Becker's Hospital Review

19 Executive Briefing Sponsored by: A s the incidence of cardiovascular diseases continues to rise, the use of Cardiac Implantable Electronic Devices (CIEDs), such as pacemakers and implantable cardioverter-defibrillators, has increased, as well. Between 1993 and 2015, the number of implantable devices in use has more than doubled. 1,2 It's estimated that 1.5 million patients receive CIEDs worldwide every year. 3 Patients who receive these devices may be at risk for life-threatening CIED infections. 4 Given the toll these infections take on patients and the associated expense for hospitals, cardiac surgeons and electrophysiologists are continually looking for ways to reduce the risk of infection. 5 One innovative device increasingly championed by cardiologists as a demonstrated deterrent against CIED infection is the TYRX™ Absorbable Antibacterial Envelope. The surgical mesh Envelope holds CIEDs in place in order to provide a stable environment and contains polymer-controlled elution of rifampin and minocycline to protect against infection.* In the WRAP-IT Study — the largest-ever randomized, controlled, global CIED trial — researchers found the use of the TYRX™ Envelope in cardiac implant patients "resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications." The New England Journal of Medicine published the results of the WRAP-IT Study in March 2019. ** Becker's Hospital Review recently spoke with two cardiac device implanters — Edward Schloss, MD † , and Christopher R. Ellis, MD † — about the TYRX™ Envelope and findings of the WRAP-IT Study. Dr. Schloss is a practicing electrophysiologist with The Christ Hospital in Cincinnati. Dr. Ellis is a cardiovascular disease specialist affiliated with Nashville, Tenn.- based Vanderbilt University Medical Center and Franklin, Tenn.- based Williamson Medical Center. Patient risk and financial costs of CIED infections Device infection is a traumatic experience for both patients and providers. Patients may require hospitalization, and lead extraction — the removal of wires that deliver energy to the cardiac implant — which can be a difficult and hazardous procedure that even result in death in some instances. 6 "On so many levels, device infection hits everyone in a negative fashion," Dr. Schloss said. "When you perform a procedure and the patient comes back with a complication directly related to the procedure, you feel responsible. In already immunocompromised patients, the morbidity and mortality of device infections is high." The literature reports 50 percent mortality at three years. †† Cardiac surgeons also are seeing an increase in patient complexity, which can increase the risk of infection. 1,2 "We are treating more patients who have lived longer with cardiovascular implantable electronic devices. They may be on their fourth, fifth, or sixth generator replacement. In those instances, the complexity of device cases has increased quite a bit. Those are very high-risk patients," explained Dr. Ellis. CIED infections are costly. Research has found that these infections cost hospitals on average between $48,000 and $83,000 per patient. 5-10 The economics are unfavorable for hospitals and the treatment is hard for patients and their families. 5-13 The WRAP-IT Study: Proof of lower CIED and pocket infection rates The WRAP-IT Study spanned 25 countries and 181 care centers. 14 Nearly 7,000 patients at an increased risk for pocket infection and 776 surgeons participated. The goal of the study was to evaluate the safety and effectiveness of the TYRX™ Envelope in reducing the risk of CIED infection. 14 The WRAP-IT Study demonstrated a 40 percent reduction in major CIED infections, a 61 percent reduction in pocket infections compared to standard-of-care pre-operative antibiotics, and no increased complication risk with the use of the TYRX™ Envelope through 12 months. 14 As one of the study investigators, Dr. Schloss noted, "The study design was straightforward and ambitious, and the results were very Landmark WRAP-IT Study reveals significant reduction in CIED infections with the TYRX™ Envelope The TYRX™ Envelope is constructed from an absorbable multifilament knitted mesh substrate. It provides a stable environment to hold CIEDs when implanted in the body 15,16 and uses an innovative tyrosine-based polymer-controlled elution to deliver a synergistic combination of minocycline and rifampin locally into the tissue pocket. 17 A minimum inhibitory concentration (MIC) of the two drugs is reached within two hours and is maintained for a minimum of seven days. The mesh fully absorbs in approximately nine weeks. 17,18

• Cover