Results from the BRUISE Control Infection Study

The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) previously demonstrated that continuing warfarin use during cardiac implantable device surgery was safe, and reduced the incidence of having a clinically significant pocket hematoma (CSH) at the device site. (Birnie, et al, New England Journal of Medicine, 2013).

The BRUISE CONTROL INFECTION study conducted an extended one-year follow-up of BRUISE CONTROL patients looking at the association between clinically significant hematoma and subsequent device infections. The study followed 659 patients for one year after their device surgery to see who developed a device-related infection, such as an infection of the device site pocket, bloodstream infection or infection within the heart or on a heart valve.

The study found that having CSH after implantable device surgery raises the risk of serious infection requiring hospitalization by more than sevenfold at one year. Infection occurred in 11% of patients with previous CSH and in 1.5% without CSH. Using antibiotics early upon the development of the hematoma did not reduce the long-term infection risk.

This is the first study to observe and make a clear-cut association between hematoma and subsequent serious infections. Previously CSH has been considered as a minor complication of device surgery, but this novel data suggests they are more serious, with major increase risk of infection.

“The key clinical message to physicians is to make every effort to reduce rates of CSH,” said lead author David Birnie, MD, of the University of Ottawa Heart Institute. 

The BRUISE CONTROL INFECTION Study was published in The Journal of the American College of Cardiology (JACC) March 22, 2016, by co-principal investigators Dr. Birnie (Univeristy of Ottawa Heart Institute) and Vidal Essebag, MD, PhD, (McGill University) and colleagues. The publication can be found at the JACC website:

Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection

The study was supported by a grant from the Canadian Institutes of Health Research.

Share This