Modified implantation height of the Sapien3™ transcatheter heart valve

Abstract

Objectives: 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.

Material and methods: 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.

Results: 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 ± 0.35cm², 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.

Conclusions: 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%.

Keywords:

• TAVI
• pacemaker implantation
• paravalvular leakage
• Sapien3
• central marker

Acknowledgement

The authors would like to thank Wolfgang Ristau and Gina Spangel for their continuous support in data collection.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. The authors had full access to the data and take full responsibility for its integrity. All authors have read and agreed to the manuscript as written.