Current evidence on the safety and efficacy of total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure is limited in quality and quantity. Therefore, 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 total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure should:
Inform the clinical governance leads in their NHS trusts.
Ensure that patients understand the uncertainty about the procedure's safety and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
Audit and review clinical outcomes of all patients having total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure (see section 6.2).
Clinicians should enter details about all patients having total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure onto an appropriate registry and review local clinical outcomes.
Patient selection should be done by a multidisciplinary team experienced in managing end-stage refractory biventricular heart failure in patients needing a heart transplant, for whom a donor organ is not expected to be available before their own heart fails completely.
This technically challenging procedure should only be done in centres specialising in heart transplantation. Only cardiothoracic surgeons with specific expertise and training in inserting the device should carry it out.
NICE encourages further research into total artificial heart implantation as a bridge to transplantation for end-stage refractory biventricular heart failure, including well matched comparative studies. NICE may update the guidance on publication of further evidence.