Bravo pH Monitoring in Gastroesophageal Reflux

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; LOPEZ, A; ALCARAZ, A.; BARDACH, A.; CIAPPONI, A

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

Gastroesophageal reflux causes a persistent heartburn feeling and/or regurgitation and affects 5- 7% of the population worldwide. In some selected cases, usually in non responders to drug therapy, it is necessary to monitor esophageal pH on continued and ambulatory bases. The standard method used for pH monitoring is the nasogastric tube. To avoid the discomfort produced by the tube, monitoring using the Bravo capsule has been proposed because it allows a wireless measurement and without the discomfort caused by the wires. Technology The Bravo capsule is a small device containing a radio transmitter, a built-in battery and electrodes to measure pH. It is placed in the distal end of the esophageal wall through a vacuum pump. This capsule is wireless and it transmits the pH information collected every 6 seconds to an external receptor through radiofrequency. Because of the capsule size, it can not be placed through the nose, but orally. After a 48-96-hour monitoring, the capsule detaches itself from the esophageal mucosa and it is passed with stools. Purpose To assess the available evidence on the efficacy, safety and coverage related aspects regarding the use of Bravo capsule for pH monitoring in gastroesophageal reflux. Methods A bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems. Results One systematic review, two RCTs, one clinical practice guideline, one HTA and several coverage policy documents were found. One systematic review published in 2012 showed that the rate of success in the device placement and monitoring ranged between 85% and 97%. In seven studies, comparing standard monitoring with those performed with the wireless device, a good correlation was observed between both devices in five of them; a similar amount of time with pH