Abstract
PurposeTwo randomized controlled trials (RCTs), Mitra-Fr and Coapt, evaluating the benefit of percutaneous repair (PR) for heart failure (HF) patients with severe mitral regurgitation, have led to conflicting results. We aimed to evaluate the impact of these trial results on the cost-effectiveness of PR using effectiveness inputs from the two RCTs.MethodsWe developed a time varying Markov type model with three mutually exclusive health states: alive without HF hospitalisation, alive with HF hospitalisation, and dead. Clinically plausible extrapolations beyond observed data were obtained by developing parametric modelling for overall survival and HF hospitalisations using published data from each trial. We adopted the perspective of the French Health System and used a 30-year time horizon. Results were expressed as € / quality-adjusted life year (QALY) gained using utility inputs from literature.FindingsResults are presented using treatment efficacy measures from Mitra-F and Coapt trials respectively. With the Mitra-Fr data, after annual discounting, the base case model generated an incremental 0.00387 QALY at a cost of €25,010, yielding an incremental cost effectiveness ratio (ICER) of €6,467,032 / QALY. The model was sensitive to changes made to model inputs. There was no potential of PR being cost-effective.With the Coapt data, the model generated 1.19 QALY gain at a cost of €26,130 yielding an ICER of €21,918 / QALY and at a threshold of >€50,000/QALY PR had a probability of 1 of being cost-effective.ImplicationsCost effectiveness results were conflicting; reconciling differences between trials is a priority and could promote optimal cost effectiveness analyses and resource allocation.
Highlights
Percutaneous repair (PR) with the Mitraclip system is a breakthrough technology which was developed to improve clinical outcomes in patients with severe mitral regurgitation (MR) [1]. the expansion of percutaneous repair (PR) has not followed the exponential growth seen with transcatheter aortic valve implantation (TAVI) [2], it is increasingly used and the cap of 100,000 Mitraclip implantations worldwide was reached late September 2019 [3].While the first randomised controlled trial (RCT) evaluating this medical device mainly enrolled patients with primary MR [4], there has been a shift over time in the indications to patients with secondary MR [5, 6]
Employing the utility values for health states, base case discounted total quality-adjusted life year (QALY) were almost identical for intervention and the control group resulting in a discounted incremental gain of only 0.00387 QALY
Total discounted costs were €34,319 and €9,309 for PR+guideline-directed medical treatment (GDMT) and GDMT groups respectively, providing an incremental difference between the two strategies of €25,010. These results provided a base case discounted incremental cost effectiveness ratio (ICER) of €6,467,032 / QALY gained
Summary
While the first randomised controlled trial (RCT) evaluating this medical device mainly enrolled patients with primary MR [4], there has been a shift over time in the indications to patients with secondary MR [5, 6] This trend was in contrast to the level of evidence supporting the clinical benefit of percutaneous repair (PR), which was low (class IIb, level C) in the absence of head-to head comparison evaluating efficacy in symptomatic heart failure (HF) patients with severe secondary MR [7]. Such approach could be relevant to explore if a potential trend towards favourable results on HF hospitalisations could have some impact in terms of reducing costs and/or improving quality of life
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
