Not long ago, patients with gastroesophageal reflux disease had two choices: a lifelong regimen of costly drugs or invasive fundoplication surgery. In large part because neither therapy with proton pump inhibitors or Nissen fundoplication is ideal, laparoscopic anti-reflux surgery is gaining in popularity among gastroenterologists and general surgeons for severe GERD.

• PPIs such as Prilosec, Nexium and Prevacid are designed to limit stomach acid production. These medications may provide symptom relief, but they don't prevent the physical reflux of stomach contents, leaving patients uncomfortable and at risk for more serious conditions. Moreover, GERD sufferers often must take drugs for their entire lives. Not only is this burdensome for the patient, but costly as well: Each year in the United States, $13 billion is spent on medications to control the symptoms of GERD.
• To directly address the weakened esophagus-stomach junction, patients can also elect to undergo an invasive surgical procedure called Nissen fundoplication. Through a series of abdominal incisions, surgeons wrap the patient's stomach tissue around the esophagus to reinforce the weakened valve. While often effective, the procedure has drawbacks. It's performed under general anesthesia and requires overnight hospitalization followed by a recovery period lasting several days.

But now, researchers have developed several outpatient endoscopic procedures that may reduce GERD symptoms and let patients reduce or eliminate daily medication and forgo more invasive surgery. All of these procedures have different mechanisms of action and none has emerged as a clear leader. Here's a review of three procedures that have received FDA clearance and two more that have made news in recent months.

Stretta System
Curon Medical, Inc.
(877) 734-2873
www.curonmedical.com
The Stretta procedure, which received FDA clearance in 2000, uses radiofrequency energy to create tiny thermal lesions in the lower esophageal sphincter. As the lesions heal, the body deposits more collagen in these areas, which bulks up the musculature of the LES and makes it more rigid and able to serve as a barrier to reflux. The procedure also ablates the afferent neural pathways in the gastric cardia, which helps stop the inappropriate muscle relaxations that can cause GERD.

The Stretta System consists of the Stretta Control Module, which is the temperature-controlling radiofrequency energy generator, and the Stretta Catheter, which consists of a wire-guided bougie tip, a balloon-basket assembly and four electrode delivery sheaths surrounding the balloon.

Here's how the procedure works: After administering conscious sedation, the surgeon advances the Stretta catheter through the mouth to one centimeter proximal to the Z-line. The surgeon then inflates the balloon to the diameter of the gastroesophageal junction and deploys four nickel-titanium needle electrodes, which deliver radiofrequency energy for about 60 seconds to the luminal wall, creating a ring of lesions about 3mm to 4mm deep. The tissue is cooled using saline irrigation delivered via the Control Module. The surgeon then moves the catheter down the esophagus in 5mm increments, creating about six sets of lesions. About 14 minutes of treatment is required; the entire procedure takes about 45 minutes.

"At first, the rigidity of the sphincter is probably due to the swelling caused by the operation," says George Triadafilopoulos, MD, a clinical professor of gastroenterology at Stanford University Medical Center who helped develop the Stretta procedure. But then, the scarring process takes over as the body starts to deposit collagen. "We see significant improvements in GERD symptoms as the tissue continues to reconfigure over six to 12 months," he says. Dr. Triadafilopoulos led a 2004 study that indicated that improvements in symptoms are related to a decrease in esophageal acid exposure, not just a desensitization of the esophageal body.1 Also, a 2003 sham-controlled study (in which 35 patients received the Stretta procedure and 29 patients received a sham procedure) showed that the Stretta procedure led to significant improvements in heartburn symptoms and quality of life at six months; the improvements persisted at 12 months.2

Dr. Triadafilopoulos notes that patients might still need medical therapy after Stretta. "Some patients still have to take medications, but they take less," he says. "Some have to take the same amount of medication, but they feel better." He only considers the procedure to have failed if patients are taking the same amount of medication and have no improvement in their symptoms.

Initial start-up costs for the Stretta Procedure are a list price of $30,000 for the Control Module, which can be leased, and about $1,000 for each disposable Stretta Catheter. The Stretta procedure is currently the only endoscopic GERD procedure to have a CPT 1 code: 43257 (APC payment rate is 0422). Facility reimbursement ranges from $977 to $2,584 depending on location.

Full-Thickness Plicator
NDO Surgical, Inc.
(508) 337-8881
www.ndosurgical.com
The Plicator procedure, which received FDA clearance in 2003, involves deploying a pre-tied suture implant to create a full-thickness plication at the gastroesophageal junction. The suture goes through all layers of the gastric wall, creating a serosa-to-serosa plication that restores the anti-reflux barrier.

The Plicator System consists of the reusable Plicator instrument (an endoscope-like device that allows for direct endoscopic visualization), a single-use cartridge containing the suture implant and an endoscopic tissue retractor. With patients under conscious sedation, the surgeon advances the Plicator instrument through the mouth to within one centimeter of the gastroesophageal junction. The surgeon then gathers the tissue and deploys the single suture. Average procedure time is about 20 minutes.

Bergein Overholt, MD, a gastroenterologist with Gastrointestinal Associates, PC, in Knoxville, Tenn., who has been involved in the clinical trials for a number of endoscopic GERD procedures, calls the Plicator procedure a "pseudo-Nissen," because it attempts to create the same kind of reflux barrier as a Nissen fundoplication. "There's a learning curve associated with getting the suture in exactly the right place, but it's not the hardest procedure to learn, and it provides good control of the tissue," he says.

In a 2005 study that followed 57 patients who underwent the Plicator procedure, 70 percent of participants were able to eliminate their use of proton pump inhibitors after one year.3 They also experienced a significant reduction in GERD symptoms. According to Bill Speranza, VP of Marketing at NDO Surgical, the results of recent sham trials data show that the Plicator procedure provides "objective and subjective improvements" in GERD symptoms.

The company declined to give details about case costs or reimbursement, saying it was dependent upon the facility and the facility location. Plicator technology was recognized for payment under Medicare's hospital outpatient payment system in April 2005. As of Jan. 1, hospital outpatient facility reimbursement for the Plicator procedure increased by about 7.5 percent. The company says that reimbursement is granted on a case-by-case basis and varies depending on location.

EndoCinch
Davol, Inc.
(800) 556-6275
www.endocinch.com
The EndoCinch procedure, which received FDA clearance in 2000, involves using a suturing device attached to an endoscope to create a series of partial-thickness pleats at or just below the gastroesophageal junction to augment the anti-reflux barrier.

The EndoCinch procedure kit contains a suturing capsule, needle, pusher wire, guidewire, suture tags, suture loader, suture anchor delivery device, suture anchor loading tool and suture threading tool, all of which are single-use. An EndoCinch handle and overtube, both multiple use, are also required.

Like the Stretta and the Plicator, the EndoCinch is performed under conscious sedation. The procedure involves suctioning a fold of tissue into the capsule chamber in order to deploy a stitch, and then repeating the procedure one centimeter adjacent to the first stitch. The surgeon then draws the two stitches together to form a plication and then repeats the entire process two or three times to form the pleats.

Even though initial clinical trial results seemed promising, long-term results of some trials have suggested that over time, plications might shift or disappear because the sutures might fall out of the tissue. In a 2003 study that followed 22 patients, for example, the plications had shifted in 35 percent of patients, and one or both plications had disappeared in five patients after one year.4 However, patients' use of PPIs was still reduced by 64 percent.

Yang Chen, MD, a gastroenterologist and professor of medicine at University of Colorado Hospital in Denver who has been performing the EndoCinch procedure for five years, points out that the procedure requires a fair amount of dexterity, and the relatively steep learning curve might explain some of the poor outcomes. "There's a fair amount of operator variability in how you make the stitches," he says.

According to the American Society for Gastrointestinal Endoscopy, the EndoCinch handle (which can be reused 50 times) lists for $1,500 and the overtube (which can be reused 25 times) lists for $150. Disposables cost $1,295. Average case cost is $1,331. The company declined to discuss average reimbursement.

Patient eligibility for MIS GERD
Laparoscopic surgery to treat severe reflux disease was effective in relieving symptoms and was associated with high rates of patient satisfaction five years after the procedure, according to a study in the October issue of Archives of Surgery.

"The patients who will get the best results from these procedures are those who have classic heartburn symptoms and who have shown some improvement with proton pump inhibitors," says Dr. Chen. He notes that if patients have shown no response to medication, chances are that endoscopic procedures or even a Nissen fundoplication won't help.

"A large proportion of patients who are being helped by PPIs are still not completely satisfied - either they have breakthrough symptoms or they resist the idea of taking a pill every day," says Dr. Chen. In his opinion, no one endoscopic procedure stands head and shoulders above the rest. "I review the entire spectrum of treatment options with my patients, describe the benefits and disadvantages of each, and help them decide what they're most comfortable with. There's no right or wrong option. It's at least partly a matter of patient preference."

References
1. Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc 2004; 18: 1038-1044.
2. Corley DA, Katz P, Wo JM, et. al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology 2003; 125: 668-676.
3. Pleskow D, Rothstein R, Lo S, et. al. Endoscopic full-thickness plication for the treatment of GERD: 12-month follow up for the North American open label trial. Gastrointest Endosc 2005; 61: 643-649.
4. Mahmood A, McMahon BP, Arfin Q, et. al. EndoCinch therapy for gastroesophageal reflux disease: a one-year prospective follow up. Gut 2003; 52: 34-39.

Further reading
Chen, Yang K. Endoscopic approaches to the treatment of gastroesophageal reflux disease. Current Opinion in Gastroenterology 2005; 21: 595-600.