Transcatheter aortic valve implantation (TAVI) outcome according to standardized endpoint definitions by the Valve Academic Research Consortium (VARC).

BACKGROUND

Transcatheter aortic valve implantation (TAVI) has become an accepted treatment option for severe aortic stenosis (AS) in high-risk individuals. Yet, current results are difficult to compare given the lack of standardized definitions.

METHODS AND RESULTS

TAVI was performed in 130 high-risk individuals. The Edwards SAPIEN (n = 50) and the Medtronic CoreValve (n = 80) prostheses were implanted by transfemoral (75%) or transapical (25%) access. Outcomes at 30 days and 1 year are reported according to the newly established Valve Academic Research Consortium (VARC) criteria. Median follow-up was 235 days (range, 44-490 days). Thirty-day device success was high (91.5%). Combined safety endpoint at 30 days was 20.8%, with an all-cause mortality of 11.5%. Major vascular complications (11.5%), life-threatening or disabling bleeding (8.5%), and acute kidney injury (6.2%) were further major adverse events. At 1-year follow-up, valve performance was accurate in 94.7% of patients. However, prosthetic-valve associated complications, such as new left bundle branch block (20.0%) or permanent pacemaker implantation (34.7%), were common; cumulative prosthetic-valve associated complications were significantly more frequent in patients treated with a Medtronic CoreValve prosthesis (p = 0.0012). Overall 1-year survival was 80%, with the VARC combined efficacy endpoint (composite of survival, freedom from therapy failure, and accurate valve performance) met in 70.2%. In particular, at 1 year, 68.5% of the patients were living independently at home.

CONCLUSION

The newly established VARC standardized definitions are useful for TAVI outcome reporting.