Safety and efficacy of transcatheter aortic valve replacement for native aortic valve regurgitation: A systematic review and meta-analysis.

Objective: The objective of this study was to analyze the available literature on using transcatheter aortic valve replacement (TAVR) for native aortic regurgitation (AR). Background: Surgical aortic valve replacement is the gold standard therapy for native AR. TAVR has emerged as an alternative approach in high-risk patients. Methods: MEDLINE, Scopus, and Cochrane CENTRAL were searched for reports of at least 5 patients undergoing TAVR for native AR. Outcomes included 30-day mortality, myocardial infarction, stroke, major bleeding, postprocedural moderate to severe AR, and device success. Pooled estimates were calculated using a random-effects model. Subgroup analysis and a meta-regression were performed to study the effects of study level covariates on outcomes. Results: Nineteen studies (n = 998 patients) were included. The rate of procedural success per Valve Academic Research Consortium - 2 (VARC-2) criteria was 86.2% (78.8%-92.2%]. Thirty-day mortality was 11.9% (9.4%-14.7%). Subgroup analysis showed the use of new generation valves was associated with lower 30-day mortality (P = 0.02) and higher device success (P = 0.009) compared with early generation valves. There was no significant difference (P = 0.13) in the rate of 30-day mortality between patients receiving purpose-specific [8.2% (4.3%-13.1%); I2 = 0%] and nonpurpose specific valves [13.0% (8.2%-18.6%); I2 = 25%]. However, device success was higher (P = 0.02) in patients who received purpose-specific valves [96.3% (92.2%-98.9%); I2 = 0%] compared with nonpurpose specific valves [84.4% (75%-91.9%); I2 = 46%]. Conclusion: TAVR for native AR is associated with acceptable procedural success but increased early mortality. However, the safety and the efficacy of the procedure increased with newer valves.