Becker's Clinical Quality & Infection Control

68 Executive Briefing a minimum of seven days. The TYRX Envelope is fully absorbed by the body about nine weeks after the procedure. Additionally, the TYRX Envelope requires no adjustment to standard surgical techniques during revision or upgrade procedures. Dr. Ellis also started using the TYRX Envelope to more effective- ly protect his patients from CIED infections approximately four years ago. Even though the Envelope may be used on any patient with an implanted device, many physicians, like Drs. Thomas, Ellis and Hanna, have opted to use it only on patients at the highest risk of developing a CIED infection. "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." Proven effective at reducing CIED infection rates "Strategies to reduce perioperative infections can significantly improve outcomes," declares George Thomas, MD, an electro- physiologist with Weill Cornell Medical Center in New York. Physicians who already use the Envelope have seen positive results within their practices. Dr. Ellis notes his practice has experienced a much lower infection rate in CIED patients. A study he co-authored, appearing in the journal Pacing and Clin- ical Electrophysiology in 2015, demonstrated the Envelope's effects. In the trial, there were zero CIED infections among pa- tients who received an absorbable TYRX Envelope (0.0 percent infection rate) while infection was reported in 6 patients who did not receive a TYRX Envelope (4.8 percent). Similar results have also been observed by Dr. Hanna. In his practice, CIED infections have been "significantly reduced" by the TYRX Envelope. In fact, even though infection rates in his practice were low to begin with, a greater than 50 percent decrease was achieved by using the Envelope. "It's quite substantial," Dr. Hanna states. "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." As found in a number of clinical studies, patients treated with a TYRX Envelope experience 70 percent to 100 percent fewer infections compared to those without it. While smaller studies have proven the Envelope's effectiveness, more trials are on the way. For example, Dr. Ellis, as of mid-April 2016, has enrolled his first patients in a four-site randomized controlled trial. The objective is to determine whether the Envelope can "stand on its own legs" and still prevent infections even if clinicians skip a perioperative antibacterial pocket wash and send patients home without any oral antibiotics. Now in progress: The first global, large-scale study in at- risk patients On a larger scale, a major new RCT is now underway that may build on the positive results seen in the earlier, smaller-scale studies. This study, called WRAP-IT (The World-Wide Random- ized Antibiotic Envelope Infection Prevention Clinical Study), is the first large-scale study of its kind to evaluate an antibacterial envelope in CIED patients at risk for infection. This ongoing CIED replacement complication study, which is currently eval- uating the effectiveness of the Envelope in CIED patients and assessing related treatment costs, is concentrating on the two most common complications related to CIED implants: infec- tion and lead system events. The study will compare the rate of major CIED infections through 12 months after the device is implanted, between pa- tients treated with and without the TYRX Envelope. Medtronic, the manufacturer of the TYRX Envelope, will utilize the results of this study to evaluate not only the outcomes achieved by the TYRX Envelope, but also to evaluate its effect on consequent healthcare cost. In this study, up to 7,764 subjects are expected to be enrolled in up to 225 investigational sites worldwide, including the U.S., Canada, Europe, Middle East, greater China, New Zealand, Latin America, Singapore, Malaysia and India. The study was initiated in January 2015, with patients being followed for a minimum of 12 months. Meeting the challenge with new technology In a single-center, retrospective cohort study from the University of Pittsburgh Medical Center, the TYRX Envelope when used as a standard of care was associated with significantly lower rates of CIED infections. In a hypothetical projection, the use of the Envelope as a standard of care prevented 6.2 infections, equat- ing to roughly $340,000 in avoided treatment costs. While the rising incidence of CIED infection — and its associated higher treatment costs — has proven persistent, the technologi- cal advances of the TYRX Envelope offer the potential to protect CIED implants from the cost and complications of infections. As studies show, the sustained local delivery of antibiotics where needed most, may improve patient outcomes and reduce treat- ment costs. n Medtronic Infection Control delivers site-specific therapy by commercializ- ing proprietary implantable medical-pharmaceutical combination 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 as- sociated with implanted devices. The first commercially available products are the TYRX™ Absorbable Antibacterial Envelope, for use with Cardiac Implantable Electronic Devices (CIEDs), and the TYRX™ Neuro Absorbable Antibacterial Envelope for use with Implantable Neurostimulators (INSs). Sponsored by:

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