Quantitative Angiographic Assessment of Aortic Regurgitation Following 11 TAVR Devices: An Update of a Multicenter Pooled Analysis

Mahmoud Abdelshafy; Patrick W Serruys; Won-Keun Kim; Andreas Rück; Rutao Wang; Ling Tao; Ahmed Elkoumy; Hesham Elzomor; Scot Garg; Yoshinobu Onuma; Darren Mylotte; Osama Soliman

doi:10.1016/j.jscai.2022.100037

Quantitative Angiographic Assessment of Aortic Regurgitation Following 11 TAVR Devices: An Update of a Multicenter Pooled Analysis

J Soc Cardiovasc Angiogr Interv. 2022 Apr 14;1(3):100037. doi: 10.1016/j.jscai.2022.100037. eCollection 2022 May-Jun.

Authors

Mahmoud Abdelshafy^{1

2}, Patrick W Serruys^{1

3

4}, Won-Keun Kim⁵, Andreas Rück⁶, Rutao Wang⁷, Ling Tao⁷, Ahmed Elkoumy^{1

8}, Hesham Elzomor^{1

8}, Scot Garg⁹, Yoshinobu Onuma¹, Darren Mylotte¹, Osama Soliman^{1

4}

Affiliations

¹ Department of Cardiology, National University of Ireland, Galway (NUIG), and CORRIB Research Centre for Advanced Imaging and Core Laboratory, Galway, Ireland.
² Department of Cardiology, Al-Azhar University, Cairo, Egypt.
³ NHLI, Imperial College London, London, United Kingdom.
⁴ CÚRAM, SFI Research Centre for Medical Devices, Galway, Ireland.
⁵ Department of Cardiology, Kerckhoff Heart Centre, Bad Nauheim, Germany.
⁶ Department of Cardiology, Karolinska Institute, Stockholm, Sweden.
⁷ Department of Cardiology, Xijing Hospital, Xi'an, China.
⁸ Islamic Center of Cardiology and Cardiac Surgery, Al-Azhar University, Cairo, Egypt.
⁹ Department of Cardiology, Royal Blackburn Hospital, Blackburn, United Kingdom.

Abstract

Background: Aortic regurgitation (AR) following transcatheter aortic valve replacement (TAVR) is a major predictor of short- and long-term survival. Thus far, no independent quantitative comparison of AR among commercially available transcatheter heart valves (THVs) has been performed.

Objectives: We sought to assess and compare the degree of acute AR following TAVR between 11 commercially available THVs and update our previous multicenter, pooled analysis.

Methods: Analyses were performed by an independent academic core lab using quantitative videodensitometry, a technique relying solely on the aortogram acquired after TAVR. The pooled analysis (n = 2665) included data from the initial cohort of 7 valves (Lotus [n = 546], Evolut PRO [n = 95], SAPIEN 3 [n = 397], Evolut R [n = 295], SAPIEN XT [n = 239], ACURATE neo [n = 120], and CoreValve [n = 532]) to which data from 4 new valves were added (ACURATE neo2 [n = 120], Myval [n = 108], VitaFlow [n = 105], and Venus-A [n = 113]).

Results: The Lotus valve had the lowest mean AR (3.5% ± 4.4%) followed by ACURATE neo2 (4.4% ± 4.8%), VitaFlow (6.1% ± 6.4%), Myval (6.3% ± 6.3%), Evolut PRO (7.4% ± 6.5%), SAPIEN 3 (7.6% ± 7.1%), Evolut R (7.9% ± 7.4%), SAPIEN XT (8.8% ± 7.5%), Venus-A (8.9% ± 10%), ACURATE neo (9.6% ± 9.2%), and CoreValve (13.7% ± 10.7%, analysis of variance P-value < .001). The only valves that statistically differed from all their counterparts were Lotus, with the lowest regurgitation in comparison to other valves except ACURATE neo2, which had less regurgitation compared with SAPIEN 3, Evolut R, SAPIEN XT, Venus-A, ACURATE neo, and CoreValve. CoreValve had the highest mean of AR, with the rates of moderate/severe AR: ACURATE neo2 (1.7%), Lotus (2.2%), Myval (2.8%), VitaFlow (4.7%), Evolut PRO (5.3%), SAPIEN 3 (8.3%), Evolut R (8.8%), SAPIEN XT (10.9%), ACURATE neo (11.3%), Venus-A (14.2%), and CoreValve (30.1%)-χ² P-value < .001.

Conclusions: In this updated pooled analysis, the Lotus valve had the lowest mean AR, while ACURATE neo2 had the lowest rate of moderate/severe AR. Myval, VitaFlow, and Venus-A THVs showed promising results.

Keywords: Transcatheter aortic valve replacement; aortic regurgitation; paravalvular leak; transcatheter aortic valve implantation; videodensitometry.