Two new procedures, one an endoscopic gastroplication technique known as EndoCinch and the other an endoscopically delivered radiofrequency energy treatment known as Stretta, are giving gastroenterologists and general surgeons a lot more flexibility to treat the estimated 7 million Americans who suffer from progressive gastroesophogeal reflux disease (GERD).

Early clinical results show that both EndoCinch and Stretta have favorable safety and success profiles. What's more, they're easier to perform than laparoscopic Nissen fundoplication, for now the minimally invasive method of choice to treat patients with GERD. Here's what you need to know about these promising new procedures.

Patient selection
The ideal patient for EndoCinch and Stretta is someone in his late 30s to mid 40s whose GERD symptoms are not controlled by dietary changes and conservative treatments, says gastroenterologist Edwin Montell, MD, of Hilo, Hawaii. What's more, these patients don't want to take proton pump inhibitors (PPIs) every day. PPIs have replaced histamine2 (H2) blockers and antacids as the mainstay of drug therapy.

One of the most promising aspects of EndoCinch is that it is effective for patients with uncomplicated GERD and patients with such severe symptoms as ulceration, strictures and Barrett's esophagus, says Charles Filipi, MD, of the Creighton University School of Medicine in Omaha, Neb. In 2001, Dr. Filipi authored the first extensive study of endoluminal gastroplication (ELGP) efficacy. (EndoCinch is the brand name for a type of ELGP.) The results through two years have been very encouraging for all categories of patients undergoing the procedure, he says.

With Stretta, the only exclusion criteria are severe hiatal hernias, erosive esophagitis, Barrett's esophagus, severe dysphagia and poor surgical profiles (ASA category III and IV patients), according to William Richards, MD, of the Vanderbilt University Medical Center in Nashville, Tenn. Even patients with erosive esophagitis are eligible for Stretta if the condition is successfully resolved via endoscopic treatment.

Anesthesia considerations
Laparoscopic fundoplication is performed under general anesthesia, but you can use propofol sedation for EndoCinch. One important factor, however, is the experience level of the anesthesia provider. The amount of propofol used, the duration of the procedure and the anesthesia-related complication rates during ELGP were largely dependent on the comfort level and experience of the anesthesia provider working with the GERD patient, according to a study conducted by Julia Liu, MD, and associates, published in the April 2002 Gastrointestinal Endoscopy. The study found that those EndoCinch procedures worked by a dedicated anesthesiologist were shorter by 30 percent (43 minutes versus 56 minutes on average). The nationwide average procedural times for EndoCinch and Stretta are each about one hour, according to data collected by the Technology Assessment Committee of the American Society for Gastrointestinal Endoscopy (ASGE).

With Stretta, most patients receive pre-op baseline doses of midazolam and Dilaudid, reports Dr. Richards. Subsequent incremental doses of fentanyl (or, alternatively, Demoral) are given during the procedure to prevent pain onset from the delivery of radiofrequency energy.

Equipment and case costs
Here are start-up and procedural cost breakdowns for the two procedures, according to the ASGE.

The EndoCinch carries an estimated per-procedure cost of $1,331. The single-use procedure kit lists for $1,295. The handle, which can be used about 50 times before replacement, lists for $1,500 and the overtube, which can get about 25 uses, costs $150.

Stretta requires a start-up cost of $24,200 for the Stretta Control Module (the machinery that delivers the radiofrequency energy). You need to use one disposable catheter per case. These cost about $940 individually or $2,820 for a box of three. The disposable guidewire needed for the procedure costs about $45 each ($135 for a three-pack).

Procedural information
Think of EndoCinch as simply using an endoscope to place mucosal stitches, says Dr. Filipi. Under endoscopic guidance, the surgeon locates the site where the sutures are to be placed and places a series of two adjacent sutures below the squamocolumnar junction (SCJ). He then brings the two adjacent stitches below the SCJ in apposition, forming a plication. The process may be repeated to form more plications, depending on the patient. The plication alters the "gate" through which acid can flow back from the stomach up through the patient's esophagus.

The Stretta procedure involves the placement of the catheter and the delivery of RF energy from the control unit into the muscle of the gastroesophogeal junction, says Dr. Richards. The catheter consists of a wire-guided bougie tip, a balloon-basket assembly and four NiTi needle electrodes (5.5 mm), which are positioned radially around the balloon. The surgeon inserts the catheter transorally and positions it 1 cm above the Z-line. Simultaneously, the surgical team begins irrigation and suctioning cooled sterile water to maintain adequate mucosal temperature.

The surgeon places the catheter, inflates the balloon, and the generator delivers radiofrequency energy for 90 seconds to each electrode. The target temperature is 85'C. The surgeon then repositions the catheter 45 degrees, and the treatment is repeated to create a ring of eight lesions. Next, the surgeon moves the catheter distally in 5-mm increments to create another ring of lesions. At the completion of the procedure, there are at least six sets of lesions (15 to 25 are typical, according to the ASGE Technology Committee report).

Learning curve and safety
While training, credentialing and privileging guidelines have yet to be established for these procedures, C.R. Bard (EndoCinch) and Curon Medical (Stretta) can arrange hands-on training for interested physicians with experienced proctors.

EndoCinch presents some technical challenges for physicians, especially the knot-tying done with sutures, notes Dr. Filipi. The fact that the configuration of the plications directly affects outcomes posed a problem when EndoCinch was first tested. However, the second-generation device simplifies the process somewhat. "It's still not absolutely straightforward, but once you get used to the technique, it's not particularly difficult," says Dr. Filipi. Others say that a fairly high level of dexterity is needed for optimal results. "This is an operator-dependent procedure," says Dr. Montell.

An EndoCinch that fails to control the patient's symptoms does not affect the patient's candidacy for traditional fundoplication or other endoscopic treatments. Reported adverse events include bleeding, pharyngitis, abdominal or chest pain, mucosal tears and hypoxia.

In a study of 558 Stretta patients (Journal of Laparoendoscopic & Advanced Surgical Techniques, Vol. 12, No. 6, 2002), surgeon experience (less than 10 versus 10 or more cases) did not have a significant effect on post-surgical outcomes.

Reported adverse events with Stretta, which occurred in 8.6 percent of patients, were typically fever, chest pain, mucosal tear and dysphagia. According to the FDA's Manufacturer And User Facility Device Experience (MAUDE) database, there have been two deaths due to vomiting and aspiration and four esophageal punctures requiring interventional surgery.

Promising outcomes
Dr. Filipi calls the results of his ELGP study very promising "considering that it was a brand new interventional procedure." Complications were minimal, despite the concerns about the complexity of the technique. After six months, 62 percent of the patients needed fewer than four medication doses per month.

However, Dr. Filipi adds that there's still a lot of research yet to be done to show long-term outcomes in controlling GERD symptoms. "But what we have right now," he says, "is a very good operation."

The Stretta study found that more than two-thirds (68.7 percent) of patients saw significant symptom control within two months of the procedure, while 8.5 percent had no improvement after six months. Patients who had previously experienced better than 50 percent symptom control on acid-controlling medications had the best results. Ninety percent of the patients in the study said they would recommend Stretta to other GERD patients.