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In‐hospital complications after transcatheter aortic valve implantation revisited according to the valve academic research consortium definitions
Author(s) -
Nuis RutgerJan,
Piazza Nicolo,
Van Mieghem Nicolas M.,
Otten Amber M.,
Tzikas Apostolos,
Schultz Carl J.,
van der Boon Robert,
van Geuns RobertJan,
van Domburg Ron T.,
Koudstaal Peter J.,
Kappetein Arie Pieter,
Serruys Patrick W.,
de Jaegere Peter P.
Publication year - 2011
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.23018
Subject(s) - medicine , clinical endpoint , adverse effect , stroke (engine) , surgery , complication , endpoint determination , clinical trial , cardiology , randomized controlled trial , mechanical engineering , engineering
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. © 2011 Wiley‐Liss, Inc.