Bravo pH Monitoring System for Diagnosing Pediatric GERD

Because the patient cannot see or feel the capsule, he or she is able to maintain normal diet and activity during the test period. Patients (or parents) keep a diary recording food intake, symptoms, and activity, including position changes. The information recorded in the diary is then synthesized with the pH readings recorded by the system receiver.

The Bravo capsule detaches itself from the esophagus through a combination of natural tissue regeneration and sheer force from eating, generally within five to seven days.

Possible Complications

In a 2004 study on the use of the Bravo capsule for pH monitoring in adult patients, the probe did not attach properly in seven of 60 subjects (12%). In all but one patient, a replacement probe was attached without difficulty (Aliment Pharmacol Ther. 2004;19(4):449-454).

The potential exists for the capsule to fail to detach promptly, but according to the manufacturer there have been no reports of this actually happening to date. In the event that the capsule does not separate in a timely fashion, it can be seen on x-ray and removed endoscopically if necessary.

Researchers also warn that the physician must be careful to place the capsule below the cricopharyngeal muscle sphincter to avoid the possibility of the Bravo capsule creating a foreign body airway obstruction when it does disconnect.

Endoscopy Adds to Risk

Other potential complications are those associated with the procedures used for placement of the capsule. Potential adverse effects associated with nasal intubation for transnasal placement, which is used for both Bravo and traditional catheter placement, can include sore throat, trauma to the nasopharynx, or bloody nose.

In addition, since upper gastrointestinal endoscopy is used to ensure proper placement of the capsule, possible complications from that procedure must be considered as well and can include:

• Perforation
• Hemorrhage
• Aspiration
• Fever
• Infection
• Hypertension
• Respiratory arrest
• Cardiac arrhythmia or arrest

Except for painful symptoms, primarily sore throat, none of the patients or parents participating in published studies on the use of the Bravo capsule in pediatric patients have reported subjective complaints. In a study published in the Journal of Pediatric Gastroenterology & Nutrition, 94.7% of parents stated a willingness to allow their children to undergo wireless pH monitoring in the future (2005;41(4):411-415). Additionally, 12 subjects (out of 44), who had previously undergone nasal catheter pH probes,  stated a preference for the wireless pH monitoring.

Marcella Bothwell, MD, assistant professor of otolaryngology and child health at the University of Missouri, uses the Bravo system in her clinical practice, but cautions that its use may not always be indicated, and additional diagnostic procedures may be necessary. The Bravo system is designed to monitor pH levels and does not detect other possible contributing factors to GERD, such as motility and pressure problems. Regarding Bravo, Dr. Bothwell said, “It is an adjunct to other methods of detection. The most important thing is suspicion of reflux. I still use other methods when I am not planning to do an airway endoscopy.”

Increased Cost

Even with the potential benefits in comfort and convenience offered by the Bravo capsule, some researchers question whether the test may be cost-prohibitive to the point of outweighing the potential benefits. List price of the Bravo pH monitoring system is $225, compared with about $62 for a traditional transnasal pH catheter. The addition of upper endoscopy for placement of the Bravo capsule also significantly increases the cost of the evaluation. In all, total cost of pH testing using the Bravo capsule is more than five times the cost of conventional pH probe testing.

Early Diagnosis of GERD Important

There is an increasing awareness that GERD may have its origin in childhood. If left untreated, GERD can lead to dysphagia, odynophagia, stricture, Barrett’s esophagus, chronic hoarseness or laryngitis, respiratory problems (such as coughing or asthma) or non-cardiac chest pain.