On-label TAVR devices for severe aortic regurgitation showed significantly better 30-day device success (97.8% vs 89.9%; P<0.001) and lower mortality (2.6% vs 5.1%; P=0.006) than off-label devices.
Meta-Analysis (n=1,851)
Does transcatheter aortic valve replacement with 'on-label' devices improve procedural success and safety compared to 'off-label' devices in patients with severe aortic regurgitation?
In patients with severe aortic regurgitation undergoing TAVR, the use of dedicated 'on-label' devices is associated with higher procedural success and lower 30-day mortality compared to 'off-label' devices.
Tasa de eventos absoluta: 97.8% vs 89.9%
valor p: p=< 0.001
The 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.
Liu et al. (Wed,) conducted a meta-analysis in severe aortic regurgitation (n=1,851). On-label devices (JenaValve and J-Valve) vs. Off-label devices was evaluated on Total device success rate at 30 days (p=< 0.001). On-label TAVR devices for severe aortic regurgitation showed significantly better 30-day device success (97.8% vs 89.9%; P<0.001) and lower mortality (2.6% vs 5.1%; P=0.006) than off-label devices.