Does Treatment of the Hiatus Influence the Outcomes of Magnetic Sphincter Augmentation for Chronic GERD?

Mihura, Matías; Blitz, Sandra; Wilshire, Candice L.; Jackson, Anee Sophia; Farivar, Alexander S.; Aye, Ralph W.; Dunst, Christy M.; Louie, Brian E.

doi:10.1007/s11605-019-04180-6

Cited by 16 publications

(10 citation statements)

References 17 publications

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“…Therefore, minimizing the amount of dissection performed and preserving the phreno-esophageal ligament may cause placement of the device below the true esophagogastric junction and may result in less effective reflux control. On the other hand, the MSA procedure is feasible even in large hernias based on our own clinical experience and other recent reports [30][31][32][33][34] .…”

Section: Discussionmentioning

confidence: 79%

Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease

Ferrari

Asti

Lazzari

et al. 2020

Sci Rep

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The magnetic sphincter augmentation (MSA) device has been proven safe and effective in controlling typical reflux symptoms and esophageal acid exposure for up to 6-year follow-up. Longer term outcomes have not been reported yet. A prospectively maintained database was reviewed to assess long-term safety and efficacy of the laparoscopic MSA procedure at a single referral center. Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), use of proton-pump inhibitors (PPI), and esophageal acid exposure were compared to baseline. Favorable outcomes were defined as ≥ 50% improvement of GERD-HRQL total score and PPI discontinuation. Between March 2007 and March 2020, 335 patients met the study inclusion criteria, and 124 of them were followed from 6 to 12 years after surgery (median 9 years, IQR 2). Mean total GERD-HRQL score significantly improved from 19.9 to 4.01 (p < 0.001), and PPI were discontinued by 79% of patients. The mean total percent time with pH < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving pH normalization. Independent predictors of a favorable outcome were age at intervention < 40 years (OR 4.17) and GERD-HRQL score > 15 (OR 4.09). We confirm long-term safety and efficacy of MSA in terms of symptom improvement, decreased drug dependency, and reduced esophageal acid exposure. The global burden of gastroesophageal reflux disease (GERD) is enormous, with a pooled prevalence of 13.3% in community-based studies 1. Symptoms and complications of GERD persist in up to 40% of patients treated with proton-pump inhibitors (PPI) 2,3 , and fundoplication is largely underused because of the steep learning curve and reported variability in outcomes 4. The aim of fundoplication is to restore lower esophageal sphincter (LES) function by remodeling the esophagogastric junction 5. Both total (Nissen) and partial (Toupet) fundoplication procedures require mobilization of the gastric fundus to be wrapped around the distal esophagus 6. To further enhance the antireflux barrier, a crural diaphragmatic repair is routinely added 7. Currently, the fact that fundoplication is offered to less than 1% of the GERD population may have an impact on the progression of symptoms and the development of Barrett's esophagus 8. The magnetic sphincter augmentation (MSA) procedure (Linx Reflux Management System, Ethicon, Johnson & Johnson, Shoreview, Mn, USA) was developed as a less disruptive and more standardized and reproducible laparoscopic surgical option for the treatment of GERD. The MSA device is composed by a variable number of interlinked titanium beads with a magnetic core inside. This ring-like system produces a magnetic force that augments the LES. The first feasibility trial and a large prospective nonrandomized study were published in 2008 9 and 2013 10 , respectively. The MSA procedure has been granted approval for clinical use by the Food and Drug Administration in 2012. Previous reports from our group have shown feasibility, safety, and efficacy of the MSA procedure...

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Section: Discussionmentioning

confidence: 79%

Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease

Ferrari

Asti

Lazzari

et al. 2020

Sci Rep

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“…concluded that an MSA procedure that included hiatal dissection, esophageal mobilization and crural closure provided the best outcome. 19 These results have led to modifying the implant procedure to include the three tenets of anti-reflux surgery 20 :…”

Section: Discussionmentioning

confidence: 99%

Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation

DeMarchi¹,

Schwiers²,

Soberman³

et al. 2021

Diseases of the Esophagus

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Summary Magnetic sphincter augmentation using the LINX® device is a minimally invasive surgical option for patients with gastroesophageal reflux disease. An estimated 30,000 devices have been implanted worldwide. Device removals and erosion are identified risks. The objective of this analysis is to explore the procedure evolution with an emphasis on the removals and associated characteristics that may guide future clinical practice. The Manufacturer and User Facility Device Experience and Ethicon’s complaint databases were queried for all surgical device explants since January 2013. Device unit sales were used to determine the rates. The endpoint was based upon the time from implant to explant. Explant and erosion rates were calculated at yearly intervals and the Kaplan-Meier estimator was used to measure the time to explant. Chi-square analyses were used to investigate the risk of explant associated with the size, geography and implant year. Overall, 7-year cumulative risk of removal was 4.81% (95% Confidence Interval (CI) CI: 4.31–5.36%). The likelihood of removal was significantly related to the device size (P < 0.0001), with smaller sizes being more likely to be explanted. The primary reasons for device removal and relative percentages were dysphagia/odynophagia (47.9%), persistent gastroesophageal reflux disease (20.5%) and unknown/other (11.2%). Overall, the 7-year cumulative risk of erosion was 0.28% (95% CI: 0.17–0.46%). The average device size increased from 14.2 beads ± 1.0 in 2013 to 15.3 beads ± 1.2 in 2019 (P < 0.001). Surgical technique and perioperative management play an important role in the outcomes. Clinical practice changes since magnetic sphincter augmentation has been incorporated into clinical use are associated with improved outcomes and should be further characterized. Smaller device size is associated with increased removal and erosion rates.

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“…The last study compared different methods of hiatal closure using pH normalization as the primary outcome and, on multivariable regression analysis, shows that full dissection of the hiatus, restoration of intraabdominal length, and crural closure was more likely to lead to pH normalization than other methods. However, this study identified that full dissection does not always lead to normalization of the post MSA pH testing (18).…”

Section: Discussionmentioning

confidence: 62%

Current laparoscopic technique of magnetic sphincter augmentation device implantation

Ohe¹,

Louie²

2020

J Vis Surg

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Gastroesophageal reflux disease (GERD) is a common medical malady on a global scale that has been treated primarily with lifestyle alterations and medical management. Surgery, specifically Nissen fundoplication, has been used for patients who are not well controlled with medical management. Though these treatment options are successful for many patients, they each carry their own risk and benefit profiles.In the last decade, the Food and Drug Administration approved a magnetic sphincter augmentation (MSA) device that can be placed around the gastroesophageal (GE) junction during a laparoscopic procedure to mimic a natural sphincter and control reflux. This treatment strategy has demonstrated similar efficacy to laparoscopic Nissen fundoplication for control of reflux symptoms. This article outlines the technical steps of this procedure as well as postoperative care and outcomes.

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Does Treatment of the Hiatus Influence the Outcomes of Magnetic Sphincter Augmentation for Chronic GERD?

Cited by 16 publications

References 17 publications

Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease

Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease

Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation

Current laparoscopic technique of magnetic sphincter augmentation device implantation

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