Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure : Rationale and design of the multicentre, prospective, observational ReTAVI registry
Parma, Radoslaw (Medical University of Silesia (Polònia))
Joner, Michael (Deutsches Herzzentrum München)
Saia, Francesco (University Hospital of Bologna)
Cuisset, Thomas (Aix-Marseille Université)
Delgado, Victoria (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Rodes-Cabau, Josep (Laval University (Quebec, Canadà))
Modine, Thomas (Universitaire de Bordeaux)
Van Belle, Eric (Centre Hospitalier Universitaire de Lille)
Fovino, Luca Nai (University of Padua Medical School)
Landes, Uri (Rabin Medical Center (Petah-Tikva, Israel))
Alvarez-Covarrubias, Hector Alfonso (Technical University of Munich)
Abdel-Wahab, Mohamed (Heart Center Leipzig at University of Leipzig)
Zamorano, José Luis (Hospital Universitario Ramón y Cajal (Madrid))
Eden, Matthias (Heidelberg University Clinic)
Cademartiri, Filippo (Fondazione Monasterio/CNR (Pisa, Itàlia))
Skipirzepa, Joabba Nawara (Medical University of Silesia (Polònia))
Kurucova, Jana (Edwards Lifesciences (Praga, República Txeca))
Greinert, Daniel (IPPMed-Institute for Pharmacology and Preventive Medicine GmbH (Cloppenburg, Alemanya))
Bramlage, Peter (IPPMed-Institute for Pharmacology and Preventive Medicine GmbH (Cloppenburg, Alemanya))
Tarantini, Giuseppe (University of Padua Medical School)

Data:	2024
Resum:	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.
Nota:	This registry is funded by an investigator\u2010initiated grant from Edwards Lifesciences, Nyon, Switzerland and performed under the sponsorship of IPPMed \u2013 Institute for Pharmacology and Preventive Medicine GmbH, Cloppenburg, Germany.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	European Journal of Clinical Investigation, Vol. 54 Núm. 9 (september 2024) , p. e14241, ISSN 1365-2362

DOI: 10.1111/eci.14241

8 p, 1.2 MB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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