Doctors are not removing heart device implants that develop infections, putting patients' lives at risk, according to a study from Duke University.
The study of more than one million Medicare patients who received a cardiovascular implantable electronic device over a thirteen-year period found only 18% of patients who developed a device infection eventually had their pacemaker or defibrillator removed. The American Heart Association recommends removing infected devices. The study's findings were presented at the 2022 American College of Cardiology Scientific Sessions.
"Not only is this important because for many patients, it's a matter of life and death, we also know from prior research that this is also a huge drain on healthcare resources," said Dr. Jonathan Piccini, associate professor of medicine at Duke University and Director of Cardio Electrophysiology at the Duke Heart Center.
Of the patients whose doctor's caught device infections, 13% had their device taken out within six days. But the majority, over 80%, didn't have devices taken out until a month after the infection was diagnosed. Piccini said there needs to be more education of doctors across the board, because many don't know the immediate danger and instead see an opportunity to treat a patient first with antibiotics as a wait-and-see strategy to prevent an avoidable procedure.
"But the other side of that is, it's an opportunity for the infection and progress to potentially become more serious before it's dealt with definitively," Piccini said.
The danger with leaving a device in longer is that the risk of death increases over time. Earlier extraction was associated with a significantly lower risk of death compared with no extraction, according to the findings.
Spotting a device infection can also be complicated. There's a list of clinical and other tests that when considered together, can tell a doctor if it's a definite or probable device infection. In 2019, the European Heart Rhythm Association published guidelines on how to spot an infection of a patient's heart device, but Piccini said the surgeons that implant these devices — heart rhythm specialists — or infectious disease doctors are some of the only clinicians widely aware of the list.
But patients most often present infection symptoms, like fever, chills or vomiting, at urgent care centers, primary care offices or emergency departments.
"While a heart rhythm specialist puts a defibrillator or a pacemaker in those patients, when they develop an infection, they can present to any part of the healthcare system and so it's the Swiss cheese phenomenon where patients may end up seeing a physician who is unaware that the device needs to come out," Piccini said.
Armed with the findings, doctors from the Duke Clinical Research Institute are launching a quality improvement demonstration project to target provide three participating hospitals with clear guidelines on how to spot a device infection and steps to follow when a diagnosis is made.
The project might involve instructing hospital intake nurses to ask about any implanted heart devices, and building an alert into an electronic health records to make physicians aware. There could also be a process to input specific risk factors, which can increase a patient's chance of developing an infection. Those include an end-stage renal disease diagnosis, certain anti-inflammatory prescription drugs, poor functioning kidneys, knowledge of accidental injury to the wall of a blood vessel during implantation surgery or a longer than usual surgery.
The study, which is currently under peer review, included more than 1 million Medicare patients who received an implant between 2006 and 2019. More than 11,000 developed a device infection, with a 68.4% rate of one-year survival rate. Female patients and Black patients were both less likely to have extraction within 30 days of device infection.