Treatment of Symptomatic Aortic Stenosis Using Noninvasive Ultrasound
- In a cohort of 40 patients with severe symptomatic aortic stenosis who were not candidates for surgical or transcatheter therapy, noninvasive transthoracic ultrasound therapy resulted in statistically significant but small improvements in valve hemodynamics (mean AVA 0.58 cm2 at baseline and 0.64 cm2 at 6-month follow-up; mean aortic gradient 41.9 mm Hg at baseline and 38.8 mm Hg at follow-up).
- No procedure-related deaths occurred by 30-day follow-up.
Is noninvasive transthoracic ultrasound therapy for severe symptomatic aortic stenosis (AS) safe and feasible?
This exploratory, first-in-human, single-arm study enrolled adult patients with severe symptomatic AS, who were not suitable candidates for surgical or transcatheter aortic valve replacement, at three European hospitals from 2019 to 2022. Transthoracic ultrasound therapy was given with the Valvosoft device (Cardiawave, France), which delivers short ultrasound pulses of very high pressure to calcified aortic valve leaflets. Primary endpoints were 30-day procedure-related death and improved valve function, defined as decrease in mean gradient and increase in aortic valve area (AVA). This manuscript reports 6-month follow-up data.
A total of 40 patients were included (mean age 83.5 years, 50% female, mean Society of Thoracic Surgeons 30-day operative mortality risk 5.6%). Most procedures were performed with conscious sedation, in an operating room or catheterization laboratory. Mean procedure time was 56 minutes. The only serious adverse procedure-related event was transient oxygen desaturation related to opioid administration. Six patients experienced transient chest pain. No procedure-related deaths occurred. Mean AVA increased from 0.58 cm2 at baseline to 0.64 cm2 (p = 0.0088), and mean aortic gradient decreased from 41.9 mm Hg to 38.8 mm Hg (p = 0.024) at 6-month follow-up. Mean New York Heart Association class improved from 3.0 at baseline to 2.3 at follow-up (p < 0.0001).
Noninvasive ultrasound therapy for severe symptomatic AS is safe and feasible, producing statistically significant but numerically small improvements in valve hemodynamics.
Currently, no validated noninvasive treatment for AS exists. Although the clinical significance of the small hemodynamic improvements seen in this study is questionable, the favorable safety results are reassuring. Large-scale, multi-arm trials will be needed to determine if this treatment can slow the progression of moderate AS or defer the need for surgical or transcatheter intervention in patients with severe AS.
Keywords: Aortic Valve Stenosis, Heart Valve Diseases, Ultrasonography
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