1 Recommendations

1 Recommendations

These recommendations apply only to patients for whom open surgical valve implantation is unsuitable.

1.1 The current evidence on the safety of transapical transcatheter mitral valve‑in‑valve implantation for a failed surgically implanted mitral valve bioprosthesis shows the potential for serious complications. However, this is in patients for whom open surgical valve implantation is unsuitable, who have severe symptoms and a high risk of death. The evidence on efficacy shows generally good symptom relief in the short term, but is based on very small numbers of patients. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2 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 NHS trusts.

  • Ensure that patients understand the uncertainty about the procedure's safety and efficacy in the long term, and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.

  • Enter details about all patients having transapical transcatheter mitral valve‑in‑valve implantation for a failed surgically implanted mitral valve bioprosthesis onto the National Institute for Cardiovascular Outcomes Research database (NICOR) and review local clinical outcomes.

1.3 Patient selection should be done by a multidisciplinary team including interventional cardiologists, cardiac surgeons, a cardiac anaesthetist and an expert in cardiac imaging. The multidisciplinary team should determine the risk level for each patient and review their suitability for alternative medical or surgical treatments.

1.4 Transapical transcatheter mitral valve‑in‑valve implantation for a failed surgically implanted mitral valve bioprosthesis should only be done by clinicians and teams with special training and experience in complex endovascular cardiac interventions, including regular experience in transcatheter valve implantation procedures. Units doing these procedures should have both cardiac and vascular surgical support for emergency treatment of complications.

1.5 NICE encourages further research into transapical transcatheter mitral valve‑in‑valve implantation for a failed surgically implanted mitral valve bioprosthesis. This may include prospective observational studies. Studies should include details on patient selection, functional outcomes, quality of life, 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.

  • National Institute for Health and Care Excellence (NICE)