IMpact of pocKet rEvision on the rate of InfecTion and other CompLications in patients rEquiring pocket mAnipulation for generator replacement and/or lead replacement or revisioN (MAKE IT CLEAN): A prospective randomized study

Abstract

Background: The fibrous capsule around cardiac implantable device generators is known to promote bacterial colonization and latent infection. Removal of the capsule during device replacement procedures may reduce infection rates but may increase hemorrhagic complications.

Objective: The purpose of this study was to evaluate the effect of pocket capsule decortication procedure on infection and bleeding rates in patients undergoing device replacement procedures.

Methods: In a prospective randomized single-blind control study, patients undergoing device replacement, upgrade, or lead extraction were randomized to Group A "with pocket revision" (n = 131) and group B "without pocket revision" (n = 127). Deep and superficial infection rates, bleeding, and prolonged serous drainage were assessed during 12 months of follow-up. Data were analyzed according to intention-to-treat principle.

Results: A total of 258 patients were enrolled in the study. Rates of generator change, upgrade, and lead extraction/replacement were similar between both groups. There was no incidence of deep infection in either group at 12-month follow-up. There was no significant difference in the incidence of superficial infection between groups (1.5% vs 4.7%, P = .13) during 12-month follow-up. There was a significant increase in acute hematoma formation in group A compared to group B (6.1% vs 0.8%, P = .03). Two patients in group A had to undergo hematoma evacuation.

Conclusion: There was increased incidence of hematoma formation in group A with no effect on infection rates. Our study suggests that there is no benefit to performing empiric pocket revision.

Trial registration: ClinicalTrials.gov NCT00599261.

Keywords: Cardiac device infection; Endocarditis; Fibrous capsule; Mortality; Pocket revision.