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Association of Bariatric Surgery With Major Adverse Liver and Cardiovascular Outcomes in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis
Open accessAbstract
IMPORTANCE: No therapy has been shown to reduce the risk of serious adverse outcomes in patients with nonalcoholic steatohepatitis (NASH). OBJECTIVE: To 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 PARTICIPANTS: In 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. EXPOSURES: Bariatric surgery (Roux-en-Y gastric bypass, sleeve gastrectomy) vs nonsurgical care. MAIN OUTCOMES AND MEASURES: The 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. RESULTS: A 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 RELEVANCE: Among 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.
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“Long-term results of MBS consistently demonstrate safety and efficacy.”
From 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 (2023) · cites this paper as [18]
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“Furthermore, MBS is associated with an 88% risk reduction of progression of NASH to cirrhosis [18].”
From 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 (2023) · cites this paper as [18]
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“Procedures like Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG) are associated with significant metabolic improvements and reductions in NAFLD severity [13,14,15], including reductions in liver fat, liver enzymes, and fibrosis [16,17,18].”
From Impact of Bariatric Surgery and Endoscopic Therapies on Liver Health in Metabolic Dysfunction-Associated Steatotic Liver Disease: A Review (2025) · cites this paper as [17]
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“Notably, the 15 mg tirzepatide group in this trial exhibited an average weight decrease of 20.9%, and an impressive 36.2% of participants successfully achieved the≥25% weight-loss goal, approaching the effects observed with bariatric surgery [32, 33].”
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“After surgery, the significant improvement of metabolic disease, as well as the decrease in overall mortality, has been reported in multiple studies further supporting the importance of this treatment modality [15–19].”
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“Surgical, compared to non-surgical treatment, was related to reduce risk of major liver-related and cardiac events in patients with MASH and obesity [88].”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [88]
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“In line with data from prospective studies, the large retrospective SPLENDOR study found signi fi cantly lower rates of adverse liver-related outcomes and major adverse cardiovascular events in individuals who underwent metabolic surgery compared to non-surgical controls.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [439]
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“After surgery, the significant improvement of metabolic disease, as well as the decrease in overall mortality, has been reported in multiple studies further supporting the importance of this treatment modality [15–19].”
From 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 (2023) · cites this paper as [18]
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“26,27 Nevertheless, GLP-1RAs provide an effective nonsurgical alternative for patients who are ineligible for surgery or prefer medical therapy and may be complementary to BS as a management strategy aimed at reducing long-term cardiovascular risk.”
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“Observational studies further suggest that MBS is associated with lower risks of major adverse liver and cardiovascular outcomes in selected patients with fibrotic MASH and in carefully selected patients with compensated MASH-related cirrhosis [14,15].”
Metabolic Dysfunction‐Associated Steatotic Liver Disease
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Metadata
- Authors
- Aminian, A., Al-Kurd, A., Wilson, R., Bena, J., Fayazzadeh, H., Singh, T., Albaugh, V. L., Shariff, F. U., Rodriguez, N. A., Jin, J., Brethauer, S. A., Dasarathy, S., Alkhouri, N., Schauer, P. R., McCullough, A. J., & Nissen, S. E.
- Affiliations
- Cleveland Clinic (US)
- Bariatric and Metabolic Institute, Department of General Surgery, Cleveland Clinic, Cleveland, Ohio
- Pennington Biomedical Research Center (US)
- Corresponding author
- Nissen, Steven E.
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2021-11-23
- Volume
- 326
- Issue
- 20
- Pages
- 2031
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC8587225
- OpenAlex
- W3214171772
- Cited by
- 375
- References
- 36
- Citations by year
- 2026: 66 · 2025: 87 · 2024: 81 · 2023: 77 · 2022: 60 · 2021: 2
- FWCI
- 51.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Diabetes and Digestive and Kidney Diseases (U01DK061732)
- Topics
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Surgery › Organ Transplantation Techniques and Outcomes
- Keywords
- bariatric surgery, nonalcoholic steatohepatitis, obesity, liver fibrosis, major adverse liver outcomes, major adverse cardiovascular events, Roux-en-Y gastric bypass, sleeve gastrectomy, cirrhosis progression, hepatocellular carcinoma, liver transplantation, cardiovascular mortality, liver-related mortality, long-term outcomes, overlap weighting
- MeSH terms
- Adult, Biopsy, Body Weight, Cardiovascular Diseases, Female, Carcinoma, Hepatocellular, Humans, Liver, Liver Cirrhosis, Liver Neoplasms, Male, Middle Aged, Obesity, Retrospective Studies, Incidence, Bariatric Surgery, Kaplan-Meier Estimate, Propensity Score, Non-alcoholic Fatty Liver Disease
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