Quantcast

Modified implantation height of the Sapien3™ transcatheter heart valve.

Research paper by Daniel D Wendt, Sharaf-Eldin SE Shehada, Luisa L König, Philipp P Kahlert, Ulrich U Frey, Fanar F Mourad, Heinz H Jakob, Matthias M Thielmann, Mohamed M El Gabry

Indexed on: 20 Aug '19Published on: 24 Apr '19Published in: Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy



Abstract

During transcatheter aortic valve implantation (TAVI), ideal positioning is crucial. The latest-generation balloon expandable Sapien3™ transcatheter heart valve (THV) comes with a marker, which is recommended to be exactly centered at the aortic annular level. We aimed to evaluate a higher "aortic" marker positioning. A total of 119 high-risk patients presenting with aortic stenosis were treated with the Sapien3™ THV. After having placed the THV more "aortic", clinical and hemodynamic data, especially postoperative pacemaker implantation and paravalvular leakages, were evaluated at 30-days according to VARC-2. The Sapien3™ THV was implanted in 92 patients via the transapical, in 13 patients via the transaortic and in 14 patients via the tranfemoral access. Mean age was 80.6 ± 5.7 years. Aortic valve area increased significantly (0.9 ± 0.3 vs. 1.80 ± 0.35cm, p < .0001) and mean pressure gradients decreased from 41.0 ± 15.0 to 10.4 ± 3.5 mmHg (p < .0001). The majority of patients showed no or mild paravalvular aortic regurgitation (99.1%, 112/113), confirmed by transthoracic echocardiography at 30-days: PVL was absent or trace in 91.2% (103/113), mild in 7.9% (9/113) and moderate in 0.9% (1/113), whereas no patient developed severe PVL. Thirty days mortality was 5.0% (6/119). All patients (n = 113) were in NYHA functional class I or II at 30 days and three patients (2.5%) needed pacemaker implantation. In conclusion, a modified higher "aortic" implantation of the Sapien3™ THV holds promise to further reduce paravalvular leakage as well as permanent pacemaker implantation in TAVI. This trial showed an extremely low postoperative pacemaker implantation rate of 2.5%.