What Is Barrett's Esophagus?

Barrett's esophagus is a pre-cancerous condition affecting the lining of the esophagus, the swallowing tube that carries foods and liquids from the mouth to the stomach.

Facts:

• In a study published in 2005, Barrett's esophagus prevalence was estimated to affect approximately 3.3 million adults over 50 years of age in the United States2,3,14
  
• Patients with Barrett's Esophagus are 30-125 times more likely to develop adenocarcinoma (esophageal cancer) than the general population7
  
• The incidence of esophageal adenocarcinoma has risen approximately six-fold in the U.S. It is rising faster than breast cancer, prostate cancer, or melanoma4,15

Stomach acid backs up into the esophagus from acid reflux or GERD, causing injury to the esophageal lining.

How Does Barrett's Esophagus Develop?

Gastroesophageal Reflux Disease (GERD) is a disorder in which stomach acid and enzymes cause injury to the esophageal lining, producing symptoms such as heartburn, regurgitation, and chest pain. In some patients with GERD, the normal esophagus cells are damaged. Over time, this damage can result in inflammation and genetic changes that cause the cells to become altered. The tissue takes on a different appearance and microscopically is no longer esophagus tissue, but rather becomes intestinal tissue. This is called “intestinal metaplasia” or Barrett’s esophagus. If a patient has GERD symptoms more than 3 times per week, they should consult their physician.

Facts:

• Approximately 13% of Caucasian men over the age of 50, who have chronic reflux, will develop Barrett's esophagus5
  
• In a study conducted by the Veteran Affairs Healthcare System and Stanford University, 25% of patients over 50 years old without GERD symptoms were found to have Barrett's esophagus14
  
• GERD is common in the U.S. adult population. Symptoms of GERD, including heartburn, occur monthly in almost 44% of U.S. adults and weekly in almost 18%16

How is Barrett's Esophagus Diagnosed?

A diagnosis of Barrett’s esophagus requires that the patient undergo an upper endoscopy procedure by their physician, typically a gastroenterologist or surgical endoscopist. Endoscopy is a non-surgical procedure and is performed using conscious sedation. Barrett’s esophagus tissue appears as a different color on examination, which directs a biopsy of the tissue for pathology evaluation. A finding of intestinal cells in the esophagus (intestinal metaplasia) confirms a Barrett’s esophagus diagnosis.

Most commonly, Barrett's esophagus is diagnosed during an upper endoscopy procedure, or also known as esophagogastroduodenoscopy (EGD).

The endoscopy procedure consists of a thin, flexible tube that is guided down the throat. The tube, known as an endoscope, has a video lens and light at its tip that transmits images to a video monitor nearby. This allows the doctor to visually inspect and capture images of the tissue of the esophagus.

There are new thin endoscopes that allow the physician to pass an endoscope through the patient's nose to quickly and conveniently check the patient for Barrett's esophagus.

There are also new small capsules with built-in cameras that the patient may swallow and have a physician screen them for Barrett's esophagus.

What Are The Different Types Of Barrett's Esophagus?

The information below is intended to provide you with a general understanding of Barrett's esophagus. Refer to a medical professional for more detailed information and to address any questions you may have.

There are different types or “grades” of Barrett’s esophagus, according to biopsy and microscopic findings. These “grades” include: intestinal metaplasia (IM) without dysplasia, IM with low-grade dysplasia, and IM with high-grade dysplasia. “Dysplasia” refers to inherent abnormalities of a tissue or cell that make it more cancer-like and disorganized. While the presence of dysplasia may raise the risk of cancer, it is not considered cancer.4,6 Ultimately, higher grades of dysplasia may be considered cancer if there are signs of tissue invasion.

1. Intestinal Metaplasia (IM) - The tissue cells have begun to change genetically and the tissue resembles the red intestinal lining rather than the normal and healthy pink esophagus lining. At this stage, a person has Barrett’s esophagus, but has not developed Dysplasia.
2. Low-grade Dysplasia (LGD IM) – Less than 50% of the abnormal cells have begun to change in size, shape, or organization and may show an increase in their growth rate. The cells are contained within the lining of the esophagus and have not spread to other areas.
3. High-grade Dysplasia (HGD IM) – As with LGD, the abnormal cells reside within the lining of the esophagus. But more than 50% of these cells do demonstrate a higher increase in abnormal growth rate and pattern.
4. Adenocarcinoma (Esophageal Cancer) – When the abnormal cells have a rapid and uncontrolled growth rate. The cells also invade the deeper layers of your esophagus and may spread beyond that. These cells can develop into malignant tumors.

What Are The Risks To The Patient who Has Barrett's Esophagus?

Barrett’s esophagus increases the risk for a patient to develop esophageal adenocarcinoma. While all grades of Barrett’s esophagus place the patient at this higher risk, low-grade and high-grade dysplasia are the highest risk sub-types.6

How Is Barrett's Esophagus managed?

Joint recommendations from medical societies recommend that a patient with Barrett's esophagus should undergo an upper endoscopy procedure with biopsies on a regular basis for the remainder of their lifetime. The frequency of endoscopy is determined by the grade of Barrett’s esophagus.

A patient with IM without dysplasia will undergo surveillance endoscopy approximately every 3 years. The frequency for a patient with low-grade dysplasia is much higher (every 6-12 months) due to the increased risk for cancer development. A patient with IM with high-grade dysplasia may undergo surveillance endoscopy every 3 months, or be referred for more definitive therapy immediately.17

Because Barrrett's esophagus is a disease without symptoms of its own, a patient won't know if the disease has progressed to a more serious stage or cancer until he or she undergoes their next upper endoscopy and biopsies.

Other Treatment Options

In addition to surveillance endoscopy approaches for Barrett’s esophagus, there are other treatment options to eliminate the Barrett’s tissue completely.

Some patients with high-grade dysplasia may have an endoscopic procedure to remove the diseased tissue, but the majority of those diagnosed with high-grade dysplasia are recommended to undergo an esophagectomy to avoid progression to esophageal cancer.

Patients should consult with their physician to determine what the optimal approach is for their particular disease state.

What Is The Treatment Option Using The Halo Technology?

“Ablation” (or coagulation) is a technique where tissue is heated until it is no longer viable or alive. Physicians have used various forms of ablation for nearly a century to treat a number of cancerous and precancerous conditions, as well as to control bleeding. The HALO ablation technology is a very specific type of ablation, in which heat energy is delivered in a precise and highly-controlled manner.

Barrett’s esophagus tissue is very thin and is therefore a good candidate for removal with ablative energy. Delivery of ablative energy with the HALO ablation technology is therefore capable of achieving complete removal of the diseased tissue without damage to the normal underlying structures.

Ablation therapy is performed in conjunction with upper endoscopy. The treatment is performed in an outpatient setting and no incisions are involved. While the actual procedure time in clinical studies has been approximately less than 28 minutes, there is needed preparation prior to the start of the procedure, and patients are monitored for a specific time afterwards. A patient should ask the physician or nurse practitioner for more information on where the procedure is performed and the time required for the procedure.11,12

What Is The Halo Technology?

The proprietary technology incorporated in the HALO360 and HALO90 Systems is designed to maximize clinical outcomes and completely remove the Barrett's epithelium without significant injury to the underlying tissue.

• Delivery of ablative energy in less than 1 second allows long or short segments of Barrett's to be treated quickly
  
  
• Consistent application of bipolar energy uniformly removes the esophageal epithelium, reducing potential for buried glands and improving patient tolerability
  
  
• Controlled treatment depth of less than 1,000 µm reduces risk of stricture formation, even after multiple energy applications

PRECISE DEPTH CONTROL

Barrett's epithelium is approximately 500 µm in thickness. The HALO Energy Generator and the HALO Ablation Catheter electrode array are designed to work in concert to achieve a uniform, superficial depth of ablation of ~1,000 µm.

The technology consists of two different devices; the HALO360+ ablation catheter and the HALO90 focal ablation device. The balloon-based HALO360+ device is capable of treating larger areas of circumferential Barrett’s esophagus, while the focal ablation device is used to treat smaller areas.

Human Esophagus Specimen (H & E Stain)

The HALO360 System provides a circumferential, 360 degree, 3 cm long ablation for treating short and long segments of Barrett's epithelium.

The components of the HALO360 System are designed to work together to achieve the removal of the Barrett's tissue in a short, well-tolerated endoscopic procedure with consistent and effective results.

The HALO90 System enables physicians to provide primary treatment for short segments of Barrett's esophagus, or provide secondary treatment after ablation with the HALO360 System, or other therapeutic devices.

During The Procedure

Using standard endoscopy techniques, the physician activates and controls the different functions of the HALO360 System.

Sizing A catheter is inserted into the esophagus along side the endoscope. At the tip of the catheter there is a small balloon that is inflated once inside your esophagus near the treatment area. The balloon and the HALO360 Energy Generator together measure the diameter of your esophagus. This information is used by the physician to select the appropriate treatment catheter. The sizing balloon is then removed and the treatment or HALO360+ Ablation Catheter is introduced.

Ablation The HALO360+ Ablation Catheter also has a balloon at the tip, but this balloon is covered by a band of radiofrequency electrodes. Once the electrodes of the balloon are positioned on the desired treatment area the balloon is inflated. The HALO360 Energy Generator and the ablation catheter then work together to deliver a short burst of energy that is circumferential: 360 degrees. The design of this technology limits the energy delivery to a depth clinically proven to remove the diseased tissue while reducing the risk of injury to the deeper healthy tissue layers The HALO360+ Ablation Catheter ablates a 3 cm circumferential segment of Barrett's tissue within the esophagus For patients with Barrett's esophagus lesions longer than 3 cm, the HALO360+ Ablation Catheter is simply repositioned and the ablation steps are repeated.

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