Clinical outcome and paravalvular leakage of the new balloon‐expandable Edwards Sapien 3 valve in comparison to its predecessor model (Edwards Sapien XT) in patients undergoing transfemoral aortic valve replacement

Objectives The aim of this study was to compare the 30‐day procedural, clinical and echocardiographic outcome of the new balloon‐expandable Edwards Sapien 3 (ES3) valve with the Edwards Sapien XT (ESXT). Background : Post‐implant paravalvular leaks (PVL) after transfemoral aortic valve replacement (TAVR) resulting in residual aortic regurgitation (AR) are a major limitation for long term outcome. New TAVR‐devices have to eliminate this problem. Methods Transfemoral TAVR was performed in 209 consecutive intermediate‐high‐risk surgical patients (pts) with symptomatic aortic stenosis (ESXT n  = 102, ES3 n  = 107). Transthoracic echocardiography (TTE) and 3‐dimensional computed tomography were used for valve size selection. Primary endpoint of the study was none/trace AR derived by TTE 30‐days after TAVR. Results All pts underwent successfully TAVR with a combined device success of 100/102 (99%) in ESXT and 107/107 (100%) in ES3 pts. Fluoroscopy time (ESXT 11.8 ± 0.5 min vs. ES3 10.0 ± 0.5 min, P  = 0.003) and contrast (ESXT 188.9 ± 5.6 mL vs. ES3 170.4 ± 4.7 mL, P  = 0.04) were significantly lower in ES3 patients. 30‐day clinical events did not differ. Transvalvular mean pressure gradients were significantly reduced to 7.4 ± 0.8 mmHg after ESXT and to 10.1± 0.4 mmHg after ES3 implantation. After 30 days none/trace AR was found in 34.3% ( n  = 35) of all ESXT pts in contrast to 89.7% ( n  = 96) of all ES3 patients. Moderate‐to‐severe AR was found rarely (ESXT 2.9% vs. ES3 0%, P  = 0.073). Conclusions Although there was no significant difference in 30 day mortality, the newer ES3 valve reduced significantly residual paravalvular leakage. © 2016 Wiley Periodicals, Inc.