CytoSorb for reducing risk of bleeding during cardiac surgery

Level of innovation

All experts said that CytoSorb is innovative because it actively removes ticagrelor from blood. One expert said that CytoSorb is the first in a new class of procedure, while the other 2 experts said that CytoSorb is definitely novel and has uncertain safety and efficacy. However, 1 expert noted that the TISORB trial is addressing these issues. Experts were unaware of any other competing or alternative technologies available to the NHS. However, 1 expert noted that there is a monoclonal antibody entering into clinical trials as an antidote for ticagrelor.

Potential patient impact

Experts said that potential benefits to patients included less bleeding with reduced need for the use of blood products and to prevent reopening- and transfusion-related complications. Two experts said that this technology would particularly benefit patients having emergency or urgent cardiac surgery, who are loaded with ticagrelor. One expert said that this can benefit older people or people with suboptimal organ function.

One expert said that 20% of the patients referred for cardiac surgery would be eligible for this technology.

Potential system impact

All experts agreed that CytoSorb has the potential to change the current pathway. It can reduce operating theatre occupancy time, and lengths of intensive care unit and hospital stays. Furthermore, there is less need to return to the theatre for re‑exploration for bleeding and cardiac tamponade, and reduced need for blood products. Two experts said that no changes to clinical facilities were needed. One expert said that changes need to be made to the perfusion department to do this procedure safely. All experts agreed that despite the cost of the technology, overall CytoSorb is likely to cost less compared with standard care.

All experts agreed that training for staff is needed. Experts were not aware of any safety issues. However, 1 expert noted some potential side effects including removal of antibiotics and other beneficial molecules, and potential thrombocytopenia and leukopenia. The expert said that this will need close monitoring. Another expert said that there are theoretical risks of allergic reactions and clotting with the device because of inadequate anticoagulation or device priming. Furthermore, there is possibility of a small blood leak from the connectors, but the expert also said that there is no evidence that CytoSorb would carry a higher risk to patients than bypass or haemofiltration alone.

General comments

All experts said that CytoSorb has the potential to replace current standard care, subject to supportive evidence from large prospective trials. Two experts said that this procedure will be done in a minority of hospitals, about 10 in the UK, in specialist cardiothoracic centres. One expert could not predict in how many hospitals this could be done. One expert identified the need for cardiopulmonary bypass or haemofiltration as a potential issue with the usability of the technology. All experts agreed that the cost could be a barrier to adoption in the NHS.

One expert noted some uncertainty around CytoSorb, such as the timing and duration. For example, whether CytoSorb is used preoperatively as a standalone application or if there is need for postoperative application in addition to intraoperative use.

All experts agreed that randomised clinical trials are needed to address the uncertainty in the evidence base. One expert said that these trials should ideally include a multi‑ethnic population. Another expert said that TISORB will address most of these issues. However, the expert said that this study has important exclusion criteria such as age, comorbidities and comedication, that should be included as these patients could benefit more from ticagrelor removal.