Balloon-expandable transcatheter aortic valve implantation with or without pre-dilation – results of a meta-analysis of 3 multicenter registries

Abstract

BackgroundTo evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis.MethodsThe meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n\xa0=\u2009339) or without (n\xa0=\u2009355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes.ResultsMedian procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93\u2009min, p\xa0=\u20090.001), as was median fluoroscopy time (7 versus 11\u2009min, p\xa0=\u20090.001). Post-delivery balloon dilation (15.5% versus 22.4%, p\xa0=\u20090.02) and catecholamine use (9.0% vs. 17.9%; p\xa0=\u20090.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p\xa0=\u20090.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30.ConclusionsThis patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.