Correcting a gut sphincter malfunction is a difficult problem. Because each sphincter has two opposite functions, that of closure and opening, repairing one there is a risk of damaging the other. Indeed, widening a narrow sphincter, such as lower esophageal sphincter (LES) and anal sphincter, may cause gastroesophageal reflux and fecal incontinence, respectively, whereas narrowing a wide sphincter, may cause a difficult transit. All the corrective treatments for difficult or retrograde transit concerning LES and anal sphincter with their unwanted consequences have been analyzed and discussed. To overcome the drawbacks of sphincter surgical repairs, researchers have devised devices capable of closing and opening the gut lumen, named artificial sphincters (ASs). Their function is based on various mechanisms, e.g., hydraulic, magnetic, mechanical etc, operating through many complicated components, such as plastic cuffs, balloons, micropumps, micromotors, connecting tubes and wires, electromechanical clamps, rechargeable batteries, magnetic devices, elastic bands, etc. Unfortunately, these structures may facilitate the onset of infections and induce a local fibrotic reaction, which may cause device malfunctioning, whereas the compression of the gut wall to occlude the lumen may give rise to ischemia with erosions and other lesions. Some ASs are already being used in clinical practice, despite their considerable limits, while others are still at the research stage. In view of the adverse events of the ASs mentioned above, we considered applying bioengineering methods to analyze and resolve biomechanical and biological interaction problems with the aim to conceive and build efficient and safe biomimetic ASs.

Transoral incisionless fundoplication (TIF) was introduced in 2006 as a concerted effort to produce a natural orifice procedure for reflux. Since that time, the device, as well as the procedure technique, has evolved. Significant research has been published during each stage of the evolution, and this has led to considerable confusion and a co-mingling of outcomes, which obscures the results of the current device and procedure. This report is intended to review the identified stages and literature associated with each stage to date and to review the current state of treatment outcomes.

Endoscopic antireflux treatments for gastroesophageal reflux disease (GERD) are still evolving, and most of the published studies address symptom relief in the short-term. Objective - We aimed to perform a systematic review and meta-analysis focused on evaluating the efficacy of the different endoscopic procedures.

Search was restricted to randomized controlled trials (RCTs) on MedLine, Cochrane, SciELO, and EMBASE for patients with chronic GERD (>6 months), over 18 years old and available follow up of at least 3 months. The main outcome was to evaluate the efficacy of the different endoscopic treatments compared to sham, pharmacological or surgical treatment. Efficacy was measured by different subjective and objective outcomes.

We analyzed data from 16 RCT, totaling 1085 patients. The efficacy of endoscopic treatments compared to sham and proton pump inhibitors (PPIs) treatment showed a significant difference up to 6 months in favor of endoscopy with no heterogeneity (P<0.00001) (I2: 0%). The subgroup analysis showed a statistically significant difference up to 6 months in favor of endoscopy: endoscopy vs PPI (P<0.00001) (I2: 39%). Endoscopy vs sham (P<0.00001) (I2: 0%). Most subjective and objective outcomes were statistically significant in favor of endoscopy up to 6 and 12 months follow up.

This systematic review and meta-analysis shows a good short-term efficacy in favor of endoscopic procedures when comparing them to a sham and pharmacological or surgical treatment. Data on long-term follow up is lacking and this should be explored in future studies.

The initial 6-month data for MUSE™ (Medigus, Omer, Israel) endoscopic stapling device were reported (Zacherl et al. in Surg Endosc 29:220-229, 2015). The current study aims to evaluate the long-term clinical outcome of 37 patients who received endoscopic gastroesophageal reflux disease (GERD) treatment with the MUSE™ device.

Efficacy and safety data for 37 patients were analyzed at baseline, 6 months, and 4 years post-procedure. In one center (IU), efficacy and safety data were evaluated at baseline, 6 months post-procedure, and then annually up to 4 years.

No new complications have been reported in our long-term analysis. The proportions of patients who remained off daily PPI were 83.8 % (31/37) at 6 months and 69.4 % (25/36) at 4 years post-procedure. GERD-Health Related Quality of Life (HRQL) scores (off PPI) were significantly decreased from baseline to 6 months and 4 years post-procedure. The daily dosage of GERD medications, measured as omeprazole equivalents (mean ± SD, mg), decreased from 66.1 ± 33.2 at baseline to 10.8 ± 15.9 at 6 months and 12.8 ± 19.4 at 4 years post-procedure (P < 0.01).

In our multi-center prospective study, the MUSE™ stapling device appears to be safe and effective in improving symptom scores as well as reducing PPI use in patients with GERD. These results appeared to be equal to or better than those of the other devices for endoluminal GERD therapy. Future studies with larger patient series, sham control group, and greater number of staples are awaited.

Electrical stimulation of the lower esophageal sphincter (LES) has been shown to improve outcomes in patients with gastroesophageal reflux disease (GERD) at 2 years. The aim of the study was to evaluate the safety and efficacy of LES stimulation in the same cohort at 3 years.

GERD patients with partial response to PPI, with % 24-h esophageal pH < 4.0 for >5 %, with hiatal hernia <3 cm and with esophagitis ≤LA grade C were treated with LES stimulation in an open-label 2-year trial. All patients were on fixed stimulation parameter of 20 Hz, 220 μs, 5 mA delivered in twelve, 30-min sessions. After completing the 2-year open-label study, they were offered enrollment into a multicenter registry trial and were evaluated using GERD-HRQL, symptom diaries and pH testing at their 3-year follow-up.

Fifteen patients completed their 3-year evaluation [mean (SD) age = 56.1 (9.7) years; men = 8] on LES stimulation. At 3 years, there was a significant improvement in their median (IQR) GERD-HRQL on electrical stimulation compared to both their on PPI [9 (6-10) vs. 1 (0-2), p = 0.001] and off PPI [22 (21-24) vs. 1 (0-2), p < 0.001]. Median 24-h distal esophageal acid exposure was significantly reduced from [10.3 (7.5-11.6) % at baseline vs. 3 (1.9-4.5) %, p < 0.001] at 3 years. Seventy-three % (11/15) patients had normalized their distal esophageal acid exposure at 3 years. Remaining four patients had improved their distal esophageal acid exposure by 39-48 % from baseline. All but four patients reported cessation of regular PPI use (>50 % of days with PPI use); three had normal esophageal pH at 3 years. There were no unanticipated device- or stimulation-related adverse events or untoward sensation reported during the 2- to 3-year follow-up.

LES-EST is safe and effective for treating patients with GERD over long-term, 3-year duration. There was a significant and sustained improvement in esophageal acid exposure and reduction in GERD symptoms and PPI use. Further, no new GI side effects or adverse events were reported.

Patients with gastroesophageal reflux disease (GERD) who are not satisfied with acid suppression therapy can benefit primarily from fundoplication, a surgical intervention. Fundoplication has been the standard surgical procedure for GERD. It is effective but is associated with adverse effects, resulting in a declining number of interventions, creating a need for alternative interventions that are effective, yet have a better adverse effect profile. One such alternative involves the application of electrical stimulation to the lower esophageal sphincter. A number of animal studies showed that such stimulation can increase resting lower esophageal sphincter pressure. An acute human study confirmed this effect, and was followed by two open-label studies, with a follow-up of up to 3 years. Results thus far show that the therapy is associated with a significant improvement in symptoms, a significant reduction in esophageal acid exposure, and a very good safety profile. This review will describe the evolution of electrical stimulation therapy for GERD, as well as the safety and efficacy of this intervention.

A previous single-centre study showed that lower oesophageal sphincter electrical stimulation therapy (LES-EST) in gastro-oesophageal reflux disease (GERD) patients improves reflux symptoms and decreases oesophageal acid exposure.

To evaluate safety and efficacy of LES-EST in GERD patients with incomplete response to proton pump inhibitors (PPIs) in a prospective, international, multicentre, open-label study.

GERD patients, partially responsive to PPIs, received LES-EST. GERD health-related quality of life (GERD-HRQL), daily symptom diaries, quality of life scores, oesophageal acid exposure, and LES resting and residual pressure were measured before and after initiation of LES-EST. Stimulation sessions were optimised based on residual symptoms and oesophageal acid exposure.

Forty-four patients were enrolled and 6-month data from 41 patients are available. Hiatal repair was performed in 16 patients. One device-related, one procedure-related and one unrelated severe adverse event were reported. GERD-HRQL improved from 31.0 (IQR 26.2-36.8) off-PPI and 16.5 (IQR 9.0-22.8) on-PPI to 4 (IQR 1-8) at 3-month and 5 (IQR 3-9) at 6-month follow-up (P < 0.0001 vs. on- and off-PPI). Oesophageal acid exposure (pH < 4.0) improved from 10.0% (IQR 7.5-12.9) to 3.8% (IQR 1.9-12.3) at 3 months (P = 0.0027) and 4.4% (IQR 2.2-7.2) at 6 months (P < 0.0001).

These interim results show an acceptable safety record of LES-EST to date, combined with good short-term efficacy in GERD patients who are partially responsive to PPI therapy. A remarkable reduction in regurgitation symptoms, without the risk of intervention-requiring dysphagia may prove to be an advantage compared with other anti-reflux procedures. ClinicalTrials.gov Identifier: NCT01574339.

There are limited options to patients with gastroesophageal reflux disease (GERD) who are not satisfied with acid suppression therapy. Fundoplication, the standard surgical procedure for GERD, is effective but is associated with adverse side effects and has thus been performed less frequently, creating a need for alternative surgical interventions that are effective, yet less invasive and reversible. Lately, two such interventions were developed: the magnetic sphincter augmentation and electrical stimulation of the lower esophageal sphincter. Human studies describing safety and efficacy over a follow-up period of a number of years have been published, documenting efficacy and safety of these interventions. Future studies should clarify the role of these procedures in the spectrum of GERD therapy.

Lower esophageal sphincter (LES) electrical stimulation therapy (EST) has been shown to improve outcome in gastroesophageal reflux disease (GERD) patients at 1 year. The aim of this open-label extension trial (NCT01578642) was to study the 2-year safety and efficacy of LES-EST in GERD patients.

GERD patients responsive partially to proton pump inhibitors (PPI) with off-PPI GERD health-related quality of life (HRQL) of ≥20, 24-hour esophageal pH ≤4.0 for >5% of the time, hiatal hernia ≤3 cm, and esophagitis LA grade C or lower participated in this trial. Bipolar stitch electrodes and a pulse generator (EndoStim BV, The Hague, The Netherlands) were implanted laparoscopically. LES-EST at 20 Hz, 215 μs, 3-8 mAmp was delivered over 30-minute sessions, 6-12 sessions per day, starting on day 1 after implantation. Patients were evaluated using GERD-HRQL, symptom diaries, Short Form-12, and esophageal pH testing at regular intervals. Stimulation sessions were optimized based on residual symptoms and esophageal pH at follow-up.

Twenty-five patients (mean age [SD] = 52 [12] years; 14 men) were implanted successfully; 23 patients participated in the 2-year extension trial, and 21 completed their 2-year evaluation. At 2 years, there was improvement in their median GERD-HRQL on LES-EST compared with both their on-PPI (9 vs 0; P = .001) and off-PPI (23.5 vs. 0; P < .001) baseline scores. Median 24-hour distal esophageal acid exposure improved from 10% at baseline to 4% (per-protocol analysis; P < .001) at 2 years with 71% demonstrating either normalization or a ≥50% decrease in their distal esophageal acid exposure. All except 5 patients (16/21) reported complete cessation of PPI use; only 2 patients were using a PPI regularly (≥50% of days). There was significant improvement in sleep quality and daily symptoms of heartburn and regurgitation on LES-EST. At baseline, 92% of the subjects (22/24) reported that they were "unsatisfied" with their condition off-PPI and 71% (17/24) on-PPI compared with 0% (0/21) "unsatisfied" at the 24-month visits on LES-EST. There were no device- or therapy-related serious adverse events and no untoward sensation or dysphagia reported with LES-EST.

LES-EST is safe and effective for treating patients with GERD over a period of 2 years. LES-EST resulted in a significant and sustained improvement in GERD symptoms, and esophageal acid exposure and eliminated PPI use in majority of patients (16 of 21). Further, LES-EST was not associated with any gastrointestinal side effects or adverse events.

Electrical stimulation of the lower esophageal sphincter (LES) in gastroesophageal reflux disease (GERD) patients, using EndoStim(®) LES stimulation system (EndoStim BV, the Hague, Netherlands), enhances LES pressure, decrease distal esophageal acid exposure, improves symptoms, and eliminates the need in many patients for daily GERD medications.

To evaluate, in a post hoc analysis, the effect of LES stimulation on proximal esophageal acid exposure in a subgroup of patients with abnormal proximal esophageal acid exposure.

Nineteen patients (median age 54 years; IQR 47-64; men-10) with GERD partially responsive to proton pump inhibitors (PPI), hiatal hernia ≤ 3 cm, esophagitis ≤ LA grade C underwent laparoscopic implantation of the LES stimulator. LES stimulation at 20 Hz, 215 μs, 5-8 m Amp sessions was delivered in 6-12, 30 min sessions each day. Esophageal pH at baseline and after 12-months of LES stimulation was measured 5 and 23 cm above the manometric upper border of LES.

Total, upright and supine values of median (IQR) proximal esophageal pH at baseline were 0.4 (0.1-1.4), 0.6 (0.2-2.3), and 0 (0.0-0.2) %, respectively, and at 12 months on LES-EST were 0 (0-0) % (p = 0.001 total and upright; p = 0.043 supine comparisons). 24-hour distal esophageal acid exposure improved from 10.2 (7.6-11.7) to 3.4 (1.6-7.0) % (p = 0.001). Seven (37%) patients had abnormal (>1.1%) 24-hour proximal acid exposure at baseline; all normalized at 12 months (p = 0.008). In these 7 patients, total, upright, and supine median proximal acid exposure values at baseline were 1.7 (1.3-4.1), 2.9 (1.9-3.7), and 0.3 (0-4.9) %, respectively, and after 12 months of LES-EST were 0 (0-0.0), 0 (0-0.1), and 0 (0-0) % (p = 0.018 total and upright; p = 0.043 supine comparisons). Distal esophageal pH for this group improved from 9.3 (7.8-17.2) at baseline to 3.2 (1.1-3.7) % at 12-months (p = 0.043). There were no GI side effects such as dysphagia, gas-bloat or diarrhea or device or procedure related serious adverse events with LES-EST. There was also a significant improvement in their GERD-HRQL scores.

LES-EST is associated with normalization of proximal esophageal pH in patients with GERD and may be useful in treating those with proximal GERD. The LES-EST is safe without typical side effects associated with traditional antireflux surgery.

Electrical stimulation therapy (EST) has been shown to increase lower esophageal sphincter (LES) pressure in animals; however, data on the effect of EST on LES pressure in patients with gastroesophageal reflux disease (GERD) are lacking.

The aim of our study was to investigate the effect of EST on LES pressure and esophageal function in patients with GERD.

Patients with a diagnosis of GERD responsive to proton pump inhibitors (PPIs), increased esophageal acid on 24-h pH monitoring off GERD medications, basal LES pressure >5 mmHg, hernia <2 cm and esophagitis <LA grade B were included. A temporary pacemaker lead was placed endoscopically in the LES by creating a 3 cm submucosal tunnel, secured to the esophagus using endoscopic clips along the body of the lead and exteriorized nasally. EST was delivered 6-12 h post-implant per protocol using (i) short-pulse 200 μs, 20 Hz, and (ii) intermediate-pulse 3 ms, 20 Hz, each for 20 min at varying amplitudes. High-resolution manometry was performed pre-, during and post-EST. Symptoms of heartburn, chest or abdominal pain and dysphagia pre-, during and post-stimulation and 7 days post-procedure were recorded. Continuous cardiac monitoring was performed during and after the EST to evaluate any effect of EST on cardiac rhythm.

Six male patients (mean age 34.6 years) underwent successful endoscopic lead implantation; the first patient had premature lead dislodgement and did not undergo EST. The remaining five patients underwent successful EST. All patients had a significant increase in LES pressure with all sessions of EST. There was no effect on swallow-induced LES relaxation, And there were no EST-related adverse symptoms or any cardiac rhythm abnormalities.

In patients with GERD, short-term EST delivered using electrodes endoscopically implanted in the LES results in a significant increase in LES pressure without affecting patients' swallow function or causing any adverse symptoms or cardiac rhythm disturbances. EST may offer a novel therapy to patients with GERD.

Late outcomes after laparoscopic Nissen fundoplication are only now becoming available. This study was undertaken to document late outcomes after laparoscopic Nissen fundoplication.

Five hundred ten patients underwent laparoscopic Nissen fundoplication >10 years ago and were prospectively followed. Preoperatively and postoperatively, patients scored the frequency and severity of symptoms (from 0 = never/not bothersome to 10 = always/very bothersome). Symptom scores before and after fundoplication were compared. Median symptom scores are presented.

Early after fundoplication, significant improvements were noted in the frequency and severity of symptoms (e.g., for heartburn, from 8 to 0 and from 8 to 0, respectively, P < .001 for each). Late after fundoplication, significant improvements were maintained in the palliation of symptoms (e.g., frequency and severity for heartburn, 2, 1; respectively). At latest follow-up, 89% of patients were pleased with their symptom resolution.

With long-term follow-up, laparoscopic Nissen fundoplication durably and significantly palliates symptoms of gastroesophageal reflux disease. This trial promotes the application of laparoscopic Nissen fundoplication.

Suture and staple-based endoluminal devices for gastroesophageal reflux disease (GERD) and obesity have failed to demonstrate long-term efficacy.

To demonstrate the feasibility of mucosal excision and full-thickness suture apposition of the excision beds to create sufficient scar tissue formation at the gastroesophageal junction for the intraluminal treatment of GERD or obesity.

Survival animal experiments.

Seven mongrel dogs. Interventions. Under general endotracheal anesthesia, a Barostat test was performed on 4 dogs. A mucosal excision device was introduced through the esophagus into the proximal stomach. Two to 4 mucosal excisions were performed on all dogs at or just below the gastroesophageal junction and the mucosal pieces were removed. After hemostasis, an intraluminal suturing instrument was introduced and either 2 or 4 sutures were placed through the excision beds to bring them into apposition. These were tied and the suture strands cut. All dogs were survived for 2 months. End-term endoscopies were performed, and a repeat Barostat procedure was performed on the animals undergoing an antireflux procedure. After euthanasia the stomachs were explanted, examined, photographed, and sectioned for histologic examination.

All dogs survived without complication. In the 4 GERD dogs, the Barostat studies demonstrated a significant decrease in gastroesophageal junction compliance. In the 3 dogs undergoing the obesity procedure, the gastric outlet apposition to a 6-mm endoscope was satisfactory with full insufflation and the desired scarring was seen on histologic examination.

It is possible to create adequate gastroesophageal junction scarring for the treatment of GERD and obesity. A clinical pilot study will be initiated.

Electrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD).

GERD patients who were at least partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, hiatal hernia ≤ 3 cm, and esophagitis ≤ LA grade C were included. Bipolar stitch electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. Electrical stimulation was delivered at 20 Hz, 215 μs, 3-8 mA in 30 min sessions. The number and timing of sessions was tailored to each patient's GERD profile. Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, SF-12, esophageal pH, and high-resolution manometry.

24 patients (mean age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0-5.5) and was significantly better than both baseline on-PPI [9.0 (range = 6.0-10.0); p < 0.001] and off-PPI [23 (21-25); p < 0.001] GERD-HRQL. Median% 24-h esophageal pH < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 6-month follow-up, 91 % (21/23) of the patients were off PPI and had significantly better median GERD-HRQL on LES stimulation compared to their on-PPI GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated implantation- or stimulation-related adverse events or untoward sensation due to stimulation. There were no reports of treatment-related dysphagia, and manometric swallow was also unaffected.

Electrical stimulation of the LES is safe and effective for treating GERD. There is a significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without any side effects with the therapy. Furthermore, the therapy can be optimized to address an individual patient's disease.

Electrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD).

GERD patients who were at least partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, hiatal hernia ≤ 3 cm, and esophagitis ≤ LA grade C were included. Bipolar stitch electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. Electrical stimulation was delivered at 20 Hz, 215 μs, 3-8 mA in 30 min sessions. The number and timing of sessions was tailored to each patient's GERD profile. Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, SF-12, esophageal pH, and high-resolution manometry.

24 patients (mean age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0-5.5) and was significantly better than both baseline on-PPI [9.0 (range = 6.0-10.0); p < 0.001] and off-PPI [23 (21-25); p < 0.001] GERD-HRQL. Median% 24-h esophageal pH < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 6-month follow-up, 91 % (21/23) of the patients were off PPI and had significantly better median GERD-HRQL on LES stimulation compared to their on-PPI GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated implantation- or stimulation-related adverse events or untoward sensation due to stimulation. There were no reports of treatment-related dysphagia, and manometric swallow was also unaffected.

Electrical stimulation of the LES is safe and effective for treating GERD. There is a significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without any side effects with the therapy. Furthermore, the therapy can be optimized to address an individual patient's disease.

Electrical stimulation (ES) of the lower esophageal sphincter (LES) increases resting LES pressure (LESP) in animal models. Our aims were to evaluate the safety of such stimulation in humans, and test the hypothesis that ES increases resting LESP in patients with gastroesophageal reflux disease (GERD).

A total of 10 subjects (nine female patients, mean age 52.6 years), with symptoms of GERD responsive to PPIs, low resting LES pressure, and abnormal 24-h intraesophageal pH test were enrolled. Those with hiatal hernia >2 cm and/or esophagitis >Los Angeles Grade B were excluded. Bipolar stitch electrodes were placed longitudinally in the LES during an elective laparoscopic cholecystectomy, secured by a clip and exteriorized through the abdominal wall. Following recovery, an external pulse generator delivered two types of stimulation for periods of 30 min: (i) low energy stimulation; pulse width of 200 μs, frequency of 20 Hz and current of 5-15 mA (current was increased up to 15 mA if LESP was less than 15 mmHg), and (ii) high energy stimulation; pulse width of 375 ms, frequency of 6 cpm, and current 5 mA. Resting LESP, amplitude of esophageal contractions and residual LESP in response to swallows were assessed before and after stimulation. Symptoms of chest pain, abdominal pain, and dysphagia were recorded before, during, and after stimulation and 7-days after stimulation. Continuous cardiac monitoring was performed during and after stimulation.

All patients were successfully implanted nine subjects received high frequency, low energy, and four subjects received low frequency, high energy stimulation. Both types of stimulation significantly increased resting LESP: from 8.6 mmHg (95% CI 4.1-13.1) to 16.6 mmHg (95% CI 10.8-19.2), P < 0.001 with low energy stimulation and from 9.2 mmHg (95% CI 2.0-16.3) to 16.5 mmHg (95% CI 2.7-30.1), P = 0.03 with high energy stimulation. Neither type of stimulation affected the amplitude of esophageal peristalsis or residual LESP. No subject complained of dysphagia. One subject had retrosternal discomfort with stimulation at 15 mA that was not experienced with stimulation at 13 mA. There were no adverse events or any cardiac rhythm abnormalities with either type of stimulation.

Short-term stimulation of the LES in patients with GERD significantly increases resting LESP without affecting esophageal peristalsis or LES relaxation. Electrical stimulation of the LES may offer a novel therapy for patients with GERD.

Endoscopic antireflux techniques have emerged as alternative therapies for gastroesophageal reflux disease (GERD). Endoscopic plication receives continuing interest as an effective and safe procedure. This treatment option has not been the subject of comparison with well-established operative therapies to date. The present study aimed at comparatively evaluating the effectiveness of endoscopic plication and laparoscopic fundoplication in terms of quality of life and symptom control.

Between October 2006 and April 2010, 60 patients with documented GERD were randomly assigned to undergo either endoscopic plication or laparoscopic fundoplication. Quality-of-life scores and symptom grading were recorded before treatment and at 3- and 12-month follow-up. Outcomes were compared with the statistical significance set at a p value of 0.05.

Twenty-nine patients from the endoscopic group and 27 patients from the operative group were available at follow-up. Quality-of-life scores showed a substantial and similar increase for both groups after treatment. Symptoms of heartburn (p < 0.02), regurgitation (p < 0.004), and asthma (p = 0.03) were significantly improved in the endoscopic group, whereas laparoscopic fundoplication was more effective in controlling symptoms of heartburn (p < 0.01) and regurgitation (p < 0.05) compared to the endoscopic procedure.

Endoscopic plication and laparoscopic fundoplication resulted in significant symptom improvement with similar quality-of-life scores in a selected patient population with GERD, whereas operative treatment was more effective in the relief of heartburn and regurgitation at the expense of higher short-term dysphagia rates.

Transoral treatment of gastroesophageal reflux disease (GERD) using the EsophyX device enables creation of an esophagogastric fundoplication with potential for better control of reflux than gastrogastric techniques. Efficacy and safety of a rotational/longitudinal esophagogastric transoral incisionless fundoplication (TIF) was evaluated retrospectively using subjective and objective outcomes.

Thirty-seven consecutive patients on antisecretory medication and with proven gastroesophageal reflux and limited hiatal hernia underwent TIF for persistent GERD symptoms. Five patients were reoperations for failed laparoscopic fundoplication.

Of the 37 treated patients, 57% were female. The median age was 58 (range=20-81) years and BMI was 25.5 (range=15.9-36.1) kg/m2. Sixty-eight percent indicated GERD-associated cough, asthma, or aspiration as a primary complaint and 32% complained of heartburn or regurgitation. The TIF procedures created tight wraps of 230°-330° extending 3-4 cm above the Z-line. Two complications occurred: one mediastinal abscess treated laparoscopically and one postoperative bleeding requiring transfusion. At 6 (range=3-14) months median follow-up TIF resulted in a significant improvement of both atypical and typical symptoms in 64% and 70-80% of patients, respectively, as indicated by the corresponding GERD health-related quality of life (HRQL) and reflux symptom index (RSI) score reduction by 50% or more compared to baseline on proton pump inhibitors (PPIs). No patient reported problems with dysphagia, bloating, or excess flatulence, and 82% were not taking any PPIs. Reflux characteristics were significantly improved and normalized in 61, 89, and 56% of patients in terms of acid exposure, number of refluxates, and DeMeester scores, respectively. TIF was effective in treating GERD in 75% of patients among whom 54% were in a complete "remission" and 21% were "improved." The remaining 25% were considered failures, and five (13.5%) patients underwent revision.

Rotational/longitudinal esophagogastric fundoplication using the EsophyX device significantly improved symptomatic and objective outcomes in over 70% of patients at median 6-month follow-up. Post-fundoplication side effects were not reported after TIF.

Reflux control may be ineffective in a substantial number of patients after endoluminal EsophyX fundoplication for gastro-oesophageal reflux disease. Subsequent laparoscopic Nissen fundoplication (LNF) might be required to relieve symptoms. The aim of this study was to evaluate the outcome of LNF after previous EsophyX fundoplication.

EsophyX failure was defined as recurrence or persistence of typical symptoms, with or without anatomical failure of the wrap or persisting pathological oesophageal acid exposure. Consecutive patients who underwent LNF after failed EsophyX fundoplication were identified. Symptomatic outcome was obtained by standardized questionnaire, and objective outcome by endoscopy, oesophageal manometry and pH monitoring.

Eleven patients were included. During LNF, intraoperative gastric perforation occurred in two patients and one developed a subphrenic abscess after operation. Daily heartburn was present in one patient after LNF and three had troublesome daily dysphagia. General quality of life after LNF was not significantly better than that before EsophyX fundoplication. Oesophageal acid exposure was normalized in all patients after surgery. Oesophagitis was absent after LNF in all except one patient who had persisting grade A oesophagitis.

Symptomatic and objective reflux control are satisfactory after LNF for a failed EsophyX procedure. Previous EsophyX fundoplication, however, is associated with a risk of gastric injury during LNF and a relatively high rate of postfundoplication dysphagia.

Transoral intraluminal surgery is less painful. However, endoscopic antireflux procedures have been unsuccessful, endoscopic foregut mucosal excision procedures are often difficult to perform, and endoscopic intra-luminal suturing is both imprecise and too shallow. We have endeavored to correct these deficiencies and report here new devices for GERD, obesity, and Barrett's mucosal excision.

A retrospective review of ex vivo and in vivo animal experiments using sharp blade mucosal excision for esophageal and gastric mucosa and a suturing device with transverse needles designed to full thickness penetrate the gastric wall were completed. A total of 338 excisions were performed in 134 ex vivo tissue experiments and in 119 in vivo attempts. Suture needle testing was performed in ex vivo human stomachs and porcine stomachs and in in vivo canine and baboon stomachs.

One excision perforation (0.9%) occurred in a live animal. Satisfactory mucosal excision depth for the Barrett's device was reproducible. Progressive suture actuation reliability improved from 83% during ex vivo testing to 96.7% in in vivo experiments.

The results demonstrate feasibility, reliability, and safety for gastric and esophageal mucosal excision. Suturing reliability improved and further studies will be performed to finalize the instrument designs, the operative techniques, and the other device applications.

Heartburn is the most common symptom associated with gastroesophageal reflux disease, and life-long proton pump inhibitor therapy is often required to control symptoms. Antireflux surgery is an alternative, but there may be significant side effects and the duration of therapeutic effect is variable. Several endoscopic antireflux techniques (E-ARTs) have been developed to enhance the function of the lower esophageal sphincter or alter the structure of the angle of His with the goal of recreating or augmenting the reflux barrier. Many methods are no longer available, and some await regulatory approval. This article reviews available data for the most common E-ARTs.

Most first-generation endoscopic antireflux procedures (EARPs) have been withdrawn because of variable success rates, economic considerations, and/or complications. As a result, subsequent methods may meet 'skepticism' by physicians and patients.

To identify potential barriers to patient recruitment for a new EARP METHODS: We prospectively analyzed our recruitment for a phase 2 study of a transoral incisionless fundoplication procedure. We contacted 50 private practices and 23 hospitals for potential referrals, and placed three newspaper advertisements. All patient replies were followed up by a phone call. Patients were then invited for a personal interview, and eligible patients underwent further preprocedure testing. In addition, poststudy questionnaires regarding their opinions about EARPs were sent to referring physicians.

Of 134 interviewed patients, only 10% (n=13) were successfully recruited. Candidates mostly responded to newspaper advertisements (87%) or were referred from our own institution (7%). Primary exclusion criteria included failure of proton pump inhibitor response (34%), lack of proton pump inhibitor use (20%), atypical symptoms (18%), or a large hiatal hernia (17%). Seventy percent of the responding physicians did not believe that new EARPs would be superior to previous methods.

The EARP market seems to be much smaller than anticipated, partially because of skepticism of referring physicians, and partially because of strict selection criteria.

To develop a North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) international consensus on the diagnosis and management of gastroesophageal reflux and gastroesophageal reflux disease in the pediatric population.

An international panel of 9 pediatric gastroenterologists and 2 epidemiologists were selected by both societies, which developed these guidelines based on the Delphi principle. Statements were based on systematic literature searches using the best-available evidence from PubMed, Cumulative Index to Nursing and Allied Health Literature, and bibliographies. The committee convened in face-to-face meetings 3 times. Consensus was achieved for all recommendations through nominal group technique, a structured, quantitative method. Articles were evaluated using the Oxford Centre for Evidence-based Medicine Levels of Evidence. Using the Oxford Grades of Recommendation, the quality of evidence of each of the recommendations made by the committee was determined and is summarized in appendices.

More than 600 articles were reviewed for this work. The document provides evidence-based guidelines for the diagnosis and management of gastroesophageal reflux and gastroesophageal reflux disease in the pediatric population.

This document is intended to be used in daily practice for the development of future clinical practice guidelines and as a basis for clinical trials.

During the 20th century, gastro-esophageal reflux moved from the status of a rare and severe disease to that of a frequent disease occurring mostly, in the absence of any significant lesions. Proton pump inhibitors (PPIs) are the mainstay of its therapy and are prescribed mainly in an empirical way. Extradigestive manifestations require more accurate diagnostic tests and therapeutic management. The modalities of prescription of the PPIs quickly progressed toward the on-demand therapy and over-the-counter PPIs should become widespread. The relative failures of PPIs led to a profusion of new antisecretory agents but clinical improvements are presently disappointing and the rationale of this escalation is questionable. The concept of non acid gastro-esophageal reflux opens more innovative diagnostic and therapeutic perspectives which, however, must be validated. In this respect, endoscopic treatment needs more reliable techniques and more rigorous trials. Gastro-esophageal reflux refractory to PPIs corresponds mainly to functional esophageal disorders that need diagnostic and therapeutic improvements. Barrett's esophagus constitutes a major challenge for the next few years. Its screening and its prevention seem, for the moment, inaccessible. Its survey and the prevention of its complications should benefit from progress of diagnostic and interventional endoscopy.

Endoscopic methods to prevent gastroesophageal reflux (GER) show scarce effectiveness and may narrow the esophageal lumen more or less stiffly, sometimes impairing bolus transit and leading to dysphagia. The aim of this study was to demonstrate the possibility of reinforcing lower esophageal sphincter (LES) tone by implanting endoluminally a magnetic device.

The device consists of two small magnetic plaques to be implanted in the submucosa close to LES with opposite polarities facing so that they attract one other, closing the esophageal lumen. The magnets were implanted by means of a special endoluminal device in five esophageal-gastric ex vivo specimens taken from swine. Variation in endoluminal pressure at the LES level was measured by means of slow pull-through of a thin side-hole manometric catheter in each specimen, before and after insertion of the magnets.

The new high-pressure zone exhibited a length of about 2 cm and a pressure of 14.2+/-1.27 mmHg [mean +/- standard deviation (SD)], significantly (p<0.001) higher than that measured before insertion of the magnetic valve (1.5+/-0.26 mmHg).

The present research demonstrates that it is possible to create at the LES level a dynamic closure of a value considered sufficient to prevent GER, by implanting in the esophageal submucosa of anatomical specimens a magnetic device by means of a special endoluminal probe. Once effectiveness and tolerability of magnets covered by a biocompatible sheath have been demonstrated in vivo, this device could become a simple and effective nonsurgical solution to GER.

Obese patients with gastroesophageal reflux disease (GERD) refractory to medical therapy are a challenging patient population as obesity is a preoperative predictor of failure after antireflux surgery. We therefore sought to evaluate outcomes using one of two commercially available endoluminal therapies in this population.

Consecutive obese patients (body mass index (BMI)>30) with GERD (DeMeester>14.5) undergoing either Plicator (NDO) or Stretta (Curon) were identified in our single-institution prospective database. Outcomes assessed were: (1) failure rate (absolutely no symptomatic improvement after procedure and/or need for subsequent antireflux surgery), (2) postoperative vs. preoperative symptom (heartburn, chest pain, regurgitation, dysphagia, cough, hoarseness, and asthma) scores, and (3) proton-pump inhibitor (PPI) medication use.

Twenty-two patients each underwent an endoluminal therapy (ten Plicator patients and 12 Stretta patients) with mean follow-up of 1.5 years. There were no treatment-associated complications. Mean BMI was not different between Plicator and Stretta groups (39.6 vs. 38.6, respectively, p=0.33). The failure rate for the entire cohort was 28% (10% Plicator vs. 42% Stretta, p=0.11). The proportion of patients reporting moderate/severe symptoms postop was significantly less than preop: chest pain 9% vs. 13% (p=0.04), cough 22% vs. 36% preop (p=0.025), voice changes 9% vs. 36% preop (p=0.012), and dysphagia 9% vs. 32% preop (p=0.04). The proportion of patients on PPI medications postop was also less than preop (45% vs. 81%, p=0.1)

Endoluminal treatment can provide a safe means of improving GERD symptoms for some obese patients, though many will continue to require medication therapy also. Further work aimed at understanding optimal candidates for endoluminal therapy in this patient population is warranted.