Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

Single-center data from 10-year-follow-up after transcatheter aortic valve implantation with first-generation device
T. Ubben1, I. Prijon1, F. Meincke2, E. P. Tigges1, E. Veliqi1, M. Schmoeckel3, C. Eickholt1, S. Willems1, S. Hakmi1
1Kardiologie, Asklepios Klinik St. Georg, Hamburg; 23. Med. Abteilung - Kardiologie, Pneumologie und Internistische Intensivmedizin, Asklepios Klinik Altona, Hamburg; 3Abteilung Herzchirurgie, Asklepios Klinik St. Georg, Hamburg;

Aims

The purpose of this study was to evaluate the long-term durability of first generation TAVI devices, whereby the incidence of valve failure and structural valve deteroriation were of particular interest.

Methods and Results

Between January 2010 and May 2011 a total of 200 patients underwent transcatheter aortic valve implantation with either Medtronic CoreValve or Sapien XT for severe aortic stenosis in our center. Mean age was 79.9 (± 5.6) years. Patients had a high surgical risk as the EuroScore II was calculated with 9.6% (± 5.4). A mean follow-up of 1071 days (± 601) was achieved. 67% of the patients underwent implantation of a CoreValve prosthesis (n=134) while 33% (n=64) patients underwent implantation of a a Sapien XT prosthesis. Initial device success was 92.5% (n=185).

Mortality at 1, 5, and 10-year follow-up was 18%, 57 and 93%, respectively.

Valve failure with need of aortic re-intervention occurred in eight patients (2.5%), whereby 25% initially underwent TAVI with Sapien XT (n=2) and 75 patients initially underwent implantation of a CoreValve prosthesis (n=6). Of those patients with valve failure, 50% (n=4) showed elevated gradients resulting in severe re-stenosis, 25% (n=2) showed mixed re-stenosis and regurgitation and 25% (n=2) showed pure severe regurgitation as a result of the valve degeneration. All those patients underwent successful re-do transcatheter aortic valve implantation. The re-do TAVI occurred after a mean of 1974 days (± 724).

Overall survival after ten years of follow-up was 7% (n=14). Those survivors had a mean gradient of 13.2 mmHg (± 3.3), resulting in an aortic valve area of 1.43 cm². No patient showed moderate or severe aortic regurgitation or other signs of structural valve deterioration at 10-year-follow-up.

Conclusion:

First-generation transcatheter aortic valve implantation devices showed a low rate of structural valve deterioration and valve failure during a follow-up period of 10 years. This provides insights in the long-term performance of transcatheter aortic valve implantation and will be of further interest as the indication for TAVI is trending towards younger patients.


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