Conference Coverage

DDW: LINX device beneficial, safe for GERD

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LINX system may be considered instead of fundoplication

At DDW this year, Dr. Ganz reported on the 5-year follow-up of the original LINX data that was published in the New England Journal of Medicine in 2013 (368:2039-40). The original study enrolled and followed 100 reflux patients for 3 years after implantation of the magnetic sphincter augmentation device, and it appears that the successful outcomes are sustained over the 5-year period. Most notable are the lasting improvement in regurgitation and the dramatic reduction in requirement for maintenance PPI therapy. These findings led the investigators to suggest that this should be considered a first-line surgical therapy for GERD. Overall, this is not an unreasonable statement when one considers the current model wherein antireflux surgery fits in the treatment of GERD. Medical therapy with proton pump inhibitors is extremely safe and effective for a substantial number of patients with GERD and based on this risk/benefit profile should be the first line therapy (Am. J. Gastroenterol. 2013;108:308-28; quiz 329). However, this treatment is not perfect and there are many patients who continue to have persistent symptoms despite PPI therapy (Clin. Gastroenterol. Hepatol. 2012;10:612-9). Although the majority of PPI nonresponders have a functional etiology, there is a distinct population that continue to have refractory reflux-related symptoms, such as regurgitation, that escape the therapeutic target of PPIs. These patients will require an augmentation of the antireflux barrier and the LINX approach appears to be as effective as fundoplication in this regard (J. Am. Coll. Surg. 2015;221:123-8). The question is whether the side effect profile and durability of LINX is better than fundoplication. The answer here is not clear and I would carefully state that LINX and fundoplication can be considered first-line surgical therapies for GERD patients who have documented pathologic acid gastroesophageal reflux and are intolerant to PPIs or not responding to PPIs.

Dr. John E. Pandolfino is professor of medicine and chief of the division of gastroenterology and hepatology at Northwestern University, Chicago. He is a speaker for Astra Zeneca/Takeda and a consultant for EndoGastric Solutions.


 

AT DDW 2015

References

WASHINGTON – Five-year follow-up data on the magnetic device approved for treating gastroesophageal reflux disease confirm its long-term safety and efficacy, Dr. Robert A. Ganz reported at the annual Digestive Disease Week.

Five years after device implantation, the proportion of patients experiencing moderate to severe regurgitation had dropped to about 1%, from almost 60% at baseline, and two-thirds of patients were not taking any proton pump inhibitors (PPIs), said Dr. Ganz, chief of gastroenterology at Abbott Northwestern Hospital, Minneapolis, and one of the study investigators. These were among the results of the study that evaluated the device, the LINX Reflux Management System. The device was approved by the Food and Drug Administration FDA) in 2012 and is for the treatment of people with GERD as defined by abnormal pH testing, who continue to have chronic GERD symptoms that persist despite maximum medical therapy for the treatment of reflux.

“Magnetic sphincter augmentation should be considered first-line surgical therapy for those with gastroesophageal reflux disease, based on the results of this study,” he said.

The 2-year results of the prospective, multicenter study were the basis of the FDA approval of the device, described by the manufacturer, Torax Medical, as a “small implant [composed] of interlinked titanium beads with magnetic cores,” implanted during standard laparoscopy. The magnetic attraction between the beads augments the existing esophageal sphincter’s barrier function to prevent reflux,” according to the company.

The study enrolled 100 patients with reflux disease with a median age of 53 years, who had experienced typical heartburn for at least 6 months with or without regurgitation and were taking PPIs daily for at least 3 months (median use 5 years). Patients had GERD for a median of 10 years (range: 1-40 years). People who had any type of previous gastric or esophageal surgery, Barrett’s esophagus, a hiatal hernia greater than 3 cm, a body mass index over 35 kg/m2, or grade C or D esophagitis were excluded.

The device was implanted in all patients, who served as their own controls; 85 patients were followed through 5 years (6 were lost to follow-up, the device was explanted in 6 patients, 2 patients did not consent to extended follow-up, and 1 patient died of an unrelated cancer). The median procedure time was 36 minutes with a range of 7-125 minutes); all procedures were successfully completed with no intraoperative complications and all patients were discharged within 24 hours on an unrestricted diet.

The median total Gastroesophageal Reflux Disease–Health-Related Quality of Life (GERD-HRQL) score at baseline was 27 points among those not on PPIs and 11 points on PPIs, dropping to 4 points at 5 years off PPIs. At baseline, 95% of patients expressed dissatisfaction related to reflux, which dropped to 7% at year 5. Moderate to severe heartburn was reported by 89% at baseline, dropping to about 12% at year 5. The proportion of patients experiencing moderate to severe regurgitation dropped from 57% at baseline to about 1% at 5 years, Dr. Ganz said.

At baseline, 100% were taking PPIs every day, compared with 15% at 5 years. (At 5 years, 75% had discontinued PPIs, and about 9% reported PRN use only). Grade A and B esophagitis decreased from 40% at baseline to 16% at 5 years, at which point most cases were grade A, and there were no patients with grade C or D esophagitis, he said. In addition, at 5 years, 100% of patients “reported the ability to belch, and those needing to vomit – about 16% – reported the ability to vomit,” demonstrating that normal physiology was preserved with the device.

At 5 years, there were no device erosions or migrations, or any significant adverse events other than dysphagia, which “was typically mild and not associated with weight loss and tended to resolve over time,” from about 70% in the first few weeks after surgery to 11% at 1 year and 7% at 5 years, Dr. Ganz said.

In seven cases, the device was removed laparoscopically, with no complications and gastric anatomy was preserved for future treatments. All removals were elective. The device was removed in four patients because of dysphagia, which completely resolved in those patients. One patient had the device removed because of vomiting of unknown cause that persisted after removal. Another two patients who “had the device removed for disease management” continued to experience reflux and had “uneventful” Nissen fundoplication,” he said.

“Five years after magnetic augmentation, we have demonstrated objective evidence of reduction in acid exposure and in the majority of patients, normalized pH [and] we demonstrated significant and durable improvement in all group parameters measured, with preservation of fundic anatomy and normal physiology, with the ability to belch and vomit,” Dr. Ganz concluded. The results also show that the “procedure is reproducible, safe and reversible if necessary,” he added, noting that one of the limitations of the study was that subjects served as their own controls. During the discussion period, he was asked about hiatal hernia repairs, an apparent trend to “decay” from years 1 to 5 in some parameters measured, and dysphagia after the procedure.

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