Economic analyses from the WRAP-IT study, sponsored by Medtronic, demonstrate the Tyrx cardiac absorbable antibacterial envelope’s (Tyrx Envelope) cost effectiveness in European markets for patients at increased risk of infections.
This follows the publication of a study in Heart Rhythm last month demonstrating a significantly lower infection risk for patients who develop haematomas after cardiac implantable electronic devices (CIEDs) when the Tyrx Envelope is used at implant.
The present analysis, recently published in the journal Value in Health, assessed the economic value of the Tyrx Cardiac Envelope when added to standard-of-care infection prevention strategies for patients receiving cardiovascular implantable electronic devices (CIEDs) in the healthcare systems of England, Germany and Italy, echoing data showing cost effectiveness of the TYRX Envelope in the US healthcare system.
WRAP-IT (Worldwide randomised antibiotic envelope infection trial) is the largest, randomised global CIED trial, enrolling 6,983 patients across 25 countries who were at elevated risk for CIED infection.
Primary results published in The New England Journal of Medicine demonstrated the Tyrx Envelope reduced the risk of major infection by 40% in patients with CIEDs and reduced pocket infections by 61% when used as adjunctive therapy in addition to standard-of-care infection-prevention strategies.
The study population included patients receiving an initial cardiac resynchronisation therapy defibrillator (CRT-D); and patients receiving a replacement, system revision or generator upgrade of an existing pacemaker, cardiac resynchronisation therapy-pacemaker (CRT-P), implantable cardioverter defibrillator (ICD) or CRT-D. Patients with diabetes, previous history of infection, renal failure, and/or congestive heart failure also are at higher risk for CIED infections.
Cost-effectiveness analyses are tools to indicate which interventions provide good value for money. This pre-specified analysis of the global WRAP-IT study compared costs and health outcomes between patients who received the Tyrx cardiac envelope and those who did not. The analyses adopted the perspectives and costs of the German health system, the Italian NHS, and the English NHS and personal social services, and only considered direct costs related to the health and social care systems. The Tyrx cardiac envelope was associated with cost-effectiveness ratios below European thresholds in selected patients at increased risk of infection, demonstrating the envelope provides value for European healthcare systems by reducing CIED infections.
The cost-effectiveness thresholds for each country used for this analysis, per quality adjusted life year (QALY) gained, were: England, £30,000; Germany, €50,000, and; Italy, €40,000.
“We are committed to identifying and creating cost-effective innovations that add value by reducing readmission rates, lowering infection risk, and decreasing hospitalisations,” said Rob Kowal, chief medical officer of the Cardiac Rhythm Management business, which is reported as part of the Cardiac and Vascular Group at Medtronic. “The Tyrx Envelope is another example of our unique, cost-effective solutions that drive greater value for patients and the overall healthcare system.”
In another important development, the TYRX Envelope recently has been approved for reimbursement in France when used in patients receiving CIED generator replacement, system revision or upgrade procedures, and initial CRT-D implantation, aligned with the patient population studied in the WRAP-IT trial.
The TYRX Envelope is an absorbable single-use device that holds a cardiac implantable electronic device or implanted neurostimulator. It is designed to stabilise the device after implantation while releasing antimicrobial agents, minocycline and rifampin, over a minimum of seven days. Constructed from a multifilament, knitted absorbable mesh, the envelope is fully absorbed by the body approximately nine weeks after implantation. The device has a one-year shelf life in Europe, the USA, Canada, Australia and New Zealand.