Real-World Cost Effectiveness of Mitraclip combined with Medical Therapy Versus Medical therapy Alone in Patients With Moderate or Severe Mitral Regurgitation

Background We evaluated the real-world cost-effectiveness of the MitraClip system (Abbott Vascular Inc., Menlo Park, CA) plus medical therapy for patients with moderate/severe mitral regurgitation, as compared with medical therapy (MT) alone. Methods Clinical records of patients with moderate to severe functional mitral regurgitation treated with MitraClip (N = 232) or with MT (N = 151) were collected and outcome analyzed with propensity score adjustment to reduce selection bias. Twelve-month outcomes were modeled over a lifetime horizon to conduct a cost-effectiveness analysis, in the payer's perspective. Costs and benefits were discounted at an annual rate of 3.5%. Results After propensity score adjustment, the average treatment effect was - 9.5% probability of dying at 12 months and, following lifetime modeling, 3.35 ± 0.75 incremental life years and 3.01 ± 0.57 incremental quality-adjusted life years. MitraClip contributed to a higher decrease in re-hospitalizations at 12 months (difference = - 0.54 ± 0.08) and generated a more likely improvement in the New York Heart Association (NYHA) class at 12 months versus NYHA at enrollment. Incremental costs, adapted to five possible scenarios, ranged from 14,493 to 29,795 € contributing to an incremental cost-effectiveness ratio ranging from 4796 to 7908 €. Conclusions Compared to MT alone and given conventional threshold values, MitraClip can be considered a cost-effective procedure. The cost-effectiveness of MitraClip is in line or superior to the one of other non-pharmaceutical strategies for heart failure