Valvular & structural heart diseaseCohort study
Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study
- Prospective cohort study
- multicentre
- single-arm
Authors' conclusion
This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible.
Study context
- Population
- Adults with severe symptomatic aortic valve stenosis, high risk with multiple severe comorbidities, 3 hospitals in France, the Netherlands and Serbia, 2019–2022
- Participants
- 40 adults
- Outcome
- Procedure-related deaths within 30 days and improved valve function
- Follow-up
- 6-month data reported
Main finding
As reported in the abstract
up to 6 months
Procedure-related mortality did not occur
0
Mean aortic valve area, baseline → follow-up: 0.58 cm² (SD 0.19) → 0.64 cm² (0.21); 10% increase
p=0.0088
Mean pressure gradient: 41.9 mm Hg (20.1) → 38.8 mm Hg (17.8); 7% decrease
p=0.024
Observational data: associations, not effects.
Further findings
NYHA score improved or stabilised · up to 6 months
- Improved or stabilised in 24 (96%) of 25 patients
Kansas City Cardiomyopathy Questionnaire score · up to 6 months
- Mean score 48.5 (SD 22.6) → 64.5 (21.0); improved by 33%
Safety
Adverse events
- Life-threatening or cerebrovascular events
- 0
- Serious procedure-related adverse event (transient decrease in peripheral oxygen saturation)
- 1
- Non-serious adverse events: pain, discomfort during treatment, transient arrhythmias
Original publication
Treatment of severe symptomatic aortic valve stenosis using non-invasive ultrasound therapy: a cohort study. Lancet. Published 14 November 2023. doi:10.1016/s0140-6736(23)01518-0
Summarised from the published abstract; every number is checked against it