TCT-843 Transcatheter Aortic Valve Implantation with Edwards SAPIEN XT™ versus Medtronic CoreValve Revalving System® with AccuTrak™: The SAPERE Pilot Study

Abstract

Background: To our knowledge no data exists comparing new generation commercially available devices for transfemoral (TF) transcatheter aortic valve implantation (TAVI). Methods: All consecutive patients from our single-center prospective registry with AS treated with TAVI with from Edwards SAPIEN XTTM (SXT) vs. Medtronic CoreValve® with AccuTrakTM delivery sy stem (MCVAT) when the devices became commercially available were included. The study endpoints were according to the Valve Academic Research Consortium (VARC) definitions. Results: In total, 235 patients treated in our center by TF TAVI for severe AS were included: 142 (60.4%) underwent SXT vs. 93 (39.6%) MCVAT. More females (60.6% vs. 43.0%; p 0.008) and smaller annulus size (23.2 1.9 vs. 24.3 2.0; p 0.001) were present in the SXT group. There were no differences between valves in 30-day combined safety endpoint (SXT 26.1% vs. MCVAT 29.7%; p 0.558), all-cause mortality (3.1% vs. 6.5%; p 0.218), cardiovascular mortality (2.3% vs. 5.4%; p 0.214), myocardial infarction (1.4% vs. 2.2%; p 0.683) or stroke (0.7% vs. 1.1%; p 0.774). Additionally, no differences were observed in life-threatening bleeding (12.4% vs. 20.4%; p 0.100) or major vascular complications (12.0% vs. 9.7%; p 0.583). Conversely, with SXT there was a lower occurrence of conduction disturbances/arrhythmia (16.5% vs. 36.6%; p 0.001) and pacemaker implantation (5.8% vs. 33.3%; p 0.001). Of note, a higher device success (96.5% vs. 88.2%; p 0.013) was observed with SXT. At median follow-up of 328 (IQR 83-401) days, there was no difference in combined efficacy endpoint (14.8% vs. 9.8%; p 0.265) or mortality (8.0% vs. 6.5%; p 0.654). Conclusions: In our single center experience, there was a lower incidence of arrhythmia and pacemaker, with higher device success with SXT. Differences in the characteristics of the patients treated with each valve may explain some of these findings.