S. Purnell1, D. Nguyen2, E. Y. Chan1, R. Chihara1, E. Graviss2, M. P. Kim1 1Houston Methodist Hospital, Thoracic Surgery, Houston, TX, USA 2Houston Methodist Hospital, Pathology And Genomic Medicine, Houston, TX, USA
Introduction: Magnetic sphincter augmentation (LINX) devices reinforce the lower esophageal sphincter preventing acid reflux into the esophagus. Placement of LINX devices with initial FDA pivotal trial criteria (standard) of pH confirmed GERD, age 21-75, hiatal hernia >3cm, LA grade A esophagitis, and BMI <35 showed excellent long-term outcomes. Subsequent studies showed excellent outcomes using criteria beyond the initial criteria (extended). We examined the long-term outcomes for patients who had LINX placement for standard compared to extended pivotal trial criteria.
Methods: We performed a retrospective analysis of patients who underwent LINX placement from 2017-2021 at our institution. Patients who met pivotal trial criteria for LINX placement were categorized into the standard criteria group (SCG). Patients who did not meet the PIVOTAL trial criteria were placed into the extended criteria group (ECG).
Results: Of 107 patients who underwent the LINX procedure, 59 patients were in SCG (n=59) and 48 in ECG. The ECG group were older (64 vs 52; p<0.001), more females (83.3% vs. 55.9%; p=0.002) and had larger LINX devices placed (16.5 vs 15; p<0.001). In short-term follow-up, both the SCG and ECGs experienced significantly improved GERD-HRQL scores and patient satisfaction. In long-term follow-up of average 2.9 ±0.9 years, there were 15 patients (14%) who required EGD balloon dilation, which was not significantly different between SCG (n=8) and ECG (n=7) groups (13.6% vs. 14.6%; p=0.88). However, there was a significantly higher rate of LINX removal in the ECG (n=7) compared to the SCG (n=1) (14.6% and 1.7%; p=0.01). In the SCG group, the LINX device was removed due to a recurrent hernia with the LINX device at the GEJ (n=1). In contrast, the ECG group, LINX was removed due to migration of stomach above the LINX device (62.5%), reflux despite good LINX location (25%), and recurrent hernia with LINX device at GEJ (12.5%). The univariate analysis of patients who underwent LINX device removal showed that LINX removal was associated with extended LINX placement criteria (RR 8.60, 95% CI 1.10, 67.53; p=0.04) and higher BMI (RR 1.12, 95% CI 1, 1.25; p=0.046).
Conclusion: Patients who had LINX devices with extended criteria experienced significantly higher LINX device removal rates compared to the standard group. Further studies are needed to understand long-term risks associated with LINX device placement in patients who do not meet pivotal trial criteria.