Demonstrated Efficacy in both screening and surveillance populations:
In a multicenter prospective trial of 1,266 patients being screened for Barrett’s esophagus and dysplasia, the addition of WATS to the standard four-quadrant forceps biopsy protocol increased the overall detection of BE by 39.8%.
In a second multicenter prospective study of 151 patients, all in high-risk dysplasia surveillance programs at tertiary care centers, the addition of WATS to the standard four-quadrant forceps biopsy protocol increased the detection of esophageal dysplasia by 42%.
In patients who had received either radiofrequency ablation or liquid nitrogen spray cryotherapy for Barrett’s esophagus, WATS3D increased detection of residual or recurrent pre-cancerous cells by 57.1% compared to using forceps biopsy alone.
Prashanth R. Vennalaganti, M.D., Vivek Kaul, M.D., Kenneth K. Wang, M.D., Gary W. Falk, M.D., MS, Nicholas J. Shaheen, M.D., Anthony Infantolino, M.D., David A. Johnson, M.D., Glenn Eisen, M.D., MPH, Lauren B. Gerson, M.D., Michael S. Smith, M.D., Prasad G. Iyer, M.D., MS., MPH, Charles J. Lightdale, M.D., Felice Schnoll-Sussman, M.D., Neil Gupta, M.D., MPH., Seth A. Gross, M.D., Julian Abrams, M.D., MPH, Gregory B. Haber, M.D., Ram Chuttani, M.D., Douglas K. Pleskow, M.D., Shivangi Kothari, M.D., John R. Goldblum, M.D., Yaxia Zhang, M.D., Prateek Sharma, M.D.
Key Findings: One hundred sixty patients (mean age 63.4 years, 76% male; 95% white) completed the trial. The median circumferential and maximal BE extents were 1.0 (IQR: 0.0-5.0) cm and 4.0 (IQR, 2.0-8.0) cm, respectively. The diagnostic yield for biopsy alone was as follows: HGD/EAC, 7 (4.4%); low-grade dysplasia (LGD), 28 (17.5%); non-dysplastic BE (NDBE), 106 (66.25%); and no BE, 19 (11.9%). The addition of WATS to biopsy yielded an additional 23 cases of HGD/EAC (absolute increase, 14.4%; 95% CI, 7.5%-21.2%). Among these 23 patients, 11 were classified by biopsy as NDBE, and 12 as LGD/IND; 14 received biopsy and 9 WATS first (p=NS) and the majority (n=21; 91.7%) had a prior dysplasia history. WATS added average of 4.5 minutes to the procedure.
Conclusion: Results of this multicenter, prospective, randomized trial demonstrate that the use of WATS in a referral BE population increases the detection of HGD/EAC.
Vennalaganti, Prashanth; Eisen, Glenn; Falk, Gary W.; Gerson, Lauren B.; Goldblum, John R.; Gross, Seth A.; Gupta, Neil; Haber, Gregory B.; Infantolino, Anthony; Iyer, Prasad; Johnson, David A.; Kaul, Vivek; Kothari, Shivangi; Lightdale, Charles J.; Schnoll-Sussman, Felice; Shaheen, Nicholas; Smith, Michael S.; Wang, Kenneth K.; Zhang, Yaxia; Sharma, Prateek
Key Findings: Seattle Protocol FB detected 7 cases of HGD/EAC, 6 of which were also detected by WATS3D with the remaining case reported by WATS3D as IND/LGD. WATS3D found an additional 23 cases of HGD/EAC not detected on FB (12 were reported by FB as IND/LGD, while 11 were reported by FB as NDBE only). Conclusion: WATS3D found 4.1x more HGD/EAC than Seattle Protocol random biopsies.
Prashanth R. Vennalaganti, MD , Vijay Naag Kanakadandi, MD, Seth A. Gross,MD, Sravanthi Parasa, MD, MPH, Kenneth K. Wang, MD, Neil Gupta , MD, MPH and Prateek Sharma
Am J Gastroenterol, 28 April 2015; doi: 10.1038/ajg.2015.116
Key Findings: The diagnosis of BE and associated dysplasia using the WATS technique has very high inter-observer agreement. This appears to be significantly higher as compared with previously published data using standard histopathology.
Data Presented at AGA/ASGE Presidential Plenary Session 2014
Seth Gross MD, Vivek Kaul MD, Anthony Infantolino MD, Michael Smith MD
Key Findings: WATS3D with computer-assisted analysis complements standard FB methods to markedly increase detection of BE and dysplasia. This is the largest series reported to date. In light of recent studies and changes to Barrett’s management guidelines, improved dysplasia detection is critical to appropriate management of these pre-cancerous lesions. This study shows that widespread use of WATS3D in community based gastroenterology practices identifies dysplasia missed by FB, leading to improved care for these patients.
Data Presented at American College of Gastroenterology Annual Meeting – 2014
Prashanth Vennalaganti MD, Vijay Nag Kanakadandi MD, Sravanthi Parasa MD, MPH, S Gross MD, Neil Gupta MD, MPH, Prateek Sharma MD
Key Findings: The diagnosis of Barrett’s esophagus and associated dysplasia using the WATS technique has a very high inter-observer agreement. WATS technique appears to be significantly better inter observer rates compared to previously published data using standard histopathology. This technology represents a significant improvement over current histopathology assessment.
Poster Presented at American College of Gastroenterology Annual Meeting – 2014
Lauren B. Gerson, MD, MSc Mark Rutenberg, Richard Scott
Key Findings: The addition of WATS3D to standard forceps biopsy increases the diagnostic yield for BE and dysplasia in patients undergoing both screening and surveillance.
– The increased yield was highest for patients undergoing screening for BE or post-ablation examinations.
– The number needed to treat (NNT) to detect an additional case of Barrett’s Esophagus ranged from 4-11 based on the 7 available studies.
Posters Presented at Digestive Disease Week – 2013
Seth A. Gross, Gina R. Sam, Matthew McKinley, Anthony Infantolino, Felice Schnoll-Sussman, Steven R. DeMeester, Jerey A. Hagen, John C. Lipham, Rahul Kataria, Michael S. Smith
Key Findings: The increased yield of Barrett’s Esophagus resulting from addition of the WATS3D biopsy from all sites was 20% (9-32%, p <.05). At three sites that had over 30 WATS3D tests performed or had on-site assistance, the increased detection yield of Barrett’s Esophagus was an average of 46% (20%-88%, p < .05, n=75).
Donald N. Tsynman, MD, Danielle Marino, MD, Vivek Kaul, MD, FACG, Center For Advanced Therapeutic Endoscopy, Division of Gastroenterology & Hepatology, University of Rochester Medical Center, Rochester, New York
Key Findings: In this pilot study of post endoscopic therapy surveillance, WATS3D increased the detection rate for Barrett’s Esophagus and/or dysplasia by 27% when used as an adjunctive technique to 4 quadrant forceps biopsy.
Rahul D. Kataria MD, Deena Midani MD, Rebecca Thomas MD, Michael S. Smith MD, MBA, Temple University School of Medicine, Philadelphia, PA
Key Findings: Adjunctive use of WATS3D with forceps increased the detection rate of residual or recurrent intestinal metaplasia by 50% (6/12). Incorporation of WATS3D into standard post ablation surveillance may facilitate earlier detection of residual or recurrent intestinal metaplasia, thereby improving patient outcomes.
Sang H. Kim, M.D., Wallace J. Wang, M.D., Moshe Rubin, M.D., Konika P. Bose, M.D., Anthony J. Nici, M.D., Syed A. Hussain, M.D. Division of Gastroenterology, New York Hospital Queens / Weill Cornell Medical College
Key Findings: In this preliminary study of patients with pancreaticobiliary malignancy, WATS3D brushing of the bile duct with computer-assisted analysis proved to have a much higher diagnostic accuracy and positive predictive value than standard brush cytology. Additionally, the WATS3D system was able to detect three additional cases of malignancy or atypia that were not detected by forceps biopsy.
Danielle Marino, MD, Donald N. Tsynman, MD, Vivek Kaul, MD, FACG, Center For Advanced Therapeutic Endoscopy, Division of Gastroenterology & Hepatology, University of Rochester Medical Center, Rochester, New York
Key Findings: In this study of post-ablation surveillance, WATS3D increased the detection rate for Barrett’s esophagus and/or dysplasia by 27.5% (11/40) when used as an adjunctive technique to standard 4 quadrant forceps biopsy.
Posters Presented at Digestive Disease Week – 2012
Anandasabapathy S, Sontag S, Graham DY, Frist S, Bratton J, Harpaz N, Waye JD. Computer-Assisted Brush-Biopsy Analysis for the Detection of Dysplasia in a High-Risk Barrett’s Esophagus Surveillance Population. Dig Dis Sci. 2011 Mar;56(3):761-6. Epub 2010 Oct 27.
Key Findings: These data suggest that computer-assisted brush biopsy is a useful adjunct to standard endoscopic surveillance regimens for the identification of dysplasia in Barrett’s esophagus.
Johanson JF, Frakes J, Eisen D; EndoCDx Collaborative Group. Computer-Assisted Analysis of Abrasive Transepithelial Brush Biopsies Increases the Effectiveness of Esophageal Screening: A Multicenter Prospective Clinical Trial by the EndoCDx Collaborative Group. Dig Dis Sci. 2011 Mar;56(3):767-72. Epub 2010 Dec 4.
Key Findings: These results suggest that adjunctive computer-assisted analysis of an abrasive brush biopsy has the potential to substantially improve the detection of Barrett’s esophagus and dysplasia in screening populations.