A prospective randomized comparison of Medtronic Mosaic and Carpentier-Edwards-SAV in the aortic position: an interim report.

BACKGROUND AND AIM OF THE STUDY: The study aim was to compare prospectively the clinical performance and long-term durability of the Medtronic Mosaic and Carpentier-Edwards porcine (CE-SAV) bioprostheses in the aortic position over 10 years. METHODS: Between January 2001 and July 2003, a total of 242 patients undergoing bioprosthetic aortic valve replacement (AVR) were prospectively randomized to receive either Medtronic Mosaic (n = 126) or CE-SAV (n = 116) valves, and followed up annually. RESULTS: The mean follow up period was 1.7 +/- 0.8 years; total follow up was 411 patient-years. Early mortality and 40-month actuarial survival were 5.5% and 93 +/- 1% for the Mosaic valve, and 2.6% and 90 +/- 1% for the CE-SAV. Among patients, 78% showed symptomatic improvement in their NYHA functional class after AVR. To date there have been no structural failures, and one patient required reoperation for prosthetic valve (Mosaic) endocarditis. Early thromboembolic events occurred in 2.9% of patients (two Mosaic, five CE-SAV). Echocardiographic evaluations between the two valves demonstrated comparable hemodynamic performance for a given size at one year after surgery. CONCLUSION: At this stage of the study there were no differences in clinical or hemodynamic outcome in patients undergoing AVR using either the Mosaic or CE-SAV porcine xenograft.

Single-layer versus multiple-layer closure of leg wounds after long saphenous vein harvest: a prospective randomized trial.

BACKGROUND: The long saphenous vein harvested by traditional techniques is an important conduit for coronary artery bypass grafting (CABG). The purpose of this study was to determine if a single-layer closure over a drain improved wound healing compared with the traditional two-layer closure after harvest. METHODS: Seventy-eight consecutive patients undergoing CABG were prospectively randomized to have their leg wound closed by either a single-layer technique with a suction drain or multiple layers. All wounds were assessed using the additional treatment, presence of serous discharge, erythema, purulent exudate, and separation of the deep tissues, isolation of bacteria, and the duration of inpatient stay (ASEPSIS) score postoperatively and 6 weeks later. RESULTS: Forty-four patients (5 females) had their wound closed by the single-layer technique and 34 (6 females) closed in multiple layers. The ASEPSIS scores were significantly lower (p = 0.001) in those patients closed with a single layer (mean, 4.4) than those with multiple layers (mean, 6.8). Patients whose legs were closed with the single-layer technique had less peripheral edema compared with the multiple-layer group (chi2, p < 0.001). Using univariate analysis there was no correlation between ASEPSIS scores and length of wound incision (p = 0.49), whereas increasing age was found to have a weak positive correlation (r =0.24; p = 0.04). CONCLUSIONS: Single-layer leg wound closure over a suction drain is superior to the traditional multiple-layer closure. A possible mechanism of better wound healing in the former technique might be through decreased tissue handling and a reduction in leg edema.

Safety and efficacy of perioperative cell salvage and autotransfusion after coronary artery bypass grafting: a randomized trial.

BACKGROUND: The aim of this study was to ascertain whether cell salvage and autotransfusion after first time elective coronary artery bypass grafting is associated with a significant reduction in the use of homologous blood, a clinically significant derangement of postoperative clotting profiles, or an increased risk of postoperative bleeding. METHODS: Patients were randomized to autotransfusion (n = 98) receiving autotransfused washed blood from intraoperative cell salvage and postoperative mediastinal fluid cell salvage after coronary artery bypass surgery or control (n = 102) receiving stored homologous blood only after coronary artery bypass surgery. RESULTS: There was no statistical difference between the groups in terms of demographics, comorbidity, risk stratification, or operative details. Mean volume of blood autotransfused was 367 +/- 113 mL. Patients in the autotransfusion group were significantly less likely to receive a homologous blood transfusion compared with controls (odds ratio 0.40, 95% confidence interval [CI] 0.22-0.71) and received significantly fewer units of blood per patient compared with controls (0.43 +/- 1.5 vs 0.90 +/- 2.0 U, p = 0.02). There was no difference between the groups in terms of postoperative blood loss, fluid requirements, blood product requirements, or in the incidence of adverse clinical events (p = NS chi(2)). Autotransfusion did not produce any significant derangement of thromboelastograph values or laboratory measures of clotting pathway function (prothrombin time, activated partial thromboplastin time, fibrinogen, and fibrinogen D-dimer levels) when compared with the effect of homologous blood transfusion (p = NS, repeated measures analysis of variance [MANOVA]). CONCLUSIONS: Autotransfusion is a safe and effective method of reducing the use of homologous bank blood after routine first time coronary artery bypass grafting.