Po-02-086 a novel antibiotic delivery approach for salvage of cardiovascular-implantable electronic devices with localized infection

Present guidelines endorse complete removal of cardiovascular-implantable electronic devices (pacemakers/defibrillators), including extraction of intracardiac electrodes, not only for systemic infections but also for localized “pocket infections.” We evaluated the efficacy of delivering “Continuous, In-situ-Targeted, ultra-high concentration of Antibiotics” (CITA) into the infected subcutaneous the device-pocket, obviating the need for device/lead-extraction. The CITA-Group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, nine patients declined lead-extraction because of prohibitive operative risk, and six patients had questionable indications for extraction. The remaining 65 patients with pocket infection, who were eligible for extraction but opted for CITA treatment, were compared to 81 patients with pocket infection and similar characteristics who underwent device/lead-extraction as primary therapy. Eighty patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (68/80) patients, who remained free of infection (median follow-up: 3 years, interquartile range 1 – 6.8 years). In the case-control study of CITA vs. device/lead extraction, cure rates were higher after device/lead-extraction than after CITA [96.2%; (78/81) vs. 84.6%; (55/65), p=0.027]. However, rates of serious complications were also higher after extraction [12 (14.8%) vs. 1 (1.5%), p=0.005]. All-cause 1-month and 1-year mortality were similar for CITA and device/lead-extraction (0% vs. 3.7%, p=0.25 and 12.3% vs. 13.6%, p=1.00, respectively). Extraction was avoided in 90.8% (59/65) extraction-eligible patients treated with CITA. CITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction.