Introduction

The RefluxStop device is a novel surgical implant that aims to manage gastroesophageal reflux disease (GERD) by reinstating the normal structure of the antireflux barrier. The nonactive implantable device achieves this by restoring the acute angle of His and gastroesophageal flap valve while acting as a mechanical stop to prevent migration of the lower esophageal sphincter into the chest cavity. This study reports the safety and efficacy of 79 subjects that underwent the RefluxStop procedure.

Aims & Methods

After informed consent was obtained, a retrospective chart review of 79 GERD subjects managed by the RefluxStop procedure was performed at a single institution in Germany between July 2021 and November 2022. Outcome measures included assessment of symptoms and associated conditions, parameters of proton pump inhibitor (PPI) usage, evaluation of perioperative adverse events or complications, and GERD health-related quality of life (GERD-HRQL) score. These measures were used to evaluate the feasibility, safety, and clinical outcomes of the RefluxStop procedure in management of active GERD.

Results

79 subjects aged 49.8±14 years were followed after undergoing the RefluxStop procedure. The mean body mass index of subjects was 25.8±4.5. 49 of the subjects were male. Associated conditions observed preoperatively included esophagitis (45.6%), Barrett’s esophagus (17.7%), and hiatal hernia (57%). Hiatal hernias had a mean size of 2.9 cm with 35% of cases classified as large. Symptoms at baseline included general GERD symptoms (35.4%), heartburn (29.1%), cough (13.9%), regurgitation (11.4%), retrosternal burning (10.1%), hoarseness (5.1%), abdominal pain or pressure (3.8%), nausea (2.5%), and other less frequent manifestations. Preoperative GERD-HRQL score was 21.5±5.2 and patients had been using PPIs for a mean of 4.7±6.8 years before surgery. At a follow-up of 10.7±3.1 months postoperatively, all subjects demonstrated significant improvement in GERD-related symptoms including dysphagia. No subjects required postoperative esophageal dilatation or reoperation and only 2.5% of subjects required PPIs to manage persistent symptoms after surgery. Furthermore, no severe perioperative complications occurred. The mean GERD-HRQL score was significantly reduced to 1.6±3.2 at follow-up, exhibiting a 92.6% improvement from baseline.

Conclusion

This study provides additional evidence to support RefluxStop as a safe and effective management option in patients with GERD. Significant improvements in PPI use and health-related quality of life outcomes were observed after intervention. Further studies are needed to validate the role of RefluxStop in GERD management.

Introduction

Standard-of-care treatments for gastroesophageal reflux disease (GERD) include proton pump inhibitor (PPI)-based medical management and conventional antireflux surgery (i.e., Nissen fundoplication). However, these modalities are associated with a significant burden of unmet needs, such as irresponsiveness and postoperative adverse events (AEs), respectively. This study presents the results of 158 patients managed with RefluxStop in Germany.

Aims & Methods

One-hundred fifty-eight reflux patients were treated with RefluxStop between July 2021 and November 2023. Clinical endpoints included GERD Health-Related Quality of Life (GERD-HRQL), postoperative AEs, and change in PPI use.

Results

Baseline characteristics are shown in Table 1. Median GERD-HRQL score improved by 90.9% from a baseline of 22 (IQR 19-31.5) to 2 (IQR 0-2) at 20±7-month follow-up (p<.001). A 96.3% reduction in PPI use was also observed; baseline PPI use in 96.5% of n=113 decreased to 3.6% of n=110 at follow-up. All cases of preoperative dysphagia (n=18) resolved after surgery. New-onset dysphagia occurred in five patients (3.2%) postoperatively but did not require esophageal dilation. Hiatal hernia recurred in 1.3% (n=2) of patients and was managed with device repositioning. Device penetration and migration occurred in 1.3% (n=2) of patients due to excessively tight suturing of the fundic pouch in which the device was invaginated. One of these patients was later treated by Toupet fundoplication.

Table 1 Baseline characteristics

Conclusion

This report demonstrates the promising clinical effectiveness of RefluxStop as a novel treatment principle in management of GERD. Additional evaluation is necessary to enhance the evidence supporting this new antireflux procedure.

Disclosure

The authors disclose travel grants and speaking honoraria from Implantica (Zug, Switzerland).

Introduction

Aims & Methods

To systematically review genetic association studies (GAS) on GERD conducted from 2012–2024 and perform a meta-analysis to assess the relationship between specific genetic polymorphisms and GERD susceptibility.
A comprehensive literature search was conducted using PubMed, Cochrane, ScienceDirect, Scopus, DisGENET, GWASCatalog, and HuGE Phenopedia databases. Inclusion criteria focused on case-control studies reporting complete genotypic and allele frequency data. Meta-analytical methods were applied to pooled data for SNPs meeting analysis thresholds, calculating odds ratios (ORs) with 95% confidence intervals (CIs) under multiple genetic models (dominant, recessive, additive, codominant). Heterogeneity and publication bias were assessed using statistical tests and funnel plots.

Results

From an initial 9788 titles, 16 GAS involving 132 variants across 105 genes met the inclusion criteria. Meta- analysis was performed on four polymorphisms with sufficient data. Among these, the GNB3 rs5443 C>T polymorphism demonstrated a significant association with GERD (OR = 2.24; 95% CI: 1.56–3.21; p < 0.001), indicating a dominant genetic model with a two-fold increased risk of GERD. Polymorphisms in TNF, IL1B, and CYP2C19 genes showed no statistically significant associations. Notably, the GNB3 gene's role implicates its involvement in brain-gut signaling and inflammatory pathways, contributing to GERD pathophysiology. Heterogeneity was low across most analyses, and publication bias could not be definitively assessed due to the limited number of studies.

Conclusion

Disclosure

No Conflict of Interest

Introduction

A substantial part of patients with gastroesophageal reflux disease (GERD) responds insufficiently to pharmacological therapy. Therefore, a novel anti-reflux endoscopic procedure - anti-reflux mucosectomy (ARMS) - has been developed. Previous studies suggest that ARMS is effective in reducing reflux symptoms and total acid exposure, although the mechanisms through which reflux is reduced has not yet been investigated.

Aims & Methods

GERD patients with a pathological acid exposure and insufficient symptom control despite twice daily PPI underwent a piecemeal multiband mucosectomy of 50% of the circumference of the esophago-gastric-junction (EGJ), extending 2cm into the cardia. Prior and 3 months following the procedure patients underwent (ambulatory and postprandial stationary) manometry and pH-impedance study, endoscopy and impedance planimetry (Endoflip). PPI treatment was temporarily stopped prior to these investigations. The main study parameter was the total number of reflux episodes assessed during ambulatory 24-h pH-impedance studies. Secondary endpoints were: total 24-h acid exposure time, number of reflux episodes and acid exposure time during prolonged postprandial stationary measurement, prevalence of transient lower esophageal sphincter relaxations (TLESRs), EGJ morphology and distensibility, grade of reflux esophagitis, symptoms and quality of life and occurrence of complications.

Results

11 patients were treated, of which follow-up is complete in 9 patients (6 men, median age 37 (36-61) years, mean BMI 28.7 (±3.1) kg/m2).
ARMS reduced the total number of reflux episodes from 71 (59.5-82.5) to 39 (28-67)(p=0.018), resulting in a reduction of both acidic (63 (50-73) vs 36 (23-55), p=0.012) and weakly acidic reflux episodes (8 (4-17) vs 4 (4-5), p=0.093). The total acid exposure was reduced from 9% (6.5-13.8) to 5.3% (4.0-6.4) (p=0.036).
The 90-minute post-prandial measurement showed an acid exposure time of 16.6% (3.1-30.2) after treatment compared to 11.2% (4.6-33) at baseline (p=0.767). Number of acidic reflux episodes (6 (3-10) vs 8 (1.5-13), p=0.953) and weakly acidic reflux episodes (0 (0-1) vs 0 (0-0.5), p=0.680) were not significantly reduced. Treatment reduced the number of TLESRs after treatment (from 4 (1-7.5) to 2 (0.5-4.5), p=0.048).
Reflux symptoms were reduced substantially (RDQ from 3.8 (3.1-4.0) to 1.4 (0.6-2.8), p=0.008) and GERD-health related quality of life improved substantially as well (28 (21-32) to 15 (6-24), p=0.012). There was no effect of treatment on dysphagia symptoms (Brief Esophageal Dysphagia Questionnaire (BEDQ) of 8.9 (±7.4) vs 9.2 (±6.5) (p=0.880).
Endoscopy showed reflux esophagitis in 89% (8/9) (3 grade A; 5 grade B) prior to treatment, this was 56% (5/9) (1 grade A; 4 grade B) after treatment (p=0.250).
Impedance planimetry showed no changes in distensibility after treatment (3.6 (±1.2) mm²/mmHg vs 4.4 (±1.2) mm²/mmHg), p=0.375). One delayed post-procedural bleeding (11%, (1/9)) occurred requiring repeat endoscopy.

Conclusion

Preliminary results show that ARMS is a successful treatment option in PPI refractory GERD patients reducing both reflux episodes and symptoms. While the mechanism could not be explained by a difference in distensibility, a reduction in TSLERs might play a role.

Disclosure

RP consultancy for Medtronic BV and Micro-Tech Endoscopy. AB received research funding from Nutricia, Norgine, SST, Thelial, Sanofi, Dr Falk Pharma and Bayer and received speaker and/or consulting fees from Laborie, Medtronic, Dr. Falk Pharma, Calypso Biotech, Alimentiv, Regeneron/Sanofi, AstraZeneca. All other authors declare no competing interests

Introduction

Gastroesophageal reflux disease (GERD) is the most common foregut disease, affecting about 20% of the adult population. It is characterized by a constant exposure of the mucosal cells to gastric acid and enzymes, which results in modification of the mucosal tissue integrity and persistent symptoms such as heartburn and regurgitation. Although GERD is associated with an esophageal epithelial barrier dysfunction, pharmacological therapies mainly aim to reduce the acidity of the gastroesophageal environment rather than protect the integrity of the esophageal tissue. Therefore, restoring the esophageal epithelium integrity, together with controlling gastric acidity, may represent an efficient approach to improve symptoms and prolong remission periods.

Aims & Methods

This study aims to evaluate the efficacy of an oral solution containing xyloglucan and pea proteins (XP) in reestablishing the integrity of gastroesophageal tissues and decreasing gastric pain in a GERD murine model.
To induce GERD, C57BL/6 mice were alternatively overfed and fasted for 56 days. Mice were then treated with XP, sodium alginate, omeprazole or omeprazole+XP twice daily for 7 days. Gastric pain and inflammatory markers were evaluated after 3 and 7 days of treatment. At day 7, after sacrifice, esophagi and stomachs were surgically removed and evaluated for macroscopic and histological examination.

Results

XP, omeprazole and omeprazole+XP were equally effective in reducing gastric pain at day 3 and 7, while alginates were ineffective at day 3. XP significantly reduced gastric macroscopic damage and demonstrated the same efficacy as omeprazole in reducing esophageal damage (p<0.001). XP was significantly able to reduce histological damage (p<0.001), with an efficacy comparable to that of omeprazole, but superior to that of alginates. Inflammatory and GERD-related markers such as iNOS and IL6 among others, were significantly reduced by XP at day 3 and 7, with a superior efficacy compared to alginates at day 7 (p<0.001). Furthermore, XP was able to significantly increase gastric pH (p<0.01).

Conclusion

Disruption of the esophageal epithelial barrier plays a fundamental role in initiating the pathophysiology of GERD. This study demonstrated that XP can effectively restore gastric homeostasis, improve esophageal integrity and decrease inflammation and pain in vivo, with a similar efficacy to that of omeprazole. Moreover, XP improves tissue integrity with a superior efficacy to alginates. Given the results, the mucoprotective properties of XP could represent a safe and effective alternative approach to manage GERD-related tissue damage. Future studies should confirm the beneficial effects of XP on esophageal mucosa to provide symptoms relief in patients suffering from GERD.

Introduction

Gastro-oesophageal reflux disease (GORD) is a common disorder with a prevalence of 10-20%. It occurs from disruption of the gastro-oesophageal flap valve (GFV) and/or a diaphragmatic abnormality causing a hiatus hernia (HH). Transoral incisionless fundoplication (TIF2.0) using the EsophyX device (Endogastric solutions) is an endoscopic treatment for GORD, which recreates the GFV through a partial 270º wrap. Prospective trials show the procedure is safe and effective and is recommended in North American guidelines, yet the experience of TIF is limited in Europe.

Aims & Methods

We conducted a UK-based, retrospective, cohort study to determine the safety and efficacy of TIF2.0. Patients undergoing TIF2.0 by a single operator were identified and analysed between 2019-2023. Patient demographics, reflux assessments (GERD-HRQL, endoscopy, pH testing), and procedural details were recorded. Primary outcomes were technical success and clinical response defined as complete (off regular anti-acid therapy) or partial (reduction from baseline in anti-acid therapy, GERD-HRQL score, and/or physiological parameters) without the need for revision. Secondary outcomes were adverse events and changes in reflux parameters measured by Wilcoxon signed-rank test. A p-value <0.05 was significant.

Results

In total, 81 patients underwent TIF2.0 with 92.0% on oral anti-acid therapy. Median age was 51 (IQR 37-64), 23 (28.4%) were female, and the median ASA grade was 1 (IQR 1-2). A HH was present in 84.6% with an average size of 1.9cm (SD 0.5). The average acid exposure time (AET) was 8.9% (SD 4.1; n=61). The clinical outcomes are summarised in table 1. Technical success was 97.5% (n=79) with an average procedural time of 38.0 minutes (SD 10.3), and 1-day (IQR 1) inpatient stay. The device could not pass the cricopharynx in two patients despite routine balloon dilatation. Over 15.5 months of median follow-up (IQR 7-24), 55% had a complete response, and 71.7% partial response. On logistic regression analysis, no variables were predictive of response. Among those with paired pre-/post-testing, the average GERD-HRQL score reduced significantly (33.9 ±18.6 to 9.1 ±9.2; P<0.001) as well as the average AET (8.9 ±4.1 to 5.1 ±4.0; P=0.005) post-procedure. Procedure or device-related adverse events occurred in 12.2% (n=10), which were all managed conservatively. The single perforation was delayed and managed with intravenous antibiotics and endoscopic vacuum therapy. Seven patients underwent a revisional procedure, including two surgical fundoplications, with 83.3% due to recurrent HH.

Conclusion

TIF2.0 is associated with technical success in 97.5%, clinical response in 71.7%, and significant improvements in GERD-HRQL and AET. Recurrent HH is a frequent cause of failure showing the importance of patient selection and/or need for concomitant HH repair.

Disclosure

RH declares educational grants to support research infrastructure from Cook medical, Odin Vision, Pentax medical, Endogastric Solutions, Apollo Endosurgery, Medtronic, and Aqua Medical