Pacemaker/ICD Bleeding Complication Increases Risk of Serious Infections

May 27, 2016

A pocket hematoma is a pooling of blood around a device such as a pacemaker or implantable cardioverter defibrillator (ICD) following the implant procedure. Research led by the Ottawa Heart Institute has found that patients who experience a clinically significant pocket hematoma (CSH) are significantly more likely to develop a device-related infection.

The study was an extension of the BRUISE CONTROL trial, which previously demonstrated that continuing warfarin use during cardiac implantable device surgery is safe and reduces the incidence of having a CSH at the device site. (See “Study Expected to Impact Device Surgeries Worldwide.”)

The BRUISE CONTROL INFECTION study followed 659 BRUISE CONTROL 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 researchers found that a CSH 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% in those without CSH. Using antibiotics early upon the development of the hematoma did not reduce the long-term infection risk.

David Birnie, MD

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.

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