Myval versus alternative balloon- and self-expandable transcatheter heart valves: A central core lab analysis of conduction disturbances.


Journal

International journal of cardiology
ISSN: 1874-1754
Titre abrégé: Int J Cardiol
Pays: Netherlands
ID NLM: 8200291

Informations de publication

Date de publication:
15 Mar 2022
Historique:
received: 02 11 2021
revised: 27 12 2021
accepted: 28 12 2021
pubmed: 4 1 2022
medline: 15 3 2022
entrez: 3 1 2022
Statut: ppublish

Résumé

Several studies have compared surface electrocardiographic changes following different self-expandable (SE) (Evolut (Medtronic, USA); Acurate (Boston Scientific, USA); Portico (Abbott, USA); and Allegra (NVT, Germany)) and balloon-expandable (BE) Sapien-3 (Edwards Lifesciences, USA) transcatheter heart valves. We aimed to compare these prosthesis with the novel Myval BE prosthesis (Meril Life, India). Academic European registry of consecutive patients with severe aortic stenosis who received any of the 6 aforementioned valves. Baseline, post-procedural, and discharge 12‑leads electrocardiograms (ECG) were centrally analyzed and compared. A total of 1131 patients were included: 135 Myval (11.9%), 290 Sapien-3 (25.6%), 298 Evolut (26.3%), 180 Acurate (15.9%), 125 Portico (11.1%), and 103 Allegra (9.1%). There were no baseline differences in intraventricular conduction disturbances rate. Compared to the novel BE Myval, there were similar procedural and in-hospital outcomes. Similar rates of early new permanent pacemaker implant (PPI) were observed amongst Myval (7.4%), Sapien-3 (13.4%), and Acurate (9.1%), but Evolut, Portico, and Allegra presented significantly higher rates (18.5%, p = 0.003; 29.5% p < 0.001 and 22%, p = 0.001, respectively). Central analysis of ECGs, unraveled significant prolongation of the PR segment with Evolut, Portico and Allegra whereas Evolut, Acurate, and Portico showed significant QRS widening compared to Myval. However, at discharge no differences in PR segment duration were observed while, Evolut, and Portico- but not Acurate, Allegra or Sapien-3 - still presented significant widening of QRS segment compared to Myval. After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances.

Sections du résumé

BACKGROUND BACKGROUND
Several studies have compared surface electrocardiographic changes following different self-expandable (SE) (Evolut (Medtronic, USA); Acurate (Boston Scientific, USA); Portico (Abbott, USA); and Allegra (NVT, Germany)) and balloon-expandable (BE) Sapien-3 (Edwards Lifesciences, USA) transcatheter heart valves. We aimed to compare these prosthesis with the novel Myval BE prosthesis (Meril Life, India).
METHODS METHODS
Academic European registry of consecutive patients with severe aortic stenosis who received any of the 6 aforementioned valves. Baseline, post-procedural, and discharge 12‑leads electrocardiograms (ECG) were centrally analyzed and compared.
RESULTS RESULTS
A total of 1131 patients were included: 135 Myval (11.9%), 290 Sapien-3 (25.6%), 298 Evolut (26.3%), 180 Acurate (15.9%), 125 Portico (11.1%), and 103 Allegra (9.1%). There were no baseline differences in intraventricular conduction disturbances rate. Compared to the novel BE Myval, there were similar procedural and in-hospital outcomes. Similar rates of early new permanent pacemaker implant (PPI) were observed amongst Myval (7.4%), Sapien-3 (13.4%), and Acurate (9.1%), but Evolut, Portico, and Allegra presented significantly higher rates (18.5%, p = 0.003; 29.5% p < 0.001 and 22%, p = 0.001, respectively). Central analysis of ECGs, unraveled significant prolongation of the PR segment with Evolut, Portico and Allegra whereas Evolut, Acurate, and Portico showed significant QRS widening compared to Myval. However, at discharge no differences in PR segment duration were observed while, Evolut, and Portico- but not Acurate, Allegra or Sapien-3 - still presented significant widening of QRS segment compared to Myval.
CONCLUSIONS CONCLUSIONS
After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances.

Identifiants

pubmed: 34979152
pii: S0167-5273(21)02052-0
doi: 10.1016/j.ijcard.2021.12.049
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

25-31

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 Elsevier B.V. All rights reserved.

Auteurs

Sandra Santos-Martinez (S)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Jonathan Halim (J)

Amphia Hospital Breda, the Netherlands.

Alex Castro-Mejía (A)

Hospital Clinico Universitario San Carlos, Madrid, Spain.

Federico De Marco (F)

IRCCS Policlinico San Donato, Milan, Italy.

Carlo Trani (C)

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.

Pedro Martin (P)

Hospital Universitario de Gran Canaria Dr Negrin, Gran Canaria, Spain.

Fabio Infusino (F)

Policlinico Umberto I, Roma, Italy.

Marco Ancona (M)

San Raffaele Scientific Institute, Milan, Italy.

Raul Moreno (R)

Hospital La Paz, Madrid, Spain.

Peter den Heijer (P)

Amphia Hospital Breda, the Netherlands.

Luis Nombela-Franco (L)

Hospital Clinico Universitario San Carlos, Madrid, Spain.

Francesco Bedogni (F)

IRCCS Policlinico San Donato, Milan, Italy.

Gennaro Sardella (G)

Policlinico Umberto I, Roma, Italy.

Matteo Montorfano (M)

San Raffaele Scientific Institute, Milan, Italy.

Ana Revilla-Orodea (A)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Jose Raúl Delgado-Arana (JR)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Alejandro Barrero (A)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Itziar Gómez-Salvador (I)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Alexander J J IJsselmuiden (AJJ)

Amphia Hospital Breda, the Netherlands.

Alfredo Redondo (A)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Hipólito Gutiérrez (H)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Ana Serrador (A)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Patrick W Serruys (PW)

Department of Cardiology, National University of Ireland, Galway and CORRIB Corelab and Center for Research and Imaging, Galway, Ireland.

J Alberto San Román (JAS)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain.

Ignacio J Amat-Santos (IJ)

CIBERCV, Hospital Clinico Universitario de Valladolid, Spain. Electronic address: ijamat@gmail.com.

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