Affiliation:
1. Department of Interventional Center of Valvular Heart Disease Beijing Anzhen Hospital Affiliated to Capital Medical University Beijing China
2. Center for Health Systems Research Sutter Health Sacramento CA USA
Abstract
AbstractThe efficacy and safety of new‐generation devices (NGDs) for severe aortic regurgitation (AR) have mostly been based on single‐arm studies with limited sample sizes. Our goal was to summarize the current evidence on NGDs and compare the safety and efficacy of ‘off‐label’ and ‘on‐label’ devices in NGDs. We searched MEDLINE, Embase, Cochrane Library, and Scopus for articles on transcatheter aortic valve replacement in patients with AR. A total of 31 studies that included 1851 patients were identified through April 2023. Among these, 1067 (57.6%) patients received treatment with ‘on‐label’ devices (JenaValve and J‐Valve). For NGDs, the total device success rate at 30 days was 94.5% (on‐label: 97.8%, off‐label: 89.9%; P < 0.001), the all‐cause mortality was 4.2% (on‐label: 2.6%, off‐label: 5.1%; P = 0.006), permanent pacemaker implantation (PPI) was 8.8% (on‐label: 6.9%, off‐label: 18.4%; P < 0.001), and the rate of greater‐than‐mild paravalvular leak (PVL) was 1.2% (on‐label: 0.9%, off‐label: 3.8%; P = 0.003). On‐label devices showed significantly better safety and efficacy in terms of the success rate, PPI, greater‐than‐mild PVL, and 30 day mortality than off‐label devices.