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