Table 3

VARC-2 Defined Endpoints

Myocardial infarction0
Cerebrovascular event0
Bleeding, major or life-threatening3 (9.7)
Access site complication
 Minor1 (3.2)
 Major3 (9.7)
Acute kidney injury
 Stage 1 or 26 (19.3)
 Stage 31 (3.2)
Permanent pacemaker implantation2 (6.4)
ICU stay, days3.2 ± 2.8
In-hospital stay, days10.8 ± 5.6
Device success30 (96.8)
Combined early safety endpoint, 30 days6 (19.3)
All-cause mortality, 30 days4 (12.9)
Cardiac mortality, 30 days1 (3.2)
All-cause mortality, 6 months6 (19.3)
Cardiac mortality, 6 months1 (3.2)

Values are n, n (%), or mean ± SD.

Thirty-day patient outcomes according to the updated Valve Academic Research Consortium definitions (14).

ICU = intensive care unit; VARC = Valve Academic Research Consortium.

  • Permanent pacemaker implantation for persistent sinus bradycardia (n = 1) and complete heart block (n = 1).