according to age such that the results before and after implantation only reflected the changes related to the implantation. The prognostic factors for good results were: a good level of oral communication before implantation, residual hearing, progressive deafness and implantation at a young age. On the other hand, poor prognostic factors were: the presence of behavioral disorders and poor communication skills prior to implantation. Overall, the major prognostic factor for a good outcome appeared to be the preoperative level of oral language, even if this was rudimentary.

HPV test results and histological follow-up results of patients with LSIL Cervical Cytology from the Largest CAP-certified laboratory in China.

PubMed

Zheng, Baowen; Yang, Huaitao; Li, Zaibo; Wei, Guijian; You, Jia; Liang, Xiaoman; Zhao, Chengquan

2017-01-01

Age-adjusted evaluations have explored the possible utility of (HPV test results in women with LSIL Pap. We investigated HPV test results and histopathologic follow-up results of LSIL patients from China's largest CAP-certified laboratory. Patients with LSIL between 2011 and 2015 from the Guangzhou Kingmed Diagnostics were retrospectively retrieved and their hrHPV test results and histological follow-up results were collected and analyzed. LSIL result was identified in 37,895 cases from 2,206,588 Pap tests (1.7%) including 1,513,265 liquid-based cytology and 693,323 conventional Pap tests. The average of these women was 38.4 years (15-88). The LSIL reporting rate in women <30 years was significantly higher than that in women > 30 years (2.1% vs 1.7%). The age specific reporting LSIL rates declined with increased age. 8,014 of 37,895 (21.2%) women with LSIL cytology also had HC2 HPV test results. 75.8% of women with LSIL Pap tests were hrHPV+ and the HPV+ rates declined with increased age except in patients older than 60 years. Overall histopathologic diagnoses within 6 months after LSIL were identified in 5,987 of 37,895 patients at Guangzhou Kingmed Diagnostics. CIN2/3 was identified in 15.2% patients, CIN1 in 66.9%, negative in 14.9% patients. No invasive carcinoma was found in all patients. Of 8014 patients with LSIL Pap test and HPV testing results, 1727 patients had histological follow-up within 6 months after Pap cytology test and HPV testing. The detection rate of CIN2/3 was significantly higher in patients with positive HPV testing result than that in patients with negative HPV testing result (17.8% vs. 8.1%). Among patients with LSIL/HPV negative tests, CIN2/3 was detected in 1 of 30 (3.3%) women aged 50 years and above, appearing lower than those in women less than 50 years (8.0%, 28/351, P=0.357). This is the largest histological follow-up study in women with LSIL Pap from China and the data are helpful in establishing a baseline for better understanding

Final 3-year Results of the Dasatinib Discontinuation Trial in Patients With Chronic Myeloid Leukemia Who Received Dasatinib as a Second-line Treatment.

PubMed

Okada, Masaya; Imagawa, Jun; Tanaka, Hideo; Nakamae, Hirohisa; Hino, Masayuki; Murai, Kazunori; Ishida, Yoji; Kumagai, Takashi; Sato, Seiichi; Ohashi, Kazuteru; Sakamaki, Hisashi; Wakita, Hisashi; Uoshima, Nobuhiko; Nakagawa, Yasunori; Minami, Yosuke; Ogasawara, Masahiro; Takeoka, Tomoharu; Akasaka, Hiroshi; Utsumi, Takahiko; Uike, Naokuni; Sato, Tsutomu; Ando, Sachiko; Usuki, Kensuke; Mizuta, Syuichi; Hashino, Satoshi; Nomura, Tetsuhiko; Shikami, Masato; Fukutani, Hisashi; Ohe, Yokiko; Kosugi, Hiroshi; Shibayama, Hirohiko; Maeda, Yasuhiro; Fukushima, Toshihiro; Yamazaki, Hirohito; Tsubaki, Kazuo; Kukita, Toshimasa; Adachi, Yoko; Nataduka, Toshiki; Sakoda, Hiroto; Yokoyama, Hisayuki; Okamoto, Takahiro; Shirasugi, Yukari; Onishi, Yasushi; Nohgawa, Masaharu; Yoshihara, Satoshi; Morita, Satoshi; Sakamoto, Junichi; Kimura, Shinya

2018-05-01

We previously reported an interim analysis of the DADI (dasatinib discontinuation) trial. The results showed that 48% of patients with chronic myeloid leukemia in the chronic phase who maintained a deep molecular response (DMR) for ≥ 1 year could discontinue second- or subsequent-line dasatinib treatment safely at a median follow-up of 20 months. However, the results from longer follow-up periods would be much more useful from a clinical perspective. The DADI trial was a prospective, multicenter trial conducted in Japan. After confirming a stable DMR for ≥ 1 year, dasatinib treatment subsequent to imatinib or nilotinib was discontinued. After discontinuation, the loss of DMR (even of 1 point) was defined as stringent molecular relapse, thereby triggering therapy resumption. The predictive factors of treatment-free remission (TFR) were analyzed. The median follow-up period was 44.0 months (interquartile range, 40.5-48.0 months). The estimated overall TFR rate at 36 months was 44.4% (95% confidence interval, 32.0%-56.2%). Only 2 patients developed a molecular relapse after the 1-year cutoff point. The presence of imatinib resistance was a significant risk factor for molecular relapse. Moreover, high natural killer cell and low γδ + T-cell and CD4 + regulatory T-cell (CD25 + CD127 low ) counts before discontinuation correlated significantly with successful therapy discontinuation. These findings suggest that discontinuation of second- or subsequent-line dasatinib after a sustained DMR of ≥ 1 year is feasible, especially for patients with no history of imatinib resistance. In addition, the natural killer cell count was associated with the TFR. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

National Surveillance of Central Diabetes Insipidus (CDI) in Denmark: results from 5 years registration of 9309 prescriptions of desmopressin to 1285 CDI patients.

PubMed

Juul, K V; Schroeder, M; Rittig, S; Nørgaard, J P

2014-06-01

Epidemiological data for central diabetes insipidus (CDI) are sparse. The purpose of this study was to provide accurate epidemiological data on CDI on a national level. This was a drug utilization and patient registry study during a 5-year period from 2007 to 2011. We used the Danish National Prescription Registry data linked with the Danish National Patient Registry to study the epidemiology of CDI using waiting time distribution and other pharmacoepidemiological methods. A total of 1285 patients with CDI were recorded in the observation period and given 9309 prescriptions for desmopressin in the nasal formulation, orodispersible tablet, or conventional tablet. The period prevalence rate of CDI in Denmark over the 5-year period investigated was 23 CDI patients per 100 000 inhabitants, with a higher prevalence in children and older adults (>80 years of age). The 1-year period prevalence rate of CDI decreased in Denmark over the 5 years from approximately 10 to 7 CDI patients per 100 000 inhabitants. The yearly incidence rate of new cases of CDI was found to be 3 to 4 patients per 100 000. The incidence of (presumable) congenital CDI was found to be 2 infants per 100 000 infants. Half of the patients with CDI prescribed as oral treatment were provided dosing instructions to only administer the drug before bedtime, and one third of the CDI patients either had no specific instructions or were instructed to use the drug as needed. Hospital admissions due to severe hyponatremia occurred in 0.9% of patients over a 5-year period, predominantly in females with an incidence ratio of women to men of 1.8:1. Half of the cases of CDI are acquired later in life. At least half of the patients with CDI are instructed to prevent nocturnal polyuria, but it is not clear whether their CDI remains uncontrolled during the daytime or, alternatively, whether they use desmopressin only as needed. Female patients with CDI had approximately twice the number of hospital admissions due to

Minimally invasive transforaminal lumbar interbody fusion for spondylolisthesis and degenerative spondylosis: 5-year results.

PubMed

Park, Yung; Ha, Joong Won; Lee, Yun Tae; Sung, Na Young

2014-06-01

Multiple studies have reported favorable short-term results after treatment of spondylolisthesis and other degenerative lumbar diseases with minimally invasive transforaminal lumbar interbody fusion. However, to our knowledge, results at a minimum of 5 years have not been reported. We determined (1) changes to the Oswestry Disability Index, (2) frequency of radiographic fusion, (3) complications and reoperations, and (4) the learning curve associated with minimally invasive transforaminal lumbar interbody fusion at minimum 5-year followup. We reviewed our first 124 patients who underwent minimally invasive transforaminal lumbar interbody fusion to treat low-grade spondylolisthesis and degenerative lumbar diseases and did not need a major deformity correction. This represented 63% (124 of 198) of the transforaminal lumbar interbody fusion procedures we performed for those indications during the study period (2003-2007). Eighty-three (67%) patients had complete 5-year followup. Plain radiographs and CT scans were evaluated by two reviewers. Trends of surgical time, blood loss, and hospital stay over time were examined by logarithmic curve fit-regression analysis to evaluate the learning curve. At 5 years, mean Oswestry Disability Index improved from 60 points preoperatively to 24 points and 79 of 83 patients (95%) had improvement of greater than 10 points. At 5 years, 67 of 83 (81%) achieved radiographic fusion, including 64 of 72 patients (89%) who had single-level surgery. Perioperative complications occurred in 11 of 124 patients (9%), and another surgical procedure was performed in eight of 124 patients (6.5%) involving the index level and seven of 124 patients (5.6%) at adjacent levels. There were slowly decreasing trends of surgical time and hospital stay only in single-level surgery and almost no change in intraoperative blood loss over time, suggesting a challenging learning curve. Oswestry Disability Index scores improved for patients with spondylolisthesis

Long-term safety and efficacy of deferasirox in young pediatric patients with transfusional hemosiderosis: Results from a 5-year observational study (ENTRUST).

PubMed

Vichinsky, Elliott; El-Beshlawy, Amal; Al Zoebie, Azzam; Kamdem, Annie; Koussa, Suzanne; Chotsampancharoen, Thirachit; Bruederle, Andreas; Gilotti, Geralyn; Han, Jackie; Elalfy, Mohsen

2017-09-01

Children with red blood cell disorders may receive regular transfusions from an early age and consequently accumulate iron. Adequate iron chelation therapy can prevent organ damage and delayed growth/development. Deferasirox is indicated for treatment of pediatric patients with chronic iron overload due to transfusional hemosiderosis; however, fewer than 10% of patients in the registration studies were aged 2 to less than 6 years. Deferasirox, a once-daily oral iron chelator, was evaluated in young pediatric patients with transfusional hemosiderosis during the observational 5-year ENTRUST study. Patients aged 2 to less than 6 years at enrollment received deferasirox according to local prescribing information, with the primary objective of evaluating safety, specifically renal and hepatic function. Serum ferritin was observed as a surrogate efficacy parameter. In total, 267 patients (mean age 3.2 years) predominantly with β-thalassemia (n = 176, 65.9%) were enrolled. Mean ± standard deviation deferasirox dose was 25.8 ± 6.5 mg/kg per day over a median of 59.9 months. A total of 145 patients (54.3%) completed 5 years' treatment. The proportion of patients with two or more consecutive postbaseline measurements (≥7 days apart) of serum creatinine higher than age-adjusted upper limit of normal (ULN) and alanine aminotransferase more than five times the ULN was 4.4% (95% confidence interval [CI]: 2.1-7.9) and 4.0% (95% CI: 1.8-7.4), respectively. Median serum ferritin decreased from 1,702 ng/ml at baseline to 1,127 ng/ml at 5 years. There were no new safety signals. Safety and efficacy of deferasirox in young pediatric patients in this long-term, observational study in everyday clinical practice were consistent with the known deferasirox profile. © 2017 The Authors. Pediatric Blood & Cancer Published by Wiley Periodicals, Inc.

Partial Breast Radiation Therapy With Proton Beam: 5-Year Results With Cosmetic Outcomes

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

Bush, David A., E-mail: dbush@llu.edu; Do, Sharon; Lum, Sharon

2014-11-01

Purpose: We updated our previous report of a phase 2 trial using proton beam radiation therapy to deliver partial breast irradiation (PBI) in patients with early stage breast cancer. Methods and Materials: Eligible subjects had invasive nonlobular carcinoma with a maximal dimension of 3 cm. Patients underwent partial mastectomy with negative margins; axillary lymph nodes were negative on sampling. Subjects received postoperative proton beam radiation therapy to the surgical bed. The dose delivered was 40 Gy in 10 fractions, once daily over 2 weeks. Multiple fields were treated daily, and skin-sparing techniques were used. Following treatment, patients were evaluated with clinical assessments andmore » annual mammograms to monitor toxicity, tumor recurrence, and cosmesis. Results: One hundred subjects were enrolled and treated. All patients completed the assigned treatment and were available for post-treatment analysis. The median follow-up was 60 months. Patients had a mean age of 63 years; 90% had ductal histology; the average tumor size was 1.3 cm. Actuarial data at 5 years included ipsilateral breast tumor recurrence-free survival of 97% (95% confidence interval: 100%-93%); disease-free survival of 94%; and overall survival of 95%. There were no cases of grade 3 or higher acute skin reactions, and late skin reactions included 7 cases of grade 1 telangiectasia. Patient- and physician-reported cosmesis was good to excellent in 90% of responses, was not changed from baseline measurements, and was well maintained throughout the entire 5-year follow-up period. Conclusions: Proton beam radiation therapy for PBI produced excellent ipsilateral breast recurrence-free survival with minimal toxicity. The treatment proved to be adaptable to all breast sizes and lumpectomy cavity configurations. Cosmetic results appear to be excellent and unchanged from baseline out to 5 years following treatment. Cosmetic results may be improved over those reported with photon

Early Treatment With Zofenopril and Ramipril in Combination With Acetyl Salicylic Acid in Patients With Left Ventricular Systolic Dysfunction After Acute Myocardial Infarction: Results of a 5-Year Follow-up of Patients of the SMILE-4 Study.

PubMed

Borghi, Claudio; Omboni, Stefano; Novo, Salvatore; Vinereanu, Dragos; Ambrosio, Giuseppe; Ambrosioni, Ettore

2017-05-01

The SMILE-4 study showed that in patients with left ventricular dysfunction (LVD) after acute myocardial infarction, early treatment with zofenopril plus acetyl salicylic acid is associated with an improved 1-year survival, free from death or hospitalization for cardiovascular (CV) causes, as compared to ramipril plus acetyl salicylic acid. We now report CV outcomes during a 5-year follow-up of the patients of the SMILE-4 study. Three hundred eighty-six of the 518 patients completing the study (51.2%) could be tracked after the study end and 265 could be included in the analysis. During the 5.5 (±2.1) years of follow-up, the primary endpoint occurred in 27.8% of patients originally randomized and treated with zofenopril and in 43.8% of patients treated with ramipril [odds ratio (OR) and 95% confidence interval, 0.65 (0.43-0.98), P = 0.041]. Such a result was achieved through a significantly larger reduction in CV hospitalization under zofenopril [OR: 0.61 (0.37-0.99), P = 0.047], whereas reduction in mortality rate with zofenopril did not achieve statistical significance versus ramipril [OR: 0.75 (0.36-1.59), P = 0.459]. These results were in line with those achieved during the initial 1-year follow-up. Benefits of early treatment of patients with LVD after acute myocardial infarction with zofenopril are sustained over many years as compared to ramipril.

Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study).

PubMed

Bulsei, Julie; Leroy, Sylvie; Perotin, Jeanne-Marie; Mal, Hervé; Marquette, Charles-Hugo; Dutau, Hervé; Bourdin, Arnaud; Vergnon, Jean-Michel; Pison, Christophe; Kessler, Romain; Jounieaux, Vincent; Salaün, Mathieu; Marceau, Armelle; Dukic, Sylvain; Barbe, Coralie; Bonnaire, Margaux; Deslee, Gaëtan; Durand-Zaleski, Isabelle

2018-05-09

The REVOLENS study compared lung volume reduction coil treatment to usual care in patients with severe emphysema at 1 year, resulting in improved quality-adjusted life-year (QALY) and higher costs. Durability of the coil treatment benefit and its cost-effectiveness at 2 years are now assessed. After one year, the REVOLENS trial's usual care group patients received coil treatment (second-line coil treatment group). Costs and QALYs were assessed in both arms at 2 years and an incremental cost-effectiveness ratio in cost per QALY gained was calculated. The uncertainty of the results was estimated by probabilistic bootstrapping. The average cost of coil treatment in both groups was estimated at €24,356. The average total cost at 2 years was €9655 higher in the first-line coil treatment group (p = 0.07) and the difference in QALY between the two groups was 0.127 (p = 0.12) in favor of first-line coil treatment group. The 2-year incremental cost-effectiveness ratio (ICER) was €75,978 / QALY. The scatter plot of the probabilistic bootstrapping had 92% of the replications in the top right-hand quadrant. First-line coil treatment was more expensive but also more effective than second-line coil treatment at 2 years, with a 2-year ICER of €75,978 / QALY. ClinicalTrials.gov Identifier NCT01822795 .

Early and mid-term results of lung transplantation with donors 60 years and older.

PubMed

López, Iker; Zapata, Ricardo; Solé, Juan; Jaúregui, Alberto; Deu, María; Romero, Laura; Pérez, Javier; Bello, Irene; Wong, Manuel; Ribas, Montse; Masnou, Nuria; Rello, Jordi; Roman, Antonio; Canela, Mercedes

2015-01-01

There are doubts about the age limit for lung donors and the ideal donor has traditionally been considered to be one younger than 55 years. The objective of this study was to compare the outcomes in lung transplantation between organs from donors older and younger than 60 years. We performed a retrospective observational study comparing the group of patients receiving organs from donors 60 years or older (Group A) or younger than 60 years (Group B) between January 2007 and December 2011. Postoperative evolution and mortality rates, short-term and mid-term postoperative complications, and global survival rate were evaluated. We analysed a total of 230 lung transplants, of which 53 (23%) involved lungs from donors 60 years of age or older (Group A), and 177 (77%) were from donors younger than 60 years (Group B). Three (5.7%) patients from Group A and 14 patients (7.9%) from Group B died within 30 days (P = 0.58). The percentage of patients free from chronic lung allograft dysfunction at 1-3 years was 95.5, 74.3 and 69.3% for Group A, and 94.5, 84.8 and 73.3% for Group B, respectively (P = 0.47). There were no statistically significant differences between Groups A and B in terms of survival at 3 years, (69.4 vs 68.8%; P = 0.28). Our results support the idea that lungs from donors aged 60-70 years can be used safely for lung transplantation with comparable results to lungs from younger donors in terms of postoperative mortality and mid-term survival. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Long-term evaluation of Astra Tech and Brånemark implants in patients treated with full-arch bridges. Results after 12-15 years.

PubMed

Ravald, Nils; Dahlgren, Simon; Teiwik, Anders; Gröndahl, Kerstin

2013-10-01

To study the long-term outcome of implant survival rate, soft and hard tissue conditions and prosthetic status in a group of individuals treated with either Astra Tech TiOblast or Brånemark turned implants supporting a full-arch bridge. Edentulous patients treated with either Astra Tech TiOblast surface or Brånemark turned implants were recalled for examination after 12-15 years. Out of initially 66 patients 46 were available for examination. Intra-oral radiographs were taken for bone level assessments. Clinical prosthetic conditions, number of surviving implants, implant stability, plaque scores, probing pocket depths, bleeding and pus after probing were recorded. Analyses of bone level changes during the total observation period were performed. Three patients in the Astra Tech group lost totally eight implants and five patients in the Brånemark group lost 10 implants during the total observation period. No statistically significant difference in implant loss or bone level change was found. Sixteen per cent of Astra Tech and 29% of Brånemark patients showed at least one implant with ≥2 mm bone loss after the first year in function. The corresponding prevalence on implant level was 6% and 5% respectively. No significant differences were found between the other examined variables. Two patients showed prosthetic complications of the supra construction in need of repair. Seven bridges had minor ceramic chippings. Treatment with Astra Tech TiOblast implants and Brånemark turned implants supporting full-arch bridges showed generally good clinical results with low numbers of implants with marginal bone loss indicative of peri-implantitis. No significant differences were found between the implant systems after 12-15 years in function. © 2012 John Wiley & Sons A/S.

Iodine-131 metaiodobenzylguanidine treatment for metastatic carcinoid. Results in 98 patients.

PubMed

Safford, Shawn D; Coleman, R Edward; Gockerman, Jon P; Moore, Joseph; Feldman, Jerome; Onaitis, Mark W; Tyler, Douglas S; Olson, John A

2004-11-01

Iodine-131 metaiodobenzylguanidine (131I-MIBG) is useful for imaging carcinoid tumors and recently has been applied to the palliative treatment of metastatic carcinoid in small studies. The authors now report their results on the therapeutic utility of high-dose 131I-MIBG treatment in a large group of patients with metastatic carcinoid tumors. The authors performed a retrospective review of 98 patients with metastatic carcinoid who were treated at their institution with 131I-MIBG over a 15-year period. Endpoints examined included the World Health Organization criteria for treatment response: symptoms, hormone (5-hydroxyindoleacetic acid [5-HIAA]) production, and clinical tumor response. Patients received a median dose of 401 +/- 202 millicuries (mCi) 131I-MIBG. The median survival after treatment was 2.3 years. Patients who experienced a symptomatic response had improved survival (5.76 years vs. 2.09 years; P < 0.01). For the 56 patients who had 5-HIAA levels monitored, the mean urine 5-HIAA levels decreased significantly after 131I-MIBG treatment (126 +/- 122 ng/mL vs. 91 +/- 125 ng/mL; P < 0.01); however, the patients with reduced 5-HIAA levels did not experience improved survival (4.11 years vs. 3.42 years; P = 0.2). Patients who received an initial 131I-MIBG dose > 400 mCi lived longer than patients who received < 400 mCi (4.69 years vs. 1.86 years; P = 0.05). Radiographic tumor response did not predict survival. Toxicity included pancytopenia, thrombocytopenia, nausea, and emesis. The current data support 131I-MIBG treatment in select patients with metastatic carcinoid who progress despite optimal medical management. Improved survival was predicted best by symptomatic response to 131I-MIBG treatment, but not by hormone or radiographic response.

Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results.

PubMed

Lammer, Johannes; Bosiers, Marc; Deloose, Koen; Schmidt, Andrej; Zeller, Thomas; Wolf, Florian; Lansink, Wouter; Sauguet, Antoine; Vermassen, Frank; Lauwers, Geert; Scheinert, Dierk; Popma, Jeffrey J; McGreevy, Robert; Rapoza, Richard; Schwartz, Lewis B; Jaff, Michael R

2016-06-13

This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA). Drug-eluting BVS has shown promise in coronary arteries. The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication. Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet. The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

PubMed

da Cruz, Lyndon; Dorn, Jessy D; Humayun, Mark S; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E; Hafezi, Farhad; Safran, Avinoam B; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V; de Juan, Eugene; Duncan, Jacque L; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C; Ho, Allen C; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V; Arditi, Aries; Greenberg, Robert J

2016-10-01

The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. Thirty participants in 10 centers in the United States and Europe. The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Natrelle round silicone breast implants: Core Study results at 10 years.

PubMed

Spear, Scott L; Murphy, Diane K

2014-06-01

Allergan's Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available. Seven hundred fifteen subjects were implanted with smooth and Biocell textured Natrelle round silicone implants and attended clinic visits at 0 to 4 weeks, 6 months, 1 year, and annually through 10 years. Approximately one-third of subjects underwent magnetic resonance imaging at years 1, 3, 5, 7, and 9 to assess rupture. Complication rates showed modest increases over the previously published 6-year rates. The Kaplan-Meier capsular contracture rate was 18.9 percent for augmentation, 28.7 percent for revision-augmentation, and 24.6 percent for reconstruction. Among augmentation subjects, capsular contracture was significantly lower (p = 0.023) for submuscular (15.7 percent) versus subglandular (26.3 percent) placement. The overall rupture rate in the magnetic resonance imaging cohort was 13.0 percent for subjects and 7.7 percent for implants. By the end of the study, 81.8 percent of augmentation subjects still had an original implant in place. Using a five-point scale, 94.2 percent of augmentation, 83.8 percent of revision-augmentation, and 90.7 percent of reconstruction subjects reported being satisfied or definitely satisfied with their implants. Significant improvement over baseline was also seen in overall breast satisfaction and satisfaction with breast size, shape, feel, and how well they matched. The 10-year data from the Natrelle Core Study, which can guide surgeons and patients in decision-making, demonstrate safety and high levels of patient satisfaction. Therapeutic, III.

Early versus delayed loading of mandibular implant-supported overdentures: 5-year results.

PubMed

Turkyilmaz, Ilser; Tözüm, Tolga F; Tumer, Celal

2010-05-01

Because of poor retention of complete removable dentures for edentulous patients, implant-supported mandibular overdentures have lately become a popular alternative for them. The aims of this prospective study were to evaluate treatment outcomes of mandibular overdentures supported by two unsplinted early-loaded implants and compare these results with those for delayed-loaded implants. A total of 26 edentulous patients were treated with two unsplinted implants supporting a mandibular overdenture. All implants were placed in the canine regions of each mandible according to the one-stage surgical protocol. There were two groups: test group, in which the overdenture was connected 1 week after surgery, and control group, in which the overdenture was connected 3 months after surgery. Standardized clinical and radiographic parameters were recorded at surgery, and after 3, 6, 12, and 18 months, and 2, 3, 4, and 5 years. No implants were lost, and 0.93 +/- 0.3 mm marginal bone resorption was noted for all implants after 5 years. Clinical implant stability measurements, clinical peri-implant parameters, and marginal bone resorptions showed no statistically significant differences between the two groups over 5 years. The results of this prospective clinical study suggest that there is no significant difference in the clinical and radiographic state of patients treated with implant supported mandibular overdentures loaded either 1 week or 3 months after surgery.

The National Early Warning Score (NEWS) for outcome prediction in emergency department patients with community-acquired pneumonia: results from a 6-year prospective cohort study

PubMed Central

Sbiti-Rohr, Diana; Kutz, Alexander; Christ-Crain, Mirjam; Thomann, Robert; Zimmerli, Werner; Hoess, Claus; Henzen, Christoph; Mueller, Beat; Schuetz, Philipp

2016-01-01

Objective To investigate the accuracy of the National Early Warning Score (NEWS) to predict mortality and adverse clinical outcomes for patients with community-acquired pneumonia (CAP) compared to standard risk scores such as the pneumonia severity index (PSI) and CURB-65. Design Secondary analysis of patients included in a previous randomised-controlled trial with a median follow-up of 6.1 years. Settings Patients with CAP included on admission to the emergency departments (ED) of 6 tertiary care hospitals in Switzerland. Participants A total of 925 patients with confirmed CAP were included. NEWS, PSI and CURB-65 scores were calculated on admission to the ED based on admission data. Main outcome measure Our primary outcome was all-cause mortality within 6 years of follow-up. Secondary outcomes were adverse clinical outcome defined as intensive care unit (ICU) admission, empyema and unplanned hospital readmission all occurring within 30 days after admission. We used regression models to study associations of baseline risk scores and outcomes with the area under the receiver operating curve (AUC) as a measure of discrimination. Results 6-year overall mortality was 45.1% (n=417) with a stepwise increase with higher NEWS categories. For 30 day and 6-year mortality prediction, NEWS showed only low discrimination (AUC 0.65 and 0.60) inferior compared to PSI and CURB-65. For prediction of ICU admission, NEWS showed moderate discrimination (AUC 0.73) and improved the prognostic accuracy of a regression model, including PSI (AUC from 0.66 to 0.74, p=0.001) and CURB-65 (AUC from 0.64 to 0.73, p=0.015). NEWS was also superior to PSI and CURB-65 for prediction of empyema, but did not well predict rehospitalisation. Conclusions NEWS provides additional prognostic information with regard to risk of ICU admission and complications and thereby improves traditional clinical-risk scores in the management of patients with CAP in the ED setting. Trial registration number

Epidemiological study of 7316 patients on haemodialysis treated in FME clinics in Spain, using data from the EuCliD® database: results from years 2009-2010.

PubMed

Pérez-García, Rafael; Palomares-Sancho, Inés; Merello-Godino, José I; Aljama-García, Pedro; Bustamante-Bustamante, Jesús; Luño, José; Maduell-Canals, Francisco; Martín-de Francisco, Angel L; Martín-Malo, Alejandro; Mirapeix-i-Vicens, Eduard; Molina-Núñez, Manuel; Praga-Terente, Manuel; Tetta, Ciro; Marcelli, Daniele

2012-01-01

Observational study of patients on hemodialysis (HD) in FMC® Spain clinics over the years 2009 and 2010. The data were collected from the EuClid® database, implemented in the clinics of FMC®, which complies with the following feature: record online, compulsory, conducted in patients incidents and that it covers the entire population on HD in these clinics. Its aim is to understand the characteristics of patients and treatment patterns, comparing them with other studies described in the literature and in order to improve their prognosis and quality of life. Include 2637 incidents patients and 4679 prevalent, which makes a total of 7316 patients. In prevalent patients: 24.4% were diabetic; 76.3% had cardio-vascular disease (CVD) and 13.4% cancer. Among the incidents, these percentages were: 33.5% diabetic; 80.6% had CVD and 12.6% cancer. The prevalent patients had such as vascular access: FAV 68.5%, prosthesis 5.6%, permanent catheter 23.7% and 2.3% temporary catheter. The average of the duration of the sessions of HD was 230 minutes. 23.2% of the prevalent patients were on on-line hemodiafiltration. These patients hospitalization rates were 0.46 hospitalizations per incident patient per year and 0.52 per prevalent patient per year. The annual gross mortality rate was 12%. The mortality of the patients in this study HD is smaller than these of the Spanish Registry of Dialysis and Transplant (GRER). The result of morbidity and mortality of the FMC clinics of Spain can, therefore, be as good compared with these of the GRER and other international series. That does not mean that there are not areas of improvement as the increase in the time of dialysis, the percentage of patients on on-line hemodiafiltration convective techniques and the percentage of FAV.

[Functional results of Hirschsprung's disease patients after Duhamel and De la Torre procedures].

PubMed

Fernández Ibieta, M; Sánchez Morote, J M; Martínez Castaño, I; Reyes Ríos, P; Cabrejos Perotti, K; Rojas Ticona, J; Ruiz Pruneda, R; Aranda García, M J; Roqués Serradilla, J L; Trujillo Ascanio, A; Hernández Bermejo, J P; Ruiz Jiménez, J I

2013-10-01

Long term results of different surgical techniques in Hirschsprung's Disease (HD) are contradictory. There are still no long term large or multicentric reports about functional results of De la Torre technique. We have studied the mid term functional results of the patients operated on Duhamel (D) and De la Torre (dlT) pull-through procedures. We collected data from medical records and telephone interviews of the HD patients operated in our unit in the last 16 years. 38 patients were found. Ages ranged from 1.5 to 21 years. Mean age was 7.7 years. Median follow up was 5.9 years. 33 (86.8%) had rectosigmoid disease and 5 (13.2%) had long segment disease. D procedure was performed in 17 (44.7%), Soave in 1 (2.6%), Duhamel-Lester-Martin in 4 (10.5%) and dlT pull-through in 16(42%). In the last visit record, 12 (31.6%), had constipation, and fecal leaks were noted in 11 (33.3%) of the 33 patients > or = 4 years old.. 10 patients (29.4% of the > or = 4 years old group) referred encopresis along the follow-up. Patients from the D group referred higher rates of constipation than those in the dlT group (53.3% vs 20% p=0.048). dlT patients referred more frequency of leaks (46,1% vs 13,3%, p=0,05) Children with very short resections (< or = 10 cm) were more prone to constipation than children with longer resections (66,6% vs 17.4% p=0.007), and less prone to present leaks (12.5% vs 47.3% p=0.08). Encopresis was similar in all groups. Both techniques show similar functional results in the mid term, although children in the D group were more prone to constipation and those in the dlT group presented more fecal leaks. All patients with EH need long follow-ups.

Implantation of a novel telemetric intraocular pressure sensor in patients with glaucoma (ARGOS study): 1-year results.

PubMed

Koutsonas, Antonis; Walter, Peter; Roessler, Gernot; Plange, Niklas

2015-01-22

We investigated the safety of a telemetric IOP sensor and the accuracy of its IOP measurements in six patients with open-angle glaucoma and cataract. The study design was a prospective, single-center clinical trial. Here we present 1-year follow-up data. A ring-shaped telemetric IOP sensor was implanted in the ciliary sulcus after implantation of the intracapsular lens, during planned cataract surgery. The sensor is encapsulated in silicone rubber and consists of a miniature device with eight pressure-sensitive capacitors and a circular microcoil antenna. IOP measurements are performed with a reader unit held in front of the eye. IOP is calculated as the differences between the absolute pressure inside the eye (pressure sensor) and that outside the eye (reader unit). The sensor was successfully implanted in all patients. Four patients developed sterile anterior chamber inflammation that resolved completely within 9 days after surgery with anti-inflammatory treatment. All patients showed mild to moderate pupillary distortion and pigment dispersion after surgery. Telemetric IOP measurement was performed in all patients at all visits, and the patients successfully performed self-tonometry at home after receiving instructions. Telemetric IOP values showed similar profiles compared to those of Goldmann applanation tonometry (GAT). Three patients showed a relevant IOP step during follow-up, and in one patient, negative values were obtained throughout the study. Despite early postoperative anterior chamber inflammation, the IOP sensor was well tolerated by all patients. We describe the first prospective clinical study of a noncontact IOP sensor that potentially enables continuous IOP monitoring in patients with glaucoma. The sensor shape and size needs to be adapted to avoid pupillary distortion and to confirm that IOP measurements are accurately recorded in comparison to those of GAT. ( www.germanctr.de; number DRKS00003335.). Copyright 2015 The Association for Research

High-intensity focused ultrasound (HIFU) for adenomyosis: Two-year follow-up results.

PubMed

Shui, Lian; Mao, Shihua; Wu, Qingrong; Huang, Guohua; Wang, Jian; Zhang, Ruitao; Li, Kequan; He, Jia; Zhang, Lian

2015-11-01

To evaluate the long-term improvement of clinical symptoms of adenomyosis after treatment with ultrasound-guided high intensity focused ultrasound (USgHIFU). From January 2010 to December 2011, 350 patients with adenomyosis were treated with USgHIFU. Among the 350 patients, 224 of them completed the two years follow-up. The patients were followed up at 3 months, 1 year, and 2 years after HIFU treatment. Adverse effects and complications were recorded. All patients completed HIFU ablation without severe postoperative complications. 203 of the 224 patients who showed varying degrees of dysmenorrhea before treatment had the symptom scores decreased significantly after treatment (P<0.001). The relief rate was 84.7%, 84.7%, and 82.3%, respectively at 3 months, 1 year, and 2 years after treatment. The menstrual volume in 109 patients with menorrhagia was significantly improved after treatment (P<0.001) with a relief rate of 79.8%, 80.7%, and 78.9%, respectively at 3 months, 1 year, and 2 years after HIFU treatment. With its ability to sustain long-term clinical improvements, HIFU is a safe and effective treatment for adenomyosis. Copyright © 2015 Elsevier B.V. All rights reserved.

[TRT: results after one year treatment].

PubMed

Madeira, G; Montmirail, Ch; Decat, M; Gersdorff, M

2007-01-01

Tinnitus Retraining Therapy (TRT) (which aims to induce changes in the mechanisms responsible for transferring signals from the auditory system to the limbic and autonomic systems) is a method for treating Tinnitus and decreased sound tolerance. An individualised explanation of Jastreboff's neurophysiological model allows greater insight and motivation on the part of the patient. Previous studies have demonstrated that daytime TRT is effective. As sleep forms a significant component of the distress associated with Tinnitus however, we hypothesised that night-time TRT could represent a useful tool in the treatment of this disabling condition. 46 patients were studied (30 male, 16 female). Patients were selected from an ENT outpatient clinic. Patients with significant psychological disability were excluded. Patients were reviewed twice by their doctor and 5 times by a therapist over 12 months. Treatment consisted of 8 hours nighttime white noise stimulation, at progressively increasing intensity. Although several objective assessments of response were undertaken, patients' subjective testimonies were considered a more accurate signal of success. In total, 80% of patients had a satisfactory response after 1 year of treatment. 20% had no response. Patients were subcategorised according to Jastreboff's categories as follows: 1. Tinnitus (n = 6), 100% improved; 2. Tinnitus with hearing loss (n = 16); 62% improved; 3. Hyperacusis (with or without Tinnitus) (n = 16), 88.5% improved; 4. Hyperacusis (with or without Tinnitus, exacerbated by noise) (n = 8), 75% improved. Tinnitus is a symptom rather than an illness, and TRT gives patients greater control, allowing re-integration of normal perception. Night-time TRT is an effective treatment for Tinnitus and decreased sound tolerance. It has the potential advantage over day-time TRT of rapidly improving sleep and decreasing use of sedative hypnotics, a secondary effect noted in the personal testimonies of our cohort of

Clinical events in coronary heart disease patients with an ejection fraction of 40% or less: 3-year follow-up results.

PubMed

Pischke, Claudia R; Elliott-Eller, Melanie; Li, Minmin; Mendell, Nancy; Ornish, Dean; Weidner, Gerdi

2010-01-01

It is unclear whether lifestyle changes can delay the need for surgical procedures in coronary heart disease (CHD) patients with asymptomatic reduced left ventricular ejection fraction (LVEF). The aim of this pilot study was to examine whether lifestyle changes can delay the need for surgical procedures in this population. We compared 3-year clinical events in 27 CHD patients eligible to receive revascularization (by insurance standards), but underwent lifestyle changes (low-fat diet, exercise, stress management) instead (intervention group [IG], LVEF < or =40%), with those of a historically matched (age, gender, LVEF, and stenosis of the 3 major coronary arteries) control group receiving usual care (UCG; n = 13) who received revascularization at study entry. Both IG and UCG patients were enrolled in the health insurance companies participating in the Multicenter Lifestyle Demonstration Project, an insurance-sponsored, community-based, secondary prevention study implemented at 8 hospital sites in the United States. At 3 months, there were more cardiac events in the UCG (6 events) than in the IG (1 event; P < .006; odds ratio = 13.27; confidence interval = 1.57-111.94). This difference was maintained over 3 years (P < .06; odds ratio = 2.75; confidence interval = 1.05-7.19). Of the 26 surviving (1 cardiac death) IG patients, 23 did not require primary revascularization. In conclusion, CHD patients with asymptomatic reduced LVEF may be able to safely delay revascularization by making changes in lifestyle with no increased risk for cardiac events or overt heart failure over 3 years.

The effect of patient selection and surgical technique on the results of Conserve® Plus hip resurfacing--3.5- to 14-year follow-up.

PubMed

Amstutz, Harlan C; Takamura, Karren M; Le Duff, Michel J

2011-04-01

The results of metal-on-metal hip Conserve® Plus resurfacings with up to 14 years of follow-up with and without risk factors of small component size and/or large femoral defects were compared as performed with either first- or second-generation surgical techniques. There was a 99.7% survivorship at ten years for ideal hips (large components and small defects) and a 95.3% survivorship for hips with risk factors optimized technique has measurably improved durability in patients with risk factors at the 8-year mark. The lessons learned can help offset the observed learning curve of resurfacing. Copyright © 2011 Elsevier Inc. All rights reserved.

Satisfaction and Clinical Outcomes Among Patients with Immediately Loaded Mandibular Overdentures Supported by One or Two Dental Implants: Results of a 5-Year Prospective Randomized Clinical Trial.

PubMed

Kronstrom, Mats; Davis, Ben; Loney, Robert; Gerrow, Jack; Hollender, Lars

The purpose of this study was to evaluate patient satisfaction and clinical outcomes among subjects with mandibular overdentures supported by one or two immediately placed dental implants 5 years after loading. Thirty-six subjects (16 men and 20 women) received one or two dental implants in the anterior mandible, and all implants were loaded the day of surgery. Subjects were scheduled for follow-up 3-, 6-, and 12 months after implant placement and thereafter annually for 4 more years. Patient satisfaction scores were measured with the Oral Health Impact Profile-EDENT (OHIPEDENT) questionnaire. Seventeen subjects (7 male and 10 female) with a mean age of 59.4 years (range, 44 to 74 years) were available for the 5-year follow-up examination. Nine subjects with 10 failing implants were excluded during the first year and nine subjects were lost to follow-up. No implants failed between the 12- and 60-month follow-up examinations, and the need for denture maintenance was low. Mean peri-implant bone change was 0.92 mm, and the Spearman test failed to show correlation between the insertion torque value and implant stability quotient. Patient satisfaction scores increased significantly when compared with baseline values and continued to be high for both groups, with no significant differences. Ten implants in nine subjects failed early, but no failures were observed after the 12-month examination. No significant differences were found between subjects in the two groups with respect to implant survival rates and peri-implant bone loss, and patient satisfaction scores continued to be high. Although patient satisfaction and implant success were high during the 12- to 60-month period, the results should be interpreted with caution because of the high number of failing implants and patients lost to follow-up. More research is needed to study outcomes of treatment with immediately loaded mandibular implant overdentures.

Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: results at three years.

PubMed

Gonwa, Thomas; Johnson, Christopher; Ahsan, Nasimul; Alfrey, Edward J; Halloran, Philip; Stegall, Mark; Hardy, Mark; Metzger, Robert; Shield, Charles; Rocher, Leslie; Scandling, John; Sorensen, John; Mulloy, Laura; Light, Jimmy; Corwin, Claudia; Danovitch, Gabriel; Wachs, Michael; VanVeldhuisen, Paul; Leonhardt, Maryanne; Fitzsimmons, William E

2003-06-27

Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years. The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC+MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA+MMF (84.1% vs. 49.9%, P=0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC+MMF, CsA+MMF, and TAC+AZA treatment arms, respectively. Furthermore, patients randomized to TAC+MMF received significantly lower doses of MMF as compared with those who received CsA+MMF. All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC+MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.

Pineal tumors: analysis of treatment results in 20 patients.

PubMed

Amendola, Beatriz E; Wolf, Aizik; Coy, Sammie R; Amendola, Marco A; Eber, Daryl

2005-01-01

The authors evaluate their results when using gamma knife surgery (GKS) in the management of patients with tumors in the pineal region. This is a retrospective clinical evaluation of 20 patients with primary tumors of the pineal region treated with GKS from November 1994 through August 2003. There were 13 germ cell tumors, two pineoblastomas, two low-grade gliomas, one primitive neuroectodermal tumor, one teratoma, and one pineocytoma. There were 10 male and 10 female patients. Their median age was 15.5 years (range 5-71 years). The median margin dose was 11 Gy (range 8-20 Gy). The median target volume was 3.1 cm3 (range 0.1-49.9 cm3). Five patients received sequential systemic chemotherapy and four underwent adjuvant conventional radiation therapy. Seventeen (85%) of 20 patients are alive with a median survival of 30.4 months (range 0-85.7 months). Two patients required retreatment. Three patients died: one of unrelated causes, one who presented with extensive local disease, and the other of meningeal carcinomatosis with local control of the primary tumor. No complications from GKS were noted. This initial experience suggests that GKS is a valuable treatment modality for the management of pineal region tumors. This technique offers excellent local tumor control and minimal patient morbidity, allowing for immediate use of systemic chemotherapy and/or conventional radiation if indicated.

Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results.

PubMed

Martin, Daniel F; Maguire, Maureen G; Fine, Stuart L; Ying, Gui-shuang; Jaffe, Glenn J; Grunwald, Juan E; Toth, Cynthia; Redford, Maryann; Ferris, Frederick L

2012-07-01

To describe effects of ranibizumab and bevacizumab when administered monthly or as needed for 2 years and to describe the impact of switching to as-needed treatment after 1 year of monthly treatment. Multicenter, randomized clinical trial. Patients (n = 1107) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial. At enrollment, patients were assigned to 4 treatment groups defined by drug (ranibizumab or bevacizumab) and dosing regimen (monthly or as needed). At 1 year, patients initially assigned to monthly treatment were reassigned randomly to monthly or as-needed treatment, without changing the drug assignment. Mean change in visual acuity. Among patients following the same regimen for 2 years, mean gain in visual acuity was similar for both drugs (bevacizumab-ranibizumab difference, -1.4 letters; 95% confidence interval [CI], -3.7 to 0.8; P = 0.21). Mean gain was greater for monthly than for as-needed treatment (difference, -2.4 letters; 95% CI, -4.8 to -0.1; P = 0.046). The proportion without fluid ranged from 13.9% in the bevacizumab-as-needed group to 45.5% in the ranibizumab monthly group (drug, P = 0.0003; regimen, P < 0.0001). Switching from monthly to as-needed treatment resulted in greater mean decrease in vision during year 2 (-2.2 letters; P = 0.03) and a lower proportion without fluid (-19%; P < 0.0001). Rates of death and arteriothrombotic events were similar for both drugs (P > 0.60). The proportion of patients with 1 or more systemic serious adverse events was higher with bevacizumab than ranibizumab (39.9% vs. 31.7%; adjusted risk ratio, 1.30; 95% CI, 1.07-1.57; P = 0.009). Most of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor (VEGF). Ranibizumab and bevacizumab had similar effects on visual acuity over a 2-year period. Treatment as needed resulted in less gain in visual acuity

Long-term safety and efficacy of eslicarbazepine acetate in patients with focal seizures: results of the 1-year ESLIBASE retrospective study.

PubMed

Villanueva, V; Serratosa, J M; Guillamón, E; Garcés, M; Giráldez, B G; Toledo, M; Salas-Puig, J; López González, F J; Flores, J; Rodríguez-Uranga, J; Castillo, A; Mauri, J A; Camacho, J L; López-Gomáriz, E; Giner, P; Torres, N; Palau, J; Molins, A

2014-09-01

Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) licensed as adjunctive therapy in adults with partial-onset or focal seizures. To evaluate in a clinical practice setting the long-term efficacy and safety of ESL in patients with focal seizures. ESLIBASE was a retrospective study that included all patients with focal seizures who started ESL between January 2010 and July 2012 at 12 hospitals. ESL was prescribed individually according to real-life practice. Efficacy and safety were evaluated over 1 year. Switching from carbamazepine (CBZ) and oxcarbazepine (OXC) was assessed. Three hundred and twenty-seven patients were included; 78% of patients were taking ≥2 other AEDs at baseline. Most (87%) began ESL because of poor seizure control and 13% because of adverse events (AEs) with CBZ or OXC. After 1 year, 237 patients (72.4%) remained on ESL. At 3, 6 and 12 months, the responder rate was 46.3%, 57.9%, and 52.5%, and 21.0%, 28.0%, and 25.3% of patients were seizure free. The responder rate significantly increased when ESL was combined with a non-sodium channel-targeting drug (non-SC drug) (66.7%) versus an SC drug (47.7%; p<0.001). At 12 months, 40.7% of patients had ≥1 AE; AEs led to treatment discontinuation in 16.2%. Dizziness, nausea, and somnolence were the most common AEs. The tolerability profile improved in >50% of the patients who switched from CBZ or OXC to ESL because of AEs. ESL was well tolerated and effective in a real-world setting over 1 year. Side-effect profile improved when OXC and CBZ recipients were switched to ESL. Copyright © 2014 Elsevier B.V. All rights reserved.

Twenty‐Year Outcome and Association Between Early Treatment and Mortality and Disability in an Inception Cohort of Patients With Rheumatoid Arthritis: Results From the Norfolk Arthritis Register

PubMed Central

Gwinnutt, James M.; Symmons, Deborah P. M.; MacGregor, Alexander J.; Chipping, Jacqueline R.; Marshall, Tarnya; Lunt, Mark

2017-01-01

Objective To describe the outcome in patients with rheumatoid arthritis (RA) over 20 years from symptom onset, and to assess the association between early treatment (with disease‐modifying antirheumatic drugs/steroids) and mortality and disability during follow‐up. Methods Patients recruited to the Norfolk Arthritis Register (NOAR) between 1990 and 1994 who met the 2010 American College of Rheumatology/European League Against Rheumatism RA criteria at baseline were included in this analysis. Demographic and clinical variables were collected at baseline and at years 1–3, 5, 7, 10, 15, and 20. Disease activity (swollen joint count [SJC]/tender joint count [TJC]), disability (Health Assessment Questionnaire disability index [HAQ DI]), and mortality over 20 years were determined. Associations between treatment group (early treatment [ET], treatment ≤6 months after symptom onset; late treatment [LT], treatment >6 months after symptom onset; never treatment [NT], no treatment) and mortality and disability were assessed using weighted pooled logistic regression and weighted multilevel mixed‐effects linear regression, respectively. Inverse weights were used to account for confounding by indication and censoring. Results This study included 602 patients with RA (median age 56 years [interquartile range 44–68 years]; 65.9% women). The median SJCs and TJCs were low during the follow‐up period (1–3 swollen joints and 3–6 tender joints). The median HAQ DI score increased after year 1 but remained at low/moderate levels (median 1.25 after year 10). The risk of mortality was reduced in the ET and LT groups compared with that in the NT group. The ET group and the NT group had comparable HAQ DI scores during the follow‐up period (β = 0.03, 95% confidence interval [95% CI] −0.06, 0.12), while the HAQ DI score was increased in the LT group (for LT versus NT, β = 0.10 [95% CI 0.02, 0.17]). Conclusion The results of this study indicate the importance of

Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation: 2-year results of the C-OPERA study, a phase III randomised trial

PubMed Central

Atsumi, Tatsuya; Tanaka, Yoshiya; Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Yasuda, Shinsuke; Yamanishi, Yuji; Kita, Yasuhiko; Matsubara, Tsukasa; Iwamoto, Masahiro; Shoji, Toshiharu; Togo, Osamu; Okada, Toshiyuki; Miyasaka, Nobuyuki; Koike, Takao

2017-01-01

Objectives To investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year methotrexate (MTX) therapy, compared with 2-year therapy with MTX alone. Methods MTX-naïve patients with early rheumatoid arthritis (RA) with poor prognostic factors were eligible to enter Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA), a multicentre, randomised, controlled study, which consisted of a 52-week double-blind (DB) period and subsequent 52-week post treatment (PT) period. Patients were randomised to optimised MTX+CZP (n=159) or optimised MTX+placebo (PBO; n=157). Following the DB period, patients entered the PT period, receiving MTX alone (CZP+MTX→MTX; n=108, PBO+MTX→MTX; n=71). Patients who flared could receive rescue treatment with open-label CZP. Results 34 CZP+MTX→MTX patients and 14 PBO+MTX→MTX patients discontinued during the PT period. From week 52 through week 104, significant inhibition of total modified total Sharp score progression was observed for CZP+MTX versus PBO+MTX (week 104: 84.2% vs 67.5% (p<0.001)). Remission rates decreased after CZP discontinuation; however, higher rates were maintained through week 104 in CZP+MTX→MTX versus PBO+MTX→MTX (41.5% vs 29.3% (p=0.026), 34.6% vs 24.2% (p=0.049) and 41.5% vs 33.1% (p=0.132) at week 104 in SDAI, Boolean and DAS28(erythrocyte sedimentation rate) remission. CZP retreated patients due to flare (n=28) showed rapid clinical improvement. The incidence of overall adverse events was similar between groups. Conclusions In MTX-naïve patients with early RA with poor prognostic factors, an initial 1 year of add-on CZP to 2-year optimised MTX therapy brings radiographic and clinical benefit through 2 years, even after stopping CZP. Trial registration number NCT01451203. PMID:28153828

The Advanced Glaucoma Intervention Study (AGIS): 13. Comparison of treatment outcomes within race: 10-year results.

PubMed

Ederer, Fred; Gaasterland, Douglas A; Dally, Leonard G; Kim, Jonghyeon; VanVeldhuisen, Paul C; Blackwell, Beth; Prum, Bruce; Shafranov, George; Allen, Robert C; Beck, Allen

2004-04-01

To present for black and white patients with medically uncontrolled glaucoma 10-year results of treatment with 1 of 2 randomly assigned surgical intervention sequences. Randomized clinical trial. Three hundred thirty-two black patients (451 eyes) and 249 white patients (325 eyes). Eyes had glaucoma that could not be controlled with medications alone. Eyes were randomly assigned to 1 of 2 sequences: argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) or trabeculectomy-ALT-trabeculectomy (TAT). Second and third interventions were offered after failure of the preceding intervention. Minimum required intraocular pressure (IOP) for intervention failure ranged upward from 18 mmHg, the value depending on whether recent optic disc or visual field (VF) deterioration occurred, and on the magnitude of the field defect. Patients were observed every 6 months, with total potential follow-up ranging from 8 years, 4 months to 13 years. The averages over follow-up of (1) the percentage of eyes having moderate loss of VF and (2) the percentage of eyes having moderate loss of visual acuity (VA). Race-treatment interactions in VF and VA loss are significant for the 2 main outcome measures; therefore, results of treatment sequence differences are presented by race. In black patients the average percent of eyes with VF loss was less in the ATT sequence than in the TAT sequence, a difference that is not statistically significant at any visit. In white patients, conversely, after 18 months the average percent of eyes with VF loss was less in the TAT sequence, a difference that increases and is statistically significant in years 8 to 10. In both black and white patients, the average percent of eyes with VA loss was less in the ATT sequence; this difference is statistically significant throughout 10 follow-up years in black patients and is statistically significant only for the first year in white patients. In both black and white patients, average IOP reductions were

Long-term efficacy and safety results of taliglucerase alfa through 5years in adult treatment-naïve patients with Gaucher disease.

PubMed

Zimran, Ari; Durán, Gloria; Giraldo, Pilar; Rosenbaum, Hanna; Giona, Fiorina; Petakov, Milan; Terreros Muñoz, Eduardo; Solorio-Meza, Sergio Eduardo; Cooper, Peter A; Varughese, Sheeba; Alon, Sari; Chertkoff, Raul

2016-07-18

Taliglucerase alfa, the first available plant cell-expressed recombinant therapeutic protein, is an enzyme replacement therapy approved for Gaucher disease (GD). PB-06-001, a pivotal phase 3, multicenter, randomized, double-blind, parallel-dose study investigated taliglucerase alfa 30 or 60U/kg every other week through 9months in treatment-naïve adults with GD; 30-month extension study PB-06-003 followed. Patients completing PB-06-001 and PB-06-003 could continue treatment in PB-06-007. Nineteen patients enrolled in PB-06-007 (30U/kg, n=8; 60U/kg, n=9; dose adjusted, n=2); 17 completed 5 total years of treatment. In these 3 groups, respectively, taliglucerase alfa resulted in mean decreases in spleen volume (-8.7, -6.9, -12.4 multiples of normal), liver volume (-0.6, -0.4, -0.5 multiples of normal), chitotriosidase activity (-83.1%, -93.4%, -87.9%), and chemokine (CC motif) ligand 18 concentration (-66.7%, -83.3%, -78.9%), as well as mean increases in hemoglobin concentration (+2.1, +2.1, +1.8mg/dL) and platelet count (+31,871, +106,800, +34,000/mm 3 ). The most common adverse events were nasopharyngitis and arthralgia. Most adverse events were mild/moderate; no serious adverse events were considered treatment-related. These results demonstrate continued improvement of disease parameters during 5years of taliglucerase alfa therapy in 17 treatment-naive patients with no new safety concerns, extending the taliglucerase alfa clinical efficacy and safety dataset. This study was registered at www.clinicaltrials.gov as NCT01422187. Copyright © 2016 Elsevier Inc. All rights reserved.

Michigan Oncology Medical Home Demonstration Project: First-Year Results.

PubMed

Kuntz, Gordon; Tozer, Jane; Snegosky, Jeff; Fox, John; Neumann, Kurt

2014-03-01

The Michigan Oncology Medical Home Demonstration Project (MOMHDP) is an innovative multipractice oncology medical home model, supported by payment reform. Sponsored by Priority Health, Physician Resource Management, and ION Solutions, MOMHDP includes four oncology practices and 29 physicians. Oncology practices used existing technologies, with MOMHDP providing evidence-based treatment guideline selection and compliance tracking, automated physician order entry, a patient portal, symptom management/standardized nurse triage, and advance care planning. To support changes in care and administrative models and to focus on quality, MOMHDP modifies provider payments. The program replaces the average sales price payment methodology with a drug acquisition reimbursement plus a care management fee, calculated to increase total drug reimbursement. Additionally, it reimburses for chemotherapy and treatment planning and advance care planning consultation. There is also a shared savings opportunity. MOMHDP will be enhanced in its second year to include a survivorship program, patient distress screening, imaging guidelines, and standardized patient satisfaction surveys. Priority Health patients receiving chemotherapy for a cancer diagnosis were recruited to the program. Results for this group were compared with a control group of patients from a prior period. In addition to the financial results, the project also accomplished the following: (1) adherence to practice-selected guidelines, (2) institution of advance care planning, (3) effective and standardized symptom management; and (4) payment reform. We have identified a number of critical success factors: strong payer/provider collaboration built on trust through transparent use and cost data; timing of clinical standardization must come from the practices, so they can effectively absorb new approaches; having comprehensive, written program documentation and consistently applied training facilitate practice understanding

Awake Craniotomy: First-Year Experiences and Patient Perception.

PubMed

Joswig, Holger; Bratelj, Denis; Brunner, Thomas; Jacomet, Alfred; Hildebrandt, Gerhard; Surbeck, Werner

2016-06-01

Awake craniotomy for brain lesions in or near eloquent brain regions enables neurosurgeons to assess neurologic functions of patients intraoperatively, reducing the risk of permanent neurologic deficits and increasing the extent of resection. A retrospective review was performed of a consecutive series of patients with awake craniotomies in the first year of their introduction to our tertiary non-university-affiliated neurosurgery department. Operation time, complications, and neurologic outcome were assessed, and patient perception of awake craniotomy was surveyed using a mailed questionnaire. There were 24 awake craniotomies performed in 22 patients for low-grade/high-grade gliomas, cavernomas, and metastases (average 2 cases per month). Mean operation time was 205 minutes. Failure of awake craniotomy because of intraoperative seizures with subsequent postictal impaired testing or limited cooperation occurred in 2 patients. Transient neurologic deficits occurred in 29% of patients; 1 patient sustained a permanent neurologic deficit. Of the 18 patients (82%) who returned the questionnaire, only 2 patients recalled significant fear during surgery. Introducing awake craniotomy to a tertiary non-university-affiliated neurosurgery department is feasible and resulted in reasonable operation times and complication rates and high patient satisfaction. Copyright © 2016 Elsevier Inc. All rights reserved.

Eight-year results of aortic root replacement with the freestyle stentless porcine aortic root bioprosthesis.

PubMed

Kon, Neal D; Riley, Robert D; Adair, Sandy M; Kitzman, Dalane W; Cordell, A Robert

2002-06-01

Stentless porcine aortic valves offer several advantages over traditional valves. Among these are superior hemodynamics, laminar flow patterns, lack of need for anticoagulation, and perhaps improved durability. One hundred four patients were operated on from September 17, 1992, to October 31, 1997, as part of a multicenter worldwide investigation of the Medtronic Freestyle stentless porcine bioprosthesis. All patients received a total aortic root replacement. The patients were evaluated postoperatively at discharge, at 3 to 6 months, and yearly by clinical examination and color flow Doppler echocardiography. Operative mortality was 3.9%. No patient experienced structural valve deterioration, nonstructural deterioration, perivalvular leak, or unacceptable hemodynamic performance. At 8 years, survival was 59.8%. Freedom from thromboembolic complications was 83.3%. Freedom from postoperative endocarditis was 96.9%. Freedom from reoperation was 100%. Mean systolic gradients did not change over the time period studied. They were 6.4 +/- 3.8 mm Hg at 1 year and 6.7 +/- 2.6 mm Hg at 8 years. Correspondingly, effective orifice area was 1.9 +/- 0.7 cm2 at 1 year and 1.8 +/- 0.8 cm2 at 8 years. The incidence of any aortic insufficiency also did not change over the length of follow-up. At 1 year, 98% of patients had no or trivial aortic insufficiency and 2% had mild aortic insufficiency. At 8 years, 100% of patients evaluated were free of any aortic insufficiency. The Medtronic Freestyle aortic root bioprosthesis can be used safely to replace the aortic root or aortic valve for aortic valve and aortic root pathology. Total root replacement allows optimal hemodynamic performance with no significant aortic regurgitation. Results up to 8 years show excellent survival and no signs of degeneration. Further follow-up is still needed to determine valve durability.

First-line management of distal humerus fracture by total elbow arthroplasty in geriatric traumatology: Results in a 21-patient series at a minimum 2years' follow-up.

PubMed

Lami, D; Chivot, M; Caubere, A; Galland, A; Argenson, J N

2017-10-01

Total elbow arthroplasty (TEA) is one option in distal humerus fracture in elderly osteoporotic patients. The study hypothesis was that, in patients aged 70years or more, TEA provides functional results and ranges of motion compatible with everyday activity, with a complications rate equal to or lower than with internal fixation, and no loss of autonomy or cognitive impairment. In this retrospective study, 21 patients receiving TEA for distal humerus fracture were included. Mean follow-up was 3.2years, with functional (Quick DASH and MEPS), cognitive (MMSE), autonomy-related (ADL) and radiological assessment (Morrey). Mean MEPS was 84 and QuickDASH 32.4. Mean extension deficit was 22°, and mean flexion 125°. There was no loss of autonomy or cognitive impairment. The complications rate was 9.5%. There were no revision surgeries. TEA proved reliable in comminuted distal humerus fracture in elderly patients. Functional results were comparable to those in the literature, and the complications rate was lower. Long-term implant survival needs confirmation to validate this option as a treatment of choice in these indications in geriatric traumatology. Retrospective non-comparative, single-center. 4. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Ten-year results of quality assurance in radiotherapy chart round.

PubMed

Taghavi Bayat, Bardia; Gill, Suki; Siva, Shankar; Tai, Keen Hun; Joon, Michael Lim; Foroudi, Farshad

2013-04-23

The Royal Australian and New Zealand College of Radiologists (RANZCR) initiated a unique instrument to audit the quality of patient notes and radiotherapy prescriptions. We present our experience collected over ten years from the use of the RANZCR audit instrument. In this study, the results of data collected prospectively from January 1999 to June 2009 through the audit instrument were assessed. Radiotherapy chart rounds were held weekly in the uro-oncology tumour stream and real time feedback was provided. Electronic medical records were retrospectively assessed in September 2009 to see if any omissions were subsequently corrected. In total 2597 patients were audited. One hundred and thirty seven (5%) patients had one hundred and ninety nine omissions in documentation or radiotherapy prescription. In 79% of chart rounds no omissions were found at all, in 12% of chart rounds one omission was found and in 9% of chart rounds two or more omissions were found. Out of 199 omissions, 95% were of record keeping and 2% were omissions in the treatment prescription. Of omissions, 152 (76%) were unfiled investigation results of which 77 (51%) were subsequently corrected. Real-time audit with feedback is an effective tool in assessing the standards of radiotherapy documentation in our department, and also probably contributed to the high level of attentiveness. A large proportion of omissions were investigation results, which highlights the need for an improved system of retrieval of investigation results in the radiation oncology department.

Laparoscopic Heller myotomy for achalasia: results after 10 years.

PubMed

Cowgill, Sarah M; Villadolid, Desiree; Boyle, Robert; Al-Saadi, Sam; Ross, Sharona; Rosemurgy, Alexander S

2009-12-01

Laparoscopic Heller myotomy was first undertaken in the early 1990s, and appreciable numbers of patients with 10-year follow-up periods are now available. This study was undertaken to determine long-term outcomes after laparoscopic Heller myotomy used to treat achalasia. Of 337 patients who have undergone laparoscopic Heller myotomy since 1992, 47 who underwent myotomy more than 10 years ago have been followed through a prospectively maintained registry. Among many symptoms, patients scored dysphagia, chest pain, vomiting, regurgitation, choking, and heartburn before and after myotomy using a Likert scale with choices ranging from 0 (never/not bothersome) to 10 (always/very bothersome). Symptom scores before and after myotomy were compared using a Wilcoxon matched-pairs test. Data are reported as median (mean ± standard deviation). The median length of the hospital stay was 2 days (mean, 3 ± 8.6 days; range, 1-60 days). Notable complications were infrequent after myotomy. There were no perioperative deaths. One patient required a redo myotomy after 5 years due to recurrence of symptoms. At this writing, 33 patients (70%) are still alive. The causes of death after discharge were unrelated to myotomy. The frequency and severity scores for dysphagia, chest pain, vomiting, regurgitation, choking, and heartburn all decreased significantly after laparoscopic Heller myotomy (p < 0.0001 for all). Laparoscopic Heller myotomy can be undertaken with few complications. This procedure significantly decreases the frequency and severity of achalasia symptoms without promoting heartburn. The symptoms of achalasia are durably ameliorated by laparoscopic Heller myotomy during long-term follow-up evaluation, thereby promoting application of this procedure.

Impact of marital status on survival of gastric adenocarcinoma patients: Results from the Surveillance Epidemiology and End Results (SEER) Database.

PubMed

Qiu, Miaozhen; Yang, Dajun; Xu, Ruihua

2016-02-15

Marital status was found to be an independent prognostic factor for survival in various cancer types. In this study, we used the Surveillance, Epidemiology and End Results database to analyze the survival difference among different marital status in the United States. Gastric adenocarcinoma patients from 2004-2012 were enrolled for study. The 5-year cause specific survival (CSS) was our primary endpoint. Totally 29,074 eligible patients were identified. We found that more male patients were married than female. Asian patients had the highest percentages of married than the other races. More married patients were covered by the insurance. Married patients had better 5-year CSS than unmarried, 30.6% vs 25.7%, P < 0.001. The median overall CSS was 17.87 and 13.61 months for the married and unmarried patients, hazard ratio: 1.09 (95% confidence interval: 1.01-1.17), P = 0.027. The survival difference was significant in the insured but not in the uninsured patients. Widowed patients had the worst prognosis compared with other groups even though they had more stage I disease and more well / moderate differentiated tumors. These results indicated that unmarried gastric adenocarcinoma patients were at greater risk of cancer specific mortality. We recommend every patient should have access to best available gastric cancer therapy.

Written instructions to patients to confirm pathology results: is this effective in the transmission of results?

PubMed

Patwardhan, Ashwin; Wilkins, Simon; Staples, Margaret; McMurrick, Paul J

2018-05-01

Bowel cancer is the second most common internal malignancy in Australia. Bowel cancer is suited to community screening methods such as faecal occult blood testing and colonoscopy. Typical reporting of histopathology results after colonoscopy takes 3-5 days. Patients were given written instructions to call the clinician within 3-5 days to discuss the histopathology results. The objective of the study was to perform an audit whether patients call the clinician to discuss their histopathology results after undergoing a colonoscopy, gastroscopy or both. A retrospective study was performed of patients attending for gastroscopy or colonoscopy at a single colorectal clinic at Cabrini Hospital, Melbourne, between 1 January and 31 December 2014. Age, pre-scope category and compliance with written instructions to callback were analysed. A total of 176 patients met the selection criteria, of whom 32.9% did not callback to discuss their histopathology results. Age and pre-scope category were independent predictors for patients to callback after endoscopy. The mean age of the patients who called back was higher (P < 0.01). Compared with patients who had a previous polyp or resection, patients in the pre-scope category of faecal occult blood testing/screening were more likely to callback (odds ratio: 4.37; 95% confidence interval: 1.17-16.31). Patients undergoing a colonoscopy for the purposes of screening and older patients were more likely to callback. Patients aged 62 years and younger were less likely to callback and should be targeted. Enhancements to the way information is presented to patients (e.g. video) should be considered for future studies. © 2017 Royal Australasian College of Surgeons.

General paediatric surgery for patients aged under 5 years: a 5-year experience at a district general hospital.

PubMed

Kwok, C-S; Gordon, A C

2016-09-01

Introduction The gradual shift of general paediatric surgery (GPS) provision from district general hospitals (DGH) to specialised units is well recognised in the UK. The consequences of centralisation include a reduction in exposure to GPS for current surgical trainees. The GPS practice of a DGH is examined here. Methods All operations performed on children aged under 5 years over a 5-year period were identified using the local electronic operation database. Electronic hospital records and clinic letters were accessed to collect data on demographics, operations performed and outcome measures. Results 472 GPS operations were performed on children between the age of 22 days and 5 years between 2009 and 2014, of which 43 were on an emergency basis and 105 were performed on patients aged less than 1 year. Three patients were admitted following day case surgery. Six patients were readmitted within 30 days. Complication rates for all procedures and the four most common procedures were similar to those found in published literature. Conclusions GPS for patients aged less than 5 years is comparatively safe in the DGH setting. The training opportunities available at DGHs are invaluable to surgical trainees and vital for sustaining the future provision of GPS by such hospitals.

Cosmetic Contact Sensitivity in Patients with Melasma: Results of a Pilot Study

PubMed Central

Prabha, Neel; Mahajan, Vikram K.; Mehta, Karaninder S.; Chauhan, Pushpinder S.

2014-01-01

Background. Some of the patients with melasma perhaps have pigmented cosmetic dermatitis. However, cosmetic contact sensitivity in melasma remains poorly studied particularly in the Indian context. Objectives. To study cosmetic contact sensitivity in patients with melasma. Materials and Methods. 67 (F : M = 55 : 12) consecutive patients with melasma between 19 and 49 years of age were patch tested sequentially during January–December, 2012, with Indian Cosmetic and Fragrance Series, Indian Sunscreen Series, p-phenylenediamine, and patient's own cosmetic products. Results. 52 (78%) patients were in the age group of 20–40 years. The duration of melasma varied from 1 month to 20 years. Centrofacial, malar, and mandibular patterns were observed in 48 (72%), 18 (27%), and 1 (1%) patients, respectively. Indian Cosmetics and Fragrance Series elicited positive reactions in 29 (43.3%) patients. Cetrimide was the most common contact sensitizers eliciting positivity in 15 (52%) patients, followed by gallate mix in 9 (31%) patients and thiomersal in 7 (24%) patients. Only 2 of the 42 patients showed positive reaction from their own cosmetics while the other 5 patients had irritant reaction. Indian Sunscreen Series did not elicit any positive reaction. Conclusion. Cosmetics contact sensitivity appears as an important cause of melasma not associated with pregnancy, lactation, or hormone therapy. PMID:25132846

Long-term results of heart valve replacement with the Edwards Duromedics bileaflet prosthesis: a prospective ten-year clinical follow-up.

PubMed

Podesser, B K; Khuenl-Brady, G; Eigenbauer, E; Roedler, S; Schmiedberger, A; Wolner, E; Moritz, A

1998-05-01

The Edwards Duromedics valve (Baxter Healthcare Corp., Edwards Division, Santa Ana, Calif.) was designed with a self-irrigating hinge mechanism to reduce thromboembolic complications. After good initial clinical results, distribution was suspended in 1988 after reports of valve fracture after 20,000 valves had been implanted. The manufacturer conducted extensive studies to improve the Edwards Duromedics and reintroduced a modified version, which is available as Edwards Tekna. The purpose of the study was the evaluation of long-term results of the original Edwards Duromedics that might be important for the current version, the Edwards Tekna valve. A prospective clinical 10-year follow-up was performed of 508 patients who underwent valve replacement with the Edwards Duromedics valve in the aortic (n = 268), mitral (n = 183), and aortic and mitral (n = 56) position. The perioperative mortality rate was 6.9%; follow-up was 98% complete, comprising 3648 patient-years for a mean follow-up of 86 months (range: 33 to 144 months). The actuarial freedom from complications at the 10-year follow-up and the incidence rate (percent per patient-year) were as follows: late mortality rate, 69.2% +/- 2.4% (3.5% per patient-year); thromboembolism, 90.7% +/- 1.6% (0.96% per patient-year); anticoagulation-related hemorrhage, 87.7% +/- 1.7% (1.34% per patient-year); prosthetic valve endocarditis, 96.7% +/- 0.09% (0.38% per patient-year); valve-related mortality rate, 89.3% +/- 1.6% (1.21% per patient-year); valve failure, 86.2% +/- 1.85% (1.54% per patient-year); and valve-related morbidity and mortality rate, 71.1% +/- 2.3% (3.2% per patient-year). Three leaflet escapes were observed (one lethal, two successful reoperations; 99.1% +/- 0.05% freedom, 0.08% per patient-year). All patients functionally improved (86% in New York Heart Association classes I and II), and incidence of anemia was insignificant. These results confirm that the Edwards Duromedics valve shows excellent performance

Results of operative fixation of unstable ankle fractures in geriatric patients.

PubMed

Pagliaro, A J; Michelson, J D; Mizel, M S

2001-05-01

It is widely accepted that operative fixation of unstable ankle fractures yields predictably good outcomes in the general population. The current literature, however reports less acceptable results in the geriatric population age 65 years and older. The current study analyzes the outcome of the surgical treatment of unstable ankle fractures in patients at least 65 years old. Twenty three patient over 65 years old were surgically treated after sustaining 21 (91%) closed and 2 (9%) open grade II unstable ankle fractures. Fractures were classified according to the Danis-Weber and Lauge-Hansen schemes. Fracture type was predominantly Weber B (21/23, 91%), or supination external rotation stage IV (21/23, 91%). Fracture union rate was 100%. There were three significant complications including a lateral wound dehiscence with delayed fibular union in an open fracture dislocation, and two below knee amputations, neither of which was directly related to the fracture treatment. There were three minor complications; one superficial wound infection and two cases of prolonged incision drainage, all of which resolved without further surgical intervention. Complications were associated with open fractures and preexisting systemic disease. These results indicate that open reduction and internal fixation of unstable ankle fractures in geriatric patients is an efficacious treatment regime that with results that are comparable to the general population.

[Acute poisoning in patients over 65 years of age].

PubMed

Miranda Arto, P; Ferrer Dufol, A; Ruiz Ruiz, F J; Menao Guillén, S; Civeira Murillo, E

2014-01-01

There are few Spanish studies on acute poisoning in the elderly despite the associated risk factors of this group of patients. Retrospective descriptive study of acute poisonings treated in the Emergency Service of the University Hospital of Zaragoza from 1995 to 2009 on patients 65 years old or older. A total of 762 patients were selected in the study (4.74% of all acute poisonings) with a mean age of 74.16 (SD ± 6) years. Ingestion was the major route of exposure (85%) and alcohol overdose (28,7%) was the most frequent type of poisoning. A trend was also observed showing a lower emetic treatment and gastric lavage and an increase in activated charcoal. Benzodiazepines (14.3%) and toxic household products (11%) with caustic properties were also the main toxics found in the study. Acute poisonings in the elderly required more hospitalizations, have a higher mortality and more autolytic attempts which result in death.

Quality of life in patients with proton-treated pediatric medulloblastoma: Results of a prospective assessment with 5-year follow-up.

PubMed

Kamran, Sophia C; Goldberg, Saveli I; Kuhlthau, Karen A; Lawell, Miranda P; Weyman, Elizabeth A; Gallotto, Sara L; Hess, Clayton B; Huang, Mary S; Friedmann, Alison M; Abrams, Annah N; MacDonald, Shannon M; Pulsifer, Margaret B; Tarbell, Nancy J; Ebb, David H; Yock, Torunn I

2018-06-15

To the authors' knowledge, health-related quality of life (HRQOL) outcomes are not well described in patients with medulloblastoma. The use of proton radiotherapy (RT) may translate into an improved HRQOL. In the current study, the authors report long-term HRQOL in patients with proton-treated pediatric medulloblastoma. The current study was a prospective cohort HRQOL study of patients with medulloblastoma who were treated with proton RT and enrolled between August 5, 2002, and October 8, 2015. Both child report and parent-proxy report Pediatric Quality of Life Inventory (PedsQL) surveys were collected at baseline during RT and annually thereafter (score range on surveys of 0-100, with higher scores indicating better HRQOL). Patients were dichotomized by clinical/treatment variables and subgroups were compared. Mixed-model analysis was performed to determine the longitudinal trajectory of PedsQL scores. The Student t test was used to compare long-term HRQOL measures with published means from a healthy child population. Survey data were evaluable for 116 patients with a median follow-up of 5 years (range, 1-10.6 years); the median age at the time of diagnosis was 7.6 years (range, 2.1-18.1 years). At baseline, children reported a total core score (TCS) of 65.9, which increased by 1.8 points annually (P<.001); parents reported a TCS of 59.1, which increased by 2.0 points annually. Posterior fossa syndrome adversely affected baseline scores, but these scores significantly improved with time. At the time of last follow-up, children reported a TCS of 76.3, which was 3.3 points lower than that of healthy children (P = .09); parents reported a TCS of 69, which was 11.9 points lower than that of parents of healthy children (P<.001). Increased follow-up time from diagnosis correlated with improved HRQOL scores. HRQOL scores appear to increase over time after treatment in children treated with proton RT for medulloblastoma but remain lower compared with those of parent

Metal-on-metal hip resurfacing in patients younger than 50 years: a retrospective analysis : 1285 cases, 12-year survivorship.

PubMed

Gaillard, Melissa D; Gross, Thomas P

2017-06-02

The Nordic registry reports patients under 50 years old with total hip replacements realize only 83% 10-year implant survivorship. These results do not meet the 95% 10-year survivorship guideline posed by the UK's National Institute for Health and Care Excellence (NICE) in 2014. The purpose of this study is threefold: First, we evaluate if metal-on-metal hip resurfacing arthroplasty meets these high standards in younger patients. Next, we compare outcomes between age groups to determine if younger patients are at higher risk for revision or complication. Lastly, we assess how outcomes between sexes changed over time. From January 2001 to August 2013, a single surgeon performed 1285 metal-on-metal hip resurfacings in patients younger than 50 years old. We compared these to an older cohort matched by sex and BMI. Kaplan-Meier implant survivorship was 96.5% at 10 years and 96.3% at 12 years; this did not differ from implant survivorship for older patients. Implant survivorship at 12 years was 98 and 93% for younger men and women, respectively; survivorship for women improved from 93 to 97% by using exclusively Biomet implants. There were four (0.3%) adverse wear-related failures, with no instances of wear or problematic ion levels since 2009. Activity scores improved from 5.4 ± 2.3 preoperatively to 7.6 ± 1.9 postoperatively (p < 0.0001), with 43% of patients reporting a UCLA activity score of 9 or 10. Hip resurfacing exceeds the stricter 2014 NICE survivorship criteria independently in men and women even when performed on patients under 50 years old.

Does 360° lumbar spinal fusion improve long-term clinical outcomes after failure of conservative treatment in patients with functionally disabling single-level degenerative lumbar disc disease? Results of 5-year follow-up in 75 postoperative patients.

PubMed

Zigler, Jack E; Delamarter, Rick B

2013-01-01

of patients using narcotics at the 5-year follow-up visit was less than half the percentage of patients who had used narcotics as part of their prior conservative treatment. The 5-year results of this post hoc analysis of 75 patients involved in a multicenter, multi-surgeon trial support 360° fusion surgery as a predictable and lasting treatment option to improve pain and function in properly selected patients with mechanical degenerative disc disease. These improvements occurred dramatically immediately after surgery and have been maintained through the scope of this follow-up period, with 98% follow-up at 2 years and 75% of patients available at 5 years.

Patients' understanding of and responses to multiplex genetic susceptibility test results.

PubMed

Kaphingst, Kimberly A; McBride, Colleen M; Wade, Christopher; Alford, Sharon Hensley; Reid, Robert; Larson, Eric; Baxevanis, Andreas D; Brody, Lawrence C

2012-07-01

Examination of patients' responses to direct-to-consumer genetic susceptibility tests is needed to inform clinical practice. This study examined patients' recall and interpretation of, and responses to, genetic susceptibility test results provided directly by mail. This observational study had three prospective assessments (before testing, 10 days after receiving results, and 3 months later). Participants were 199 patients aged 25-40 years who received free genetic susceptibility testing for eight common health conditions. More than 80% of the patients correctly recalled their results for the eight health conditions. Patients were unlikely to interpret genetic results as deterministic of health outcomes (mean = 6.0, s.d. = 0.8 on a scale of 1-7, 1 indicating strongly deterministic). In multivariate analysis, patients with the least deterministic interpretations were white (P = 0.0098), more educated (P = 0.0093), and least confused by results (P = 0.001). Only 1% talked about their results with a provider. Findings suggest that most patients will correctly recall their results and will not interpret genetics as the sole cause of diseases. The subset of those confused by results could benefit from consultation with a health-care provider, which could emphasize that health habits currently are the best predictors of risk. Providers could leverage patients' interest in genetic tests to encourage behavior changes to reduce disease risk.

Five-year safety and performance results from the Argus II Retinal Prosthesis System clinical trial

PubMed Central

da Cruz, Lyndon; Dorn, Jessy D.; Humayun, Mark S.; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E.; Hafezi, Farhad; Safran, Avinoam B.; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V.; de Juan, Eugene; Duncan, Jacque L.; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C.; Ho, Allen C.; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V.; Arditi, Aries; Greenberg, Robert J.

2016-01-01

Purpose The Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) was developed to restore some vision to patients blind from retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception due to end-stage RP. Design The study is a prospective, multicenter, single-arm, clinical trial. Within-patient controls included the non-implanted fellow eye and patients' native residual vision compared to their vision when using the System. Subjects There were 30 subjects in 10 centers in the U.S. and Europe. Methods The worse-seeing eye of blind patients was implanted with the Argus II System. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. Main Outcome Measures The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by three computer-based, objective tests. Secondary measures included functional vision performance on objectively-scored real-world tasks. Results Twenty-four out of 30 patients remained implanted with functioning Argus II Systems at 5 years post-implant. Only one additional serious adverse event was experienced since the 3-year time point. Patients performed significantly better with the System ON than OFF on all visual function tests and functional vision tasks. Conclusions The five-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. PMID:27453256

Year to year change in FEV1 in patients with cystic fibrosis and different mutation classes.

PubMed

De Boeck, K; Zolin, A

2017-03-01

In patients with cystic fibrosis, most treatments addressing the underlying basic defect are mutation or mutation class specific. These treatments are disease modifying if they lower the year to year change in lung function. We therefore calculated the current loss of lung function, measured by year to year change in forced expired volume in 1s in 11,417 patients included in the European Cystic Fibrosis Society Patient Registry. Whereas patients with at least one mutation of class IV or V have on average a lower year to year change, we did not find a difference between patients with a stop codon mutation, homozygous for F508del or at least one class III mutation. These data are useful background information to discuss the impact of different disease modifying treatments. Copyright © 2016 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Safety and efficacy of a hydrogel inlay with laser in situ keratomileusis to improve vision in myopic presbyopic patients: one-year results.

PubMed

Garza, Enrique Barragan; Chayet, Arturo

2015-02-01

To study the safety and efficacy of implanting a hydrogel corneal inlay (Raindrop Near Vision Inlay) concurrently with performing laser in situ keratomileusis (LASIK) to treat myopic presbyopia and to compare the results with results of the same treatment in emmetropic and hyperopic patients. Two private clinics, Tijuana and Monterrey, Mexico. Prospective nonrandomized clinical trial. Bilateral myopic LASIK was performed and a corneal inlay was concurrently implanted in the nondominant eye under a flap created using a femtosecond laser. Primary safety outcomes were the retention of corrected distance (CDVA) and near (CNVA) visual acuities. Efficacy was evaluated on the basis of uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities. A patient questionnaire was used to assess the preoperative and postoperative incidence of visual symptoms, the ability to perform common tasks with no correction, and patient satisfaction with vision. Thirty eyes were enrolled. At each postoperative visit, the mean CDVA and CNVA were within one half line of preoperative measurements and no eye lost 2 or more lines of CDVA. The mean binocular UDVA, UIVA, and UNVA were better than 20/25 Snellen at all postoperative visits. By 6 months, 93% of patients had a binocular Snellen acuity of 20/25 or better across all visual ranges. According to patient questionnaires, 1 year after surgery, visual symptoms were at preoperative levels, 98% of all visual tasks could be easily performed without correction, and 90% of patients were satisfied or very satisfied with their overall vision. A hydrogel corneal inlay with concurrent LASIK was safe and effective for treating myopic presbyopia. Drs. Garza and Chayet are consultants to and investigators for Revision Optics, Inc. Copyright © 2015. Published by Elsevier Inc.

RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT WITH THE CENTRAL THIRD OF THE QUADRICEPS MUSCLE TENDON: ANALYSIS OF 10-YEAR RESULTS

PubMed Central

Guimarães, Marcus Valladares; Junior, Lúcio Honório de Carvalho; Terra, Dalton Lopes

2015-01-01

Objective: Assess clinical results using two different protocols, 10 years after ACL reconstruction surgery with the central third of quadriceps muscle tendon (QT). Method: Between November /1997 and April/1998, 25 patients were submitted to 25 ACL reconstructions with QT by transtibial technique. The bone portion of the graft was fixated on femoral tunnel with interference screw and the tendinous portion of tibial tunnel with screw with washer. Two patients injured the new when playing soccer. Six patients were not available for follow-up (24%). Seventeen patients were evaluated, 15 men and two women, with mean age at surgery time of 28.53 ± 6.64 years. All patients were examined at six months, one year, and ten years after surgery. Clinical evaluation was made by the Lysholm scale, and the knee evaluation, with the Hospital for Special Surgery scale. Results: The patients had their injuries operated after 9.87 ± 14.42 months of the accident. According to Lysholm scale, the results at the end of the first year were 98.71 ± 2.47 and, after 10 years, 97.35 ± 3.12. Using the Hospital for Special Surgery scale, the mean score was 95.07 ± 5.23 in one year, and 94.87 ± 4.16 in 10 years. All patients returned to their professional activities with the same previous status. Fifteen (88.24%) patients were able to return to their sports activities, one by modifying the practice, while another one switched to another sport. No patient complained of pain on the donor area in the medium and long term. The sports return rate was excellent, and no changes were found on the femoropatellar joint. PMID:27022511

Operative Management of Adult Spinal Deformity Results in Significant Increases in QALYs Gained Compared to Nonoperative Management: Analysis of 479 Patients With Minimum 2-Year Follow-Up.

PubMed

Scheer, Justin K; Hostin, Richard; Robinson, Chessie; Schwab, Frank; Lafage, Virginie; Burton, Douglas C; Hart, Robert A; Kelly, Michael P; Keefe, Malla; Polly, David; Bess, Shay; Shaffrey, Christopher I; Smith, Justin S; Ames, Christopher P

2018-03-01

Retrospective review of prospective multicenter adult spinal deformity (ASD) database. To compare the quality-adjusted life years (QALYs) between operative and nonoperative treatments for ASD patients. Operative management of ASD repeatedly demonstrates improvements in HRQOL over nonoperative treatment. However, little is reported regarding QALY improvements after surgical correction of ASD. Inclusion criteria: ≥18 years, ASD. Health utility values were calculated from SF6D scores and used to calculate QALYs at minimum 2 years from the baseline utility value as well as at 1, 2, and 3 years for the available patients. A 1:1 propensity score matching using six baseline variables was conducted to account for the nonrandom distribution of operative and nonoperative treatments. Four hundred seventy-nine patients were included (OP:258, 70.7%, NONOP:221, 47.1%). One hundred fifty-one (OP:90, NONOP:61) had complete 1, 2, and 3 year data available for QALY trending. Unmatched results are not listed in the abstract. Mean baseline utility scores were statistically similar between the matched groups (OP: 0.609 ± 0.093, NONOP: 0.600 ± 0.091, P = 0.6401) and at 2 year min postop mean OP QALY was greater than NONOP (1.377 ± 0.345 vs. 1.256 ± 0.286, respectively, P < 0.01). For the subanalysis cohort, mean OP QALYs at 1, 2, and 3 years postoperative were all significantly greater than NONOP, P < 0.03 for all (1 yr: 0.651 ± 0.089 vs. 0.61 ± 0.079, 2 yr: 1.29 ± 0.157 vs. 1.189 ± 0.141, and 3 yr: 1.903 ± 0.235 vs. 1.749 ± 0.198, respectively). Matched OP had a larger QALYs gained (from baseline) at 2 year minimum postoperative (0.112 ± 0.243 vs. 0.008 ± 0.195, P < 0.01). For subanalysis of patients with complete 1 to 3 years data, OP had a significantly larger QALYs gained at 1, 2, and 3 years compared with NONOP: 1 year (0.073 ± 0.121 vs. 0.029 ± 0.082, P = 0.0447), 2 years (0.167 ± 0

Very long-term results (more than 20 years) of valve repair with carpentier's techniques in nonrheumatic mitral valve insufficiency.

PubMed

Braunberger, E; Deloche, A; Berrebi, A; Abdallah, F; Celestin, J A; Meimoun, P; Chatellier, G; Chauvaud, S; Fabiani, J N; Carpentier, A

2001-09-18

Mitral valve repair is considered the gold standard in surgery of degenerative mitral valve insufficiency (MVI), but the long-term results (>20 years) are unknown. We reviewed the first 162 consecutive patients who underwent mitral valve repair between 1970 and 1984 for MVI due to nonrheumatic disease. The cause of MVI was degenerative in 146 patients (90%) and bacterial endocarditis in 16 patients (10%). MVI was isolated or, in 18 cases, associated with tricuspid insufficiency. The mean age of the 162 patients (104 men and 58 women) was 56+/-10 years (age range 22 to 77 years). New York Heart Association functional class was I, II, III, and IV in 2%, 39%, 52%, and 7% of patients, respectively. The mean cardiothoracic ratio was 0.58+/-0.07 (0.4 to 0.8), and 72 (45%) patients had atrial fibrillation. Valve analysis showed that the main mechanism of MVI was type II Carpentier's functional classification in 152 patients. The leaflet prolapse involved the posterior leaflet in 93 patients, the anterior leaflet in 28 patients, and both leaflets in 31 patients. Surgical technique included a Carpentier's ring annuloplasty in all cases, a valve resection in 126 patients, and shortening or transposition of chordae in 49 patients. During the first postoperative month, there were 3 deaths (1.9%) and 3 reoperations (2 valve replacements and 1 repeat repair [1.9%]). Six patients were lost to follow-up. The remaining 151 patients with mitral valve repair were followed during a median of 17 years (range 1 to 29 years; 2273 patient-years). The 20-year Kaplan-Meier survival rate was 48% (95% CI 40% to 57%), which is similar to the survival rate for a normal population with the same age structure. The 20-year rates were 19.3% (95% CI 11% to 27%) for cardiac death and 26% (95% CI 17% to 35%) for cardiac morbidity/mortality (including death from a cardiac cause, stroke, and reoperation). During the 20 years of follow-up, 7 patients were underwent surgery at 3, 7, 7, 8, 8, 10, or 12

Usefulness of morning home blood pressure measurements in patients with type 2 diabetes mellitus: results of a 10-year, prospective, longitudinal study.

PubMed

Kamoi, Kyuzi

2015-01-01

Previous cross-sectional studies and 6-year longitudinal study have demonstrated that home blood pressure (HBP) measurements upon awakening have a stronger predictive power for death, micro- and macrovascular complications than clinic blood pressure (CBP) measurements in patients with type 2 diabetes (T2DM). This study investigated which of these measurements offers stronger predictive power for outcomes over 10 years. At baseline, 400 Japanese patients with T2DM were classified as having hypertension (HT) or normotension (NT) based on HBP and CBP. The mean survey duration was 95 months. Primary and secondary end-points were death and new or worsened micro- and macrovascular complications, respectively. Differences in outcomes for each end-point between HT and NT patients were analyzed using Kaplan-Meier survival curves and log-rank testing. Associated risk factors were assessed using Cox proportional hazards analysis. Based on HBP, death and micro- and macrovascular complications were significantly higher in patients with HT than with NT at baseline and end-point. Based on CBP, there were no significant differences in incidence of death, micro- or macrovascular complications between patients with HT and NT at baseline and end-point, although a significant difference in incidence of death was observed between the HT and NT groups at end-point. However, the significance was significantly lower in CBP than in HBP. One risk factor associated with micro- and macrovascular complications in patients with HBP was therapy for HT. This 10-year longitudinal study of patients with T2DM demonstrated that elevated HBP upon awakening is predictive of death, and micro- and macrovascular complications.

Aortic root remodeling: ten-year experience with 274 patients.

PubMed

Aicher, Diana; Langer, Frank; Lausberg, Henning; Bierbach, Benjamin; Schäfers, Hans-Joachim

2007-10-01

Dilatation of the aortic root with concomitant aortic regurgitation can be treated by valve-preserving surgery. We have consistently chosen root remodeling rather than reimplantation whenever the aortoventricular junction was not dilated. We have analyzed our 11-year experience with root remodeling. Between October 1995 and October 2006, 274 patients (201 male; 73 female, aged 59 +/- 15 years) were treated by root remodeling in the presence of a preserved aortoventricular diameter (<30 mm). Acute aortic dissection was present in 46 patients. The valve anatomy was tricuspid in 193 and bicuspid in 81 patients. Cusp disease was additionally corrected in 173 (63%) patients. Follow-up was complete in 99%. Cumulative follow-up was 1045 patient-years (mean of 4.0 +/- 2.7 years). Hospital mortality was 3.6% (elective 3.1%; emergency 6.5%). One patient had endocarditis 2 months postoperatively and subsequently underwent valve replacement. Freedom from aortic regurgitation of grade II or more was 91% and 87% at 10 years for bicuspid and tricuspid aortic valves. Nine patients required reoperation: in 6 patients the valve was replaced and in 3 patients rerepaired. Freedom from reoperation was 96% at 5 and 10 years, and freedom from valve replacement was 98% at 5 and 10 years. A comparison of 3 operative periods (1995-1998, 1999-2002, and 2003-2006) showed that with increasing experience cusp prolapse was diagnosed and corrected more frequently (8/49 = 17%; 62/105 = 59%; 103/108 = 82%; P < .0001), and repair stability significantly improved over time (P = .007). Root remodeling leads to durable restoration of aortic valve function in both tricuspid and bicuspid valve anatomy. Aggressive correction of cusp prolapse seems to have a beneficial effect on aortic valve competence.

Cooled radiofrequency denervation for treatment of sacroiliac joint pain: two-year results from 20 cases

PubMed Central

Ho, Kok-Yuen; Hadi, Mohamed Abdul; Pasutharnchat, Koravee; Tan, Kian-Hian

2013-01-01

Background Sacroiliac joint pain is a common cause of chronic low back pain. Different techniques for radiofrequency denervation of the sacroiliac joint have been used to treat this condition. However, results have been inconsistent because the variable sensory supply to the sacroiliac joint is difficult to disrupt completely using conventional radiofrequency. Cooled radiofrequency is a novel technique that uses internally cooled radiofrequency probes to enlarge lesion size, thereby increasing the chance of completely denervating the sacroiliac joint. The objective of this study was to evaluate the efficacy of cooled radiofrequency denervation using the SInergy™ cooled radiofrequency system for sacroiliac joint pain. Methods The charts of 20 patients with chronic sacroiliac joint pain who had undergone denervation using the SInergy™ cooled radiofrequency system were reviewed at two years following the procedure. Outcome measures included the Numeric Rating Scale for pain intensity, Patient Global Impression of Change, and Global Perceived Effect for patient satisfaction. Results Fifteen of 20 patients showed a significant reduction in pain (a decrease of at least three points on the Numeric Rating Scale). Mean Numeric Rating Scale for pain decreased from 7.4 ± 1.4 to 3.1 ± 2.5, mean Patient Global Impression of Change was “improved” (1.4 ± 1.5), and Global Perceived Effect was reported to be positive in 16 patients at two years following the procedure. Conclusion Cooled radiofrequency denervation showed long-term efficacy for up to two years in the treatment of sacroiliac joint pain. PMID:23869175

Surgical versus Non-Operative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

PubMed Central

Lurie, Jon D.; Tosteson, Tor D.; Tosteson, Anna N. A.; Zhao, Wenyan; Morgan, Tamara S.; Abdu, William A.; Herkowitz, Harry; Weinstein, James N.

2014-01-01

Study Design Concurrent prospective randomized and observational cohort studies. Objective To assess the 8-year outcomes of surgery vs. non-operative care. Summary of Background Data Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial. Methods Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter. Results Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (−36.2 vs. −24.8; −11.2; −13.6 to −9.1). Conclusion Carefully

Cognitive impairments in former patients with work-related stress complaints - one year later.

PubMed

Eskildsen, Anita; Andersen, Lars Peter; Pedersen, Anders Degn; Andersen, Johan Hviid

2016-11-01

Patients on sick leave due to work-related stress often present with cognitive impairments. The aim of this prospective cohort study was to examine the long-term consequences of prolonged work-related stress in terms of cognitive functioning one year after initial professional care seeking. We tested a group of patients with work-related stress with a comprehensive neuropsychological test battery at two occasions, one year apart. At both time points, we compared the performance of patients with healthy controls matched pairwise on sex, age and length of education. This paper presents the results from the one-year follow-up. When adjusting for practice effects, patients improved on measures of prospective memory and processing speed. However, patients continued to perform worse than controls on all tests, though only half of the comparisons reached statistical significance. The effect sizes of the differences between the two groups at one-year follow-up were small to medium. In conclusion, former patients with prolonged work-related stress improved, but they continued to perform worse than controls after one year. In the acute phase, the largest impairments were related to executive function and mental speed but at follow-up memory impairments also became apparent.

Severe hyperkalaemia resulting from octreotide use in a haemodialysis patient.

PubMed

Adabala, Madhuri; Jhaveri, Kenar D; Gitman, Michael

2010-10-01

A 48-year-old man, with end-stage renal disease (ESRD) on haemodialysis, presented to the emergency department with sulphonylurea-induced hypoglycaemia. His hypoglycaemia was persistent despite glucose infusion, so he was treated with octreotide. Octreotide administration reversed the hypoglycaemia but also resulted in severe hyperkalaemia. The patient was urgently dialysed, the octreotide was discontinued and his potassium normalized. We believe that the hyperkalaemia was caused by octreotide-induced insulin suppression and resultant impaired cellular potassium uptake. Although octreotide may be an effective therapy in refractory sulphonylurea-induced hypoglycaemia, it should be used with caution in patients on dialysis.

Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease

PubMed Central

Germain, Dominique P; Charrow, Joel; Desnick, Robert J; Guffon, Nathalie; Kempf, Judy; Lachmann, Robin H; Lemay, Roberta; Linthorst, Gabor E; Packman, Seymour; Scott, C Ronald; Waldek, Stephen; Warnock, David G; Weinreb, Neal J; Wilcox, William R

2015-01-01

Background Fabry disease results from deficient α-galactosidase A activity and globotriaosylceramide accumulation causing renal insufficiency, strokes, hypertrophic cardiomyopathy and early demise. We assessed the 10-year outcome of recombinant α-galactosidase A therapy. Methods The outcomes (severe clinical events, renal function, cardiac structure) of 52/58 patients with classic Fabry disease from the phase 3 clinical trial and extension study, and the Fabry Registry were evaluated. Disease progression rates for patients with low renal involvement (LRI, n=32) or high renal involvement (HRI, n=20) at baseline were assessed. Results 81% of patients (42/52) did not experience any severe clinical event during the treatment interval and 94% (49/52) were alive at the end of the study period. Ten patients reported a total of 16 events. Patients classified as LRI started therapy 13 years younger than HRI (mean 25 years vs 38 years). Mean slopes for estimated glomerular filtration rate for LRI and HRI were −1.89 mL/min/1.73 m2/year and −6.82 mL/min/1.73 m2/year, respectively. Overall, the mean left ventricular posterior wall thickness and interventricular septum thickness remained unchanged and normal. Patients who initiated treatment at age ≥40 years exhibited significant increase in left ventricular posterior wall thickness and interventricular septum thickness. Mean plasma globotriaosylceramide normalised within 6 months. Conclusions This 10-year study documents the effectiveness of agalsidase beta (1 mg/kg/2 weeks) in patients with Fabry disease. Most patients remained alive and event-free. Patients who initiated treatment at a younger age and with less kidney involvement benefited the most from therapy. Patients who initiated treatment at older ages and/or had advanced renal disease experienced disease progression. PMID:25795794

Penile brachytherapy: Results for 49 patients

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

Crook, Juanita M.; Jezioranski, John; Grimard, Laval

2005-06-01

Purpose: To report results for 49 men with squamous cell carcinoma (SCC) of the penis treated with primary penile interstitial brachytherapy at one of two institutions: the Ottawa Regional Cancer Center, Ottawa, and the Princess Margaret Hospital, Toronto, Ontario, Canada. Methods and Materials: From September 1989 to September 2003, 49 men (mean age, 58 years; range, 22-93 years) had brachytherapy for penile SCC. Fifty-one percent of tumors were T1, 33% T2, and 8% T3; 4% were in situ and 4% Tx. Grade was well differentiated in 31%, moderate in 45%, and poor in 2%; grade was unspecified for 20%. Onemore » tumor was verrucous. All tumors in Toronto had pulsed dose rate (PDR) brachytherapy (n = 23), whereas those in Ottawa had either Iridium wire (n 22) or seeds (n = 4). Four patients had a single plane implant with a plastic tube technique, and all others had a volume implant with predrilled acrylic templates and two or three parallel planes of needles (median, six needles). Mean needle spacing was 13.5 mm (range, 10-18 mm), mean dose rate was 65 cGy/h (range, 33-160 cGy/h), and mean duration was 98.8 h (range, 36-188 h). Dose rates for PDR brachytherapy were 50-61.2 cGy/h, with no correction in total dose, which was 60 Gy in all cases. Results: Median follow-up was 33.4 months (range, 4-140 months). At 5 years, actuarial overall survival was 78.3% and cause-specific survival 90.0%. Four men died of penile cancer, and 6 died of other causes with no evidence of recurrence. The cumulative incidence rate for never having experienced any type of failure at 5 years was 64.4% and for local failure was 85.3%. All 5 patients with local failure were successfully salvaged by surgery; 2 other men required penectomy for necrosis. The soft tissue necrosis rate was 16% and the urethral stenosis rate 12%. Of 8 men with regional failure, 5 were salvaged by lymph node dissection with or without external radiation. All 4 men with distant failure died of disease. Of 49 men, 42 had

Superion Interspinous Spacer Treatment of Moderate Spinal Stenosis: 4-Year Results.

PubMed

Nunley, Pierce D; Patel, Vikas V; Orndorff, Douglas G; Lavelle, William F; Block, Jon E; Geisler, Fred H

2017-08-01

To determine 4-year clinical outcomes in patients with moderate lumbar spinal stenosis treated with minimally invasive stand-alone interspinous process decompression using the Superion device. The 4-year Superion data were extracted from a randomized, controlled Food and Drug Administration investigational device exemption trial. Patients with intermittent neurogenic claudication relieved with back flexion who failed at least 6 months of nonsurgical management were enrolled. Outcomes included Zurich Claudication Questionnaire (ZCQ) symptom severity (ss), physical function (pf) and patient satisfaction (ps) subdomains, leg and back pain visual analog scale (VAS), and Oswestry Disability Index (ODI). At 4-year follow-up, 89 of the 122 patients (73%) provided complete clinical outcome evaluations. At 4 years after index procedure, 75 of 89 patients with Superion (84.3%) demonstrated clinical success on at least 2 of 3 ZCQ domains. Individual component responder rates were 83% (74/89), 79% (70/89), and 87% (77/89) for ZCQss, ZCQpf, and ZCQps; 78% (67/86) and 66% (57/86) for leg and back pain VAS; and 62% (55/89) for ODI. Patients with Superion also demonstrated percentage improvements over baseline of 41%, 40%, 73%, 69%, and 61% for ZCQss, ZCQpf, leg pain VAS, back pain VAS, and ODI. Within-group effect sizes all were classified as very large (>1.0): 1.49, 1.65, 1.42, 1.12, and 1.46 for ZCQss, ZCQpf, leg pain VAS, back pain VAS, and ODI. Minimally invasive implantation of the Superion device provides long-term, durable relief of symptoms of intermittent neurogenic claudication for patients with moderate lumbar spinal stenosis. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of gender-specific mortality in patients < 70 years versus ≥ 70 years old with acute myocardial infarction.

PubMed

Ishihara, Masaharu; Inoue, Ichiro; Kawagoe, Takuji; Shimatani, Yuji; Miura, Fumiharu; Nakama, Yasuharu; Dai, Kazuoki; Ootani, Takayuki; Ooi, Kuniomi; Ikenaga, Hiroki; Miki, Takashi; Nakamura, Masayuki; Kishimoto, Shinji; Sumimoto, Youji

2011-09-15

The aim of the present study was to investigate the gender-specific mortality after acute myocardial infarction in those aged < 70 years versus ≥ 70 years. The present study consisted of 2,677 consecutive patients with acute myocardial infarction who had undergone coronary angiography within 24 hours after the onset of symptoms. The patients were divided into 2 groups: 1,810 patients < 70 years old and 867 patients ≥ 70 years old. Women were older and had a greater incidence of hypertension and diabetes mellitus and a lower incidence of current smoking and previous myocardial infarction in both groups. The in-hospital mortality rate was significantly greater in women ≥ 70 years old age than in men ≥ 70 years old (16.2% vs 9.3%, respectively; p = 0.003) but was comparable between women and men in patients < 70 years old (5.7% vs 4.9%, respectively; p = 0.59). On multivariate analysis, the association between female gender and in-hospital mortality in patients ≥ 70 years old remained significant (odds ratio 1.78, 95% confidential interval 1.05 to 3.00), but the gender difference was not observed in patients < 70 years old (odds ratio 1.09, 95% confidence interval 0.53 to 2.24). In conclusion, female gender was associated with in-hospital mortality after acute myocardial infarction in patients ≥ 70 years old but not in patients < 70 years old. Copyright © 2011 Elsevier Inc. All rights reserved.

10-year results of a new low-monomer cement: follow-up of a randomized RSA study.

PubMed

Söderlund, Per; Dahl, Jon; Röhrl, Stephan; Nivbrant, Bo; Nilsson, Kjell G

2012-12-01

The properties and performance of a new low-monomer cement were examined in this prospective randomized, controlled RSA study. 5-year data have already been published, showing no statistically significant differences compared to controls. In the present paper we present the 10-year results. 44 patients were originally randomized to receive total hip replacement with a Lubinus SPII titanium-aluminum-vanadium stem cemented either with the new Cemex Rx bone cement or with control bone cement, Palacos R. Patients were examined using RSA, Harris hip score, and conventional radiographs. At 10 years, 33 hips could be evaluated clinically and 30 hips could be evaluated with RSA (16 Cemex and 14 Palacos). 9 patients had died and 4 patients were too old or infirm to be investigated. Except for 1 hip that was revised for infection after less than 5 years, no further hips were revised before the 10-year follow-up. There were no statistically significant clinical differences between the groups. The Cemex cement had magnitudes of migration similar to or sometimes lower than those of Palacos cement. In both groups, most hips showed extensive radiolucent lines, probably due to the use of titanium alloy stems. At 10 years, the Cemex bone cement tested performed just as well as the control (Palacos bone cement).

Outcomes of hip arthroscopy in patients aged 50 years or older compared with a matched-pair control of patients aged 30 years or younger.

PubMed

Domb, Benjamin G; Linder, Dror; Finley, Zachary; Botser, Itamar B; Chen, Austin; Williamson, Joseph; Gupta, Asheesh

2015-02-01

Age has been suggested as a negative prognostic factor for hip arthroscopy. The purpose of this study was to compare patient characteristics and outcomes after hip arthroscopy in patients aged 50 years or older with a matched control group of patients aged 30 years or younger at a minimum postoperative follow-up of 2 years. Between September 2008 and March 2010, data were prospectively collected on all patients aged 50 years or older undergoing primary hip arthroscopy. Fifty-two patients met our inclusion and matching criteria, of whom all 52 (100%) were available for follow-up at a minimum of 2 years. This cohort was compared with a matched-pair control group of patients aged 30 years or younger who underwent similar procedures. The mean age of the study group was 54.8 years (range, 50 to 69 years), and that of the control group was 20.3 years (range, 13 to 30 years). The groups were matched at a 1:1 ratio, including 18 male patients (34.6%) and 34 female patients (65.4%) in each group, with a mean follow-up period of 32 months (range, 24 to 54 months). In the younger control group, the score improvement from preoperatively to 2 years' follow-up was 62.9 to 84.2 for the modified Harris Hip Score, 60.5 to 84.2 for the Non-Arthritic Hip Score, 63.1 to 86.5 for the Hip Outcome Score-Activities of Daily Living, and 42.2 to 72.7 for the Hip Outcome Score-Sport-Specific Subscale. In the older study group, the score improvement from preoperatively to 2 years' follow-up was 61.2 to 82.2 for the modified Harris Hip Score, 59.9 to 80.4 for the Non-Arthritic Hip Score, 63.9 to 83 for the Hip Outcome Score-Activities of Daily Living, and 41.2 to 64.6 for the Hip Outcome Score-Sport-Specific Subscale. All improvements in both groups were statistically significant at the 2-year postoperative follow-up (P < .001). There was no significant difference for all patient-reported outcome (PRO) scores at final follow-up between both groups. When we compared the change in PRO scores (�

Medicare Spending for Breast, Prostate, Lung, and Colorectal Cancer Patients in the Year of Diagnosis and Year of Death.

PubMed

Chen, Christopher T; Li, Ling; Brooks, Gabriel; Hassett, Michael; Schrag, Deborah

2017-07-26

To characterize spending patterns for Medicare patients with incident breast, prostate, lung, and colorectal cancer. 2007-2012 data from the Surveillance, Epidemiology, and End Results Program linked with Medicare fee-for-service claims. We calculate per-patient monthly and yearly mean and median expenditures, by cancer type, stage at diagnosis, and spending category, over the years of diagnosis and death. Over the year of diagnosis, mean spending was $35,849, $26,295, $55,597, and $63,063 for breast, prostate, lung, and colorectal cancer, respectively. Over the year of death, spending was similar across different cancer types and stage at diagnosis. Characterization of Medicare spending according to clinically meaningful categories may assist development of oncology alternative payment models and cost-effectiveness models. © Health Research and Educational Trust.

Sientra portfolio of Silimed brand shaped implants with high-strength silicone gel: a 5-year primary augmentation clinical study experience and a postapproval experience-results from a single-surgeon 108-patient series.

PubMed

Haws, Melinda J; Schwartz, Michael R; Berger, Lewis H; Daulton, Kimber L

2014-07-01

The Sientra portfolio of silicone gel breast implants was approved by the Food and Drug Administration on March 9, 2012, and included the first approved shaped implants in the United States. The 5-year results from Sientra's Core Gel and Continued Access Study and the results of a single surgeon are presented. This analysis used the data of 640 shaped implants in 321 primary augmentation patients implanted by 16 study surgeons through 5 years. The Kaplan-Meier method was used to analyze safety endpoints. In addition, analysis is presented for a single surgeon's results of 213 shaped implants in 108 postapproval patients through up to 16 months of follow-up (9-month mean) using a separate frequency analysis. The overall risk of rupture for primary augmentation patients through 5 years was 0.4%, the risk of infection was 1.4%, and the risk of capsular contracture (Baker grade III/IV) was 3.9%. Reported surgeon satisfaction was 100%, and patient satisfaction remained high. In the separate single-surgeon analysis, after 16 months, 4 of the 108 patients experienced a complication (3.7%) and 3 underwent a reoperation (2.8%). Complications included infection, ptosis (0.9%, each), and capsular contracture (1.9%). The results of Sientra's large clinical study and the postapproval data from a single surgeon demonstrate the safety and effectiveness of Sientra's shaped implants. The review of the data and author's experience illustrate the ease of incorporating shaped implants into any surgical practice.

Synchronous and metachronous neoplasms in gastric cancer patients: A 23-year study

PubMed Central

Ławniczak, Małgorzata; Gawin, Alicja; Jaroszewicz-Heigelmann, Halina; Rogoza-Mateja, Wiesława; Raszeja-Wyszomirska, Joanna; Białek, Andrzej; Karpińska-Kaczmarczyk, Katarzyna; Starzyńska, Teresa

2014-01-01

AIM: To determine the prevalence and characteristics of additional primary malignancies in gastric cancer (GC) patients. METHODS: GC patients (862 total; 570 men, 292 women; mean age 59.8 ± 12.8 years) diagnosed at the Department of Gastroenterology at Pomeranian Medical University over a period of 23 years were included in this retrospective analysis of a prospectively maintained database. Mean follow-up time was 31.3 ± 38.6 mo (range 1-241 mo). The following clinicopathological features of patients with synchronous tumors were compared to those with metachronous tumors: age, sex, symptom duration, family history of cancer, tumor site, stage (early vs advanced), histology, and blood group. GC patients with and without a second tumor were compared in terms of the same clinicopathological features. RESULTS: Of 862 GC patients, 58 (6.7%) developed a total of 62 multiple primary tumors, of which 39 (63%) were metachronous and 23 (37%) synchronous. Four (6.9%) of the 58 multiple GC patients developed two or more neoplasms. The predominant tumor type of the secondary neoplasms was colorectal (n = 17), followed by lung (n = 9), breast (n = 8), and prostate (n = 7). Age was the only clinicopathological feature that differed between GC patients with synchronous vs metachronous malignancies; GC patients with synchronous neoplasms were older than those with metachronous neoplasms (68.0 ± 10.3 years vs 59.9 ± 11.1 years, respectively, P = 0.008). Comparisons between patients with and without a second primary cancer revealed that the only statistically significant differences were in age and blood group. The mean age of the patients with multiple GC was higher than that of those without a second primary tumor (63.4 ± 11.4 years vs 59.5 ± 13.0 years, respectively, P = 0.026). GC patients with a second primary tumor were more commonly blood group O than those without (56.2% vs 31.6%, respectively, P = 0.002). CONCLUSION: GC patients may develop other primary cancers

The 3-Year Incidence of Gout in Elderly Patients with CKD

PubMed Central

Tan, Vivian S.; Garg, Amit X.; McArthur, Eric; Lam, Ngan N.; Sood, Manish M.

2017-01-01

Background and objectives The risk of gout across CKD stages is not well described. Design, setting, participants, & measurements We performed a retrospective cohort study using linked health care databases from Ontario, Canada from 2002 to 2010. The primary outcome was the 3-year cumulative incidence of gout, on the basis of diagnostic codes. We presented our results by level of kidney function (eGFR≥90 ml/min per 1.73 m2, 60–89, 45–59, 30–44, 15–29, and chronic dialysis) and by sex. Additional analyses examined the risk of gout adjusting for clinical characteristics, incidence of gout defined by the receipt of allopurinol or colchicine, and gout risk in a subpopulation stratified by the level of eGFR and albuminuria. Results Of the 282,925 adults aged ≥66 years, the mean age was 75 years and 57.9% were women. The 3-year cumulative incidence of gout was higher in older adults with a lower level of eGFR. In women, the 3-year cumulative incidence of gout was 0.6%, 0.7%, 1.3%, 2.2%, and 3.4%, and in men the values were 0.8%, 1.2%, 2.5%, 3.7%, and 4.6%, respectively. However, patients on chronic dialysis had a lower 3-year cumulative incidence of gout (women 2.0%, men 2.9%) than those with more moderate reductions in kidney function (i.e., eGFR 15–44 ml/min per 1.73 m2). The association between a greater loss of kidney function and a higher risk of diagnosed gout was also evident after adjustment for clinical characteristics and in all additional analyses. Conclusions Patients with a lower level of eGFR had a higher 3-year cumulative incidence of gout, with the exception of patients receiving dialysis. Results can be used for risk stratification. PMID:28153936

Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study

PubMed Central

Sieper, J.; Kivitz, A.; Blanco, R.; Cohen, M.; Martin, R.; Readie, A.; Richards, H. B.; Porter, B.

2017-01-01

Objective Secukinumab improved the signs and symptoms of ankylosing spondylitis (AS) over 52 weeks in the phase III MEASURE 2 study. Here, we report longer‐term (104 weeks) efficacy and safety results. Methods Patients with active AS were randomized to subcutaneous secukinumab 150 mg, 75 mg, or placebo at baseline; weeks 1, 2, and 3; and every 4 weeks from week 4. The primary end point was the Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response rate at week 16. Other end points included ASAS40, high‐sensitivity C‐reactive protein, ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form 36 health survey physical component summary, ASAS partial remission, EuroQol 5‐domain measure, and Functional Assessment of Chronic Illness Therapy fatigue subscale. End points were assessed through week 104, with multiple imputation for binary variables and a mixed‐effects model repeated measures for continuous variables. Results Of 219 randomized patients, 60 of 72 (83.3%) and 57 of 73 (78.1%) patients completed 104 weeks of treatment with secukinumab 150 mg and 75 mg, respectively; ASAS20/ASAS40 response rates at week 104 were 71.5% and 47.5% with both secukinumab doses, respectively. Clinical improvements with secukinumab were sustained through week 104 across all secondary end points. Across the entire treatment period (mean secukinumab exposure 735.6 days), exposure‐adjusted incidence rates for serious infections and infestations, Crohn's disease, malignant or unspecified tumors, and major adverse cardiac events with secukinumab were 1.2, 0.7, 0.5, and 0.7 per 100 patient‐years, respectively. No cases of tuberculosis reactivation, opportunistic infections, or suicidal ideation were reported. Conclusion Secukinumab provided sustained improvement through 2 years in the signs and symptoms of AS, with a safety profile consistent with previous reports. PMID:28235249

The Advanced Glaucoma Intervention Study (AGIS): 4. Comparison of treatment outcomes within race. Seven-year results.

PubMed

1998-07-01

The purpose of this report is to present separately for black and white patients with advanced glaucoma 7-year results of two alternative surgical intervention sequences. A randomized controlled trial. A total of 332 black patients (451 eyes), 249 white patients (325 eyes), and 10 patients of other races (13 eyes) participated. Potential follow-up ranged from 4 to 7 years. Eyes were randomly assigned to either an argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) sequence or a trabeculectomy-ALT-trabeculectomy (TAT) sequence. The second and third interventions were offered after failure of the first and second interventions, respectively. Average percent of eyes with decrease of visual field (APDVF), average percent of eyes with decrease of visual acuity (APDVA), and average percent of eyes with decrease of vision (APDV) are the outcome measures. Decrease of visual field (DVF) is an increase from baseline of at least 4 points on a glaucoma visual field defect scale ranging from 0 to 20, decrease of visual acuity (DVA) is a decrease from baseline of at least 15 letters (3 lines), and decrease of vision (DV) is the occurrence of either DVF or DVA. The averages are of percent decreases observed at 6-month intervals from the first 6-month visit to the end of the specified observation period. In both black and white patients throughout 7-year follow-up, the mean decrease in intraocular pressure was greater in eyes assigned to TAT, and the cumulative probability of failure of the first intervention was greater in eyes assigned to ATT. In black patients, APDVF, APDVA, and APDV are less for the ATT sequence than for the TAT sequence throughout the 7 years. In white patients, APDVF also favors the ATT sequence but only for the first year, after which it favors the TAT sequence through the seventh year; APDVA also favors the ATT sequence, but the ATT-TAT difference progressively diminishes over 7 years; and APDV favors ATT over TAT initially, but after 4

[Short-Term Results of Surgical Treatment of Patients with Hallux Rigidus].

PubMed

Dygrýnová, M; Uvízl, M; Gallo, J

2017-01-01

PURPOSE OF THE STUDY Hallux rigidus is common and degenerative arthritis of the first metatarsophalangeal joint. The aim of this study was to assess the results of cheilectomy and total joint replacement (TJR) in patients with hallux rigidus. Minimum duration of followup was 18 months. MATERIAL AND METHODS The study included fifty-nine patients who underwent surgery at our Department due to hallux rigidus between January 2013 and December 2014. Thirty-seven patients underwent cheilectomy and twenty-two patients had total joint arthroplasty using METIS®. The outcomes were assessed by comparing preoperative and postoperative ranges of motion, VAS (Visual Analogue Scale), AOFAS-HMI (American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal Interphalangeal) and patients' satisfaction with operative treatment. Preoperative and postoperative outcomes were compared for the individual types of surgery using the repeated measures ANOVA. The level of statistical significance was set at p < 0.01. RESULTS The mean age was 47.9 ± 7.0 years in patients who underwent cheilectomy and 62.5 ± 5.5 years in patients after TJR METIS®. There was a significant decrease (p < 0.001) in the VAS pain score and a significant improvement in dorsiflexion, range of movements, AOFAS-HMI scores in both the treatment groups. In both the groups more than 75% of patients reported good or excellent subjective results. DISCUSSION Our results are in agreement with findings of other studies assessing the results of cheilectomy and TJR surgery in patients with hallux rigidus. Direct comparison of the VAS pain score, AOFAS-HMI and ranges of motion across studies is difficult because of variability in the evaluation systems. Cheilectomy is mostly recommended for young active patients with mild osteoarthritis. Moreover, it is also possible to use minimally invasive surgery with early and reliable outcomes. At our Department, we perform cheilectomy also in younger patients with moderate

Years of disability-adjusted life gained as a result of thrombolytic therapy for acute ischemic stroke.

PubMed

Hong, Keun-Sik; Saver, Jeffrey L

2010-03-01

Disability-adjusted life year (DALY) metric reflects years of healthy life lost because of living with disability and years of life lost because of premature mortality. Widely used in epidemiological analyses, DALY has not been applied to acute stroke trials. From previous studies, we derived, for each modified Rankin Scale level, disability weights, disability-linked mortality hazard ratios, and age-specific life expectancies. We then analyzed patient level data from the 2 publicly available National Institute of Neurological Disorders and Stroke (NINDS) recombinant tissue plasminogen activator trials. For each subject, we abstracted age, treatment assignment, and 3-month modified Rankin Scale outcome and calculated the DALYs lost resulting from the qualifying stroke. The disability-linked hazard ratios for premature annual mortality for a modified Rankin Scale score of 0 to 5 were 1.53, 1.52, 2.17, 3.18, 4.55, and 6.55, respectively. In the NINDS recombinant tissue plasminogen activator trials, DALYs (mean+/-SE) lost as a result of the qualifying stroke were substantially less with recombinant tissue plasminogen activator than with placebo (4.64+/-0.17 versus 5.91+/-0.21; P<0.0001), a finding that remained robust after adjustment for baseline prognostic factors. When DALYs gained were apportioned to the 29% of patients experiencing any benefit from lytic therapy, each patient gained an average of 4.4 DALYs. DALY analysis showed greater power than dichotomized modified Rankin Scale analysis in discriminating treatment effects overall and in patients >or=70 years of age. For patients who benefit from treatment, <3-hour thrombolytic therapy adds the equivalent of 4.4 years of healthy life, free of disability. The DALY metric provides a continuous scale that increases statistical power, is intuitively understandable, and is applicable to a wide range of conditions and treatments.

The 3-Year Incidence of Gout in Elderly Patients with CKD.

PubMed

Tan, Vivian S; Garg, Amit X; McArthur, Eric; Lam, Ngan N; Sood, Manish M; Naylor, Kyla L

2017-04-03

The risk of gout across CKD stages is not well described. We performed a retrospective cohort study using linked health care databases from Ontario, Canada from 2002 to 2010. The primary outcome was the 3-year cumulative incidence of gout, on the basis of diagnostic codes. We presented our results by level of kidney function (eGFR≥90 ml/min per 1.73 m 2 , 60-89, 45-59, 30-44, 15-29, and chronic dialysis) and by sex. Additional analyses examined the risk of gout adjusting for clinical characteristics, incidence of gout defined by the receipt of allopurinol or colchicine, and gout risk in a subpopulation stratified by the level of eGFR and albuminuria. Of the 282,925 adults aged ≥66 years, the mean age was 75 years and 57.9% were women. The 3-year cumulative incidence of gout was higher in older adults with a lower level of eGFR. In women, the 3-year cumulative incidence of gout was 0.6%, 0.7%, 1.3%, 2.2%, and 3.4%, and in men the values were 0.8%, 1.2%, 2.5%, 3.7%, and 4.6%, respectively. However, patients on chronic dialysis had a lower 3-year cumulative incidence of gout (women 2.0%, men 2.9%) than those with more moderate reductions in kidney function ( i.e. , eGFR 15-44 ml/min per 1.73 m 2 ). The association between a greater loss of kidney function and a higher risk of diagnosed gout was also evident after adjustment for clinical characteristics and in all additional analyses. Patients with a lower level of eGFR had a higher 3-year cumulative incidence of gout, with the exception of patients receiving dialysis. Results can be used for risk stratification. Copyright © 2017 by the American Society of Nephrology.

Peroral endoscopic myotomy for achalasia in patients aged ≥ 65 years

PubMed Central

Li, Chen-Jie; Tan, Yu-Yong; Wang, Xue-Hong; Liu, De-Liang

2015-01-01

AIM: To investigate the safety and efficacy of peroral endoscopic myotomy (POEM) for achalasia in patients aged ≥ 65 years. METHODS: From November 2011 to August 2014, 15 consecutive patients (aged ≥ 65 years) diagnosed with achalasia were prospectively recruited and all underwent POEM at our institution. Eckardt score, lower esophageal sphincter (LES) pressure, esophageal diameter, SF-36 questionnaire, and procedure-related complications were used to evaluate the outcomes. RESULTS: All 15 patients were treated successfully by POEM, with a median operation time of 55 min. Median myotomy length was 10 cm. Three patients underwent circular myotomy and 12 full-thickness myotomies. Symptoms remitted in all cases during post-POEM follow-up of 6-39 mo. Eckardt score reduced significantly (pre-operation vs post-operation: 8.0 vs 1.0, P < 0.05). Median LES pressure decreased from 27.4 to 9.6 mmHg (P < 0.05). Median diameter of the esophagus was significantly decreased (pre-operation vs post-operation: 51.0 mm vs 30.0 mm, P < 0.05). Only one patient had reflux, which was resolved with oral proton pump inhibitors. No serious complications related to POEM were found. The quality of life of the 15 patients improved significantly after POEM. CONCLUSION: POEM is a safe and effective technique for treatment of achalasia in patients aged ≥ 65 years, with improvement in symptoms and quality of life. PMID:26290645

Progress in the second year of patients with quiescent pulmonary tuberculosis after a year of domiciliary chemotherapy, and influence of further chemotherapy on the relapse rate*

PubMed Central

Velu, S.; Andrews, R. H.; Angel, J. H.; Devadatta, S.; Fox, Wallace; Gangadharam, P. R. J.; Narayana, A. S. L.; Ramakrishnan, C. V.; Selkon, J. B.; Somasundaram, P. R.

1961-01-01

This study from the Tuberculosis Chemotherapy Centre, Madras, summarizes the progress during the second year of those patients in a 1-year comparison of four domiciliary chemotherapeutic regimens (isoniazid plus PAS and three regimens of isoniazid alone) whose pulmonary tuberculosis had attained bacteriological quiescence at the end of the year of chemotherapy. During the second year, about half of the patients received further chemotherapy, with isoniazid alone, and the remainder received a placebo, calcium gluconate. The main objects of the study were to determine the influence on the progress during the second year of (a) a second year of chemotherapy with isoniazid alone, (b) residual cavitation at the end of the first year, and (c) the chemotherapeutic regimen received during the first year, and to compare the results with those obtained in an earlier study by the Centre of the progress during the second year of patients with quiescent pulmonary tuberculosis after a year's chemotherapy with isoniazid plus PAS at home or in sanatorium. The results of the present study, which was planned on the same lines as the earlier one, showed that relapse in the second year was unrelated to the chemotherapeutic regimen received in the first year, and it was therefore permissible to amalgamate the findings in the two studies. The amalgamated results showed that the relapse rate in the second year was low (5.9%) and that a second year of treatment with isoniazid alone was of definite value for the patients with no residual cavitation at the end of the first year, but had no effect on the relapse rate of those with residual cavitation. The combined data from the two studies have thus clarified the position with regard to the effectiveness of isoniazid in preventing bacteriological relapse in patients without residual cavitation, slight evidence of which was apparent in the earlier study. PMID:13925282

Clinical features in 27 patients with Angelman syndrome resulting from DNA deletion.

PubMed Central

Smith, A; Wiles, C; Haan, E; McGill, J; Wallace, G; Dixon, J; Selby, R; Colley, A; Marks, R; Trent, R J

1996-01-01

We report the clinical features in 27 Australasian patients with Angelman syndrome (AS), all with a DNA deletion involving chromosome 15(q11-13), spanning markers from D15S9 to D15S12, about 3 center dot 5 Mb of DNA. There were nine males and 18 females. All cases were sporadic. The mean age at last review (end of 1994) was 11 center dot 2 years (range 3 to 34 years). All patients were ataxic, severely retarded, and lacking recognisable speech. In all patients, head circumference (HC) at birth was normal but skewed in distribution, with 62 center dot 5% at the 10th centile. At last review HC was around the 50th centile in three patients (12 center dot 5%) while 15 had poor postnatal head growth. Short stature was not invariable, 5/26 (19%) were on or above the 50th centile. Hypotonia at birth was recorded in 15/24 (63%) and neonatal feeding difficulties were recorded in 20/26 (77%). Epilepsy was present in 26/27 (96%) with onset by the third year of life in 20 patients (83%). Improvement in epilepsy was reported in 11/16 patients (69%) with age. An abnormal EEG was reported in 25/25 patients. Hypopigmentation was present in 19/26 (73%). One patient had oculocutaneous albinism. Five patients could not walk independently. Of the remaining 22 who could walk, age of onset of walking ranged from 2 to 8 years. Disrupted sleep patterns were present in 18/21 patients (86%), with improvement in 9/12 patients (75%) over 10 years of age. The clinical features in this group of deletional AS patients were similar to previous reports, but these have not separated patients into subgroups based on DNA studies. In our group of deletional cases, 100% showed severe mental retardation, ataxic movements, absent language, abnormal EEG, happy disposition (noted in infancy in 95%), normal birth weight and head circumference at birth, and a large, wide mouth. These features occurred with a higher frequency than in AS patients as a whole. Our study also provided information on the evolution

Roux-en-Y gastric bypass stands the test of time: 5-year results in low body mass index (30-35 kg/m(2)) Indian patients with type 2 diabetes mellitus.

PubMed

Lakdawala, Muffazal; Shaikh, Shehla; Bandukwala, Saifee; Remedios, Carlyne; Shah, Miloni; Bhasker, Aparna Govil

2013-01-01

Our objective was to evaluate the long-term results of laparoscopic Roux-en-Y gastric bypass on excess weight loss, remission of the metabolic syndrome, and complications in Indian patients with uncontrolled type 2 diabetes mellitus (T2DM) with a body mass index of 30-35 kg/m(2). The setting was a corporate hospital in Mumbai, India. The present prospective observational study was begun in January 2006. A total of 52 patients with uncontrolled T2DM and a body mass index of 30-35 kg/m(2) elected to undergo laparoscopic Roux-en-Y gastric bypass. The duration of T2DM was 3.5-14.5 years (median 8.4). Of the 52 patients, 61.5% had hypertension and 59.6% had dyslipidemia. Remission of T2DM and other components of the metabolic syndrome were assessed. All patients were followed up for 5 years. The median percentage of excess weight loss was 72.2% at 1 year and 67.8% at 5 years. Of the 52 patients, 84.6% had achieved euglycemia and 73.1% had achieved complete remission, 23.1% partial remission, and 3.84% no remission at 1 year. Weight regain occurred in 8 patients. They required antihypertensive drugs and statins, decreasing the complete remission rate to 57.7% and partial remission rate to 38.5% at 5 years. However, 96.2% improvement in metabolic status was found at the end of 5 years. Laparoscopic Roux-en-Y gastric bypass is a safe, efficacious, and cost-effective treatment for uncontrolled T2DM in patients with a body mass index of 30-35 kg/m(2). Early-onset T2DM, better weight loss, and greater C-peptide levels were predictors of success after surgery. The improvement after surgery in hyperglycemia, hypertension, and dyslipidemia could help in controlling the occurrence of micro- and macrovascular complications and decrease the morbidity and mortality associated with T2DM. Copyright © 2013 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Results of total knee replacement with a cruciate-retaining model for severe valgus deformity--a study of 48 patients followed for an average of 9 years.

PubMed

Koskinen, Esa; Remes, Ville; Paavolainen, Pekka; Harilainen, Arsi; Sandelin, Jerker; Tallroth, Kaj; Kettunen, Jyrki; Ylinen, Pekka

2011-06-01

The objectives of the present study were to find out the results and the factors affecting survival after primary knee arthroplasty with a cruciate-retaining prosthesis in severe valgus deformity. Forty-eight patients (52 knees) participated in the current follow-up study. All patients were followed at least 5 years or to first revision. Mean follow-up time was 9 years (range, 1 to 17 years).The Kaplan-Meier analysis revealed 79% (95% CI 68% to 91%) survival rate with revision for any reason and 81% (95% CI 70% to 93%) survival rate with revision for instability as an endpoint at 10 years. Preoperatively TFA was 23° (range, 15°-51°) in valgus and 7° (range, 21° valgus-4° varus) in valgus postoperatively. Of the 14 re-operated patients, eight were revised because of progressive postoperative medial collateral ligament instability. All re-operations were performed during the first 4 years of the follow-up. The mean TFA was 15.5° valgus postoperatively for those eight and the odds ratio for a revision was 2 (95% CI 1-3, p = 0.025) when compared to the rest of the study population. The residual valgus deformity increases the risk of re-operation and it should be avoided. If proper soft-tissue balance cannot be achieved or there is no functional medial collateral ligament present more constrained implants should be used. In selected cases where both bony correction and ligament balancing have properly been achieved the use of a cruciate-retaining type of prosthesis is justified. Copyright © 2010 Elsevier B.V. All rights reserved.

Three-year results after directional atherectomy of calcified stenotic lesions of the superficial femoral artery.

PubMed

Minko, P; Buecker, A; Jaeger, S; Katoh, M

2014-10-01

To investigate the 3-year outcome of patients with peripheral arterial disease (PAD) and heavily calcified stenotic lesions of the superficial femoral artery after directional atherectomy. Fifty-three patients (mean age 67 ± 10 years; 18 females, 35 males, TASC B and C, mean lesion length 7.9 ± 3.5 cm) with PAD (Rutherford 2-6) were enrolled into this prospective monocentric study. In total, 59 calcified lesions of the superficial femoral artery were treated with the Silverhawk atherectomy device (Covidien, Plymouth, MN, USA). Patients were followed-up for 36 months with a 6-month interval to perform clinical re-evaluation, including measurement of maximum walking distance and ankle-brachial index (ABI) as well as duplex-sonography. The primary success rate of the procedure was 92 %. In five cases (8 %), additional balloon-PTA and/or stent-PTA was necessary. Procedure-related embolization occurred in seven cases (12 %), which were all successfully treated by aspiration. The primary patency rate after 3 years was 55 %. Median Rutherford score decreased significantly from 5 to 0 after 36 months (p < 0.001). At the same time, the ABI increased from 0.65 to 1.12 (not significant). The limb-salvage rate after 3 years was 87 %. In this subgroup of patients with POD and calcified stenotic lesions, atherectomy was successfully applied to decrease the plaque burden. Results after 3 years showed a significant decrease of Rutherford score with persistent improvement of ABI and reasonable patency rate.

Extraperitoneoscopic transcapsular adenomectomy: complications and functional results after at least 1 year of followup.

PubMed

Porpiglia, Francesco; Fiori, Cristian; Cavallone, Barbara; Morra, Ivano; Bertolo, Riccardo; Scarpa, Roberto Mario

2011-05-01

Laparoscopic simple prostatectomy has been proposed to treat large glands. To date groups have investigated the feasibility and perioperative results of laparoscopic simple prostatectomy but to our knowledge no study has focused on its complications and functional results at longer followup. We investigated complications and functional results in patients with a large prostate who were treated with laparoscopic simple prostatectomy and had at least 1 year of followup. From our prospectively maintained database we extracted data on 78 patients treated with laparoscopic simple prostatectomy at our institution who had at least 1 year of reported followup. Demographics, perioperative results, early and late complications, and functional results were evaluated. Followup was planned at 1, 3, 6 and 12 months, and every 6 months thereafter. Mean followup was 30 months. Grade III complications were recorded in 2 cases and late complications were reported in 4 (5%). Statistically significant differences were observed in the International Prostate Symptom Score, the International Prostate Symptom Score quality of life index and maximum urine flow when comparing preoperative and postoperative results. No significant differences were recorded in maximum urine flow or the International Prostate Symptom Score quality of life index during followup. Results suggest that laparoscopic simple prostatectomy is safe and effective even after a significant period, as indicated by the low complication rate and positive, stable functional results found during followup. In our opinion laparoscopic simple prostatectomy can be offered to patients as a valid treatment option for a large prostate at advanced laparoscopic centers. Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Electrons for intraoperative radiotherapy in selected breast-cancer patients: late results of the Montpellier phase II trial

PubMed Central

2013-01-01

Background The Montpellier cancer institute phase II trial started in 2004 and evaluated the feasibility of intraoperative radiotherapy (IORT) technique given as a sole radiation treatment for patients with an excellent prognostic and very low recurrence risk. Methods Forty-two patients were included between 2004 and 2007. Inclusion criteria were patients ≥ 65 years old, T0-T1, N0, ductal invasive unifocal carcinoma, free-margin > 2 mm. IORT was delivered using dedicated linear accelerator. One fraction of 21 Gy was prescribed and specified at the 90% isodose using electrons. In vivo dosimetry was performed for all patients. Primary end-point was the quality index. Secondary endpoints were quality of life, local recurrences, cosmetic results, specific and overall survival. Results At inclusion, median age was 72 years (range, 66–80). Median tumor diameter was 10 mm. All patients received the total prescribed dose. No acute grade 3 toxicities were observed. Late cosmetic results were good at 5 years despite the poor agreement of accuracy assessment between patients and physicians. Four patients (9.5%) experienced a local failure and underwent salvage mastectomy. The 5 year-disease free survival is 92.7% (range 79.1−97.6). All patients are still alive with a median follow-up of 72 months (range 66–74). Conclusion Our results confirm with a long-term follow-up that exclusive partial breast IORT is feasible for early-breast cancer in selected patients. IORT provides good late cosmetics results and should be considered as a safe and very comfortable “one-step” treatment procedure. Nevertheless, patient assessments are essential for long-term quality results. PMID:23902825

Increased long-term mortality in patients less than 55 years old who have undergone knee replacement for osteoarthritis: results from the Swedish Knee Arthroplasty Register.

PubMed

Robertsson, O; Stefánsdóttir, A; Lidgren, L; Ranstam, J

2007-05-01

Patients with osteoarthritis undergoing knee replacement have been reported to have an overall reduced mortality compared with that of the general population. This has been attributed to the selection of healthier patients for surgery. However, previous studies have had a maximum follow-up time of ten years. We have used information from the Swedish Knee Arthroplasty Register to study the mortality of a large national series of patients with total knee replacement for up to 28 years after surgery and compared their mortality with that of the normal population. In addition, for a subgroup of patients operated on between 1980 and 2002 we analysed their registered causes of death to determine if they differed from those expected. We found a reduced overall mortality during the first 12 post-operative years after which it increased and became significantly higher than that of the general population. Age-specific analysis indicated an inverse correlation between age and mortality, where the younger the patients were, the higher their mortality. The shift at 12 years was caused by a relative over-representation of younger patients with a longer follow-up. Analysis of specific causes of death showed a higher mortality for cardiovascular, gastrointestinal and urogenital diseases. The observation that early onset of osteoarthritis of the knee which has been treated by total knee replacement is linked to an increased mortality should be a reason for increased general awareness of health problems in these patients.

The National Early Warning Score (NEWS) for outcome prediction in emergency department patients with community-acquired pneumonia: results from a 6-year prospective cohort study.

PubMed

Sbiti-Rohr, Diana; Kutz, Alexander; Christ-Crain, Mirjam; Thomann, Robert; Zimmerli, Werner; Hoess, Claus; Henzen, Christoph; Mueller, Beat; Schuetz, Philipp

2016-09-28

To investigate the accuracy of the National Early Warning Score (NEWS) to predict mortality and adverse clinical outcomes for patients with community-acquired pneumonia (CAP) compared to standard risk scores such as the pneumonia severity index (PSI) and CURB-65. Secondary analysis of patients included in a previous randomised-controlled trial with a median follow-up of 6.1 years. Patients with CAP included on admission to the emergency departments (ED) of 6 tertiary care hospitals in Switzerland. A total of 925 patients with confirmed CAP were included. NEWS, PSI and CURB-65 scores were calculated on admission to the ED based on admission data. Our primary outcome was all-cause mortality within 6 years of follow-up. Secondary outcomes were adverse clinical outcome defined as intensive care unit (ICU) admission, empyema and unplanned hospital readmission all occurring within 30 days after admission. We used regression models to study associations of baseline risk scores and outcomes with the area under the receiver operating curve (AUC) as a measure of discrimination. 6-year overall mortality was 45.1% (n=417) with a stepwise increase with higher NEWS categories. For 30 day and 6-year mortality prediction, NEWS showed only low discrimination (AUC 0.65 and 0.60) inferior compared to PSI and CURB-65. For prediction of ICU admission, NEWS showed moderate discrimination (AUC 0.73) and improved the prognostic accuracy of a regression model, including PSI (AUC from 0.66 to 0.74, p=0.001) and CURB-65 (AUC from 0.64 to 0.73, p=0.015). NEWS was also superior to PSI and CURB-65 for prediction of empyema, but did not well predict rehospitalisation. NEWS provides additional prognostic information with regard to risk of ICU admission and complications and thereby improves traditional clinical-risk scores in the management of patients with CAP in the ED setting. ISRCTN95122877; Post-results. Published by the BMJ Publishing Group Limited. For permission to use (where not

Can baseline ultrasound results help to predict failure to achieve DAS28 remission after 1 year of tight control treatment in early RA patients?

PubMed

Ten Cate, D F; Jacobs, J W G; Swen, W A A; Hazes, J M W; de Jager, M H; Basoski, N M; Haagsma, C J; Luime, J J; Gerards, A H

2018-01-30

At present, there are no prognostic parameters unequivocally predicting treatment failure in early rheumatoid arthritis (RA) patients. We investigated whether baseline ultrasonography (US) findings of joints, when added to baseline clinical, laboratory, and radiographical data, could improve prediction of failure to achieve Disease Activity Score assessing 28 joints (DAS28) remission (<2.6) at 1 year in newly diagnosed RA patients. A multicentre cohort of newly diagnosed RA patients was followed prospectively for 1 year. US of the hands, wrists, and feet was performed at baseline. Clinical, laboratory, and radiographical parameters were recorded. Primary analysis was the prediction by logistic regression of the absence of DAS28 remission 12 months after diagnosis and start of therapy. Of 194 patients included, 174 were used for the analysis, with complete data available for 159. In a multivariate model with baseline DAS28 (odds ratio (OR) 1.6, 95% confidence interval (CI) 1.2-2.2), the presence of rheumatoid factor (OR 2.3, 95% CI 1.1-5.1), and type of monitoring strategy (OR 0.2, 95% CI 0.05-0.85), the addition of baseline US results for joints (OR 0.96, 95% CI 0.89-1.04) did not significantly improve the prediction of failure to achieve DAS28 remission (likelihood ratio test, 1.04; p = 0.31). In an early RA population, adding baseline ultrasonography of the hands, wrists, and feet to commonly available baseline characteristics did not improve prediction of failure to achieve DAS28 remission at 12 months. Clinicaltrials.gov, NCT01752309 . Registered on 19 December 2012.

Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial.

PubMed

Benamouzig, Robert; Uzzan, Bernard; Deyra, Jacques; Martin, Antoine; Girard, Bernard; Little, Julian; Chaussade, Stanislas

2012-02-01

Aspirin inhibits colorectal carcinogenesis. In a randomised double-blind placebo-controlled trial, daily soluble aspirin significantly reduced recurrence of colorectal adenomas at 1-year follow-up. In this study the results of daily intake of low-dose aspirin on polyp recurrence at 4-year follow-up are presented. 272 patients (naive for chronic aspirin use) with colorectal adenomas were randomly assigned to treatment with lysine acetylsalicylate 160 mg/day (n=73) or 300 mg/day (n=67) or placebo (n=132) for 4 years. The primary endpoints were adenoma recurrence and adenomatous polyp burden at year 4, comparing aspirin at either dose with placebo. The same endpoints were also assessed at year 1 or 4 (last colonoscopy performed for each patient). At the final year 4 colonoscopy the analysis included 185 patients (55 receiving aspirin 160 mg/day, 47 aspirin 300 mg/day and 83 placebo). There was no difference in the proportion of patients with at least one recurrent adenoma between patients receiving aspirin at either dose and those treated with placebo (42/102 (41%) vs 33/83 (40%); NS) or in the adenomatous polyp burden (3.1 ± 5.8 mm vs 3.4 ± 6.2 mm; NS). Also, the proportion of patients with at least one advanced recurrent adenoma did not differ (10/102 [corrected] (10%) in the aspirin group vs 7/83 (8.4%) [corrected] in the placebo group; NS). Daily low-dose aspirin decreased adenoma recurrence significantly at 1 year but not at year 4. This discrepancy might be explained by a differential effect of aspirin according to the natural history of the polyp. NCT 00224679.

Success of benznidazole chemotherapy in chronic Trypanosoma cruzi-infected patients with a sustained negative PCR result.

PubMed

Murcia, L; Carrilero, B; Ferrer, F; Roig, M; Franco, F; Segovia, M

2016-11-01

Cure assessment in chronic Trypanosoma cruzi infection is controversial, mainly because of the lack of reliable tests to ensure parasite elimination. Here, we assess the impact of benznidazole therapy on the conventional serology and parasitaemia in chronic Chagas disease. A total of 455 patients with long-term Trypanosoma cruzi infection underwent specific chemotherapy with benznidazole. Their parasitological status was assessed by polymerase chain reaction (PCR) detection of T. cruzi DNA. Drops in the titres of antibody levels were serially measured by indirect immunofluorescence assay (IFI) and chemiluminescent microparticle immunoassay (CMIA). Patients were monitored during the treatment period and for a further 90, 150 and 240 days. Controls were repeated yearly during the 7-year follow-up. The PCR result was negative in all patients between 60-day (n = 22) and 90-day (n = 294) controls. Treatment failure was detected in 45 patients and was significantly more frequent in those who did not complete the therapy [12 out of 13 (92 %) vs. 33 out of 442 (7 %)] (p = 0.0001). A significant drop in serum titres was detected after the first follow-up year in patients with sustained negative PCR results: 2nd year (p = 0.029 by IFI; p = 0.002 by CMIA), 5th year (p = 0.036 by IFI; p = 0.039 by CMIA) and 6th year (p = 0.028 by IFI; p = 0.019 by CMIA). The results point to a beneficial effect of benznidazole and may be the cure of chronic patients who had a consistently negative PCR result throughout the follow-up period.

Assessment of surgical treatment and postoperative nutrition in gastric cancer patients older than 80 years.

PubMed

Nakanoko, Tomonori; Kakeji, Yoshihiro; Ando, Koji; Nakashima, Yuichiro; Ohgaki, Kippei; Kimura, Yasue; Saeki, Hiroshi; Oki, Eiji; Morita, Masaru; Maehara, Yoshihiko

2015-01-01

A gastrectomy for gastric cancer is sometimes required in patients older than 80 years due to the continuously increasing age of society. However, if a gastrectomy worsens the postoperative quality of life and daily activity in elderly patients because of poor nutrition, the procedure may not always be a useful treatment strategy. Clinicopathological data of patients with gastric cancer who underwent a gastrectomy at our Department between 1998 and 2008 (N=471) were collected and analyzed. The results of treatment for patients older than 80 years (N=41) were analyzed and compared against those of patients younger than 80 years (N=430). Patients older than 80 years had a higher frequency of preoperative co-morbidities than patients younger than 80 years. However, there was no statistical difference in postoperative complications regarding nutrition between the two groups. Older age is not a determinant of poor nutrition following gastrectomy. Gastrectomy for gastric cancer is, therefore, a useful treatment strategy, regardless of ageing. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

[Interhospital transport with extracorporeal life support: results and perspectives after 5 years experience].

PubMed

Desebbe, O; Rosamel, P; Henaine, R; Vergnat, M; Farhat, F; Dubien, P Y; Bastien, O

2013-04-01

Describing the experience of a referral center for interhospital patients transport treated with extracorporeal circulatory or respiratory support (ECLS), the difficulties encountered and the results obtained. Retrospective and observational study. All patients with respiratory or circulatory failure accepted for extracorporeal assistance for which routine medical transport was life threatening. A descriptive analysis was performed (median and interquartile deviation). Comparison of biological data was performed using a non-parametric Wilcoxon test and 5 years overall survival was determined by a Kaplan-Meier analysis. Over a 55-month period, 29 patients were selected for transportation under ECMO or ECLS. Indication was respiratory failure in 38 % of cases, hemodynamic instability in 52 % of cases and combined symptoms in 10 % of cases. Average duration of transportation was 40 km (9-64 km). No complication related to transport was observed. Incidence of intrahospital death was 57 %. There was no correlation between death and indication of ECLS. Five-year survival was 55 % and 39 % for venovenous and arteriovenous ECLS, respectively. In our experience, interhospital transport of patients under ECMO is feasible in satisfactory conditions of safety with trained team and standard procedures. Copyright © 2013 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.

Gentamicin ototoxicity: a 23-year selected case series of 103 patients.

PubMed

Ahmed, Rebekah M; Hannigan, Imelda P; MacDougall, Hamish G; Chan, Raymond C; Halmagyi, G Michael

2012-06-18

To review patients with severe bilateral vestibular loss associated with gentamicin treatment in hospital. A retrospective case series of presentations to a balance disorders clinic between 1988 and 2010. Relationship between vestibulotoxicity and gentamicin dose or dosing profile; indications for prescribing gentamicin. 103 patients (age, 18-84 years; mean, 64 years) presented with imbalance, oscillopsia or both, but none had vertigo. Only three noted some hearing impairment after having gentamicin, but audiometric thresholds for all patients were consistent with their age. In all patients, the following tests gave positive results: a bilateral clinical head-impulse test, a vertical head-shaking test for vertical oscillopsia, and a foam Romberg test. In 21 patients, imbalance occurred during gentamicin treatment (ignored or dismissed by prescribers in 20) and in 66 after treatment; the remaining 16 could not recall when symptoms were first noticed, except that it was after gentamicin treatment in hospital. Total gentamicin dose range was 2-318 mg/kg (mean, 52 mg/kg), daily dose range was 1.5-5.6 mg/kg (mean, 3.5mg/kg), and duration was 1-80 days (mean, 17 days). Six patients had only a single dose; 26 had five or fewer doses. Serum gentamicin levels, measured in 82 patients, were in the recommended range in 59. Time to diagnosis ranged from 4 days to 15 years. Nephrotoxicity developed in 43 patients. Gentamicin dosage complied with contemporary or current Australian antibiotic guidelines in under half the patients. Gentamicin ototoxicity is vestibular, not cochlear, producing permanent loss of balance, but not of hearing. Gentamicin can be vestibulotoxic in any dose, in any regimen, at any serum level.

Long-term results of aortic valve replacement with Edwards Prima Plus stentless bioprosthesis: eleven years' follow up.

PubMed

Auriemma, Stefano; D'Onofrio, Augusto; Brunelli, Massimo; Magagna, Paolo; Paccanaro, Mariemma; Rulfo, Fanny; Fabbri, Alessandro

2006-09-01

The Edwards Lifesciences Prima Plus stentless valve (ELSV) is a bioprosthesis manufactured from a porcine aortic root. The study aim was to evaluate late clinical outcomes after aortic valve replacement (AVR) with ELSV implanted as a miniroot in patients with aortic valve disease. Between 1993 and 2004, 318 patients (232 males, 86 females; mean age 69 +/- 9 years; range: 37-83 years) underwent AVR with the ELSV. Preoperatively, 102 patients (32%), 162 (51%) and 54 (17%) were in NYHA classes I/II, III and IV, respectively. Aortic stenosis, aortic regurgitation and combined lesions were present in 124 patients (39%), 114 (36%) and 41 (13%), respectively. Twenty patients (6%) were referred for an acute aortic dissection, 20 (6%) for an aortic root aneurysm, and 139 (44%) had an associated aneurysmal dilatation of the ascending aorta. The ascending aorta was replaced in 159 patients (50%); aortic arch replacement was required in 10 (3%). Coronary artery bypass graft was performed in 86 patients (27%). The follow up was based on clinical data. Operative mortality was 5% (n = 17). There were 49 late deaths (5.2%/pt-yr). Valve-related mortality occurred in 10 patients (1%/pt-yr). Actuarial survival at five and 10 years was 78% and 33%, respectively. Actuarial freedom from valve reoperation and structural valve deterioration at 10 years were 100% and 64%. Actuarial freedom from embolic events and endocarditis at 10 years were 84% and 81%, respectively. The ELSV, when implanted as a miniroot, provided good early and long-term results in terms of survival and freedom from major complications.

The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.

PubMed

Silaschi, Miriam; Treede, Hendrik; Rastan, Ardawan J; Baumbach, Hardy; Beyersdorf, Friedhelm; Kappert, Utz; Eichinger, Walter; Rüter, Florian; de Kroon, Thomas L; Lange, Rüdiger; Ensminger, Stephan; Wendler, Olaf

2016-11-01

Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

PubMed

Alfonso, Fernando; Pérez-Vizcayno, María José; García Del Blanco, Bruno; Otaegui, Imanol; Masotti, Mónica; Zueco, Javier; Veláquez, Maite; Sanchís, Juan; García-Touchard, Arturo; Lázaro-García, Rosa; Moreu, José; Bethencourt, Armando; Cuesta, Javier; Rivero, Fernando; Cárdenas, Alberto; Gonzalo, Nieves; Jiménez-Quevedo, Pilar; Fernández, Cristina

2016-06-27

The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents

Have cementless and resurfacing components improved the medium-term results of hip replacement for patients under 60 years of age?

PubMed Central

Mason, James; Baker, Paul; Gregg, Paul J; Porter, Martyn; Deehan, David J; Reed, Mike R

2015-01-01

Background and purpose The optimal hip replacement for young patients remains unknown. We compared patient-reported outcome measures (PROMs), revision risk, and implant costs over a range of hip replacements. Methods We included hip replacements for osteoarthritis in patients under 60 years of age performed between 2003 and 2010 using the commonest brand of cemented, cementless, hybrid, or resurfacing prosthesis (11,622 women and 13,087 men). The reference implant comprised a cemented stem with a conventional polyethylene cemented cup and a standard-sized head (28- or 32-mm). Differences in implant survival were assessed using competing-risks models, adjusted for known prognostic influences. Analysis of covariance was used to assess improvement in PROMs (Oxford hip score (OHS) and EQ5D index) in 2014 linked procedures. Results In males, PROMs and implant survival were similar across all types of implants. In females, revision was statistically significantly higher in hard-bearing and/or small-stem cementless implants (hazard ratio (HR) = 4) and resurfacings (small head sizes (< 48 mm): HR = 6; large head sizes (≥ 48 mm): HR = 5) when compared to the reference cemented implant. In component combinations with equivalent survival, women reported significantly greater improvements in OHS with hybrid implants (22, p = 0.006) and cementless implants (21, p = 0.03) (reference, 18), but similar EQ5D index. For men and women, National Health Service (NHS) costs were lowest with the reference implant and highest with a hard-bearing cementless replacement. Interpretation In young women, hybrids offer a balance of good early functional improvement and low revision risk. Fully cementless and resurfacing components are more costly and do not provide any additional benefit for younger patients. PMID:25285617

Aneurysmal subarachnoid hemorrhage in patients under 35-years-old: a single-center experience.

PubMed

Chalouhi, Nohra; Teufack, Sonia; Chandela, Sid; Dalyai, Richard; Tjoumakaris, Stavropoula; Hasan, David M; Dumont, Aaron S; Gonzalez, L Fernando; Rosenwasser, Robert H; Jabbour, Pascal M

2013-06-01

Aneurysmal subarachnoid hemorrhage (SAH) is relatively uncommon in young adults. There is a paucity of data pertaining to the management of aneurysmal SAH in young patients, especially with endovascular therapy. We reviewed all SAH patients under the age of 35 years treated at Jefferson Hospital for Neuroscience, Philadelphia, USA, from 2004 to 2009. A total of 40 patients (15 males and 25 females) under the age of 35 were treated for aneurysmal SAH. The average patient age was 30 years (17-35 yo); 25 (62.5%) were smokers. Seventeen patients presented with a Hunt and Hess Grade I or II (42.5%), 20 with a Grade III (50%), and 3 with a Grade IV (7.5%). Thirty-two aneurysms (80%) were located in the anterior circulation and 8 (20%) in the posterior circulation. Thirty-five patients (87.5%) were treated with coil embolization versus 5 with craniotomy and clipping. The endovascular and microsurgical occlusion rates were 90.6% and 100%, respectively. There were no procedural complications with endovascular therapy. Of 35 patients undergoing endovascular treatment, 24 (68.6%) had excellent outcomes at time of discharge with a Glasgow outcome scale of 5. There were no deaths in the series. No patient experienced a rehemorrhage after endovascular treatment. Smoking, female sex, and anterior circulation aneurysms are highly prevalent in young adults with SAH. Endovascular treatment resulted in an overall favorable outcome with no rehemorrhages in patients under the age of 35 years. Our results suggest that endovascular therapy is a reasonable treatment for young patients with SAH. Copyright © 2012 Elsevier B.V. All rights reserved.

Characteristics and Outcomes of Patients with Ewing Sarcoma Over 40 Years of Age at Diagnosis

PubMed Central

Karski, Erin E.; Matthay, Katherine K.; Neuhaus, John M.; Goldsby, Robert E.; DuBois, Steven G.

2012-01-01

Background The peak incidence of Ewing sarcoma (EWS) is in adolescence, with little known about patients who are ≥ 40 years at diagnosis. We describe the clinical characteristics and survival of this rare group. Methods This retrospective cohort study utilized the Surveillance Epidemiology and End Results database. 2780 patients were identified; including 383 patients diagnosed ≥ 40 years. Patient characteristics between age groups were compared using chi-squared tests. Survival from diagnosis to death was estimated via Kaplan-Meier methods, compared with log-rank tests, and modeled using multivariable Cox methods. A competing risks analysis was performed to evaluate death due to cancer. Results Patients ≥ 40 years of age were more likely to have extra-skeletal tumors (66.1% v 31.7%; p<0.001), axial tumors (64.0% v 57.2%; p=0.01), and metastatic disease at diagnosis (35.5% v 30.0%; p=0.04) compared to younger patients. Five-year survival for those age ≥ 40 and age < 40 were 40.6% and 54.3%, respectively (p<0.0001). A Cox multivariable model controlling for differences between groups confirmed inferior survival for older patients (hazard ratio for death of 2.04; 95% CI 1.63 - 2.54; p < 0.0001); though treatment data were unavailable and not controlled for in the model. A competing risks analysis confirmed increased risk of cancer-related death in older patients. Conclusion Patients ≥ 40 years at diagnosis with EWS are more likely to have extra-skeletal tumors, metastatic disease, and axial primary tumors suggesting a difference in tumor biology. Independent of differences in these characteristics, older patients also have a lower survival rate. PMID:22959474

Results of the tension-free vaginal tape procedure for stress incontinence: patient's perspective.

PubMed

Manikandan, Ramaswamy; Kujawa, Magda; Pearson, Evelyn; O'Reilly, Patrick H; Brown, Stephen C W

2004-04-01

To evaluate the results of the tension-free vaginal tape procedure (TVT) from a patient's perspective. Between May 1999 and January 2002, 90 patients underwent a TVT for genuine stress incontinence (GSI) and mixed incontinence. Prior to the procedure, GSI was confirmed by clinical examination and urodynamic studies. Results were then audited from patient notes and the same patients were sent questionnaires to examine results from a patient perspective. Overall response rate to the questionnaire was 70 (77%). The mean age of the patients was 50.4 years (range 31-83 years). Sixty-one patients had spinal anesthesia, seven had general anesthesia and two had local anesthesia. Mean hospital stay was 3.36 days (range 2-14 days) and mean period from the operation to the time of the survey and audit was 16.34 months (range 3-28; SD 6.92). Thirty-nine (56%) of the 70 patients who answered said that the operation had cured their incontinence, 16 (23%) had an improvement in their symptoms, 7 (10%) had worsening of their symptoms and 8 (11%) felt that the operation did not make any difference. The overall success rate according to the patients' perspective was 79%, whereas our audit showed an overall success rate of 86% (77% and 82%, respectively, when we compared only the 66 patients who had both notes and replies available for analysis). Although a patient's perception regarding the success of TVT tends to differ from that of a clinician, it was not found to be statistically significant (P = 0.22, McNemar test). The TVT is a very successful operation, but realistic cure rates should be offered to patients.

Outcomes in cardiac surgery in 500 consecutive Jehovah's Witness patients: 21 year Experience

PubMed Central

2012-01-01

Background Refusal of heterogenic blood products can be for religious reasons as in Jehovah's Witnesses or otherwise or as requested by an increasing number of patients. Furthermore blood reserves are under continuous demand with increasing costs. Therefore, transfusion avoidance strategies are desirable. We describe a historic comparison and current results of blood saving protocols in Jehovah's Witnesses patients. Methods Data on 250 Jehovah's Witness patients operated upon between 1991 and 2003 (group A) were reviewed and compared with a second population of 250 patients treated from 2003 to 2012 (group B). Results In group A, mean age was 51 years of age compared to 68 years in group B. An iterative procedure was performed in 13% of patients in group B. Thirty days mortality was 3% in group A and 1% in group B despite greater operative risk factors, with more redo, and lower ejection fraction in group B. Several factors contributed to the low morbidity-mortality in group B, namely: preoperative erythropoietin to attain a minimal hemoglobin value of 14 g/dl, warm blood cardioplegia, the implementation of the Cornell University protocol and fast track extubation. Conclusions Cardiac surgery without transfusion in high-risk patients such as Jehovah Witnesses can be carried out with results equivalent to those of low risk patients. Recent advances in surgical techniques and blood conservation protocols are main contributing factors. PMID:23013647

Fifteen-Year Survival of Endoscopic Anterior Cruciate Ligament Reconstruction in Patients Aged 18 Years and Younger.

PubMed

Morgan, Matthew D; Salmon, Lucy J; Waller, Alison; Roe, Justin P; Pinczewski, Leo A

2016-02-01

The current body of literature surrounding anterior cruciate ligament (ACL) survival and the variables contributing to further ACL injuries after primary ACL reconstruction in children and adolescents is limited, with no long-term evidence examining the incidence and contributing factors of further ACL injuries in this younger patient population. To determine the long-term survival of the ACL graft and the contralateral ACL (CACL) after primary reconstruction in patients aged ≤18 years and to identify the factors that increase the odds of subsequent ACL injuries. Case series; Level of evidence, 4. Patients having undergone primary ACL reconstruction at age ≤18 years between 1993 and 1998 who were included in a prospective database by a single surgeon were considered for this study. Single-incision endoscopic ACL reconstruction was performed with either an autologous bone-patellar tendon-bone graft or a hamstring tendon graft. At a minimum of 15 years after ACL reconstruction, patients completed a subjective survey involving the International Knee Documentation Committee (IKDC) questionnaire in addition to questions regarding current symptoms, further ACL injuries, family history of ACL injury, and current level of activity. A total of 288 adolescents (age range, 13-18 years) met the inclusion criteria, of whom 242 (84%) were reviewed at a mean of 16 years and 6 months after ACL reconstruction. Of these patients, 75 (31%) sustained a further ACL injury: 27 (11.2%) suffered an ACL graft rupture, 33 suffered a CACL injury (13.6%), and 15 sustained both an ACL graft rupture and a CACL injury (6.2%) over 15 years. Survival of the ACL graft was 95%, 92%, 88%, 85%, and 83% at 1, 2, 5, 10, and 15 years, respectively, and survival of the CACL was 99%, 98%, 90%, 83%, and 81%, respectively. Survival of the ACL graft was less favorable in those with a family history of ACL injury than in those without a family history (69% vs 90%, respectively; hazard ratio [HR], 3.6; P

One-Year Outcomes Following Directional Atherectomy of Infrapopliteal Artery Lesions: Subgroup Results of the Prospective, Multicenter DEFINITIVE LE Trial.

PubMed

Rastan, Aljoscha; McKinsey, James F; Garcia, Lawrence A; Rocha-Singh, Krishna J; Jaff, Michael R; Noory, Elias; Zeller, Thomas

2015-12-01

To report a subgroup analysis of the prospective, multicenter, single-arm DEFINITIVE LE trial to assess the effectiveness of directional atherectomy for the treatment of infrapopliteal artery lesions at 1 year. In the DEFINITIVE LE trial, follow-up assessments occurred up to 1 year postprocedure. Of the 800 patients enrolled, 145 subjects with 189 infrapopliteal lesions met the criteria for this analysis. Seventy (48.3%) and 75 (51.7%) patients were suffering critical limb ischemia (CLI) and intermittent claudication, respectively; 68.3% (99/145) had diabetes. The mean lesion length was 58±44 mm (all lesions); 20.2% were occluded. The primary endpoint for patients with claudication was duplex ultrasound-derived primary patency, while for subjects with CLI it was freedom from major amputation of the target limb at 1 year. Endpoints and adverse events were independently assessed. Procedure success (≤30% residual stenosis) was achieved in 84% of treated lesions. The 1-year primary patency rate was 84% (claudicants 89.6% and CLI patients 78%, p=0.11), and the freedom from major amputation rate was 97.1% (claudicants 100% and CLI 93.8%, p=0.03). In both claudication and CLI patients, significant improvements in Rutherford category and objective measures of walking distance and quality of life were seen at 1 year in comparison to baseline. This study demonstrates that directional atherectomy in infrapopliteal arteries results in promising technical and clinical results at 1 year for claudicant as well as CLI patients. © The Author(s) 2015.

Pancreaticoduodenectomy: a 20-year experience in 516 patients.

PubMed

Schmidt, C Max; Powell, Emilie S; Yiannoutsos, Constantin T; Howard, Thomas J; Wiebke, Eric A; Wiesenauer, Chad A; Baumgardner, Joel A; Cummings, Oscar W; Jacobson, Lewis E; Broadie, Thomas A; Canal, David F; Goulet, Robert J; Curie, Eardie A; Cardenes, Higinia; Watkins, John M; Loehrer, Patrick J; Lillemoe, Keith D; Madura, James A

2004-07-01

Pancreaticoduodenectomy (PD) is a safe procedure for a variety of periampullary conditions. Retrospective review of a prospectively collected database. Academic tertiary care hospital. A total of 516 consecutive patients who underwent PD. Patient outcomes and survival factors. Pathological examination demonstrated 57% periampullary cancers, 22% chronic pancreatitis, 12% cystic neoplasms, 4% islet cell neoplasms, and 5% other. Fifty-one percent of patients underwent pylorus preservation. Median operating time was 5 hours; blood loss, 1300 mL; and transfusion requirement, 1.5 U. Postoperative complications occurred in 43% of patients, including cardiopulmonary events (15%), fistula (9%), delayed gastric emptying (7%), and sepsis (6%). Additional surgery was required in 3% of patients, most commonly because of bleeding. Perioperative mortality was 3.9% overall but only 1.8% in patients with chronic pancreatitis; 25% of patients who died had preoperative complications associated with their periampullary condition. Three-year survival was 15% after resection for pancreatic cancer, 42% for duodenal cancer, 53% for ampullary cancer, and 62% for bile duct cancer. Univariate predictors of long-term survival in patients with periampullary adenocarcinoma included elevated glucose levels, liver function test results, abnormal tumor markers, blood loss, transfusion requirement, type of operation, and pathologic findings (periampullary adenocarcinoma type, differentiation, and margin and node status). Multivariate predictors were serum total bilirubin level, blood loss, operation type, diagnosis, and lymph node status. Pancreaticoduodenectomy continues to be associated with considerable morbidity. With careful patient selection, PD can be performed safely. Long-term survival in patients with periampullary adenocarcinoma can be predicted by preoperative laboratory values, intraoperative factors, and pathologic findings.

[Efficacy of motivational interviewing for reducing medication errors in chronic patients over 65 years with polypharmacy: Results of a cluster randomized trial].

PubMed

Pérula de Torres, Luis Angel; Pulido Ortega, Laura; Pérula de Torres, Carlos; González Lama, Jesús; Olaya Caro, Inmaculada; Ruiz Moral, Roger

2014-10-21

To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over 65 with polypharmacy. Cluster randomized trial that included doctors and nurses of 16 Primary Care centers and chronic patients with polypharmacy over 65 years. The professionals were assigned to the experimental or the control group using stratified randomization. Interventions consisted of training of professionals and revision of patient treatments, application of motivational interviewing in the experimental group and also the usual approach in the control group. The primary endpoint (medication error) was analyzed at individual level, and was estimated with the absolute risk reduction (ARR), relative risk reduction (RRR), number of subjects to treat (NNT) and by multiple logistic regression analysis. Thirty-two professionals were randomized (19 doctors and 13 nurses), 27 of them recruited 154 patients consecutively (13 professionals in the experimental group recruited 70 patients and 14 professionals recruited 84 patients in the control group) and completed 6 months of follow-up. The mean age of patients was 76 years (68.8% women). A decrease in the average of medication errors was observed along the period. The reduction was greater in the experimental than in the control group (F=5.109, P=.035). RRA 29% (95% confidence interval [95% CI] 15.0-43.0%), RRR 0.59 (95% CI:0.31-0.76), and NNT 3.5 (95% CI 2.3-6.8). Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over 65 with polypharmacy. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

Mandatory presuit mediation: 5-year results of a medical malpractice resolution program.

PubMed

Jenkins, Randall C; Smillov, Arlene E; Goodwin, Matthew A

2014-01-01

The Florida Patient Safety and Presuit Mediation Program (FLPSMP) is a mandatory mediation program designed to provide deserving patients with fast, fair compensation while limiting the healthcare provider expenses incurred during traditional litigation. Mediation occurs before litigation begins; therefore, patients with meritorious claims receive compensation often years earlier than they would with extended litigation. This early mediation fosters confidential and candid communication between doctors and patients, which promotes early fact-finding and candid discussion. The program went into effect across the University of Florida (UF) Health system on January 1, 2008. In an article previously published in this journal, we discussed the positive trend observed 2 years after the implementation of the FLPSMP. This article incorporates 5 years of data, which includes new benchmarks with state and national data, to demonstrate that the program can be used successfully as a medical malpractice solution. © 2014 American Society for Healthcare Risk Management of the American Hospital Association.

[Independent risk factors for severe cardiovascular events in male patients with gout: Results of a 7-year prospective study].

PubMed

Eliseev, M S; Denisov, I S; Markelova, E I; Glukhova, S I; Nasonov, E L

To determine risk factors for severe cardiovascular (CV) events (CVEs) in male patients with crystal-verified gout. 251 male patients with crystal-verified gout were prospectively followed up in 2003 to 2013. The mean follow-up period was 6.9±2.0 years. New severe CVE cases and deaths were recorded. Logistic regression was used to analyze the impact of traditional and other risk factors and allopurinol use on the risk for severe CVEs. 32 patients died during the follow-up period. Severe CVEs were recorded in 58 (23.1%) patients; CVE deaths were notified in 22 (8.8%) patients. The risk of all severe CVEs was high for hypertension, increased serum high-sensitivity C-reactive protein (hs-CRP) level (>5 mg/l), ≥ stage III chronic kidney disease (CKD) (glomerular filtration rate, <60 ml/min/1.73 m2), alcohol intake (>20 g/day), coronary heart disease (CHD), and a family history of premature CHD. The risk of fatal CVEs was highest for elevated serum hs-CRP level, ≥ stage III CKD, a family history of premature CHD, hypercholesterolemia, upper quartile of serum uric acid levels (>552 µmol/l), and regular intake of allopurinol. In addition to the traditional risk factors of CV catastrophes, the presence of chronic inflammation and the impact of high serum uric acid levels may explain the high frequency of CV catastrophes.

Is Bilateral Internal Mammary Arterial Grafting Beneficial for Patients Aged 75 Years or Older?

PubMed

Itoh, Satoshi; Kimura, Naoyuki; Adachi, Hideo; Yamaguchi, Atsushi

2016-07-25

Although bilateral internal mammary artery (BIMA) grafting is performed with increasing regularity in elderly patients, whether it is truly beneficial, and therefore indicated, in these patients remains uncertain. We retrospectively investigated early and late outcomes of BIMA grafting in patients aged ≥75 years. We identified 460 patients aged ≥75 years from among 2,618 patients who underwent either single internal mammary artery (SIMA) grafting (n=293) or BIMA grafting (n=107). Early outcomes did not differ between the SIMA and BIMA patients (30-day mortality: 1.7% vs. 0%, P=0.39; sternal wound infection: 1.0% vs. 4.7%; P=0.057). Late outcomes, 10-year survival in particular, were improved in the BIMA group (36.6% vs. 48.1%, P=0.033). In the analysis of the results in propensity score-matched groups (196 patients in the SIMA group, 98 patients in the BIMA group), improved 10-year survival was documented in the BIMA group (34.8% vs. 47.6%, P=0.030). Cox proportional regression analysis showed SIMA usage (non-use of BIMA) to be a predictor for late mortality (hazard ratio: 0.65, 95% confidence interval: 0.43-0.98, P=0.042). We further compared outcomes between the total non-elderly patients (n=2,158) and total elderly patients (n=460). BIMA usage was similar, as was 30-day mortality (1.0% vs. 1.3%, respectively). A survival advantage, with no increase in early mortality, can be expected from BIMA grafting in patients aged ≥75 years. (Circ J 2016; 80: 1756-1763).

Clinical correlation of biopsy results in patients with temporal arteritis.

PubMed

Yuksel, Volkan; Guclu, Orkut; Tastekin, Ebru; Halici, Umit; Huseyin, Serhat; Inal, Volkan; Canbaz, Suat

2017-11-01

Temporal arteritis is systemic vasculitis of medium and large sized vessels. The lowest incidence rates were reported in Turkey, Japan and Israel. We aimed to investigate the results of patients with biopsy-proven temporal arteritis and those classified according to the American College of Rheumatology criteria from a low-incidence region for temporal arteritis. The results of our study are noteworthy, since there is limited data on pathologic diagnosis of temporal arteritis in Turkey. We studied the medical records, laboratory findings such as erythrocyte sedimentation rate and C-reactive protein levels, biopsy results, and postoperative complications of all the patients operated for temporal artery biopsy at our clinic. We used the computerized laboratory registry that keeps all records of 42 consecutive temporal artery biopsy results from January 2011 to December 2016. The mean age was 66±12.5 years. The most common manifestations on admission were temporal headache, optic neuritis and jaw claudication, respectively. Temporal artery biopsy  results confirmed tempoal arteritis in eight out of 42 (19%) patients. There was no statistically significant difference between biopsy-positive and biopsy-negative groups in terms of sex, age, erythrocyte sedimentation rate, C-reactive protein and biopsy length. We were not able to find a correlation between the analysis of biopsy results and clinical evaluation of patients with temporal arteritis. We suggest that diagnosis of temporal arteritis  depends on clinical suspicion. Laboratory examination results may not be helpful in accurate diagnosis of tempoal arteritis.

Arthroscopic treatment of femoroacetabular impingement in patients older than 60 years.

PubMed

Mardones, Rodrigo; Via, Alessio Giai; Rivera, Alvaro; Tomic, Alexander; Somarriva, Marcelo; Wainer, Mauricio; Camacho, Daniel

2016-01-01

The indications of hip arthroscopy increased over the past decade. Although mostly recommended for treatment of femoroacetabular impingement (FAI) in young patients, well-selected older patients (> 60 years old) may benefit from this surgery. However, the role of hip arthroscopy for the management of older patients is controversial. The aim of the study is to evaluate the clinical outcomes of a series of patients aged 60 years and older who underwent hip arthroscopy for FAI at mid-term follow-up. Sixty-year-old patients and older, with a joint space greater than 2 mm, and a grade I and II hip osteoarthrosis (OA) according Tönnis scale were included into the study. Twenty-three patients (28 hips) met the inclusion criteria. The T-Student test was used to detect for differences between variables (p<0.05). The mean age of the patients was 63.4 years, and the mean follow-up was 4.4 years (2-9 years). We found an improvement in mHHS and VAS score from the baseline to the final follow-up in 87% of patients (p<0.05). Three patients (13%) were submitted to a THA at a mean of 12 months, while the survivorship rate at the final follow-up was 75%. No major complications have been reported. Arthroscopic treatment of FAI in patients over 60 years old, with no signs of advanced osteoarthrosis, showed a significant improvement of functional score and pain in most of cases, and it can be consider a reasonable option in well selected patients. Level of evidence: IV case series.

A 5- to 8-year retrospective study comparing the clinical results of implant-supported telescopic crown versus bar overdentures in patients with edentulous maxillae.

PubMed

Zou, Duohong; Wu, Yiqun; Huang, Wei; Zhang, Zhiyong; Zhang, Zhiyuan

2013-01-01

The objective of this study was to compare implant survival and success rates, peri-implant parameters, and prosthodontic maintenance efforts for implant-supported telescopic crown overdentures and bar overdentures to restore maxillary edentulism. This retrospective clinical study involved patients with maxillary edentulism who were fitted with implant-supported overdentures from January 2004 to June 2007. During a 5- to 8-year follow-up period, the implant survival and success rates, biologic and mechanical complications, prosthodontic maintenance, and patient satisfaction were retrospectively analyzed. The data were evaluated statistically and P < .05 was considered to be statistically significant. Forty-four patients with maxillary edentulism received implant-supported removable overdentures. Twenty-one patients chose telescopic crown overdentures and 23 patients chose bar overdentures. A total of 41 patients and 201 implants were available for follow-up. The implant survival and success rates, average bone resorption, and subjective patient satisfaction scores showed no difference between the telescopic crown and the bar overdenture group at follow-up. However, there were higher values for Plaque and Calculus Indexes in the bar group compared with the telescopic crown group, and these values showed a statistically significant difference annually from the 3-year follow-up (P < .05). Each year, the number of prosthodontics maintenance procedures per patient did not significantly differ between the telescopic crown (approximately 0.36 to 0.58) and bar groups (approximately 0.30 to 0.49) (P = .16). Although there were higher plaque and calculus levels in the bar group and more maintenance was required for the telescopic crown group, overdentures provided a healthy peri-implant structure for implants in both groups. Implant-supported telescopic crown or bar overdentures can provide a good treatment option for patients with edentulous maxillae.

Primary Helicobacter pylori resistance in elderly patients over 20 years: A Bulgarian study.

PubMed

Boyanova, Lyudmila; Gergova, Galina; Markovska, Rumyana; Kandilarov, Nayden; Davidkov, Lyubomir; Spassova, Zoya; Mitov, Ivan

2017-07-01

We evaluated the antibiotic susceptibility of 233 Helicobacter pylori strains isolated in the period 2011-2016, involving 62 strains from elderly patients aged 66-93years and 171 strains from younger adults. To assess resistance evolution, primary resistance rates in 92 strains from as many patients aged ≥60years in 1996-2003 were compared with those in 85 strains from infected patients in the same age group in 2011-2016. In the patients aged >65years evaluated during the last 6 years, amoxicillin resistance according to EUCAST and prior breakpoints was 1.6 and 0%, respectively. Resistance rates were the same by both breakpoint systems to metronidazole (35.5%), clarithromycin (22.6%), tetracycline (1.6%) and levofloxacin (32.3%). In 2011-2016, there were no significant differences between resistance rates in the subjects aged >65years and the younger adults. Notably, during the last 6 years, double/triple resistance was found in 21.0% of the subjects aged >65years. Moreover, the prevalence of quinolone primary resistance (30.0%) was significantly (3.4-fold) higher than that (8.9%) observed in 1996-2003. Briefly, the presence of both combined resistance and a strikingly high primary levofloxacin resistance in the elderly implies a cautious antibiotic choice for H. pylori eradication. In vitro susceptibility testing of the strains is highly important in this age group. The results can be linked to more frequent comorbidities and co-infection treatment in older compared with younger patients and, additionally, to the national antibiotic consumption. The high prevalence of quinolone resistance in the elderly patients is an alarming finding. Copyright © 2017 Elsevier Inc. All rights reserved.

A population-based study of disability and institutionalisation after TIA and stroke: 10-year results of the Oxford Vascular Study

PubMed Central

Luengo-Fernandez, Ramon; Paul, Nicola L.M.; Gray, Alastair M.; Pendlebury, Sarah T.; Bull, Linda M.; Welch, Sarah J.V.; Cuthbertson, Fiona C.; Rothwell, Peter M.

2016-01-01

Background and Purpose Long-term outcome information after TIA and stroke is required to help plan and allocate care services. We evaluated the impact of TIA and stroke on disability and institutionalisation over 5 years using data from a population-based study. Methods Patients from a UK population-based cohort study (Oxford Vascular Study) were recruited from 2002 to 2007, and followed-up to 2012. Patients were followed-up at 1, 6, 12, 24 and 60 months post-event and assessed using the modified Rankin Scale (mRS). A multivariate regression analysis was performed to assess the predictors of disability post-event. Results 748 index stroke and 440 TIA cases were studied. For TIA patients, disability levels increased from 14% (63/440) pre-morbidly to 23% (60/256) at 5 years (p=0.002), with occurrence of subsequent stroke being a major predictor of disability. For stroke survivors, the proportion disabled (mRS>2) increased from 21% (154/748) pre-morbidly to 43% (273/634) at 1-month (p<0.001), with 39% (132/339) of survivors disabled 5 years post-stroke. 5 years post-event, 70% (483/690) of stroke patients and 48% (179/375) of TIA patients were either dead or disabled. The 5-year risk of care home institutionalisation was 11% after TIA and 19% after stroke. The average 5-year cost per institutionalised TIA patient was $99,831 (S.D. 67,020) and $125,359 (S.D. 91,121) for stroke patients. Conclusions Our results show that 70% of stroke patients are either dead or disabled 5 years after the event. There therefore remains considerable scope for improvements in acute treatment and secondary prevention to reduce post-event disability and institutionalisation. PMID:23920019

Risk factors of poor functional results at 1-year after pseudocontinent perineal colostomy for ultralow rectal adenocarcinoma.

PubMed

Souadka, Amine; Majbar, Mohammed Anass; Bougutab, Abdeslam; El Othmany, Azzedine; Jalil, Abdelouahed; Ahyoud, Fatema Zahra; El Malki, Hadj Omar; Souadka, Abdelilah

2013-10-01

Pseudocontinent perineal colostomy is one of the techniques that helps recover the body image of patients undergoing abdominoperineal resection. This technique is rarely used internationally given its unknown functional results. The study aimed to evaluate 1-year functional outcomes of perineal pseudocontinent colostomy and to determine the risk factors for "poor" functional results. This study is a retrospective interventional case series. This study was conducted at a tertiary care university hospital and oncological center in Morocco. From January 1993 to December 2007, 149 patients underwent pseudocontinent perineal colostomy after abdominoperineal resection for low rectal adenocarcinoma. Pseudocontinent perineal colostomy was performed with the use of the Schmidt technique after abdominoperineal resection. One-year functional results were assessed according to the Kirwan classification system. Functional results were considered "poor" when the Kirwan score was C, D, or E. Univariable and multivariable analyses were used to evaluate the impact of age, sex, type of surgery, irrigation frequency, palpable muscular ring, concomitant chemoradiotherapy, stage, and perineal complications on functional results. One hundred forty-six patients were analyzed. According to the Kirwan system, the scores showed that 100 (68.5%) patients had "good" continence results (stage A-B) and 46 (31.5%) patients had altered functional results (stage C-D-E). With the exception of pelvic recurrences, no conversions from a perineal colostomy to an abdominal colostomy were performed for dissatisfactory functional results. In multivariate analysis, the only independent predictive factors of poor functional results were the occurrence of perineal complications (OR, 3.923; 95% CI, 1.461-10.35; p = 0.007) and extended resection (OR, 3.03; 95% CI, 1.183-7.750; p = 0.021) LIMITATION OF THE STUDY:: This study is an observational retrospective study on selected patients (mainly a young population

[Economic efficiency of renal denervation in patients with resistant hypertension: results of Markov modeling].

PubMed

Kontsevaia, A V; Suvorova, E I; Khudiakov, M B

2014-01-01

Aim of this study was to evaluate the cost-effectiveness of renal denervation (RD) in resistant arterial hypertension (AH) in Russia. Modeling of Markov conducted economic impact of RD on the Russian population of patients with resistant hypertension in combination with optimal medical therapy (OMT) compared with OMT using a model developed by American researchers based on the results of international research. The model contains data on Russian mortality, and costs of major complications of hypertension. The simulation results showed a significant reduction in relative risk reduction of adverse outcomes in patients with resistant hypertension for 10 years (risk of stroke is reduced by 30%, myocardial infarction - 32%). RD saves 0.9 years of quality-adjusted life (QALY) by an average of 1 patient with resistant hypertension. Costs for 1 year stored in the application of quality of life amounted to RD 203 791.6 rubles. Which is below the 1 gross domestic product and therefore indicates the feasibility of this method in Russia.

Organizational results : annual report, fiscal year 2010.

DOT National Transportation Integrated Search

2010-01-01

What can you do in five years? Pay off a car? Send your kid to college? How about change an : organizations culture? Over the past five years thats what Organizational Results has attempted to do. : By placing business process experts and resea...

Arthroscopic Hemitrapeziectomy for First Carpometacarpal Arthritis: Results at 7-year Follow-up

PubMed Central

Leak, Robert S.; Culp, Randall W.; Osterman, A. Lee

2008-01-01

The purpose of this study was to determine the outcome of arthroscopic hemitrapeziectomy combined with thermal capsular plication and temporary K-wire fixation in patients with painful thumb basal joint due to either osteoarthritis or posttraumatic arthritis. There were 18 thumbs that were evaluated in this retrospective study of arthroscopic hemitrapeziectomy of the distal trapezium in addition to a pancapsular thermal shrinkage at an average of 7.6-year follow-up. No patient has required further surgery. A subjective improvement in pain, pinch activities, strength, and range of motion (ROM) was noted in all patients, and no patient had further surgery on their thumb. On exam, no patient had a first carpal–metacarpal grind or laxity. Total ROM of the thumb axis decreased by 20%, but all patients could oppose to the fifth finger. Grip strength remained unchanged, key pinch improved from 8 to 11 lbs, and tip pinch improved from 4 to 5 lbs. Radiographs showed a metacarpal subsidence of 1.8 mm (0–4 mm). Four complications were noted: two cases of dorsal radial nerve neuritis, one rupture of the flexor pollicis longus, and one prolonged hematoma. Results demonstrate that arthroscopic hemitrapeziectomy and capsular shrinkage for first carpometacarpal arthritis is an effective technique that provides high patient satisfaction, a functional pain-free thumb, and a reliable rate of return to activity. PMID:18820976

Labral Reattachment in Femoroacetabular Impingement Surgery Results in Increased 10-year Survivorship Compared With Resection.

PubMed

Anwander, Helen; Siebenrock, Klaus A; Tannast, Moritz; Steppacher, Simon D

2017-04-01

Since the importance of an intact labrum for normal hip function has been shown, labral reattachment has become the standard method for open or arthroscopic treatment of hips with femoroacetabular impingement (FAI). However, no long-term clinical results exist evaluating the effect of labral reattachment. A 2-year followup comparing open surgical treatment of FAI with labral resection versus reattachment was previously performed at our clinic. The goal of this study was to report a concise followup of these patients at a minimum of 10 years. We asked if patients undergoing surgical hip dislocation for the treatment of mixed-type FAI with labral reattachment compared with labral resection had (1) improved hip pain and function based on the Merle d'Aubigné-Postel score; and (2) improved survival at 10-year followup. Between June 1999 and July 2002, we performed surgical hip dislocation with femoral neck osteoplasty and acetabular rim trimming in 52 patients (60 hips) with mixed-type FAI. In the first 20 patients (25 hips) until June 2001, a torn labrum or a detached labrum in the area of acetabular rim resection was resected. In the next 32 patients (35 hips), reattachment of the labrum was performed. The same indications were used to perform both procedures during the periods in question. Of the 20 patients (25 hips) in the first group, 19 patients (95%) (24 hips [96%]) were available for clinical and/or radiographic followup at a minimum of 10 years (mean, 13 years; range, 12-14 years). Of the 32 patients (35 hips) in the second group, 29 patients (91%) (32 hips [91%]) were available for clinical and/or radiographic followup at a minimum of 10 years (mean, 12 years; range, 10-13 years). We used the anterior impingement test to assess pain. Function was assessed using the Merle d'Aubigné- Postel score and ROM. Survivorship calculation was performed using the method of Kaplan-Meier with failure defined as conversion to THA, progression of osteoarthritis (of one

Cochlear implant surgery in patients more than seventy-nine years old.

PubMed

Eshraghi, Adrien A; Rodriguez, Michael; Balkany, Thomas J; Telischi, Fred F; Angeli, Simon; Hodges, Annelle V; Adil, Eelam

2009-06-01

To evaluate the surgical complications, auditory performance, and hearing handicap following cochlear implantation in patients greater than 79 years of age. Retrospective trial, tertiary referral center. The study group was comprised of 21 patients implanted after 79 years of age from 1996 through 2006 with follow-ups past their 8th decade. Pre-op evaluation consisted of pure-tone audiometry and speech discrimination scores (Hearing in Noise Test and City University of New York sentence test). The results of these tests were compared to similar tests taken post-op. A validated hearing handicap questionnaire was used to evaluate the outcome. There were no permanent medical or surgical complications. However, two patients developed exacerbations of previous comorbid conditions (i.e., urinary retention and acute delirium). Implanted patients experienced a significant improvement in audiologic performance, post-op pure tone average, and post-op speech scores (P < .001). A majority of them were able to use the phone and reported that the cochlear implant was of great benefit to them. The post-op hearing handicap inventory for the elderly demonstrated a significant decrease of hearing handicap scores. This is the first study to focus on a patient group this advanced in age. With increasing life expectancy, we should begin to stratify risk versus benefit of cochlear implantation in this age group. Cochlear implantation improved audiologic performance and the quality of life in patients older than 79 years old. There were no permanent medical or surgical complications. Chronic pain and temporary vertigo were the most common complications reported in this elderly group. Laryngoscope, 2009.

Infliximab therapy in pediatric patients 7 years of age and younger.

PubMed

Kelsen, Judith R; Grossman, Andrew B; Pauly-Hubbard, Helen; Gupta, Kernika; Baldassano, Robert N; Mamula, Petar

2014-12-01

Infliximab (IFX) is efficacious for induction and maintenance of remission in pediatric patients with moderate-to-severe inflammatory bowel disease (IBD). It has, however, not been studied in patients 7 years old and younger. Our aim was to characterize efficacy and safety of IFX therapy in this cohort. This was a retrospective study of patients with IBD ages 7 years and younger, treated with IFX between 1999 and 2011. Medical records were reviewed for age of diagnosis, disease phenotype, therapy, surgery, IFX infusion dates, dose, and intervals. Outcome measures included physician global assessment, corticosteroid requirement, and adverse events. Thirty-three children (ages 2.4-7 years) were included. Twenty patients had Crohn disease, 4 had ulcerative colitis, and 9 had indeterminate colitis. Maintenance of IFX therapy at 1, 2, and 3 years was 36%, 18%, and 12%, respectively. Patients of age 5 years and younger had the lowest rates of maintenance of therapy at 25% at year 1, and 10% at years 2 and 3 combined. Nine percent of all of the patients demonstrated response measured by the physician global assessment and were steroid free at 1 year. There were 8 infusion reactions. There were no malignancies, serious infections, or deaths. IFX demonstrated a modest response rate and a low steroid-sparing effect in patients with IBD 7 years old and younger. Although this is a limited study, there appears to be a trend for decreased sustained efficacy with IFX in this age group, particularly in children 5 years old and younger, when compared with the previously published literature in older children.

Motor recovery of stroke patients after rehabilitation: one-year follow-up study.

PubMed

Kuptniratsaikul, Vilai; Kovindha, Apichana; Suethanapornkul, Sumalee; Massakulpan, Pornpimon; Permsirivanich, Wutichai; Kuptniratsaikul, Patcharawimol Srisa-An

2017-01-01

Purpose To investigate motor recovery of stroke patients 1 year after rehabilitation. Materials and Methods A cross-sectional study of 192 stroke patients discharged from rehabilitation wards in nine tertiary hospitals was conducted. Motor recovery was assessed using the Brunnstrom motor recovery stages (BMRS), at 6 and 12 months after discharge. Factors related to the BMRS of the hand, arm and leg were analyzed. Results The mean age of patients was 62.2 years (57.3% male). Significantly more patients presented improvement of at least one BMRS of the hand, arm and leg compared with those with decreasing BMRS (p < 0.001). The percentage of patients with BMRS III- VI at 6 months was greater than that at discharge, but the recovery at 12 months was slightly higher than that at 6 months. It seems that motor recovery from stroke was near maximal at six months. Regarding the factors related to motor recovery, only lengths of stay (LOS) <30 d during the first admission and Barthel index at discharge ≥10 were related to the improvement of BMRS of the hand, arm and leg on multivariate analysis. Additionally, no complication at discharge was associated with the improvement of BMRS of the leg. Conclusions Approximately half of our stroke patients had motor improvement of at least one stage of BMRS at one year. Motor recovery after stroke at the end of the first year was associated with shorter LOS during the first admission, higher discharge Barthel index score and absence of complications at discharge.

High-Dose-Rate Monotherapy for Localized Prostate Cancer: 10-Year Results

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

Hauswald, Henrik; Kamrava, Mitchell R.; Fallon, Julia M.

2016-03-15

Purpose: High-dose-rate (HDR) brachytherapy was originally used with external beam radiation therapy (EBRT) to increase the dose to the prostate without injuring the bladder or rectum. Numerous studies have reported HDR brachytherapy is safe and effective. We adapted it for use without EBRT for cases not requiring lymph node treatment. Patients and Methods: We entered the patient demographics, disease characteristics, and treatment parameters into a prospective registry and serially added follow-up data for 448 men with low-risk (n=288) and intermediate-risk (n=160) prostate cancer treated from 1996 to 2009. Their median age was 64 years (range 42-90). The median prostate-specific antigen (PSA)more » level was 6.0 ng/mL (range 0.2-18.2). The Gleason score was ≤6 in 76% and 7 in 24%. The median dose was 43.5 Gy in 6 fractions. The clinical and biochemical disease control and survival rates were calculated. Adverse events were graded according to the Common Toxicity Criteria of Adverse Events. Results: The median follow-up period was 6.5 years (range 0.3-15.3). The actuarial 6- and 10-year PSA progression-free survival was 98.6% (95% confidence interval [CI] 96.9%-99.4%) and 97.8% (95% CI 95.5%-98.9%). Overall survival at 10 years was 76.7% (95% CI 69.9%-82.2%). The local control, distant metastasis-free survival, and cause-specific survival were 99.7% (95% CI 97.9%-99.9%), 98.9% (95% CI 96.3%-99.7%), and 99.1% (95% CI 95.8%-99.8%). T stage, initial PSA level, Gleason score, National Comprehensive Cancer Network risk group, patient age, and androgen deprivation therapy did not significantly correlate with disease control or survival. No late grade 3 to 4 rectal toxicities developed. Late grade 3 to 4 genitourinary toxicity occurred in 4.9% (grade 3 in 4.7%). Conclusions: HDR monotherapy is a safe and highly effective treatment of low- and intermediate-risk prostate cancer.« less

The Mosaic bioprosthesis in the aortic position: 17 years' results.

PubMed

Gansera, Brigitte; Hapfelmeier, Alexander; Brandl, Kristina; Spiliopoulos, Kyriakos; Gundling, Felix; Eichinger, Walter

2014-02-01

The Mosaic bioprosthesis (Medtronic Inc., Minneapolis, Minnesota, United States), a stented porcine aortic valve, combines glutaraldehyde fixation with zero-pressure, root-pressure techniques and antimineralization treatment with amino-oleic acid for improved hemodynamics and tissue durability. The first device has been implanted worldwide at the authors' institution in September 1993. The aim of the present study was to collect mid- to long-term data of the prosthesis. A total of 272 patients (124 males and 148 females) underwent isolated aortic valve replacement with the Mosaic bioprosthesis between September 1993 and August 2007. Median age at implant was 76.8 years (range, 31.3 to 90.7). Median follow-up was 12.0 years (range, 0 to 17.2 years); follow-up was complete for 223 (82%) patients. Early mortality (30 days) was 4% (12 patients). Overall survival at 5, 10, 15, and 17 years was 68.6% ± 3.1%, 36.4% ± 3.3%, 17.1% ± 3.6%, and 10.7% ± 4.3%, respectively. Eleven late deaths (5%) were cardiac related. There were 24 thromboembolic events, 1 hemorrhagic, and 6 reoperations/explants. At a median follow-up of 12 years, freedom from any cause of death was 27.0% ± 3.2% acting as a competing risk for the incidence of thromboembolic events (16.4% ± 3.5%), hemorrhage (0.5% ± 0.5%), and reoperation/explant (4.1% ± 1.8%). Two redos were due to structural valve deterioration (SVD), two for nonstructural dysfunction (paravalvular leakage), one for thrombosed prosthesis, and one for endocarditis. Performance and late outcome of the Mosaic bioprosthesis was satisfactory during 17 years after clinical introduction. The Mosaic bioprosthesis showed low incidence of SVD or need for reoperation in the long term. Georg Thieme Verlag KG Stuttgart · New York.

Quality of life among patients undergoing bariatric surgery: associations with mental health- A 1 year follow-up study of bariatric surgery patients

PubMed Central

2011-01-01

Background Preoperative mental health seems to have useful predictive value for Health Related Quality of Life (HRQOL) after bariatric surgery. The aim of the present study was to assess pre- and postoperative psychiatric disorders and their associations with pre- and postoperative HRQOL. Method Data were assessed before (n = 127) and one year after surgery (n = 87). Psychiatric disorders were assessed by Mini International Neuropsychiatric Interview (M.I.N.I.) and Structured Clinical Interview (SCID-II). HRQOL was assessed by the Short Form 36 (SF-36) questionnaire. Results Significant improvements were found in HRQOL from preoperative assessment to follow-up one year after surgery. For the total study population, the degree of improvement was statistically significant (p values < .001) for seven of the eight SF-36 subscales from preoperative assessment to follow-up one year after surgery. Patients without psychiatric disorders had no impairments in postoperative HRQOL, and patients with psychiatric disorders that resolved after surgery had small impairments on two of the eight SF-36 subscales compared to the population norm (all effect sizes < .5) at follow-up one year after surgery. Patients with psychiatric disorders that persisted after surgery had impaired HRQOL at follow-up one year after surgery compared to the population norm, with effect sizes for the differences from moderate to large (all effect sizes ≥ .6). Conclusion This study reports the novel finding that patients without postoperative psychiatric disorders achieved a HRQOL comparable to the general population one year after bariatric surgery; while patients with postoperative psychiatric disorders did not reach the HRQOL level of the general population. Our results support monitoring patients with psychiatric disorders persisting after surgery for suboptimal improvements in quality of life after bariatric surgery. Trial Registration The trial is registered at http://www.clinicaltrials.gov prior

Efficacy and safety of once-yearly zoledronic acid in Japanese patients with primary osteoporosis: two-year results from a randomized placebo-controlled double-blind study (ZOledroNate treatment in Efficacy to osteoporosis; ZONE study).

PubMed

Nakamura, T; Fukunaga, M; Nakano, T; Kishimoto, H; Ito, M; Hagino, H; Sone, T; Taguchi, A; Tanaka, S; Ohashi, M; Ota, Y; Shiraki, M

2017-01-01

In a 2-year randomized, placebo-controlled study of 665 Japanese patients with primary osteoporosis, once-yearly administration of zoledronic acid (5 mg) reduced the risk of new morphometric vertebral fractures. The purpose of this study was to determine the efficacy and safety of once-yearly intravenous infusion of ZOL in Japanese patients with primary osteoporosis. This was a two-year multicenter, randomized, placebo-controlled, double-blind, parallel-group comparative study (ZONE Study). Subjects were 665 Japanese patients between the ages of 65 and 89 years who had prevalent vertebral fracture. Subjects were randomly assigned to receive once-yearly intravenous infusion of 5 mg of ZOL or placebo at baseline and 12 months. The 2-year incidence of new morphometric vertebral fracture was 3.0 % (10/330 subjects) in the ZOL group and 8.9 % (29/327) in the placebo group (p = 0.0016). The 24-month cumulative incidence of new morphometric vertebral fracture was 3.3 % in the ZOL group versus 9.7 % in the placebo group (log-rank test: p = 0.0029; hazard ratio: 0.35; 95 % confidence interval: 0.17-0.72). The cumulative incidence of any clinical fracture, clinical vertebral fracture, and non-vertebral fracture was significantly reduced in the ZOL group by 54, 70, and 45 %, respectively, compared to the placebo group. At 24 months, ZOL administration increased bone mineral density in the lumbar spine, femoral neck, and total hip (t test: p < 0.0001). No new adverse events or osteonecrosis of the jaw were observed in this study. Once-yearly administration of ZOL 5 mg to Japanese patients with primary osteoporosis reduced the risk of new morphometric vertebral fractures and was found to be safe.

Clinical results of proton beam therapy for twenty older patients with esophageal cancer

PubMed Central

Ono, Takashi; Nakamura, Tatsuya; Azami, Yusuke; Yamaguchi, Hisashi; Hayashi, Yuichiro; Suzuki, Motohisa; Hatayama, Yoshiomi; Tsukiyama, Iwao; Hareyama, Masato; Kikuchi, Yasuhiro; Nemoto, Kenji

2015-01-01

Background In an aging society, increasing number of older patients are diagnosed with esophageal cancer. The purpose of this study was to assess the clinical efficacy and safety of proton beam therapy for older patients with esophageal cancer. Patients and methods. Older patients (age: ≥ 65 years) newly diagnosed with esophageal cancer between January 2009 and June 2013 were enrolled in this study. All patients underwent either proton beam therapy alone or proton beam therapy with initial X-ray irradiation. Toxicities were evaluated using the Common Terminology Criteria for Adverse Events version 4.0. Results Twenty patients were eligible for this study and all completed the treatment. The median age was 78 years (range: 65–89 years) and the median follow-up time was 26.5 months (range: 6–62 months). Seven patients had lymph node metastases and 10 had stage II/III cancer. The median dose of proton beam therapy was 72.6 Gy relative biological dose effectiveness (RBE) (range: 66–74.8 Gy [RBE]) for proton beam therapy alone and 33 Gy (RBE) (range: 30.8–39.6 Gy [RBE]; total dose range: 66.8–75.6 Gy [RBE]) for proton beam therapy with initial X-ray irradiation. The 2-year overall survival rate was 81.8% (95% confidence interval [CI]: 62.4%–100%), and the 2-year local control rate was 89.4% (95% CI: 75.5%–100%). Grade 2 or 3 toxicities occurred in some cases; however, no grade 4 or 5 toxicity was observed. Conclusions High-dose (66–75.6 Gy [RBE]) proton beam therapy without chemotherapy was an efficacious and safe treatment for older patients with esophageal cancer. PMID:26834524

Outpatient thoracic surgical programme in 300 patients: clinical results and economic impact.

PubMed

Molins, Laureano; Fibla, Juan J; Pérez, Javier; Sierra, Ana; Vidal, Gonzalo; Simón, Carlos

2006-03-01

To evaluate clinical aspects, results and the economic impact of the outpatient thoracic surgery programme (OTSP) developed in our Department. Prospective study of 300 patients who entered in the OTSP from April 2001 to March 2005. The procedures performed were video-mediastinoscopy (MC), video-thoracoscopic lung biopsy (LB) and video-thoracoscopic bilateral thoracic sympathectomy (TS). All procedures were performed under general anaesthesia and patients were discharged in 4-6h. We analyse demographic data, the substitution index (SI), the admission rate (AR) and readmission rate (RR) after the procedure. We calculate the economic impact of stay expenses on our hospital and on other Spanish hospitals. The female/male ratio of the 300 patients was 83/217, with a mean age of 58.1 years (range: 15-85 years). There were no deaths. Mediastinoscopy was performed as outpatient procedure in 210 patients (mean age: 65.6 years) out of 244 total MC (SI=86.1%). Two patients were admitted (AR=0.95%) to observe a minimal pneumothorax and because of late night end. There were no readmissions after MC (RR=0%). We included 32 ambulatory patients for lung biopsy (mean age: 61.5 years) out of 64 total LB (SI=50.0%). One patient was admitted because of air leak (AR=3.1%) and there were no readmissions after LB (RR=0%). Fifty-eight patients were included in the OTSP for bilateral sympathectomy (mean age: 27.1 years) out of 83 total TS (SI=69.9%); there were no admissions (AR=0%) and one patient was readmitted after 9 days because of a hemothorax (RR=1.7%). Sixty-four patients out of the 91 not included in the OTSP were included in an 'afternoon surgical programme' and dismissed the morning after surgery, without contraindication for their inclusion in the OTSP. The hospital's total stay saving was 12,668 euros (88,226 euros if performed elsewhere), 42 euros per patient (294 euros per patient if performed elsewhere). Video-assisted mediastinoscopy, lung biopsy and bilateral

Cementless Total Knee Arthroplasty in Patients Older Than 75 Years.

PubMed

Newman, Jared M; Khlopas, Anton; Chughtai, Morad; Gwam, Chukwuweike U; Mistry, Jaydev B; Yakubek, George A; Harwin, Steven F; Mont, Michael A

2017-11-01

Some surgeons have been hesitant to use cementless fixation for total knee arthroplasty (TKA) in elderly patients due to concerns regarding successful bone biological fixation. Therefore, this study evaluated: (1) implant survivorship, (2) functional outcomes, (3) radiographic outcomes, and (4) complications in patients over 75 years of age who underwent cementless total knee arthroplasty. A total of 134 patients (142 TKAs) older than 75 years at a single institution between June 2008 and June 2014 were retrospectively reviewed. Their mean follow-up was 4 years (range: 2-8 years). The cohort consisted of 91 women and 43 men who had a mean age of 80 years (range: 76 to 88 years). The preoperative diagnoses were osteoarthritis ( n  = 107 patients), rheumatoid arthritis ( n  = 21 patients), and osteonecrosis ( n  = 6 patients). Descriptive statistics were used to calculate the means and ranges and a Kaplan-Meier analysis was performed to determine the aseptic and all cause implant survivorship. Radiographic evaluation was performed using the new Knee Society Radiographic Evaluation and Scoring System. Functional outcomes at the final follow-up as well as all medical and surgical complications were recorded for each patient. The aseptic implant survivorship was 99.3% (95% CI: 7.9-8.1), and the all cause implant survivorship was 98.6% (95% CI: 7.9-8.1). There was one aseptic revision and one septic revision. At the latest follow-up the mean Knee Society pain score was 93 points (range, 80-100 points), and the mean Knee Society function score was 84 points (range, 70-90 points). On radiographic evaluation, there were no progressive radiolucencies, subsidence, and loosening of prostheses at the latest follow-up. The use of cementless TKA demonstrated excellent survivorship, mid-term clinical and functional outcomes, as well as no progressive radiolucencies or subsidence in patients older than 75 years. In addition, there was a low rate of surgical and medical

[Five-year survival analysis in patients with penile cancer].

PubMed

Montiel-Jarquín, Álvaro José; Contreras-Díaz, Antonio Jesús; Vázquez-Cruz, Eduardo; Chopin-Gazga, Marco Antonio; Romero-Figueroa, María Socorro; Etchegaray-Morales, Ivet; Alvarado-Ortega, Ivan

2017-01-01

Short-term survival of penile cancer is poor. The objective was to describe the 5-years penile cancer survival. Retrospective cohort study. We included patients with penile cancer managed surgically from 2010 to 2014. Descriptive statistics were used for socio-demographic variables and the Kaplan-Meier estimator for survival function. We studied 22 patients with a mean age of 64.95 years and a time of evolution of 25 months after the diagnosis. 68.2% of patients smoked or had human papillomavirus (HPV); they all presented phimosis; 72.7% had pain in the penis and the groin area; 81.8% had palpable lymph nodes and 45.5% lesions ≥ 3 cm; 86.3% were diagnosed in clinical stage IIIa. 59.1% underwent partial penectomy and 86.4% had squamous cell variety. 40.9% of patients died six months after the surgery. 66% of the smokers presented metastasis; all of the patients that smoked and had HPV infection had neurovascular invasion and died; 83.3% of the patients (n = 6) who underwent partial penectomy and positive lymph node dissection due to metastases died. The 5-years mortality of patients with penile cancer was 40.9%. Tobacco use and HPV increase morbidity and mortality in patients with penile cancer; lesions greater than 5 cm are more common in smokers. The size of the lesion increases with the delay in treatment.

Time to look beyond one-year mortality in critically ill hematological patients?

PubMed

Moors, Ine; Benoit, Dominique D

2014-02-11

The spectacular improvement in long-term prognosis of patients with hematological malignancies since the 1980s, coupled with the subsequent improvement over the past decade in short- and mid-term survival in cases of critical illness, resulted in an increasing referral of such patients to the ICU. A remaining question, however, is how these patients perform in the long term with regard to survival and quality of life. Here we discuss the present multicenter study on survival beyond 1 year in critically ill patients with hematological malignancies. We conclude with suggestions on how we can further improve the long-term outcome of these patients.

Randomized Clinical Trial of a Self-Adhering Flowable Composite for Class I Restorations: 2-Year Results.

PubMed

Sabbagh, J; Dagher, S; El Osta, N; Souhaid, P

2017-01-01

Objectives. To compare the clinical performances of a self-adhering resin composite and a conventional flowable composite with a self-etch bonding system on permanent molars. The influence of using rubber dam versus cotton roll isolation was also investigated. Materials and Methods. Patients aged between 6 and 12 years and presenting at least two permanent molars in need of small class I restorations were selected. Thirty-four pairs of restorations were randomly placed by the same operator. Fifteen patients were treated under rubber dam and nineteen using cotton rolls isolation and saliva ejector. They were evaluated according to the modified USPHS criteria at baseline, 6 months, and 1 and 2 years by two independent evaluators. Results. All patients attended the two-year recall. For all measured variables, there was no significant difference between rubber dam and cotton after 2 years of restoration with Premise Flowable or Vertise Flow ( p value > 0.05). The percentage of restorations scored alpha decreased significantly over time with Premise Flowable and Vertise Flow for marginal adaptation and surface texture as well as marginal discoloration while it did not vary significantly for color matching. After 2 years, Vertise Flow showed a similar behaviour to the Premise Flowable used with a self-adhesive resin system.

Alcohol and other psychoactive drugs in trauma patients aged 10–14 years

PubMed Central

Li, G.; Chanmugam, A.; Rothman, R.; DiScala, C.; Paidas, C.; Kelen, G.

1999-01-01

Objective—To examine the prevalence of alcohol and/or other psychoactive drugs, such as marijuana and cocaine (AODs), involved in preteen trauma patients. Methods—Toxicological testing results were analyzed for 1356 trauma patients aged 10–14 years recorded in the National Pediatric Trauma Registry for the years 1990–95. Results—Of the 1356 patients who received toxicological screening at the time of admission, 116 (9%) were positive for AODs. AOD involvement increased with age. Patients with pre-existing mental disorders were nearly three times as likely as other patients to be AOD positive (23% v 8%, p<0.01). AOD involvement was more prevalent in intentional injuries and in injuries that occurred at home. Conclusions—AODs in preteen trauma are of valid concern, in particular among patients with mental disorders or intentional injuries. The role of AODs in childhood injuries needs to be further examined using standard screening instruments and representative study samples. PMID:10385826

Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease.

PubMed

Germain, Dominique P; Charrow, Joel; Desnick, Robert J; Guffon, Nathalie; Kempf, Judy; Lachmann, Robin H; Lemay, Roberta; Linthorst, Gabor E; Packman, Seymour; Scott, C Ronald; Waldek, Stephen; Warnock, David G; Weinreb, Neal J; Wilcox, William R

2015-05-01

Fabry disease results from deficient α-galactosidase A activity and globotriaosylceramide accumulation causing renal insufficiency, strokes, hypertrophic cardiomyopathy and early demise. We assessed the 10-year outcome of recombinant α-galactosidase A therapy. The outcomes (severe clinical events, renal function, cardiac structure) of 52/58 patients with classic Fabry disease from the phase 3 clinical trial and extension study, and the Fabry Registry were evaluated. Disease progression rates for patients with low renal involvement (LRI, n=32) or high renal involvement (HRI, n=20) at baseline were assessed. 81% of patients (42/52) did not experience any severe clinical event during the treatment interval and 94% (49/52) were alive at the end of the study period. Ten patients reported a total of 16 events. Patients classified as LRI started therapy 13 years younger than HRI (mean 25 years vs 38 years). Mean slopes for estimated glomerular filtration rate for LRI and HRI were -1.89 mL/min/1.73 m(2)/year and -6.82 mL/min/1.73 m(2)/year, respectively. Overall, the mean left ventricular posterior wall thickness and interventricular septum thickness remained unchanged and normal. Patients who initiated treatment at age ≥ 40 years exhibited significant increase in left ventricular posterior wall thickness and interventricular septum thickness. Mean plasma globotriaosylceramide normalised within 6 months. This 10-year study documents the effectiveness of agalsidase beta (1 mg/kg/2 weeks) in patients with Fabry disease. Most patients remained alive and event-free. Patients who initiated treatment at a younger age and with less kidney involvement benefited the most from therapy. Patients who initiated treatment at older ages and/or had advanced renal disease experienced disease progression. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Sensitization to aeroallergens in patients with respiratory allergies based on skin-prick test results.

PubMed

Lokaj-Berisha, V; Berisha, N; Lumezi, B; Ahmetaj, L; Bejtullahu, G; Karahoda, N; Pupovci, H

2012-01-01

The aim of this study was to identify the most common aeroallergens in patients with asthma and rhinitis. The study enrolled 102 participants including 64 patients with respiratory allergies (among them 15 were clinically diagnosed as asthma patients, 41 with rhinitis, 8 were both) and 38 healthy controls. All of participants were subject of skin prick tests (SPT) with series of common allergenic extracts. Sera from all participants were tested for total IgE and eosinophil count. To measure airflow limitation and reversibility in asthma patients the pulmonary function testing were carried out. M/F ratio was 1:1.6 in patients and 1:0.7 in control group with mean age 28.88 year (SD 13.16; range 6 - 55 year) and 20.47 respectively (SD 1.16; range 19-23 year). The most common risk factors in these patients were total IgE more than 100 IU/ml, eosinophils above 4% and positive family history of atopy. Skin prick testing results showed prevalence rates for allergen groups in this manner: house dust mites 81.3 %, pollens 57.8 %, animal dandruff 12.5% and moulds 4.9%. Polysensitization was common in 51.6% of all sensitized patients being positive to more than one group of allergens. House dust mites are the main sensitizing allergens among our allergic patients as well as healthy controls. Next in importance, in all participants, are grasses. This pattern of prevalence was expected based on herbal geography, climate and specially lifestyle. It was also compatible with the results from studies carried out in places with the same habitat.

Correlation between MRI results and intraoperative findings in patients with silicone breast implants

PubMed Central

Lindenblatt, Nicole; El-Rabadi, Karem; Helbich, Thomas H; Czembirek, Heinrich; Deutinger, Maria; Benditte-Klepetko, Heike

2014-01-01

Background Silicone gel breast implants may silently rupture without detection. This has been the main reason for magnetic resonance imaging (MRI) of the augmented or reconstructed breast. The aim of the present study was to investigate the accuracy of MRI for implant rupture. Methods Fifty consecutive patients with 85 silicone gel implants were included in the study. The mean age of the patients was 51 (range 21–72) years, with a mean duration of implantation of 3.8 (range 1–28) years. All patients underwent clinical examination and breast MRI. Intraoperative implant rupture was diagnosed by the operating surgeon. Results Nineteen of the 50 patients suffered from clinical symptoms. An implant rupture was diagnosed by MRI in 22 of 85 implants (26%). In seven of 17 removed implants (41%), the intraoperative diagnosis corresponded with the positive MRI result. However, only 57% of these patients were symptomatic. Ultrasound imaging of the harvested implants showed signs of interrupted inner layers of the implant despite integrity of the outer shell. By microsurgical separation of the different layers of the implant shell, we were able to reproduce this phenomenon and to produce signs of implant rupture on MRI. Conclusion Our results show that rupture of only the inner layers of the implant shell with integrity of the outer shell leads to a misdiagnosis on MRI. Correlation with clinical symptoms and the specific wishes of the patient should guide the indication for implant removal. PMID:25114595

A Prognostic Model for One-year Mortality in Patients Requiring Prolonged Mechanical Ventilation

PubMed Central

Carson, Shannon S.; Garrett, Joanne; Hanson, Laura C.; Lanier, Joyce; Govert, Joe; Brake, Mary C.; Landucci, Dante L.; Cox, Christopher E.; Carey, Timothy S.

2009-01-01

Objective A measure that identifies patients who are at high risk of mortality after prolonged ventilation will help physicians communicate prognosis to patients or surrogate decision-makers. Our objective was to develop and validate a prognostic model for 1-year mortality in patients ventilated for 21 days or more. Design Prospective cohort study. Setting University-based tertiary care hospital Patients 300 consecutive medical, surgical, and trauma patients requiring mechanical ventilation for at least 21 days were prospectively enrolled. Measurements and Main Results Predictive variables were measured on day 21 of ventilation for the first 200 patients and entered into logistic regression models with 1-year and 3-month mortality as outcomes. Final models were validated using data from 100 subsequent patients. One-year mortality was 51% in the development set and 58% in the validation set. Independent predictors of mortality included requirement for vasopressors, hemodialysis, platelet count ≤150 ×109/L, and age ≥50. Areas under the ROC curve for the development model and validation model were 0.82 (se 0.03) and 0.82 (se 0.05) respectively. The model had sensitivity of 0.42 (se 0.12) and specificity of 0.99 (se 0.01) for identifying patients who had ≥90% risk of death at 1 year. Observed mortality was highly consistent with both 3- and 12-month predicted mortality. These four predictive variables can be used in a simple prognostic score that clearly identifies low risk patients (no risk factors, 15% mortality) and high risk patients (3 or 4 risk factors, 97% mortality). Conclusions Simple clinical variables measured on day 21 of mechanical ventilation can identify patients at highest and lowest risk of death from prolonged ventilation. PMID:18552692

Weight loss, weight regain, and conversions to Roux-en-Y gastric bypass: 10-year results of laparoscopic sleeve gastrectomy.

PubMed

Felsenreich, Daniel M; Langer, Felix B; Kefurt, Ronald; Panhofer, Peter; Schermann, Martin; Beckerhinn, Philipp; Sperker, Christoph; Prager, Gerhard

2016-11-01

With promising short-term results, laparoscopic sleeve gastrectomy (SG) has become the second most frequently performed bariatric procedure worldwide. Aside from a growing number of reports covering up to 10 years of follow-up, only limited data have been published so far on long-term results. The aim of the study was to present a 10-year follow-up for SG. University hospital setting, Austria. We present the first complete 10-year follow-up of 53 consecutive patients who underwent SG before 2006. In this multicenter study, weight loss success, weight regain, and revisional surgery were analyzed beside Bariatric Analysis and Reporting Outcome System (BAROS) scores. A mean maximum percent excess weight loss of 71±25% (percent total weight loss: 28±15%) was reached at a median of 12 (range 12-120) months after SG. At 10 years, a mean percent excess weight loss of 53±25% was achieved by 32 patients, corresponding to a percent total weight loss of 26.3±13.4%. Nineteen of the 53 patients (36%) were converted to Roux-en-Y gastric bypass (n = 18) or duodenal switch (n = 1) due to significant weight regain (n = 11), reflux (n = 6), or acute revision (n = 2) at a median of 36 months. Two patients died at 3 and 101 months postoperatively, unrelated to SG. A total of 31 patients (59%) suffered from weight regain of 10 kg or more, among them 24 patients (45%) with 15 kg or more, 16 patients (30%) with 20 kg or more, and 7 patients (13%) with 25 kg or more weight regain from nadir. Mean BAROS score was 2.4±2.2 at 10 years follow-up, classifying SG as "fairly efficient." Within a long-term follow-up of 10 years or more after SG, a high incidence of both significant weight regain and intractable reflux was observed, leading to conversion, most commonly to Roux-en-Y gastric bypass. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Treatment of complex coronary artery disease in patients with diabetes: 5-year results comparing outcomes of bypass surgery and percutaneous coronary intervention in the SYNTAX trial.

PubMed

Kappetein, Arie Pieter; Head, Stuart J; Morice, Marie-Claude; Banning, Adrian P; Serruys, Patrick W; Mohr, Friedrich-Wilhelm; Dawkins, Keith D; Mack, Michael J

2013-05-01

This prespecified subgroup analysis examined the effect of diabetes on left main coronary disease (LM) and/or three-vessel disease (3VD) in patients treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the SYNTAX trial. Patients (n = 1800) with LM and/or 3VD were randomized to receive either PCI with TAXUS Express paclitaxel-eluting stents or CABG. Five-year outcomes in subgroups with (n = 452) or without (n = 1348) diabetes were examined: major adverse cardiac or cerebrovascular events (MACCE), the composite safety end-point of all-cause death/stroke/myocardial infarction (MI) and individual MACCE components death, stroke, MI and repeat revascularization. Event rates were estimated with Kaplan-Meier analyses. In diabetic patients, 5-year rates were significantly higher for PCI vs CABG for MACCE (PCI: 46.5% vs CABG: 29.0%; P < 0.001) and repeat revascularization (PCI: 35.3% vs CABG: 14.6%; P < 0.001). There was no difference in the composite of all-cause death/stroke/MI (PCI: 23.9% vs CABG: 19.1%; P = 0.26) or individual components all-cause death (PCI: 19.5% vs CABG: 12.9%; P = 0.065), stroke (PCI: 3.0% vs CABG: 4.7%; P = 0.34) or MI (PCI: 9.0% vs CABG: 5.4%; P = 0.20). In non-diabetic patients, rates with PCI were also higher for MACCE (PCI: 34.1% vs CABG: 26.3%; P = 0.002) and repeat revascularization (PCI: 22.8% vs CABG: 13.4%; P < 0.001), but not for the composite end-point of all-cause death/stroke/MI (PCI: 19.8% vs CABG: 15.9%; P = 0.069). There were no differences in all-cause death (PCI: 12.0% vs CABG: 10.9%; P = 0.48) or stroke (PCI: 2.2% vs CABG: 3.5%; P = 0.15), but rates of MI (PCI: 9.9% vs CABG: 3.4%; P < 0.001) were significantly increased in the PCI arm in non-diabetic patients. In both diabetic and non-diabetic patients, PCI resulted in higher rates of MACCE and repeat revascularization at 5 years. Although PCI is a potential treatment option in patients with less-complex lesions, CABG should be the

Long-term functional and echocardiographic assessment after penetrating cardiac injury: 5-year follow-up results.

PubMed

Carr, John Alfred; Buterakos, Roxanne; Bowling, William M; Janson, Lisa; Kralovich, Kurt A; Copeland, Craig; Link, Renee; Roiter, Cecilia; Casey, Gregory; Wagner, James W

2011-03-01

There is almost no data describing the long-term functional outcome of patients after penetrating cardiac injury. A retrospective study at a Level I trauma center from 2000 to 2009. Sixty-three patients had penetrating cardiac injuries from 28 stabbings and 35 gunshots. Men comprised 89% (56) of the patients. Overall, there were 21 survivors (33%) and 42 died in the emergency room or perioperative period. The mean age did not significantly differ between survivors (36 years ± 12 years) compared with those who died (30 years ± 11 years; p=0.07). There was an increased chance of survival after being stabbed compared with being shot (17 patients vs. 4 patients; odds ratio=12; p=0.002). Thirteen (62%) had injuries to the right ventricle only. Three patients died during follow-up: one from lung cancer and two other patients died from myocardial infarctions, one 9 years later at the age of 45 years and the other 8 years later at the age of 55 years. The survivors had functional follow-up evaluations from 2 months to 114 months (median, 71; interquartile range, 34-92 months) and echocardiographic follow-up from 2 months to 107 months (median, 64; interquartile range, 31-84 months) after their injuries. Functionally, all patients were in NYHA class 1 status, except one patient in class II who was 54 years old and had a mild exertional limitation. The previously injured area could only be identified by echocardiogram in one patient who had a patch repair of a ventricular septal defect (VSD). The mean ejection fraction improved over time from a mean of 51% ± 8% in the immediate postoperative period to 60% ± 9% after a mean follow-up of 59 months (p=0.01). After surgery, 43% of patients had a mild to moderate pericardial effusion; however, the long-term follow-up studies showed that all these had resolved. Wall motion abnormalities occurred in 33% of patients in the immediate postoperative period and, again, all these resolved during long-term follow-up. Patients who

Prognosis of patients with dementia: results from a prospective nationwide registry linkage study in the Netherlands

PubMed Central

van de Vorst, Irene E; Vaartjes, Ilonca; Geerlings, Mirjam I; Bots, Michael L; Koek, Huiberdina L

2015-01-01

Objective To report mortality risks of dementia based on national hospital registry data, and to put these risks into perspective by comparing them with those in the general population and following cardiovascular diseases. Design Prospective cohort study from 1 January 2000 through 31 December 2010. Setting Hospital-based cohort. Participants A nationwide hospital-based cohort of 59 201 patients with clinical diagnosis of dementia (admitted to a hospital or visiting a day clinic) was constructed (38.7% men, 81.4 years (SD 7.0)). Main outcomes and measures 1-year and 5-year age-specific and sex-specific mortality risks were reported for patients with dementia visiting a day clinic compared with the general population; for patients hospitalised with dementia compared with patients hospitalised for acute myocardial infarction (AMI), heart failure or stroke, these were presented as absolute and relative risks (RRs). Results 1-year mortality was 38.3% in men and 30.5% in women. 5-year risk was 65.4% and 58.5%, respectively. Mortality risks were significantly higher in patients with dementia admitted to the hospital than in those visiting a day clinic (1-year RR 3.29, 95% CI 3.16 to 3.42; and 5-year RR 1.79, 95% CI 1.76 to 1.83). Compared with the general population, mortality risks were significantly higher among patients visiting a day clinic (1-year RR for women 2.99, 95% CI 2.84 to 3.14; and for men 3.94, 95% CI 3.74 to 4.16). 5-year RRs were somewhat lower, but still significant. Results were more pronounced at younger ages. Mortality risks among admitted patients were comparable or even exceeded those of cardiovascular diseases (1-year RR for women with dementia vs AMI 1.24, 95% CI 1.19 to 1.29; vs heart failure 1.05, 95% CI 1.02 to 1.08; vs stroke 1.07, 95% CI 1.04 to 1.10). 5-year RRs were comparable. For men, RRs were slightly higher. Conclusions Dementia has a poor prognosis as compared with other diseases and the general population. The risks among

Percutaneous Transhepatic Removal of Bile Duct Stones: Results of 261 Patients

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

Ozcan, Nevzat, E-mail: nevzatcan@yahoo.com; Kahriman, Guven, E-mail: guvenkahriman@hotmail.com; Mavili, Ertugrul, E-mail: ertmavili@yahoo.com

2012-08-15

Purpose: To determine the effectiveness of percutaneous transhepatic removal of bile duct stones when the procedure of endoscopic therapy fails for reasons of anatomical anomalies or is rejected by the patient. Methods: Between April 2001 and May 2010, 261 patients (138 male patients and 123 female patients; age range, 14-92 years; mean age, 64.6 years) with bile duct stones (common bile duct [CBD] stones = 248 patients and hepatolithiasis = 13 patients) were included in the study. Percutaneous transhepatic cholangiography was performed, and stones were identified. Percutaneous transhepatic balloon dilation of the papilla of Vater was performed. Then stones weremore » pushed out into the duodenum with a Fogarty balloon catheter. If the stone diameter was larger than 15 mm, then basket lithotripsy was performed before balloon dilation. Results: Overall success rate was 95.7%. The procedure was successful in 97.5% of patients with CBD stones and in 61.5% of patients with hepatolithiasis. A total of 18 major complications (6.8%), including cholangitis (n = 7), subcapsular biloma (n = 4), subcapsular hematoma (n = 1), subcapsular abscess (n = 1), bile peritonitis (n = 1), duodenal perforation (n = 1), CBD perforation (n = 1), gastroduodenal artery pseudoaneurysm (n = 1), and right hepatic artery transection (n = 1), were observed after the procedure. There was no mortality. Conclusion: Our experience suggests that percutaneous transhepatic stone expulsion into the duodenum through the papilla is an effective and safe approach in the nonoperative management of the bile duct stones. It is a feasible alternative to surgery when endoscopic extraction fails or is rejected by the patient.« less

Surgical and conservative treatment of patients with congenital scoliosis: α search for long-term results

PubMed Central

2011-01-01

Background In view of the limited data available on the conservative treatment of patients with congenital scoliosis (CS), early surgery is suggested in mild cases with formation failures. Patients with segmentation failures will not benefit from conservative treatment. The purpose of this review is to identify the mid- or long-term results of spinal fusion surgery in patients with congenital scoliosis. Methods Retrospective and prospective studies were included, reporting on the outcome of surgery in patients with congenital scoliosis. Studies concerning a small numbers of cases treated conservatively were included too. We analyzed mid-term (5 to 7 years) and long-term results (7 years or more), both as regards the maintenance of the correction of scoliosis and the safety of instrumentation, the early and late complications of surgery and their effect on quality of life. Results A small number of studies of surgically treated patients were found, contained follow-up periods of 4-6 years that in the most cases, skeletal maturity was not yet reached, and few with follow-up of 36-44 years. The results of bracing in children with congenital scoliosis, mainly in cases with failure of formation, were also studied. Discussion Spinal surgery in patients with congenital scoliosis is regarded in short as a safe procedure and should be performed. On the other hand, early and late complications are also described, concerning not only intraoperative and immediate postoperative problems, but also the safety and efficacy of the spinal instrumentation and the possibility of developing neurological disorders and the long-term effect these may have on both lung function and the quality of life of children. Conclusions Few cases indicate the long-term results of surgical techniques, in the natural progression of scoliosis. Similarly, few cases have been reported on the influence of conservative treatment. In conclusion, patients with segmentation failures should be treated

Streptococcus Endophthalmitis Outbreak after Intravitreal Injection of Bevacizumab: One-year Outcomes and Investigative Results

PubMed Central

Goldberg, Roger A.; Flynn, Harry W.; Miller, Darlene; Gonzalez, Serafin; Isom, Ryan F.

2013-01-01

Purpose To report the one-year clinical outcomes of an outbreak of Streptococcus endophthalmitis after intravitreal injection of bevacizumab, including visual acuity outcomes, microbiological testing and compound pharmacy investigations by the Food and Drug Administration (FDA). Design Retrospective consecutive case series. Participants 12 eyes of 12 patients who developed endophthalmitis after receiving intravitreal bevacizumab prepared by a single compounding pharmacy. Methods Medical records of patients were reviewed; phenotypic and DNA analyses were performed on microbes cultured from patients and from unused syringes. An inspection report by the FDA based on site-visits to the pharmacy that prepared the bevacizumab syringes was summarized. Main Outcome Measures Visual acuity, interventions received, time-to-intervention; microbiological consistency; FDA inspection findings. Results Between July 5 and July 8, 2011, 12 patients developed endophthalmitis after intravitreal bevacizumab from syringes prepared by a single compounding pharmacy. All patients received initial vitreous tap and injection, and eight (67%) subsequently underwent pars plana vitrectomy (PPV). After twelve months follow-up, outcomes have been poor: 7 patients (58%) required evisceration or enucleation, and only one patient regained pre-injection visual acuity. Molecular testing using real time polymerase chain reaction, partial sequencing of the groEL gene, and multilocus sequencing of 7 housekeeping genes confirmed the presence of a common strain of Streptococcus mitis/oralis in vitreous specimens and seven unused syringes prepared by the compounding pharmacy at the same time. An FDA investigation of the compounding pharmacy noted deviations from standard sterile technique, inconsistent documentation, and inadequate testing of equipment required for safe preparation of medications. Conclusions In this outbreak of endophthalmitis, outcomes have been generally poor and PPV did not improve

Patient-Reported Outcomes, Quality of Life, and Satisfaction Rates in Young Patients Aged 50 Years or Younger After Total Knee Arthroplasty.

PubMed

Goh, Graham Seow-Hng; Liow, Ming Han Lincoln; Bin Abd Razak, Hamid Rahmatullah; Tay, Darren Keng-Jin; Lo, Ngai-Nung; Yeo, Seng-Jin

2017-02-01

Recent studies have shown a discrepancy between traditional functional outcomes and patient satisfaction, with some reporting less than 85% satisfaction in older patients undergoing total knee arthroplasty (TKA). As native knee biomechanics are not completely replicated, the resulting functional limitations may cause dissatisfaction in higher-demand individuals. Few studies have recorded patient-reported outcomes, health-related quality of life scores, and patient satisfaction in a young population undergoing TKA. One hundred thirty-six primary TKAs were performed in 114 patients aged 50 years or younger (mean age, 47.0 years; range, 30-50 years) at a single institution. The main diagnoses were osteoarthritis (85%) and rheumatoid arthritis (10%). The range of motion, Knee Society Score, Oxford Knee Score, and Physical and Mental Component Scores of Short Form-36 increased significantly (P < .001). At 2 years, 85.3% of patients had good/excellent knee scores, 71.3% had good/excellent function scores, 94.9% met the minimal clinically important difference for the Oxford Knee Score, and 84.6% met the minimal clinically important difference for the Physical Component Score. We found that 88.8% of patients were satisfied with their surgeries, whereas 86.8% had their expectations fulfilled. Survivorship using revision as an end point was 97.8% at a mean of 7 years (range, 3-16 years). Patients aged 50 years or younger undergoing TKA can experience significant improvements in their quality of life, have their expectations met, and be satisfied with their surgeries, at rates similar to those of non-age-restricted populations. Surgeons should inform them of these benefits and the potential risk of revision surgery in the future, albeit increasingly shown to be low. Copyright © 2016 Elsevier Inc. All rights reserved.

Orbital Atherectomy for Treating De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial).

PubMed

Généreux, Philippe; Lee, Arthur C; Kim, Christopher Y; Lee, Michael; Shlofmitz, Richard; Moses, Jeffrey W; Stone, Gregg W; Chambers, Jeff W

2015-06-15

Percutaneous coronary intervention of severely calcified lesions has historically been associated with major adverse cardiac event (MACE) rates as high as 30%. In the ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial, treatment of de novo severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) resulted in low rates of procedural and 30-day adverse ischemic events. The long-term results from this trial have not been reported. We sought to determine the 1-year outcomes after orbital atherectomy of severely calcified coronary lesions. ORBIT II was a single-arm trial enrolling 443 subjects at 49 US sites with severely calcified lesions usually excluded from randomized trials. OAS utilizes a centrifugal differential sanding mechanism of action for plaque modification prior to stent implantation. After OAS drug-eluting stents were implanted in 88.2% of the patients. The primary safety end point was 30-day MACE, the composite of cardiac death, myocardial infarction, or target vessel revascularization [TVR]. The present analysis reports the 1-year follow-up results from ORBIT II. One-year data were available in 433 of 443 patients (97.7%), with median follow-up time of 16.7 months. The 1-year MACE rate was 16.4%, including cardiac death (3.0%), myocardial infarction (9.7%), and target vessel revascularization (5.9%). The 1-year target lesion revascularization rate was 4.7%, and stent thrombosis occurred in 1 patient (0.2%). Independent predictors of 1-year MACE and target vessel revascularization were diameter stenosis at baseline and the use of bare-metal stents. In patients with severely calcified lesions who underwent percutaneous coronary intervention, the use of OAS was associated with low rates of 1-year adverse ischemic events compared with historical controls. This finding has important clinical implications for the selection of optimum treatment strategies for patients

Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study.

PubMed

Marzo-Ortega, H; Sieper, J; Kivitz, A; Blanco, R; Cohen, M; Martin, R; Readie, A; Richards, H B; Porter, B

2017-07-01

Secukinumab improved the signs and symptoms of ankylosing spondylitis (AS) over 52 weeks in the phase III MEASURE 2 study. Here, we report longer-term (104 weeks) efficacy and safety results. Patients with active AS were randomized to subcutaneous secukinumab 150 mg, 75 mg, or placebo at baseline; weeks 1, 2, and 3; and every 4 weeks from week 4. The primary end point was the Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response rate at week 16. Other end points included ASAS40, high-sensitivity C-reactive protein, ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form 36 health survey physical component summary, ASAS partial remission, EuroQol 5-domain measure, and Functional Assessment of Chronic Illness Therapy fatigue subscale. End points were assessed through week 104, with multiple imputation for binary variables and a mixed-effects model repeated measures for continuous variables. Of 219 randomized patients, 60 of 72 (83.3%) and 57 of 73 (78.1%) patients completed 104 weeks of treatment with secukinumab 150 mg and 75 mg, respectively; ASAS20/ASAS40 response rates at week 104 were 71.5% and 47.5% with both secukinumab doses, respectively. Clinical improvements with secukinumab were sustained through week 104 across all secondary end points. Across the entire treatment period (mean secukinumab exposure 735.6 days), exposure-adjusted incidence rates for serious infections and infestations, Crohn's disease, malignant or unspecified tumors, and major adverse cardiac events with secukinumab were 1.2, 0.7, 0.5, and 0.7 per 100 patient-years, respectively. No cases of tuberculosis reactivation, opportunistic infections, or suicidal ideation were reported. Secukinumab provided sustained improvement through 2 years in the signs and symptoms of AS, with a safety profile consistent with previous reports. © 2017 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of

Characteristics and outcomes of patients with multiple myeloma aged 21-40 years versus 41-60 years: a multi-institutional case-control study.

PubMed

Jurczyszyn, Artur; Nahi, Hareth; Avivi, Irit; Gozzetti, Alessandro; Niesvizky, Ruben; Yadlapati, Sujitha; Jayabalan, David S; Robak, Paweł; Pika, Tomas; Andersen, Kristian T; Rasche, Leo; Mądry, Krzysztof; Woszczyk, Dariusz; Raźny, Małgorzata; Usnarska-Zubkiewicz, Lidia; Knopińska-Posłuszny, Wanda; Wojciechowska, Małgorzata; Guzicka-Kazimierczak, Renata; Joks, Monika; Grosicki, Sebastian; Ciepłuch, Hanna; Rymko, Marcin; Vesole, David H; Castillo, Jorge J

2016-12-01

We compared the outcomes of multiple myeloma (MM) patients aged 21-40 and 41-60 years in the novel agent era. This case-control study included 1089 patients between 2000 and 2015. Cases and controls were matched for sex, International Staging System (ISS) stage and institution. There were 173 patients in the younger group and 916 patients in the older group. Younger patients presented with a higher incidence of lytic lesions (82% vs. 72%; P = 0·04) and high-risk cytogenetic abnormalities (83% vs. 68%; P = 0·007), but lower rate of elevated lactate dehydrogenase (21% vs. 44%; P < 0·001). Five- and 10-year overall survival (OS) in younger versus older patients was 83% vs. 67% and 56% vs. 39%, respectively (P < 0·001). Similar results were seen when studying the subset of 780 patients who underwent autologous transplantation. Younger patients with ISS stage 1 had a better OS than older patients (P < 0·001). There was no survival difference between younger and older patients with ISS stage 2 or 3. Younger MM patients, aged 21-40 years, treated in the era of novel agents have a better OS than their counterparts aged 41-60 years, but the survival advantage observed in younger patients was lost in more advanced stages of MM. © 2016 John Wiley & Sons Ltd.

Comparison of functional gains after arthroscopic rotator cuff repair in patients over 70 years of age versus patients under 50 years of age: a prospective multicenter study.

PubMed

Moraiti, Constantina; Valle, Pablo; Maqdes, Ali; Boughebri, Omar; Dib, Chourky; Giakas, Giannis; Kany, Jean; Elkholti, Kamil; Garret, Jérôme; Katz, Denis; Leclère, Franck Marie; Valenti, Philippe

2015-02-01

To assess rotator cuff rupture characteristics and evaluate healing and the functional outcome after arthroscopic repair in patients older than 70 years versus patients younger than 50 years. We conducted a multicenter, prospective, comparative study of 40 patients younger than 50 years (group A) and 40 patients older than 70 years (group B) treated with arthroscopic rotator cuff repair. Patients older than 70 years were operated on only if symptoms persisted after 6 months of conservative treatment, whereas patients younger than 50 years were operated on regardless of any persistent symptoms. Imaging consisted of preoperative magnetic resonance imaging and postoperative ultrasound. Preoperative and postoperative function was evaluated with Constant and modified Constant scores. Patient satisfaction was also assessed. The evaluations were performed at least 1 year postoperatively. No patient was lost to follow-up. The incidence of both supraspinatus and infraspinatus tears was greater in group B. Greater retraction in the frontal plane and greater fatty infiltration were observed in group B. The Constant score was significantly improved in both groups (51 ± 12.32 preoperatively v 77.18 ± 11.02 postoperatively in group A and 48.8 ± 10.97 preoperatively v 74.6 ± 12.02 postoperatively in group B, P < .05). The improvement was similar in both groups. The modified Constant score was also significantly improved in both groups (57.48 ± 18.23 preoperatively v 81.35 ± 19.75 postoperatively in group A and 63.09 ± 14.96 preoperatively v 95.62 ± 17.61 postoperatively in group B, P < .05). The improvement was greater for group B (P < .05). Partial rerupture of the rotator cuff occurred in 2 cases in group A and 5 cases in group B. Complete rerupture was observed in 2 patients in group B. In group A, 29 patients (72.5%) were very satisfied, 8 (20%) were satisfied, and 3 (7.5%) were less satisfied. In group B, 33 patients (82.5%) were very satisfied, 6 (15%) were

Predictors of failure after single faecal microbiota transplantation in patients with recurrent Clostridium difficile infection: results from a 3-year, single-centre cohort study.

PubMed

Ianiro, G; Valerio, L; Masucci, L; Pecere, S; Bibbò, S; Quaranta, G; Posteraro, B; Currò, D; Sanguinetti, M; Gasbarrini, A; Cammarota, G

2017-05-01

Faecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile infection (CDI). Although a single faecal infusion is usually sufficient to eradicate CDI, a considerable number of patients need multiple infusions to be cured. The aim of this study was to identify predictors of failure after single faecal infusion in patients with recurrent CDI. We included patients with recurrent CDI prospectively treated with FMT by colonoscopy. By means of univariate and multivariate analysis, variables including female gender, age, number of CDI recurrences, severity of CDI, hospitalization, inadequate bowel preparation, unrelated donor, and use of frozen faeces, were assessed to predict failure after single faecal infusion. Sixty-four patients (39 women; mean age 74 years) were included. Of them, 44 (69%) were cured by a single faecal infusion, whereas 20 (31%) needed repeat infusions. Overall, FMT cured 62 of 64 (97%) patients. In the subgroup of patients with severe CDI, only eight of 26 (30%) were cured with a single infusion. At multivariate analysis, severe CDI (OR 24.66; 95% CI 4.44-242.08; p 0.001) and inadequate bowel preparation (OR 11.53; 95% CI 1.71-115.51; p 0.019) were found to be independent predictors of failure after single faecal infusion. Severe CDI and inadequate bowel preparation appear to be independent predictors of failure after single faecal infusion in patients treated with FMT by colonoscopy for recurrent CDI. Our results may help to optimize protocols and outcomes of FMT in patients with recurrent CDI. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Clinical Outcome, Social Impact and Patient Expectation: a Purposive Sampling Pilot Evaluation of Patients in Benin Seven Years After Surgery.

PubMed

White, Michelle C; Randall, Kirsten; Avara, Esther; Mullis, Jenny; Parker, Gary; Shrime, Mark G

2018-05-01

Access to affordable and timely surgery is not equitable around the world. Five billion people lack access, and while non-governmental organizations (NGOs) help to meet this need, long-term surgical outcomes, social impact or patient experience is rarely reported. In 2016, Mercy Ships, a surgical NGO, undertook an evaluation of patients who had received surgery seven years earlier with Mercy Ships in 2009 in Benin. Using purposive sampling, patients who had received maxillofacial, plastics or orthopedic surgery were invited to attend a surgical evaluation day. In this pilot study, we used semi-structured interviews and questionnaire responses to assess patient expectation, surgical and social outcome. Our results show that seven years after surgery 35% of patients report surgery-related pain and 18% had sought further care for a clinical complication of their condition. However, 73% of patients report gaining social benefit from surgery, and overall patient satisfaction was 89%, despite 35% of patients saying that they were unclear what to expect after surgery indicating a mismatch of doctor/patient expectations and failure of the consent process. In conclusion, our pilot study shows that NGO surgery in Benin provided positive social impact associated with complication rates comparable to high-income countries when assessed seven years later. Key areas for further study in LMICs are: evaluation and treatment of chronic pain, consent and access to further care.

One-Year Outcomes following Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in Japanese Patients: The APOLLO Study.

PubMed

Oshima, Yuji; Kimoto, Kenichi; Yoshida, Noriko; Fujisawa, Kimihiko; Sonoda, Shozo; Kubota, Toshiaki; Murata, Toshinori; Sakamoto, Taiji; Yoshida, Shigeo; Sonoda, Koh-Hei; Ishibashi, Tatsuro

2017-01-01

To evaluate 1-year outcomes of intravitreal injections of aflibercept (IVA) in Japanese polypoidal choroidal vasculopathy (PCV) patients. In this prospective, open-label, single-arm multicenter clinical trial, treatment-naïve PCV patients received IVA (2.0 mg) every 2 months, after 3 initial monthly doses. The primary endpoint assessed was the proportion of patients maintaining baseline best-corrected visual acuity (BCVA) at 1 year. Fifty eyes with PCV were included in the study. BCVA was maintained or improved in 97.6% of the patients. Mean logMAR BCVA at baseline was 0.33, and had improved to 0.12 logMAR 1 year after the initiation of aflibercept treatment (p < 0.001). Mean central foveal thickness decreased from 356 to 239 μm (p < 0.001). Complete regression of polypoidal lesions was seen in 72.5% after 1 year of treatment. One year of IVA resulted in stabilization of BCVA and anatomical improvement in Japanese PCV patients. © 2017 S. Karger AG, Basel.

[Long term result of arytenoidectomy with CO₂ laser for dyspnoea in iatrogenic bilateral vocal fold paralysis patients].

PubMed

Cheng, Q H; Ge, P J; Sheng, X L; Jiang, J; Zhang, S Y; Chen, S H

2016-03-20

Objective: To investigate the optimal time of tracheotomy/arytenoidectomy and the improvement of dyspnoea, dysphonia and dysphagia after arytenoidectomy with CO₂ laser in iatrogenic bilateral vocal folds paralysis patients. Method: Thirty patients [29 females, 56 (49-60) years, one male, 49 years] with bilateral vocal cords paralysis resulted from neck surgery were retrospectively analyzed by case archived information and following-up questionnaire. The data included patients' dysponea time, degree and duration from tracheotomy/arytenoidectomy to neck surgery. Twenty sixty patients required unilateral partial/total arytenoidectomy. The results of treatment were evaluated by questionnaire including dyspnoea, dysphonia and dysphagia. Result: All patients whose bilateral vocal paralysis were resulted from thyroid gland surgery. Dysponea occurred immediately after thyroidectomy surgery in 14 cases (46.7%), and 2 years later after thyroidectomy in 13 cases (43.3%), 8 years later in 3 cases (10.0%). There was one (3.3%) patient without tracheotomy. The duration of tracheotomy/arytenoidectomy to neck surgery was significantly correlated with duration of tracheotomy/arytenoidectomy to dyspnoea appearance ( r =0.879, P <0.05), not correlated with duration of thyroid surgery to dyspnoea appearance. There is significantly negative correlation between degree of dyspnoea and duration of tracheotomy/arytenoidectomy to neck surgery ( r =0.452, P <0.05). Twenty six patients appeared dyspnoea and underwent CO₂ laser arytenoidectomy after thyoidectomy 0.5-23 years. Five patients did unilateral total arytenoidectomy and 21 patients did unilateral partial arytenoidectomy. After 12-96 months following up, dyspnoea improved in 24 patients, no improved in 2 patients. Dysphonia improved and remained in 17 patients, being worse mildly in 8 patients and obviously in one patient. Dysphagia improved and remained in 24 patients, being worse in 2 patients. There was no difference between

Optic neuritis in paediatric patients: Experience over 27 years and a management protocol.

PubMed

Monge Galindo, L; Martínez de Morentín, A L; Pueyo Royo, V; García Iñiguez, J P; Sánchez Marco, S; López-Pisón, J; Peña-Segura, J L

2018-03-08

In this article, we present our experience on optic neuritis (ON) and provide a diagnostic/therapeutic protocol, intended to rule out other aetiologies (particularly infection), and a fact sheet for parents. We conducted a descriptive, retrospective study of patients with ON over a 27-year period (1990-2017). A review of the available scientific evidence was performed in order to draft the protocol and fact sheet. Our neuropaediatrics department has assessed 20,744 patients in the last 27 years, of whom 14 were diagnosed with ON: 8 had isolated ON, 1 had multiple sclerosis (MS), 1 had clinically isolated syndrome (CIS), 3 had acute disseminated encephalomyelitis, and 1 had isolated ON and a history of acute disseminated encephalomyelitis one year previously. Patients' age range was 4-13 years; 50% were boys. Eight patients were aged over 10: 7 had isolated ON and 1 had MS. Nine patients had bilateral ON, and 3 had retrobulbar ON. MRI results were normal in 7 patients and showed involvement of the optic nerve only in 2 patients and optic nerve involvement + central nervous system demyelination in 5. Thirteen patients received corticosteroids. One patient had been vaccinated against meningococcus-C the previous month. Progression was favourable, except in the patient with MS. A management protocol and fact sheet are provided. ON usually has a favourable clinical course. In children aged older than 10 years with risk factors for MS or optic neuromyelitis (hyperintensity on brain MRI, oligoclonal bands, anti-NMO antibody positivity, ON recurrence), the initiation of immunomodulatory treatment should be agreed with the neurology department. The protocol is useful for diagnostic decision-making, follow-up, and treatment of this rare disease with potentially major repercussions. The use of protocols and fact sheets is important. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Ranibizumab for choroidal neovascularization secondary to pseudoxanthoma elasticum: 4-year results from the PIXEL study in France.

PubMed

Mimoun, Gérard; Ebran, Jean-Marc; Grenet, Typhaine; Donati, Alain; Cohen, Salomon-Yves; Ponthieux, Anne

2017-08-01

To evaluate the long-term effectiveness and safety of ranibizumab 0.5 mg in patients with choroidal neovascularization (CNV) secondary to pseudoxanthoma elasticum (PXE) in a real-world setting. A descriptive, observational, multicenter study in a retrospective and prospective cohort was conducted in France that included patients who had received at least one injection of ranibizumab 0.5 mg during the period October 2011 to October 2014, for CNV secondary to PXE. Eligible patients were identified by review of medical records or during routine consultations. The main objectives were to describe patient characteristics, assess changes in best-corrected visual acuity [VA, Early Treatment Diabetic Retinopathy Study (ETDRS) letters] over time, the number and reasons for ranibizumab treatment and overall safety. Of the 72 enrolled patients (98 eyes) from 23 centers, 39 (54.2%) were male and mean [±standard deviation (SD)] age was 59.6 (±8.3) years. The mean VA was 64.6 letters at the first ranibizumab injection, which was maintained at the 1-year follow-up (64.7 letters). Thereafter, the mean VA was stable until the 4-year follow-up. At 4 years, the proportion of eyes with VA gain of ≥15 letters was 3/19 (15.8%) and stable VA (change between -15 and +15 letters) was 10/19 (52.6%). Mean (±SD) annual number of ranibizumab injections was 4.1 (±4.0), lower in the second versus first year. The most common reason for ranibizumab treatment was progression of neovascular activity (42.9%). No deaths or new safety findings were reported. In patients with CNV secondary to PXE, ranibizumab 0.5 mg resulted in stable VA over 4 years with a limited number of injections. Safety findings were consistent with the established safety profile of ranibizumab.

Six-year follow-up of the treatment of patients with dissociative disorders study.

PubMed

Myrick, Amie C; Webermann, Aliya R; Loewenstein, Richard J; Lanius, Ruth; Putnam, Frank W; Brand, Bethany L

2017-01-01

Objective : Literature on the treatment of dissociative disorders (DDs) suggests that these individuals require long-term and specialized treatment to achieve stabilization and functionality. There is considerable empirical support for specialized phasic, dissociation-focused treatment in reducing a myriad of psychological symptoms and self-harm in this population. However, until recently, there has been a paucity of longitudinal treatment research on DD patients. Method : In the present six-year follow-up study, 61 therapists who participated in the initial phase of the Treatment of Patients with Dissociative Disorders (TOP DD) study answered questionnaires about their study patient's stressors, quality of life, global functioning, victimization, and safety. These results provided a view of patients' progress six years since the beginning of the TOP DD study. Results : Longitudinal analyses demonstrated patients had significantly fewer stressors ( Χ 2 (6) = 18.76, p  < .01, canonical r  = .48, N  = 76), instances of sexual revictimization ( X 2 (1) = 107.05, p  < .001) and psychiatric hospitalizations ( t (54) = 2.57, p  < .05, Cohen's d  = .43), as well as higher global functioning ( Χ 2 (2) = 59.27, p  < .001, canonical r  = .65, N  = 111). Conclusions : These findings continue to support the initial results of the TOP DD study that, despite marked initial difficulties and functional impairment, DD patients benefit from specialized treatment.

Comparison of Outcomes of Acute Coronary Syndrome in Patients ≥80 Years Versus Those <80 Years in Israel from 2000 to 2013.

PubMed

Shechter, Michael; Rubinstein, Roy; Goldenberg, Ilan; Matetzki, Shlomi

2017-10-15

Although patients ≥80 years old constitute the fastest-growing segment of the population and have a high prevalence of coronary artery disease, few data exist regarding the outcome of octogenarians with acute coronary syndrome (ACS). In a retrospective study based on data of 13,432 ACS patients who were enrolled in the ACS Israel Survey, we first evaluated the clinical outcome of 1,731 ACS patients ≥80 years (13%) compared with 11,701 ACS patients <80 years (87%) hospitalized during 2000 to 2013. Second, we evaluated the clinical outcome of patients ≥80 years hospitalized during the 2000 to 2006 ("early") period (n = 1,037) compared with those of the same age group of patients hospitalized during the 2008 to 2013 ("late") period (n = 694). Implementation of the ACS AHA/ACC/ESC therapeutic guidelines was lower in ACS patients ≥80 years compared with patients <80 years. Multivariate Cox regression analysis demonstrated a worse 1-year survival rate in the ACS patients ≥80 years compared with those <80 years. During the late period, patients ≥80 years were more frequently treated with guideline-recommended therapies compared with patients from the same age group who were hospitalized in the early period. Multivariate Cox regression analysis demonstrated a better 1-year survival rate of patients ≥80 years during the late period compared with the early period (hazard ratio 1.17, 95% confidence interval 1.15 to 1.61; p = 0.01). In addition, adverse outcome rates of ACS patients ≥80 years were significantly higher compared with those of patients <80 years. However, survival rates of ACS patients ≥80 years were improved over the 200 to 2013 period. Copyright © 2017 Elsevier Inc. All rights reserved.

Survival of two post systems--five-year results of a randomized clinical trial.

PubMed

Schmitter, Marc; Hamadi, Khaled; Rammelsberg, Peter

2011-01-01

To assess the survival rate of two different post systems after 5 years of service with a prospective randomized controlled trial. One hundred patients in need of a post were studied. Half of the patients received long glass fiber-reinforced posts, while the other half received long metal screw posts. The posts were assigned randomly. After at least 5 years (mean, 61.37 months), follow-ups were established. When a complication occurred prior to this recall, the type and time of the complication was documented. Statistical analysis was performed using the log-rank test and Kaplan-Meier analysis. Additionally, a Cox regression was performed to analyze risk factors. The survival rate of fiber-reinforced posts was 71.8%. In the metal screw post group, the survival rate was significantly lower, 50.0% (log-rank test, P = .026). Metal posts resulted more often in more unfavorable complications (eg, root fractures); consequently, more teeth (n = 17) had to be extracted. The Cox regression identified the following risk factors: position of the tooth (anterior vs posterior teeth), degree of coronal tooth destruction, and the post system (fiber-reinforced post vs metal screw post). Fiber-reinforced restorations loosened in several patients; in some of these cases (n = 6), patients did not notice this, leading to the extraction of teeth. Long metal screw posts should be used with great care in endodontically treated teeth. Besides the selection of the post system, other factors influence the survival of the restoration.

A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study.

PubMed

Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Hain, Bernhard; Mack, Isabelle; Schellberg, Dieter; Müller-Stich, Beat Peter; Weiner, Rudolf; Meile, Tobias; Rudofsky, Gottfried; Königsrainer, Alfred; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

2015-01-01

For severely obese patients, bariatric surgery has been recommended as an effective therapy. The Bariataric Surgery and Education (BaSE) study aimed to assess the efficacy of a videoconferencing-based psychoeducational group intervention in patients after bariatric surgery. The BaSE study is a randomized, controlled multicenter clinical trial involving 117 patients undergoing bariatric surgery (mean preoperative body mass index [BMI] 49.9 kg/m(2), SD 6.4). Patients were enrolled between May 2009 and November 2012 and were randomly assigned to receive either conventional postsurgical visits or, in addition, a videoconferencing-based 1-year group program. Primary outcome measures were weight in kilograms, health-related quality of life (HRQOL), and general self-efficacy (GSE). Secondary outcome measures were depression symptoms and eating behavior. 94% of the patients completed the study. Mean weight loss for all patients was 45.9 kg (SD 16.4) 1 year after surgery (mean excess weight loss [EWL] 63%). Intention-to-treat analyses revealed no differences in weight loss, EWL, HRQOL, or self-efficacy between study groups at 1 year after surgery. However, patients with clinically significant depression symptoms (CSD) at baseline assigned to the intervention group (n = 29) had a significantly better HRQOL (P = .03), lower depression scores (P = .02), and a trend for a better EWL (.06) 1 year after surgery compared with the control group (n = 20). We could not prove the efficacy of the group program for the whole study sample. However, results indicate that the intervention is effective for the important subgroup of patients with CSD. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Results of 45 arthroscopic Bankart procedures: Does the ISIS remain a reliable prognostic assessment after 5 years?

PubMed

Boughebri, Omar; Maqdes, Ali; Moraiti, Constantina; Dib, Choukry; Leclère, Franck Marie; Valenti, Philippe

2015-05-01

The Instability Severity Index Score (ISIS) includes preoperative clinical and radiological risk factors to select patients who can benefit from an arthroscopic Bankart procedure with a low rate of recurrence. Patients who underwent an arthroscopic Bankart for anterior shoulder instability with an ISIS lower than or equal to four were assessed after a minimum of 5-year follow-up. Forty-five shoulders were assessed at a mean of 79 months (range 60-118 months). Average age was 29.4 years (range 17-58 years) at the time of surgery. Postoperative functions were assessed by the Walch and Duplay and the Rowe scores for 26 patients; an adapted telephonic interview was performed for the 19 remaining patients who could not be reassessed clinically. A failure was defined by the recurrence of an anterior dislocation or subluxation. Patients were asked whether they were finally very satisfied, satisfied or unhappy. The mean Walch and Duplay score at last follow-up was 84.3 (range 35-100). The final result for these patients was excellent in 14 patients (53.8 %), good in seven cases (26.9 %), poor in three patients (11.5 %) and bad in two patients (7.7 %). The mean Rowe score was 82.6 (range 35-100). Thirty-nine patients (86.7 %) were subjectively very satisfied or satisfied, and six (13.3 %) were unhappy. Four patients (8.9 %) had a recurrence of frank dislocation with a mean delay of 34 months (range 12-72 months). Three of them had a Hill-Sachs lesion preoperatively. Two patients had a preoperative ISIS at 4 points and two patients at 3 points. The selection based on the ISIS allows a low rate of failure after an average term of 5 years. Lowering the limit for indication to 3 points allows to avoid the association between two major risk factors for recurrence, which are valued at 2 points. The existence of a Hill-Sachs lesion is a stronger indicator for the outcome of instability repair. Level IV, Retrospective Case Series, Treatment Study.

Adolescent idiopathic scoliosis patients report increased pain at five years compared with two years after surgical treatment.

PubMed

Upasani, Vidyadhar V; Caltoum, Christine; Petcharaporn, Maty; Bastrom, Tracey P; Pawelek, Jeff B; Betz, Randal R; Clements, David H; Lenke, Lawrence G; Lowe, Thomas G; Newton, Peter O

2008-05-01

A multicenter study of changes in Scoliosis Research Society (SRS) outcome measures after surgical treatment of adolescent idiopathic scoliosis (AIS). To evaluate changes in patient determined outcome measures between 2 and 5 years after AIS surgery. Current surgical procedures have been shown to improve subjective measures in patients with AIS. At 2-year follow-up, AIS patients reported significant improvement in all 4 preoperative domains of the SRS questionnaire. In addition, the major Cobb angle was shown to be negatively correlated with preoperative scores in the pain, general self-image, and general function domains. Five-year SRS scores have not been evaluated previously. A multicenter, prospectively generated database was used to obtain perioperative, radiographic, and SRS-24 outcomes data. The inclusion criteria were: a diagnosis of AIS, surgical treatment (anterior, posterior, or combined), a comprehensive set of radiographic measures, and completed preoperative, 2-year, and 5-year SRS questionnaires. Repeated measures analysis of variance was used to compare changes in patient responses for each of the 7 outcome domains. Univariate analysis of variance was used to compare the change in pain score at 5 years to the level of the lowest instrumented vertebrae and surgical approach. A correlation analysis was used to determine the association between changes in any of the radiographic variables and changes in SRS scores. The data were checked for normality and equal variances, and the level of significance was set at P < 0.01. Forty-nine patients (42 women, 7 men; 14.2 +/- 2.1 year old; 5.4 +/- 0.6 years follow-up) met the inclusion criteria for this study. Thirty-seven of 49 (76%) of these patients underwent an open or thoracoscopic anterior procedure. SRS-24 scores improved significantly in 3 of the 4 preoperative domains at the 2-year visit. At 5 years postop, a statistically significant decrease in the pain score (4.2 +/- 0.6 to 3.9 +/- 0.9, P = 0

German new onset diabetes in the young incident cohort study: DiMelli study design and first-year results.

PubMed

Thümer, Leonore; Adler, Kerstin; Bonifacio, Ezio; Hofmann, Frank; Keller, Manfred; Milz, Christine; Munte, Axel; Ziegler, Anette-Gabriele

2010-01-01

Diabetes incidence in childhood and youth is increasing worldwide, including autoimmune and non-autoimmune cases. Recent findings suggest that there is a larger than expected proportion of type 2 diabetes in youth, and potential cases of intermediate diabetes phenotypes. Most pediatric diabetes registries focus on type 1 diabetes. Also, there is an absence of reliable data on type 2 diabetes incidence in youth. The DiMelli study aims to establish a diabetes incidence cohort registry of patients in Germany, diagnosed with diabetes mellitus before age 20 years. It will be used to characterize diabetes phenotypes by immunologic, metabolic, and genetic markers. DiMelli will assess the contribution of obesity and socio-demographic factors to the development of diabetes in childhood and youth. Recruitment of patients started in 2009, and is expected to continue at a rate of 250 patients per year. 84% of the 216 patients recruited within the first year were positive for multiple islet autoantibodies, 12% for one islet autoantibody, and 4% were islet autoantibody-negative. Patients with multiple islet autoantibodies were younger and had lower fasting C-peptide levels, compared to islet autoantibody-negative patients (median age 10.0 vs. 14.1 years, p < 0.01). Results from the first year of the study show that DiMelli will help to reveal new knowledge on the etiology of diabetes, and the contribution of genetic predisposition and environmental risk factors to the different types of diabetes.

[Ovarian tissue cryopreservation in cancer patients--six years of clinical experience].

PubMed

Huser, M; Záková, J; Crha, I; Smardová, L; Král, Z; Revel, A; Ventruba, P

2012-04-01

Presentation of clinical results and experience with this technique during past six years. Original paper. Gynekologicko-porodnická klinika LF MU a FN Brno, Interní hemato-onkologická klinika LF MU a FN Brno, Department of Obstetrics and Gynecology. Hadassah University Hospital Ein-Karem, Jerusalem, Izrael. Ovarian tissue cryopreservation (OTC) and its future auto-transplantation becomes an alternative for patients to prevent serious damage of ovarian function by oncology treatment. Patient is indicated to OTC in case of high risk of ovarian failure due to planned chemotherapy and impossibility to use other oncofertility techniques. Ovarian tissue harvesting is done by laparoscopy in short-term general anesthesia. After tissue processing the samples are cryopreserved in programmable automatic freezer or by vitrification. The auto-transplantation of ovarian tissue is planned after the complete cure of patient's malignancy. Our workplace doesn't have own experience with tissue transplantation - until now cryopreserved tissue has not yet been utilized by the patients. Clinical experience with this technique gained by our team during academic stay in abroad Israeli clinic is presented. During the years of 2005-2011 the OTC was performed in 19 cancer patients before chemotherapy. In majority of cases, patients suffered from blood or lymph node systemic malignancy (84%). Average age of women was 26 years. The patient set consisted of mostly nulliparous women (88%). Patient's average body mass index was 23,9 kg/m2. The length of systemic chemotherapy averaged 7.1 months. Time from fertility preservation counseling to chemotherapy was not exceeding one week (7.2 days on average). Ovarian tissue harvesting was conducted by laparoscopic surgery in all cases. The length of surgery did not exceed 60 minutes and no surgical complications were observed. The case of ovarian tissue transplantation performed on abroad university settings is discussed. In the consensus of with

Long-Term (7 Years) Follow-Up of Roux-en-Y Gastric Bypass on Obese Adolescent Patients (<18 Years).

PubMed

Vilallonga, Ramon; Himpens, Jacques; van de Vrande, Simon

2016-01-01

Few data are available about obesity surgery in adolescent patients. To assess long-term outcomes after laparoscopic Roux-en-Y gastric bypass (LRYGB) in patients <18 years. University Hospital, Europe. A retrospective study of prospectively collected data of patients <18 years (childhood group; ChG) (n = 28) treated by LRYGB of which 19 were available for follow-up between 2.4 and 10.2 years (mean 7.2 years). This group of patients was matched with an adult control group (AdG) of randomly chosen patients with similar characteristics who underwent LRYGB during the same period. The extensive survey included a telephonic questionnaire. 19 (12 females) of the 28 patients (67.9%) were available for follow-up. Preoperatively, 3 had type 2 diabetes mellitus (T2DM), 1 arterial hypertension, 5 dyslipidemia and 1 sleep apnea. In the ChG, average BMI after 7 years dropped from 38.9 kg/m2 preoperatively to 27.5 kg/m2. In the AdG, average BMI decreased from 39.4 to 27.1 kg/m2 in the same time period (nonsignificant between groups). One patient in the ChG needed a reoperation (internal hernia) versus 3 patients in the AdG (1 leak, 2 obstructions). All patients resolved their initial comorbidities. Two of 12 female patients in the ChG became pregnant 6 and 8 years after surgery, respectively, despite seemingly adequate oral contraception. Compliance with postoperative guidelines was good in 16/19 patients in ChG and in 14/18 patients in the AdG. Overall degree of satisfaction was high: 8.2/10 (SD 1.2, range 6-10) in the ChG and 8.9/10 (SD 1.7, range 5-10) in the AdG. LRYGB seems to be safe, provide good weight loss, and cure comorbidities in an adolescent population. Satisfaction degree is high. Inadvertent pregnancy despite conventional contraception is a possible issue. © 2016 S. Karger GmbH, Freiburg.

A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: Results at the 2-year follow-up.

PubMed

Chang, Jin Woo; Park, Chang Kyu; Lipsman, Nir; Schwartz, Michael L; Ghanouni, Pejman; Henderson, Jaimie M; Gwinn, Ryder; Witt, Jennifer; Tierney, Travis S; Cosgrove, G Rees; Shah, Binit B; Abe, Keiichi; Taira, Takaomi; Lozano, Andres M; Eisenberg, Howard M; Fishman, Paul S; Elias, W Jeffrey

2018-01-01

Magnetic resonance guided focused ultrasound (MRgFUS) has recently been investigated as a new treatment modality for essential tremor (ET), but the durability of the procedure has not yet been evaluated. This study reports results at a 2- year follow-up after MRgFUS thalamotomy for ET. A total of 76 patients with moderate-to-severe ET, who had not responded to at least two trials of medical therapy, were enrolled in the original randomized study of unilateral thalamotomy and evaluated using the clinical rating scale for tremor. Sixty-seven of the patients continued in the open-label extension phase of the study with monitoring for 2 years. Nine patients were excluded by 2 years, for example, because of alternative therapy such as deep brain stimulation (n = 3) or inadequate thermal lesioning (n = 1). However, all patients in each follow-up period were analyzed. Mean hand tremor score at baseline (19.8 ± 4.9; 76 patients) improved by 55% at 6 months (8.6 ± 4.5; 75 patients). The improvement in tremor score from baseline was durable at 1 year (53%; 8.9 ± 4.8; 70 patients) and at 2 years (56%; 8.8 ± 5.0; 67 patients). Similarly, the disability score at baseline (16.4 ± 4.5; 76 patients) improved by 64% at 6 months (5.4 ± 4.7; 75 patients). This improvement was also sustained at 1 year (5.4 ± 5.3; 70 patients) and at 2 years (6.5 ± 5.0; 67 patients). Paresthesias and gait disturbances were the most common adverse effects at 1 year-each observed in 10 patients with an additional 5 patients experiencing neurological adverse effects. None of the adverse events worsened over the period of follow-up, and 2 of these resolved. There were no new delayed complications at 2 years. Tremor suppression after MRgFUS thalamotomy for ET is stably maintained at 2 years. Latent or delayed complications do not develop after treatment. Ann Neurol 2018;83:107-114. © 2017 American Neurological Association.

Patient-reported symptoms and changes up to 1 year after meniscal surgery.

PubMed

Skou, Søren T; Pihl, Kenneth; Nissen, Nis; Jørgensen, Uffe; Thorlund, Jonas Bloch

2018-06-01

Background and purpose - Detailed information on the symptoms and limitations that patients with meniscal tears experience is lacking. This study was undertaken to map the most prevalent self-reported symptoms and functional limitations among patients undergoing arthroscopic meniscal surgery and investigate which symptoms and limitations had improved most at 1 year after surgery. Patients and methods - Patients aged 18-76 years from the Knee Arthroscopy Cohort Southern Denmark (KACS) undergoing arthroscopic meniscal surgery were included in this analysis of individual subscale items from the Knee Injury and Osteoarthritis Outcome Score and 1 question on knee stability. Severity of each item was scored as none, mild, moderate, severe, or extreme. Improvements were evaluated using Wilcoxon's signed-rank test and effect size (ES). Results - The most common symptoms were knee grinding and clicking, knee pain in general, pain when twisting and bending the knee and climbing stairs (88-98%), while the most common functional limitations were difficulty bending to the floor, squatting, twisting, kneeling, and knee awareness (97-99%). Knee pain in general and knee awareness improved most 1 year after meniscal surgery (ES -0.47 and -0.45; p < 0.001), while knee instability and general knee difficulties improved least (ES 0.10 and -0.08; p < 0.006). Interpretation - Adults undergoing surgery for a meniscal tear commonly report clinical symptoms and functional limitations related to their daily activities. Moderate improvements were observed in some symptoms and functional limitations and small to no improvement in others at 1 year after surgery. These findings can assist the clinical discussion of symptoms, treatments, and patients' expectations.

High-Dose-Rate Brachytherapy as Monotherapy for Intermediate- and High-Risk Prostate Cancer: Clinical Results for a Median 8-Year Follow-Up

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

Yoshioka, Yasuo, E-mail: yoshioka@radonc.med.osaka-u.ac.jp; Suzuki, Osamu; Isohashi, Fumiaki

2016-03-15

Purpose: To present mature results of high-dose-rate brachytherapy (HDR-BT) as monotherapy for intermediate- and high-risk prostate cancer. Methods and Materials: From 1995 through 2012, 190 patients, 79 with intermediate-risk and 111 with high-risk prostate cancer, were treated with HDR-BT alone using 48 Gy/8 fractions, 54 Gy/9 fractions, or 45.5 Gy/7 fractions over 4 to 5 days. Neoadjuvant with or without adjuvant androgen deprivation therapy was administered to 139 patients, 35 intermediate- and 104 high-risk. Results: Median follow-up time was 92 months (range, 10-227 months), with a minimum of 2 years for surviving patients. Respective rates of cause-specific survival, overall survival, metastasis-free survival, and biochemical no evidence ofmore » disease for the intermediate-risk patients were 100%, 100%, 96%, and 93% at 5 years, and 100%, 96%, 91%, and 91% at 8 years. Corresponding rates for the high-risk patients were 97%, 93%, 84%, and 81% at 5 years, and 93%, 81%, 74%, and 77% at 8 years. The cumulative incidence of late grade 2 to 3 genitourinary toxicity was 5% at 5 years and 10% at 8 years, and that of late grade 3 was 0 at 5 years and 1% at 8 years. The cumulative incidence of late grade 2-3 gastrointestinal toxicity was 4% at 5 years and 6% at 8 years, and that of late grade 3 was 0 at 5 years and 2% at 8 years. No grade 4 or 5 toxicity was detected. Conclusions: Our single-institution study with a median 8-year follow-up showed that HDR-BT as monotherapy was safe and effective for patients with intermediate- and high-risk prostate cancer.« less

Long-term patient-reported outcome after fractures of the clavicle in patients aged 10 to 18 years.

PubMed

Randsborg, Per-Henrik; Fuglesang, Hendrik F S; Røtterud, Jan H; Hammer, Ola-Lars; Sivertsen, Einar A

2014-06-01

Fractures of the clavicle are common among adolescents and have traditionally been treated nonoperatively. Recent literature has demonstrated less satisfactory results than expected after conservative management of displaced fractures in adults. The purpose of this study was to evaluate the long-term patient-reported outcome after clavicle fractures in older children and adolescents. Children aged 10 to 18 years who sustained a fracture of the clavicle between 2006 and 2008 were identified in our institution's computerized files. The radiographs were examined and the fracture patterns, degree of dislocation, and shortening were measured. Medical records were reviewed and the patient-reported outcome was assessed using the Oxford Shoulder score and the Quick version of the Disability of Arm, Shoulder, and Hand questionnaire, and specific and general satisfaction scores. A total of 185 patients (median age, 14.4 y) with 172 midshaft and 13 lateral fractures were included in the study. Sixty-five (37.8%) of the midshaft fractures were displaced, and 9 of these were operated. There was one case of nonunion and one delayed union. One hundred twenty-two (70.9%) of the patients with a midshaft fracture responded to the questionnaires on an average 4.7 years after injury. Overall results were good to excellent for the majority of nonoperatively treated patients; however, shortening of the fracture had a negative effect on the Oxford Shoulder score (P=0.02), the cosmetic satisfaction score (P=0.02), and the overall satisfaction score (P=0.01). The long-term patient-reported outcome after nonoperatively treated fractures of the clavicle in adolescents is good to excellent for the majority of the patients, and nonunion is rare. However, shortening of the fracture had a small negative effect on the outcome. Conservative management should remain the mainstay of management for fractures of the clavicle in this age group. Level IV-retrospective case series.

Stage I nonsmall cell lung cancer in patients aged > or =75 years: outcomes after stereotactic radiotherapy.

PubMed

Haasbeek, Cornelis J A; Lagerwaard, Frank J; Antonisse, Marilisa E; Slotman, Ben J; Senan, Suresh

2010-01-15

The number of patients aged > or =75 years who present with a stage I nonsmall cell lung cancer (NSCLC) is increasing. Elderly patients often have significant comorbidity and may be unfit for surgery. Furthermore, surgery in the elderly is associated with increased mortality and morbidity. In this study, the authors evaluated the outcomes of stereotactic radiotherapy (SRT) in elderly patients. Since 2003, 203 tumors in 193 patients aged > or =75 years were treated using SRT (118 T1 tumors, 85 T2 tumors). The median patient age was 79 years, 80% of patients were considered medically inoperable, and 20% of patients declined surgery. The median Charlson comorbidity score was 4, and severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease Class III or greater) was present in 25% of patients. Risk-adapted SRT schemes were used with the same total dose of 60 grays in 3 fractions (33%), 5 fractions (50%), or 8 fractions (17% of patients), depending on the patient's risk for toxicity. SRT was well tolerated, and all but 1 patient completed treatment. Survival rates at 1 year and 3 years were 86% and 45%, respectively. Survival was correlated with performance score (P = .001) and pre-SRT lung function (P = .04). The actuarial local control rate at 3 years was 89%. Acute toxicity was uncommon, and late Radiation Therapy Oncology Group grade > or =3 toxicity was observed in <10% of patients. SRT achieved high local control rates with minimal toxicity in patients aged > or =75 years despite their significant medical comorbidities. These results indicated that more active diagnostic and therapeutic approaches are justified in elderly patients and that SRT should be considered and discussed as a curative treatment alternative.

8-year survivorship analysis and subjective results of 687 primary Balgrist hip sockets.

PubMed

Echtler, B; Jacob, H A; Houweling, M; Hersche, O

1999-09-01

The Balgrist hip socket consists of an outer split ring in the form of a truncated cone, made of titanium, which is expanded by a tapered HDPE insert during implantation, thus ensuring firm primary press-fit and the possibility of retightening in the postoperative remodelling phase. Between November 1987 and October 1996, 687 primary Balgrist hip sockets were implanted in 555 patients. Five hundred and thirty-seven patients were investigated. Of these patients, 71.1% never had pain in the operated hip, 88.1% had no problems putting on their shoes, 76.2% were able to walk one or more hours. Furthermore, 91.7% are very or mostly content with the postoperative result. Nineteen hip sockets had to be revised until April 1997. With a 92.1% Kaplan-Meier survivorship rate after 8 years the Balgrist hip socket ranks among the most successful noncemented acetabular components.

Patient Attitudes towards Physician Nonverbal Behaviors during Consultancy: Result from a Developing Country

PubMed Central

Khan, Fahad Hanif; Hanif, Raheela; Tabassum, Rumina

2014-01-01

Background. Nonverbal behaviors have a significant impact on patients during consultations. This study was undertaken to find out the attitudes and preferences of the patients regarding nonverbal communication during consultations with physicians, in a tertiary care hospital. Methods. A questionnaire based cross-sectional study was carried out at the Aga Khan University Hospital, Karachi, Pakistan, during the months of January to March 2012. All patients (>18 years of age) coming for consultancy in the family medicine clinics were approached; out of 133, 120 agreed to participate. The subjects were asked questions regarding physician's comforting touch and eye contact and their responses were noted. The data were analyzed using SPSS and chi-square test was used to identify corelations. Results. Overall, 120 patients were enrolled. About 58.3% were men and 41.7% were women with a mean age of 34.9 ± 10.9 years. 95.8% were Muslims and 57.6% had more than 12 years of education. Among females 74% wanted supportive touch from doctors, used to comfort the patient (45%) or to show respect (27.5%) or as healing (30%). 86.1% of the respondents believe that establishing eye contact with the patient shows that the doctor is attentive towards his/her patient. The eye contact should be brief but regular (54.1%) and prolonged staring (36.7%) makes them uncomfortable. Conclusion. Nonverbal communication helps to strengthen the doctor-patient relation as patients do appreciate positive touch and eye contact from their physicians. PMID:24977140

Bovine and PTFE vascular graft results in hemodialysis patients.

PubMed

Sert, S; Demirogullari, B; Ziya Anadol, A; Guvence, N; Dalgic, A

2000-01-01

Purpose. There are many reports of patency periods, failure rates, thrombosis and infection attacks connected with vascular grafts. In this article, the results of polytetrafluoroethylene (PTFE) and Bovine grafts were compared in a forty-four month period. Methods. 61 vascular grafts (29 PTFE, 32 bovine) were placed in 49 patients. The grafts were compared in different ways, such as survival, complication rates and placement area using life survey analysis. Results. Mean survival time was 17 mo (SE +/- 2.8) for PTFE grafts and 11 mo (SE +/- 1.1) for bovine grafts. A failure rate of 34% due only to graft complications were found in PTFE and 25% in bovine grafts. All graft complications were seen in the first year. Comparison of the cumulative survival rates of the groups were found to be insignificant during the study period and the first year ( p>0.05). Regardless of the type, there was no signif-icant difference between the grafts placed in the forearm and the grafts in the thigh (p>0.05). Conclusions. There is no survival difference between PTFE and bovine grafts. First year of the grafts is important for developing complications.

Three year naturalistic outcome study of panic disorder patients treated with paroxetine

PubMed Central

Dannon, Pinhas N; Iancu, Iulian; Cohen, Ami; Lowengrub, Katherine; Grunhaus, Leon; Kotler, Moshe

2004-01-01

Background This naturalistic open label follow-up study had three objectives: 1) To observe the course of illness in Panic Disorder patients receiving long-term versus intermediate-term paroxetine treatment 2) To compare the relapse rates and side-effect profile after long-term paroxetine treatment between patients with Panic Disorder and Panic Disorder with Agoraphobia. 3) To observe paroxetine's tolerability over a 24 month period. Methods 143 patients with panic disorder (PD), with or without agoraphobia, successfully finished a short-term (ie 12 week) trial of paroxetine treatment. All patients then continued to receive paroxetine maintenance therapy for a total of 12 months. At the end of this period, 72 of the patients chose to discontinue paroxetine pharmacotherapy and agreed to be monitored throughout a one year discontinuation follow-up phase. The remaining 71 patients continued on paroxetine for an additional 12 months and then were monitored, as in the first group, for another year while medication-free. The primary limitation of our study is that the subgroups of patients receiving 12 versus 24 months of maintenance paroxetine therapy were selected according to individual patient preference and therefore were not assigned in a randomized manner. Results Only 21 of 143 patients (14%) relapsed during the one year medication discontinuation follow-up phase. There were no significant differences in relapse rates between the patients who received intermediate-term (up to 12 months) paroxetine and those who chose the long-term course (24 month paroxetine treatment). 43 patients (30.1%) reported sexual dysfunction. The patients exhibited an average weight gain of 5.06 kg. All patients who eventually relapsed demonstrated significantly greater weight increase (7.3 kg) during the treatment phase. Conclusions The extension of paroxetine maintenance treatment from 12 to 24 months did not seem to further decrease the risk of relapse after medication discontinuation

Percutaneous Transhepatic Removal of Bile Duct Stones: Results of 261 Patients

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

Ozcan, Nevzat, E-mail: nevzatcan@yahoo.com; Kahriman, Guven, E-mail: guvenkahriman@hotmail.com; Mavili, Ertugrul, E-mail: ertmavili@yahoo.com

2012-06-15

Purpose: To determine the effectiveness of percutaneous transhepatic removal of bile duct stones when the procedure of endoscopic therapy fails for reasons of anatomical anomalies or is rejected by the patient. Methods: Between April 2001 and May 2010, 261 patients (138 male patients and 123 female patients; age range, 14-92 years; mean age, 64.6 years) with bile duct stones (common bile duct [CBD] stones = 248 patients and hepatolithiasis = 13 patients) were included in the study. First, percutaneous transhepatic cholangiography was performed and stones were identified. Percutaneous transhepatic balloon dilation of the papilla of Vater was performed. Then stonesmore » were pushed out into the duodenum with a Fogarty balloon catheter. If the stone diameter was larger than 15 mm, then basket lithotripsy was performed before balloon dilation. Results: Overall success rate was 95.7%. The procedure was successful in 97.5% of patients with CBD stones and in 61.5% of patients with hepatolithiasis. A total of 18 (6.8%) major complications, including cholangitis (n = 7), subcapsular biloma (n = 4), subcapsular hematoma (n = 1), subcapsular abscess (n = 1), bile peritonitis (n = 1), duodenal perforation (n = 1), CBD perforation (n = 1), gastroduodenal artery pseudoaneurysm (n = 1), and right hepatic artery transection (n = 1), were seen after the procedure. There was no mortality. Conclusion: Our experience suggests that percutaneous transhepatic stone expulsion into the duodenum through the papilla is an effective and safe approach in the nonoperative management of the bile duct stones. It is a feasible alternative to surgery when endoscopic extraction fails or is rejected by the patient.« less

Impaired quality of life in patients with treated acromegaly despite long-term biochemically stable disease: Results from a 5-years prospective study.

PubMed

Kyriakakis, Nikolaos; Lynch, Julie; Gilbey, Stephen G; Webb, Susan M; Murray, Robert D

2017-06-01

Patients with acromegaly demonstrate impaired quality of life (QoL), but data on long-term QoL changes in treated acromegaly are limited. This study evaluates and identifies factors that influence QoL in patients with long-term biochemical remission. The study consists of a cross-sectional arm comparing QoL between patients with treated and controlled acromegaly and healthy controls; and a longitudinal arm assessing QoL changes in patients with biochemically stable disease during 5.7±0.6 years of follow-up. A total of 58 patients and 116 matched controls were recruited for the cross-sectional arm; 28 patients completed the longitudinal arm. Three generic questionnaires (Psychological General Well-Being Schedule [PGWBS], 36-item Short-Form [SF-36], EuroQoL [EQ-5D]) and the disease-specific acromegaly QoL questionnaire (AcroQoL) were applied. Quality of life assessment was performed 11.6±8.2 years following diagnosis and treatment of acromegaly. Patients with treated acromegaly had lower QoL scores compared with controls in all questionnaires with the exception of the PGWBS "Anxiety" subscale. The AcroQoL "Appearance" subscale and the "Physical Function" subscales of the remaining questionnaires were the most underscored domains. No difference in the total and subscale scores of all questionnaires was observed between baseline and follow-up, with the exception of the SF-36 "Physical Function," where a decline was found (58.5±24.7% vs 43.1±31.1%; P=.002). However, after adjusting for covariates, no significant change in any of the QoL scores was seen. Duration of IGF-1/GH control was positively correlated with QoL scores in most questionnaires at baseline, whereas use of GH lowering therapy at the time of QoL assessment was a negative predictive factor of QoL. Patients with biochemically controlled acromegaly demonstrate impaired QoL, which persists despite long-term disease control. This primarily consists of impaired physical function and secondly of impaired

Biochemical criteria at 1 year are not robust indicators of response to ursodeoxycholic acid in early primary biliary cirrhosis: results from a 29-year cohort study

PubMed Central

Papastergiou, V; Tsochatzis, E A; Rodriquez-Peralvarez, M; Thalassinos, E; Pieri, G; Manousou, P; Germani, G; Rigamonti, C; Arvaniti, V; Karatapanis, S; Burroughs, A K

2013-01-01

Background In primary biliary cirrhosis (PBC), biochemical criteria at 1 year are considered surrogates of response to ursodeoxycholic acid (UDCA). However, due to the slow natural history of PBC, evaluation at 1 year may be suboptimal to assess the therapeutic response, particularly in early disease. Aim To determine whether evaluation of biochemical criteria at 1 year is a reliable surrogate of UDCA response in early PBC. Methods We analysed the prospectively collected data of 215 patients (untreated = 129; UDCA-treated = 86) with early PBC (normal baseline bilirubin/albumin) and a median follow-up of 8 years (range: 1–29.1). The 1-year attainment rates of the Barcelona, Paris-I, Paris-II and Toronto definitions, and their predictive relevance for a poor outcome (death, transplantation, complications of cirrhosis), were assessed either as a result of UDCA or no treatment. Independent associations with attaining each UDCA response definition were identified by multivariate analysis. Results Untreated patients displayed 1-year biochemical features compatible with ‘treatment response’ at rates (Barcelona: 36.4%, Paris-I: 66.7%, Toronto: 59.7%, Paris-II: 40.3%) similar to those obtained under UDCA. Depending on the definition, baseline ALP≤3xULN (OR: 4.80–35.90), AST≤2xULN (OR: 5.63–9.34) and early histological stage (OR: 3.67–3.87) were the stronger predictors for attaining the criteria. UDCA treatment was associated with attaining Barcelona (OR = 2.16) and Paris-II (OR = 2.84), but not Paris-I, and not Toronto definition when excluding late histological cases. Paris-I criteria were significantly predictive of long-term outcomes (HR = 2.83) in untreated patients. Conclusions In early PBC, biochemical criteria at 1 year reflect severity of the disease rather than the therapeutic response to UDCA. PMID:24117847

Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL.

PubMed

Graff, J N; Baciarello, G; Armstrong, A J; Higano, C S; Iversen, P; Flaig, T W; Forer, D; Parli, T; Phung, D; Tombal, B; Beer, T M; Sternberg, C N

2016-02-01

Prostate cancer disproportionately affects older men. Because age affects treatment decisions, it is important to understand the efficacy and tolerability of therapies for advanced prostate cancer in elderly men. This analysis describes efficacy and safety outcomes in men aged ≥75 years who received enzalutamide, an androgen receptor inhibitor, in the phase III PREVAIL trial. PREVAIL was a randomised, double-blind, multinational study of oral enzalutamide 160 mg/day (N = 872) versus placebo (N = 845) in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Overall survival (OS) and radiographic progression-free survival (rPFS) were coprimary end points. Subgroup analysis of men aged ≥75 years (elderly) and men aged <75 years was pre-specified for the coprimary end points and adverse events (AEs). Among 609 elderly patients (35%) who participated in PREVAIL, median treatment duration was 16.6 and 5.0 months in the enzalutamide and placebo arms, respectively. In the elderly subgroup, OS was greater with enzalutamide than with placebo [32.4 months (95% confidence interval (CI) 27.7-not yet reached] versus 25.1 months (95% CI 22.6-28.0); hazard ratio (HR) = 0.61 (95% CI 0.47-0.79); P = 0.0001], as was rPFS [not yet reached (95% CI 12.3-not yet reached) versus 3.7 months (95% CI 3.6-5.3); HR = 0.17 (95% CI 0.12-0.24); P < 0.0001]. Irrespective of treatment assignment, incidence of AEs was similar between the two age groups, except for an overall higher incidence of falls among elderly patients than younger patients [84/609 (13.8%) versus 62/1106 (5.6%)] and among elderly patients receiving enzalutamide than those receiving placebo [61/317 (19.2%) versus 23/292 (7.9%)]. Elderly men benefited from treatment with enzalutamide in terms of OS and rPFS. Enzalutamide was well tolerated in the elderly subgroup and those aged <75 years. Age and enzalutamide treatment were associated with a higher incidence of falls. NCT01212991, ClinicalTrials.gov. �

[BONE MINERAL DENSITY IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS--OUR RESULTS].

PubMed

Gracanin, Ana Gudelj; Marković, Ivan; Loncarević, Jelena; Golob, Majda; Morović-Vergles, Jadranka

2015-01-01

Patients with systemic lupus erythematosus (SLE) are at an increased risk of developing low bone mass (LBM) or osteoporosis, either because of the disease itself or due to its treatment. Osteoporosis and osteoporotic fractures significantly contribute to morbidity and mortality. We aimed to determine the associations of bone mineral density (BMD) changes with the duration of SLE, age, gender, and glucocorticoid treatment in SLE patients treated at our Department. BMD measurements of the lumbar spine and total hip were performed by dual-energy X-ray absorptiometry (DXA). Osteoporosis and LBM were determined according to the 1994 World Health Organization definition. In the statistical analysis, the independent Mann-Whitney U test and Tukey post-hoc testing were used. The study included 48 SLE patients (44 female and 4 male), with a mean age of 45.8 years and an average SLE duration of 9.8 years. Osteoporosis was diagnosed in 21%, and LBM in 15% of the patients. The mean ages of the subgroups with normal BMD, LBM, and osteoporosis were 41.1, 47.6, and 59.0 years, respectively. Variant analysis showed a statistically significant correlation between age and BMD (p < 0.05). The duration of SLE was significantly shorter in patients with normal BMD (7.3 years), compared to patients with LBM (16.1 years) and osteoporosis (12.9 years) (p < 0.05). Nearly all patients (47 of 48) were on long-term treatment with glucocorticoids. One third (33.3 %) of patients did not take vitamin D3, and 56.3 % did not take calcium supplements. The etiopathogenesis of decreased BMD in SLE patients is multifactorial and includes both traditional and SLE-related risk factors. In our group of SLE patients age and glucocorticoid treatment were the major risk factors for LBM. Timely prevention and treatment of LBM and osteoporosis in SLE patients, according to current knowledge, are essential for reducing morbidity and mortality.

Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation: 2-year results of the C-OPERA study, a phase III randomised trial.

PubMed

Atsumi, Tatsuya; Tanaka, Yoshiya; Yamamoto, Kazuhiko; Takeuchi, Tsutomu; Yamanaka, Hisashi; Ishiguro, Naoki; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Yasuda, Shinsuke; Yamanishi, Yuji; Kita, Yasuhiko; Matsubara, Tsukasa; Iwamoto, Masahiro; Shoji, Toshiharu; Togo, Osamu; Okada, Toshiyuki; van der Heijde, Désirée; Miyasaka, Nobuyuki; Koike, Takao

2017-08-01

To investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year methotrexate (MTX) therapy, compared with 2-year therapy with MTX alone. MTX-naïve patients with early rheumatoid arthritis (RA) with poor prognostic factors were eligible to enter Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA), a multicentre, randomised, controlled study, which consisted of a 52-week double-blind (DB) period and subsequent 52-week post treatment (PT) period. Patients were randomised to optimised MTX+CZP (n=159) or optimised MTX+placebo (PBO; n=157). Following the DB period, patients entered the PT period, receiving MTX alone (CZP+MTX→MTX; n=108, PBO+MTX→MTX; n=71). Patients who flared could receive rescue treatment with open-label CZP. 34 CZP+MTX→MTX patients and 14 PBO+MTX→MTX patients discontinued during the PT period. From week 52 through week 104, significant inhibition of total modified total Sharp score progression was observed for CZP+MTX versus PBO+MTX (week 104: 84.2% vs 67.5% (p<0.001)). Remission rates decreased after CZP discontinuation; however, higher rates were maintained through week 104 in CZP+MTX→MTX versus PBO+MTX→MTX (41.5% vs 29.3% (p=0.026), 34.6% vs 24.2% (p=0.049) and 41.5% vs 33.1% (p=0.132) at week 104 in SDAI, Boolean and DAS28(erythrocyte sedimentation rate) remission. CZP retreated patients due to flare (n=28) showed rapid clinical improvement. The incidence of overall adverse events was similar between groups. In MTX-naïve patients with early RA with poor prognostic factors, an initial 1 year of add-on CZP to 2-year optimised MTX therapy brings radiographic and clinical benefit through 2 years, even after stopping CZP. NCT01451203. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Successful early dietary intervention avoids obesity in patients with Prader-Willi syndrome: a ten-year follow-up.

PubMed

Schmidt, H; Pozza, S Bechtold-Dalla; Bonfig, W; Schwarz, H P; Dokoupil, K

2008-07-01

Hyperphagia is a frequent symptom in patients with Prader-Willi syndrome (PWS) and results in marked obesity with the risk of metabolic and cardiovascular complications. To investigate whether early diagnosis of PWS and strict dietary intervention prevents excessive weight gain in patients with PWS. A strict fat reduced and modified carbohydrate diet consisting of 10 kcal/ cm height was provided to nine patients (seven female, two male) diagnosed early with PWS (group A). Patients were prospectively followed at our center with follow-up visits every three months. Eight patients with late diagnosis of PWS served as controls (group B). Body mass index (BMI) SDS and height SDS were compared between these two groups over a ten-year period. At the age of two years height SDS and BMI SDS were significantly lower in group A (-2.9 vs -1.2, p <0.05, and BMI SDS -0.1 vs +1.8, p < 0.05). After ten years BMI SDS increased significantly to +1.2 SDS in group A, but was still significantly lower than in group B (BMI SDS +2.4), p <0.005. Patients without restrictive diet were significantly taller than patients on the diet (height SDS group A -2.8 vs group B -1.3, p < 0.05). Early dietary treatment starting at the second year of life and continued until the age of ten years is effective in avoiding excessive weight gain in patients with PWS, but results in shorter stature. Therefore growth hormone may be a useful additional treatment in these patients.

Exeresis and Brachytherapy as Salvage Treatment for Local Recurrence After Conservative Treatment for Breast Cancer: Results of a Ten-Year Pilot Study

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

Guix, Benjamin, E-mail: bguix@imor.or; Lejarcegui, Jose Antonio; Tello, Jose Ignacio

2010-11-01

Purpose: To analyze the long-term results of a pilot study assessing excision and brachytherapy as salvage treatment for local recurrence after conservative treatment of breast cancer. Methods and Materials: Between December 1990 and March 2001, 36 patients with breast-only recurrence less than 3 cm in diameter after conservative treatment for Stage I or II breast carcinoma were treated with local excision followed by high-dose rate brachytherapy implants (30 Gy in 12 fractions over a period of 5 days). No patient was lost to follow-up. Special attention was paid to local, regional, or distant recurrences; survival; cosmesis; and early and latemore » side effects. Results: All patients completed treatment. During follow-up (range, 1-13 years), 8 patients presented metastases (2 regional and 6 distant) as their first site of failure, 1 had a differed local recurrence, and 1 died of the disease. Actuarial results at 10 years were as follows: local control, 89.4%; disease-free survival, 64.4%; and survival, 96.7%. Cosmetic results were satisfactory in 90.4%. No patient had Grade 3 or 4 early or late complications. Of the 11 patients followed up for at least 10 years, all but 1 still had their breast in place at the 10-year stage. Conclusions: High-dose rate brachytherapy is a safe, effective treatment for small-size, low-risk local recurrence after local excision in conservatively treated patients. The dose of 30 Gy of high-dose rate brachytherapy (12 fractions over a period of 5 days twice daily) was well tolerated. The excellent results support the use of breast preservation as salvage treatment in selected patients with local recurrence after conservative treatment for breast cancer.« less

Results of stereotactic radiosurgery for patients with imaging defined cavernous sinus meningiomas

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

Pollock, Bruce E.; Stafford, Scott L.

2005-08-01

Introduction: The purpose of this study was to evaluate the efficacy and safety of stereotactic radiosurgery as primary management for patients with imaging defined cavernous sinus meningiomas. Methods: Between 1992 and 2001, 49 patients had radiosurgery for dural-based masses of the cavernous sinus presumed to be meningiomas. The mean patient age was 55.5 years. The mean tumor volume was 10.2 mL; the mean tumor margin dose was 15.9 Gy. The mean follow-up was 58 months (range, 16-144 months). Results: No tumor enlarged after radiosurgery. Twelve of 38 patients (26%) with preexisting diplopia or facial numbness/pain had improvement in cranial nervemore » function. Five patients (10%) had new (n = 3) or worsened (n = 2) trigeminal dysfunction; 2 of these patients (4%) underwent surgery at 20 and 25 months after radiosurgery despite no evidence of tumor progression. Neither patient improved after partial tumor resection. One patient (2%) developed an oculomotor nerve injury. One patient (2%) had an ischemic stroke related to occlusion of the cavernous segment of the internal carotid artery. Event-free survival was 98%, 85%, and 80% at 1, 3, and 7 years after radiosurgery, respectively. Univariate analysis of patient and dosimetric factors found no analyzed factor correlated with postradiosurgical morbidity. Conclusions: Radiosurgery was an effective primary management strategy for patients with an imaging defined cavernous sinus meningioma. Except in situations of symptomatic mass effect, unusual clinical presentation, or atypical imaging features, surgery to confirm the histologic diagnosis is unlikely to provide clinical benefit.« less

Screening of Psychological Distress 4.5 Years after Diagnosis in Breast Cancer Patients Compared to Healthy Population.

PubMed

Svěrák, T; Skrivanova, K; Anderkova, L; Bendová, M; Brancikova, D; Elfmarková, N; Peterkova, H; Jarkovský, J; Benesova, K; Minar, L; Dusek, L; Nedvěd, J; Protivánková, M

2016-01-01

Survival rate of breast cancer patients has improved significantly in recent years. Cancer diagnosis represents a great psychological distress for patients which may not stem solely from the disease itself. Patients may experience higher distress even several years after treatment. The study was carried out at the Department of Obstetrics and Gynecology and Department of Internal Medicine, Haematology and Oncology, Faculty Hospital Brno. Results of 85 patients at 4.5 years after diagnosis of breast cancer compared to 72 healthy controls are presented in this paper. The data were collected in the form of semi-structured interviews, from the patients medical records and by Symp-tom Check List-90. The overall rate of psychological distress (GSI) 4.5 years after breast cancer dia-gnosis does not differ significantly (p = 0.703) from the healthy population. Also, we did not find any statistically significant relationship between the observed factors and the level of psychological distress in breast cancer patients. Screening investigation showed no difference in the psychological distress in breast cancer patients 4.5 years following diagnosis, compared with the healthy population.

Persistence of impaired health status of Q fever patients 4 years after the first Dutch outbreak.

PubMed

Limonard, G J M; Peters, J B; Besselink, R; Groot, C A R; Dekhuijzen, P N R; Vercoulen, J H; Nabuurs-Franssen, M H

2016-04-01

A significant proportion of Q fever patients from the first Dutch Q fever outbreak in 2007 showed impairment in health status up to 1 year after infection. Interested in whether this decrease in health status persisted, we set out to determine the health status in the same cohort of patients, 4 years after primary infection and to compare health status scores at the individual patient level between 1 and 4 years follow-up. Health status was assessed with the Nijmegen Clinical Screening Instrument (NCSI). Patients were serologically tested to exclude patients with possible, probable or proven chronic Q fever. Results on the NCSI sub-domains at group level [2008 (n = 54) and 2011 (n = 46)] showed a persistent significant percentage of patients exhibiting clinically relevant ('severe') scores for all NCSI sub-domains. After 4 years, undue fatigue was present in 46% and exactly half of all patients experienced a severely impaired general quality of life. Patients with NCSI scores available in both 2008 and 2011 (n = 37) showed no difference in all sub-domain scores, except for a small decrease in dyspnoea emotions in 2011. In this group, a significant proportion of patients either improved or worsened in one or more sub-domains of health status. We conclude that at the group level, health status of Q fever patients remained impaired 4 years after primary infection. At the individual patient level, health status may change.

[Stigmatizing Attitudes towards Cancer Patients--Results of a Representative Population Survey].

PubMed

Ernst, Jochen; Brähler, Elmar; Hinz, Andreas; Friedrich, Michael; Lehmann-Laue, Antje; Mehnert, Anja; Weißflog, Gregor

2016-03-01

To investigate stigmatizing attitudes towards cancer patients in the general population and to examine their association with socio-structural characteristics and perceived causes of disease. We recruited a representative sample from the German general population (n=2420; mean age: 52 years; 54% women). Stigmatizing attitudes were assessed with a 9-item scale. Predictors of stigmatizing attitudes were identified using a regression analysis. Agreement with stigmatization items ranged from 3.6% (item: work together with a cancer patient) to 18.9% (item: use the same dishes as a cancer patient). Perceived causes of disease with a high levels of personal responsibility showed only weak correlations with stigmatizing attitudes (all r<0.31) and were partially statistical significant (e. g. food intake) or not significant (e. g. alcohol). The strongest predictors of stigmatizing attitudes were lack of cancer-related experiences (Beta=-0,26), age <60 years (Beta=0,1) and the assumption that one cannot protect oneself from cancer (Beta=0,11) (all p<0.001). Further predictors were male gender and living in rural area (p<0.01). The results demonstrate a need for further research and the development of valid methodological instruments to assess stigmatization towards cancer patients. © Georg Thieme Verlag KG Stuttgart · New York.

Congenital scoliosis treated with posterior vertebral column resection in patients younger than 18 years: longer than 10-year follow-up.

PubMed

Chang, Dong-Gune; Yang, Jae Hyuk; Lee, Jung-Hee; Kim, Jin-Hyok; Suh, Seung-Woo; Ha, Kee-Yong; Suk, Se-Il

2016-08-01

OBJECTIVE There have been no reports on the long-term radiographic outcomes of posterior vertebral column resection (PVCR) in patients with congenital scoliosis. The purpose of this study was to evaluate the surgical outcomes and complications after PVCR and its long-term effects on correcting this deformity in children with congenital scoliosis. METHODS The authors retrospectively analyzed the medical records of 45 patients with congenital scoliosis who were younger than 18 years at the time of surgery and who underwent PVCR and fusion with pedicle screw fixation (PSF). The mean age of the patients at the time of surgery was 11.3 years (range 2.4-18.0 years), and the mean length of follow-up was 12.8 years (range 10.1-18.2 years). RESULTS The mean Cobb angle of the main curve was 46.5° before PVCR, 13.7° immediately after PVCR, and 17.6° at the last follow-up. For the compensatory cranial curve, PVCR corrected the preoperative Cobb angle of 21.2° to 9.1° postoperatively and maintained it at 10.9° at the last follow-up. For the compensatory caudal curve, the preoperative Cobb angle of 23.8° improved to 7.7° postoperatively and was 9.8° at the last follow-up. The authors noted 22 complications, and the overall incidence of complications was 48.9%. CONCLUSIONS Posterior vertebral column resection is an effective procedure for managing congenital scoliosis in patients younger than 18 years. Use of PVCR and fusion with PSF for congenital scoliosis achieved rigid fixation and satisfactory deformity correction that was maintained over the long term. However, the authors note that PVCR is a technically demanding procedure and entails risks for major complications and excessive blood loss.

The Ross Procedure in Pediatric Patients: A 20-Year Experience of Ross Procedure in a Single Institution

PubMed Central

Yoon, Dong Woog; Yang, Ji-Hyuk; Jun, Tae-Gook; Park, Pyo Won

2017-01-01

Background The Ross/Ross-Konno procedure is considered a good option for irreparable aortic valve disease in pediatric patients because of its hemodynamic performance and potential for growth of the pulmonary autograft. This study is a review of the long-term results of our 20-year experience with the Ross and Ross-Konno operations in a single institution. Methods Between June 1995 and January 2016, 16 consecutive patients (mean age, 6.0±5.9 years; range, 16 days to 17.4 years) underwent either a Ross operation (n=9) or a Ross-Konno operation (n=7). The study included 12 males and 4 females, with a median follow-up period of 47 months (range, 6 to 256 months). Results There were no cases of in-hospital or late mortality. Six reoperations were performed in 5 patients. Four patients underwent right ventricular-pulmonary artery (RV-PA) conduit replacement. Two patients underwent concomitant replacement of the pulmonary autograft and RV-PA conduit 10 years and 8 years after the Ross operation, respectively. The rate of freedom from adverse outcomes of the pulmonary autograft was 88% and 70% at 5 and 10 years, respectively. The rate of freedom from valve-related reoperations was 79% and 63% at 5 and 10 years, respectively. Conclusion Pulmonary autografts demonstrated good durability with low mortality. The Ross/Ross-Konno procedure is a good option that can be performed safely in pediatric patients with aortic valve disease, even in a small-volume center. PMID:28795027

Long-term benefit of liposuction in patients with lipoedema: a follow-up study after an average of 4 and 8 years.

PubMed

Baumgartner, A; Hueppe, M; Schmeller, W

2016-05-01

Long-term results following liposuction in patients with lipoedema are available only for an average period of 4 years. To find out whether the improvement of complaints persists for a further 4 years. In a single-centre study, 85 patients with lipoedema had already been examined after 4 years. A mail questionnaire - often in combination with clinical controls - was repeated after another 4 years (8 years after liposuction). Compared with the results after 4 years, the improvement in spontaneous pain, sensitivity to pressure, oedema, bruising and restriction of movement persisted. The same held true for patient self-assessment of cosmetic appearance, quality of life and overall impairment. Eight years after surgery, the reduction in the amount of conservative treatment (combined decongestive therapy, compression garments) was similar to that observed 4 years earlier. These results demonstrate for the first time the long-lasting positive effects of liposuction in patients with lipoedema. © 2015 British Association of Dermatologists.

[Ocular findings in patients older than 99 years].

PubMed

Cypel, Marcela Colussi; Palácio, Guilherme; Dantas, Paulo Elias Correa; Lottenberg, Cláudio Luis; Belfort, Rubens

2006-01-01

To determine vision conditions and ocular findings in patients older than 99 years. Patients were recruited by media advertisement and examined at the Vision Institute of UNIFESP. The following examinations were performed: visual acuity, ectoscopy, refraction, biomicroscopy, tear film break-up time, Schirmer basal test, tonometry, direct and indirect ophthalmoscopy. Complementary examinations such as optical coherence tomography were performed when indicated. Thirty patients older than 99 years were identified. Mean age of 101.5+/-1.8, 25 females and 5 males. Most common systemic disease, according to history, was arterial hypertension. In 11 patients (55%), the best corrected far visual acuity was 20/100 or better. The best corrected near visual acuity was J4 or better also in 55% (11 patients) and 63.0% (7 patients) of these were the ones that had not been submitted to cataract surgery. The most frequent visual complaint was low vision for reading (55%) and other 8 patients (40%) reported no disturbance (satisfied with their vision). Lens opacity was present in 9 patients (60%) and 8 patients (40%) had previous cataract surgery (5 aphakic eyes, 9 pseudophakic eyes). Cataract was identified as important for impairment of vision in 5 patients but only 2 of them wanted to be submitted to surgery. The main cause of visual impairment was age-related macular degeneration, present in all patients, 95% with no exudative form. Vision improved with new refractive prescription in 4 patients. Once we understand the needs we can plan specific diagnostic and treatment strategies. This sample showed that most were female (83.3%), with good general health (35%), most with systemic arterial hypertension (40%), complaining of low vision for reading (55%) because of age-related macular degeneration (100%, 95% dry form). Only 40% had been previously submitted to cataract surgery. Most of the patients with cataract said to be satisfied with their vision; of the 5 patients that could

Radial Artery as a Coronary Artery Bypass Conduit: 20-Year Results.

PubMed

Gaudino, Mario; Tondi, Paolo; Benedetto, Umberto; Milazzo, Valentina; Flore, Roberto; Glieca, Franco; Ponziani, Francesca Romana; Luciani, Nicola; Girardi, Leonard N; Crea, Filippo; Massetti, Massimo

2016-08-09

There is a lack of evidence for the choice of the second conduit in coronary surgery. The radial artery (RA) is a possible option, but few data on very-long-term outcomes exist. This study describes 20-year results of RA grafts used for coronary artery bypass grafting and the effects of RA removal on forearm circulation. We report the results of the prospective 20-year follow-up of the first 100 consecutive patients who received the RA as a coronary bypass conduit at our institution. Follow-up was 100% complete. There were 64 deaths, 23 (35.9%) from cardiovascular causes. Kaplan-Meier 20-year survival was 31%. Of the 36 survivors, 33 (91.6%) underwent RA graft control at a mean of 19.0 ± 2.5 years after surgery. The RA was found to be patent in 24 cases (84.8% patency). In the overall population, probability of graft failure at 20 years was 19.0 ± 0.2% for the left internal thoracic artery (ITA), 25.0 ± 0.2% for the RA, and 55.0 ± 0.2% for the saphenous vein (p = 0.002 for RA vs. saphenous vein, 0.11 for RA vs. ITA, and p < 0.001 for ITA vs. saphenous vein). Target vessel stenosis >90%, but not location of distal anastomosis, significantly influenced long-term RA graft patency. No patients reported hand or forearm symptoms. The ulnar artery diameter was increased in the operated arm (2.44 ± 0.43 mm vs. 2.01 ± 0.47 mm; p < 0.05) and correlated with the peak systolic velocity of the second palmar digital artery (Pearson coefficient: 0.621; p < 0.05). The 20-year patency rate of RA grafts is good, and not inferior to the ITA, especially when the conduit is used to graft a vessel with >90% stenosis. RA harvesting does not lead to hand or forearm symptoms, even at a very-long-term follow-up. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

[Dialin: infection surveillance network for haemodialysis patients. First results].

PubMed

Ayzac, Louis; Béruard, Michel; Girard, Raphaële; Hannoun, Jacques; Kuentz, François; Marc, Jean-Michel; Moreau-Gaudry, Xavier; Roche, Catherine; Tressières, Benoît; Uzan, Marc

2009-02-01

To show results of the first year of an infection surveillance network for haemodialysis patients (Dialin). In order to improve the security and quality of care, six haemodialysis centers have organized an infection watching network. The purpose of the network is to compare of the watching results between centers. This comparison includes vascular access infection (VAI), bacteraemia and C viral hepatitis. The heterogeneous pattern has been also taken into account. SURVEY TYPE: Multicenter prospective permanent survey. Six hundred and sixty-four haemodialyzed chronic patients, followed during one year (2005), in six voluntary haemodialysis centers. This survey has based on 71,688 treatment sessions corresponding to 6257.5 months of haemodialysis (HM). As with the heterogeneity among centers, the acquired infection standardized ratios (observed/expected) (AISR) and 95% confidence interval are computed with Cox model which includes confounding factors found in literature or in the preliminary stage of the survey. VAI crude rate was 0.47 per 100HM, 0.10 per 1000 native fistulae utilisation days, 0.45 per 1000 days of prosthetic graft utilisation and 0.44 per 1000 days of catheter utilisation. Bacteraemia crude incidence rate was 0.69 per 100HM, 0.02 per 1000 days of native fistulae utilisation, 0.00 per 1000 days of prosthetic graft utilisation and 0.39 per 1000 days of catheter utilisation. No new case of C viral hepatitis was found. Prevalence rate at the beginning of the survey was 5.3% (35 over 664). Two centers had a significantly high AISR for VAI and two centers had a significantly low AISR for VAI. One center had a significantly high AISR for bacteraemia and one center had a significantly low AISR for bacteraemia. The first year of Dialin running demonstrates the importance of standardised surveillance method in VAI and bacteraemia surveillance but not for viral hepatitis.

Patient-reported outcomes 5 years after laser in situ keratomileusis.

PubMed

Schallhorn, Steven C; Venter, Jan A; Teenan, David; Hannan, Stephen J; Hettinger, Keith A; Pelouskova, Martina; Schallhorn, Julie M

2016-06-01

To assess vision-related, quality-of-life outcomes 5 years after laser in situ keratomileusis (LASIK) and determine factors predictive of patient satisfaction. Optical Express, Glasgow, Scotland. Retrospective case series. Data from patients who had attended a clinical examination 5 years after LASIK were analyzed. All treatments were performed using the Visx Star S4 IR excimer laser. Patient-reported satisfaction, the effect of eyesight on various activities, visual phenomena, and ocular discomfort were evaluated 5 years postoperatively. Multivariate regression analysis was performed to determine factors affecting patient satisfaction. The study comprised 2530 patients (4937 eyes) who had LASIK. The mean age at the time of surgery was 42.4 years ± 12.5 (SD), and the preoperative manifest spherical equivalent ranged from -11.0 diopters (D) to +4.88 D. Five years postoperatively, 79.3% of eyes were within ±0.50 D of emmetropia and 77.7% of eyes achieved monocular uncorrected distance visual acuity (UDVA) and 90.6% of eyes achieved binocular UDVA of 20/20 or better. Of the patients, 91.0% said they were satisfied with their vision and 94.9% did not wear distance correction. Less than 2.0% of patients noticed visual phenomena, even with spectacle correction. Major predictors of patient satisfaction 5 years postoperatively were postoperative binocular UDVA (37.6% variance explained by regression model), visual phenomena (relative contribution of 15.0%), preoperative and postoperative sphere and their interactions (11.6%), and eyesight-related difficulties with various activities such as night driving, outdoor activities, and reading (10.2%). Patient-reported quality-of-life and satisfaction rates remained high 5 years after LASIK. Uncorrected vision was the strongest predictor of satisfaction. Dr. S.C. Schallhorn is a consultant to Abbott Medical Optics, Inc., Zeiss Meditec AG, and Autofocus Inc. and a global medical director for Optical Express. No other

Characteristics and outcomes of patients with Ewing sarcoma over 40 years of age at diagnosis.

PubMed

Karski, Erin E; Matthay, Katherine K; Neuhaus, John M; Goldsby, Robert E; Dubois, Steven G

2013-02-01

The peak incidence of Ewing sarcoma (EWS) is in adolescence, with little known about patients who are ≥40 years at diagnosis. We describe the clinical characteristics and survival of this rare group. This retrospective cohort study utilized the Surveillance Epidemiology and End Results database. 2780 patients were identified; including 383 patients diagnosed ≥40 years. Patient characteristics between age groups were compared using chi-squared tests. Survival from diagnosis to death was estimated via Kaplan-Meier methods, compared with log-rank tests, and modeled using multivariable Cox methods. A competing risks analysis was performed to evaluate death due to cancer. Patients ≥40 years of age were more likely to have extra-skeletal tumors (66.1% vs. 31.7%; p < 0.001), axial tumors (64.0% vs. 57.2%; p = 0.01), and metastatic disease at diagnosis (35.5% vs. 30.0%; p = 0.04) compared to younger patients. Five-year survival for those age ≥40 and age <40 were 40.6% and 54.3%, respectively (p < 0.0001). A Cox multivariable model controlling for differences between groups confirmed inferior survival for older patients (hazard ratio for death of 2.04; 95% CI 1.63-2.54; p < 0.0001); though treatment data were unavailable and not controlled for in the model. A competing risks analysis confirmed increased risk of cancer-related death in older patients. Patients ≥40 years at diagnosis with EWS are more likely to have extra-skeletal tumors, metastatic disease, and axial primary tumors suggesting a difference in tumor biology. Independent of differences in these characteristics, older patients also have a lower survival rate. Copyright © 2012 Elsevier Ltd. All rights reserved.

Can Good Infection Control Be Obtained in One-stage Exchange of the Infected TKA to a Rotating Hinge Design? 10-year Results.

PubMed

Zahar, Akos; Kendoff, Daniel O; Klatte, Till O; Gehrke, Thorsten A

2016-01-01

Prosthetic joint infection (PJI) occurs in 1% to 2% of total knee arthroplasties (TKAs). Although two-stage exchange is the preferred management method of patients with chronic PJI in TKA in North America, one-stage exchange is an alternative treatment method, but long-term studies of this approach have not been conducted. We reviewed our minimum 9-year results of 70 patients who underwent one-stage exchange arthroplasty with a rotating hinge design to determine: (1) What was the proportion of patients free of infection? (2) What was the patient rate of survival free of any reoperation? (3) What were the clinical outcomes as measured by Hospital for Special Surgery scores? (4) What proportion of patients developed radiographic evidence of loosening? All one-stage revision TKAs for infection between January 1 and December 31, 2002, with a minimum 9-year followup (mean, 10 years; range, 9-11 years), in which patients had been seen within the last 1 year, were included in this retrospective review. During that period, 11 patients with infected TKAs were treated with other approaches (including two-stage approaches in eight); the general indication for one-stage revision was the diagnosis of PJI with a known causative organism. Exclusion criteria were culture-negative preoperative aspiration, known allergy to local antibiotics or bone cement, or cases in which radical débridement was impossible as a result of the involvement of important anatomical structures. Eighty-one patients with PJI were seen during this period; 70 underwent one-stage exchange using our strict protocol and were reimplanted with a rotating hinge TKA. Eleven patients (15.7%) were lost to followup. Hospital for Special Surgery scores were recorded and all radiographs were evaluated for prosthetic loosening. Failure was defined as revision surgery for infection or any other cause. Our 10-year infection-free survival was 93% (mean, 4.1; 95% confidence interval [CI], 89%-96%; p < 0.007); and the

Impact of Extent of Surgery on Survival for Papillary Thyroid Cancer Patients Younger Than 45 Years

PubMed Central

Abdelgadir Adam, Mohamed; Pura, John; Goffredo, Paolo; Dinan, Michaela A.; Hyslop, Terry; Reed, Shelby D.; Scheri, Randall P.; Sosa, Julie A.

2015-01-01

Context: Papillary thyroid cancer (PTC) patients <45 years old are considered to have an excellent prognosis; however, current guidelines recommend total thyroidectomy for PTC tumors >1.0 cm, regardless of age. Objective: Our objective was to examine the impact of extent of surgery on overall survival (OS) in patients <45 years old with stage I PTC of 1.1 to 4.0 cm. Design, Setting, and Patients: Adult patients <45 years of age undergoing surgery for stage I PTC were identified from the National Cancer Data Base (NCDB, 1998–2006) and the Surveillance, Epidemiology, and End Results dataset (SEER, 1988–2006). Main Outcome Measure: Multivariable modeling was used to compare OS for patients undergoing total thyroidectomy vs lobectomy. Results: In total, 29 522 patients in NCDB (3151 lobectomy, 26 371 total thyroidectomy) and 13 510 in SEER (1379 lobectomy, 12 131 total thyroidectomy) were included. Compared with patients undergoing lobectomy, patients having total thyroidectomy more often had extrathyroidal and lymph node disease. At 14 years, unadjusted OS was equivalent between total thyroidectomy and lobectomy in both databases. After adjustment, OS was similar for total thyroidectomy compared with lobectomy across all patients with tumors of 1.1 to 4.0 cm (NCDB: hazard ratio = 1.45 [confidence interval = 0.88–2.51], P = 0.19; SEER: 0.95 (0.70–1.29), P = 0.75) and when stratified by tumor size: 1.1 to 2.0 cm (NCDB: 1.12 [0.50–2.51], P = 0.78; SEER: 0.95 [0.56–1.62], P = 0.86) and 2.1 to 4.0 cm (NCDB: 1.93 [0.88–4.23], P = 0.10; SEER: 0.94 [0.60–1.49], P = 0.80). Conclusions: After adjusting for patient and clinical characteristics, total thyroidectomy compared with thyroid lobectomy was not associated with improved survival for patients <45 years of age with stage I PTC of 1.1 to 4.0 cm. Additional clinical and pathologic factors should be considered when choosing extent of resection. PMID:25337927

Excimer laser photorefractive keratectomy for myopia: preliminary results at one year

NASA Astrophysics Data System (ADS)

Thompson, Keith P.; Waring, George O., III; Steinert, Roger; Durrie, Daniel S.; Gordon, Michael; Brint, Stephen F.

1992-08-01

Excimer laser photorefractive keratectomy (PRK) is presently under investigation for the correction of myopia. Two companies in the United States, Summit Technology (Waltham, Mass.) and VisX, Inc. (Sunnyvale, Calif.) have developed excimer laser delivery systems and are participating in an FDA study to determine the safety and efficacy of PRK. This is a preliminary report on the refractive and visual results of 51 of 100 eyes treated between October 10, 1990 and March 7, 1991 by the Summit Technology UV200LA excimer laser under the FDA Phase IIB FDA protocol one year after surgery. More detailed information on eight patients treated at Emory University Eye Center (Emory Subgroup) is also reported.

A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

PubMed

López-Mínguez, José R; Nogales-Asensio, Juan M; Doncel-Vecino, Luis J; Merchán-Herrera, Antonio; Pomar-Domingo, Francisco; Martínez-Romero, Pedro; Fernández-Díaz, José A; Valdesuso-Aguilar, Raúl; Moreu-Burgos, José; Díaz-Fernández, José

2014-07-01

Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

High-dose cytarabine in induction treatment improves the outcome of adult patients younger than age 46 years with acute myeloid leukemia: results of the EORTC-GIMEMA AML-12 trial.

PubMed

Willemze, Roelof; Suciu, Stefan; Meloni, Giovanna; Labar, Boris; Marie, Jean-Pierre; Halkes, Constantijn J M; Muus, Petra; Mistrik, Martin; Amadori, Sergio; Specchia, Giorgina; Fabbiano, Francesco; Nobile, Francesco; Sborgia, Marco; Camera, Andrea; Selleslag, Dominik L D; Lefrère, Francois; Magro, Domenico; Sica, Simona; Cantore, Nicola; Beksac, Meral; Berneman, Zwi; Thomas, Xavier; Melillo, Lorella; Guimaraes, Jose E; Leoni, Pietro; Luppi, Mario; Mitra, Maria E; Bron, Dominique; Fillet, Georges; Marijt, Erik W A; Venditti, Adriano; Hagemeijer, Anne; Mancini, Marco; Jansen, Joop; Cilloni, Daniela; Meert, Liv; Fazi, Paola; Vignetti, Marco; Trisolini, Silvia M; Mandelli, Franco; de Witte, Theo

2014-01-20

Cytarabine plays a pivotal role in the treatment of patients with acute myeloid leukemia (AML). Most centers use 7 to 10 days of cytarabine at a daily dose of 100 to 200 mg/m(2) for remission induction. Consensus has not been reached on the benefit of higher dosages of cytarabine. The European Organisation for Research and Treatment of Cancer (EORTC) and Gruppo Italiano Malattie Ematologiche dell' Adulto (GIMEMA) Leukemia Groups conducted a randomized trial (AML-12; Combination Chemotherapy, Stem Cell Transplant and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia) in 1,942 newly diagnosed patients with AML, age 15 to 60 years, comparing remission induction treatment containing daunorubicin, etoposide, and either standard-dose (SD) cytarabine (100 mg/m(2) per day by continuous infusion for 10 days) or high-dose (HD) cytarabine (3,000 mg/m(2) every 12 hours by 3-hour infusion on days 1, 3, 5, and 7). Patients in complete remission (CR) received a single consolidation cycle containing daunorubicin and intermediate-dose cytarabine (500 mg/m(2) every 12 hours for 6 days). Subsequently, a stem-cell transplantation was planned. The primary end point was survival. At a median follow-up of 6 years, overall survival was 38.7% for patients randomly assigned to SD cytarabine and 42.5% for those randomly assigned to HD cytarabine (log-rank test P = .06; multivariable analysis P = .009). For patients younger than age 46 years, survival was 43.3% and 51.9%, respectively (P = .009; multivariable analysis P = .003), and for patients age 46 to 60 years, survival was 33.9% and 32.9%, respectively (P = .91). CR rates were 72.0% and 78.7%, respectively (P < .001) and were 75.6% and 82.4% for patients younger than age 46 years (P = .01) and 68.3% and 74.8% for patients age 46 years and older (P = .03). Patients of all ages with very-bad-risk cytogenetic abnormalities and/or FLT3-ITD (internal tandem duplication) mutation, or with secondary AML benefitted from HD

Age-related injury patterns in Spanish trauma ICU patients. Results from the RETRAUCI.

PubMed

Llompart-Pou, Juan Antonio; Chico-Fernández, Mario; Sánchez-Casado, Marcelino; Alberdi-Odriozola, Fermín; Guerrero-López, Francisco; Mayor-García, María Dolores; González-Robledo, Javier; Ballesteros-Sanz, María Ángeles; Herrán-Monge, Rubén; León-López, Rafael; López-Amor, Lucía; Bueno-González, Ana

2016-09-01

Injury patterns may differ in trauma patients when age is considered. This information is relevant in the management of trauma patients and for planning preventive measures. We included in the study all patients admitted for traumatic disease in the participating ICUs from November 23 rd , 2012 to July 31 st , 2015 with complete records. Data on epidemiology, injury patterns, severity scores, acute management, resources utilisation and outcome were recorded and compared in the following groups of age: ≤55years (young adults), 56-65 years (adults), 66-75 years (elderly), >75years (very elderly). Quantitative data were reported as median (Interquartile Range (IQR) 25-75) and categorical data as number and percentage. Comparison between groups of age with quantitative variables was performed using the analysis of variance (ANOVA) test. Differences between groups with categorical variables were compared using the chi-square test. A value of p<0.05 was considered significant. We included 2700 patients (78.9% male). Median age was 46 (31-62) years. Blunt trauma was present in 93.7% of the patients. Median RTS was 7.55 (5.97-7.84). Median ISS was 20 (13-26). High-energy trauma secondary to motor-vehicle accident with rhabdomyolysis and drugs abuse showed an inverse linear association with ageing, whilst pedestrian falls with isolated brain injury, being run-over and pre-injury antiplatelets or anticoagulant treatment increased with age (in all cases p<0.001). Multiple injuries were more common in young adults (p<0.001). Acute kidney injury prevalence was higher in elderly and very elderly patients (p<0.001). ICU Mortality increased with age in spite of similar severity scores in all groups (p<0.001). The main cause of death in all groups was intracranial hypertension. Different injury patterns exist in relation with ageing in trauma ICU patients. Adult patients were more likely to present high-energy trauma with significant injuries in different areas whilst elderly

Correlation between MRI results and intraoperative findings in patients with silicone breast implants.

PubMed

Lindenblatt, Nicole; El-Rabadi, Karem; Helbich, Thomas H; Czembirek, Heinrich; Deutinger, Maria; Benditte-Klepetko, Heike

2014-01-01

Silicone gel breast implants may silently rupture without detection. This has been the main reason for magnetic resonance imaging (MRI) of the augmented or reconstructed breast. The aim of the present study was to investigate the accuracy of MRI for implant rupture. Fifty consecutive patients with 85 silicone gel implants were included in the study. The mean age of the patients was 51 (range 21-72) years, with a mean duration of implantation of 3.8 (range 1-28) years. All patients underwent clinical examination and breast MRI. Intraoperative implant rupture was diagnosed by the operating surgeon. Nineteen of the 50 patients suffered from clinical symptoms. An implant rupture was diagnosed by MRI in 22 of 85 implants (26%). In seven of 17 removed implants (41%), the intraoperative diagnosis corresponded with the positive MRI result. However, only 57% of these patients were symptomatic. Ultrasound imaging of the harvested implants showed signs of interrupted inner layers of the implant despite integrity of the outer shell. By microsurgical separation of the different layers of the implant shell, we were able to reproduce this phenomenon and to produce signs of implant rupture on MRI. Our results show that rupture of only the inner layers of the implant shell with integrity of the outer shell leads to a misdiagnosis on MRI. Correlation with clinical symptoms and the specific wishes of the patient should guide the indication for implant removal.

Nine-year outcome after anatomic stemless shoulder prosthesis: clinical and radiologic results.

PubMed

Hawi, Nael; Magosch, Petra; Tauber, Mark; Lichtenberg, Sven; Habermeyer, Peter

2017-09-01

Several stemless shoulder implants are available on the market, but only a few studies have presented results with sufficient mid- to long-term follow-up. The present study evaluated clinical and radiologic outcomes 9 years after anatomic stemless shoulder replacement. This is a prospective cohort study evaluating the stemless shoulder prosthesis since 2005. Anatomic stemless shoulder replacement using a single prosthesis was performed in 49 shoulders; 17 underwent total shoulder replacement, and 32 underwent hemiarthroplasty. Forty-three patients were clinically and radiologically monitored after a mean of 9 years (range, 90-127 months; follow-up rate, 88%). The indications for shoulder replacement were primary osteoarthritis in 7 shoulders, post-traumatic in 24, instability in 7, cuff tear arthropathy in 2, postinfectious arthritis in 1, and revision arthroplasty in 2. The Constant-Murley Score improved significantly from 52% to 79% (P < .0001). The active range of motion also increased significantly for flexion from 101° to 118° (P = .022), for abduction from 79° to 105° (P = .02), and for external rotation from 21° to 43° (P < .0001). Radiologic evaluation revealed incomplete radiolucency in 1 patient without clinical significance or further intervention. No revision caused by loosening or countersinking of the humeral implant was observed. The 9-year outcome after stemless shoulder replacement is comparable to that of third- and fourth-generation standard shoulder arthroplasty. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Effects of time and recall of patch test results on quality of life (QoL) after testing. Cross-sectional study analyzing QoL in hand eczema patients 1, 5 and 10 years after patch testing.

PubMed

Jamil, Wasim N; Lindberg, Magnus

2017-08-01

Patch testing can improve health-related quality of life (HRQOL). To study the impact on HRQOL of elapsed time after patch testing (1-10 years), and how the outcome of testing and patients' recall affects HRQOL. The Dermatology Life Quality Index (DLQI) questionnaire was sent to all patients (aged 18-65 years) who were patch tested for suspected contact allergy in 2009, 2005 and 2000 at the Department of Dermatology in Örebro. The response rate was 51% (n = 256). The DLQI score was significantly lower at 10 years after patch testing (mean DLQI = 5.5) than at 1 year (mean DLQI = 7.7). Work was the most impaired aspect. A binary logistic model showed that only time (10 years after testing) was associated with no effect, a light effect or a moderate effect (DLQI < 10) on HRQOL. No such association was seen for patients with negative or positive test results concerning full recall, partial recall or no recall of diagnosed allergens. Although there was an improvement in HRQOL over time, the work aspect remained a major problem. The improvement was not affected by the outcome of testing and patients' recall of test results. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Gait strategy in genetically obese patients: a 7-year follow up.

PubMed

Cimolin, V; Vismara, L; Galli, M; Grugni, G; Cau, N; Capodaglio, P

2014-07-01

The aim of this study was to quantitatively evaluate the change in gait and body weight in the long term in patients with Prader-Willi Syndrome (PWS). Eight adults with PWS were evaluated at baseline and after 7 years. During this period patient participated an in- and out-patient rehabilitation programs including nutritional and adapted physical activity interventions. Two different control groups were included: the first group included 14 non-genetically obese patients (OCG: obese control group) and the second group included 10 age-matched healthy individuals (HCG: healthy control group). All groups were quantitatively assessed during walking with 3D-GA. The results at the 7-year follow-up revealed significant weight loss in the PWS group and spatial-temporal changes in gait parameters (velocity, step length and cadence). With regard to the hip joint, there were significant changes in terms of hip position, which is less flexed. Knee flexion-extension showed a reduction of flexion in swing phase and of its excursion. No changes of the ankle position were evident. As for ankle kinetics, we observed in the second session higher values for the peak of ankle power in terminal stance in comparison to the first session. No changes were found in terms of ankle kinetics. The findings demonstrated improvements associated to long-term weight loss, especially in terms of spatial-temporal parameters and at hip level. Our results back the call for early weight loss interventions during childhood, which would allow the development of motor patterns under normal body weight conditions. Copyright © 2014 Elsevier Ltd. All rights reserved.

Nonelective colon cancer resections in elderly patients: results from the dutch surgical colorectal audit.

PubMed

Kolfschoten, N E; Wouters, M W J M; Gooiker, G A; Eddes, E H; Kievit, J; Tollenaar, R A E M; Marang-van de Mheen, P J

2012-01-01

The aim of the study was to assess which factors contribute to postoperative mortality, especially in elderly patients who undergo emergency colon cancer resections, using a nationwide population-based database. 6,161 patients (1,172 nonelective) who underwent a colon cancer resection in 2010 in the Netherlands were included. Risk factors for postoperative mortality were investigated using a multivariate logistic regression model for different age groups, elective and nonelective patients separately. For both elective and nonelective patients, mortality risk increased with increasing age. For nonelective elderly patients (80+ years), each additional risk factor increased the mortality risk. For a nonelective patient of 80+ years with an American Society of Anesthesiologists score of III+ and a left hemicolectomy or extended resection, postoperative mortality rate was 41% compared with 7% in patients without additional risk factors. For elderly patients with two or more additional risk factors, a nonelective resection should be considered a high-risk procedure with a mortality risk of up to 41%. The results of this study could be used to adequately inform patient and family and should have consequences for composing an operative team. Copyright © 2012 S. Karger AG, Basel.

Effect of patient socioeconomic status on perceptions of first- and second-year medical students

PubMed Central

Woo, James K.H.; Ghorayeb, Sahar H.; Lee, Cheong K.; Sangha, Harpreet; Richter, Suzanne

2004-01-01

Background Physician decision-making and perceptions of patients are affected by a patient's socioeconomic status (SES). We sought to determine if the perceptions of first- and second-year medical students are similarly affected. We also wanted to determine whether a student's own SES affects his or her perceptions of patients from a low or high SES background. Methods Two similar videos of a physician–patient interview were created. One video featured a patient of apparently high SES and the other featured a patient of apparently low SES. Differences in SES were portrayed by means of clothing, accessories and dialogue. First- and second-year medical students at the University of Western Ontario were recruited to view 1 of the videos and to answer a questionnaire using a 5-point Likert scale. Results Responses were obtained from 205 (89%) of the 231 medical students invited to participate. Respondents' perceptions of the low SES and high SES patients were significantly different in the following respects. The low SES patient was perceived to be less compliant in taking medications and less likely to return for follow-up visits; was perceived to have a lower level of social support, poorer overall health and a worse prognosis; and was perceived to be more adversely affected in his occupational duties by illness (p < 0.05). Furthermore, second-year students who watched the video with the low SES patient were less inclined to want that patient in their practice than second-year students who watched the video with the high SES patient (p = 0.032). One hundred and six students (52%) were categorized as having high SES and 37 (18%) as having low SES (the remaining students were categorized as having mid-level SES). Among students who watched the video with the low SES patient, the level of agreement with the statement “This person is the kind of patient I would like to have in my practice” was greater among low SES students than among high SES students (p = 0

Long-term Safety and Efficacy of Tapentadol Extended Release Following up to 2 Years of Treatment in Patients With Moderate to Severe, Chronic Pain: Results of an Open-label Extension Trial.

PubMed

Buynak, Robert; Rappaport, Stephen A; Rod, Kevin; Arsenault, Pierre; Heisig, Fabian; Rauschkolb, Christine; Etropolski, Mila

2015-11-01

Tapentadol extended release (ER) has demonstrated efficacy and safety for the management of moderate to severe, chronic pain in adults. This study evaluated the long-term safety and tolerability of tapentadol ER in patients with chronic osteoarthritis or low back pain. Patients were enrolled in this 1-year, open-label extension study after completing one of two 15-week, placebo-controlled studies of tapentadol ER and oxycodone controlled release (CR) for osteoarthritis knee pain (NCT00421928) or low back pain (NCT00449176), a 7-week crossover study between tapentadol immediate release and tapentadol ER for low back pain (NCT00594516), or a 1-year safety study of tapentadol ER and oxycodone CR for osteoarthritis or low back pain (NCT00361504). After titrating the drug to an optimal dose, patients received tapentadol ER (100-250 mg BID) for up to 1 year (after finishing treatment in the preceding studies); patients who were previously treated with tapentadol ER in the 1-year safety study received tapentadol ER continuously for up to 2 years in total. Of the 1,154 patients in the safety population, 82.7% were aged >65 years and 57.9% were female; 50.1% had mild baseline pain intensity. Mean (SD) pain intensity scores (11-point numerical rating scale) were 3.9 (2.38) at baseline (end of preceding study) and 3.7 (2.42) at end point, indicating that pain relief was maintained during the extension study. Improvements in measures of quality of life (eg, EuroQol-5 Dimension and the 36-item Short Form Health Survey [SF-36]) health status questionnaires) achieved during the preceding studies were maintained during the open-label extension study. Tapentadol ER was associated with a safety and tolerability profile comparable to that observed in the preceding studies. The most common treatment-emergent adverse events (incidence ≥10%; n = 1154) were headache (13.1%), nausea (11.8%), and constipation (11.1%). Similar efficacy and tolerability results were shown for patients who

Liposuction: 25 years of experience in 26,259 patients using different devices.

PubMed

Triana, Lina; Triana, Carlos; Barbato, Carlos; Zambrano, Marco

2009-01-01

The development of liposuction provided plastic surgeons with a safe and effective way to sculpt the human figure. The techniques and instrumentation used in the performance of liposuction have evolved significantly since its introduction. The authors review their experience with different liposuction techniques over the past 25 years. Data from patients who had undergone liposuction were collected from the personal databases of four different surgeons and from the database at the Corpus and Rostrum Plastic Surgery Clinic in Cali, Colombia. A retrospective review was conducted and the results from different liposuction techniques were compared. A total of 26,259 patient charts were reviewed. The results showed that 5% of patients experienced a postsurgical seroma. Postsurgical fibrosis developed to some degree in 2.3% of patients. Anemia was present in 18% of all patients and in 60% of those patients who underwent dry liposuction. Ninety percent of patients reported postoperative pain. The incidence of deep vein thrombosis was 0.03%, as was the incidence of pulmonary embolism. Mortality was 0.01% and was mainly caused by pulmonary embolism. Patient satisfaction was similar for all of the described techniques. The incidence of anemia was reduced significantly in patients undergoing tumescent liposuction versus dry liposuction. However, the occurrence of seroma increased with the introduction of tumescent liposuction. The incidence of postoperative pain and fibrosis was similar for all liposuction techniques reviewed. The aesthetic results obtained using ultrasound- or laser-assisted liposuction were similar to those obtaining using other techniques.

Overcoming resistance to bisphosphonates through the administration of alfacalcidol: results of a 1-year, open follow-up study.

PubMed

Gaál, János; Bender, Tamás; Varga, József; Horváth, Irén; Kiss, Judit; Somogyi, Péter; Surányi, Péter

2009-11-01

This study intended to determine whether the replacement of vitamin D3 with alfacalcidol results in any bone mineral density (BMD) increase in 76 patients unresponsive to the combination of alendronate and conventional vitamin D3 treatment. In these patients the conventional vitamin D3 had been replaced with alfacalcidol (0.5 μg/day), and then the patients were followed up for a year. After treatment for 1 year, Wilcoxon test revealed a small but statistically significant (P < 0.001) increase in the BMD values of the forearm and lumbar vertebrae, in the serum calcium and urinary calcium/creatinine ratio in first-voided morning urine. However, the serum alkaline phosphatase activity, phosphorus, parathormone, osteocalcin levels and the urinary d-pyr/creatinine ratio decreased significantly (P < 0.001). As suggested by our results, combination therapy with alendronate and alfacalcidol increases bone density and improves the biochemical markers of bone turnover, without any substantial increase in the incidence of adverse effects.

[6-year experience with a drug information service for patients].

PubMed

Huber, Martin; Kullak-Ublick, Gerd A; Kirch, Wilhelm

2009-03-15

Many patients are inadequately informed about their drug therapy. There is thus a need for providing additional drug information to patients. The authors here report on a 6-year experience with a drug information service for patients. The information service was available by telephone, e-mail or regular mail and was addressed initially to patients in Saxony and since 2005 to patients throughout Germany. Demographic and drug therapy data of the patients were registered and analyzed using a relational database. All enquiries to the information service between August 2001 and January 2007 were evaluated. 5,587 enquiries were registered. 61.4% of the persons calling were female and 33.8% male (sex was unknown in 4.8% by anonymous calls). The most frequent reasons for an enquiry were a general need for information about drugs and therapy (27.5%) and adverse drug reactions (24.7%). The drug group most frequently enquired about were cardiovascular drugs, accounting for 34.4%, followed by neuropsychiatric drugs (15.1%). The results of this analysis show an evident need for a drug information service for patients. This need is possibly caused by the shortage of time that physicians can devote to patients. An independent and competent drug information service may improve the quality of medical care and the satisfaction of the patients involved.

Effect of marital quality on eight-year survival of patients with heart failure.

PubMed

Rohrbaugh, Michael J; Shoham, Varda; Coyne, James C

2006-10-15

Recent evidence suggests that psychosocial factors such as self-efficacy, psychological distress, perceived social support, and marital quality have prognostic significance for morbidity and mortality after heart failure. Previously, we reported that interview and observational measures of marital quality obtained from 189 patients with heart failure (139 men and 50 women) and their spouses predicted all-cause patient mortality during the next 4 years, independent of the baseline illness severity (New York Heart Association class). We present additional follow-up results for this sample, with Cox regression analyses showing that a couple-level composite measure of marital quality continued to predict survival during an 8-year period (p <0.001), especially when the patient was a woman, and did so substantially better than individual (patient-level) risk and protective factors, such as psychological distress, hostility, neuroticism, self-efficacy, optimism, and breadth of perceived emotional support. In conclusion, relationship factors may be especially relevant in managing a difficult chronic condition such as heart failure, which makes stringent and complex demands on patients and their families.

Results of patch testing in 10 patients with peristomal dermatitis.

PubMed

Landis, Megan N; Keeling, James H; Yiannias, James A; Richardson, Donna M; Nordberg Linehan, Diane L; Davis, Mark D P

2012-09-01

Peristomal dermatitis is a common problem in patients with ostomies that is a source of considerable morbidity. Irritant contact dermatitis is most common, but allergic contact dermatitis can also occur. Because of the lack of published reports on patch testing for this indication, we undertook a retrospective study of patch testing results in patients with suspected peristomal allergic contact dermatitis. We sought to describe our patch testing experience with patients referred with peristomal dermatitis. This was a retrospective review of medical records of patients with ostomies and peristomal dermatitis who underwent patch testing in the Mayo Clinic Departments of Dermatology in Jacksonville, FL; Rochester, MN; and Scottsdale, AZ, during a 10-year period (2000-2010). Ten patients with peristomal dermatitis were referred for patch testing (6 in Minnesota, 2 in Florida, and 2 in Arizona). Patients were patch tested to the materials used in their stoma devices, to the standard series, and in some cases to supplemental series. All 10 had at least one allergic patch test reaction, most commonly to stoma paste (3 of 10 patients). Retrospective nature of study via chart review is a limitation. Patch testing is a useful tool for identification of allergens in patients with peristomal dermatitis. Copyright © 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Cognitive performance of detoxified alcoholic Korsakoff syndrome patients remains stable over two years.

PubMed

Fujiwara, Esther; Brand, Matthias; Borsutzky, Sabine; Steingass, Hans-P; Markowitsch, Hans J

2008-07-01

Excessive alcohol consumption is assumed to promote cognitive decline, eventually increasing the risk of dementia. However, little is known about the time course of cognitive functions in patients with chronic alcoholic Korsakoff syndrome (KS). Therefore, we assessed neuropsychological performance in 20 detoxified chronic KS inpatients at time 1 (T1) with a follow-up after two years (T2). The neuropsychological tests assessed verbal and visual short- and long-term memory, working memory, basic executive functions, language, general knowledge, and visual-spatial abilities. Surveys with caregivers and medical records provided information about current and previous disease-related parameters, drinking history, additional pathologies, as well as psychosocial and cognitive therapy within the two-year period. At both sessions, the majority of the KS patients' results were inferior to those of normal subjects. Comparing T1 and T2 revealed no significant decline in any of the investigated functions. Instead, general knowledge, visual long-term memory, and verbal fluency improved slightly after two years, though they still remained within pathological range. Comparing most improved and most deteriorated patients, better outcome occurred more frequently in men than women and was associated with higher premorbid education and fewer detoxifications in the past. In this sample of detoxified KS patients there was no indication of accelerated cognitive decline or onset of dementia-like symptoms over two years.

Reverse shoulder arthroplasty in young patient with achondroplasia - Ten year follow up: Case report.

PubMed

van den Broek, M; Verborgt, O; Declercq, G

2017-11-01

Skeletal dysplasia in achondroplasia can affect all body joints - including the glenohumeral joint - and is prone to develop to degenerative osteoarthritis (OA). This may cause pain and mobility problems at young age. Surgical treatment is challenging due to the dysplastic anatomy of the shoulder joint - with a dysplastic deformed short humerus, a small, hypoplastic medialized glenoid and lateralized acromion - and the long life expectancy of these patients. The indications for reverse shoulder arthroplasty (RSA) evolved during years with rotator cuff tears and rotator cuff arthropathy in combination with or without glenohumeral OA as the main indicator, with good short to mid-term results. Long term results of RSA are rarely found in literature, especially in young patients. The use of a RSA in glenohumeral OA with an intact rotator cuff has rarely been reported. In this case report we present the ten-year clinical and radiographic results of a RSA for the treatment of degenerative OA with glenohumeral dysplasia in a young patient with achondroplasia. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Effect and sustainability of part-time occlusion therapy for patients with anisometropic amblyopia aged > or =8 years.

PubMed

Hwang, D J; Kim, Y J; Lee, J Y

2010-09-01

To study the effect and long-term sustainability of part-time occlusion therapy for anisometropic amblyopia after 8 years of age. A total of 41 anisometropic amblyopes aged > or =8 years were analysed. In six patients, best-corrected visual acuity (BCVA) of amblyopic eye improved more than two lines within 2 weeks of full-time spectacle wear. The remaining patients were assigned to perform part-time patching during out-of-school hours. Long-term results were assessed in patients who were observed over 1 year after the end of the treatment. Among 35 patients, four dropped out, refusing further treatment, and one changed to atropine penalisation. The part-time patching schedule was completed in 30 patients. 90% of patients (27/30) complied well. Mean BCVA in the amblyopic eye improved significantly (p<0.001), and 96.7% of patients (29/30) achieved the final BCVA of 0.1 logMAR or better. In long-term results, 87% preserved the BCVA of 0.1 logMAR or better. None of four dropouts achieved the BCVA of 0.1 logMAR or better in long-term results even on the continuous spectacle wear. The part-time occlusion treatment in school-aged amblyopes, which had been carried out after school hours, was successful and the effect was sustained in most cases.

One-year results from a prospective randomized trial comparing phlebotomy with deferasirox for the treatment of iron overload in pediatric patients with thalassemia major following curative stem cell transplantation.

PubMed

Inati, Adlette; Kahale, Mario; Sbeiti, Nada; Cappellini, Maria Domenica; Taher, Ali T; Koussa, Suzanne; Nasr, Therese A; Musallam, Khaled M; Abbas, Hussein A; Porter, John B

2017-01-01

Iron overload is well documented in patients with β-thalassemia major, and patients who have undergone hematopoietic stem cell transplantation (HSCT) remain at risk as a result of pre- and immediate post-HSCT transfusions. This is a prospective, randomized, 1-year clinical trial that compares the efficacy and safety of the once-daily oral iron chelator deferasirox versus phlebotomy for the treatment of iron overload in children with β-thalassemia major following HSCT. Patients (aged 12.4 years) received deferasirox (n = 12, 10 mg/kg/day starting dose) or phlebotomy (n = 14, 6 ml/kg/2 weeks) for 1 year. In two and five patients, deferasirox dose was increased to 15 and 20 mg/kg/day, respectively. Magnetic resonance imaging (MRI)-assessed liver iron concentration (LIC) decreased with deferasirox (mean 12.5 ± 10.1 to 8.5 ± 9.3 mg Fe/g dry weight [dw]; P = 0.0005 vs. baseline) and phlebotomy (10.2 ± 6.8 to 8.3 ± 9.2 mg Fe/g dw; P = 0.05). LIC reductions were greater with deferasirox than with phlebotomy for patients with baseline serum ferritin 1,000 ng/ml or higher (-8.1 ± 1.5 vs. -3.5 ± 5.7 mg Fe/g dw; P = 0.048). Serum ferritin and non-transferrin-bound iron also decreased significantly. In two patients with severe cardiac siderosis, a clinically relevant improvement in myocardial T2* was seen, following phlebotomy and deferasirox therapy (n = 1 each). Adverse effects with deferasirox were skin rash, gastrointestinal upset, and increased liver function tests (all n = 1), while those for phlebotomy were difficulty with venous access (n = 4) and distress during procedure (n = 1). Parents of 13/14 children receiving phlebotomy wished to switch to deferasirox, with 1/14 being satisfied with phlebotomy. Deferasirox treatment or phlebotomy reduces iron burden in pediatric patients with β- thalassemia major post-HSCT, with a manageable safety profile. © 2016 Wiley Periodicals, Inc.

Reality of obesity paradox: Results of percutaneous coronary intervention in Middle Eastern patients.

PubMed

Jarrah, Mohamad; Hammoudeh, Ayman J; Khader, Yousef; Tabbalat, Ramzi; Al-Mousa, Eyas; Okkeh, Osama; Alhaddad, Imad A; Tawalbeh, Loai Issa; Hweidi, Issa M

2018-04-01

Objective The aim of this study was to assess the baseline clinical characteristics, coronary angiographic features, and adverse cardiovascular events during hospitalization and at 1 year of follow-up in obese patients compared with overweight and normal/underweight patients. Methods A prospective, multicenter study of consecutive patients undergoing percutaneous coronary intervention was performed. Results Of 2425 enrolled patients, 699 (28.8%) were obese, 1178 (48.6%) were overweight, and 548 (22.6%) were normal/underweight. Obese patients were more likely to be female and to have a higher prevalence of diabetes, hypertension, hypercholesterolemia, or previous percutaneous coronary intervention. Acute coronary syndrome was the indication for percutaneous coronary intervention in 77.0% of obese, 76.4% of overweight, and 77.4% of normal/underweight patients. No significant differences in the prevalence of multi-vessel coronary artery disease or multi-vessel percutaneous coronary intervention were found among the three groups. Additionally, no significant differences were found in stent thrombosis, readmission bleeding rates, or cardiac mortality among the three groups during hospitalization, at 1 month, and at 1 year. Conclusion The major adverse cardiovascular event rate was the same among the three groups throughout the study period. Accordingly, body mass index is considered a weak risk factor for cardiovascular comorbidities in Arab Jordanian patients.

One year survival of ART and conventional restorations in patients with disability

PubMed Central

2014-01-01

Background Providing restorative treatment for persons with disability may be challenging and has been related to the patient’s ability to cope with the anxiety engendered by treatment and to cooperate fully with the demands of the clinical situation. The aim of the present study was to assess the survival rate of ART restorations compared to conventional restorations in people with disability referred for special care dentistry. Methods Three treatment protocols were distinguished: ART (hand instruments/high-viscosity glass-ionomer); conventional restorative treatment (rotary instrumentation/resin composite) in the clinic (CRT/clinic) and under general anaesthesia (CRT/GA). Patients were referred for restorative care to a special care centre and treated by one of two specialists. Patients and/or their caregivers were provided with written and verbal information regarding the proposed techniques, and selected the type of treatment they were to receive. Treatment was provided as selected but if this option proved clinically unfeasible one of the alternative techniques was subsequently proposed. Evaluation of restoration survival was performed by two independent trained and calibrated examiners using established ART restoration assessment codes at 6 months and 12 months. The Proportional Hazard model with frailty corrections was applied to calculate survival estimates over a one year period. Results 66 patients (13.6 ± 7.8 years) with 16 different medical disorders participated. CRT/clinic proved feasible for 5 patients (7.5%), the ART approach for 47 patients (71.2%), and 14 patients received CRT/GA (21.2%). In all, 298 dentine carious lesions were restored in primary and permanent teeth, 182 (ART), 21 (CRT/clinic) and 95 (CRT/GA). The 1-year survival rates and jackknife standard error of ART and CRT restorations were 97.8 ± 1.0% and 90.5 ± 3.2%, respectively (p = 0.01). Conclusions These short-term results indicate that ART appears to be an

Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study.

PubMed

Louie, Brian E; Smith, C Daniel; Smith, Christopher C; Bell, Reginald C W; Gillian, George Kevin; Mandel, Jeffrey S; Perry, Kyle A; Birkenhagen, Walter Kurt; Taiganides, Paul A; Dunst, Christy M; McCollister, Howard M; Lipham, John C; Khaitan, Leena K; Tsuda, Shawn T; Jobe, Blair A; Kothari, Shanu N; Gould, Jon C

2018-04-24

To report 1-year results from a 5-year mandated study. In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study. Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors. A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported. Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.

Treatment results of nasopharyngeal carcinoma: a 15-year single institutional experience.

PubMed

Khademi, Bijan; Mahmoodi, Jalal; Omidvari, Shapour; Mohammadianpanah, Mohammad

2006-06-01

Nasopharyngeal Carcinoma (NPC) is a common malignant neoplasm of the head and neck that occurs most commonly in people in the South Eastern Asia but its condition in Iran is not much clear. In this retrospective study, we evaluated the treatment characteristics determining the outcome in patients with NPC. In this retrospective study, we reviewed the records of one hundred and seven patients with biopsy proven diagnosis of NPC who were referred to the radiation oncology department, Nemazee Hospital, Shiraz University of Medical Sciences, Iran, during the time period from January 1985 to December 2000. Eightyfive patients (79.4%) received 60-70Gy radiation (1.8- 2Gy/fraction, one fraction per day, and 5 fractions per week). Sixty-two patients (57.5%) received radiotherapy combined with adjuvant chemotherapy which consisted of cisplatin and 5-fluorouracil. Eighty-six patients (80.4%) had WHO II-III histopathologic diagnosis. According to the AJCC 1997 staging system, 4 (3.6%), 3 (2.7%), 33 (30.8%) and 67 (62%) patients were in stages I, II, III and IV, respectively. With a median follow-up of 12 months, the 2-year overall and disease-free survival rates were 35% and 21%, respectively. According to the multivariate analysis for overall survival, patients under 40 years had a better prognosis (p=0.041). Node stage and stage of disease were significant prognostic factors (p=0.0001). On multivariate analysis for disease-free survival, age and node stage were significant prognostic factors. The patients who received more than 60Gy radiation had a better prognosis (p=0.02), however; sequential adjuvant chemotherapy had no impact on survival and response (p=0.6). Our experience confirmed earlier reports showing poor outcomes for locoregionally advanced nasopharyngeal carcinomas. This study failed to demonstrate improvement in the outcome regarding overall and disease-free survival by adding sequential adjuvant chemotherapy after radiotherapy for patients with advanced NPC.

Outcomes of surgery in patients aged ≥90 years in the general surgical setting.

PubMed

Sudlow, A; Tuffaha, H; Stearns, A T; Shaikh, I A

2018-03-01

Introduction An increasing proportion of the population is living into their nineties and beyond. These high risk patients are now presenting more frequently to both elective and emergency surgical services. There is limited research looking at outcomes of general surgical procedures in nonagenarians and centenarians to guide surgeons assessing these cases. Methods A retrospective analysis was conducted of all patients aged ≥90 years undergoing elective and emergency general surgical procedures at a tertiary care facility between 2009 and 2015. Vascular, breast and endocrine procedures were excluded. Patient demographics and characteristics were collated. Primary outcomes were 30-day and 90-day mortality rates. The impact of ASA (American Society of Anesthesiologists) grade, operation severity and emergency presentation was assessed using multivariate analysis. Results Overall, 161 patients (58 elective, 103 emergency) were identified for inclusion in the study. The mean patient age was 92.8 years (range: 90-106 years). The 90-day mortality rates were 5.2% and 19.4% for elective and emergency procedures respectively (p=0.013). The median survival was 29 and 19 months respectively (p=0.001). Emergency and major gastrointestinal operations were associated with a significant increase in mortality. Patients undergoing emergency major colonic or upper gastrointestinal surgery had a 90-day mortality rate of 53.8%. Conclusions The risk for patients aged over 90 years having an elective procedure differs significantly in the short term from those having emergency surgery. In selected cases, elective surgery carries an acceptable mortality risk. Emergency surgery is associated with a significantly increased risk of death, particularly after major gastrointestinal resections.

Surgical results of mitral valve repair for congenital mitral valve stenosis in paediatric patients.

PubMed

Cho, Sungkyu; Kim, Woong-Han; Kwak, Jae Gun; Lee, Jeong Ryul; Kim, Yong Jin

2017-12-01

Mitral valve (MV) repairs have been performed in paediatric patients with congenital MV stenosis. However, congenital MV stenosis lesions are a heterogeneous group of lesions, and their repair remains challenging. From March 1999 to September 2014, MV repair was performed in 22 patients with congenital MV stenosis. The median age was 10.3 months (ranging from 22 days to 9.1 years), and the mean body weight was 7.9 ± 4.0 kg at the time of the operation. Multiple-level left-side heart obstructions were present in 9 (45%) patients. The main aetiology of the mitral stenosis was a supravalvular mitral ring in 8 patients, valvular stenosis in 4 patients, a parachute deformity of the papillary muscles in 4 patients and other abnormal papillary muscles in 6 patients. The mean MV pressure gradient improved from 10.4 ± 3.9 mmHg to 3.4 ± 1.7 mmHg after MV repair (n = 18, P < 0.0001). The mean follow-up duration was 6.7 ± 5.4 years. One patient died postoperatively due to septic shock. Four patients required a second operation (2 patients for mitral stenosis, 1 patient for left ventricular outflow tract obstruction and mitral stenosis and 1 patient for mitral regurgitation). Among them, 2 patients died: 1 patient died due to cardiopulmonary bypass weaning failure and another patient died due to multiple cerebral infarcts. At the last follow-up, the mean MV pressure gradient was 4.5 ± 3.1 mmHg for all patients who did not have reoperation, and moderate or greater mitral insufficiency was detected in 3 patients. At 10 years, the survival rate was 85.9 ± 7.6%, and the freedom from reoperation rate was 77.5 ± 10.1%. In the log-rank test, MV repair in the neonate was associated with mortality (P = 0.010), and presentation of mitral insufficiency was associated with reoperation (P = 0.003). MV repair in paediatric patients with congenital mitral stenosis showed acceptable results. The follow-up echocardiogram also

First-year results of the Global Influenza Hospital Surveillance Network: 2012–2013 Northern hemisphere influenza season

PubMed Central

2014-01-01

Background The Global Influenza Hospital Surveillance Network (GIHSN) was developed to improve understanding of severe influenza infection, as represented by hospitalized cases. The GIHSN is composed of coordinating sites, mainly affiliated with health authorities, each of which supervises and compiles data from one to seven hospitals. This report describes the distribution of influenza viruses A(H1N1), A(H3N2), B/Victoria, and B/Yamagata resulting in hospitalization during 2012–2013, the network’s first year. Methods In 2012–2013, the GIHSN included 21 hospitals (five in Spain, five in France, four in the Russian Federation, and seven in Turkey). All hospitals used a reference protocol and core questionnaire to collect data, and data were consolidated at five coordinating sites. Influenza infection was confirmed by reverse-transcription polymerase chain reaction. Hospitalized patients admitted within 7 days of onset of influenza-like illness were included in the analysis. Results Of 5034 patients included with polymerase chain reaction results, 1545 (30.7%) were positive for influenza. Influenza A(H1N1), A(H3N2), and both B lineages co-circulated, although distributions varied greatly between coordinating sites and over time. All age groups were affected. A(H1N1) was the most common influenza strain isolated among hospitalized adults 18–64 years of age at four of five coordinating sites, whereas A(H3N2) and B viruses were isolated more often than A(H1N1) in adults ≥65 years of age at all five coordinating sites. A total of 16 deaths and 20 intensive care unit admissions were recorded among patients with influenza. Conclusions Influenza strains resulting in hospitalization varied greatly between coordinating sites and over time. These first-year results of the GIHSN are relevant, useful, and timely. Due to its broad regional representativeness and sustainable framework, this growing network should contribute substantially to understanding the

Ten-Year Results of the Press Fit Condylar Sigma Cobalt-Chrome Total Knee Replacement.

PubMed

Keenan, Oisin; Brenkel, Ivan; Walmsley, Phil

2018-04-10

Total knee arthroplasty (TKA) is reliant on safe and effective implants. The Press Fit Condylar Sigma Cobalt-Chrome (PFCSCC) was introduced in 2006, but no reports have examined long-term failure rates and patient-reported outcome measures (PROMs). The primary aim of this study was to assess survival outcomes of the PFCSCC at 10 years after implantation. Prospective data collection was performed on all patients undergoing primary TKA in one orthopaedic department using this prosthesis exclusively from February 1, 2006, to January 31, 2007. Follow-up was at 10 years. Survival analysis was performed using two primary outcome measures: (1) all-cause joint revision and (2) aseptic revision. Secondary outcomes measures included the American Knee Society Score (AKSS) and Oxford Knee Score (OKS). In total, 249 knees of 233 patients underwent primary TKA. Mean patient age was 66.7 years (range 34-80), and mean body mass index (BMI) was 30 kg/m 2 (20.7-40.1). Reviewing all causes of revisions, 14 joints (5.6%) of 14 patients required reoperation. Of these, nine were for deep infection, including six in the first year. Four (1.6%) underwent aseptic revision. Mean AKSS changed from 47.6 to 90.4 ( n  = 140; p  < 0.001) at 10 years, and mean OKS changed from 38.3 to 23.2 ( n  = 149; p  < 0.001). Prospective analysis of consecutive TKA cases using this design of prosthesis demonstrated high survival rates of 94.4% (all-cause revision) and 98.4% (aseptic revision) at 10 years. Postoperative gains in PROMs were sustained at 10 years. These real-world data represent a substantial extension to previous reports for the PFCSCC and suggest that it is not prone to late mechanical failure. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Employment outcome four years after a severe traumatic brain injury: results of the Paris severe traumatic brain injury study.

PubMed

Ruet, Alexis; Jourdan, Claire; Bayen, Eléonore; Darnoux, Emmanuelle; Sahridj, Dalila; Ghout, Idir; Azerad, Sylvie; Pradat Diehl, Pascale; Aegerter, Philippe; Charanton, James; Vallat Azouvi, Claire; Azouvi, Philippe

2017-05-18

To describe employment outcome four years after a severe traumatic brain injury by the assessment of individual patients' preinjury sociodemographic data, injury-related and postinjury factors. A prospective, multicenter inception cohort of 133 adult patients in the Paris area (France) who had received a severe traumatic brain injury were followed up postinjury at one and four years. Sociodemographic data, factors related to injury severity and one-year functional and cognitive outcomes were prospectively collected. The main outcome measure was employment status. Potential predictors of employment status were assessed by univariate and multivariate analysis. At the four-year follow-up, 38% of patients were in paid employment. The following factors were independent predictors of unemployment: being unemployed or studying before traumatic brain injury, traumatic brain injury severity (i.e., a lower Glasgow Coma Scale score upon admission and a longer stay in intensive care) and a lower one-year Glasgow Outcome Scale-Extended score. This study confirmed the low rate of long-term employment amongst patients after a severe traumatic brain injury. The results illustrated the multiple determinants of employment outcome and suggested that students who had received a traumatic brain injury were particularly likely to be unemployed, thus we propose that they may require specific support to help them find work. Implications for rehabilitation Traumatic brain injury is a leading cause of persistent disablity and can associate cognitive, emotional, physical and sensory impairments, which often result in quality-of-life reduction and job loss. Predictors of post-traumatic brain injury unemployment and job loss remains unclear in the particular population of severe traumatic brain injury patients. The present study highlights the post-traumatic brain injury student population require a close follow-up and vocational rehabilitation. The study suggests that return to work post

Patient perceptions of having 1st- and 2nd-year medical students involved in their care.

PubMed

Isaacson, J Harry; Neides, Daniel; Mayer, Mark; Nottingham, Kelly

2014-01-01

Medical student education has shifted to earlier clinical experiences and increased use of ambulatory settings. Little is known about patient perceptions of having 1st- and 2nd-year medical students involved in their care. The purpose of this article is to study patient perceptions of having 1st- and 2nd-year medical students involved in their care in an ambulatory setting. In 2011 we surveyed 314 patients seen in 2 primary care clinics who saw 1st- or 2nd-year medical students. The survey included questions regarding patient visit satisfaction and perception of overall quality of the visit, adequacy of visit time, benefit of having a student involved in their care, and willingness to see a student in clinic again. Comparisons were made for patients who saw a student and a preceptor (n = 201) and patients who saw only the preceptor (n = 113). Overall visit satisfaction was very high for patients who saw students (83% very satisfied) and patients who saw only the preceptor (91% very satisfied). More than 95% of patients were satisfied with the visit time, and all patients rated the overall quality of their visit as good or excellent. Eighty-five percent of patients would want to see a student again or had no preference. Forty-three percent of patients felt the presence of a student added value to their visit. White patients were more likely than non-White patients to be very satisfied with their visit and rated the overall quality of the visit as excellent. There were no differences based on student gender or year of training. Our results suggest that 1st- and 2nd-year students can be successfully integrated into clinical settings while maintaining patient satisfaction and perceived value of the care they receive.

Comprehensive care program for elderly patients over 65 years with hip fracture.

PubMed

Fernández-Moyano, A; Fernández-Ojeda, R; Ruiz-Romero, V; García-Benítez, B; Palmero-Palmero, C; Aparicio-Santos, R

2014-01-01

To report the health outcomes of a multidisciplinary care program for patients over 65 years with hip fracture. We have developed a care coordination model for the comprehensive care of hip fracture patients. It establishes what, who, when, how and where orthopedists, internists, family physicians, emergency, intensive care, physiotherapists, anesthetists, nurses and workers social intervene. All elderly patients over 65 years admitted with the diagnosis of hip fracture (years 2006 to 2010) were retrospectively evaluated. One thousand episodes of hip fracture, corresponding to 956 patients, were included. Mean age was 82 years and mean stay 6.7 days. This was reduced by 1.14 days during the 5 years of the program. A total of 85.1% were operated on before 72 yours, and 91.2% during the program. Incidence of surgical site infection was 1.5%. In-hospital mortality was 4.5%, (24.2% at 12 months). Readmissions at one years was 14.9%. Independence for basic activity of daily living was achieved by 40% of the patients. This multidisciplinary care program for hip fracture patients is associated with positive health outcomes, with a high percentage of patients treated early (more than 90%), reduced mean stay (less than 7 days), incidence of surgical site infections, readmissions and inpatient mortality and at one year, as well as adequate functional recovery. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Long-term efficacy and safety of mipomersen in patients with familial hypercholesterolaemia: 2-year interim results of an open-label extension

PubMed Central

Santos, Raul D.; Duell, P. Barton; East, Cara; Guyton, John R.; Moriarty, Patrick M.; Chin, Wai; Mittleman, Robert S.

2015-01-01

Aims To evaluate the efficacy and safety of extended dosing with mipomersen in patients with familial hypercholesterolaemia (HC) taking maximally tolerated lipid-lowering therapy. Methods and results A planned interim analysis of an ongoing, open-label extension trial in patients (n = 141) with familial HC receiving a subcutaneous injection of 200 mg mipomersen weekly plus maximally tolerated lipid-lowering therapy for up to 104 weeks. The mean changes in low-density lipoprotein cholesterol (LDL-C) from baseline to weeks 26 (n = 130), 52 (n = 111), 76 (n = 66), and 104 (n = 53) were −28, −27, −27, and −28%; and in apolipoprotein B −29, −28, −30, and −31%, respectively. Reductions in total cholesterol, non-high-density lipoprotein-cholesterol, and lipoprotein(a) were comparable with decreases in LDL-C and apolipoprotein B levels. Mean high-density lipoprotein cholesterol increased from baseline by 7 and 6% at weeks 26 and 52, respectively. The long-term safety profile of mipomersen was similar to that reported in the associated randomized placebo-controlled Phase 3 trials. Adverse events included injection site reactions and flu-like symptoms. There was an incremental increase in the median liver fat during the initial 6–12 months that appeared to diminish with continued mipomersen exposure beyond 1 year and returned towards baseline 24 weeks after last drug dose suggestive of adaptation. The median alanine aminotransferase level showed a similar trend over time. Conclusion Long-term treatment with mipomersen for up to 104 weeks provided sustained reductions in all atherosclerotic lipoproteins measured and a safety profile consistent with prior controlled trials in these high-risk patient populations. Clinicaltrials.gov NCT00694109. PMID:24366918

Cause-Specific Mortality in HIV-Positive Patients Who Survived Ten Years after Starting Antiretroviral Therapy