Performance of balloon-expandable transcatheter bioprostheses in inoperable patients with pure aortic regurgitation of a native valve: The BE-PANTHEON international project

Enrico Poletti; Ignacio Amat-Santos; Enrico Criscione; Antonio Popolo Rubbio; Mario García-Gómez; Mateusz Orzalkiewicz; Manuel Pan; Antonio Sisinni; Mattia Squillace; Bruno García Del Blanco; Francesco Bruno; Vasileios Panoulas; Radoslaw Pracon; Ole De Backer; Maurizio Taramasso; Giuliano Costa; Marco Barbanti; Nicolas M Van Mieghem; Damiano Regazzoli; Antonio Mangieri; Andrea Scotti; Azeem Latib; Francesco Saia; Francesco Bedogni; Luca Testa

doi:10.1016/j.carrev.2024.08.007

Performance of balloon-expandable transcatheter bioprostheses in inoperable patients with pure aortic regurgitation of a native valve: The BE-PANTHEON international project

Cardiovasc Revasc Med. 2024 Aug 22:S1553-8389(24)00630-4. doi: 10.1016/j.carrev.2024.08.007. Online ahead of print.

Authors

Enrico Poletti¹, Ignacio Amat-Santos², Enrico Criscione¹, Antonio Popolo Rubbio¹, Mario García-Gómez², Mateusz Orzalkiewicz³, Manuel Pan⁴, Antonio Sisinni¹, Mattia Squillace¹, Bruno García Del Blanco⁵, Francesco Bruno⁶, Vasileios Panoulas⁷, Radoslaw Pracon⁶, Ole De Backer⁸, Maurizio Taramasso⁹, Giuliano Costa¹⁰, Marco Barbanti¹¹, Nicolas M Van Mieghem¹², Damiano Regazzoli¹³, Antonio Mangieri¹³, Andrea Scotti¹⁴, Azeem Latib¹⁴, Francesco Saia³, Francesco Bedogni¹, Luca Testa¹⁵

Affiliations

¹ Clinical and Interventional Cardiology Department, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Milan, Italy.
² Instituto de Ciencias del Corazón (ICICOR), Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
³ Interventional Cardiology Unit, Cardio-Thoracic-Vascular Department, IRCCS University Hospital of Bologna, Bologna, Italy.
⁴ Department of Cardiology, Hospital Universitario Reina Sofía, University of Córdoba, IMIBIC - CIBERCV, Spain.
⁵ Cardiology Department, Hospital Val d'Hebron, Barcelona, Spain.
⁶ Harefield Hospital, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, United Kingdom of Great Britain and Northern Ireland.
⁷ Harefield Hospital, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, United Kingdom of Great Britain and Northern Ireland; Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, United Kingdom of Great Britain and Northern Ireland.
⁸ Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
⁹ Klinik Hirslanden, HerzZentrum Hirslanden Zurich, Zurich, Switzerland.
¹⁰ Division of Cardiology, C.A.S.T., Azienda Ospedaliero-Universitaria Policlinico G. Rodolico - San Marco, University of Catania, Catania, Italy.
¹¹ Università degli Studi di Enna "Kore", Enna, Italy.
¹² Department of Interventional Cardiology, Erasmus University Medical Centre, Rotterdam, the Netherlands.
¹³ Cardio Center, IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy.
¹⁴ Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
¹⁵ Clinical and Interventional Cardiology Department, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Milan, Italy. Electronic address: luctes@gmail.com.

PMID: 39198100
DOI: 10.1016/j.carrev.2024.08.007

Abstract

Background: The off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR.

Methods: Consecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives.

Results: Between February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001). Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group.

Conclusions: Off-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable.

Non-standard abbreviations and acronyms: AR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.

Keywords: Balloon-expandable; MyVal; Pure aortic regurgitation; Sapien; TAVR; Transcatheter aortic valve replacement.