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 = 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.
Highlights
To 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
Aortic valve disease characteristics were similar in both groups
Values are median unless indicated otherwise AV Aortic valve, BAV Balloon aortic valvuloplasty, CI Confidence interval, OR Odds ratio, PG Pressure gradient, TAVI Transcatheter aortic valve implantation versus 4.1%, p = 0.035); the unadjusted odds ratio supported a reduced risk in the no-BAV group, this was no longer significant in the adjusted analysis (Table 3)
Summary
To 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. Ashauer et al BMC Cardiovascular Disorders (2019) 19:172 of PV-leaks); 3) A limited balloon inflation can facilitate smooth introduction of the valve into the annulus. To address this lack of data, three prospective, multicenter, registry studies evaluated TAVI using the balloonexpandable Edwards SAPIEN prosthetic valves, with and without BAV, and found that direct TAVI was feasible, safe and provided adequate efficacy in a real-world setting [15,16,17] (Schymik G, Rudolph TK, Jacobshagen C, Rothe J, Treede H, Kerber S, Frank D, Sykorova L, Okamoto M, Thoenes M, et al Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation – findings from the EASE-IT TF multicentre registry, submitted). A meta-analysis of these three studies has been conducted to provide additional information on the use of TAVI without BAV in a real-world setting
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