Efficacy and safety of a Venus A valve among Chinese patients undergoing transcatheter aortic valve replacement: a systematic review and single-arm meta-analysis.

Background: The Venus A valve is a first-generation self-expanding valve used in China for transcatheter aortic valve replacement (TAVR). However, data on its efficacy and safety remain limited. The present study assessed the efficacy and safety of the Venus A valve in Chinese patients undergoing TAVR. Methods: A single-arm meta-analysis was performed, and relevant studies were systematically retrieved from PubMed, Embase, Web of Science, the Cochrane Library, ClinicalTrials.gov, and Google Scholar from inception until 1 June 2022. Domestic libraries were not searched due to data overlap. All study types evaluating the Venus A valve were considered for inclusion, except case reports or reviews. Non-English language studies or those without corresponding data were excluded. The Newcastle-Ottawa scale (NOS) was used to evaluate the included retrospective studies, and the methodological index for non-randomized studies (MINORS) was used to assess the included non-randomized study (single-arm study). The random-effects model was used to calculate the combined proportion and 95% confidence interval (CI) when Results: This meta-analysis included 15 studies involving 1,144 Chinese patients who underwent TAVR with a Venus A valve. The device/procedure success rate was 90%. The mean transvalvular gradient decreased from 58.52 to 10.85 mmHg, and the peak jet velocity decreased from 4.86 s to 2.23 m/s. At the 30-day follow-up evaluation, the all-cause mortality rate was 3%. The requirement for a second valve accounted for 12% of cases. Major vascular complications were uncommon, as were major bleeding, stroke, acute kidney injuries, and new-onset atrial fibrillation. At the 1-year follow-up evaluation, the all-cause mortality rate was 7%. The incidence of new permanent pacemaker implantation in patients with bicuspid aortic valves was 16%, and the all-cause mortality rate was 8% at the 30-day follow-up evaluation. Conclusions: Despite its relatively high requirement for a second valve, the Venus A valve is feasible for Chinese patients undergoing TAVR. Its effectiveness and safety were demonstrated by a high device/procedure success rate, immediate hemodynamic improvement, and low incidence of complications.