Long-Term Clinical Outcomes of Transcatheter Aortic Valve Replacement Using J-Valve System for Patients with Pure Native Aortic Regurgitation

Background: The J-Valve, an "on-label" transcatheter heart valve, has been used for over a decade in patients with pure native aortic regurgitation (PNAR); however, long-term follow-up outcomes have not yet been documented. This study aims to evaluate the long-term safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with PNAR. Methods: We retrospectively reviewed 36 patients with PNAR who underwent TAVR using the J-Valve. Clinical data were collected, and follow-up assessments were performed via telephone or during outpatient visits. Results: The median follow-up duration was 5.26 years, and the cumulative 5-year survival rate was 74.0%. The initial procedural success rate of the J-Valve was remarkably high at 94.44%. There was no significant morphological or hemodynamic structural valve deterioration observed among these patients. Only one patient experienced moderate paravalvular leakage, which required surgical aortic valve replacement 4 years after the TAVR. Additionally, no instances of moderate or severe intra-prosthetic regurgitation were detected in this cohort. A significant reduction in left ventricular end-diastolic dimension was observed during the follow-up period compared to pre-operative measurements (p < 0.001). Conclusions: The J-Valve exhibited favorable long-term clinical outcomes, robust valve durability, and optimal hemodynamic performance in patients with PNAR.