Complications: Revisions MISS 2010 Bruce M. Wolfe Professor of Surgery Oregon Health & Science University

Complications: Revisions Provider error – Large gastric pouch – Incomplete gastric division – Incorrect limbs 2

Complications: Revisions Patient and/or provider factors – Marginal ulcer – Stricture – Intestinal obstruction 3

Complications: Revisions Poor weight loss or regain – Anatomic factor Gastric pouch size Dilated gastrojejunostomy Gastrogastric fistula – Patient factor Operative anatomy as expected 4

Marginal Ulcer Evaluation – Endoscopy – UGI Intraoperative endoscopy – Define pouch – Confirm resection – Test anastomosis ± Vagotomy 5

Background Revisional bariatric surgery – Indications: Side effects or complications of prior bariatric surgery Inadequate weight loss – Higher morbidity than with first time procedures 6

GSPH Clinical Center Data Coordinating Center NIDDK / ORWH OHSU/ Legacy UWashington/ VMason NRI/UND UPMC Columbia/ Cornell ECU NIDDK/ ORWH Sacramento Bariatric 7

Aim – To determine independent risk factors for adverse outcome in patients undergoing revisional bariatric surgery – To compare the outcome between first-time and revisional bariatric cases 8

LABS-1 Total 5069 patients/operations 5033 Primary, revisional or reversal operations 30 Second stage procedures 6 Other secondary obesity procedures 3803 stapled bariatric procedures 1230 Adjustable gastric banding 3802 patients/operations 1 patient underwent 2 separate procedures: a revision followed by a reversal; The reversal was excluded from the analysis 3577 primary procedures225 revision/reversal procedures 9

Data definitions Composite endpoint (CE) – Death – Deep venous thrombosis (DVT) or venothromboembolism (VTE) – Re-intervention with percutaneous, endoscopic or operative techniques – Failure to discharge within 30-days of surgery 10

Statistical Analysis Characteristics across subgroups: – Categorical variables: Pearson’s chi-square test – Continuous: Kruskal-Wallis test 30-day adverse outcomes: – Fisher’s exact test Association between baseline patient characteristics and the odds of 30-day adverse outcome : – Multivariable generalized linear logistic regression models 11

Patient characteristics for revisional patients Characteristic Median Age49 years Age categories (years)n (%) <3010 (4) (17) (29) (41) (6) 65+7 (3) 12

Patient characteristics for revisional patients Characteristicn (%) Male29 (13) BMI (kg/m 2 ) <3564 (29) 35-<4038 (17) 40-<5075 (34) 50-<6036 (16) (5) Median BMI41 kg/m 2 13

Comorbidities Mean, median comorbidities1.4, 1 # co-morbiditiesn (%) None71(32) 1 or more151 (68) 2 or more87 (39) 3 or more40 (18) 4 or more20 (9) 14

Major comorbidities and medication use Characteristicn (%) Hypertension103 (46) Diabetes46 (20) History of DVT or PE 18 (8) Sleep apnea61 (27) Ischemic heart disease 15 (7) Narcotic use63 (28) Antidepressant108 (48) 15

Prior Obesity or Foregut Surgery Proceduren (%) Gastric bypass84 (38.0) BPD1 (0.5) DS11 (5.0) Gastric banding42 (19.0) VBG47 (21.3) Sleeve4 (7.7) Prior foregut17 (22.2) 16

Surgery Performed Proceduren (%) RYGB146 (64.9) BPD2 (0.9) DS8 (3.6) Banded RYGB2 (0.9) Sleeve19 (8.4) Other48 (21.1) 17

Adverse outcome Eventn (%) Death1 (0.4) DVT/PE4 (1.8) Tracheal reintubation5 (2.2) Placement of percutaneous drain3 (1.3) Endoscopy10 (4.4) Abd reoperation18 (8) Composite event34 (15.1) 18

Predictors of CE among revisional surgeries Event OR (95% CI) pAdjusted OR (95% CI) p Patient age (per year) 1.04 (0.999, 1.09) (0.995, 1.08) 0.08 History of DVT Yes vs. No 4.09 (1.40, 11.92) (1.25, 11.1)

Revisional vs. Primary Unadjusted Odds of CE is more than twice high for revisional surgeries compared to primary surgeries (OR = 2.4, 95% CI ) 20

Revisional vs. Primary Adjusted for important comorbidities and other patient characteristics, odds of CE was more than twice as high for revisional surgeries compared to primary surgeries (OR = 2.3, 95% CI ) 21

Conclusions Revisional bariatric surgery can be performed without substantial mortality but with a greater incidence of adverse outcome compared to primary surgery 22

Acknowledgments This clinical study was a cooperative agreement funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Grant numbers: DCC -U01 DK066557; Columbia-Presbyterian - U01-DK66667; University of Washington - U01-DK66568 (in collaboration with GCRC, Grant M01RR-00037); Neuropsychiatric Research Institute - U01-DK66471; East Carolina University – U01-DK66526; University of Pittsburgh Medical Center – U01-DK66585; Oregon Health & Science University – U01-DK The authors thank the LABS study participants for their contributions. 23