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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Stretta System Triadafilopoulos et al. conducted two prospective, multicenter trials of patients with a heterogeneous spectrum of clinical disease severity, but with minimal active esophagitis or hiatal hernia (Triadafilopoulos, 2001; Triadafilopoulos, 2002). The first study followed 47 patients for 6 months and the second study followed 118 patients for 12 months. Both studies reported that radiofrequency energy delivery significantly improved GERD symptoms, QOL, and esophageal acid exposure, while eliminating the need for antisecretory medications in most patients. However, there were no improvements in other physiological measures, such as LES pressure, peristaltic amplitude, and LES length. The procedure was well-tolerated, with a low rate of self-limited complications. A third, smaller single-center study, which included some of the patients from the first study, also reported that radiofrequency energy delivery provided effective Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline symptom relief over the short term (6 months), but there were no changes in QOL or esophageal motility or pH parameters (DiBaise, 2002). For all of these studies, limitations included lack of a comparison group, small to moderate sample size, and short- to moderate-length follow-up.

A large, retrospective, patient registry study, in a diverse group of patients at multiple centers, reported that the Stretta procedure resulted in significant GERD symptom control and patient satisfaction. Treatment effect was durable beyond 1 year (for 88 patients with 1 year follow-up) and most patients were off all antisecretory medications at follow-up.

Limitations were retrospective study design and short follow-up period for most patients. There were no data available on objective outcomes, such as esophageal acid exposure, and LES pressure and length (DiBaise, 2002).

Investigators of a small randomized, double-blind, sham-controlled, multicenter trial reported that radiofrequency energy delivery significantly improved GERD symptoms and QOL compared with the sham procedure, but it did not decrease esophageal acid exposure, LES pressure, or medication use at 6 months. Nevertheless, responders, with a 50% reduction in health-related quality of life (HRQL) score, experienced significant median decreases in 24-hour acid exposure time. In addition to a 13% dropout rate, a greater than anticipated number of sham patients discontinued their medications, so that the study was underpowered (Corley, 2003).

One prospective study compared the Stretta procedure with a surgical procedure, laparoscopic fundoplication. Patients were stratified to one or the other procedure according to size of their hiatal hernia, LES pressure, and the presence or absence of significant pulmonary symptoms or Barrett's esophagus. Both patient groups were highly satisfied and had similar improvements in GERD symptoms and QOL, although follow-up was short term. However, only 58% of Stretta patients were able to discontinue PPI medications postprocedure, compared with 97% of surgical patients. The authors concluded that Stretta appears to be a moderately effective and safe alternative to laparoscopic fundoplication in wellselected patients. This comparative study was not randomized and patients in the Stretta group had less severe disease, potentially biasing results (Richards, 2003).

Go et al. evaluated the Stretta procedure in 50 patients (Go, 2004). All were evaluated post procedure, but only 74% completed a post procedure survey. Heartburn scores and overall symptoms satisfaction scores all improved as compared to prior to the procedure. Four patients had subsequent antireflux surgery. This study was a small case series and the evaluations were subjective.

Triadafilopoulos conducted a subgroup analysis of responder and nonresponder groups (combined total 118) from a U.S.

open label trial (Triadafilopoulos, 2004). Responders had significant improvement in esophageal acid exposure, but nonresponders had little or no change. This study was a small case series, nonrandomized, and not case controlled.

Torquati et al. evaluated 36 patients who had undergone the Stretta procedure (Torquati, 2004). Eighteen months post procedure, 30 patients were highly satisfied with the procedure and would have it done again, 55.6% had completely discontinued their use of proton pump inhibitors, and 30.5% had reduced their dose significantly. Again, this was a small case series.

The remaining two prospective studies had similar results to the previous studies, both suggesting that Stretta is safe and significantly improves GERD symptoms and QOL while eliminating the need for PPIs in the majority of patients.

However, both were methodologically flawed, with small sample size, no comparison group, and short-term follow-up (Houston, 2003; Tam, 2003). One of these studies also reported significant effects on LES function that were associated with improvement in the antireflux barrier, including a reduced rate of postprandial transient lower esophageal sphincter relaxations (tLESRs) and increased postprandial basal LES pressure. These effects were associated with a reduction in reflux events and esophageal acid exposure (Tam, 2003).

Endoscopic/Plication Suturing Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline There are two basic techniques designed to place sutures or "staples" at the cardia during upper endoscopy: superficial, mainly submucosal, stitching devices; and deep transmural plicating devices. Conceptually, both allow for the creation of pleats or plications of tissue just beneath the gastroesophageal junction. Two devices are commercially available in the United States: Bard EndoCinch Suturing System and the Plicator (Hayes, 2007).

Bard EndoCinch Three studies evaluated the EndoCinch procedure, an example of endoscopic/plication suturing. Investigators of a small, prospective multicenter trial reported that endoscopic gastroplasty, or EndoCinch, is safe and associated with improved symptom control and reduction in the use of medications at the 6-month follow-up in patients with early-stage uncomplicated GERD (Filipi, 2001). In addition, QOL results showed a significant improvement in bodily pain and there was a reduction in esophageal acid reflux. However, there was no difference in LES pressure measurements. Small sample size, lack of a comparison group and long-term follow-up, as well as a 20% dropout rate and 17% retreatment rate were limitations of this study.

Three small, uncontrolled prospective studies with longer follow-up (12 months) also evaluated EndoCinch. The first confirmed that the procedure is safe, significantly improves symptomatology and QOL, and reduces patients' requirements for PPIs. However, physiological measurements were made over a 3-month period only and, while there were significant reductions in acid exposure and number of reflux episodes during this time period, there were no changes in LES pressure and length (Mahmood, 2003). The second study reported that endoscopic suturing resulted in only modest alterations in LES function, and these changes were associated with minor, but significant, improvements in reflux control, including improvement in QOL and reduction in severity of reflux symptoms, that were sustained at 12 months. However, the plications may not be durable and the lack of durability may directly influence clinical outcomes (Tam, 2004). In the third, heartburn symptoms did not improve and proton pump inhibitor medication used exceeded 50% of the initial dose in 56 of 70 patients and there was total suture loss in 18 of 70 patients (Schiefke, 2005b).

Schiefke et al. used a new endoscopic suturing device, the "ESD" in 20 patients who had initially been treated with the EndoCinch but had relapsed after a median of 7.5 months (Schiefke, 2005a). After 6 months, only one patient still had all sutures in situ and in three patients, no sutures could be detected. There were no significant improvements in clinical findings.

In a randomized, placebo controlled study by Montgomery et al., 46 patients with gastro-esophageal reflux disease requiring regular use of proton-pump inhibitors (PPIs) were enrolled to evaluate the effects of the EndoCinch plication technique (Montgomery, 2006). Patients were randomized to the EndoCinch plication technique or a sham procedure. Preand post-procedure assessments included gastro-esophageal endoscopy, esophageal manometry and 24-h pH recording, quality of life (QoL) assessment and use of PPIs. Reflux-specific symptoms and use of PPIs (total intake as well as number of patients not taking PPIs) improved in both groups at 6 weeks and at 3 and 12 months post-procedure with an increased improvement in the treatment group at 3 months compared to controls (p Plicator Two studies evaluated the EPS procedure, another type of endoscopic/plication suturing. A very small pilot study reported that endoscopic full-thickness plication is safe, feasible, and durable, and appears to reduce symptoms and medication use associated with GERD (Chuttani, 2003). The second study, somewhat larger and conducted at several clinical sites, confirmed these findings and, in addition, reported a significant reduction in esophageal acid exposure, but no changes in LES pressure or esophageal amplitude. This study had a 27% dropout rate (Pleskow, 2004). Both studies were limited by small sample size, lack of a control group, and short-term follow-up.

Schilling et al. studied a new endoluminal suture device, the Ti-Knot device, in 20 patients with mild esophagitis, small or no hiatal hernia and signs of abnormal acid exposure (Schilling, 2005). After three months, 12% of all placations persisted, the clinical response was poor, and two patients required endoscopic therapy for acute bleeding.

Endoscopic Therapies For Gastroesophageal Reflux Disease (GERD) - Commercial Medical Management Guideline In a randomized, single-blind, prospective, multicenter trial by Rothstein et al., 159 patients were selected to either undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture (n-78) or a sham procedure (n=81) to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastro-esophageal reflux disease (GERD) (Rothstein, 2006). Group assignments were revealed following the 3-month evaluation. The primary end point was or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. By intention-to-treat analysis, at 3 months, the proportion of patients achieving or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P.001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs. 24%; P =.002). The percent reduction in median percent time pH 4 was significantly improved within the active group versus baseline (7 vs. 10, 18%, P.001) but not in the sham group (10 vs. 9, -3%, P =.686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH 4 (P =.010). The authors concluded that endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure. Additional studies are needed to evaluate long term results.

There were no peer-reviewed published studies that evaluated ESD/Sew-Right (an endoscopic/plication suturing technique).

Polymer Injection and Implantation Techniques The concept of these procedures is to place or implant inert material into the region of the gastroesophageal junction. The low-viscosity bulking agents are injected through a standard or large-bore needle and then change to a solid state at the injection site. The 2 products tested (Enteryx and Gatekeeper) have been withdrawn from FDA approval.

The first device (Enteryx) became commercially available in the United States in 2003 but was voluntarily recalled by the manufacturer in 2005 due to safety issues (FDA, 2005). The development of the Gatekeeper device was suspended in late 2005 by the manufacturer due to concerns in the evolving market conditions related to endoscopic antireflux devices, as well as anticipated regulatory concerns.

Professional Organizations American Gastroenterological Association (AGA): In a 2006 position statement, the AGA stated that to better understand the role of endoscopic therapies, sham-controlled trials will be required for every new endoscopic device and technique, as well as long-term follow-up of at least 3-5 years. Most studies of endoscopic therapy have only limited follow-up information, and data suggest that some of these techniques, in their current iterations, are not durable. While newer devices and improvements in endoscopic anti-reflux techniques may yield better and more durable treatment outcomes, current data suggest that there are no definite indications for endoscopic therapy for GERD at this time. Both practitioners and patients need to be aware of the limitations in the evidence that exist with these devices at present" (Falk, 2006).

In 2008, the AGA published a Medical Position Statement of the Management of Gastroesophageal Reflux Disease which further supports their position that routine endoscopy in subjects with erosive or nonerosive reflux disease to assess for disease progression is not recommended, as the evidence shows that risks associated with endoscopy outweigh the benefits (AGA, 2008). The AGA further states that endoscopically monitoring patients with chronic GERD symptoms has not been shown to diminish the risk of cancer, and this practice is discouraged.

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