Unadjusted (A) and adjusted (B) rates of perioperative complications between patients with ESRD and normal kidney function. Surgical complications include 1 or more of the following: unplanned reoperation, endoscopic intervention, transfusion, superficial surgical site infection (SSI), leak, sepsis, deep or organ space surgical site infection, or unplanned percutaneous drain placement. Medical complications include 1 or more of the following: unplanned intensive care unit (ICU) stay, pneumonia, new venous thromboembolism (VTE), unplanned intubation, need for cardiopulmonary resuscitation (CPR), myocardial infarction, and stroke. Bands indicate upper 95% confidence interval.
aVariables included in the multivariable regression analysis: patient age, black race/ethnicity, sex, smoking status, hypertension, diabetes, obstructive sleep apnea, chronic steroid/immunosuppressant use, previous percutaneous cardiac intervention and/or surgery, fully or partially dependent functional status, and surgery type (laparoscopic sleeve gastrectomy or roux-en-Y gastric bypass). Patients with unknown/not reported race/ethnicity were assigned a dummy variable and included in the multivariable linear regression analysis (4.5% of ESRD cohort [n = 56] and 5.4% of normal kidney function cohort [n = 22 678]).
bNo occurrences of stroke in the ESRD cohort.
cIndicates P < .05.
dIndicates P < .001.
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Montgomery JR, Waits SA, Dimick JB, Telem DA. Risks of Bariatric Surgery Among Patients With End-stage Renal Disease. JAMA Surg. 2019;154(12):1160–1162. doi:10.1001/jamasurg.2019.2824
Pretransplant morbid obesity among patients with end-stage renal disease (ESRD) is a significant predictor of delayed access to transplant and inferior posttransplant patient and kidney allograft outcomes.1-3 Despite this, policies directly addressing pretransplant weight management do not exist. While the association between bariatric surgery and long-term weight loss and comorbidity improvement among obese patients with ESRD is well established, surgery is underused in this population owing to perceptions of unacceptable increased perioperative risk.4,5 Perioperative risks of bariatric surgery among obese patients with ESRD are poorly characterized, with limited studies that may not detect rare events.6 In this context, we performed an analysis of perioperative safety of bariatric surgery in obese patients with ESRD using a national registry capturing greater than 95% of bariatric operations.
Patients who underwent primary, laparoscopic sleeve gastrectomy or roux-en-Y gastric bypass between 2015 and 2017 were identified from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program participant use file. The primary outcomes were 30-day surgical complications, medical complications, and death. The University of Michigan institutional review board deemed this study exempt owing to the deidentified nature of the data set; patient consent was not required for this registry/quality improvement data. Univariate and multivariable logistic regression was used to compare outcomes between patients with ESRD and those with normal kidney function (preoperative creatinine ≤2 mg/dL; to convert to micromoles per liter, multiply by 88.4) (Figure). These covariates were included in the regression analysis because they are associated with the primary outcomes and occur at different rates between the study cohorts. Analyses were performed with Stata, version 15.1 (StataCorp LLC). Statistical significance was set at P less than .05, with 2-sided tests.
During the study period, 418 647 bariatric operations were performed; of these, 1244 patients (0.3%) had ESRD and 417 403 patients (99.7%) had normal kidney function. Patients with ESRD were statistically significantly more likely to be older, be men, be of black race/ethnicity, be fully or partially dependent, have more medical comorbidities, and have lower preoperative hematocrit levels (Table). On multivariable analysis, ESRD was associated with statistically significantly higher rates of all primary outcomes (Figure). Differences in surgical complications were driven by statistically significantly increased rates of unplanned reoperation (3.1% vs 1.1%; P < .001), endoscopic intervention (1.6% vs 0.9%; P < .001), transfusion (1.5% vs 0.7%; P = .01), and sepsis (0.4% vs 0.2%; P = .02). Differences in medical complications were driven by statistically significantly increased rates of unplanned intensive care unit stay (1.5% vs 0.7%; P < .001) and pneumonia (0.6% vs 0.2%; P = .02). However, the absolute rate differences did not exceed 4% for any individual or composite outcome.
End-stage renal disease was associated with increased rates of surgical complications, medical complications, and death after bariatric surgery when compared with patients with normal kidney function. However, the absolute rate differences were 4% or less for each individual and composite outcome. Surgical complications were driven by increased rates of unplanned reoperation, endoscopic intervention, transfusion, and sepsis. There were no differences in anastomotic leak rate. Increased reoperation and endoscopic intervention rates may be owing to lower surgeon threshold for aggressive interventions among patients with ESRD for fear of failure to rescue among a more clinically vulnerable population. This explanation is supported by the increased rate of unplanned intensive care unit admission among patients with ESRD. The risk-adjusted rate of perioperative death was rare among patients with ESRD, occurring in an estimated 3.1 per 1000 cases.
This study was limited by potential misclassification bias and inability to assess for outcomes clustering by clinician or hospital characteristics. The results may not be generalizable to the entire obese ESRD population because only obese patients with ESRD healthy enough to undergo surgery were eligible for analysis. However, given the potential for improved access to transplant and better posttransplant outcomes, the common misperception that patients with ESRD have prohibitively high perioperative risks to undergo bariatric surgery is not justified and should not preclude obese patients with ESRD from operative consideration. Analysis of long-term bariatric surgery outcomes among patients with ESRD is necessary.
Corresponding Author: Dana A. Telem, MD, MPH, Department of Surgery, University of Michigan, 1500 E Medical Center Dr, Ann Arbor, MI 48109 (firstname.lastname@example.org).
Accepted for Publication: June 11, 2019.
Published Online: September 25, 2019. doi:10.1001/jamasurg.2019.2824
Author Contributions: Drs Montgomery and Telem had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: All authors.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Montgomery, Waits.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Montgomery, Telem.
Obtained funding: Dimick.
Administrative, technical, or material support: Dimick.
Supervision: Waits, Dimick, Telem.
Conflict of Interest Disclosures: Dr Dimick has a financial interest in ArborMetrix Inc. Dr Telem has research funding from Medtronic and is a member of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program data committee. Dr Telem also reports grants from the Agency for Healthcare Research and Quality, Medtronic, and the National Institutes of Health. No other disclosures were reported.
Funding/Support: Dr Montgomery is supported by the Obesity Surgery Scientist Fellowship Award administered from the National Institute of Diabetes and Digestive and Kidney Diseases (T32-DK108740). Dr Dimick is supported by the Long-Term Comparative Safety and Economic Consequences of Sleeve Gastrectomy grant administered by the National Institute of Diabetes and Digestive and Kidney Diseases (R01-DK115401). Dr Telem is supported by the Developing and Implementing Evidence-Based Hernia Care grant administered by the Agency for Healthcare Research and Quality (K08-HS025778).
Role of the Funder/Sponsor: The funding organizations and committee had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: Dr Dimick is Surgical Innovation Editor of JAMA Surgery, but he was not involved in any of the decisions regarding review of the manuscript or its acceptance.
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