Summary

Summary

  • The technology described in this briefing is CentriMag, a ventricular assist device for short‑term cardiopulmonary support in people with heart failure. The smaller version for children is called PediVAS.

  • The innovative aspects are that it is the only short‑term ventricular assist device available for 30‑day use and that it operates without mechanical bearings or seals, which may reduce blood-related complications.

  • The intended place in therapy would be as an alternative to other short‑term ventricular assist devices, or in addition to medical therapy in people with end-stage or acute heart failure. It would be used until a person recovers, until they have a heart transplant, or while a decision is being made about suitable longer‑term treatments.

  • The key points from the evidence summarised in this briefing are from 1 systematic review and 5 retrospective case series, 3 of which were set in the UK. These studies included 1,060 patients with pre- or post-cardiotomy cardiogenic shock, graft failure or rejection after transplant, or right ventricular failure after left ventricular assist device placement. Results show that CentriMag can be used in different groups of people with heart failure with varying survival rates. Device failure was rare (0.08% to 0.58% of cases) but adverse events occurred. There was a higher incidence of bleeding and thrombosis in children than in adults.

  • Key uncertainties around the evidence are that there is a lack of comparative evidence and so the benefits of CentriMag in children or adults compared with alternative treatments, such as extracorporeal membrane oxygenation, are not clear.

  • The cost of CentriMag is £6,042 per unit (exclusive of VAT). The resource impact would be in addition to standard care because of increased staffing and care needs.