Issue link: https://beckershealthcare.uberflip.com/i/483154
20 Executive Briefing: Cardiovascular Implantable Electronic Device Infections The product, which was cleared by the U.S. Food and Drug Ad- ministration in May 2013, is a mesh envelope that holds an im- plantable cardiac device like a pacemaker or defibrillator. It sta- bilizes 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 surgi- cal techniques in subsequent surgeries. Dr. Ellis also started using the absorbable envelope in his prac- tice 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 de- vice, 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 signifi- cant 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 se- lection 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 re- duced" 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 pa- tients and assessing healthcare costs related to treatment of pa- tients with CIED Infections. The global clinical trial will enroll about 7,000 patients at 225 sites worldwide. "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." — Ibrahim Hanna, MD, medical director of cardiac electrophysiology with Baptist Health Centers in Birmingham, Ala. Medtronic Infection Control delivers site-specific therapy by commercializing proprietary implantable medical-pharmaceutical combina- tion devices for multiple surgical markets. The Medtronic Infection Control product line is focused on a singular goal: creating unique, cost-effective solutions that address surgical-site infections (SSIs) and inflammatory tissue-reaction associated with implanted devices. The first commercially available products are the TYRX™ Antibacterial Envelopes for Cardiac Implantable Electronic Devices (CIEDs)— in both absorbable and non-absorbable options.