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The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective matched cohort study of patients with diabetes that underwent bariatric surgery at the Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10. Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as a completing risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric Surgery | Patients with type 2 diabetes with BMI >=30 that underwent bariatric surgery |
| |
| Non-Surgical Control | Matched non-surgical controls with type 2 diabetes and BMI >=30 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric Surgery | Procedure | Patients chosen using the following codes: Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of All-Cause Mortality and Cardiovascular Outcomes | Time to first occurrence of all-cause mortality, coronary artery disease event, stroke, heart failure, nephropathy, or atrial fibrillation | From index date through a maximum of 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Adverse Cardiovascular Event (MACE-3) | Time to first occurrence of all-cause mortality, myocardial infarction or ischemic stroke | From index date through a maximum of 10 years |
| All-Cause Mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Body Weight | Percentage change in body weight from index date to years 1, 3 and 5 post-index date | 1,3 and 5 years post-index date |
| Percentage Change in Hemoglobin A1c | Percentage change in hemoglobin A1c from index date to years 1, 3 and 5 post-index date |
Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetes patients with obesity (BMI>=30) between 18-80 years old.
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| Name | Affiliation | Role |
|---|---|---|
| Phil Schauer, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31475297 | Derived | Aminian A, Zajichek A, Arterburn DE, Wolski KE, Brethauer SA, Schauer PR, Kattan MW, Nissen SE. Association of Metabolic Surgery With Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes and Obesity. JAMA. 2019 Oct 1;322(13):1271-1282. doi: 10.1001/jama.2019.14231. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 7, 2022 | |
| Reset | Nov 15, 2022 | |
| Release | Sep 9, 2023 | |
| Reset | Mar 20, 2024 | |
| Release | Oct 9, 2024 | |
| Reset | Nov 29, 2024 | |
| Release | May 5, 2025 | |
| Reset | May 19, 2025 | |
| Release | May 28, 2026 | |
| Reset | Jun 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 7, 2022 | Nov 15, 2022 | |||
| Sep 9, 2023 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
Time to occurrence of death from any cause
| From index date through a maximum of 10 years |
| Incidence of Coronary Disease Events | Time to first occurrence of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting | From index date through a maximum of 10 years |
| Incidence of Cerebrovascular Events | Time to first occurrence of ischemic or hemorrhagic stroke, carotid stenting or endarterectomy | From index date through a maximum of 10 years |
| Incidence of Heart Failure | Time to first occurrence of heart failure | From index date through a maximum of 10 years |
| Development of Nephropathy | Time to first occurrence of nephropathy defined as >=2 measures of estimated Glomerular Filtration Rate (eGFR) <60 ml/min/1.73m^2 separated by at least 90 days without intervening values >=60 | From index date through a maximum of 10 years |
| Incidence of Atrial Fibrillation | Time to first occurrence of atrial fibrillation defined by the following codes: International Classification of Diseases ICD-9: 427.31 ICD-10: i48.0, i48.1, i48.2, i48.91 Current Procedural Terminology (CPT): 93650, 93653, 93656, 93657 | From index date through a maximum of 10 years |
| 1,3 and 5 years post-index date |
| Percentage Change in Systolic Blood Pressure (SBP) | Percentage change in SBP from index date to years 1, 3 and 5 post-index date | 1,3 and 5 years post-index date |
| Percentage Change in Diastolic Blood Pressure (DBP) | Percentage change in DBP from index date to years 1, 3 and 5 post-index date | 1,3 and 5 years post-index date |
| Percentage Change in High Density Lipoprotein (HDL) | Percentage change in HDL from index date to years 1, 3 and 5 post-index date | 1,3 and 5 years post-index date |
| Percentage Change in Low Density Lipoprotein (LDL) | Percentage change in LDL from index date to years 1, 3 and 5 post-index date | 1,3 and 5 years post-index date |
| Percentage Change in Triglycerides | Percentage change in triglycerides from index date to years 1, 3 and 5 post-index date | 1,3 and 5 years post-index date |
| Mar 20, 2024 |
| Oct 9, 2024 | Nov 29, 2024 |
| May 5, 2025 | May 19, 2025 |
| May 28, 2026 | Jun 23, 2026 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |