Advice
The technology
The technology
CytoSorb (LINC Medical) therapy is designed to reduce the levels of cytokines in the blood. The body can produce excessive levels of cytokines as part of the inflammatory response to severe infection (sometimes referred to as a 'cytokine storm') and this can contribute to toxicity, sepsis and septic shock.
CytoSorb consists of a single-use haemadsorption cartridge for use with standard blood pumps, such as dialysis machines. The CytoSorb cartridge, or adsorber, is filled with sorbent beads made from a porous polymer, which adsorb and capture cytokines as blood passes through the device. The adsorption of cytokines is concentration-dependent and so the higher the levels of cytokines in the blood, the faster the levels are reduced.
Blood is continuously recirculated between the adsorber and the patient for up to 24 hours before the cartridge is replaced. CytoSorb adsorbers can be replaced daily for up to 7 days of continuous use. Patients typically have CytoSorb therapy for 48 to 72 hours.
CytoSorb therapy is designed for treating sepsis and septic shock. It can be used for other indications in which cytokine levels are raised, such as during or after cardiac surgery, during extracorporeal membrane oxygenation procedures, in liver failure, and in people with burns, but these indications are outside the scope for this briefing.
The innovation
Although the principle is not new, CytoSorb is the only currently available CE-marked device to lower excessive cytokines in people with sepsis. Standard therapy does not directly target raised cytokine levels, which are associated with severe sepsis. Elevated cytokine levels can lead to several pathophysiologic changes that increase morbidity and mortality (Kellum 2007), such as peripheral vasodilation, hypotension, tachycardia, restriction of blood flow, and disseminated intravascular coagulation. Reducing cytokine levels may help to control the excessive inflammatory response and possibly avoid complications.
Current NHS pathway
Each year, about 123,000 people in England are diagnosed with sepsis and there are around 37,000 deaths (NHS England 2015). Severe sepsis can develop within hours and close monitoring and therapeutic support are needed to improve the chance of survival.
NICE's guideline on sepsis makes recommendations on the recognition, diagnosis and early management of the condition. Early treatments include intravenous fluids, oxygen therapy, antibiotics, steroids, vasopressors (to increase blood pressure) and inotropic therapy (to support cardiac function). Additional treatments may include sedation, mechanical ventilation and renal replacement therapy or blood purification, such as dialysis (Zhou 2013). Severe sepsis is usually managed in an intensive care setting where organ function can be monitored and supported (Dellinger 2013).
NHS England's action plan (2015) also summarises essential actions that health and care organisations need to take to improve the outcomes for people with sepsis. These actions aim to prevent avoidable cases of sepsis, increase awareness of sepsis, improve identification, treatment, and consistency in reporting of sepsis, and maintain the appropriate use of antibiotics.
NICE is not aware of other CE-marked devices that appear to fulfil a similar function to CytoSorb.
Population, setting and intended user
CytoSorb therapy could be used to treat severe sepsis and excessive levels of cytokines, and would be used alongside standard care, which may include renal replacement therapy in intensive care settings. The therapy would be given by anaesthetists, intensivists and nursing staff who have been trained in its use.
The UK distributor (LINC Medical) provides training in the form of set-up demonstrations, dummy devices on which to practise set up, booklets, videos, and telephone support. A representative from LINC Medical can be present when CytoSorb therapy is given to the first patient (and others after this if needed), depending on the where the patient is in relation to the distributor and the urgency of the treatment.
Costs
Device costs
The list price of the single-use CytoSorb cartridge is £920 per unit excluding VAT, which includes bloodline sets and standard delivery to the centre. Urgent courier delivery may be arranged at additional cost. There are no additional costs for accessories or consumables.
Pressure monitoring of the bloodline between the blood pump and the CytoSorb device is recommended. This is done with the standard safety equipment of the pump systems, with which CytoSorb is usually used, and which also include air detection and blood detection. If the pump system is not equipped with a pressure-sensing device for this line, use of an accessory pressure monitoring device is recommended.
Costs of standard care
In 2014 to 2015, the NHS reference costs of septic shock were £1,415 to £2,107, and for sepsis with multiple interventions this was £6,424 to £9,673.
Resource consequences
CytoSorb therapy has been used to treat about 20 patients across 7 NHS Trusts.
If adopted, CytoSorb would be used with existing blood pumps and significant changes to current facilities or infrastructure are unlikely to be needed. Therapeutic drug monitoring of certain antibiotics is recommended. This will be an additional cost if it is not part of standard care, but therapeutic drug monitoring may already be done during renal replacement therapy in some trusts. The cost of CytoSorb would be in addition to standard care, but any technology which improves outcomes in severe sepsis could save other NHS resources.