Transcatheter aortic valve replacement for pure aortic valve regurgitation: "on-label" versus "off-label" use of TAVR devices

Abstract

Introduction: Transcatheter aortic valve replacement (TAVR) has become the mainstay of treatment for aortic stenosis in patients with high surgical risk. Pure aortic regurgitation (PAR) is considered a relative contraindication for TAVR; however, TAVR is increasingly performed in PAR patients with unfavorable risk profile. Herein, we aim to summarize available data on TAVR for PAR with special emphasis on "on-label" versus "off-label" TAVR devices.

Methods and results: Pubmed was searched for studies of patients undergoing TAVR for PAR. Primary outcome was 30 day-mortality. Pooled estimated event rates were calculated. Twelve studies including a total of 640 patients were identified until December 2017. Among these, 208 (33%) patients were treated with devices with CE-mark approval for PAR ("on-label"; JenaValve and J valve). Overall, the procedural success rate was 89.9% (95% CI 81.1-96.1%; I² 80%). Major bleeding was reported in 6.4% (95% CI 2.9-10.8%; I² 48%). All-cause mortality at 30 days was 10.4% (95% CI 7.1-14.2%; I² 20%). Stroke occurred in 2.2% (95% CI 0.9-3.9%; I² 0%). A permanent pacemaker was required in 10.7% (95% CI 7.3-14.6%; I² 23%). At 30 days after TAVR, ≥ moderate AR post-interventional was observed in 11.5% (95% CI 2.9-23.6%; I² 90%). In the "on-label"-group, success rate was 93.0% (95% CI 85.9-98.1%; I² 52%). 30-day-mortality was 9.1% (95% CI 3.7-16.0%; I² 36%). More than trace AR was present in 2.8% (95% CI 0.1-7.6%; I² 0%). Compared to first-generation devices, second-generation devices were associated with significantly lower 30-day-mortality (r = - 0.10; p = 0.02), and significantly higher procedural success rates (r = 0.28; p < 0.001). Compared to other second-generation devices, the use of J valve or JenaValve was not associated with altered mortality (r = 0.04; p = 0.50), rates of > trace residual AR (r = - 0.05; p = 0.65) but with a significantly higher procedural success (r = 0.15; p = 0.042).

Conclusion: Based on this summary of available observational data TAVR for PAR is feasible and safe in patients deemed inoperable. First-generation TAVR devices are associated with inferior outcome and should be avoided. The "on-label" use of PAR-certified TAVR devices is associated with a significantly higher procedural success rate and might be favorable compared to other second-generation devices.

Keywords: Aortic insufficiency; Aortic regurgitation; TAVI; TAVR; Transcatheter aortic valve implantation; Transcatheter aortic valve replacement.