Safety and tolerability of transoral Bravo capsule placement after transnasal manometry using a validated conversion factor.

OBJECTIVES

To prospectively calculate and validate a conversion factor in healthy volunteers that allows accurate nonsedated, transoral (TO) Bravo capsule placement after transnasal (TN) manometry, and to evaluate the ease and safety of nonendoscopic Bravo placement compared with endoscopic placement.

METHODS

Part 1. Twenty-five healthy volunteers underwent sequential TN and TO esophageal manometry to measure the distance to the lower esophageal sphincter (LES). A TN to TO conversion factor was calculated from these measurements. Part 2. Twenty volunteers underwent TN manometry followed by unsedated TO Bravo capsule placement using the conversion factor calculated in part 1. TN endoscopy then measured the location of the Bravo capsule in relationship to the squamocolumnar junction (SCJ). Part 3. During an 18-month period, 370 consecutive patients referred for a Bravo procedure underwent nonendoscopic, unsedated TO placement (308 patients) or standard endoscopically assisted placement (62 patients).

RESULTS

Part 1. All 25 volunteers completed TN and TO manometry; a conversion factor of 4 cm was calculated. Part 2. Using the calculated conversion factor of 4 cm, a Bravo capsule was deployed TO 5 cm above the proximal border of the LES. The mean +/- standard deviation (SD) TN endoscopic distance to the capsule was 6.0 cm (+/-0.3 cm) above the SCJ. Part 3. A total of 333 patients completed the entire study (90%). Analysis of 48-h pH measurements did not reveal any significant differences between the two groups.

CONCLUSIONS

A reliable and valid conversion factor of 4 cm following TN manometry permits accurate TO placement of the Bravo capsule without endoscopy. TO, unsedated Bravo placement is safe, well tolerated, and may minimize costs and potential risks associated with endoscopy.