Chronic aortic regurgitation (AR) poses a significant challenge as far as transcatheter alternatives go due to the absence of calcification and a suitable anchoring area, along with annular dilation, which is generally associated with poor prognosis.
The J-Valve system was specifically designed to treat AR by incorporating a valve with an anchoring ring and a delivery system capable of angulation and flexibility.
The aim of this study was to assess the effectiveness and safety of the J-Valve in symptomatic patients with AR who were deemed inoperable or at high surgical risk. Patients with vascular events in the previous month, other valve disease requiring intervention, or severe ventricular dysfunction (<20%) were excluded from the study.
Analyzed events were cardiovascular mortality, pacemaker implantation, hemodynamic performance, left ventricular remodeling, functional improvement, and quality of life.
The study included a total of 127 patients, of which 124 underwent successful implantation, while 3 crossed over to surgical replacement. The average patient age was 73.9 years; 36.2% of subjects were women, the mean STS score was 6.1, and 74% of patients were classified as New York Heart Association (NYHA) functional class III or IV.
Overall, 96% of cases were related to the tricuspid valve, with an average annular perimeter of 81.3 mm and a mean angle of 55.5°. Large valves (sizes 29, 31, 34) were used in 15% of the cases, while 81.9% of patients received medium-sized valves (25, 27, 28).
The technical success rate for the procedure was 93.6%. Cardiovascular mortality was 1.6%, and the rate for pacemaker implantation was 9.5%.
Read also: Sievers Type 1 Bicuspid Valves: Which to Use?
From a hemodynamic perspective, there was a reduction in the transvalvular gradient along with optimization of the effective orifice area. Paravalvular leak (PVL) was mild and showed improvement over time. There were also positive changes in ventricular remodeling, and patients experienced significant improvement in quality of life.
Presented by Lai Wei at Top Late-Breaking Trials, PCR London Valves, November 24, 2024, London, Great Britain.
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