Three factors predict poorer outcomes of Linx procedure for GERD
While most GERD patients had favorable outcomes after magnetic sphincter augmentation with the Linx device, higher BMI, a structurally defective lower esophageal sphincter, and higher lower esophageal sphincter pressure were linked to poorer outcomes, according to study results shared at the Society of American Gastrointestinal and Endoscopic Surgeons Surgical Spring Week.
Linx (Torax Medical) is a small, surgically implanted ring of interlinked titanium beads with magnetic cores that prevent reflux in patients with refractory GERD by augmenting the barrier function of the esophageal sphincter.
Brian E. Louie
“As surgeons, we’ve gained a lot of experience implanting this device since it was approved in 2012, and we need to learn from these experiences to consistently achieve excellent outcomes,” Brian E. Louie MD, MHA, MPH, FRCSC, FACS, director of thoracic research and education, and co-director of the minimally invasive thoracic surgery program at the Swedish Medical Center and Cancer Institute in Seattle, told Healio Gastroenterology. “This is one of the first studies that starts to help us refine who will or will not benefit from magnetic sphincter augmentation.”
Aiming to determine why up to a quarter of patients do not achieve favorable outcomes with this procedure, Louie and colleagues retrospectively analyzed data on 99 pivotal trial patients and 71 patients from a prospective database (median age, 53 years; median BMI, 27). Outcomes were defined based on quality of life scores, PPI use and esophagitis.
At baseline, the median DeMeester score was 37.9, and 93.5% of patients had typical symptoms, 69% had atypical symptoms, 47% had a structurally intact lower esophageal sphincter, and 43% had esophagitis.
They found that 48 months after the procedure, 47% of patients had excellent outcomes, 28% had good outcomes, 22% had fair outcomes and 3% had poor outcomes. The median DeMeester score was 15.6, 17.6% of patients had esophagitis and 17% of patients continued to use daily PPIs.
Multivariable analysis showed that excellent and good outcomes were negatively affected by higher BMI, a structurally defective lower esophageal sphincter, and residual lower esophageal sphincter pressure before the procedure.
“I think it’s important to be able to counsel patients about their anticipated outcomes from any surgery and data such as this allows us to do that,” Louie said. “A structurally defective sphincter is something that surgeons can potentially help restore by repairing the hiatal hernia or ensure that a portion of esophagus is restored into the abdominal cavity during repair and before placement of the magnetic sphincter.” – by Adam Leitenberger
Warren HF, et al. Abstract S141. Presented at: SAGES Surgical Spring Week; March 22-25, 2017; Houston, Texas.
Disclosures: Louie reports he is a member of the medical advisory board for Torax Medical, has received a research grant from the company, and teaches surgeons about magnetic sphincter augmentation.