Transcript Treating Barrett`s esophagus

REDEFINING
REFLUX CARE
A PROACTIVE APPROACH TO
MANAGING GERD AND BARRETT’S
ESOPHAGUS
PRESENTED BY LEVEL 1
NAME LEVEL 2
GERD MACRO TRENDS
GERD has a serious effect on healthcare—in terms of both patient
outcomes and economic burden
Gastroesophageal reflux disease (GERD) affects up to 40% of the U.S.
population in their lifetime1
$10 billion per year is spent on proton pump inhibitors2
PPIs have been associated with several complications, including
osteoporosis, bone fracture, hypomagnesaemia and pneumonia3
About 30% of GERD patients fail to respond symptomatically to
standard dose PPIs1
GERD may lead to serious health consequences, including esophagitis,
strictures, ulcers and Barrett’s esophagus1
1. Vaezi M, Zehrai A, Yuksel E. Testing for refractory gastroesophageal reflux disease. ASGE Leading Edge. 2012;2(2):1-13. American Society Gastroenterology Endoscopy, Pages 1-4.
2. Shaheen N, Hansen R, Morgan D, Gangarosa L, Ringel Y, Thiny M, et al. The burden of gastrointestinal and liver diseases. American Journal of Gastroenterology. 2006;101:2128-2138.
3. Nimish V. Prescribing proton pump inhibitors: Is it time to pause and rethink? Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison WI. Drugs. 2012;72:437-445.
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GERD PUBLIC HEALTH TRENDS
 Symptoms of GERD are
heterogeneous, making diagnosis
difficult1
 Annual spending on PPIs is a large
public health burden2
 Prescribing PPIs without a diagnosis
further exacerbates spending3
 Reflux testing is a reimbursed
procedure that helps definitively
diagnose GERD4
 Insights gained from reflux testing
help the physician choose the right
therapeutic option or stop
unnecessary therapy4
1.
2.
3.
4.
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Richter J, Pandolfino J, Vela M, et al. Utilization of wireless pH monitoring technologies: a summary of the proceedings from the Esophageal Diagnostic working Group. Disease of the Esophagus, 2012 August 7.
Shaheen N, Hansen R, Morgan D, Gangarosa L, Ringel Y, Thiny M, et al. The burden of gastrointestinal and liver diseases. American Journal of Gastroenterology. 2006;101:2128-2138.
Vakil N. Prescribing Proton Pump Inhibitors: Is it Time To Pause and Rethink? Drugs. 2012;72:437-445.
Gawron A, Pandolfino JE. Ambulatory reflux monitoring in GERD: Which test should be performed and should therapy be stopped? Curr Gastrenterol Rep. 2013;15:316.
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THE PATIENT JOURNEY
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CLINICAL RECOMMENDATIONS
UTILIZATION OF WIRELESS PH MONITORING
TECHNOLOGIES1
“The optimal work-up for patients being evaluated for GERD symptoms without
previous objective evidence of abnormal pathologic acid reflux is ambulatory pH
monitoring done ‘OFF’ medication”
 Patients who continue to have symptoms when on double dose PPI therapy
should be tested “OFF” PPI therapy to help determine which patients do not
have pathologic acid gastroesophageal reflux and should stop using PPIs;
which patients should be referred for treatment focused on non-GERD
etiologies; and which patients may require further testing for optimizing GERD
management
 Wireless ambulatory pH monitoring should be performed for at least 48 hours,
in order to increase the diagnostic yield and reduce false negative studies
 pH impedance monitoring can be utilized as an adjunct diagnostic test to
support management decisions in patients with objective evidence of GERD
1. Richter J, Pandolfino J, Vela M, Kahrilas P, Lacy B, Ganz R, et al. Utilization of wireless pH monitoring technologies: a summary of the proceedings from the Esophageal Diagnostic Working Group. Disease of the
Esophagus. 2013;26:755-765
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CLINICAL RECOMMENDATIONS
GUIDELINES FOR THE DIAGNOSIS AND MANAGEMENT
OF GASTROESOPHAGEAL REFLUX DISEASE1
“Patients with refractory GERD and negative evaluation by endoscopy or
evaluation by ENT, pulmonary, and allergy specialists should undergo ambulatory
reflux monitoring”
 It has been estimated that failure to control symptoms occurs in up to 40%
of patients treated with a PPI
 The vast majority of patients with heartburn and regurgitation will not have
erosions limiting upper endoscopy as an initial diagnostic test in patients with
suspected GERD
 In a patient with a negative test “OFF” therapy, PPIs can be stopped and the
diagnostic effort should be steered toward non-GERD etiologies
 Telemetry capsule pH monitoring offers increased patient tolerability and the
option to extend the monitoring period to 48 or perhaps to 96 hours
 Catheter-based monitoring allows for the addition of impedance and detection
of weakly acidic or non-acid reflux
1. Katz P, Gerson B, Vela M. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;(3):308-28.
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CLINICAL RECOMMENDATIONS
USE OF MOTILITY TESTING IN PATIENTS
WITH REFRACTORY GERD
HIGH RESOLUTION ESOPHAGEAL MANOMETRY
 Manometry is indicated to establish the diagnosis of dysphagia in instances in
which a mechanical obstruction (e.g., stricture) cannot be found, especially in
cases where a diagnosis of achalasia is suspected1
 Manometry is recommended to evaluate patients with a suspected esophageal
GERD syndrome who have not responded to an empirical trial of twice-daily
PPI therapy and have normal findings on endoscopy2
 All patients with suspected achalasia who do not have evidence of a
mechanical obstruction on endoscopy or esophagram should undergo
esophageal motility testing before a diagnosis of achalasia can be confirmed3
 Esophageal manometry is recommended for preoperative evaluation—all
patients should undergo preoperative manometry to rule out achalasia or
scleroderma-like esophagus4
1.
2.
3.
4.
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Pandolfino JE, Kahrilas PJ. AGA medical position statement. Clinical use of esophageal manometry. Gastroenterology. 2005;128:207-208.
Hiltz SW, et al. AGA medical position statement on management of GERD. Gastroenterology. 2008; 135:1383-1391.
Vaezi MF, et al. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastro. 2013;108(8):1238-49.
Katz PO, et al. Guidelines for the diagnosis and management of GERD. Am J Gastro. 2013;108:308-328.
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THE DIAGNOSTIC PATHWAY
Reflux testing aids in effective patient management1
 Evaluate patients with normal EGD who are refractory to PPI therapy
 Discontinue PPI therapy if GERD is ruled out
 Refer patients for assessment of non-GERD causes of symptoms
1. Richter J, Pandolfino J, Vela M, Kahrilas P, Lacy B, Ganz R, et al. Utilization of wireless pH monitoring technologies: a summary of the proceedings from the Esophageal Diagnostic Working Group. Disease of the
Esophagus. 2013;26:755-765
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RECOMMENDED APPROACH TO DIAGNOSIS1,2
1. Kleiman DA, Beninato BP, et al. Early referral for esophageal pH monitoring is more cost-effective than prolonged empiric trial of proton pump inhibitors for suspected gastroesophageal reflux disease.
J Gastrointest Surg. 2014;26-33.
2. Gawron A, Pandolfino J. Ambulatory reflux monitoring in GERD – Which test should be performed and should therapy be stopped? Published online: 9 March 2013.
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A SERIOUS DISEASE PROGRESSION
Timely diagnosis and treatment of GERD is essential, as it is part of a
serious disease progression that can lead to Barrett’s esophagus and
esophageal adenocarcinoma1
Normal, healthy
esophagus
Esophagus damaged
by prolonged
acid exposure
Barrett’s
esophagus tissue
1. “Complications of Heartburn and GERD.” WebMD. N.p., 2016. Web. 15 Feb. 2016.
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Dysplastic
Barrett’s esophagus
Esophageal
adenocarcinoma
TREATING BARRETT’S ESOPHAGUS
SURVEILLANCE VS. RADIOFREQUENCY (RFA) ABLATION
A study of patients with confirmed low-grade dysplasia (LGD) Barrett’s
esophagus compared the efficacy of surveillance vs. radiofrequency ablation for
reducing progression to high-grade dysplasia (HGD) or esophageal
adenocarcinoma (EAC)1
1. Phoa KN, van Vilsteren FG, Weusten BL, Bisschops R, Schoon EJ, Ragunath K, et al. Radiofrequency ablation vs. endoscopic surveillance for patients with Barrett’s esophagus and low-grade dysplasia: a randomized
clinical trial. JAMA. 2014;311(12):1208-1217.
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TREATING BARRETT’S ESOPHAGUS
SURVEILLANCE VS. RADIOFREQUENCY ABLATION
A study of patients with confirmed low-grade dysplasia (LGD) Barrett’s
esophagus compared the efficacy of surveillance vs. radiofrequency ablation for
reducing progression to high-grade dysplasia (HGD) or esophageal
adenocarcinoma (EAC)1
1. Phoa KN, van Vilsteren FG, Weusten BL, Bisschops R, Schoon EJ, Ragunath K, et al. Radiofrequency ablation vs. endoscopic surveillance for patients with Barrett’s esophagus and low-grade dysplasia: a randomized
clinical trial. JAMA. 2014;311(12):1208-1217.
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TREATING BARRETT’S ESOPHAGUS
SURVEILLANCE VS. RADIOFREQUENCY ABLATION
The Barrx™ radiofrequency ablation system reduced progression of lowgrade dysplasia (LGD) to high-grade dysplasia (HGD) or esophageal
adenocarcinoma (EAC) by 94%1
1. Phoa KN, van Vilsteren FG, Weusten BL, Bisschops R, Schoon EJ, Ragunath K, et al. Radiofrequency ablation vs. endoscopic surveillance for patients with Barrett’s esophagus and low-grade dysplasia: a randomized
clinical trial. JAMA. 2014;311(12):1208-1217.
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INNOVATIVE SOLUTIONS
BRAVO™ REFLUX TESTING SYSTEM
 Capsule-based pH monitoring system
transmits pH data to recorder
 96 hours of pH recording increases the
identification of both symptoms and
acid reflux episodes1
 Allows physicians to document
relationships between symptoms
and acid reflux events
 Catheter-free design is less invasive
and allows patients to resume
regular activities
1. Garrean CP, Zhang Q, Gonsalves N, Hirano I. Acid reflux detection and symptom-reflux association using 4-day wireless pH
recording combining 48-hour periods off and on PPI therapy. Am J Gastroenterol. 2008;103:1631-1637. Page 1636, Col 2.
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INNOVATIVE SOLUTIONS
DIGITRAPPER™ PH AND IMPEDANCE TESTING SYSTEM
 Helps to correlate extra-esophageal
symptoms with reflux and
differentiates between acid and nonacid reflux to better identify the root
cause of symptoms1
 Improves accuracy of ruling out
weakly acidic NERD in order to
diagnose functional heartburn2
 Provides confirmation of efficacy of
PPI therapy, helping to maximize
appropriate treatment3
 Helps identify patients who are likely
to benefit from anti-reflux surgery4
1. Sifrim D, Castell D, Dent J, Kahrilas PJ. Gastro-oesophageal reflux monitoring: review and consensus report on detection and definitions of acid, non-acid, and gas reflux. Gut. 2004;53(7):1024-1031. Page 1030.
2. Mainie I, Tutuian R, Shay S, et al. Acid and non-acid reflux in patients with persistent symptoms despite acid suppressive therapy: a multicentre study using combined ambulatory impedance-pH monitoring. Gut.
2006;55(10):1398-1402.
3. Gawron AJ, Pandolfino JE. Ambulatory reflux monitoring in GERD: which test should be performed and should therapy be stopped? Curr Gastroenterol Rep. 2013;15(4):316 Page 7.
4. Hershcovici T, Fass R. Step-by-step management of refractory gastro-oesophageal reflux disease. Diseases of the Esophagus. 2012, Page 7.
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INNOVATIVE SOLUTIONS
MANOSCAN™ ESOPHAGEAL MANOMETRY SYSTEM
 Provides additional motor correlates
for esophageal hypermotility
and GERD1
 Enables complete physiological
mapping of motor function from
pharynx to stomach2
 Helps distinguish patterns of
esophageal pressurization to aid in
the diagnosis of multiple subtypes
of achalasia3
 Esophageal manometry offers useful
clinical information before anti-reflux
surgery and provides insights that
may alter surgical decisions1
1. Mello M, Gyawali C. Esophageal Manometry in Gastroesophageal Reflux Disease. Gastroenterology Clinics of North America. 2014;43(1):83.
2. Kahrilas P. Esophageal Motor Disorders in Terms of High-Resolution Esophageal Topography: What Has Changed? Am J Gastroenterology. 2010;105: 981-987.
3. Bansal A, et al. Has high-resolution manometry changed the approach to esophageal motility disorders? Curr Opin Gastroenterol. 2010;26;344-351.
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INNOVATIVE SOLUTIONS
BARRX™ RADIOFREQUENCY ABLATION SYSTEM
 Patients with low-grade dysplasia
have a substantial progression risk1
 The Barrx™ radiofrequency ablation
system is proven to reduce the risk of
low-grade dysplasia progressing to
high-grade dysplasia or esophageal
adenocarcinoma by 94%1
 Endoscopic ablation will move the
standard of care of Barrett’s
esophagus from surveillance to a
cancer prevention strategy2
 Comprehensive results for RFA have
been presented in more than 90 peerreviewed publications1,3
1. Phoa KN, van Vilsteren FG, Weusten BL, Bisschops R, Schoon EJ, Ragunath K, et al. Radiofrequency ablation vs. endoscopic surveillance for patients with Barrett’s esophagus and low-grade dysplasia:
a randomizedclinical trial. JAMA. 2014;311(12):1208-1217.
2. El-Serag HB, Graham DY. Routine polypectomy for colorectal polyps and ablation for Barrett’s esophagus are intellectually the same. Gastroenterology. 2011;140:386-388.
3. Shaheen NJ et al. Radiofrequency ablation in Barrett's esophagus with dysplasia. N Engl J Med. 2009;360(22):2277-88.
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RISK INFORMATION
Caution: Federal law restricts this device to sale by or on the order of a licensed
healthcare practitioner. Rx only.
Risk Information: The risks of the Bravo™ reflux testing system include premature
detachment, discomfort, failure to detach, failure to attach, capsule aspiration, capsule
retention, tears in the mucosa, bleeding, and perforation. Endoscopic placement may
present additional risks. Medical, endoscopic, or surgical intervention may be necessary
to address any of these complications, should they occur. Because the capsule contains
a
small magnet, patients should not have an MRI study within 30 days of undergoing the
Bravo™ reflux test. Please refer to the product user manual or medtronic.com/gi for
detailed information.
The risks of catheter insertion into the nasal passage associated with the Digitrapper™ pH
and impedance testing system include: discomfort, nasal pain, minor bleeding, runny
nose, throat discomfort, irregular heartbeat with dizziness, and perforation. In rare
instances, the catheter may be misdirected into the trachea causing coughing or choking,
or the catheter may shift up or down causing false results. Medical, endoscopic, or
surgical intervention may be necessary to address any of these complications, should
they occur. The system is not compatible for use in an MRI magnetic field. Please refer to
the product user manual or medtronic.com/gi for detailed information.
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RISK INFORMATION
The risks of catheter insertion into the nasal passage associated with the ManoScan™
ESO high resolution manometry system include: discomfort, nasal pain, minor bleeding,
runny nose, throat discomfort, irregular heartbeat with dizziness, and perforation. In rare
instances, the catheter may be misdirected into the trachea causing coughing or choking,
or the catheter may shift up or down causing false results. Medical, endoscopic, or
surgical intervention may be necessary to address any of these complications, should
they occur. These systems are not compatible for use in an MRI magnetic field. Please
refer to the product user manual or medtronic.com/gi for detailed information.
The following are transient side effects that may be expected after treatment: chest pain,
difficulty swallowing, painful swallowing, throat pain and/or fever. Complications observed
at a very low frequency include: mucosal laceration, minor and major acute bleeding,
stricture, perforation, cardiac arrhythmia, pleural effusion, aspiration, and infection.
Potential complications that have not been observed include: death. Please refer to the
product user manual or medtronic.com/gi for detailed information.
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