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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.

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.

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.

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.

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.

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.

This study aimed to assess the efficacy and safety of endoscopically implanting a nonresorbable biocompatible polymer (Enteryx) in the distal esophagus and proximal gastric cardia for the treatment of gastroesophageal reflux disease (GERD).In a prospective, multicenter, international trial, 85 well-controlled GERD patients who were receiving chronic proton pump inhibitor (PPI) therapy underwent Enteryx implantation under fluoroscopic visualization, without general anesthesia. After the procedure, patients were discharged within approximately 2-4 h. Patients were judged to be treatment responders if after implantation they reduced PPI dosage by/=50%. Follow-up evaluations were conducted at 1, 3, 6, and 12 months and included medication usage, symptoms, quality of life, endoscopy, pH monitoring, manometry, and documentation of adverse events.At 12 months, 80.3% (95% CI = 69.9%-88.3%) of 81 evaluable patients were treatment responders. Of the responders, 87.7% completely discontinued PPIs, and 12.3% reduced PPI dosage by/=50%. Treatment response was more likely in patients with residual implant volume of/=5 mL (p = 0.027). Other patient and treatment variables were not predictive. Both GERD heartburn and regurgitation symptom scores significantly improved at 12 months compared with baseline (p0.001). There were significant reductions in median supine, upright, and total percent time of esophageal exposure to pH4. Endoscopically assessed esophagitis grades were unchanged. No serious adverse events were encountered. Transient retrosternal chest pain was experienced by 91.8% of patients. This pain was seldom severe and was typically successfully managed with prescription pain medication.Enteryx implantation allows most patients to discontinue PPI therapy, improves their symptoms, and reduces esophageal acid exposure. The effects of implantation are long-lasting, and morbidity is transient and minimal. The procedure requires basic endoscopic skills and seems to provide a useful option in the effective clinical management of GERD.

To the Editor: The recent opinion piece by Konda and Waxman (1) regarding endotherapy for Barrett's esophagus misstates the AGA Medical Position Statement (2) on the management of Barrett's and requires correction. Konda writes that the AGA statement does not recommend endotherapy for Barrett's non-dysplasia or low-grade dysplasia, but erroneously cites the text. On page 1089, the Position statement clearly states that “radiofrequency ablation should also be a therapeutic option for treatment of patients with confirmed low-grade dysplasia,” and select individuals with non-dysplastic Barrett's who are judged to be at increased risk for progression to high-grade dysplasia or cancer.

BACKGROUND A prospective, multicenter clinical study to evaluate outcomes of patients undergoing anti-reflux surgery included patients with pre-operative extra-esophageal symptoms (EES) as well as heartburn and regurgitation. All patients underwent a laparoscopic procedure to mechanically augment the lower esophageal sphincter (LES) with a magnetic device (LINX Reflux Management System, Torax Medical). METHOD In post-hoc analysis, patients reporting at least one EES prior to implant were identified from a questionnaire administered before surgery. Patients with pre-operative EES were compared to those without EES. Comparisons included demographics, esophageal pH measurements, GERD-Health Related Quality of Life (GERD-HRQL) score, and PPI use. All clinical outcomes were based on 3-year data, with the exception of the esophageal pH, which was collected at 1-year post-implant. RESULTS 100 hundred patients were enrolled in this study. Prior to implant, all patients were taking daily PPIs and had confirmed abnormal esophageal acid exposure. Of the 100 patients, 51% (51/100) reported at least one EES at baseline. Recurrent cough was reported by 37% (37/100), change of voice by 25% (25/100), nocturnal cough by 13% (13/100) and asthma by 11% (11/100). Of the patients with EES, the mean age was 51.3 years and 41% (21/51) were male and 59% (30/51) female. Baseline characteristics for patients with and without EES were statistically non-significant, expect for gender. Females were more likely than males to report pre-operative extra-esophageal symptoms (p=0.03). After implant, the percentage of patients reporting no EES improved to 88% (84/95) at 1 year, 88% (79/90) at 2 years and 90% (78/87) at 3 years compared to 49% (49/100) at baseline. The median total % time pH , 4 improved from 10.2% at baseline to 2.3% at l year in the EES group and 11.6% to 4.2% in the non-EES group, and the median DeMeester score improved from 33.9 to 9.9 in the EES and 41.0 to 16.1 in the non-EES group. The median GERD-HRQL at 3 years was 2 for the EES group and 3 for the non-EES group compared to 26 and 27 before implant off PPIs, respectively. Cessation of PPIs at 3 years was achieved in 84% (38/45) of patients in the EES group compared to 88% (38/43) in the non-EES group. CONCLUSION In this study of a magnetic sphincter device for GERD, the majority of patients reported extra-esophageal symptoms along with typical symptoms such as heartburn and regurgitation at baseline. Following treatment, the number of patients reporting extra-esophageal symptoms decreased from 51% to 10% at 3 years. Improvement in quality of life, reduction in esophageal acid and cessation of PPIs were reported in patients with pre-operative extra-esophageal symptoms. Magnetic Sphincter augmentation appears to be effective in treating this difficult group of patients and deserves further study.