Bravo pH Monitoring System

Frequently Asked Questions About Gastroesophageal Reflux Disease & the BRAVO pH Monitoring System

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When is pH monitoring used?

According to the American Gastroenterological Association, there are several situations in which esophageal pH recording is definitely indicated:

  • to document abnormal esophageal acid exposure in an endoscopy-negative patient
  • to evaluate patients after anti-reflux surgery who are suspected to have ongoing abnormal reflux
  • to evaluate patients with either normal or equivocal endoscopic findings and reflux symptoms that are refractory to proton pump inhibitor therapy

It may be appropriate to monitor pH levels in other patients. Those with non-cardiac chest pain, chronic respiratory disorders, or otolaryngologic manifestations, may be evaluated after other causes have been explored.

How is pH Monitoring traditionally done?

Traditional pH monitoring systems involve a catheter that is passed through the nasal passage into the esophagus and directly connected to a recording device. The catheter remains in place to collect pH measurements for 24 hours. Because of the discomfort, inconvenience, and embarrassment associated with a nasoesophageal catheter protruding from the nose, most patients tend to stay home for work or school, alter their diets, and assume a more sedentary lifestyle during the test period. This could comprise the value of the test results since the goal of the test is to measure reflux during patient’s normal, everyday activities.

How has the Bravo pH Monitoring System improved pH monitoring?

The Bravo pH capsule with delivery system measures gastroesophageal acid levels (pH) in the evaluation of GERD. As an ambulatory, catheter-free system for esophageal pH monitoring, the Bravo system provides an alternative to traditional pH monitoring systems that require a nasoesophageal catheter. By allowing patients to maintain their regular diet and activities, the Bravo System provides added convenience for patients and more clinical information for physicians.

What does the Bravo pH Monitoring System do?

The Bravo pH capsule, that contains the radiotelemetry pH sensor, is a little larger than a “gelcap.” It is temporarily inserted into the esophagus with the assistance of the Bravo delivery system. Once the Bravo pH capsule is in position, the delivery system is removed, leaving the capsule behind to monitor and transmit esophageal pH levels to an external, pager-sized receiver for up to 48 hours. The Bravo capsule measures pH levels in the esophagus every six seconds. Every 12 seconds it transmits the readings via radiofrequency telemetry to the Bravo receiver worn on the patient’s belt. Data from the recorder is uploaded to a computer for analysis and report.

How is the Bravo capsule inserted into the esophagus?

The Bravo capsule is introduced orally or trans-nasally into the esophagus via a delivery system that can insert it accurately above the lower esophageal sphincter. After the capsule is positioned, suction is applied, drawing a small amount of the esophageal mucosa into the well. A locking pin within the capsule is advanced, penetrating the mucosa and inserting the capsule. Then, the delivery system is withdrawn. The capsule is left in place to begin pH recording. Following the study, normal functions such as swallowing and passage of food will cause the disposable capsule to slough off and pass through the patient’s digestive tract.

How do you know that the Bravo system is more acceptable to patients than traditional ambulatory pH monitoring using a nasoesophageal catheter?

In a study by Tina Ours, M.D. and Joel Richter, M.D., the Bravo pH system was compared to conventional ambulatory catheter pH monitoring to evaluate satisfaction, discomfort, and ability to carry out activities of daily living in both GERD subjects and healthy volunteers. Twenty-two subjects (11 GERD, 11 controls) underwent endoscopic placement and 48 hours of monitoring with a Bravo pH system. Additionally, 30 consecutive age and gender matched symptomatic patients underwent traditional ambulatory esophageal 24-hour pH testing with a nasal catheter. Subjects completed a questionnaire regarding their monitoring experience. Mean satisfaction with Bravo testing vs. catheter testing was 0.8 vs. 1.9 on a six-point visual scale (0=very satisfied) (pâ?¤0.001). Discomfort associated with the Bravo system vs. catheter pH monitoring: no discomfort (8/22 Bravo group vs. 4/30 catheter group, not significant), throat discomfort (4/22 Bravo group vs. 22/30 catheter group, p<0.0001) and esophageal discomfort (10/22 Bravo group vs. 5/30 catheter group, p=0.05). Esophageal discomfort in the group monitored with the Bravo system was significantly more common in the healthy controls (9/11) than the subjects with GERD (1/11) (p=0.002).

The percentage of patients reporting changes in daily activities due to pH monitoring was 0/2 or 0% in the Bravo group vs. 11/30 or 37% in the catheter group (p=0.001). Five percent (1/22) in the Bravo group changed their diet during monitoring vs. 47% (14/30) subject in the catheter group (p=0.001). None or the subjects in the Bravo group (0/22) changed their level of activity during pH monitoring, vs. 60% (18/30) of those in the catheter group (p<0.001) who did so. Monitoring with the Bravo system causes significantly less throat discomfort and impairment of daily activities, including diet and activity level, than the traditional monitoring method. While healthy volunteers noted some esophageal discomfort with the Bravo system, this was no a problem for most patients with GERD. The authors found no serious complications with either pH system. These improvements over the traditional method allow the monitoring to occur within the context of the patients normal, daily experience without modification of diet or activity level.

What is gastroesophageal reflux disease?

Gastroesophageal reflux disease (abbreviated GERD) is the rising (reflux) of gastric contents from the stomach into the esophagus. In normal functioning, the sphincter at the bottom of the esophagus (lower esophageal sphincter, abbreviated LES), opens to let food pass into the stomach and closes thereafter to prevent the gastric contents in the stomach from rising into the esophagus.

When a person has GERD, the lower esophageal sphincter relaxes transiently at random times, allowing gastric contents from the stomach to reflux into the esophagus. Almost everyone experiences the reflux of gastric contents into the esophagus at some time, with symptoms such as heartburn after a meal, sour or bitter taste from regurgitation of stomach contents, and difficult or painful swallowing. Occasional symptoms can generally be treated with over-the-counter antacids. But when reflux is frequent and severe enough to impact a person’s daily life and/or damage the esophagus, the clinical condition is referred to as GERD.

What are the consequences of untreated GERD?

GERD can have serious health consequences beyond the persistent burning pain of heartburn. It can lead to more serious medical problems such as: difficulty swallowing (dysphagia), painful swallowing (odyniphagia), narrowing of the esophagus (strictures), and Barrett’s esophagus, believed to be a premalignant lesion. Chronic hoarseness or laryngitis, respiratory problems (e.g., coughing, wheezing, asthma, recurrent pneumonia), and non-cardiac chest pain, are sometimes associated with GERD. In addition, patients with GERD report greater impairment of quality of life than do patients with peptic ulcer disease, angina, mild congestive heart failure, or menopause

What are the symptoms of gastroesophageal reflux disease?

Some common symptoms are:

  •  A great deal of indigestion or burning sensations in the center of your chest.
  • Gastric contents or bitter tasting fluids regurgitating into your throat or mouth.
  • Necessity to sleep sitting up or to avoid bending over to prevent fluids from coming up from the stomach.

What percent of people have GERD?

It is estimated that 7% to 10% of the U.S. adult population experiences symptoms of GERD on a daily basis. The direct and indirect costs associated with GERD in the U.S. were estimated to be $9.8 billion in 1998 dollars.

What is the economic impact of GERD?

The chronic nature of GERD and the availability of effective drugs have resulted in substantial utilization of health care resources. It has been estimated that the H-receptor antagonists for the treatment of GERD may account for 7% to 10% of a managed care pharmacy’s budget, and sales of proton pump inhibitors have increased significantly in recent years.

How is GERD treated?

When reflux symptoms are experienced, lifestyle modification, dietary modification, and over-the-counter medications including antacids, are generally the first lines of treatment. If these measures fail to relieve the symptoms, medications such as Histamine-2 receptor blockers or proton pump inhibitors (PPI) may be prescribed. If symptoms are refractory to medications, an endoscopy is generally performed to determine whether or not there is gross evidence of GERD. If the diagnosis of GERD is definitive, the physician may pursue either medical or surgical treatment. Patients for whom a definitive diagnosis of GERD cannot be made with endoscopy may be further evaluated with an ambulatory pH test. Whenever a surgical approach is pursued, both a manometry test and ambulatory pH testing are necessary precursors to surgical intervention. Even for those patients whose symptoms resolve following medication, lifetime drug maintenance may not be desirable. Drug therapy can be expensive, may cause side effects, and my potentially not address all the problems fully. Surgical intervention is an important treatment alternative. Ambulatory pH monitoring can be a helpful diagnostic tool at any point within the treatment algorithm.

What side effects are associated with use of the Bravo system?

Endoscopic placement of the capsule involves procedures that are similar to gastrointestinal endoscopy (used for both the Bravo system and traditional catheter placement), include, but are not limited to perforation, hemorrhage, aspiration, fever, infection, hypertension, respiratory arrest, cardiac arrhythmia or arrest. Potential complications associated with nasal intubation for trans-nasal placement (again, used in both Bravo and traditional catheter placement) include, but are not limited to sore throat, trauma to the nasopharynx, or bloody nose. Complications associated with the Bravo system include premature detachment of the capsule, failure of the capsule to slough off in a timely way, or discomfort associated with the capsule requiring endoscopic removal.