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A GERDx™ arms are opened. B Tissue retractor is advanced to serosa. C, D Gastric wall is retracted into the GERDx™ arms. E A pre-tied transmural pledgeted suture is deployed. F Full-thickness plication is restructuring the GE junction

A GERDx™ arms are opened. B Tissue retractor is advanced to serosa. C, D Gastric wall is retracted into the GERDx™ arms. E A pre-tied transmural pledgeted suture is deployed. F Full-thickness plication is restructuring the GE junction

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Background: Previous studies suggest clinical effectiveness of endoscopic full-thickness plication in selected patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the clinical safety and efficiency of the GERDx™ device by evaluating clinical parameters, reflux symptom scores, and quality of life (QoL). Method...

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... In the thirty patients available at the 3-month follow-up, an improvement of DM score, reflux related symptoms and gastrointestinal quality of life index were observed. However, three patients needed PPI treatment daily and eight on demand at the 3-month follow-up (204). In conclusion, the GERDx device does not seem to display satisfactory efficacy and safety for rGERD patients. ...
Article
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Gastroesophageal reflux disease (GERD) is one of the most frequent gastrointestinal disorders. Proton pump inhibitors (PPIs) are effective in healing lesions and improving symptoms in most cases, although up to 40% of GERD patients do not respond adequately to PPI therapy. Refractory GERD (rGERD) is one of the most challenging problems, given its impact on the quality of life and consumption of health care resources. The definition of rGERD is a controversial topic as it has not been unequivocally established. Indeed, some patients unresponsive to PPIs who experience symptoms potentially related to GERD may not have GERD; in this case the definition could be replaced with “reflux-like PPI-refractory symptoms.” Patients with persistent reflux-like symptoms should undergo a diagnostic workup aimed at finding objective evidence of GERD through endoscopic and pH-impedance investigations. The management strategies regarding rGERD, apart from a careful check of patient’s compliance with PPIs, a possible change in the timing of their administration and the choice of a PPI with a different metabolic pathway, include other pharmacologic treatments. These include histamine-2 receptor antagonists (H2RAs), alginates, antacids and mucosal protective agents, potassium competitive acid blockers (PCABs), prokinetics, gamma aminobutyric acid-B (GABA-B) receptor agonists and metabotropic glutamate receptor-5 (mGluR5) antagonists, and pain modulators. If there is no benefit from medical therapy, but there is objective evidence of GERD, invasive antireflux options should be evaluated after having carefully explained the risks and benefits to the patient. The most widely performed invasive antireflux option remains laparoscopic antireflux surgery (LARS), even if other, less invasive, interventions have been suggested in the last few decades, including endoscopic transoral incisionless fundoplication (TIF), magnetic sphincter augmentation (LINX) or radiofrequency therapy (Stretta). Due to the different mechanisms underlying rGERD, the most effective strategy can vary, and it should be tailored to each patient. The aim of this paper is to review the different management options available to successfully deal with rGERD.
... 22 Another prospective study of 40 patients in 2018 showed similar results with seven patients undergoing LF at 3 months due to persistent symptoms. 24 In a recently published RCT by Kalapala et al., 70 patients with PPI dependent GERD were randomized to either EFTP or a sham procedure in a 1:1 ratio. The primary endpoint of GERD-HRQL score improvement was more frequently achieved in the EFTP group (65.7% vs. 2.9%; P < 0.001) with 62.8% of patients off-PPI at 12 months compared to 11.4% in the sham group (P < 0.001). ...
Article
Endoscopic therapies in proton pump inhibitors (PPI) dependant/refractory gastroesophageal reflux disease (GERD) are increasingly indicated in patients who are not suitable or willing for chronic medical therapy and surgical fundoplication. Currently available endoluminal antireflux procedures include radiofrequency therapy (Stretta), suturing/plication and mucosal ablation/resection techniques at the gastroesophageal junction. Meticulous work up and patient selection results in a favourable outcome with these endoscopic therapies, especially the quality of life and partially the PPI independency. Stretta can be considered in patients with PPI refractory GERD and might have a role in patients with reflux hypersensitivity and functional heartburn. Endoscopic fundoplication using Esophyx device and GERD-X device have strong evidence (multiple randomized controlled trials) in patients with small hiatus hernia and high volume reflux episodes. Mucosal resection/ablation techniques like anti-reflux mucosectomy (ARMS) and anti-reflux mucosal ablation (ARMA) have shown promising results but need long term follow-up studies to prove their efficacy. The subset of PPI dependent GERD population will benefit from endoscopic therapies and the future of endoscopic management of GERD looks promising.
... Various endoscopic approaches have been developed over the last two decades for use in patients with normal gastric anatomy. This includes performing endoscopic fundoplication by using proprietary devices such as transoral incisionless fundoplication [6][7][8], GERDx [9] and MUSE [10][11][12] which have shown improved symptom control and a reduced requirement for use of PPI in the short to medium term. Other endoscopic therapies, including radiofrequency wave therapy at gastroesophageal junction (GEJ), have been shown to be beneficial in the short term [13][14][15][16][17]. Inoue et al described anti-reflux mucosectomy in 10 patients with medically refractory GERD with normal gastric anatomy, resulting in excellent symptom improvement and 24-hour pH study at 2 months [3]. ...
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Background and study aims Gastroesophageal reflux disease (GERD) is common, especially in patients after gastric surgery. Medical management of GERD is ineffective in up to 30 % patients and revisional gastric surgery for management of GERD is associated with higher morbidity. We aimed to assess the safety, feasibility, and efficacy of a novel endoscopic resection and plication (RAP) anti-reflux procedure for management of medically refractory GERD in patients with altered gastric anatomy. Patients and methods The RAP procedure involves endoscopic mucosal resection and full-thickness plication over the right posterior-medial axis extending 15 mm above and 20 to 30 mm below the squamocolumnar junction. Adverse events, technical feasibility, GERD health-related quality-of-life (GERD-HRQL) scores, and medication use were prospectively recorded. Results Twenty consecutive patients with previous gastric surgery underwent RAP between September 2018 and August 2020 with a median follow-up of 5.7 months. The median procedure duration was 66 minutes (IQR 53.8–89.5). RAP was technically successful in 19 patients. One patient developed gastric hemorrhage from suture dehiscence, which was managed endoscopically, and four patients developed esophageal stricture requiring endoscopic dilation. Following the RAP procedure, significant improvement in GERD-HRQL score was observed (mean 26.9, 95 %CI 23.36–30.55, P < 0.01). Fourteen of 19 patients reported > 50 % improvement in GERD-HRQL scores. Sixteen of 18 patients reported reduction in requirement for or cessation of antacid therapy. Conclusions Patients with refractory GERD after gastric surgery have limited therapeutic options. We have demonstrated that the RAP procedure is feasible, safe, and clinically effective at short-term follow-up. It provides a potential alternative to revisional surgery in patients with altered gastric anatomy.
... It consists of hydraulic elements for control, a plicator instrument's shaft with jaws in the distal end, a corkscrew tissue-grasper, and a 5.9-mm thin endoscope that passes through the device and serves as a light source to visualize the jaws. [75,76] The procedure is performed under general anesthesia. The GERDx device is introduced into the stomach over a guidewire. ...
... However, the preliminary results obtained from a few small studies that have been conducted so far are encouraging and indicate the possibility of future use of the device for the treatment of GERD. [76,77] In a recent prospective trial, the efficacy and safety of the GERDx procedure were evaluated in 40 patients with refractory GERD. The authors demonstrated a significant improvement in the quality of life as assessed by the Endoscopic Anti-Reflux Procedures: Ready for Clinical Use? Shibli and Fass ...
... All these adverse events required an intervention (Fig. 5). [76] Anti-reflux mucosectomy Endoscopy (P Siersema, Section Editor) esophagus and high-grade dysplasia. Contraction of the scared area during the healing period led to the tightening of the cardia opening, resulting in significant improvement of GERD symptoms. ...
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Purpose of review Endoscopic intervention is one of the therapeutic modalities that are currently available for GERD. Endoscopic treatment for GERD has been recently positioned as an alternative for chronic medical therapy or anti-reflux surgery. Patients who are candidates for these procedures include those with typical symptoms of GERD, low-grade erosive esophagitis (Los Angeles A and B), abnormal esophageal acid exposure if normal endoscopy, small hiatal hernia (< 3 cm), and partial or complete response to PPI treatment. This review will highlight the present and emerging data available about current and new endoscopic therapeutic modalities for GERD. Recent findings Presently, there are three endoscopic techniques that are approved for GERD, including the Stretta procedure, transoral incisionless fundoplication (TIF), and Medigus ultrasonic surgical endostapler (MUSE). Overall, all endoscopic techniques for GERD have reported excellent control of GERD-related symptoms, improvement of health-related quality of life, durability, and safety. However, the quality of evidence to support these claims varies greatly from one procedure to the other. Furthermore, there is an important discrepancy between improvement of subjective clinical parameters versus objective clinical parameters. There is a growing interest in positioning the endoscopic techniques in patient’s post-bariatric surgery, after peroral endoscopic myotomy (POEM), and in those who also require hiatal hernia repair. There are several new endoscopic interventions for GERD that are currently under investigation. Summary Endoscopic techniques are currently part of our therapeutic armamentarium for GERD. Criticism about their limited effect on objective clinical endpoints has tempered the enthusiasm of patients and physicians alike about their therapeutic value. However, endoscopic therapy for GERD is here to stay as more patients are looking for alternatives to medical and surgical therapy.
... A previous prospective single-arm study had reported positive results on the efficacy of the GERD-X device for the treatment of patients with GERD on PPIs and refractory GERD. 12 However, randomised trials and long-term follow-up data are needed to determine the efficacy and safety of the device in treating patients with GERD. The objective of this single-centre, randomised, sham-control trial was to determine the efficacy and safety of EFTP (GERD-X) in patients with PPI-dependent GERD, compared with the sham procedure, in improving the health-related quality of life (GERD-HRQL), GERD symptoms and oesophageal acid exposure. ...
... The arms were closed, and as per the study protocol 2 pre-tied transmural pledget sutures were deployed to ensure full-thickness plication and tight closure of gastro-oesophageal junction around the device. 12 The EFTP system and the ultraslim endoscope were then straightened, removed and the gastroscope was reintroduced to evaluate the post plication gastro-oesophageal junction. No retreatments were allowed. ...
Article
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ABSTRACT Background The majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD. Design Patients with proton pump inhibitor (PPI)- dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months. Results Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29–42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9–100.0) versus 8.0 (2.2–21.6); p<0.001) and 12 (92.3 (84.4–100.0) versus 9.1 (4.8–36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group. Conclusion EFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate. Trial registration number NCT03322553.
... Only 10% of patients required PPI daily, 26.7% on-demand, without significant effects on manometric characteristics in the context in which the technique does not involve structural changes in the esophageal hiatus. Koch, Witzel and Weitzen recommend the method as a good alternative to the chronic use of PPI by reducing the exposure of the distal esophagus to acid and improving typical symptoms related to reflux and quality of life [43]. ...
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Full-text available
Reflux disease continues to be one of the most common pathologies in the world. There is much discussion regarding the mechanism of developing and the variety of possible symptoms. In recent years, the use of new technologies, like high-resolution manometry and pH impedance, brought new insights into this disease. Also, there are emerging therapies that are covering the gap between the patients treated with proton-pump inhibitor (PPI) therapy and those who benefit the most from laparoscopic treatment (hiatal hernia, complications of gastroesophageal reflux disease (GERD). Also, most of them are less invasive than a laparoscopic fundoplication. We present a short review of the treatment options in patients who need more than lifestyle changes and PPI therapy.
... Serious adverse events (SAE) were observed in 10% of the patients (4 out of 40), 2 were rated as moderate (hematoma at the GE junction and pneumonia with pleural effusion), and 2 as severe (sutures passed through the liver, and Mallory-Weiss tear at the GE junction). All these adverse events required an intervention [107]. ...
Article
Full-text available
Purpose of review: Despite the many areas of unmet needs in gastroesophageal reflux disease (GERD), proton pump inhibitors (PPIs) remain the cornerstone of medical therapy. However, since their introduction, the therapeutic limitations of PPIs in GERD management have been increasingly recognized. Recent findings: In this review we discuss the new medical, endoscopic, and surgical therapeutic modalities that have been developed over the last decade. They include the potassium-competitive acid blockers (P-CABs) which provide a rapid onset, prolonged, and profound acid suppression, mucosal protectants which promote the physiological protective barrier of the esophageal mucosa, new prokinetics and neuromodulators. There are growing numbers of novel therapeutic endoscopic techniques that are under investigation or were recently introduced into the market, further expanding our therapeutic armamentarium for GERD. The development of diverse therapeutic modalities for GERD, despite the availability of PPIs, suggests that there are many areas of unmet need in GERD that will continue and drive future exploration for novel therapies.
... A few years ago, the product was acquired by a German company, and the device completely reengineered. The current GERD-X is disposable, controlled by precise hydraulic movements, and has a more user-friendly handle [2]. Nevertheless, additional studies are still awaited on this new version of the device. ...
... The device uses hydraulic elements for control and requires a slim gastroscope that works as a light source, and it has been evaluated in a few small studies. 35,36 Weitzendorfer and colleagues prospectively assessed the outcomes of 40 patients with refractory GERD who were treated with the GERDx device. 36 There was significant improvement in reflux symptoms, quality of life, and DeMeester scores in 30 patients who completed 3 months of follow-up. ...
... 35,36 Weitzendorfer and colleagues prospectively assessed the outcomes of 40 patients with refractory GERD who were treated with the GERDx device. 36 There was significant improvement in reflux symptoms, quality of life, and DeMeester scores in 30 patients who completed 3 months of follow-up. Six patients required antireflux surgery within 3 months of the plication procedure due to persistent symptoms. ...
... serious adverse events: gastroesophageal junction hematoma resulting in severe postoperative pain and dysphagia, pneumonia with pleural effusion, Mallory-Weiss tear, and intractable postprocedure pain requiring surgical removal of the suture. 36 The authors attributed these adverse events partly to the manufacturer's change of the suture material (from 2.0 monofilament to 0.0 braided nonabsorbable suture) and suture length (from 6 to 7.6 mm). ...
Article
Gastroesophageal reflux disease (GERD) is one of the most commonly encountered gastrointestinal diseases in outpatient clinics. Proton pump inhibitors (PPIs) are the cornerstone of the treatment of GERD. However, approximately one-third of patients have suboptimal response to PPIs. The management options in such cases include antireflux surgery or endoscopic antireflux treatments. Antireflux surgery is not popular due to its invasive nature and potential for adverse events. Therefore, minimally invasive endoscopic antireflux therapies are gaining popularity for the management of PPI-dependent and PPI-refractory GERD. These endoscopic therapies include radiofrequency application , endoscopic fundoplication modalities, and mucosal resec-tion techniques. In appropriately selected patients, the response to these endoscopic modalities is encouraging. Unlike surgical fundoplication, endoscopic antireflux therapies are less likely to be associated with complications such as dysphagia and gas-bloat syndrome. On the other hand, antireflux surgery remains the ideal treatment in patients with a large hiatal hernia (laparoscopic Nissen fundoplication), morbid obesity (gastric bypass), and severe reflux esophagitis. Endoscopic treatment modalities bear the potential to narrow the treatment gap between PPIs and antireflux surgery. Long-term follow-up studies and randomized comparison with antireflux surgery are required to provide a clear understanding of the current role of endoscopic modalities in patients with PPI-refractory and PPI-dependent GERD.
Article
The last decade has seen the rise of multiple novel endoscopic techniques to treat gastroesophageal reflux disease, many of which are efficacious when compared with traditional surgical options and allow relief from long-term dependence on antacid medications. This review will explore the latest endoscopic treatment options for gastroesophageal reflux disease including a description of the technique, review of efficacy and safety, and future directions.