Early clinical and hemodynamic outcomes of balloon-expandable versus self-expanding transcatheter aortic valve replacement in patients with large aortic annulus: a study-level meta-analysis.

Purpose: This study aimed to compare early clinical and hemodynamic outcomes of transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis and large aortic annulus using either balloon-expandable valves (BEVs) or self-expanding valves (SEVs). Methods: A comprehensive search of PubMed, Scopus, and the Cochrane Central Register of Controlled Trials was conducted through September 10, 2023, to perform a meta-analysis comparing the clinical outcomes of BEV versus SEV for large aortic annulus (annulus perimeter ≥ 80 mm). Results: Seven studies (one propensity-matched study and six observational studies) met our eligibility criteria, including a total of 2167 patients (BEV, 1521; SEV, 646). The rates of procedural stroke (pooled odds ratio 0.55, 95% confidence interval 0.32-0.98), valve embolization (0.11, 0.05-0.24), need for second valve implantation (0.21, 0.17-0.26), permanent pacemaker implantation (0.43, 0.28-0.67), and aortic regurgitation ≥ moderate (0.23, 0.08-0.68) were significantly lower in the BEV group. Conversely, postoperative transvalvular gradient was significantly lower in the SEV group (pooled standard mean difference 0.55, 0.12-0.98). Subgroup analysis with newer-generation valves also showed significant differences in the need for second valve implantation and permanent pacemaker implantation, as well as aortic regurgitation ≥ moderate, favoring BEVs. Conclusions: BEV provides better early outcomes in TAVR for large aortic annulus in terms of lower rates of stroke, valve embolization, need for second valve, permanent pacemaker implantation, and aortic regurgitation ≥ moderate. Conversely, SEV provides a better transvalvular gradient in the early period after TAVR. Supplementary Information: The online version contains supplementary material available at 10.1007/s12055-024-01770-1.