Does Sleeve Gastrectomy Worsen Gastroesophageal Reflux Disease in Obese Patients? A Prospective Study

Background To evaluate the impact of laparoscopic sleeve gastrectomy (LSG) and gastric bypass (LGB) on gastroesophageal reflux disease (GERD). Methods GERD was evaluated by the Modified Italian Gastroesophageal reflux disease—Health-Related Quality of Life (MI-GERD-HRQL) questionnaire, pH-manometry, endoscopy, and Rx-esophagogram, before and 12 months after surgery. Based on these exams, patients without GERD underwent LSG, and patients with GERD underwent LGB. Results Thirteen and six patients underwent LSG and LGB, respectively. After LSG, the only statistically significant difference observed at pH-manometry was the median DeMeester score, from 5.7 to 22.7 (P = .0026). De novo GERD occurred in 6 patients (46.2%), with erosive esophagitis in one. The median MI-GERD-HRQL score improved from 3 to 0. Overall, nine patients underwent LGB, but three were lost to follow-up. Preoperative pH-manometry changed the surgical indication from LSG to LGB in 7 out of 9 patients (77.8%). Six patients who underwent LGB completed the study, and at pH-manometry, statistically significant differences were observed in the percentage of total acid exposure time, with the number of reflux episodes lasting >5 minutes and DeMeester score (P = .009). The median MI-GERD-HRQL score improved from 6.5 to 0. Statistically significant differences were not observed at endoscopy and Rx-esophagogram findings in both groups. Conclusions LSG has a negative impact on GERD, even in patients without preoperative GERD. LGB confirmed to be the intervention of choice in patients with GERD. Preoperative pH-manometry may identify patients with silent GERD, to candidate them to LGB rather than LSG. pH-manometry should be used more liberally to establish the correct surgical indication on objective grounds.

Laparoscopic Fundoplication Using the Excluded Stomach as a Novel Management Option for Refractory Bile Reflux Following One Anastomosis Gastric Bypass (OAGB)

Background One anastomosis gastric bypass (OAGB) is now a mainstream bariatric procedure. Refractory gastroesophageal reflux is a significant complication following OAGB, and conversion to Roux-en-Y has long been the treatment of choice for this issue. Strengthening the lower esophageal sphincter by Nissen fundoplication (NF) has been reported as an effective anti-reflux surgery. Here we report the short-term outcomes of a modified NF procedure using the excluded stomach (excluded stomach fundoplication—ESF) to treat refractory bile reflux in post-OAGB patients. Methods Thirteen post-OAGB patients underwent ESF for refractory bile reflux during the study, as detailed in the surgical technique. This paper reports the 12 patients whose follow-up data are available. Results Following ESF, the GERD-HRQL heartburn score improved from 22.7 ± 3.9 to 1.8 ± 3.5 (p < 0.05). The mean aggregate GERD-HRQL score improved from 27.9 ± 5.3 to 5.7 ± 5.9 (p < 0.05). The GERD-HRQL global satisfaction score showed that 100% of patients were satisfied with the improvement of symptoms. The mean VISICK score improved from 3.8 ± 0.39 to 1.2 ± 0.39 (p < 0.05). One patient was returned to the operating theatre to have the wrap loosened due to dysphagia. Eleven patients did not require PPIs after surgery. Conclusions ESF significantly improved the VISICK score and GERD-HRQL of post-OAGB patients with refractory bile reflux in the short term. The current study is being continued to increase the sample size and the follow-up period.

RefluxStopTM, a novel device to address gastroesophageal reflux disease: Short-term results

Objective To report safety, feasibility, and patient’s functional short-term outcome of novel RefluxStop anti reflux operation. Methods All patients (n = 20) who received laparoscopic implantation of the RefluxStop device from September 2018 to November 2020 in a university hospital were included for retrospective analysis. Incidence of adverse device-effects and procedure-related adverse events are reported as safety endpoints. Feasibility was assessed reporting operation duration, rate of conversion to open surgery and technically correct position of the device by control radiography during patient’s follow up. Subjective (Gastroesophageal Reflux Disease - Health Related Quality of Life (GERD-HRQL) - questionnaires; after 6 weeks and every six-month thereof) and objective data (24h-pH-manometry, barium swallows and upper endoscopies) are reported as functional outcome parameters. Comparison between values at baseline versus post-procedure follow-up are performed using the paired samples T-test, if appropriate. Results Median follow up was 4 (1 – 22) month. Three out of 20 patients had previous upper gastrointestinal surgery (EndoStim implantation). No serious adverse device related events occurred. One patient with dysphagia required balloon dilatation at the oesophageal gastric junction 4 weeks postoperatively. Median duration of surgery was 85 (59-188) minutes. There was no conversion to open surgery. There was significant reduction in the mean of total GERD-HRQL score at baseline compared to 6-weeks after surgery with 23.9 and 4.3 (p &lt; 0.001) as well as at baseline and 6 month after surgery with 28.4 and 6.8 (p = 0.021), respectively. At 6 weeks follow up, all of the subjects had over 50% improvement of the GERD-HRQL score compared to baseline. One patient with acceptable device positioning developed symptom recurrence and received conversion to laparoscopic Toupet fundoplication after 10 months. Conclusion RefluxStop procedure seems to be a safe operation with promising short-term results. For high-level recommendation, further studies looking for long-term results and randomized comparisons to the standard anti reflux procedures like Nissen or Toupet fundoplication are required.

The Benefits of Nonablative Radiofrequency Treatment of the Lower Esophageal Sphincter After Transoral Incisionless Fundoplication

Non-ablative radiofrequency treatment to the lower esophageal sphincter (Stretta) has been shown to be beneficial after failed Nissen fundoplication. To our knowledge, this is the first report of Stretta after transoral incisionless fundoplication (TIF). This patient is a 17-year-old female who had gastroesophageal reflux disease (GERD) symptoms for 9 years. She presented with heartburn, regurgitation, and epigastric discomfort. She used omeprazole for 9 years. Esophagogastroduodenoscopy (EGD) showed a 2 cm sliding hiatal hernia and DeMeester score of 25. The GERD Health-Related Quality of Life (GERD-HRQL) score on omeprazole was 14. Patient underwent a TIF procedure, which was uneventful. Her symptoms resolved, and she discontinued omeprazole. Six months later, she had episodes of repeated violent vomiting followed by recurrence of regurgitation, nausea, bloating, and dysphagia. She resumed omeprazole. Diagnostic workup included gastric emptying scan, which was normal. EGD showed no hiatal hernia and partial disruption of the TIF valve. DeMeester score was 36.3. Esophageal manometry with impedance showed intact peristalsis and normal relaxation of the lower esophageal sphincter. The patient underwent Stretta, which was uneventful. The previous TIF did not increase the complexity of the procedure. There were no immediate or postoperative complications. The patient reported gradual improvement of her symptoms with complete resolution 2 months postoperatively. She discontinued omeprazole. The GERD-HRQL score 17 months post-Stretta was 0. This case highlights the feasibility, safety, and efficacy of performing Stretta following TIF. It provides an endoluminal alternative to complex revisional antireflux surgery. Prospective studies with longer follow-up are required to validate this concept.

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

BACKGROUND RefluxStop™ is an implantable, non-active, single use device used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original, anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In a prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD were operated using a standardized surgical technique between December 2016 and September 2017. They were followed up for one year (CE-mark investigation 6-months). Primary safety outcome was prevalence of serious adverse events related to the device, and primary effectiveness outcome reduction of GERD symptoms based on GERD-HRQL score. Secondary outcomes were prevalence of adverse events other than serious adverse events, reduction of total acid exposure time in 24-hour pH monitoring, and reduction in average daily PPI usage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-hour pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001), with 98% of subjects showing normal 24-hour pH. At 1 year: No new cases of dysphagia were recorded, present in 2 subjects, which existed already at baseline. Regular daily PPI usage occurred in all 50 subjects at baseline. At 1-year follow-up, only 1 subject took regular daily PPIs due to a too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects.CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow-up, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

BACKGROUND RefluxStop™ is an implantable, non-active, single use device to be used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD had been included. They were operated using standardized surgical technique between December 2016 and September 2017 and followed up for one year (CE-mark investigation 6-months). Primary safety outcome was the prevalence of serious adverse events related to the device and primary effectiveness outcome reduction of GERD symptoms based on the GERD HRQL score. Secondary outcomes were the prevalence of the adverse events apart from serious, reduction of the total acid exposure time on 24-hour pH monitoring, reduction in average daily PPI dosage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001). At 1-year: No new cases of dysphagia were recorded, occurred in 2 subjects, both significantly reduced compared to baseline. Regular daily PPI use before surgery occurred in all 50 subjects. At the 1-year follow-up only 1 subject took regular daily PPIs due to too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow up visit, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation

ObjectiveNumber of reflux episodes, an adjunctive metric on pH-impedance monitoring, is incompletely studied. We aimed to determine if number of reflux episodes associates with therapeutic outcome in regurgitation predominant gastro-oesophageal reflux disease (GERD).DesignWe performed post hoc analysis of postintervention pH-impedance data from adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI), randomised to either two times a day PPI or magnetic sphincter augmentation (MSA) in 2:1 allocation. After 6 and 12 months, symptom response was defined by improvement in Foregut Symptom Questionnaire (FSQ) regurgitation score to none or minimal, ≥50% reduction in GERD health-related quality of life (HRQL) score and satisfaction with therapy. Univariate and multivariate analyses were performed to determine predictors of symptom improvement.ResultsOf 152 randomised patients, 123 (age 46.9±1.2 year, 43% female) had complete data. Symptom and satisfaction scores significantly improved after MSA compared with two times a day PPI. Both acid exposure time (13.4%±0.7% to 1.3±0.2%, p<0.001) and reflux episodes (86±4 to 48±4, p<0.001) declined with therapy. Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis. On multivariate analysis, improvement in regurgitation score remained independently predictive of satisfaction with therapy (p<0.001 for each). In patients crossing over to MSA, >80 episodes pretreatment predicted improvement.ConclusionsReduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GERD.Trail registration numberClinicalTrials.gov: NCT02505945.

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

BACKGROUND RefluxStop™ is an implantable, non-active, single use device to be used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD had been included. They were operated using standardized surgical technique between December 2016 and September 2017 and followed up for one year (CE-mark investigation 6-months). Primary safety outcome was the prevalence of serious adverse events related to the device and primary effectiveness outcome reduction of GERD symptoms based on the GERD HRQL score. Secondary outcomes were the prevalence of the adverse events apart from serious, reduction of the total acid exposure time on 24-hour pH monitoring, reduction in average daily PPI dosage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001). At 1-year: No new cases of dysphagia were recorded, occurred in 2 subjects, both significantly reduced compared to baseline. Regular daily PPI use before surgery occurred in all 50 subjects. At the 1-year follow-up only 1 subject took regular daily PPIs due to too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow up visit, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

BACKGROUND RefluxStop™ is an implantable, non-active, single use device to be used in the laparoscopic treatment of GERD. RefluxStop™ aims to block the movement of the LES up into the thorax and keep the angle of His in its original anatomically correct position. This new device restores normal anatomy, leaving the food passageway unaffected. METHODS In prospective, single arm, multicentric clinical investigation analyzing safety and effectiveness of the RefluxStop™ device to treat GERD, 50 subjects with chronic GERD had been included. They were operated using standardized surgical technique between December 2016 and September 2017 and followed up for one year (CE-mark investigation 6-months). Primary safety outcome was the prevalence of serious adverse events related to the device and primary effectiveness outcome reduction of GERD symptoms based on the GERD HRQL score. Secondary outcomes were the prevalence of the adverse events apart from serious, reduction of the total acid exposure time on 24-hour pH monitoring, reduction in average daily PPI dosage and subject satisfaction. RESULTS There were no serious adverse events related to the device. Average GERD-HRQL total score at 1 year improved 86% from baseline (p<0.001). 24-h pH monitoring compared to baseline showed a mean reduction percentage of overall time with pH<4 from 16.35% to 0.80% at the 6-month visit (p<0.001). At 1-year: No new cases of dysphagia were recorded, occurred in 2 subjects, both significantly reduced compared to baseline. Regular daily PPI use before surgery occurred in all 50 subjects. At the 1-year follow-up only 1 subject took regular daily PPIs due to too low placement of the device thereby prohibiting its function. None or minimal occasional episodes of regurgitation occurred in 97.8% of evaluable subjects. Gas bloating disappeared in 30 subjects and improved in 7 subjects. CONCLUSION The new principle of RefluxStop™ is safe and effective to treat GERD according to investigation results. At 1-year follow up visit, both the GERD-HRQL score and 24-h pH monitoring results indicate success for the new treatment principle. In addition, with the dynamic treatment for acid reflux, which avoids compressing the food passageway, prevalence of dysphagia and gas bloating are significantly reduced.

P173 HIGH-RESOLUTION MANOMETRIC FINDINGS AFTER MAGNETIC SPHINCTER AUGMENTATION

Aim The aim of this study was to evaluate esophageal motility before and after Magnetic Sphincter Augmentation (MSA) for medically refractory Gastro-Esophageal Reflux Disease (GERD). Background and Methods MSA (LINX® Reflux Management System) is intended for patients with chronic GERD with incomplete symptom relief from proton-pump inhibitors (PPI) and abnormal acid exposure. A prospectively collected database of patients who underwent MSA between 2007 and 2019 was queried. All patients who completed pre- and post-operative high-resolution manometry (HRM) were included in the study. Additional investigations included Health-Related Quality of Life (GERD-HRQL) questionnaire, Functional Outcome Swallowing Scale (FOSS), upper gastrointestinal endoscopy, barium swallow, and 24-96 hours pH-study. Data were analyzed using Wilcoxon signed rank test and McNemar test. Results Forty-five patients met the inclusion criteria. The median follow-up was 10 months (IQR 6). Compared to baseline, there was a statistically significant reduction in PPI use (p=0.000), rate of heartburn (p=0.000), regurgitation (p=0.008), and extra-esophageal symptoms (p=0.000). Only three (6.7%) patients required dietary changes. The GERD-HRQL score significantly improved (p=0.000). There was a significant increase in the Lower Esophageal Sphincter (LES) competency, including LES length (p=0.004) and Esophago-gastric Contractile Integral ((EGJ-CI) (p=0.000). A significant increase in integrated relaxation pressure (IRP) (p=0.000), mean Distal Contractile Integral (DCI) (p=0.008) and intrabolus pressure (p=0.000) was also found. Thirteen (28.9%) patients presented pre-operative Ineffective Esophageal Motility (IEM) and five of them resolved postoperatively. Two patients (4.4%) developed IEM after surgery: both had IRP and DCI values within normal limits, and one of them complained of dysphagia. However, the GERD-HRQL score recovered in both patients. Conclusion MSA was clinically effective in relieving both typical and atypical GERD symptoms. LES competency increased after MSA. EGJ outflow obstruction was uncommon and not associated with symptoms. Finally, ineffective esophageal motility may reverse to normal after MSA.