New information suggests that taking PPIs for chronic reflux symptoms may increase your risk of heart attack.
LISTEN as Dr Sewell discusses Acid Reflux with Dr. David Samadi on World Health News - PART 2
Magnetic Device Achieves Steady Control Of GERD at Five Years
by Ted Bosworth
Washington—Five years after surgical placement, a magnetic device to augment the lower esophageal sphincter continues to provide relatively tight control of gastroesophageal reflux, new data show.
The device (LINX Reflux Management System, Torax Medical) consists of a ring of magnetic beads that is placed laparoscopically and encircles the lower esophageal sphincter to restore function. The relatively sustained response was observed across many parameters of gastroesophageal reflux disease (GERD), including remaining off proton pump inhibitors (PPIs), according to the investigators.
“Magnetic sphincter augmentation should be considered first-line surgical therapy for those with gastroesophageal reflux disease based on results of this study,” said Robert A. Ganz, MD, of Minnesota Gastroenterology, in Minneapolis. Dr. Ganz presented the findings at Digestive Disease Week 2015 (abstract 688).
In contrast to many endoscopic procedures for control of GERD that have been associated with diminishing efficacy over time, the new results showed that the effectiveness of the magnetic system did not appear to wane significantly over time. These outcomes included subjective measures of quality of life (QoL) as well as pH scores, esophagitis grading and use of PPIs. For example, the proportion of patients completely off PPIs one year after surgery was 86%, according to data published previously (N Engl J Med 2013;368:719-727). At five years, the proportion was 75%. The proportion of patients who had at least a 50% improvement in a validated QoL measure was 89% at five years, compared with 92% at one year after surgery.
The five-year data come from follow-up of a study involving 14 centers mainly in the United States. One hundred patients were treated, and 85 provided data from the five-year mark. Of the remaining 15, eight were lost to follow-up or declined to participate; one died of cancer unrelated to treatment; and six had their device removed electively.
In four cases, removal was performed due to complaints of dysphagia, which resolved. In one, the removal was based on recurrent vomiting of unknown etiology, which persisted after device removal.
All patients included in the trial had persistent symptoms of GERD with at least partial response to PPIs. The average duration of PPI treatment before placement of the device was five years, with a range of one to 20 years. Slightly more than half of the patients were male, and the average age was 53 years. The average procedure time to place the device was 36 minutes.
Many efficacy end points were monitored during follow-up, including acid exposure over 24 hours; GERD Health Related Quality of Life scale; PPI use; grading of esophagitis; DeMeester score; and scoring of specific symptoms, such as heartburn, dysphagia and regurgitation. Compared with baseline, all improved by a highly statistically and clinically significant degree at one year and remained controlled with only slight decay at five years.
Notably, 11.9% of the patients reported moderate to severe heartburn at five years, down from 89% before placement of the device. The proportion with moderate to severe regurgitation fell from 87% to 1.2%. Esophagitis was present in 40% of the patients before the procedure but in 16% at year 5, of which 90% was grade A and none was grade C or higher.
The device has been well tolerated with no serious adverse events, according to the researchers. The most common side effect was dysphagia, reported by the majority of patients in the immediate postoperative period but by only 11% by year 1 and 7% by year 5. No migrations, erosions or malfunctions were reported during the study period. No significant complications occurred in device placement or elective removal. Patients fitted with the device have reported no impairment in their ability to belch or vomit when necessary.
The durability of benefit correlates with the underlying magnetic force that augments the sphincter, but the device will separate to permit sphincter function. Dr. Ganz said the magnetic attraction of the beads is “precise, will never decay and will last into perpetuity.”
The LINX system does not involve the gastric fundus or any alteration of the gastrointestinal anatomy, and removal does not prevent additional therapy with other techniques. The device costs roughly $5,000, and surgery to implant it adds another $10,000 or more.
The ability of the magnet therapy to provide sustained control of acid and heartburn symptoms out to five years changed the minds of some of those accustomed to seeing diminishing efficacy of GERD treatments over time.
Gary W. Falk, MD, co-director of the GI motility/physiology program at the Hospital of the University of Pennsylvania, in Philadelphia, called the data “intriguing” and encouraging.
“I am certainly revisiting this concept on the basis of these results,” Dr. Falk said. For those selected on the basis of acid-driven symptoms, such as improvement with PPIs, “this may be something to add to the armamentarium,” he said.
However, Dr. Falk cautioned that the study population was relatively small and carefully selected, raising questions about whether there might be “nuances” in isolating those patients most likely to benefit. In particular, Dr. Falk pointed out that the patients studied had classic heartburn and acid regurgitation. Selection for this study was not based on atypical GERD manifestations, poor response to PPIs or a large hiatal hernia.
As a result, Dr. Falk said, “I am very concerned about extrapolating these results to these more challenging patient groups, which were not the focus of this study.”
June 11, 2015
The Real Risk of Gastroesophageal Reflux Disease (GERD)
By: Robert Sewell, MD, FACS
Feb 16, 2015
Click Here to read the entire article
May 10, 2015
November 18, 2015
Everyone knows about the risk of breast cancer, as well we should. We also hear about many other common malignancies, such as cancers of the colon, prostate and lung, but do you know which cancer is increasing in occurrence faster that any other? If you said adenocarcinoma of the esophagus you’d be right.
Cancer of the esophagus comes in two types. The first is squamous cell carcinoma, which occurs in the upper part of the esophagus, typically in pipe or cigar smokers, alcoholics, and in people who have suffered a chemical or thermal injury to their esophagus, and the incidence of this type of cancer has remained unchanged for decades. The other type, adenocarcinoma, occurs in the lower part of the esophagus, but unlike every other malignancy, the frequency of esophageal cancer has risen an astounding 600%, just in the last three decades. Esophageal carcinoma is now the sixth leading cause of cancer deaths in the United States, not only because of this dramatic increase in the number of patients afflicted with the disease, but also because of its aggressive nature and extremely poor prognosis.
The overall five years survival rate for esophageal cancer is only about 15%. In part this is because few patients are diagnosed with early stage disease. These types of tumors cause few if any symptoms until late in their course when difficulty swallowing, chest pain and weight loss are the result of partial obstruction of the esophagus.
A number of theories have been suggested as to why the incidence of esophageal cancer has risen so dramatically, but there is as yet no proof as to the cause. What we do know is that adenocarcinoma is generally preceded by the development of a condition known as Barrett’s esophagus, and Barrett’s changes are the result of repeated exposure of the esophagus to stomach contents; a common condition known as gastroesphageal reflux disease (GERD).
The most common symptom of GERD is heartburn, which is due to stomach acid refluxing up onto the sensitive lining of the esophagus. Ten’s of millions of people take medications every day to reduce stomach acid, and these drugs are often very effective at controlling the symptoms of acid reflux. However, not everyone with reflux has heartburn. Many have other symptoms such as chest pain, chronic belching, trouble swallowing, raspy voice, chronic cough, and a variety of other respiratory and airway symptoms. While medications can alleviate the burning, they do not stop the actual reflux of stomach contents, and there is growing evidence that Barrett’s disease is caused by gastric contents bathing the lower esophagus, with or without acid.
Approximately 10% of people with chronic gastric reflux will develop Barrett’s esophagus and their risk for developing esophageal cancer increases over time. While anyone with reflux is at risk for developing Barrett’s, the group that appears to be at highest risk for developing esophageal cancer are caucasian men over the age of fifty. The only way to diagnose patients with Barrett’s esophagus is by visually inspecting the inside of the esophagus with an endoscope and performing biopsies. These examinations are performed using an upper GI endoscope, which requires the patient to be sedated. However, there is now a less costly and even less invasive test called a Transnasal Esophagoscopy (TNE) which can be performed in an office setting without the need for sedation, to screen patients for Barrett’s esophagus. If this test is diagnostic or even suggestive of Barrett’s changes, a formal endoscopy with biopsies should be performed to determine whether additional treatment is necessary.
Perhaps the most important question to ask is who is at risk for developing esophageal cancer, and can it be prevented? The jury is still out on that question, however, it is only logical to assume that if Barrett’s esophagus is caused by the mechanical reflux of stomach contents up into the esophagus, stopping that process would be the first step. There are a number of treatment options available to accomplish that objective, but the question remains, who is at risk for developing esophageal cancer? The answer is, any patient with symptoms of GERD, whether they’re acid suppressing medications are helping control their symptoms or not. They should all be screened for Barrett’s changes so we can begin to get a handle on this silent killer.
Dr. Sewell is a general surgeon in Southlake, Texas. His practice, Master Center® for Minimally Invasive Surgery is located adjacent to the Texas Health Harris Methodist Hospital - Southlake. To learn more about reflux disease and its treatments go to www.myrefluxisgone.com and signup to attend the next free roundtable discussion.