Cardiac implant infections must be every specialty’s concern

Cardiac implantable electronic devices are commonly used for correcting and monitoring abnormal heart rhythm and atrial fibrillation, managing prior cardiac arrest or syncope and otherwise preventing cardiac incidents in patients at high risk of cardiac arrest or heart failure.

Also known as CIEDs, these devices include pacemakers, cardiac defibrillators and resynchronization devices. They are proven safe and effective at helping providers improve patient survival rates and quality of life; however, they require ongoing maintenance and awareness of the potential development of issues such as infections.

As an increasing number of patients receive CIEDs, a wide variety of specialties beyond electrophysiology and cardiology are likely to encounter patients with an infected device. Therefore, the prevalence of these devices makes it imperative for physicians across specialties to keep the potential for infection top of mind.

Globally, more than 1 million new CIEDs are implanted in patients each year, and 1 in 20 will develop a CIED infection within about 3 years.

However, many patients with CIED infections do not receive proper treatment.

“In the U.S., late-breaking data found less than 20 percent of patients with CIED infections will receive treatment in accordance with treatment guidelines from leading medical societies,” said Dr. Bruce Wilkoff, chair of the American Heart Association’s CIED Infection Group, supported by Philip’s Image-Guided Therapy. The study found this lack of appropriate treatment contributes to an estimated 7,000-plus preventable deaths each year.

“There really is only one treatment that is proven effective,” said Dr. Wilkoff. “That is to remove not just the device but also the leads.”

Removing the entire device and leads, which are the wires that connect the device through the vein to the heart, enables providers to fully clean out the infection underneath the skin, said Dr. Wilkoff, who is also director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic. Once the infection has cleared up following complete device removal, along with the help of antibiotics, providers then can reimplant the device if necessary, from a different location.

When clinicians can readily identify and address CIED infection according to this specific protocol, known as transvenous lead extraction — which has the American Heart Association’s endorsement — the intervention is often life- saving. This has been demonstrated by research comparing the survival rates of patients who undergo early CIED removal with the survival rates of patients in a control group.

A 2021 article published in Circulation concluded “clinical studies assessing CIED extraction for infection consistently reported high procedural success (~95%), low major procedural complication rates (0% to 4.8%) and very low procedural mortality rates (0% to 2.4%).”

Clinical studies assessing CIED extraction for infection consistently reported high procedural success (~95%) Circulation, 2021 Comparatively, allowing the infection to go untreated properly for too long, or untreated altogether, is very dangerous, according to Dr. Wilkoff.

“If you don’t do [complete extraction and] treatment relatively quickly, the risk of dying goes up,” he said. “If you don’t do it at all, the chance of dying increases exponentially.”

While it’s clear within electrophysiology networks that complete CIED removal paired with a course of antibiotics is the gold standard for CIED infection treatment, the information hasn’t necessarily reached other health care specialties. Awareness is not as widespread as it should be, putting patient lives at risk.

One of the biggest barriers to optimal treatment of CIED infection is that device infections can present so many different ways. Moreover, these infections often come with a wide range of nonspecific symptoms that can mimic other conditions, misleading both patients and clinicians, said Dr. Jonathan Piccini, a volunteer expert for the American Heart Association and researcher sounding the alarm on CIED infection protocols.

In about 80% of cases, the infection can be traced back to a previous operation on the device, whether that was the initial implantation, a subsequent revision or replacement due to worn-down batteries. But since symptoms of CIED infection don’t appear right away — and may not until months after the operation — patients don’t make this connection. The gap can also lead providers to mistakenly dismiss the role of CIED infection in a patient’s symptoms.

Also preventing appropriate treatment is the misconception that CIED infection is rare. The risk might be just 1% to 2% with the initial implantation, but with multiple device changes over the years, that risk increases significantly, Dr. Wilkoff pointed out.

“Say a person gets a pacemaker when they’re 60 years old; they could have another 30 years to live,” he said. “From the first time it’s replaced to the third time, the cumulative risk of CIED infection ends up being 10% to 15% over that person’s lifetime.”

To avoid misdiagnosis, clinicians of all kinds must understand what CIED infection looks like in patients. It may appear as localized swelling or redness at the pocket site where the subcutaneous device was implanted, but there are also more systemic presentations in which a person might be experiencing fever or chills, Dr. Wilkoff explained. In some cases, systemic and localized symptoms might both occur.

Once CIED infection is correctly identified, there is still the challenge of false perceptions about how to treat it. For example, patients tend to be more afraid that lead extraction will cause life-threatening internal bleeding than they are of risks related to untreated infection. But whereas untreated CIED infection can cause mortality in 10% to 20% of cases, fatal complications from transvenous lead extraction are much rarer, occurring at a rate as low as a fraction of a percent.

There are also misconceptions about treatment on the provider side, particularly regarding antibiotics, according to Dr. Wilkoff.

“The perception of an infection is that antibiotics are the cure,” he said, giving pneumonia, bladder infections and strep throat as examples. “While antibiotics are part of the treatment, in this case, they’re not a cure. The reason is that the bacteria that generally cause pacemaker and defibrillator infections are mostly gram-positive.”

These gram-positive bacteria produce a sticky, almost mucus-like biofilm that prevents white blood cells and antibiotics from getting in. So, even if antibiotics can temporarily suppress symptoms of a CIED infection, they do not entirely eliminate bacteria, and the infection simply returns at some point down the line.

That is, unless the entire CIED — leads and all — is removed.

Greater awareness of CIED infection in patients, as well as knowledge of the treatment protocol that yields the best outcomes, can have a multipronged impact on healthcare.

Of primary importance is the benefit to patients themselves.

Individuals shouldn’t have to wait for the occasional appointment with a cardiac specialist to find out they have a potentially life-threatening issue. As patients might make more frequent visits to specialists such as family care practitioners, nephrologists or gynecologists, equipping these and other providers with knowledge about CIED infection can translate directly into timely referrals for proper treatment and better outcomes.

Of course, improved outcomes are also advantageous to health systems from an operational standpoint. CIED infections are associated with high morbidity and mortality, both of which increase costs, according to a study published in 2016.

“CIED infection is a very costly problem for hospitals, payers and society as a whole” said Dr. Piccini. “Timely diagnosis and treatment is imperative, not only to improve patient outcomes and maximize health, but also to minimize the financial impact and cost of treatment.”

Finally, improved outcomes are important to clinicians themselves, a benefit that’s especially crucial to note amid rampant staff burnout. Helping people live healthier lives is the primary reason many go into the profession in the first place, and it can also be the reason they stay. Better understanding of the role they can play in CIED identification and treatment can give clinicians a sense of fulfillment, purpose and pride, making the health care industry stronger in the long run.

While there is a need for improvement in CIED infection awareness and treatment, Dr. Wilkoff can point to several advancements that make him excited about the future.

First is evidence that using an antibiotic envelope reduces the frequency of infection. Dr. Wilkoff said this is the kind of information he shares with peers in the specialty. There’s also the rise of non- transvenous devices, such as leadless pacemakers or subcutaneous defibrillators, which mitigate some of the risks seen with transvenous devices.

The use of electronic medical records to flag patients when they enter the health system with an infection is cause for optimism as well because it creates the potential for better identification of patients with CIED infection.

At the end of the day, though, what stands out is the overwhelming gratitude from patients, Dr. Wilkoff said. It boils down to the fact that transvenous lead extraction saves lives.

“Obviously, nobody wants to have an infection, but they really don’t want to be ignored,” he said. “Thousands of patients have not received the care they need to, or they keep getting temporizing types of answers to their questions. It’s very important that clinicians are aware that more can be done.”

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