Gastrointestinal

A new surgical intervention for reflux treatment

LINX is a new surgical procedure developed to treat chronic gastroesophageal reflux disease (GERD). Originally developed and tested in the United Kingdom, LINX was approved in the United States by the Food and Drug Administration (FDA) in March 2012. This procedure involves laparoscopic placement of a ring of linked magnetic beads around the lower esophageal sphincter (LES) to augment the function of a weakened or incompetent sphincter

This article reviews the use of LINX, starting with the condition it’s used for—GERD. Incidence rates of and hospitalizations related to GERD have soared over the past several years, with 20% of the US population currently suffering from the disease. A statistical analysis of hospital data from 1998 to 2005 by the Agency for Healthcare Research and Quality (AHRQ) indicates that hospitalizations related to GERD increased 216% during this time period. The increase is thought to be related to the high obesity rates in the United States.

The problem of chronic reflux

The primary function of the LES, located at the junction of the esophagus and stomach, is to prevent retrograde flow of gastric content, which is corrosive to the esophageal lining. Normally, the esophageal pressure changes that occur with normal peristalsis trigger this sphincter to open and allow passage of food and fluids from the esophagus into the stomach.

Occasionally, factors such as the increased stomach pressure associated with pregnancy or increased acidity of stomach contents, which occurs with spicy foods, can cause the sphincter to relax, allowing gastric content to slip into the esophagus. Irritation of the esophageal lining by the highly acidic stomach acid may lead to symptoms such as heartburn, reflux, epigastric pain, or belching. Long-term exposure to highly concentrated acids causes cellular changes in the esophageal lining, which can lead to dysphagia, Barrett’s esophagus, and esophageal cancer.

Risk factors for GERD can be categorized as follows:

  • Those that increase stomach pressure—obesity, pregnancy, hiatal hernia
  • Those that relax LES—smoking, age, connective tissue disorders
  • Those that increase the acidity of stomach contents—spicy foods, alcohol, caffeine.

Unfortunately, a gold standard diagnostic test for GERD doesn’t exist. Instead, it’s diagnosed after thorough symptom analysis and identification of specific esophageal tissue changes through endoscopy or pH monitoring.


Quality of life

Chronic reflux symptoms can interfere with daily life and routines. For example, patients with chronic reflux may not be able to lie flat to sleep because stomach acid flows back into the esophagus when they lie down. These patients may have to sleep with several pillows or raise the head of their bed.

Family occasions may not be as enjoyable because the patient may not be able to tolerate most foods, or may experience heartburn throughout the day. The patient may not be able to participate in favorite physical activities, such as gardening or recreational sports, because excessive physical movement or actions such as bending over may precipitate movement of gastric content into the esophagus, causing exacerbation of symptoms.

Some chronic reflux patients may feel like their daily life and diet is scheduled around medication doses and symptom flare ups.

Medical and surgical treatment

Primary treatment for GERD includes diet modification and losing excess weight. Medications, such as proton pump inhibitors including omeprazole (Nexium) and pantoprazole (Protonix), and H-2 receptor blockers, such as famotidine (Pepcid) and ranitidine (Zantac), may be prescribed to help control symptoms.

Surgical intervention is considered when no adequate symptom relief has been achieved with other treatment methods. Currently, two primary surgical procedures for GERD treatment are the Laparoscopic Nissen Fundoplication (Lap Nissen) and the LINX procedure. Lap Nissen involves wrapping the fundus of the stomach around the LES. This procedure may be indicated for patients with hiatal hernia, who are not appropriate candidates for the LINX procedure, or have not had adequate symptom control after the LINX procedure.

Ring of beads

The LINX procedure involves laparoscopic insertion of a ring of magnetic beads around the LES. The beads are composed of rare earth metals that are sensitive to the earth’s magnetic poles, so the ring is expected to last the lifetime of the patient. The link between the beads is weak enough to allow ring expansion and normal passage of food and fluids, but also strong enough to prevent retrograde flow of gastric content.

This minimally invasive procedure can be completed in less than an hour and, if necessary, can be completely reversed in less time. Patients are able to resume a regular diet immediately after the procedure. About 98% of patients are able to stop all reflux medications.

Currently, this procedure is indicated for patients over 18 years whose GERD symptoms are not adequately controlled by other methods, who do not have hiatal hernia or history of hiatal hernia, are healthy enough to undergo anesthesia and laparoscopic surgery, do not have any other metal implants (such as pacemakers), and do not have a diagnosis or any history of psychological disorders (particularly schizophrenia or psychotic disorders). During clinical trials, a patient with schizophrenia reported psychosomatic symptoms that the patient believed were caused by the implant. Further research is needed for the implant’s appropriateness for patients with a diagnosis of psychological disorders. This procedure is contraindicated for patients who are allergic to titanium, stainless steel, nickel, and/or iron.

Caring for patients undergoing LINX

Patient education is essential to any successful LINX procedure. Preoperatively, nurses should educate patients about what to expect during and after the procedure. Encourage patients to increase their fluid intake the day before the procedure to help maintain adequate hydration, which can accelerate the recovery process, but tell them to stop oral intake at least 8 hours before the procedure.

Explain to patients that after surgery they may experience some mild discomfort, including pain at the port sites, gas pain, or a “sore throat” related to temporary intubation for anesthesia. Patients can begin regular food intake immediately after the procedure. Currently, LINX patients are hospitalized overnight to monitor for any surgical complications, such as infection or dysphagia.

Encourage patients to immediately report any difficulty swallowing, nausea, or vomiting related to food intake, which may be signs that the ring is too tight or has migrated out of place. Postoperative ambulation is important to help expel the CO2 gas used during the laparoscopic procedure and to prevent venous thrombosis.

Common complications reported during clinical trials include stomach bloating, dysphagia, pain, nausea, and vomiting. Tell patients that the implant is a metal device, so they cannot undergo MRI in the future. Also, patients should inform healthcare providers that they have a LINX implant. Patients are provided with a wallet card to carry at all times in case they need to show it to emergency personnel or airport security.

A promising procedure

The LINX procedure shows promise as a highly effective and optimal treatment for uncontrolled GERD symptoms. The procedure is minimally invasive, completely reversible, and does not alter the anatomy of the esophagus and stomach. Most patients are able to stop all reflux medications and resume normal diet and activity.

In clinical trials, 1% to 2% of reflux patients after LINX reported reflux symptoms that still affected daily activities, compared with 50% to 76% of patients who reported similar symptoms before the procedure. Two-year follow up data indicated that about 8% of reflux patients after LINX still had to take medication to control symptoms. Other data indicate that the implant’s 2-year efficacy rate is unchanged, even slightly improved in some cases, from 6 month postoperative measurements.

However, little is known about the long-term effects of this procedure and implant, making close patient monitoring by the patient’s primary healthcare provider key.

Patients who may require a metal implant in the future should discuss LINX and other appropriate options, such as a Lap Nissen, with their primary healthcare provider. The table below compares the two options:

The good news is that for many patients with GERD, the LINX procedure can help them live more normal lives.

Lyla Taft is a nurse on a medical/surgical unit at Phoebe Putney Memorial Hospital in Albany Georgia.

Selected references

AstraZeneca. (2012). http://www.gastrosource.com/disease-area-information/GERDoverview?itemId=11506361. Accessed December 19, 2012.

Mayo Foundation for Medical Education and Research (MFMER). (2012). http://www.mayoclinic.com/health/gerd/DS00967/DSECTION=treatments-and-drugs. Accessed December 19, 2012.

New GERD device offered at Mayo Clinic. Medical News Today ; 2012 http://www.medicalnewstoday.com/articles/244152.php. Accessed December 19, 2012.

National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health: National Digestive Diseases Information Clearinghouse. http://digestive.niddk.nih.gov/statistics/statistics.aspx#specific. 2012. Accessed December 19, 2012.

Smith C. Laparoscopic Nissen Fundoplication and LINX Procedure. Lecture presented at Phoebe Putney Memorial Hospital in Albany, GA; June 25, 2012

Healthcare Cost and Utilization Project (HCUP). Statistical Brief #44. Gastroesophageal Reflux Disease (GERD) Hospitalizations in 1998 and 2005. December 2007. Agency for Healthcare Research and Quality, Rockville, MD. www.hcup-us.ahrq.gov/reports/statbriefs/sb44.js. Accessed December 19, 2012.

The Reflux Centre. http://linxrefluxsurgery.com/acid-reflux-treatments/gord-surgery/new-linx-surgery. 2011. Accessed December 19, 2012.

Torax Medical Inc. The LINX Reflux Management System: Stop Reflux at its Source. 2011. http://www.toraxmedical.com/linx/. Accessed December 19, 2012.

Torax Medical Inc. LINX Reflux Management System. Gastroentorology and Urology Medical Devices Panel Meeting. Gaithersburg, MD; January 2011.
http://www.toraxmedical.com/linx/downloads/ToraxMedicalPresentationtoFDAAdvisoryPanel.pdf. Accessed December 19, 2012.

Torax Medical Inc. LINX Reflux Management System: Patient Information. 2011. http://www.toraxmedical.com/linx/downloads/LINXReflux-Management-System-Info-Guide.pdf. Accessed December 19, 2012.

U.S. Food and Drug Administration. 2012. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm300790.htm. Accessed December 19, 2012.

U.S.News & World Report. GERD.; 2012. http://health.usnews.com/health-conditions/digestive-disorders/gerd. Accessed December 19, 2012.

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