LINX

But while it looks like the best alternative to Nissen fundoplication presently, there are also some concerns.

It has been heavily promoted on the possible adverse effects of Nissen fundoplication and it has gained free media attention in the United States whenever another clinic offers this new device. But whereas they have been quick to point to possible shortcomings of Nissen fundoplication, the manufacturers do not so readily publicise the possible adverse effects of the device leading one journal to produce an article: "Heartburn Hell on the NBC Today Show: omitting things consumers might want to know about a $14K device" in response to one such publicity feature.     [r-iv]

A report in the Journal of American College of Surgeons highlighted on the Torax website, "One Hundred Consecutive Patients Treated with Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease: 6 Years of Clinical Experience from a Single Center" [r-v] examined results of patients having had the implant an average of 3 years.

It concluded "Magnetic sphincter augmentation for GERD in clinical practice provides safe and long-term reduction of esophageal acid exposure, substantial symptom improvement, and elimination of daily PPI use." and "Freedom from daily dependence on PPIs was achieved in 85% of patients."

The report also included the reasons patients gave for choosing the device instead of Nissen fundoplication saying they believed the alternative was "effective only in the short-term, too invasive, resulted in dysphagia,inability to belch/vomit and was not reversible".

The approval of the FDA in America, coupled with the positive news items, has meant a surge in demand for the device but patients have found a reluctance on the part of insurance companies to pay for it. Most commercial insurers still see the Linx as too new to cover. Spokespeople with Aetna and Blue Cross and Blue Shield of Minnesota said they consider the device “investigational,” needing further study. [r-vi]

A report from the University of Southern California [r-vii], revealed that 63% of LINX recipients experienced difficulty swallowing following implantation. The problem being the bolus of food travelling down the oeosphagus needs to be dense enough and propelled strongly enough by the patient's peristalsis to push the magnets apart.

NICE guidelines [r-viii] permit the use of LINX "with special arrangements for clinical governance, consent and audit or research" because "the evidence on the safety and efficacy of laparoscopic insertion of a magnetic bead band for gastro-oesophageal reflux disease (GORD) is limited in quantity". The cost to NHS is double that of a Laparoscopic Nissen Fundoplication so the availability of LINX on the NHS is currently limited, but it's available privately. The price for private treatment is in the region of £8,000-£9,000.

A paper published in May 2017 found LINX more effective than PPIs for treating regurgitation in GERD. [r-xi] (But, as demonstrated in the chapter on LPR, PPIs do not addess reflux but acidity.)

A December 2022 paper in Diseases of the Esophagus, Magnetic sphincter augmentation and high-resolution manometry: impact of biomechanical properties on esophageal motility and clinical significance for selection and outcomes found, "contrary to the LNF, which retains neurohormonal relaxation capability during deglutition, the magnetic forces remain constant until forcibly opened. Therefore, the burden of overcoming EJG resistance is placed solely on the esophageal body contractile force, as measured by distal contractile integral and distal esophageal amplitude. The main utility of preoperative manometry is in determining whether a patient’s esophagus has sufficient contractility or peristaltic reserve to adapt to the challenge of an MSA."

A study published in March 2023 in Diseases of the Esophagus, Longer-term outcomes of gastroesophageal reflux disease treated with magnetic sphincter augmentation, reported the outcomes of 200 patients followed for 5 years post op. It concluded, "There was a significant reduction in antacid use at all postoperative time points. Postoperative dilatation was necessary in 7.4% of patients, and the device was removed in 1.4%. Erosion occurred in no patients. MSA is safe and effective at reducing symptom burden and improving QOL scores in patients with both esophageal and laryngopharyngeal symptoms, including those with severe reflux."