Multi Institutional Outcomes Using Magnetic Sphincter Augmentation Versus Nissen Fundoplication for Chronic Gastroesophageal Reflux Disease.

Press Release from a Poster presented at Sages 2015 (S034)

MD1,Jessica L Reynolds, MD2, John C Lipham, MD2, Joerg Zehetner, MD2, Nikolai A Bildzukewicz, MD2, Paul A Taiganides, MD3, Ralph W Aye, MD1, Alexander S Farivar, MD1, Brian E Louie, MD, MPH1.1Swedish Cancer Institute and Medical Center, 2University of Southern California,3Knox Community Hospital

Background: Historically, surgical intervention for gastroesophageal reflux disease (GERD) has been limited to fundoplication. Recently, magnetic sphincter augmentation (MSA) of the reflux barrier has garnered interest as an alternative surgical intervention in the treatment of GERD. Single and multicenter case series have shown safety and efficacy of MSA but comparative data to fundoplication is lacking and is required to determine the role of MSA in GERD management. We aimed to compare perioperative and clinical outcomes following MSA or Nissen fundoplication (NF).

Methods: A multi-institution retrospective review of prospectively collected data for consecutive patients undergoing either MSA or NF with chronic GERD. Data included demographics, baseline endoscopic findings and reflux characteristics, operating time, length of stay and major and minor morbidities. Measured postoperative outcomes included GERD health related quality of life (GERD HRQL) scores, resumption of proton pump inhibitors (PPI), dysphagia, gas bloat, ability to belch and vomit and overall patient reported satisfaction.

Results: Four hundred patients underwent surgical intervention for GERD (186 MSA and 214 NF). The groups were similar with respect to age, gender, GERD HRQL, pH and DeMeester scores, reports of preoperative dysphagia, and findings of esophagitis on endoscopy. Patients undergoing MSA had a significantly smaller body mass index than those undergoing NF (27kg/m2 versus 28 kg/m2 p<0.05), hiatal hernia size (1 centimeter versus 2 centimeters, p<0.01) and prevalence of Barrett’s (17% versus 32%, p<0.01).

The operating time and length of stay were significantly shorter in patients undergoing MSA versus NF (57 versus 76 minutes; and 11 versus 32 hours respectively; p<0.01). There were no mortalities, and there were no significant differences in minor and major morbidities, which included one MSA erosion requiring endoscopic removal and two failed NF requiring surgical revision.

A minimum of one year follow up was attained for 134 (72%) MSA and 152 (71%) NF patients. Both groups reported significant improvement in GERD HRQL scores (preoperative 21 and 19 versus postoperative 3 and 3 for MSA and NF respectively). Patients who underwent MSA were less likely to experience severe gas bloat (7% MSA versus 16% NF; p<0.05) and more likely to retain the ability for eructation (98% MSA versus 82% NF; p<0.01) and emesis (94% MSA versus 34% NF, p<0.01). Postoperative dysphagia was equal between the two groups. Patients undergoing NF were less likely to resume PPIs (13% versus 19%, p<0.05), and were more likely to report satisfaction with the procedure (92% versus 83%, p<0.05), while an equal distribution of MSA and NF patients reported they would undergo the procedure again.

Conclusions: Both MSA and NF improve the quality of life in patients with chronic GERD; thus, MSA is an alternative to NF. However, subtle differences in efficacy, procedural side effects and patient perceived satisfaction are apparent. These differences can be used to educate patients regarding the advantages and disadvantages of each option and assist in informed decision making, allowing for an individualized and potentially optimized approach to anti-reflux surgery.