Outcomes of perventricular off-pump versus conventional closure of ventricular septal defects: a prospective randomized study.

Abstract

Perventricular device closure (PVDC) of ventricular septal defects (VSDs) has demonstrated excellent clinical results. However, no prospective studies have compared PVDC with the conventional approach (CA). Between June 2012 and August 2014, 640 consecutive patients with isolated VSD were enrolled in the study, and randomized into the PVDC group ( n = 320) and the CA group ( n = 320). The mean ages were 36.2 (10; 36) months and 36.2 (10; 36) months, respectively. The average weights were 13.9 (8.1; 15.0) kg and 14.5 (6.9; 13.8) kg, respectively. The mean follow-up was 24.9 (standard deviation 1.8) months. No early or late deaths occurred in either group. The procedural success rate reached 96.6% in the PVDC group, with a 3.4% conversion rate to CA. Mean procedure time was 56.9 (30; 70) min in the PVDC group and 162 (120; 180) min in the CA group ( P = 0.000). Thirteen (3.9%) patients in the CA group and only 4 (1.3%) in the PVDC group required postoperative blood transfusion in the intensive care unit ( P = 0.040). At the final follow-up, significantly more residual shunts were found in the CA group. No rhythm or conduction disorders occurred in any patient of either group. According to the mid-term follow-up results, PVDC has similar efficacy to CA for VSD closure. The off-pump PVDC technique reduces blood product transfusion and the procedural time and minimizes surgical trauma while providing excellent cosmetic results.