Efficacy and safety of the LifeTech™ Multifunctional Occluder (Konar-MFO) in transcatheter closure of ventricular septal defects: a systematic review and meta-analysis

Abstract

Ventricular septal defect (VSD) constitutes nearly 40% of congenital heart defects, and around 60% are perimembranous in origin. Transcatheter closure of VSDs has gained popularity in recent years due to its less invasiveness, shorter duration of hospital stays, and avoidance of complications associated with cardiopulmonary-bypass-related conditions. The main emerging issues with the transcatheter closure approach are the development of complete atrioventricular block and valvular injury. LifeTech (TM) Multifunctional Occluder (Konar-MFO) is a novel device, recently approved by CE in 2018, that affirms to minimize damage to adjacent structures and reduces rhythm complications compared to its counterparts. There have been studies evaluating efficacy and safety of Konar-MFO, but a meta-analysis of these studies has not been conducted yet. Hence, the study aims to close this gap in literature. According to PRISMA guidelines, Pubmed, Cochrane Library, Medline (OVID), Scopus, Web of Science and CINAHL databases were searched for original studies published from January, 2018 to November, 2024 by using appropriate Medical Subject Headings (MeSH) terms and keywords related to VSD closure and Konar-MFO occluder. Peer-reviewed articles on Konar-MFO use in closure of perimembranous and/or muscular VSD across all age groups were considered eligible. A total of 19 studies comprising 839 patients were included in this study. The overall estimated device implementation success rate was 94.2% (95% CI: 90.1-96.5; Q test: p < 0.001; I-2 = 63.1). Device embolization was observed in 4.1% (95% CI: 2.8-6.0; Q test: p = 0.710 I-2 = 0%) of procedures. On follow-up of the patients after the procedure, complete atrioventricular block was observed in 2.3% (95% CI: 2.3-5.6; Q test: p = 0.697; I-2 = 0%) of the patients. The incidence of new-onset aortic valve regurgitation (AR) and tricuspid valve regurgitation (TR) after the procedure was 4.4% (95% CI: 3.0-6.4; Q test: p = 0.684; I-2 = 0% and 3.7% (95% CI: 1.9-7.3; Q test: p = 0.000; I-2 = 64.3%) respectively. The pooled incidence of other arrhythmias, including RBBB, LBBB, 1st and 2nd atrioventricular block, were 4.5% (95% CI: 6.3-16.1; Q test: p < 0.001; I-2 = 82.9%). The incidence of complete atrioventricular (cAVB) block observed in follow-up was low. The prevalence of new onset aortic valve regurgitation (AR) and tricuspid valve regurgitation (TR) seen after the procedure is important due to the risk of progression associated with these defects and may require follow-up if detected. Even though the estimated incidence rate is low, bundle branch blocks and other fascicular blocks require attention due to the potential risk of causing ventricular dysfunction.