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Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections

Institution:	1. Department of Cardiology, Sourasky Tel Aviv Medical Center, Tel Aviv, Israel;2. Emeritus Plastic Surgery Unit, Hillel Yaffe Medical Center, Hadera, Israel;3. Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel;4. Heart Institute, Hillel Yaffe Medical Center, Hadera, Israel;5. Heart Institute, Laniado Medical Center, Netanya, Israel;6. Adelson School of Medicine, Ariel University, Samaria, Israel;7. Bruce Rappaport School of Medicine, Technion, Haifa, Israel;8. Department of Internal Medicine, Meir Medical Center, Kfar Saba, Israel;9. Heart Institute, Sheba Medical Center, Tel-Hashomer, Israel;10. Jesselson Integrated Heart Center, Shaare Zedek Medical Center and Hebrew University, Jerusalem, Israel;11. Infectious Disease Unit, Sourasky Tel Aviv Medical Center, Tel Aviv, Israel;1. Department of Nuclear Medicine, Molecular Imaging Lab, Beijing Anzhen Hospital, Capital Medical University, Beijing, China;2. Division of Nuclear Technology and Applications, Institute of High Energy Physics, Chinese Academy of Sciences, Beijing, China;3. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China;4. Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Vienna General Hospital, Medical University of Vienna, Vienna, Austria;5. Department of Nuclear Medicine, First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China;1. Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA;2. Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA;3. Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA;4. Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA;5. Minneapolis Heart Institute, Abbott Northwestern Hospital, and Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, USA;6. Leon H. Charney Division of Cardiology, Department of Medicine, New York University School of Medicine, New York, New York, USA;7. Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas, USA;8. Division of Cardiology, Pauley Heart Center, Virginia Commonwealth University, Richmond, Virginia, USA;9. Department of Laboratory Medicine and Pathology, Hennepin Healthcare/HCMC, Minneapolis, Minnesota, USA;10. Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA;11. Division of Cardiovascular Medicine, Department of Medicine, University of California San Diego, La Jolla, California, USA;12. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA;13. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA;14. Heart Failure and Biomarker Trials, Baim Institute for Clinical Research, Boston, Massachusetts, USA;1. Department of Cardiology, Christian Medical College, Vellore, India;2. Department of Clinical Rheumatology, Christian Medical College, Vellore, India;3. Department of Radiology, Christian Medical College, Vellore, India

Abstract:	BackgroundPresent guidelines endorse complete removal of cardiovascular implantable electronic devices (pacemakers/defibrillators), including extraction of all intracardiac electrodes, not only for systemic infections, but also for localized pocket infections.ObjectivesThe authors evaluated the efficacy of delivering continuous, in situ–targeted, ultrahigh concentration of antibiotics (CITA) into the infected subcutaneous device pocket, obviating the need for device/lead extraction.MethodsThe CITA group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, 9 patients declined lead extraction because of prohibitive operative risk, and 6 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 with 81 patients with pocket infection and similar characteristics who underwent device/lead extraction as primary therapy.ResultsA total of 80 patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (n = 68 of 80) of patients, who remained free of infection (median follow-up 3 years IQR: 1.0-6.8 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% n = 78 of 81] vs 84.6% n = 55 of 65]; P = 0.027). However, rates of serious complications were also higher after extraction (n = 12 14.8%] vs n = 1 1.5%]; P = 0.005). All-cause 1-month and 1-year mortality were similar for CITA and device/lead extraction (0.0% vs 3.7%; P = 0.25 and 12.3% vs 13.6%; P = 1.00, respectively). Extraction was avoided in 90.8% (n = 59 of 65) of extraction-eligible patients treated with CITA.ConclusionsCITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction. (Salvage of Infected Cardiovascular Implantable Electronic Devices CIED] by Localized High-Dose Antibiotics; NCT01770067)

Keywords:	defibrillator infection lead extraction pacemaker CIED"} {"#name":"keyword" "$":{"id":"kwrd0035"} "$$":[{"#name":"text" "_":"cardiovascular implantable electronic devices CITA"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"continuous in situ–targeted ultrahigh concentration of antibiotics eGFR"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"estimated glomerular filtration rate ICD"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"implantable cardioverter-defibrillator IKAR"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"infective indications kidney dysfunction age ≥56 years removal of high voltage leads LVEF"} {"#name":"keyword" "$":{"id":"kwrd0085"} "$$":[{"#name":"text" "_":"left ventricular ejection fraction
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