A novel device for improving visualization in an inadequately prepared colon.

BACKGROUND AND AIMS: Adequate bowel preparation is crucial for a quality colonoscopy. Poor bowel preparation can result in longer procedural times, missed adenomas, earlier repeat procedures, increase costs, and decreased patient satisfaction. Pure-Vu (MOTUS GI, Tirat Carmel, Israel) is a system that facilitates intraprocedural cleaning of a poorly prepared colon during a colonoscopy by irrigating the colon and evacuating the fluid and feces. The study aims were to evaluate Pure-Vu's cleansing capabilities and its usability and safety in a live animal colon. METHODS: The Pure-Vu system was used by 4 experienced gastroenterologists in 35 Yorkshire cross swine (66% female) that received a reduced bowel preparation to ensure an inadequate bowel preparation at baseline. Before colonoscopy the Pure-Vu was attached to the colonoscope, and the baseline prep was assessed during insertion. The Pure-Vu system was then used to cleanse the colon and the prep then assessed after Pure-Vu use. RESULTS: No adverse effects and no failed or prematurely terminated cases were noted. Fourteen percent of the swine colons were adequately prepped at baseline (median Boston Bowel Preparation Scale [BBPS] score = 0 [25th percentile = 0; 75th percentile = 1; interquartile range = 1]) and improved to 100% after use of Pure-Vu (Wilcoxon signed rank test P < .001) (median BBPS score = 3 [25th percentile = 3; 75th percentile = 3; interquartile range = 0]). The physicians found Pure-Vu easy and intuitive to operate. CONCLUSIONS: The Pure-Vu system effectively cleaned inadequately prepped swine colons and proved to be easy to use. The Pure-Vu device, applied in clinical practice, may result in improved overall prep quality and a reduction in repeat examinations because of inadequately prepped colons.

A Modern Magnetic Implant for Gastroesophageal Reflux Disease.

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.

Esophageal sphincter device for 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.).

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux.

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.

Barrett's esophagus is frequently overdiagnosed in clinical practice: results of the Barrett's Esophagus Endoscopic Revision (BEER) study.

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 pilot study of endoluminal US for stool liquefaction.

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.

Update in procedural therapy for GERD--magnetic sphincter augmentation, endoscopic transoral incisionless fundoplication vs laparoscopic Nissen fundoplication.

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.

The LINX® reflux management system: confirmed safety and efficacy now at 4 years.

BACKGROUND: Sphincter augmentation with the LINX® 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. METHODS: 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. RESULTS: For esophageal acid exposure, the mean total % time pH < 4 was reduced from 11.9 % at baseline to 3.8 % at 3 years (p < 0.001), with 80 % (18/20) of patients achieving pH normalization (≤ 5.3 %). At ≥ 4 years, 100 % (23/23) of the patients had improved quality-of-life measures for GERD, and 80 % (20/25) had complete cessation of the use of PPIs. There have been no reports of death or long-term device-related complications such as migration or erosion. CONCLUSIONS: Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits with no safety issues, as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects and no safety issues. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation.

Understanding the GERD.

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.

SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch.

Introduction: Pruritus ani, or rectal or anal itch, is a common perianal disorder that affects ~5% of the population of the developed world. Treatments for this disorder are somewhat limited and include conservative non-medical perianal hygiene care, and topical medical treatments including topical steroids, antibacterial and antifungal agents, and topical anesthetic/analgesics such as lidocaine or capsaicin; astringents and vasoconstrictors such as ephedrine can also be used. Methods: The study was IRB approved. We assessed the efficacy of a novel, composite, over-the-counter, topical lidocaine ointment that included an epidermal barrier and antimicrobial effect along with the typical lidocaine anesthetizing effect, in a single arm, observational, longitudinal, population of 20 ambulatory pruritus ani patients. Patients applied the ointment twice daily, and were studied for 2 weeks; primary outcomes included time to symptom resolution and clinical exam resolution as measured on a 5-point visual analog scale. Results: Twenty-nine consecutive patients were screened and 20 patients (12 males; 8 females) were enrolled in the study. Ninety percent of patients achieved 100% symptom resolution by 2 weeks, and most were improved within 72 h of initiating treatment; 95% of patients had a normal visual exam by the 2 week endpoint. There were no significant adverse events attributable to the therapy. Conclusion: Use of a novel composite topical lidocaine agent, demonstrated rapid and effective relief of pruritus ani in an ambulatory population. Additional studies are underway. Clinical trial registered: Clinicaltrials.gov, identifier NCT05288907.

Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial.

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 < 0.0001). Complete cessation of PPI use was reported by 90% of patients at 1 year and by 86% of patients at 2 years. Early dysphagia occurred in 43% of the patients and self-resolved by 90 days. One device was laparoscopically explanted for persistent dysphagia without disruption of the anatomy or function of the cardia. There were no device migrations, erosions, or induced mucosal injuries. At 1 and 2 years, 77% and 90% of patients had a normal esophageal acid exposure. The mean percentage time pH was less than 4 decreased from a baseline of 11.9% to 3.1% (P < 0.0001) at 1 year and to 2.4% (P < 0.0001) at 2 years. Patient satisfaction was 87% at 1 year and 86% at 2 years. CONCLUSIONS: The new laparoscopically implanted sphincter augmentation device eliminates GERD symptoms without creating undue side effects and is effective at 1 and 2 years of follow-up.

A new injectable agent for the treatment of GERD: results of the Durasphere pilot trial.

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 <3 cm, and no or mild erosive esophagitis. 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.