Outcomes of Symetis-Acurate Neo 2 vs. Edwards-Sapien 3 and Medtronic Evolut Pro/Pro+ Heart Valves in Patients Undergoing Transcatheter Aortic Valve Replacement.
2Epidemiology & Community Health Sciences & Children's Department, Clalit-Health Services, Israel
3Cardiology, Rabin Medical Center, Israel
Introduction
Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis (AS). Comparative data on the efficacy and safety of newer transcatheter heart valve (THV) devices is still evolving. We aim to compare clinical and hemodynamic outcomes of the Symetis-Acurate Neo-2® vs. the Medtronic-Evolut Pro/Pro+® and the Edwards-Sapien 3® THVs, from a large cohort of patients undergoing TAVR.
Methods
In this retrospective, all-comer, single center trial, patients undergoing TAVR were treated with either Acurate Neo2, Evolut Pro/Pro+ or Sapien 3 THVs. Baseline clinical, demographic and follow-up data was collected.
Results
Patients (N=1049) (female 48.6%) mean age was 80.1±7.7 years. The Acurate Neo-2, Evolut Pro/Pro+, and Sapien 3 THVs were implanted in 240, 324 and 485 patients respectively. Acurate Neo-2 patients were predominantly female (81%) in comparison to Evolut Pro/Pro+ (59%) and Sapien 3 (26%). All-cause mortality rates showed no significant differences. Need for new permanent pacemaker implantation (PPI) was lower in the Acurate Neo-2 group compared to the Evolut Pro/Pro+ group (8% vs. 17%, p=0.01; respectively) and similar to the Sapien 3 group (8% vs 11% p=0.25; respectively). Rates of ≥ moderate paravalvular leak (PVL) were similar in the Acurate Neo-2 group compared to the Evolut Pro/Pro+ group (3% vs 3% at 1 month and 4% vs. 7% at 1 year, p=0.56, respectively), and higher compared to the Sapien 3 group (3% vs 1% at 1 month, P<0.001 and 4% vs 2% at 1 year follow up, p=0.08; respectively).
Conclusion
In our center the Acurate Neo-2 was used predominantly in female patients. All-cause mortality rates were similar among the devices. Acurate Neo 2 had lower rates of new PPI compared to Evolut Pro/Pro+ and Similar compared to Sapien 3, and rates of PVL were similar compared to Evolut Pro/Pro+ and higher than Sapien 3.
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