Abstract

Complete capsulectomy has been proposed to reduce the risk of reinfection in patients with cardiac implantable electronic device (CIED) infection after transvenous lead extraction (TLE). However, it is time consuming and requires extensive tissue debridement with a potentially higher risk of hematoma formation. To compare the outcomes of chlorhexidine gluconate (CHG) and saline pocket irrigation without capsulectomy vs. capsulectomy after TLE in CIED-related infection. Consecutive patients who underwent TLE for CIED-related infection were included. In the no-capsulectomy group, after complete device removal thorough scrubbing of the generator pocket with 20 cc of 2% CHG followed by irrigation with 1000 cc of saline was undertaken. The pocket was dried, and the wound was closed with separate intradermal absorbable suture. In patients undergoing capsulectomy, extensive tissue debridement aiming for complete removal of the capsule was undertaken. Patients were evaluated 6 weeks after the procedure and every 6 months thereafter. The primary safety outcome was hematoma formation; primary efficacy outcome was reinfection. Secondary outcomes included any adverse reaction to chlorhexidine, need for reintervention, and infection related mortality. A total of 94 patients were included between July 2013 and September 2020 (mean age 67.4±13.1 years; 32 female), out of which 39 patients underwent CHG pocket irrigation and 55 underwent capsulectomy after CIED extraction. Mean follow-up was 673 days. Six patients presented hematomas in the capsulectomy group vs. 0 in the CHG group (9.2%vs 0%, p=0.04). One patient in the CHG group and 3 patients in the capsulectomy group (2.6% vs 5.4%, p=0.49) died of worsening sepsis despite device extraction. There were no cases of reinfection, even though 50 patients (53.2%) had a new device. In patients with CIED infection, the use of CHG without capsulectomy resulted in a lower risk of hematoma formation than standard pocket management with capsulectomy, without increasing the risk of reinfection or any adverse effects associated with chlorhexidine use.

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