RT Journal Article
SR Electronic
T1 Minimally invasive perventricular versus open surgical ventricular septal defect closure in infants and children: a randomised clinical trial
JF Heart
JO Heart
FD BMJ Publishing Group Ltd and British Cardiovascular Society
SP 2035
OP 2043
DO 10.1136/heartjnl-2017-312793
VO 104
IS 24
A1 Hong Liu
A1 Feng-xia Lu
A1 Jie Zhou
A1 Fei Yan
A1 Si-chong Qian
A1 Xin-ya Li
A1 Si-qiang Zheng
A1 Jun-quan Chen
A1 Ji-sheng Zhong
A1 Qiao-Ling Feng
A1 Tong Ding
A1 Jun Fan
A1 Hai-tao Gu
A1 Xiao-cheng Liu
YR 2018
UL http://heart.bmj.com/content/104/24/2035.abstract
AB 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.