Aims: Our purpose was to determine long-term outcome of high-risk patients who underwent transcatheter aortic valve implantation (TAVI) with first-generation CoreValve device defining valve durability according to the 2017 EAPCI/ESC/EACTS definitions.
Methods and results: 278 consecutive patients in our prospective single-centre registry undergoing TAVI with first-generation CoreValve device between 09/2007 and 07/2013 were retrospectively analysed (mean age 82.26±5.51 years, mean STS score 6.36±4.95%). Kaplan-Meier estimates of survival and the Cox proportional hazards model were used to identify independent predictors of all-cause-mortality.
At 1, 5, and 8 years, estimated survival rates were 82.0%, 45.2%, and 20%, respectively.
Age-adjusted baseline predictors of mortality included impaired kidney function and severe COPD. The only independent procedure-related predictor for all-cause mortality was acute kidney injury. Among late adverse events including bioprosthetic valve failure, COPD exacerbation/respiratory failure requiring hospitalization was the only independent predictor of mortality.
Freedom from re-hospitalization for cardiovascular events was 80%, 57% and 40% at 1-, 5- and 8-years.
At both five and seven years, 98% and 92% of surviving patients were in NYHA Class I or II.
Paravalvular leak was mild or less in the majority of patients at discharge and throughout follow-up. Mean pressure gradients remained steady over the whole follow-up.
The overall crude cumulative incidences of structural valve deterioration and bioprosthetic valve failure were 3,6% and 2,5% respectively, at 8 years.
Conclusions: TAVI with the CoreValve device was associated with stable clinical outcomes up to 8-year follow-up, with a low rate (2.5%) of bioprosthetic valve failure.