Clinically significant pocket hematoma following cardiac device surgery was associated with an increased risk of 1-year device-related infection (11% vs 1.5%; HR 7.7; 95% CI 2.9-20.5; p<0.0001).
Cohort (n=659)
Blinded outcome adjudication
Hazard Ratio: 7.7 (95% CI 2.9–20.5)
Absolute Event Rate: 11% vs 1.5%
p-value: p=< 0.0001
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. OBJECTIVES: 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).
“This is the first study to observe and make a clear-cut association between hematoma and subsequent serious infections. Until now, CSH has been considered a minor complication of device surgery, but this novel data suggests it is more serious, with substantial increased risk of infection.”
Essebag et al. (2016) conducted a cohort in Cardiac implantable electronic device surgery (n=659). Clinically significant pocket hematoma vs. No clinically significant pocket hematoma was evaluated on Device-related infection requiring hospitalization (pocket infection, endocarditis, or bloodstream infection) (HR 7.7, 95% CI 2.9 to 20.5, p=< 0.0001). Clinically significant pocket hematoma following cardiac device surgery was associated with an increased risk of 1-year device-related infection (11% vs 1.5%; HR 7.7; 95% CI 2.9-20.5; p<0.0001).