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Outpatient Monitoring of Oesophageal pH With Catheter Free pH

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Outpatient Monitoring of Oesophageal pH
With a Catheter-Free pH-Meter (Bravo® System).
A Study of Tolerance, Safety, and Efficacy
Luisa F. Martínez de Haro, Vicente Munitiz, Ángeles Ortiz, David Ruiz de Angulo, M. Dolores Navarro, and Pascual Parrilla
Servicio de Cirugía General, Hospital Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain




Abstract                                                                conventional pH as well as with the Bravo®. If we analyse
                                                                        the patient group with disease due to gastric-
  Background and objective. A new catheter-free                         oesophageal reflux with those on whom both techniques
outpatient oesophageal pH-meter system (Bravo®), has                    were used (group 3), 7 of the 10 patients had a
recently been developed.The objective of this study is                  pathological reflux that only showed up on measuring
to test the tolerance, safety and efficacy of the system                pH with the Bravo® system.
in the measurement of gastric-oesophageal reflux by                       Conclusions. Catheter-free pH measurements (Bravo®)
comparing it with a conventional pH system.                             is better tolerated and with better satisfaction for the
  Patients and method. The study was performed on a                     healthy volunteers and patients than with conventional
control group consisting of 10 healthy volunteers (group                PH, even, on occasions being more efficient for studying
1) and in a group of 40 patients with symptoms of gastric-              acid reflux due to the lower incidence of negative results.
oesophageal reflux disease (groups 2 and 3). An upper
digestive sytem endoscopy, oesophageal manometry                        Key words: pH monitoring. Esophagus. Gastroesophageal
and oesophageal pH measurements with a conventional                     reflux. Bravo.
system and/or with the Bravo® catheter-free system,
was performed on all patients. All patients who had both
tests done (groups 1 and 2) filled in a questionnaire on
any physical problems and changes in their daily activity.
  Results. The test tolerance was higher with the Bravo®                MONITORIZACIÓN AMBULATORIA DEL PH
system in the 9 parameters studied. In the group of                     ESOFÁGICO CON PH-METRÍA SIN SONDA (SISTEMA
healthy volunteers (group 1), the median (range) of the                 BRAVO®). ESTUDIO DE TOLERANCIA, SEGURIDAD
total percentage of pH<4 was 1.1% (0.5-3.1) with the                    Y EFICACIA
conventional pH and 1.7% (0-3.4) with the Bravo®.When
comparing the patients with symptoms of gastric-                          Fundamento y objetivo. Recientemente se ha desa-
oesophageal reflux disease (group 2) with those who                     rrollado un nuevo sistema de pH-metría esofágica
had only one type of pH measurement made, the acid                      ambulatoria sin catéter, el sistema Bravo®. El objetivo
reflux was significantly higher in patients with Barrett’s              de este estudio es comprobar la tolerancia, la seguri-
oesophagus than in the rest of the groups, with                         dad y la eficacia del sistema en la medición del reflu-
                                                                        jo gastroesofágico, en comparación con la pH-metría
                                                                        convencional.
                                                                          Pacientes y método. El estudio se realizó en un
                                                                        grupo control constituido por 10 voluntarios sanos
                                                                        (grupo 1) y en un grupo de 40 pacientes con sínto-
                                                                        mas de enfermedad por reflujo gastroesofágico (gru-
This study has been carried out thanks to the grant from the FIS
(Carlos III Health Institute) No. 03/0497.                              pos 2 y 3). A todos los pacientes se les realizó en-
                                                                        doscopia digestiva alta, manometría esofágica y
Correspondence: Dra. L.F. Martínez de Haro.                             pH-metría esofágica convencional y/o pH-metría sin
Servicio de Cirugía General. Hospital Universitario Virgen              catéter con el sistema Bravo®. Todos los pacientes a
de la Arrixaca.                                                         los que se realizaron ambas pruebas (grupos 1 y 3)
Ctra. Cartagena, s/n. 30120 El Palmar. Murcia. España.                  rellenaron un cuestionario sobre molestias físicas y
E-mail: marial.martinez6@carm.es                                        alteraciones de su actividad diaria.
                                                                          Resultados. La tolerancia de la prueba fue mejor
Manuscript received December 15, 2007; accepted for publication         con el sistema Bravo® en 9 de los 10 parámetros es-
April 9, 2008.

                                                                                                      Cir Esp. 2008;84(4):201-9   201
Martínez de Haro LF et al. Outpatient Monitoring of Oesophageal pH With a Catheter-Free pH-Meter (Bravo® System).
A Study of Tolerance, Safety, and Efficacy


tudiados. En el grupo de voluntarios sanos (grupo 1),                  With the aim of avoiding the aforementioned
la mediana (intervalo) del porcentaje total de pH < 4                inconveniences, a new system of outpatient monitoring of
fue del 1,1% (0,5-3,1%) con la pH convencional y el                  oesophageal pH is now being used which does not require
1,7% (0-3,4%) con el sistema Bravo®. En cuanto a los                 the use of a permanent catheter to study pH levels. The
pacientes con síntomas de enfermedad con reflujo                     Bravo® system (Medtronics Inc., Shoreview, United States)
gastroesofágico (grupo 2) a los que se realizó sólo                  consists of a measuring capsule which is inserted in the
un tipo de pH-metría, el reflujo ácido fue significativa-            oesophagus. It measures the pH level and transmits the
mente mayor en los pacientes con esófago de Barrett                  data by radiotelemetry to a receiver. This system has been
que en el resto de los grupos, tanto con la pH con-                  previously tested on animals and in clinical studies in
vencional como con el Bravo®. Si analizamos al gru-                  control groups using healthy volunteers.6,7 Others authors
po de pacientes con enfermedad por reflujo gastro-                   have published their experiences with a technology similar
esofágico a los que se realizaron ambas técnicas                     to Bravo® for studying gastric function and oesophageal
(grupo 3), 7 de los 10 pacientes tenían un reflujo pa-               pH.9
tológico que sólo se evidenció al realizar pH-metría                   The aim of this study is to check the tolerance, safety, and
con el sistema Bravo®.                                               efficacy of the catheter-free pH-monitoring system with
  Conclusiones. La pH-metría sin sonda (Bravo®) es                   radiotelemetry (Bravo®) in the measurement of gastro-
mejor tolerada y de mayor satisfacción para los vo-                  oesophageal reflux and to compare it with conventional pH
luntarios sanos y los pacientes que la pH-metría con-                measuring systems.
vencional, en ocasiones incluso es más eficaz para el
estudio del reflujo ácido por la menor frecuencia de
resultados negativos.
                                                                     Patients and Method
Palabras clave: pH-metría. Esófago. Reflujo gastroesofá-               This study included 10 healthy volunteers and 40 patients with GORD
gico. Bravo.                                                         who were grouped as follows:

                                                                        – Group 1. Both types of pH-monitoring were carried out on the 10
                                                                     healthy volunteers (average age, 27 [range, 25-59], 5 males and 5 females).
                                                                     The pH results were compared for both methods, as were the degree of
                                                                     satisfaction, the level of discomfort, and alterations to daily activities
                                                                        – Group 2. Thirty of the patients with GORD symptoms were divided
Introduction                                                         into 3 subgroups according to endoscopic findings: A: 10 no oesophagitis;
                                                                     B: 10 with I-II oesophagitis with no Barrett’s oesophagitis (BO); and C: 10
                                                                     with Barrett’s oesophagitis. Half the patients in each group underwent
   Twenty-four hour outpatient monitoring of oesophageal             standard pH-monitoring (n=15; 45 years of age [17-73], 9 males and 6
pH is the standard method for quantifying acid reflux1 as it         females) and the other half were monitored with the Bravo® system (n=15;
is the most specific and sensitive, and it has shown a good          37 years of age [21-59], 8 males and 7 females)
correlation with the severity of the symptoms and endoscopic            – Group 3. The remaining 10 patients (36.5-year-old [18-56], 7 males
                                                                     and 3 females) who had shown clear symptoms of GORD and a normal
injuries.2 It has also be proven very useful for checking the        or bordering on normal oesophageal pH level with the standard monitoring
efficacy of medical and surgical treatments for gastro-              system were re-tested with the Bravo® system to confirm whether or not
oesophageal reflux disease (GORD).3                                  they had acid reflux. The endoscopic findings in these 10 patients were
   Initially, studies into oesophageal pH were carried out in        as follows: 4 patients with I-II oesophagitis, 4 patients with BO, and 2
a motility laboratory which required a complex use of                patients with no oesophageal lesions.The degree of satisfaction, discomfort
                                                                     and alterations to daily activity were also recorded for these patients
infrastructure and the use of pH crystal catheters for
measuring oesophageal acid. Acid reflux measurements                 Inclusion Criteria
could be carried out for 24 hours afterwards, but always                 – General criteria: over the age of 18, informed consent of the risks,
inside the motility laboratory. In 1974, Johnson et al4 described    benefits and alternative diagnostic tests, committed to completing the
the most representative pH-monitoring parameters for the             follow-up protocol
                                                                         – Control group: fewer than 2 episodes of pyrosis or regurgitation per
study of pathological oesophageal acid reflux. During the            month, no dysphagia or other atypical reflux symptoms, no oesophageal
1980s, the introduction of analogical to digital data converters     motility disorders, not taken medication for acid reflux (proton pump inhibitors,
allowed the storage of a higher number of results in portable        anti-H2 and prokinetics). All patients had an upper endoscopy of the
units, and since then this exploration has been carried out          digestive tract which showed no evidence of a hiatal hernia or oesophagitis
in outpatients departments. However, despite this                        – Patient group: typical reflux symptoms (pyrosis and/or regurgitation)
                                                                     requiring treatment, and inflammatory lesions due to reflux in the
improvement in technology, the traditional method continues          oesophageal mucosa in subgroups B (oesophagitis) and C (BO) from
to require a catheter being passed through the nose and              group 2
down the oesophagus with the discomfort of having to remain
in this position for 24 hours, linked up to an external system       Exclusion Criteria
which collects and records the required data. This system               The following patients were excluded from the test: those under 18 years
                                                                     of age, those with oesophageal stenosis, oesophageal varix, any type of
can cause nose and throat discomfort, rhinorrhea,                    lesion affecting the nostrils, severe oesophageal motor disorders, high
cephalalgia, odynophagia, and certain social discomfort. All         anaesthetic risk (ASA-IV-V), previous history of coagulopathy, haemorrhage,
of these inconveniences limit daily activity and the ingestion       intake of anticoagulants or platelet antiaggregates, history of myocardial
of foods, conditioning the lifestyle of the patient over the         infarction or cerebrovascular accident in the 6 months before the study,
course of the study and even negatively affecting it. This           pregnant, history of radiotherapy in the thoracic region, history of digestive
                                                                     haemorrhage in the 6 months prior to the study, any known medical disorder
system can produce false negatives or the actual reflux              which could alter the data in the study, unable to accept all the study
presented by the patient can be underestimated.5                     protocols.

202     Cir Esp. 2008;84(4):201-9
                        Martínez de Haro LF et al. Outpatient Monitoring of Oesophageal pH With a Catheter-Free pH-Meter (Bravo® System).
                                                                                                  A Study of Tolerance, Safety, and Efficacy




                                                                                 Figure 2. Image showing the Bravo radio-receiver and delivery device
                                                                                 for capsule insertion. There is an orifice on the handle for creating
                                                                                 the suction and at the top there is a button for extracting the needle
Figure 1. Image of the capsule.                                                  which fixes the capsule to the oesophageal mucosa.


Endoscopy of the Upper Digestive Tract                                           upper border of the IOS (previously located with a manometry), negative
   An endoscopy of the upper digestive tract was carried out on all the          pressure is applied with a suction device connected to the proximal side
subjects to assess the presence of oesophageal inflammatory lesions              of the delivery device which applies suction to a section of the oesophageal
(Savary-Miller10), metaplastic epithelium, oesophageal varix, oesophageal        mucosa through a 3.5 mm orifice in the capsule. A device then inserts a
stenosis or any other oesophageal or pharyngeal lesions which could              small needle in place, thereby fixing the capsule to the mucosa. The
complicate the study and which could lead to complications for the patient       introduction of the delivery device and the placement of the capsule are
or volunteer.                                                                    mostly carried out without the need for a simultaneous endoscopy. In
                                                                                 previous studies carried out in the Surgery Department of the University
Stationary Oesophageal Manometry                                                 of Southern Carolina,6 the percentage of cases in which the capsule was
   A stationary oesophageal manometry was carried out on each subject            attached correctly to the mucosa was 97%. Once the capsule is in place,
to exactly identify the location of the inferior oesophageal sphincter (IOS).    it begins to register and transmit a signal to the receiver (Figure 2), which
A continuous perfusion 4-electrode catheter was used for the manometry           is a small device (100 mm × 70 mm × 30 mm and weighing 165 grams)
with a hydropneumo-caplliary perfusion pump (JS Biomedicals Inc., Ventura,       which can be fixed to a belt, with a small screen where the pH value is
CA, United States) and a polygraph (Synectics Medical, Stockholm, Sweden)        displayed.
connected to a personal computer. The technique has been described in                The test was carried out over 48 consecutive hours in a outpatient
previous studies.11                                                              departments. It also requires keeping a record of meal times and supine
                                                                                 position.This is also the case with the conventional ph-monitoring system.
                                                                                 After 48 hours the patient or the volunteer returns to the motility laboratory
Conventional pH-Monitoring
                                                                                 to return the receiver and the diary they have kept. The receiver transmits
   For those patients selected to be monitored with the conventional ph-
                                                                                 the data to a personal computer using infrared rays. A software programme
monitoring, the procedure was carried out using a Digitrapper Mark III ph-
                                                                                 is then used to analyse the data following the Johnson and DeMeester
monitoring (Synectics, Stockholm, Sweden) and a pH catheter with an
                                                                                 methodologies, as is also the case with the conventional ph-monitoring
antinomy electrode placed 5 cm above the upper edge of the IOS, which
                                                                                 (Figure 3A and B).
itself had previously located with an oesophageal manometry. For both the
                                                                                     For all patients using the Bravo® system, a simple radiograph of the
conventional ph-monitoring and the Bravo® system the pH electrodes were
                                                                                 thorax and abdomen was carried out after 7 days to check that the capsule
calibrated in pH 7 and pH 1 buffers, and GORD medication was withdrawn
                                                                                 had been expelled. This was repeated at 15 days if required (Figure 4A
from the patients at least 1 week before the study. The results obtained
                                                                                 and B), as mentioned by previous authors.6,7,13
were analysed by a computer programme (Esophogram Gastrosoft, Irving,
                                                                                     All the patients completed a questionnaire (Figure 5) about any possible
United States) following the Johnson et al4 methodology. Normality values
                                                                                 physical problems (nasal, pharyngeal, thoracic), or alterations to their daily
were established in line with those universally agreed: percentage of total
                                                                                 life, moods, sleep pattern, or meals, as well as their degree of satisfaction
time with oesophageal pH <4 less than 4.5%, or a DeMeester score of
                                                                                 with the test carried out. In total, 10 parameters were tested with 5 options
less than 14.7 points.
                                                                                 each (1=none [problems or alterations], 2=few, 3=moderate, 4=a lot,
                                                                                 5=unbearable problems or complete alterations to daily activity).
Radiotelemetry-pH-Monitoring (Bravo®)
   For the patients and volunteers selected for the catheter-free pH-            Statistical Analysis
monitoring this was carried out with a radiotelemetry ph-monitoring known           All the data was analysed using the SPSS 14 computer programme
as the Bravo® system (Medtronics, IN., Shoreview, United States). It             (SPSS, Inc. Chicago, Illinois, United States). The average, median and
consists of a small measuring capsule (25 mm × 6 mm × 5.5 mm) (Figure            range were taken for all the data. The comparison between the results of
1) which contains an antimony pH electrode, a radio-transmitter and a            the subjective assessment of both test types on the volunteers (group 1)
battery. It measures the pH in the oesophagus every 6 seconds and every          and the patients with GORD from group 3 were carried out using the
12 seconds it transmits the pH data to a receiving unit via radio waves.         Wilcoxon statistical text.The percentages of the study of pH-measurement
The delivery device for putting the capsule in place (Figure 2) has the          with both systems were compared using the t-student statistical method.
capsule attached to its distal side and a connection device for applying         A P value less than .05 was considered significant.
suction attached to its proximal side.This is then inserted nasally or orally.      This study was carried out with the authorisation of our hospital’s Ethical
Once the distal side of the delivery device is in place, 5 cm above the          Committee and Research Committee.

                                                                                                                       Cir Esp. 2008;84(4):201-9          203
Martínez de Haro LF et al. Outpatient Monitoring of Oesophageal pH With a Catheter-Free pH-Meter (Bravo® System).
A Study of Tolerance, Safety, and Efficacy




                                                                                                                                   A




                                                                                                                                   B

Figure 3. pH recordings with the Bravo system. A: control group, with no pathological gastro-oesophageal acid reflux, (total percentage with
pH<4=1.6%). B: patients with Barrett’s oesophagitis, severe pathological GER (total percentage with pH<4=47.4%). The records correspond
to a 48 hour period.



Results                                                                 up from the 10 parameters (minimum 10 points = no
                                                                        problems, maximum 50 points = unbearable), gives an
Placement and Expulsion of Bravo®                                       average of 24 points (16-29) in the conventional ph-
                                                                        monitoring system, and 12 points (11-15) with the Bravo®
   The device was inserted nasally in 25 patients and orally            system ( P =.01); there was generally a higher level of
in 10. This was the preference for the latter patients as they          satisfaction with the Bravo® system than the conventional
were more tolerant to it and found it easier. In these 10               ph-monitoring system. All the volunteers in the control
patients, the manometry was also carried out orally. Three              group chose the Bravo® system as being the most tolerated
patients experienced a failure in the placement of the Bravo®           choice should they have to repeat the test.
capsule as it was incorrectly inserted in the oesophageal                  As can be seen in Table, the measuring time was longer
mucosa. In 2 patients the capsule fell into the stomach, and            in Bravo® than in the conventional ph-monitoring test as it
in the third patient, the capsule was immediately vomited               was done over a 48 hour period. However there were no
back up. Insertion was reattempted 15 days later for the first          differences in either method with regards to the quantification
2 patients. All the patients excreted the capsule in the 15             of the total percentage of time with pH<4 (1.1% with the
days following the test.                                                conventional pH test and 1.7% with the Bravo® test), keeping
                                                                        in mind that both tests were carried out on the same subjects.
                                                                        The 95 percentile was 2.7 in the conventional test and 2.9%
Group 1: Control Group                                                  in the Bravo® test.

   In the group of healthy volunteers, there were significant
differences in the subjective assessment of both tests                  Group 2: Patients With GORD
( P <.05) (Figure 6); a lower score was recorded (less
problems or alterations to daily activity) for the catheter-              Table shows the results from the oesophageal pH text
free ph-monitoring (Bravo®) in 9 of the 10 parameters                   using both systems on each one of the subgroups with
studied. Thoracic discomfort was higher with the Bravo®                 patients with GORD. It can be seen that with both the
system (not statistically significant). Adding all the scores           conventional ph-monitoring and the Bravo® system, acid

204     Cir Esp. 2008;84(4):201-9
                     Martínez de Haro LF et al. Outpatient Monitoring of Oesophageal pH With a Catheter-Free pH-Meter (Bravo® System).
                                                                                               A Study of Tolerance, Safety, and Efficacy




A                                                                        B

Figure 4. A: radiography of a control thorax showing the capsule in position in the oesophagus; the electrode, radio transmitter, batteries, and
antenna can be seen. B: radiography of the abdomen 7 days after placement of the Bravo® capsule. The capsule has still not been expelled
and is seen here in the rectosigmoid area. A new radiography carried out 48 hours later showed the expulsion.



reflux was significantly higher (P<.05) in those patients with            pH using the Bravo® system (Figure 7). As with the control
BO (subgroup C) than in those with oesophagitis with no                   group, the degree of satisfaction with the Bravo® system
BO (subgroup B) and in the patients with symptoms of                      was significantly higher than with the conventional ph-
gastro-oesophageal reflux without inflammatory lesions                    monitoring system (Figure 6).
(subgroup A), although we cannot compare between both
techniques in this groups as they were carried out on different
patients.                                                                 Discussion
   Lastly, we did compare the results from the first 24 hours,
the second 24 hours and the total results with the Bravo®                    Our results show that carrying out outpatients catheter-
system in patients with GORD (group 2). We could see that                 free oesophageal pH monitoring with the Bravo® system is
in 4 of the 15 patients (27%) there were discrepancies                    of great benefit to the patient and their tolerance to the test,
between the 2 days of monitoring and the final results, what              and it also provides more reliable results. All the patients
let us observe 4 patients showing pathological acid reflux                who took both tests (conventional pH-monitoring and Bravo®
that would have a negative result in a conventional 24 hour               system) preferred the catheter-free pH monitoring system,
pH-monitoring system.                                                     showing significant differences between the 2. The Bravo®
                                                                          system causes less nasal and pharyngeal discomfort for
                                                                          the patient, it barely alters the patient’s daily activities and
Group 3: Patients With GORD and a Negative                                it allows them to carry out their work normally and to have
Conventional pH                                                           a normal diet without any restrictions. These patients did
                                                                          frequently refer to the feeling of having a foreign body inside
  We noticed a higher period of time with pH<4 in the results             them and to a mild and transitory thoracic pain, above all
from the Bravo® studies (8.8%; 0.7-16.7) than with the                    in relation to the capsule being put in place in the oesophageal
conventional pH-monitoring results (4.1%; 0.8-4.5), with                  mucosa, and they also referred to a slight oesophageal
significant differences (P<.001). In total, 7 of the 10 patients          motor disturbance occurring in the area where the capsule
had pathological reflux which was only seen when measuring                was located.12

                                                                                                            Cir Esp. 2008;84(4):201-9      205
Martínez de Haro LF et al. Outpatient Monitoring of Oesophageal pH With a Catheter-Free pH-Meter (Bravo® System).
A Study of Tolerance, Safety, and Efficacy



  1. Have you experienced any discomfort in the nose during the test?
  None (1)             A little (2)    Average (3)     A lot (4)            Unbearable (5)

  2. Have you experienced any discomfort in the throat during the test?
  None (1)             A little (2)    Average (3)     A lot (4)            Completely (5)

  3. Have you experienced any discomfort in the chest during the test?
  None (1)             A little (2)    Average (3)     A lot (4)            Completely (5)

  4. Did the test alter your physical activity? (walking, gym, sport, etc)
  None (1)             A little (2)    Average (3)     A lot (4)            Completely (5)

  5. Did the test alter your daily meals? (type of food, quantity, drinks, etc)
  None (1)             A little (2)    Average (3)     A lot (4)            Completely (5)

  6. Did the test alter your sleep pattern? (Did you sleep more/less hours, or worse?)
  None (1)             A little (2)    Average (3)     A lot (4)            Completely (5)

  7. Did the test alter your ability to work (hours, concentration, difficulties, etc)
  None (1)             A little (2)    Average (3)     A lot (4)            Completely (5)

  8. Did the test alter your mental state or your mood?
  None (1)             A little (2)    Average (3)     A lot (4)            Completely (5)

  9. In general, did the test alter your daily life?
  None (1)             A little (2)    Average (3)     A lot (4)            Completely (5)

  10. Your overall degree of satisfaction with the test is:
  Very satisfied (1)   Satisfied (2)   Average (3)     Dissatisfied (4)     Very dissatisfied (5)    Figure 5. Individual questionnaire on
                                                                                                     tolerance, satisfaction, and modifications
                                                                                                     to daily life with the pH-monitoring.




   The method for inserting the capsule varies from author                with less nausea.This method was used in 10 patients from
to author. Some13-15 place it using an endoscopy to locate                our study and is currently the process of choice.16
the squamocolumnar junction of the oesophageal and gastric                   The Bravo® system safe and well tolerated. So far no
epithelium as a reference, and then the capsule is inserted               serious complications have been recorded in relation to its
6 cm above this, this point coincides with manometry                      placement.The capsule is not inserted very deeply (3 mm),
referencing. Therefore, an endoscopy needs to be carried                  almost like an endoscopic biopsy so there is virtually no risk
out, generally under sedation which increases the expense                 of perforation. Possible oesophageal haemorrhaging is also
of carrying out an outpatients pH-test. Also, in those patients           not an issue in the puncture area if logical precautions are
with Barrett’s oesophagitis, as the union of the epitheliums              taken such as contraindication in patients with oesophageal
is raised by the metaplasia, some of the points of reference              varix and extrinsic (anticoagulants or antiaggregants) or
are missed and it is almost impossible to securely place the              intrinsic coagulation. The capsule generally detaches in 3-
capsule. However, in patients who undergo a simultaneous                  5 days, although in some patients it can take longer than a
endoscopy as part of the investigation into their oesophageal             week and it is advisable to carry out a radiography of the
disorder, it can be useful to put the Bravo® capsule in place             thorax after 7 days to check. If after 15 days the capsule
at this stage. With regards to our study, and as is the case              has not become detached or there is any unbearable thoracic
with other authors,6 we prefer to place the electrode 5 cm                pain, it is advisable to carry out an endoscopy to extract the
above this reference point. Usually, most manometers and                  capsule.This has not been necessary in any of our patients,
Bravo® positioning devices are inserted nasally. Occasionally,            but other authors13 have communicated existing cases. Also,
due to the size of the capsule and/or disorder in the nostril,            none of our patients experienced the capsule becoming
insertion can be painful and in some cases, traumatic with                blocked in any section of the gastrointestinal tract after its
mild epistaxis. However, if the manometric monitoring of the              detachment and during its expulsion. For extra safety it could
IOS is carried out orally then the Bravo® positioning device              be advisable to carry out an abdominal radiograph (Figure
can be inserted more easily and quickly through the mouth                 5B) to check that it has been expelled.

206    Cir Esp. 2008;84(4):201-9
                      Martínez de Haro LF et al. Outpatient Monitoring of Oesophageal pH With a Catheter-Free pH-Meter (Bravo® System).
                                                                                                A Study of Tolerance, Safety, and Efficacy




                                                                           Conventional pH (n=20)                   Bravo (n=20)

                              A Lot 4
                                                                                                   P<.05


                           Average 3



                            A Little 2




                    No Discomfort 1
                                            e




                                                                                     ax



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Figure 6. Results on tolerance, satisfaction, and modifications to daily activity with both types of pH-monitoring in groups 1 (n=10) and 3
(n=10). Classification: 1 = no discomfort of alterations; 2 = few; 3 = average; 4 = a lot; 5 = unbearable discomfort or total alterations to activity.
In the last item (overall satisfaction with the test) 1 = very satisfied, 5 = very dissatisfied. P<.05 in all cases, except in thoracic discomfort.




                                                                                                                    Bravo       pH-Monitoring
                                                                        20
                                                                        18
                                                                        16
                                                                        14
                                                         Total pH, %




                                                                        12
Figure 7. Results of the pH-monitoring                                  10
in the subgroup with 10 patients (group 3)                               8
with evident symptoms of GORD and
negative pH levels in the conventional                                   6
pH-monitoring test or almost negative                                    4
levels in comparison with those then                                     2
obtained from the Bravo® system. The
dotted line show the normality level                                     0
                                                                                 1          2           3       4           5      6         7          8          9   10
(oesophageal pH<4 with regards the
total, 4.5%).



  However, although pH-monitoring with the Bravo® is safe                                         on the severity of oesophageal lesions which were much
and well tolerated by patients, it should also be pointed out                                     more prevalent in patients with BO (subgroup C), the same
that it is just as efficient as the conventional ph-monitoring                                    happened in a different group of patients who underwent
system in the quantification of oesophageal acid reflux.                                          the study with a conventional pH-monitoring. Other authors13,14
Pandolfino et al17 have carried out simultaneous studies of                                       have shown that the Bravo® system is more efficient than
oesophageal pH in healthy volunteers with the Bravo® and                                          the conventional pH-monitoring method as the pH recordings
conventional pH-monitoring systems and they have recorded                                         are not altered by modifications to daily activities or diet. On
some discrepancies in the measurements taken with both                                            occasion, when monitoring pH with an outpatients
systems due to problems of thermal calibration, which were                                        oesophageal pH-monitoring on a patient with typical
then resolved by modifying the software (Polygram Net,                                            symptoms of gastro-oesophageal reflux (pyrosis and acid
Medtonic, Inc.). Either way, it is necessary to establish some                                    regurgitation) the results have shown that there is no
normal values of oesophageal acid reflux with the Bravo®                                          pathological acid reflux (pH<4 with regards to the total
system which can be used as a reference for the scientific                                        <4.5%). In these cases the negative result can be explained
community as a whole.15                                                                           by various circumstances: a) it can happen that the symptoms
  From our results we can see that in group 2, the reflux                                         are due to reflux with a high biliary content; in this case
quantified using the Bravo® system increased depending                                            outpatient monitoring of oesophageal bilirubin (Bilitec®) or

                                                                                                                                            Cir Esp. 2008;84(4):201-9       207
Martínez de Haro LF et al. Outpatient Monitoring of Oesophageal pH With a Catheter-Free pH-Meter (Bravo® System).
A Study of Tolerance, Safety, and Efficacy


                                                                                                                                                                                                                                                                                                                                                                                                                                                         oesophageal impedance testing can be diagnostic; b)




                                                                                                                                                                                                                                           47.3 (44.2-47.5)
                                                                                                                                                                                                                                          27.3a (8.8-47.4)
                                                                                                                                                                                                                                          18.5b (5.1-38.1)

                                                                                                                                                                                                                                          30.9a (8.9-45.1)
                                                                                                                                                                                                                                                                                                                                                                                                                                                         symptoms can be caused by visceral hypersensitivity or by




                                                                                                                                                                                                                           Bravo (n=5)




                                                                                                                                                                                                                                          33.8a (2-69.7)
                                                                                                                                                                                                                                                                                                                                                                                                                                                         a gastric or biliary disorder in which case other diagnostic
                                                                                                                                                                                             Barrett’s Oesophagitis
                                                                                                                                                                                                                                                                                                                                                                                                                                                         tests need to be carried out for confirmation; c) it could be
                                                                                                                                                                                                                                                                                                                                                                                                                                                         the case of a false negative recorded due to significant
                                                                                                                                                                                                      (n=10)                                                                                                                                                                                                                                             modification in the habitual activity and diet of the patient
                                                                                                                                                                                                        (C)

                                                                                                                                                                                                                                                                                                                                                                                                                                                         which resulted in the test showing that the patient did not
      Results of the pH Study With the Conventional System and the Bravo® System in Healthy Volunteers and Patients With Gastro-Oesophageal Reflux Disease (GORD)




                                                                                                                                                                                                                                          34.7a (13.1-55.1)
                                                                                                                                                                                                                                           20.8 (20.1-22.2)
                                                                                                                                                                                                                                                                                                                                                                                                                                                         have reflux on that day or that it was under-recorded; and


                                                                                                                                                                                                                                          22.4a (9.7-29.2)
                                                                                                                                                                                                                       Conventional




                                                                                                                                                                                                                                            14b (5.1-28)

                                                                                                                                                                                                                                          31.1a (25-43)
                                                                                                                                                                                                                          (n=5)                                                                                                                                                                                                                          d) lastly the negative results could be because reflux varies
                                                                                                                                                                                                                           pH
                                                                                                                                                                                                                                                                                                                                                                                                                                                         in the same individual from one day to the next19 and on the
                                                                                                                                                                                                                                                                                                                                                                                                                                                         day of the pH-monitoring the patient did not show any signs
                                                                                                                                                                                                                                                                                                                                                                                                                                                         of pathological reflux. In these last 2 cases, carrying out
                                                                                                                                                                                                                                                                                                                                                                                                                                                         catheter-free pH monitoring with the Bravo® system could
                                                                                                                                                                                                                                                                                                                                                                                                                                                         be very useful and could clarify the diagnosis. In the current
                                                                                                                                                                                                                                          22.2 (21.2-22.5) 45.7 (43.4-46.6)
                                                                                                                                                                                                                                                            8.2 (7.5-14.3)
                                                                                                                                                                                                                                                            7.9 (4.8-14.6)
                                                                                                                                                                                                                                                            9.5 (5.5-15.2)
                                                                                                                                                                                                                                                              6 (5.5-21.9)
                                                                                                                                                                                                                           Bravo (n=5)
                                                                                                                                                                      GORD Group (Group 2)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         study the group of 10 patients with GORD all had negative
                                                                                                                                                                                                                                                                                                                                                                                                                                                         pH results with conventional pH-monitoring (group 3). This
                                                                                                                                                                                             Oesophagitis (B)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         group was re-tested with the Bravo® system and evidence
                                                                                                                                                                                              Non Barrett’s




                                                                                                                                                                                                                                                                                                                                                                                                                                                         of pathological reflux was shown in only 7 of those patients.
                                                                                                                                                                                                 (n=10)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         To explain this “recovery” in these patients with negative
                                                                                                                                                                                                                                                                                                                                                                                                                                                         results in the initial pH-testing it can be seen that the results
                                                                                                                                                                                                                                           7.5 (4.3-20.4)
                                                                                                                                                                                                                                          15.1 (7.3-19.8)
                                                                                                                                                                                                                       Conventional




                                                                                                                                                                                                                                                                                                                                                                                                                                                         of the questionnaire on test-tolerance and quality of life
                                                                                                                                                                                                                                           7.9 (3-19.5)
                                                                                                                                                                                                                                             7 (2.5-14)
                                                                                                                                                                                                                          (n=5)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         which the patients answered subjectively, are significantly
                                                                                                                                                                                                                           pH




                                                                                                                                                                                                                                                                                                                                                                                                                                                         better when carrying using the Bravo® system. In other words
                                                                                                                                                                                                                                                                                                                                                                                                                                                         the Bravo® system is more accepted and does not affect
                                                                                                                                                                                                                                                                                                                                                                                                                                                         daily activities.
                                                                                                                                                                                                                                                                                                                                                                                                                                                            On the other hand, this new system is currently more
                                                                                                                                                                                                                                           6.2 (0.9-11.8)
                                                                                                                                                                                                                                          45.7 (36-47.5)
                                                                                                                                                                                                                           Bravo (n=5)




                                                                                                                                                                                                                                           7.6 (0-11.2)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         expensive as the pH-monitoring capsule (Bravo®) can only
                                                                                                                                                                                                                                           6.1 (0.7-6)


                                                                                                                                                                                                                                           7.1 (0-9.5)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         be used once and the related technology increases its price.
                                                                                                                                                                                             No Oesophagitis




                                                                                                                                                                                                                                                                                                                                                                                                                                                         The cost is compensated by the efficacy of the study and
                                                                                                                                                                                                                                                                                                                                                                                                                                                         the possibility for the patient to completely carry out their
                                                                                                                                                                                                 (n=10)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         normal lives without any inconveniences or discomfort.
                                                                                                                                                                                                   (A)




                                                                                                                                                                                                                                                                                                                          P=.02 with regards to other groups. Without any other differences in any other the groups between conventional pH and Bravo.




                                                                                                                                                                                                                                                                                                                                                                                                                                                            To conclude, patients have a much better tolerance of the
                                                                                                                                                                                                                       Conventional




                                                                                                                                                                                                                                           5.8 (0.3-19.5)
                                                                                                                                                                                                                                           6.3 (0.1-13.7)
                                                                                                                                                                                                                                             3 (0.1-37.7)
                                                                                                                                                                                                                                          22.3 (21.4-24)



                                                                                                                                                                                                                                           6.7 (0-55.5)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         new system of outpatient monitoring of pH using a catheter-
                                                                                                                                                                                                                          (n=5)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         free pH meter (Bravo® system) than of the conventional pH-
                                                                                                                                                                                                                           pH




                                                                                                                                                                                                                                                                                                                                                                                                                                                         monitoring. It alters their daily life less and therefore it
                                                                                                                                                                                                                                                                                                                                                                                                                                                         decreases the number of negative results and is therefore
                                                                                                                                                                                                                                                                                                                                                                                                                                                         put forward as an efficient alternative to conventional
                                                                                                                                                                                                                                                                                     22.1 (20.1-23.2) 44.1 (23.3-47.5)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         oesophageal motility studies.
                                                                                                                                                                                                                           Bravo (n=10)



                                                                                                                                                                                                                                                                                                       1.7 (0-3.4)
                                                                                                                                                                                                                                                                                                       1.9 (0-4.8)
                                                                                                                                                                                                                                                                                                         1 (0-3.7)
                                                                                                                                                                                                                                                                                                       1.5 (0-8.2)
                                                                                                                                                                                             Control Group (Group 1)




                                                                                                                                                                                                                                                                                                                                                                                                                                                         References
                                                                                                                                                                                                      (n=10)




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                                                                                                                                                                                                                       Convention al




                                                                                                                                                                                                                                                                                      1.1 (0.5-3.1)
                                                                                                                                                                                                                                                                                      1.8 (0.4-4.8)

                                                                                                                                                                                                                                          Time in postprandial position with pH<4, % 1.7 (0.4-9.1)




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                                                                                                                                                                                                                                                                                      0.9 (0-3.4)




                                                                                                                                                                                                                                                                                                                                                                                                                                                             of gastroesophageal reflux and their contribution to patient management.
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                                                                                                                                                                                                                            pH




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                                                                                                                                                                                                                                          Duration, h




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                       Martínez de Haro LF et al. Outpatient Monitoring of Oesophageal pH With a Catheter-Free pH-Meter (Bravo® System).
                                                                                                 A Study of Tolerance, Safety, and Efficacy


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                                                                                                                   Cir Esp. 2008;84(4):201-9          209

				
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