Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project

Enrico Poletti; Ole De Backer; Andrea Scotti; Giuliano Costa; Francesco Bruno; Claudia Fiorina; Nicola Buzzatti; Alessia Latini; Tanja K Rudolph; Mark M P van den Dorpel; Christina Brinkmann; Kush P Patel; Vasileios Panoulas; Joachim Schofer; Arturo Giordano; Marco Barbanti; Damiano Regazzoli; Maurizio Taramasso; Francesco Saia; Andreas Baumbach; Francesco Maisano; Nicolas M Van Mieghem; Lars Søndergaard; Azeem Latib; Ignacio J Amat Santos; Francesco Bedogni; Luca Testa

doi:10.1016/j.jcin.2023.07.026

Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project

JACC Cardiovasc Interv. 2023 Aug 28;16(16):1974-1985. doi: 10.1016/j.jcin.2023.07.026.

Authors

Enrico Poletti¹, Ole De Backer², Andrea Scotti³, Giuliano Costa⁴, Francesco Bruno⁵, Claudia Fiorina⁶, Nicola Buzzatti⁷, Alessia Latini⁸, Tanja K Rudolph⁹, Mark M P van den Dorpel¹⁰, Christina Brinkmann¹¹, Kush P Patel¹², Vasileios Panoulas⁵, Joachim Schofer¹¹, Arturo Giordano¹³, Marco Barbanti¹⁴, Damiano Regazzoli⁸, Maurizio Taramasso¹⁵, Francesco Saia¹⁶, Andreas Baumbach¹², Francesco Maisano⁷, Nicolas M Van Mieghem¹⁰, Lars Søndergaard², Azeem Latib³, Ignacio J Amat Santos¹⁷, Francesco Bedogni¹, Luca Testa¹⁸

Affiliations

¹ Clinical and Interventional Cardiology Department, IRCCS Policlinico San Donato, Milan, Italy.
² Department of Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
³ Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York, USA.
⁴ Division of Cardiology, CAST, Azienda Ospedaliero - Universitaria Policlinico G. Rodolico - San Marco, University of Catania, Catania, Italy.
⁵ Department of Cardiology, Royal Brompton and Harefield Hospitals, Guy's and St. Thomas' NHS Foundation Trust, Harefield Hospital, Harefield, United Kingdom.
⁶ Spedali Civili Brescia, Brescia, Italy.
⁷ IRCCS, San Raffaele Scientific Institute, Milan, Italy.
⁸ Cardio Center, IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy.
⁹ Department for General and Interventional Cardiology/Angiology, Heart and Diabetes Center North Rhine-Westphalia Bochum, University Hospital of the Ruhr University, Bad Oeynhausen, Germany.
¹⁰ Department of Interventional Cardiology, Erasmus University Medical Centre, Rotterdam, the Netherlands.
¹¹ MVZ Department of Structural Heart Disease at St. Georg, Hamburg, Germany.
¹² Department of Cardiology, Barts Heart Centre, Barts Health NHS Trust, London United Kingdom.
¹³ Cardiovascular Interventional Operative Unit, Presidio Ospedaliero Pineta Grande, Castel Volturno, Caserta, Italy; Operative Unit of Hemodynamics, Casa di Salute Santa Lucia, Naples, Italy.
¹⁴ Università Degli Studi di Enna "Kore," Enna, Italy.
¹⁵ HerzZentrum Hirslanden Zurich Clinic of Cardiac Surgery, Zurich, Switzerland.
¹⁶ Cardiology Unit, Cardio-Thoracic-Vascular Department, IRCCS University Hospital of Bologna, Bologna, Italy.
¹⁷ Instituto de Ciencias del Corazón, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
¹⁸ Clinical and Interventional Cardiology Department, IRCCS Policlinico San Donato, Milan, Italy. Electronic address: luctes@gmail.com.

PMID: 37648345
DOI: 10.1016/j.jcin.2023.07.026

Abstract

Background: Transcatheter aortic valve replacement (TAVR) in patients with pure severe native aortic valve regurgitation (NAVR) has been associated with suboptimal results. The available evidence concerns mostly outdated transcatheter heart valves (THVs).

Objectives: The aim of this study was to investigate the performance of new-generation THVs in patients treated for pure severe NAVR.

Methods: The PANTHEON (Performance of Currently Available Transcatheter Aortic Valve Platforms in Inoperable Patients With Pure Aortic Regurgitation of a Native Valve) study retrospectively included patients who underwent TAVR with currently available devices (both self-expanding [SE] and balloon expandable [BE]) for severe NAVR. Technical and device success rates as well as a composite of all-cause mortality and heart failure rehospitalization at 1 year were evaluated. The rate and clinical consequences of acute transcatheter valve embolization or migration (TVEM) were also considered.

Results: A total of 201 patients were included. Overall technical and device success rates were 83.6% and 76.1%, respectively, and did not differ between SE and BE devices. These figures were due mostly to TVEM occurrence (14.6% vs 16.1%; P = 0.47) and residual moderate or greater aortic regurgitation (9.2% vs 10.1%; P = 0.87). Patients who experienced TVEM compared with those without TVEM had a significantly higher incidence of the composite endpoint at 1 year (25.7% vs 15.8%; P = 0.05).

Conclusions: Despite improved THV platforms and techniques, TAVR for pure severe NAVR remains a challenging procedure, with significant risk for TVEM. SE and BE platforms demonstrated comparable performance in this setting. (Performance of Currently Available Transcatheter Aortic Valve Platforms in Inoperable Patients With Pure Aortic Regurgitation of a Native Valve [PANTHEON]; NCT05319171).

Keywords: pure native aortic regurgitation; transcatheter aortic valve replacement; transcatheter valve embolization.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Aortic Valve / diagnostic imaging
Aortic Valve / surgery
Aortic Valve Insufficiency* / diagnostic imaging
Aortic Valve Insufficiency* / etiology
Aortic Valve Insufficiency* / surgery
Humans
Retrospective Studies
Transcatheter Aortic Valve Replacement* / adverse effects
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT05319171