SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Dr. Evan Alicuben
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.