SAFETY AND EFFICACY OF TRANSCATHETER AORTIC VALVE REPLACEMENT FOR NATIVE PURE AORTIC VALVE REGURGITATION: SINGLE–CENTER EXPERIENCE

Background: Considering unique procedural challenges posed by native pure aortic regurgitation (NPAR), our aim was to evaluate off–label transcatheter treatment with new generation devices. Materials and Methods: We retrospectively enrolled 65 consecutive patients, the largest single-centre cohort to the best of our knowledge, who underwent TAVR for NPAR between 2017 and 2024, because deemed ineligible for surgery. Mean logistic and Euroscore II were 18,01±11,42% and 5,66±5,71%, though they did not accurately reflect surgical ineligibility: 8 patients (12,3%) had active cancer and 5(7,7%) end–stage liver failure. Patients with valve calcifications or stenosis were excluded. Primary endpoints were technical and device success. Results: We adopted local anesthesia in 60 patients (92,3%), reducing ICU admission and stay (26,2% and 1,86±6,32days). Most frequently implanted prostheses were Evolut R/Pro 34(41,5%), Sapien 3/Ultra 29(26,2%) and Accurate Neo M (10,8%). Approximately half of the population was shortly supported(23,53±24,13 minutes) with percutaneous fem–fem VA- ECMO, reducing hemodynamic instability. However, no increase in neither minor nor major vascular complication was observed (p=0,11 and p=0,27). One intraprocedural death was recorded (1,5%). Although 30–day mortality was 7,7%, primary outcomes were significantly better in the second half of the population (p=0,023 and p=0,026), reflecting the role of a standardized approach and surgeons’ higher expertise. Only 1 moderate paravalvular leaks was detected at 1–month follow–up. Conclusions: TAVR is still considered an off–label approach for NPAR because of increased stroke volume and absence of annular and leaflets calcification. Nonetheless a standardized approach, with the aid of brief VA ECMO support for complex cases, should be considered a safe and valid option for inoperable patients.