Background Robust evidence is lacking regarding the clinical efficacy, safety and cardiopulmonary performance of perventricular closure. This study investigated the perioperative efficacy, safety and cardiorespiratory performance of perventricular closure of perimembranous ventricular septal defects (pmVSDs).
Methods Operation-naïve infants and young children aged 5–60 months with isolated pmVSDs were randomised to receive either standard open surgical or minimally invasive perventricular closure via direct entry into the ventricle with a catheter from a subxiphoid incision. The primary outcomes included complete closure at discharge, major and minor adverse events and the changes in perioperative cardiorespiratory performance from baseline. Complete closure was mainly analysed in the modified intention-to-treat (mITT) population, with sensitivity analyses for the ITT, per-protocol (PP) and as-treated (AT) populations (non-inferiority margin −5.0%).
Results We recruited 200 patients with pmVSDs for this study (mean age 24.38 months, range 7–58 months, 104 girls), of whom 100 were randomly allocated to one of the study groups. The non-inferiority of perventricular to surgical closure regarding complete closure at discharge was not shown in the ITT (absolute difference −0.010 (95% CI −0.078 to 0.058)) and mITT populations (−0.010 (95% CI −0.069 to 0.048)), but was shown in the PP (0.010 (95% CI −0.043 to 0.062)) and AT populations (0.048 (95% CI −0.009 to 0.106)). Perventricular closure reduced the rate of compromising cardiac haemodynamics, electrophysiological responses, cardiomyocyte viability, respiratory mechanics, ventilatory and gas exchange function and oxygenation and tissue perfusion compared with surgical closure (all between-group P<0.05).
Conclusions For infants and young children with pmVSD, perventricular closure reduced the rate of postoperative cardiorespiratory compromise compared with surgical closure, but the non-inferiority regarding complete closure should be interpreted in the context of the specific population.
Trial registration number NCT02794584 ;Results.
- congenital heart disease surgery
- ventricular septal defect
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HL, F-L, JZ and FY contributed equally.
Contributors HL and HG developed the study concept and design, drafted the protocol and analysis plan, and drafted the manuscript. All authors coordinated protocol implementation, acquisition, analysis, or interpretation of data. All authors contributed to the interpretation of the findings as well as critical revision of the manuscript for important intellectual content, and approved the final version of the report. XL and HG were responsible for administration and supervision of this study as well as technical or material support.
Funding HL was supported by the Innovation Patents Program of State Intellectual Property Office of China (CN104091094A, CN104091062A) and Graduate Practice Innovation Program of Jiangsu Higher Schools (SJZZ20140118). H-tG was supported by the Priority Academic Development Program of Jiangsu Higher Education Institutions (JX10231081) and Innovation Award of Jiangsu Med-Tech Introduction (JPH-2014035). X-cL was supported by National Clinical Key Specialty Construction Projects of China. FY was supported by National Natural Science Foundation of China (grant 81571701).
Competing interests None declared.
Patient consent Parental/guardian consent obtained.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data are included in this manuscript and supplemental material.