Approximately 20 percent1 of Americans suffer from chronic gastroesophageal reflux disease (GERD). Roughly 10 to 15 percent2 of those individuals will be diagnosed with Barrett’s esophagus (BE), a condition that if left untreated, may lead to esophageal cancer.
Historically, it has been difficult for physicians to accurately detect BE and esophageal dysplasia. Fortunately, this is no longer the case. Becker’s ASC Review recently spoke with three experts and the CEO of CDx Diagnostics about an innovative diagnostic technology called Wide Area Transepithelial Sampling with Three-Dimensional imaging with AI analysis (WATS3D), which is transforming how clinicians screen and monitor patients for known or suspected BE. These interviewees were:
- James Boss, MD, Gastroenterologist, Waco Gastroenterology Endoscopy Center, Texas
- Russell Mann, RN, Endoscopy Manager, Waco Gastroenterology Endoscopy Center, Texas
- Robert Odze, MD, former Professor of Pathology, Harvard Medical School, and former Chief of GI Pathology Service, Brigham and Women’s Hospital, Massachusetts
- William Huffnagle, CEO, CDx Diagnostics, New York
Waco Gastroenterology Endoscopy Center has adopted WATS3D to preempt esophageal cancer
The current standard of care for identifying BE, the Seattle Protocol, is associated with a high rate of sampling error. Following this protocol, endoscopists take 4 quadrant biopsies every 1 to 2 centimeters throughout the area at question, combined with targeted biopsies of visible lesions.
“This approach has huge limitations; in a nutshell, it doesn’t work,” Dr. Odze said. “The current standard of care has a very low level of sensitivity — in the 10 to 20 percent range — and a low level of specificity. In addition, it suffers from a high degree of sampling error and has a low rate of adherence. As a result, there are many missed precursor lesions, dysplasias, and even cancers.”
“In recent decades, esophageal cancer has become one of the fastest growing and deadliest cancers,” Mr. Huffnagle said. “It has a mortality rate of over 80 percent at five years.3” The CDx Diagnostics WATS3D platform is a three-tiered solution to detect and diagnose Barrett’s esophagus and dysplasia — comprised of enhanced tissue sampling, proprietary3D imaging with neural network analysis, and a team of expert GI pathologists.
Waco Gastroenterology Endoscopy Center was an early adopter of WATS3D and has been using the system since March 2014, before WATS3D was included in the American Society for Gastrointestinal Endoscopy (ASGE) guidelines. The endoscopy center, which is a partnership between Waco Gastroenterology and AMSURG, has eight gastroenterologists who see 600 to 650 patients each month.
Waco Gastroenterology Endoscopy Center offers routine screenings and diagnostic colonoscopies, upper endoscopies including screening for Barrett’s esophagus, and flexible sigmoidoscopies. The team handles both diagnostic and therapeutic procedures. As Mr. Mann noted, “WATS3D fits well with our practice because it’s all about early detection. The sooner we can get patients into the recall loop, the sooner we can prevent the progression of disease.”
Within the first few months of using WATS3D, the team was struck by the significance of their findings. “Once we added WATS3D, we compared the numbers to what we had been doing previously to identify Barrett’s dysplasia,” Dr. Boss said. “After the first three months, we were taken aback by the diagnostic implications of using WATS3D.”
Based on the positive results, Dr. Boss started using WATS3D on all GERD patients that have irregular Z lines, which is suggestive of Barrett’s, even if they didn’t have a preexisting Barrett’s diagnosis. He also began regularly using WATS3D during surveillance procedures for Barrett’s patients as well.
Case reports for Waco Gastroenterology Endoscopy Center indicate that WATS3D increased detection of goblet cell metaplasia/Barrett’s esophagus and dysplasia. Based on 228 cases, it detected dysplasia in 29 patients while forceps biopsies detected only one.
According to Dr. Boss, “If you consider esophageal dysplasias that are potentially being missed, the best thing you can do for your patients is to utilize tools like WATS3D that are more sensitive and can potentially pick up a Barrett’s esophagus — or more importantly dysplasia — that you might not see.”
Dr. Boss has found that some patients with stomach ulcers also have silent acid reflux. In addition, many other patients with damaging acid reflux have no symptoms. “Regardless of the indication for the EGD, if I see changes raising a concern for Barrett’s, I perform a biopsy and WATS3D,” he explained.
Once Dr. Boss diagnoses a patient with Barrett’s esophagus without dysplasia, he conducts follow-up surveillance every three years. If the results are indefinite, he doubles the proton pump inhibitors and brings the patient back within six months. This is often the case with low-grade dysplasia. “Even with indefinite or low-grade dysplasia, I’ll bring patients back within six months and repeat the WATS3D procedure. I do four quadrant biopsies every one centimeter to see what that shows. That dictates what we do next. If the patient has high-grade dysplasia, they will need radiofrequency ablation which we don’t do in the ASC setting,” Dr. Boss said.
“When you start looking at missed high-grade dysplasia, WATS3D is a no-brainer,” Dr. Boss said. “It’s easy to use and it adds just a small amount of time to procedures. In addition, it is very easy to learn, and all of my nurses and techs know how to use it.”
WATS3D is a quick process in and out of the procedure room. The physician and staff will sample with the brushes, place the samples in prepared vials, and ship them to the CDx Diagnostics Lab in the prepaid boxes provided by CDx. A WATS3D expert pathologist will make diagnoses, and the attending physician will have results within 5 days.
CDx Diagnostics has designed WATS3D to be an easy-to-adopt technology that can be integrated into ASC workflows. “We provide WATS3D kits to ASCs at no charge and no purchase order is required,” Mr. Huffnagle said. “We include the kits as part of our service, so centers have everything they need with no hassle. It costs ASCs nothing to use this technology.”
“We’ve been using WATS3D for eight years, and given the results and benefits for patients, it’s become a routine part of our prevention protocol. There is no burden associated with the sample preparation and we share the yield results with the staff at least once or twice a year. They buy into why we are doing this,” Mr. Mann said.
Artificial intelligence in gastroenterology
Artificial intelligence is being applied in a variety of ways to assist gastroenterologists. Technologies like Medtronic’s GI Genius are used in the colon to assist endoscopists in detecting polyps during live colonoscopies. At CDx Diagnostics, WATS3D utilizes AI technology to detect cellular changes in the tissue that is acquired during an endoscopy in order to assist pathologists in rendering diagnoses.
“When people hear the term ‘AI,’ they assume that a machine is replacing human intellect, but that couldn’t be further from the truth,” Dr. Odze said. “A highly trained pathologist on staff at CDx Diagnostics makes the final diagnosis. The WATS3D tools merely enhance the overall diagnostic process.”
“These technologies are making a difference. One is used during live colonoscopies to aid in visualization, and the other is used by the pathologist to increase diagnostic precision,” Dr. Odze said. “Ultimately, both are using artificial intelligence to help endoscopists more reliably detect pre-cancer and save patient lives.”
Gastroenterologists recognize WATS3D as an effective tool for screening and monitoring Barrett’s esophagus patients
In recent years, 15 peer-reviewed publications have highlighted the effectiveness and the overall utility of WATS3D. “Based on that body of evidence, WATS3D has been recognized by four major gastrointestinal societies,” Mr. Huffnagle said. “Their members are becoming much more aware of the value of WATS3D.”
The American Society for Gastrointestinal Endoscopy (ASGE) included WATS3D as a recommendation in its 2019 guidelines for the screening and surveillance of Barrett’s esophagus. In July 2022, the American Gastroenterological Association’s (AGA) Clinical Practice Update included WATS3D in their Best Practice Advise Statements. Both the American Foregut Society (AFS) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recommended WATS3D for routine use.
Conclusion
Millions of people are walking around with GERD and Barrett’s esophagus, and they might not even know it. “The key to detecting these conditions is by screening patients as a first line of defense,” Dr. Odze said. “The faster you can screen patients at the grassroots level in ASCs, the easier it is to recognize precursors to cancers.”
The good news is that with WATS3D, effective biopsies can be performed in any ASC by any endoscopist. “Employees at CDx Diagnostics get up each day with the desire to execute on our mission,” Mr. Huffnagle said. “Every sample is critically important to us. We empower physicians with innovative technology to prevent esophageal cancer, one patient at a time.”
1 National Institutes of Health, National Institute of Diabetes and Digestive Kidney Diseases, niddk.nih.gov/health-information/digestive-diseases/acid-reflux-ger-gerd-adults/definition-facts#:~:text=see%20your%20doctor.-,How%20common%20is%20GERD%3F,the%20United%20States%20have%20 GERD.
2 Johns Hopkins Medicine, The Sidney Kimmel Comprehensive Cancer Center, www.hopkinsmedicine.org/kimmel_cancer_center/cancers_we_treat/esophageal_cancer/prevention/barretts-esophagus.html#:~:text=Barrett’s%20esophagus%20is%20a%20complication,GERD%20will%20develop%2.
3 National Institutes of Health, National Cancer Institute, www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-digestive-system-tumors/esophageal#:~:text=Doctors%20estimate%2
Dr. Robert Odze is a consultant of CDx Diagnostics.