GERD: Magnetic Device Called Safe, Effective

Larry Hand

October 07, 2013

Magnetic sphincter augmentation (MSA) proved safe and effective for most of the first 100 patients with gastroesophageal reflux disease (GERD) to undergo the laparoscopic implant procedure at a medical center in Italy, according to an article published in the October issue of the Journal of the American College of Surgeons. MSA may be an alternative to the more invasive fundoplication procedure for some patients, the researchers write.

Luigi Bonavina, MD, from the Department of Biomedical Sciences for Health at the University of Milano Medical School in Italy, and colleagues analyzed the records of 100 consecutive patients who underwent laparoscopic MSA for GERD at their institution between March 2007 and February 2012. They tracked postimplant clinical outcomes for patients and compared those data with presurgical esophageal pH measurements, symptom scores, and proton pump inhibitor (PPI) use.

MSA involves implanting a device consisting of a series of magnetic beads connected by wires around the external tubular esophagus. The device is implanted in the lower esophageal sphincter area, using standard laparoscopic techniques.

The patients had a median age of 44.5 years, 74% were men, and had a median body mass index of 24 kg/m2. All patients had been taking daily PPIs, the men for a median of 5.5 years and the women for a median of 4.0 years. The first 30 patients were part of a pilot phase and were treated with a first-generation device. The remaining 70 patients were treated with a second-generation device, which differed only in the way it was secured (by a clasp instead of suture).

Quality-of-Life Scores

Before surgery, patients had a median GERD health-related quality-of-life (HRQL) score of 24 (of a possible 50) when not taking PPIs and 16 while taking PPIs. After surgery, the median score improved to 2 (P < .001) when not taking PPIs.

In addition, the median heartburn score went from 15 to 2, and 87% of patients reported they were satisfied with their postimplant condition compared with 5% at baseline.

Of the patients followed-up for 5 years, 28 of 30 had a 50% or more reduction in GERD-HRQL, and of patients at 1.6 years of follow-up, 55 of 65 had the same reduction. At last follow-up for all patients, 81 of 95 patients reported they had stopped taking PPIs.

Twenty of the 30 patients at last follow-up available achieved normalization of pH, 15 of 20 patients achieved normalization at 5 years follow-up, and 85% of patients were free of daily dependence on PPIs after implant. Esophageal acid exposure went down 50% or more for 25 of 30 patients, and the procedure led to an overall acid exposure reduction for 87% of patients.

The median procedure time, not counting preparation, was 47 minutes. No long-term complications have resulted, the researchers write. Three patients had the device removed for persistent GERD, odynophagia, or dysphagia and were treated in other ways for resolution of symptoms. Hospital stays lasted less than 24 hours for 70 patients, 24 to 48 hours for 26 patients, and more than 48 hours for 4 patients.

"[MSA] represents the first major advancement for antireflux surgery in decades, and is a much needed alternative treatment for patients with reflux disease refractory to medical therapy," the researchers conclude. "Patient selection is an important consideration and has contributed to our successful results. Patients with large hernias, motility disorders, advanced esophagitis, previous surgery at the [gastroesophageal junction], and Barrett's esophagus have not been studied under a controlled protocol, so no recommendations or conclusions can be made about safety and efficacy in these patients."

The researchers add that MSA offers advantages over fundoplication, which lacks standardization of procedure and has variable outcomes. MSA can be uniformly implanted and can eliminate many variables, they note. A previously reported study also found similar results for MSA from a multicenter trial in the United States.

More Trials Needed

Surgeons at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, however, are waiting for more evidence before they adopt MSA as a procedure, David C. Metz, MD, professor of medicine in the Department of Gastroenterology at the school, told Medscape Medical News in a telephone interview.

"My concern about this device is I need to see studies comparing all comers with reflux disease randomized to get this device or not get his device in a comparative trial. It looks good, and it seems safe, but it's only a small nucleus of patients and it hasn't been compared to the standard of care."

Dr. Metz added, "Getting out of the hospital earlier is a benefit, but [it's] only a benefit if it's considerably more successful. I'd rather have a patient in the hospital a day longer and know that I have a surgery that is going to be durable and works forever and not have complications."

He said he treats most acid reflux patients medically, but in the rare case where surgery is indicated, 'I send them for fundoplication, and I think it's going to be very hard to improve on that using this device, but I may be wrong. In the interest of my patients, I want to see more data before I say this thing is the greatest thing since sliced bread."

This research was funded in part by Torax Medical, which owns the branded procedure. Dr. Bonavina reports receiving consultant fees from Torax Medical. The other authors have disclosed no relevant financial relationships. Dr. Metz has performed services for proton pump inhibitor companies, most recently Takeda.

J Am Coll Surg. 2013;217(4):577-585. Abstract

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