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Study Demonstrates Long Term Durability of Plicator Procedure

Patients treated for gastro esophageal reflux disease (GERD) using the endoscopic Plicator procedure show long-term benefits in reducing reflux disease symptoms with no need for long-term prescription antacids, according to a study led by doctors at Beth Israel Deaconess Medical Center (BIDMC).

BOSTON - Patients treated for gastro esophageal reflux disease (GERD) using the endoscopic Plicator procedure show long-term benefits in reducing reflux disease symptoms with no need for long-term prescription antacids, according to a study led by doctors at Beth Israel Deaconess Medical Center (BIDMC).

The majority of patients had complete relief of acid reflux symptoms without the need for prescription proton pump inhibitors and only rare use of antacids according to Douglas Pleskow, MD, the study's principal investigator.

The findings, appearing in the online edition of the journal Surgical Endoscopy, demonstrate a sustained reduction in GERD symptoms and medication use three years post-procedure. GERD is a condition in which the acidic liquid content of the stomach is regurgitated, causing damage in the lining of the esophagus.

Pleskow says patients suffering from GERD can feel worse than those suffering from depression, heart attacks and even diabetes. "It affects their productivity, their employment so it's very important to help control gastro esophageal reflux disease."

The treatment, called endoscopic plication, uses a device called the Plicator to restore the anti-reflux barrier, "a fold over the top part of the stomach that acts to prevent acid and other stomach contents from going up into the esophagus which then reduces symptoms," says Pleskow.

The study involved 29 patients with chronic heartburn who required daily maintenance of their symptoms with medication. Patients were treated at five sites, each receiving plication treatment. They were then evaluated for GERD symptoms and medication use 12 and 36 months after treatment.

All but one of the 29 patients in the study required daily proton pump therapy prior to the procedure. The other patient was on high dose histamine -2 antagonist therapy. Over half the medication dependant patients remained off the daily treatment at the 36 month follow-up and 50 percent were able to stop medication completely.

Pleskow initially studied the effects of plication in a larger study conducted five years ago with 64 patients. That focused primarily on the efficacy and safety of the device but included a one-year follow-up. It was then determined that a study focusing on the longer-term results of the procedure was necessary. Only 29 of the original 64 original patients were available for long term follow up.

"When we initially looked at the study, there were 59 percent of the patients who had had plication at one year completely symptom free," Pleskow says. "What the data shows now at three years is that 55 percent of the original patient population had complete symptom relief."

Pleskow's goal is to look at the data again in two years. He doesn't anticipate much drop-off in numbers. In fact with time, he anticipates better results, because this study reflects the early experience of the Plicator. As time has passed the physicians using this device have developed newer techniques at placing the sutures.

"We're much better at performing the procedure than when we started out and the equipment we're using now is much more advanced," Pleskow says, adding he hopes greater availability to the general public will allow for a much larger study in the future.

In addition to Pleskow, study co-authors include BIDMC's Anthony Lembo, MD, Richard Rothstein, MD, of Dartmouth-Hitchcock Medical Center in Lebanon, NH, Richard Kozarek, MD, of the Virginia Mason Medical Center in Seattle, Gregory Haber, MD, of Lenox Hill Hospital in New York and Christopher Gostout, MD, of the Mayo Clinic in Rochester, MN.

This study was funded by a grant from NDO Surgical, Inc. in Mansfield, MA.

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and ranks third in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox.