Four-year clinical results of transcatheter self-expanding Medtronic CoreValve implantation in high-risk patients with severe aortic stenosis.

Background: transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients with severe aortic stenosis considered inoperable or at high operative risk, but the long-term outcome remains unknown.

Hypothesis: we assessed the 4-year clinical and echocardiographic outcomes of patients undergoing TAVI with the self-expanding Medtronic CoreValve prosthesis.

Methods: sixty-three patients (mean age 80 ± 6 years) with severe aortic stenosis (AS) at high risk for surgical aortic valve replacement (Logistic EuroSCORE 28.8 ± 10.9%) were included in this study.

Results: all-cause cumulative mortality at 1, 2, 3 and 4 years was 14.3, 25.4, 28.6 and 36.5%, respectively. The cumulative incidence of documented major stroke at 4 years was 6.3%. In survivors, there was a significant improvement in functional status at 4 years. Paravalvular leak (trivial/mild to moderate) was observed in the majority of patients post-TAVI with no case of progression to severe regurgitation at 4-year follow-up. In multivariate analysis, independent predictor for increased all-cause mortality was left ventricular ejection fraction <40% (HR: 5.347, 95% CI: 1.126-25.381, P = 0.035).

Conclusion: our study demonstrated favourable long-term (4 years) outcomes after successful TAVI using the third-generation Medtronic CoreValve device.