Gastroesophageal reflux disease (GERD) captured a significant amount of attention during this year’s Digestive Disease Week conference in Chicago. GERD is the most common esophageal disorder and one of the costliest digestive disorders. Research has indicated that nearly 45% of Americans experience heartburn at least once per month, 20% once per week. In 1998, the cost of drugs to treat GERD surpassed $9 billion, and accounted for more than 60% of all direct costs for GERD in the U.S.
The traditional treatment, fundoplication, is an open or laparoscopic surgical treatment that carries some significant risks. In fundoplication procedures, surgeons wrap and sew the part of the stomach closest to the esophagus around the lower end of the esophagus, including the esophageal sphincter, which, because it is not working properly, allows the stomach acid to flow back up the esophagus.
Until the late 1990s, fundoplication was the only non-pharmacologic treatment for GERD, but it is being rapidly supplanted thanks to the introduction of several less-invasive therapies. Those include Boston Scientific’s (Natick, Massachusetts) Enteryx, C.R. Bard’s (Murray Hill, New Jersey) EndoCinch Suturing System, Curon Medical’s (Fremont, California) Stretta and NDO Surgical’s (Mansfield, Massachusetts) Plicator.
Those GERD therapies were cited in a story on Digestive Disease Week that ran in the July issue of The BBI Newsletter. C.R. Bard contacted BBI in late July, disputing some of the data attributed to its procedure in a table accompanying that report was incorrect. We have republished that table (Table 5 below), including the EndoCinch data Bard provided, based on a study published in the journal, Gastrointestinal Endoscopy.
The minimally invasive EndoCinch Suturing System, manufactured by Bard subsidiary Davol (Cranston, Rhode Island), is a suturing device passed down the throat through a flexible endoscope. There, it is used to place stitches just below the esophagus to create a pleat to help prevent acid from flowing from the stomach back up the esophagus. The procedure normally is performed in one hour or less, usually requires only “moderate” sedation “and does not limit further treatment options,” the company said.
What Bard described as “the first long-term outcomes study of endoscopic gastroplication patients” showed “significantly reduced” symptoms of heartburn and regurgitation and their dependence on medications, the company said. The study of one-year and two-year results from the EndoCinch treatment were described in “Long-term Outcomes of Endoluminal Gastroplication: A U.S. Multi-Center Trial,” published in the May edition of Gastrointestinal Endoscopy.
The Bard-supported study, which enrolled 85 patients, measured heartburn frequency and severity, incidence of regurgitation and level of medication use at 12 and 24 months post-procedure. The study results showed a reduction in median medication costs of 88% at two years. It also showed that at 12 and 24 months: 70% and 66% of patients, respectively, had no or minimal regurgitation; 50% and 43%, respectively, had no or minimal heartburn; and 73% and 69%, respectively, had either stopped taking their GERD medications or had reduced them by at least half.
Citing the finding that symptoms of severe heartburn were reduced for at least two years, Yang Chen, MD, of the University of Colorado Hospital (Denver), the study’s lead investigator, said, “This study reveals that endoscopic gastroplication is safe and effective.” He described the ELGP procedure using EndoCinch as “a less-invasive, less-expensive and less-risky procedure than the traditional alternative.”
The multi-center study included patients with such conditions as hiatal hernia and esophagitis, who according to Bard were excluded from studies of some competing minimally invasive procedures. These difficult-to-treat patients, however, are more typical among the patient population that suffers from GERD, according to the company.
In the journal article, Chen wrote: “The advantages of ELGP are several. Compared with laparoscopic fundoplication, ELGP is minimally invasive, requires only intravenous sedation in the majority of patients, does not limit further treatment options, and typically requires only 30 to 60 minutes to perform.”
Noting that long-term outcomes with ELGP had not previously been prospectively examined, the article cited the study’s aim of evaluating long-term safety and effectiveness of the procedure.
The report said that improvements in heartburn after ELGP “were statistically significant and through- out the 24-month follow-up period,” and that “regurgitation symptoms also were significantly reduced.” About half of all patients had complete resolution of heartburn symptoms 12 and 24 months after ELGP, three-fourths of the patients had complete resolution of regurgitation symptoms at 12 months, and 69% had resolution 24 months after the procedure.
More than 22,000 physicians, researchers and academicians attended the mid-May Digestive Disease Week conference, the largest international gathering in the fields of endoscopy, gastroenterology, hepatology and gastrointestinal surgery.