Associazione Nazionale Medici Cardiologi Ospedalieri




Cavalli Giulio Giovanni San Giovanni Rotondo(Foggia) – IRCCS Ospedale Casa Sollievo della Sofferenza | Vallabini Albino San Giovanni Rotondo(Foggia) – IRCCS Ospedale Casa Sollievo della Sofferenza | Spatuzza Paola San Giovanni Rotondo(Foggia) – IRCCS Ospedale Casa Sollievo della Sofferenza

Background: TAVR has become the standard of care for high-risk patients with aortic stenosis. Considering unique procedural challenges posed by native pure aortic regurgitation (NPAR), our aim was to evaluate early and mid-term results of off-label treatment with new generation devices.

Materials and Methods: We retrospectively enrolled 61 consecutive patients, who underwent TAVR for NPAR between 2017 and 2023, because deemed ineligible for surgery. Mean logistic and Euroscore II were 17,07±11 and 5,62±5,9, though they did not accurately reflect surgical ineligibility: 7 patients (11,5%) had active cancer and 5 (8,2%) end-stage liver failure. Patients with valve calcifications or stenosis were excluded. A CT scan was obtained to choose device model and size, and access site. A percutaneous VA ECMO support was used in patients at higher risk for hemodynamic instability and procedural failure. Local anesthesia was preferred whenever feasible. Primary endpoints were technical and device success. Secondary endpoint was clinical efficacy at 1 year.

Results: Mean age was 75,69±9,01. Considering the high-risk population, we adopted local anesthesia in 56 patients (91,8%), reducing ICU admission and stay (27,9% and 1,98±6,51days). Mean aortic annulus diameter, perimeter and area were 25,5±2,16mm, 82,2±5,84mm and 520,04±74,32mm2. Consequently, the most frequently implanted prostheses were Evolut R/Pro 34 (41%), Sapien 3/Ultra 29 (26,2%) and Accurate neo M (9,8%). Approximately half of the population (54,1%) was shortly supported (24,46±24,7 minutes) with fem-fem VA ECMO, reducing hemodynamic instability due to rapid pacing. However, no increase in vascular complication was observed (p=0,58). One intraprocedural death was recorded (1,6%). Although 30-day mortality was 8,2%, primary outcomes were significantly better in the second half of the population (p=0,044 and p=0,036), reflecting the role of a standardized approach and surgeons’ higher expertise. Only 4 paravalvular leaks (6,6%) were detected at 1-month follow-up, 3 mild and 1 moderate (1,6%). Mean follow-up was 18,54±18,48 months. Clinical efficacy at 1 year was 76,3%, available for 38 patients.

Conclusions: TAVR is still considered an off-label approach for NPAR because of increased stroke volume and absence of annular and leaflet 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.