Early outcomes of redo-TAVI with the SAPIEN 3 platform: the prospective, multicentre ReTAVI registry

Giuseppe Tarantini¹, MD, PhD; Luca Nai Fovino¹, MD; Héctor Alfonso Alvarez Covarrubias², MD, PhD, MSc; Rafał Wolny³, MD, PhD; Tommaso Fabris¹, MD; Joanna Nawara Skipirzepa⁴, MD; Matthias Eden⁵, MD; Jose Luis Zamorano⁶, MD; Michael Joner², MD; Thomas Cuisset⁷^,⁸, MD, PhD; Victoria Delgado⁹, MD, PhD; Josep Rodés-Cabau¹⁰, MD; Francesco Saia¹¹, MD, PhD; Gintautas Bieliauskas¹², MD; Eric Van Belle¹³, MD; Thomas Modine¹⁴, MD; Tobias Rheude², MD; Philippe GAROT¹⁵, MD; Christian Jung¹⁶, MD, PhD; Tanja K. Rudolph¹⁷, MD; Lionel Leroux¹⁸, MD, PhD; Wolfgang Rottbauer¹⁹, MD; Thomas Nestelberger²⁰, MD; Thibault Lhermusier²¹, MD, PhD; Mohammed Nejjari²², MD; Ander Regueiro²³, MD, PhD; David Meier²⁴, MD; Chiara Fraccaro¹, MD, PhD; Tau Hartikainen²⁵, MD; Nicole Karam²⁶, MD, PhD; Martin Swaans²⁷, MD, PhD; Alberto Rodrigues²⁸, MD; Henryk Dreger²⁹^,³⁰, MD; Christian Hengstenberg³¹, MD; Thomas Schmitz³², MD; Sarah Mauler-Wittwer³³, MD; Nicolo Piazza³⁴, MD; Nicolas Combaret³⁵, MD; Vincent Letocart³⁶, MD; Vincent Auffret³⁷, MD, PhD; Eric Durand³⁸, MD, PhD; Marina Urena-Alcázar³⁹, MD; Raquel del Valle-Fernández⁴⁰, MD; Andrea Drago⁴¹, MD; Marco De Carlo⁴², MD, PhD; Victor Alfonso Jimenez Diaz⁴³, MD; Maciej Dąbrowski³, MD, PhD; Julia Mascherbauer⁴⁴, MD; Arnaud Sudre⁴⁵, MD; Peter Ong⁴⁶, MD; Birgid Gonska⁴⁷, MD; Massimo Mancone⁴⁸, MD, PhD; Enrico Fabris⁴⁹, MD, PhD; Rui Campante Teles⁵⁰^,⁵¹, MD; Luis Nombela-Franco⁵², MD; Lluis Asmarats⁵³, MD, PhD; Victoria Vilalta⁹, MD, PhD; Marcin Protasiewicz⁵⁴, MD, PhD; John Graydon Webb⁵⁵, MD; Gábor Tóth-Gayor⁵⁶, MD; Andreas Zierer⁵⁷^,⁵⁸^,⁵⁹, , MD; Gilles Rioufol⁶⁰, MD, PhD; Moritz Seiffert⁶¹, MD; Marianna Adamo⁶², MD, PhD; Francesco Meucci⁶³, MD; Alfonso Ielasi⁶⁴, MD; Francesco Burzotta⁶⁵, MD; Maria Lopez Benito⁶⁶, MD; Itamar Loewenstein⁶⁷, MD; Paweł Kralisz⁶⁸, PhD; Jacek Legutko⁶⁹^,⁷⁰, MD, PhD; Zenon Huczek⁷¹, MD; Andrea Pavei⁷², MD, PhD; Radka Raková⁷², RND; Wilbert Wesselink⁷², PhD; Marie Zielinski⁷³, BEng; Nataliya Trushina⁷³, MSc; Peter Bramlage⁷³, MD, PhD; Radoslaw Parma⁴, MD, PhD

1. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy; 2. Department of Cardiology, TUM University Hospital German Heart Centre, School of Medicine and Health, Technical University Munich, Munich, Germany; 3. Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland; 4. Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland; 5. Department of Internal Medicine III (Cardiology, Angiology, Pneumology), Heidelberg University Clinic, Heidelberg, Germany; 6. University Hospital Ramón y Cajal, Madrid, Spain; 7. Department of Cardiology, CHU Timone, Marseille, France; 8. CV2N, Aix-Marseille University, INSERM, INRAE, Marseille, France; 9. Department of Cardiology, University Hospital Germans Trias i Pujol, Badalona, Spain; 10. Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada; 11. Department of Interventional Cardiology, IRCCS University Hospital of Bologna, Policlinico S. Orsola, Bologna, Italy; 12. Department of Interventional Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; 13. Interventional Cardiology, Centre Hospitalier Universitaire de Lille, Lille, France; 14. Department of Cardiology, Hospital Haut Lévêque – Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; 15. Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France; 16. Department of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, University Hospital and Heinrich-Heine University, Düsseldorf, Germany; 17. Department of General and Interventional Cardiology/Angiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr-University Bochum, Bad Oeynhausen, Germany; 18. Department of Interventional Cardiology, Cardiology Hospital of the Haut-Lévêque, University of Bordeaux, Pessac, France; 19. Department of Internal Medicine II, University of Ulm, Ulm, Germany; 20. Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Basel, Switzerland; 21. Department of Cardiology, Centre Hospitalier Universitaire de Toulouse Rangueil, Toulouse, France; 22. Department of Cardiology, Centre Cardiologique du Nord, Saint-Denis, France; 23. Department of Cardiology, Hospital Clínico de Barcelona, Barcelona, Spain; 24. Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland; 25. Department of Cardiology and Angiology, University Heart Center Freiburg – Bad Krozingen, Bad Krozingen, Germany; 26. Department of Cardiology, European Hospital Georges Pompidou, Paris, France; 27. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands; 28. Department of Cardiology, Centro Hospitalario de Gaia Espinho, Vila Nova de Gaia, Portugal; 29. Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité, Campus Virchow Klinikum, Berlin, Germany; 30. Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; 31. Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria; 32. Department of Cardiology and Angiology, Elisabeth Hospital Essen, Essen, Germany; 33. Department of Medicine, Cardiology Division, Structural Heart Unit, University Hospital of Geneva, Geneva, Switzerland; 34. Division of Cardiology, McGill University Health Centre, Montreal, QC, Canada; 35. Department of Cardiology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France; 36. Department of Cardiology, Centre Hospitalier Universitaire de Nantes, Nantes, France; 37. Department of Cardiology, Centre Hospitalier Universitaire de Rennes, Rennes, France; 38. Department of Cardiology, Rouen University Hospital, Rouen, France; 39. Department of Cardiology, Hôpital Bichat Claude Bernard, Paris, France; 40. Department of Cardiology, Asturias Central University Hospital, Oviedo, Spain; 41. Department of Cardiology, San Bortolo Hospital, Vicenza, Italy; 42. Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy; 43. Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain; 44. Department of Cardiology, University Hospital Sankt Pölten, Karl Landsteiner University of Health Sciences, Krems, Austria; 45. Heart and Lung Institute, University Hospital Lille, Lille, France; 46. Department of Cardiology and Angiology, Robert Bosch Medical Centre, Stuttgart, Germany; 47. Department of Cardiology, Kerckhoff-Heart and Thorax Center, Bad Nauheim, Germany; 48. Department of Internal Clinical Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy; 49. Cardiothoracovascular Department, University of Trieste, Trieste, Italy; 50. Department of Cardiology, Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Carnaxide, Portugal; 51. Comprehensive Health Research Center (CHRC), NOVA Medical School, Lisbon, Portugal; 52. Department of Cardiology, Cardiovascular Institute, Hospital Clínico San Carlos, IdISSC, Madrid, Spain; 53. Department of Cardiology, Hospital de la Santa Creu I Sant Pau, Institut de Recerca Sant Pau (IR Sant Pau), Barcelona, Spain; 54. Department of Cardiology, Institute of Heart Diseases, Wrocław Medical University, Wroclaw, Poland; 55. Centre for Heart Valve Innovation, St. Paul’s Hospital, University of British Columbia, Vancouver, BC, Canada; 56. Department of Cardiology, University Heart Center Graz, Medical University of Graz, Graz, Austria; 57. Department of Cardiovascular and Thoracic Surgery, Medical Faculty, Johannes Kepler University Linz, Kepler University Hospital Linz, Linz, Austria; 58. Department of Cardiovascular and Thoracic Surgery, Hospital Wels-Grieskirchen GmbH, Wels, Austria; 59. Clinical Research Institute for Cardiovascular and Metabolic Diseases, Medical Faculty, Johannes Kepler University Linz, Linz, Austria; 60. Hospices Civils de Lyon, Lyon, France; 61. Department of Cardiology and Angiology, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany; 62. Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, Cardiac Catheterization Laboratory and Cardiology, ASST Spedali Civili Brescia, University of Brescia, Brescia, Italy; 63. Cardiothoracovascular Department, Careggi University Hospital, Florence, Italy; 64. Department of Cardiology, IRCCS Ospedale Galeazzi-Sant’Ambrogio, Milan, Italy; 65. Department of Cardiovascular Sciences-CUORE, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy; 66. Department of Cardiology, University Hospital of León, León, Spain; 67. Department of Cardiology, Tel Aviv Medical Center, Tel Aviv, Israel; 68. Department of Invasive Cardiology, University Hospital, Białystok, Poland; 69. Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland; 70. Clinical Department of Interventional Cardiology, Saint John Paul II Hospital, Krakow, Poland; 71. Department of Cardiology, Medical University of Warsaw, Warsaw, Poland; 72. Edwards Lifesciences, Prague, Czech Republic; 73. IPPMed – Institute for Pharmacology and Preventive Medicine GmbH, Cloppenburg, Germany

Abstract

Background: Transcatheter aortic valve implantation (TAVI) is increasingly performed in younger and lower-risk patients. Since many of these patients will outlive their transcatheter heart valve (THV), redo-TAVI procedures are expected to rise in number. Yet, real-world evidence on the procedural safety and efficacy of redo-TAVI remains limited.

Aims: We aimed to evaluate the 30-day procedural and clinical outcomes of redo-TAVI using the balloon-expandable SAPIEN 3 platform.

Methods: The ReTAVI registry is a prospective, international study enrolling consecutive patients with a failed aortic THV undergoing redo-TAVI with a balloon-expandable SAPIEN 3 THV. Data were collected across 59 international centres. All imaging was centrally analysed, and major clinical events were adjudicated by an independent committee.

Results: â¨A total of 143 patients (median age 84 years; 40.6% female; median Society of Thoracic Surgeons risk score 7.0%) were enrolled. The predominant failing THVs were balloon-expandable SAPIEN 3 (30.1%), self-expanding CoreValve/Evolut (53.1%), and ACURATE (14.0%) platforms. The most common failure mode was isolated regurgitation (48.6%), followed by stenosis (35.2%) and a mixed pathology (16.2%). The replacement valve was successfully implanted in 95.1% of patients, with a 30-day mortality rate of 3.5%. The 30-day stroke and pacemaker implantation rates were 0.7% and 6.3%, respectively. Redo-TAVI significantly improved valve haemodynamics, with mean gradients decreasing overall (Δ=–12.0 mmHg), and a more pronounced reduction in stenotic failures (Δ=–29.0 mmHg). Coronary obstruction was observed in 1.4% of cases.

Conclusions: Redo-TAVI with a balloon-expandable SAPIEN 3 THV platform is a safe and effective reintervention strategy across diverse failed THV types, when guided by the Heart Team, standardised procedural planning, and comprehensive imaging. ClinicalTrials.gov: NCT05601453

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Coronary interventions Interventions for valvular disease Interventions for heart failure Peripheral interventions Interventions for hypertension Interventions for stroke STEMI NSTEMI Stable CAD Stents and scaffolds Left main and multivessel disease Bifurcation lesions CTO TAVI Mitral valve replacement and repair Tricuspid / Pulmonary valve Acute heart failure Chronic heart failure Below the knee AAA Iliac / Femoral / Popliteal Renal artery angioplasty Renal denervation Carotid stenting LAA closure Ischaemic stroke

aortic stenosis transcatheter aortic valve implantation structural valve deterioration bioprosthetic valve dysfunction aortic valve regurgitation TAV-in-TAV

Volume 22 Number 11

Jun 1, 2026