Clinical outcomes and economic impact of transcatheter mitral leaflet repair in heart failure patients

Abstract

Background: Mitral regurgitation (MR) is a common valvular heart disorder requiring intervention once it becomes severe. Transcatheter mitral repair with the MitraClip device is a safe and effective therapy for selected patients denied surgery. The authors sought to evaluate the clinical outcomes and economic impact of this therapy compared to medical management in heart-failure patients with symptomatic mitral regurgitation.

Methods and results: The study was comprised of two phases; an observational study of patients with heart failure and mitral regurgitation treated with either medical therapy or the MitraClip, and an economic model. Results of the observational study were used to estimate parameters for the decision model, which estimated costs, and benefits in a hypothetical cohort of patients with heart failure and moderate-to-severe mitral regurgitation treated with either standard medical therapy or MitraClip. The cohort of patients treated with the MitraClip was propensity matched to a population of heart failure patients, and their outcomes compared. At a mean follow-up of 22 months, all-cause mortality was 21% in the MitraClip cohort and 42% in the medical management cohort (p = .007). The decision model demonstrated that MitraClip increased life expectancy from 1.87–3.60 years and quality-adjusted life years (QALY) from 1.13–2.76 years. The incremental cost was $52,500 Canadian dollars, corresponding to an incremental cost-effectiveness ratio (ICER) of $32,300.00 per QALY gained. Results were sensitive to the survival benefit.

Conclusion: In heart failure patients with symptomatic moderate–severe mitral regurgitation, therapy with the MitraClip is associated with superior survival and is cost-effective compared to medical therapy.

Keywords:

• Mitral regurgitation
• Heart failure
• Transcatheter mitral repair
• Cost-effectiveness

Transparency

Declaration of funding

This work was supported by a grant from the Montreal Heart Institute Foundation.

Declaration of financial/other interests

AA, AD, and RB are on the speaker’s bureau for Abbott Vascular. AA, RB, and DC are consultants for Medtronic Vascular and Edwards LifeSciences. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors would like to acknowledge the work and collaboration of Heather Cameron, Lisa Bernard, and Daniel Grima to the model design, model review, and preparation of this manuscript. We would also like to acknowledge the work of Charaf-Eddine Ahnadi for his assistance with the Heart Failure Clinic database.

Previous presentation

This was presented at the ISPOR annual meeting in Montreal, QC, Canada, 2014.