CRT-700.1 Multi-Center Compassionate use Early Feasibility Evaluation of J-Valve Transcatheter Treatment for Severe Aortic Valve Regurgitation: Preliminary Results
Bashir H, Reardon M, Goel SS, Fam N, Jelisejevas J, Webb JG, Ye J, Frisoli TM, Siddiqui M, Garcia S, Answini GA, and Kereiakes DJ. CRT-700.1 Multi-Center Compassionate use Early Feasibility Evaluation of J-Valve Transcatheter Treatment for Severe Aortic Valve Regurgitation: Preliminary Results. JACC Cardiovasc Interv 2023; 16(4):S85-S86.
JACC Cardiovasc Interv
Background: Although transcatheter aortic valve replacement (TAVR) is accepted therapy for treatment of symptomatic severe aortic valve stenosis (AS), current devices are associated with increased procedural complications and sub-optimal outcomes when used to treat of aortic valve regurgitation (AR). Severe AR is the indication for 20-30% of surgical aortic valve replacements and is associated with increased morbidity and mortality. J-valve is a short frame, self-expanding TAVR device. (Figure) specifically designed for treatment of severe AR. Anchor rings facilitate commissural alignment and secure attachment to non-calcified native valves.
Methods: From Sept 2019 through Oct 2022, patients with symptomatic severe AR who were not surgical candidates or excluded from the ALIGN-AR trial were enrolled into a compassionate use early feasibility study at 5 North American centers. All patients signed informed consent for protocol approved by respective institutional review boards.
Results: Data from 13/28 patients (mean age 80 yrs; 38.5% male) with symptomatic (92.3% NYHA class III/IV; mean LVEF 48% [range 23-64%]) severe (92% grade III/IV) AR, atrial fibrillation (53.8%), and pacemaker/ICD (15.4%), had J-valve TAVR (15.4% alternative access). There were no deaths to 30 days and post-procedural AR grade was none/trivial in all patients. In follow-up (mean 333 days) there are 0 cardiac deaths (total mortality 30.7%; 3 malignancies, 1 sepsis). Serial echocardiograms demonstrate AR grade none/mild in 89%, and 100% at 30 days and 1 year respectively).
Conclusion: Despite high risk profile, preliminary analysis of this multi-center compassionate use study suggests that J-valve is safe with durable effectiveness for the treatment of symptomatic severe AR. Full data set on all patients will be presented.