Comparative Effectiveness and Safety of Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Abstract

Background: Transcatheter aortic valve replacement (TAVR) is a safe alternative to surgical aortic valve replacement for patients with symptomatic severe aortic stenosis at increased surgical risk. However, comparative data on self-expanding valves (SEV) versus balloon-expanding valves (BEV) remain limited.

Methods: A comprehensive review of PubMed and Embase was conducted through April 2024, identifying eight studies (five randomized controlled trials and three propensity-matched observational studies) comparing SEV and BEV in TAVR. Primary outcomes included all-cause mortality, cardiovascular mortality, and device success per Valve Academic Research Consortium criteria, while secondary outcomes assessed bioprosthetic valve dysfunction and adverse events (annulus rupture/dissection, coronary artery occlusion, valve dislocation/embolization, valve thrombosis, moderate and severe paravalvular aortic regurgitation, endocarditis, permanent pacemaker implantation, major or life-threatening bleeding, acute kidney injury, and stroke).

Results: The analysis included 4,032 patients (SEV = 2,006; BEV = 2,017). SEV was associated with higher rates of moderate-to-severe paravalvular aortic regurgitation [OR, 1.76; CI 1.13-2.74; P = 0.01] and permanent pacemaker placement [OR, 1.57; CI, 1.23-2.00; P = 0.0002] compared to BEV. No significant differences were observed in 30-day or 1-year all-cause mortality, cardiovascular mortality, device success, bioprosthetic valve dysfunction, valve dislocation/embolization, valve thrombosis, endocarditis, major or life-threatening bleeding, coronary artery occlusion, stroke, rehospitalization, or acute kidney injury.

Conclusion: SEV and BEV demonstrated comparable outcomes in mortality and device success. However, the higher risk of moderate-to-severe paravalvular aortic regurgitation and permanent pacemaker placement with SEV should be considered when selecting the optimal TAVR valve for individual patients.