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ASA PAPER Gastroesophageal Reflux Disease Outcomes After Vertical Sleeve Gastrectomy and Gastric Bypass Daniel Leslie, MD,  Y Eric Wise, MD, MA,  Adam Sheka, MD,  Hisham Abdelwahab,  Ryan Irey, MA, MS,y Ashley Benner, MPH,z and Sayeed Ikramuddin, MD, MHA  Objective: The objective of this study is to assess whether vertical sleeve gastrectomy (VSG) increases the incidence of gastroesophageal reflux disease (GERD), esophagitis and Barrett esophagus (BE) relative to patients undergoing Roux-en-Y gastric bypass (RYGB) in patients with and without preoperative GERD. Summary of Background Data: Concerns for potentiation of GERD, supported by multiple high-quality retrospective studies, have hindered greater adoption of the VSG. Methods: From the OptumLabs Data Warehouse, VSG and RYGB patients with 2 years enrollment were identified and matched by follow-up time. GERD [reflux esophagitis, prescription for acid reducing medication (Rx) and/or diagnosis of BE], upper endoscopy (UE), and re-admissions were evaluated beyond 90 days. Results: A total of 8362 patients undergoing VSG were matched 1:1 to patients undergoing RYGB, on the basis of post-operative follow-up interval. Age, sex, and follow-up time were similar between the 2 groups (P > 0.05). Among all patients, postoperative GERD was more frequently observed in VSG patients relative to RYGB patients (60.2% vs 55.6%, respectively; P < 0.001), whereas BE was more prevalent in RYGB patients (0.7% vs 1.1%; P ¼ 0.007). Postoperatively, de novo esophageal reflux symptomatology was more common in VSG patients (39.3% vs 35.3%; P < 0.001), although there was no difference in development of the histologic diagnoses reflux esophagitis and BE. Furthermore, postoperative re-admission was higher in the RYGB cohort (38.9% vs 28.9%; P < 0.001). Conclusions: Compared to RYGB, VSG may not have inferior long-term GERD outcomes, while also leading to fewer re-hospitalizations. These data challenge the prevailing opinion that patients with GERD should undergo RYGB instead of VSG. Keywords: acid reflux, Barrett’s esophagus, esophagitis, gastroesophageal reflux disease, GERD, heartburn, Rouxen-Y gastric bypass, RYGB, vertical sleeve gastrectomy, VSG (Ann Surg 2021;274:646–653) S ince its endorsement as a stand-alone primary bariatric procedure by the American Society of Metabolic and Bariatric Surgery in 2012,1 the vertical sleeve gastrectomy (VSG) has surpassed the Rouxen-Y gastric bypass (RYGB) as the most frequently performed bariatric operation. The VSG is uniformly performed in a minimally invasive From the Department of Surgery, University of Minnesota, Minneapolis, MN; yInstitute for Healthcare Informatics, University of Minnesota, Minneapolis, MN; and zClinical & Translational Science Institute, University of Minnesota, Minneapolis, MN. lesli002@umn.edu. Reprints will not be available from the author. The authors report no conflict of interests. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.annalsofsurgery.com). Copyright ß 2021 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0003-4932/21/27404-0646 DOI: 10.1097/SLA.0000000000005061 646 | www.annalsofsurgery.com fashion, with both laparoscopic and robotic-assist approaches employed. Advantages of the VSG are avoidance of anatomic rearrangement, relative technical simplicity and noninferior remission of diabetes mellitus relative to RYGB.2 A putative disadvantage is VSG’s propensity for non-resolution or potentiation of symptomatic gastroesophageal reflux disease (GERD) and sequelae. Mechanisms of de novo GERD or worsening of pre-existing GERD after VSG have been proposed, and these include lack of gastric compliance, increased intraluminal and lower esophageal sphincter pressures, narrowing at the hiatus, persistence of hiatal hernia, and residual fundus.3,4 In contrast, the RYGB is often regarded as a gold-standard operation for GERD due to a decrease in parietal cell mass exposed to the esophagus.3 The weight loss inherent in both operations reduces intra-abdominal pressure, alleviating a major contributing factor to GERD. Nonetheless, the RYGB is still considered by many the bariatric operation of choice for obese patients with GERD. Barrett esophagus (BE), the metaplastic change from squamous to columnar epithelium at the gastroesophageal junction induced by prolonged acid exposure, is a consequential risk of sustained and unmanaged GERD.5 Although only routinely screened for among high-risk groups, its prevalence among adults in the United States is estimated to be 5.6%.6 Further dysplasia of these cells can lead to esophageal adenocarcinoma if untreated. A recent meta-analysis commissioned by the International Federation for the Surgery of Obesity notes the benefits of RYGB in patients with preoperative BE, including regression of disease, but does not make a recommendation against VSG due to the paucity of data with respect to outcomes of these patients. Moreover, data on de novo BE after RYGB and VSG is even less well characterized.7 In this study, it is hypothesized that clinically germane GERD-related outcomes after VSG and RYGB can be determined and contrasted by analyzing a comprehensive, real-world insurance claims database. METHODS Data Source This study utilized administrative insurance claims data from the OptumLabs Data Warehouse (OLDW), which contains de-identified, longitudinal health information on enrollees and patients, representing a mixture of ages, ethnicities, and geographical regions across the United States. The data in OLDW include medical claims, pharmacy claims, laboratory results, and enrollment records for commercial and Medicare Advantage enrollees.8 Because the data analyzed here are preexisting and deidentified, this study was deemed exempt from the University of Minnesota Institutional Review Board review process. Patients This study used a retrospective cohort model to examine the prevalence of postoperative GERD in patients having had a RYGB or VSG (Fig. 1). Patients undergoing these procedures were identified Annals of Surgery  Volume 274, Number 4, October 2021 Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved. Annals of Surgery  Volume 274, Number 4, October 2021 GERD Outcomes After Bariatric Surgery FIGURE 1. CONSORT flow diagram of included and excluded patients undergoing bariatric surgery along with final matched cohort. ß 2021 Wolters Kluwer Health, Inc. All rights reserved. www.annalsofsurgery.com | 647 Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved. Annals of Surgery  Volume 274, Number 4, October 2021 Leslie et al and retained for inclusion in the cohort if they were aged 18 years or older at time of surgery, had their operation between 2004 and 2018, had at least 1 year of preoperative continuous enrollment, and had at least 2 years of postoperative continuous enrollment. International Classification of Diseases, Ninth Revision (ICD-9) and Tenth Revision (ICD-10) codes, as well as Current Procedural Terminology (CPT) codes, were used to identify VSG procedures (43.82, 0DB64Z3, and 43775, respectively) and RYGB procedures (43644; CPT only). Data were not analyzed beyond 5 years postoperatively. Cohort Matching Patients having had a RYGB procedure were matched 1:1 to patients having had a VSG procedure. RYGB patients were exact matched to VSG patients based on the number of days of postoperative continuous enrollment. When exact matching was not possible, nearest neighbor matching was used. Preoperative Comorbidities A panel of known diseases and conditions associated with obesity were collected from the OLDW claims data, including diabetes mellitus, hyperlipidemia, hypertension, sleep apnea, and osteoarthrosis/itis. ICD-9 and ICD-10 codes were used for attribution of these conditions (Supplementary Table 1, http://links.lww.com/ SLA/D261). Pre- and Postoperative Procedures In addition to these comorbidities, data on other procedures used to evaluate the foregut were collected both preoperatively and postoperatively, including esophagogastroduodenoscopy, esophagoscopy, pH monitoring study, and manometry. Finally, mucosal diseases diagnosed from these procedures were collected, including peptic/esophageal ulcers and esophageal cancer. Acid-Treating Prescriptions One set of features within the OLDW dataset describes information surrounding the administration of prescription medication. From these available data, inferences can be drawn about the use of acid-treating prescriptions before bariatric surgery and beyond the window of typical postoperative care (91 days post-surgery, up to 1825 days or 5 years). Here, the term ‘‘new’’ is used to describe instances of a prescription, procedure, or diagnosis that is observed in the postoperative analysis window (91 to 1825 days post-operation) that is not otherwise observed before surgery. Prescription information was obtained by searching via specific therapeutic class, generic name, and/or brand name. Due to variations in abbreviation and spelling of generic names and brand names found in the data, the codes for specific therapeutic class were utilized. Specifically, drugs from the classes of gastroprotective agents (GPA; D4B, D4E), proton-pump inhibitors (PPI; D4J), and H2 Blockers (H2B; Z2D, Z2T) were queried. Detailed information on the generic drugs found in the data from these classes can be found in Supplemental Table 2, http://links.lww.com/SLA/D261. GERD In this study, GERD was taken to represent a composite diagnosis resulting from any of the following conditions: esophageal reflux, reflux esophagitis, and BE. When studying the underlying diagnoses comprising a patient’s GERD status, all present conditions were counted, but in terms of analytical consideration, only the patient’s most severe condition (BE > reflux esophagitis > esophageal reflux) was counted. Additionally, the prefix de novo has been used to indicate the presence of GERD in a patient who otherwise did not have GERD before bariatric surgery. 648 | www.annalsofsurgery.com Re-Hospitalization Another set of features within the OLDW dataset describes information relating to hospital stays, including admission dates, lengths of stay, and admission diagnosis codes. From these available data, we were able to discern patient re-hospitalizations following their bariatric surgery. Patient re-hospitalization data was collected as a binary variable (ie, whether a patient had any postoperative rehospitalization), the total number of days a patient spent admitted to a hospital following their procedure, the number of distinct hospital stays following their procedure (ie, distinct, nonoverlapping rehospitalization events), and the patient’s average length of stay (eg, a patient with 3 postoperative rehospitalizations of 1 day, 4 days, and 1 day, respectively, has an average length of stay of 2 days). Statistical Analysis Statistical analyses and modeling were performed using Python version 3.5.2 (Python Core Team, 2018) and R version 3.5.0 (R Core Team, 2018). A detailed listing of software names and versions can be found in Supplemental Table 3, http://links.lww.com/SLA/D261. Where cell sizes were appropriately large, cohort characteristics were compared using the Chi-square test for categorical variables; Fisher exact test was used for comparisons involving small cell counts of 15. For comparison of continuous variables, the Mann-Whitney U test was used. A significance level (a) of 0.05 was used for all analyses, although all P values were reported in accordance with recommendations from the American Statistical Association.9 Additionally, the association between bariatric procedure type and postoperative GERD was evaluated using the Kaplan–Meier method. RESULTS Preoperative Patient Characteristics: Within 1 Year Before Surgery A total of 54,695 patients having had a RYGB or VSG procedure were identified. After applying continuous enrollment, age, and minimum index date requirements, 19,721 patients were available for matching: 11,359 RYGB patients and 8362 VSG patients. To control for differences in postoperative follow-up time between surgery groups, each VSG patient was matched to a RYGB patient (without replacement) based on follow-up time (U ¼ 35,240,898.0, P ¼ 0.37). Thus, the final cohort under study comprised 8362 RYGB patients and 8362 VSG patients (n ¼ 16,724; Fig. 1). Based on this matched cohort, approximately 79% of each group were females and 21% males with median age 47 years at the time of the bariatric procedure. Mean follow-up time was 4.1 years, ranging from 2 to 5 years in each group. The VSG group was observed to have lower rates of T2DM (Chi-squared ¼ 111.4, P < 0.001), hyperlipidemia (Chi-squared ¼ 49.5, P < 0.001), hypertension (Chi-squared ¼ 52.3, P < 0.001), and osteoarthrosis/osteoarthritis (Chi-squared ¼ 19.23, P < 0.001). Conversely, the baseline VSG group was observed to have higher rates of sleep apnea (Chi-squared ¼ 20.1, P < 0.001), EGD (Chi-squared ¼ 131.4, P < 0.001), esophagoscopy (Chi-squared ¼ 26.7, P < 0.001), peptic/ esophageal ulcers (Chi-squared ¼ 54.3, P < 0.001), and acidreducing prescriptions (Chi-squared ¼ 21.1, P < 0.001). Rates of pH monitoring studies (Chi-squared ¼ 0.3, P ¼ 0.57), manometry (Chi-squared ¼ 2.1, P  1.0), and esophageal cancer (odds ratio ¼ 0.9, P  1.0) were rare and statistically similar between the 2 surgery groups. Preoperative GERD Preoperative GERD was common in both surgery groups, affecting approximately 77% of RYGB patients and 80% of VSG ß 2021 Wolters Kluwer Health, Inc. All rights reserved. Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved. Annals of Surgery  Volume 274, Number 4, October 2021 GERD Outcomes After Bariatric Surgery TABLE 1. Baseline Demographics, Follow-Up, Comorbidities, Procedures, Diagnoses, Prescriptions, and GERD Summary of Cohort -365 to -1 days, Pre-Op, n ¼ 16,724 RYGB N Sex Female Male Index age Mean SD Median Follow-up time, days Mean SD Median Preoperative comorbidities Diabetes mellitus Hyperlipidemia Hypertension Sleep apnea Osteoarthrosis/it is Procedures Esophagogastroduodenoscopy Esophagoscopy pH monitoring study Manometry Diagnoses Peptic or esophageal ulcer Esophageal cancer Acid-treating prescriptions GERD Barrett esophagus Reflux esophagitis Esophageal reflux VSG 8362 50.0% 8362 50.0% Ps 6637 1725 79.4% 20.6% 6576 1786 78.6% 21.4% 0.26 46.8 10.8 47.1 46.7 10.8 46.6 0.21 1502.9 541.8 1421 1490.0 521.8 1421 0.37 3424 5011 5860 3433 1514 40.9% 59.9% 70.1% 41.1% 18.1% 2764 4560 5421 3816 1296 33.1% 54.5% 64.8% 45.6% 15.5% <0.001 <0.001 <0.001 <0.001 <0.001 3717 29 59 99 44.5% 0.3% 0.7% 1.2% 4459 85 52 79 53.3% 1.0% 0.6% 0.9% <0.001 <0.001 0.57 1.0 2681 <11 1013 6456 70 897 5489 32.1% <0.1% 12.1% 77.2% 1.1% 13.9% 85.0% 3136 <11 1216 6697 57 810 5830 37.5% <0.1% 14.5% 80.1% 0.9% 12.1% 87.1% <0.001 1.0 <0.001 <0.001 0.29 0.64 <0.001 SD indicates standard deviation. patients (Chi-squared ¼ 20.5, P < 0.001). The vast majority of preoperative GERD was based on the diagnosis of esophageal reflux; approximately 85% in the RYGB group and 90% in the VSG group. Among GERD diagnoses that required a biopsy (reflux esophagitis and BE), rates between the 2 groups were statistically similar (Chi-squared ¼ 0.6, P ¼ 0.46). These data are summarized in Table 1. Postoperative Patient Characteristics: 91 Days to 5 Years Following Surgery The VSG group was observed to have lower postoperative rates of EGD (Chi-squared ¼ 130.6, P < 0.001), peptic/esophageal ulcer (Chi-squared ¼ 53.4, P < 0.001), and new acid-reducing prescriptions (Chi-squared ¼ 24.7, P < 0.001). Conversely, the VSG group was observed to have higher rates of pH monitoring studies (Chi-squared ¼ 7.5, P ¼ 0.006), and manometry (Chi-squared ¼ 4.5, P ¼ 0.03). Rates of esophagoscopy (Chi-squared  0.0, P  1.0), esophageal cancer (Chi-squared ¼ 0.5, P ¼ 0.48), and acid-reducing medications lasting >90 days (Chi-squared ¼ 0.2, P ¼ 0.68) were rare and statistically similar between the 2 surgery groups. Re-Hospitalization Over the assessed follow-up period, rates of re-hospitalization were greater in RYGB patients relative to VSG patients (Chi-squared ¼ 187.8, P < 0.001). Furthermore, VSG patients had a shorter mean length of stay than RYGB patients (1.3 days vs 1.5 days, respectively; P < 0.001). ß 2021 Wolters Kluwer Health, Inc. All rights reserved. Postoperative GERD Postoperative GERD was assessed from a nested perspective: both with and without consideration for whether participants were considered to have had GERD preoperatively. Such de novo GERD implies that a patient did not have GERD preoperatively and that diagnoses comprising the GERD composite diagnosis occurring in the first 90 days following surgery were not noted as new, postoperative GERD. Postoperative GERD—regardless of preoperative GERD status—was observed at a higher rate for patients having had a VSG procedure (Chi-squared ¼ 36.8, P < 0.001). However, a more granular inspection of the 3 GERD components revealed that there was no difference in reflux esophagitis (Chi-squared ¼ 0.29, P ¼ 0.59), whereas VSG had a greater prevalence of esophageal reflux (Chi-squared ¼ 45.9, P < 0.001) and RYGB had a greater prevalence of BE (Chi-squared ¼ 7.2, P ¼ 0.007). Additionally, among these patients, RYGB recipients were observed to have higher rates of new acid-reducing prescriptions (Chi-squared ¼ 17.2, P < 0.001). Although the rate of de novo esophageal reflux was higher in the VSG cohort (Chi-squared ¼ 6.3, P ¼ 0.01), there was no difference in the rates of BE (p  1.0) and reflux esophagitis (Chisquared ¼ 0.02, P ¼ 0.88). These postoperative outcomes for all patients are summarized in Table 2. As use of acid-reducing medication can be due to institution-specific postoperative protocols, rates of use after 5 years of follow-up were assessed. VSG patients (269/2,152 with five year follow-up) were on medication at rates no different from RYGB patients (309/2345 with 5-year www.annalsofsurgery.com | 649 Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved. Annals of Surgery  Volume 274, Number 4, October 2021 Leslie et al TABLE 2. Postoperative Procedures, Diagnoses, Prescriptions, Re-Hospitalizations, and GERD Summary of Cohort 91 to 1825 Days, Post-Op n ¼ 16,724 RYGB N Procedures Esophagogastroduodenoscopy Esophagoscopy pH monitoring study Manometry Diagnoses Peptic or esophageal ulcer Gastrojejunal ulcer Esophageal cancer New acid-treating prescription(s) Re-hospitalization Re-hospitalization; count Mean SD Median Re-hospitalization; average length of stay Mean SD Median GERD New acid-treating prescription(s) Barrett esophagus Reflux esophagitis Esophageal reflux De novo GERD Patients with no preoperative GERD New acid-treating prescription(s) Barrett esophagus Reflux esophagitis Esophageal reflux VSG 8362 50.0% 8362 50.0% Ps 2442 31 32 73 29.2% 0.4% 0.4% 0.9% 1798 31 59 102 21.5% 0.4% 0.7% 1.2% <0.001 1.0 0.006 0.03 1990 525 33 677 3254 23.8% 6.3% 0.4% 8.1% 38.9% 1601 37 40 511 2415 19.1% 0.4% 0.5% 6.1% 28.9% <0.001 <0.001 0.48 < 0.001 <0.001 0.8 1.9 0 0.6 1.5 0 <0.001 1.5 3.6 0 4650 519 93 542 4015 <0.001 55.6% 6.2% 1.1% 6.5% 48.0% 1.3 6.9 0 5038 397 60 525 4453 60.2% 4.7% 0.7% 6.3% 53.3% <0.001 <0.001 0.007 0.59 <0.001 1906 113 <11 67 672 22.8% 5.9% <0.6% 3.5% 35.3% 1665 76 <11 57 655 19.9% 4.6% <0.7% 3.4% 39.3% <0.001 0.07 1.0 0.88 0.01 SD indicates standard deviation. Condition is a subset of the first row in the section only.  follow-up) after 5 years (12.5% vs 13.2%, Chi-squared ¼ 0.46, P ¼ 0.50). DISCUSSION This study represents a retrospective analysis of a comprehensive administrative claims database, examining GERD-related sequelae of bariatric surgery. Patients with obesity who underwent VSG were matched to those who underwent RYGB. Matching was performed based on length of follow-up, as opposed to demographics, initial body mass index or preoperative comorbidities. Furthermore, only patients with continuous enrollment for at least 1 year before surgery and 2 to 5 years after surgery were included. This was critical to ensure equal capture of the spectrum of GERD, reflux esophagitis, and BE, which may be picked up on an initial postoperative endoscopy or in the context of a surveillance protocol.10 Furthermore, there is a highly regimented postoperative visit schedule recommendation by the American Society for Metabolic and Bariatric Surgery, making matching on the basis of follow-up interval more critical.11 Expectedly, the burden of comorbid illness was higher in the RYGB group, as these patients may have both higher initial body-mass indices and severity of diabetes mellitus. Nonetheless, it was deemed that the matching algorithm on followup only was most critical to ensure adequate comparisons during which symptomatic GERD, reflux esophagitis, and BE could ostensibly develop. 650 | www.annalsofsurgery.com Mechanistically, VSG is expected to have a propensity for increased post-operative persistent and de novo GERD, and subsequently, need for GERD medications, incidence of reflux esophagitis, and Barrett metaplastic and dysplastic changes.12 This has further been suggested in more recent smaller studies, which conclude that GERD symptoms are either improved or not exacerbated by VSG, although de novo incidence of GERD is greater.13,14 The VSG is associated with a decreased lower esophageal sphincter pressure and increased total and recumbent acid exposure times, in comparison to RYGB.12 Furthermore, a wrap operation is not feasible after a VSG, as these patients are sometimes converted to RYGB for refractory reflux or even BE.15,16 Using a comprehensive real world dataset, this study examined the prevalence of GERD-related outcomes after both procedures, but also specifically examined them in the cohort that did not have GERD preoperatively. The primary findings of this study are twofold. Among all patients, incidence of postoperative GERD was significantly greater after VSG relative to RYGB (60.2% vs 55.6% for VSG and RYGB, respectively; P < 0.001), and there was no difference in reflux esophagitis (6.3% vs 6.5%; P ¼ 0.59), whereas BE was actually more prevalent in the RYGB cohort (1.1% vs 0.7%; p ¼ 0.007). Second, although de novo esophageal reflux symptomatology occurred less frequently in RYGB patients relative to VSG patients (39.3% vs 35.3%; P ¼ 0.01), there was no difference in the frequency of de novo ß 2021 Wolters Kluwer Health, Inc. All rights reserved. Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved. Annals of Surgery  Volume 274, Number 4, October 2021 reflux esophagitis (3.4% vs 3.5%; P ¼ 0.88) and BE (<0.7% vs <0.6%; P ¼ 1.0). While conferring little benefit with respect to GERD-related outcomes, RYGB patients in this dataset did experience more frequent re-hospitalizations and more re-hospitalized days reflecting the increased risk of associated complications, at a rate commensurate with findings from van Olst et al in a recent meta-analysis.17 Postoperative re-hospitalizations were specifically chosen for concurrent analysis due to facility of accurate data capture, prevalence and importance of, as reflected by its use as a benchmark of quality. Thirty-day readmissions are known to be more frequent after RYGB relative to VSG, according to the MBSAQIP national data registry.18 Findings both from Garg et al, and Gero et al suggest that a very high percentage of re-hospitalizations in the first post-operative year are surgically related, typically due to abdominal pain or dietary issues; reported data beyond 1 year are lacking.19,20 This finding is plausibly attributable to both the higher burden of comorbidities in RYGB patients, and the increased risk of digestive and pain syndromes as well as higher prevalence of short- and long-term complications.17 This study definitively shows the persistence of this trend in the longterm postoperative period; however, assessments of longer-term reasons for readmission after bariatric surgery, beyond 1 year, are lacking. Preoperative BE was found in 0.8% of all patients who underwent RYGB, and 0.7% of patients who underwent VSG, data consistent with the preoperative prevalence reported in a metaanalysis by Qumseya et al in 2020.21 The absolute rates of postoperative BE in this study were low, at 1.1% in the RYGB cohort and 0.7% in the VSG cohort, similar to the rates reported in other large studies worldwide.22,23 In contrast, when followed to 5 years, other estimates of BE after VSG vary widely, from between 11% and 19%.24,25 Recently, the International Federation for the Surgery of Obesity and Metabolic Disorders estimated an incidence of BE after bariatric surgery. Derived from meta-analyses, the incidence of BE after VSG was estimated at 4.6% in patients with at least 2 years of follow-up, comparable to the 4.2% rate estimated in similarly followed patients irrespective of procedure type.7 Widely disparate reported rates of BE prevalence can be attributed to lack of routine endoscopic surveillance protocols, reporting bias and patient selection bias, however, of greatest clinical relevance is the lack of increased risk of BE development in patients who underwent VSG relative to RYGB. This study did not examine progression of BE, and only conclusions about BE prevalence before and after bariatric surgery can be derived. However, the natural history of progression of known BE is of critical importance when deciding the appropriateness of bariatric procedure. Recently, Mahawar et al reported the first modified Delphi consensus statement on VSG. Notably, there was near universal agreement that in patients with BE, VSG was not a suitable primary surgical weight loss option.26 Data on the natural history of patients with BE after RYGB are even more scarce. Goonawardena and Ward recently examined 5 publications reporting the nature of BE progression after RYGB. Regression rates varied widely, from 36% to 62%, although it was not evident whether the BE regression persisted, there was poor compliance with diagnostic and reporting protocols suggested by the American College of Gastroenterology, and there were only 58 patients examined across the five studies.27 In our data, there were very few patients who had BE postoperatively than pre-operatively in the VSG cohort, and even fewer additional patients with BE after RYGB, relative to before. This study, more than all else, demonstrates the need for a prospective, long-term study to determine the natural history of both development and progression of BE and subsequent esophageal adenocarcinoma with routine and long-term endoscopic surveillance after both VSG and RYGB, as present studies rely on retrospective data with ß 2021 Wolters Kluwer Health, Inc. All rights reserved. GERD Outcomes After Bariatric Surgery inherently unstandardized methods of follow-up and endoscopy. Although difficult to assess and detect due to low incidence, longterm development of esophageal cancer from BE does not appear to be increased after VSG, relative to RYGB.28,29 There were multiple limitations to this study within which the context of our findings must be considered. Although expansive, this study is subject to selection and reporting bias inherent in retrospective data collection. Furthermore, as a claims-based dataset, attribution of comorbidities, procedures, and diagnoses is necessarily dependent on accurate and fully captured coding.30 Systematic miscoding errors are undetectable using this methodology and may introduce error. Nonetheless, procedural attribution via CPT code use is quite common and mandated with studies considering Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database, whereas comorbidity attribution via presence of relevant ICD-9 or ICD-10 codes has been used in myriad well-designed analyses whose outcomes have been verified.31–33 As a retrospective dataset, inferences about temporal causality cannot be ascertained. Specifically, inferences on reasons for initiation of antireflux medications and indications for EGDs cannot be determined with the dataset. Next, as discussed previously, matching was performed on the basis of follow-up interval, meaning differences in demographics or comorbidities may have unduly influenced development of GERD-related outcomes. Specifically, RYGB patients expectedly had a higher burden of comorbidities including diabetes mellitus and hypertension, whereas VSG patents were more frequently on acid-reducing medications preoperatively. Despite the limitations, this large dataset demonstrates that although GERD may be slightly more prevalent after VSG than RYGB, differences in postoperative reflux esophagitis and BE are not observed, challenging the notion that RYGB is superior to VSG in patients with pre-existing GERD or even BE. REFERENCES 1. Committee ACI. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2012;8:e21–e26. 2. Wolnerhanssen BK, Peterli R, Hurme S, et al. 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Esophageal pathophysiologic changes and adenocarcinoma after bariatric surgery: a systematic review and meta-analysis. Clin Transl Gastroenterol. 2020;11:e00225. www.annalsofsurgery.com | 651 Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved. Annals of Surgery  Volume 274, Number 4, October 2021 Leslie et al 13. Silveira FC, Poa-Li C, Pergamo M, et al. The effect of laparoscopic sleeve gastrectomy on gastroesophageal reflux disease. Obes Surg. 2021;31:1139–1146. 14. Balla A, Quaresima S, Palmieri L, et al. Effects of laparoscopic sleeve gastrectomy on quality of life related to gastroesophageal reflux disease. J Laparoendosc Adv Surg Tech A. 2019;29:1532–1538. 15. de Tomas J. Conversion to gastric bypass in patients with Barret’s esophagus after sleeve gastrectomy. Cir Esp. 2021. 16. Parmar CD, Mahawar KK, Boyle M, et al. Conversion of sleeve gastrectomy to Roux-en-Y gastric bypass is effective for gastro-oesophageal reflux disease but not for further weight loss. 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Zacharakis G, Almasoud A, AlZahrani J, et al. Upper gastrointestinal tract involvement in the management of bariatric patients in the Kingdom of Saudi Arabia. Ann Gastroenterol. 2021;34:177–182. 23. Al Sabah S, AlWazzan A, AlGhanim K, et al. Does laparoscopic sleeve gastrectomy lead to Barrett’s esophagus, 5-year esophagogastroduodenoscopy findings: a retrospective cohort study. Ann Med Surg (Lond). 2021;62:446–449. 24. Sebastianelli L, Benois M, Vanbiervliet G, et al. Systematic endoscopy 5 years after sleeve gastrectomy results in a high rate of Barrett’s esophagus: results of a multicenter study. Obes Surg. 2019;29:1462–1469. 25. Qumseya BJ, Qumsiyeh Y, Ponniah SA, et al. Barrett’s esophagus after sleeve gastrectomy: a systematic review and meta-analysis. Gastrointest Endosc. 2021;93:343–352. e2. 26. Mahawar KK, Omar I, Singhal R, et al. The first modified Delphi consensus statement on sleeve gastrectomy. Surg Endosc. 2021. 27. Goonawardena J, Ward S. Effect of Roux-en-Y gastric bypass on Barrett’s esophagus: a systematic review. Surg Obes Relat Dis. 2021;17:221–230. 28. Andalib A, Bouchard P, Demyttenaere S, et al. Esophageal cancer after sleeve gastrectomy: a population-based comparative cohort study. Surg Obes Relat Dis. 2021;17:879–887. 29. Bevilacqua LA, Obeid NR, Yang J, et al. Incidence of GERD, esophagitis, Barrett’s esophagus, and esophageal adenocarcinoma after bariatric surgery. Surg Obes Relat Dis. 2020;16:1828–1836. 30. Wirth K, Kizy S, Abdelwahab H, et al. Bariatric surgery outcomes in Medicare beneficiaries. Obes Sci Pract. 2021;7:176–191. 31. Wise ES, Amateau SK, Ikramuddin S, et al. Prediction of thirty-day morbidity and mortality after laparoscopic sleeve gastrectomy: data from an artificial neural network. Surg Endosc. 2020;34:3590–3596. 32. Grieco A, Huffman KM, Cohen ME, et al. The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program bariatric surgical risk/benefit calculator: 30-day risk. Surg Obes Relat Dis. 2021. 33. Skulsky SL, Dang JT, Battiston A, et al. Higher Edmonton Obesity Staging System scores are associated with complications following laparoscopic Roux-en-Y gastric bypass. Surg Endosc. 2020;34:3102–3109. DISCUSSANT Dr. Aurora D. Pryor I am Aurora Pryor from Stony Brook, New York, and I would like to thank the American Surgical Association for the invitation to discuss this paper. I would also like to congratulate Daniel Leslie from the University of Minnesota for this outstanding article evaluating GERD after vertical sleeve gastrectomy and RYGB. Dr. Leslie 652 | www.annalsofsurgery.com used an insurance claims database to evaluate matched patients undergoing RYGB and sleeve gastrectomy for a claims-based diagnosis of gastroesophageal reflux disease before and after surgery. The groups were well matched. There was 77% GERD in the preop bypass patient group and 80% in sleeve. Interestingly, there was no significant difference in baseline BE. Following surgery at 91 days to 5 years, post-op GERD was seen in 56% or bypass patients and 60% of VSG, with denovo GERD in 12 or 11.7%, respectively. Surprisingly, postoperative BE and do novo GERD were significantly less in the sleeve population. My questions to the author are the following: 1. As this cohort is based on an insurance claims database, is this study possibly confounded by patients carrying a GERD diagnosis for empiric use of PPI beyond 90 days post-op? Or, is it possible the PPI use was for an alternative diagnosis, such as marginal ulcer? If so, did you look at alternative diagnoses or break down the presence of GERD into timepoints further out from surgery? 2. This study also noted a higher number of hospitalizations following gastric bypass. What were the reasons for those visits? 3. Did you look for any diagnoses of esophageal cancer in either group, potentially as a sequelae of BE? 4. Following this study, for which patient populations would you consider RYGB the preferred operation? Thank you again for the opportunity to discuss this paper. Response Dr. Daniel Leslie We would like to thank the moderators, and the American Surgical Association and its membership for the opportunity to present our data; thank you, Dr. Pryor, for your thorough and insightful review. Your questions significantly improved our submitted manuscript. To answer your first question, we attempted to control for early postoperative confounding by only counting diagnoses beyond 91 days through up to 5 years after surgery. We view the first 90 days as a somewhat chaotic and choppy period of diagnosis and prescribing is more empiric and protocol-based; for most patients, surgical healing has completed by the 3 month point and longer-term GERD was analyzed after that. Beyond 90 days, all bariatric teams prescribe empirically at one point or another, and the study cannot decipher this intent. Typically, a prescription requires a diagnosis and symptoms of esophageal reflux are likely the most common for this. Endoscopies are not always done, unfortunately. We also identified marginal ulcers in 6.4% of patients who underwent gastric bypass and this needs to be part of a balanced discussion. Reporting requirements for the OptumLabs Datawarehouse mandate that >10 patients carry a specific diagnosis, so further breakdowns into windows of time and comparisons within those windows become less useful, even with such a large data set. Regarding your second question about hospitalizations, many were for nausea, vomiting or abdominal pain and were brief; however, the reporting is for all-cause hospitalizations and could include those for orthopedic or obstetric reasons as well; we view these data as a project for a different analysis. To address your 3rd question, there were 73 cases of esophageal cancer post-bariatric surgery, 33 in gastric bypass and 40 in sleeve, not significantly different and are in our submitted manuscript. Interestingly, none of these patients had antecedent Barrett’s. Moreover, there were no esophageal cancers in the gastric bypass population post-surgery and <11 in the sleeve population; the difference was not significant and the exact number NOT reportable. Finally, your last question regarded procedural selection and our use of the gastric bypass. In our practice at the University of ß 2021 Wolters Kluwer Health, Inc. All rights reserved. Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved. Annals of Surgery  Volume 274, Number 4, October 2021 Minnesota, the RYGB is the preferred operation in very few patients currently; we exclude consideration of gastric bypass in patients with a history of large abdominal wall hernia or prior small bowel or colon resection, immune disorders, major psychological disorders, chronic opiate requirement, long-term need for NSAID therapy, and history of smoking or addiction. In some of these cases, we strongly support medical weight management without bariatric surgery. For patients ß 2021 Wolters Kluwer Health, Inc. All rights reserved. GERD Outcomes After Bariatric Surgery who don’t have these histories, a gastric bypass is considered for patients who understand risks and prefer this approach. The data I presented don’t support using the presence of GERD as a primary reason for selecting a gastric bypass compared to a sleeve gastrectomy. However, they certainly will inform our preoperative discussion with patients about short- and long-term risks of the operations and side effects in the first 5 years after surgery. www.annalsofsurgery.com | 653 Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.