Multicenter Study

. 2023 Dec 16;402(10419):2317-2325.

doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14.

Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study

Affiliations

¹ Cardiovascular Department, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France; Paris Cardiovascular Research Center, Inserm UMR_U970, Université Paris-Cité, Paris, France; STOP-AS Research Consortium, Recherche Hospitalo-Universitaire, Rouen, France. Electronic address: emmanuel.messas@aphp.fr.
² Cardiology Department, Amphia Hospital, Breda, Netherlands.
³ Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Clinic for Cardiology, University Clinical Centre of Serbia, Belgrade, Serbia.
⁴ Department of Anaesthesiology and Intensive Care Medicine, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France; Innovative Therapies in Haemostasis, Inserm UMR_S1140, Université Paris-Cité, Paris, France.
⁵ Cardiovascular Department, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France; Paris Cardiovascular Research Center, Inserm UMR_U970, Université Paris-Cité, Paris, France.
⁶ Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Department of Anaesthesiology and Intensive Care at Clinic for Cardiac Surgery, University Clinical Centre of Serbia, Belgrade, Serbia.
⁷ Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Clinic for Cardiac Surgery, University Clinical Centre of Serbia, Belgrade, Serbia.
⁸ Clinic for Cardiac Surgery, University Clinical Centre of Serbia, Belgrade, Serbia.
⁹ Physics for Medicine Paris, Inserm/ESPCI Paris-PSL/CRNS, Paris, France.
¹⁰ Cardiovascular Department, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France.

PMID: 37972628
DOI: 10.1016/S0140-6736(23)01518-0

Multicenter Study

Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study

Emmanuel Messas et al. Lancet. 2023.

. 2023 Dec 16;402(10419):2317-2325.

doi: 10.1016/S0140-6736(23)01518-0. Epub 2023 Nov 14.

Affiliations

¹ Cardiovascular Department, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France; Paris Cardiovascular Research Center, Inserm UMR_U970, Université Paris-Cité, Paris, France; STOP-AS Research Consortium, Recherche Hospitalo-Universitaire, Rouen, France. Electronic address: emmanuel.messas@aphp.fr.
² Cardiology Department, Amphia Hospital, Breda, Netherlands.
³ Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Clinic for Cardiology, University Clinical Centre of Serbia, Belgrade, Serbia.
⁴ Department of Anaesthesiology and Intensive Care Medicine, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France; Innovative Therapies in Haemostasis, Inserm UMR_S1140, Université Paris-Cité, Paris, France.
⁵ Cardiovascular Department, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France; Paris Cardiovascular Research Center, Inserm UMR_U970, Université Paris-Cité, Paris, France.
⁶ Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Department of Anaesthesiology and Intensive Care at Clinic for Cardiac Surgery, University Clinical Centre of Serbia, Belgrade, Serbia.
⁷ Faculty of Medicine, University of Belgrade, Belgrade, Serbia; Clinic for Cardiac Surgery, University Clinical Centre of Serbia, Belgrade, Serbia.
⁸ Clinic for Cardiac Surgery, University Clinical Centre of Serbia, Belgrade, Serbia.
⁹ Physics for Medicine Paris, Inserm/ESPCI Paris-PSL/CRNS, Paris, France.
¹⁰ Cardiovascular Department, Hôpital Européen Georges-Pompidou, Université Paris-Cité, Paris, France.

PMID: 37972628
DOI: 10.1016/S0140-6736(23)01518-0

Abstract

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: 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: 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 cm² (SD 0·19) at baseline to 0·64 cm² (0·21) at follow-up (p=0·0088), and a 7% decrease in mean pressure gradient from 41·9 mm Hg (20·1) to 38·8 mm Hg (17·8; p=0·024). At 6 months, the New York Heart Association score had improved or stabilised in 24 (96%) of 25 patients, and the mean Kansas City Cardiomyopathy Questionnaire score had improved by 33%, from 48·5 (SD 22·6) to 64·5 (21·0). One serious procedure-related adverse event occurred in a patient who presented with a transient decrease in peripheral oxygen saturation. Non-serious adverse events included pain, discomfort during treatment, and transient arrhythmias.

Interpretation: This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible.

Funding: Cardiawave.

PubMed Disclaimer

Conflict of interest statement

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.

Comment in

Non-invasive high-energy ultrasound: alternative treatment before transcatheter aortic valve implantation?
Di Mario C, Mattesini A. Di Mario C, et al. Lancet. 2023 Dec 16;402(10419):2267-2269. doi: 10.1016/S0140-6736(23)02186-4. Epub 2023 Nov 14. Lancet. 2023. PMID: 37972627 No abstract available.
Non-invasive ultrasound therapy for calcified aortic valve stenosis.
Huynh K. Huynh K. Nat Rev Cardiol. 2024 Feb;21(2):71. doi: 10.1038/s41569-023-00968-x. Nat Rev Cardiol. 2024. PMID: 38036670 No abstract available.
Limitations of non-invasive ultrasound therapy for valve stenosis.
Ou D, Hu C, Huang S. Ou D, et al. Lancet. 2024 Aug 17;404(10453):653. doi: 10.1016/S0140-6736(24)01346-1. Lancet. 2024. PMID: 39153808 No abstract available.
Limitations of non-invasive ultrasound therapy for valve stenosis.
Komamura K, Miyake H, Kobayashi K, Iwase M. Komamura K, et al. Lancet. 2024 Aug 17;404(10453):653-654. doi: 10.1016/S0140-6736(24)01348-5. Lancet. 2024. PMID: 39153809 No abstract available.

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Supplementary concepts

Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov
Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
- ClinicalKey
- Elsevier Science
Medical
- ClinicalTrials.gov
Research Materials
- NCI CPTC Antibody Characterization Program

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study

Affiliations

Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study

Authors

Affiliations

Abstract

Conflict of interest statement

Comment in

Publication types

MeSH terms

Supplementary concepts

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials