Interpreting Bravo pH Studies

A 3-Step Process
 Interpreting Bravo pH Studies
A 3-Step Process

STEP 1 Assess
Assess the pH Tracing
The pH tracing is a graphical representation of the data that has been
collected during the pH test. To assess the pH tracing, review the patient
history, visually inspect the data (diary and artifacts), and develop a
preliminary diagnosis.

STEP 2 Affirm
Affirm Preliminary Diagnosis
The Reflux Tables and DeMeester Scores are used to affirm the preliminary
diagnosis. Examine each 24-hour period separately, using the worst day
for diagnosis, since the number of acid reflux episodes can vary from day
to day.

STEP 3 Associate
Associate Symptoms
Symptom correlation is an important component of an accurate diagnosis.
Evaluate the SAP & SI Tables to determine whether the symptoms are
associated with reflux events.
 Detailed Example and Notes
STEP 1 Assess the pH Tracing
The pH tracing is a graphical representation of the data that have been collected during the pH test. To assess the pH
tracing, review the patient history, visually inspect the data (diary and artifacts), and develop a preliminary diagnosis.

A. Review the Patient History and Reason for the Bravo pH Test
B. Verify Diary Entry
The software uses all of the diary information in calculations. If this information has not been entered... STOP!
Do not interpret study until the entire diary (Meals, Supine & Symptoms) has been entered.
Verify that the Meal and Supine times have been entered.
Verify that the symptoms have been entered (indicated by a line and identified above the tracing).
Note any artifacts (indicated by gray sections above graph corresponding with gaps in pH line). These will not be
used in calculations.
Verfiy that capsule did not detach during study. If detachment occurred, enter it as an Ignore event in the diary
see Example of Early Detachment on page 13.

Meals Artifact Supine

Heartburn

Acid Reflux Events

C. Review the Tracing

Look at the tracing in 12-16 hour segments. Observe acid reflux events (when blue tracing line dips below red
pH 4 line) and consider:
- Are there a large number of reflux events and/or symptoms?
- Do reflux events occur during supine or upright periods, or both?
- Do symptoms appear to be occurring in or around reflux events? (Symptom association is considered positive if
the symptom occurs within two minutes of the reflux event. A more detailed view of the tracing may be required.)

D. Form Preliminary Diagnosis

From this information, determine whether you believe the patient has acid reflux or not, based on how often
and how long the tracing shows the pH < 4, and whether this occurs during daytime, nighttime, or both.
Step 2 will use the data from the study to affirm your preliminary findings.
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 Detailed Example and Notes
STEP 2 Affirm Preliminary Diagnosis
The Reflux Table and DeMeester Scores are used to affirm the preliminary diagnosis. Examine each 24-hour period
separately, using the worst day for diagnosis, since the number of acid reflux episodes can vary from day to day.

A. Examine Reflux Tables

Total Fraction Time (%) that pH < 4 is the single parameter which has been shown to best correlate with
endoscopic damage.1 Normal is < 4.4% on the worst day.

Reflux Tables
Reflux Tables compile the data that have been
collected during the test, much of which is used
in the other pH report measurements. The
important parameter from the tables is Total
Fraction Time pH < 4 (%), examined for each 24-
hour period separately, using the worst day for
diagnosis.
1. Total number of reflux events
2. Total number of reflux events > 5 minutes Worst Day
3. Duration of longest reflux episode
4. Time pH < 4 (min)
5. Total Fraction Time (%) that pH < 4 is the
single parameter which has been shown to
best correlate with endoscopic damage.1
Normal is < 4.4% on the worst day.
DeMeester Score-Day 2
Total score - 69.1 , DeMeester normals less than 14.72 (95th percentile)

B. Observe DeMeester Score2

Normal = < 14.72 Examine each 24-hour period separately, using the worst day for diagnosis.

DeMeester Score
The DeMeester Score is a method of adding
weights to six common pH measurement para-
meters and presenting esophageal acid exposure
data as a cumulative score. The score is then
compared to data from normal individuals. The
DeMeester Score takes into account and weights
these six parameters:
1. Total percent time pH < 4.0
2. Percent time pH < 4.0 in the upright period
3. Percent time pH < 4.0 in the recumbent period Worst Day
4. The total number of reflux episodes
5. The total number of reflux episodes longer > 5
minutes
6. The duration of the longest reflux episode

DeMeester Normal = < 14.72 Examine each
24-hour period separately, using the worst day
for diagnosis, since the number of acid reflux DeMeester Score-Day 2
Total score - 69.1 , DeMeester normals less than 14.72 (95th percentile)
episodes can vary from day to day.

C. Affirm Preliminary Diagnosis

Assure that Total Fraction Time pH < 4 and the DeMeester Score for the worst day affirm the preliminary tracing
diagnosis. If not, review Step 1 again and look for opportunities to reconcile the tracing with the Reflux Table and
DeMeester Score.
1 Am J Gastroenterol, 1992; 87:11021111.
2 Arch Surg, 2004; 139:848-854.

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 Detailed Example and Notes
STEP 3 Associate Symptoms
Symptom association is an important component of an accurate diagnosis. Evaluate the SAP & SI Tables to determine
whether the symptoms are associated with reflux events.

A. Review SAP Calculations

The SAP calculates the probability that the observed association between reflux and symptom occurred by chance.

SAP > 95% indicates that there is a < 5% probability that the observed symptom-to-reflux associations occurred
by chance.

Symptom Association Probability (SAP)1

The SAP test is a statistical method for
determining if there is a true correlation
between symptoms and reflux or whether
the proposed correlation is actually only a
chance occurrence. A chi-square test is used
to compare symptoms and reflux episodes.
A calculation, expressed as a p value, is
performed to determine the probability that
chance has caused correlation between
symptoms and reflux events.

B. Review SI Calculations
The SI provides data on the strength of the association between symptoms and reflux events.

SI > 50% is significant and indicates that > 50% of the observed symptoms were associated with reflux.

Symptom Index (SI)2

The SI is defined as the number of times the
symptom occurred when pH was < 4, divided
by the total number of times the symptom was
reported. The quotient is multiplied by 100 to
give the percentage of symptom episodes that
correlated with reflux. (There are drawbacks to
the SI, in that it is insensitive to the number of
reflux episodes.)

1 Gastroenterology, 1994; 107:17411745.

2 American Journal of Gastroenterology, 1988; 83: 358361.

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 Normal Case
Interpretation: Negative Bravo with Post-prandial Reflux
History
Female patient with history of sore throat and hoarseness
ENT evaluation positive for laryngitis
Patient was unresponsive to PPI qid
Patient had low probability for GERD

STEP 1 Assess the pH Tracing

4 Meal & Supine times are entered
q 4
q Artifacts (if any) are noted
4 Symptoms are entered and/or uploaded
q 4
q Capsule did not detach during study

Acid reflux occurs primarily after meals

Post-prandial Acid Reflux Artifact

Drink

5
 Normal Case
STEP 2 Affirm Preliminary Diagnosis
Fraction Time pH < 4 is < 4.4% on both days
DeMeester Score is normal (< 14.72) on both days

Worst Day

DeMeester Score-Day 1
Total score - 5.1 , DeMeester normals less than 14.72 (95th percentile)

STEP 3 Associate Symptoms

SAP Table has no significant associations (values > 95%)
SI Table has no associations (values > 50%), so it is not shown on report

Additional Physician Notes

All values are normal

Findings verify that sore throat and hoarseness are not caused by reflux
Need to look for other cause of symptoms/other diagnosis

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 Abnormal Daytime Case
Interpretation: Positive Bravo with Upright Reflux
History
Female patient with complaints of heartburn and regurgitation

STEP 1 Assess the pH Tracing

4 Meal & Supine times are entered
q 4
q Artifacts (if any) are noted
4 Symptoms are entered and/or uploaded
q 4
q Capsule did not detach during study

Reflux occurs mostly post-prandially and during the upright position

Post-prandial reflux lasted a prolonged period of time

Artifact

Long Period of
Post-prandial Acid Reflux

Heartburn

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 Abnormal Daytime Case
STEP 2 Affirm Preliminary Diagnosis
Fraction Time pH < 4 is > 4.4% on both days
DeMeester Score is > normal (14.72) on both days

Worst Day

DeMeester Score-Day 1
Total score - 47.7 , DeMeester normals less than 14.72 (95th percentile)

STEP 3 Associate Symptoms

SAP Table has associations (values > 95%)
SI Table has associations (one with value > 50%)

Additional Physician Notes

Further studies were done to check patient for delayed gastric emptying; studies were positive
Patient had no history of diabetes
After Bravo study, patient began a dopamine antagonist and PPIs were stopped; improvement
was noted
Reflux was secondary to delayed gastric emptying

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 Abnormal Nighttime Case
Interpretation: Positive Bravo pH Monitoring with Supine Reflux
History
Patient with a history of 4 cm hiatal hernia
Noted low LES pressure on esophageal manometry
EGD positive for esophagitis
Testing was done as pre-operative evaluation prior to surgery for reflux

STEP 1 Assess the pH Tracing

4 Meal & Supine times are entered
q 4
q Artifacts (if any) are noted
4 Symptoms are entered and/or uploaded
q 4
q Capsule did not detach during study

Reflux occurs often at night (and often during the day as well)
Tracing shows symptom associations

Short Artifact

Supine Acid Reflux

Heartburn Associated
with Acid Reflux

Heartburn

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 Abnormal Nighttime Case
STEP 2 Affirm Preliminary Diagnosis
Fraction Time pH < 4 is > 4.4% on both days
DeMeester Score is > normal (14.72) on both days
Worst Day

DeMeester Score-Day 1
Total score - 78.8 , DeMeester normals less than 14.72 (95th percentile)

STEP 3 Associate Symptoms

SAP Table shows good correlation of symptom (98.7% heartburn) which can also be seen on the tracing
SI Table has heartburn association as well (but at 46.7%)

Additional Physician Notes

Patient proceeded to surgery

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 Abnormal Combination Case

Interpretation: Positive Bravo for Reflux

History
Male patient with history of short-segment Barretts esophagus
History of cough (to the point of passing out)
Complaints of mild heartburn which was well controlled on PPI (bid)
Testing was done off medication
Testing done for evaluation prior to surgical Nissen fundoplication

STEP 1 Assess the pH Tracing

4 Meal & Supine times are entered
q 4
q Artifacts (if any) are noted
4 Symptoms are entered and/or uploaded
q 4
q Capsule did not detach during study

Reflux occurs during both day and night

Tracing shows symptom associations

Artifact
Belch

Heartburn Associated
with Acid Reflux

Daytime and Nighttime Acid Reflux

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 Abnormal Combination Case
STEP 2 Affirm Preliminary Diagnosis
Fraction Time pH < 4 is > 4.4% on both days
DeMeester Score is > normal (14.72) on both days

Worst Day

DeMeester Score-Day 2
Total score - 69.1, DeMeester normals less than 14.72 (95th percentile)

STEP 3 Associate Symptoms

SAP Table shows no symptom association value > 95%
SI Table has heartburn and belch associations (values > 50%); Note that there was only one belch throughout
the study

Additional Physician Notes

Patient proceeded to surgery

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 Example of Early Detachment
Additional Physician Notes

This study is an example of early detachment of the capsule prior to completion of 48 hours of recording
The capsule remains in the stomach, as evidenced by pH levels of approximately 2.0
There is an atypical blip with pH > 4 after the detachment; however, capsule detachment is still evident
due to long period with pH < 2 followed by a sharp rise to pH ~7
Capsule leaves the stomach and enters the duodenum at approximately 00:00 (as evidenced by pH ~ 7.0;
indicating that capsule is reading alkaline pH which suggests bile is now being detected)
REMEMBER: You MUST create an Ignore diary event from the point of capsule detachment to the end
of the recording. Otherwise, the pH data captured during this period will be included in the softwares
calculation.
There may still be enough data to provide an interpretation, depending on the amount of time data was
captured before the detachment. (In this case, the capsule detached after 30+ hours.)

Detachment pH < 2 Atypical Blip > 4 Entered

for Extended Period Small Bowel pH ~7

You MUST create an Ignore diary event from the point of capsule detachment
to the end of the recording. Otherwise, the pH data captured during this period
will be included in the softwares calculation.

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Risks include: premature detachment, discomfort, failure to detach, tears in the mucosa,
bleeding, and perforation. Endoscopic or transnasal placement may present additional
risks. Medical, endoscopic, or surgical intervention may be necessary to address any
of these complications, should they occur. Please consult the User Manual or refer to
www.givenimaging.com for detailed information.

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