This scientific statement outlines a comprehensive pre-clinical evaluation strategy for novel transcatheter aortic valves, emphasizing long-term durability and lifetime management for younger patients.
This ESC/EAPCI scientific statement provides updated guidance on the pre-clinical evaluation of novel TAVI technologies, focusing on long-term durability for younger, lower-risk patients.
Abstract This scientific statement addresses 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 TAVI technologies requires a comprehensive pre-clinical evaluation strategy addressing not only device performance but also long-term durability. The document delves into the biological mechanisms 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 (MDR) and the US Food and Drug Administration (FDA) regarding the requirements for the development and clinical evaluation of TAVI technologies. Reconciling scientific needs, clinical research, and regulatory guidelines ensures the safe and effective introduction of innovative TAVI technologies.
Buszman et al. (Mon,) conducted a review in Transcatheter aortic valve replacement. Pre-clinical evaluation of novel transcatheter aortic valves was evaluated. This scientific statement outlines a comprehensive pre-clinical evaluation strategy for novel transcatheter aortic valves, emphasizing long-term durability and lifetime management for younger patients.