How to quell the rising trend of CIED infections

This content is sponsored by Medtronic

As hospitals and healthcare providers continue to strive to reduce healthcare-associated infections, they have been successful in several areas, like in reducing central line-associated bloodstream infections and in some surgical site infections. However, one type of SSI has persisted and actually is on the rise: Cardiovascular Implantable Electronic Device Infections.

In fact, the increase in admissions for CIED infections is five-fold the increase in CIED implantations, according to data published in Pacing and Clinical Electrophysiology and the Journal of the American College of Cardiology.

"The rates have been steadily increasing…and we're seeing more infections and more serious infections" despite the best efforts of physicians, says Ibrahim Hanna, MD, the medical director of cardiac electrophysiology with Baptist Health Centers in Birmingham, Ala.

There are a few possible reasons for the recent increase in CIED Infections. One is because physicians are treating older patients who have more comorbidities. Since people are living longer, they are more likely to need a pacemaker, or defibrillator, and as a result, are more likely at a later time to have their device revised, replaced or upgraded. One tool that helps measure the risk of a given patient contracting a CIED Infection is by the use of odds ratio's which measure a patient's increased risk of infection if they have certain risk factors. These risk factors can originate from the patient themselves, the medications they take, and/or the procedure that a patient is going to have or has even had in the past. An example would be that if a patient has diabetes, which has an odds ratio of 3.5, a diabetic is 3.5 times more likely to get a CIED Infection than a patient who does not have diabetes. Another example would be that if a patient has renal failure, which has an odds ratio of 11.97, so the patient is 11.97 times more likely to get a CIED Infection than a patient who does not have renal failure. Common risk factors for CIED Infection include early reintervention, history of previous infection, having congestive heart failure, and the use of corticosteriods.

"I've had patients in the last five to 10 years who are living longer and I'm doing more and more device change-outs, and those specifically have much higher infection rates than a new implant," explains Christopher Ellis, MD, the director of cardiac electrophysiology at Vanderbilt University Medical Center in Nashville, Tenn.

Additionally, Dr. Hanna at Baptist notes the increase in antibiotic resistance has made preventing such infections more difficult and made the infections themselves more difficult to treat.

No matter the reason, the rising infection trend is troubling, as CIED Infections can cost nearly $100,000 to treat: CMS estimates that the average cost of a single CIED infection in the U.S. is $72,485.

"The big question in the near future is who is going to pay for that," Dr. Ellis notes, as hospitals are being penalized for having high infection rates and becoming more and more responsible for paying the cost of those infections themselves.

And, as Dr. Hanna points out, the effects of CIED Infections range far beyond money. "It's not just healthcare economics. It's about the patient's quality of life and mortality."

CIED Infections can be debilitating or deadly to the patients they affect. A study in PACE shows patients with a CIED Infection, when compared to device recipients without an infection, had increased mortality persisting for three years, even after successful treatment of the infection. The rate of mortality is around 50 percent depending on the device, the study found. Therefore, preventing CIED Infections is not just a matter of cost — it can be the difference between life and death.

What can be done?

As with all surgery-related infections, steps can be taken to prevent CIED Infection occurrence. "Strategies to reduce perioperative infections can significantly improve outcomes," says George Thomas, MD, an electrophysiologist with Weill Cornell Medical Center.

Dr. Hanna notes that his practice's goal is to reduce infections down to zero, and he and his colleagues have taken several approaches to reduce instances of CIED Infections. One tool he has added to his arsenal is the TYRX™ Absorbable Antibacterial Envelope.

The product, which was cleared by the U.S. Food and Drug Administration in May 2013, is a mesh envelope that holds an implantable cardiac device like a pacemaker or defibrillator. It stabilizes the device and releases two antibiotics (minocycline and rifampin) directly into the surgical pocket over the course of a minimum of seven days. The envelope is then fully absorbed by the body about nine weeks after the procedure. This is different from earlier antibacterial envelopes that remain in the patient. The fully absorbable product requires no adjustment in standard surgical techniques in subsequent surgeries.

Dr. Ellis also started using the absorbable envelope in his practice to protect his patients from CIED Infections more effectively nearly two years ago.

"A locally delivered antibacterial tool that can prevent infection…is a nice thing," he explains. "Knowing that it dissolves away and that the patient is left with a clean pocket and leads was a pretty effective sell for me."

Even though the envelope could be used on any patient with a device, many physicians, like Drs. Thomas, Ellis and Hanna, started using the envelope only on patients who are at the highest risk of developing a CIED Infection, like diabetics or people with significant kidney dysfunction.

"We don't use it on everybody, but we do use it on people with multiple risk factors for infection," Dr. Ellis explains. "By limiting use, we keep costs down and have gotten the best benefit we can from the product.

Dr. Thomas recommends using the product on patients with long procedure times, as well.

Dr. Hanna notes that he chose carefully in terms of patient selection at first, especially when using the first generation non-absorbable envelope, but is now "much more free with using the envelope" since it is absorbable and will not remain in the patient.

Outcomes & the future

Physicians who already use the envelope have seen the results within their practices. Dr. Ellis notes that his practice experienced a much lower infection rate in CIED patients once physicians started using the antibacterial envelope. A study he co-authored in PACE showed the envelope's effects: In a trial, there was just one CIED Infection among patients who received an antibacterial envelope (a 0.4 percent infection rate) while 19 patients in the control group developed an infection (3 percent).

Dr. Hanna has also seen CIED Infections be "significantly reduced" after introducing the antibacterial envelope in his practice. In fact, even though infection rates there were low to begin with, he saw a more than 50 percent decrease in infection rates by using the antibacterial envelope. "It's quite substantial," he says. "I have felt a significant change and improvement, even though we're still treating the same population and doing the same types of procedures. It's been effective in my own institution."

Medtronic Infection Control data shows the TYRX Antibacterial Envelope is associated with 70 to 90 percent fewer infections compared to patients who don't have the envelope.

While smaller studies have proven the antibacterial envelope's effectiveness, more trials are on the way. For example, Dr. Ellis plans to see if the envelope can "stand on its own legs" and still prevent infections even if clinicians skip an antibacterial wash and send patients home without any oral antibiotics.

On a larger scale, a randomized controlled trial which enrolled its first patient in January is evaluating the effectiveness of the antibacterial envelope in reducing major infections in CIED patients and assessing healthcare costs related to treatment of patients with CIED Infections. The global clinical trial will enroll about 7,000 patients at 225 sites worldwide.

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