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In a randomized trial, 5243 patients undergoing cardiac surgery were assigned to a restrictive or a liberal red-cell transfusion threshold. The restrictive threshold was noninferior to the liberal one for the composite outcome of death, myocardial infarction, stroke, or renal failure.

Asymptomatic patients with very severe aortic stenosis were randomly assigned to either early valve-replacement surgery or conservative care. At a median of 6 years of follow-up, the composite of operative mortality or death from cardiovascular causes occurred less frequently in the early-surgery group.

In a randomized trial involving more than 2000 patients, transcatheter aortic-valve replacement was noninferior to surgical replacement in the primary end point of death from any cause or disabling stroke at 2 years. Transcatheter aortic-valve replacement (TAVR) is a new therapy for patients with severe aortic stenosis who are not candidates for surgery 1 , 2 or who are at high risk for complications due to surgery. 3 , 4 The acceptance of the use of TAVR in high-risk patients was based on evidence from clinical trials 5 , 6 that used early-generation TAVR devices; these procedures were associated with considerable procedure-related complications. 7 – 9 Recently, increased operator experience and enhanced transcatheter valve systems have led to a worldwide trend to use TAVR in patients who are at low or intermediate risk. 10 – 12 This trend has been evaluated in small . . .

Intermediate-risk patients with aortic stenosis were randomly assigned to undergo either transcatheter or surgical aortic-valve replacement. At 5 years, there was no significant difference between the two groups in the incidence of death or disabling stroke. The incidence of aortic regurgitation was higher with transcatheter AVR.

In this randomized trial comparing ACGME duty-hour policies with more flexible policies for surgical residents, the flexible policies resulted in noninferior patient outcomes and no significant difference in residents' satisfaction with overall well-being and education quality. In response to concerns about patient safety and resident well-being, the Accreditation Council for Graduate Medical Education (ACGME) introduced national regulations in 2003 that limited resident duty periods to 80 hours per week, capped overnight shift lengths, and mandated minimum time off between shifts. 1 , 2 Concerns persisted, 3 and in 2011, the ACGME implemented further restrictions to shorten maximum shift lengths for interns and increase time off after overnight on-call duty for residents. 1 , 4 , 5 Although most observers agree that some duty-hour regulation was necessary, critics cite a weak evidence base for the 2003 and 2011 reforms. 3 , 6 , 7 Several retrospective . . .

In this large randomized trial involving patients undergoing cardiac surgery who were at moderate-to-high risk, the outcomes at 6 months show that a restrictive red-cell transfusion strategy was noninferior to a liberal strategy with respect to the composite outcome.

Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3·1 years (SD 1·0). The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients (90 [7% per year]) in the no-testing group than patients who did receive it (104 [8% per year]; HR 0·86, 95% CI 0·65–1·14; pnon-inferiority <0·0001). The first safety composite outcome occurred in 69 (5·6%) of 1236 patients with no-testing and in 81 (6·5%) of 1242 patients with defibrillation testing, p=0·33. The second, pre-specified safety composite outcome, which included only events most likely to be directly caused by testing, occurred in 3·2% of patients with no-testing and in 4·5% with defibrillation testing, p=0·08. Heart failure needing intravenous treatment with inotropes or diuretics was the most common adverse event (in 20 [2%] of 1236 patients in the no-testing group vs 28 [2%] of 1242 patients in the testing group, p=0·25). Routine defibrillation testing at the time of ICD implantation is generally well tolerated, but does not improve shock efficacy or reduce arrhythmic death. Boston Scientific and the Heart and Stroke Foundation (Ontario Provincial office).

Postoperative pancreatic fistula is a common complication of pancreatic surgery. In this trial, patients undergoing pancreatic resection who received pasireotide, a somatostatin analogue, had a decreased occurrence of postoperative pancreatic fistula, leak, or abscess. Although mortality after pancreatectomy has decreased to approximately 2% at high-volume centers, the operative morbidity after these procedures has remained between 30% and 50%. 1 , 2 Postoperative pancreatic fistula, leak, and abscess are complications that result from leakage of pancreatic exocrine secretions at the anastomosis or closure of the pancreatic remnant. Postoperative pancreatic fistula is the most common major complication after pancreatectomy, with reported rates between 10% and 28%. Studies suggest that patients in whom postoperative pancreatic fistula develops have a risk of death that is approximately doubled. 3 , 4 Because of the magnitude of this problem, numerous studies have investigated methods . . .

In this report from the Swedish Obese Subjects study, the rate of incident type 2 diabetes in usual-care and bariatric-surgery groups was 28.4 and 6.8 cases per 1000 person-years, respectively. These findings suggest that surgery is much more efficient than usual care. Multiple studies have shown associations between obesity and type 2 diabetes 1 – 6 and between changes in body weight and incident type 2 diabetes. 7 , 8 It is also well established that the worldwide increase in obesity is associated with an increase in the prevalence of type 2 diabetes. 9 Currently, 285 million people have type 2 diabetes, and this number is predicted to increase to 439 million by 2030. 10 Among persons in a prediabetic state, the incidence of type 2 diabetes is reduced by approximately 40 to 45% with effective lifestyle changes or drug treatment, 11 – 15 and the effects persist, in part, . . .

Objective To assess the three year clinical outcomes and cost effectiveness of a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair for patients with suspected ruptured abdominal aortic aneurysm.Design Randomised controlled trial.Setting 30 vascular centres (29 in UK, one in Canada), 2009-16.Participants 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm, of whom 502 underwent emergency repair for rupture.Interventions 316 patients were randomised to an endovascular strategy (275 with confirmed rupture) and 297 to open repair (261 with confirmed rupture).Main outcome measures Mortality, with reinterventions after aneurysm repair, quality of life, and hospital costs to three years as secondary measures.Results The maximum follow-up for mortality was 7.1 years, with two patients in each group lost to follow-up by three years. After similar mortality by 90 days, in the mid-term (three months to three years) there were fewer deaths in the endovascular than the open repair group (hazard ratio 0.57, 95% confidence interval 0.36 to 0.90), leading to lower mortality at three years (48% v 56%), but by seven years mortality was about 60% in each group (hazard ratio 0.92, 0.75 to 1.13). Results for the 502 patients with repaired ruptures were more pronounced: three year mortality was lower in the endovascular strategy group (42% v 54%; odds ratio 0.62, 0.43 to 0.88), but after seven years there was no clear difference between the groups (hazard ratio 0.86, 0.68 to 1.08). Reintervention rates up to three years were not significantly different between the randomised groups (hazard ratio 1.02, 0.79 to 1.32); the initial rapid rate of reinterventions was followed by a much slower mid-term reintervention rate in both groups. The early higher average quality of life in the endovascular strategy versus open repair group, coupled with the lower mortality at three years, led to a gain in average quality adjusted life years (QALYs) at three years of 0.17 (95% confidence interval 0.00 to 0.33). The endovascular strategy group spent fewer days in hospital and had lower average costs of −£2605 (95% confidence interval −£5966 to £702) (about €2813; $3439). The probability that the endovascular strategy is cost effective was >90% at all levels of willingness to pay for a QALY gain.Conclusions At three years, compared with open repair, an endovascular strategy for suspected ruptured abdominal aortic aneurysm was associated with a survival advantage, a gain in QALYs, similar levels of reintervention, and reduced costs, and this strategy was cost effective. These findings support the increasing use of an endovascular strategy, with wider availability of emergency endovascular repair.Trial registration Current Controlled Trials ISRCTN48334791; ClinicalTrials NCT00746122.