LINX Reflux Management System at the Sachsenhausen Clinic, Germany, Frankfurt

LINX Reflux Management System

New treatment option for gastroesophageal reflux disease

The LINX® Reflux Management System offers the option of a simple laparoscopic operation (keyhole operation) to strengthen the lower sphincter between the esophagus and the stomach. This will restore your body's natural barrier prior to the occurrence of reflux disease without any anatomical changes or minimal side effects. (see animation) Patients' experience shows that they do not have any symptoms immediately after the operation, and therefore the quality of life increases significantly.

What is the LINX® System?

The LINX® Reflux Management System is a small flexible chain composed of titanium beads with a magnetic core. The magnetic attraction between the beads keeps the sphincter closed, thus preventing reflux. On the contrary, the chain opens when you swallow and relieve excessive stomach pressure, for example to enable burping or vomiting.

At our clinic we implant the latest generation of the LINX system. These models are adapted to the MRI!

LINX Reflux System Installation Procedure

This procedure is performed only in specialized and producer certified centers.

At our clinic we use the LINX system to treat the esophagus just above the stomach with a routine, minimally invasive surgical procedure called laparoscopy or keyhole surgery. This treatment for reflux disease is performed under general anesthesia and usually takes less than an hour.

The LINX reflux system works immediately after implantation. After the procedure you will be able to eat normally under our guidance and usually resume normal activities in less than a week. Unlike other types of reflux surgery, the insertion of the LINX system does not require any anatomical changes in the stomach.

It is important to eat small portions of food several times a day after surgery to ensure that the LINX system works properly. In some cases, it has been noticed that, approximately 2 weeks after the operation, a slight discomfort may occur in the esophagus because of healing or scarring around the LINX reflux implant. At this stage it is extremely important to continue to eat regularly to maintain the mobility of the LINX magnetic reflux system. Since each patient has different responses to these situations, the symptoms range from very mild to significant. We will be with you during this time and can have a positive impact on your treatment. Most patients have almost no symptoms 6 weeks after the operation. The healing is complete 12 weeks after the operation and the patient can eat and drink whatever they want, no more medications are needed.

The LINX is a small implant that consists of interconnected titanium beads with magnetic cores. The magnetic attraction between the beads increases the strength of the esophageal sphincter and thus prevents reflux. The device is implanted by using the laparoscopic standard technique and is an alternative to fundoplication which is usually used as a surgical treatment for reflux disease. The LINX reflux management system is indicated for patients who have been diagnosed with Gastroesophageal Reflux Disease (GERD) by detecting abnormal pH levels and who still suffer from symptoms of chronic GERD, although maximum therapy has been provided for the treatment of reflux.

We have recently published new data on the comparison made between LINX®, a magnetic device for gastroesophageal sphincter augmentation and laparoscopic fundoplication used in 249 patients. The data from this study are an important addition to the growing amount of evidence that LINX is a safer and more effective way for patients suffering from gastroesophageal reflux disease (GERD). In the case of surgical treatment (fundoplication), the tissues of the stomach are placed around the esophagus to prevent reflux. The LINX device provides protection against reflux without restricting the stomach, at the same time minimizing the side effects normally associated with the surgical technique used today.

Prof. Dr. med. J. Stein of the Reflux Treatment Center, one of the authors of this prospective study "Magnetic Sphincter Augmentation and GERD Fundoplication in Clinical Practice", in which several medical centers were involved, explains: "If the acid reducing therapy does not help to relieve the reflux disease in patients, it is a huge clinical problem. In this study, the majority of patients reported that, despite taking acid-reducing medications, they had symptoms of reflux that were serious enough to affect their daily activities. After a minimally invasive, laparoscopic anti-reflux operation, both in the case of LINX and in the case of fundoplication, both groups experienced a significant improvement in the quality of life. Patients who had the LINX system were less likely to have meteorisms, and compared to the group that had undergone fundoplication, they could, if necessary, cause vomiting earlier. The LINX group was noticeably more likely to abandon acidity-reducing medications (81.8%) than the fundoplication group (63.0%).

Thanks to this study, an important breakthrough was made in the treatment of reflux disease. With the LINX system, the patient receives the same benefits of reflux management as with fundoplication, but without serious complications.

In the few studies we have published to date, implantation of the LINX system has enabled both acid exposure of the distal esophagus (percentage acid exposure time pH <4 from pre-op. 11.9% to 3.1% after one year and 3.8% after 3 years) and the GERD-HRQL score (from an average of 25.7 preoperatively to 3.3 after 4 years postoperatively) were significantly reduced. Normalization of the pH was described in 58% of the patients after one year and in another study in 80% of the operated patients after 3 years. This resulted in patient satisfaction of 94% after 3 years and 87.5% after 4 years, comparable to patient satisfaction after Nissen fundoplication.

The LINX system, according to official FDA clinical trials, has not only been safer but also more effective. The FDA has approved it for use in the United States since the beginning of 2012. The LINX is available in the USA, as well as in Europe at clinics trained in the use of the LINX system.

Contraindications

The LINX reflux management system is prohibited for use in patients with expected or existing allergies to titanium, noble steel, nickel or iron materials.

Warnings

The LINX device is considered to be conditionally MR-compatible with a magnetic resonance imaging (MRI) scanner with a power of up to 0.7 Tesla (0.7 T) or 1.5 Tesla (1.5 T), depending on the LINX implantable model. Scanning for various reasons can cause serious damage and/or affect the magnetic performance and function of the device. If alternative diagnostic techniques cannot be used and an MRI is required, the LINX system can be safely removed by means of laparoscopic techniques, which do not adversely affect the standard method of reflux treatment.

If the LINX device is not properly attached, it may be displaced later, which will require repeated surgery.

General Precautionary Measures

The LINX is an implant for a prolonged period of time, but surgery may be required to remove and replace it at any time. Treatment of side effects may include removal and/or replacement of the implant.

The effect of the LINX device on patients with paraesophageal hernia larger than 3 cm has not been studied. When using the LINX device in patients with a paraesophageal hernia larger than 3 cm, it is necessary to take into account the patient's medical history and the degree of symptomatic expression.

The safety and effectiveness of the LINX system for patients with Barrett's syndrome or esophagitis grade C or D (Los Angeles classification) have not been studied.

The safety and effectiveness of the LINX device for patients with electrical implants such as pacemakers or defibrillators, as well as other metal implants inserted into the abdominal cavity, have not been researched.

The safety and effectiveness of the LINX reflux management system has not been proven under the following conditions:

  • Scleroderma
  • Suspected or detected gastric or esophageal cancer
  • Previously undergone gastric and esophageal surgery or endoscopic interventions
  • Distal oesophagus motility disorders: peristaltic amplitude with a wet swallow of less than 35 mmHg or <70% (pushing) peristaltic waves, as well as peristaltic disorders such as achalasia, nodule esophagus, diffuse esophageal spasm or hypertensive gastroesophageal sphincter
  • Dysphagia symptoms more than once a week over the last 3 months
  • Stricture of the esophagus or macroscopic esophageal anatomical abnormalities (Schatzki ring, obstructive changes, etc.)
  • Esophageal or gastric varices
  • Breastfeeding, pregnancy or planning a baby
  • Morbid obesity (BMI> 35)

Possible Complications

Possible complications because of the use of the LINX reflux management system may include achalasia ( lack of relaxation of the lower part of the esophagus), bleeding, death, damage to the esophagus surface by the device, removal of the device/ repeated surgery, device failure, displacement of the device (the device is not detected at the site of its implantation), diarrhoea, dysphagia ("difficulty swallowing"), and inability to burp or vomit, infection, impaired gastric peristalsis, damage to the esophagus, spleen or stomach, nausea, painful swallowing, organ damage caused by device displacement, pain, peritonitis, pneumothorax (lung collapse), burping, saliva/ mucus production, gastric bloating, vomiting, and worsening of pre-operative symptoms (including dysphagia, heartburn, etc.).

Prof., Dr. Stein

Prof., Dr. Stein

Head physician

Holger Bahn

Holger Bahn

Senior physician

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