Objective: The aim of this study was to identify patients’ characteristics that may predict failure and removal of the Linx sphincter augmentation device, and to report the results of 1-stage laparoscopic removal and fundoplication.
Background: The Linx device is a long-term magnetic implant that was developed as a less disruptive and more reproducible surgical option for patients with early-stage gastroesophageal reflux disease (GERD). Removal of the device has been shown to be feasible, but no long-term results of this procedure have been reported yet.
Methods: A review of the prospectively collected research database of antireflux surgery was performed to identify all patients who underwent a Linx implant between 2007 and 2015 in our Institution. Demographics, duration of symptoms and proton pump inhibitor (PPI) therapy, GERD-Health Related Quality of Life scores, esophageal acid exposure, lower esophageal sphincter pressure, number of beads (size) of the implanted device, concurrent crura repair, angle of inclination of the device at postoperative chest film, operative time, postoperative complications, and length of stay were recorded. Data of the explanted patients were compared with those with the device in situ in an attempt to identify factors associated with Linx removal.
Results: Over the study period, 164 patients underwent a laparoscopic Linx implant and had a median follow-up of 48 months [interquartile range (IQR) 36]. Eleven (6.7%) of these patients were explanted at a later date. The estimated removal-free probability at 80 months was 0.91 [confidence interval (CI) 0.86–0.96]. Supine esophageal acid exposure before the index operation was associated with Linx removal (odds ratio 1.05, CI 1.01–1.11, P = 0.037). The main presenting symptom requiring device removal was recurrence of heartburn or regurgitation in 5 patients (46%), followed by dysphagia (n = 4, 37%) and chest pain (n = 2, 18%). In 2 patients, full-thickness erosion of the esophageal wall with partial endoluminal penetration of the device occurred. The median implant duration was 20 months, with 82% of the patients being explanted between 12 and 24 months after the implant. Device removal was most commonly combined with partial fundoplication. There were no conversions to laparotomy and the postoperative course was uneventful in all patients. At the latest follow-up, ranging from 12 to 58 months, the GERD-HRQL score was within normal limits in all patients.
Conclusions: Laparoscopic removal of the Linx device can be safely performed as a 1-stage procedure and in conjunction with fundoplication even in patients presenting with device erosion.
Department of Biomedical Sciences for Health, Division of General Surgery, University of Milan, Milan, Italy.
Reprints: Prof. Luigi Bonavina, MD, FACS, Department of Surgery, IRCCS Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese (Milano), Italy. E-mail: firstname.lastname@example.org.
No financial support was received for this study. Dr Bonavina received consultant fees by Torax Medical Inc. for the Linx feasibility study.
The authors report no conflicts of interest.