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Magnetic esophageal sphincter device effectively treats GERD
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Patients with GERD experienced reduced esophageal acid exposure, improved symptoms and better quality of life following lower esophageal sphincter augmentation with a magnetic device in a recent study.
Researchers assessed the efficacy of the device in 100 adult patients with GERD, and have reported the 3-year results of the ongoing 5-year study. All participants had shown partial response to proton pump inhibitors (PPI).
The device consists of a series of magnetic neodymium iron boride beads placed around the esophagus, which expand with intragastric pressure or the passage of food. All devices were implanted laparoscopically in a median of 36 minutes with no complications.
The majority of patients completed follow-up at 1 (98%), 2 (90%) and 3 years (85%). Sixty-four percent experienced normalization of acid exposure — defined as 4.5% or less of a 24-hour period with a pH less than 4 — or a 50% or larger reduction at 1 year after the procedure. Nearly all participants (93%) reported a 50% or greater reduction in PPI use, and 92% indicated improvement by at least 50% as measured by the Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire.
Ninety-five percent of patients were satisfied with their reflux condition at 1 year, while 90% and 94% were satisfied at 2 and 3 years of follow-up, respectively, compared with 13% at baseline (P<.001 for all comparisons). Fewer people reported moderate-to-severe regurgitation symptoms during follow-up (57% at baseline vs. 2% at 1 year and 1% at 2 and 3 years; P<.001 for comparisons).
Dysphagia, the most commonly reported adverse event, occurred in 68% of patients following the procedure, 11% at 1 year and 4% at 3 years of follow-up. Six patients experienced serious adverse events, and six patients required device removal.
“The device decreased exposure to esophageal acid, improved reflux symptoms, and allowed cessation of proton pump inhibitors in the majority of patients,” the researchers wrote. “Studies with larger samples and longer-term follow-up are needed to confirm these early results and assess longer-term safety.”
Disclosure: See the study for a full list of relevant disclosures.
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