A randomized comparative study of patients undergoing myocardial revascularization with or without cardiopulmonary bypass surgery: The MASS III Trial

The MASS III Trial is a large project from a single institution, The Heart Institute of the University of Sao Paulo, Brazil (InCor), enrolling patients with coronary artery disease and preserved ventricular function. The aim of the MASS III Trial is to compare medical effectiveness, cerebral injury, quality of life, and the cost-effectiveness of coronary surgery with and without of cardiopulmonary bypass in patients with multivessel coronary disease referred for both strategies. The primary endpoint should be a composite of cardiovascular mortality, cerebrovascular accident, nonfatal myocardial infarction, and refractory angina requiring revascularization. The secondary end points in this trial include noncardiac mortality, presence and severity of angina, quality of life based on the SF-36 Questionnaire, and cost-effectiveness at discharge and at 5-year follow-up. In this scenario, we will analyze the cost of the initial procedure, hospital length of stay, resource utilization, repeat hospitalization, and repeat revascularization events during the follow-up. Exercise capacity will be assessed at 6-months, 12-months, and the end of follow-up. A neurocognitive evaluation will be assessed in a subset of subjects using the Brain Resource Center computerized neurocognitive battery. Furthermore, magnetic resonance imaging will be made to detect any cerebral injury before and after procedures in patients who undergo coronary artery surgery with and without cardiopulmonary bypass

Report of the Dutch experience with the Ross procedure in 343 patients

Objective: Limited information is available on outcome after auto-raft aortic valve replacement, in particular with respect to the durability of the autograft and of the allograft used to reconstruct the right ventricular outflow tract. A retrospective follow-up study of all patients who underwent a Ross procedure in the Netherlands since 1988 was done to obtain an overview of the Dutch experience with this procedure. Methods: From 1988 to January 2000, 348 Ross procedures were performed in nine centers in the Netherlands. Pre-operative, per-operative and follow-up data from 343 patients in seven centers (99% of all Dutch autograft patients) were collected and analyzed. Results: Mean patient age was 26 years (SD 14, range 0-58) and male/female ratio was 2.1. Bicuspid valve or other congenital heart valve disease was the most common indication for operation. The root replacement technique was used in 95% of patients and concomitant procedures were done in 12%. Hospital mortality was 2.6% (N = 9). Mean follow-up was 4 years (median 3.8. SD 2.8. range 0-12.5). Overall cumulative survival was 96% at 1 year (95% confidence interval (CI) 94-98%) and 94% at 5 and 7 post-operative years, respectively (95% CI 91-97%). At last follow-up, 87% of the surviving patients was in New York Heart Association (NYHA) class I. Independent predictors of overall mortality were pre-operative NYHA class IV/V and longer perfusion time. Autograft reoperation had to be performed in 14 patients and reintervention on the pulmonary allograft in 10 patients. Freedom from any valve-related reintervention was 88% at 7 years (95% CI 81-94%). Conclusions: The Dutch experience with the Ross procedure is favorable, with low operative mortality and good mid-term results. Although both the autograft in aortic position and the allograft in the right ventricular outflow tract have a limited durability, this has not yet resulted in considerable reoperation rates and associated morbidity and mortality. (C) 2002 Elsevier Science B.V. All rights reserved

The Association of Surgical Margins and Local Recurrence in Women with Ductal Carcinoma In Situ Treated with Breast-Conserving Therapy: A Meta-Analysis

PURPOSE: There is no consensus on adequate negative margins in breast-conserving surgery (BCS) for ductal carcinoma in-situ (DCIS). We systematically review the evidence on margins in BCS for DCIS. METHODS: Study-level meta-analysis of local recurrence (LR), microscopic margin status and threshold distance for negative margins. LR proportion was modelled using random-effects logistic meta-regression (frequentist), and network meta-analysis (Bayesian) that allows for multiple margin distances per study, adjusting for follow-up time. RESULTS: Based on 20 studies (LR: 865 of 7,883), odds of LR were associated with margin status (logistic: odds ratio (OR) 0.53 for negative vs positive/close [P<0.001]; network: OR=0.45 for negative vs positive). In logistic meta-regression, relative to >0 or 1mm, ORs for 2mm (0.51), 3 or 5mm (0.42) and 10mm (0.60) showed comparable significant reductions in the odds of LR. In the network analysis, ORs relative to positive margins for 2mm (0.32), 3mm (0.30) and 10mm (0.32) showed similar reductions in the odds of LR that were greater than for >0 or 1mm (0.45). There was weak evidence of lower odds at 2mm compared to >0 or 1mm (Relative OR=0.72, 95% credible interval [CrI] 0.47-1.08), and no evidence of a difference between 2mm and 10mm (Relative OR=0.99, 95% CrI 0.61-1.64). Adjustment for covariates, and analyses based only on studies using whole-breast radiotherapy, did not change findings. CONCLUSION: Negative margins in BCS for DCIS reduce the odds of LR; however, minimum margins distances above 2mm are not significantly associated with further reduced odds of LR in women receiving radiation