Transcatheter aortic valve replacement for native pure aortic regurgitation in inoperable patients achieved 76.3% clinical efficacy at 1 year with a 7.7% 30-day mortality rate.
Does off-label TAVR (with optional VA ECMO support) provide technical success and clinical efficacy in inoperable patients with native pure aortic regurgitation?
TAVR for native pure aortic regurgitation in inoperable patients demonstrates acceptable technical success and 1-year clinical efficacy, particularly when utilizing brief VA ECMO support for complex cases.
Aims Transcatheter aortic valve replacement has become the standard of care for high-risk patients with aortic stenosis. Considering the unique procedural challenges posed by native pure aortic regurgitation (NPAR), our aim was to evaluate the early and mid-term results of off-label transcatheter aortic valve replacement (TAVR), investigating the possibility of brief Veno-Arterial extracorporeal membrane oxygenation (VA ECMO) support for most complex procedures. Methods We retrospectively enrolled 65 consecutive patients, who underwent TAVR for NPAR because they were deemed ineligible for surgery. Patients with aortic valve calcification or stenosis were excluded. Primary endpoints were technical and device success according to the VARC-3 criteria. Secondary endpoints were clinical efficacy at 1 year and absence of at least moderate paravalvular leak. Results Patients’ mean age was 76.15 ± 8.91. We adopted light sedation and local anesthesia in 60 patients (92.3%). High-risk patients (53.8%) were briefly supported with percutaneous femoro-femoral VA ECMO, allowing safer and more precise valve deployment. One intraprocedural death was recorded (1.5%). Although the overall 30-day mortality was 7.7%, primary composite outcomes were significantly better in the second half of the population ( P = 0.023 and P = 0.026). Only one moderate paravalvular leak (1.5%) was detected at 1-month follow-up. Clinical efficacy at 1 year was 76.3%, being available for 38 patients. Conclusion TAVR is still considered an off-label approach for NPAR because of the increased stroke volume and absence of annular and leaflet calcification, which might increase the complication rate. Nonetheless, a standardized approach, with the aid of brief VA ECMO support for complex cases, should be considered a safe and valid option in high-volume centers for inoperable patients.
Cavalli et al. (2026) studied this question. Transcatheter aortic valve replacement for native pure aortic regurgitation in inoperable patients achieved 76.3% clinical efficacy at 1 year with a 7.7% 30-day mortality rate.