Introduction:
The magnetic sphincter augmentation device (MSA) with the LINX Reflux Management System is an emerging surgical therapy for medically refractory GERD. Post-operative dysphagia is a common adverse effect seen in up to 19% of patients. Dysphagia persisting beyond 8 weeks requires endoscopic dilation or device removal. The aim of this study was to identify the incidence and risk factors for persistent dysphagia requiring dilation in patients after MSA placement.
Methods: This is a single-center retrospective review of all patients undergoing MSA placement from 2014-2023. Demographics (age, gender, BMI, insurance status) and variables including size of MSA device, comorbidities, time to first dilation, repeat dilations, size of repeat dilations, complications (post dilation pain, need for hospitalization, perforation, need for surgery, need for device explant) were recorded. Patients were divided into two groups- those requiring dilation post MSA vs those who did not. Among patients who required esophageal balloon dilations, further analysis was performed to compare patients who underwent dilations with <20mm balloon size vs 30mm balloon size. Chi-square and Fisher exact tests were used to compare categorical variables, and t-test for continuous variables. Multivariable logistic regression analysis was performed to determine associations between risk factors and need for dilation after MSA. A two-tailed p value < 0.05 was considered statistically significant.
Results: A total of 302 patients had MSA device placed. Of these, 69 (23%) underwent subsequent esophageal dilations. 43 were dilated with a balloon size of < 20mm and 26 were dilated with 30mm balloon size. Patients undergoing dilation were older and more likely to be female. While statistically significant, neither BMI nor the size of MSA device were clinically different between the two groups (Table 1).
On multivariable logistic regression, the risk of requiring esophageal dilations was significantly associated with older age (OR 1.17per 5 year increase; 95% CI 1.04-1.32; p=0.01) and female gender (OR 2.37; 95% CI 1.13-4.96; p=0.02). Patients with a history of IBS/CIC also had higher odds (OR 3.01; 95% CI 1.21-7.46; p=0.02) of requiring dilation, while an increase in BMI (OR 0.67 per 5 unit increase; 95% CI 0.46-0.97; p=0.04) was found to be protective. Size of MSA (OR 0.75; 95% CI 0.56-1.01; p=0.05) was not significantly associated with requiring dilation.
Conclusions:
This single-center study revealed that 22.8% of patients with MSA placement underwent esophageal dilation for persistent dysphagia. Risk factors for needing dilation in this cohort included increasing age, female gender, and having a history of IBS/CIC. Protective factors included a higher BMI. This data may help inform evidence-based patient selection and informed consent in those considering MSA placement.
Table 1- Baseline characteristics of patients requiring endoscopic balloon dilation vs not requiring endoscopic balloon dilation
Table 2- Risk factors associated with requiring any esophageal dilation in all patients with MSA
