Real-world cost effectiveness of MitraClip combined with Medical Therapy Versus Medical therapy alone in patients with moderate or severe mitral regurgitation
Introduction
The relative burden of mitral valve diseases is often underestimated [1]. Untreated mitral regurgitation (MR) may lead to deterioration of left ventricular function, poor prognosis and adverse clinical events. The advent of less invasive techniques is providing potential new opportunities for patients previously not treated or at high surgical risk [2]. MitraClip (Abbott Vascular Inc. Menlo Park, CA) has been launched into the market in 2008. Before and after its introduction, several international studies and trials have evaluated the effectiveness of the MitraClip procedure [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14]. In its early uptake, MitraClip has been used both for functional and degenerative MR [15]. A large European registry provided some evidence of MitraClip effectiveness, with relatively few events and low mortality rates in high-risk, elderly patients, mainly affected by functional MR [16].
Economic evaluations of medical devices pose several challenges [17], [18] that sometimes make randomized trials difficult and eventually unethical if there is sufficient agreement on a new treatment's higher effectiveness. Observational studies are recognized as a valuable source of evidence when evidence from randomized clinical trials is scarce, being capable of timely informing regional and national policies on one side and to support evidence-based technologies' adoption on the other side, with remarkable impacts on medical device companies [17]. At present, the most appropriate comparator to evaluate MitraClip cost-effectiveness in patients with MR and severe heart failure may not be the traditional surgical intervention, since most patients receiving the implant in contemporary practice would not be ideal surgical candidates.
On the background of the available evidence and to address the economic evaluation challenges in the treatment for MR, the present study aimed at assessing the cost-effectiveness of MitraClip combined with medical therapy versus medical therapy alone in patients with moderate/severe MR and severe heart failure. Secondary objectives were to identify the impact of MitraClip treatment on different dimensions of effectiveness (i.e., consumption of drugs and hospitalizations) and to compare relevant cost items across treatment groups in the payer's perspective.
Section snippets
Study datasets
This is a retrospective, nonrandomized, and observational study of patients with heart failure. We used data from 383 patients with heart failure and moderate/severe functional MR (232 consecutive patients treated with MitraClip plus medical therapy [MC group] treated between 2008 and 2012, and a control group of 151 randomly selected patients treated with medical therapy only [MT group] treated between 2007 and 2009, Table 1). Medical therapy was defined as the use of guideline-recommended
Baseline characteristics and medications
Table 1 reports baseline characteristics of the MC and MT groups before adjustment for potential confounders. Age and gender were distributed similarly in the two groups. NYHA at enrollment was significantly higher in the MC group while the number of hospitalizations in the previous year was lower. Other significant differences were the prevalence of previous revascularization, previous pacemaker implantation, dyslipidemia, and hypertension, all higher in the MC group, and creatinine at
Discussion
Technological innovation is evolving at a higher pace than economic growth. This represents a challenge for decision-makers who struggle between scarcity of resources and access to innovations. Cost-effectiveness analysis represents a viable approach to estimate the incremental benefit for the unit of cost thus advising resource allocation. Source of clinical evidence is more challenging for devices than for drugs with the first showing true effectiveness when already adopted in clinical
Conflict of interest
Davide Capodanno, Carmelo Grasso, Corrado Tamburino and Francesco Maisano report speakers' honoraria from Abbott Vascular. Aldo Pietro Maggioni is a member of the Executive Committee of a trial sponsored by Abbott Vascular. All the other authors have no conflict of interest to disclose.
Acknowledgments
The study was conducted thanks to an unrestricted grant from Abbott Vascular and developed at CERGAS Bocconi. The authors thank the two hospitals involved in the study, San Raffaele Hospital in Milan and Ferrarotto Hospital in Catania, and the Italian Association of Hospital Cardiologists (ANMCO), all clinicians and medical staff. They also thank Aureliano Paolo Finch for the relevant suggestions provided on statistical analysis methods.
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