GERD Health-related Quality Of Life Research Articles

Clinical Outcomes and Financial Impact of a POEM Program at a Rural Tertiary Medical Center: Our First five Years.

The purpose of this study was to assess the 5-year impact of a per oral endoscopic myotomy (POEM) program on both clinical and financial outcomes for our hospital system and the rural community we serve. We evaluated the clinical and financial outcomes of all patients who underwent POEM for achalasia. Patients were also contacted by phone to complete the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire postoperatively. Financial data for all robot-assisted laparoscopic Heller myotomy patients from our institution during the same period were also obtained for cost comparison. A total of 107 patients underwent POEM in the first 5 years following program implementation, with a mean age of 61.4 ± 17.9 years. There were 75 patients (70%) who participated in the GERD-HRQL survey at a mean follow-up of 84 weeks (range, 6 to 244 weeks). There were 88.2% of respondents who reported no or minimal dysphagia symptoms, and 93.4% of respondents reported no or minimal reflux symptoms. On postoperative upper endoscopy, 19.1% of patients had esophagitis. Implementation of the POEM program resulted in a substantial increase in case volume, growing from 5 myotomy cases per year to 24 myotomy cases per year after 2017. Cost analysis demonstrated a significantly lower index encounter cost for POEM compared with robot-assisted laparoscopic Heller myotomy of approximately $6,000. This study demonstrates the effectiveness and positive financial impact for both our community and hospital system following implementation of a POEM program at a tertiary medical center serving a large, rural population.

Efficacy of endoscopic radiofrequency ablation for proton pump inhibitor-dependent gastroesophageal reflux disease: Multicenter prospective cohort study.

To evaluate the effects of endoscopic radiofrequency ablation (RFA) on proton pump inhibitor (PPI)-dependent gastroesophageal reflux disease (GERD) in a Chinese population, and to explore the factors associated with favorable efficacy. A multicenter, single-armed prospective cohort study was conducted. PPI-dependent GERD patients were enrolled and underwent RFA. The primary outcome was improvement of GERD health-related quality of life (GERD-HRQL). Secondary outcomes were symptom improvement, satisfaction, PPI use, and the indicators of 24-h pH-impedance monitoring. A nomogram to predict complete remission was constructed. In total, 66 patients were included. The GERD-HRQL score was significantly reduced at the 3 month (mean difference, 14.7 [12.6-16.9]), 6 month (mean difference, 15.9 [13.8-18.1]), 12 month (mean difference, 16.7 [14.4-18.9]), 24 month (mean difference, 18.4 [16.2-20.1]), 36 month (mean difference, 18.2 [16.3-20.4]), and 48 month follow-up (mean difference, 16.1 [14.2-18.3]), all P < 0.001. The esophageal and extra-esophageal symptom scores were all significantly decreased. The proportion of satisfaction and no PPI use were significantly higher. With regard to the indicators of 24-h pH-impedance monitoring, acid exposure time (AET), and DeMeester score, but not lower esophageal sphincter (LES) pressure, decreased significantly at the 12 month follow-up. A nomogram based on age, body mass index (BMI), baseline AET, and LES pressure was then constructed and showed good discrimination in the prediction of complete remission following RFA. This study demonstrated that RFA improved life quality as well as symptoms in PPI-dependent GERD patients in a Chinese population. Younger age, higher BMI, lower baseline AET, and higher baseline LES pressure indicate favorable efficacy of RFA.

Patient reported outcomes and decision regret scores in redo-paraesophageal hernia repair.

Recurrent paraesophageal hernia (PEH) repair presents significant technical challenges, with limited data weighing the benefit to the operative risk. This study aims to describe our experience with recurrent PEH repair, including long-term surgical and patient reported outcomes(PROs). We conducted a retrospective review of recurrent PEH repairs from June 2018-March 2023 using our institutional database. A blinded review of post-operative imaging was conducted to assess for recurrence. Quality of life (QOL) and decision regret were measured using the GERD Health-Related Quality-of-Life (GERD-HRQL) questionnaire and Decision Regret Scale (DRS) at maximum follow up. Eighty-eight patients underwent recurrent PEH repair at our institution for PEH, classified as type II (13.6%), type III (72.7%) and type IV (13.6%). There was significant heterogeneity in operative techniques used: one-third of patients had mesh placed at the hiatus, 11.4% had a Collis gastroplasty, and one-third of patients underwent fundoplication. Intraoperative complications included gastric (5.7%), esophageal (2.3%), vascular (1.1%) and pulmonary (1.1%) injuries. Follow up was available for 73 patients with median follow up of 35.2months. Of patients with radiographic follow up, 20 (35.7%) had a radiographic recurrence: 12 (21.4%) were 2-5cm and 8 (14.3%) were > 5cm. Patients reporting PROs (53 patients; 60.2%) reported low symptom severity (mean GERD-HRQL 13.1 ± 12) and low decision regret (mean DRS 13.3 ± 19.4) with 75.5% scoring in the lowest quartile (DRS < 25). Radiographic recurrence was associated with worse QOL (p < 0.05), but no significant difference in decision regret (p = 0.125). We found significant heterogeneity amongst recurrent PEH repair techniques with continued high recurrence rate during follow up. Radiographic recurrence was correlated with worse QOL, yet patients reported low symptom severity and low decision regret, suggesting continued value in these challenging operations. Future studies should aim to identify more effective techniques to reduce recurrence rates in this patient population.

A retrospective study assessing RefluxStop surgery for gastroesophageal reflux disease: Clinical outcomes in 79 patients from Germany.

This study reports outcomes of the RefluxStop procedure treating gastroesophageal reflux disease (GERD) in clinical practice at a high-volume regional hospital in Germany. A retrospective analysis was conducted on 79 patients with chronic GERD that underwent the RefluxStop procedure, comprising high mediastinal dissection, loose cruroplasty, esophagogastroplication between vagal trunks, and fundus invagination of the RefluxStop implant. The primary outcome was GERD Health-Related Quality-of-Life (GERD-HRQL) score and improvement from baseline. Secondary outcomes included proton pump inhibitor (PPI) use and intra- and postoperative complications, including dysphagia, esophageal dilatation, and reoperation. Baseline characteristics (n=79) included large hiatal hernia >3cm (32.4%) and previous antireflux surgery (20.3%). At mean (SD) follow-up of 11 (4.4) months ranging from 4 to 19months, the median (IQR) and mean (SD) improvements in GERD-HRQL score were 100% (90.2-100%) and 92.4% (13.9%) from baseline, respectively. Significant reduction in PPI use was observed from a baseline of 94.9% to 2.5% at follow-up. All cases of preoperative dysphagia (7.6%) completely resolved. New-onset, mild dysphagia occurred in one subject (1.3%) at final follow-up. One subject (1.3%) experienced asymptomatic device migration into the stomach, likely due to surgical technique with a much too tight invagination, with subsequent conversion to Toupet fundoplication. Analysis of this cohort that underwent RefluxStop surgery indicates excellent safety and effectiveness over this short-term follow-up. Significant improvements in quality of life and PPI use were observed in a population where half had either large hiatal hernia >3cm or reoperation for previously failed antireflux surgery, a demographic with usually much higher complication rates.

BN O03 - Pooled two-year results of the novel RefluxStop implantable device in management of gastroesophageal reflux disease in Germany: Retrospective analysis

Abstract Background The most common gastrointestinal disorder globally is gastroesophageal reflux disease (GERD). Standard-of-care treatments for GERD are medical therapy, via proton pump inhibitors (PPIs), and traditional antireflux surgery (i.e., Nissen fundoplication). Unfortunately, PPI therapy is associated with medication irresponsiveness in up to 40% of cases and Nissen fundoplication results in significant rates of postoperative adverse events (AEs), such as postoperative dysphagia. Notably, patients with large hiatal hernia (&amp;gt;3 cm) are exceedingly difficult to treat with antireflux surgery. This report presents the clinical results of patients treated with an emerging technology, the RefluxStop device, in Germany at our two centers. Method Between July of 2021 and November of 2023, 158 patients were operated on with RefluxStop surgery. This procedure entails correction of a defunct antireflux barrier through cruroplasty (with hiatal hernia reduction, if necessary), limited (90-120°) esophagogastroplication to recreate the acute angle of His and gastroesophageal flap valve, and regional stabilization of newly constructed anatomy with implantation of the RefluxStop device in a fully invaginated fundic pouch. Clinical outcomes included GERD Health-Related Quality of Life (GERD-HRQL) score, PPI use, and perioperative AEs. Results Patients of mean age 49±13.3 years and male (51.3%) had hiatal hernia &amp;gt;3 cm (22.2%). At 20±7-month follow-up, the median (IQR) GERD-HRQL score improved by 90.9% to 2 (0-2) from a baseline of 22 (19-31.5) (p&amp;lt;.001). PPI use decreased by 96.3%. Preoperative dysphagia (n=18) resolved in all patients with five cases (3.2%) of new-onset dysphagia occurring, but none requiring postoperative dilation. Hiatal hernia recurred in two patients (1.3%) and was treated with device repositioning. Device migration presented in two patients (1.3%) from excessively tight suturing of the fundic pouch. One of these patients was converted to Toupet fundoplication. Conclusion This study shows that RefluxStop provides excellent effectiveness and safety outcomes. Quality-of-life improvements were particularly appreciated with a 90.9% reduction in GERD-HRQL score. With the added context of 22.2% of this pooled cohort composed of difficult-to-treat patients (i.e., hiatal hernia &amp;gt;3 cm), RefluxStop surgery provides favorable efficacy in real-world settings with such patients. As with any novel surgical procedure, training is paramount to optimizing surgical outcomes and minimizing unwanted AEs. Further study is required to bolster the evidence supporting this emerging technology.

Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, double-blind, non-inferiority phase Ⅲ trial.

An evidence gap still exists regarding the efficacy and safety of tegoprazan in Chinese patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs. esomeprazole in patients with EE in China. This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50mg/day vs. esomeprazole 40mg/day. This study was conducted in 32sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement. A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs. 92.8%, difference: -1.7, 95% confidence interval [CI]: -8.5, 5.0, P=0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P>0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients' diaries, were similar between the two groups (all P>0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively. Tegoprazan 50mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40mg/day. ClinicalTrials.gov, NCT03615677.

Bolus exposure as a novel predictor of postoperative symptom resolution after laparoscopic Nissen fundoplication: a two-institutional retrospective cohort study.

Even in the absence of definite evidence of pathological acid reflux, antireflux surgery (ARS) can still effectively improve gastroesophageal reflux symptoms. Nonetheless, predicting postoperative reflux symptom improvement has been primarily dependent on acid-based parameters. No objective index reflecting both acid and nonacid reflux was identified to select ARS candidates. Prospectively collected data of 121 patients with gastroesophageal reflux disease (GERD), who underwent laparoscopic Nissen fundoplication from two institutions, were retrospectively reviewed. The patients reported preoperative and postoperative GERD symptoms using the Korean version of the GERD questionnaire, along with the gastroesophageal reflux disease-health-related quality of life (GERD-HRQL). The patients were assessed for reflux symptoms using bolus exposure, acid exposure time (AET), and DeMeester score (DMS) as measurements were selected. For each reflux parameter, its association, correlation, and predictive capacity of the degree of postoperative symptom resolution were analyzed using χ2 tests, point-biserial correlations, logistic regression analyses, and receiver operating characteristic curve analyses. Seventy-two patients were eligible for this study. Bolus exposure was superior to the other parameters in terms of the degree of association and correlation with a resolution of typical symptoms. Bolus exposure also showed a higher diagnostic accuracy in predicting the resolution of epigastric pain (area under the curve [AUC]=0.723, P =0.013) and regurgitation (AUC=0.981, P <0.001). Secondary analyses were performed in patients without pathological reflux, defined as the DMS-negative (DMS <14.7) or AET-negative (AET <6%) groups. In the secondary analyses, bolus exposure showed considerable diagnostic accuracy with statistical significance for all typical symptoms in both the DMS-negative (heartburn: AUC=0.717, P =0.025; epigastric pain: AUC=0.717, P =0.025; regurgitation: AUC=0.975, P <0.001) and AET-negative (heartburn: AUC=0.681, P =0.045; epigastric pain: AUC=0.749, P =0.009; regurgitation: AUC=0.975, P <0.001) groups. Bolus exposure, a parameter of total reflux, was superior to AET or DMS in defining candidates for ARS. Further studies investigating the surgical indications for ARS in patients with nonacid reflux using bolus exposure are required.

The Effect of Laparoscopic Sleeve Gastrectomy on Gastroesophageal Reflux Disease, A Prospective Observational Study

Abstract Background Obesity, defined by the world health organization as a body mass index (BMI) greater than 30, it is an epidemic issue that has major complications on health. It is estimated that more than 200 million men and 500 million women around the world more than 10% of the world’s population are obese. Aim of the Work to examine the effects of LSG on GERD. Depending on gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire before and after undergoing elective LSG by 6 months (at least) and result will be confirmed by pH metry for positive cases only (score &amp;gt;35). Patients and Methods This study is a prospective observational study. Conducted patients from outpatient clinic of the general surgery department in Ain Shams university hospitals during the period starting from August 2022, till March 2023. Results Regarding the GERD-HQOL score distribution among study group (n = 100), we found that There were 92 cases (92%) score &amp;lt;35 &amp;8patients (8.0%) score &amp;gt;35; with ranged score 0-38 with mean 14.73±4.27. Regarding the Relation between positive GERD- HQOL score and pH metry (n = 8) among study group, we found that there was a 8 patients were positive GERD-HQOL out of them 7 patients were positive pH metry with agreement 87.5% while there was one cases were negative pH metry, with p-value &amp;lt;0.001 highly significant. Conclusion we found that GERD-HQOL Questionnaire is comparable to pH metry with high index of agreement between questionnaire and pH metry after LSG.

213. A NEW MANOMETRIC TOOL TO EVALUATE THE EFFICACY OF LAPAROSCOPIC ANTIREFLUX SURGERY

Abstract Background High resolution manometry (HRM) has been proven able to describe the pathophysiological pathway leading to gastroesophageal reflux disease (GERD). Recently, a new manometric tool, the Milan Score (MS), has been introduced and validated to evaluate the risk of pathologic GERD, defined as Acid Exposure Time (AET) &amp;gt;6% at pH-study. Aim of this study is to validate this score in the post-operative assessment after laparoscopic antireflux surgery (LARS). Methods All patients who underwent HRM after LARS between October 2020 and May 2023 were included. The MS was calculated assessing four manometric variables: esophagogastric junction (EGJ) type, EGJ contractile integral (EGJ-CI), ineffective esophageal motility (IEM) and response to the straight leg raise (SLR) manoeuvre. The MS was considered pathologic if ≥137 (risk of GERD ≥50%). The risk of GERD was categorized into six classes, according to the MS score. The MS was compared with validated questionnaires for reflux symptoms, including GERD Questionnaire (GERD-Q), GERD Health-Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI), and with postoperative endoscopy findings. Results A total of 160 patients were included (63% males, age: 53 years, time from surgery: 30 months). Surgical techniques included magnetic sphincter augmentation in 54% of patients, Toupet fundoplication in 29% and Nissen or Dor fundoplication in 17%. The proportion of patients with MS ≥137 among those with pathologic questionnaires was 73% for GERD-Q (p&amp;lt;0.001), 75% for GERD-HRQL (p&amp;lt;0.001) and 78% for RSI (p&amp;lt;0.001). The rate of pathologic questionnaires increased for higher MSs. A MS ≥137 was related to recurrent hiatal hernia (23%, p=0.046) and esophagitis (21%, p=0.007) at endoscopy. Clinical and manometric outcomes were similar among different surgical techniques. Conclusions The MS is an efficient tool to assess the efficacy of LARS. Various surgical techniques have similar distribution in the different risk classes for GERD identified by MS, and similar clinical results. HRM with MS represent an easy and feasible assessment of surgical outcomes after LARS, providing an objective evaluation of the antireflux barrier after surgery.

481. STRONG SYMPTOMATIC IMPROVEMENT AT 1 YEAR AND BEYOND FOLLOWING REFLUXSTOP SURGERY FOR GASTRO-ESOPHAGEAL REFLUX DISEASE: A 40-PATIENT COHORTT

Abstract Background Despite well-established medical and surgical options for gastro-esophageal reflux disease (GERD), there remains a high unmet need for a treatment that improves symptoms without adverse effects. Symptoms of bloating, inability to belch or vomit, and dysphagia are among the more common side effects of standard anti-reflux surgery. RefluxStop is a novel device for the treatment of GERD that does not encircle the food passageway to avoid such side effects. The surgical technique is based on restoration of the normal anatomy of the gastroesophageal junction and maintaining the lower esophageal sphincter within the abdomen. Methods This study presents a case series of 40 patients who underwent RefluxStop surgery between July 2021 and November 2022 reaching at least 12 months of follow-up. A retrospective review of medical records was conducted. Baseline GERD Health-Related Quality of Life (GERD-HRQL) score was reported in addition to demographic and clinical characteristics. At follow-up, GERD-HRQL score, patient-reported GERD symptoms, and proton-pump inhibitor (PPI) use were reported. Peri-operative procedure-related and device-related adverse events (AEs) were recorded. Results Baseline patient characteristics are presented in Table 1. Mean follow-up was 14.5 (range 12-19) months. Mean GERD-HRQL score decreased dramatically from 19.5±3.8 at baseline to 1.1±2.2 at follow-up, reflecting a 91.9% improvement. At follow-up, reflux was reported as a symptom in only two patients (5%) (described as mild and occasional in one of them). None reported regurgitation or dysphagia. Only two patients (5%) reported bloating. The necessity for PPI therapy decreased from 97.5% (n=40) at baseline to 2.5% at follow-up. There were no intra-operative AEs or reoperations. Conclusion These data provide real-world evidence on the performance of RefluxStop in clinical practice. In this series of patients, the outcomes at 1 year and beyond indicate excellent effectiveness in reducing or eliminating GERD symptoms, as demonstrated by spontaneously reported symptoms and the validated, disease-specific, quality-of-life questionnaire. The discontinuation of PPI therapy is an additional indicator of effective symptomatic improvement. Importantly, this treatment did not induce dysphagia, a common consequence of established anti-reflux surgical techniques. RefluxStop is a promising option for patients with chronic GERD seeking definitive treatment while minimizing AEs.

506. CLINICAL OUTCOMES OF A NEW SURGICAL TREATMENT FOR GASTROESOPHAGEAL REFLUX DISEASE: RETROSPECTIVE CHART REVIEW OF 28 PATIENTS FROM GERMANY

Abstract Background Gastroesophageal reflux disease (GERD) is a troublesome gastrointestinal ailment with significant prevalence worldwide. First-line treatment is attempted with proton pump inhibitor (PPI) therapy, but about 40% of patients experience irresponsiveness. Inadequate response, intolerance, or aversion to long-term therapy are indications for anti-reflux surgery. Fundoplication techniques, magnetic sphincter augmentation, and endoscopic techniques are existing surgical options, but are often associated with postoperative complications like dysphagia. The RefluxStop implant is an emerging technology that has demonstrated effectiveness in managing patients with chronic GERD. This report summarizes the clinical outcomes of 28 patients managed with RefluxStop at a German institution. Methods The RefluxStop procedure was performed on 28 patients with chronic GERD in a German center between July 2021 and November 2023. Data was obtained from a retrospective chart review to present the clinical outcomes following RefluxStop surgery, including GERD Health-Related Quality of Life (GERD-HRQL), PPI use, symptom resolution, patient satisfaction, and perioperative adverse events (AEs). Results Twenty-eight patients were followed for 14.1±4.7 months. Baseline patient characteristics are shown in Table 1. Median GERD-HRQL score decreased by 90% from a baseline of 40 (IQR 17) to 4 (IQR 5) at follow-up. PPI use decreased from 96.4% at baseline to 7.1% at follow-up. Almost 93% of reflux symptoms were eliminated. Only one patient (3.6%) was not satisfied with treatment. All patients with dysphagia at baseline (42.9%) experienced complete resolution. No reoperations or esophageal dilations were required. Seven patients experienced minor intraoperative AEs (e.g., neck emphysema) but none were procedure- or device-related. Conclusion This cohort of GERD patients in Germany demonstrated the safety and effectiveness of the RefluxStop procedure. Significant improvements in quality of life, PPI use, and reflux-related symptoms were observed without consequential safety concerns for over one year. Furthermore, this study corroborates the existing evidence of favorable postoperative safety outcomes associated with RefluxStop. Additional study is necessary to continue validation of this promising new treatment option.

811. POOLED 1-YEAR SAFETY AND QUALITY-OF-LIFE DATA AFTER REFLUXSTOP SURGERY AT TWO LARGE HOSPITALS IN SWITZERLAND: A RETROSPECTIVE CHART ANALYSIS

Abstract Background The standards of care in reflux disease management are proton pump inhibitor (PPI) therapy and conventional antireflux surgery, however, both options carry the caveats of medication irresponsiveness and troublesome postoperative sequelae, respectively. More specifically, PPIs respond inadequately in up to 40% of cases and Nissen fundoplication is associated with postoperative dysphagia in a significant proportion of patients. RefluxStop is an innovative technology that was adopted at our two respective institutions following promising safety and effectiveness data from its CE mark trial. We present the pooled safety and quality-of-life data of our 1-year experience with RefluxStop surgery. Methods Between September 2018 and August 2023, RefluxStop surgery was performed on 121 patients as part of routine clinical care at two hospitals, both of which are high-volume centers for antireflux surgery. The procedure involves crural repair with hiatal hernia reduction, reconstruction of the flap valve and angle of His, narrow esophagogastric (90-110°) plication, and device implantation in an external pouch on the gastric fundus (Figure 1). A retrospective chart analysis was conducted to document perioperative adverse events (AEs) and quality-of-life improvements via Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) score. Higher GERD-HRQL scores are indicative of more severe disease. Results Baseline patient characteristics included mean age 54.7 years, female sex (52.9%), body mass index 27.2±4.1 kg/m2, large hiatal hernia &amp;gt;3 cm (46.3%) of median (IQR) size 3 (2-5) cm, abnormal esophageal motility (60.3%), and Barrett’s esophagus (27.3%). At 1-year follow-up, patients experienced a median (IQR) reduction of 90.5% (81.4-100%) in total GERD-HRQL score. Intraoperative AEs included conversion to laparotomy for adhesiolysis with bleeding (n=1), bleeding short gastric arteries leading to return to the operating room the next day (n=1), and esophageal perforation repaired intraoperatively (n=1). Postoperative AEs are summarized in Table 1. Conclusion The results of this pooled retrospective chart analysis support the promising early data of the RefluxStop CE mark trial. Few and predictable AEs occurred during the study period while significant improvements in quality of life were observed, as evidenced by 90.5% (81.4-100%) reductions in GERD-HRQL score. Notably, this pooled cohort of patients was comprised of substantial proportions of difficult-to-treat patients (i.e., abnormal esophageal motility in 60.3%, large hiatal hernia &amp;gt;3 cm in 46.3%), providing evidence for wider implementation of RefluxStop surgery in real-world settings. Additional evaluation is required to further delineate the role of this promising innovative antireflux surgery.

The impact of obesity on gastroesophageal reflux disease recurrence following re-operative anti-reflux surgery.

Obese patients represent a large proportion of patients experiencing recurrent reflux and re-operations after initial anti-reflux surgery. However, there is a limited data describing the impact of obesity on GERD recurrence following re-operative procedures. A review of patients who underwent re-operative anti-reflux surgery (Re-ARS) between 2012 and 2023. Peri-operative characteristics and post-operative Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores were compared across the three BMI categories: (BMI < 25kg/m2, 25 ≤ BMI > 30kg/m2, and BMI ≥ 30kg/m2) over 12 IQR (9-14.9) months follow-up. Impedance planimetry measurements were included when it was utilized intraoperatively. Of 718 patients who underwent robotic ARS, 84 patients (11.6%) underwent Re-ARS, of which 29.7% had a BMI < 25kg/m2, 35.7% were ≤ 25 BMI < 30kg/m2, and 34.5% had a BMI ≥ 30kg/m2. The lower esophageal sphincter distensibility decreased similarly between groups with no differences in post-induction [3.2 ± 2 vs 4.5 ± 3.1 vs 3.9 ± 2.5 mm2/mmHg, p = 0.44] or post-fundoplication values [1 ± 0.6 vs 1.3 ± 0.7 vs 1.2 ± 0.6 mm2/mmHg, p = 0.46]. There was a significant improvement in GERD-HRQL scores postoperatively compared to preoperative levels across the three BMI classes (BMI < 25kg/m2: pre 17 IQR (12-22), post 7.5 (1.5-15), p = 0.04 vs ≤ 25 BMI < 30kg/m2: pre 26 IQR (10-34), post 8 IQR (0-17), p < 0.01 vs BMI ≥ 30kg/m2: pre 44 IQR (26-51), post 5 IQR (3.5-14.5), p < 0.001) during 12 IQR (9-14.9) months follow-up. The rates of hiatal hernia recurrence on barium swallow [5.2 vs 15.7 vs 13.7%, p = 0.32] during 7 IQR (5.2-9.2) months follow-up, and endoscopy [13.3 vs 16.6 vs 7.1%, p = 0.74] during 11.8 (IQR 5.6-17.1) months follow-up period were also similar between groups. GERD-HRQL scores in obese patients are expected to improve similarly compared to non-obese patients. Indicating that Re-ARS may be appropriate for patients across a range of BMIs.

Full esophageal mobilization during hiatal hernia repair with concomitant sleeve gastrectomy improves postoperative reflux symptoms for patients with preexisting reflux.

Hiatal hernia repair (HHR) performed concurrently with vertical sleeve gastrectomy (VSG) has been shown to improve postoperative gastroesophageal reflux disease (GERD). However, data on the optimal extent of esophageal mobilization during repair are lacking. Mobilization techniques for HHR during VSG include partial (PM) or full (FM) mobilization of the esophagus. We hypothesize that patients who undergo full mobilization will be less likely to develop postoperative reflux. A single-institution retrospective review of all patients who underwent a VSG with a HHR between 2014 and 2021 was conducted. The primary outcome was postoperative reflux symptoms defined by diagnosis in the medical record, utilization of anti-reflux medications, and GERD health-related quality of life (GERD-HRQL) scores obtained via patient surveys. There were 190 patients included with 80 patients (42.1%) undergoing PM and 110 (57.9%) undergoing FM. Rates of preoperative reflux were similar between the two groups (47.5% vs. 51.8%; p = 0.55). During the GERD-HRQL survey, there were 114 patients (60.0%) contacted with a participation rate of 91.2% (104 patients). Patients with preoperative reflux who underwent PM were found to have a higher rate of reported postoperative reflux (90.0% vs. 62.5%; p = 0.03) and higher GERD-HRQL scores (16.40 ± 9.95 vs. 10.84 ± 9.01; p = 0.04). Patients without preoperative reflux did not have a significant difference in reported reflux (55.0% vs. 51.7%; p = 0.82) or GERD-HRQL scores (12.35 ± 14.14 vs. 9.93 ± 9.46; p = 0.25). Our study found that postoperative GERD was higher in patients with preexisting reflux who underwent partial esophageal mobilization during concurrent hiatal hernia repair with vertical sleeve gastrectomy. In patients without preoperative GERD, our data suggest that postoperative reflux symptoms are not dependent on the extent of esophageal mobilization during hiatal hernia repair with vertical sleeve gastrectomy.

Short-term symptomatic outcomes of GERD in patients with gastroparesis after gastric per oral endoscopic pyloromyotomy.

Gastroparesis (Gp) patients often have gastroesophageal reflux disease (GERD). Management of GERD in Gp patients is a challenge. Many studies have shown that gastric peroral endoscopic pyloromyotomy (G-POEM or POP) is moderately effective in reducing nausea and vomiting in patients with Gp. This study aims to determine whether G-POEM can improve GERD in Gp Patients. Patients who underwent G-POEM from July 2021 to October 2022 were enrolled in the study. GERD Health-Related Quality of Life (GERD HRQL) and Reflux Symptom Index (RSI) were used to assess patients' GERD before and after G-POEM. The use of proton pump inhibitors (PPIs) before and after G-POEM were also documented. The Gastroparesis Cardinal Symptom Index (GCSI) was used to assess the severity of Gp before and after G-POEM. A 'Welch two-sample t-test' was used to find differences in GERD HRQL (health-related quality of life) and RSI scores before and after the procedure. Pearson's chi-square test was used to find differences for use of PPI before and after G-POEM. Twenty-three consecutive refractory Gp patients with 30% male (average age 63.2) and 70% female patients (average age 53.9) were enrolled. Of these, 14 had diabetes, 3 had a history of surgery, and 6 had idiopathic Gp. The mean follow-up was 41days (range 7-61days). There was a significant decrease in the mean GERD HRQL score from 16.5 to 6.5 after G POEM with a P-value <0.0001 (95% level of significance) and a significant decrease in mean RSI score from 15.3 to 5.2 after G-POEM with P-value <0.0001 (95% level of significance). The proportion of use of PPI before GPOEM was 0.91, and the proportion of PPI use after GPOEM was 0.43 (P = 0.0008). The mean GCSI pre- and post-GPOEM were 3.53 and 1.59, respectively. Eighteen had clinical success in Gp as defined by decreased mean GCSI score greater than 1. In this short-term outcome study, 87% of patients' GERD HRQL scores and RSI scores decreased after G-POEM. These findings indicate that GPOEM not only effectively reduces Gp symptoms but also improves GERD symptoms leading to decreased or more effective use of PPI in these patients. To our knowledge, this is the first study to comprehensively show G-POEM significantly improves GERD. Further studies with a larger patient population and long-term outcomes are needed.

Patients report significant improvement in quality of life following hiatal hernia repair-despite recurrence.

Hiatal hernia (HH) repairs have been associated with high recurrence rates. This study aimed to investigate if changes in patient's self-reported GERD health-related quality of life (HRQL) scores over time are associated with long-term surgical outcomes. Retrospective chart reviews were conducted on all patients who had laparoscopic or robotic HH repairs between 2018 and 2022 at a tertiary care center. Information was collected regarding initial BMI, endoscopic HH measurement, surgery, and pre- and post-operative HRQL scores. Repeat imaging at least a year following surgical repair was then evaluated for any evidence of recurrence. Paired t tests were used to compare pre- and post-operative HRQL scores. Wilcoxon ranked-sum tests were used to compare the HRQL scores between the recurrence cohort and non-recurrence cohorts at different time points. A total of 126 patients underwent HH repairs and had pre- and post-operative HRQL scores. Mesh was used in 23 repairs (18.25%). 42 patients had recorded HH recurrences (33.3%), 35 had no evidence of recurrence (27.7%), and 49 patients (38.9%) had no follow-up imaging. The average pre-operative QOL score was 24.99 (SD ± 14.95) and significantly improved to 5.63 (SD ± 8.51) at 2-week post-op (p < 0.0001). That improvement was sustained at 1-year post-op (mean 7.86, SD ± 8.26, p < 0.0001). The average time between the initial operation and recurrence was 2.1years (SD ± 1.10). Recurrence was significantly less likely with mesh repairs (p = 0.005). There was no significant difference in QOL scores at 2weeks, 3months, 6months, or 1 year postoperatively between the cohorts (p = NS). Patients had significant long-term improvement in their HRQL scores after surgical HH repair despite recurrences. The need to re-intervene in patients with HH recurrence should be based on their QOL scores and not necessarily based on established recurrence.

Safety and efficacy of robotic anti-reflux surgery in geriatric patients: a comparative analysis.

As our population ages, older adults are being considered for anti-reflux surgery (ARS). Geriatric patients typically have heightened surgical risk, and literature has shown mixed results regarding postoperative outcomes. We sought to evaluate the safety and efficacy of robotic ARS in the geriatric population. We conducted a single-institution review of ARS procedures performed between 2009 and 2023. Patients ≥ 65 were assigned to the geriatric cohort. We compared operative details, lengths of stay (LOS), readmissions, reoperations, and complications between the two cohorts. The gastroesophageal reflux disease health-related quality of life (GERD-HRQL) survey and review of clinic notes were used to evaluate ARS efficacy. 628 patients were included, with 190 in the geriatric cohort. This cohort had a higher frequency of diabetes (16.3% vs 5.9% p < 0.0001), hypertension (50.0% vs 21.5% p < 0.0001), and heart disease (17.9% vs 2.3% p < 0.0001). Geriatric patients were more likely to exhibit hiatal hernias on imaging (51.6% vs 34.2% p < 0.0001) and were more likely to have large hernias (30.0% vs 7.1% p < 0.0001). Older adults were more likely to undergo Toupet fundoplications (58.4% vs 41.3%, p < 0.0001), Collis gastroplasties (9.5% vs 2.7% p < 0.0001), and relaxing incisions (11.6% vs 1.4% p < 0.0001). Operative time was longer for geriatric patients (132.0min vs 104.5min p < 0.0001). There were no significant differences in LOS, readmissions, or reoperations between cohorts. Geriatric patients exhibited lower rates of complications (7.4% vs. 14.6%, p = 0.011), but similar complication grades. Both groups had significant reduction in symptom scores from preoperative values. There were no significant differences in the reported symptoms between cohorts at any follow-up timepoint. Geriatric robotic ARS patients tend to do as well as younger adults regarding postoperative and symptomatic outcomes, despite presenting with larger hiatal hernias and shorter esophagi. Clinicians should be aware of possible need for lengthening procedures or relaxing incisions in this population.

Does Antrum Size Matter in Sleeve Gastrectomy? Volume II-A Retrospective Multicentric Study with Long-Term Follow-Up.

Background: Laparoscopic sleeve gastrectomy (LSG) is the most widespread bariatric procedure due to its safety and efficacy. Despite continuous refinement, achieving a globally standardized procedure remains challenging. Moreover, due to its wide adoption, numerous studies have focused on complications associated with the technique, such as gastroesophageal reflux disease (GERD). This study evaluates the impact of antrum size (wide antrectomy versus small antrectomy) in LSG on long-term anthropometric outcomes and complications in patients with morbid obesity. Methods: Body mass index (BMI), percentage of excess weight loss (%EWL) at a 5-year follow-up, GERD Health-Related Quality-of-Life (GERD-HRQL) scores, and obesity-related diseases of patients undergoing LSG with gastric resections starting 2 cm and 6 cm from the pylorus were retrospectively evaluated. Results: Between January 2015 and November 2019, 597 patients who met the criteria for LSG were included in the study. Group A (241 patients) underwent wide antrectomy, while Group B (356 patients) underwent small antrectomy. Weight, BMI, %EWL, and %TWL significantly improved at 6 and 12 months in the wide-antrectomy group. However, these differences diminished by 24 months, with no significant long-term differences in weight loss outcomes between the two groups at 5 years. Conversely, GERD-HRQL scores were significantly better in the small-antrectomy group until 24 months; thereafter, results were comparable between groups over the long term. Conclusions: Therefore, while wide antrectomy may offer superior short-term anthropometric outcomes, both techniques yield similar long-term results regarding weight management and GERD incidence. Larger prospective studies are needed to further address this issue.

Endoscopic full-thickness plication along with argon plasma coagulation for treatment of proton pump inhibitor dependent gastroesophageal reflux disease

BACKGROUND Most endoscopic anti-reflux interventions for gastroesophageal reflux disease (GERD) management are technically challenging to practice with inadequate data to support it utility. Therefore, this study was carried to evaluate the effectiveness and safety newer endoscopic full-thickness fundoplication (EFTP) device along with Argon Plasma Coagulation to treat individuals with GERD. AIM To evaluate the effectiveness and safety newer EFTP device along with Argon Plasma Coagulation to treat individuals with GERD. METHODS This study was a single-center comparative analysis conducted on patients treated at a Noble Institute of Gastroenterology, Ahmedabad, hospital between 2020 and 2022. The research aimed to retrospectively analyze patient data on GERD symptoms and proton pump inhibitor (PPI) dependence who underwent EFTP using the GERD-X system along with argon plasma coagulation (APC). The primary endpoint was the mean change in the total gastroesophageal reflux disease health-related quality of life (GERD-HRQL) score compared to the baseline measurement at the 3-month follow-up. Secondary endpoints encompassed enhancements in the overall GERD-HRQL score, improvements in GERD symptom scores at the 3 and changes in PPI usage at the 3 and 12-month time points. RESULTS In this study, patients most were in Hill Class II, and over half had ineffective esophageal motility. Following the EFTP procedure, there were significant improvements in heartburn and regurgitation scores, as well as GERD-HRQL scores (P &lt; 0.001). PPI use significantly decreased, with 82.6% not needing PPIs or prokinetics at end of 1 year. No significant adverse events related to the procedures were observed in either group. CONCLUSION The EFTP along with APC procedure shows promise in addressing GERD symptoms and improving patients' quality of life, particularly for suitable candidates. Moreover, the application of a lone clip with APC yielded superior outcomes and exhibited greater cost-effectiveness.

Predictability of magnetic sphincter augmentation device explantation: a nomogram-based scoring tool from an experienced quaternary center

BackgroundMagnetic sphincter augmentation (MSA) explantation is an uncommon occurrence, and there are limited studies characterizing factors predictive of MSA explantation. This study aimed to create a nomogram to aid in determining the probability of explantation in patients before MSA implantation. MethodsAn institutional review board–approved, prospectively maintained database was retrospectively reviewed for all patients undergoing antireflux surgery between February 2015 and May 2023. All patients who underwent MSA-related procedures were included. Patients were divided into 2 groups, explant group and nonexplant group, and differences were analyzed. A multivariable logistic regression model was fitted to identify independent risk factors for predicting MSA explantation, and a nomogram-based scoring tool was developed. ResultsThere were 227 patients (134 females and 93 males) with a mean age of 51.4 years. The explant group included 28 patients (12.3%), whereas the nonexplant group included 199 patients (87.7%). Patient sociodemographic characteristics, medical comorbidities, preoperative testing results, and surgical history were included in the analysis. The multivariable regression model resulted in 4 significant variables that were included in the nomogram. These included preoperative DeMeester score, preoperative gastroesophageal reflux disease health–related quality of life score, preoperative distal contractile integral value on manometry, and body mass index. Based on these variables, a scoring nomogram was developed with values ranging from 0 to 18. ConclusionOur data were used to develop a scoring calculator capable of predicting the probability of MSA explantation. This scoring tool can guide preoperative patient selection and treatment decisions.