Comprehensive and Contemporary Pre-clinical Evaluation of Novel Transcatheter Aortic Valves. A Scientific Statement of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC, the ESC Working Group on Cellular Biology

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.

Authors

Institutions

Publication Details

Journal
European Heart Journal - Valvular and Structural Heart Disease
Published
2026-05-11
DOI
https://doi.org/10.1093/ehjvshd/xwag039
Primary Topic
Cardiac Valve Diseases and Treatments
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Comprehensive and Contemporary Pre-clinical Evaluation of Novel Transcatheter Aortic Valves. A Scientific Statement of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC, the ESC Working Group on Cellular Biology

Cinzia Perrino, Vincent Garitey, Maurizio Pesce, Yoshi Onuma et al.
European Heart Journal - Valvular and Structural Heart Disease
Cardiac Valve Diseases and Treatments
article

Comprehensive and Contemporary Pre-clinical Evaluation of Novel Transcatheter Aortic Valves. A Scientific Statement of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC, the ESC Working Group on Cellular Biology

Cinzia Perrino, Vincent Garitey, Maurizio Pesce, Yoshi Onuma, Roman Gottardi, Sabine Bleiziffer, R A Byrne, A Baumbach, A Chieffo, P W Serruys, Nikolaos Bonaros, Antonio Esposito, Paweł E Buszman, Emanuele Barbato, Dariusz Dudek, Juan F Granada, Wojciech Wojakowski, Nicolas Amabile, Renu Virmani, Marco Barbanti, Piotr P Buszman, Stephan Windecker, Giulio Stefanini, Ryan Stanfield
article en

Abstract

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.

European Heart Journal - Valvular and Structural Heart Disease
Jan Długosz University (PL), Jagiellonian University (PL), Humanitas University (IT), Innsbruck Medical University (AT), Vita-Salute San Raffaele University (IT), University of Freiburg (DE), Medical University of Silesia (PL), Queen Mary University of London (GB), Ollscoil na Gaillimhe – University of Galway (IE), Università degli Studi di Enna Kore (IT), University of Medicine and Health Sciences (KN), Utah Geological Survey (US), Heart and Diabetes Center North Rhine-Westphalia (DE), University Hospital of Bern (CH), Centro Cardiologico Monzino (IT), IRCCS Policlinico San Donato (IT), The Institute of the Polish Language of the Polish Academy of Sciences (PL), Federico II University Hospital (IT), Azienda Ospedaliera Sant'Andrea (IT), Mater Private Hospital (AU), Universitäts-Herzzentrum Freiburg-Bad Krozingen (DE), CVPath Institute (US), American Heart of Poland (PL), Institut Cardiovasculaire Paris Sud (FR), Cardiovascular Research Foundation (US), Bioengineering Center (RU), Andrzej Frycz Modrzewski Krakow University (PL), Cleveland Clinic London (GB), William Harvey Research Institute (GB), Istituti di Ricovero e Cura a Carattere Scientifico (IT), ViVitro Labs (Canada) (CA), IRCCS Humanitas Research Hospital (IT)
Openalex Percentile: Top 6%
Cardiac Valve Diseases and Treatments
DOISourceOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.