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

2021 ◽  
Author(s):  
Janet DeMarchi ◽  
Michael Schwiers ◽  
Mark Soberman ◽  
Allison Tokarski
Keyword(s):  
Clinical Practice ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Cumulative Risk ◽  
Magnetic Sphincter Augmentation ◽  
Chi Square ◽  
Erosion Rates ◽  
Minimally Invasive Surgical ◽  
Device Size

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.

Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies

2018 ◽  
Vol 70 (3) ◽  
pp. 323-330 ◽  
Author(s):  
Emanuele Asti ◽  
Alberto Aiolfi ◽  
Veronica Lazzari ◽  
Andrea Sironi ◽  
Matteo Porta ◽  
...  
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Clinical Studies ◽  
Magnetic Sphincter Augmentation

Esophageal Magnetic Sphincter Augmentation as a Novel Approach to Post-bariatric Surgery Gastroesophageal Reflux Disease

2018 ◽  
Vol 28 (10) ◽  
pp. 3080-3086 ◽  
Author(s):  
John P. Kuckelman ◽  
Cody J. Phillips ◽  
Michael J. Derickson ◽  
Byron J. Faler ◽  
Matthew J. Martin
Keyword(s):  
Bariatric Surgery ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Magnetic Sphincter Augmentation ◽  
Novel Approach ◽  
Post Bariatric Surgery

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

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Davide Ferrari ◽  
Emanuele Asti ◽  
Veronica Lazzari ◽  
Stefano Siboni ◽  
Daniele Bernardi ◽  
...  
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Magnetic Sphincter Augmentation

Magnetic Sphincter Augmentation with the LINX Device for Gastroesophageal Reflux Disease after U.S. Food and Drug Administration Approval

2014 ◽  
Vol 80 (10) ◽  
pp. 1034-1038 ◽  
Author(s):  
Jessica L. Reynolds ◽  
Joerg Zehetner ◽  
Nikolai Bildzukewicz ◽  
Namir Katkhouda ◽  
Giovanni Dandekar ◽  
...  
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Drug Administration ◽  
Reflux Disease ◽  
Food And Drug Administration ◽  
Intraoperative Complications ◽  
Gastroesophageal Junction ◽  
Balloon Dilation ◽  
Magnetic Sphincter Augmentation ◽  
Related Quality

Magnetic sphincter augmentation (MSA) of the gastroesophageal junction with the LINX Reflux Management System is an alternative to fundoplication for gastroesophageal reflux disease (GERD) that was approved by the U.S. Food and Drug Administration (FDA) in March 2012. This is a prospective observational study of all patients who underwent placement of the LINX at two institutions from April 2012 to December 2013 to evaluate our clinical experience with the LINX device after FDA approval. There were no intraoperative complications and only four mild postoperative morbidities: three urinary retentions and one readmission for dehydration. The mean operative time was 60 minutes (range, 31 to 159 minutes) and mean length of stay was 11 hours (range, 5 to 35 hours). GERD health-related quality-of-life scores were available for 83 per cent of patients with a median follow-up of five months (range, 3 to 14 months) and a median score of four (range, 0 to 26). A total of 76.9 per cent of patients were no longer taking proton pump inhibitors. The most common postoperative complaint was dysphagia, which resolved in 79.1 per cent of patients with a median time to resolution of eight weeks. There were eight patients with persistent dysphagia that required balloon dilation with improvement in symptoms. MSA with LINX is a safe and effective alternative to fundoplication for treatment of GERD. The most common postoperative complaint is mild to moderate dysphagia, which usually resolves within 12 weeks.

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