In-Hospital Complications After Transcatheter Aortic Valve Implantation Revisited According to the Valve Academic Research Consortium Definitions

Objectives: To determine the occurrence of in-hospital complications after transcatheter aortic valve implantation (TAVI) according to the Valve Academic Research Consortium (VARC) criteria in addition to the length of stay (LOS). Background: The absence of uniformity in endpoint definitions challenges the comparison between previously reported major adverse cerebro-and cardiovascular event rates after TAVI. To address this, in 2009, the VARC was established aiming to provide standardized endpoint definitions for TAVI clinical trials. Methods: Between November 2005 and September 2010, we prospectively enrolled 150 consecutive patients who underwent TAVI with the Medtronic CoreValve System in our institution. Complications, prosthetic valve associated endpoints, and therapy-specific endpoints were defined according to the definitions provided by the VARC. Results: The mean age (+/- SD) was 81 (+/- 7) years and 55% were female. Thirty-day or in-hospital mortality was 11%, and the 30-day combined safety endpoint was 22%. Seventy-six patients (51%) had >= 1 cardiovascular and/or noncardiovascular complication of whom 16 also underwent a new permanent pacemaker implantation (PPI). In the 74 patients with uneventful TAVI, 12 patients (8%) underwent PPI. TAVI was truly uneventful in 62 patients (41%). Bleeding complications were observed most frequently (31%), followed by acute kidney injury (18%), vascular complications (16%), and stroke/TIA (11%). The median LOS in patients with a complicated and a truly uncomplicated TAVI was 14.0 (8.0-20.5) and 8.0 (7.0-10.8) days, respectively (P < 0.001). Conclusion: TAVI was associated with >= 1 cardiovascular and/or noncardiovascular event in 51% of the patients; new PPI was needed in another 8%, and TAVI was truly uncomplicated in 41%. Complications and need for new PPI significantly prolonged LOS. (C) 2011 Wiley-Liss, Inc.