NON-ENDOSCOPIC VERSUS ENDOSCOPIC PLACEMENT OF THE BRAVO pH CAPSULE

Abstract

Purpose: The BRAVO pH capsule system is a relatively new device that measures esophageal acid reflux. It is recommended that it be placed after upper endoscopy. However, endoscopy is expensive, carries some risk, and sedation may reduce oral intake on Day 1, leading to falsely low pH values. BRAVO capsule placement without sedation (Non-Endo) may increase patient access and provide more accurate pH measurements than placement after endoscopy with sedation (Endo). Methods: Oral placement of the BRAVO capsule was 5 cm above the LES, which was identified by manometry on the same day. Endoscopic placement of the BRAVO capsule was 6 cm above the z-line. These locations have previously been shown to be similar. Results: 252 consecutive patients were scheduled for BRAVO pH capsule placement over a 14 month period (9/02 to 11/03). Reflux symptoms were the predominant reason for referral (78.7%), followed by regurgitation, and chest pain. 210 patients were scheduled for Non-Endo BRAVO pH capsule placement; 185 (125F:60M) completed the study (88.1%). There were 8 equipment failures (3.8%), 13 premature capsule releases (6.2%), 1 incomplete study due to patient request (0.48%), and 3 patients who were intolerant of oral placement and underwent Endo placement. Mean time for premature capsule release was 12.6 hrs. 45 patients were scheduled for Endo BRAVO placement. 40 studies (25F:15M) were completed (88.9%). There were 3 equipment failures (6.7%), and 2 premature capsule releases (4.4%; mean = 2 hours). In the Non-Endo group, the mean Demeester scores on Day 1, Day 2, and Total were 25.60, 25.49, and 26.44, respectively. The mean percentage of time with distal esophageal acid exposure on Days 1, 2, and Total were 7.66, 7.58, and 7.50. In the Endo group, the mean Demeester scores on Day 1, Day 2, and Total were 24.14, 24.22, and 25.14, respectively. In the Endo group, the mean percentage of time with distal esophageal acid exposure on Day 1, 2, and Total were: 7.31, 6.86, and 7.09, respectively. No complications occurred in either group. Conclusions: Non-Endo placement of the BRAVO pH capsule is safe, well-tolerated, and easily accomplished in out-patients. No significant differences were found between endoscopic placement and non-endoscopic placement. Non-Endo BRAVO placement may reduce costs associated with the procedure and improve patient access.