Balloon-expandable valves significantly reduced all-cause mortality compared to self-expanding valves in patients undergoing TAVI (OR 0.89, p=0.01).
Meta-Analysis
Do balloon-expandable valves improve clinical and procedural outcomes compared to self-expanding valves in patients undergoing TAVI for severe aortic stenosis?
In patients undergoing TAVI for severe aortic stenosis, balloon-expandable valves are associated with lower all-cause mortality, stroke, pacemaker implantation, and paravalvular leak compared to self-expanding valves.
Odds Ratio: 0.89
p-value: p=0.01
Abstract Introduction Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic severe aortic stenosis, with two primary valve types: balloon-expandable (BE) and self-expanding (SE) prostheses. BE valves offer precise deployment with rapid post-dilation stability but may be associated with higher radial forces and increased risk of annular rupture. SE valves provide continuous expansion and adaptability to anatomical variations, potentially reducing conduction disturbances but carrying a higher risk of paravalvular leak. Purpose This meta-analysis aims to compare the clinical and procedural outcomes of balloon-expandable (BE) versus self-expanding (SE) valves in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis. By evaluating key endpoints such as mortality, stroke, pacemaker implantation, and paravalvular leak, this study seeks to provide insights into the relative efficacy and safety of these two valve types, aiding in the optimization of TAVI outcomes. Methodology A systematic review and meta-analysis were conducted following PRISMA guidelines. A comprehensive literature search was performed across PubMed, Embase, and Cochrane databases for studies comparing balloon-expandable (BE) and self-expanding (SE) valves in TAVI patients. Inclusion criteria encompassed randomized controlled trials and observational studies reporting clinical and procedural outcomes.. Pooled effect sizes were calculated using random-effects model. A total of 16 studies were analyzed using Revman 5..4.1 software. Results In this meta-analysis of 16 studies, balloon-expandable valves (BEV) were associated with an 11% reduction in all-cause mortality compared to self-expanding valves (SEV) (OR = 0.89, p = 0.01). Cardiovascular mortality showed no significant difference between the two valve types (OR= 0.96, p= 0.58). BEV significantly reduced the risk of stroke by 20% (OR = 0.80, p = 0.001), while rehospitalization for heart failure remained incomparable between both groups (OR = 0.90, p = 0.75). Major adverse cardiovascular and cerebrovascular events (MACCE) also showed no significant difference (OR = 0.90, p = 0.58). However, BEV significantly lowered the need for permanent pacemaker implantation by 37% (OR = 0.63, p 0.0001) and reduced the incidence of paravalvular leak by 58% (OR = 0.42, p 0.00001). Conclusion This meta-analysis suggests that balloon-expandable valves (BEV) offer significant advantages over self-expanding valves (SEV) in TAVI patients, including lower all-cause mortality, reduced stroke risk, fewer permanent pacemaker implantations, and a significantly lower incidence of paravalvular leak. However, cardiovascular mortality, rehospitalization for heart failure, and MACCE showed no significant differences. These findings highlight the potential benefits of BEV in optimizing TAVI outcomes.
Ranasinghe et al. (Sat,) conducted a meta-analysis in severe aortic stenosis. Balloon-expandable valves vs. Self-expanding valves was evaluated on all-cause mortality (OR 0.89, p=0.01). Balloon-expandable valves significantly reduced all-cause mortality compared to self-expanding valves in patients undergoing TAVI (OR 0.89, p=0.01).