CIED Infections Have Risen Over the Past 2 Decades

Megan Brooks

September 24, 2019

A trends analysis shows an increasing incidence of cardiac implantable electronic device (CIED) infections over the past 2 decades.

And while the overall incidence of CIED infections is low for new implants, the risk for infection is significantly increased for generator replacement and device upgrade procedures, the researchers found.

"More aggressive prophylactic measures in addition to strict sterilization and perioperative antibiotic use may be considered to reduce the incidence of CIED infection in high-risk patients," the researchers, with lead author Yong-Mei Cha, MD, Mayo Clinic, Rochester, Minnesota, conclude.

The study was published in the September issue of JACC: Clinical Electrophysiology.

For this analysis, the researchers identified 2163 adults with CIED living in Olmsted County, Minnesota from 1988 to 2015.

Over the span of about 25 years, 62 CIED infection cases occurred in 59 unique patients (three patients had recurrent infections after device system removals and reimplants).

Most CIED infection events occurred after the initial implant (>50%), a finding that reinforces the importance of "universal precautions, such as proper sterile technique and prophylactic intravenous antibiotics during device implantation," the researchers say.

Of the 62 cases of CIED infection, 41 (66.1%) were pocket infections (nine with bacteremia) and 21 (33.9%) were bloodstream infections (including seven cases of endocarditis. Fifty-four (87%) cases had microbiologic diagnoses.

Implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy (CRT) introduce a greater risk for CIED infection than permanent pacemakers (PPMs), the results show.

The overall incidence of CIED infection per 1000 person-years was 4.2 (95% CI, 1.2 - 7.9). For ICDs, it was 8.4 (95% CI, 3.5 - 11.6), and for CRT, it was 11.0 (95% CI, 2.7 - 18.2), and for PPMs, it was 2.9 (95% CI, 0.3 - 4.6).

The cumulative probability of an CIED infection was 6.2% (95% CI, 4.0 - 8.4) after 15 years of follow-up and 11.7% (95% CI, 6.8 - 17.3) after 25 years.

The CIED infection rate increased substantially after the third procedure, compared with the first and second procedures. The incidence of infection after the first, second, and third procedures was 1.5% (33/2163), 2.9% (18/620), and 5% (11/220), respectively.

The 15-year cumulative probabilities of the CIED infection was 2.6% (95% CI, 1.4 - 3.8) after the first procedure and 2.7% (95% CI, 1.2 - 4.2) after the second, but increased to 24.1% (95% CI, 3.8 - 44.4) after the third.

Generator changes and upgrades were significantly associated with CIED infection, with hazard ratios of 3.91 (95% CI, 1.47 - 10.37; P = .006) and 3.08 (95% CI, 1.24 - 7.62; P = .02), respectively.

"It is conceivable that when reopening a relatively larger device pocket capsule or prolonged pocket exposure time for adding a new lead may predispose patients to CIED infection," Cha and colleagues say. "This finding suggests that it is important to consider risks/benefits in upgrades or need for generator replacement in ICD/CRT-D patients, especially the third procedure."

CIED Infections a "Big Deal"

In an editorial accompanying the publication, Khaldoun G. Tarakji, MD, Section of Cardiac Pacing and Electrophysiology, Heart and Vascular Institute, Cleveland Clinic, writes that despite some limitations, "the investigators and their findings redefine our view of CIED infection risk to reflect the reality from a patient's perspective over a lifetime.

"An infection that complicates a simple generator change in a patient with a pre-existing device and older leads triggers a series of additional procedures, including the need for CIED and lead extraction, and the challenge of reimplantation when indicated," Tarakji writes. "Although we might not remember the last 100 device replacements we have performed, we vividly remember the one patient who developed an infection and the rough course these patients have to endure afterward."

For these reasons, he writes, "prevention is the cornerstone to address CIED infection, and it is a responsibility shared by clinicians, researchers, and industry." Prevention should start with the decision of whether or not to implant a device, "strict adherence" to sterile surgical techniques, and proper management of anticoagulation, he notes. More research is needed on the risk stratification of patients considered for primary prevention devices, and industry should be working to increase battery longevity and reliable leads.

"The investigators should be commended for reminding us that CIED infection is not only a procedure risk, but a lifetime risk," he concludes. "As clinicians, researchers, and industry, we collectively share the responsibility of getting this risk as close to zero as possible to continue to provide our patients with healthier and longer lives."

"CIED infections are a big deal at the time of generator changes and upgrades. Really, the battery should outlive the patient because when you change out these devices, you put them at great risk for CIED infection," Ranjit Suri, MD, electrophysiologist, Mount Sinai St. Luke's, New York City, who was not involved in the analysis, told theheart.org | Medscape Cardiology.

"Clearly, the number of device-related infections is going up," Suri said. "The folks who get defibrillators are sicker people with many more comorbidities, so one can imagine these are some of the risk factors for CIED infections," he noted.

"We need to be very circumspect about who gets a device. For people with a lot of comorbidities, we should have a really good reason to implant them. I think we have too low a threshold to implant devices in this country," said Suri.

The study also "highlights the importance of putting in devices with enhanced longevity," such as those using manganese oxide battery technology, said Suri. Also, "perhaps an antibiotic-impregnated biodegradable pouch should be routine in patients getting generator changes and upgrades," he said.

In the WRAP-IT trial, adjunctive use of an antibacterial pouch resulted in a significantly lower incidence of major CIED infection than standard-of-care infection-prevention strategies alone, without a higher incidence of complications, as reported by theheart.org | Medscape Cardiology.

The WRAP-IT study results were released March 17 at the American College of Cardiology 2019 Scientific Sessions, with simultaneous publication in the New England Journal of Medicine.

JACC Clin Electrophysiol. 2019;5:1071-1080, 1081-1083. Abstrast, Editorial

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