Advice

The technology

The technology

CentriMag is an external blood pump, connected to a surgically inserted cannula. It is designed for short‑term cardiopulmonary support (up to 30 days) in adults and children with end-stage or acute heart failure. It can be used to support a person until they recover (bridge to recovery), until they have a heart transplant (bridge to transplant), or while a decision is being made about suitable longer‑term treatments (bridge to decision). The device can provide total circulatory support (acting as a biventricular assist device, or BiVAD) or individual left or right ventricular support (LVAD or RVAD). It can also be used as a part of an extracorporeal membrane oxygenation (ECMO) circuit, but this use is beyond the scope of this briefing.

CentriMag comprises a reusable motor, a console, a flow probe and a single-use centrifugal blood pump and circuit. The circuit has an inflow and an outflow cannula, which are both inserted through an cut in the upper abdomen and surgically connected to the heart. These cannulae are then connected to the external pump, which sits in the motor and is connected to the console. A flow probe is used to measure the blood flow. The external parts of CentriMag sit on a trolley, next to the patient. The motor magnetically levitates the impeller (rotor) and operates without mechanical bearings or seals. This minimises friction, wear and heat generation, which may reduce the risk of blood-related complications.

PediVAS (called PediMag in the US) is a smaller version of CentriMag specifically designed for children. It works with the same hardware platform as the CentriMag.

The innovation

CentriMag is the only short‑term VAD that is CE marked for 30‑day use; other short‑term VADs can only be used for up to 7 days. CentriMag is small enough to allow transfer of patients between beds and wards if needed, which could enable patient transfer in emergency situations.

Current NHS pathway

NICE has produced guidelines on acute heart failure and chronic heart failure, as well as interventional procedures guidance on short-term circulatory support with LVADs as a bridge to cardiac transplantation or recovery, and implanting an LVAD for destination therapy in people ineligible for heart transplantation.

Management for end-stage or acute heart failure currently involves medical therapy, mechanical assist devices, such as intra‑aortic balloon pumping or LVADs, and heart transplant. If a mechanical assist device is needed, treatment would take place at a specialist cardiothoracic transplant or ECMO centre.

Implantable LVADs are most commonly used to support a patient's haemodynamic function for months or years while they await a heart transplant, although they may also be used as indefinite long‑term support in people ineligible for heart transplant. Short‑term LVADs are used to support a person's haemodynamic function as they recover from a heart attack or other cardiac event. Long‑term VADs can be used for short‑term support, but their prohibitive prices mean that this is rarely considered in practice. Most VAD support in the NHS is for the left ventricle; RVADs are limited to acute graft failure after heart transplants. Occasionally BiVAD implantation is needed when implanting an LVAD reveals right ventricular failure.

Patients who may need temporary haemodynamic support include those who:

  • have had cardiac surgery

  • have had an acute heart attack

  • have deteriorating end-stage heart failure

  • have had a heart transplant

  • have right ventricular failure after LVAD implantation.

Temporary haemodynamic support may also be used in people with cardiogenic shock. Around 2% to 5% of all patients having cardiac surgery experience cardiogenic shock afterwards (Shuhaiber, 2008). About 4% of people hospitalised with a heart attack develop acute cardiogenic shock, and around 40% of these die (Goldberg, 2016).

NICE is unaware of any other devices which are CE marked for 30 days' use.

Population, setting and intended user

CentriMag is used in NHS cardiothoracic transplant and ECMO centres. It is used by cardiac surgeons, intensivists and cardiologists.

Adopting CentriMag is unlikely to need any significant changes to current NHS care pathways in centres that already do transplants and extracorporeal membrane oxygenation.

Costs

Device costs

The list price for CentriMag is £6,042 (converted from €6,710 on 2 November 2016). Including capital equipment costs, maintenance costs and single-use elements, the cost per use is estimated to be £3,542 for CentriMag and £3,559 for PediVAS (Borisenko, 2014b).

Costs of standard care

The manufacturer sponsored a cost impact study of short‑term VADs and extracorporeal life-support systems which evaluated 3 indications: children and adults with post-cardiac surgery cardiogenic shock, children and adults with deteriorating end-stage heart failure, and adults only with post-acute myocardial infarction cardiogenic shock. The analysis only included device costs, placement costs and the cost of replacement procedures. Three devices were compared in adults (CentriMag, Biomedicus BPX-80 [off-label use], and Abiomed Impella) and 2 were compared in children (PediVAS and Biomedicus BPX-50 [off-label use]).

Across all indications, in both adults and children, CentriMag and PediVAS cost less than the comparator (which the authors stated were available and used in the NHS). For example, in adults with end-stage heart failure, the modelled device costs for CentriMag, BPX 80/BPX 50 (with Carmeda) and Impella 5.0 were £15,669, £35,731 and £74,865 respectively. However, the analyses provide only a limited basis for comparing CentriMag with current standard care for several reasons:

  • Costs for some likely comparators, such as extracorporeal membrane oxygenation, intra-aortic balloon pump or intensive medical support, were not included.

  • Some of the comparisons included off-label device use.

  • The analysis only included costs that differed across devices; any costs that were the same were not included. Costs will therefore be higher in practice than those presented because the estimates did not include the costs of ICU and other supportive care.

  • Comparator devices are not directly comparable with CentriMag because they are licensed for shorter use times (2 to 5 days). The analysis therefore included costs for continued replacement of these devices until the average time for support was met.

Resource consequences

According to the manufacturer, use of CentriMag is well established within the NHS.

Adoption of the technology would be as an alternative to ECMO support. It could be used instead of or in addition to intensive inotropic support or intra-aortic balloon pumps in the appropriate indications.

NHS England currently commissions long‑term VADs for bridging to transplantation for use within designated transplant centres. However, CentriMag could be used in cardiac centres that are currently not transplant centres, in particular for the post-cardiotomy indication. If used in other cardiac centres, it could increase the number of patients for whom CentriMag could be used. If this led to improved survival, it may increase demand for medications, VAD and heart transplant provision, as well as hospital stays. People having CentriMag would need recovery time in post-cardiac surgery beds, and this use would have staffing and training implications.