Key Points
- Investigators have published initial safety data from a first-in-human study to treat calcific aortic stenosis.
- Cardiawave’s Valvosoft® device uses focused ultrasound to nonthermally soften a calcified aortic valve.
- Post-procedure MRIs revealed no acute ischemic changes, major adverse events, or signs of stroke.
French manufacturer Cardiawave is currently developing the Valvosoft® focused noninvasive ultrasound therapy (NIUT) device to treat calcific aortic stenosis (CAS). The device is not CE-marked and is for clinical investigations only. Study investigators and Professor Emmanuel Messas, a cardiologist at Hôpital Européen Georges Pompidou, recently published initial safety data from a prospective, single-center first-in-human study in Serbia using the device.
To confirm safety, the team used diffusion-weighted MRI to determine whether any of the study participants experienced silent cerebrovascular events after undergoing NIUT with Valvosoft®. The brain MRIs, which were performed one to four days post-procedure, revealed no acute ischemic changes, no major adverse events, and no signs of stroke. The group also measured cardiac markers, such as creatine kinase (CK), creatine kinase-myocardial band (CK-MB), and cardiac troponin, with no clinically significant changes and conducted mini mental state examinations, which remained stable.
The Valvosoft® technology is designed as a treatment option for the approximately 16% of patients with CAS who do not qualify for transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) due to comorbidities or the risk of procedural complications (e.g., stroke). TAVR has revolutionized treatment for aortic valve disease, which is increasing with the aging population, but not all patients qualify for TAVR.
Valvosoft® uses focused ultrasound to create pulsed cavitation (a bubble cloud) that mechanically and nonthermally softens the heart valve by cracking calcium buildup inside the valve leaflets. The device is guided with real-time ultrasound imaging. Treatment was feasible for the 10 study participants who were enrolled in Serbia (median age, 80 years), and each received up to six 10-minute treatment sessions for a maximum 60 minutes of energy. The participants were ineligible for other treatments, and they had significant levels of co-existing diseases: concomitant coronary artery disease (70%), diabetes mellitus (40%), renal insufficiency (40%), or a prior cerebrovascular event (10%). Beyond safety, aortic valve area, mean pressure gradient, and New York Heart Association (NYHA) functional classification all improved at one-month post-procedure. NYHA is the most commonly used heart failure classification system.
As a next step, the Valvosoft® Pivotal Study began in June 2022 and is currently enrolling 60 participants at 11 sites in France, Germany, and the Netherlands. Enrollment is expected to be complete this month.
See European Heart Journal – Cardiovascular Imaging (Open Source)
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