Local Antibiotic Delivery Shows Promise in Treating Cardiac Device Pocket Infections

Cardiac Implantable Electronic Device (CIED) infection is a serious complication of CIED implantation. It is estimated to occur in 1-4% of CIED procedures and carries a high rate of morbidity and mortality.¹ Majority of CIED infections are device pocket infections. In patients with a CIED infection, extraction remains the gold standard of treatment.² However, extraction also comes with risks of complications, and certain patient populations may prefer not to undergo extraction or may be deemed to have high or prohibitive risk.

In 2007, Dr. Topaz developed a procedure that involves continuous, in situ-targeted, ultra-high concentration of antibiotics (CITA) into infected device pockets using a percutaneous catheter. In the January 2023 issue of the Journal of American College of Cardiology, he and his colleagues reported their 14-year experience with the use of CITA in patients with CIED pocket infections.³

In their cohort study involving 80 patients who underwent CITA for pocket infection instead of device extraction (due to patient preference, debatable extraction indications or prohibitive extraction risks), they found that CITA was curative in 85% (n =65 out of 80) of patients. They defined cure as no evidence of device infection throughout follow-up (median of 3 years). CITA failure was defined as the need to still perform CIED extraction for infection, development of chronic infection, death from within 30 days of the procedure and death from infection related to the original pocket infection. Device extraction was avoided in 90.8% of extraction-eligible patients who underwent CITA.

In their case-control study comparing 65 extraction-eligible patients who opted for CITA with 81 similar patients who underwent CIED extraction for pocket infection, they found that device extraction had higher cure rates compared to CITA (96.2% vs 84.6%, p = 0.027). However, rates of serious complications were also higher for the extraction group (14.8% vs 1.5% p = 0.005), with 2 perioperative deaths during device extraction.

It should be noted that this study exclusively was done for CIED pocket infections. It excluded patients with signs of systemic infection, fever, positive blood cultures, lead vegetation(s). Moreover, they excluded any patient who had a Staphylococcus aureus in their CIED pocket culture.

Dr. Jacques Rizkallah, Cardiac Electrophysiologist and Clinical Assistant Professor at Libin Cardiovascular Institute at the University of Calgary comments, “The continuous, in situ-targeted, ultrahigh concentration of antibiotics (CITA) study by Dr. Topaz and colleagues is a breath of fresh air in the field of cardiac implantable electrical device infection management.  In this setting, where complete and often complex system extraction remains the gold standard, the CITA study offers a glimmer of hope that perhaps in some select cases where the complication risk of a complex system extraction is prohibitive a more conservative approach to manage CIED pocket infection might be feasible.”

He adds, “The consideration of a more conservative approach in the management of CIED infections has often been traditionally frowned upon as compared to complex full system extraction.  However, it is undeniable that even in expert hands, the tragic 1-2% risk of mortality during a complex lead extraction procedure is more than humbling for all involved.  As such, a novel and safer treatment approach is long overdue.”

“This promising study will hopefully be the first of many to further explore the potential role of a conservative approach in the management of device infections,” Dr. Rizkallah concludes.

References.

1. Han HC, Hawkins NM, Pearman CM, et al. Epidemiology  cardiac implantable electronic device infections: incidence and risk factors. Europace. 2021 Jun 23;23(23 Suppl 4):iv3-iv10. doi: 10.1093/europace/euab042. PMID: 34051086; PMCID: PMC8221051.
2. Kusumoto FM, Schoenfeld MH, Wilkoff BL, et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. Erratum in: Heart Rhythm. 2021 Oct;18(10):1814. PMID: 28919379.
3. Topaz M, Chorin E, Schwartz A, et al. Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections. J Am Coll Cardiol. 2023 Jan, 81 (2) 119–133. https://doi.org/10.1016/j.jacc.2022.10.022