The majority of patients were asymptomatic and remained satisfied with the results of the Stretta procedure for GERD at 10 years, and results confirmed that there were no adverse outcomes, according to a study published in journal Surgical Endoscopy. The study, which is the first to examine the procedure over such an extended period of time, revealed 64 percent of patients experience a 50 percent or greater reduction in proton pump inhibitor use and 41 percent of patients eliminated PPI use entirely. The lead author of the study Mark Noar, MD, MPH, of The Heartburn and Reflux Study Center at Endoscopic Microsurgery Associates and head gastroenterologist at The Endoscopy Center in Towson, Md., answers questions on the long-term Stretta data and what it means for GERD treatment.
Question: How long have you been performing the Stretta procedure?
Dr. Mark Noar: The Stretta procedure was developed in the late 1990s as a corrective procedure for gastroesophageal reflux disease. The pivotal FDA study on the procedure was published in the early 2000s, after which the procedure was released commercially. I was the first clinical adopter of the procedure in June 2000. The procedure, designed to strengthen the lower esophageal sphincter, is largely indicated for medically or surgically refractory patients or a subset of patients who are unable to take other medical therapies. Stretta corrects reflux and limits symptoms, including laryngeal symptoms of reflux, and appears to play a role in the regression of Barrett's esophagus, and may therefore limit the risk of esophageal cancer.
Q: What was your role in this recent study on the Stretta procedure?
MN: As the first clinical user in the U.S., I also developed several research protocols to study the effect of Stretta, including this prospective 10-year clinical trial. We knew we needed to answer the questions of long-term efficacy and safety. As the trial progressed, we noted promising results at the one-year mark and four-year mark, which reinforced my expectation was that this would be resilient over time, but strong long-term data would be needed.
Q: What are a few highlights from the long-term results?
MN: We were very happy to see 72 percent of patients asymptomatic at 10 years. In addition to this, 41 percent of patients did not require any further medication. As further confirmation of the procedure's efficacy, we also noted significant improvements in patient satisfaction. Stretta demonstrated success in controlling the underlying disease and symptoms.
Q: What indications does Stretta have for Barrett's esophagus patients?
MN: Though the majority of this patient population was made up of general reflux patients without Barrett’s, we also decided to include Barrett's esophagus patients. In this population, the Barrett's subset mostly included patients with short segment and non-dysplastic Barrett’s. Since Barrett’s is essentially a result of chronic reflux, we felt that there was the potential that by reducing the reflux using the Stretta procedure, there would be a positive impact on Barrett’s. Thus, we were very interested to see what would happen long-term.
At the least, we expected to see stability amongst the Barrett's patients, but it was a pleasant surprise to see the Barrett's metaplastic tissue disappear in 85% of patients. In fact, in one patient with dysplasia, there was not only the disappearance of the metaplasia but also the dysplasia. This further emphasizes that anything we can do to control reflux is capable of controlling this pre-cancerous condition.
Q: What patients are considered candidates for the procedure?
MN: Patients that are already taking one or two doses of a PPI daily, but still complain of daily symptoms are the main candidates, as well as those who have failed prior surgical procedures such as Nissen fundoplication. The patients who have achalasia, severe scleroderma or a hiatal hernia greater than 2-3 cm in size are excluded. There are other more invasive procedures, such as Nissen fundoplication, that can treat patients with larger hernias.
For the Nissen fundoplication patients that failed to respond to treatment or have relapsed, they can also benefit from the Stretta procedure. Notably, it is because Nissen corrects the anatomical defect of the hiatal hernia that the Stretta success rates in these patients is exceptionally high.
Q: Does this procedure make sense for ambulatory surgery centers?
MN: Stretta can be performed as an outpatient in either an ASC or hospital outpatient unit. I am performing the procedure, done with standard IV sedation, in an endoscopy center. The patients included in this study were sedated with versed and sublimaze, the standard medications of the time. A variety of anesthesia options are utilized and are at the discretion of the treating physician. There have been no safety concerns associated with the procedure or the required sedation.
Q: How does Stretta work?
MN: In 2000 the exact mechanism of action was not specifically known. There was much unfounded conjecture that the procedure worked by desensitizing and creating a barrier comprised of scar tissue. A significant volume of clinical studies now show the mechanism of action to be reduced transient relaxations of the lower esophageal sphincter (LES), as well as a bulking of the LES, and no formation of scar tissue or incidence of fibrosis.
Stretta is essentially low power, low temperature, RF electrical stimulation to the esophageal sphincter muscle. This then results in hypertrophy, creating a longer and thicker sphincter. Studies have been able to demonstrate that this causes a net decrease in compliance, and increase in the number of muscle bundles and muscle fiber mass within the sphincter. It is specifically because of these changes that the muscle is strengthened, that the number of transient reflux-causing relaxations are significantly diminished, and the gastric yield pressure increases making it more difficult to reflux.
Q: Do you have plans to conduct further research on Stretta outcomes?
MN: Officially this study ended with the collection and publication of the 10-year data. However, because a number of patients had not yet arrived at the 10-year mark when we closed the data set, we will continue to collect data on these patients. I also plan to look at the outcomes data at 15 and 20 years. In regard to cancer risk associated with chronic reflux disease, it would be impressive to further confirm no esophageal cancer development and diminished risk in Stretta patients. Further analysis and/or trials either ongoing or about to start will look at: 1) the cost benefit analysis in the 10-year trial group, 2) their cancer risk over time, and 3) the effect of Stretta in patients with LPR (laryngeal reflux) and sleep apnea. In particular this latter area of investigation appears to be demonstrating in early results a significant impact of Stretta and reflux correction on these extra esophageal manifestations of reflux disease.
More Articles on Gastroenterology:
How to Create a Bundled Payment Model for Colonoscopy
President Obama Declares March National Colorectal Cancer Awareness Month
The Biggest Challenges in GI Reimbursement: 3 Gastroenterologists Share Insight