Radiofrequency Ablation for Dysplastic Barrett's Esophagus Including Post-PDT Salvage Therapy Using the HALO360 and HALO90 Ablation Systems - The Duke Experience

Abstract

Background & Aim: Barrett's esophagus (BE) is a well-known premalignant condition that can be associated with the development of dysplasia and adenocarcinoma. A number of endoscopic ablative therapies have been attempted in BE. These include thermal modalities that use laser irradiation, multipolar electrocoagulation, argon plasma coagulation (APC), photodynamic therapy (PDT), or radiofrequency energy (RFA). The aim of this study is to report our outcomes using the HALO360 and HALO90 RFA Systems (BÂRRX Medical, Sunnyvale, CA) for the endoscopic ablation of BE with dysplasia, including a report on patients who previously have undergone ablation with PDT without complete endoscopic response (CER) and/or complete histologic response (CHR). Methods: A retrospective analysis from our electronic database of patients with BE and dysplasia who have undergone treatment with the HALO360 and HALO90 RFA Systems was performed. Inclusion criteria included patients with BE and either low-grade (LGD) or high-grade dysplasia (HGD) diagnosed after adequate acid suppressive therapy with a PPI. Histopathology was confirmed by expert pathologists. Patients who had previously undergone treatment with PDT were also included. Following RFA therapy, esophageal biopsies were obtained as per the Seattle protocol every 3 months to assess for residual BE and dysplasia. Results: 12 patients with dysplasia were treated for a total of 25 RFA sessions. 9 patients had at least one follow-up endoscopy with biopsies. All subjects were males with a mean age of 59 yrs and an age range of 38 to 77 yrs. Prior to RFA therapy, 6/12 (50%) patients had LGD and 6/12 (50%) had at least focal HGD. The mean length of BE with LGD was 7.33 cm and the mean length of BE with at least focal HGD was 4.5 cm. The mean # of ablation sessions was 2.08. The mean # of post-ablation biopsy sessions was 1.66. Following RFA therapy, 8/9 (89%) patients had some favorable endoscopic response, and 5/9 (55.5%) had some favorable histologic response. Further analysis revealed that 4/9 (44%) had CER and CHR, and a further 4/9 (44%) had partial endoscopic response (PER). Also, 3/9 (33%) status post PDT for HGD who had residual disease (both non-CER and non-CHR) were treated with RFA. Following RFA in this post-PDT subset, 2/3 (66.6%) were found to have PER and partial histologic response (PHR), and one patient had a CER and CHR. No significant adverse events were reported. Conclusions: Radiofrequency ablation for dysplastic Barrett's esophagus utilizing the HALO360 and HALO90 ablation system is safe and effective. This therapy also appears to be promising in patients with residual BE and dysplasia following PDT.