Clinical impact of capsulectomy during cardiac implantable electronic device generator replacement: a prospective randomized trial

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Abstract Funding Acknowledgements Type of funding sources: None. Background The avascular capsule around the generator of cardiac implantable electronic device (CIED) could be susceptible for 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. Methods This study was a prospective randomized trial. Patients receiving generator replacement were enrolled from December 2013 to December 2019. A total of 195 patients were 1:1 randomly assigned, for patients in the intervention group (n=97), capsule removal was performed on the floor of the pocket during generator replacement but not for patients in the control group (n=98). In both groups, microbiological culture was performed in the pocket. The primary outcome was the occurrence of device infection requiring pocket revision. Results Of the 195 patients included (mean age 70.2 ± 13.6years, 55.4% women), 54 (27.7%) included additional lead revision, 19 (9.7%) had biventricular device. Among 182 patients undergoing microbiological cultures of pockets, 19 (10.4%) were confirmed positive, 4 S. epidermidis (21.1%) and 3 S. aureus (15.8%) were identified most frequently. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (Intervention group 3 (3.1%) vs Control group 1 (1.0%), p=0.606). Hematoma was occurred in 10 patients (Intervention group 3 (3.1%) vs Control group 7 (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). Conclusion In this study, capsulectomy during replacement of 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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