Minimally-invasive-perventricular-device-occlusion versus surgical-closure for treating perimembranous-ventricular-septal-defect: 3-year outcomes of a multicenter randomized clinical trial

BACKGROUND: Minimally-invasive-perventricular-device-occlusion (MIPDO) combined superiority of surgical-repair and percutaneous-device-closure in treating perimembranous-ventricular-septal-defect (pmVSD). This study was to evaluate the efficacy and safety of MIPDO for treating pmVSD, comparing with surgical-repair. METHODS: Patients aged ≥3 months with isolated pmVSDs were randomized to undergo either surgical or MIPDO procedure, with the median follow-up time of 49 months. The primary outcome was the rate of complete pmVSD closure at discharge. The secondary outcomes included the adverse events during hospitalization and follow-up, chest tube output volume, blood transfusion volume, procedural duration, ventilation time, hospitalization duration and hospitalization cost. Also, perioperative cardiac performance and systemic conditions were evaluated. RESULTS: Of the 313 patients (9 months to 42 years old; median, 4 years old) with pmVSDs recruited from 3 centers, 100 were finally enrolled and randomly allocated 1:1 into two groups. The non-inferiority (non-inferiority margin −8.0%) of MIPDO to surgical closure regarding efficacy was shown in both intention-to-treat (0, 95% CI: −0.055 to 0.055) and per-protocol populations (0.02, 95% CI: −0.018 to 0.058). Although the rate of adverse events was similar between groups, the MIPDO group showed superiority in procedural duration, ventilation time, chest tube output volume, postoperative hospitalization time and hospitalization cost compared with surgical group (P<0.05). Moreover, MIPDO method showed comparable perioperative cardiac performance with milder change of systemic condition. CONCLUSIONS: In patients with pmVSDs, MIPDO method showed non-inferiority to surgical closure in efficacy for both intention-to-treat and per-protocol population with easier perioperative recovery, economic benefit and promising outcomes.