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Surg Endosc (2012) 26:29442949 DOI 10.1007/s00464-012-2289-1
The LINX reux management system: conrmed safety and efcacy now at 4 years
John C. Lipham Tom R. DeMeester
Robert A. Ganz Luigi Bonavina Greta Saino
Daniel H. Dunn Paul Fockens Willem Bemelman
Received: 9 March 2012 / Accepted: 26 March 2012 / Published online: 27 April 2012 Springer Science+Business Media, LLC 2012
Abstract
Background Sphincter augmentation with the LINX
Reux 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.
Methods In 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 patients baseline GERD status served as the control for evaluations post implant. Long-term efcacy measures included esophageal acid exposure, GERD quality-of-life measures, and use of PPIs. Adverse events and long-term complications were closely monitored. Results For 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 (B5.3 %). At C4 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.
Conclusions Sphincter augmentation with the LINX Reux Management System provided long-term clinical benets 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 benet from treatment with sphincter augmentation.
Keywords Gastroesophageal reux disease Sphincter
augmentation Lower esophageal sphincter Proton pump
inhibitors Nissen fundoplication
Presented at the SAGES 2012 Annual Meeting, March 710, 2012, San Diego, CA.
J. C. Lipham (&) T. R. DeMeester
Department of Surgery, University of Southern California, 1510 San Pablo Street, HCC514, Los Angeles, CA 90033, USA e-mail: [email protected]; [email protected]
R. A. GanzMinnesota Gastroenterology, Minneapolis, MN, USA
R. A. GanzDepartment of Gastroenterology, Abbott-Northwestern Hospital, Minneapolis, MN, USA
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