title: In-hospital complications after transcatheter aortic valve implantation revisited according to the Valve Academic Research Consortium definitions.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Rutger-Jan
authors.initials: RJ
authors.lastname: Nuis
authors.forename: Nicolo
authors.initials: N
authors.lastname: Piazza
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: Van Mieghem
authors.forename: Amber M
authors.initials: AM
authors.lastname: Otten
authors.forename: Apostolos
authors.initials: A
authors.lastname: Tzikas
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Schultz
authors.forename: Robert
authors.initials: R
authors.lastname: van der Boon
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Ron T
authors.initials: RT
authors.lastname: van Domburg
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Koudstaal
authors.forename: Arie Pieter
authors.initials: AP
authors.lastname: Kappetein
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Peter P
authors.initials: PP
authors.lastname: de Jaegere
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology; D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D002304:Cardiac Pacing, Artificial; D002318:Cardiovascular Diseases / Q000209:etiology / Q000628:therapy; D016009:Chi-Square Distribution; D023381:Endpoint Determination / Q000592:standards*; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation / Q000401:mortality; D006470:Hemorrhage / Q000209:etiology; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008297:Male; D009426:Netherlands; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome