Magnetic sphincter augmentation (MSA) in patients with hiatal hernia: clinical outcome and patterns of recurrence

Abstract

Introduction Magnetic sphincter augmentation (MSA) is an effective treatment for patients with gastroesophageal reflux disease. In early studies, patients with a hiatal hernia (HH) ≥ 3 cm were excluded from consideration for implantation and initially the FDA considered its use as "precautionary" in this context. This early approach has led to an attitude of hesitance among some surgeons to offer this therapy to patients with HH. This study was designed to evaluate the impact of HH status on the outcome of MSA and to report the rate of HH recurrence after MSA. Methods and procedures This is a retrospective review of prospectively collected data of patients who underwent MSA between June 2013 and August 2017. Baseline clinical and objective data were collected. Patients were divided into four groups based on HH status: no HH, small HH (< 3 cm), large HH (≥ 3 cm), and paraesophageal hernia (PEH). Patient satisfaction, GERD-HRQL and RSI data, freedom from PPI, need for postoperative dilation, length of hospitalization, 90-day readmission rate, need for device removal, and HH recurrence was compared between groups. Results There were 350 patients [60% female, mean (SD) age: 53.5 (13.8)] who underwent MSA. There were 65 (18.6%) with no HH, 205 (58.6%) with small HH (< 3 cm), 58 (16.6%) with large HH (≥ 3 cm) and 22 (6.2%) with PEH. At a mean follow-up of 13.6 (10.4) months, the rate of outcome satisfaction was similar between the groups (86%, 87.9%, 92.2% and 93.8%, p = 0.72). This was also true for GERD-HRQL total score clinical improvement (79.1%, 77.8%, 82% and 87.5%, p = 0.77). The rate of postoperative dysphagia (p = 0.33) and freedom from PPIs (p = 0.96) were similar among the four groups. Duration of hospitalization was higher among those with a large HH or PEH, and only PEH patients had a higher 90-day readmission rate (p = 0.0004). There was no difference between the need for dilation among groups (p = 0.13). The need for device removal (5% overall) was similar between the four groups (p = 0.28). HH recurrence was 10% in all groups combined, and only 7 of 240 (2.9%) patients required reoperation; the majority of these patients underwent a minimal dissection approach (no hernia repair) at the index operation. The incidence of recurrent HH increased in direct correlation with the preoperative HH size (0%, 10.1%, 16.6 and 20%, p = 0.032). Conclusion In the largest series of MSA implantation, we demonstrate that the excellent outcomes and high degree of satisfaction after MSA are independent of the presence or size of HH. Despite higher rates of hernia recurrence in large HH and PEH patients, the rates of postoperative endoscopic intervention, and device removal is similar to those with no or small HH. The minimal dissection approach to MSA should be abandoned. Keywords Gastroesophageal reflux disease (GERD) • Hiatal hernia • Magnetic sphincter augmentation Gastroesophageal reflux disease (GERD) is the most common foregut disease that affects about 10% of the western population [1-3]. In this chronic disease, bot...

Clinical Outcomes and Predictors of Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with More than 500 Patients

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Efficacy of Magnetic Sphincter Augmentation Across the Spectrum of GERD Disease Severity

“…A recurrence was considered present if the EGJ was found to be proximal to the crural impressions on anterograde or retroflexion endoscopic view. Recurrence of hernia and device position were characterized using previously described criteria (8).…”

“…Initially, MSA with the LINX device (Ethicon, Johnson & Johnson; Shoreview, MN) was targeted toward "early" GERD patients with minimal structural decompensation so as to cure the disease and cease progression to a more severe form of GERD (3). In the years following its inception, the utility of MSA has expanded to more complex cases including patients with large hiatal hernias, severe esophagitis, and Barrett's esophagus (BE), yielding encouraging results (4)(5)(6)(7)(8)(9)(10). While these patient subsets may serve as a surrogate suggesting more severe gastroesophageal reflux disease, no study has evaluated the performance and durability of MSA stratified by the degree of esophageal acid exposure, the most objective measure for disease severity.…”

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“…[94][95][96] Magnetic sphincter augmentation is also a seemingly effective alternative to laparoscopic fundoplication in patients with GERD, with or without a hiatal hernia. 97 Transoral incisionless fundoplication (TIF) is an endoluminal antireflux intervention option for GERD, particularly in cases without significant disruption of the antireflux barrier. 98,99 Bariatric surgery is the mainstay surgical option for patients with GERD and obesity.…”