DATA SHOWS THE NEW BARD ENDOSCOPIC SUTURING SYSTEM EFFECTIVELY TREATS CHRONIC HEARTBURN, REDUCING SYMPTOMS AND RELIANCE ON MEDICATION
Data from Two Studies Presented at Digestive Disease Week 2000
MURRAY HILL, NJ/SAN DIEGO, CA, -- May 24, 2000 --
Results from two recent studies designed to evaluate endoluminal gastroplication in patients suffering from gastroesophageal reflux disease (GERD) were presented today, demonstrating potential clinical and patient advantages of this new procedure. GERD is a chronic condition where stomach acid flows back up into the esophagus, causing severe heartburn. GERD can also lead to ulcers, asthma and can be a precursor to esophageal cancer.
The first study, conducted at the Royal London Hospital, UK, evaluated 102 GERD patients who had been unsuccessfully treated with long-term medical therapy and who declined open or laparoscopic anti-reflux surgery and were ineligible for general anesthesia. The endoluminal gastroplication procedure, using the Bard Endoscopic Suturing System, was performed using a flexible endoscope inserted down the patient’s throat. This outpatient procedure was performed in a median duration of 35 minutes. Post-procedure assessments were made at 12 weeks, showing a decrease in GERD symptoms, increased sphincter length and pressure, and a decrease in pH levels. There was also a highly significant reduction in the use of proton pump inhibitor drugs following this procedure.
"We saw significant improvement in symptoms, reduced reflux and increased sphincter length and pressure in our study participants following this procedure," said Paul Swain, M.D., Professor, Royal London Hospital, U.K. and the inventor of the device. "This procedure is easily repeatable, reversible, has a short operation time and no need for general anesthesia or incisions. Patients are able to return to their normal activities the next day."
Complications included minor haematemesis (vomiting of blood because of internal bleeding) in two patients and transient dysphagia (difficulty in swallowing) in three study subjects.
Longer-term follow-up suggests that most patients with good improvement maintain that improvement after two to four years. Endoscopic evaluation also shows that stitches are usually still present after two to four years following the procedure. In a small sample of patients, repeat pH measurements at one, two and three years showed no reflux.
The second study, conducted at eight sites in the U.S., enrolled 64 patients suffering from symptomatic GERD who experienced three or more heartburn episodes per week while off medication, were dependent on medication, and had documented acid reflux by pH monitoring. This study showed that symptoms were reduced by an average 73 percent and that 62 percent of patients required fewer than four doses of acid reduction medicine per month. The number of patients on daily PPIs or multiple medications was reduced by 75 percent. While 97 percent of patients experienced at least some regurgitation at baseline, more than 90 percent reported no or only mild regurgitation at 6 months.
Complications included hypoxia (oxygen deficiency) experienced by four patients during the procedure and two patients experienced mucosal tears secondary to an overtube. Both patients with mucosal tears recovered fully. One patient experienced pain and fever after the procedure and required a 3-day hospitalization for a microperforation of the esophagus. No sequalae were experienced thereafter, and the patient had excellent relief of his reflux symptoms.
"Patient quality of life showed improvement in reducing heartburn frequency, severity and regurgitation," said lead investigator Charles J. Filipi, M.D., Associate Professor of Surgery, Creighton University. "We are encouraged by these results and intend to investigate this procedure further."
About C. R. Bard, Inc.
C. R. Bard, Inc., headquartered in Murray Hill, New Jersey, is a leading multinational developer, manufacturer and marketer of healthcare products. Bard Endoscopic Technologies, headquartered in Billerica, MA, is a division of C. R. Bard, Inc. (NYSE-BCR), specializing in the field of gastroenterology. For more than ten years, Bard Endoscopic Technologies (formerly Bard Interventional Products) has been developing minimally invasive diagnostic and therapeutic products used in conjunction with procedures requiring flexible endoscopy. Visit the company website at www.crbard.com.
Find a Physician
