title: Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study.
abstract: BACKGROUND
  The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma.
  
  
  OBJECTIVE
  The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection.
  
  
  METHODS
  The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection.
  
  
  RESULTS
  The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk.
  
  
  CONCLUSIONS
  CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137).
authors.affiliation: Department of Medicine, Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada; Department of Medicine, Division of Cardiology, Hôpital Sacré-Coeur de Montréal, Montreal, Quebec, Canada. Electronic address: vidal.essebag@mcgill.ca.
authors.forename: Vidal
authors.initials: V
authors.lastname: Essebag
authors.affiliation: Southlake Regional Health Centre, Newmarket, Ontario, Canada.
authors.forename: Atul
authors.initials: A
authors.lastname: Verma
authors.affiliation: Population Health Research Institute, Hamilton, Ontario, Canada.
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Healey
authors.affiliation: University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Krahn
authors.affiliation: Department of Medicine, Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada; Department of Cardiology, Galilee Medical Center, Nahariya, Israel.
authors.forename: Eli
authors.initials: E
authors.lastname: Kalfon
authors.affiliation: Department of Medicine, Division of Cardiology, Centre Hospitalier Université de Montréal, Montreal, Quebec, Canada.
authors.forename: Benoit
authors.initials: B
authors.lastname: Coutu
authors.affiliation: Centre Hospitalier Université de Sherbrooke, Sherbrooke, Quebec, Canada.
authors.forename: Felix
authors.initials: F
authors.lastname: Ayala-Paredes
authors.affiliation: University of Western Ontario, London, Ontario, Canada; University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Tang
authors.affiliation: Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Sapp
authors.affiliation: Department of Medicine, Division of Cardiology, Hôpital Sacré-Coeur de Montréal, Montreal, Quebec, Canada.
authors.forename: Marcio
authors.initials: M
authors.lastname: Sturmer
authors.affiliation: University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Arieh
authors.initials: A
authors.lastname: Keren
authors.affiliation: University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: George A
authors.initials: GA
authors.lastname: Wells
authors.affiliation: University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: David H
authors.initials: DH
authors.lastname: Birnie
mesh_terms: D000368:Aged; D001938:Brazil / Q000453:epidemiology; D002170:Canada / Q000453:epidemiology; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006406:Hematoma / Q000150:complications*; D006801:Humans; D015994:Incidence; D007239:Infections / Q000453:epidemiology / Q000209:etiology*; D008297:Male; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D019106:Postoperative Hemorrhage / Q000150:complications*; D018570:Risk Assessment; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors
keywords: anticoagulants; hemorrhage; infection; risk factors