Journal of the American College of Surgeons study reports that a minimally invasive procedure for GERD reduces acid reflux, relieves symptoms, and eliminates medication use
NEWS FROM THE AMERICAN COLLEGE OF SURGEONS | FOR IMMEDIATE RELEASE
CHICAGO (October 3, 2013): For people who regularly suffer from severe gastroesophageal reflux disease, a minimally invasive surgical procedure, called LINX magnetic sphincter augmentation (MSA), is a safe and effective option for relieving their difficult-to-control symptoms, according to new study findings appearing in the October issue of the Journal of the American College of Surgeons.
GERD is a common digestive disorder in which acid contents from the stomach flow backwards into the esophagus, the tube that connects the throat to the stomach. These stomach juices, often called acid reflux, inflame the lining of the esophagus and cause heartburn and other symptoms.
In most GERD patients, the esophageal sphincter (a muscular ring that seals the esophagus from the stomach) is weakened and does not close tightly between swallows, allowing digestive juices to move back into the esophagus and irritate the esophageal lining. Long-term exposure to esophageal acid puts these patients at risk for other health problems as well.
Until now, treatment options for people who regularly suffer acid reflux include lifestyle changes and medications, such as over-the-counter antacids, proton pump inhibitors (PPIs), prescription medications, and a surgical procedure called fundoplication.
Currently, a fundoplication operation is an option for chronic GERD patients who cannot get relief from medication and lifestyle therapy. During this operation, excess stomach tissue is folded around the esophagus and sewn in place to strengthen the lower esophageal sphincter. Laparoscopic LINX with MSA is a minimally invasive alternative to fundoplication and provides patients with another approach to this problem.
To evaluate this novel implantable device (the LINX Reflux Management System) that uses MSA to strengthen the weakened esophageal sphincter, researchers from University of Milan Medical School in Italy followed 100 consecutive patients who underwent laparoscopic MSA for GERD between 2007- 2012.
These researchers are among the first to use the LINX device, which consists of a series of magnetic beads connected to each other by wires to form a ring shape. The device is surgically implanted around the lower end of the esophagus to help keep a weak esophageal sphincter closed between swallows. This technique prevents stomach contents from flowing back into the esophagus.
For the study, researchers tracked clinical outcomes over a six-year period on the following measures: esophageal pH measurements, symptoms scores, proton pump inhibitor use (PPI), and quality of life scores. For each patient, they then compared that data with presurgical data.
Study results showed that acid reflux was substantially reduced. The median total acid exposure time dropped from 8 percent before implant to 3.2 percent following implant. In addition, 85 percent of GERD patients were able to eliminate their daily use of PPIs. Finally, patients reported an overall satisfaction with their quality of life. The median GERD Health Related Quality of Life score at baseline was 16 on PPIs, 24 off PPIs, and upon last follow up improved to a score of two.
“The main finding from our study is that MSA was very safe and well tolerated, and our patients were very satisfied with the procedure,” said lead study author Luigi Bonavina, MD, FACS, professor of surgery at the University of Milan Medical School. “MSA has become a standard treatment at our institution because control of reflux symptoms and pH normalization can be achieved with minimal side effects and preservation of gastric anatomy.”
The implantable device is now ready to be tested in a larger study. “We found that the results of the procedure were consistent in a large patient population, and we think that this LINX device has the potential to solve the problem in most patients with early-stage GERD,” Dr. Bonavina said. “Now we will need to take the next step and conduct a clinical trial that compares this procedure against the gold standard.”
Other participants in the study include Greta Saino, MD; Davide Bona, MD; Andrea Sironi, MD; and Veronica Lazzari, MD.
Dr. Bonavina serves as a consultant for Torax® Medical, Inc. (LINX® Reflux Management System).
Citation: Journal of the American College of Surgeons, October 2013: Vol. 217(4): 577-85.
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The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 79,000 members and is the largest organization of surgeons in the world. For more information, visit www.facs.org.