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Benefits and risks

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:

  • reduced blood pressure in some patients (using the device with 1 or 2 electrodes)

  • fewer drugs were needed to control blood pressure in patients whose blood pressure responded to the device with 2 electrodes.

The studies showed that the risks of the procedure for the device with 2 electrodes were:

  • nerve damage, which was permanent in 14 patients and temporary in 12 patients

  • stroke related to high blood pressure in 6 patients. Another patient had a stroke around the time of the operation, with no lasting effects

  • a sudden, severe increase in blood pressure in 16 patients

  • infection needing removal of the device in 4 patients

  • wound problems in 7 patients

  • breathing complications after the device was implanted in 7 patients

  • 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:

  • blood collecting at the site where the device was implanted in 1 patient

  • 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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