Feasibility and efficacy of transcatheter interatrial shunt devices for chronic heart failure: A systematic review and meta-analysis.

Abstract

AIMS\nTo assess the feasibility and efficacy of interatrial shunt devices (IASD) for the treatment of chronic heart failure (CHF).\n\n\nMETHODS\nMEDLINE and the Cochrane Central Register of Controlled Trials from inception until April 2021 were searched for prospective studies investigating dedicated transcatheter IASD for the treatment of CHF. Standardised mean differences were calculated for the within-group changes before and after implantation of the IASD. The predefined primary outcome was change in six-minute walking distance (6MWD) from baseline to 12\u2009months. Other outcomes were change in NYHA class, health-related quality of life (HRQoL), echocardiographic and hemodynamic data, device performance and safety. Subgroup analyses were crude univariable meta-regression analyses.\n\n\nRESULTS\nSix studies (five single-arm open-label studies, one sham-controlled trial) were included. In these, 226 patients underwent IASD implantation using four different devices. From baseline to 12\u2009months, 6MWD increased by 28.1\u2009m (95% CI: 10.9 to 45.3) with no evidence for a difference between devices (p for interaction\xa0=\xa00.66) and patients with left-ventricular ejection fraction (LVEF) >40% or\u2009≤\u200940% (p for interaction\xa0=\xa00.21). At 12\u2009months, HRQoL improved by 17.7 points (95% CI: 10.8 to 24.6) and pulmonary capillary wedge pressure (PCWP) decreased by 2.0\u2009mmHg (95% CI: -3.6 to -0.4), respectively. There were no changes in LVEF or NT-proBNP during follow-up. Shunt patency ranged from 50% for the first-generation v-Wave to 100% for the Corvia IASD II and the second-generation v-Wave system. The summary risk of serious adverse device-related effects was 8% (95% CI: 1 to 20) at 12\u2009months.\n\n\nCONCLUSION\nIASD implantation in CHF is feasible and associates with improved submaximal exercise capacity (measured by 6MWD) and HRQoL, and reductions in PCWP. This article is protected by copyright. All rights reserved.