Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients.


Journal

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139

Informations de publication

Date de publication:
02 2022
Historique:
revised: 26 07 2021
received: 05 05 2021
accepted: 02 08 2021
pubmed: 15 8 2021
medline: 8 4 2022
entrez: 14 8 2021
Statut: ppublish

Résumé

We aimed to describe hemodynamic performance and clinical outcomes at 30-day follow-up of the balloon-expandable (BE) Myval transcatheter heart valve (THV) in low-risk patients. The results of the next-generation BE Myval THV in low-risk aortic stenosis (AS) patients are still unknown. Retrospective registry performed in nine European centers including patients with low predicted operative mortality risk according to Society of thoracic surgeons (STS) and European system for cardiac operative risk evaluation (EuroSCORE-II) scores. Between September 2019 and February 2021, a total of 100 patients (51% males, mean age 80 ± 6.5 years) were included. Mean STS score and EuroSCORE-II were 2.4 ± 0.8% and 2.2 ± 0.7%, respectively. Intermediate sizes were used in 39% (21.5 mm: 8%, 24.5 mm: 15%, 27.5 mm: 15%). There were no cases of valve embolization, coronary artery occlusion, annulus rupture, or procedural death. A definitive pacemaker implantation was needed in eight patients (8%). At 30-day follow-up aortic valve area (0.7 ± 0.2 vs. 2.1 ± 0.6 cm Hemodynamic performance and 30-day clinical outcomes of the BE Myval THV in low-risk AS patients were favorable. Longer-term follow-up is warranted.

Sections du résumé

OBJECTIVES
We aimed to describe hemodynamic performance and clinical outcomes at 30-day follow-up of the balloon-expandable (BE) Myval transcatheter heart valve (THV) in low-risk patients.
BACKGROUND
The results of the next-generation BE Myval THV in low-risk aortic stenosis (AS) patients are still unknown.
METHODS
Retrospective registry performed in nine European centers including patients with low predicted operative mortality risk according to Society of thoracic surgeons (STS) and European system for cardiac operative risk evaluation (EuroSCORE-II) scores.
RESULTS
Between September 2019 and February 2021, a total of 100 patients (51% males, mean age 80 ± 6.5 years) were included. Mean STS score and EuroSCORE-II were 2.4 ± 0.8% and 2.2 ± 0.7%, respectively. Intermediate sizes were used in 39% (21.5 mm: 8%, 24.5 mm: 15%, 27.5 mm: 15%). There were no cases of valve embolization, coronary artery occlusion, annulus rupture, or procedural death. A definitive pacemaker implantation was needed in eight patients (8%). At 30-day follow-up aortic valve area (0.7 ± 0.2 vs. 2.1 ± 0.6 cm
CONCLUSIONS
Hemodynamic performance and 30-day clinical outcomes of the BE Myval THV in low-risk AS patients were favorable. Longer-term follow-up is warranted.

Identifiants

pubmed: 34390296
doi: 10.1002/ccd.29923
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

889-895

Informations de copyright

© 2021 Wiley Periodicals LLC.

Références

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Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705.
Sharma SK, Rao RS, Chandra P, et al. First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study. EuroIntervention. 2020;16(5):421-429.
Rao RS. Safety and effectiveness of next-generation balloon-expandable transcatheter heart valve: six-month results of MyVal-1 study. Presented as Late Breaking Trial at: EuroPCR; May 19-22, 2020.
Kawashima H, Wang R, Mylotte D, et al. Quantitative angiographic assessment of aortic regurgitation after transcatheter aortic valve implantation among three balloon-expandable valves. Glob Heart. 2021;16(1):20. https://doi.org/10.5334/gh.959
Delgado-Arana JR, Gordillo-Monge MX, Halim J, et al. Early clinical and haemodynamic matched comparison of balloon-expandable valves. Heart. 2021. https://doi.org/10.1136/heartjnl-2021-319349. [Epub ahead of print].
Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013;145(1):6-23.
Thyregod HGH, Steinbrüchel DA, Ihlemann N, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol. 2015;65(20):2184-2194.
Kawashima H, Soliman O, Wang R, et al. Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: the LANDMARK trial. Am Heart J. 2021;232:23-38. https://doi.org/10.1016/j.ahj.2020.11.001

Auteurs

Mario García-Gómez (M)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Jose Raúl Delgado-Arana (JR)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Jonathan Halim (J)

Cardiology Department, Amphia Hospital Breda, Breda, Netherlands.

Federico De Marco (F)

Cardiology Department, IRCCS Policlinico San Donato, Milan, Italy.

Carlo Trani (C)

Cardiology Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Pedro Martin (P)

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

Kim Won-Keun (K)

Cardiology Department, Kerckhoff Heart Center, Bad Nauheim, Germany.

Matteo Montorfano (M)

Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.

Peter den Heijer (P)

Cardiology Department, Amphia Hospital Breda, Breda, Netherlands.

Francesco Bedogni (F)

Cardiology Department, IRCCS Policlinico San Donato, Milan, Italy.

Gennaro Sardella (G)

Cardiology Department, Policlinico Umberto I, Rome, Italy.

Alexander J J IJsselmuiden (AJJ)

Cardiology Department, Amphia Hospital Breda, Breda, Netherlands.

Rui Campante Teles (R)

Cardiology Department, Hospital de Santa Cruz, Lisbon, Portugal.

Christian H Aristizabal-Duque (CH)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Ximena Gordillo (X)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Sandra Santos-Martinez (S)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Alejandro Barrero (A)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Itziar Gómez-Salvador (I)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Marco Ancona (M)

Cardiology Department, San Raffaele Scientific Institute, Milan, Italy.

Alfredo Redondo (A)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

J Alberto San Román (JAS)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Ignacio J Amat-Santos (IJ)

Cardiology Department, CIBERCV, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

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