The Milan score: A novel manometric tool for a more efficient diagnosis of gastro-esophageal reflux disease.

OBJECTIVE: A definitive diagnosis of gastroesophageal reflux disease (GERD) depends on endoscopic and/or pH-study criteria. However, high resolution manometry (HRM) can identify factors predicting GERD, such as ineffective esophageal motility (IEM), esophago-gastric junction contractile integral (EGJ-CI), evaluating esophagogastric junction (EGJ) type and straight leg raise (SLR) maneuver response. We aimed to build and externally validate a manometric score (Milan Score) to stratify the risk and severity of the disease in patients undergoing HRM for suspected GERD. METHODS: A population of 295 consecutive patients undergoing HRM and pH-study for persistent typical or atypical GERD symptoms was prospectively enrolled to build a model and a nomogram that provides a risk score for AET > 6%. Collected HRM data included IEM, EGJ-CI, EGJ type and SLR. A supplemental cohort of patients undergoing HRM and pH-study was also prospectively enrolled in 13 high-volume esophageal function laboratories across the world in order to validate the model. Discrimination and calibration were used to assess model's accuracy. Gastroesophageal reflux disease was defined as acid exposure time >6%. RESULTS: Out of the analyzed variables, SLR response and EGJ subtype 3 had the highest impact on the score (odd ratio 18.20 and 3.87, respectively). The external validation cohort consisted of 233 patients. In the validation model, the corrected Harrel c-index was 0.90. The model-fitting optimism adjusted calibration slope was 0.93 and the integrated calibration index was 0.07, indicating good calibration. CONCLUSIONS: A novel HRM score for GERD diagnosis has been created and validated. The MS might be a useful screening tool to stratify the risk and the severity of GERD, allowing a more comprehensive pathophysiologic assessment of the anti-reflux barrier. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05851482).

Tumor differentiation impacts response to neoadjuvant therapy and survival in patients with esophageal adenocarcinoma.

OBJECTIVE: The current staging system for esophageal adenocarcinoma only considers tumor grade in early tumors. The aim of this study was to evaluate the impact of tumor differentiation on response to neoadjuvant chemoradiotherapy and survival in patients with locally advanced esophageal adenocarcinoma. METHODS: This was a multi-institution retrospective review of all patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy followed by esophagectomy from January 2010 to December 2017. Response to neoadjuvant therapy and survival was compared between patients with well- or moderately differentiated (G1/2) tumors versus poorly differentiated (G3) tumors. RESULTS: There were 550 patients, 485 men (88.2%) and 65 women. The median age was 61 years, and the tumor was G1/2 in 288 (52.4%) and G3 in 262 patients. Overall clinical stage before neoadjuvant therapy was similar between groups. Pathologic complete response (pCR) was found in 87 patients (15.8%). The frequency of pCR was similar between groups, but residual disease in the esophagus and lymph nodes was significantly more likely with G3 tumors. Median follow-up was 63 months and absolute survival, overall survival, and disease-free survival were all significantly worse in patients with G3 tumors. Further, even with pCR, patients with G3 tumors had significantly worse survival. CONCLUSIONS: This study showed that response to neoadjuvant therapy was not affected by tumor differentiation. However, poor differentiation was associated with worse survival compared with patients with G1/2 tumors, even among those with pCR. These results suggest that poor differentiation should be considered as an added risk factor for clinical staging in patients with locally advanced esophageal adenocarcinoma.

Evolution in the treatment of gastroesophageal reflux disease over the last century: from a crural-centered to a lower esophageal sphincter-centered approach and back.

The surgical management of gastroesophageal reflux disease (GERD) has evolved significantly over the past century, driven by increased understanding of the physiology of the reflux barrier, its anatomic components, and surgical innovation. Initially, emphasis was on reduction of hiatal hernias and crural closure as the etiology behind GERD was felt to be solely related to the anatomic alterations caused by hiatal hernias. With persistence of reflux-related changes in some patients despite crural closure, along with the development of what is now modern manometry and the discovery of a high-pressure zone at the distal esophagus, focus evolved to surgical augmentation of the lower esophageal sphincter (LES). With this transition to an LES-centric approach, attention shifted to reconstruction of the angle of His, ensuring sufficient intra-abdominal esophageal length, development of the now commonly employed Nissen fundoplication, and creation of devices that directly augment the LES such as magnetic sphincter augmentation. More recently, the role of crural closure in antireflux and hiatal hernia surgery has again received renewed attention due to the persistence of postoperative complications including wrap herniation and high rates of recurrences. Rather than simply preventing transthoracic herniation of the fundoplication as was originally thought, diaphragmatic crural closure has been documented to have a key role in re-establishing intra-abdominal esophageal length and contributing to the restoration of normal LES pressures. This progression from a crural-centric to a LES-centric approach and back has evolved along with our understanding of the reflux barrier and will continue to do so as more advances are made in the field. In this review, we will discuss the evolution of surgical techniques over the past century, highlighting key historical contributions that have shaped our management of GERD today.

Effect of Intrapleural Fibrinolytic Therapy vs Surgery for Complicated Pleural Infections: A Randomized Clinical Trial.

Importance: There is a paucity of high-quality prospective randomized clinical trials comparing intrapleural fibrinolytic therapy (IPFT) with surgical decortication in patients with complicated pleural infections. Objective: To assess the feasibility, safety, and efficacy of an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections. Design, Setting, and Participants: This parallel pilot randomized clinical trial was performed at a single urban community-based center from March 1, 2019, to December 31, 2021, with follow-up for 90 days. Seventy-four individuals were screened and 48 were excluded. Twenty-six patients 18 years or older with clinical pleural infection and positive findings of pleural fluid analysis were included. Of these, 20 patients underwent randomized selection (10 in each group), and 6 were observed. Interventions: Intrapleural tissue plasminogen activator plus deoxyribonuclease therapy vs surgical decortication. Main Outcomes and Measures: Primary outcomes were the percentage of patients enrolled to study completion and multidisciplinary adherence. Secondary outcomes included the number of patients with and the reason for inadequate screening, screening to enrollment failures, time to accrual of 20 patients or the number accrued at 1 year, and clinical data. Results: Twenty-six patients were enrolled, 10 were randomized to each group, and 6 were observed. There was 100% enrollment to study completion in each treatment group, no protocol deviations, 2 minor protocol amendments, and no screening to enrollment failures. It took 32 months to enroll 26 patients. The 20 randomized patients had a median age of 57 (IQR, 46-65) years, were predominantly men (15 [75%]), and had a median RAPID (Renal, Age, Purulence, Infection Source, and Dietary Factors) score of 2 (IQR, 1-3). Treatment failure occurred in 1 patient and 2 crossover treatments occurred, all of which were in the IPFT group. Intraprocedure and postprocedure complications were similar between the groups. There were no reoperations or in-hospital deaths. Median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups (P = .21). Median hospital stay tended to be longer in the IPFT (11 [IQR, 4-18] days) vs surgery (5 [IQR, 4-6] days) groups, although the difference as not significantly different (P = .08). There were no 30-day readmissions or 30- or 90-day deaths. Conclusions and Relevance: In this pilot randomized clinical trial, the study algorithm was feasible, safe, and efficacious. This provides evidence to move forward with a multicenter randomized clinical trial. Trial Registration: ClinicalTrials.gov Identifier: NCT03873766.

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.

Improving the Diagnostic Yield of High-Resolution Esophageal Manometry for GERD: The "Straight Leg-Raise" International Study.

BACKGROUND & AIMS: The straight leg raise (SLR) maneuver during high-resolution manometry (HRM) can assess esophagogastric junction (EGJ) barrier function by measuring changes in intraesophageal pressure (IEP) when intra-abdominal pressure is increased. We aimed to determine whether increased esophageal pressure during SLR predicts pathologic esophageal acid exposure time (AET). METHODS: Adult patients with persistent gastroesophageal reflux disease (GERD) symptoms undergoing HRM and pH-impedance or wireless pH study off proton pump inhibitor were prospectively studied between July 2021 and March 2022. After the HRM Chicago 4.0 protocol, patients were requested to elevate 1 leg at 45º for 5 seconds while supine. The SLR maneuver was considered effective when intra-abdominal pressure increased by 50%. IEPs were recorded 5 cm above the lower esophageal sphincter at baseline and during SLR. GERD was defined as AET greater than 6%. RESULTS: The SLR was effective in 295 patients (81%), 115 (39%) of whom had an AET greater than 6%. Hiatal hernia (EGJ type 2 or 3) was seen in 135 (46%) patients. Compared with patients with an AET less than 6%, peak IEP during SLR was significantly higher in the GERD group (29.7 vs 13.9 mm Hg; P < .001). Using receiver operating characteristic analysis, an increase of 11 mm Hg of peak IEP from baseline during SLR was the optimal cut-off value to predict an AET greater than 6% (area under the receiver operating characteristic curve, 0.84; sensitivity, 79%; and specificity, 85%), regardless of the presence of hiatal hernia. On multivariable analysis, an IEP pressure increase during the SLR maneuver, EGJ contractile integral, EGJ subtype 2, and EGJ subtype 3, were found to be significant predictors of AET greater than 6% CONCLUSIONS: The SLR maneuver can predict abnormal an AET, thereby increasing the diagnostic value of HRM when GERD is suspected. CLINICALTRIALS: gov ID: NCT04813029.

High-Risk Features of Esophageal Adenocarcinoma Following Neoadjuvant Chemoradiation: Patients for Whom Surgery Should Not Be Delayed.

OBJECTIVE: Clinical predictors of pathological complete response have not reliably identified patients for whom an organ-sparing approach following neoadjuvant chemoradiation be undertaken for esophageal cancer patients. We sought to identify high-risk predictors of residual carcinoma that may preclude patients from a selective surgical approach. BACKGROUND: Patients treated with neoadjuvant chemoradiation followed by esophagectomy for esophageal adenocarcinoma were identified. PATIENTS AND METHODS: Correlation between clinical and pathologic complete responses were examined. Regression models and recursive partitioning were utilized to identify features associated with residual carcinoma. External validation of these high-risk factors was performed on a data set from an independent institution. RESULTS: A total of 326 patients were identified, in whom clinical complete response was noted in 104/326 (32%). Pathologic complete response was noted in only 33/104 (32%) of these clinical complete responders. Multivariable analysis identified that the presence of stricture ( P =0.011), positive biopsy ( P =0.010), and signet ring cell histology ( P =0.019) were associated with residual cancer. Recursive partitioning corroborated a 94% probability of residual disease, or greater, for each of these features. The positive predictive value was >90% for these characteristics. A SUV max >5.4 at the esophageal primary in the absence of esophagitis was also a high-risk factor for residual carcinoma. External validation confirmed these high-risk factors to be implicated in the finding of residual carcinoma. CONCLUSIONS: Clinical parameters of response are poor predictors of complete pathologic response leading to challenges in selecting candidates for active surveillance. However, we characterize several high-risk features for residual carcinoma which indicate that esophagectomy should not be delayed.

Comparing Initial Surgery versus Fibrinolytics for Pleural Space Infections: A Retrospective Multicenter Cohort Study.

Rationale: When drainage of complicated pleural space infections alone fails, there exists two strategies in surgery and dual agent-intrapleural fibrinolytic therapy; however, studies comparing these two management strategies are limited. Objectives: To determine the outcomes of surgery versus fibrinolytic therapy as the primary management for complicated pleural space infections (CPSI). Methods: A retrospective review of adults with a CPSI managed with surgery or fibrinolytics between 1/2015 and 3/2018 within a multicenter, multistate hospital system was performed. Fibrinolytics was defined as any dose of dual-agent fibrinolytic therapy and standard fibrinolytics as 5-6 doses twice daily. Treatment failure was defined as persistent infection with a pleural collection requiring intervention. Crossover was defined by any fibrinolytics after surgery or surgery after fibrinolytics. Logistic regression with inverse probability of treatment weighting (IPTW) were employed to account for selection bias effect of management strategies in treatment failure and crossover. Results: We identified 566 patients. Surgery was the initial strategy in 55% (311/566). The surgery group had less additional treatments (surgery: 10% [32/311] versus fibrinolytics: 39% [100/255], P < 0.001), treatment failures (surgery: 7% [22/311] versus fibrinolytics: 29% [74/255], P < 0.001), and crossovers (surgery: 6% [20/311] versus fibrinolytics: 19% [49/255], P < 0.001). Logistic regression analysis with IPTW demonstrated a lower odds of treatment failure with surgery compared with any fibrinolytics (odds ratio [OR], 0.20; 95% confidence interval [CI], 0.10-0.30; P < 0.001); and compared with standard fibrinolytics (OR, 0.20; 95% CI, 0.11-0.35; P < 0.001). Conclusions: Although there is a lack of consensus as to the optimal management strategy for patients with a CPSI, in surgical candidates, operative management may offer more benefits and could be considered early in the management course. However, our study is retrospective and nonrandomized; thus, prospective trials are needed to explore this further.

The Nissen-Hill Hybrid Repair: Experience With the First 500.

INTRODUCTION: A new repair for gastroesophageal reflux and hiatal hernia, the Nissen-Hill hybrid repair, was developed to combine the relative strengths of its component repairs with the aim of improved durability. In several small series, it has been shown to be safe, effective, and durable for paraesophageal hernia, Barrett esophagus, and gastroesophageal reflux disease. This study represents our experience with the first 500 consecutive repairs for all indications. METHODS: Retrospective study of prospectively collected data for the first 500 consecutive Nissen-Hill hybrid repairs from March 2006 to December 2016, including all indications for surgery. Three quality of life metrics, manometry, radiographic imaging, and pH testing were administered before and at defined intervals after repair. RESULTS: Five hundred patients were included, with a median follow-up of 6.1 years. Indications for surgery were gastroesophageal reflux disease in 231 (46.2%), paraesophageal hernia in 202 (40.4%), and reoperative repair in 67 (13.4%). The mean age was 59, with body mass index of 30 and 63% female. A minimally invasive approach was used in 492 (98%). Thirty-day operative mortality was 1 (0.2%), with a 4% major complication rate and a median length of stay of 2 days. Preoperative to postoperative pH testing was available for 390 patients at a median follow-up of 7.3 months, with the median DeMeester score improving from 45.9 to 2.7. At long-term follow-up (229 responses), all median quality of life scores improved: Quality Of Life in Reflux And Dyspepsia 4 to 6.9, Gastroesophageal Reflux Disease-Health Related Quality of Life 22 to 3, and Swallowing 37.5 to 45 and proton pump inhibitor use dropped from 460 (92%) to 50 (10%). Fourteen (2.8%) underwent reoperation for failure. CONCLUSION: The combined Nissen-Hill hybrid repair is safe and effective in achieving excellent symptomatic and objective outcomes and low recurrence rates beyond 5 years.

Changes in Distensibility Index During an Incremental POEM Myotomy.

BACKGROUND: A longer myotomy for the treatment of achalasia is associated with worse gastroesophageal reflux disease despite palliating dysphagia. Recently, clinical outcomes have been correlated to the distensibility of the distal esophagus, which is measured intra-operatively using an endoscopic functional luminal image probe (EndoFLIP). We aimed to determine the minimum per oral endoscopic myotomy (POEM) length to allow for adequate distensibility index (DI). METHODS: A 6-cm myotomy conducted in 2-cm increments during POEM was performed for patients with achalasia I and II from 2017 to 2019. The EndoFLIP was used to measure the DI intra-operatively: (1) prior to intervention, (2) following creation of the submucosal tunnel, (3) following transection of the high-pressure zone (HPZ), (4) following the distal extension, and (5) following the proximal esophageal extension. RESULTS: A total of 16 patients underwent POEM. Ages ranged from 21 to 78 years, 10 were male, and 13 had type II achalasia. The median DI was 2.7 (1.4-3.6) mm2/mmHg prior to intervention; 2.4 (1.4-3.3) mm2/mmHg following the submucosal tunnel; 3.2 (1.6-4.4) mm2/mmHg following transection of the HPZ; 3.8 (2.6-4.5) mm2/mmHg following the gastric extension; and 4.5 (3.3-7.1) mm2/mmHg following the proximal extension. Our target range DI was achieved for 50% of patients after transection of the HPZ. CONCLUSIONS: Distensibility changed with each myotomy increment and fell within the target range for most patients following a 2-4-cm myotomy. This suggests that a shorter myotomy may be appropriate for select patients, and the use of the EndoFLIP intra-operatively may allow for a tailored myotomy length.

Persistent N2 After Induction Is Not a Contraindication to Surgery for Lung Cancer.

BACKGROUND: Surgical management for potentially resectable stage IIIA-N2 non-small cell lung cancer (NSCLC) is controversial. For some, persistent N2 disease after induction therapy is a contraindication to resection. We examined outcomes of a well-selected surgical cohort of postinduction IIIA-N2 NSCLC patients with persistent N2 disease. METHODS: We retrospectively reviewed all resected clinical IIIA-N2 NSCLC patients from 2001 to 2018. Thorough preoperative staging, including invasive mediastinal staging, was performed. Those with nonbulky N2 disease, appropriate restaging, and potential for a margin-negative resection were included. After resection, patients were classified as having persistent N2 disease or mediastinal downstaging (N2 to >N0/N1). Persistent N2 patients were further classified as uncertain resection (R[un]) or complete resection (R0) according to the International Association for the Study of Lung Cancer definition. Kaplan-Meier survival analysis was used. RESULTS: Fifty-four patients met inclusion criteria. After induction, 31 patients (57%) demonstrated persistent N2 disease, and 23 patients (43%) had mediastinal downstaging. Preinduction invasive mediastinal staging was performed in 98.1%. Most had clinical single-station N2 disease (75.9%). Margin-negative resections were performed in 100%. Eight patients were reclassified as R(un) due to positive highest sampled mediastinal station. The median overall survival for persistent N2 was 26 months for R(un) and 69 months for R0. Overall survival for the downstaged group was 67 months (P = .31). CONCLUSIONS: Overall survival for patients with non-R(un) or persistent N2 (true R0) was similar to those with mediastinal downstaging. Well-selected patients with persistent N2 disease experience reasonable survival after resection and should have surgery considered as part of their multimodality treatment. This study underscores the importance of classifying the extent of mediastinal involvement for persistent N2 patients, supporting the proposed International Association for the Study of Lung Cancer R(un) classification.

Minimally invasive thymectomy for myasthenia gravis favours left-sided approach and low severity class.

OBJECTIVES: Complete thymectomy is a key component of the optimal treatment for myasthenia gravis. Unilateral, minimally invasive approaches are increasingly utilized with debate about the optimal laterality approach. A right-sided approach has a wider field of view, while a left-sided approach accesses potentially more thymic tissue. We aimed to assess the impact of laterality on perioperative and medium-term outcomes, and to identify predictors of a 'good outcome' using standard definitions. METHODS: We performed a multicentre review of 123 patients who underwent a minimally invasive thymectomy for myasthenia gravis between January 2000 and August 2015, with at least 1-year follow-up. The Myasthenia Gravis Foundation of America standards were followed. A 'good outcome' was defined by complete stable remission/pharmacological remission/minimal manifestations 0, and a 'poor outcome' by minimal manifestations 1-3. Univariate and multivariable logistic regression analyses were performed to assess factors associated with a 'good outcome'. RESULTS: Ninety-two percent of thymectomies (113/123) were robotic-assisted. The left-sided approach had a shorter median operating time than a right-sided: 143 (interquartile range, IQR 110-196) vs 184 (IQR 133-228) min, P = 0.012. At a median of 44 (IQR 27-75) months, the left-sided approach achieved a 'good outcome' (46%, 31/68) more frequently than the right-sided (22%, 12/55); P = 0.011. Multivariable analysis identified a left-sided approach and Myasthenia Gravis Foundation of America class I/II to be associated with a 'good outcome'. CONCLUSIONS: A left-sided thymectomy may be preferred over a right-sided approach in patients with myasthenia gravis given the shorter operating times and potential for superior medium-term symptomatic outcomes. A lower severity class is also associated with a 'good outcome'.

Retrospective multicenter study on endoscopic treatment of upper GI postsurgical leaks.

BACKGROUND AND AIMS: Therapeutic endoscopy plays a critical role in the management of upper GI (UGI) postsurgical leaks. Data are scarce regarding clinical success and safety. Our aim was to evaluate the effectiveness of endoscopic therapy for UGI postsurgical leaks and associated adverse events (AEs) and to identify factors associated with successful endoscopic therapy and AE occurrence. METHODS: This was a retrospective, multicenter, international study of all patients who underwent endoscopic therapy for UGI postsurgical leaks between 2014 and 2019. RESULTS: Two hundred six patients were included. Index surgery most often performed was sleeve gastrectomy (39.3%), followed by gastrectomy (23.8%) and esophagectomy (22.8%). The median time between index surgery and commencement of endoscopic therapy was 16 days. Endoscopic closure was achieved in 80.1% of patients after a median follow-up of 52 days (interquartile range, 33-81.3). Seven hundred seventy-five therapeutic endoscopies were performed. Multimodal therapy was needed in 40.8% of patients. The cumulative success of leak resolution reached a plateau between the third and fourth techniques (approximately 70%-80%); this was achieved after 125 days of endoscopic therapy. Smaller leak initial diameters, hospitalization in a general ward, hemodynamic stability, absence of respiratory failure, previous gastrectomy, fewer numbers of therapeutic endoscopies performed, shorter length of stay, and shorter times to leak closure were associated with better outcomes. Overall, 102 endoscopic therapy-related AEs occurred in 81 patients (39.3%), with most managed conservatively or endoscopically. Leak-related mortality rate was 12.4%. CONCLUSIONS: Multimodal therapeutic endoscopy, despite being time-consuming and requiring multiple procedures, allows leak closure in a significant proportion of patients with a low rate of severe AEs.

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.