Novel ‘Cure’ May Avert Lead Extraction in CIED Pocket Infections

Infections associated with pacemaker or implantable defibrillator systems, even when limited to the subcutaneous pocket, generally call for removal of the pulse-generator and leads.

But alternative strategies would be welcome; extraction of old transvenous leads can be a sticky procedure with a troubling risk of serious complications.

A new report proposes a novel technique for delivering antibiotics as a potential alternative for many patients with cardiac implantable electronic device (CIED) infections limited to the pocket.

The procedure — dubbed CITA, for continuous, in situ–targeted, “ultrahigh” concentration of antibiotics — calls for direct instillation of the drugs into the pocket via an indwelling catheter. It seemed to “cure” such infections, obviating device and lead extraction, researchers say, in 85% of cases conducted over 14 years at two centers in Israel.

The series’ 80 patients had been “unsuitable or unwilling” to undergo device and lead extraction, often because they were at “prohibitive risk” for the procedure, notes a report on the experience published January 9 in the Journal of the American College of Cardiology.

A similar rate of cure was observed in those patients who were deemed eligible for device and lead extraction but instead underwent CITA. They were compared with a cohort of similar patients who underwent the extraction procedure as primary therapy. Cure was more likely in the latter group, but so were serious complications.

And mortality at 30 days and at 1 year was “similar in candidates for lead extraction whether they were treated with CITA or CIED/lead extraction as first therapy,” write the authors, led by Moris Topaz, MD, PhD, Tel Aviv Sourasky Medical Center.

The study “was underpowered to reach definitive conclusions regarding the noninferiority of CITA vs CIED/lead extraction,” the report notes. But it also suggests that CITA for CIED pocket infections “provides a reasonable alternative to immediate extraction,” especially when extraction isn’t a good option, “achieving cure in most patients while reducing the risk of complications.”

‘A Viable Approach’

Topaz and colleagues, states an accompanying editorial, “have taken the first step toward identifying a realistic alternative to device extraction for the treatment of localized pocket infections.”

Although CITA was “inferior to CIED extraction in curing pocket infections,” lead-extraction complication risk “remains a serious concern,” write Anne B. Curtis, MD, and Aamir Ahmed, MD, both of the University at Buffalo, Buffalo, New York.

“In highly selected patients, especially in those who are at high operative risk, CITA appears to be a viable approach to treating localized CIED pocket infections.”

Still, “The gold standard remains complete removal of all hardware when there is a CIED pocket infection, unless and until we have data from larger cohorts further characterizing optimal patient selection and outcomes.”

What CITA Entails

The procedure starts with surgical debridement of the pocket wound, “thorough cleaning” of the pocket itself, and closure leaving a 6F indwelling catheter in place. High-concentration antibiotics are instilled for 14 days. The device and leads are extracted if there are any signs of systemic infection.

Antibiotics are given at the same dosages recommended for intravenous (IV) administration. But the localized delivery produces “ultrahigh concentrations” within the infected pocket, 102 to 104 times the minimal inhibitory concentration. Diffusion of the antibiotic into the circulation eventually achieves nontoxic, therapeutic serum levels, the report states.

CITA should be started as early as possible on recognition of an infection limited to a CIED pocket, Topaz told | Medscape Cardiology. “That would certainly be better than treating these patients with IV antibiotics.” The minority for whom CITA doesn’t work “can always get the extraction treatment later.”

The patients remained hospitalized throughout the 2 weeks, but Topaz predicts that in practice, only about 3 days would be necessary. “The latter stages will be done ambulatory,” he said. “A short hospitalization, then they would get the antibiotic treatment at home.”

Cohort and Case-Control Studies

Eighty patients underwent CITA for pocket infections from 2007 to 2021. The procedure was avoided in patients with systemic infection, fever, positive blood cultures, lead vegetations on echocardiography, or “Staphylococcus aureus growth in their CIED pocket cultures at the time of recruitment.”

Their devices included standard permanent pacemakers or biventricular pacemakers in 28 cases and defibrillators, with or without biventricular pacing, in 52 cases.

CITA was curative in 68 patients, or 85%, who remained infection free for a median of 3 years. The other 15% had CITA “failure,” defined as development of chronic infection, any need for device and lead extraction, death from infection related to the index pocket infection, or any death within 30 days of the procedure.

Twelve patients (15%) died during the follow-up; three deaths were from infections, the report notes.

Several patients treated in more recent years had received an antibiotic envelope with their CIED, and CITA “worked just as well in this group” as it did overall, Topaz said.

Of the 80 CITA recipients, 65 had been eligible for but elected not to undergo device and lead extraction. They were separately compared to 81 similar patients with pocket infections who had undergone device and lead extraction as their primary therapy and served as a control group.

Cure rates were 84.6% after CITA and 96.2% (P = .027) for those with primary extraction. But the rates of serious complications were 1.5% and 96.2%, respectively (P = .005). Such events included stroke, need for thoracotomy, urgent blood transfusion, and severe valve injury, the report notes.

Only six of the 65 CITA patients eligible for device and lead extraction (9.2%) ultimately underwent the extraction procedure.

Implications of the study, which is really about “a new method of antibiotic administration,” extend beyond cardiology, Topaz proposed. Patients with CIEDs “are just one group that we treat this way.”

Others he has managed with CITA include patients with “infected wounds, osteomyelitis, sternal wounds,” and other infections best treated with antibiotics at concentrations too high to be achieved orally or intravenously.

Topaz is an employee of and has equity interest in IVT Medical. The other authors report no relevant disclosures. Curtis discloses serving on an advisory board for Medtronic, Abbott, Janssen Pharmaceuticals, Sanofi, Milestone Pharmaceuticals, and Eagle Pharmaceuticals; and receiving honoraria for speaking from Medtronic and Abbott. Ahmed discloses serving as a clinical consultant for Medtronic.

J Am Coll Cardiol. Published online January 9, 2023. Abstract. Editorial.

Follow Steve Stiles on Twitter: @SteveStiles2.

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