A mesh envelope embedded with antibiotics cut the risk of major device-related infections by 40 percent when placed around cardiac implantable electronic devices (CIEDs) like pacemakers and defibrillators, researchers reported in the New England Journal of Medicine.
The randomized WRAP-IT trial included nearly 7,000 patients from 25 countries who were undergoing an initial defibrillator implantation, a CIED pocket revision, generator replacement or system upgrade. Participants were randomized to receive one of the envelopes or to a control group, and both groups received standard strategies to prevent infection.
Within one year of their procedures, 0.7 percent of patients in the envelope group and 1.2 percent in the control group experienced a major device infection—a relative reduction of 40 percent.
“The overall infection rate was lower than expected. This is great news for all electrophysiologists and a testament for the quality of all participating centers in adhering to best practices to minimize infection,” lead author Khaldoun G. Tarakji, MD, MPH, associate section head of cardiac electrophysiology at the Cleveland Clinic Heart and Vascular Institute, said in a press release. “Even so, using the antibiotic envelope led to an additional 40 percent reduction in major device-related infection during the first year after implantation. And we saw no increase in complications with the use of the envelope, indicating that it is safe to use.”
Major device infection was defined as an infection resulting in a system extraction or revision, long-term antibiotic therapy with infection recurrence or death.
Throughout the entire average follow-up of 20.7 months, there was a 37 percent reduction in major infections with the envelope treatment versus standard infection prevention. The envelope, manufactured by Medtronic, is made of bioabsorbable mesh and embedded with the antibiotics rifampin and minocycline, which are slowly released into the device pocket over a seven-day period. The entire envelope is fully absorbed by the body between eight and nine weeks post-implantation, according to the release.
At the American College of Cardiology’s scientific sessions, where the results were presented, Dhanunjaya Lakkireddy, MD, said because of the low device infection rates across the board, about 200 patients would need to be treated with the envelope to prevent one infection. Considering that the current cost of the device is about $1,000, Lakkireddy questioned whether there was a more affordable way to deliver the antibiotics to CIED pockets and lower infection rates.
Tarakji and colleagues plan to conduct a cost-effectiveness analysis for the intervention. They stressed that standard-of-care protocols to prevent CIED infections remain important, but the envelope represents an additional tool to further reduce device-related infections.