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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.
Parma, Radoslaw; Joner, Michael; Saia, Francesco; Cuisset, Thomas; Delgado, Victoria; Rodes-Cabau, Josep; Modine, Thomas; Van Belle, Eric; Fovino, Luca Nai; Landes, Uri; Alvarez-Covarrubias, Hector Alfonso; Abdel-Wahab, Mohamed; Zamorano, Jose Luis; Eden, Matthias; Cademartiri, Filippo; Skipirzepa, Joanna Nawara; Kurucova, Jana; Greinert, Daniel; Bramlage, Peter; Tarantini, Giuseppe.
Afiliación
  • Parma R; Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
  • Joner M; DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
  • Saia F; Department of Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Munich, Germany.
  • Cuisset T; Cardiology Unit, Cardio-Thoraco-Vascular Department, Policlinico S. Orsola-Malpighia, University Hospital of Bologn, Bologna, Italy.
  • Delgado V; Département de Cardiologie, Centre Hospitalier Universitaire de Timone, Marseille, France.
  • Rodes-Cabau J; Aix Marseille Université, INSERM, INRA, C2VN & Faculté de Médecine, Marseille, France.
  • Modine T; Department of Cardiology, University Hospital Germans Trias i Pujol, Badalona, Spain.
  • Van Belle E; Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Québec, Canada.
  • Fovino LN; Department of Cardiology, Hopital Haut Levêque-Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
  • Landes U; Interventional Cardiology, Centre Hospitalier Universitaire de Lille, Lille, France.
  • Alvarez-Covarrubias HA; Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy.
  • Abdel-Wahab M; Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
  • Zamorano JL; DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
  • Eden M; Department of Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Munich, Germany.
  • Cademartiri F; Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
  • Skipirzepa JN; University Hospital Ramón y Cajal, Head of Cardiology, Madrid, Spain.
  • Kurucova J; Heidelberg University Clinic, Department Internal Medicine III (Cardiology, Angiology, Pneumology), Heidelberg, Germany.
  • Greinert D; Department of Radiology, Fondazione Monasterio/CNR, Pisa, Italy.
  • Bramlage P; Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
  • Tarantini G; Edwards Lifesciences, Prague, Czech Republic.
Eur J Clin Invest ; 54(9): e14241, 2024 Sep.
Article en En | MEDLINE | ID: mdl-38767226
ABSTRACT

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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estenosis de la Válvula Aórtica / Sistema de Registros / Reemplazo de la Válvula Aórtica Transcatéter Límite: Aged / Humans / Male Idioma: En Revista: Eur J Clin Invest Año: 2024 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estenosis de la Válvula Aórtica / Sistema de Registros / Reemplazo de la Válvula Aórtica Transcatéter Límite: Aged / Humans / Male Idioma: En Revista: Eur J Clin Invest Año: 2024 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Reino Unido