Landmark WRAP-IT Study reveals significant reduction in CIED infections with the TYRX™ Envelope

As 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 favorable. When we used the TYRX Envelope, infection rates decreased, so that was gratifying. The WRAP-IT Study has realworld clinical applications."

The TYRX™ Envelope is constructed from an absorbable multifilament knitted mesh substrate. It provides a stable environment to hold CIEDs when implanted in the body15,16 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

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."

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

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