Choice of vein-harvest technique for coronary artery bypass grafting: rationale and design of the REGROUP trial.

The Randomized Endo-vein Graft Prospective (REGROUP) trial (ClinicalTrials.gov NCT01850082) is a randomized, intent-to-treat, 2-arm, parallel-design, multicenter study funded by the Cooperative Studies Program (CSP No. 588) of the US Department of Veterans Affairs. Cardiac surgeons at 16 Veterans Affairs (VA) medical centers with technical expertise in performing both endoscopic vein harvesting (EVH) and open vein harvesting (OVH) were recruited as the REGROUP surgeon participants. Subjects requiring elective or urgent coronary artery bypass grafting using cardiopulmonary bypass with use of ≥1 saphenous vein graft will be screened for enrollment using pre-established inclusion/exclusion criteria. Enrolled subjects (planned N = 1150) will be randomized to 1 of the 2 arms (EVH or OVH) after an experienced vein harvester has been assigned. The primary outcomes measure is the rate of major adverse cardiac events (MACE), including death, myocardial infarction, or revascularization. Subject assessments will be performed at multiple times, including at baseline, intraoperatively, postoperatively, and at discharge (or 30 days after surgery, if still hospitalized). Assessment of leg-wound complications will be completed at 6 weeks after surgery. Telephone follow-ups will occur at 3-month intervals after surgery until the participating sites are decommissioned after the trial's completion (approximately 4.5 years after the full study startup). To assess long-term outcomes, centralized follow-up of MACE for 2 additional years will be centrally performed using VA and non-VA clinical and administrative databases. The primary MACE outcome will be compared between the 2 arms, EVH and OVH, at the end of the trial duration.

Early and late results of the surgical correction of cardiac prosthetic paravalvular leaks.

BACKGROUND AND AIM OF THE STUDY: Although the incidence of paravalular leaks, the most common cause of non-structural dysfunction after valve replacement, is well defined, the results of their surgical correction are not. Given the growing enthusiasm for interventional catheter-based correction of paravalvular leaks, a current surgical baseline against which to compare these results is important. METHODS: All patients who had surgical correction of an aortic or mitral paravalvular leak unrelated to acute bacterial endocarditis between 1986 and 2001 were identified from a computerized registry. Hospital records were reviewed, and follow up data obtained. RESULTS: A total of 136 consecutive patients (73 males, 63 females; mean age 64 years) underwent surgical correction of a paravalvular leak. Of the valves, 44 (32%) were aortic and 92 (68%) mitral. More than one previous cardiac operation had been performed in 68 patients (50%). In 107 patients (79%; 32 aortic (73%), 75 mitral (82%)), the leak was the primary indication for reoperation, while for 29 patients (21%; 12 aortic (27%), 17 mitral (18%)) the correction was secondary to another cardiac procedure. In 65 patients (48%; 12 aortic (27%), 53 (58%) mitral)) the leak was repaired primarily, while in 71 patients (52%; 32 aortic (73%), 39 (42%) mitral)) the prosthesis was replaced. Operative mortality was 6.6% (n = 9). There were no significant multivariable predictors of hospital death. Perioperative stroke occurred in seven cases (5.1%), and hospital stay was >14 days in 40 patients (29%). The 10-year Kaplan-Meier survival was 30 (CI 20-39)%. Ten-year actual versus actuarial freedom from repeat paravalvular leak was 84 (CI 68-92)% versus 63 (CI 49-76)%. CONCLUSION: Surgical correction of cardiac paravalvular leaks can be performed with acceptable mortality and morbidity. Patients with surgically corrected paravalvular leaks have a limited life expectancy, but reasonable freedom from recurrent paravalvular leak.

Endoscopic versus open saphenous vein harvest: a comparison of postoperative wound complications.

BACKGROUND: Wound complications associated with long incisions used to harvest the greater saphenous vein are well documented. Recent reports suggest that techniques of endoscopic vein harvest may result in decreased wound complications. A prospective, nonrandomized study was developed to compare outcomes of open versus endoscopic vein harvest procedures. METHODS: There were 106 patients in the open vein harvest group, and 154 patients in the endoscopic vein harvest group. Patient characteristics and demographics were similar in both groups. Wound complications identified were dehiscence, drainage for greater than 2 weeks postoperatively, cellulitis, hematoma, and seroma/lymphocele. RESULTS: Wound complications were significantly less in the endoscopic vein harvest group (9 of 133, 6.8%) versus the open vein harvest group (26 of 92, 28.3%), p less than 0.001. By multivariable analysis with logistic regression, the open vein harvest technique was the only risk factor for postoperative leg wound complication (relative risk 4.0). CONCLUSIONS: Endoscopic vein harvest offered improved patient outcomes in terms of wound healing compared with the open vein harvest technique.