A safety and effectiveness evaluation of RefluxStop in the treatment of acid reflux comparing large and small hiatal hernia groups: results from 99 patients in Switzerland with up to 4-years follow-up - Report - MDSpire
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A safety and effectiveness evaluation of RefluxStop in the treatment of acid reflux comparing large and small hiatal hernia groups: results from 99 patients in Switzerland with up to 4-years follow-up
Safety and Efficacy of RefluxStop in Small vs Large Hiatal Hernia GERD Patients
Overview
This study evaluates the safety and effectiveness of the RefluxStop device in managing GERD patients with small (≤3 cm) and large (4–10 cm) hiatal hernias over a four-year follow-up. The novel device demonstrated favorable outcomes in preventing acid reflux and reherniation, particularly addressing the unmet need in large hiatal hernia cases.
Background
Gastroesophageal reflux disease (GERD) is a prevalent condition with serious complications including Barrett’s esophagus and esophageal adenocarcinoma, which have high mortality rates. Proton pump inhibitors (PPIs) are the first-line treatment but do not address the mechanical causes of reflux and have limitations including persistent symptoms and long-term risks. Surgical options like Nissen fundoplication and magnetic sphincter augmentation exist but have challenges, especially in large hiatal hernia patients where recurrence rates are high. The RefluxStop device offers a novel approach by mechanically anchoring the gastroesophageal junction without encircling the esophagus, aiming to restore normal anatomy and reduce reherniation.
Data Highlights
Parameter
Small Hiatal Hernia (≤3 cm)
Large Hiatal Hernia (4–10 cm)
Number of Patients
Not specified separately
Not specified separately
Follow-up Duration
Up to 4 years
Reherniation Rate
Lower than large HH group
Historically up to 55% at 5 years with other surgeries
Adverse Events
Monitored rigorously, no serious swallowing difficulties reported
Monitored rigorously, favorable safety profile
Key Findings
RefluxStop device restores the antireflux barrier by anchoring the lower esophageal sphincter inferiorly in the abdomen without encircling the esophagus.
The procedure maintains dynamic flexibility during respiration and swallowing, reducing complications seen with traditional surgeries.
In large hiatal hernia patients, RefluxStop addresses the high recurrence rates seen with other surgical options by preventing reherniation effectively.
Four-year follow-up data from 99 patients demonstrate sustained safety and efficacy in both small and large hiatal hernia groups.
The device realigns the angle of His and restores normal gastroesophageal junction anatomy, contributing to reflux control.
Clinical Implications
RefluxStop offers a promising surgical alternative for GERD patients, especially those with large hiatal hernias where current treatments have high failure rates. Its unique mechanism avoids esophageal encirclement, potentially reducing postoperative dysphagia and other side effects. Clinicians should consider this device as part of the treatment landscape for refractory GERD with hiatal hernia.
Conclusion
The RefluxStop procedure demonstrates a safe and effective approach to managing GERD with concomitant hiatal hernias, particularly large hernias, by restoring normal anatomy and preventing reherniation over a four-year period. This novel device addresses a critical unmet need in reflux surgery.
References
Yan Xie et al. 2020 -- Excess Mortality Associated with Proton Pump Inhibitor Use
Watson et al. 2020 -- Randomized Clinical Trial on Hiatal Hernia Recurrence
