One out of three Americans suffer from heartburn symptoms. Many of those sufferers have gastroesophageal reflux disease (GERD) and they don’t even know it.
Until recently the only cure was a surgical procedure known as "Nissen fundoplication," which has the potential to cause side effects that lead many to delay or avoid surgery. Last year, the Food and Drug Administration approved a new treatment device called the LINX Reflux Management System to offer a new approach to treating GERD, a disease that is increasing at a rate of 30 percent every decade.
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Paul Taiganides, M.D., is the medical director of the Knox Regional Heartburn Treatment Center at Knox Community Hospital in Mount Vernon, Ohio. Dr. Taiganides and Knox Community Hospital were one of 14 locations selected to participate in the initial US clinical trials for the LINX device. Since then, Dr. Taiganides has performed more LINX procedures than any other U.S. surgeon. The center has done more than 700 Nissen fundoplication surgical procedures in the last seven years. Recently, he has trained surgeons in the LINX technique at Harvard University and Northwestern University.
"I was recommended to the LINX by Tom DeMeester [M.D.] and William Dengler [M.D.], medical advisors to RefluxMD. Dr. DeMeester is the recognized global leader on reflux disease and a senior medical advisor to Torax Medical, the innovator behind the LINX System," said Dr. Taiganides. "This is the first advancement in the surgical treatment of GERD in 50 years — and I believe this small titanium band will have a huge impact on how we surgically treat reflux disease."
Here are 10 things you need to know about the LINX procedure.
No. 1: It is focused on the underlying cause of reflux disease not the side effect.
Reflux disease is a result of a damaged lower esophageal sphincter (LES). The LES is a muscle that is constantly closed, but allows food and liquid to pass into the stomach. When the LES loses its strength, acidic stomach juices can back up into the esophagus creating the painful symptom of heartburn. The LINX device wraps around the LES, augmenting it to prevent reflux.
No. 2: It is safer than the long-term use of proton pump inhibitors (PPIs).
PPIs only treat symptoms. More importantly, studies have proven that reflux disease can progress even when PPI therapy has effectively eliminated GERD symptoms. Furthermore, daily PPI use has been associated with Barrett’s Esophagus, a pre-cancerous condition, an increase in bone fractures, a higher risk of pneumonia, an increased incidence of C. difficile intestinal infections, and increased risk of heart arrhythmias.
No. 3: LINX is effective at reducing symptoms and improving quality of life.
A recent study published in the New England Journal of Medicine tracked 100 patients for three years after their LINX surgery. That study found an overall decrease in stomach contents reaching the esophagus, fewer reflux symptoms, and a substantial reduction in PPI usage.
No. 4: The side effects disappear over time in most cases.
Initially, most patients experience some discomfort, but it typically dissipates over several weeks. In addition, the most commonly reported side effect is mild difficulty swallowing, which usually subsides over time.
No. 5: The cost of the device is approximately $5,000.
Surgery costs between $12,000 and $20,000. A traditional Nissen fundoplication surgical procedure is estimated in excess of $18,000. The cost can be much less than a lifetime of PPI use: a 2010 study by Consumer Reports found once-a-day PPI use can range from $2,000 to $4,500 per year for brand name prescription PPIs.
No. 6: There are very few physicians performing the LINX procedure.
Like all surgical procedures, a surgeon’s proficiency is largely dependent upon the number of procedures performed each year. Torax Medical has been very selective in choosing their surgeons seeking the most experienced physicians available.
No. 7: This is minimally invasive and is performed as an out-patient procedure.
The LINX procedure is usually completed in less than one hour. After the use of general anesthesia, small surgical instruments and a video camera are used in this laparoscopic procedure. Within 24 hours most patients return to a normal diet although there is some difficulty getting used to a functioning LES. These difficulties typically subside in 10 to 15 days and most patients report no symptoms after two or three months.
No. 8: LINX is reversible and can be replaced.
Since the LINX band is placed around the LES, the device can be removed or replaced, if necessary. This requires a surgical procedure, and Dr. Taiganides noted that this has not been necessary for any of his patients.
No. 9: This procedure is recommended for those with continued GERD symptoms under maximum therapy prescribed by a specialist.
I agree with Dr. DeMeester that a reflux disease has defined stages. Early stages must be treated with diet and lifestyle changes along with intermittent drug therapy. When these therapies fail to manage GERD symptoms impacting daily activities or sleep, the LINX System should be considered as an option.
No. 10: LINX is not for everyone with advanced GERD.
Today LINX is not approved for those with Barrett’s Esophagus or anyone suffering from esophageal cancer. It is important for everyone suffering from advanced stages of reflux disease to explore all available options before their disease progresses to the point where options are limited.
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It is important to take your heartburn symptoms seriously because it is a signal from your body that something is wrong. Since reflux disease is a progressive chronic condition, you need to make the necessary changes before you have to schedule a surgery.
William C. Dengler, M.D., is a board-certified general surgeon, GERD specialist, and medical director for RefluxMD.com
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