Favorable mid-term performance of fully biodegradable implantable device for ventricular septal defect closure.

Abstract

To assess the mid-term safety and efficacy of transthoracic perimembranous ventricular septal defect (Pm-VSD) closure using a new biodegradable device. Implantation entailed right subaxillary minithoracotomy under transesophageal echocardiography guidance. Between October 2019 and January 2020, 13 patients (males, 5; mean age, 3.6±2.5years) with Pm-VSDs underwent transthoracic device closures at Zhengzhou University Central China Fuwai Hospital as described previously. Delivery pathways were established by manipulating a hollow probe from right atrium through tricuspid valve to right ventricle and then through VSDs to left ventricle, whereupon installation took place. All occluder implantations were successfully executed. Mean defect size was 4.1±1.0mm, and mean device waist size was 5.2±1.1mm. One patient (7.7%) with 1.5-mm residual shunt showed complete closure at discharge. There was 1 instance of postoperative incomplete right bundle branch block, which converted to complete right bundle branch block at month 1. During patient follow-up (mean, 24.6±0.8months), no device dislocations, new residual shunts, new valvular regurgitation, or detectable atrioventricular block ensued. Closure of Pm-VSDs using a novel, fully biodegradable occluder in the manner described has proven safe and effective at mid-term follow-up. Long-term safety and efficacy of this device must be further corroborated in a large patient cohort going forward.