Does routine upper gastrointestinal swallow study after metabolic and bariatric surgery lead to earlier diagnosis of leak?

BACKGROUND: It is unclear whether routine upper gastrointestinal swallow study (SS) in the immediate postoperative period is associated with earlier diagnosis of gastrointestinal leak after bariatric surgery. OBJECTIVE: To investigate the relationship between routine SS and time to diagnosis of postoperative gastrointestinal leak. SETTING: MBSAQIP-accredited hospitals in the United States and Canada. METHODS: We conducted an observational cohort study of adults who underwent laparoscopic primary Roux-en-Y gastric bypass (RYGB) (n = 82,510) and sleeve gastrectomy (SG) (n = 283,520) using the MBSAQIP 2015-2019 database. Propensity scores were used to match patient cohorts who underwent routine versus no routine SS. Primary outcome was time to diagnosis of leak. Median days to diagnosis of leak were compared. The Nelson-Aalen estimator was used to determine the cumulative hazards of leak. RESULTS: In our study, 36,280 (23%) RYGB and 135,335 (33%) SG patients received routine SS. Routine SS was not associated with earlier diagnosis of leak (RYGB routine SS median 7 [IQR 3-12] days v. no routine SS 6 [2-11] days, P = .9; SG routine SS 15 [9-22] days v. no routine SS 14 [8-21] days, P = .06) or lower risk of developing leak (RYGB HR 1.0, 95%-CI .8-1.2; SG HR 1.1, 95%-CI 1.0-1.4). More routine SS patients had a length of stay 2 days or greater (RYGB 78.3% v. 61.1%; SG 48.6% v. 40.3%). CONCLUSIONS: Routine SS was not associated with earlier diagnosis of leaks compared to the absence of routine SS. Surgeons should consider abandoning the practice of routine SS for the purpose of obtaining earlier diagnosis of postoperative leaks.

Current recommendations for procedure selection in class I and II obesity developed by an expert modified Delphi consensus.

Metabolic and bariatric surgery (MBS) is widely considered the most effective option for treating obesity, a chronic, relapsing, and progressive disease. Recently, the American Society of Metabolic and Bariatric Surgery (ASMBS) and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) issued new guidelines on the indications for MBS, which have superseded the previous 1991 National Institutes of Health guidelines. The aim of this study is to establish the first set of consensus guidelines for selecting procedures in Class I and II obesity, using an Expert Modified Delphi Method. In this study, 78 experienced bariatric surgeons from 32 countries participated in a two-round Modified Delphi consensus voting process. The threshold for consensus was set at an agreement or disagreement of ≥ 70.0% among the experts. The experts reached a consensus on 54 statements. The committee of experts reached a consensus that MBS is a cost-effective treatment option for Class II obesity and for patients with Class I obesity who have not achieved significant weight loss through non-surgical methods. MBS was also considered suitable for patients with Type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30 kg/m2 or higher. The committee identified intra-gastric balloon (IGB) as a treatment option for patients with class I obesity and endoscopic sleeve gastroplasty (ESG) as an option for patients with class I and II obesity, as well as for patients with T2DM and a BMI of ≥ 30 kg/m2. Sleeve gastrectomy (1) and Roux-en-Y gastric bypass (RYGB) were also recognized as viable treatment options for these patient groups. The committee also agreed that one anastomosis gastric bypass (OAGB) is a suitable option for patients with Class II obesity and T2DM, regardless of the presence or severity of obesity-related medical problems. The recommendations for selecting procedures in Class I and II obesity, developed through an Expert Modified Delphi Consensus, suggest that the use of standard primary bariatric endoscopic (IGB, ESG) and surgical procedures (SG, RYGB, OAGB) are acceptable in these patient groups, as consensus was reached regarding these procedures. However, randomized controlled trials are still needed in Class I and II Obesity to identify the best treatment approach for these patients in the future.

Safety and cost of performing laparoscopic sleeve gastrectomy with same day discharge at a large academic hospital.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is the most common surgical treatment for morbid obesity. While certain specialized ambulatory surgery centers offer LSG on an outpatient basis, patients undergoing LSG at most academic centers are admitted to hospital for initial postoperative convalescence and monitoring. Our institution has begun to offer LSG with same-day discharge (SDD) in select patients. We aimed to compare the perioperative outcomes and costs for patients undergoing LSG with inpatient admission versus SDD. METHODS: All patients enrolled in the SDD program from December 2020 through July 2022 were identified from a prospectively maintained database. Patients enrolled in this pathway were analyzed on an intention-to-treat basis even if ultimately admitted postoperatively. Propensity scoring was used to match these patients 1:1 to those with planned inpatient recovery based on age, BMI, and ASA classification. RESULTS: Seventy-five patients were enrolled in the LSG with SDD program during the study period. Among these, 62 patients (82.7%) had successful immediate postoperative discharge. Reasons for cancelation of planned SDD included anxiety (n = 5), pain (n = 3), nausea (n = 2), and one patient each with hypotension, urinary retention, and bleeding. After matching, there were no differences in age, BMI, or ASA classification in a comparison group of patients with planned inpatient recovery. There were no differences in perioperative complications. There were no readmissions or requirements for outpatient intravenous fluids among patients with SDD, compared to n = 3 (4.0%) and n = 2 (2.7%) in the inpatient cohort, respectively. The total perioperative cost for patients undergoing LSG with planned SDD was 6.8% less than those with inpatient recovery. CONCLUSION: With appropriate protocols, LSG with same-day discharge can safely be performed at large academic surgery centers without increased morbidity or need for additional services in the perioperative period. SDD may be associated with decreased costs and allows for more efficient hospital bed allocation.

First report of outcomes from the patient-reported outcome measures program in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program.

BACKGROUND: Health-related quality-of-life (HRQoL) is one of the most important outcomes to metabolic and bariatric surgery (MBS) patients but was not measured by the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP). A patient-reported outcome measures (PROMs) program pilot started in 2016 with MBSAQIP implementation in 2019. OBJECTIVES: To measure how MBS impacts patient HRQoL 1 and 2 years after primary laparoscopic Roux-en-Y gastric bypass (bypass) or laparoscopic sleeve gastrectomy (sleeve). SETTING: The 82 centers in the United States participating in the MBSAQIP PROMs program. METHODS: Preoperative HRQoL scores and satisfaction were compared with postoperative scores 1 and 2 years after surgery with univariate comparisons and adjusted regression models. RESULTS: There were 13,901 PROMs responses from 11,146 patients. Patient satisfaction with their MBS decision was 97%. On average, patients had significant improvement in Obesity-related Problem (OP) scores (65.8 preoperatively, 23.0 at 1 yr, and 26.3 at 2 yr; P <.05), Obesity and Weight-Loss Quality-of-Life (OWLQOL) scores (36.7 preoperatively, 77.2 at 1 yr, and 74.6 at 2 yr; P < .05), their physical health (39.2 preoperatively versus 51.7 at 1 yr and 50.0 at 2 yr), and mental health (45.6 preoperatively versus 53.3 at 1 yr and 51.4 at 2 yr). Compared with bypass patients, sleeve patients had significantly lower odds of having low OP scores postoperatively (odds ratio [95% CI) ] .67 [.53, .83]) and lower odds of high OWLQOL (.61 [.48, .77]) at 1 year. CONCLUSION: All patients regardless of procedure on average report significant improvement in their scores for OP, OWLQOL, and physical and mental health after MBS. At 1 and 2 years, bypass patients reported greater improvement in their obesity-related PROMs than sleeve patients.

Selection of patient-reported outcomes measures for implementation in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program.

BACKGROUND: The Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP) assesses safety after metabolic and bariatric surgery and the impact on weight and obesity-related diseases. However, changes in quality of life are likely what matters most to patients, and these are not currently assessed. The best way to measure health-related quality of life (HRQoL) is to use validated patient-reported outcomes measures (PROMs), which capture patients' perspectives of their quality of life both before and after surgery. OBJECTIVES: Identify the outcomes most important to bariatric surgery patients and identify the most appropriate validated PROMs to implement in a national program for the MBSAQIP. SETTING: Five hospitals from a single healthcare system in New England. METHODS: A series of 18 focus groups and/or interviews conducted with patients, patients' family members, and bariatric health providers determined the outcomes most important to bariatric patients and which validated PROMs would accurately measure those outcomes. Immersion crystallization was used to analyze focus group data and identify appropriate PROMs. RESULTS: Focus group participants ranked health as the most important outcome for metabolic and bariatric surgery. Self-confidence, mobility, and everyday activities were the next highest ranked HRQoL domains. The Patient-Reported Outcomes Measurement Information System 10-Item Global Health Survey was selected as the general health measure. The Obesity-Related Problems scale and the Obesity and Weight-Loss Quality of Life Instrument were the disease-specific measures selected for inclusion in the MBSAQIP PROMs program. CONCLUSION: The addition of PROMs to the MBSAQIP provides a unique opportunity to monitor HRQoL at the national level, which can foster improved shared decision-making before surgery.

External validation of the Codman score in colorectal surgery: a pragmatic tool to drive quality improvement.

AIM: The simple six-variable Codman score is a tool designed to reduce the complexity of contemporary risk-adjusted postoperative mortality rate predictions. We sought to externally validate the Codman score in colorectal surgery. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) participant user file and colectomy targeted dataset of 2020 were merged. A Codman score (composed of six variables: age, American Society of Anesthesiologists score, emergency status, degree of sepsis, functional status and preoperative blood transfusion) was assigned to every patient. The primary outcome was in-hospital mortality and secondary outcome was morbidity at 30 days. Logistic regression analyses were performed using the Codman score and the ACS NSQIP mortality and morbidity algorithms as independent variables for the primary and secondary outcomes. The predictive performance of discrimination area under receiver operating curve (AUC) and calibration of the Codman score and these algorithms were compared. RESULTS: A total of 40 589 patients were included and a Codman score was generated for 40 557 (99.02%) patients. The median Codman score was 3 (interquartile range 1-4). To predict mortality, the Codman score had an AUC of 0.92 (95% CI 0.91-0.93) compared to the NSQIP mortality score 0.93 (95% CI 0.92-0.94). To predict morbidity, the Codman score had an AUC of 0.68 (95% CI 0.66-0.68) compared to the NSQIP morbidity score 0.72 (95% CI 0.71-0.73). When body mass index and surgical approach was added to the Codman score, the performance was no different to the NSQIP morbidity score. The calibration of observed versus expected predictions was almost perfect for both the morbidity and mortality NSQIP predictions, and only well fitted for Codman scores of less than 4 and greater than 7. CONCLUSION: We propose that the six-variable Codman score is an efficient and actionable method for generating validated risk-adjusted outcome predictions and comparative benchmarks to drive quality improvement in colorectal surgery.

Black-versus-White racial disparities in 30-day outcomes at Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program-accredited centers: a needed quality indicator.

BACKGROUND: Creating a metric in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) to assess Black-versus-White disparities is critical if we are to ensure equitable care for all. OBJECTIVE: To investigate Black-versus-White disparities while replicating MBSAQIP methodology with regard to covariates and modeling so that the results can serve as the foundation to create a benchmarked site-level Disparities Metric for MBSAQIP. SETTING: United States and Canada. METHODS: Across the 2015-2019 MBSAQIP cohorts, 543,976 adults underwent primary or revision sleeve gastrectomy or Roux-en-Y gastric bypass and were reported as either White or Black. Using a set of covariates derived from published MBSAQIP performance models, we performed multivariable logistic modeling with 10-fold cross-validation for the 11 outcomes evaluated in MBSAQIP Semiannual Reports, plus venous thromboembolism (VTE) and death. We analyzed primary and revision cases separately. RESULTS: After risk adjustment, Black patients experienced higher odds of all-occurrence morbidity (odds ratio [OR], 1.22; 95% confidence interval [CI], 1.19-1.25; P < .001), serious events (OR, 1.08; 95% CI, 1.04-1.13; P < .001), all-cause intervention (OR, 1.31; 95% CI, 1.24-1.37; P < .001), related intervention (OR, 1.29; 95% CI, 1.22-1.37; P < .001), all-cause readmission (OR, 1.37; 95% CI, 1.33-1.41; P < .001), related readmission (OR, 1.41; 95% CI, 1.36-1.46; P < .001), venous thromboembolism (OR, 1.49; 95% CI, 1.34-1.65; P < .001), and death (OR, 1.59; 95% CI, 1.34-1.89; P < .001) after primary procedures. Black patients experienced lower odds of morbidity (OR, .94; 95% CI, .91-.98; P = .004) and surgical-site infection (OR, .72; 95% CI, .66-.78; P < .001). CONCLUSIONS: Black patients experienced a higher risk for serious complications and required more readmissions, reoperations, and postoperative interventions. This study supports the creation of a site-level Disparities Metric for the MBSAQIP and provides the framework to do so.

Evaluating agreement between clinic- and patient-reported outcomes for weight and co-morbidities at 1 year after bariatric surgery.

BACKGROUND: Development of patient-reported outcomes (PROs) to include traditionally clinic-reported data has the potential to decrease the data-collection burden for patients and clinicians and increase follow-up rates. However, replacing clinic report by patient report requires that the data reasonably agree. OBJECTIVE: To assess agreement between PROs and clinical registry data at 1 year after bariatric surgery. SETTING: Not-for-profit organization, bariatric surgery data registry, PROs platform. METHODS: Patient- and clinic-reported 1-year postoperative weight and co-morbidities were compared for matched PROs and registry records. The co-morbidities evaluated were diabetes, sleep apnea, hypertension, gastroesophageal reflux disease, and hyperlipidemia. Weight difference in pounds and nominal groupings (binary, 4-level) for co-morbidities were assessed for agreement between data sources using descriptive statistics, Bland-Altman plots, multiple regression, and kappa coefficients. Sensitivity analyses and follow-up by response method were examined. RESULTS: Among 1130 patients with both 1-year PROs and registry weights, 95% of patient-reported weights were within 13 lb of the registry-recorded weight, and patients underreported their weight by ∼2 lb, on average. Percent agreement and kappa coefficients were highest for diabetes (n = 999; binary: 94%, κ = .72; 4-level: 86%, κ = .71) and lowest for gastroesophageal reflux disease (n = 1032; binary: 75%, κ = .40; 4-level: 57%, κ = .35). Of patients eligible for both PROs and registry 1-year follow-up, 21% had PROs only. CONCLUSIONS: One-year patient- and clinic-reported weights and disease status for patients with diabetes and hypertension showed high agreement. The degree of bias from patient report was low. Patient report is a viable alternative to clinic report for certain objective measurements and may increase follow-up.

The United States Experience with One Anastomosis Gastric Bypass at MBSAQIP-Accredited Centers.

PURPOSE: One anastomosis gastric bypass (OAGB) has emerged as a potentially safe and effective weight-loss procedure. Worldwide, OAGB is the third most commonly performed primary bariatric procedure, comprising 4% of the annual volume. In the USA, OAGB has yet to be endorsed as a primary bariatric procedure and can only be performed under research protocols or as a revision procedure. MATERIALS AND METHODS: We performed an observational cohort study to describe the preoperative, intraoperative, and postoperative characteristics of adult patients who underwent primary or revision OAGB from 2015 to 2019 at MBSAQIP centers. Exclusion criteria included emergent surgery, incomplete 30-day follow-up, and non-laparoscopic- or robotic approach. RESULTS: During the study period, 803,906 bariatric procedures were performed and 645 (0.08%) were OAGB. Among these, 436 (67.6%) were primary and 209 (32.4%) were revision OAGB. The mean operation time was 89 min (SD, 59) and 8% were performed using a robotic approach. The overall complication rate was 7.4% and there was one death (0.2%). The post-operative complication rates were generally higher than the early complication rate (3.4%) reported in the YOMEGA trial, an RCT from France. Revision OAGB had a longer mean operation time of 141 min (SD, 85, p < 0.001). CONCLUSION: Primary OAGB was a rarely performed bariatric procedure at MBSAQIP-accredited centers comprising only 0.05% compared to 4% worldwide. Future studies should compare safety of OAGB to that of established bariatric procedures like Roux-en-Y gastric bypass and sleeve gastrectomy.

American Society for Metabolic and Bariatric Surgery 2020 estimate of metabolic and bariatric procedures performed in the United States.

BACKGROUND: Metabolic and bariatric surgery (MBS), despite being the only effective durable treatment for obesity, remains underused as approximately 1% of all patients who qualify undergo surgery. The American Society for Metabolic and Bariatric Surgery created a Numbers Taskforce to specify annual rate of utilization for obesity treatment interventions and to determine if patients in need are receiving appropriate treatment. OBJECTIVE: The objective of this study was to provide the best estimated number of metabolic and bariatric procedures performed in the United States in 2020. SETTING: United States. METHODS: We reviewed data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), National Surgical Quality Improvement Program, Bariatric Outcomes Longitudinal Database, and Nationwide Inpatient Sample. In addition, data from industry and state databases were used to estimate activity at nonaccredited centers. Data from 2020 were compared mainly with data from the previous 2 years. RESULTS: Compared with 2019, the total number of MBS performed in 2020 decreased from approximately 256,000 to 199,000. Sleeve gastrectomy continues to be the most common procedure. The gastric bypass procedure trend remained relatively stable, and the gastric band procedure trend continued to decline. The percentage of revision procedures and biliopancreatic diversion with duodenal switch procedures increased slightly. Single-anastomosis duodeno-ileostomy was listed for the first time in 2020. Intragastric balloons placement declined from the previous year. CONCLUSION: There was a 22.5% decrease in MBS volume from 2019 to 2020, which coincided with the COVID-19 pandemic. Sleeve gastrectomy continues to be the dominant procedure, and for the first time, single-anastomosis duodeno-ileostomy is reported in the MBSAQIP database.

Comparison of Short-term Safety of One Anastomosis Gastric Bypass to Roux-en-Y Gastric Bypass and Sleeve Gastrectomy in the United States: 341 cases from MBSAQIP-accredited Centers.

BACKGROUND: One anastomosis gastric bypass (OAGB) is the third most common (4%) primary bariatric procedure worldwide but is seldom performed in the United States and is currently under consideration for endorsement by the American Society for Metabolic and Bariatric Surgery. Evidence from the United States on safety of OAGB compared to Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) is limited. OBJECTIVE: To compare the short-term safety outcomes of the three primary bariatric procedures. SETTING: Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-accredited hospitals in the United States and Canada. METHODS: Using the 2015-2019 MBSAQIP database, we compared the safety outcomes of adult patients who underwent primary laparoscopic OAGB, RYGB, and SG. Exclusion criteria included age over 80 years, emergency operation, conversion, and incomplete follow-up. The primary outcome was 30-day overall complication. Secondary outcomes were 30-day surgical and medical complications and hospitalization length. RESULTS: A total of 341 patients underwent primary OAGB. Using propensity scores, we matched the OAGB cohort 1:1 with two cohorts of similar baseline characteristics who underwent RYGB and SG, respectively. The OAGB cohort had a lower overall complication rate than the RYGB cohort (6.7% versus12.3%, P = .02) and a similar rate to the SG cohort (5.0%, P = .43). The OAGB cohort had a similar rate of surgical complication to the RYGB cohort (5.0% versus 8.5%, P = .1) and a higher rate than the SG group (1.2%, P = .009). The OAGB cohort had a shorter median hospitalization than the RYGB cohort (1 d [interquartile range (IQR) 1-2 d] versus 2 d [IQR 1-2 d], P < .001) and a similar hospitalization length to the SG cohort ([1-2 d], P = .46). CONCLUSION: Using the largest and the most current U.S. data, this study demonstrated that the short-term safety profile of primary OAGB is acceptable, but future studies should determine the long-term safety.

Distinct Hepatic Gene-Expression Patterns of NAFLD in Patients With Obesity.

Approaches to manage nonalcoholic fatty liver disease (NAFLD) are limited by an incomplete understanding of disease pathogenesis. The aim of this study was to identify hepatic gene-expression patterns associated with different patterns of liver injury in a high-risk cohort of adults with obesity. Using the NanoString Technologies (Seattle, WA) nCounter assay, we quantified expression of 795 genes, hypothesized to be involved in hepatic fibrosis, inflammation, and steatosis, in liver tissue from 318 adults with obesity. Liver specimens were categorized into four distinct NAFLD phenotypes: normal liver histology (NLH), steatosis only (steatosis), nonalcoholic steatohepatitis without fibrosis (NASH F0), and NASH with fibrosis stage 1-4 (NASH F1-F4). One hundred twenty-five genes were significantly increasing or decreasing as NAFLD pathology progressed. Compared with NLH, NASH F0 was characterized by increased inflammatory gene expression, such as gamma-interferon-inducible lysosomal thiol reductase (IFI30) and chemokine (C-X-C motif) ligand 9 (CXCL9), while complement and coagulation related genes, such as C9 and complement component 4 binding protein beta (C4BPB), were reduced. In the presence of NASH F1-F4, extracellular matrix degrading proteinases and profibrotic/scar deposition genes, such as collagens and transforming growth factor beta 1 (TGFB1), were simultaneously increased, suggesting a dynamic state of tissue remodeling. Conclusion: In adults with obesity, distinct states of NAFLD are associated with intrahepatic perturbations in genes related to inflammation, complement and coagulation pathways, and tissue remodeling. These data provide insights into the dynamic pathogenesis of NAFLD in high-risk individuals.

ADAMTSL2 protein and a soluble biomarker signature identify at-risk non-alcoholic steatohepatitis and fibrosis in adults with NAFLD.

BACKGROUND & AIMS: Identifying fibrosis in non-alcoholic fatty liver disease (NAFLD) is essential to predict liver-related outcomes and guide treatment decisions. A protein-based signature of fibrosis could serve as a valuable, non-invasive diagnostic tool. This study sought to identify circulating proteins associated with fibrosis in NAFLD. METHODS: We used aptamer-based proteomics to measure 4,783 proteins in 2 cohorts (Cohort A and B). Targeted, quantitative assays coupling aptamer-based protein pull down and mass spectrometry (SPMS) validated the profiling results in a bariatric and NAFLD cohort (Cohort C and D, respectively). Generalized linear modeling-logistic regression assessed the ability of candidate proteins to classify fibrosis. RESULTS: From the multiplex profiling, 16 proteins differed significantly by fibrosis in cohorts A (n = 62) and B (n = 98). Quantitative and robust SPMS assays were developed for 8 proteins and validated in Cohorts C (n = 71) and D (n = 84). The A disintegrin and metalloproteinase with thrombospondin motifs like 2 (ADAMTSL2) protein accurately distinguished non-alcoholic fatty liver (NAFL)/non-alcoholic steatohepatitis (NASH) with fibrosis stage 0-1 (F0-1) from at-risk NASH with fibrosis stage 2-4, with AUROCs of 0.83 and 0.86 in Cohorts C and D, respectively, and from NASH with significant fibrosis (F2-3), with AUROCs of 0.80 and 0.83 in Cohorts C and D, respectively. An 8-protein panel distinguished NAFL/NASH F0-1 from at-risk NASH (AUROCs 0.90 and 0.87 in Cohort C and D, respectively) and NASH F2-3 (AUROCs 0.89 and 0.83 in Cohorts C and D, respectively). The 8-protein panel and ADAMTSL2 protein had superior performance to the NAFLD fibrosis score and fibrosis-4 score. CONCLUSION: The ADAMTSL2 protein and an 8-protein soluble biomarker panel are highly associated with at-risk NASH and significant fibrosis; they exhibited superior diagnostic performance compared to standard of care fibrosis scores. LAY SUMMARY: Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of liver disease worldwide. Diagnosing NAFLD and identifying fibrosis (scarring of the liver) currently requires a liver biopsy. Our study identified novel proteins found in the blood which may identify fibrosis without the need for a liver biopsy.

Intraoperative leak test is associated with lower postoperative bleed rate in primary sleeve gastrectomy: a propensity matched analysis of primary and revision bariatric surgery using the MBSAQIP database.

BACKGROUND: Gastrointestinal leaks after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) occur infrequently but lead to clinical and socioeconomic burden on patients. Surgeons perform intraoperative leak test (IOLT) via gastric tube or endoscopy to help prevent postoperative leaks. However, there is knowledge gap in the literature on effectiveness of IOLT during bariatric surgery. METHODS: In this observational cohort study using the 2015-2017 MBSAQIP database, we compared the outcomes in patients who received IOLT with those who did not during primary or revision RYGB and SG. The primary outcome was 30-day postoperative leak. Secondary outcomes were procedure duration and the rates of 30-day postoperative bleed, readmission, reoperation and intervention. Propensity score matching was used to assemble cohorts of patients with similar baseline characteristics. RESULTS: Among 363,042 patients, 82% underwent IOLT. Four subgroups of patients who underwent operations with or without IOLT during primary RYGB (n = 13,756), primary SG (n = 110,810), revision RYGB (n = 1140), and revision SG (n = 5576) had similar propensity scores and were matched 1:1. Patients who underwent IOLT had similar postoperative leak rates compared to those who did not (Primary RYGB with IOLT 0.7% v. without IOLT 0.6%; Primary SG 0.4% v. 0.3%; Revision RYGB 2.3% v. 1.0%; Revision SG 1.1% v. 0.7%). In primary SG subgroup, patients who underwent IOLT had lower postoperative bleed rates (0.6% v. 0.8%, p = 0.002). In primary RYGB and SG subgroups, operations with IOLT were slightly longer. CONCLUSION: Postoperative leak rates after primary and revision bariatric surgery were low and similar irrespective of IOLT. Patients who had IOLT during primary SG had lower postoperative bleed rates. Current judgment as to whether to perform an IOLT leads to excellent outcomes, and thus, current practices should continue. However, one should consider an IOLT during primary SG, not necessarily to reduce leak rates but to help reduce postoperative bleeding occurrences.

Zoledronic acid for prevention of bone loss in patients receiving bariatric surgery.

PURPOSE: Bariatric surgery is an effective treatment for severe obesity but causes substantial bone loss and increased risk of fractures. To date, there have been no studies examining whether pharmacologic treatments can prevent bone loss after bariatric surgery. We performed an exploratory study to examine the preliminary safety and efficacy of zoledronic acid (ZOL), a potent anti-resorptive bisphosphonate, to suppress bone turnover markers (BTM) and prevent declines in bone mineral density (BMD) after Roux-en-Y gastric bypass (RYGB) surgery. METHODS: We performed an open-label pilot study of pre-operative ZOL in postmenopausal women with obesity who were planning RYGB (n = 4). A single dose of zoledronic acid 5 mg was given intravenously prior to RYGB. Serum bone biochemistries including C-telopeptide (CTX) and procollagen type 1 N-terminal propeptide (P1NP) were measured at multiple timepoints throughout the 24-week study. BMD was also obtained at the spine and hip by dual-energy x-ray absorptiometry (DXA) and at the trabecular spine by quantitative computed tomography (QCT) at pre-operative baseline and 24 weeks. Results were compared against pre-operative baseline and against changes among RYGB historical controls (n = 10). RESULTS: At 2 weeks after RYGB, there was a nonsignificant trend for CTX and P1NP levels to be lower than baseline levels in the ZOL group. By 24 weeks after RYGB, however, participants who received ZOL had a significant increase in CTX above pre-operative baseline (+0.228 ± 0.117 ng/dL, p = 0.030) but this CTX rise was less than that observed in the controls (+0.601 ± 0.307 ng/dL, p = 0.042 between groups). Despite ZOL use, participants had significant areal BMD loss at the total hip as compared to pre-operative baseline (-4.2 ± 1.5%, p = 0.012) that was similar in magnitude to total hip BMD loss in the controls (-5.5 ± 3.9%, p = 0.005). There was a suggestion that the ZOL group might be protected against trabecular spine volumetric bone loss as compared to the control group (+4.8 ± 8.0% vs. -5.9 ± 7.0%, p = 0.075 between groups). Serum calcium, 25-hydroxyvitamin D, and parathyroid hormone did not change in either group. No hypocalcemia or serious adverse events were reported after ZOL. CONCLUSION: In this proof of concept study, a single dose of ZOL prior to RYGB appeared to transiently mitigate but not fully prevent high bone turnover in the acute postoperative period. At 24 weeks after RYGB, our preliminary data suggest that ZOL was not sufficient to prevent bone loss at the hip, although it may preserve bone density at the trabecular spine. Further prospective, controlled studies are needed to confirm our findings and to identify the best strategies for preventing bone loss in bariatric patients receiving RYGB.

Use of noninvasive scores for advanced liver fibrosis can guide the need for hepatic biopsy during bariatric procedures.

BACKGROUND: Patients with obesity are at increased risk for nonalcoholic fatty liver disease (NAFLD). The effectiveness of noninvasive screening tests for ruling out advanced fibrosis (stage 3-4) is unknown. OBJECTIVES: To determine the prevalence of advanced fibrosis in patients undergoing routine liver biopsy during bariatric surgery and assess the effectiveness of existing noninvasive risk calculators. SETTING: Academic medical center in the United States. METHODS: Routine liver biopsies were obtained during first-time bariatric surgery (January 2001-December 2017). Patient demographic characteristics, co-morbidities, and preoperative laboratory values were compiled. Sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) were compared between 3 noninvasive risk calculators for advanced fibrosis: the fibrosis-4 index, NAFLD fibrosis score, and aminotransferase-to-platelet ratio index (APRI). RESULTS: Among 2465 patients, the prevalence of advanced fibrosis (stage 3-4) was 3.4%. The mean age was 45.5 years, and the mean body mass index was 46.8. The sensitivity of noninvasive risk calculators ranged from 85% (NAFLD fibrosis score) to 24% (APRI). The NAFLD fibrosis score performed best in screening out advanced fibrosis, with an NPV of 99%. The PPV ranged from 9% to 65%. In this study cohort, the use of the NALFD fibrosis score correctly ruled out advanced fibrosis in 893 (36%) patients, with 13 false negatives. CONCLUSIONS: The prevalence of advanced fibrosis in individuals undergoing routine first-time bariatric procedures is 3.4%. Use of the NALFD fibrosis score can rule out advanced fibrosis in one-third of this population, and guide surgical decision-making.

Pandemic Care Through Collaboration: Lessons From a COVID-19 Field Hospital.

During the surge of Coronavirus Disease 2019 (COVID-19) infections in March and April 2020, many skilled-nursing facilities in the Boston area closed to COVID-19 post-acute admissions because of infection control concerns and staffing shortages. Local government and health care leaders collaborated to establish a 1000-bed field hospital for patients with COVID-19, with 500 respite beds for the undomiciled and 500 post-acute care (PAC) beds within 9 days. The PAC hospital provided care for 394 patients over 7 weeks, from April 10 to June 2, 2020. In this report, we describe our implementation strategy, including organization structure, admissions criteria, and clinical services. Partnership with government, military, and local health care organizations was essential for logistical and medical support. In addition, dynamic workflows necessitated clear communication pathways, clinical operations expertise, and highly adaptable staff.

Bone Density and Trabecular Morphology at Least 10 Years After Gastric Bypass and Gastric Banding.

Roux-en-Y gastric bypass (RYGB) instigates high-turnover bone loss in the initial 5 years after surgery, whereas skeletal changes after adjustable gastric banding (AGB) are less pronounced. Long-term skeletal data are scarce, and the mechanisms of bone loss remain unclear. We sought to examine bone density and microarchitecture in RYGB and AGB patients a decade after surgery and to determine whether prior published reports of bone loss represent an appropriate adaptation to new postsurgical weight. In this cross-sectional study, 25 RYGB and 25 AGB subjects who had bariatric surgery ≥10 years ago were matched 1:1 with nonsurgical controls for age, sex, and current body mass index (BMI). We obtained bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA), volumetric BMD and microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT), trabecular morphology by individual trabecular segmentation, and metabolic bone laboratory results. As compared with BMI-matched controls, RYGB subjects had significantly lower hip BMD, and lower total volumetric BMD at the distal radius and tibia. Substantial deficits in cortical and trabecular microarchitecture were observed in the RYGB group compared to controls, with reduced trabecular plate bone volume fraction and estimated failure load at both the radius and tibia, respectively. Bone turnover markers CTX and P1NP were 99% and 77% higher in the RYGB group than controls, respectively, with no differences in serum calcium, 25-hydroxyvitamin D, or parathyroid hormone. In contrast, the AGB group did not differ from their BMI-matched controls in any measured bone density, microarchitecture, or laboratory parameter. Thus, RYGB, but not AGB, is associated with lower than expected hip and peripheral BMD for the new weight setpoint, as well as deleterious changes in bone microarchitecture. These findings suggest that pathophysiologic processes other than mechanical unloading or secondary hyperparathyroidism contribute to bone loss after RYGB, and have important clinical implications for the long-term care of RYGB patients. © 2020 American Society for Bone and Mineral Research.

American Society for Metabolic and Bariatric Surgery 2018 estimate of metabolic and bariatric procedures performed in the United States.

BACKGROUND: Metabolic and bariatric surgery, despite being the only effective durable treatment for obesity, remains underused as approximately 1% of all patients who qualify undergo surgery. The American Society for Metabolic and Bariatric Surgery created a Numbers Taskforce to specify annual rate of utilization for obesity treatment interventions and to determine if patients in need are receiving appropriate therapy. OBJECTIVES: The objective of this study was to provide the best estimated number of metabolic and bariatric procedure performed in the United States in 2018. SETTING: United States. METHODS: We reviewed data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, National Surgical Quality Improvement Program, Bariatric Outcomes Longitudinal Database, and Nationwide Inpatient Sample. In addition, data from industry and outpatient centers were used to estimate outpatient center activity. Data from 2018 were compared mainly with data from the previous 2 years. RESULTS: Compared with 2017, the total number of metabolic and bariatric procedures performed in 2018 increased from approximately 228,000 to 252,000. The sleeve gastrectomy continues to be the most common procedure. The gastric bypass procedure trend remained relatively stable and the gastric band procedure trend continued to decline. The percentage of revision procedures and biliopancreatic diversion with duodenal switch procedures increased slightly. Finally, intragastric balloons placement continues as a significant contributor to the cumulative total number of procedures performed but declined from the previous year. CONCLUSIONS: There was a 10.8% increase in the number of metabolic and bariatric procedures performed in 2018, compared with 2017, with an overall increase of approximately 60% since 2011. When taking into account primary procedures only, approximately 1.1% of patients who qualified for metabolic and bariatric surgery were treated with surgery in 2018.