In-hospital complications after transcatheter aortic valve implantation revisited according to the valve academic research consortium definitions

• Published in: Catheterization and cardiovascular interventions Vol. 78; no. 3; pp. 457 - 467
• Main Authors: Nuis, Rutger-Jan, Piazza, Nicolo, Van Mieghem, Nicolas M., Otten, Amber M., Tzikas, Apostolos, Schultz, Carl J., van der Boon, Robert, van Geuns, Robert-Jan, van Domburg, Ron T., Koudstaal, Peter J., Kappetein, Arie Pieter, Serruys, Patrick W., de Jaegere, Peter P.
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01-09-2011
• Subjects: Acute Kidney Injury - etiology; Aged; Aged, 80 and over; aortic stenosis; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - therapy; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Cardiac Catheterization - mortality; Cardiac Pacing, Artificial; Cardiovascular Diseases - etiology; Cardiovascular Diseases - therapy; Chi-Square Distribution; complications adult cath/intervention; Endpoint Determination - standards; Female; heart disease; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - mortality; Hemorrhage - etiology; Hospital Mortality; Humans; Kaplan-Meier Estimate; Length of Stay; Male; Netherlands; Prospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Netherlands
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.23018

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.