LCD L39780: Lower Esophageal Magnetic Sphincter Augmentation

Lower esophageal magnetic sphincter augmentation (MSA) is considered medically reasonable and necessary when all the following conditions are met:

• Patient is diagnosed with gastroesophageal reflux disease (GERD) defined by abnormal pH testing in which acid exposure time (AET) is greater than 6% 1

• Patient has undergone appropriate endoscopic and esophageal manometric evaluation to rule out extragastrointestinal etiology of symptoms

• Patient has chronic GERD symptoms despite maximum medical therapy for the treatment of reflux defined as maximum (or maximum tolerated) dose of proton pump inhibitors (PPI) for at least 6 months 1

• Implantation of the device is performed by a surgeon with experience in laparoscopic anti-reflux procedures and has received product specific training

Because safety and efficacy has not been established, coverage is excluded for the following:

• Patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials

• Patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants

• Unrepaired hiatal hernia >3 cm or a paraesophageal hernia

• Barrett’s Esophagus or esophagitis Los Angeles (LA) class C or D

• Scleroderma

• Suspected or confirmed esophageal or gastric cancer

• Prior esophageal or gastric surgery or endoscopic intervention

• Distal esophageal motility less than 35mmHg peristaltic amplitude on wet swallows or

• Symptoms of dysphagia more than once per week within the last 3 months

• Esophageal stricture or gross esophageal anatomic abnormalities (Schatzki’s ring, obstructive lesions, etc.)

• Esophageal or gastric varices

• Lactating, pregnant or plan to become pregnant

• Morbid obesity (body mass index (BMI) >35)

• Age

Definitions:

The LA Classification of GERD 2 :

Grade A-One (or more) mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds

Grade B-One (or more) mucosal break more than 5 mm long that does not extend between the tops of 2 mucosal folds

Grade C-One (or more) mucosal break that is continuous between the tops of 2 or more mucosal folds, but which involve less than 75% of the circumference

Grade D-One (or more) mucosal break which involves at least 75% of the esophageal circumference

Overview

The Montreal Consensus defines GERD as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". 3 It includes a spectrum of symptoms, including heartburn, regurgitation, dysphagia, laryngitis, dental problems, adult-onset asthma, and aspiration pneumonia. The prevalence of GERD is high and increasing globally. 4

Lifestyle modification and medications are the mainstay of treatment for GERD. Despite proper medical therapy, 10 to 40% of patients continue to have significant symptoms. 5,6 Surgical intervention is generally reserved for patients who have persistent symptoms or develop complications despite optimal medical therapy. Fundoplication is a well-established surgical intervention that dates to the 1950’s. Since then, multiple variations of the fundoplication have been established. The laparoscopic fundoplication (LF) and its variations are considered highly effective and durable but also associated with significant potential for adverse effects, including dysphagia, difficulty in vomiting, and gas bloating. 7

Since the advent of fundoplication, other less invasive options that do not alter the gastric fundus have been developed. MSA is 1 of those options. It is performed using the LINX ® Reflux Management System. This device treats GERD by augmenting the LES with an extraluminal ring consisting of a series of magnets. The magnetic attraction increases the LES closure pressure but permits food passage when swallowing.