Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

Hideyuki Kawashima,Rutao Wang,Peter Den Heijer,Yoshinobu Onuma,William Wijns,Alfonso Ielasi,Dariusz Jagielak,Frederico De Marco,Osama Soliman,Darren Mylotte,Christian Juhl Terkelsen,Patrick W Serruys

doi:10.5334/gh.959

Abstract

Objectives:The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among three balloon-expandable valves.Background:Quantitative videodensitometric aortography is an objective, accurate, and reproducible tool for adjudication of AR following TAVI.Methods:This is a retrospective corelab analysis, independent from industry, of aortograms from patients treated with TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., India), Sapien 3, and XT THVs (Edwards Lifesciences, Irvine, CA, USA). The study comprised of 108 analyzable aortograms from consecutive patients in a multicenter European registry who underwent Myval THV implantation. The results of quantitative assessment of AR in the Sapien 3 THV (n = 397) and Sapien XT THV (n = 239) were retrieved from a published pooled database.Results:The Myval THV had the lowest proportion of patients with moderate or severe angiographic quantitative AR (2.8%) compared to the Sapien 3 THV (8.3%; p = 0.049) and Sapien XT THV (10.9%; p = 0.012). Furthermore, the Myval THV had the lowest mean angiographic quantitative AR (6.3 ± 6.3%), followed by Sapien 3 THV (7.6 ± 7.1%) and Sapien XT THV (8.8 ± 7.5%), and it was significantly lower than that of the Sapien XT THV (p = 0.006), but not significantly different from Sapien 3 THV (p = 0.246).Conclusion:The Myval THV, in comparison with other BEV’s analyzed in our database, showed a lower occurrence of moderate or severe AR after TAVI. These results should be confirmed in prospective cohorts of randomized patients with head-to-head THV comparisons.

Highlights

The aim of the present analysis is to compare the quantitative angiographic aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) among the three BEVs (i.e., Myval transcatheter heart valve (THV), Sapien 3 THV, and Sapien XT THV). This is a retrospective corelab analysis, independent from industry, of aortography from patients treated with TAVI using the Myval THV, Sapien 3 THV, and Sapien XT THV
The final study cohort comprised of 108 analyzable aortograms from patients who underwent Myval THV implantation according to each participating institution’s heart team recommendation
Continuous variables were reported as mean ± standard deviations

Summary

Introduction

Moderate or severe aortic regurgitation (AR) following transcatheter aortic valve implantation (TAVI) has been associated with increased short- and long-term mortality [1]. In the PARTNER 3 trial, among low surgical-risk patients, the rates of moderate or severe AR after TAVI with the balloon-expandable Sapien 3 transcatheter heart valve (THV)(Edwards Lifesciences, Irvine, CA, USA) at 30 days and at one year were similar to those after surgical aortic valve replacement [2]. The aim of the present analysis is to compare the quantitative angiographic AR after TAVI among the three BEVs (i.e., Myval THV, Sapien 3 THV, and Sapien XT THV).

Objectives

Results

Conclusion