Endoscopic Management of GERD.

Gastroesophageal reflux disease (GERD) has consistently been the most frequently diagnosed gastrointestinal malady in the USA. The mainstay of therapy has traditionally been medical management, including lifestyle and dietary modifications as well as antacid medications. In those patients found to be refractory to medical management or with a contraindication to medications, the next step up has been surgical anti-reflux procedures. Recently, though innovative advancements in therapeutic endoscopy have created numerous options for the endoscopic management of GERD, in this review, we discuss the various endoscopic therapy options, as well as suggested strategies we use to recommend the most appropriate therapy for patients.

The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective.

BACKGROUND: Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0. METHODS: A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated. RESULTS: Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P < .001). CONCLUSION: In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.

New Minimally Invasive Endoscopic and Surgical Therapies for Gastroesophageal Reflux Disease (GERD).

GERD has become one of the most frequent pathology of the upper GI tract. It is a spectrum disease and is a progressive disease as well. Serious and severe complications are possible. The mainstream therapy in most of the patients is the medical therapy with PPI's. The most severe cases with an impaired LES (Lower Esophageal Sphincter) function as well as important anatomical disruptions are of surgical indication, the gold standard being laparoscopic fundoplication, an elective therapy with long term follow up outcomes at the expense of de novo symptoms associated with fundoplications in general. 30% to 40% of the patients are PPI refractory with partial symptom control, but they are not willing to go for the laparoscopic fundoplication because of the invasive character and because of potential postfundoplications syndromes. There is a "treatment gap" for these patients with GERD. For a well selected patient population with GERD, with mild forms of the disease, without complications and without major anatomical disruptions (patients with small hiatal hernias), patients who are refractory on PPI medication, there are today new alternative therapies, minimally invasive. These therapies are less aggressive and basically with no side effects or new onset symptoms that Laparoscopic Fundoplications will give. These are endoscopic therapies which improve the LES function: Stretta utilizes radiofrequence therapy, a novel technique describes mucosal resection at the level of the cardia, while a partial fundoplication from within the stomach can be realized with EsophyX, Muse or Gerd-X. Form all these procedures, EsophyX is the most advanced with more than 20,000 patients treated worldwide, with good clinical outcomes and with no de novo symptoms. The laparoscopic techniques treat hiatal hernias larger than 2 cm. Linx utilizes a magnetic ring at the LES level. EndoStim utilizes electrodes in order to stimulate the LES muscle. These procedures are effective on short term and there are few patients treated with Linx or EndoStim. More research for Linx and EndoStim is necessary with randomized clinical trials, with improvement of the devices and with long term follow up.

Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.

BACKGROUND & AIMS: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS: We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO Randomized Clinical Trial.

BACKGROUND: Incomplete control of troublesome regurgitation and extraesophageal manifestations of chronic gastroesophageal reflux disease (GERD) is a known limitation of proton pump inhibitor (PPI) therapy. This multicenter randomized study compared the efficacy of transoral incisionless fundoplication (TIF) against PPIs in controlling these symptoms in patients with small hiatal hernias. METHODS: Between June and August 2012, 63 patients were randomized at 7 US community hospitals. Patients in the PPI group were placed on maximum standard dose (MSD). Patients in the TIF group underwent esophagogastric fundoplication using the EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation or extraesophageal symptoms. Secondary outcomes were normalization of esophageal acid exposure (EAE), PPI usage and healing of esophagitis. RESULTS: Of 63 randomized patients (40 TIF and 23 PPI), 3 were lost to follow-up leaving 39 TIF and 21 PPI patients for analysis. At 6-month follow-up, troublesome regurgitation was eliminated in 97% of TIF patients versus 50% of PPI patients, relative risk (RR) = 1.9, 95% confidence interval (CI) = 1.2-3.11 (P = .006). Globally, 62% of TIF patients experienced elimination of regurgitation and extraesophageal symptoms versus 5% of PPI patients, RR = 12.9, 95% CI = 1.9-88.9 (P = .009). EAE was normalized in 54% of TIF patients (off PPIs) versus 52% of PPI patients (on MSD), RR = 1.0, 95% CI = 0.6-1.7 (P = .914). Ninety percent of TIF patients were off PPIs. CONCLUSION: At 6-month follow-up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraesophageal symptoms of GERD.

Three-year results of a multicenter prospective study of transoral incisionless fundoplication.

BACKGROUND: To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. METHODS: A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry. RESULTS: Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years. CONCLUSIONS: The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.

Laparoscopic Hiatal Hernia Repair With Concomitant Transoral Incisionless Fundoplication.

Patients with gastroesophageal reflux disease and a large hiatal hernia can have life-disrupting symptoms, such as heartburn, regurgitation, cough, and hoarseness. Gastroesophageal reflux disease symptoms are often treated with proton pump inhibitors and occasionally treated with surgery. The last decade has seen the development of a new procedure-laparoscopic hiatal hernia repair with concomitant transoral incisionless fundoplication. When transoral incisionless fundoplication is performed immediately after a laparoscopic hiatal hernia repair, it may enable the discontinuation of proton pump inhibitors and improve a patient's quality of life. This article explores the development of the transoral incisionless fundoplication procedure as well as its concomitant use after hiatal hernia repair at all stages of perioperative care. Also included is a hypothetical case study that illustrates the perioperative nursing care of a patient undergoing this procedure.

Long-Term Outcomes of Transoral Incisionless Fundoplication in a High-Risk Pediatric Population.

INTRODUCTION: Laparoscopic Nissen fundoplication (LNF) is the standard for surgical treatment of gastroesophageal reflux disease (GERD), but postoperative complications and pain are common in patients with severe neurological impairment (NI) and those undergoing reoperative procedures. Transoral incisionless fundoplication (TIF) is an endoscopic alternative to treat GERD. Long-term results in pediatric populations are unknown. METHODS: Eleven patients who underwent TIF between January 2008 and September 2010 were included. A retrospective chart review was performed to evaluate long-term patient outcomes. Median follow-up was 5.6 years (range = 0.42-8.76 years). RESULTS: Average patient age was 16.5 ± 5.1 years. Severe NI was present in 81.8% (9/11) of patients, and 63.6% (7/11) had undergone one or more prior fundoplication attempts. Overall, symptomatic reflux recurred or persisted in 54.5% (6/11) of patients. Recurrent symptoms were more common among those who had previous fundoplications than those who did not (71.4% [5/7] vs. 25% [1/4]). Four patients went on to require reoperation, including one laparoscopic Nissen and three disconnects. At last follow-up, 81.8% (9/11) of patients were still on antireflux medications. CONCLUSIONS: This is the first report of long-term outcomes for treatment of GERD using TIF in a pediatric population. The recurrence rate was high, likely related to the fact that the population treated was extremely high risk. Recurrence was higher in patients with a prior fundoplication, perhaps identifying prior antireflux operations as a relative contraindication to TIF. Nevertheless, complications were low, and a subset of patients did receive a durable benefit from the procedure.

Transoral incisionless fundoplication for gastro-esophageal reflux disease: Techniques and outcomes.

Gastro-esophageal reflux disease (GERD) is a very common disorder that results primarily from the loss of an effective antireflux barrier, which forms a mechanical obstacle to the retrograde movement of gastric content. GERD can be currently treated by medical therapy, surgical or endoscopic transoral intervention. Medical therapy is the most common approach, though concerns have been increasingly raised in recent years about the potential side effects of continuous long-term medication, drug intolerance or unresponsiveness, and the need for high dosages for long periods to treat symptoms or prevent recurrences. Surgery too may in some cases have consequences such as long-lasting dysphagia, flatulence, inability to belch or vomit, diarrhea, or functional dyspepsia related to delayed gastric emptying. In the last few years, transoral incisionless fundoplication (TIF) has proved an effective and promising therapeutic option as an alternative to medical and surgical therapy. This review describes the steps of the TIF technique, using the EsophyX(®) device and the MUSE(TM) system. Complications and their management are described in detail, and the recent literature regarding the outcomes is reviewed. TIF reconfigures the tissue to obtain a full-thickness gastro-esophageal valve from inside the stomach, by serosa-to-serosa plications which include the muscle layers. To date the procedure has achieved lasting improvement of GERD symptoms (up to six years), cessation or reduction of proton pump inhibitor medication in about 75% of patients, and improvement of functional findings, measured by either pH or impedance monitoring.

Endoscopic treatment of gastroesophageal reflux disease.

Multiple new endoluminal devices and therapies have been devised to create a more effective antireflux barrier in patients with gastroesophageal reflux disease (GERD). Most of these therapies have been abandoned, because they were ineffective and/or had significant adverse effects. However, there are currently two therapies (Stretta, EsophyX) that have US Food and Drug Administration approval and continue to be used in select patients with GERD. The clinical management of GERD, disease complications, endoluminal techniques, evidence for efficacy, and controversies concerning endoluminal therapy for GERD are reviewed and discussed.

Update on novel endoscopic therapies to treat gastroesophageal reflux disease: A review.

Endoscopic treatments for gastroesophageal reflux disease (GERD) have become increasingly popular in recent years. While surgical intervention with the Laparoscopic Nissen Fundoplication remains the gold standard, two endoscopic interventions, specifically, are gaining traction in clinical use (EsophyX and Stretta). The EsophyX (EndoGastric Solutions, Inc., Redmond, WA, United States) was developed as a method of restoring the valve at the GE junction through an endoluminal fundoplication (ELF) technique. Long-term data suggests that transoral incisional fundoplication (TIF) with EsophyX may be effective for symptom control and proton pump inhibitor reduction or cessation for up to 2-6 years. There is no evidence that EsophyX is more effective than surgical intervention. TIF may be most effective for patients with HH < 2 cm and Hill Grade I/II valves. Stretta (Mederi Therapeutics, Greenwich, CT, United States) was approved by the Food and Drug Administration in 2000. It delivers radiofrequency energy to the lower esophageal sphincter and gastric cardia. Published reviews of the literature are conflicted in their recommendations of Stretta in the management of GERD. The literature suggests that the Stretta procedure has an acceptable safety profile and may be effective in reducing symptom burden and quality of life scores up to 8 years post-intervention. However, there does not appear to be any sustained improvement in objective outcomes and there is no evidence that Stretta results in improved outcomes as compared to surgical intervention. Treatment modalities for GERD, as a field, suffer from a lack of standardization in primary and secondary outcomes. Although many studies have looked at health related quality of life, the tools used to do so are markedly heterogeneous. Future directions for the endoscopic treatment of GERD include novel techniques like endoscopic submucosal dissection.

Transoral incisionless fundoplication for the treatment of gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) is a common and costly chronic medical condition affecting millions of patients. It is associated with substantial morbidity and negatively impacts quality of life. Reflux of gastric contents into the esophagus damages the esophageal mucosa and is associated with conditions including esophagitis and esophageal stricture. While GERD is most commonly seen in Western populations, changes in dietary patterns and the global increase in obesity have led to a pronounced increase in its prevalence worldwide. Medical and surgical GERD therapies are costly and pose considerable side effects, leading many to pursue effective endoscopic treatment options. Transoral incisionless fundoplication is an endoluminal procedure that offers patients a minimally invasive treatment option with the potential to eliminate the need for medical acid suppression with a low risk of side effects.

Endoscopic treatment of refractory gastroesohageal reflux disease.

Though efficient acid suppression with proton pump inhibitors (PPIs) remains the mainstay of treatment of gastroesophageal reflux disease (GERD), some of the patients showed refractory response to PPIs, necessitating further intervention. After increasing dose of PPIs and other kinds of pharmacological intervention adopting prokinetics or others, variable endoscopic treatments are introduced for the treatment of these refractory cases. The detailed introduction regarding endoscopic treatment for GERD is forwarded in this review article. Implantation of reabsorbable or synthetic materials in the distal esophagus was tried in vain and is expelled from the market due to limited efficacy and serious complication. Radiofrequency energy delivery (Stretta) and transoral incisionless fundoplication (EsophyX) are actively tried currently.

Endoscopic Treatment of Refractory Gastroesohageal Reflux Disease

Though efficient acid suppression with proton pump inhibitors (PPIs) remains the mainstay of treatment of gastroesophageal reflux disease (GERD), some of the patients showed refractory response to PPIs, necessitating further intervention. After increasing dose of PPIs and other kinds of pharmacological intervention adopting prokinetics or others, variable endoscopic treatments are introduced for the treatment of these refractory cases. The detailed introduction regarding endoscopic treatment for GERD is forwarded in this review article. Implantation of reabsorbable or synthetic materials in the distal esophagus was tried in vain and is expelled from the market due to limited efficacy and serious complication. Radiofrequency energy delivery (Stretta) and transoral incisionless fundoplication (EsophyX) are actively tried currently.