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Transcript of GERD: More than just heartburn? - Chicago SGNA … · GERD: More than just heartburn? GERD is the...
GERD: More than just heartburn?
GERD is the third most prevalent disease in the United States1
Half of U.S. adults experience symptoms of GERD almost monthly while 20 percent experience symptoms weekly2
1. “Gastroesophageal Reflux Disease; Patients swallow "camera-in-a-pill" to help doctors check for GERD,” NewsRx.com 2005 Science Letter. 17 May 2005
<http://www.newsrx.com/cgi-bin/single_article_search.cgi>.
2. Shaheen, Nicholas. et al. Gastroesophageal Reflux, Barrett’s Esophagus and Esophageal Cancer Scientific Review. JAMA. 2002.Vol. 287. No. 15.
Well dear colleagues this is for sure the most severe
heart burn I have ever seen
i
• Epidemic of GERD is due to our “Super Size” culture and unhealthy eating habits
• According to the CDC more than half of the U.S. population is overweight or obese
Human Evolution in the US
Esophagus
Gastroesophageal Junction
Barrett’s Tissue
Stomach
Gastric Contents
Barrett’s Esophagus
Approximately 3.3 million adults in the United States have Barrett’s Esophagus
It is estimated that 13% of the people who have chronic acid reflux also have Barrett’s Esophagus
Top of Gastric Folds
SQJx
Sir Norman Barrett
Histologically
Esophageal Cancer EpidemicLinked to Obesity
Pohl H and Welch HG. J Natl Cancer Inst 2005; 95-142-146
Melanoma
Colorectal
Prostate
Esophagus
Lung/Breast
Complications due to GERDNormal Barrett’s Esophagus
Esophageal
Adenocarcinoma
Disease Progression
Grading of Barrett’s Esophagus
Biopsy samples from Barrett’s esophagus tissue are examined under a microscope by a pathologist to confirm
the diagnosis and grade the severity of cellular changes (dysplasia).
Intestinal Metaplasia (IM), or Non-dysplastic
Barrett’s Esophagus (NDBE)
The earliest stage of Barrett’s esophagus. Normal
flat (squamous) cells are replaced with glandular
intestinal cells.
Low-grade Dysplasia (LGD)
High-grade Dysplasia (HGD)
Adenocarcinoma (esophageal cancer)
The most disorganized cell appearance with invasion
of the cells into deeper tissue layers.
The abnormal cells have begun to change in size,
shape, or organization.
Cellular abnormalities are more pronounced with the
nuclei of the cells (dark blue) being larger and more
irregularly positioned.
Barrett’s Treatment Goals
Reduce acid exposure
Destroy intestinal metaplasia (IM)
Maintain healed mucosa
Reduce the risk of cancer
Knowing what you know, if you had Barrett’s
Esophagus, which would you choose?
3 years
3 months
Or…
Who To Treat
Whether AGA (GI) or SAGES (Surgery) Guidelines, Direction is Comparable:
Treat All High Grade Dysplasia
An Option for Low Grade Dysplasia
Select Intestinal Metaplasia Patients At Risk of Progression to Cancer1
Family History of Cancer
Young
Long Segment of Barrett’s Esophagus
Anxious About Having Barrett’s
Smoker
Diabetic
(1) Criteria for treating IM patients may vary, but these are reasons often cited at the podium by respected physicians such as Shaheen (2010 ACG), Canto (2011 RMIE).
Most Common Treatment Options
Surveillance – Watch & wait
Endoscopic Mucosal Resection (EMR) – Resection of identified areas of Barrett’s
Thermal Ablation – The use of energy to remove the Barrett’s cells in the esophagus
“Barrett’s Esophagus,” 2002 MedicineNet.com, MedicineNet, 3 August 2005 <http://www.medicinenet.com/barretts_esophagus/page11.htm>.
Ideal Ablation Procedure
Removes all IM
Doesn’t go deeper than muscularis mucosa
Automated process
Quick
Avoids strictures
Human Esophagus
Muscularis Mucosa
(Ablation Target
Depth)
Submucosa
Muscularis Propria
Ablation target
GG
Controlling ablation
depth avoids
stricture
EMR
depth
Surgical depth
Step 1: Injection of Target Lesion
Step 2: Positioning the Snare
Step 3: Suction and Snare of Lesion
•Indications
•Raised lesions
•Focal area of dysplasia
•Suspicion of malignancy
Hand-held “Point and Shoot”
Technically demanding to achieve proper effect
Non-uniform ablation & energy delivery
Visual endpoint for completing session
APC
MPEC
HALO360 System
Balloon-based endoscopic ablation
Circumferential ablative therapy
Controlled depth (no submucosal injury)
1/22/2015
Confidential 2008
• Insert endoscope
• Identify landmarks: TIM and TGF
• Apply Mucomyst
• Introduce guidewire
• Remove scope (leave wire in place)
Top of Intestinal
Metaplasia (TIM)
Top of Gastric Folds (TGF)
Esophagoscopy
Once inflated, the HALO360 sizing balloon automatically measures the inner diameter of the
esophagus
1/22/2015
Confidential 2008
• Start sizing 12 cm above TGF
• Move balloon distally by 1 cm, repeat sizing
• Typically no more than 5 sizing steps are required
TGF
Sizing Steps
1/22/2015
Confidential 2008
Example of how an increase
in the sizing measurements may
occur
• If more than one size ablation catheter is recommended, choose the smallest
catheter
Sizing Steps
1/22/2015
Confidential 2008
Ablation StepsCOPE
• Introduce ablation catheter over guidewire
• Insert endoscope along-side the catheter
• Position the proximal electrode 1 cm proximal to the TIM
• Suction
TIM
1/22/2015
Confidential 2008
SOPE
• Deliver energy
• Only ablate 1 time per 3 cm segment
• Once energy is delivered confirm balloon is deflated
• Advance 3 cm distally
Ablation Steps
1/22/2015
Confidential 2008
• Visually align electrode with distal margin of first ablation zone and treat
• Repeat until the ablation zone overlaps the TGF
• Remove endoscope, catheter, and guidewire with direct visualization
Ablation Steps
Elimination of Barrett’s Epithelium
Sloughing of Barrett’s Epithelium Occurs
Baseline
Result after first ablation
Insertion of HALO360+ ablation catheter
Result after cleaning the ablation zone
Cleaning the Ablation Catheter
1. Remove from the esophagus and inflate the balloon
2. Clean the electrode surface in a circumferential direction with a clean moist 4x4 gauze in the direction of the electrode rings
3. Deflate and prepare for reintroduction
4. Insure that the ablation catheter is folded in a low profile before reintroduction
Example of Using a Cleaning Cap
Transparent Cap
Coagulum
Post-Cleaning
1/22/2015
Confidential 2008
Second Set of Ablations
• Introduce ablation catheter over guidewire
• Insert endoscope along side the catheter
• Repeat ablation stepsTIM
1/22/2015
Confidential 2008
• Remove endoscope, ablation catheter, and guidewire together
• Introduce endoscope
• Evacuate gastric contents
• Inspect ablation zone and esophagus
Final Inspection
HALO90 System
Scope-mounted endoscopic ablation
Focal ablative therapy
Primary therapy is short segment Barrett’s
Touch-up for focal residual disease after ablation
Ablation with the HALO90 System
1. MOUNT 2. ABLATE
3. CLEAN & REPEAT
Nursing & GI Tech Responsibilities
Sedation, positioning, & vital signs monitoring
Airway management
Documentation
Equipment set up prior to and during the procedure
Assist with proper guidewire and catheter management
Provide irrigation when needed
Cleaning of ablation catheter
Patient discharge instructions and follow-up
Case Study - 1Long segment Barrett’s with flat HGD
Baseline Endoscopy
Endoscopic Appearance
Baseline Ablation
First Follow up EGD at 2 Months
2 Months-HALO 90 Focal Treatment
4 months…no IM on biopsy Before
BE
HALO Summary
20 Peer reviewed, published papers validating safety with efficacy (CR)
No dysplasia, LGD, HGD
Approximately 27,000 procedures to date
Safety profile: SAE (serious adverse event rate of 0.17%)
Stricture
Chest pain
Bleeding
Perforation (Non-thermal)
Summary
Barrett’s esophagus and esophageal cancer is a significant and growing problem
Barrett’s is caused by GERD. You don’t always have to have GERD symptoms to have Barrett’s
There are several endoscopic ablative techniques for Barrett’s esophagus
BARRX +/- EMR is thus far the ideal endoscopic approach for pts with Barrett’s esophagus
Thank you for your attention
Rameez Alasadi, M.D.
630-717-2600
www.DuPagemd.com