Evidence map›Paper›PMID 22538694›Full record

ArticleSurgical endoscopy2012

The LINX® reflux management system: confirmed safety and efficacy now at 4 years.

John C Lipham, Tom R DeMeester, Robert A Ganz, Luigi Bonavina, Greta Saino, Daniel H Dunn, Paul Fockens, Willem Bemelman

Registry-linked trialAbstract readControlled Clinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Article in Surgical endoscopy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01058070 (An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter), which is not on this map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
8.6field-weighted citation impact, top 2% of its field
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

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01058070 nacompletednot on this map

An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter

TypeinterventionalSponsorTorax Medical IncorporatedRan2007 to 2013Enrolled44ConditionsGastroesophageal Reflux DiseaseArmsTorax Medical, Inc. LINX Reflux Management System
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 132 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  6. Article
  7. Article
  8. Review
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  10. Observational
  11. Review
  12. Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2021
    Article
  13. Article
  14. Gastroesophageal Reflux After Sleeve Gastrectomy.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2021
    Review
  15. Article
  16. Article
  17. LINXWorld journal of clinical cases · 2020
    Article
  18. Review
  19. Article
  20. Article
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 at 5 institutions in 3 countries.

John C LiphamDepartment of Surgery, University of Southern California, 1510 San Pablo Street, HCC-514, Los Angeles, CA 90033, USA. jlipham@surgery.usc.edu
Tom R DeMeester
Robert A Ganz
Luigi Bonavina
Greta Saino
Daniel H Dunn
Paul Fockens
Willem Bemelman
IRCCS Policlinico San Donato · ITUniversity of Southern California · USAcademic Medical Center · NLMinnesota Gastroenterology · USUniversity of Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSphincter augmentation with the LINX® Reflux Management System is a surgical option for patients with chronic gastroesophageal disease (GERD) and an inadequate response to proton pump inhibitors (PPIs). Clinical experience with sphincter augmentation is now available out to 4 years.

methodsIn a multicenter, prospective, single-arm study, 44 patients underwent a laparoscopic surgical procedure for placement of the LINX System around the gastroesophageal junction (GEJ). Each patient's baseline GERD status served as the control for evaluations post implant. Long-term efficacy measures included esophageal acid exposure, GERD quality-of-life measures, and use of PPIs. Adverse events and long-term complications were closely monitored.

resultsFor esophageal acid exposure, the mean total % time pH < 4 was reduced from 11.9 % at baseline to 3.8 % at 3 years (p < 0.001), with 80 % (18/20) of patients achieving pH normalization (≤ 5.3 %). At ≥ 4 years, 100 % (23/23) of the patients had improved quality-of-life measures for GERD, and 80 % (20/25) had complete cessation of the use of PPIs. There have been no reports of death or long-term device-related complications such as migration or erosion.

conclusionsSphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues, as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation.

Indexed as

Prostheses and ImplantsAdultAgedChronic DiseaseEquipment SafetyEsophageal pH MonitoringEsophagogastric JunctionFemaleFollow-Up StudiesFundoplicationGastroesophageal RefluxHumansMaleMiddle AgedPatient SatisfactionProsthesis DesignProton Pump Inhibitors

Identifiers

PMID22538694
OpenAlexW2085351850

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.