Abstract

Introduction: Less than 1% of eligible patients undergo bariatric surgery, mainly due to apprehensions over adverse events. Endoscopic sleeve gastroplasty (ESG) may increase adoption of bariatric procedures while limiting potential procedural morbidity. Although there are no guidelines that specify applicability, ESG is still predominantly offered to patients with class I (BMI 30-35 kg/m2) and class II obesity (BMI 35-40 kg/m2). There is a lack of data evaluating ESG amongst its surgical bariatric alternatives in patients with class III obesity (BMI > 40 kg/m2). This is the largest study yet to assess short term (30d) safety and efficacy of ESG in patients with class III obesity and compare its performance to sleeve gastrectomy (SG) and Roux-en-Y bypass (RNYB). Methods: We retrospectively evaluated over 500,000 patients undergoing ESG, SG, and RNYB across 800 hospitals from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database from 2016-2020. ESG patients were grouped by obesity class (Class III and Class I-II) and propensity matched to compare outcomes between groups. ESG patients with class III obesity were also propensity matched separately to SG and RNYB patients with class III obesity to compare outcomes. Outcomes measured at 30d included adverse events (AE), readmissions, reoperations, reinterventions, total body weight loss (TBWL), emergency room (ER) visits, and outpatient treatments for dehydration. Results: In patients who underwent ESG, there was no difference in AE, readmissions, reoperations, or reinterventions between Class III and Class I-II obesity cohorts (p >0.05). ESG led to greater mean %TBWL at 30d in Class III obesity versus Class I-II obesity (p< 0.05). For class III obese patients, ESG had similar AE to SG (p >0.05) and far less than RNYB (p< 0.05). ESG led to nearly identical mean %TBWL as SG and RNYB at 30d (p< 0.05). ESG patients had similar rates of readmissions and reoperations (p >0.05) compared to SG, but more reinterventions (p < 0.05). SG had more outpatient treatments for dehydration (p< 0.05) and ER visits (p< 0.05) than ESG. Compared to RNYB, ESG had fewer readmissions, reoperations, outpatient treatments for dehydration, and ER visits (p< 0.05). Conclusion: ESG is safe in class III obesity, with no difference in AE between obesity classes. The safety of ESG in class III obesity mirrored SG and exceeded RNYB, with comparable efficacy. Clinicians should consider expanding access to ESG regardless of BMI. Table 1. - Short-Term Safety and Efficacy of Endoscopic Sleeve Gastroplasty in Class III Obesity versus Bariatric Surgery ESG in Class III Obesity (n= 2,626) ESG in Class I-II Obesity (n= 2,626) P SG in Class III Obesity (n= 5,252) P RNYB in Class III Obesity (n= 5,252) P Mean BMI (SD) 47.79 (7.23) 35.38 (2.73) < 0.001 48.31 (7.44) 0.003 47.85 (6.84) 0.707 Mean Change from Pre-Op to Post-Op BMI (SD) -2.44 (3.42) -1.30 (1.84) < 0.001 -2.65 (2.29) 0.002 -2.58 (2.47) 0.057 Mean % Total Body Weight Loss at 30d (SD) 5.0 (6.0) 3.2 (7.3) < 0.001 5.4 (3.8) < 0.001 5.3 (4.4) 0.003 Mean Number of Days from Procedure to Discharge (SD) 1.01 (1.65) 0.73 (2.23) < 0.001 1.52 (1.33) < 0.001 1.94 (1.84) < 0.001 Mean Procedure Length, minutes (SD) 68.94 (49.15) 60.49 (44.48) < 0.001 78.99 (40.17) < 0.001 134.97 (65.25) < 0.001 Major Adverse Event, n (%) 36 (1.4) 37 (1.4) 1 76 (1.4) 0.866 172 (3.3) < 0.001 Anastomotic Leak, n (%) 0 (0.0) 0 (0.0) 1 1 (0.2) 0.808 2 (0.3) 0.718 Pneumonia, n (%) 2 (0.1) 7 (0.3) 0.182 9 (021) 0.784 24 (0.5) 0.01 Intra-operative or Post-operative Blood Transfusion, n (%) 11 (0.4) 15 (0.6) 0.555 25 (0.5) 0.859 68 (1.3) < 0.001 Mean Number of Blood Products Transfused (SD) 0.11 (0.87) 0.10 (0.56) 0.965 0.10 (0.56) 0.835 0.25 (1.05) 0.017 Vein Thrombosis requiring therapy, n (%) 0 (0.0) 2 (0.1) 0.479 12 (0.2) 0.032 10 (0.2) 0.057 Sepsis, n (%) 6 (0.2) 6 (0.2) 1 7 (0.1) 0.492 13 (0.2) 1 Unplanned Admission to ICU, n (%) 12 (0.5) 9 (0.3) 0.662 29 (0.6) 0.698 58 (1.1) 0.006 Bowel Obstruction, n (%) 1 (0.3) 0 (0.0) 1 2 (0.0) 0.883 6 (0.9) 0.383 Reoperation within 30 days, n (%) 32 (1.2) 33 (1.3) 1 53 (1.0) 0.464 138 (2.6) < 0.001 Readmission within 30 days, n (%) 101 (3.8) 92 (3.5) 0.557 179 (3.4) 0.355 334 (6.4) < 0.001 Reintervention within 30 days, n (%) 68 (2.6) 62 (2.4) 0.657 53 (1.0) < 0.001 125 (2.4) 0.624 Received Treatment for Dehydration Outpatient, n (%) 75 (2.9) 54 (2.1) 0.075 206 (3.9) 0.019 269 (5.1) < 0.001 Emergency Department Visit Not Resulting in Admission, n (%) 148 (5.6) 108 (4.1) 0.012 364 (6.9) 0.032 522 (9.9) < 0.001

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