Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".