The BRUISE CONTROL trial (Brid
ge or Continue Coumadin for Device Sur
gery Randomized Controlled Trial) demonstrated that a strate
gy of continued warfarin durin
g cardiac implantable electronic device sur
gery was safe and reduced the incidence of clinically si
gnificant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requirin
g further sur
gery and/or resultin
g in prolon
gation of hospitalization of at least 24 h, and/or requirin
g interruption of anticoa
gulation. 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 differin
g 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]; gov/ct2/show/NCT00800137?term=NCT00800137&rank=1">NCT00800137)