The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Implantation of a sphenopalatine ganglion stimulation device for chronic cluster headache, in June 2015.
August 2019: The device used in this procedure no longer has a current CE mark. The CE mark is necessary for medical devices to be marketed in the European Union. A non-CE marked device can only be used in the context of clinical investigations with MHRA and research ethics approval.
Cluster headaches are characterised by episodes of unilateral periorbital pain, conjunctival injection, lacrimation and rhinorrhoea. This form of neurovascular headache most commonly affects middle-aged men. Headache attacks can last from a few minutes to several hours and can occur many times a day, over several days. Chronic cluster headaches can be separated by headache-free periods of less than 1 month, or not separated at all.
The usual treatments for acute cluster headache attacks are oxygen inhalation and/or with or without medications such as triptans. Medications such as corticosteroids, verapamil and occipital nerve blocks are used to prevent or reduce the number of attacks. Surgical treatments are reserved for patients with distressing symptoms that are refractory to medical treatments. They include deep brain stimulation to modulate central processing of pain signals and radiofrequency ablation to interrupt trigeminal sensory or autonomic pathways.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.