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
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.