Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation.

Abstract

Background: Transcatheter aortic valve replacement (TAVR) for high surgical risk patients with severe native aortic regurgitation (AR) presents unique challenges. Dedicated devices such as the JenaValve (JenaValve Technology) and J-Valve (JC Medical Inc) show promising results in addressing these challenges.

Objectives: This study compares the safety and efficacy of dedicated vs off-label devices among high surgical risk patients with pure native AR.

Methods: We systematically searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials through July 11, 2024, for studies on TAVR among patients with pure severe native AR. The primary endpoint was 30-day all-cause mortality. Secondary endpoints were device success, residual AR ≥ moderate, valve embolization/migration, pacemaker implantation, reintervention, and all-cause mortality at 1 year. Summary estimates were constructed using a random effects model.

Results: A total of 34 studies encompassing 2,162 patients (mean age 75.4 ± 0.2, 42.8% women) were included in the meta-analysis. Patients undergoing TAVR with dedicated devices had a lower all-cause 30-day mortality rate (3% vs 9%; P < 0.01) and higher device success (93% vs 82%; P < 0.01) compared with off-label devices. The risk of AR ≥ moderate (2% vs 5%; P = 0.03), valve embolization/migration (2% vs 8%; P < 0.01), pacemaker implantation (11% vs 20%; P < 0.01), and reintervention (4% vs 10%; P < 0.01) at 30 days and all-cause mortality at 1 year (6% vs 24%; P < 0.01) were lower in the dedicated device group.

Conclusions: Dedicated TAVR devices for native AR show superior device success and reduced mortality, residual AR, and reintervention rates compared with off-label devices. These findings support the use of dedicated devices as a safer alternative for high-risk patients.