Heather F Warren, MD1, Lisa M Brown, MD2, Matias Mihura, MD3, Alexander S Farivar, MD3, Ralph W Aye, MD3, Brian E Louie, MD3. 1Dignity Health Medical Group, 2UC Davis Medical Center, 3Swedish Cancer Institute and Medical Center
OBJECTIVES: Magnetic sphincter augmentation (MSA) is a surgical treatment option for patients with GERD. The criteria used to select patients were based on limited data and with the goal of augmenting a relatively normal sphincter in patients with early GERD. In most patients, MSA results in substantial improvement in quality of life, freedom from PPIs and a low rate of esophagitis. However, 15-24% of patients resume PPIs, 11-12% have esophagitis and up to 3-4% will undergo device removal. We sought to identify factors predicting favorable outcomes after MSA placement with the aim of refining selection criteria.
METHODS: We retrospectively analyzed clinical, endoscopic, manometric, pH data and intra-operative factors from two databases: Pivotal Trial (N=100) and our prospectively maintained esophageal database (N=98). We defined apriori outcomes as excellent (GERD-HRQL<5, no PPI, no esophagitis); good (GERD-HRQL 6-15, no PPI, grade A esophagitis); Fair (GERD-HRQL 16 to 25, PPI use, grade B esophagitis); and, poor (GERD-HRQL>25, PPI use, grade C or D esophagitis). Univariate and multivariate analyses were done to predict which patients had either an excellent or good outcome.
RESULTS: A total of 198 patients underwent MSA with median age 52 years, 104 (53%) male and median BMI=27 (IQR=25-30).
At baseline, 186 (94%) patients experienced typical symptoms, 138 (70%) also reported atypical symptoms. PPI use led to complete relief in 83 (42%) and partial relief in 85 (43%). DeMeester score was 36.2 (IQR 26.8-51.7) with a structurally intact sphincter in 88 (44%). Esophagitis of any grade occurred in 88 (36%).
Operative time was 52 minutes (IQR:29-71). The hiatus was closed in 81 (41%) patients and a 14 bead device (N=89, 45%) was most common.
At 16 months after MSA, excellent outcomes were achieved in 81 (41%), good in 49 (25%), fair in 36 (18%) and poor in 8 (4.0%) (missing=24, 12%). Median DeMeester score was 14.7 (IQR=5.3-25.7), esophagitis detected in 31 (30%) and daily PPI use in 28 (14%).
At univariate analysis, excellent/good outcomes were adversely impacted by increasing BMI (OR=0.91, p=0.03), hiatal closure (OR=0.51, p=0.05), a structurally defective sphincter (OR=0.51, p=0.07) but positively impacted by longer LES length (OR=1.32, p=0.08). At multivariate analysis, BMI, defective LES and hiatal closure remained key factors.
CONCLUSIONS: Magnetic sphincter augmentation results in excellent/good outcomes in the majority of patients. Patients with a higher BMI and a structurally defective sphincter along with hiatal closure during implantation are less likely to have a favorable outcome after MSA.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 79946
Program Number: S141
Presentation Session: Plenary 2
Presentation Type: Podium