Antibacterial envelope for cardiac implantable devices cost-effective in most subgroups
Prevention of infection by wrapping cardiac implantable devices in a bioabsorbable antibiotic-eluting envelope plus standard prevention measures was cost-effective compared with standard care alone, researchers reported.
This analysis of the WRAP-IT trial demonstrated that use of an antibacterial envelope (Tyrx, Medtronic) in addition to standard infection prevention was associated with a cost-effectiveness ratio below that of the upper willingness-to-pay threshold of $150,000 per quality-adjusted life-year, a figure supported by American College of Cardiology/American Heart Association guidelines.
As Healio previously reported, in the main results of WRAP-IT presented at the 2019 ACC Scientific Session, the use of a bioabsorbable antibacterial envelope combined with standard care reduced risk for device-related infections by approximately 40%.
In addition, On Sept. 22, the company announced that its Tyrx antibiotic-eluting product, when produced as a driveline wrap, is designed to securely hold a percutaneous driveline in patients undergoing ventricular assist device implantation, and received breakthrough device designation by the FDA.
“The primary endpoint of the WRAP-IT study showed reduced total infections of 40% and 60% reduction in pocket infections, over 12 months,” Bruce L. Wilkoff, MD, FACC, FHRS, FAHA, director of cardiac pacing and tachyarrhythmia devices and a staff cardiologist in the Robert and Suzanne Tomsich department of cardiovascular medicine, section of cardiac pacemakers and electrophysiology at Cleveland Clinic, professor of medicine at Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and Cardiology Today Editorial Board Member, told Healio. “We had an effective therapy. The disease we were trying to treat killed people and cost a lot of money, so the question was, is it worth the cost? The implications of this study were that it was not only effective, but it was cost-effective and worth the investment.
“The patients who had multiple device changes over the years, who had renal insufficiency or immunosuppression are the patients for whom this was most cost-effective,” Wilkoff told Healio. “In these patients with replacements and upgrades, particularly those with renal dysfunction or immunosuppression, for some it was actually cost-saving to use the antibacterial envelope, whereas for others, it was just cost-attractive. We used a willingness-to-pay threshold supported by the ACC/AHA guidelines of $150,000 per QALY, but for some of these subgroups, the cost was less than $50,000.”
For this analysis, published in Circulation: Arrhythmia and Electrophysiology, investigators utilized a decision tree model to evaluate the cost-effectiveness of antibacterial envelope use plus standard care, compared with standard care alone. Patients included in this analysis underwent procedures such as cardiac implantable electronic device (CIED) revision, replacement, upgrade or initial cardiac resynchronization therapy defibrillator implantation.
Antibacterial envelope cost-effectiveness
Researchers observed that the incremental cost-effectiveness ratio of an antibacterial envelope plus standard care was $112,603 per QALY vs. standard care alone.
“We had observational data before, but now with the primary endpoint of the large, randomized trial saying that it worked, and now that it’s cost-efficient in the U.S. health care system, yes, it absolutely should be employed, particularly among high-risk subgroups,” Wilkoff said in an interview.
Subgroups analysis
In an analysis of antibacterial envelope cost-effectiveness among various subgroups, investigators found that the device was:
- dominant in patients with prior CIED infection;
- high-value in patients who are immunocompromised ($312 per QALY);
- high-value in patients with at least two procedures involving ICD or CRT-D ($32,396 per QALY);
- high-value in patients who underwent revision or upgrade of a pacemaker or CRT pacemaker ($32,396 per QALY);
- intermediate-value in patients with a history of renal dysfunction ($65,422 per QALY);
- intermediate-value in patients who underwent revision or upgrade of ICD or CRT-D ($80,520 per QALY);
- intermediate-value in patients with at least two prior procedures involving a pacemaker or CRT pacemaker ($127,186 per QALY);
- intermediate-value in patients with one prior procedure involving ICD or CRT-D ($144,686 per QALYS);
- less economically attractive in patients with one prior procedure involving a pacemaker or CRT pacemaker ($166,074 per QALY); and
- less economically attractive in patients with de novo implantation of a CRT-D ($337,184 per QALY)
“We have additional analyses that look at the European cost-effectiveness. We are finding that it likely is to be cost-efficient in at least some of the environments in Europe, but each one is unto itself,” Wilkoff told Healio. “We’re also looking at the risk factors for infection so that we can learn how to avoid them.
“Infections are such a horrific complication, with reducing both quality of life and survival, that it’s important we not only use the envelope, but we find out how else we can reduce infections,” Wilkoff said in an interview. “Should we be cleaning out the capsule of the scar tissue at the time? What can we do to reduce hematomas, which is a high risk for infection situation? All these factors, particularly anticoagulation and antiplatelet use during this period will be coming out. In terms of a randomized trial, this is the definitive study showing the effectiveness of an antibacterial envelop during device implantation.”
For more information:
Bruce L. Wilkoff, MD, FACC, FHRS, FAHA, can be reached at wilkofb@ccf.org.
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