• Jannik Ole Ashauer, Nikolaos Bonaros, Markus Kofler, Gerhard Schymik, Christian Butter, Mauro Romano, Vinayak Bapat, Justus Strauch, Holger Schröfel, Andreas Busjahn, Cornelia Deutsch, Peter Bramlage, Jana Kurucova, Martin Thoenes, Stephan Baldus, and Tanja K Rudolph.
• Department of Cardiology, University of Cologne Heart Center, Cologne, Germany.
• Bmc Cardiovasc Disor. 2019 Jul 19; 19 (1): 172.

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 = 339) or without (n = 355) 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 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) 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 = 0.035) 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.

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