210 TAVI WITH SAPIEN 3 ULTRA AND ACURATE NEO2: OUTCOMES FROM A HIGH VOLUME CENTER

Abstract

Abstract Background Latest iterations of devices for transcatheter aortic valve implantation (TAVI) have brought refinements to further improve patients outcomes, but comparisons of balloon-expandable Sapien 3 ULTRA (ULTRA) and self-expanding Acurate Neo 2 (NEO2) valves are lacking. Objectives To compare hemodynamic and clinical outcomes of patients undergoing TAVI with ULTRA or NEO 2 devices. Methods Patients undergoing TAVI with ULTRA and NEO 2 and enrolled in the REPLACE Registry from June 2019 to July 2022 (n=174) were analyzed. The primary efficacy and safety outcomes were VARC-3 device success and early safety, respectively. Secondary outcomes included technical success, 30-day clinical outcomes and echocardiographic device performance. Results A total of 119 patients receiving ULTRA (68.4%) and 55 receiving NEO 2 (31.6%) were compared. The primary efficacy (90.8% vs. 87.3%, for ULTRA and NEO2 respectively, p=0.483) and safety (87.4% vs. 85.5%, for ULTRA and NEO2 respectively, p=0.725) outcomes did not differ between patients receiving ULTRA or NEO 2 transcatheter aortic valves. On post-TAVI echocardiography, no cases of severe PVR were detected. The rate of mild-to-moderate paravalvular regurgitation (PVR) was lower in the ULTRA group (0.9% vs. 6.1%, p=0.002), with similar mean transvalvular gradients between the study groups (median 10 vs. 8.5 mmHg, for ULTRA and NEO2 respectively, p=0.11). Conclusions In this comparison, device success rates were high with both new-generation devices, with overall low rates of adverse events at 30 days after TAVI. Very low PPI rates were reported with both devices. PVR rates were low, but higher in patients receiving NEO 2.