The novel, noninvasive ultrasound therapy is safe and may help improve valvular function in patients with calcified aortic stenosis, according to a study.
The study included 40 high-risk adult patients with severe symptomatic aortic valve stenosis (mean Society of Thoracic Surgeons score 5.6 percent) and multiple severe comorbidities. These patients underwent noninvasive ultrasound therapy delivered transthoracically. Follow-ups were conducted at 1, 3, 6, 12, and 24 months.
The primary endpoints included procedure-related deaths within 30 days and improved valve function. There were no procedure-related deaths documented within 30 days of treatment. Improvements in valve function occurred up to 6 months. Specifically, mean aortic valve area increased by 10 percent, from 0.58 cm2 at baseline to 0.64 cm2 (0·21) at follow-up (p=0.0088). In addition, mean pressure gradient dropped by 7 percent, from 41.9 mm Hg to 38.8 mm Hg (p=0.024).
At 6 months, 24 of 25 patients (96 percent) had improved or stabilized New York Heart Association score. Moreover, the mean Kansas City Cardiomyopathy Questionnaire score increased by 33 percent, from 48.5 to 64.5.
A serious procedure-related adverse event—a transient decrease in peripheral oxygen saturation—occurred in a single patient. Nonserious adverse events included pain, discomfort during treatment, and transient arrhythmias.