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The use of adhesive iodine-impregnated drapes led to lower swab culture positivity and fewer infections in patients undergoing repeat implantation of electronic devices to maintain normal rhythm, according to a randomized trial appearing in JAMA Cardiology.

Cardiac implantable electronic devices (CIEDs) such as pacemakers and implantable cardioverter-defibrillators are vital for patients with bradycardia or heart failure and in preventing sudden cardiac death, said Alper Aydin, MD, of the University of Ottawa Heart Institute, in Ottawa, Ontario, Canada, who led the new research.

However, CIED implantation may lead to infections. “One of the most feared complications of these procedures is infection, which can cause significant morbidity and mortality, often necessitating device removal and prolonged hospitalization,” Aydin said.

Contamination of Device Is Likely Source of Infection

A likely route of infection is contamination of the device pocket during implantation, Aydin added. Other factors may contribute to infection risk, including the presence of foreign material and fibrous capsule formation, the study team wrote: “Bacteria can form biofilms on the device, which trap bacteria and allow them to remain on the surface indefinitely. This biofilm hinders antibiotic penetration to deeper layers of microorganisms.”

“Preventing skin contamination at the time of surgery may reduce this risk,” Aydin said. “We hypothesized that applying an iodine-impregnated adhesive drape to the skin before incision, and removing it after skin closure, would lower the rate of pocket colonization and, in turn, device-related infections.”

In the new trial, Aydin and his colleagues found using iodine-impregnated drapes during repeat CIED implantation significantly lowered the rate of pocket colonization and was linked with a notable decrease in the number of infections a year after surgery.

The trial randomly assigned 418 adults undergoing a repeat procedure on the same CIED pocket to two groups: 208 underwent the surgery with a drape group and 208 received standard care. After accounting for patients who were not suitable study candidates, the final analysis consisted of 189 patients in the drape group and 195 patients in the no-drape group.

Culture positivity of the pocket swabs was significantly lower in the adhesive drape group (10.1%) than in the no-drape group (20.5%), representing a 50% reduction in relative risk (95% CI, 0.24-0.75; P = .005).

At the 1-year follow-up, no patients in the drape group had developed a surgical site infection compared with four in the no-drape group (P = .02). Of those, two had positive pocket swabs. In contrast, among the 380 patients without infections, 10.3% had positive swabs (odds ratio, 8.74; 95% CI, 1.20-63.82; P = .01).

“In this randomized controlled trial, iodine-impregnated adhesive drapes during repeat CIED implantation significantly reduced pocket colonization and was associated with a lower rate of device infections at 1 year,” Aydin said.

Advocating Routine Use

Kenneth A. Ellenbogen, MD, director of Clinical Cardiac Electrophysiology and Pacing at Pauley Heart Center at VCU Health, in Richmond, Virginia, agreed that the study shows iodine-impregnated drapes used to prepare the patient’s chest prior to surgery significantly reduce the rate of infection.

“Pacemaker pocket infections are incredibly costly and lead to poor patient outcomes,” Ellenbogen said. “This is a simple and inexpensive way to reduce infections. Overall, the infection rate with implanted devices is about 1% and a reduction to 0% is quite remarkable. The risk for positive swabs also decreased, from 3.4% to 0.6%.”

Ellenbogen added that to maximize the benefits of the approach, clinicians will need to identify patients at high risk for infection. The use of iodinated adhesive drapes “would allow patients at high risk to undergo device implantation with a low risk of infection,” he said.

Aydin reported no relevant financial conflicts of interest. Ellenbogen disclosed receiving honoraria from Medtronic.

Martta Kelly is a medical journalist from the New York metropolitan area.