A Cleveland Clinic-led research team has found that using an absorbable, antibiotic-eluting envelope when implanting cardiac devices like pacemakers and defibrillators can cut the rate of major infections by 40%. The research present today at the American College of Cardiology’s; 68th Annual Scientific Session and simultaneously published in the New England Journal of Medicine. It will also present tomorrow at the European Heart Rhythm Association 2019 Congress.

Abnormal heart rhythms

Approximately 1.7 million patients worldwide receive cardiac implantable electronic devices every year. These devices use to correct abnormal heart rhythms and include pacemakers and implantable cardioverter defibrillators. While the devices are safe, there is a risk of infection, particularly following device replacements; so other secondary procedures such as pocket revisions, lead changes and upgrades.

While the risk of major infections is low, when they do occur, they can be devastating for patients, resulting in invasive procedures, device removal, prolong hospital stays and potentially death; said Khaldoun Tarakji, M.D., MPH, associate section head of cardiac electrophysiology at Cleveland Clinic and the lead author of the study.

Other than the use of antibiotics right before the device procedures; so this is the first intervention proven to reduce the risk of infection in a randomize clinical trial of this magnitude. The envelope is made of absorbable mesh that encases the defibrillator or pacemaker; also it is design to stabilize the device when it is implant in the body.

Implantable electronic devices

It is coat with two antibiotics minocycline and rifampin which are continuously release into the device pocket over a minimum of seven days. The envelope is fully absorb in approximately nine weeks. The global trial enroll 6,983 patients at 181 centers in 25 countries; receiving new defibrillators for cardiac resynchronization therapy or undergoing specific procedures on their cardiac implantable electronic devices; also including pocket revisions, generator replacements or upgrades.

They were randomize to receive the envelope or not and were follow for at least 12 months. All patients receive the standard preventive antibiotics prior to the operation to minimize infection risks. In the control group; so 1.2% (42 patients) develop a major infection compare with 0.7% (25 patients) in the envelope group a reduction of 40%.

Of the major infections, 17 were endocarditis, an infection of the heart’s inner lining, and 50 were pocket infections.  There were less pocket infections in the envelope group. The infection rates in our study were overall very low compare with other trials, and yet; so they find the envelope was still able to provide a significant infection reduction benefit to patients.
Given the seriousness of cardiac device infections, they strive to bring infection rates to as close to zero as possible, said Bruce Wilkoff. The trial also examine the safety of the envelope. Researchers find no increase in complication rates when the envelope was use. The envelope, manufacture by Medtronic, approve by the FDA in 2013 for use in cardiac implantable electronic devices.