Abstract
ObjectivesTo model the cost-effectiveness of the TYRX Absorbable Antibacterial Envelope when used in patients at increased risk of cardiac implantable electronic device (CIED) infection in the context of 3 European healthcare systems: Germany, Italy, and England. MethodsA decision tree model with a lifetime horizon was populated using data from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial, a large multicenter randomized controlled trial. Use of the antibacterial envelope adjunctive to standard of care was compared to standard of care infection prevention alone. Patients in the model were divided into subgroups based on presence of factors known to increase infection risk. ResultsThe antibacterial envelope had the most favorable cost-effectiveness profile when patients had previously experienced CIED infection, had a history of immunosuppressive therapy, or had a Prevention of Arrhythmia Device Infection Trial (PADIT) score indicating high risk of infection (scores ≥6) at cost-effectiveness thresholds of €50 000 in Germany (assumed in the absence of an official threshold), €40 000 in Italy, and £30 000 in England. Probabilistic sensitivity analysis indicated that the antibacterial envelope was likely to be cost-effective in patients with other risk factors (including replacement of high power CIEDs, generator replacement with lead modification, and PADIT scores indicating intermediate risk of infection) when used with some device types and in some countries. ConclusionsThe absorbable antibacterial envelope was associated with cost-effectiveness ratios below European benchmarks in selected patients at increased risk of infection, suggesting the envelope provides value for European healthcare systems by reducing CIED infections.
Highlights
Cardiac implantable electronic devices (CIED) include pacemakers, implantable cardioverter-defibrillators, and devices for cardiac resynchronization therapy, and they are established treatments for a variety of cardiac arrhythmias.[1]
Infection is a serious complication of CIED implantation that is difficult to diagnose and treat, and these events are associated with prolonged hospital stays, substantial morbidity, and death.[2,3]
Incremental cost-effectiveness ratios (ICERs) for patients with Prevention of Arrhythmia Device Infection Trial (PADIT) scores $6 were below the cost-effectiveness thresholds used in the respective countries
Summary
Cardiac implantable electronic devices (CIED) include pacemakers, implantable cardioverter-defibrillators, and devices for cardiac resynchronization therapy, and they are established treatments for a variety of cardiac arrhythmias.[1]. Costs associated with hospital treatment, device extraction, and subsequent implantation of a new CIED have been estimated at V21 760-V70 329 in various European countries.[5,6,7,8,9,10,11]
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