Off-label use of Myval Octacor and Octapro transcatheter heart valves in high-risk patients with pure noncalcified aortic regurgitation achieved technical and device success in 87.5% of cases.
Cohort (n=32)
Does TAVI with Myval Octacor and Octapro balloon-expandable THVs provide technical and device success in high-risk patients with severe pure non-calcified native aortic regurgitation?
Off-label use of Myval Octacor and Octapro balloon-expandable THVs for severe pure non-calcified aortic regurgitation is feasible and yields acceptable clinical outcomes in high-risk patients.
the treatment of high-risk or inoperable patients with severe, pure native non calcified aortic regurgitation (NCAR) poses unique procedural challenges for the trans -catheter technologies. In particular the lack of leaflet calcification and dilated aortic anatomies increase the risk of technical failure with the currently available trans -catheter heart valves (THV). This study sought to evaluate the feasibility, safety, and clinical outcomes following the off-label usage of the Myval Octacor and Octapro balloon-expandable (BE) THV in patients with pure NCAR. a retrospective cohort analysis was performed on consecutive high-risk surgical patients with severe, pure NCAR who underwent TAVI between January 2023 and June 2025 with the second (Octacor) and third (Octapro) generation of the Myval BE THV. Main end-points were technical and device success according to the Valve Academic Research Consortium (VARC) 3 criteria. The rates of permanent pace-maker implantation (PPI) and moderate-to-severe residual AR both, in-hospital and at the longest available follow-up were also evaluated. during the study period, 32 patients (Octacor, n = 21 and Octapro, n = 11) with pure, NCAR were treated. Mean age was 79.3 ± 7.6 years while 81.2% were male. The mean left ventricular ejection fraction was 43.1 ± 7.4%. An XL size was implanted in 21 patients of whom 15 were 32 mm. The average percentage of THV oversize was 19.7 ± 6.9. Technical success was achieved in 87.5% of the cases due to partial migration of 4 THVs (all 32 mm implanted in large annuli) into the LVOT requiring rescue implantation of a second prosthesis. This strategy was effective in achieving a good result in 2 cases while in the remaining 2, the THVs embolized in the left ventricle requiring surgical conversion. No intraprocedural death or disabling strokes were reported. PPI rate at discharge was 9.4% while moderate residual AR was reported in 1 patient (including patient underwent successful rescue THV-in-THV). Device success was 87.5%. At 1-year follow-up, mortality and PPI rates were 3.1% and 15.6%, respectively with no severe residual AR cases reported. Octacor and Octapro BE THVs implantation in patients with pure NCAR is feasible and yields acceptable clinical outcomes in a high-risk population. Further studies are warranted to better understand the potential role of these THVs in this complex scenario.
Ielasi et al. (Thu,) conducted a cohort in Severe pure non calcified native aortic regurgitation (n=32). Myval Octacor and Octapro trans-catheter heart valves was evaluated on Technical and device success according to the Valve Academic Research Consortium (VARC) 3 criteria. Off-label use of Myval Octacor and Octapro transcatheter heart valves in high-risk patients with pure noncalcified aortic regurgitation achieved technical and device success in 87.5% of cases.