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Hemodynamic comparison of CoreValve and SAPIEN-XT TAVI valves in Japanese patients

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Abstract

Transcatheter aortic valve implantation (TAVI) is a viable treatment option for high-risk patients with severe aortic stenosis. In Japan, TAVI can be performed using first-generation self-expandable Medtronic CoreValve or balloon-expandable Edwards SAPIEN-XT from 2012. Since the durability and hemodynamic outcomes after transcatheter heart valve (THV) implantation in Japanese patients have not been clearly elucidated, we assessed serial changes in post-TAVI THV performances over a-3-year period by transthoracic echocardiography (TTE). From January 2012 to September 2014, among 83 patients with severe aortic stenosis, 26 underwent TAVI with CoreValve and 57 underwent TAVI with SAPIEN-XT. We assessed the serial changes in first post-implant (FPI) and 3-year post procedure THV hemodynamics by TTE. Valve performance was evaluated by serial assessment of aortic valve mean pressure gradient (PG) and aortic valve area (AVA) assessments. Three-year clinical outcomes were compared between the patients with CoreValve and those with SAPIEN-XT. Seventeen patients with CoreValve and 34 patients with SAPIEN-XT had FPI and 3-year TTEs. The AVA decreased significantly from FPI to 3-year follow-up among patients with SAPIEN-XT, but not among patients with CoreValve. The mean aortic PG decreased significantly from FPI to the 3-year follow-up point among patients with CoreValve; however, it was not significantly different from those with SAPIEN-XT. The absolute change in mean PG from FPI to the 3-year follow-up point decreased significantly among those with CoreValve compared to those with SAPIEN-XT. Clinical outcomes after TAVI were similar for both devices at 3-years after TAVI. In this study, long-term clinical outcomes for CoreValve and SAPIEN XT were similar. The 3-year THV performance of both devices was maintained after TAVI. Serial change in mean aortic PGs for CoreValve decreases significantly from FPI to the 3-year follow-up point compared to that for SAPIEN-XT.

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Acknowledgements

We thank Keiko Aso, who is a clinical research nurse at our hospital, for her enormous help with the data collection.

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This research study did not receive any grants from any funding agency from public, commercial, or not-for-profit sectors.

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Correspondence to Koki Shishido.

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Dr. Saito is a clinical proctor for Edwards Lifesciences and Medtronic. The Authors declare that there is no conflict of interest.

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Shishido, K., Yamanaka, F., Ochiai, T. et al. Hemodynamic comparison of CoreValve and SAPIEN-XT TAVI valves in Japanese patients. Heart Vessels 34, 1674–1683 (2019). https://doi.org/10.1007/s00380-019-01414-0

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