Use of a 30 mm hydrostatic balloon dilator (EsoFLIP-330) was safe in treating patients with esophageal motility disorders and was most effective in those with achalasia, according to results from a retrospective multicenter study published in Gastroenterology and Endoscopy.
Researchers retrospectively recruited patients (N=51) with achalasia (n=37) or esophagogastric junction outflow obstruction (EGJOO; n=14) who underwent hydrostatic balloon dilation at 4 centers in the United States of America between 2015 and 2018. Patients were evaluated using Eckardt scores at baseline and after undergoing procedures. Clinical success was defined as an Eckardt score ≤3.
Mean age of participants was 54.1. In total, 51% were male, 72.5% underwent hydrostatic dilation for achalasia and 27.5% underwent the procedure for EGJOO. Most patients (92.2%) had a median Eckardt score of 5 (range, 3-8) at baseline. Participants with achalasia had a median score of 6 (range, 3-8) and those with EGJOO had a median score of 4 (range, 3.25-6.5).
Use of EsoFLIP-330 lowered mean esophageal diameter in patients from 10.77±3.54 mm to 19.54 ± 5.37 mm (P <.001) and mean cross-sectional area from 75.2 ± 54.4 mm2 to 291.7 ± 158.34 mm2 (P <.001).
Hydrostatic dilation lead to clinical success in 60% of patients overall. Patients with achalasia had a higher, but nonsignificant, rate of success compared with those with EGJOO (68.4% vs 33.3%; P =.18). Median follow-up time was 180.5 days. Upon patient follow-up assessment, median reported Eckardt score dropped to 1.5 (range, 1-4.75; P <.001). The drop in Eckardt score was only statistically significant in patients with achalasia (median, 1; range, 1-4; P <.001).
In total, 1 patient experienced an adverse event, that being mild post-procedural chest pain.
A limitation of this study was the short follow-up time. Likewise, it remains unclear whether the procedure had long-term durability.
The researchers concluded that dilation with EsoFLIP-330 was safe for use in the treatment of esophageal motility disorders. In total, clinical success was achieved for 2 out of every 3 patients with achalasia and 1 out of every 3 patients with EGJOO.
Sloan J A, Triggs J R, Pandolfino J E, et al. Treatment experience with a novel 30-mm hydrostatic balloon in esophageal dysmotility: a multicenter retrospective analysis. [available online May 14, 2020]. Gastrointest Endosc. doi:10.1016/j.gie.2020.04.076