Q&A: Evaluating The Effectiveness Of Stretta As A Treatment For GERD
Stretta is a minimally invasive, outpatient procedure that dramatically reduces GERD symptoms and offers an alternative to anti-reflux surgery in so-called “refractory” GERD sufferers, or those who do not get adequate relief from medications used to treat the symptoms of GERD. The procedure involves delivery of radiofrequency energy to the muscle of the lower esophageal sphincter and gastric cardia (upper most portion of the stomach). Generally, Stretta is appropriate for patients who do not achieve adequate symptom control from, or are intolerant of medications. Because Stretta doesn't alter the anatomy or involve a foreign implant, it offers GERD sufferers a valuable treatment option in the management of their symptoms. Below are some relevant facts about Stretta:
- There have been more than 20,000 procedures performed since its initial launch.
- Published studies as well as reports from the FDA Maude Database show a very low rate of adverse events <1 percent--lower than the reported rate for diagnostic endoscopy.
- Stretta offers benefits to the patient, and the healthcare system as it is a proven effective treatment that is a less expensive and less invasive alternative to anti-reflux surgery, with a lower complication rate.
Steven Schwaitzberg, MD, FACS, past president of SAGES, Chief of Surgery, Cambridge Hospital Campus (general surgery, minimally invasive surgery), recently spoke with Surgical Products about Stretta.
SP: Can you tell me a little bit about the Stretta procedure and what makes it such a viable alternative to anti-reflux surgery?
Schwaitzberg: There are tens of millions of Americans who have heartburn, but only a small subset of that group have gastroesophageal reflux disease (GERD) that requires a little more thought than the simple occasional heartburn who are well served by the over-the-counter HT blockers or PPIs that have become more of the mainstay of therapy. There are many millions of other sufferers for whom medical therapy is either not tolerated or is insufficient for a number of reasons. First of all, their lower esophageal sphincter, the muscle at the bottom of the esophagus that creates the barrier between the stomach and the esophagus, is either too weak to close or closes slowly after food is passed through, and those are called transient prolonged relaxations.
Some patients certainly require surgery. There is no doubt about it. Large trials that have compared medical therapy to surgical therapy, and there are certainly patients that have long-term improved quality of life through surgery.
It is in this subset of patients that Stretta can be a benefit. Of the endoscopic therapies, so far to date really only Stretta has withstood the test of time. One of the great challenges for this endoscopic procedure is it gets lumped in with all the other procedures that have clearly failed. That’s a problem. It’s a problem for patients that would like to seek out this option if they are suitable candidates, and it’s a problem for physicians who spend more time trying to get paid than actually doing the procedure. This grouping of Stretta in with other procedures is really unfortunate since it works by a totally different mechanism. It works by the application of radiofrequency energy to the lower esophageal sphincter. Therefore, there’s really no reason to associate this procedure in together with failed suturing or bulking therapies .
SP: What are the characteristics of a Stretta patient?
Schwaitzberg: That’s really the heart of the matter. The goal is to identify the right kinds of patients who will benefit from such a procedure. It is best for people with little to no hiatal hernia who have some preservation of their lower esophageal sphincter and who have reflux that is severe enough to consider an option beyond medical therapy. These patients don’t represent the worst cases of reflux. It’s a therapy for mild or moderate disease.
It’s a really unique therapy because it gives us an opportunity to not use the blunt end of an instrument to treat all disease. When you have a patient who looks like he or she meets the criteria for Stretta, you can offer a procedure that is less expensive overall to perform, probably less dangerous, less complicated, but less effective than a fundoplication.
SP: Can you talk about the patient’s decision-making process as it relates to this procedure and alternative options?
Schwaitzberg: Having offered Stretta to a number of patients, it is interesting to watch the decision-making process with them. I have some patients who simply say “I want the bigger procedure, I want one procedure, and I want to get it over with.”
You have this interesting dynamic of decision-making. Certainly some people want to go for the big procedure. But in general, if a patient could have their problem solved medically, they would, If not medically then endoscopically. If not endoscopically, then minimally-invasively. Then big surgery is the last resort for serious problems. Stretta really fits into that continuum for the right kinds of patients. I’d say three out of four choose the endoscopic therapy. They’d rather have a chance to have their problems solved with the least-invasive procedure.
SP: How does Stretta compare with its alternatives in terms of complications?
Schwaitzberg: Compared with Nissen fundoplication, it has fewer complications. The complication rate is less than 1percent, while the Nissen fundoplication complication rate is about 4 percent. The earliest version of the device was not placed over a guidewire, and there were some early technical problems with the device that don’t apply to the current iteration. There are rare to non-existent esophageal perforations in recent years, very little gas bloating, no stricture, and so it is an extremely safe procedure.