For those in whom acid-suppression therapy is no longer sufficient to control their symptoms of acid reflux, the only option remaining is surgical which, until now, effectively meant a Nissen Fundoplication. The Nissen procedure is technically complex, requires a major alteration to the anatomy of the stomach and has variable success rates. Accordingly, it tends to be reserved for those patients who have reached the point where there is really no other alternative.
The LINX™ System fulfils a treatment gap between those whose symptoms are not well controlled on drug treatment, but not severe enough to warrant a Nissen procedure which is not only complex, but is also irreversible. See a comparison of the Nissen and LINX™ System.
How Does the LINX™ System Work?
The LINX™ System is designed to prevent gastric reflux by augmenting the lower oesophageal sphincter (LES) – the body’s natural anti-reflux barrier. The LINX™ device consists of a series of miniature magnetic beads linked together to form a “bracelet” around the lower oesophagus, supporting the LES. The magnetic attraction between the beads helps to keep the lower esophageal sphincter (LES) closed to prevent reflux, but will open to allow swallowing or the release of higher gastric pressures (eg during belching).
The device is implanted using keyhole (laparoscopic) surgery in a day-case (outpatient) procedure that takes around 30 minutes. The device is placed around the lower part of the oesophagus, preventing upward movement of acid but allowing normal downward movement of food. Once placed the device will begin working immediately and patients should be able to resume a normal diet and normal activities in less than a week.
Clinical Trial Results
Further studies on the LINX™ System are currently underway but results of clinical trials to date are encouraging. A recent 2-year follow-up was recently presented at the 2010 Meeting of the European Surgical Association.
This report was based on a study of 44 patients who underwent implantation with the LINX™ device between February 2007 and October 2008. There were 26 (59%) males and 18 (41%) females. Heartburn was the principal complaint in all cases and all subjects were taking maximum doses of proton pump inhibitors (PPI’s). Prior to surgery, the degree of reflux and GORD symptoms were measured using a standard questionnaire – the Gastro-esophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire. This questionnaire consists of six heartburn-related questions, two swallow-related questions, one gas-bloating question and one question related to medication use. The higher the GERD-HRQL score, the worse the symptoms.
The main findings of the study were as follows:
- All devices were implanted without any complications
- The mean GERD-HRQL score decreased by 85% at 12 months and by 90% at two years
- After 2-years follow-up, 86% of the patients were completely off medication
- All patients retained their ability to belch