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

Sandra Santos-Martinez, Jonathan Halim, Alex Castro-Mejía, Federico De Marco, Carlo Trani, Pedro Martin, Fabio Infusino, Marco Ancona, Raul Moreno, Peter den Heijer, Luis Nombela-Franco, Francesco Bedogni, Gennaro Sardella, Matteo Montorfano, Ana Revilla-Orodea, Jose Raúl Delgado-Arana, Alejandro Barrero, Itziar Gómez-Salvador, Alexander J.J. IJsselmuiden, Alfredo RedondoHipólito Gutiérrez, Ana Serrador, Patrick W. Serruys, J. Alberto San Román, Ignacio J. Amat-Santos

Research output: Contribution to a Journal (Peer & Non Peer)Articlepeer-review

25 Citations (Scopus)

Abstract

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: 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: 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: After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances.

Original languageEnglish
Pages (from-to)25-31
Number of pages7
JournalInternational Journal of Cardiology
Volume351
DOIs
Publication statusPublished - 15 Mar 2022

Keywords

  • Conduction disturbances
  • ECG
  • Pacemaker
  • TAVI
  • TAVR

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