procedure, which is an endoscopic suturing technique. This allowed us to tighten up the valve area at the end of the esophagus where it meets the stomach where there is a natural muscle barrier to prevent the reflux. And reflux, again, is the backward movements of the stomach contents back up into the food tube or esophagus, which manifests itself in a variety of fashions, most commonly, heartburn, regurgitation and swallowing difficulty. So Endocinch came out from the Bard Corporation in 2000.
At the same time, Curon Medical came out with another technique called the Stretta® technique. Stretta is essentially a balloon that inflates in the esophagus and has certain little point electrodes that pierce into the muscle layer, generating heat energy and causing a thermal scarring to the muscle layer. Bulking up from that scarring, the valve area, again at the border between the food tube and the stomach functions as an anti-reflux enhancer for the lower esophageal sphincter muscle that I mentioned.
Then came last year the approval of another technique by Boston Scientific, which is an injection, implantable substance called Enteryx®. This is a technique done endoscopically where a solution called Enteryx, which is ethylene vinyl alcohol, is mixed in a vehicle called DMSO - basically, this is a liquid, which when injected into the muscle layer and therefore implanted, changes from a liquid to a semi-solid spongiform type of substance. What happens is we inject this and implant it under fluoroscopy using radiology simultaneously with endoscopy, and we place approximately anywhere from 6-8 cc or mL of this fluid. When it's placed into the muscle layer and it comes into contact with the bodily fluid that's there, it takes on this spongiform semi-solid appearance and therefore expands. When it expands, it expands in the muscle layer in a certain arrangement that we place. There is a bulking effect, but more important is the idea that it reduces compliance of the ability of the lower esophageal sphincter muscle to open. This has shown to be effective in the control of reflux.
And then, more recently this year, there is another technique by a company called NDO, Nancy David Oscar Surgical, which is a device called a fundoplicator. This is a system that involves the passage of an instrument that looks like one of our scopes, and then we pass one of our regular endoscopes through this endoscope, and essentially we observe what happens at the end of their instrument. That instrument has a jaw which opens if you were to separate your thumb and forefinger and it has a way of grabbing the tissue just as it comes out of the esophagus, pinching it, and making a stitch. A single stitch. That simulates the surgical fundoplication. That's interesting and effective, it's new, and we're excited about it.
Reflux1: So that single stitch is placed on the lower end of the esophagus?
Dr. Starpoli: It is really on the stomach side of that border.
Reflux1: Can you talk about hiatal hernias? How does that relate to GERD?
Dr. Starpoli: The hernia is often mistaken for a hernia that occurs on other parts of the body. Most hernias appear like a bulge through the muscle or skin layer. It's not that kind of a hernia. What happens is the stomach protrudes through the diaphragm. A brief descriptive of the anatomy - the food tube or esophagus runs down inside the chest and it passes through the horizontal layer of diaphragm, the breathing muscle; it goes through and it attaches to the stomach. So typically, the stomach lies below the diaphragm, the esophagus is more or less above the diaphragm, maybe just joining the diaphragm. For a variety of reasons, the stomach will protrude up through that opening in the diaphragm and then lie above the diaphragm - and that creates what we call a hiatal hernia sac. We see this in 83% of patients who have reflux - they are very common findings.
But just because you have a hiatal hernia doesn't mean you have reflux. It is something associated. Clearly, it affects the competency of the lower esophageal muscle function. It probably indicates poor diaphragmatic support of the whole anti-reflux mechanism, because you can imagine that while you have this muscle inside the esophagus and stomach that lies normally at the level of the diaphragm, the diaphragm acts as an extrinsic support system to that anti-reflux mechanism. We look at the lower esophageal sphincter as the intrinsic muscle, which controls reflux, or prevents reflux, and we look at the diaphragm as the extrinsic or external support to that system. When the hernia occurs, and the stomach protrudes up above, there is a misalignment of those two sphincteric mechanisms. Essentially, it renders the lower esophageal sphincter less competent and also creates a low-pressure zone where food can sort of stagnate. And if it can't get out into the stomach, well, lo and behold, it travels backwards up into the esophagus into the throat and so forth.
Reflux1: How is the hiatal hernia different from a paraesophageal hernia?
Dr. Starpoli: Well, they're all kind of similar. There are different hernias where the stomach will come up and wrap itself around the esophagus. Look at it as varying degrees of that stomach protruding up through. Probably the most common would be the sliding hiatal hernia, where sometimes the stomach's above, and sometimes it slides back down.
Reflux1: All of these hernias can still affect GERD, basically?
Dr. Starpolie: Sure. Having a hiatal hernia will in all likelihood predispose you, all things being equal.
Reflux1: A bit earlier, you were speaking about endoscopic suturing. What is that procedure like?
Dr. Starpoli: The Endocinch procedure - also called the endoscopic suturing or endoluminal gastroplication (ELGP) - this is a technique where, on a standard video endoscope, a suturing device is attached, like a small sewing machine attached to the tip of the scope. Through a variety of maneuvers, the instrument is passed into the throat, into the stomach. It does require an overtube, which is a large tube that we first pass into the mouth and esophagus, and it rests there. It allows us to put this instrumentation through with minimal risk to the patient and gives us a working environment. We take the suturing device system down to the lower esophageal sphincter area. Anatomically, endoscopically, it is described as the Z line. It represents the change from the esophageal lining to the stomach lining. We work at that level or below, and the device is used to place stitches. So, we place a stitch, we take the system out, we reload it, we go back in, and when we pull that out after the first stitch, the suture material is very long and it runs through the tissue that we captured. We capture that tissue under some vacuum suctioning, which brings it into that sewing machine device, stitch, come out, reload, go back in and we stitch at an area next to the first stitch. Once you do two stitches and try to tie them together, which we do, it creates a pleat, or a plication. So you need two stitches to make a plication. We will typically place anywhere from two to four plications in order to close off that space a little bit and enhance the anti-reflux barrier.
The tying off of those two suture ends - because you can imagine, there are two ends and you need to tie them together - happens with a separate scope which we place an anchoring device that creates a knot to secure everything. The procedure typically takes about 45 minutes to an hour. It is done without general anesthesia. There are no incisions, there is no cutting, everything is done through the mouth with this typical endoscope.
Reflux1: How would you advise a patient before he or she goes in for a procedure like this?
Dr. Starpoli: Patients should be carefully selected for all GERD endotherapeutic procedures. We would begin classically with a history of reflux of chronic duration, meaning at least 6 months. Then you want to be sure that its reflux. If it's heartburn, regurgitation, it has responded to the typical acid-lowering medications that are out there, then you've got a pretty strong likelihood that they have reflux.
We may do additional studies such as 24 hour monitoring for reflux. We have acid monitoring, but more recently we employ a more sophisticated monitoring system called impedence monitoring, or the Sleuth system, which is made by Sandhill Scientific. This allows us to assess not only acid reflux, but also all forms of non-acid reflux. We may do these studies, and then we would of course probably do an endoscopy to look at the anatomy to see if it's feasible. Too large a hiatal hernia may keep us away from doing these forms of GERD endotherapy. And of course, we advise the patient before all of this to change their habits. Some are smokers, some are coffee drinkers, they drink too much alcohol, they're having too-fatty foods, they're overweight, and so forth, so we really spend time counseling them to make sure that they've made a sure effort on doing the basics. Because if the basics cure their problem, they don't need GERD endotherapy.
We also advise patients of all of the alternatives available to them in terms of the procedures, what might be more suitable for them, as well as surgical options, because surgery certainly has a longer track record than GERD endotherapies.
Reflux1: When you speak of surgery, are you referring to laparoscopic types of surgeries?
Dr. Starpoli: Yes, surgery would be Laparoscopic Nissen Fundoplication. That would be the most classic performed today. That is making a complete distinction against GERD endoscopic therapies, which are totally non-invasive, or we should say truly, minimally invasive. Because, of course, the surgeons like to say that the laparoscopic surgeries are minimally invasive, when it is invasive. It may be less invasive than if you were to have a large incision, but it is still an invasive procedure entering the abdominal or chest cavity. The endoscopic approaches are done through the mouth into the stomach and never exit those areas.
Reflux1: Can you tell us more about your personal practice with GERD patients? How have you seen your practice change throughout the years? Do you foresee any more changes in your field?
Dr. Starpolie: I think the public awareness of GERD has taken off exponentially in the last five years. Awareness against the deleterious effects of chronic reflux, namely pre-cancerous conditions like Barrett's esophagus, the ever-increasing rise in the gastroesophageal cancers; since the mid-1970s, we've seen a 350% rise in those cancers. We're not really quite sure why, it maybe early recognition. Interestingly it seems to be afflicting middle-aged white people in our country, actually middle-aged white men to be specific. So a greater public awareness drives things. Of the drug therapies that are available, the proton pump inhibitors probably have become the number one prescription-type drugs in the world. We're talking about Nexium, Prevacid, Prilosec, Protonix - these medicines really are being prescribed like water. Patients respond very well to them. If you have chronic reflux, which is really truly a chronic relapsing condition that gets worse after the age of 40, and you start on these medications, you're going to in all likelihood continue to take them. So, we're seeing patients that are finding themselves, young patients in their 20s, 30s, 40s, who are saying, "Gee, I'm on these medications - I can't get off them." Not to mention that some patients, albeit a small percentage of the patients, will suffer from headaches, change in bowel habits, abdominal pain; there have been some cases of hair loss related to these drugs, which, you know affects everyone - especially men - which I have seen in my practice.
I think all of these things are making people very aware that they have a chronic condition, and what we're seeing is that there is a certain appetite for some therapies that might offer a chance for a patient to get off of chronic medical therapy. This is by no means an endorsement or a suggestion that patients should not take medical therapy and that people should have endotherapeutic procedures. I think these procedures are more than interesting; however they are still in their early stages. The companies who are involved in these procedures are certainly for the most part very, very responsible in terms of their training programs to physicians, and encourage appropriate patient selection. But, there is an appetite. I think that for a gastroenterologist who is interested in this area, which really, as I said earlier, comprises at least three-quarters of my practice at least, I think this is a whole new frontier.
We've talked really mostly about typical GERD, but there's a whole world of atypical reflux disease, which includes asthma, sinusitis, chronic cough, hoarseness - these things that can be now proven especially utilizing impedence monitoring. With the Sleuth system, you can actually show all forms of reflux. These patients are recalcitrant to acid reducing therapy, because the only thing that those drugs really do, is lower the acid content. It doesn't keep things from still moving up. So if you're aspirating them, choking on them, or they're going into your vocal chords, you're still having a lot of irritation from the other components to those stomach juices. So, we see a lot of those patients, because therapies are not helping. They're afraid to go to surgery, they're not really sure they want to do that. Doing an endoscopic approach to treating their reflux does not preclude patients from having surgery. So if it works for them, they're very excited even if they're not sure where it's going to go. And if a procedure is safe, although novel, safety is really important; patients are very interested to try these things. And I think for someone who is committed to the endotherapy of reflux disease and who immerses themselves in this, patients probably have very little to lose to investigate that, have an appropriate evaluation, and move on from there.
Reflux1: Does insurance normally cover a procedure like this?
Dr. Starpoli: It's a mixed bag. It's a regional phenomenon. Sometimes insurance companies will cover it. Clearly, there is a change in this venue. We meet with medical directors; in some cases we can get the cases approved. Clearly, they're more likely to pay for an invasive surgery than one of these endotherapeutic approaches. But this is all part of education, presenting long-term data, showing that there is safety, there is durability, and then you've got to compare those things to the gold standards like surgery. Surgery, which is readily approved, does carry a certain intra-operative complication rate. There are certain post-operative complications that can occur. It's not a risk-free procedure. If you review the literature, it is very operator-dependent. If you are a surgeon that does very few of these every year, your outcomes are different than someone who does hundreds a year. I think that we're going to see those differences with GERD endotherapy. Not all GERD endoscopists perform endoscopy the same way, and not all have the interest level. There's sort of a growing breed, if you will, of advanced endoscopists who are interested in this area. We work with the companies and researchers to try to improve these products and choose patients carefully.
Reflux1: Are there any last words you'd like to add about your practice or gastroenterology and your contribution to the field?
Dr. Starpoli: My practice and my institution are committed to the better development of endoscopic approaches for treating reflux. I think we are interested in all of the technologies. We probably have our own inherent biases to a certain of them. We want to be able to offer our patients all of the opportunities, including surgery and including continuing their medical therapy, because not everyone is a candidate for GERD endotherapy. I think our concentration here is what distinguishes us.