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Comparison of Outcomes of Balloon-Expandable Versus Self-Expandable Transcatheter Heart Valves for Severe Aortic Stenosis.

Am J Cardiol. 2017 Jan 5. pii: S0002-9149(16)32016-1. doi: 10.1016/j.amjcard.2016.12.016. [Epub ahead of print]

Wijeysundera HC, Qiu F, Koh M, Prasad TJ, Cantor WJ, Cheema A, Chu MW, Czarnecki A, Feindel C, Fremes SE, Kingsbury KJ, Natarajan MK, Peterson M, Ruel M, Strauss B, Ko DT.

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Abstract

Transcatheter aortic valve implantation (TAVI) is the treatment of choice for inoperable and high-risk patients with severe aortic stenosis. Our objectives were to elucidate potential differences in clinical outcomes and safety between balloon-expandable versus self-expandable transcatheter heart valves (THV). We performed a retrospective cohort study of all transfemoral TAVI procedures in Ontario, Canada, from 2007 to 2013. Patients were categorized into either balloon-expandable or self-expandable THV groups. The primary outcomes were 30-day and 1-year death, with secondary outcomes of all-cause readmission. Safety outcomes included bleeding, permanent pacemaker implantation, need for a second THV device, postprocedural paravalvular aortic regurgitation, stroke, vascular access complication, and intensive care unit length of stay. Inverse probability of treatment-weighted regression analyses using a propensity score were used to account for differences in baseline confounders. Our cohort consisted of 714 patients, of whom 397 received a self-expandable THV, whereas 317 had a balloon-expandable THV system. There were no differences in death or all-cause readmission. In terms of safety, the self-expandable group was associated with significantly higher rates of inhospital stroke (p value <0.05), need for a second THV device (5.3% vs 2.7%; p value = 0.013), and permanent pacemaker (22.6% vs 8.9%; p value <0.001), whereas the balloon-expandable group had more vascular access site complications (23.1% vs 16.7%; p value = 0.002). Thus, we found similar clinical outcomes of death or readmission for patients who underwent transfemoral TAVI with either balloon-expandable or self-expandable THV systems. However, there were important differences in their safety profiles.

Copyright © 2017 Elsevier Inc. All rights reserved.

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