Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial.

IMPORTANCE

One potential pathophysiological mechanism for cardiac implantable electronic device (CIED) infections is pocket contamination during the implantation procedure. Preventing contamination at this stage may significantly reduce the risk of infections.

OBJECTIVE

To determine whether the application of an intraoperative adhesive iodine-impregnated drape would reduce the rate of end-of-procedure pocket-swab positivity and subsequent CIED infections.

DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, double-armed, single-blinded, randomized clinical trial, conducted from November 2020 to May 2024. Patients, the staff performing the swabs, and the microbiologists were blinded to group assignments. This was a single-center study that included patients undergoing repeat procedures on the same device pocket. These patients were randomized in a 1:1 ratio to either the iodine-impregnated drape group or the control group.

INTERVENTION

Application of an iodine-impregnated drape at the beginning of the procedure.

MAIN OUTCOMES AND MEASURES

The primary end point was end-of-procedure pocket-swab culture positivity.

RESULTS

A total of 418 patients were randomized (210 to the drape group and 208 to the no-drape group). The final analysis included 189 patients in the drape group and 195 patients in the no-drape group, with both groups well balanced in demographics. In the drape group, 143 participants were male (75.7%), and mean (SD) age was 73.9 (12.1) years; in the no-drape group, 140 were male (71.8%), and mean (SD) age was 73.2 (12.6) years. Pocket-swab culture positivity was found in 19 of 189 patients (10.1%) in the drape group compared with 40 of 195 patients (20.5%) in the no-drape group (relative risk reduction [RRR], 0.50; 95% CI, 0.24-0.75; P = .005). Adjudicated CIED infections occurred in 4 of 195 patients (1.9%) in the no-drape group vs 0 of 189 in the drape group (P = .02). CIED infections were observed in 2 of 59 patients (3.4%) with positive swabs and in 2 of 325 patients (0.6%) with negative swabs (odds ratio, 5.67; 95% CI, 0.78-41.04; P = .08).

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, the use of iodine-impregnated drapes during repeat CIED implantation resulted in reduction in swab culture positivity and 1-year CIED infection rates. This is a simple and cost-effective intervention to reduce CIED pocket contamination and subsequent infections.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04591366.