Trial reportJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2024
Clinical impact of capsulectomy during cardiac implantable electronic device generator replacement: a prospective randomized trial.
Trial report in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Capsulectomy at Explant: Rethinking Spinal Cord Stimulator Infected Generator Pocket Management in the Immunocompromised-A Case Series.Pain practice : the official journal of World Institute of Pain · 2026Article
- Clinical Impact of the Incision of the Capsule Floor During Generator Replacement on Cardiac Implantable Electronic Device Infection Risk: A Single-Center Experience.Journal of cardiovascular electrophysiology · 2025Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe avascular capsule around the generator of the cardiac implantable electronic device (CIED) could be susceptible to bacterial colonization and source of infection. Capsulectomy during CIED generator replacement may be beneficial in preventing device infection, but there is a lack of evidence.
methodsThis prospective randomized trial, conducted from December 2013 to December 2019, included 195 patients divided equally into two groups. In the intervention group (n = 97), capsule removal was performed on the floor of the pocket, while it was not performed in the control group (n = 98). In both groups, swab culture was performed in the pocket. The primary outcome was the occurrence of device infection requiring pocket revision.
resultsA total of 195 patients were included (mean age 70.2 ± 13.6 years, 55.4% women), with an average follow-up period of 54.3 ± 28.9 months. Among 182 patients undergoing microbiological cultures of pockets, 19 (10.4%) were confirmed positive, and Staphylococcus species were identified most frequently. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (3.1% vs. 1.0%, p = 0.606). Hematoma has occurred in 10 patients (3.1% vs. 7.1%, p = 0.338), one of them required wound revision. In multivariable analysis, the occurrence of hematoma was the only independent risk factor associated with device infection (HR 13.6, 95% CI 1.02-181.15, p = 0.048).
conclusionsIn this long-term prospective study, capsulectomy during the replacement of the generator did not reduce the incidence of device infection. There was no association between bacterial colonization in the capsule around the generator and CIED infection.
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Registered trials
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