Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort.

Astrid Van Nieuwkerk ,Katia Orvin,Mattia Lunardi,Jan Baan,Ronak Delewi,Nicolas Dumonteil,Samantha Sartori,Giuseppe Tarantini,Azeem Latib,Matteo Pagnesi,Marco Barbanti,Alexandre Abizaid,Jan J Piek,Juan Manuel Nogales-Asensio,Paola D’Errigo,Flavio Ribichini,Roxana Mehran,Angie Ghattas,Leire Andraka,Augusto D’Onofrio,Francisco Ten,Ran Kornowski,George Dangas,Raquel B Santos ,Didier Tchétché ,Fábio Sândoli De Brito

doi:10.3390/jcm10174005

Abstract

Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. Results: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0–12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02–1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86–1.37, p = 0.48). Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.

Highlights

Transcatheter aortic valve implantation (TAVI) is a life-saving treatment for patients with severe aortic valve stenosis
The absence of device success was associated with higher one-year mortality (Odds Ratio (OR) 4.14, 95%confidence interval (CI) 3.23–5.30, p < 0.001)
Permanent pacemaker implantation was associated with lower one-year mortality

Summary

Introduction

Transcatheter aortic valve implantation (TAVI) is a life-saving treatment for patients with severe aortic valve stenosis. BE-valves (Edwards Sapien, Sapien XT, and Sapien 3) are built out of bovine pericardium leaflets on the inside of the cobalt chromium frame They are expanded during rapid pacing by inflation of a balloon [3]. Two recent French observational studies showed higher two-year mortality in patients receiving BE-valves than in patients receiving SE-valves [11,12] It is unknown whether these results reflect only local practice. Given the limited and conflicting data beyond 30 days follow-up, we aimed to assess one-year mortality and stroke rates in patients receiving BE vs SE-valves. Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice.

Objectives

Methods

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Conclusion