Advice
The technology
The technology
CytoSorb (CytoSorbents Corporation) is a technology for purifying the blood outside of the body. The technology is designed to remove ticagrelor (a blood thinner) from the blood during on-pump cardiac surgery to prevent bleeding complications. CytoSorb consists of a 300 ml cartridge containing small absorbent polymer beads that permit the removal of hydrophobic substances. The sorbent cartridge can be stored for up to 36 months.
CytoSorb is used for multiple indications. More details are available in:
Innovations
The company claims that CytoSorb is the first of its kind and the only option available to remove ticagrelor from the blood during cardiopulmonary bypass surgery. There are no other medical devices or drugs approved for the removal of ticagrelor or the inhibition of ticagrelor activity. The company also claims that compared with standard care, CytoSorb allows cardiac surgery to be done immediately in people who have been taking ticagrelor, without the need for a washout period. This can reduce perioperative and postoperative morbidity by reducing ticagrelor-associated bleeding complications.
Current care pathway
People with acute coronary syndrome (ACS) who have ischaemic electrocardiogram changes or elevation of cardiac troponin should have immediate treatment with both aspirin (300 mg loading dose) and ticagrelor (180 mg loading dose). Ticagrelor is an oral antagonist of the P2Y12 adenosine diphosphate receptor that inhibits platelet aggregation and thrombus formation in atherosclerotic disease. Ticagrelor in combination with low‑dose aspirin is recommended for up to 12 months as a treatment option in adults with ACS with:
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ST-elevation myocardial infarction that cardiologists intend to treat with primary percutaneous coronary intervention (PCI), or
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non-ST-elevation myocardial infarction, or
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admission to hospital with unstable angina.
Current standard care for emergency cardiac surgery is no ticagrelor removal and medical management of expected bleeding complications. These include surgical management of bleeding, blood product transfusions, and prolonged hospital care after operation.
Current standard care for urgent cardiac surgery is delaying surgery for 5 to 7 days for natural ticagrelor clearance. This requires hospitalisation and potentially adjunctive bridging treatments such as short‑acting drugs or low molecular weight heparin.
The following publications have been identified as relevant to this care pathway:
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NICE's technology appraisal guidance on ticagrelor for the treatment of acute coronary syndromes
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NICE's technology appraisal guidance on ticagrelor for preventing stroke after previous ischaemic stroke or high-risk transient ischaemic attack. Publication expected June 2022.
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NICE's technology appraisal guidance on ticagrelor for preventing cardiovascular events in people with type 2 diabetes and coronary artery disease. Publication to be confirmed.
Population, setting and intended user
CytoSorb is used for people who need urgent or emergency cardiac surgery, including for acute cardiovascular events, acute deterioration, or a failed PCI.
The technology is used by cardiothoracic surgeons, cardiac anaesthesiologists, perfusionists and specialised nurses. It is used in tertiary care during cardiac surgery.
The company states that CytoSorb can be integrated into the extracorporeal circuit by a perfusionist or specialised nurse, and only minimal training is needed. The company offers free-of-charge training on-site or by video conferencing, depending on the preference of the hospital.
Costs
Technology costs
CytoSorb costs £1,500 per device.
Cost of cardiac surgery was calculated based on the average theatre time and the length of stay in hospital. For surgery with CytoSorb, the average theatre time costs £5,760 and length of stay in hospital costs around £6,254, which included 2 days in an intensive care unit (ICU) and 11 days of hospital stay (Javanbakht et al. 2020).
Costs of standard care
For standard care, costs of cardiac surgery were £7,060 for average theatre time and around £8,620 for average length of stay in hospital, which included 3 days for ICU stay and 14 days of hospital stay (Javanbakht et al. 2020).
Among people who need emergency cardiac surgery, results from a de novo cost‑utility analysis indicate that over a 30‑day time period, removal of ticagrelor using CytoSorb during surgery is less costly (£12,933 versus £16,874) and more effective (0.06201 quality‑adjusted life years [QALYs] versus 0.06091 QALYs) than standard care.
Among people who need urgent cardiac surgery, results indicate that over a 30‑day time period, removal of ticagrelor using CytoSorb during surgery was less costly than delaying surgery for natural ticagrelor washout without adjunctive therapy (£12,912 versus £12,959), or with adjunctive therapy using short‑acting antiplatelet agents (£12,939 versus £13,200) or low molecular weight heparin (£12,959 versus £13,030; Javanbakht et al. 2020).
Resource consequences
CytoSorb is used in 8 NHS centres as part of the TISORB study. The company estimates that it is also used in 6 additional hospitals across the UK.
The company claims that using CytoSorb to remove ticagrelor during cardiac surgery is a cost‑saving strategy because it improves outcomes during and after surgery and decreases health resource use.
The company states CytoSorb is compatible with virtually all heart-lung machines that are already present in NHS cardiac surgery operating theatres.