Next-generation balloon-expandable Myval transcatheter heart valve in low-risk aortic stenosis patients.
TAVR
aortic stenosis
balloon-expandable
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
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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
889-895Informations de copyright
© 2021 Wiley Periodicals LLC.
Références
Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the Management of Patients with Valvular Heart Disease. J Am Coll Cardiol. 2021;77(4):e25-e197.
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