Evidence map›Paper›PMID 42117783›Full record

ArticleAnnals of surgery2026

Long-term (>5 Years) Outcomes after Magnetic Sphincter Augmentation.

Brian E Louie, Henok G Woldu, Reginald C W Bell, Kyle A Perry, Christy M Dunst, John C Lipham, Blair A Jobe, Post-approval Study Investigators

Abstract read
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Article in Annals of surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Brian E LouieDivision of Thoracic Surgery, Swedish Medical Center, Seattle, WA.ORCID 0000-0002-7599-1000
Henok G WolduBiostatistics, Ethicon Inc., Raritan, NJ.
Reginald C W BellSOFI Center for Esophageal Wellness, Englewood, CO.
Kyle A PerryDepartment of Surgery, Ohio State University, Columbus, OH.
Christy M DunstCenter for Advanced Surgery, The Oregon Clinic, Portland, Oregon.ORCID 0000-0002-8320-5428
John C LiphamDepartment of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA.ORCID 0000-0002-6203-5263
Blair A JobeEsophageal and Lung Institute, Allegheny Health Network, Pittsburgh, PA.ORCID 0000-0001-6550-5315
Post-approval Study Investigators

Funding

Torax Medical
6 · The paper itself

Abstract

objectiveTo report the long-term (5 years) patient-reported outcomes and objective pH measurements of patients undergoing magnetic sphincter augmentation (MSA).

backgroundMSA controls gastroesophageal reflux disease (GERD) as demonstrated in multiple studies. Consistent patient-reported outcomes and objective data support its use in short-term follow-up. Long-term data are required.

methodsThis FDA post-approval study enrolled patients from 2013 to 2015, with confirmed GERD despite acid suppression therapy, undergoing laparoscopic implantation of a magnetic sphincter with a minimum of 5 years of follow-up were included. Clinical success was defined as a ≥50% improvement in the total GERD-health-related quality of life score compared with the baseline off proton pump inhibitors (PPIs). Secondary outcomes were objective evidence of GERD control on pH testing and the use of PPIs.

resultsA total of 136/200 patients were available for follow-up. A ≥50% improvement in the GERD-health-related quality of life score was achieved in 81.6% with the median score improving from 26 to 4. Freedom from daily PPI use was 90.4%. Objectively, the % time pH <4 went from 9.1 to 3.2, and the DeMeester score from 29 to 11 in 81 patients. The ability to belch and vomit was retained if needed. Dysphagia occurred in 5%. There were 27 (13%) devices explanted with only 4 (2%) erosions. Of these, 25 (92.6%) patients had resolution of their symptoms with removal, conversion to fundoplication, or replacement of the device.

conclusionsMSA controls symptoms of GERD without the need for PPIs but may need explantation in 13% of patients.

Indexed as

Esophageal Sphincter, LowerGastroesophageal RefluxProstheses and ImplantsAdultAgedFemaleFollow-Up StudiesHumansLaparoscopyMaleMiddle AgedPatient Reported Outcome MeasuresProton Pump InhibitorsQuality of LifeTime FactorsTreatment OutcomeProton Pump Inhibitorsgastroesophageal reflux diseaseLINXmagnetic sphincter augmentationproton pump inhibitorsquality of life

Identifiers

PMID42117783
PMCPMC13218435

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