The first modified Delphi consensus statement on sleeve gastrectomy.

INTRODUCTION: Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG. METHODS: We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus. RESULTS: The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1 cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5 years after surgery to screen for BE. CONCLUSION: A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic.

PUM1 and RNase P genes as potential cell-free DNA markers in breast cancer.

BACKGROUND: Cell-free DNA (cfDNA) is used in clinical research to identify biomarkers for diagnosis of and follow-up on cancer. Here, we propose a fast and innovative approach using traditional housekeeping genes as cfDNA targets in a copy number analysis. We focus on the application of highly sensitive technology such as digital PCR (dPCR) to differentiate breast cancer (BC) patients and controls by quantifying regions of PUM1 and RPPH1 (RNase P) in plasma samples. METHODS: We conducted a case-control study with 82 BC patients and 82 healthy women. cfDNA was isolated from plasma using magnetic beads and quantified by spectrophotometry to estimate total cfDNA. Then, both PUM1 and RPPH1 genes were specifically quantified by dPCR. Data analysis was calibrated using a reference genomic DNA in different concentrations. RESULTS: We found RNase P and PUM1 values were correlated in the patient group (intraclass correlation coefficient [ICC] = 0.842), but they did not have any correlation in healthy women (ICC = 0.519). In dPCR quantification, PUM1 showed the capacity to distinguish early-stage patients and controls with good specificity (98.67%) and sensitivity (100%). Conversely, RNase P had lower cfDNA levels in triple-negative BC patients than luminal subtypes (p < 0.025 for both), confirming their utility for patient classification. CONCLUSION: We propose the PUM1 gene as a cfDNA marker for early diagnosis of BC and RNase P as a cfDNA marker related to hormonal status and subtype classification in BC. Further studies with larger sample sizes are warranted.

Diagnostic and psychosocial differences in psychiatrically hospitalized military service members with single versus multiple suicide attempts.

INTRODUCTION: Individuals with multiple versus single suicide attempts present a more severe clinical picture and may be at greater risk for suicide. Yet group differences within military samples have been vastly understudied. PURPOSE: The objective is to determine demographic, diagnostic, and psychosocial differences, based on suicide attempt status, among military inpatients admitted for suicide-related events. METHOD: A retrospective chart review design was used with a total of 423 randomly selected medical records of psychiatric admissions to a military hospital from 2001 to 2006. RESULTS: Chi-square analyses indicated that individuals with multiple versus single suicide attempts were significantly more likely to have documented childhood sexual abuse (p =.025); problem substance use (p=.001); mood disorder diagnosis (p=.005); substance disorder diagnosis (p =.050); personality disorder not otherwise specified diagnosis (p =.018); and Axis II traits or diagnosis (p=.038) when compared to those with a single attempt history. Logistic regression analyses showed that males with multiple suicide attempts were more likely to have problem substance use (p=.005) and a mood disorder diagnosis (p =.002), while females with a multiple attempt history were more likely to have a history of childhood sexual (p =.027). DISCUSSION: Clinically meaningful differences among military inpatients with single versus multiple suicide attempts exist. Targeted Department of Defense suicide prevention and intervention efforts that address the unique needs of these two specific at-risk subgroups are additionally needed.

Evaluating metabolic and bariatric surgery fellows' attitudes toward their training.

BACKGROUND: The American Society of Metabolic and Bariatric Surgeons (ASMBS) Leadership Academy is conducted at the ASMBS Weekend to prepare surgeons for practice, while in their fellowship. OBJECTIVES: The aim of this analysis is to gather the views of current fellows in training on issues regarding practice patterns and career development. SETTING: Survey at ASMBS Fellows Leadership Academy. METHODS: An online survey was conducted at the last 2 ASMBS Leadership Academy Meetings at the ASMBS Weekend. There were 14 questions. There were 61 respondents. Twenty-three respondents had incomplete surveys and were not included in the final analysis. There were 24 fellows surveyed at the Leadership Academy in November 2022, in San Antonio, TX and 37 in January 2022, in Las Vegas, NV. RESULTS: Fifty-eight percent of attendees were interviewing for employment after their fellowship with 3.64% already employed. Eighteen percent had employment secured upon completion of their fellowship. Of the academic fellows, 29.1% believe that private practice will no longer exist in 2030 and 10.9% of attendees believe that we will have Medicare for all by 2030. Fellows in academic programs ranked their fellowship as either "best decision of my life" or "great" (96.4%) and 3.6% ranked it as "useless (not good/not bad)." Ninety-three percent of attendees said they would do a bariatric fellowship again. Of those that said they would not, all were from a robotic fellowship program. Of those that would do a bariatric fellowship again, 80% stated they would do so at the same institution. CONCLUSIONS: The fellows that attended the ASMBS Leadership Academy overall were very pleased with their fellowship experience, and most would choose to do a MIS/bariatric fellowship again.

Comparative analysis of sleeve conversions of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program 2020 Database.

BACKGROUND: Although the sleeve gastrectomy (SG) is the dominant bariatric procedure, studies have shown conversion rates of up to 30%. These conversions are generally for weight regain (WR), insufficient weight loss (IWL) or gastroesophageal reflux disease (GERD). Before 2020, details on why conversions were being performed were not collected in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Participant Use Data File (PUF). Now, the indication for sleeve conversion is noted in the PUF, allowing identification and reporting sleeve conversion reasons. OBJECTIVE: We aimed to examine the reasons for SG conversions nationwide. SETTING: The 2020 MBSAQIP PUF. METHODS: The 2020 MBSAQIP PUF was examined to determine the reasons why SG were converted to other operations. The data field of "Revision/Conversion Final Indication" was used along with "Procedure type." Primary bariatric operations were excluded. Descriptive statistics were applied. Different reasons for conversion and operations were compared by preoperative characteristics and operative outcomes. RESULTS: There were 103,782 primary SG reported in the 2020 PUF. There were 7181 SG that were converted to other operations. The most common conversion (86.2%) was to Roux-en-Y gastric bypass (RYGB). The main reason for SG conversion was GERD at 48.4%, followed by WR/IWL (41.9%). Biliopancreatic diversion with duodenal switch and single-anastomosis duodenoileal bypass with sleeve patients differed significantly from RYGB patients in specific preoperative characteristics and operative outcomes. CONCLUSION: The most common procedure SG is converted to is the RYGB. GERD was the most common reason for SG conversion, followed by WR/IWL.

American Society for Metabolic and Bariatric Surgery 2022 estimate of metabolic and bariatric procedures performed in the United States.

BACKGROUND: Metabolic and bariatric surgery (MBS), despite being the most effective durable treatment for obesity, remains underused as approximately 1% of all qualified patients undergo surgery. The American Society for Metabolic and Bariatric Surgery established a Numbers Taskforce to specify the annual rate of obesity treatment interventions utilization and to determine if patients in need are receiving appropriate treatment. OBJECTIVE: To provide the best estimated number of metabolic and bariatric procedures being performed in the United States in 2022. SETTING: United States. METHODS: We reviewed data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program and National Surgical Quality Improvement Program. In addition, data from industry and state databases were used to estimate activity at non-accredited centers. Data from 2022 were compared mainly with data from the previous 2 years. RESULTS: Compared with 2021, the total number of MBS performed in 2022 increased from approximately 262,893 to 280,000. The sleeve gastrectomy (SG) continues to be the most commonly performed procedure. The gastric bypass procedure trend remained relatively stable. The percentage of revision procedures and biliopancreatic diversion with duodenal switch procedures increased slightly. Intragastric balloon placement increased from the previous year. Endoscopic sleeve gastroplasty increased in numbers. CONCLUSIONS: There was a 6.5% increase in MBS volume from 2021 to 2022 and a 41% increase from 2020, which demonstrates a recovery from the COVID-19 pandemic. SG continues to be the most dominant MBS procedure.

Scientific evidence for the updated guidelines on indications for metabolic and bariatric surgery (IFSO/ASMBS).

The 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) updated the indications for metabolic and bariatric surgery (MBS), replacing the previous guidelines established by the National Institutes of Health (NIH) over 30 years ago. The evidence supporting these updated guidelines has been strengthened to assist metabolic and bariatric surgeons, nutritionists, and other members of multidisciplinary teams (MDTs), as well as patients. This study aims to assess the level of evidence and the strength of recommendations compared to the previously published criteria.

Scientific Evidence for the Updated Guidelines on Indications for Metabolic and Bariatric Surgery (IFSO/ASMBS).

The 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) updated the indications for Metabolic and Bariatric Surgery (MBS), replacing the previous guidelines established by the NIH over 30 years ago. The evidence supporting these updated guidelines has been strengthened to assist metabolic and bariatric surgeons, nutritionists, and other members of multidisciplinary teams, as well as patients. This study aims to assess the level of evidence and the strength of recommendations compared to the previously published criteria.

Metabolic and Bariatric Surgery in Patients with Obesity Class V (BMI > 60 kg/m2): a Modified Delphi Study.

BACKGROUND: Metabolic and bariatric surgery (MBS) is the preferred method to achieve significant weight loss in patients with Obesity Class V (BMI > 60 kg/m2). However, there is no consensus regarding the best procedure(s) for this population. Additionally, these patients will likely have a higher risk of complications and mortality. The aim of this study was to achieve a consensus among a global panel of expert bariatric surgeons using a modified Delphi methodology. METHODS: A total of 36 recognized opinion-makers and highly experienced metabolic and bariatric surgeons participated in the present Delphi consensus. 81 statements on preoperative management, selection of the procedure, perioperative management, weight loss parameters, follow-up, and metabolic outcomes were voted on in two rounds. A consensus was considered reached when an agreement of ≥ 70% of experts' votes was achieved. RESULTS: A total of 54 out of 81 statements reached consensus. Remarkably, more than 90% of the experts agreed that patients should be notified of the greater risk of complications, the possibility of modifications to the surgical procedure, and the early start of chemical thromboprophylaxis. Regarding the choice of the procedure, SADI-S, RYGB, and OAGB were the top 3 preferred operations. However, no consensus was reached on the limb length in these operations. CONCLUSION: This study represents the first attempt to reach consensus on the choice of procedures as well as perioperative management in patients with obesity class V. Although overall consensus was reached in different areas, more research is needed to better serve this high-risk population.

A global survey on the use of the international classification of diseases codes for metabolic dysfunction-associated fatty liver disease.

BACKGROUND: With the implementation of the 11th edition of the International Classification of Diseases (ICD-11) and the publication of the metabolic dysfunction-associated fatty liver disease (MAFLD) nomenclature in 2020, it is important to establish consensus for the coding of MAFLD in ICD-11. This will inform subsequent revisions of ICD-11. METHODS: Using the Qualtrics XM and WJX platforms, questionnaires were sent online to MAFLD-ICD-11 coding collaborators, authors of papers, and relevant association members. RESULTS: A total of 890 international experts in various fields from 61 countries responded to the survey. We also achieved full coverage of provincial-level administrative regions in China. 77.1% of respondents agreed that MAFLD should be represented in ICD-11 by updating NAFLD, with no significant regional differences (77.3% in Asia and 76.6% in non-Asia, p = 0.819). Over 80% of respondents agreed or somewhat agreed with the need to assign specific codes for progressive stages of MAFLD (i.e. steatohepatitis) (92.2%), MAFLD combined with comorbidities (84.1%), or MAFLD subtypes (i.e., lean, overweight/obese, and diabetic) (86.1%). CONCLUSIONS: This global survey by a collaborative panel of clinical, coding, health management and policy experts, indicates agreement that MAFLD should be coded in ICD-11. The data serves as a foundation for corresponding adjustments in the ICD-11 revision.

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.

One Anastomosis Gastric Bypass Versus Single Anastomosis Duodenoileostomy with Sleeve: Comparative Analysis of 30-Day Outcomes Using the MBSAQIP.

INTRODUCTION/PURPOSE: One anastomosis gastric bypass (OAGB) and single anastomosis duodenoileostomy with sleeve (SADI-S) are two highly effective bariatric procedures that have been recently endorsed by the American Society of Metabolic and Bariatric Surgery (ASMBS). We compared the outcomes and safety profiles of SADI-S and OAGB using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. MATERIALS AND METHODS: Retrospective analysis on patients who underwent SADI-S or OAGB obtained from the MBSAQIP database 2020-2021. Patients who underwent concurrent procedures (besides EGD) or had missing data were removed. Variables included age, sex, body mass index, American Society of Anesthesiologists (ASA) class, and pertinent medical comorbidities. Data were analyzed for 30-day postoperative morbidity, mortality, reoperation, reintervention, and readmissions. p values were calculated using Student's t-test or Fisher analysis. RESULTS: A total of 694 and 1068 patients respectively underwent SADI-S or OAGB. Statistically significant comorbidities included age (42.2 ± 10.8 vs. 43.7 ± 12.2), BMI (50.6 ± 9.1 vs. 45.3 ± 7.1), ASA 2 (66 (9.5%) vs. 165 (15.4%)), ASA 4 [69 (9.9%) vs. 20 (1.9%)], and immunosuppressive therapy [24 (3.5%) vs. 17 (1.6%)]. Clavien-Dindo-based analysis highlighted that SADI-S had higher grade 2 (p = 0.005) and grade 4b (p = 0.001) complications. Patients who underwent SADI-S were twice as likely to be readmitted within 30 days (3.7% vs. 1.9%; p = 0.021). CONCLUSION: SADI-S had higher readmission rates and higher Clavien-Dindo grade 2 and 4b complications. To note, SADI-S patients had higher BMIs. Further studies are needed to determine the long-term complications and efficacy of both operations.

Classification of Slippage Following Laparoscopic BariClip Gastroplasty.

INTRODUCTION: Laparoscopic BariClip gastroplasty (LBCG) is a new reversible gastric sleeve-like procedure without gastrectomy proposed to minimize the risk of severe complications. Still one of the possible complications described with LBCG is slippage. The purpose of the current manuscript is to analyze different cases of slippage and propose a classification of this complication. METHODS: A number of 381 patients who underwent LBCG in 8 different centers were analyzed concerning the risk of slippage. All cases with documented slippage were carefully reviewed in terms of patients' symptomatology (presence of satiety, vomiting), history of weight loss, radiological data, and management of their slippage. A new classification was proposed depending on the anatomy, the symptomatology, and the time of occurrence. RESULTS: We have identified a total of 17 cases (4.46%) of slippage following LBCG. In 11 patients, the slippage was symptomatic with repetitive vomiting and nausea, and in the remaining 6 patients, the slippage was identified by radiological studies for insufficient weight loss, weight regain, or routine radiological follow-up. Depending on the interval time, the slippage was classified as either immediate (in first 7 days) in 6 cases, early (in less than 90 days) in 4 cases, and late (after 3 months) in 7 cases. Evaluation of the radiological studies in these cases identified the following: anterosuperior displacement (type A) in 9 cases, posteroinferior displacement (type B) in 6 cases (one case after 3 months), and lateral displacement (type C) in the remaining 2 cases. The management of the slippage consisted of BariClip removal in 7 cases, repositioning in 5 cases, and conservative treatment in the remaining 5 cases. All patients with conservative treatment were recorded at the beginning of the experience. CONCLUSIONS: Slippage is a possible complication after LBCG. This classification of the different types of slippage can benefit the surgeon in the management and treatment of this complication of LBCG.

Evolving Technique of Laparoscopic Vertical Gastric Clip Placement.

INTRODUCTION: Laparoscopic BariClip gastroplasty (LBCG) will address a similar tubular restriction than the one achieved with the laparoscopic sleeve gastrectomy (LSG) at the level of the gastric fundus, while maintaining the advantage of simplicity and anatomic preservation. The purpose of the current study was to analyze the risk of slippage and to present the evolving technique by adding gastro-gastric plication of the gastric wall covering the BariClip at those areas where the gastric wall "slips" between the limbs of the clip. METHODS: All patients undergoing LBCG with the evolving technique of gastric plication around the device associated with antral gastroplasty from January 2021 to May 2022 were included in the study group (group A). A control group (group B) was designed with patients who underwent previous LBCG technique between May 2017 and June 2019. This is a case-controlled group with patients matched by gender and BMI. We have analyzed the postoperative complications and more notably the slippage. RESULTS: One hundred seventy-six patients (44 male and 132 female) with a mean age of 33 years (± 11) underwent evolving technique of LBCG. A control group of 67 patients who underwent previous technique of LBCG was included. All procedures were completed by laparoscopy with no intraoperative complication. For the study group, we have recorded a number of 5 slippages (2.8%). The diagnosis occurred during the first 6 months after the operation. The management consisted of repositioning-3 cases-and BariClip removal-2 cases. For the control group, we have recorded a number of 3 slippages (4.3%). All three patients underwent BariClip removal, with no repositioning. CONCLUSIONS: We reported a new technique of placement of the BariClip with additional gastric plication anterior, posterior, and volume reduction in the antrum to potentially reduce the rate of slippage and improve weight loss outcomes.

2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery.

MAJOR UPDATES TO 1991 NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR BARIATRIC SURGERY: Metabolic and bariatric surgery (MBS) is recommended for individuals with a body mass index (BMI) >35 kg/m2, regardless of presence, absence, or severity of co-morbidities.MBS should be considered for individuals with metabolic disease and BMI of 30-34.9 kg/m2.BMI thresholds should be adjusted in the Asian population such that a BMI >25 kg/m2 suggests clinical obesity, and individuals with BMI >27.5 kg/m2 should be offered MBS.Long-term results of MBS consistently demonstrate safety and efficacy.Appropriately selected children and adolescents should be considered for MBS.(Surg Obes Relat Dis 2022; https://doi.org/10.1016/j.soard.2022.08.013 ) © 2022 American Society for Metabolic and Bariatric Surgery. All rights reserved.

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.

First report from the American Society of Metabolic and Bariatric Surgery closed-claims registry: prevalence, causes, and lessons learned from bariatric surgery medical malpractice claims.

BACKGROUND: Bariatric surgery has demonstrated sustained improvements in quality. Malpractice closed claims have been offered as a means of assessing quality. Few studies have investigated malpractice closed claims and opportunities for improvement in bariatric surgery. OBJECTIVES: To examine the prevalence and causes of malpractice claims with examination of prospects for quality improvement. SETTING: University hospital, United States; private practice. METHODS: Four national malpractice insurers participated in the closed-claims registry. Data regarding patients, staff, procedures, and hospital status were gathered from closed-claims files. Following data collection, a clinical summary of each closed claim was collected and later assessed by an expert panel on the basis of the following: contributing diagnosis and treatment events; whether complications were potentially preventable by the surgeon; the role of language, fatigue, distraction, workload, or teaching hospital/trainee supervision; communication concerns; and final care determination. RESULTS: A total of 175 closed claims were collected from index bariatric surgeries within the period from 2006-2014. Of these, 75.9% of surgeons were board certified and 43.3% of the hospitals were accredited for bariatric surgery. Most clinical complications after bariatric surgery that led to malpractice lawsuits were mortality (35.1%) and leaks (17.5%). While they were not the common cause for malpractice suits, bleeding (5.3%), retained foreign body (5.3%), and vascular injury (4.4%) occurred at higher rates than national averages. CONCLUSION: Prevalence of malpractice claims regarding bariatric surgery is low. Failure to diagnose, delay in treatment, postoperative care, and communication domain responses indicate future opportunities for improvement.

2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery.

Major updates to 1991 National Institutes of Health guidelines for bariatric surgery.

Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study.

BACKGROUND: The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented. OBJECTIVES: To determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives. SETTING: Nine academic and/or private institutions. METHODS: The participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires. RESULTS: The reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was -7.01 ± 5.45 kg/m2 at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures. CONCLUSION: No new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature.