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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.

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 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.

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.

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.

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.

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.

A Novel Method for Determining the Inner Diameter of the Esophageal Body Using a Non-Compliant Balloon Catheter and Pressure/Volume Monitoring and Inflation System Michael B. Kimmey, Robert A. Ganz, Ronald E. Pruitt, Alvaro Reymunde, Virender K. Sharma, David E. Fleischer Background: Esophageal physiological testing includes manometry, 24-hr pH, esophagram, and impedance testing. More recently, it is possible to measure the inner diameter (ID) of the esophageal body (EB) using a non-compliant balloon with a pressure/volume monitoring/inflation system. Methods: This technology was developed as an adjunct to balloon-based ablation of Barrett’s esophagus (BE) using the HALO360 Ablation System (BÂRRX Medical, Sunnyvale, CA). Prior to ablation, ID measurement of the EB is required to: 1) select an ablation balloon size that fits the targeted EB, to ensure electrode contact and mitigate against overstretch, and 2) set ablation energy density (J/cm) based on the EB ID. The sizing catheter has a non-compliant balloon with outer diameter (OD) 33.7 mm and length 4 cm. Calibration is first performed to record the balloon volume at 4 psi (HALO360 generator). The calibrated (deflated) balloon is passed over a wire, positioned in the EB (5-cm proximal to the top of the BE in cases of ablation), autoinflated to 4 psi, held at steady state for w3 seconds, then auto-deflated. The system displays ID (mm), based on pressure/volume at steady state. Prior to human use, a bench model using 24 cylinders of varying ID (22-33.5 mm) were measured with the system and results of measured vs. actual ID were compared. Thereafter, the system was evaluated in patients undergoing ablation of BE, comparing measured ID, selected ablation balloon ID, and ablation effect. Results: In the cylinder testing, 72 measurements were obtained. The median difference between measured and actual ID was -0.3 mm (IQR -0.5 to 0.0) or -1.2% (IQR -1.7 to 0.0). Thereafter, 238 measurements were made in 34 patients who were undergoing ablation. In the first 20 patients, balloon migration occurred near the gastroesophageal junction (GEJ), confounding measurements. In the final 14 patients, starting higher in the EB resulting in highly reproducible EB ID estimates (median EB ID 25.9 mm, range 21.7-32.6). In 14/14 (100%) cases, an accurate estimate of targeted EB ID was achieved, based on subsequent electrode size and effect. Conclusion: This is the first report of a novel method for measuring the ID in the EB. The results are accurate (within 0.3 mm) and reproducible, and the device is now implemented as an adjunct to ablation of BE (HALO360 Ablation System). Other potential applications may include characterization of non-cardiac CP, quantifying success of stricture dilation, and assessing complications of gastric bypass, fundoplication, and surgical anastomoses.

Assisted Colonoscopy Using a Clip-On Propulsion Device Robert Ganz, Chris Gostout, Tim Sheridan, Troy Ziegler, Randy Meyer Background: There is great interest in improving colonoscopy particularly as regards patient comfort, sedation use and ease of cecal intubation. Pain and difficulty reaching the cecum has been associated with loop formation as the scope advances. Any device that limits looping would be a significant improvement for this procedure. We tested a new colonoscopic propulsion device (Softscope) that prevents colon looping and improves advancement of a colonoscope. Device: The Softscope Propulsion Device (SPD) is a short (6 cm), fluid-cushioned cylinder with a hollow core, that perpetually involutes on itself via a proprietary drive mechanism. The device functions as a continuously circulating cylindrical surface. The SPD is easily seated on any colonoscope by placing the tip of the colonoscope through the center of the device and tightening it in place just behind the bending section of the insertion tube. Visualization, tip deflection, and use of suction and working channels are unimpaired. The device has variable speed and can be run in either forward or reverse direction. Methods: Colonoscopy was performed using an Olympus PCF-140 scope, with and without the SPD, ex-vivo and then subsequently in live animals. Ex-vivo pig colons were housed in a clear aquarium pressurized at 14 cm H2O, to mimic human peritoneal conditions, and to allow direct visualization of colon movement. Endpoints for the ex-vivo study included visual looping of the colons and ease of advancement. Live porcine colonoscopies were then performed using a Golytely prep and general anesthesia; endpoints included ease of advancement, total length of scope insertion, and subjective looping as determined by the endoscopist. Pigs were chosen as the live model due to their challenging colon anatomy, particularly the acute splenic flexure and corkscrew shape of the proximal colon. Results: In the ex-vivo colon model the SPD visually prevented looping and enhanced forward movement. In live pigs the scope with SPD could typically be advanced the full length of the instrument, an average of 90 cm farther than non-SPD colonoscopy. The SPD readily negotiated all turns and corners including the proximal corkscrew configuration, whereas the non-SPD colonoscopies could not be advanced beyond the splenic flexure. All cases were subjectively much easier using the SPD. Conclusions: The SPD improved colonoscopy performance and prevented looping during both ex-vivo and live porcine colonoscopy, and allowed for standard visualization, tip deflection and use of existing instrument channels. We plan human trials to determine if the SPD can enhance cecal intubation rates and decrease pain and sedation needs.

Clinical Benefits of Enteryx for High-Dose PPI Patients David A. Johnson, James Aisenberg, Lawrence B. Cohen, Robert A. Ganz, Glen A. Lehman, T. Raymond Foley, Jacques Deviere, Gregory B. Haber, Jeffrey H. Peters Purpose: The primary objective was to evaluate if the effectiveness of Enteryx is predictable based on the pretreatment dose of proton pump inhibitor (PPI) required to control symptoms. Background: Enteryx is a biocompatible copolymer designed to help the lower esophageal sphincter (LES) form a more effective reflux barrier to treat gastroesophageal reflux disease (GERD) symptoms. Recent data 12 months post-Enteryx showed a $50% decrease in PPI use or total elimination of PPIs in 80.3% of 81 patients (76.5% of 85 patients, intent to treat), with improvements in health-related quality of life (GERDHRQL) heartburn and regurgitation scores (Johnson et al., AJG 2003;98: 1921). We investigated whether the clinical benefit at 12 months was related to the baseline PPI dose, dichotomized as standard or high dose. Methods: Analyses were conducted on 117 patients with PPI use and GERD-HRQL symptom score data available at 12 month follow-up visit. Standardized doses were calculated to permit comparisons across different PPIs. Patient data were dichotomized into High Dose and Standard Dose groups. Results: Following Enteryx treatment at 12 month follow-up, High Dose PPI dependent GERD patients benefited from elimination or $50% decrease in PPI use in 88% of patients and benefited from GERD-HRQL symptom score improvement in 72% of patients. In the Standard Dose group the PPI improvement was found in 82% of patients and the GERDHRQL improvement in 79%of patients.A 23 2 contingency tablewith chi-square analysis determined no significant difference between the 2 groups in terms of PPI use (p=0.461) and symptom score (p=0.406). Conclusions: Following Enteryx , patients who takeHighDose PPIs at baseline experience similar clinical benefits as patients who take Standard Dose PPIs at baseline. *W1519 Comparison of Endoluminal Gastroplication Configuration Techniques: A Long Term Study Richard Davis, Janese Gerhardt, Rebecca Welch, Charles Filipi Background: Endoluminal gastroplication (ELGP) is an increasingly popular therapy for gastroesophageal reflux disease (GERD). This 18 month trial compares outcomes associated with the circumferential and helical plication patterns. Methods: Twenty patients underwent ELGP. Nine patients received the circumferential pattern (Group A) and 11 the helical pattern (Group B). Inclusion criteria were: symptomatic GERD, dependence on medication, and a positive 24hour pH monitoring score. Exclusion criteria were: grade 3-4 esophagitis, hiatal hernia >2 cm, and symptoms refractory to medical therapy. Manometry, endoscopy and 24-hour pHmonitoring were performed at baseline and 6 months. Symptom scores and medication use were assessed at baseline, 1, 3, 6, 12 and 18 months. Statistical analysis was performed using the paired t-test. Results: The average number of plications in groupAwas 2.11 and in group Bwas 3.91. During the study period 2 patients dropped out and 5 had a laparoscopic Nissen fundoplication. Out of the remaining 13 patients at 18 month follow-up the average Heartburn Score decreased from 68.1 to 22.5 (p

Accurate Localization of Enteryx into the Deep Esophageal Wall Without Fluoroscopy Robert A. Ganz, Mark Rydell, Paul Termin Background: Endoscopic injection of Enteryx is a FDA-approved GERD therapy. A recent trial (Johnson, Ganz et al) showed significant efficacy of this procedure when the polymer was localized into the deep esophageal layers i.e. the muscle or deep submucosa. Current use of Enteryx requires fluoroscopy for accurate localization; this is cumbersome, expensive, and exposes the patient and physician to hazardous radiation. Goal: To assess the use of a new device for accurate placement of Enteryx into the deep esophageal wall, without fluoroscopy, in a porcine model. Methods: Endoscopy was performed on 5 consecutive pigs. At 5cm, 10cm, and 15cm above the GEJ, 4 circumferential 1 cc injections of Enteryx were made (60 total) using a new injection device, without fluoroscopy. Injections were assessed as superficial, deep into the esophageal wall, or transmural. Injections deemed transmural or superficial were repeated until the endoscopist felt that a deep injection had been made. The procedure was timed. A blinded pathologist sacrificed each animal and harvested the esophagus. The mediastinal cavity and contiguous organs were searched for any extravasated Enteryx material. The esophagus was examined grossly for Enteryx adherent to the outside wall. The esophagus was then fixed in formalin and serially sectioned to identify the location of the Enteryx at each site. Injection sites were classified as superficial (mucosa or submucosa), deep (muscularis propria or submucosa contiguous to muscularis), or subadventitial (between muscle and adventitia). Only deep injections were deemed adequate. Results: There was one area of transmural injection, with Enteryx adherent to the outside esophageal wall. There was no extravasatedEnteryx found in themediastinum, or adherent to contiguous organs. In three areas the injection could not be assessed due to absence of material; these areas were counted as inadequate injections. Areas where there was both superficial and deep material were counted as deep injections. 85% of the injections were deep. The average time to place 12 injections was 24 minutes. Conclusions: 1) Using a new injection device without fluoroscopy, Enteryx can be consistently deposited into the deep esophageal wall with a high degree of accuracy in a minimal amount of time. 2) A human trial is underway to confirm these findings. 3) Specifics of the new device will be presented. *W1505 Does an Administration Technique of Botulinum Toxin (BT) Injection Matter? Final Results of a Randomized, Double-Blind Study in Patients with Non-advanced Achalasia Jan Martinek, Marek Benes, Milan Siroky, Julius Spicak, Pavel Drastich, Jan Bures BACKGROUND&AIM: BT injection is an alternative treatment for achalasia. We have suggested in a pilot study that standard BT injection from the antegrade view may not result in adequate lower esophageal sphincter (LES) infiltration and that combining BT injection from both antegrade and retroflexed views might be better. The aim of the study was to compare the standard and the modified administration techniques. The primary endpoint was the proportion of asymptomatic subject one year after the single injection. METHODS: A total of 35 patients with non-advanced achalasia were included into the study. In 18 patients, BT was administered from the antegrade view (group A). In 17 patients, BTwas administered fromboth antegrade and retroflexed views (groupB). In both groups, a total of 250 IUofDysport (Beaufor Ipsen, France) was used.RESULTS: The mean age was 51.9 years (range 24-78) and there were 19 women and 16 men. The patients were followed up for a median of 24 months (13-30). There were two non-responders (one in each group). All remaining patients had rapid symptomatic improvement. In group A, 14 (82.4%) patients experienced a relapse during a median of 11 (6-15) months after the first injection. Three patients (17.6%) remained asymptomatic during a median of 29 (23-30) months. In group B, 10 patients (62.5%) reported a relapse over amedian of 10.5 (5-16)months after the first injection. Six patients (37.5%) remained asymptomatic during amedian of 20 (13-24) months (p=0.08 vs. group A). One year after the single BT injection, there were 7 asymptomatic patients in group A and 8 asymptomatic patients in group B (NS). Six relapsers (three in each group) were treated by the second and two of them (group B) by the third BT injection. Four of these patients remained asymptomatic. Remaining relapsers were treated by balloon dilatation (13 patients), surgery (3 patients) or calcium antagonists (2 patients). CONCLUSION: The modified BT administration technique combining BT injection from both antegrade and retroflexed views is at least as effective as the standard BT injection from the antegrade view. It can be used in patients where it is technically difficult to inject the BT from the antegrade view due to e.g. spastic sphincter or food residues.