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Off-pump minimal access mitral valve repair by artificial chordae insertion can be used in the NHS during the evidence generation period, as an option to treat mitral regurgitation caused by mitral valve leaflet prolapse in adults when open-heart surgery and other mitral valve repair procedures are unsuitable. There must be enhanced informed consent and auditing of outcomes.
More research is needed on off-pump minimal access mitral valve repair by artificial chordae insertion to treat mitral regurgitation caused by mitral valve leaflet prolapse in adults when open-heart surgery or other mitral valve repair procedures are suitable, before it can be used in the NHS.
This procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.
What this means in practice
When open-heart surgery and other mitral valve repair procedures are unsuitable
There are uncertainties around the safety and efficacy of this procedure. It can be used for this group, if needed, while more evidence is generated.
After this, this guidance will be reviewed and the recommendations may change.
Healthcare professionals do not have to offer this procedure and should always discuss the available options with the person with mitral regurgitation before a joint decision is made.
Hospital trusts will have their own policies on funding procedures and monitoring results. NHS England may also have policies on funding of procedures.
Enhanced informed consent
Because there are uncertainties about whether this procedure is safe and efficacious, there must be an emphasis on informed consent. Healthcare professionals must make sure that people (and their families and carers as appropriate) understand the uncertainty and lack of evidence around a procedure's safety and efficacy using NICE's advice on shared decision making and NICE's information for the public. Healthcare professionals must also inform the clinical governance leads in their organisation if they want to do the procedure.
When open-heart surgery or other mitral valve repair procedures are suitable
There is not enough evidence on the safety and efficacy of this procedure. Off-pump minimal access mitral valve repair by artificial chordae insertion should only be done as part of formal research in this group.
For everyone having the procedure
Auditing of outcomes
Healthcare professionals doing this procedure should collect data on safety and outcomes of the procedure. Enter details about everyone having this procedure into the National Institute for Cardiovascular Outcomes Research (NICOR) Transcatheter Mitral and Tricuspid Valve procedure registry. Regularly review the data on outcomes and safety.
Who should be involved with the procedure
Patient selection should be done by a multidisciplinary team including cardiac surgeons, cardiologists and cardiac anaesthetists with experience in this procedure.
This procedure should only be done by a cardiac surgeon with experience in mitral valve surgery and with expert 2D and 3D transoesophageal echocardiography support.
This procedure should only be done in cardiac surgery centres experienced in minimal access valve surgery with transoesophageal echocardiography. Centres should follow any proctoring requirements associated with the device used.
More research, ideally in the form of randomised controlled trials in people with mitral regurgitation caused by mitral valve leaflet prolapse, is needed. Healthcare professionals must collect data specifically around the safety and efficacy of this procedure.
This includes:
patient selection, including:
mitral valve prolapse anatomy
criteria to assess procedure suitability
adverse events
patient-reported outcomes
quality of life outcomes
survival
longer-term outcomes.
There is a lack of high-quality evidence on the efficacy and safety of this procedure. The available clinical evidence comes mainly from short-term, small observational studies or registries that are not based in the UK. This evidence shows that there are well-recognised safety concerns but suggests that the procedure can reduce mitral regurgitation and associated symptoms.
There are limited options for treating mitral regurgitation caused by mitral valve prolapse when open-heart surgery and other mitral valve repair procedures are unsuitable. This procedure may have potential benefits for people when there are no alternative treatments, so it can be used with evidence generation in this group.
For some people, open-heart surgery or other mitral valve repair procedures may be suitable. For these people, it is unclear whether the benefits of this procedure outweigh the risks. Therefore, this procedure should only be done within formal research in this group.
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