title: Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial.
abstract: OBJECTIVE
  This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR).
  
  
  BACKGROUND
  VC after TF-TAVR are frequent and may be associated with unfavorable prognosis.
  
  
  METHODS
  From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed.
  
  
  RESULTS
  Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio [HR]: 2.31 [95% confidence interval (CI): 1.08 to 4.98], p = 0.03). Major VC (HR: 2.31 [95% CI: 1.20 to 4.43], p = 0.012), and renal disease at baseline (HR: 2.26 [95% CI: 1.34 to 3.81], p = 0.002) were identified as independent predictors of 1-year mortality.
  
  
  CONCLUSIONS
  Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.
authors.affiliation: Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York 10032, USA.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.forename: Susheel K
authors.initials: SK
authors.lastname: Kodali
authors.forename: Lowell F
authors.initials: LF
authors.lastname: Satler
authors.forename: William F
authors.initials: WF
authors.lastname: Fearon
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Davidson
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Eisenhauer
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.forename: Geoffrey W
authors.initials: GW
authors.lastname: Bergman
authors.forename: Vasilis
authors.initials: V
authors.lastname: Babaliaros
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.forename: Omaida C
authors.initials: OC
authors.lastname: Velazquez
authors.forename: Mathew R
authors.initials: MR
authors.lastname: Williams
authors.forename: Irene
authors.initials: I
authors.lastname: Hueter
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D000082882:Bicuspid Aortic Valve Disease; D006328:Cardiac Catheterization / Q000009:adverse effects*; D015331:Cohort Studies; D005263:Femoral Artery / Q000601:surgery; D006330:Heart Defects, Congenital / Q000453:epidemiology* / Q000601:surgery*; D006349:Heart Valve Diseases / Q000453:epidemiology* / Q000601:surgery*; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects*; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D011237:Predictive Value of Tests; D014652:Vascular Diseases / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology