2 The procedure
2.1.1 Gastro-oesophageal reflux disease (GORD) is a common condition that can have a significant impact on the quality of life of an individual. It is caused by failure of the sphincter mechanism at the lower end of the oesophagus. Symptoms of GORD can be broadly grouped into those directly related to reflux episodes, such as heartburn, regurgitation and waterbrash; and those symptoms caused by complications of reflux disease, including dysphagia and respiratory symptoms.
2.1.2 Lifestyle modifications and drug therapy are the standard treatment for patients with mild symptomatic GORD. Drug therapy includes antacids/alginates and acid-lowering agents, such as H-2 antagonists and proton pump inhibitors (PPIs). Patients with volume reflux or symptoms that do not respond to medical treatment may be treated with anti-reflux surgery. Injection therapy may be considered as an alternative to surgery.
2.2.1 The patient is sedated and given an injection of antibiotics. A needle catheter is then introduced through an endoscope and passed down the oesophagus into the gastro-oesophageal junction, so narrowing the lumen. This catheter is filled with a bio-compatible polymer and solvent and is used to inject or implant the polymer into the gastro-oesophageal junction. The injection is made along the muscle layer or deep submucosal layer of the cardia. Multiple injections (often four) are performed in a circumferential manner around the oesophagus under fluoroscopic and endoscopic control.
2.3.1 Evidence of efficacy was based primarily on one uncontrolled study of 85 patients with GORD receiving chronic PPI therapy. This study reported that, at 12 months, 67% (57/85) of patients were no longer taking PPIs and that a further 9% (8/85) of patients had reduced PPI usage by 50% or more. Both heartburn and regurgitation symptom scores had improved at 12 months. Small reductions in acid reflux, as assessed by measuring oesophageal pH, were seen but no improvement in endoscopic grades was observed. Efficacy of treatment was related to the residual implant volume, and repeat treatments may be required to enhance this volume. For more details, refer to the Sources of evidence section.
2.3.2 The Specialist Advisors considered that this was a procedure at an early stage of development and that its efficacy was unknown.
2.4.1 Transient mild-to-moderate chest pain was the most commonly reported adverse event occurring after injection; the incidence in the studies ranged from 53% (8/15) to 92% (78/85). Other complications included dysphagia, fever and nausea. For more details, refer to the Sources of evidence section.
2.4.2 The Specialist Advisors had no major safety concerns.
2.5.1 These recommendations were based on evidence presented to the Interventional Procedures Advisory Committee on the use of a bio-compatible polymer as a bulking agent. The Institute may review the procedure if further data become available.