Assessment of an Edge-to-Edge Mitral Valve Repair Clip and its Implantation

Transcription

1 b MEDICAL DEVICES ASSESSMENT DEPARTMENT Assessment of an Edge-to-Edge Mitral Valve Repair Clip and its Implantation Summary of the Technology Assessment report

2 This dossier can be downloaded at Haute Autorité de Santé Documentation and Public Information Department 2, avenue du Stade de France - F Saint-Denis La Plaine CEDEX Tel.: +33 (0) Fax: +33 (0) How to cite this report: Haute Autorité de Santé. Evaluation d un clip de réparation mitrale bord à bord et de son acte d implantation. Service d évaluation des dispositifs. Saint-Denis La Plaine : HAS ; 2015 Haute Autorité de Santé 2015

3 Assessment of an Edge-to-Edge Mitral Valve Repair Clip and its Implantation Table of Contents Contributors... 2 Summary

4 Contributors This dossier was produced by Elodie Velzenberger-Maquart (Project Manager, Medical Devices Assessment Department, tel.: , Secretarial duties were carried out by Fadila Chebili (Assistant, Medical Devices Assessment Department, tel.: , Managers Medical Devices Assessment Department: - Catherine Denis, Head of Department - Hubert Galmiche, Deputy Head of Department Surgical Procedures Assessment Department: - Michèle Morin-Surocca, Head of Department - Denis-Jean David, Deputy Head of Department 2

5 Summary Introduction and context Mitral insufficiency is the second-most common valve disease in Europe. It is a serious lifethreatening condition for patients. It is important to distinguish: primary (degenerative) mitral insufficiency caused by disease of the mitral valve. Valve failure is the main cause resulting secondly in left ventricular dysfunction. The standard treatment for this condition is valve repair surgery. secondary (functional) mitral insufficiency caused by a left ventricular dysfunction inducing ventricular remodelling with secondary impairment of valve function. The standard treatment of this aetiology is still management of the heart failure. The results of surgery are discussed. A randomised controlled trial called EVEREST II was conducted in order to compare the MITRACLIP device to conventional valve repair or replacement surgery in surgery-eligible patients with degenerative (primary) or functional (secondary) mitral valve disease. It has demonstrated the feasibility of MITRACLIP device implantation, along with the improvement in patient symptoms with an acceptable rate of complications. However, this study shows that this is achieved without reducing mitral valve insufficiency over time, unlike surgery, and with recurring surgical procedures due to mitral valve dysfunction. This study demonstrates that the MITRACLIP technique should not apply to all patients in general, but only to selected patients. Thus, many studies have been conducted in patients with a high surgical risk or a contraindication to mitral valve replacement or repair surgery. The National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) received an application dossier for inclusion on the List of products and services qualifying for reimbursement (LPPR) for the edge-to-edge mitral valve repair clip, MITRACLIP. Since its implantation had neither been assessed nor priced, a joint assessment of the medical device and its procedure was carried out. This work is part of a special procedure related to the high potential for improving the care of patients with mitral insufficiency. For these technologies, the ambition of the French National Authority for Health (Haute Autorité de santé, HAS) is to reduce assessment times as much as possible, while avoiding: overly early access to an insufficiently assessed technique, possibly resulting in excessive health and/or financial risks; delayed supply of the healthcare system when these technologies are vehicles of progress. Scope of the assessment The assessment focuses on the MITRACLIP device from Abbott Vascular and its implantation. Working method The general method adopted by HAS is based on the critical analysis of data from the literature, data submitted by the manufacturer, clinical practice guidelines, and technological assessments. 3

6 Data analysis Clinical data There are 10 studies including the EVEREST II HRR (High Risk Registry) study and 9 noncomparative cohort studies performed in patients at high surgical risk or with a contraindication to surgery (nearly 1,800 patients). In the treatment of patients at high surgical risk or who are inoperable (mean logistic EuroSCORE between 12 and 41%, STS score between 10 and 24%) with mitral insufficiency, several noncomparative observational studies demonstrate the feasibility of the technique which has no major, procedural, or short-term complication. The mortality rate observed at 1 year of follow-up was between 10 and 24%. These studies report improvements in mitral insufficiency, functional status, and the quality of life of patients in the short- to medium-term, but with persistence of residual regurgitation for 30% of patients, which can lead to re-hospitalisation or another surgery. The studies reflect real-life implantations, i.e., implantations of the MITRACLIP device for patients mainly with symptomatic mitral insufficiency of a functional origin, with a left ventricular ejection fraction between 35 and 45%. There are numerous missing data that may overestimate the effect of the treatment. The implanted patients have multiple aetiologies of mitral insufficiency with heterogeneous baseline characteristics and therapeutic strategies that are not identical. Control of parallel medical treatments that may have an impact on the mitral valve disease or heart failure is not indicated. Complications at 1 year of follow-up are not systematically described in the studies. Evidence is limited to small numbers and short follow-up periods. The efficacy cannot be assessed by type of mitral insufficiency, and the notion of a high surgical risk varies depending on the study (though the involvement of a multidisciplinary team for patient selection is systematic). The technique has a learning curve, but this is not considered in the studies. Overall, no good comparative data are available in the indications claimed for the application for reimbursement. Clinical practice guidelines The conclusions of the American and European guidelines for the treatment of valve diseases and heart failure are consensual regarding the benefit of the MITRACLIP device for the treatment of patients with symptomatic primary mitral insufficiency at high surgical risk and a reasonable life expectancy. These guidelines emphasise the need to carefully select patients by accurately analysing the anatomy of the mitral valve, which must be compatible with the implantation of the MITRACLIP device. As for the treatment of secondary mitral insufficiency, the guidelines are more mixed. The benefit of the device remains uncertain in view of the available clinical studies that focus on small cohorts. The European recommendations encourage the completion of larger-scale, comparative, randomised trials. Technological assessments Five technological assessments are available: NICE (United Kingdom, 2009), Ludwig Boltzmann Institut (Austria, 2012), National Health Committee (New Zealand, 2013), FDA (United States, 2013) and Medical Services Advisory Committee (Australia, 2014). These technological assessments are all based on the same clinical data, but the conclusions of the agencies differ. Of the five assessments authenticated: three do not recommend treatment with the MITRACLIP device based on the uncertainty of clinical benefit and safety of the technique, and its cost (LBI - Austria, NHC - New Zealand, MSAC - Australia); 4

7 two agencies recommend treatment with the MITRACLIP but with different indications. NICE proposes treatment with the technique for mitral insufficiency patients (regardless of their aetiology) eligible for mitral valve repair or replacement surgery. The FDA, meanwhile, recommends limiting treatment to only those patients with degenerative mitral insufficiency with a prohibitive surgical risk. Conclusion In the current state of knowledge, HAS recommends limiting implantations of the MITRACLIP device to patients with severe degenerative mitral insufficiency which is symptomatic despite optimal medical treatment, who are not eligible for valve replacement or repair surgery and who meet the echocardiographic eligibility criteria. HAS emphasises the validation of criteria and surgical contraindication by an ad hoc multidisciplinary team including at minimum an interventional cardiologist, a clinical cardiologist, an echocardiographer, a cardiovascular and thoracic surgeon, and an anaesthesiologist. Obtaining the opinion of geriatrician is highly recommended. Only patients with a life expectancy greater than 1 year should undergo the procedure. In this indication, HAS believes that there is no alternative and that the need is not covered. In this indication, the improvement in treatment is substantial in relation to the lack of alternatives. The population reached in this clinical situation is estimated at 1,350 patients per year in France. In the other indications (functional or mixed mitral insufficiency) and/or for lower surgical risks, the role of the MITRACLIP edge-to-edge mitral valve repair clip in the therapeutic strategy remains undetermined. This role needs to be assessed with trials comparing it to standard treatments. The treatment of functional mitral insufficiency is under clinical research in several national and international trials, and HAS encourages the inclusion of patients in these studies. Considering the difficulty of the technique for implanting an edge-to-edge mitral valve repair clip, the resulting learning curve, and the strict patient selection, HAS recommends that MITRACLIP implantation be supervised, pursuant to Article L of the French Public Health Code. Finally, HAS recommends the establishment of a registry, carried out with the participation of the involved healthcare professionals, to document, at minimum, in all patients who undergo implantation in France: death, repeat procedures due to mitral valve dysfunction, stage 3+/4+ mitral leak, and the evolution of heart failure. Follow-up should be carried out at 1 month, 1 year, then once per year for 3 years. Patient characteristics at inclusion should be recorded (type and severity of mitral insufficiency, NYHA classification, comorbidities, etc.). 5

8 All HAS publications can be downloaded at 6