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Observational Study
. 2024 Jul 22;17(14):1652-1663.
doi: 10.1016/j.jcin.2024.05.002. Epub 2024 May 14.

Incidence, Predictors, and Outcomes of Paravalvular Regurgitation After TAVR in Sievers Type 1 Bicuspid Aortic Valves

Andrea Zito  1 , Andrea Buono  2 , Andrea Scotti  3 , Won-Keun Kim  4 , Tommaso Fabris  5 , Chiara de Biase  6 , Michele Bellamoli  2 , Nicholas Montarello  7 , Giuliano Costa  8 , Mesfer Alfadhel  9 , Ofir Koren  10 , Simone Fezzi  11 , Barbara Bellini  12 , Mauro Massussi  13 , Lin Bai  14 , Giulia Costa  15 , Alessandro Mazzapicchi  16 , Enrico Giacomin  17 , Riccardo Gorla  18 , Karsten Hug  19 , Carlo Briguori  20 , Luca Bettari  2 , Antonio Messina  2 , Emmanuel Villa  2 , Mauro Boiago  5 , Enrico Romagnoli  21 , Ady Orbach  22 , Giulia Laterra  23 , Cristina Aurigemma  21 , Marco De Carlo  15 , Matthias Renker  4 , Mario Garcia Gomez  24 , Carlo Trani  25 , Alfonso Ielasi  26 , Uri Landes  22 , Tobias Rheude  19 , Luca Testa  18 , Ignacio Amat Santos  24 , Antonio Mangieri  27 , Francesco Saia  16 , Luca Favero  17 , Mao Chen  14 , Marianna Adamo  13 , Anna Sonia Petronio  15 , Matteo Montorfano  28 , Raj R Makkar  10 , Darren Mylotte  11 , Daniel J Blackman  9 , Marco Barbanti  23 , Ole De Backer  7 , Didier Tchètchè  6 , Giuseppe Tarantini  5 , Azeem Latib  3 , Diego Maffeo  2 , Francesco Burzotta  29
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Free article
Observational Study

Incidence, Predictors, and Outcomes of Paravalvular Regurgitation After TAVR in Sievers Type 1 Bicuspid Aortic Valves

Andrea Zito et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR).

Objectives: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis.

Methods: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up.

Results: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09).

Conclusions: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.

Keywords: aortic stenosis; bicuspid aortic valve; paravalvular leak; paravalvular regurgitation; transcatheter aortic valve replacement.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Aurigemma has reported speaker fees from Abbott, Medtronic, Abiomed, and Terumo. Dr Trani has been involved in advisory board meetings or received speaker fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. Dr Adamo has reported speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Burzotta has been involved in advisory board meetings or has received speaker fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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