Benefits and risks
When NICE looked at the evidence, it decided that there was not enough evidence about this procedure. NICE looked at 5 studies (377 patients) that used the device with 2 electrodes and 3 studies (99 patients) that used the device with 1 electrode.
Generally, the studies showed the following benefits for up to 28 months after implanting the device:
The studies showed that the risks of the procedure for the device with 2 electrodes were:
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nerve damage, which was permanent in 14 patients and temporary in 12 patients
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stroke related to high blood pressure in 6 patients. Another patient had a stroke around the time of the operation, with no lasting effects
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a sudden, severe increase in blood pressure in 16 patients
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infection needing removal of the device in 4 patients
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wound problems in 7 patients
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breathing complications after the device was implanted in 7 patients
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movement of the device in 1 patient, needing surgery to reposition it.
The studies showed that the risks of the procedure for the device with 1 electrode were:
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blood collecting at the site where the device was implanted in 1 patient
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pain within 30 days of the device being implanted in 1 patient, which cleared up by itself.
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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