Key result
Balloon aortic valvuloplasty with Valver balloon catheters in adults with severe aortic stenosis resulted in 3 periprocedural complications and a 38.9% mortality rate at 12 months.
Why the study?
The study was conducted to assess the feasibility and safety of performing balloon aortic valvuloplasty with the Valver balloon catheter in adults with severe aortic stenosis as a bridge or palliative treatment.
Is balloon aortic valvuloplasty with Valver balloon catheter feasible and safe as a bridge or palliative treatment in adults with severe aortic stenosis?
Observational (n=18)
Is balloon aortic valvuloplasty with Valver balloon catheter feasible and safe as a bridge or palliative treatment in adults with severe aortic stenosis?
Balloon aortic valvuloplasty with the Valver balloon catheter is a feasible and relatively safe palliative or bridge treatment for severe aortic stenosis, improving hemodynamics despite high 12-month mortality.
Retrospective data suggest Valver BAV feasibility in severe AS; leaves open prospective validation before wider use.
OBJECTIVE: The aim: We aimed to assess the feasibility and safety of performing balloon aortic valvuloplasty (BAV) with Valver balloon catheter (Balton, Poland) in adults with severe aortic stenosis as a bridge or palliative treatment. PATIENTS AND METHODS: Materials and methods: We identified consecutive patients who underwent BAV procedures between May 2019 and March 2020 using Valver balloon catheters. Demographic data, medical history, and clinical characteristics were retrospectively collected in all study patients together with periprocedural data as well as 12-month follow-up data. RESULTS: Results: We included 18 patients. The mean population age was 78.1±8.9 years, and women were 61.1%. The most common co-morbidities were arterial hypertension (88.9%), dyslipidemia (83.3%), and coronary artery disease (72.2%). The baseline mean aortic valve pressure gradient was 49.94±27.02 mmHg and the mean aortic valve area (AVA) was 0.65±0.20 cm2. In all cases, the procedure was performed from the femoral access via the 8F sheath. Two Valver balloon catheter sizes were used 18x40mm (33.3%) and 20x40mm (66.7%). Three periprocedural complications were observed, and none was associated with the Valver balloon catheter per se. The transthoracic echocardiography after the procedure revealed a decrease in the mean pressure gradient of 11.1±8.85 mmHg, and an increase in AVA of 0.21±0.19 cm2. At 12-month follow-up, the mortality rate was 38.9%. CONCLUSION: Conclusions: BAV is a procedure increasingly performed in catheterization laboratories worldwide. This paper confirmed the relative safety of BAV with Valver balloon catheters in the modern era, showing a low incidence of valve and vascular complications.
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Bil et al. (2021) conducted an observational in severe aortic stenosis (n=18). Balloon aortic valvuloplasty with Valver balloon catheter was evaluated on feasibility and safety (periprocedural complications and 12-month mortality). Balloon aortic valvuloplasty with Valver balloon catheters in adults with severe aortic stenosis resulted in 3 periprocedural complications and a 38.9% mortality rate at 12 months.
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