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Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study
Vidal Essebag1, Atul Verma2, Jeff S Healey3
1Department 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.
Insights
Clinically significant pocket hematoma (CSH) after cardiac implantable electronic device surgery significantly increases infection risk. Preventing CSH may reduce long-term device infection rates.
Area of Science:
- Cardiology
- Infectious Disease
- Medical Device Technology
Background:
- The BRUISE CONTROL trial found continued warfarin safe for cardiac implantable electronic device (CIED) surgery, reducing clinically significant pocket hematoma (CSH).
- Previous studies inconsistently linked hematoma to device infection due to retrospective designs and varied definitions.
- CSH is defined as a post-procedure hematoma requiring surgery, prolonged hospitalization, or interrupted anticoagulation.
Purpose of the Study:
- To prospectively investigate the association between CSH and subsequent CIED infection.
- To identify predictors of CIED-related infection following surgery.
Main Methods:
- 659 patients undergoing CIED surgery were followed for 1 year.
- Primary outcome: CIED-related infection requiring hospitalization (pocket, endocarditis, or bloodstream infection).
- Outcomes adjudicated by a blinded committee; multivariable analysis used to identify infection predictors.
Main Results:
- The overall 1-year CIED-related infection rate was 2.4%.
- Patients with CSH had an 11% infection rate versus 1.5% without CSH.
- CSH was the sole independent predictor of infection, conferring a >7-fold increased risk (HR: 7.7; 95% CI: 2.9-20.5; p < 0.0001).
Conclusions:
- CSH is significantly associated with an increased risk of hospitalization for CIED infection within 1 year.
- Strategies to minimize CSH may reduce the long-term incidence of CIED infections.
- Empiric antibiotics for hematoma did not lower long-term infection risk.
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).
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