Most patients with implantable device infections do not receive extraction
WASHINGTON — Contrary to guideline recommendations, most patients with infections related to implantable cardiac devices do not get their devices explanted, despite extraction leading to better outcomes, researchers reported.
Sean D. Pokorney, MD, MBA, assistant professor of medicine at Duke University School of Medicine and member in the Duke Clinical Research Institute, presented findings from an analysis of Medicare fee-for-service patients who had a cardiac device implanted from 2006 to 2019 at the American College of Cardiology Scientific Session.
The cohort included 1,065,549 patients (median age, 78 years; 49% women) who were followed for a median of 4.6 years. During the study period, 1.1% of patients had a device-related infection. Pokorney said the infection rates were 0.3% at 1 year, 0.6% at 2 years and 1.1% at 3 years, and the mean time of infection was 3.7 years after implant.
Compared with those who did not get an infection, those who did were less likely to be women (39.7% vs. 49.1%); more likely to be Black (15.6% vs. 7.6%); more likely to have comorbidities such as diabetes, ischemic heart disease, peripheral vascular disease, HF, chronic obstructive pulmonary disease and renal disease; and more likely to be implanted with an implantable cardioverter defibrillator or a cardiac resynchronization therapy device than a pacemaker, Pokorney said at a press conference organized by Philips, which makes technology used in device extraction.
Among those who had an infection, women were less likely to have an extraction than men, and people of other races and ethnicities were less likely to have an extraction than white patients, he said.
“We see an example of a disparity where although women are equally represented in terms of infection, they have a lower rate of getting extraction relative to men,” Pokorney said at the press conference. “We see similar disparities by race, and patients with more comorbidities are less likely to be extracted.”
Whereas extraction of the device is a class I recommendation in various guidelines for patients who have a device-related infection, 81.8% of patients with an infection did not have an extraction during the study period, and only 13% had extraction within 6 days of diagnosis, he said.
Nearly one-third (32.4%) of patients who had a device-related infection but did not receive extraction died within 1 year of infection, Pokorney said. Extraction within 6 days was associated with a 41% reduced risk for mortality (adjusted HR = 0.59; 95% CI, 0.52-0.67; P < .001) and extraction from 7 to 30 days was associated with a 22% reduced risk for mortality (aHR = 0.78; 95% CI, 0.65-0.94; P = .008). Very few patients received extraction after 30 days following diagnosis, he said.
Pokorney also said “one of the highest risk periods for infection is when the battery gets changed out,” which often happens at 8 to 10 years, longer than the median follow-up from the present analysis. “When you look over a much longer time horizon, at 15 years, 6% of patients will end up with an infection, and when you go out to 25 years, when patients have had multiple battery changes, the infection rate can be as high as 12%. Infection is a major concern for these patients over time.”
He noted that in contrast to previous studies, the population in this study had a high rate of patients with endocarditis, which is a strong indication for extraction.
In response to the data, the Duke Clinical Research Institute has begun a demonstration project for improving care of device-related infections at three U.S. centers, one a large academic system, one a large private system, and one a single community-based hospital, Pokorney said.
“There are many barriers to the successful diagnosis and management of [cardiac implantable electronic device] infections, which are a significant life-threatening public health problem,” Cardiology Today Editorial Board Member Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS, associate professor of medicine and director of cardiac electrophysiology at Duke University Medical Center and member in the Duke Clinical Research Institute, said during a discussion at the press conference. “Lack of awareness of treatment guidelines and outcomes are key challenges for our community.”
Piccini said there is no evidence that extraction leads to increased mortality risk in patients who required an extraction for reasons not related to infection, and although there are some patients for whom it will be too risky to extract an infected device, that is not a reason to forgo extraction in most patients.
“If we did a nationwide analysis that showed only 20% of Americans were getting guideline-directed medical therapy for heart failure or only 20% of patients with an acute MI were getting reperfusion therapy, we would not say a significant chunk were too sick for therapy,” he said. “This is a real problem. The mortality of device infection is far greater than acute MI, particularly in the case of recurrent infection, and is higher than the 1-year mortality for mild HF.”
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Pokorney SD, et al. Featured Clinical Research II. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).