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

Abstract

OBJECTIVES: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.