SAGES TAVAC safety and efficacy analysis WATS3D (CDx Diagnostics, Suffern, NY)

Abstract

Background: Wide-area transepithelial sampling of the esophagus with computer-assisted three-dimensional analysis (WATS3D, CDx Diagnostics, Suffern, NY) is an adjunctive technique to random biopsies for early detection of Barrett's esophagus. The aim of the SAGES Technology and Value Assessment Committee aims is to evaluate the efficacy, value, and safety of WATS3D.

Methods: Clinical studies involving WATS3D were identified via a search of the PubMed/Medline databases ( www.ncbi.nlm.nih.gov/pubmed ) conducted in March of 2019 using search terms, such as wide-area transepithelial sampling, three-dimensional (3D) computer-assisted analysis, WATS-3D, Barrett's esophagus and WATS-3D, Barrett's esophagus and wide-area transepithelial sampling with three-dimensional computer-assisted analysis, Barrett's esophagus, and emerging technology. Bibliographies of key references were searched for relevant studies not covered by the PubMed search. Case reports and small case series were excluded.

Results: No significant morbidity or mortality was reported within the literature associated with the WATS^3D technology. WATS^3D increases diagnostic yield by 38-150% for Barrett's Esophagus, by 40-150% for Low Grade Dysplasia; and by 420% for High Grade Dysplasia; when compared to forceps biopsy alone. WATS^3D technique has very high inter-observer agreement for the pathological diagnosis of non-dysplastic and dysplastic Barrett's Esophagus. Increased detection of pre-malignant diseases of the esophagus by the adjunctive use of WATS^3D supports screening and surveillance by the adjunctive use of WATS^3D during upper endoscopy in appropriate patients.

Conclusion: Wide-area transepithelial sampling with three-dimensional computer-assisted analysis (WATS^3D, CDx Diagnostics) is a safe and effective adjunct to forcep biopsies in the evaluation of Barrett's Esophagus, Low Grade Dysplasia, and High Grade Dysplasia.

Keywords: Barrett’s esophagus and WATS-3D; Barrett’s esophagus and emerging technology; Barrett’s esophagus and wide-area transepithelial sampling with three-dimensional computer-assisted analysis; Three-dimensional (3D) computer-assisted analysis; WATS-3D; Wide-area transepithelial sampling.