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A magnetic implant for the treatment of gastroesophageal reflux disease (GERD) was Food and Drug Administration-approved in 2012 and has been extensively evaluated. The device is a ring of magnets that are placed around the gastroesophageal junction, augmenting the native lower esophageal sphincter and preventing reflux yet preserving lower esophageal sphincter physiologic function and allowing belching and vomiting. Magnetic force is advantageous, being permanent and precise, and forces between magnets decrease with esophageal displacement. Multiple patient cohorts have been studied using the magnetic device, and trials establish consistent, long-term improvement in pH data, GERD symptom scores, and proton-pump inhibitor use. A 5-year Food and Drug Administration trial demonstrated that most patients achieved normal pH scores, 85% stopped proton-pump inhibitors, and GERD health-related quality of life symptom scores improved from 27 to 4 at 5 years. Seven studies have compared magnetic augmentation with laparoscopic Nissen fundoplication and demonstrated that the magnetic device achieved comparable efficacy with regard to proton-pump inhibitor cessation, GERD symptom score improvement, and heartburn and regurgitation scores. However, to date there have been no randomized, controlled trials comparing the 2 techniques, and the study cohorts are not necessarily comparable regarding hiatal hernia size, severity of reflux, body mass index scores, or esophagitis scores. Dysphagia incidence was similar in both groups. Reoperation rates and safety profiles were also comparable, but the magnetic device demonstrated significant beneficial differences in allowing belching and vomiting. The magnetic device is safe, with the main adverse event being dysphagia with an approximate 3%-5% chronic incidence. Device removals in clinical trials have been between 0% and 7% and were uneventful. There have been no erosions, perforations, or infections in FDA clinical trials; erosions have rarely been noted in practice. Magnetic augmentation of the lower esophageal sphincter is a safe and effective operation for GERD, and should be considered a surgical option for those seeking a fundic-sparing operation, particularly those with parameters consistent with study cohorts. Additional randomized, controlled trials are underway.

Use of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) is increasing. As this innovative treatment for GERD gains widespread use and adoption, an assessment of its safety since U.S. market introduction is presented.Events were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, which reports events submitted to the Food and Drug Administration (FDA) of suspected device-associated deaths, serious injuries, and malfunctions. The reporting period was from March 22, 2012 (FDA approval) through May 31, 2016, and included only events occurring in the United States. Additional information was provided by the manufacturer, allowing calculation of implant rates and durations.An estimated 3283 patients underwent magnetic sphincter augmentation (165 surgeons at 191 institutions). The median implant duration was 1.4 years, with 1016 patients implanted for at least 2 years. No deaths, life-threatening events, or device malfunctions were reported. The overall rate of device removal was 2.7% (89/3283). The most common reasons for device removal were dysphagia (52/89) and persistent reflux symptoms (19/89). Removal for erosion and migration was 0.15% (5/3283) and 0% (0/3283), respectively. There were no perforations. Of the device removals, 57.3% (51/89) occurred1 year after implant, 30.3% (27/89) between 1 and 2 years, and 12.4% (11/89)2 years after implant. The rate of device removal and erosion with an implant duration2 years were 1.1% (11/1016) and 0.1% (1/1016), respectively. All device removals and erosions were managed nonemergently, with no complications or long-term consequences.During a 4-year period in more than 3000 patients, no unanticipated MSAD complications have emerged, and there is no data to suggest a trend of increased events over time. The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GERD. MSAD is considered safe for the widespread treatment of GERD.

Background & Aims Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. Methods We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD–health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. Results Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. Conclusions Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.

Antireflux surgery with a magnetic sphincter augmentation device (MSAD) restores the competency of the lower esophageal sphincter with a device rather than a tissue fundoplication. As a regulated device, safety information from the published clinical literature can be supplemented by tracking under the Safe Medical Devices Act. The aim of this study was to examine the safety profile of the MSAD in the first 1000 implanted patients. We compiled safety data from all available sources as of July 1, 2013. The analysis included intra/perioperative complications, hospital readmissions, procedure-related interventions, reoperations, and device malfunctions leading to injury or inability to complete the procedure. Over 1000 patients worldwide have been implanted with the MSAD at 82 institutions with median implant duration of 274 days. Event rates were 0.1% intra/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations. All reoperations were performed non-emergently for device removal, with no complications or conversion to laparotomy. The primary reason for device removal was dysphagia. No device migrations or malfunctions were reported. Erosion of the device occurred in one patient (0.1%). The safety analysis of the first 1000 patients treated with MSAD for gastroesophageal reflux disease confirms the safety of this device and the implantation technique. The overall event rates were low based on data from 82 institutions. The MSAD is a safe therapeutic option for patients with chronic, uncomplicated gastroesophageal reflux disease.

BACKGROUND Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year. Secondary outcomes were 50% or greater improvement in quality of life related to gastroesophageal reflux disease and a 50% or greater reduction in the use of proton-pump inhibitors at 1 year. For each outcome, the prespecified definition of successful treatment was achievement of the outcome in at least 60% of the patients. The 3-year results of a 5-year study are reported. RESULTS The primary outcome was achieved in 64% of patients (95% confidence interval [CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed. CONCLUSIONS In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997.)

Treatment of gastroesophageal reflux disease in the United States today is binary, with the majority of patients with gastroesophageal reflux disease being treated with antisecre-tory medications and a minority of patients, typically those with volume regurgitation, undergoing Nissen fundoplication. However, there has been increasing dissatisfaction with proton pump inhibitor therapy among a significant number of patients with gastroesophageal reflux disease owing to cost, side effects, and refractory symptoms, and there has been a general reluctance to undergo surgical fundoplication due to its attendant side-effect profile. As a result, a therapy gap exists for many patients with gastroesophageal reflux disease. Alternative techniques are available for these gap patients, including 2 endoscopic fundoplication techniques, an endoscopic radiofrequency energy delivery technique, and 2 minimally invasive surgical procedures. These alternative techniques have been extensively evaluated; however, there are limitations to published studies, including arbitrary definitions of success, variable efficacy measurements, deficient reporting tools, inconsistent study designs, inconsistent lengths of follow-up postintervention, and lack of comparison data across techniques. Although all of the techniques appear to be safe, the endoscopic techniques lack demonstrable reflux control and show variable symptom improvement and variable decreases in proton pump inhibitor use. The surgical techniques are more robust, with evidence for adequate reflux control, symptom improvement, and decreased proton pump inhibitor use; however, these techniques are more difficult to perform and are more intrusive. Additionally, these alternative techniques have only been studied in patients with relatively normal anatomy. The field of gastroesophageal reflux disease treatment is in need of consistent definitions of efficacy, standardized study design and outcome measurements, and improved reporting tools before the role of these techniques can be fully ascertained.

Gastroesophageal reflux disease (GERD), commonly manifested by heartburn or regurgitation, is a chronic, progressive condition in which failed sphincter function allows the contents of the stomach to reflux into the esophagus, the airways and the mouth. Chronic GERD affects 10% of Western society. The majority of patients receive adequate relief from proton pump inhibitors, but up to 40% have incomplete relief of symptoms that cannot be addressed by increasing the dose of medications. The laparoscopic Nissen fundoplication is the surgical gold standard; however, the level of technical difficulty and its side effects have limited its use to less than 1% of the GERD population. These factors have contributed to the propensity of patients to persist with medical therapy, even when inadequate to control symptoms and complications of the disease. Consequently, a significant gap in the treatment continuum for GERD remains evident in current clinical practice. The LINX(™) Reflux Management System (Torax Medical) is designed to provide a permanent solution to GERD by augmenting the physiologic function of the sphincter barrier with a simple and reproducible laparoscopic procedure that does not alter gastric anatomy and can be easily reversed if necessary.

Gastroesophageal reflux disease (GERD) can be difficult to diagnose - symptoms alone are often not enough, and thus, objective testing is often required. GERD is a manifestation of pathologic levels of reflux into the esophagus of acidic, nonacidic, and/or bilious gastric content. However, in our current evidence-based knowledge approach, we only have reasonable outcome data in regards to acid reflux, as this particular type of refluxate predictably causes symptoms and mucosal damage, which improves with medical or surgical therapy. While there are data suggesting that nonacid reflux may be responsible for ongoing symptoms despite acid suppression in some patients, outcome data about this issue are limited. Therefore, this working group believes that it is essential to confirm the presence of acid reflux in patients with 'refractory' GERD symptoms or extraesophageal symptoms thought to be caused by gastroesophageal reflux before an escalation of antireflux therapy is considered. If patients do not have pathologic acid reflux off antisecretory therapy, they are unlikely to have clinically significant nonacid or bile reflux. Patients who do not have pathologic acid gastroesophageal reflux parameters on ambulatory pH monitoring then: (i) could attempt to discontinue antisecretory medications like proton pump inhibitors and H2-receptor antagonists (which are expensive and which carry risks - i.e. C. diff, etc.); (ii) may undergo further evaluation for other causes of their esophageal symptoms (e.g. functional heartburn or chest pain, eosinophilic esophagitis, gastroparesis, achalasia, other esophageal motor disorders); and (iii) can be referred to an ear, nose, and throat/pulmonary/allergy physician for assessment of non-GERD causes of their extraesophageal symptoms.

Health care reform has created special challenges and hurdles to the introduction of new technology and innovative medical devices in gastroenterology and other medical fields. The implication of new regulations will be enormous as we begin to see venture-capital funding flee our specialty for more lucrative and "sure bets." This article, written by an experienced entrepreneur and practicing gastroenterologist, outlines some of the implications of this emerging challenge. Few other sources of information are available that truly articulate the insider view of coming changes.

The diagnosis and treatment of esophageal diseases have undergone major changes over the last several years, and these are expected to continue. This article highlights these changes.

Background and objective Helicobacter pylori infects the mucus layer of the human stomach and causes peptic ulcers and adenocarcinoma. We have previously shown that H. pylori accumulates photoactive porphyrins making the organism susceptible to inactivation by light, and that small spot endoscopic illumination with violet light reduced bacterial load in human stomachs. This study assessed the feasibility and safety of whole-stomach intra-gastric violet phototherapy for the treatment of H. pylori infection. Study design/materials and methods A controlled, prospective pilot trial was conducted using a novel light source consisting of laser diodes and diffusing fibers to deliver 408-nm illumination at escalating total fluences to the whole stomach. Eighteen adults (10 female) with H. pylori infection were treated at three U.S. academic endoscopy centers. Quantitative bacterial counts were obtained from biopsies taken from the antrum, body, and fundus, and serial urea breath tests. Results The largest reduction in bacterial load was in the antrum (>97%), followed by body (>95%) and fundus (>86%). There was a correlation between log reduction and initial bacterial load in the antrum. There was no dose-response seen with increasing illumination times. The urea breath test results indicated that the bacteria repopulated in days following illumination. Conclusion Intra-gastric violet light phototherapy is feasible and safe and may represent a novel approach to eradication of H. pylori, particularly in patients who have failed standard antibiotic treatment. This was a pilot study involving a small number of patients. Further research is needed to determine if phototherapy can be effective for eradicating H. pylori.

The high prevalence of gastroesophageal reflux disease continues to encourage the development of treatment modalities to fill the gap between acid-suppression therapy and the laparoscopic Nissen fundoplication. The Magnetic Sphincter Augmentation device has been designed to augment the lower esophageal sphincter barrier using magnetic force. A multi-center feasibility trial was done to evaluate safety and efficacy.Patients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia3 cm were excluded from the study. The device was implanted laparoscopically around the distal esophagus.Over a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97% of patients were discharged within 48 h. The mean follow-up was 209 days (range 12-434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p0.005). At 3 months post-operatively, 89% of patients were off anti-reflux medications, and 79% of patients had a normal 24-h pH test. All patients preserved the ability to belch. Mild dysphagia occurred in 45% of patients. No migrations or erosions of the device occurred.Laparoscopic implant of the MSA device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.

Background The management strategies for Barrett's esophagus (BE) that contains high-grade dysplasia (HGD) include intensive endoscopic surveillance, photodynamic therapy, thermal ablation, EMR, and esophagectomy. Objective To assess the safety and effectiveness of endoscopic circumferential balloon-based ablation by using radiofrequency energy for treating BE HGD. Design Multicenter U.S. registry. Setting Sixteen academic and community centers; treatment period from September 2004 to March 2007. Patients Patients with histologic evidence of intestinal metaplasia (IM) that contained HGD confirmed by at least 2 expert pathologists. A prior EMR was permitted, provided that residual HGD remained in the BE region for ablation. Intervention Endoscopic circumferential ablation with follow-up esophageal biopsies to assess the histologic response to treatment. Outcomes Histologic complete response (CR) end points: (1) all biopsy specimen fragments obtained at the last biopsy session were negative for HGD (CR-HGD), (2) all biopsy specimens were negative for any dysplasia (CR-D), and (3) all biopsy specimens were negative for IM (CR-IM). Results A total of 142 patients (median age 66 years, interquartile range [IQR] 59-75 years) who had BE HGD (median length 6 cm, IQR 3-8 cm) underwent circumferential ablation (median 1 session, IQR 1-2). No serious adverse events were reported. There was 1 asymptomatic stricture and no buried glands. Ninety-two patients had at least 1 follow-up biopsy session (median follow-up 12 months, IQR 8-15 months). A CR-HGD was achieved in 90.2% of patients, CR-D in 80.4%, and CR-IM in 54.3%. Limitations A nonrandomized study design, without a control arm, a lack of centralized pathology review, ablation and biopsy technique not standardized, and a relatively short-term follow-up. Conclusions Endoscopic circumferential ablation is a promising modality for the treatment of BE that contains HGD. In this multicenter registry, the intervention safely achieved a CR for HGD in 90.2% of patients at a median of 12 months of follow-up.

The success of fundoplication surgery varies widely; furthermore, complications after fundoplication can be common. We introduced a new device to treat GERD: biomechanical augmentation of the lower esophageal sphincter (LES) by use of a magnetic reinforcing appliance.The aim was to determine whether a magnetic appliance could safely increase LES pressure, maintain a closed sphincter except during swallowing and belching, and increase the gastric yield pressure in a porcine model.Ex vivo work-assessed design variables that would augment the reflux barrier yet still preserve swallow function. Porcine acute and chronic (44 weeks) postimplant studies were also performed. A single animal underwent planned device removal.Gastric yield pressure, animal behavior, endoscopy, barium studies, balloon expansion studies, esophageal manometry, and histology.Gastric yield pressure correlated with increasing magnetic forces (R(2)=0.5608, P.001). The sphincter augmentation device was safe in all animals, with no observed effect on eating behavior and normal weight gain. The mucosa of the esophagus appeared normal at all intervals, and there was no device migration or significant tissue inflammation. The average LES pressure rose after implantation (P.005). Balloon and barium studies demonstrated a closed sphincter with normal opening of the gastroesophageal junction during swallowing.Magnetic sphincter augmentation is a novel approach for the treatment of GERD. This study demonstrates the safety and feasibility of such a device in a porcine model. Further investigation of this device for the treatment of GERD in humans seems warranted.

Background: As previously reported, the magnetic sphincter augmentation device (MSAD) preserves gastric anatomy and results in less severe side effects than traditional antireflux surgery. The final 5-year results of a pilot study are reported here. Patients and Methods: A prospective, multicenter study evaluated safety and efficacy of the MSAD for 5 years. Prior to MSAD placement, patients had abnormal esophageal acid and symptoms poorly controlled by proton pump inhibitors (PPIs). Patients served as their own control, which allowed comparison between baseline and postoperative measurements to determine individual treatment effect. At 5 years, gastroesophageal reflux disease (GERD)-Health Related Quality of Life (HRQL) questionnaire score, esophageal pH, PPI use, and complications were evaluated. Results: Between February 2007 and October 2008, 44 patients (26 males) had an MSAD implanted by laparoscopy, and 33 patients were followed up at 5 years. Mean total percentage of time with pH

Two main developments will dominate the future of gastroenterology in the United States. The first is changing demography, and the second is revolutionary change in the structure of health insurance, that is, the advent of consumer-driven health care. This article details some of the demographic and insurance changes that gastroenterologists will have to contend with in the future and outlines some of the opportunities and challenges that lie ahead.

Background Enteryx (Boston Scientific Corp, Natick, Mass) is an injectable polymer used for the treatment of GERD. Current use of Enteryx requires fluoroscopy for accurate placement into the deep esophageal wall (ie, the deep submucosa or muscularis propria). In this study, we assessed the use of a new double-lumen, double-needle injection catheter for accurate placement of Enteryx into the deep esophageal wall, without fluoroscopy, in a porcine model. Methods All procedures were performed by using a new injection catheter (GZ Medical, LLC, Minnetonka, Minn), which allows for tissue depth assessment via the flow of gas through one lumen and the injection of a therapeutic substance (Enteryx) via a second lumen. Endoscopy was performed on 5 consecutive pigs by using the new catheter alone, without fluoroscopy, and attempting deep injections. Four injections of Enteryx were made at the gastroesophageal junction, 10 cm above the junction, and 15 cm above the junction. A total of 60 sites (12 per animal) were injected. The animals were sacrificed and each esophagus was harvested. The mediastinal cavity was searched for extravasated Enteryx material, and the esophagus was examined grossly for Enteryx adherent to the outside wall. Injection sites then were classified morphologically as superficial (mucosa or submucosa), deep (muscularis propria or deep submucosa contiguous to muscularis), subadventitial (between muscle and adventitia), or transmural. Only deep injections were considered adequate. Results No extravasated Enteryx was found in the mediastinum in 60 injected sites. One area of transmural injection had Enteryx adherent to the outside esophageal wall (1.7%). Fifty-one injected sites (85%) were adequate deep injections, 4 injections (6.7%) were subadventitial, 1 injection (1.7%) was superficial, and 3 injections (5%) could not be assessed. There were no complications observed in any animal. Conclusions By using a new injection device without fluoroscopy, Enteryx can be deposited consistently into the deep esophageal wall with a high degree of accuracy, avoiding mediastinal extravasation. Additional clinical trials are necessary to determine the relative accuracy and role of the new technique compared to standard radiographically guided placement.

Minimally invasive esophagectomy (MIE) is an evolving surgical alternative to traditional open esophagectomy. Despite considerable technical challenges, it was hypothesized that MIE could be performed effectively by surgeons experienced in open esophageal resection and advanced laparoscopic surgery. The authors report their experience with 25 patients who underwent MIE for esophageal disease. A multidisciplinary esophageal cancer team evaluated all the patients enrolled in this institutional review board–approved retrospective review study. Over an 18-month period, 25 consecutive patients (22 men and 3 women; mean age, 62 years; range, 48–77 years) with resectable esophageal cancer underwent MIE. Six patients were treated with neoadjuvant chemoradiotherapy. The preoperative diagnoses were adenocarcinoma (64%, n = 16), high-grade dysplasia (20%, n = 5), and squamous cell cancer (16%, n = 4). The outcomes evaluated included operative course, hospital and intensive care unit lengths of stay, pathologic stage, morbidity, and mortality. Two patients required conversion to open esophagectomy. Operative mortality was 4% (n = 1). The mean operative time was 350 min (range, 300–480), and the average blood loss was 200 ml. The patients remained ventilated for a median of 12 h, and the median intensive care unit utilization was 1 day. The median hospital length of stay was 9 days (range, 6–33 days). Major complications occurred in 32% of the patients. The anastomotic leak rate was 12%. Minor pulmonary complications occurred in 32% and atrial fibrillation in 16% of the patients. An anastomotic stricture developed in 24% of all the patients. One patient showed a positive proximal margin in the final pathology results. Minimally invasive esophagectomy is a technically challenging procedure that can be performed safely at the Virginia Piper Cancer Institute. Optimal results require appropriate patient selection and a multidisciplinary team experienced in the management of esophageal cancer.

Helicobacter pylori colonizes the mucus layer of the human stomach and duodenum, causes chronic gastritis, gastric ulcer, and is a risk factor for gastric adenocarcinoma. There is a 20% failure rate in antibiotic therapy, which is increasingly due to antibiotic resistance and necessitates the search for alternative antimicrobial methods. We have discovered that H. pylori when cultured in liquid medium, accumulates significant quantities of coproporphyrin and protoporphyrin IX, both in the cells and secreted into the medium. These photoactive porphyrins lead to cell death (up to 5 logs) by photodynamic action upon illumination with low doses of visible light, with blue/violet light being most efficient. The degree of killing increases with the age of the culture and is greater than that found with Propionibacterium acnes (another bacterium known to be photosensitive due to porphyrin accumulation). Both virulent and drug-resistant strains are killed. The data suggest that phototherapy might be used to treat H. pylori infection in the human stomach.

Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects.An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure.At 12 months, PPI use was reducedor =50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQLor =11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, aor =50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients.This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.

This prospective, multicenter, single-arm study evaluated the safety and efficacy of the endoscopic implantation of Enteryx, a biocompatible, non-biodegradable liquid polymer for the treatment of GERD.Eighty-five patients with heartburn symptoms responsive to proton pump inhibitor (PPI) use were enrolled. Inclusion requirements were HRQL scoreor = 11 on PPI andor = 20 off PPI, and 24-hour PH probe withor = 5% total time at PHor = 4. Patients with a hiatus hernia3 cm, grade 3 or 4 esophagitis, or esophageal motility disorder were excluded. Using a 4-mm needle tipped catheter during standard endoscopy, implants were made in 3-4 quadrants deep into the wall of the cardia. Use of PPI medications, pH-metry, manometry, GERD symptoms, and patient quality of life were assessed over a 6-month follow-up period.At 6 months, PPI use was eliminated in 74% and reduced by50% in 10% of patients. The median HRQL score improved from 24.0 pre-implant (baseline off PPIs) to 4.0 at 6 months (p0.001). Mean total esophageal acid exposure time was 9.5% pretherapy and 6.7% at 6 months (p0.001). Mean LES length increased from 2.0 cm at baseline to 3.0 cm posttherapy (p = 0.003). There were no clinically serious adverse events. Transient mild-to-moderate chest pain commonly occurred after implantation.The endoscopic implantation of Enteryx is a safe and effective therapy for eliminating or decreasing the need for PPI medications, improving GERD symptoms and patient quality of life, and decreasing esophageal acid exposure among patients suffering from GERD.

Regulatory and certification issues for endoscopy are complex, detailed, and broad. The different sources of the myriad regulations often have conflicting agendas, and the venues that seek to regulate endoscopic practice often overlap and seem redundant. Nonetheless, in spite of, or perhaps as a result of stringent regulation, endoscopy in the United States in thriving and continues to grow each year. Moreover, the penalties for not following the various regulations can be severe, and may result in criminal and civil sanctions. Any physician starting or already participating in a freestanding endoscopy center is well served by becoming familiar with the intent and generalities of each regulatory situation, and seeking appropriate legal and consulting counsel for specifics.

Gastroesophageal reflux disease (GERD) is a common and progressive condition manifested by heartburn or regurgitation. Though Nissen fundoplication has been and remains the gold standard for procedural therapy for GERD, two newer interventions have gained popularity: magnetic sphincter augmentation (MSA), which entails the placement of a self expanding magnetic ring around the gastroesophageal (GE) junction, and transoral incisionless fundoplication (TIF), an endoscopic approach that creates a neogastroesophageal valve near the fundus. Collective data gathered from four studies published within the past year suggest that the three modalities share comparable effectiveness in pH monitoring and patient satisfaction, TIF may have a lower proton pump inhibitor cessation rate, and Nissen fundoplication required longer recovery time and had a more serious adverse effects profile. Large, prospective, randomized controlled studies are needed to reliably compare the three procedures.

Specialty practice in general, and gastroenterology in particular, is undergoing significant transformation as we head into the new millennium. Gastroenterologists will need to adapt to the continued evolution and consolidation of managed care. Among other issues, gastroenterologists will need strategies for dealing with pricing pressures, changing technology, increased consumerism, a perceived specialist oversupply, and a rapidly aging population. These and other developments will drive a myriad of physician responses in an effort to confront changing practice realities.

Operative management for gastroesophageal reflux disease (GERD) has evolved into minimally invasive approaches utilizing robotic assisted technologies. Here, we present an overview of robotic assisted operations and outcomes for surgical management of patients with GERD. The specific surgical procedures described here are hiatus hernia repair with and without mesh. Nissen fundoplication a Collis gastroplasty. Additionally, a summary of various pre-operative diagnostic evaluations available for GERD and their relevance in district clinical situations is also provided.

Background There is a need to cleanse patients who are poorly prepared for colonoscopy safely and efficiently during the procedure to minimize rescheduling. US is already being used in catheter-based intravascular thrombolysis, and time-reversal acoustic (TRA) has been explored in assisting drug delivery to the brain. Objective To explore the efficacy and safety of a miniaturized endoluminal US device in stool dissolution as a means to salvage poor bowel preparation. Design Proof of concept experimental study. Settings Animal laboratory. Interventions Low-frequency US and TRAs. Main Outcome Measurements Feasibility, efficacy, and safety of US to liquefy stools ex vivo. Results Depending on parameters, such as pulse rate, acoustic intensity, and duration, increases in liquefaction speeds by a factor of 50 and 100 times were obtained. There was a significant difference in weight change between the 20-kHz–treated sample compared with controls ( P ≤ .0001). There was no difference in sloughing of mucosa and mechanical injury among the US, water spray, and control groups. Limitations Animal model. Conclusion Endoluminal US can liquefy stools at acoustic exposure levels that do not damage ex vivo colonic mucosa. Endoluminal US should be able to dissolve stools more rapidly than water spray alone, thereby optimizing colonoscopic evaluation in vivo.

Background The published prevalence of Barrett's esophagus (BE) varies from 0.9% to 25%, in part because of differences in the endoscopic interpretation of the disease. Objective We studied the accuracy of diagnosis in 130 patients previously labeled as having BE. Our aim was to determine the interobserver consistency of endoscopic findings and assess the percentage of patients with confirmed BE versus those with a revised diagnosis. Design/Setting/Patients Patients previously diagnosed with BE of any length and due for surveillance endoscopy were eligible for study. Interventions After intensive consensus anatomic and endoscopic review, study patients underwent endoscopy and biopsy by 1 of 3 endoscopists. BE was defined as any length of columnar-lined esophagus with goblet cells. Main Outcome Measurements Patients were photographed/videotaped for review by the other 2 endoscopists, and BE was either confirmed or revised. Results Eighty-eight patients (67.7%) had confirmed BE, and 42 (32.3%) had their diagnosis revised to no BE (95% confidence interval, 24.4%-41.1%) because there was no visible columnar-lined esophagus proximal to the gastric folds or no goblet cells were found on biopsy. BE length, site of previous endoscopy, age, sex, and hiatal hernia size were predictors of revision. All 3 endoscopists agreed on all confirmed BE cases and 38 of 42 of those revised. Limitations Retrospective analysis, possible sampling error. Conclusions BE is overdiagnosed in clinical practice with important implications for patient care including increased costs, reduced insurability, and psychological stress. The true BE cancer risk may also be underestimated. This study suggests the need for a better definition of the gastroesophageal junction, stricter accountability for BE diagnosis, and improved endoscopic education.

A references to symptomatic hemorrhoidal disease date back thousands of years and can be found in the ible as well as early Egyptian, Babylonian, and Greek scripts.1–3 The first known mention of this condition is from an Egyptian papyrus in 1700 BC, which advises . . . “Thou shouldest give an ointment of acacia leaves, ground and titurated together . . . and place in the anus, that he recovers immediately.”4 Indeed, there are few diseases more recounted in human history than hemorrhoids. The word hemorrhoid is derived from the Greek, with haima meaning blood and rhoos meaning flowing. Another common word for hemorrhoids used in the vernacular is “pile,” which comes from the Latin pila, meaning a ball. As aptly noted by Senagore, “although few people have died of hemorrhoidal disease, many patients who have undergone certain hemorrhoid therapies wish they had,” and this entity is one of the few diseases with its own patron saint (St Fiachre, the patron saint of gardeners and hemorrhoid sufferers).1 Symptomatic hemorrhoids are common, and those with hemorrhoids along with other anorectal diseases frequently present to the gastroenterologist with lower gastrointestinal (GI) bleeding and perianal complaints for evaluation and treatment. These patients and their referring physicians have an expectation that the gastroenterologist who examines this area should be able to provide comprehensive care of any nonsurgical anorectal ailments that are present. However, in large part because of the fact that formal training in anorectal pathology is not included in the combined Gastroenterology Core Curriculum, the care of these problems is often deferred to surgical specialties.5,6 There now seems to be an increasing recognition of this gap in the training of gastroenterology fellows, because an increasing number of GI programs are beginning to include nonsurgical anorectal care into their curricula. Some have called for the formal inclusion of anorectal entities into GI fellowship training.5 It is the intent of this article to serve as a general introduction of the nonsurgical care of hemorrhoids to gastroenterologists, helping them provide a more complete continuum of care to their patients.

Gastroesophageal reflux disease (GERD) is the most common gastrointestinal disorder in the United States. Without proper treatment, patients may be at risk for long-term complications including Barrett's esophagus and adenocarcinoma of the esophagus. Because reflux is a common complaint, clinicians need to know how to rule out causes other than GERD and how to treat patients suspected of having GERD. This article discusses how to diagnose GERD, the medical and surgical treatment options, and how to evaluate patients who are at risk for long-term complications.

Sphincter augmentation with the LINXA (R) Reflux Management System is a surgical option for patients with chronic gastroesophageal disease (GERD) and an inadequate response to proton pump inhibitors (PPIs). Clinical experience with sphincter augmentation is now available out to 4 years. In a multicenter, prospective, single-arm study, 44 patients underwent a laparoscopic surgical procedure for placement of the LINX System around the gastroesophageal junction (GEJ). Each patient's baseline GERD status served as the control for evaluations post implant. Long-term efficacy measures included esophageal acid exposure, GERD quality-of-life measures, and use of PPIs. Adverse events and long-term complications were closely monitored. For esophageal acid exposure, the mean total % time pH

Background & Aims Esophageal adenocarcinoma (EA) is increasingly common among patients with Barrett's esophagus (BE). We aimed to provide consensus recommendations based on the medical literature that clinicians could use to manage patients with BE and low-grade dysplasia, high-grade dysplasia (HGD), or early-stage EA. Methods We performed an international, multidisciplinary, systematic, evidence-based review of different management strategies for patients with BE and dysplasia or early-stage EA. We used a Delphi process to develop consensus statements. The results of literature searches were screened using a unique, interactive, Web-based data-sifting platform; we used 11,904 papers to inform the choice of statements selected. An a priori threshold of 80% agreement was used to establish consensus for each statement. Results Eighty-one of the 91 statements achieved consensus despite generally low quality of evidence, including 8 clinical statements: (1) specimens from endoscopic resection are better than biopsies for staging lesions, (2) it is important to carefully map the size of the dysplastic areas, (3) patients that receive ablative or surgical therapy require endoscopic follow-up, (4) high-resolution endoscopy is necessary for accurate diagnosis, (5) endoscopic therapy for HGD is preferred to surveillance, (6) endoscopic therapy for HGD is preferred to surgery, (7) the combination of endoscopic resection and radiofrequency ablation is the most effective therapy, and (8) after endoscopic removal of lesions from patients with HGD, all areas of BE should be ablated. Conclusions We developed a data-sifting platform and used the Delphi process to create evidence-based consensus statements for the management of patients with BE and early-stage EA. This approach identified important clinical features of the diseases and areas for future studies.

Objectives: One- and 2-year evaluation of a feasibility trial (clinicaltrials.gov registration numbers NCT01057992, NCT01058070, and 01058564) to assess the safety and efficacy of a laparoscopically implanted sphincter augmentation device for the treatment of gastroesophageal reflux disease (GERD). Methods: A sphincter augmentation device (LINX Reflux Management System; Torax Medical, Shoreview, MN), designed to prevent reflux due to abnormal opening of the lower esophageal sphincter (LES), was laparoscopically implanted at the gastroesophageal junction in 44 patients. At baseline, all patients had abnormal esophageal acid exposure on 24-hour pH monitoring and improved, but persistent, typical GERD symptoms while on acid suppression therapy with proton pump inhibitors (PPIs). The device comprises a miniature string of interlinked titanium beads, with magnetic cores, placed around the gastroesophageal junction. The magnetic bond between adjacent beads augments sphincter competence. The beads temporarily separate to accommodate a swallowed bolus, allow belching or vomiting, and reapproximate to augment the LES in the closed position. Patients were evaluated after surgery by GERD Health-Related Quality of Life symptom score, PPI usage, endoscopy, esophageal manometry, and 24-hour esophageal pH monitoring. Results: The total mean GERD Health-Related Quality of Life symptom scores improved from a mean baseline value of 25.7 to 3.8 and 2.4 at 1- and 2-year follow-up, representing an 85% and 90% reduction, respectively (P

Helicobacter pylori infects the mucus layer of the human stomach and causes peptic ulcers and adenocarcinoma. We have previously shown that H. pylori accumulates photoactive porphyrins making the organism susceptible to inactivation by light, and that small spot endoscopic illumination with violet light reduced bacterial load in human stomachs. This study assessed the feasibility and safety of whole-stomach intra-gastric violet phototherapy for the treatment of H. pylori infection.A controlled, prospective pilot trial was conducted using a novel light source consisting of laser diodes and diffusing fibers to deliver 408-nm illumination at escalating total fluences to the whole stomach. Eighteen adults (10 female) with H. pylori infection were treated at three U.S. academic endoscopy centers. Quantitative bacterial counts were obtained from biopsies taken from the antrum, body, and fundus, and serial urea breath tests.The largest reduction in bacterial load was in the antrum (97%), followed by body (95%) and fundus (86%). There was a correlation between log reduction and initial bacterial load in the antrum. There was no dose-response seen with increasing illumination times. The urea breath test results indicated that the bacteria repopulated in days following illumination.Intra-gastric violet light phototherapy is feasible and safe and may represent a novel approach to eradication of H. pylori, particularly in patients who have failed standard antibiotic treatment. This was a pilot study involving a small number of patients. Further research is needed to determine if phototherapy can be effective for eradicating H. pylori.

Background A variety of endoscopic modalities have been introduced to treat GERD, including radiofrequency energy, suturing, plication, and injection therapy. Objective Our purpose was to assess the long-term safety and effectiveness of Durasphere (Carbon Medical Technologies, St Paul, Minn), a new injectable bulking agent, in the treatment of mild-moderate GERD. Design Initial human pilot study. Setting Single endoscopy center; study period from January 2005 to August 2006. Patients Ten GERD subjects, confirmed by pH monitoring, on daily proton pump inhibitor (PPI) therapy, hiatal hernia Intervention Endoscopic injection with Durasphere, a new submucosal bulking agent, at the gastroesophageal junction. Outcomes Change in symptom scores, PPI use, pH scores, and endoscopic findings; monitoring of safety profile. Results Nine of 10 patients completed the 12-month trial. There were no adverse events. The procedure was well tolerated with minimal patient discomfort and no dysphagia. At 12 months 70% of patients discontinued all antacid medication completely; 90% of patients reduced PPI use by greater than 50%. DeMeester scores improved from a mean of 44.5 at baseline to 26.5 at 12 months; 4 patients achieved normal pH scores. There was no esophagitis at 12 months, and no erosion, ulceration or sloughing of material was noted at any injection site. The Durasphere material did not appear to migrate. Limitations Nonrandomized study design without a control group; small number of subjects. Conclusions Durasphere appears to be a promising new injectable bulking agent for the treatment of mild-moderate GERD, with demonstrable efficacy and no significant adverse events in a small cohort.