Becker's ASC Review

15 EXECUTIVE BRIEFING 2 EXECUTIVE BRIEFING SPONSORED BY How one ASC is using AI-based diagnostics to prevent esophageal cancer Insights from Waco Gastroenterology Endoscopy Center A pproximately 20 percent 1 of Americans suffer from chronic gastroesophageal reflux disease (GERD). Roughly 10 to 15 percent 2 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 (WATS 3D ), 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 WATS 3D 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 WATS 3D platform is a three-tiered solution to detect and diagnose Barrett's esophagus and dysplasia — comprised of enhanced tissue sampling, proprietary 3D imaging with neural network analysis, and a team of expert GI pathologists. Waco Gastroenterology Endoscopy Center was an early adopter of WATS 3D and has been using the system since March 2014, before WATS 3D 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, "WATS 3D 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 WATS 3D , the team was struck by the significance of their findings. "Once we added WATS 3D , 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 WATS 3D ." Based on the positive results, Dr. Boss started using WATS 3D 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 WATS 3D during surveillance procedures for Barrett's patients as well. Case reports for Waco Gastroenterology Endoscopy Center indicate that WATS 3D 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 WATS 3D that are more sensitive and can potentially pick up a Barrett's esophagus — or more importantly dysplasia — that you might not see." Dr. Robert Odze is a consultant of CDx Diagnostics.

• Cover