Esophageal magnetic sphincter augmentation shows promise beyond standard indications

Last Updated: 2017-06-15

By Will Boggs MD

NEW YORK (Reuters Health) - Esophageal magnetic sphincter augmentation (MSA) appears to be effective for gastroesophageal reflux disease (GERD) in patients who don't meet standard criteria for the procedure, researchers report.

"MSA shows true promise for use outside the current standard indications and ideally centers familiar with placing the device should pursue prospective randomized trials in these populations to determine their true role in the treatment of GERD for patients with larger hiatal hernias and in those who have undergone foregut operations in the past, particularly sleeve gastrectomy or Roux-en-Y gastric bypasses,” Dr. John P. Kuckelman from Madigan Army Medical Center, Joint Base Lewis-McChord, in Tacoma, Washington, told Reuters Health by email.

Standard indications for MSA include patients with GERD, normal motility, body mass index (BMI) <35, no prior foregut surgery and no or small (<3 cm) hiatal defect.

Dr. Kuckelman's team evaluated the postoperative outcomes associated with MSA in their retrospective review of 31 patients, 15 of whom had large hiatal hernia, BMI >35, or prior foregut surgery (i.e., the expanded indication, or EI, group).

During a median follow-up of 12 months, the overall improvement rate, as determined by GERD quality-of-life scores, was 84% for the standard indications (SI) group versus 74% for the EI group (p=0.28), the researchers report in JAMA Surgery, online June 7.

No patients in the EI group and only one in the SI group reported dissatisfaction with the outcomes.

Overall complication rates did not differ significantly between the SI group (15%) and the EI group (20%, p=0.46).

“I would like to emphasize how exciting it is that there is a new surgical option for patients with GERD, particularly as we continue to learn more about long-term proton pump inhibitor (PPI) use,” Dr. Kuckelman said. “Furthermore, we believe MSA has the potential to be the superior option in patients with GERD who have foregut anatomy that limits the ability to perform a fundoplication.”

He added that he thinks MSA indications should be expanded to include patients like these.

“We don’t know and won't truly know until there are larger studies done with long-term outcomes to report,” Dr. Kuckelman cautioned. “The post-bariatric patients who develop GERD are the most likely to see benefit, and we believe that MSA will become a common option for these patients due to the simplicity of the operation and ability to maintain the anatomy of their weight-loss operation.”

Dr. John C. Lipham from Keck Medical Center of USC, in Los Angeles, told Reuters Health by email, “Studies have shown that 30-40% of patients with GERD continue to have symptoms despite medical therapy and this is mainly continued regurgitation symptoms. Data from a randomized controlled trial of Linx (MSA system) vs. PPI for GERD and regurgitation were recently presented at Digestive Disease Week and showed that Linx abolishes these regurgitation symptoms in 93% of the patients while PPIs only help in less than 10%. It is the treatment of choice for patients with continued regurgitation symptoms despite medical therapy.”

“Linx is an option for any patient with reflux that is not happy with medical therapy or concerned about the long-term side effects of PPIs,” he concluded. “The Linx replaces Nissen fundoplication, which was fraught with problems, for the treatment of GERD.”

Dr. C. Daniel Smith from Esophageal Institute of Atlanta, Georgia, told Reuters Health by email, "In nearly any case where a fundoplication would be used, as long as esophageal motility has been tested and is normal, magnetic sphincter augmentation can be considered as an alternative to fundoplication, thereby avoiding the invasiveness, permanence, progressive failure, and side effects of the fundoplication.”

“Additionally, in the post-bariatric surgery patient, it is especially appealing since a fundoplication is not possible, and without MSA the alternative would be another more invasive procedure (conversion to gastric bypass),” he said.

“Careful patient selection for these expanded indications should continue to yield these good results with MSA,” Dr. Smith said. “Fundoplication will increasingly have a more limited role in management of GERD.”

Both Dr. Smith and Dr. Lipham have served as paid consultants to Torax Medical, which makes the LINX system.

The authors reported no funding or conflicts of interest.

SOURCE: http://bit.ly/2sCLF2W

JAMA Surg 2017.