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Commissioning Policy: Percutaneous Mitral Valve Leaflet Repair for Primary Degenerative Mitral Regurgitation in Adults

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Commissioning Policy: Percutaneous Mitral Valve Leaflet Repair for Primary Degenerative Mitral Regurgitation in Adults Clinical Commissioning Policy: Percutaneous mitral valve leaflet repair for primary degenerative mitral regurgitation in adults NHS England Reference: 170128P Standard Operating Procedure: Clinical Commissioning Policy: Percutaneous mitral valve leaflet repair for primary degenerative mitral regurgitation in adults First published: July 2019 Prepared by NHS England Specialised Services Clinical Reference Group for Cardiac Services Publishing Approval Reference: 000826 Published by NHS England, in electronic format only. Contents Policy Statement ..................................................................................................... 4 Equality Statement .................................................................................................. 4 Plain Language Summary ...................................................................................... 5 1 Introduction ......................................................................................................... 7 2 Definitions ........................................................................................................... 8 3 Aims and Objectives ........................................................................................... 9 4 Epidemiology and Needs Assessment ................................................................ 9 5 Evidence Base .................................................................................................. 11 6 Criteria for Commissioning ................................................................................ 17 7 Patient Pathway ................................................................................................ 19 8 Governance Arrangements ............................................................................... 20 9 Mechanism for Funding ..................................................................................... 21 10 Audit Requirements ........................................................................................... 21 11 Documents which have informed this Policy ..................................................... 22 12 Date of Review .................................................................................................. 22 References ............................................................................................................... 23 Policy Statement NHS England will commission Percutaneous mitral valve leaflet repair for primary degenerative mitral regurgitation in adults in accordance with the criteria outlined in this document. In creating this policy NHS England has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population in England. Our policies provide access on the basis that the prices of therapies will be at or below the prices and commercial terms submitted for consideration at the time evaluated. NHS England reserves the right to review policies where the supplier of an intervention is no longer willing to supply the treatment to the NHS at or below this price and to review policies where the supplier is unable or unwilling to match price reductions in alternative therapies. Equality Statement Promoting equality and addressing health inequalities are at the heart of NHS England’s values. Throughout the development of the policies and processes cited in this document, we have: • Given due regard to the need to eliminate discrimination, harassment and victimisation, to advance equality of opportunity, and to foster good relations between people who share a relevant protected characteristic (as cited under the Equality Act 2010) and those who do not share it; and • Given regard to the need to reduce inequalities between patients in access to, and outcomes from healthcare services and to ensure services are provided in an integrated way where this might reduce health inequalities Plain Language Summary About Percutaneous mitral valve edge-to-edge leaflet repair for primary degenerative mitral regurgitation in adults The heart contains four valves which ensure the proper flow of blood through the heart. The mitral valve is on the left side of the heart and ensures the forward flow of blood into the left ventricle). The left ventricle is the main pumping chamber of the heart. The valve has two leaflets (or flaps of tissue) that open and close to ensure blood travels in one direction into the left ventricle. Sometimes the valve does not close properly resulting in blood leaking back (regurgitating) into the left upper chamber (left atrium). If the volume of blood leaking backwards is large, the heart works harder to effectively pump blood through the body. Symptoms caused by the heart having to work harder are shortness of breath and fatigue and over time this will lead to fluid retention due to heart failure. This impacts on quality of life and makes daily activities harder. The cause of mitral regurgitation is broadly divided into degenerative (or ‘primary mitral regurgitation’ where the valve itself is structurally abnormal) and functional (or ‘secondary mitral regurgitation’ where the valve is structurally normal, but another condition affects the structure and/or function of the heart so that the valve cannot close properly). This policy focusses on adults with primary degenerative mitral regurgitation (DMR). About current treatments The current standard of care in adults is mitral valve repair or replacement surgery. Some adults however will not be able to undergo surgery because of the risk caused by other health conditions. These patients end up being treated with medication to try and control symptoms, but medical therapy cannot alter the underlying valve disease process. About the new treatment Mitral valve repair can now be undertaken without the need for open heart surgery. A less invasive procedure to repair the valve leaflets involves inserting a large flexible tube or catheter into a large vein in the groin which leads to the right side of the heart. This tube is passed to the left upper chamber of the heart (left atrium) and the valve leaflet repair device is advanced through this tube. The device is then advanced down to the mitral valve and positioned at the areas that are leaking. The device such as a clip brings the leaking portions of the two leaflets of the valve together so that the blood leaking back from the lower chamber (left ventricle) into the upper chamber (left atrium) of the heart is reduced. The device replicates an accepted surgical repair technique called an “edge-to-edge leaflet repair” to improve the valve function and in selected patients this procedure can reduce the symptoms due to severe mitral regurgitation and can improve quality of life. What we have decided NHS England has carefully reviewed the evidence to treat primary, degenerative mitral regurgitation with percutaneous mitral valve edge-to-edge leaflet repair in adults. We have concluded that there is enough evidence to make the treatment available to patients who meet the criteria described in this policy. 1 Introduction Primary or degenerative mitral regurgitation (DMR) describes pathology causing structural abnormality of the valve. In adults whilst there may be an indication for mitral valve surgery in the presence of symptomatic, severe DMR, a significant proportion of patients do not undergo surgery due to advanced age, frailty and co- morbidities. These adults have an increased risk of complications, prolonged intensive care unit stay and mortality which may make a surgical option high risk or inappropriate. Progressive worsening mitral regurgitation however risks decline into a heart failure syndrome whereby the left ventricle struggles to maintain its function. The percutaneous mitral valve edge-to-edge leaflet repair system offers an alternative approach to treating adults with DMR who may be inoperable or at high surgical risk but would benefit from intervention. Percutaneous mitral valve edge-to-edge leaflet repair is a minimally invasive procedure for the treatment of leaking of the mitral valve known as mitral regurgitation (MR). It is performed in the cardiac catheterisation laboratory/hybrid theatre under general anaesthesia with trans-oesophageal echocardiography (ultrasound imaging by placing a specialised probe in the oesophagus) and X-ray guidance. The percutaneous leaflet repair system is based on a surgical technique described as the "Alfieri stitch" but instead of a stitch, a device (for example a clip) is attached to the mitral valve leaflets to reduce retrograde blood flow through the valve. Vascular access is via the femoral vein which leads to the right atrium and trans-septal puncture is performed to access the left atrium and place a guide catheter. The device is delivered via this guide catheter within a delivery system. The device can be manoeuvred in the left atrium to approach the mitral valve. For example, in the case of the MitraClip device specifically, the arms of the clip open, the MitraClip is passed below the valve and then pulled back to grasp and bring together the segments of the two valve leaflets responsible for the leak. The reduction in MR is assessed and if necessary, the
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