title: Incidence, predictors, and treatment options of critical limb ischaemia after use of collagen plug-based vascular closure devices.
abstract: OBJECTIVE
  Limited data are available on the frequency and predictors of vascular closure device (VCD) failure with subsequent vascular complications. The aim of this study was to investigate the incidence, clinical characteristics, and treatment options in patients with critical limb ischaemia (CLI) after use of a collagen plug-based VCD.
  
  
  RESULTS
  A high-volume, single-centre prospectively maintained database was retrospectively interrogated, and cases of collagen plug-based VCD-related CLI were identified between June 2006 and December 2013. CLI was defined as acute onset of rest pain after VCD application requiring endovascular or surgical treatment. Among 13,595 coronary procedures, 43 patients (0.3%) were identified with an Angio-Seal-related CLI. In a multivariable logistic regression analysis, peripheral artery disease and renal insufficiency were identified as independent predictors for CLI after Angio-Seal application. Treatment was performed in 27 patients (63%) by surgery and in 16 patients (37%) with endovascular angioplasty.
  
  
  CONCLUSIONS
  CLI after use of a collagen plug-based VCD is rare. Peripheral artery disease was identified as an independent predictor of CLI. Interventional cardiologists should be aware of potentially high-risk patients and complications after use of a VCD to provide prompt and adequate therapy.
authors.affiliation: Department of Internal Medicine - Cardiology, University of Leipzig - Heart Center, Leipzig, Germany.
authors.forename: Omran
authors.initials: O
authors.lastname: Amer
authors.forename: Siri
authors.initials: S
authors.lastname: Binger
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.forename: Hans Michael
authors.initials: HM
authors.lastname: Harnoss
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.forename: Ingo
authors.initials: I
authors.lastname: Eitel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty; D003094:Collagen / Q000009:adverse effects; D015897:Comorbidity; D016638:Critical Illness; D016208:Databases, Factual; D005260:Female; D005858:Germany / Q000453:epidemiology; D061847:Hospitals, High-Volume; D006801:Humans; D015994:Incidence; D007511:Ischemia / Q000139:chemically induced / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D007676:Kidney Failure, Chronic / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D058729:Peripheral Arterial Disease / Q000453:epidemiology; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D065506:Vascular Closure Devices / Q000009:adverse effects*; D014656:Vascular Surgical Procedures
chemical_list: D003094:Collagen