Supra‐Annular Versus Intra‐Annular Devices for Transcatheter Aortic Valve‐in‐Valve Replacement: The PANDORA International Registry
Year: 2026
Type: article
Study design: Observational Study
Abstract: Background As transcatheter aortic valve replacement (TAVR) expands to younger, lower‐risk populations, the need for repeat procedures due to valve degeneration is expected to increase. TAVR‐in‐TAVR has emerged as a feasible strategy, although outcomes across supra‐annular (SAV) and intra‐annular (IAV) valve combinations remain unclear. The PANDORA (Supra‐Annular Versus Intra‐Annular Devices for TAVR‐in‐TAVR) international registry study assessed safety, hemodynamic performance, and clinical outcomes of TAVR‐in‐TAVR according to prosthetic configurations. Methods From an international multicenter registry (2011–2024), 172 TAVR‐in‐TAVR cases were identified among ≈30 000 TAVR procedures, with a median interval of 1401 days. Patients were stratified into 4 groups: SAV‐IAV (n=32), SAV‐SAV (n=29), IAV‐SAV (n=74), and IAV‐IAV (n=37). Results CoreValve/Evolut (49.4%) and Edwards SAPIEN (35.5%) were the most frequent index prostheses, whereas the second valve was mainly Edwards SAPIEN (60.5%), followed by Evolut (35.5%) and Myval/Octacor (4.0%). Structural valve deterioration was the leading failure mechanism (77.9%), while nonstructural valve deterioration dysfunction, alone or combined with structural valve deterioration, occurred in 40.7%. Overall Valve Academic Research Consortium 3 technical success was 91.3%, numerically highest in SAV‐IAV and IAV‐SAV ( P =0.090). Thirty‐day device success was 68%, also higher in SAV‐IAV (75.9%, P =0.301), mainly influenced by elevated residual gradients (≥20 mm Hg in 12.7%) and the 30‐day mortality rate (7.3%). At 1 year, the IAV‐IAV group showed the numerically lowest freedom from death and heart failure hospitalization (76.1%, P =0.734). Male sex and chronic kidney disease independently predicted death at follow‐up. Conclusions TAVR‐in‐TAVR is feasible with generally favorable outcomes, although clinical and procedural profiles vary by the different prosthesis combinations. These findings highlight the need for further studies to refine device selection strategies.
Authors: Antonio Popolo Rubbio, Antonio Sisinni, Enrico Criscione, Enrico Poletti, Nicolas Van Mieghem, Gaspare S. Cannone, Didier Tchétché, Azeem Latib, Andrea Scotti, Ole De Backer, Michele Morosato, Damiano Regazzoli, Ignacio A. Santos, Michiel Voskuil, Matjaz Bunc, David Hildick‐Smith, Joachim Schofer, Christina Brinkmann, Kush P. Patel, Andreas Baumbach, Francesco Bedogni, Luca Testa
Institutions: IRCCS Policlinico San Donato, Erasmus MC, Clinique Pasteur, Montefiore Medical Center, Copenhagen University Hospital, Rigshospitalet, Centro de Investigación en Red en Enfermedades Cardiovasculares, Centro de Investigación Biomédica en Red, University of Ljubljana, University Hospitals Sussex NHS Foundation Trust, Asklepios Klinik St. Georg, Queen Mary University of London, Barts Health NHS Trust
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,810
OpenAlex ID: W7154584824