A Canadian cost-effectiveness analysis of transcatheter mitral valve repair with the MitraClip system in high surgical risk patients with significant mitral regurgitation

Abstract

Objective:

In patients with significant mitral regurgitation (MR) at high risk of mortality and morbidity from mitral valve surgery, transcatheter mitral valve repair with the MitraClip System is associated with a reduction in MR and improved quality-of-life and functional status compared with baseline. The objective was to evaluate the cost-effectiveness of MitraClip therapy compared with standard of care in patients with significant MR at high risk for mitral valve surgery from a Canadian payer perspective.

Methods:

A decision analytic model was developed to estimate the lifetime costs, life years, quality-adjusted life years (QALYs), and incremental cost per life year and QALY gained for patients receiving MitraClip therapy compared with standard of care. Treatment-specific overall survival, risk of clinical events, quality-of-life, and resource utilization were obtained from the Endovascular Valve Edge-to-Edge REpair High Risk Study (EVEREST II HRS). Health utility and unit costs (CAD $2013) were taken from the published literature. Sensitivity analyses were conducted to explore the impact of alternative assumptions and parameter uncertainty on results.

Results:

The base case incremental cost per QALY gained was $23,433. Results were most sensitive to alternative assumptions regarding overall survival, time horizon, and risk of hospitalization for congestive heart failure (CHF). Probabilistic sensitivity analysis showed MitraClip therapy to have a 92% chance of being cost-effective compared with standard of care at a willingness-to-pay threshold of $50,000 per QALY gained.

Study limitations:

Key limitations include the small number of patients included in the EVEREST II HRS which informed the analysis, the limited data available to inform clinical events and disease progression in the concurrent comparator group, and the lack of a comparator group from a randomized control trial.

Conclusion:

MitraClip therapy is likely a cost-effective option for the treatment of patients at high risk for mitral valve surgery with significant MR.

Keywords::

• Cost-effectiveness analysis
• Cost-utility analysis
• MitraClip
• Mitral regurgitation
• Transcatheter mitral valve repair
• Mitral valve repair
• Mitral valve replacement

Transparency

Declaration of funding

The work reported in this manuscript was funded via a consultancy agreement between Cornerstone Research Group, Inc. and Abbott Vascular.

Declaration of financial/other relationships

HLC and LMB disclose that they are consultants commissioned by Abbott Vascular to perform this study. JH and VG disclose that they are employees of Abbott Vascular. AA has received speakers honoraria from Abbott Vascular. The final manuscript has been read and approved by all authors. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.