Dataset Information

Association Between Bariatric Surgery and Major Adverse Diabetes Outcomes in Patients With Diabetes and Obesity.

ABSTRACT:

Importance

There are high-quality randomized clinical trial data demonstrating the effect of bariatric surgery on type 2 diabetes remission, but these studies are not powered to study mortality in this patient group. Large observational studies are warranted to study the association of bariatric surgery with mortality in patients with type 2 diabetes.

Objective

To determine the association between bariatric surgery and all-cause mortality among patients with type 2 diabetes and severe obesity.

Design, setting, and participants

This retrospective, population-based matched cohort study included patients with type 2 diabetes and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) 35 or greater who underwent bariatric surgery from January 2010 to December 2016 in Ontario, Canada. Multiple linked administrative databases were used to define confounders, including age, baseline BMI, sex, comorbidities, duration of diabetes diagnosis, health care utilization, socioeconomic status, smoking status, substance abuse, cancer screening, and psychiatric history. Potential controls were identified from a primary care electronic medical record database. Data were analyzed in 2020.

Exposure

Bariatric surgery (gastric bypass and sleeve gastrectomy) and nonsurgical management of obesity provided by the primary care physician.

Main outcomes and measures

The primary outcome was all-cause mortality. Secondary outcomes were cause-specific mortality and nonfatal morbidities. Groups were compared through a multivariable Cox proportional Hazards model.

Results

A total of 6910 patients (mean [SD] age at baseline, 52.04 [9.45] years; 4950 [71.6%] women) were included, with 3455 patients who underwent bariatric surgery and 3455 match controls and a median (interquartile range) follow-up time of 4.6 (3.22-6.35) years. In the surgery group, 83 patients (2.4%) died, compared with 178 individuals (5.2%) in the control group (hazard ratio [HR] 0.53 [95% CI, 0.41-0.69]; P < .001). Bariatric surgery was associated with a 68% lower cardiovascular mortality (HR, 0.32 [95% CI, 0.15-0.66]; P = .002) and a 34% lower rate of composite cardiac events (HR, 0.68 [95% CI, 0.55-0.85]; P < .001). Risk of nonfatal renal events was also 42% lower in the surgical group compared with the control group (HR, 0.58 [95% CI, 0.35-0.95], P = .03). Of the groups that had the highest absolute benefit associated with bariatric surgery, men had an absolute risk reduction (ARR) of 3.7% (95% CI, 1.7%-5.7%), individuals with more than 15 years of diabetes had an ARR of 4.3% (95% CI, 0.8%-7.8%), and individuals aged 55 years or older had an ARR of 4.7% (95% CI, 3.0%-6.4%).

Conclusions and relevance

These findings suggest that bariatric surgery was associated with reduced all-cause mortality and diabetes-specific cardiac and renal outcomes in patients with type 2 diabetes and severe obesity.

SUBMITTER: Doumouras AG

PROVIDER: S-EPMC8076963 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceMacrovascular disease is a leading cause of morbidity and mortality for patients with type 2 diabetes, and medical management, including lifestyle changes, may not be successful at lowering risk.ObjectiveTo investigate the relationship between bariatric surgery and incident macrovascular (coronary artery disease and cerebrovascular diseases) events in patients with severe obesity and type 2 diabetes.Design, setting, and participantsIn this retrospective, matched cohort study, patients with severe obesity (body mass index ≥35) aged 19 to 79 years with diabetes who underwent bariatric surgery from 2005 to 2011 in 4 integrated health systems in the United States (n = 5301) were matched to 14 934 control patients on site, age, sex, body mass index, hemoglobin A1c, insulin use, observed diabetes duration, and prior health care utilization, with follow-up through September 2015.ExposuresBariatric procedures (76% Roux-en-Y gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) were compared with usual care for diabetes.Main outcomes and measuresMultivariable-adjusted Cox regression analysis investigated time to incident macrovascular disease (defined as first occurrence of coronary artery disease [acute myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting] or cerebrovascular events [ischemic stroke, hemorrhagic stroke, carotid stenting, or carotid endarterectomy]). Secondary outcomes included coronary artery disease and cerebrovascular outcomes separately.ResultsAmong a combined 20 235 surgical and nonsurgical patients, the mean (SD) age was 50 (10) years; 76% of the surgical and 75% of the nonsurgical patients were female; and the baseline mean (SD) body mass index was 44.7 (6.9) and 43.8 (6.7) in the surgical and nonsurgical groups, respectively. At the end of the study period, there were 106 macrovascular events in surgical patients (including 37 cerebrovascular and 78 coronary artery events over a median of 4.7 years; interquartile range, 3.2-6.2 years) and 596 events in the matched control patients (including 227 cerebrovascular and 398 coronary artery events over a median of 4.6 years; interquartile range, 3.1-6.1 years). Bariatric surgery was associated with a lower composite incidence of macrovascular events at 5 years (2.1% in the surgical group vs 4.3% in the nonsurgical group; hazard ratio, 0.60 [95% CI, 0.42-0.86]), as well as a lower incidence of coronary artery disease (1.6% in the surgical group vs 2.8% in the nonsurgical group; hazard ratio, 0.64 [95% CI, 0.42-0.99]). The incidence of cerebrovascular disease was not significantly different between groups at 5 years (0.7% in the surgical group vs 1.7% in the nonsurgical group; hazard ratio, 0.69 [95% CI, 0.38-1.25]).Conclusions and relevanceIn this observational study of patients with type 2 diabetes and severe obesity who underwent surgery, compared with those who did not undergo surgery, bariatric surgery was associated with a lower risk of macrovascular outcomes. The findings require confirmation in randomized clinical trials. Health care professionals should engage patients with severe obesity and type 2 diabetes in a shared decision making conversation about the potential role of bariatric surgery in the prevention of macrovascular events.

Project description:ImportanceAlthough metabolic surgery (defined as procedures that influence metabolism by inducing weight loss and altering gastrointestinal physiology) significantly improves cardiometabolic risk factors, the effect on cardiovascular outcomes has been less well characterized.ObjectiveTo investigate the relationship between metabolic surgery and incident major adverse cardiovascular events (MACE) in patients with type 2 diabetes and obesity.Design, setting, and participantsOf 287 438 adult patients with diabetes in the Cleveland Clinic Health System in the United States between 1998 and 2017, 2287 patients underwent metabolic surgery. In this retrospective cohort study, these patients were matched 1:5 to nonsurgical patients with diabetes and obesity (body mass index [BMI] ≥30), resulting in 11 435 control patients, with follow-up through December 2018.ExposuresMetabolic gastrointestinal surgical procedures vs usual care for type 2 diabetes and obesity.Main outcomes and measuresThe primary outcome was the incidence of extended MACE (composite of 6 outcomes), defined as first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation. Secondary end points included 3-component MACE (myocardial infarction, ischemic stroke, and mortality) and the 6 individual components of the primary end point.ResultsAmong the 13 722 study participants, the distribution of baseline covariates was balanced between the surgical group and the nonsurgical group, including female sex (65.5% vs 64.2%), median age (52.5 vs 54.8 years), BMI (45.1 vs 42.6), and glycated hemoglobin level (7.1% vs 7.1%). The overall median follow-up duration was 3.9 years (interquartile range, 1.9-6.1 years). At the end of the study period, 385 patients in the surgical group and 3243 patients in the nonsurgical group experienced a primary end point (cumulative incidence at 8-years, 30.8% [95% CI, 27.6%-34.0%] in the surgical group and 47.7% [95% CI, 46.1%-49.2%] in the nonsurgical group [P < .001]; absolute 8-year risk difference [ARD], 16.9% [95% CI, 13.1%-20.4%]; adjusted hazard ratio [HR], 0.61 [95% CI, 0.55-0.69]). All 7 prespecified secondary outcomes showed statistically significant differences in favor of metabolic surgery, including mortality. All-cause mortality occurred in 112 patients in the metabolic surgery group and 1111 patients in the nonsurgical group (cumulative incidence at 8 years, 10.0% [95% CI, 7.8%-12.2%] and 17.8% [95% CI, 16.6%-19.0%]; ARD, 7.8% [95% CI, 5.1%-10.2%]; adjusted HR, 0.59 [95% CI, 0.48-0.72]).Conclusions and relevanceAmong patients with type 2 diabetes and obesity, metabolic surgery, compared with nonsurgical management, was associated with a significantly lower risk of incident MACE. The findings from this observational study must be confirmed in randomized clinical trials.Trial registrationClinicalTrials.gov Identifier: NCT03955952.

Project description:ImportanceNo therapy has been shown to reduce the risk of serious adverse outcomes in patients with nonalcoholic steatohepatitis (NASH).ObjectiveTo investigate the long-term relationship between bariatric surgery and incident major adverse liver outcomes and major adverse cardiovascular events (MACE) in patients with obesity and biopsy-proven fibrotic NASH without cirrhosis.Design, setting, and participantsIn the SPLENDOR (Surgical Procedures and Long-term Effectiveness in NASH Disease and Obesity Risk) study, of 25 828 liver biopsies performed at a US health system between 2004 and 2016, 1158 adult patients with obesity were identified who fulfilled enrollment criteria, including confirmed histological diagnosis of NASH and presence of liver fibrosis (histological stages 1-3). Baseline clinical characteristics, histological disease activity, and fibrosis stage of patients who underwent simultaneous liver biopsy at the time of bariatric surgery were balanced with a nonsurgical control group using overlap weighting methods. Follow-up ended in March 2021.ExposuresBariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy) vs nonsurgical care.Main outcomes and measuresThe primary outcomes were the incidence of major adverse liver outcomes (progression to clinical or histological cirrhosis, development of hepatocellular carcinoma, liver transplantation, or liver-related mortality) and MACE (a composite of coronary artery events, cerebrovascular events, heart failure, or cardiovascular death), estimated using the Firth penalized method in a multivariable-adjusted Cox regression analysis framework.ResultsA total of 1158 patients (740 [63.9%] women; median age, 49.8 years [IQR, 40.9-57.9 years], median body mass index, 44.1 [IQR, 39.4-51.4]), including 650 patients who underwent bariatric surgery and 508 patients in the nonsurgical control group, with a median follow-up of 7 years (IQR, 4-10 years) were analyzed. Distribution of baseline covariates, including histological severity of liver injury, was well-balanced after overlap weighting. At the end of the study period in the unweighted data set, 5 patients in the bariatric surgery group and 40 patients in the nonsurgical control group experienced major adverse liver outcomes, and 39 patients in the bariatric surgery group and 60 patients in the nonsurgical group experienced MACE. Among the patients analyzed with overlap weighting methods, the cumulative incidence of major adverse liver outcomes at 10 years was 2.3% (95% CI, 0%-4.6%) in the bariatric surgery group and 9.6% (95% CI, 6.1%-12.9%) in the nonsurgical group (adjusted absolute risk difference, 12.4% [95% CI, 5.7%-19.7%]; adjusted hazard ratio, 0.12 [95% CI, 0.02-0.63]; P = .01). The cumulative incidence of MACE at 10 years was 8.5% (95% CI, 5.5%-11.4%) in the bariatric surgery group and 15.7% (95% CI, 11.3%-19.8%) in the nonsurgical group (adjusted absolute risk difference, 13.9% [95% CI, 5.9%-21.9%]; adjusted hazard ratio, 0.30 [95% CI, 0.12-0.72]; P = .007). Within the first year after bariatric surgery, 4 patients (0.6%) died from surgical complications, including gastrointestinal leak (n = 2) and respiratory failure (n = 2).Conclusions and relevanceAmong patients with NASH and obesity, bariatric surgery, compared with nonsurgical management, was associated with a significantly lower risk of incident major adverse liver outcomes and MACE.

Project description:ImportanceHanding over the care of a patient from one anesthesiologist to another occurs during some surgeries and might increase the risk of adverse outcomes.ObjectiveTo assess whether complete handover of intraoperative anesthesia care is associated with higher likelihood of mortality or major complications compared with no handover of care.Design, setting, and participantsA retrospective population-based cohort study (April 1, 2009-March 31, 2015 set in the Canadian province of Ontario) of adult patients aged 18 years and older undergoing major surgeries expected to last at least 2 hours and requiring a hospital stay of at least 1 night.ExposureComplete intraoperative handover of anesthesia care from one physician anesthesiologist to another compared with no handover of anesthesia care.Main outcomes and measuresThe primary outcome was a composite of all-cause death, hospital readmission, or major postoperative complications, all within 30 postoperative days. Secondary outcomes were the individual components of the primary outcome. Inverse probability of exposure weighting based on the propensity score was used to estimate adjusted exposure effects.ResultsOf the 313 066 patients in the cohort, 56% were women; the mean (SD) age was 60 (16) years; 49% of surgeries were performed in academic centers; 72% of surgeries were elective; and the median duration of surgery was 182 minutes (interquartile [IQR] range, 124-255). A total of 5941 (1.9%) patients underwent surgery with complete handover of anesthesia care. The percentage of patients undergoing surgery with a handover of anesthesiology care progressively increased each year of the study, reaching 2.9% in 2015. In the unweighted sample, the primary outcome occurred in 44% of the complete handover group compared with 29% of the no handover group. After adjustment, complete handovers were statistically significantly associated with an increased risk of the primary outcome (adjusted risk difference [aRD], 6.8% [95% CI, 4.5% to 9.1%]; P < .001), all-cause death (aRD, 1.2% [95% CI, 0.5% to 2%]; P = .002), and major complications (aRD, 5.8% [95% CI, 3.6% to 7.9%]; P < .001), but not with hospital readmission within 30 days of surgery (aRD, 1.2% [95% CI, -0.3% to 2.7%]; P = .11).Conclusions and relevanceAmong adults undergoing major surgery, complete handover of intraoperative anesthesia care compared with no handover was associated with a higher risk of adverse postoperative outcomes. These ﬁndings may support limiting complete anesthesia handovers.

Project description:BackgroundIndividual characteristics associated with weight loss after bariatric surgery are well established, but the neighborhood characteristics that influence outcomes are unknown.ObjectivesThe objective of this study was to determine if neighborhood characteristics, including social determinants and lifestyle characteristics, were associated with weight loss after bariatric surgery.SettingSingle university healthcare system, United States.MethodsIn this retrospective cohort study, all patients who underwent primary bariatric surgery from 2008 to 2017 and had at least 1 year of follow-up data were included. Patient-level demographics and neighborhood-level social determinants (area deprivation index, urbanicity, and walkability) and lifestyle factors (organic food use, fresh fruit/vegetable consumption, diet to maintain weight, soda consumption, and exercise) were analyzed. Median regression with percent total body weight (%TBW) loss as the outcome was applied to examine factors associated with weight loss after surgery.ResultsOf the 647 patients who met inclusion criteria, the average follow-up period was 3.1 years, and the mean %TBW loss at the follow-up was 22%. In adjusted median regression analyses, Roux-en-Y gastric bypass was associated with greater %TBW loss (11.22%, 95% confidence interval [8.96, 13.48]) compared to sleeve, while longer follow-up time (-2.42% TBW loss per year, 95% confidence interval [-4.63, -0.20]) and a preoperative diagnosis of diabetes (-1.00% TBW loss, 95% confidence interval [-1.55, -0.44]) were associated with less. None of the 8 neighborhood level characteristics was associated with weight loss.ConclusionsPatient characteristics rather than neighborhood-level social determinants and lifestyle factors were associated with weight loss after bariatric surgery in our cohort of bariatric surgery patients. Patients from socioeconomically deprived neighborhoods can achieve excellent weight loss after bariatric surgery.

Project description:Rationale & objectiveThe association between bariatric surgery, type 2 diabetes, and chronic kidney disease (CKD) is poorly understood. We studied whether remission of type 2 diabetes induced by bariatric surgery influences markers of kidney disease, if CKD is associated with remission of diabetes after bariatric surgery, and if baseline levels of gut hormones and peptides modify these associations.Study designProspective observational study.Study participants737 bariatric surgery patients with type 2 diabetes who participated in a multicenter cohort study for up to 5 years.PredictorsDemographics, blood pressure, medications, type of bariatric surgery, anthropometrics, markers of kidney disease, and circulating levels of gut hormones and peptides.OutcomesEstimated glomerular filtration rate (eGFR), urinary albumin excretion, prognostic risk for CKD, and remission of diabetes.Analytical approachLinear mixed models for eGFR; generalized linear mixed models with logit link for albuminuria, prognostic risk for CKD, and diabetes remission.ResultsRemission of diabetes at 5 years post-bariatric surgery was not independently associated with eGFR but was associated with lower risk for moderate/severe increase in albuminuria (risk ratio, 0.66; 95% CI, 0.48-0.90) and stabilization in prognostic risk for CKD. These findings were modified by baseline ghrelin level. Lower preoperative eGFR and greater prognostic risk for CKD were independently associated with reduced likelihood of diabetes remission. The association with preoperative GFR was modified by C-peptide level. Higher baseline circulating ghrelin level was independently associated with a lower prognostic risk for CKD.LimitationsA minority of participants had baseline CKD; lack of comparison group; no information on duration of diabetes, other clinical end points, or kidney biopsy results.ConclusionsRemission of type 2 diabetes 5 years after bariatric surgery was associated with improvements in albuminuria and stabilized prognostic risk for CKD, but not with eGFR. Lower kidney function and greater prognostic risk at the time of bariatric surgery was linked to a lower likelihood of diabetes remission. These results highlight the need to identify the mechanisms through which bariatric surgery may delay the long-term progression of CKD in type 2 diabetes.

Project description:ImportanceBariatric surgical weight loss is associated with reduced cardiovascular mortality; however, the mechanisms underlying this association are incompletely understood.ObjectivesTo identify variables associated with vascular remodeling after bariatric surgery and to examine how sex, race, and metabolic status are associated with microvascular and macrovascular outcomes.Design, setting, and participantsThis population-based longitudinal cohort included 307 individuals who underwent bariatric surgery. Participants were enrolled in the bariatric weight loss program at Boston Medical Center, a large, multi-ethnic urban hospital, with presurgical and postsurgical assessments. Data were collected from December 11, 2001 to August 27, 2019. Data were analyzed in September 2019.ExposureBariatric surgery.Main outcomes and measuresFlow-mediated dilation (FMD) and reactive hyperemia (RH) (as measures of macrovascular and microvascular function, respectively) and clinical variables were measured preoperatively at baseline and at least once postoperatively within 12 months of the bariatric intervention.ResultsA total of 307 participants with obesity (mean [SD] age, 42 [12] years; 246 [80%] women; 199 [65%] White; mean [SD] body mass index, 46 [8]) were enrolled in this study. Bariatric surgery was associated with significant weight loss and improved macrovascular and microvascular function across subgroups of sex, race, and traditional metabolic syndrome (mean [SD] pre- vs postsurgery weight: 126 [25] kg vs 104 [25] kg; P < .001; mean [SD] pre- vs postsurgery FMD: 9.1% [5.3] vs 10.2% [5.1]; P < .001; mean [SD] pre- vs postsurgery RH: 764% [400] vs 923% [412]; P < .001). Factors associated with change in vascular phenotype correlated most strongly with adiposity markers and several metabolic variables depending on vascular territory (eg, association of weight change with change in RH: estimate, -3.2; 95% CI, -4.7 to -1.8; association of hemoglobin A1c with change in FMD: estimate, -0.5; 95% CI, -0.95 to -0.05). While changes in macrovascular function among individuals with metabolically healthy obesity were not observed, the addition of biomarker assessment using high-sensitivity C-reactive protein plasma levels greater than 2 mg/dL identified participants with seemingly metabolically healthy obesity who had low-grade inflammation and achieved microvascular benefit from weight loss surgery.Conclusions and relevanceThe findings of this study suggest that bariatric intervention is associated with weight loss and favorable remodeling of the vasculature among a wide range of individuals with cardiovascular risk. Moreover, differences in arterial responses to weight loss surgery by metabolic status were identified, underscoring heterogeneity in physiological responses to adiposity change and potential activation of distinct pathological pathways in clinical subgroups. As such, individuals with metabolically healthy obesity represent a mixed population that may benefit from more refined phenotypic classification.