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Benefits and risks

Benefits and risks

When NICE looked at the evidence, it decided that there was enough evidence to show that the procedure works, but that it was not clear who will get the most benefit from it. This is because the patients in the studies had a range of different conditions. There was also evidence of a high risk of serious complications. The 12 studies that NICE looked at involved a total of 9097 patients.

Generally, the results showed the procedure helped patients recover or go on to further treatment, sometimes a heart transplant. The survival rate in hospital in seriously ill patients who had the procedure was between 24% and 59%. In 1 small study, quality of life seemed to be improved significantly around a year after the procedure.

The studies showed that the some patients having ECMO had the following complications:

  • bleeding within the skull

  • major bleeding elsewhere in the body, sometimes needing another operation

  • stroke

  • arteries or veins being damaged

  • feet or legs having to be amputated

  • complications because of muscle swelling in the leg caused by reduced blood flow (known as compartment syndrome), which sometimes needed an operation to relieve the swelling

  • poor blood flow in the feet or legs, which sometimes needed an operation

  • blood clots

  • infection

  • pneumonia

  • the ECMO device not working properly

  • nerve damage in the neck or arm.

Fifty-two patients died during the procedure in a study of 131. According to this study, in 'most cases' this was because of multiple organ failure or severe bacterial infection (sepsis). In another study of 219, 167 patients died within 30 days of having the procedure – the main cause of death was heart failure. One patient in another study, whose spinal nerves were injured when ECMO equipment was inserted, died 55 days later from a variety of complications.

NICE was also told about some other possible risks: brain or nervous system problems because of lack of oxygen flow, bleeding in the chest, blood clots in the heart, and damage to the lungs.

If you want to know more about the studies see the guidance. Ask your health professional to explain anything you don't understand.

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