LINX(®) Reflux Management System in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux

Abstract

Gastroesophageal reflux disease (GERD) results from incompetency of the lower esophageal sphincter that allows the contents of the stomach to reflux into the esophagus, the airways, and the mouth. The disease affects about 10% of the western population and has a profound negative impact on quality of life. The majority of patients are successfully treated with proton-pump inhibitors, but up to 40% have incomplete relief of symptoms even after dose adjustment. The laparoscopic Nissen fundoplication represents the surgical gold standard, but is largely underused because of the level of technical difficulty and the prevalence of side effects. These factors have contributed to the propensity of patients to continue with medical therapy despite inadequate symptom control and complications of the disease. As a consequence, a significant 'therapy gap' in the treatment of GERD remains evident in current clinical practice. The LINX(®) Reflux Management System (Torax Medical, St. Paul, MN, USA) is designed to provide a permanent solution to GERD by augmenting the sphincter barrier with a standardized, reproducible laparoscopic procedure that does not alter gastric anatomy and is easily reversible. Two single-group trials confirmed that a magnetic device designed to augment the lower esophageal sphincter can be safely and effectively implanted using a standard laparoscopic approach. The device decreased esophageal acid exposure, improved reflux symptoms and quality of life, and allowed cessation of proton-pump inhibitors in the majority of patients.

Keywords: Barrett’s; Nissen; adenocarcinoma; esophagitis; fundoplication; gastroesophageal reflux disease; heartburn; lower esophageal sphincter augmentation; proton-pump inhibitors; regurgitation.

Figure 1.

The LINX Reflux Management System encircling the distal esophagus in the closed position (a) and in the open position (b) [Bonavina, 2013]. Reproduced with kind permission from Springer Science and Business Media.

Figure 2.

Minimal dissection of the gastroesophageal junction with preservation of the phrenoesophageal ligament is highly recommended during implantation of the LINX device.

Figure 3.

Intraoperative images show tunneling between the posterior vagus nerve and the esophageal wall (a); the sizing device in place to measure the esophageal circumference (b); and the LINX device positioned at the gastroesophageal junction (c) [Bonavina, 2013]. Reproduced with kind permission from Springer Science and Business Media.

Figure 4.

Postoperative chest film confirming the subdiaphragmatic position and the typical inclination angle of the LINX device

Figure 5.

Esophageal acid exposure. Results of sequential esophageal pH monitoring studies up to 3 years of follow up showing significant and durable control of gastroesophageal reflux over time. BL, baseline; PPI, proton-pump inhibitor.

Figure 6.

GERD HRQL score off PPIs. The Gastro-Esophageal Reflux Disease Health Related Quality of Life (GERD HRQL) total score significantly decreased and remained stable after the LINX implant. BL, baseline; PPI, proton-pump inhibitor.

Figure 7.

Daily PPI use. The proportion of patients requiring daily use of proton-pump inhibitors (PPIs) significantly decreased and remained stable after the LINX implant.