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Corticosteroid-releasing bioabsorbable stent or spacer insertion during endoscopic sinus surgery for chronic rhinosinusitis can be used in the NHS while more evidence is generated. It can only be used with special arrangements for clinical governance, consent, and audit or research.
Clinicians wanting to do corticosteroid-releasing bioabsorbable stent or spacer insertion during endoscopic sinus surgery for chronic rhinosinusitis should:
Inform the clinical governance leads in their healthcare organisation.
Ensure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Take account of NICE's advice on shared decision making, including NICE's information for the public.
Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.
Regularly review data on outcomes and safety for this procedure.
Evidence generation, in the form of randomised controlled trials or registry data, is needed on:
patient selection
patient-reported outcomes
longer-term outcomes.
There is not enough long-term evidence on this procedure. Also, there is not enough good-quality evidence on long-term benefits and improvements that matter to patients (patient-reported outcomes). It is unclear who would benefit most from the procedure. There are no major safety concerns. So, it can be used with special arrangements.
The paranasal sinuses are air-filled cavities, located in the bony structures of the face. Small openings (ostia) connect the sinuses with the nasal space. Rhinosinusitis occurs when the mucosal lining of the paranasal sinuses becomes inflamed and infected. Typical symptoms include fever, pain and tenderness over the infected area, together with a blocked or runny nose. Acute rhinosinusitis frequently resolves spontaneously with little or no treatment, but in some cases it becomes chronic.
The symptoms of chronic rhinosinusitis are usually managed with a combination of analgesics, antibiotics, topical corticosteroids and nasal irrigation. If these interventions fail, surgical procedures may be needed to enhance drainage from the sinuses and allow topical medical therapy to reach the sinus mucosa. But adhesions and scarring may develop after surgery, compromising drainage. Scarring occurs less frequently if the mucosa remains intact. Foam dressings, nasal packing and middle meatal spacers are sometimes used after surgery to try and maintain sinus patency.
Inserting a corticosteroid-releasing bioabsorbable stent or spacer during surgery for chronic rhinosinusitis aims to deliver topical corticosteroids directly to the sinus mucosa after surgery and to maintain patency of the newly created drainage system. It is usually done with the patient under general anaesthesia, during functional endoscopic sinus surgery. At the end of the surgery, the corticosteroid-eluting stent or spacer is inserted into the relevant ostium under endoscopic guidance. The stent or spacer dissolves over time.
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