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BACKGROUND:
Reporting of outcomes after transcatheter aortic valve implantation (TAVI) has been variable. To allow comparison of multiple trials, the Valve Academic Research Consortium (VARC) recently introduced standardized endpoint definitions. We sought to re-evaluate our single-center experience with TAVI according to the VARC definitions.
METHODS:
TAVI was performed in 299 patients (mean age 80.4±7.1 years, 54.8% female) using the Edwards Sapien through a transapical (55.2%, ES TA) or transfemoral (29.8%, ES TF) approach or using the transfemoral Medtronic CoreValve (15.0%, CV TF). Device choice was based on vascular status, left ventricular function, and annulus size. Data were gathered prospectively and analysed retrospectively according to the defined VARC endpoints.
RESULTS:
Despite differences in predicted operative risk (logistic EuroSCORE: 25.9±13.8% [ES TA], 19.5±12.7% [ES TF], 21.8±13.4% [CV TF]; p=0.001) no significant differences in all-cause mortality were noted at 30 days (12.2% [ES TA], 9.1% [ES TF], 8.9%[CV TF], p=0.58). Device success, as defined by the VARC, was achieved in 86.1%, 80.9%, and 93.3% of procedures (p=0.15), respectively, and was a predictor of overall-survival (HR 0.47, 95% CI 0.29-0.77; p=0.003). The combined 30-day safety endpoint was reached in 21.8% (ES TA), 23.6% (ES TF), and 13.3% (CV TF) of patients (p=0.395). Over a median follow-up of 255 (IQR 42-421) days, no differences in estimated cumulative 1-year survival were noted (70.5% [ES TA], 72.1% [ES TF], 56.7% [CV TF]; p=0.72). Postprocedural VARC outcomes differed with respect to access site complications (7.3% [ES TA], 19.1% [ES TF], 11.1% [CV TF]; p=0.001), all-stage renal injury (33.9%, 21.3%, 24.4%; p=0.03), and permanent pacemaker implantation rate (16.4%, 12.4%, 40.0%; p=0.001). No differences were observed concerning stroke, bleeding, and myocardial infarction.
CONCLUSIONS:
According to standardized VARC endpoints, TAVI with TA and TF approaches using two devices were performed with similar outcomes despite different risk profiles at baseline. The data emphasize the importance of interdisciplinary patient evaluation. To achieve optimal hemodynamic results, different access routes and prosthesis types are necessary, which will eventually translate into improved clinical outcome.