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.

The Impact of Ineffective Esophageal Motility on Patients Undergoing Magnetic Sphincter Augmentation.

OBJECTIVE: To evaluate and characterize outcomes of MSA in patients with IEM. SUMMARY BACKGROUND DATA: MSA improves patients with gastroesophageal reflux and normal motility. However, many patients have IEM, which could impact the outcomes of MSA and discourage use. METHODS: An international, multi-institutional case control study of IEM patients undergoing MSA matched to normal patients was performed. Primary outcomes were new onset dysphagia and need for postoperative interventions. RESULTS: A total of 105 IEM patients underwent MSA with matching controls. At 1 year after MSA: GERD-Health Related Quality of Life was similar; DeMeester scores in IEM patients improved to 15.7 and 8.5 in controls ( P = 0.021); and normalization of the DeMeester score for IEM = 61.7% and controls = 73.1% ( P = 0.079).In IEM patients, 10/12 (83%) with preop dysphagia had resolution; 11/66 (17%) had new onset dysphagia and 55/66 (83%) never had dysphagia. Comparatively, in non-IEM patients, 22/24 (92%) had dysphagia resolve; 2/24 (8%) had persistent dysphagia; 7/69 (10%) had new onset dysphagia, and 62/69 (90%) never had dysphagia.Overall, 19 (18%) IEM patients were dilated after MSA, whereas 12 (11%) non-IEM patients underwent dilation ( P = 0.151). Nine (9%) patients in both groups had their device explanted. CONCLUSIONS: Patients with IEM undergoing MSA demonstrate improved quality of life and reduction in acid exposure. Key differences in IEM patients include lower rates of objective GERD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GERD patients with IEM should be counselled about these possibilities.

Abnormal response after multiple rapid swallow provocation is not predictive of post-operative dysphagia following a tailored fundoplication approach.

INTRODUCTION: The aim was to evaluate the clinical significance of multiple rapid swallows (MRS) during high-resolution manometry (HRM) prior to fundoplication. Despite pre-operative HRM, up to 38% of patients report post-fundoplication dysphagia. Suggestion that MRS improves prediction of dysphagia after fundoplication has not been investigated when using a tailored approach. We hypothesize response to MRS is predictive of dysphagia after tailored fundoplication. METHODS: A retrospective cohort study was performed on patients undergoing HRM with MRS provocation 5/2019-7/2021 at a single institution. Patients who underwent subsequent index laparoscopic fundoplication, without peptic stricture or achalasia, were included. After performing standard 10-swallow HRM, MRS provocation was performed. Patient-reported dysphagia frequency scores were collected at initial consultation and post-operative follow-up. At least weekly symptoms were considered clinically significant. Normal MRS response was defined as adequate deglutitive inhibition and MRS contractile response. Fundoplications were tailored based on standard HRM values. RESULTS: HRM was performed in 1201 patients, 220 met inclusion criteria. Clinically significant pre-operative dysphagia was reported by 85 (38.6%). Patients undergoing partial fundoplication (n = 123, 55.9%) had lower mean distal contractile integer, distal esophageal contraction amplitude, and percent peristalsis (p < 0.005). Post-operatively, 120 (54.5%) were without dysphagia, 59 (26.8%) had improved dysphagia, 26 (11.8%) had unchanged dysphagia, and 15 (6.8%) reported new dysphagia. There was no statistical difference in early or late dysphagia outcome between tailored fundoplication groups (p = 0.69). On univariate and multivariate analysis, neither MRS response, nor standard HRM metrics were significantly associated with post-operative dysphagia. Younger age (OR 0.96, 95% CI 0.94-0.986, p = 0.042) and the presence of pre-operative dysphagia (OR 2.54, 95% CI 1.17-5.65, p = 0.015) were significant predictors of post-operative dysphagia. CONCLUSION: The risk of clinically significant dysphagia post-fundoplication is low when using a tailored approach based on standard HRM metrics. Additional data provided by MRS does not add to surgical decision-making using the investigated approach.

Diaphragmatic relaxing incisions for complex hiatal reconstruction: longer-term follow-up confirms safety, efficacy and rare complications.

BACKGROUND: Tension is an important factor in hernia repairs. Relaxing incisions to reduce tension are common with ventral hernia repairs, and techniques for relaxing incisions also exist for the hiatus. The aim of this study was to update our original experience with a diaphragm relaxing incision (DRI) in a larger group of patients with longer follow-up. METHODS: A retrospective chart review was performed to identify all patients who had a DRI between August 2016 and September 2021 during hiatal hernia repair. All DRI defects were repaired with permanent mesh remote from the esophagus. Objective follow-up was with chest x-ray, upper GI series (UGI) or both. RESULTS: Seventy-three patients had a total of 79 DRI (right in 63, left in 4, and bilateral in 6 patients), during a primary (n = 52) or redo (n = 21) hiatal hernia repair. Concomitant Collis gastroplasty was used in 38 patients (52%). A single intra-operative complication occurred where the right crus tore during a right DRI. At a median of 15 months, 78% of patients had objective follow-up. There was one hernia through a repaired right DRI (1.2%). No patient had evidence of diaphragm paralysis and there were no mesh infections. The 1-year hernia recurrence rate in these patients was 3.9%. CONCLUSIONS: A DRI can be done safely with minimal risk of intra- or post-operative complications. There was a low rate of herniation through the defect when repaired with permanent mesh. No patient developed a mesh infection despite concomitant Collis gastroplasty in 52% of patients, and there was no evidence of diaphragm paralysis on imaging studies. Further, the low rate of hiatal hernia recurrence suggests efficacy of a DRI to reduce crural closure tension. These excellent outcomes should encourage use of a DRI in patients with a difficult hiatus during hernia repair.

The Development and Natural History of Hiatal Hernias: A Study Using Sequential Barium Upper Gastrointestinal Series.

OBJECTIVE: The aim of this study was to use barium upper gastrointestinal series (UGI) to evaluate the development and natural history of a hiatal hernia. SUMMARY OF BACKGROUND DATA: Hiatal hernias are common but the natural history of sliding and paraesophageal type hernias is poorly understood. METHODS: We reviewed UGI reports from 1987 to 2017 using a word scanning software program to identify individuals that had a hiatal hernia. Only those with at least 2 UGI studies 5 or more years apart were selected. The studies were then reviewed. RESULTS: There were 89 individuals that met inclusion criteria. Twenty-one people had no hiatal hernia on initial UGI and over a median of 99 months a sliding hiatal hernia (SHH) developed in 16 and a PEH developed in 5 people. A SHH was present on initial UGI in 55 people and at a median of 84 months subsequent UGI showed the SHH was stable in 11 (20%), increased in size in 30 (55%), and changed to a PEH in 14 people (25%). In 13 people a PEH was present on initial UGI and over a median of 97 months it was stable in 5 and increased in size in 8 people (62%). CONCLUSIONS: We showed that both SHH and PEH can develop over time and that the majority of both increased in size on follow-up UGI study. Further, 25% of SHH became a PEH over time. Recognizing an increase in size or change in type of a hiatal hernia may be clinically relevant to help understand changing or worsening symptoms in an individual.

High Resolution Manometry in a Functioning Fundoplication - Establishing a Standard Profile: Retrospective Chart Review.

OBJECTIVE: The aim of this study was to provide a full HRM data set in patients with a normal functioning fundoplication. BACKGROUND: The Chicago classification was devised to correlate HRM values to the clinical status of patients with swallowing disorder. However, it is unclear whether those values are applicable after fundoplication as the literature is sparse. METHODS: We identified patients with pre- and postoperative HRM who had a normal functioning primary fundoplication as defined by (1) resolution of preoperative symptoms without significant postoperative side effects, (2) no dysphagia reported on a standardized questionnaire given on the day of the postoperative HRM and (3) normal acid exposure determined objectively by esophageal pH-testing. RESULTS: Fifty patients met inclusion criteria for the study. Thirty-three patients (66%) underwent complete fundoplication and 17 patients (34%) underwent posterior partial fundoplication. Postoperative HRM was performed at a median of 12 months after primary surgery. Lower esophageal sphincter (LES) values significantly increased with the addition of a fundoplication. Median integrated relaxation pressure (IRP) was 14 mm Hg ( P = 0.0001), median resting pressure 19.5 mm Hg ( P = 0.0263), and median total length LES was 3.95 cm ( P = 0.0098). The 95th percentile for IRP in a complete fundoplication was 29 versus 23 mm Hg in a partial fundoplication ( P = 0.3667). CONCLUSION: We offer a new standard manometric profile for a normally functioning fundoplication which provides a necessary benchmark for analyzing postoperative problems with a fundoplication. The previously acceptedupper limit defining esophageal outflow obstruction (IRP >20 mm Hg) is not clinically applicable after fundoplication as the majority of patients in this dysphagia-free cohort exceeded this value. Interestingly, there does not seem to be a significant difference in HRM LES values between complete and partial fundoplication.

Multicenter randomized controlled trial comparing forceps biopsy sampling with wide-area transepithelial sampling brush for detecting intestinal metaplasia and dysplasia during routine upper endoscopy.

BACKGROUND AND AIMS: Intestinal metaplasia (IM) in the esophagus is a potentially premalignant mucosal change. The aim of this study was to compare the frequency of IM detection during upper endoscopy by forceps biopsy sampling (FB) versus wide-area transepithelial sampling (WATS) brush. METHODS: Patients presenting for upper endoscopy for foregut symptoms or surveillance of Barrett's esophagus (BE) at 9 centers in the United States were randomized to either FB or WATS. RESULTS: Of 1002 patients, FB was done in 505 and WATS in 497. The overall frequency of finding IM was 21% and was similar with FB (19.6%) and WATS (22.7%, P = .2). Low-grade dysplasia was found in 8 patients. No patient had high-grade dysplasia. There was no difference in detection of dysplasia between FB and WATS. In patients with no history of IM, WATS found significantly more IM compared with FB when a columnar-lined esophagus (CLE) was present (32.4% with WATS vs 15.2% with FB, P = .004). In 184 patients with known BE, FB and WATS found IM with similar frequency (38.5% FB vs 41.9% WATS, P = .6) with no difference in short- or long-segment BE. CONCLUSIONS: Overall, FB and WATS detected a similar frequency of IM and dysplasia. WATS was twice as likely as FB to find IM in patients without a history of BE who had CLE on endoscopy. In patients with known BE, WATS and FB showed IM and dysplasia with similar frequency. These findings suggest that WATS can be used instead of FB with similar or improved efficacy at detecting IM and dysplasia. (Clinical trial registration number: NCT03859557.).

Experience-based expert consensus on the intra-operative usage of the Endoflip impedance planimetry system.

INTRODUCTION: The Endoluminal Functional Lumen Imaging Probe (Endoflip™) is a balloon-based catheter that provides real-time, objective feedback regarding the distensibility of any sphincter in the gastrointestinal tract. Usage of the Functional Lumen Imaging Probe (FLIP) has not been standardized, which has limited the interpretation and generalizability of published data. The purpose of this consensus statement is to provide a standardized protocol for obtaining FLIP measurements in order to create a more uniform approach to data collection. METHODS: Five expert foregut surgeons, all of whom utilize the FLIP system in their daily practice, convened on March 19, 2019, to create a standardized protocol for obtaining FLIP measurements during hiatal hernia repair and fundoplication, magnetic sphincter augmentation, laparoscopic Heller myotomy, and peroral endoscopic myotomy. Existing literature was presented and reviewed. Each step of the protocol was discussed in detail until a unanimous consensus was reached. RESULTS: A standardized protocol was developed for obtaining FLIP measurements during hiatal hernia repair and fundoplication, magnetic sphincter augmentation, laparoscopic Heller myotomy, and peroral endoscopic myotomy. CONCLUSION: The FLIP impedance planimetry system is the only technology available that provides surgeons an objective way to assess the tightness of a fundoplication or adequacy of a myotomy during an operation. While considerable research remains to correlate FLIP measurements to patient outcomes, this consensus statement will provide standardization of data collection among FLIP users that will enhance the understanding of future study results.

POEM: clinical outcomes beyond 5 years.

BACKGROUND: The short-term success of peroral endoscopic myotomy (POEM) is well documented but the durability of the operation is questioned. The aim of this study was to evaluate the clinical outcomes of the POEM procedure for esophageal motility disorders in a large cohort in which all patients had at least 5 years of follow-up. METHODS: All patients from a single center who underwent a POEM between October 2010 and September 2014 were followed for long-term clinical outcomes. Postoperative Eckardt symptom scores of short term and ≥ 5 years were collected through phone interview. Clinical success was defined as an Eckardt score < 3. Overall success was defined as Eckardt score < 3 and freedom from additional interventions. RESULTS: Of 138 patients, 100 patients were available for follow-up (mean age 56, 52% male). The indication for operation was achalasia in 94. The mean follow-up duration was 75 months (range: 60-106 months). Dysphagia was improved in 91% of patients. Long-term overall success was achieved in 79% of patients (80% of achalasia patients, 67% of DES patients). Preoperative mean Eckardt score was 6. At 6 months, it was 1, and at 75 months, it was 2 (p = 0.204). Five-year freedom from intervention was 96%. Overall, 7 patients had additional treatments: 1 balloon dilation (35 mm), 4 laparoscopic Heller myotomy, and 2 redo POEM at a mean of 51 months post-POEM. Ninety-three percent expressed complete satisfaction with POEM. CONCLUSION: A multitude of studies has shown the early benefits of POEM. Here, we show that nearly 80% of patients report clinical success with no significant decrement in symptom scores between their short- and long-term follow-up. Clearly POEM is an effective option for achalasia with durable long-term treatment efficacy.

SAGES guidelines for the use of peroral endoscopic myotomy (POEM) for the treatment of achalasia.

BACKGROUND: Peroral endoscopic myotomy (POEM) is increasingly used as primary treatment for esophageal achalasia, in place of the options such as Heller myotomy (HM) and pneumatic dilatation (PD) OBJECTIVE: These evidence-based guidelines from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) intend to support clinicians, patients and others in decisions about the use of POEM for treatment of achalasia. RESULTS: The panel agreed on 4 recommendations for adults and children with achalasia. CONCLUSIONS: Strong recommendation for the use of POEM over PD was issued unless the concern of continued postoperative PPI use remains a key decision-making concern to the patient. Conditional recommendations included the option of using either POEM or HM with fundoplication to treat achalasia, and favored POEM over HM for achalasia subtype III.

Safety and efficacy of magnetic sphincter augmentation dilation.

BACKGROUND: The magnetic sphincter augmentation device (MSA) provides effective relief of gastroesophageal reflux symptoms. Dysphagia after MSA implantation sometimes prompts endoscopic dilation. The manufacturer's instructions are that it be performed 6 or more weeks after implantation under fluoroscopic guidance to not more than 15 mm keeping 3 or more beads closed. The purpose of this study was to assess adherence to these recommendations and explore the techniques used and outcomes after MSA dilation. METHODS AND PROCEDURES: We conducted a multicenter retrospective review of patients undergoing dilation for dysphagia after MSA placement from 2012 to 2018. RESULTS: A total of 144 patients underwent 245 dilations. The median size of MSA placed was 14 beads (range 12-17) and the median time to dilation was 175 days. A second dilation was performed in 67 patients, 22 patients had a third dilation and 7 patients underwent 4 or more dilations. In total, 17 devices (11.8%) were eventually explanted. The majority of dilations were performed with a balloon dilator (81%). The median dilator size was 18 mm and 73.4% were done with a dilator larger than 15 mm. There was no association between dilator size and need for subsequent dilation. Fluoroscopy was used in 28% of cases. There were no perforations or device erosions related to dilation. DISCUSSION: There is no clinical credence to the manufacturer's recommendation for the use of fluoroscopy and limitation to 15 mm when dilating a patient for dysphagia after MSA implantation. Use of a larger size dilator was not associated with perforation or device erosion, but also did not reduce the need for repeat dilation. Given this, we would recommend that the initial dilation for any size MSA device be done using a 15 mm through-the-scope balloon dilator. Dysphagia prompting dilation after MSA implantation is associated with nearly a 12% risk of device explantation.

Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial.

BACKGROUND & AIMS: Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. METHODS: Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. RESULTS: Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. CONCLUSIONS: In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.

Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U.S. panel.

BACKGROUND AND AIMS: The objective of this study was to examine expert opinion and agreement on the treatment of distinct GERD profiles from surgical and therapeutic endoscopy perspectives. METHODS: We used the RAND/University of California, Los Angeles Appropriateness Method over 6 months (July 2018 to January 2019) to assess the appropriateness of antireflux interventions among foregut surgeons and therapeutic gastroenterologists. Patients with primary atypical or extraesophageal symptoms were not considered. Patient scenarios were grouped according to their symptom response to proton pump inhibitor (PPI) therapy. The primary outcome was appropriateness of an intervention. RESULTS: Antireflux surgery with laparoscopic fundoplication (LF) and magnetic sphincter augmentation (MSA) were ranked as appropriate for all complete and partial PPI responder scenarios. Transoral incisionless fundoplication was ranked as appropriate in complete and partial PPI responders without a hiatal hernia. Radiofrequency energy was not ranked as appropriate for complete or partial responders. There was lack of agreement between surgery and interventional gastroenterology groups on the appropriateness of LF and MSA for PPI nonresponders. Rankings for PPI nonresponders were similar when results from impedance-pH testing on PPI therapy were available, except that LF and MSA were not ranked as appropriate for PPI nonresponders if the impedance-pH study was negative. CONCLUSIONS: This work highlights areas of agreement for invasive therapeutic approaches for GERD and provides impetus for further interdisciplinary collaboration and trials to compare and generate novel and effective treatment approaches and care pathways, including the role of impedance-pH testing in PPI nonresponders.

Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study.

OBJECTIVE: To report 1-year results from a 5-year mandated study. SUMMARY BACKGROUND DATA: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study. METHODS: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors. RESULTS: A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported. CONCLUSIONS: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.

Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial.

BACKGROUND AND AIMS: GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. METHODS: One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. RESULTS: Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P < .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD-health-related quality of life scores (P < .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (P < .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia. CONCLUSION: Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.).

Robotic-assisted versus laparoscopic unilateral inguinal hernia repair: a comprehensive cost analysis.

BACKGROUND: Cost-effectiveness of robotic-assisted surgery is still debatable. Robotic-assisted inguinal hernia repair has no clear clinical benefit over laparoscopic repair. We performed a comprehensive cost-analysis comparison between the two approaches for evaluation of their cost-effectiveness in a large healthcare system in the Western United States. METHODS: Health records in 32 hospitals were queried for procedural costs of inguinal hernia repairs between January 2015 and March 2017. Elective robotic-assisted or laparoscopic unilateral inguinal hernia repairs were included. Cost calculations were done using a utilization-based costing model. Total cost included: fixed cost, which comprises medical device and personnel costs, and variable cost, which comprises disposables and reusable instruments costs. Other outcome measures were length of stay (LOS), conversion to open, and operative times. Statistics were done using t test for continuous variables and χ2 test for categorical variables. A p-value < 0.05 was considered significant. RESULTS: A total of 2405 cases, 734 robotic-assisted (633 Primary: 101 recurrent) and 1671 laparoscopic (1471 Primary: 200 recurrent), were included. The average total cost was significantly higher (p < 0.001) in the robotic-assisted group ($5517) compared to the laparoscopic group ($3269). However, the average laparoscopic variable cost ($1105) was significantly higher (p < 0.001) than the robotic-assisted cost ($933). Whereas there was no significant difference between the two groups for LOS and conversion to open, average operative times were significantly higher in the robotic-assisted group (p < 0.001). Subgroup analysis for primary and recurrent inguinal hernias matched the overall results. CONCLUSIONS: Robotic-assisted inguinal hernia repair has a significantly higher cost and significantly longer operative times, compared to the laparoscopic approach. The study has shown that only fixed cost contributes to the cost difference between the two approaches. Medical device cost plus the longer operative times are the main factors driving the cost difference. Laparoscopic unilateral inguinal hernia repair is more cost-effective compared to a robotic-assisted approach.

Long-term outcomes following POEM for non-achalasia motility disorders of the esophagus.

BACKGROUND: Optimal treatment for symptomatic patients with non-achalasia motility disorders (NAD) such as diffuse esophageal spasm, esophagogastric junction outlet obstruction, and hypercontractile disorder is not well established. POEM has been offered to these patients since it is a less invasive and less morbid procedure but long-term outcomes remain undetermined. The aim of this study was to assess long-term outcomes of POEM for patients with NAD. METHODS: Records of 40 consecutive patients undergoing POEM for NAD from May 2011 to January 2016 at a single center were retrospectively reviewed. Preoperative and 6-month postoperative symptom scores, high-resolution manometry, pH testing, and timed barium swallow (TBS) data were collected. Patients were contacted by phone to obtain long-term symptom assessment. Symptoms were assessed using a standardized symptom questionnaire with scores for symptoms graded according to frequency and the Eckardt score. RESULTS: Ten percent had minor complications with no postoperative sequelae. 90% of patients had significant improvement in their mean Eckardt scores (5.02 vs. 1.12, p < 0.001) at early follow-up. Improvements in chest pain (1.02-0.36, p = 0.001) and dysphagia (2.20 vs. 0.40, p = 0.001) were seen. Significant improvements in manometric pressures and esophageal emptying on TBS were observed across groups. 38% (10/26) of patients had a postoperative pH score > 14.72. Long-term (median 48 months) symptom scores were obtained from 29 (72.5%) patients. 82% of patients (24/29) had sustained symptom improvement. A small increase in the dysphagia scores was reported in the long-term follow-up compared to the immediate postoperative period (0.36-0.89, p = 0.046). CONCLUSIONS: Chest pain and dysphagia are effectively palliated with POEM in patients with non-achalasia disorders of the esophagus. Significant improvements are durable in long-term follow-up. Despite earlier reports by our group suggesting possible inferior outcomes from POEM for this difficult group of patients, this study is far more encouraging. POEM should be considered in the treatment of patients with non-achalasia disorders of the esophagus.

Real-time diagnosis of Barrett's esophagus: a prospective, multicenter study comparing confocal laser endomicroscopy with conventional histology for the identification of intestinal metaplasia in new users.

INTRODUCTION: Endoscopic evaluation with high-definition white light endoscopy and random 4-quadrant biopsy (Seattle Protocol) is the current standard of care for the detection of Barrett's esophagus (BE). Recently, enhanced imaging technologies have become available to provide real-time diagnosis of intestinal metaplasia (IM) and dysplasia, reducing the need for tissue biopsy. Probe-based confocal laser endomicroscopy (pCLE) provides dynamic microscopic mucosal views, rapidly capturing digital images that become optical biopsies. This study examined the role of pCLE in BE screening and surveillance as compared to the Seattle Protocol. METHODS: Patients undergoing BE screening or surveillance endoscopy were enrolled at eight US centers. Optical biopsy using pCLE was interpreted in real time. Endoscopists performing pCLE were new users with a median experience of 8.5 months and no formal training in surgical pathology. Seattle Protocol biopsies were then taken. Recorded pCLE images were reviewed by a blinded expert in optical biopsy interpretation. RESULTS: Early pCLE users identified significantly more patients with IM than the Seattle Protocol overall (99/172 vs. 46/172, p < 0.0001). Early users of pCLE also identified significantly more patients with IM than the Seattle Protocol in the patients with visible columnar lined esophagus (75 vs. 31, p < 0.0001), but not in the 76 patients without columnar lined esophagus (24 vs. 15, p = 0.067). There was no statistically significant difference between early pCLE users and expert review. CONCLUSION: Optical biopsy using pCLE technology allows for the real-time evaluation of entire segments of columnar lined esophagus. Consequently, pCLE is considerably more sensitive in the detection of BE than the Seattle Protocol, which leaves a majority of epithelium unexamined. This effect is seen even in new users and increases with experience. Overall, pCLE provides a promising advance in Barrett's detection which will likely result in superior identification of individuals at risk for esophageal adenocarcinoma.

Preoperative High-Resolution Manometry Criteria are Associated with Dysphagia After Nissen Fundoplication.

BACKGROUND: Dysphagia after Nissen fundoplication is challenging for patients. High-resolution manometry (HRM) has rarely been studied preoperatively to determine whether manometry values correlated with postoperative dysphagia after fundoplication. We aim to determine whether HRM criteria could predict dysphagia after Nissen fundoplication. METHODS: A retrospective review of single-institution laparoscopic Nissen fundoplications (LNF) from 2013 to 2015 was completed. Dysphagia was graded using a standard scale. Four groups were: those with new postoperative dysphagia (ND), never had dysphagia (NV), continued dysphagia (CD), and resolved dysphagia (RD). Manometry criteria included distal contractile integral (DCI), contraction front velocity (CFV), distal latency (DL), integrated relaxation pressure (IRP), percent peristalsis (PP), and distal esophageal contraction amplitude (DECA). Statistical bootstrapping was used to power sample sizes for ANOVA analysis. RESULTS: Ninety-four patients were included in the original cohort. Statistical bootstrapping sample size was 2992 patients. Among patients who did not have dysphagia prior to LNF, no HRM metric was associated with developing new dysphagia. Among those with dysphagia prior to LNF, a higher DCI, CFV, DL, PP, and DECA were associated with resolution of dysphagia. The RD group was 2.77 times more likely to have a DCI ≥ 1000 mmHg-s-cm compared with the CD group. CONCLUSIONS: HRM criteria could not predict the development of postoperative dysphagia. However, in those with preoperative dysphagia and strong manometry criteria, dysphagia is more likely to resolve after Nissen fundoplication. Meanwhile, in those with preoperative dysphagia and weak manometry, dysphagia may persist and these patients may be better served with a partial fundoplication.

An international multicenter study evaluating the clinical efficacy and safety of per-oral endoscopic myotomy in octogenarians.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) for achalasia is particularly appealing in the elderly because it is minimally invasive. However, data in patients aged ≥80 years are scarce. The aim of this study was to assess the clinical outcome of POEM in octogenarians. METHODS: This was a multicenter retrospective study at 8 centers. Consecutive octogenarians with achalasia who underwent POEM between 2010 and 2016 were included. Rates of technical success (completion of myotomy), clinical response (Eckardt score ≤3), and adverse events (severity graded as per American Society for Gastrointestinal Endoscopy lexicon) were assessed. RESULTS: A total of 76 patients (47.4% female, mean age 84 years) underwent POEM for treatment of achalasia: type I, 17.1%; type II, 35.5%; type III, 17.1%; and unspecified, 30.3%. Overall, 41.1% were treatment naïve, whereas others had previous botulinum toxin injection and/or pneumatic dilation. The mean (± standard deviation [SD]) age-adjusted Charlson comorbidity index score was 6.2 ± 2.4, with the majority of patients having American Society of Anesthesiologists Physical Status Classification System (ASA) scores of II/III. Technical success was 93.4%, with a median follow-up of 256 days. Fourteen adverse events occurred in 11 patients (14.5%). There were 3 inadvertent mucosotomies, 6 cases of symptomatic capnoperitoneum and/or capnomediastinum, 2 esophageal leaks, 1 cardiac arrhythmia, and 2 other). The severities of these adverse events were mild (78.6%), moderate (14.3%), and severe (7.1%). Clinical success was achieved in 90.8% of patients, with a mean (± SD) Eckardt score reduction from 7.0 ± 2.3 to 0.8 ± 0.1 (P < .001), a median follow-up of 256 days, and interquartile range of 66 to 547. CONCLUSION: Although the rate of technical success may be somewhat lower and the rate of adverse events slightly higher than previously reported, our data suggest that POEM in octogenarians is safe and effective, supporting its role as a primary modality for achalasia in this patient population.