Abstract Background Although Transcatheter Aortic Valve Implantation (TAVI) has gained ground in the management of severe aortic stenosis (AS), evidence about its safety and efficacy for patients with pure native aortic regurgitation (AR) remains limited. Purpose The aim of the study is to systematically review and summarize available data regarding the safety and the outcomes of TAVI in pure AR. Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 1, 2024, for studies assessing the characteristics and outcomes of patients undergoing TAVI for pure AR. Primary endpoint of our systematic review and meta-analysis is the in-hospital, 30-days and 1-year mortality rates. Secondary endpoints comprised in-hospital stroke, major bleeding, and permanent pacemaker implantation (PPM) implantation. Endpoint definitions followed the Valve Academic Research Consortium 2 criteria. The cumulative incidence of primary and secondary endpoints and the corresponding 95% confidence intervals (CI) were estimated. A random effects model (DerSimonian-Laird) was used to account for heterogeneity among the included studies. Results Our meta-analysis included a total of 22 studies and 6,710 patients undergoing TAVI for pure-AR. Our analysis showed that patients undergoing TAVI for pure AR had 3.4% (95% CI: 2%-4.7%), 7.9% (95% CI: 5.2%-10.6%) and 15.5% (95% CI: 9.9%-21.2%) in-hospital, 30-days and 1-year all-cause mortality. In-hospital stroke occurred in 1.9% (95% CI: 1.5%-2.2%) of the patients, while 4.9% (95% CI: 3.3%-6.6%) of the patients suffered from major bleeding events. Finally, considering the PPM implantation rates, patients had a 10.7% (95% CI: 7.4%-13.9%) in-hospital incidence. Conclusion Our systematic review and meta-analysis shows a promising safety profile for TAVI treating pure AR. It demonstrated relatively low in-hospital, 30-days and 1-year mortality incidence, comparable to the TAVI treating severe AS, according to the existing literature. Taking into consideration that TAVI for pure-AR might be the only therapeutic option for an increasing number of patients, further studies are needed to further assess the safety and efficacy of the procedure.TAVI for pure AR mortality rates
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