Is laparoscopic sleeve gastrectomy safer than laparoscopic gastric bypass?

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Is laparoscopic sleeve gastrectomy safer than laparoscopic gastric bypass? A comparison of 30-day complications using the MBSAQIP data registry Sandhya B. Kumar MD, Barbara C. Hamilton MD, Soren Jonzzon, Stephanie G. Wood MD, Stanley J. Rogers MD, Jonathan T. Carter MD, Matthew Y.C. Lin MD University of California, San Francisco Department of Surgery

Disclosures Dr. Kumar s fellowship is supported through a grant from the Foundation of Surgical Fellowships

1. Peterli R, Borbély Y, Kern B, et al. Early results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS): a prospective randomized trial comparing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Annals of Surgery. 2013;258(5):690 4. 2. Helmiö M, Victorzon M, Ovaska J, et al. SLEEVEPASS: a randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. Surgical Endoscopy. 2012;26(9):2521-2526. 3. Young MT, Gebhart A, Phelan MJ, Nguyen NT. Use and Outcomes of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Gastric Bypass: Analysis of the American College of Surgeons NSQIP. Journal of the American College of Surgeons. 2015;220(5):880-885. Introduction Laparoscopic sleeve gastrectomy (LSG) is now the most popular bariatric procedure in the United States Some studies have shown LSG to have fewer overall complications than laparoscopic gastric bypass (LRYGB), but there is lingering concern about a higher leak rate The Metabolic and Bariatric Surgery Accreditation and Quality Improvement (MBSAQIP) registry is the largest bariatric-specific dataset available and therefore the best data set to compare LSG and LRYGB in a real-world setting.

Objective To compare LSG and LRYGB with respect to mortality, serious morbidity, and leak, adjusting for patient characteristics.

Methods Patients: all patients undergoing bariatric surgery captured by the 2015 MBSAQIP database Inclusion criteria: all cases of primary LSG or LRYGB identified using CPT codes Exclusion criteria: revisional operations, open operations Predictors: Patient demographics and comorbidities

Methods- Outcome variables Death Leak = any of Leak outcome Drain at 30-days Organ space infection Leak-related readmission Leak-related reoperation Leak-related intervention Morbidity = any of Deep or organ space infection Wound disruption Leak ICU admission Sepsis Renal failure Transfusion Cardiac arrest, myocardial infarction Cerebrovascular accident, coma Pneumonia, >48h vent, reintubation Pulmonary embolism, DVT Intervention, reoperation, readmission within 30-days

Statistical Methods Missing value imputation Partition in to Training (70%) and Testing (30%) sets Variable importance using Random Forest Algorithms Multivariate Regression Model using forward and backwards stepwise selection, minimizing Aikake Information Criterion (AIC) Model Diagnostics Receiver Operating Characteristic Curves

Patient Characteristic LSG (n=93,062) LRGYB (n=41,080) P-value 8 Age (years) 44 (35 53) 45 (36 54) < 0.001 BMI (kg/m 2 ) 44 (40 49) 45 (41 51) < 0.001 Albumin (mg/dl) 4.1 (3.9 4.3) 4.0 (3.8 4.2) < 0.001 Female 79% 79% 0.001 Diabetes < 0.001 None 77% 65% None-insulin dependent 16% 21% Insulin dependent 7% 15% Hyperlipidemia 23% 30% < 0.001 Gastroesophageal Reflux 29% 37% < 0.001 Obstructive Sleep Apnea 35% 43% < 0.001 COPD 1.7% 2.2% < 0.001 Oxygen Dependence 0.7% 1.0% < 0.001 Hypertension 48% 54% < 0.001 History of MI 1.2% 1.6% < 0.001 Prior PCI 2.0% 2.5% < 0.001 Prior Cardiac Surgery 1.2% 1.2% 0.816 Renal Insufficiency 0.7% 0.7% 0.648 Dialysis Dependence 0.3% 0.2% < 0.001 History of DVT 1.6% 1.8% < 0.001 History of PE 1.1% 1.2% 0.04 Prior IVC Filter 1.0% 1.2% < 0.001 Venous Stasis 0.9% 1.4% < 0.001 Therapeutic Anticoagulation 2.2% 2.4% 0.172 Chronic Steroid Use 1.6% 1.4% < 0.001 Smoking History 9% 9% 0.246 Prior Surgery 1.9% 1.7% 0.006 Need for Mobility Device 1.8% 2.4% < 0.001

9 Patient Characteristic LSG (n=93,062) LRGYB (n=41,080) P-value Functional Status < 0.001 Independent 99% 99% Partially dependent 0.6% 0.8% Totally dependent 0.4% 0.2% Level of Training of assistant < 0.001 None 16% 12% PA/NP/RN 37% 39% Resident 17% 17% MIS Fellow 8% 12% Attending Weight Loss Surgeon 16% 14% Attending - Other 6% 6% ASA Class < 0.001 I 0.5% 0.2% II 26% 17% III 70% 78% IV 3.5% 4.6% V 0.01% < 0.01%

Random Forest Algorithm Diabetes Oxygen Dependence Mobility Device Steroids OSA Hyperlipidemia Cardiac Disease ASA Class Cardiac Disease Functional Status LSG or LRYGB Diabetes Age Albumin OSA Male LSG or LRYGB Cardiac Disease GERD Diabetes BMI

Unadjusted 30-day outcome LSG LRGYB P-value Leak 0.8% 1.6% < 0.001 Morbidity 5.8% 11.7% < 0.001 Mortality 0.1% 0.2% < 0.001

Unadjusted 30-Day Outcomes Complication LSG (n=93,062) LRGYB (n=41,080) P-value Urinary tract infection 0.31% 0.47% < 0.001 Deep SSI 0.03% 0.20% < 0.001 Organ space infection 0.29% 0.60% < 0.001 Wound disruption 0.03% 0.1% < 0.001 Sepsis 0.22% 0.61% < 0.001 Renal failure 0.19% 0.38% < 0.001 Bleeding requiring transfusion 0.57% 1.19% < 0.001 Pneumonia 0.19% 0.51% < 0.001 Venous thromboembolism 0.23% 0.23% 0.994 Pulmonary embolism 0.11% 0.15% 0.052 Myocardial infarction 0.03% 0.08% 0.001 Cardiac arrest 0.05% 0.09% 0.003 Cerebrovascular accident 0.01% 0.01% 0.526 Coma 0.01% < 0.01% 0.137 Unplanned intubation 0.16% 0.40% < 0.001 ICU admission 0.71% 1.65% < 0.001 Ventilator greater than 48 hours 0.11% 0.39% < 0.001 Intervention within 30 days 1.51% 3.33% < 0.001 Reoperation within 30 days 1.22% 3.19% < 0.001 Readmission within 30 days 4.05% 7.32% < 0.001

Multivariate Model - Leak Variable OR 95% CI P-value LRYGB (compared to LSG) 2.10 1.88 2.34 < 0.001 Age (per year) 1.01 1.00 1.01 0.012 BMI (per kg/m 2 ) 1.01 1.00 1.02 0.001 Hyperlipidemia 0.82 0.71 0.94 0.004 Obstructive Sleep Apnea 1.22 1.09 1.37 0.001 Hypertension 1.20 1.06 1.36 0.004 Therapeutic Anticoagulation 1.82 1.39 2.39 < 0.001 Chronic Steroid Use 1.51 1.06 2.16 0.023 Need for Mobility Device 0.81 0.56 1.19 0.289 Functional Status (Compared to Independent) Partially dependent 2.52 1.62 3.91 < 0.001 Totally dependent 2.32 1.22 4.41 0.01 Level of training of assistant (compared to none) PA/NP/RN 1.16 0.97 1.40 0.101 Resident 1.06 0.86 1.35 0.573 MIS Fellow 0.80 0.62 1.04 0.100 Attending Weight Loss Surgeon 0.81 0.65 1.02 0.075 Attending Other 3.90 3.19 4.77 < 0.001 ASA Class (Compared to Class I) II 0.54 0.31 0.96 0.034 14 III 0.42 0.24 0.74 0.003 IV 0.37 0.20 0.69 0.002

Multivariate Model - Morbidity Variable OR 95% CI P-value LRGYB (compared LSG) 2.02 1.94 2.11 < 0.001 BMI (per kg/m 2 ) 1.01 1.01 1.01 < 0.001 Albumin (per mg/dl) 0.80 0.75 0.84 < 0.001 Male (compared to Female) 0.91 0.86 0.96 < 0.001 Diabetes (compared to none) Non-insulin dependent 1.04 0.98 1.10 0.203 Insulin dependent 1.25 1.17 1.34 < 0.001 Hyperlipidemia 0.93 0.88 0.98 0.006 GERD 1.22 1.16 1.27 < 0.001 OSA 1.05 1.00 1.10 0.030 COPD 1.38 1.21 1.56 < 0.001 Oxygen dependence 1.47 1.23 1.76 < 0.001 Hypertension 1.17 1.12 1.22 < 0.001 History of MI 1.14 0.97 1.32 0.103 Prior Cardiac Surgery 1.54 1.32 1.79 < 0.001 Renal Insufficiency 1.67 1.38 2.02 < 0.001 Dialysis Dependence 1.69 1.26 2.27 0.001 History of PE 1.36 1.17 1.60 < 0.001 History of DVT 1.34 1.17 1.53 < 0.001 Prior IVC filter 1.76 1.51 2.05 < 0.001 Therapeutic Anticoagulation 1.64 1.46 1.84 < 0.001 Chronic Steroid Use 1.29 1.21 1.49 < 0.001 Smoking history 1.10 1.02 1.18 0.009 Prior Surgery 1.28 1.12 1.47 < 0.001 Need for Mobility Device 1.26 1.11 1.42 < 0.001 Functional Status (compared to Independent) Partially dependent 1.07 0.87 1.32 0.505 Totally dependent 1.50 1.13 2.00 0.005 Level of training of assistant (compared to none) PA/NP/RN 1.06 1.00 1.13 0.076 Resident 1.23 1.14 1.32 < 0.001 MIS Fellow 1.16 1.07 = 1.27 0.001 Attending Weight Loss Surgeon 1.11 1.03 1.20 0.006 Attending - Other 1.38 1.26 1.52 < 0.001

Multivariate Model - Mortality Variable OR 95% CI P-value LRYGB (compared to LSG) 1.64 1.22 2.22 0.001 Age (per year) 1.04 1.03 1.06 < 0.001 BMI (per kg/m 2 ) 1.06 1.05 1.07 < 0.001 Male (compared to female) 2.22 1.63 3.01 < 0.001 Diabetes (compared to none) Non-insulin dependent 1.38 0.94 2.01 0.096 Insulin dependent 1.84 1.23 2.76 0.003 Hyperlipidemia 1.32 0.93 1.85 0.12 Oxygen dependence 2.65 1.43 4.91 0.002 Therapeutic Anticoagulation 3.13 2.04 4.82 < 0.001 Need for Mobility Device 1.69 1.00 2.88 0.051

Model Performance

Conclusions In the first 30 days, LSG was safer than LRYGB: - LSG had half the risk-adjusted odds of leak - LSG had half the risk-adjusted odds of morbidity - LSG had nearly half the risk-adjusted odds of death The reduced risk with LSG must be weighed against the benefits. Long term weight outcomes, metabolic disease resolution, and risk of GERD progression with LSG are still under study LSG is a better choice for high risk candidates.

Limitations Our study used a composite outcome of leak and morbidity. The discriminative ability of the models was poor for leak or morbidity. Outcomes after 30-days were not studied delayed leak, stricture, ulcers, etc. are not included To really decide which procedure to recommend for a patient, better characterization of long-term results are needed: weightloss maintenance, need for conversion, GERD, and diabetes resolution

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