Comprehensive and contemporary pre-clinical evaluation of novel transcatheter aortic valves: a scientific statement of the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology, the European Society of Cardiology Working Group on Cellular Biology of the Heart, and the European Society of Cardiology Working Group on Cardiovascular Surgery
Year: 2026
Type: article
Abstract: Background The evolving landscape of the pre-clinical evaluation of transcatheter aortic valve replacement technologies, emphasizing on long-term durability as the field evolves into a lower-risk and younger patient population. The rapid advancement of transcatheter aortic valve implantation (TAVI) technologies requires a comprehensive pre-clinical evaluation strategy addressing not only device performance but also long-term durability. Aims The document aims to discuss the biological mechanisms of bioprosthetic valve failure, current approches to pre-clinical testing, future TAVI technologies, and regulatory considerations related to the development and clinical evaluation of TAVI devices. Methods and results The document delves into the biological mechanism of bioprosthetic valve failure, focusing on the differences between xenogenic pericardial tissue and native leaflet tissue. Also, the document highlights the importance of testing tailored to study technical and procedural performance. However, the treatment of younger patients and future need for reintervention has forced a paradigm shift from a technology driven assessment to a more lifetime management focused approach. The paper also discusses the future of TAVI, primarily focusing on polymeric and tissue-engineered heart valves, and emphasizes the need for the development of more specific test methods applicable to their unique properties and biological interactions. Finally, details of specific testing methods such as computational, in vitro, and in vivo models in predicting the long-term performance of TAVI technologies are also discussed. The document concludes by presenting a discussion of regulatory considerations, including perspectives from the European Union Medical Device Regulation and the US Food and Drug Administration regarding the requirements for the development and clinical evaluation of TAVI technologies. Conclusion Reconciling scientific needs, clinical research, and regulatory guidelines ensures the safe and effective introduction of innovative TAVI technologies.
Authors: Piotr P Buszman, Piotr P Buszman, Juan F Granada, Nicolas Amabile, Emanuele Barbato, Marco Barbanti, Andreas Baumbach, Sabine Bleiziffer, Nikolaos Bonaros, Paweł E Buszman, Paweł E Buszman, Robert Byrne, Alaide Chieffo, Dariusz Dudek, Antonio Esposito, Vincent Garitey, Roman Gottardi, Cinzia Perrino, Maurizio Pesce, Ryan Stanfield, Giulio Stefanini, Yoshi Onuma, Stephan Windecker, Wojciech Wojakowski, Renu Virmani, Patrick W Serruys
Institutions: Jan Długosz University, American Heart of Poland, Andrzej Frycz Modrzewski Krakow University, Cardiovascular Research Foundation, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Azienda Ospedaliera Sant'Andrea, Sapienza University of Rome, Università degli Studi di Enna Kore, National Health Service, Queen Mary University of London, Barts Health NHS Trust, William Harvey Research Institute, University Hospitals of the Ruhr-University of Bochum, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Innsbruck Medical University, Universität Innsbruck, IRCCS Policlinico San Donato, Royal College of Surgeons in Ireland, IRCCS Ospedale San Raffaele, Jagiellonian University, Vita-Salute San Raffaele University, University of Freiburg, Universitäts-Herzzentrum Freiburg-Bad Krozingen, University of Naples Federico II, Centro Cardiologico Monzino, University of Utah, Humanitas University, IRCCS Humanitas Research Hospital, Ollscoil na Gaillimhe – University of Galway, University Hospital of Bern, Medical University of Silesia, CVPath Institute
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7160924989