LINX Statement of Support from ASGS

Gastroesophageal Reflux Disease (GERD) in the United States is steadily becoming a medical conundrum and a financial nightmare. Nearly 7% of people in this country experience heartburn symptoms on a daily basis and this group spends more than $3000 per year more on medical care than asymptomatic patients. Of the 20 million patients on PPI therapy 30-40% describe themselves as unsatisfied and concerned about their continued symptoms. PPI therapy is generally safe but associated side effects from long-term use are starting to be recognized by the FDA and medical literature. The prevalence of Barrett’s Esophagus is increasing and the overall incidence of esophageal adenocarcinoma has increased 700% since the early 1970s. Medical management is often effective, but in its current state millions of our citizens continues to suffer from symptomatic regurgitation and disease progression.
Although a complete understanding of the pathophysiology of GERD eludes all physicians it has long been understood that control of gastric regurgitation through an incompetent gastroesophageal junction is a final pathway of symptom production. That recognition has lead to the development of surgical therapies designed to restore the integrity of this “valve” since the 1950’s. The currently accepted gold standard of therapy for this condition is the laparoscopic Nissen fundoplication. Despite the fact that it can generate durable long-term control of symptoms in most patients the frequency of this operation has been steadily decreasing after peaking nearly a decade ago. The reasons for this are multifactorial. The skill set required for this operation is high and variable surgical outcomes have occurred due to variations in technique, training and patient selection. The lukewarm enthusiasm on the part of our non-surgical colleagues and the prevalence of post procedure side effects (gas bloat, dysphagia and early satiety) have also contributed to the laparoscopic Nissen becoming a less frequent procedure than would be anticipated based on the frequency of failure that medical management has demonstrated in the past few decades.

The LINX procedure was developed with the goal of augmenting the function of the lower esophageal sphincter with a durable but less complex procedure. The LINX procedure is an implantable device consisting of a series of titanium beads, each containing a magnetic core connected together with independent titanium wires that allow expansion of the device. The procedure requires precise placement of the devise at the gastroesophageal junction by a surgeon skilled in laparoscopic surgery and foregut procedures. Once in place the attractive forces of the magnetic beads provide additional strength to augment a weak LES and restore sphincter competence. The device is placed in a standardized fashion and the size and resistance to expansion are based on easily obtained intraoperative measurements. This reduces variability from surgeon to surgeon and facility to facility. Unlike other laparoscopic anti-reflux procedures there is limited anatomic disruption of surrounding structures and significant improvement with respect to predictability of results. A safety analysis of the first 1000 patients treated with this device at 82 institutions worldwide has shown no device migration or malfunction after a median implant duration of 274 days. There were no adverse events leading to any serious long-term complications or deaths. The reoperation rate for this group was 3.4%. These reoperative procedures involved removal of the LINX device and all were accomplished laparoscopically. Indication for removal was typically for persistent dysphagia, continued GERD symptoms and in one case for device erosion.

The first LINX device was implanted in 2007 and FDA approval occurred five years later. Multiple peer review articles have been subsequently published as data and patient experience has accrued. Durable control of symptoms as measure by the GERD-HRQL has been demonstrated beyond 4 years. 85% cessation of PPI use at 6 years has been shown. Greater than 90% of patients are satisfied with their symptom improvement and side effects typically associated with laparoscopic Nissen fundoplication like gas bloat, inability to burp/vomit and persistent dysphagia have been largely eliminated.

It is the opinion of the American Society of General Surgeons that all that can be done for complete control of the symptoms and complications of GERD has yet to be achieved. Total management will likely rely upon a combination of medical and surgical care in the current and near future. With this idea in mind a durable reproducible surgical procedure that will provide safe control of GERD with minimal side effects is obviously preferred. Based on currently available information and the experience of our members with the procedure we do support the LINX procedure as mechanism for controlling GERD when it is placed by properly trained laparoscopic surgeons with experience in foregut surgery and the management of GERD patients.

The ASGS Board of Trustees 2014

Supporting literature:

Safety analysis of the first 1000 patients treated with magnetic sphincter augmentation for Gastroesophageal reflux disease. Dis Esophagus. 2014 March 11 [Epub ahead of print].

Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013 Feb 21:368980:719-27

The LINX reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012 Oct;26(10):2944-9

One Hundred Consecutive Patients Treated with Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease: 6 Years of Clinical Experience from a Single Center. J Am Coll Surg 2013 Oct;217(4):577-585

Kendall, B., et al., Am J Gastroenterol 2006:101:1178-1182

Increasing incidence of Barrett’s oesophagus a population-based study. Eur J Epidemiol. 2011 26:739-745

Cancer Epidemiol Biomarkers Prev; 19(6):1468-70

Trends and perioperative outcomes of inpatient antireflux surgery in the United States, 1993-2006. Dis Esophagus (2011) 24;215-223