Abstract
BackgroundTo determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT).MethodsCost-utility analysis using a combination of a decision tree and Markov process was performed. The clinical effectiveness was determined based on the results of the Transcatheter Implantation of Carillon Mitral Annuloplasty Device (TITAN) trial. The mean age of the target population was 62 years, 77 % of the patients were males, 64 % of the patients had severe FMR and all patients had New York Heart Association functional class III. The epidemiological, cost and utility data were derived from the literature. The analysis was performed from the German statutory health insurance perspective over 10-year time horizon.ResultsOver 10 years, the total cost was €36,785 in the PMVR arm and €18,944 in the OMT arm. However, PMVR provided additional benefits to patients with an 1.15 incremental quality-adjusted life years (QALY) and an 1.41 incremental life years. The percutaneous procedure was cost-effective in comparison to OMT with an incremental cost-effectiveness ratio of €15,533/QALY. Results were robust in the deterministic sensitivity analysis. In the probabilistic sensitivity analysis with a willingness-to-pay threshold of €35,000/QALY, PMVR had a 84 % probability of being cost-effective.ConclusionsPercutaneous mitral valve repair may be cost-effective in inoperable patients with FMR due to heart failure.
Highlights
To determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT)
The current clinical evidence for CE-marked Carillon® Mitral Contour System® is based on the single arm AMADEUS [12] and the non-randomized controlled Transcatheter Implantation of Carillon Mitral Annuloplasty Device (TITAN) [13] trials, which makes it possible to perform an early economic evaluation to inform decision-making about the cost-effectiveness of PMVR and ensure the timely access of patients to this treatment option
Percutaneous mitral valve repair, provided a significant benefit to the patients compared with the optimal medical treatment (1.15 incremental quality-adjusted life years (QALY) and 1.41 incremental life years)
Summary
To determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT). FMR can lead to increased mortality, reduced functional capacity and increased healthcare cost, only a few targeted treatments, The Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) is a novel percutaneous coronary sinus-based mitral annuloplasty device designed to treat FMR. This approach has been shown to significantly reduce FMR, improve functional capacity and quality of life as well as induce reverse left ventricular remodeling [12,13,14]. The current clinical evidence for CE-marked Carillon® Mitral Contour System® is based on the single arm AMADEUS [12] and the non-randomized controlled Transcatheter Implantation of Carillon Mitral Annuloplasty Device (TITAN) [13] trials, which makes it possible to perform an early economic evaluation to inform decision-making about the cost-effectiveness of PMVR and ensure the timely access of patients to this treatment option
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