Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry.


Journal

Journal of the American Heart Association
ISSN: 2047-9980
Titre abrégé: J Am Heart Assoc
Pays: England
ID NLM: 101580524

Informations de publication

Date de publication:
03 11 2020
Historique:
pubmed: 27 10 2020
medline: 27 3 2021
entrez: 26 10 2020
Statut: ppublish

Résumé

Background Transcatheter aortic valve replacement (TAVR) requires large-bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large-scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1-year follow-up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65-0.99];

Identifiants

pubmed: 33103545
doi: 10.1161/JAHA.120.018042
pmc: PMC7763424
doi:

Banques de données

ClinicalTrials.gov
['NCT02713932']

Types de publication

Comparative Study Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

e018042

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Auteurs

Sergio Berti (S)

Department of Diagnostic and Interventional Cardiology Gabriele Monasterio Tuscany Foundation, G. Pasquinucci Heart Hospital Massa Italy.

Francesco Bedogni (F)

Department of Clinical and Interventional Cardiology IRCCS Policlinico San Donato Milan Italy.

Arturo Giordano (A)

Unità Operativa di Interventistica Cardiovascolare Pineta Grande Hospital Castel Volturno Italy.

Anna S Petronio (AS)

Department of Cardiology Azienda Ospedaliero-Universitaria Pisana Pisa Italy.

Alessandro Iadanza (A)

Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte Siena Italy.

Antonio L Bartorelli (AL)

Centro Monzino IRCCS and Department of Biomedical and Clinical Sciences "Luigi Sacco" University of Milan Italy.

Bernard Reimers (B)

Cardio Center Humanitas Research Hospital IRCCS Rozzano-Milan Italy.

Carmen Spaccarotella (C)

Division of Cardiology CCU and Interventional Cardiology Cardiovascular Research Center University Magna Graecia Catanzaro Italy.

Carlo Trani (C)

Institute of Cardiology Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy.

Tiziana Attisano (T)

Cardiologia Interventistica Dipartimento Cardio Toraco Vascolare AOU S. Giovanni di Dio e Ruggi D'Aragona Salerno Italt.

Angela Marella Cenname (A)

Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy.

Gennaro Sardella (G)

Department of Cardiology Policlinico "Umberto I" Sapienza University of Rome Italy.

Roberto Bonmassari (R)

Department of Cardiology S. Chiara Hospital Trento Italy.

Massimo Medda (M)

Istituto Clinico Sant'Ambrogio, Gruppo San Donato Milano Italy.

Fabrizio Tomai (F)

Division of Cardiology European Hospital Rome Italy.

Giuseppe Tarantini (G)

A.O. Policlinico Universitario di Padova, Centro Gallucci Padova Italy.

Eliano P Navarese (EP)

Department of Cardiology and Internal Medicine Interventional Cardiology and Cardiovascular Medicine Research Nicolaus Copernicus University Bydgoszcz Poland.
Faculty of Medicine University of Alberta Edmonton Canada.
SIRIO MEDICINE Research Network Bydgoszcz Poland.

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