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Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure: Rationale and design of the multicentre, prospective, observational ReTAVI registry
R. Parma, M. Joner, F. Saia, T. Cuisset, V. Delgado, J. Rodes-Cabau, T. Modine, E. Van Belle, LN. Fovino, U. Landes, HA. Alvarez-Covarrubias, M. Abdel-Wahab, JL. Zamorano, M. Eden, F. Cademartiri, JN. Skipirzepa, J. Kurucova, D. Greinert, P....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, pozorovací studie, multicentrická studie
Grantová podpora
Edwards Lifesciences
PubMed
38767226
DOI
10.1111/eci.14241
Knihovny.cz E-zdroje
- MeSH
- aortální stenóza * chirurgie MeSH
- lidé MeSH
- prospektivní studie MeSH
- registrace * MeSH
- selhání protézy MeSH
- senioři MeSH
- srdeční chlopně umělé MeSH
- transkatetrální implantace aortální chlopně * metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI. METHODS: The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025. CONCLUSIONS: The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis.
Aix Marseille Université INSERM INRA C2VN and Faculté de Médecine Marseille France
Département de Cardiologie Centre Hospitalier Universitaire de Timone Marseille France
Department of Cardiology and Structural Heart Diseases Medical University of Silesia Katowice Poland
Department of Cardiology Deutsches Herzzentrum München Technical University of Munich Munich Germany
Department of Cardiology Quebec Heart and Lung Institute Laval University Québec Canada
Department of Cardiology Rabin Medical Center Petah Tikva Israel
Department of Cardiology University Hospital Germans Trias i Pujol Badalona Spain
Department of Radiology Fondazione Monasterio CNR Pisa Italy
DZHK partner site Munich Heart Alliance Munich Germany
Edwards Lifesciences Prague Czech Republic
Heidelberg University Clinic Department Internal Medicine 3 Heidelberg Germany
Interventional Cardiology Centre Hospitalier Universitaire de Lille Lille France
IPPMed Institute for Pharmacology and Preventive Medicine GmbH Cloppenburg Germany
University Hospital Ramón y Cajal Head of Cardiology Madrid Spain
Citace poskytuje Crossref.org
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