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Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Karen Elise Jensen Foundation Background Cardiac resynchronisation therapy (CRT) re-operations are associated with a particularly high risk of device-related infection (DRI). An antibacterial envelope has been shown to reduce the occurrence of DRIs in a broad population of moderate-to-high risk patients. Purpose To investigate the efficacy of an antibacterial envelope in a very high-risk patient population undergoing CRT re-operation. Methods In this Danish two-centre, observational cohort study, we included consecutive patients who underwent a CRT pacemaker- or defibrillator re-operation procedure between January 2008 and November 2019. We obtained data from the Danish Pacemaker and ICD Register and through systematic medical chart review. Follow-up was restricted to two years. Results A total of 1943 patients were included in the study; 736 (38%) patients received an antibacterial envelope. Envelope patients had more independent risk factors for infection than non-envelope patients. Sixty-seven (3.4%) patients met the primary end point of DRI requiring device system extraction; 50 in the non-envelope group and 17 in the envelope group (4.1% vs. 2.3%, adjusted hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.30-0.90, p = 0.021). This difference persisted in propensity score analysis (HR 0.51 95% CI 0.29-0.90, p = 0.019). Conclusion Use of an antibacterial envelope was associated with a clinically and statistically significant reduction in DRIs in patients undergoing CRT re-operations. Our results were comparable to those recently reported from a large randomized controlled trial, which suggests a proportional effect of the envelope even in very high risk patients.

Rate of device-related infections using an antibacterial envelope in patients undergoing cardiac resynchronisation therapy re-operations