1. There was no procedure-related mortality or life-threatening events reported.
2. At the 6-month follow-up, improved valve function was noted with increased mean aortic valve area and decreased mean pressure gradient.
Evidence Rating Level: 2 (Good)
Study Rundown: Calcific aortic stenosis is often challenging to treat with conventional interventions given the burden of comorbidities among many patients. This has led to the exploration of non-invasive therapies for high-risk patients. This prospective, single-arm series assessed the safety and efficacy of trans-thoracically delivered non-invasive ultrasound therapy in patients with severe symptomatic aortic valve stenosis. The primary endpoint was procedure-related mortality within 30 days, while key secondary endpoint was all-cause mortality. According to study results, there was no procedure-related mortality, and no life-threatening or cerebrovascular events at the 6-month follow-up. Furthermore, improvements in aortic valve function were seen with increased mean aortic valve area and decreased mean pressure gradients. Although this study was well done, it was limited by its non-randomized, single-arm nature, necessitating further validation.
Click to read the study in The Lancet
Relevant Reading: Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis
In-depth [prospective cohort]: This prospective cohort study included 40 adult patients with severe symptomatic aortic valve stenosis, ineligible for traditional interventions, at three hospitals in France, the Netherlands, and Serbia. Altogether, 40 high-risk patients with a mean Society of Thoracic Surgeons score of 5.6% and multiple severe comorbidities were included in the final analysis. The primary outcome of procedure-related mortality did not occur, and no life-threatening events were reported. Improved valve function, evidenced by a 10% increase in mean aortic valve area and a 7% decrease in mean pressure gradient at 6 months, was observed. The New York Heart Association score improved or stabilized in 96% of patients, with a 33% improvement in the Kansas City Cardiomyopathy Questionnaire score. Non-serious adverse events included pain, discomfort, and transient arrhythmias. Findings from this study suggest that non-invasive ultrasound therapy for calcified aortic stenosis is safe and feasible.
Image: PD
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