Mid-term outcomes in aortic stenosis patients treated with contemporary balloon expandable and self-expanding valves; does valve size have an impact on outcome?

Abstract

Abstract Background No data currently exists comparing the performance of the contemporary iterations of balloon-expandable (BE) Edwards SAPIEN 3/Ultra and the self-expanding (SE) Medtronic Evolut PRO/R34 valves. In addition, no direct head to head comparisons of the aforementioned devices have been performed in patients with small annuli with the exception of small registries. Purpose Aim of the study was the head-to-head comparison of these transcatheter heart valves (THV) with emphasis on patients with small aortic annulus. Methods In this retrospective registry, peri-procedural outcomes and mid-term all-cause mortality were analyzed. Results 1673 patients (917 SE vs. 756 BE) were followed-up for a median of 15 months. Baseline demographics were similar apart from worse left ventricle systolic function amongst SE patients and more extensive coronary artery disease amongst BE patients. 194 patients died (11.6%) during follow-up. SE and BE groups showed similar survival at one (92.6 vs. 90.6%) and three-years (80.3% vs. 85.2%), plog-rank=0.136. Compared to the BE group, patients treated with SE device had lower peak (16.3±8mmHg SE vs. 21.9±8mmHg BE, p=0.001) and mean (8.8±5mmHg SE vs. 11.5±5mmHg BE, p=0.001) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation (PVR) post-operatively (5.6% vs. 0.7% for SE and BE valves respectively, p<0.001). In patients treated with small THV (≤26 for SE and ≤23mm for BE; N=284 for SE and N=260 for BE) survival was higher amongst patients treated with SE valves at both 1 (96.7% SE vs. 92.1% BE) and 3-years (91.8% SE vs. 82.2% BE), plog-rank=0.042. Conclusions Real-world comparison of the latest generation SE and BE devices demonstrated similar survival up to 3 years follow-up. Among patients with small aortic annulus, those treated with SE valves seem to demonstrate improved survival rates.36months survival rates