Abstract Body (Do not enter title and authors here):
Background: Transcatheter aortic valve replacement (TAVR) has become the primary treatment for severe aortic stenosis, surpassing surgery in multiple trials. However, there is limited evidence between self-expandable valves (SEV) and balloon-expandable valves (BEV). Therefore, we performed a systematic review and meta-analysis comparing the efficacy of SEV and BEV undergoing TAVR in severe aortic stenosis patients.
Methods: We systematically searched Pubmed, Cochrane, and Embase for randomized controlled trials (RCTs) comparing SEV and BEV in patients with severe aortic stenosis. Our primary endpoint was (1) All-cause mortality. Additionally, we reported the following secondary outcomes:(2) stroke, (3)all-cause mortality within 30 days, and (4) stroke within 30 days. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled across studies using a random-effects model.
Results: Our meta-analysis included six RCTs comprising 3488 patients, of whom 1617 subjects (46.3%) underwent SEV. The mean age was 81 years, and the mean follow-up was 2 years. In the pooled analysis, our results show no significant difference in all-cause mortality (RR: 0.95; CI 95%: 0.81,1.12; p= 0.56; Fig. 1A ) and stroke (RR:0.97; CI 95%: 0.72,1.32; p= 0.86; Fig. 2A) between SEV and BEV in patients with severe aortic stenosis undergoing TAVR. Our 30 days follow-up analysis also showed no significant change in all-cause mortality (RR: 1.74; CI 95%: 0.88,3.45; p= 0.11; Fig. 1B) and stroke (RR: 0.59; CI 95%: 0.17,1.98; p= 0.39; Fig. 2B).
Conclusion: In this meta-analysis comparing SEV versus BEV in patients undergoing TAVR in patients with severe aortic stenosis, there was no significant difference between all-cause mortality and stroke. These findings were consistent in our 30-day follow-up subanalysis.