Issue link: https://beckershealthcare.uberflip.com/i/1235187
20 Executive Briefing favorable. When we used the TYRX Envelope, infection rates decreased, so that was gratifying. The WRAP-IT Study has real- world clinical applications." According to Dr. Ellis, WRAP-IT study data are helping practitioners make a persuasive argument to their hospitals to use the TYRX Envelope as a means of reducing pocket infections. The literature reports a 20 percent one-year mortality rate associated with device-related infections. 9 "Pocket and device-related infections are the most dangerous things that electrophysiologists deal with. Many people minimize the risk, but it has a big impact on patients," he said. TYRX™ Envelope and device "pocket" management In a world where patients are living longer and device replacements, upgrades, extractions and revisions are more common, Dr. Ellis sees the integrity of the CIED pocket as incredibly important to surgeons. According to the cardiovascular disease specialist, scar tissue can build up over time after a device has been implanted and sometimes leads can become embedded in calcifications. This can cause more complex surgeries that may increase patient risk for complications. Dr. Ellis has found that the TYRX™ Envelope promotes healthy pockets and helps address some of these issues — it is fully absorbed in approximately nine weeks, with no foreign body nidus. 10 "When we re-enter pockets several years later, after doing an initial implant with the TYRX™ Envelope, we're finding favorable, thin capsules," Dr. Ellis said. "We've sent a few to the pathology lab for a histological assessment. We are pleased with how thin and well-formed the capsule is — it looks like a brand-new pocket. It makes the pocket a better environment for the leads and device, and a safer environment to operate in." Greater confidence and lower costs The medical community has been dealing with the high physical, emotional and financial costs of CIED infections. Fortunately, clinical and economic studies have demonstrated that the TYRX™ Envelope is an effective approach as adjunctive therapy for protecting against costly CIED infections. 14,19-24 "I've seen how complex cases can turn out when the patient gets an infection. It can be a series of back-to-back unfortunate events that result in huge bills," Dr. Ellis said. "It's a difficult scenario when patients have to sit in the hospital for a month on intravenous antibiotics and temporary pacing systems." The TYRX™ Envelope also provides cardiac surgeons and electrophysiologists with greater confidence, according to Dr. Schloss. "I want to be able to say, 'Yes, we are doing everything we can to take good care of you,'" he said. "That's a very gratifying thing to be able to say to a patient." n References 1. Greenspon A, et al. J Am Coll Cardiol. 2011;58(10):1001-1006. 2. Dai M, et al. JACC EP 2019;5:1071–80. 3. Mond HG et al. Pacing Clin Electrophysiol. 2011;34:1013-1027. 4. Sohail MR et al. PACE. 2015;38(2):231-239. 5. Sohail MR, et al. Arch Intern Med. 2011;171:1821-8. 6. Wilkoff BL, et al. AHA Scientific Sessions 2019; Su3088. 7. Medicare Provider Analysis and Review (MEDPAR) File, FY 2012, on file with Medtronic, plc. 8. Shariff N, et al. J Cardiovasc Electrophysiol. July 2015;26(7):783-789. 9. 2012 Premier Healthcare Database, data on file with Medtronic plc. 10. Lopatto, et al. Antibacterial Envelope is Associated with Medical Cost Savings in Patients at High Risk for Cardiovascular Implantable Electronic Device Infection. Poster presented at ACC 2017 Scientific Sessions. Data on file with Medtronic plc. 11. Sohail MR, et al. Circ Arrhyth Electrophysiol. 2016;9(8):e003929. 12. Greenspon AJ, et al. PACE. 2018;41(5):495-5034. 13. 2011-2015 large US healthcare claims analysis, data on file with Medtronic plc. 14. Tarakji KG, et al. N Engl J Med. 2019;380:1895-1905. 15. Huntingdon Life Sciences Study TR-2011-054. 16. Osoro M et al. Pacing Clin Electrophysiol. 2018;41:136-142. 17. Huntingdon Life Sciences Study TR-2013-001. 18. Sinclair Labs Study D13599. 19. Bloom HL, et al. Pacing Clin Electrophysiol. 2011;34:133-142. 20. Mittal S, et al. Heart Rhythm. 2014;11:595-601. 21. Kolek MJ, et al. J Cardiovasc Electrophysiol. 2015;26:1111- 1116. 22. Shariff N, et al. J Cardiovasc Electrophysiol. 2015;26:783-789. 23. Henrikson CA, et al. JACC Clin Electrophysiol. 2017;3:1158- 1167. 24. Kolek MJ, et al. Pacing Clin Electrophysiol. 2013;36:354-361. *TYRX Absorbable Antibacterial Envelope, instructions for use. **Tarakji KG, et al. N Engl J Med. 2019;380:1895-1905. †Dr. Schloss was an investigator in the WRAP-IT Study, and Dr. Ellis is a consultant to Medtronic ††Sohail MR et al. Pacing Clin Electrophysiol. 2015;38(2):231-239 TYRX™ Absorbable Antibacterial Envelope The TYRX™ Absorbable Antibacterial Envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to provide a stable environment when implanted in the body. The TYRX Absorbable Antibacterial Envelope contains the antimicrobial agents minocycline and rifampin, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. The TYRX Absorbable Antibacterial Envelope is NOT indicated for use in patients who have an allergy or history of allergies to tetracyclines, rifampin, or absorbable sutures. The TYRX Absorbable Antibacterial Envelope is also NOT indicated for use in patients with contaminated or infected wounds, or Systemic Lupus Erythematosus (SLE). The use of this product in patients with compromised hepatic and renal function, or in the presence of hepatotoxic or renal toxic medications, should be considered carefully, because minocycline and rifampin can cause additional stress on the hepatic and renal systems. Patients who receive the TYRX Absorbable Antibacterial Envelope and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity.