Evidence on the safety of transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis is adequate and shows some serious but well‑recognised complications. Evidence on its efficacy is limited in quality. So, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
Clinicians wishing to do transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis should:
Inform the clinical governance leads in their healthcare organisation.
Give patients (and their families and carers, as appropriate) clear written information to support shared decision making, including NICE's information for the public.
Ensure that patients have been told and understand about all alternative treatment options and their advantages and disadvantages.
Enter details about all patients having transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis onto a national registry when 1 is available.
Audit and review clinical outcomes of all patients having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedures outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for every patient having this procedure.
Regularly review data on outcomes and safety for this procedure.
Patient selection should be done by a multidisciplinary team which must include interventional cardiologists experienced in the procedure, cardiac surgeons, an expert in cardiac imaging, and where appropriate, a cardiac anaesthetist and a specialist in medicine for older people. The multidisciplinary team should determine the risk level for each patient and the device most suitable for them.
The procedure is technically challenging and should only be done in specialised centres, and only by clinical teams with special training and experience in complex endovascular cardiac interventions, including regular experience in transcatheter valve implantation procedures. Centres doing these procedures should have cardiac surgical support for emergency treatment of complications and subsequent patient care.
Report any problems with a medical device using the Medicines and Healthcare products Regulatory Agency's Yellow Card Scheme.
NICE encourages further research into transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis. Studies should include details on patient selection, type and size of valve used, functional outcomes (New York Heart Association functional class, mitral valve regurgitation), quality of life, patient‑reported outcome measures, survival and complications. Studies should report long‑term follow up of clinical outcomes and valve durability. NICE may update this guidance on publication of further evidence.