Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study.
Journal
Lancet (London, England)
ISSN: 1474-547X
Titre abrégé: Lancet
Pays: England
ID NLM: 2985213R
Informations de publication
Date de publication:
13 Nov 2023
13 Nov 2023
Historique:
received:
10
05
2023
revised:
13
07
2023
accepted:
18
07
2023
medline:
17
11
2023
pubmed:
17
11
2023
entrez:
16
11
2023
Statut:
aheadofprint
Résumé
Calcific aortic stenosis is commonly treated using surgical or transcatheter aortic valve replacement; however, many patients are not considered suitable candidates for these interventions due to severe comorbidities and limited life expectancy. As such, non-invasive therapies might offer alternative therapeutic possibilities in these patients. This study aimed to assess the safety of non-invasive ultrasound therapy and its ability to improve valvular function by softening calcified valve tissue. This prospective, multicentre, single-arm series enrolled 40 adult patients with severe symptomatic aortic valve stenosis at three hospitals in France, the Netherlands, and Serbia between March 13, 2019, and May 8, 2022. Patients were treated with transthoracically delivered non-invasive ultrasound therapy. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months. The primary endpoints were procedure-related deaths within 30 days and improved valve function. We report the 6-month data. This study is registered at ClinicalTrials.gov, NCT03779620 and NCT04665596. 40 high-risk patients with a mean Society of Thoracic Surgeons score of 5·6% (SD 4·4) and multiple severe comorbidities were included. The primary endpoint, procedure-related mortality, did not occur; furthermore, no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed up to 6 months, reflected by a 10% increase in mean aortic valve area from 0·58 cm This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible. Cardiawave.
Sections du résumé
BACKGROUND
BACKGROUND
Calcific aortic stenosis is commonly treated using surgical or transcatheter aortic valve replacement; however, many patients are not considered suitable candidates for these interventions due to severe comorbidities and limited life expectancy. As such, non-invasive therapies might offer alternative therapeutic possibilities in these patients. This study aimed to assess the safety of non-invasive ultrasound therapy and its ability to improve valvular function by softening calcified valve tissue.
METHODS
METHODS
This prospective, multicentre, single-arm series enrolled 40 adult patients with severe symptomatic aortic valve stenosis at three hospitals in France, the Netherlands, and Serbia between March 13, 2019, and May 8, 2022. Patients were treated with transthoracically delivered non-invasive ultrasound therapy. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months. The primary endpoints were procedure-related deaths within 30 days and improved valve function. We report the 6-month data. This study is registered at ClinicalTrials.gov, NCT03779620 and NCT04665596.
FINDINGS
RESULTS
40 high-risk patients with a mean Society of Thoracic Surgeons score of 5·6% (SD 4·4) and multiple severe comorbidities were included. The primary endpoint, procedure-related mortality, did not occur; furthermore, no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed up to 6 months, reflected by a 10% increase in mean aortic valve area from 0·58 cm
INTERPRETATION
CONCLUSIONS
This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible.
FUNDING
BACKGROUND
Cardiawave.
Identifiants
pubmed: 37972628
pii: S0140-6736(23)01518-0
doi: 10.1016/S0140-6736(23)01518-0
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03779620', 'NCT04665596']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests EM, AI, DT-Z, EP, BC, JH, RK, MvG, DT, VM, and GG are investigators of the study. EM reports being a co-founder and scientific advisory board member of, and holding shares in Cardiawave. DT-Z reports honoraria for lectures from AstraZeneca, Boehringer Ingelheim, Pfizer, Hemofarm, and Amicus Therapeutics; support to attend meetings from and participation in data safety monitoring and advisory boards for Boehringer Ingelheim; and being the President of the Echocardiographic Society of Serbia. MT and MP are co-founders of and hold shares in Cardiawave. All other authors declare no competing interests.