Laparoscopic antireflux surgery with the RefluxStop implant for severe sufferers with complex disease: a retrospective study of the first 100 patients with 12-month follow-up at an early adopter institution

BACKGROUND: The RefluxStop procedure, shown to effectively eliminate gastroesophageal reflux disease (GERD) symptoms in clinical trial, has been offered at our clinic since 2020. Promising short-term outcomes in the initial cohorts have been published. The outcomes for 100 patients with a follow-up of at least 1 year have been presented. METHODS: A retrospective cohort study was conducted with the first 100 patients to reach the 12-month postoperative follow-up. The primary endpoint was symptom resolution, which was quantified using the GERD Health-Related Quality of Life (GERD-HRQL) score. The secondary effectiveness endpoints included patient satisfaction and proton pump inhibitor (PPI) use. Safety data were reported as surgical complications up to 90 days and device- or surgery-related complications during the 12-month follow-up. RESULTS: At baseline, 53% of the patients had a hiatal hernia of ≥4 cm, 66% of the patients had ineffective esophageal motility, and 46% of the patients reported preoperative dysphagia. The median GERD-HRQL score (0-75 points) decreased by 97.6% from 42.5 (IQR, 29.0-50.0) preoperatively to 1.0 (IQR, 0.0-5.0) at 12 months (P <.001). PPI use decreased from 94.8% at baseline to 5.2% at 12 months. Two cases of early device penetration to the stomach occurred, attributable to surgical technique with unduly tight pouch closure; no intervention was required. In addition, two patients (2%) required revision surgery for hiatal repair, with both having a hernia of >7 cm at baseline. CONCLUSION: In this cohort of 100 patients with severe symptoms, the RefluxStop procedure resulted in excellent 12-month outcomes, with a median of 97.6% improvement in the total GERD-HRQL score, resolving GERD symptoms to a high level of satisfaction, even in patients with clinically complex conditions.