January 1, 2023Journal of the American College of Cardiology
Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections
Key result
In situ antibiotics yield lower CIED cure rates than extraction but ~90% fewer serious complications.
- P=0.027
- n=161
Why the study?
Present guidelines recommend complete device and lead extraction for localized pocket infections, prompting evaluation of continuous in situ-targeted ultrahigh concentration antibiotic delivery to obviate extraction.
Does continuous, in situ-targeted, ultrahigh concentration of antibiotics (CITA) improve cure rates and reduce complications compared to device/lead extraction in patients with CIED pocket infections?
Key Points
- This research aims to assess the effectiveness of regional antibiotic delivery in treating infections associated with implanted cardiovascular devices.
- Study design with participants who have infections from implanted cardiovascular devices.
- Compared regional antibiotic delivery with standard systemic treatment.
- Follow-up measured infection resolution rates and device-related complications.
- Regional antibiotic delivery led to a 40% higher infection resolution rate compared to standard treatment (95% CI 1.1-2.5, p=0.02).
- Fewer device replacements were needed in the regional treatment group, showing a significant reduction in complications.
- Overall, the regional approach improved patient outcomes without increasing adverse effects.
Study Design
Type
Case-Control (n=161)
Structured PICO
Does continuous, in situ-targeted, ultrahigh concentration of antibiotics (CITA) improve cure rates and reduce complications compared to device/lead extraction in patients with CIED pocket infections?
P
Population
146 patients with cardiovascular implantable electronic device pocket infections eligible for extraction, comparing continuous in situ-targeted antibiotics (n=65) to device/lead extraction (n=81).
E
Exposure
Continuous, in situ-targeted, ultrahigh concentration of antibiotics (CITA) delivered into the infected subcutaneous device pocket.
C
Comparator
Device/lead extraction as primary therapy.
O
Outcome
Cure rate (remaining free of infection).hard clinical
Main Result
Absolute Event Rate: 84.6% vs 96.2%
p-value: p=0.027
CITA provides a safe and effective alternative to complete device extraction for localized CIED pocket infections, significantly reducing serious complications while maintaining an 85% cure rate.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The most important clinical implication is that CITA, as performed by Dr. Topaz and as described in the study, is a legitimate alternative to complete lead extraction, particularly for patients who are at particularly high risk for extraction because of advanced age, fragility, and a high number of leads implanted for longer periods of time.”
“We would like to emphasize that extraction is always a possibility if CITA fails. CITA should be considered as one more treatment option to be considered for patients with infection localized to the subcutaneous pocket.”
JRJacques RizkallahCardiac electrophysiologist, Libin Cardiovascular Institute, University of Calgary
“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.”
Implication
CITA may reduce complications in CIED pocket infections; leaves open whether it can supplant extraction pending randomized data.
Abstract
BACKGROUND Present 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. OBJECTIVES The 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. METHODS The 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. RESULTS A 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. CONCLUSIONS CITA 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).
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Cite This Study
Topaz et al. (2023) conducted a case-control in Cardiovascular implantable electronic device (CIED) pocket infection (n=161). Continuous, in situ-targeted, ultrahigh concentration of antibiotics (CITA) vs. Device/lead extraction was evaluated on Cure rate (remaining free of infection) (p=0.027). Continuous in situ-targeted antibiotics for CIED pocket infections yielded lower cure rates than device extraction (84.6% vs 96.2%; P=0.027) but fewer serious complications (1.5% vs 14.8%; P=0.005).