ENDOSCOPIC SLEEVE GASTROPLASTY: THE IDENTIFICATION OF THE KEY PROCEDURAL STEPS THROUGH A MODIFIED DELPHI METHOD.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an innovative, minimally invasive bariatric procedure with an excellent safety and efficacy profile in adults with obesity. The purpose of the procedure is to shorten and tubularize the stomach along its greater curvature. Nevertheless, there is some heterogeneity in approach to ESG, which will be important to address as the procedure sees increasingly widespread clinical adoption. Here, we present an expert consensus on standardized ESG technique. METHODS: The Modified Delphi Method was used with the goal of establishing the key procedural steps of an ESG. A panel of 8 experts was selected of which 6 participated. The panel was selected based on their experience with performing the procedure and consisted of 1 bariatric surgeon and 5 interventional gastroenterologists. A neutral facilitator was designated and produced a skeletonized initial version of the key steps that was sent to each of the experts. Each survey began with the experts rating the given steps on a Likert scale of 1-5, with 1 being the most inaccurate and 5 being the most accurate. The final product was also rated. The survey continued with open-ended questions designed to revise and polish the key steps. Areas of discrepancy were addressed with binary questions and majority vote. Respondents were given 10 days to complete each survey. At the end of each round, the survey was then redistributed with updated key steps and questions. This process was continued for a predesignated three rounds. RESULTS: Of the 8 experts that were queried 6/8, 5/8, and 5/8 replied to each round, respectively. The given ratings for the accuracy of the steps in each round were 4.2, 4.6, and 4.4. The final rating was 4.8. While expert opinion varied around smaller portions of the procedure, such as the placement of an overtube and the shape of each suture line, there was consensus on the need for full-thickness bites and an appropriate swirling of the tissue with the helix device. Whether or not to include the fundus in the gastroplasty was an additional area of discrepancy. 4/5 of the experts agreed that the fundus should remain intact. The final protocol consisted of 21 steps curated from the summarized responses of the experts. CONCLUSIONS: Using the Modified Delphi method, we have described 21 key steps to a safe, effective ESG. This rubric will standardize across institutions and practitioners. Furthermore, these findings allow for the generation of educational assessment tools to facilitate training and increase the adoption of ESG by endoscopists.

Personalized anti-reflux surgery: connecting GERD phenotypes in 690 patients to outcomes.

BACKGROUND: Anti-reflux operations are effective treatments for GERD. Despite standardized surgical techniques, variability in post-operative outcomes persists. Most patients with GERD possess one or more characteristics that augment their disease and may affect post-operative outcomes-a GERD "phenotype". We sought to define these phenotypes and to compare their post-operative outcomes. METHODS: We performed a retrospective review of a prospective gastroesophageal database at our institution, selecting all patients who underwent an anti-reflux procedure for GERD. Patients were grouped into different phenotypes based on the presence of four characteristics known to play a role in GERD: hiatal or paraesophageal hernia (PEH), hypotensive LES, esophageal dysmotility, delayed gastric emptying (DGE), and obesity. Patient-reported outcomes (GERD-HRQL, dysphagia, and reflux symptom index (RSI) scores) were compared across phenotypes using the Wilcoxon rank-sum test. RESULTS: 690 patients underwent an anti-reflux procedure between 2008 and 2022. Most patients underwent a Nissen fundoplication (302, 54%), followed by a Toupet or Dor fundoplication (205, 37%). Twelve distinct phenotypes emerged. Non-obese patients with normal esophageal motility, normotensive LES, no DGE, with a PEH represented the most common phenotype (134, 24%). The phenotype with the best post-operative GERD-HRQL scores at one year was defined by obesity, hypotensive LES, and PEH, while the phenotype with the worst scores was defined by obesity, ineffective motility, and PEH (1.5 ± 2.4 vs 9.8 ± 11.4, p = 0.010). There was no statistically significant difference in GERD-HRQL, dysphagia, or RSI scores between phenotypes after five years. CONCLUSIONS: We have identified distinct phenotypes based on common GERD-associated patient characteristics. With further study these phenotypes may aid surgeons in prognosticating outcomes to individual patients considering an anti-reflux procedure.

Practice patterns and outcomes of endoscopic sleeve gastroplasty based on provider specialty.

Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons ( P <0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases ( P <0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists ( P <0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists ( P >0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.

Peroral endoscopic myotomy for spastic esophageal dysmotility among opioid users: a multicenter propensity score matching study.

BACKGROUND AND AIMS: Opioid-induced esophageal dysfunction (OIED) often presents as spastic esophageal disorders (SEDs) and esophagogastric junction outflow obstruction (EGJOO). The aim of this study was to evaluate and compare clinical outcomes of peroral endoscopic myotomy (POEM) for SEDs and EGJOO among opioid users and nonusers. METHODS: This propensity score (PS) matching study included consecutive opioid users and nonusers who underwent POEM for SEDs and EGJOO between January 2018 and September 2022. The following covariates were used for the PS calculation: age, sex, duration of symptoms, Eckardt score, type of motility disorder, and length of myotomy during POEM. Clinical response was defined as a post-POEM Eckardt score ≤3. RESULTS: A total of 277 consecutive patients underwent POEM during the study period. PS matching resulted in the selection of 64 pairs of patients strictly matched 1:1 (n = 128) with no statistically significant differences in demographic, baseline, or procedural characteristics or in the parameters considered for the PS between the 2 groups. Clinical response to POEM was significantly lower among opioid users (51 of 64 [79.7%]) versus nonusers (60 of 64 [93.8%]) (P = .03) at a median follow-up of 18 months. Among opioid users, higher opioid dose (>60 morphine milligram equivalents per day) was associated with a higher likelihood of failure to respond to POEM (odds ratio, 4.59; 95% confidence interval, 1.31-3.98; P = .02). CONCLUSIONS: Clinical response to POEM for SEDs and EGJOO is significantly lower among opioid users versus nonusers. There was a dose-relationship between opioids and response to POEM, with higher daily opioid usage associated with a higher likelihood of treatment failure.

A Delphi Method for Development of a Barrett's Esophagus Question Prompt List as a Communication Tool for Optimal Patient-physician Communication.

BACKGROUND METHODS: The question prompt list content was derived through a modified Delphi process consisting of 3 rounds. In round 1, experts provided 5 answers to the prompts "What general questions should patients ask when given a new diagnosis of Barrett's esophagus" and "What questions do I not hear patients asking, but given my expertise, I believe they should be asking?" Questions were reviewed and categorized into themes. In round 2, experts rated questions on a 5-point Likert scale. In round 3, experts rerated questions modified or reduced after the previous rounds. Only questions rated as "essential" or "important" were included in Barrett's esophagus question prompt list (BE-QPL). To improve usability, questions were reduced to minimize redundancy and simplified to use language at an eighth-grade level (Fig. 1). RESULTS: Twenty-one esophageal medical and surgical experts participated in both rounds (91% males; median age 52 years). The expert panel comprised of 33% esophagologists, 24% foregut surgeons, and 24% advanced endoscopists, with a median of 15 years in clinical practice. Most (81%), worked in an academic tertiary referral hospital. In this 3-round Delphi technique, 220 questions were proposed in round 1, 122 (55.5%) were accepted into the BE-QPL and reduced down to 76 questions (round 2), and 67 questions (round 3). These 67 questions reached a Flesch Reading Ease of 68.8, interpreted as easily understood by 13 to 15 years olds. CONCLUSIONS: With multidisciplinary input, we have developed a physician-derived BE-QPL to optimize patient-physician communication. Future directions will seek patient feedback to distill the questions further to a smaller number and then assess their usability.

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.

The Laparoscopy in Biliary Exploration Research and Training Initiative (LIBERTI) trial: simulator-based training for laparoscopic management of choledocholithiasis.

BACKGROUND: Laparoscopic cholecystectomy with common bile duct exploration (LCBDE) is equivalent in safety and efficacy to endoscopic retrograde cholangiopancreatography (ERCP) plus laparoscopic cholecystectomy (LC) while decreasing number of procedures and length of stay (LOS). Despite these advantages LCBDE is infrequently utilized. We hypothesized that formal, simulation-based training in LCBDE would result in increased utilization and improve patient outcomes across participating institutions. METHODS: Data was obtained from an on-going multi-center study in which simulator-based transcystic LCBDE training curricula were instituted for attending surgeons and residents. A 2-year retrospective review of LCBDE utilization prior to LCBDE training was compared to utilization up to 2 years after initiation of training. Patient outcomes were analyzed between LCBDE strategy and ERCP strategy groups using χ2, t tests, and Wilcoxon rank tests. RESULTS: A total of 50 attendings and 70 residents trained in LCBDE since November 2020. Initial LCBDE utilization rate ranged from 0.74 to 4.5%, and increased among all institutions after training, ranging from 9.3 to 41.4% of cases. There were 393 choledocholithiasis patients analyzed using LCBDE (N = 129) and ERCP (N = 264) strategies. The LCBDE group had shorter median LOS (3 days vs. 4 days, p < 0.0001). No significant differences in readmission rates between LCBDE and ERCP groups (4.7% vs. 7.2%, p = 0.33), or in post-procedure pancreatitis (0.8% v 0.8%, p > 0.98). In comparison to LCBDE, the ERCP group had higher rates of bile duct injury (0% v 3.8%, p = 0.034) and fluid collections requiring intervention (0.8% v 6.8%, p < 0.009) secondary to cholecystectomy complications. Laparoscopic antegrade balloon sphincteroplasty had the highest technical success rate (87%), followed by choledochoscopic techniques (64%). CONCLUSION: Simulator-based training in LCBDE results in higher utilization rates, shorter LOS, and comparable safety to ERCP plus cholecystectomy. Therefore, implementation of LCBDE training is strongly recommended to optimize healthcare utilization and management of patients with choledocholithiasis.

Outcomes after per-oral endoscopic myotomy for Zenker's diverticula (Z-POEM) and correlation with impedance planimetry (FLIP).

INTRODUCTION: Zenker's diverticulum (ZD) is a false pulsion diverticulum of the cervical esophagus. It is typically found in older adults and manifests with dysphagia. The purpose of this study is to describe our experience with Per-oral endoscopic myotomy for Zenker's (Z-POEM) and intraoperative impedance planimetry (FLIP). METHODS: We performed a single institution retrospective review of patients undergoing Z-POEM in a prospective database between 2014 and 2022. Upper esophageal sphincter (UES) distensibility index (DI, mm2/mmHg) was measured by FLIP before and after myotomy. The primary outcome was clinical success. Secondary outcomes included technical failure, adverse events, and quality of life as assessed by the gastroesophageal health-related quality of life (GERD-HRQL), reflux severity index (RSI), and dysphagia score. A statistical analysis of DI was done with the paired t-test (p < 0.05). RESULTS: Fifty-four patients underwent Z-POEM, with FLIP measurements available in 30 cases. We achieved technical success and clinical success in 54/54 (100%) patients and 46/54 patients (85%), respectively. Three patients (6%) experienced contained leaks. Three patients were readmitted: one for aforementioned contained leak, one for dysphagia, and one post-operative pneumonia. Three patients with residual dysphagia underwent additional endoscopic procedures, all of whom had diverticula > 4 cm. Following myotomy, mean DI increased by 2.0 ± 1.7 mm2/mmHg (p < 0.001). In those with good clinical success, change in DI averaged + 1.6 ± 1.1 mm2/mmHg. Significant improvement was found in RSI and GERD-HRQL scores, but not dysphagia score. CONCLUSION: Z-POEM is a safe and feasible for treatment of ZD. We saw zero cases of intraoperative abandonment. We propose that large diverticula (> 4 cm) are a risk factor for poor outcomes and may require additional endoscopic procedures. An improvement in DI is expected after myotomy, however, the ideal range is still not known.

Impedance planimetry and panometry (EndoFLIP™) can replace manometry in preoperative anti-reflux surgery assessment.

BACKGROUND: Endoluminal functional impedance planimetry and panometry assesses secondary peristalsis in response to volumetric distention under sedation. We hypothesize that impedance planimetry and panometry can replace high-resolution manometry in the preoperative assessment prior to anti-reflux surgery. METHODS: Single institution prospective data were collected from patients undergoing anti-reflux surgery between 2021 and 2023. A 16-cm functional luminal imaging probe (FLIP) assessed planimetry and panometry prior to surgery under general anesthesia at the start of each case. Panometry was recorded and esophageal contractile response was classified as normal (NCR), diminished or disordered (DDCR), or absent (ACR) in real time by a single panometry rater, blinded to preoperative HRM results. FLIP results were then compared to preoperative HRM. RESULTS: Data were collected from 120 patients, 70.8% female, with mean age of 63 ± 3 years. There were 105 patients with intraoperative panometry, and 15 with panometry collected during preoperative endoscopy. There were 60 patients (50%) who had peristaltic dysfunction on HRM, of whom 57 had FLIP dysmotility (55 DDCR, 2 ACR) resulting in 95.0% sensitivity. There were 3 patients with normal secondary peristalsis on FLIP with abnormal HRM, all ineffective esophageal motility (IEM). No major motility disorder was missed by FLIP. A negative predictive value of 91.9% was calculated from 34/37 patients with normal FLIP panometry and normal HRM. Patients with normal HRM but abnormal FLIP had larger hernias compared to patients with concordant studies (7.5 ± 2.8 cm vs. 5.4 ± 3.2 cm, p = 0.043) and higher preoperative dysphagia scores (1.5 ± 0.7 vs. 1.1 ± 0.3, p = 0.021). CONCLUSION: Impedance planimetry and panometry can assess motility under general anesthesia or sedation and is highly sensitive to peristaltic dysfunction. Panometry is a novel tool that has potential to streamline and improve patient care and therefore should be considered as an alternative to HRM, especially in patients in which HRM would be inaccessible or poorly tolerated.

Performance of Endoscopic Sleeve Gastroplasty by Obesity Class in the United States Clinical Setting.

INTRODUCTION: Endoscopic sleeve gastroplasty (ESG) has gained popularity over the past decade and has been adopted in both academic and private institutions globally. We present outcomes of the largest cohort of patients from the United States undergoing ESG and evaluate these according to obesity class. METHODS: We performed a retrospective analysis of adult patients who underwent ESG. Medical information was abstracted from the electronic record with weight records up to 2 years after ESG. Percent total body weight loss (%TBWL) at 6, 12, 18, and 24 months was calculated based on baseline weight at the procedure. SPSS (version 29.0) was used for all statistical analyses. RESULTS: A total of 1,506 patients from 7 sites were included (501 Class I obesity, 546 Class II, and 459 Class III). Baseline demographics differed according to obesity class due to differences in age, body mass index (BMI), height, sex distribution, and race. As early as 6 months post-ESG, mean BMI for each class dropped to the next lower class and remained there through 2 years. %TWBL achieved in the Class III group was significantly greater when compared with other classes at all time points. At 12 months, 83.2% and 60.9% of patients had ≥10% and ≥15% TBWL for all classes. There were no differences in adverse events between classes. DISCUSSION: Real-world data from a large cohort of patients of all BMI classes across the United States shows significant and sustained weight loss with ESG. ESG is safe to perform in a higher obesity class with acceptable midterm efficacy.

Outcomes and predictors of treatment failure after anti-reflux mucosectomy for management of gastroesophageal reflux disease.

BACKGROUND: Anti-reflux mucosectomy is a novel endoscopic treatment for gastroesophageal reflux disease that serves as an intermediate therapy between medical and surgical intervention. We aimed to evaluate outcomes and identify predictors of treatment failure in patients requiring anti-reflux mucosectomy. METHODS: A prospective quality database was retrospectively reviewed. Upper endoscopy, pH testing, and functional luminal impedance planimetry were obtained at preop and 1 year post-operation. Quality of life outcomes were assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life, Reflux Symptom Index, and dysphagia scores preoperatively and up to 5 years postoperatively. RESULTS: Fifty-eight patients requiring anti-reflux mucosectomy were analyzed between 2016 and 2023. Preop Gastroesophageal Reflux Disease-Health Related Quality of Life mean scores improved at all time points 3 weeks to 2 years postoperatively (all P < .05). Preop mean Reflux Symptom Index scores also significantly improved at 6-month, 1-year, and 2-year timepoints (all P < .05). Dysphagia at 3 weeks was higher than preop scores (1.2 vs 2.1, P < .01) but returned to baseline. Upon follow-up, 43 patients (74.1%) had symptom improvement off proton pump inhibitors, 29 of whom reported complete symptom resolution. Out of 58 patients, 31 (53.4%) failed treatment due to DeMeester score (n = 22), erosive esophagitis (n = 2), Gastroesophageal Reflux Disease-Health Related Quality of Life ≥13 (n = 4), or <70% symptom resolution in the absence of pH or survey data (n = 3). Current smoking status was predictive of treatment failure (odds ratio 3.52, P < .031). Body mass index, DeMeester score, acid exposure time, and hiatal hernia ≤2 cm were not associated with treatment failure. CONCLUSION: Anti-reflux mucosectomy is associated with significant improvement in quality of life; however, symptom resolution may not correlate with objective reflux control. Smoking is a predictor of treatment failure and should be considered in patient selection.

Roux-en-Y gastric bypass versus fundoplication for gastroesophageal reflux disease in patients with obesity results in comparable outcomes.

BACKGROUND: Roux-en-Y gastric bypass and fundoplication are effective treatments for gastroesophageal reflux disease, though the optimal procedure of choice in obesity is unknown. We hypothesize that Roux-en-Y gastric bypass is non-inferior to fundoplication for symptomatic control of gastroesophageal reflux disease in patients with obesity. METHODS: We conducted a retrospective review of a prospectively maintained quality database. Patients with a body mass index ≥of 35 who presented for gastroesophageal reflux disease and subsequently underwent Roux-en-Y gastric bypass or fundoplication were included. Perioperative outcomes and pH testing data were reviewed. Patient-reported outcomes included Reflux Symptom Index, Dysphagia, Gastroesophageal Reflux Disease-Health Related Quality of Life, and Short Form-36 scores. Data were analyzed using the Wilcoxon rank sum test. RESULTS: Ninety-five patients underwent fundoplication (n = 72, 75.8%) or Roux-en-Y gastric bypass (n = 23, 24.2%) during the study period. All patients saw an improvement in gastroesophageal reflux disease symptoms and overall quality of life. There were no significant differences in postoperative Reflux Symptom Index, Dysphagia, or Short-Form-36 scores. Significant differences in gastroesophageal reflux disease-Health Related Quality of Life scores were seen at preoperative, 1, 2, and 5 years postoperative (P < .05), with better symptom control in the fundoplication group. No significant difference was noted in postoperative DeMeester scores or percent time pH <4. Weight loss was significantly higher in the Roux-en-Y gastric bypass group at all postoperative time points up to 5 years (P < .05). CONCLUSION: Roux-en-Y gastric bypass and fundoplication both decrease gastroesophageal reflux disease symptoms. Subjective data shows that patients undergoing Roux-en-Y gastric bypass may complain of worse symptoms compared to patients undergoing fundoplication. Objective data notes no significant difference in postoperative pH testing. Despite previous data, offering fundoplication or Roux-en-Y gastric bypass to patients with a body mass index of ≥35 kg/m2 is appropriate. The choice of surgical approach should be more directed to patient needs and desired goals at the time of the initial clinic visit.

Teaching endoscopic management of gastrointestinal hemorrhage using a modular simulation curriculum.

BACKGROUND: As flexible endoscopy is increasingly adopted as a minimally invasive approach to surgical challenges, an efficient curriculum is needed to train surgeons in therapeutic endoscopy. We developed a simulation-based approach to teaching endoscopic management of gastrointestinal hemorrhage as part of a modular curriculum, complete with task performance pre- and post-testing. METHODS: Two sessions of our advanced flexible endoscopy course were taught using ex vivo porcine models to simulate active gastrointestinal hemorrhage and allow for training in hands-on endoscopic management. The module is composed of hands-on pretesting, didactics, mentored practice sessions, and postcourse assessments. Pre- and postcourse tests and surveys evaluated knowledge, confidence, and performance of participants and results were analyzed using the paired t test. RESULTS: Sixteen practicing surgeons participated in the course. After course completion, overall knowledge-based assessments improved from 3.4 (±1.9) to 5.8 (±2.0) (P < .001). Although participants with glove sizes >7.0 and ≥2 years in practice had higher pretest evaluator scores (P = .045 and P = .020), all participants demonstrated overall improvement in endoscopic management of hemorrhage, with postcourse evaluator score increases from 20.9 (±1.6) to 23.6 (±2.0) (P = .001) and specific improvements in identification of target bleeding (P = .015), endoscopic clip setup (P < .001), and clip deployment (P = .002). Surveys also found increased confidence in competency after curriculum completion, 11.6 (±3.4)-23.0 (±5.5) (P < .001). CONCLUSION: Our simulation-based approach to teaching the endoscopic management of gastrointestinal bleeding emphasizes hands-on pretesting and provides an effective training model to improve the knowledge, confidence, and technical performance of practicing surgeons.

Long-term outcomes of Zenker's peroral endoscopic myotomy (Z-POEM) for treatment of Zenker's diverticulum.

Background and study aims Z-POEM is now an established therapy for symptomatic Zenker's diverticulum (ZD). Short-term follow-up of up to 1-year post Z-POEM suggests excellent efficacy and safety; however, long-term outcomes are not known. Thus, we sought to report on longer-term outcomes (≥ 2 years) following Z-POEM for treatment of ZD. Patients and methods This was an International multicenter retrospective study at eight institutions across North America, Europe, and Asia over a 5-year period (from December 3, 2015 to March 13, 2020) of patients who underwent Z-POEM for management of ZD with a minimum 2-year follow-up. The primary outcome was clinical success, defined as improvement in dysphagia score to ≤ 1 without need for further procedures during the first 6 months. Secondary outcomes included rate of recurrence in patients initially meeting clinical success, rate of reintervention, and adverse events (AEs). Results A total of 89 patients (male 57.3 %, mean age 71 ±â€Š12 years) underwent Z-POEM for treatment of ZD (mean diverticulum size was 3.4 ±â€Š1.3 cm). Technical success was achieved in 97.8 % of patients (n = 87) with a mean procedure time of 43.8 ±â€Š19.2 minutes. The median post-procedure hospital stay was 1 day. There were eight AEs (9 %) (3 mild, 5 moderate). Overall, clinical success was achieved in 84 patients (94 %). Mean dysphagia, regurgitation, and respiratory scores all improved dramatically from 2.1 ±â€Š0.8, 2.8 ±â€Š1.3, and 1.8 ±â€Š1.6 pre-procedure to 0.13 ±â€Š0.5, 0.11 ±â€Š0.5, and 0.05 ±â€Š0.4, respectively, post-procedure at most recent follow-up (all P  < 0.0001). Recurrence occurred in six patients (6.7 %) during a mean length of follow-up of 37 months (range 24 to 63 months). Conclusions Z-POEM is a highly safe and effective treatment for Zenker's diverticulum with durable treatment effect to at least 2 years.

Target distensibility index on impedance planimetry during fundoplication by choice of wrap and choice of bougie.

INTRODUCTION: Impedance planimetry (FLIP) provides objective feedback to optimize fundoplication outcomes. Ideal FLIP ranges for differing wraps and bougies have not yet been established. We report FLIP measurements during fundoplication grouped by choice of wrap and bougie with associated outcomes. METHODS: A retrospective review of a prospective gastroesophageal database was performed for all Nissen or Toupet fundoplication with intraoperative FLIP using an 8-cm catheter, 30-mL and/or 40-mL fill and/or 16-cm catheter, 60-mL fill. Surgeons used no bougie, the FLIP balloon as bougie, or a hard bougie. Outcomes included perioperative data, Reflux Symptom Index, GERD-HRQL, Dysphagia scores, need for dilation, postoperative EGD findings, and hernia recurrence. Group comparisons were made using two-tailed Kruskal-Wallis and Fisher's exact tests. RESULTS: Between 2016 and 2022, 333 patients underwent fundoplication and intraoperative FLIP. Procedures included Toupet with hard bougie (TFHB, N = 147), Toupet with FLIP bougie (TFFB, N = 69), Toupet without bougie (TFNB, N = 78), Nissen with hard bougie (NFHB, n = 20), or Nissen with FLIP bougie (NFFB, N = 19). FLIP measurements at 30-mL/40-mL fills varied significantly between groups, notably distensibility index at crural closure (CCDI) and post-fundoplication (FDI). No significant differences in FLIP measurements were seen between those who developed poor postoperative outcomes and those who did not, including when grouping by choice of wrap and bougie. At a 40-mL fill, abnormal motility patients with CCDI > 3.5 mm2/mmHg developed zero postoperative dysphagia. TFFB abnormal motility patients with CCDI > 3.5 mm2/mmHg or FDI > 3.6 mm2/mmHg developed zero postoperative dysphagia. CONCLUSION: Intraoperative FLIP measurements vary by fundoplication and bougie choice. A CCDI > 3.5 mm2/mmHg (40 mL fill) should be sought in abnormal motility patients, regardless of wrap or bougie, to avoid postoperative dysphagia. TFFB abnormal motility patients with FDI > 3.6 mm2/mmHg (40 mL fill) also developed zero postoperative dysphagia. FDI > 6.2 mm2/mmHg (40 mL fill) was seen in all postoperative hernia recurrences.

A 13-year experience with biologic and biosynthetic absorbable mesh reinforced laparoscopic paraesophageal hernia repair.

BACKGROUND: Mesh reinforced cruroplasty during laparoscopic paraesophageal hernia repair remains controversial due to wide variation in surgical technique and mesh composition. This study aims to review outcomes and rates of recurrence following laparoscopic paraesophageal hernia repair (LPEHR) with mesh reinforced cruroplasty utilizing absorbable mesh at a single institution. METHODS: A retrospective review of all patients who underwent LPEHR with mesh was performed. Medical records were reviewed for patient reported, radiographic or endoscopic evidence of recurrence, defined as > 2 cm of vertical intrathoracic stomach. If no studies were available for review, patients were considered to have no recurrence. Outcomes and mesh-related complications were also reviewed. RESULTS: Between 10/2008 and 9/2021, 473 patients underwent LPEHR with absorbable mesh; 1.3% type 2 hernias, 86.0% type 3 hernias, 12.7% type 4 hernias. Three types of mesh were used: initially biologic mesh (n = 83), then heavyweight synthetic bioabsorbable mesh (n = 261), and finally lightweight synthetic bioabsorbable mesh (n = 111). There were no significant differences in age, ASA, BMI, gender, smoking status, chronic steroid use, preoperative acid suppression, hernia type, or recurrent hernia between groups. There were no significant differences in 30-day postoperative outcomes. Reflux Symptom Index, GERD-HRQL, and Dysphagia Scores at 1- and 2-year postoperative timepoints were not significantly different. The overall recurrence rate was 16.7%, with no significant differences in recurrence rates between biologic, heavyweight or lightweight biosynthetic absorbable mesh through 2 years after surgery. A shorter median time to recurrence (10 months, p = 0.016) was seen in the lightweight group. CONCLUSION: LPEHR with absorbable mesh reinforced cruroplasty is feasible and safe, with equivalent patient-reported outcomes, including dysphagia, up to 2-years postop regardless of mesh choice. No significant differences in recurrence rates between biologic, heavyweight, or lightweight synthetic bioabsorbable mesh were seen up to 2 years after LPEHR.

Acid exposure time better predicts outcomes following anti-reflux surgery than DeMeester score.

BACKGROUND: Criteria to diagnose gastroesophageal reflux disease (GERD) vary. The American Gastroenterology Association (AGA) 2022 Expert Review on GERD focuses on acid exposure time (AET) rather than DeMeester score from ambulatory pH testing (BRAVO). We aim to review outcomes following anti-reflux surgery (ARS) at our institution, grouped by differing criteria for the diagnosis of GERD. METHODS: A retrospective review of a prospective gastroesophageal quality database was performed for all patients undergoing evaluation for ARS with preoperative BRAVO ≥ 48 h. Group comparisons were made using two-tailed Wilcoxon rank-sum and Fisher's exact tests and two-tailed statistical significance of p < 0.05. RESULTS: Between 2010 and 2022, 253 patients underwent an evaluation for ARS with BRAVO testing. Most patients (86.9%) met our institution's historical criteria: LA C/D esophagitis, Barrett's, or DeMeester ≥ 14.72 on 1+ days. Fewer patients (67.2%) met new AGA criteria: LA B/C/D esophagitis, Barrett's, or AET ≥ 6% on 2+ days. Sixty-one patients (24%) met historical criteria only, with significantly lower BMI, ASA, less hiatal hernias, and less DeMeester and AET-positive days, a less severe GERD phenotype. There were no differences between groups in perioperative outcomes or % symptom resolution. Objective GERD outcomes (need for dilation, esophagitis, and postop BRAVO) were equivalent between groups. Patient-reported quality of life scores, including GERD-HRQL, RSI, and Dysphagia Score did not differ between groups from preop through 1 year postop. Those who met our historical criteria only reported significantly worse RSI scores (p = 0.03) and worse GERD-HRQL scores at 2 years postop, though not statistically significant (p = 0.07). CONCLUSION: Updated AGA GERD guidelines exclude a portion of patients who historically would have been diagnosed with and surgically treated for GERD. This cohort appears to have a less severe GERD phenotype but equivalent outcomes up to 1 year, with more atypical GERD symptoms at 2 years postop. AET may better define who should be offered ARS than DeMeester score.

Per-Oral Plication of (Neo)Esophagus: Technical Feasibility and Early Outcomes.

BACKGROUND: Endoscopic sleeve gastroplasty is an example of endoscopic sutured plications being used to remodel a gastrointestinal organ. With per-oral plication of the esophagus (POPE), similar plications are used to remodel the dilated and redundant megaesophagus of end-stage achalasia. Redundancies and dilations can also develop in the neoesophagus of a patient with prior esophagectomy. Megaesophagus and a redundant neoesophagus can both lead to debilitating dysphagia, regurgitation, and recurrent aspiration pneumonia. Traditionally, this anatomic problem requires complex revisional or excisional surgery, to which POPE offers an incisionless alternative. METHODS: This is a dynamic manuscript with video demonstration of POPE, as well as review of five cases performed in 1 year. Data were collected in a prospectively maintained database, and the institutional review board approved retrospective review for this publication. The procedure is performed using a dual-channel upper endoscope fixed with an endoscopic suturing device, with the patient supine under general anesthesia. RESULTS: POPE was technically completed in all cases with no serious complications, and patients either went home the same day or spent one night for observation. Most patients reported immediate and substantial symptomatic improvement. Objective pre- and post-measures include esophagram and nuclear gastric emptying studies. CONCLUSION: This article discusses early experience at one institution with POPE, with detailed description of the procedure and technical considerations. An accompanying video reviews two cases, one with megaesophagus and one with a gastric conduit. While this novel procedure has limited and rare indications, it offers a low-morbidity solution to a challenging anatomic problem that traditionally requires invasive surgery.

Experience with Impedance Planimetry for Surgical Foregut Disease in 1,097 Cases.

BACKGROUND: The geometry and compliance of gastrointestinal sphincters may be assessed by impedance planimetry using a functional lumen imaging probe (FLIP). We describe our institutional foregut surgeon experience using FLIP in 1,097 cases, highlighting instances where FLIP changed operative decision making. STUDY DESIGN: A retrospective review of an IRB-approved prospective quality database was performed. This included operative and endoscopic suite foregut procedures using FLIP between February 2013 and May 2022. RESULTS: During the study period, FLIP was used a total of 1,097 times in 919 unique patients by 2 foregut surgeons. Intraoperative FLIP was used during 573 antireflux procedures and 272 endoscopic myotomies. FLIP was also used during 252 endoscopic suite procedures. For those undergoing preoperative workup of GERD, starting in 2021, esophageal panometry was performed in addition to standard FLIP measurements at the lower esophageal sphincter. In 77 cases, intraoperative FLIP changed operative decision making. During antireflux procedures, changes included adding or removing crural sutures, adjusting a fundoplication tightness, choice of full vs partial wrap, and magnetic sphincter augmentation sizing. For endoscopic procedures, changes included aborting peroral endoscopic myotomy or Zenker's peroral endoscopic myotomy, performing a myotomy when preoperative diagnosis was unclear, or performing additional myotomy. CONCLUSIONS: FLIP is a useful tool for assessing the upper esophageal sphincter, lower esophageal sphincter, pylorus, and secondary esophageal peristalsis that can be used in a wide variety of clinical situations within a foregut surgeon's practice. It can also function as an adjunct in intraoperative decision making.

Zenker's peroral endoscopic myotomy for management of large Zenker's diverticulum.

BACKGROUND: Zenker's diverticulum peroral endoscopic myotomy (zPOEM) is a minimally invasive treatment strategy for Zenker's diverticulum, with excellent results for management of small-to-moderate Zenker's diverticulum. We evaluated its use in the management of large Zenker's diverticulum. METHODS: This was a retrospective multicenter cohort study across 11 international centers including adult patients with large Zenker's diverticulum ≥ 40 mm treated by zPOEM between March 2017 and March 2022. The primary outcome was clinical success (dysphagia score ≤ 1 without need for further intervention). Secondary outcomes included technical success (complete myotomy as intended), adverse events (AEs), and rate of recurrence. RESULTS: 83 patients (male 62.7 %, mean age 72.6 [SD 11.5] years) underwent zPOEM for treatment of large Zenker's diverticulum (median size 50 mm, interquartile range [IQR] 41-55 mm, range 40-80 mm). The zPOEM procedure was technically successful in 82 patients (98.8 %), with a mean procedure time of 48.7 (SD 23.2) minutes. Clinical success was achieved in 71 patients (85.5 %). Median (IQR) symptom scores improved significantly from baseline for dysphagia (2 2 3 vs. 0 [0-2]; P < 0.001), regurgitation (3 2 3 4 vs. 0 [0-0]; P < 0.001), and respiratory symptoms (2 [0-3] vs. 0 [0-0]; P < 0.001). Among patients achieving clinical success, only one recurrence (1.4 %) was recorded during a median follow-up of 12.2 months (IQR 3-28). Post-procedure AEs, all mild to moderate, occurred in four patients (4.8 %). CONCLUSION: This study demonstrated safe and effective use of zPOEM in the management of large Zenker's diverticulum.