1 Recommendations

1 Recommendations

1.1 For patients with aortic bioprosthetic valve dysfunction for whom surgical aortic valve replacement (SAVR) is considered to be unsuitable (see section 1.6), the evidence on the safety and efficacy of valve-in-valve transcatheter aortic valve implantation (ViV‑TAVI) is adequate. For these patients, ViV‑TAVI may be used with normal arrangements for clinical governance, consent and audit. Details of all patients should be entered into the UK Central Cardiac Audit Database.

1.2 For patients with aortic bioprosthetic valve dysfunction for whom surgical aortic valve replacement (SAVR) is considered to be suitable but to pose a high risk (see sections 1.4, 1.5 and 1.6), the evidence on the safety and efficacy of valve-in-valve transcatheter aortic valve implantation (ViV‑TAVI) is inadequate. For these patients, ViV‑TAVI should only be used with special arrangements for clinical governance, consent and data collection or research. Details of all patients should be entered into the UK Central Cardiac Audit Database.

1.3 For patients with aortic bioprosthetic valve dysfunction for whom surgical aortic valve replacement (SAVR) is considered to be suitable and not to pose a high risk (see sections 1.5 and 1.6), the evidence on the safety and efficacy of valve-in-valve transcatheter aortic valve implantation (ViV‑TAVI) is inadequate. For these patients, ViV‑TAVI should only be used in the context of research. In addition, details of all patients should be entered into the UK Central Cardiac Audit Database.

1.4 Clinicians wishing to carry out valve-in-valve transcatheter aortic valve implantation (ViV‑TAVI) for patients with aortic bioprosthetic dysfunction for whom surgical aortic valve replacement (SAVR) is considered to be suitable but to pose a high risk (see section 1.2) should take the following actions:

Inform the clinical governance leads in their NHS trusts.

  • Ensure that patients understand the risk of death, and the uncertainty about the procedure's efficacy in the long term.

  • Provide them with clear written information.

In addition, the use of NICE's information for the public is recommended.

Patient selection should be carried out 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.

1.5 Valve-in-valve transcatheter aortic valve implantation (ViV‑TAVI) is a technically challenging procedure that should only be done by clinicians and teams with special training and experience in complex endovascular cardiac interventions, including regular experience in the use of TAVI. Units doing this procedure should have both cardiac and vascular surgical support for emergency treatment of complications.

1.6 NICE encourages further research into valve-in-valve transcatheter aortic valve implantation (ViV‑TAVI) for aortic bioprosthetic dysfunction. Comparative studies between ViV‑TAVI and surgical aortic valve replacement (SAVR) for patients who are judged to have a low risk from SAVR should describe patient selection clearly and should report fully on complications and valve durability in the short and long term.

1.7 NICE may review this procedure on publication of further evidence.

  • National Institute for Health and Care Excellence (NICE)