• Emmanuel Messas, Alexander Ijsselmuiden, Danijela Trifunović-Zamaklar, Bernard Cholley, Etienne Puymirat, Jonathan Halim, Radmila Karan, Menno van Gameren, Duško Terzić, Vladimir Milićević, Mickael Tanter, Mathieu Pernot, and Guillaume Goudot.
• 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.
• Lancet. 2023 Dec 16; 402 (10419): 231723252317-2325.

BackgroundCalcific 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.MethodsThis 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.Findings40 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.InterpretationThis novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible.FundingCardiawave.Copyright © 2023 Elsevier Ltd. All rights reserved.

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