1. Lap-Band Surgery for Adolescents NYU Medical Center Program for Surgical Weight Loss George Fielding, MD Associate Professor of Surgery Evan P. Nadler, MD Assistant Professor of Surgery, Director of Minimally Invasive Pediatric Surgery Christine Ren, MD Assistant Professor of Surgery

2. NYU Adolescent Bariatric Experience Three Phases: Brisbane, Australia (1998-2004) n= 41 Off-label experience (2002- 4) n= 41 FDA Study (2005) n=17

3. Brisbane n=41 17.1 YRS ( 12-19) Y No. Wt (lbs) BMI % EWL 0 41 275 43 1 21 210 32 50 2 18 200 29 69 3 16 200 29 70 4 5 193 29 63 6 3 171 27 65

4. Teenagers ? Success 80% had lost at least 50% of their excess body weight at 36 months 80% had a BMI < 30 kg/m 2 at 36 months Visits in 2 yrs: 12.3 (5 - 22)

5. NYU Bariatric Program Largest lap- band experience in world Dedicated to long term follow-up Multi-Disciplinary In-house Nutritional Team Includes Pediatric Surgeon Psych care at NYU Child Study Centre

6. Lap- Band in Adolescents Demographics n= 58 Gender Female: 46 Male: 12 Age 13yrs 5 14-17 yrs 40 18-19 yrs 13 Race Caucasian 50 Hispanic 5 African American 3

7. Pre-OP Co-Morbidities PreOp Co-Morbidities Dyslipidemia22 % Depression20 % Type 2 DM/IGT20 % LBP20 % OA17 % Asthma17 % HTN14 % PCOS14 % GERD9 % OSA7 % Skin Rashes6 % N: 58

8. Pre-Op Weight and BMI Pre-OP and OP Data Average Initial Wt Average Initial BMI 296.31 lbs47.43 Average OR Time Average LOS 35 mins24 hrs

9. Lap Band Peri-operative complications All patients discharged <24 hrs Increasing use of same-day approach Complications Mortality 0 PE 0 Acute re-op 0 Acute readmission <30 days 1 (perforated appendicitis)

10. Follow Up Weight Loss Report Avg Initial Wt Avg Initial BMI F/U Avg Wt Avg BMI Avg %EWL N 29647.43 n/a 58 3 months268 42.7617.7939 6 months25239.7634.8731 9 months232 36.9146.6129 30648.5312 months21834.4457.1113 34354.6718 months24839.53496 33554.362 Years23938.6650.25 33755.423 Years24941.0842.54 356634 Years17030821

11. Post-OP 1 Year Nutritional Panel Reference Range Fe57.537-170 Folate10.9>2.8 VitB12419.6239-931 N: 6

12. 14-17 Years Old n=40 Average OR Time34 Average LOS24 Gender Male8 Female32 Race Caucasian33 Hispanic4 African American3

13. 14-17 Years Old Age 14 years old3 15 years old7 16 years old11 17 years old19 Trial FDA Trial15 Non FDA Trial25

14. Wt Loss & Complications Avg WT Avg BMI Avg %EWLNComplication Initial292.7046.93n/a40none 3 months270.8542.8019.4828 1, Perforated Appendicitis and 1, Gastroenteritis 6 months245.1538.9336.4221none 9 months237.6637.4647.1317 1, Hiatal Hernia and 1, Band Slip 12 months224.2035.3855.50111, Hiatal Hernia 18 months240.0036.1356.0031 Band Slip 2 years211.3337.4051.003none 3 years223.0039.4342.333none 4 years170.0030.0082.001none

15. Lap – Band Complications Reflux (GERD) All patients have yearly esophagrams 4 / 58 patients have complained of reflux symptoms, typically in the evening All 4 then had diagnostic esophagrams Findings: 2 true slips 2 concentric dilatations ( hiatal hernia) Outcome: 2 patients hiatal hernia repair 2 patients repair slipped band All 4 done as day- cases All 4 resolved, off treatment, band re- adjusted, ongoing weight loss

16. FDA STUDY: STUDY TITLE: A prospective, open-label study to evaluate the safety and efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17) STUDY OBJECTIVES: to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss. to assess the status of co-morbidities and changes in quality of life from baseline.

17. FDA Trial (Age 14-17) Patients enrolled : 22 Patients had surgery : 17 Gender Female: 13 Male: 4 Age 14 years old: 4 15 years old: 4 16 years old: 5 17 years old: 4 Race Caucasian: 10 Hispanic: 5 African American: 1 Native American: 1

18. Pre-OP and OP Data N:17 Avg Initial Wt Avg Initial BMI Avg OP Time Avg LOS 29347.6430 mins24 hrs

19. Pre-Op Co-Morbidities Pre-OP Co-Morbidities DM or IGT37% Back Pain37% Dyslipidemia37% Depression31% OA25% Asthma19% GERD19% Hypertension19% Exertional Dyspnea19% Stress Incontinence6%

20. Lipid Panel CholesterolTriglyceridesHDLLDL CholHDL Ratio Pre-OP (N:17)16311837994.68 Post-OP (N:4) 3 months15912241944.08

21. Nutritional Panel FeFolateVitB12 VitD HydroxyPTH Phos phorusMg Pre-OP (N:17)60.1317.05494.8424.5634.574.074.40 Post-OP (N:4) 3 months37.2511.15530.5017.2531.753.451.98

22. Post OP Weight Loss Initial WT (N:17) Initial BMI (N:17) 3 months F/U Wt (N:4) 3 months F/U BMI (N:4) 3 Month F/U % EBW (N:4) 29347.64274.3342.9217.76

23. Lap Band Surgery for Adolescents Conclusions The surgery is safe The Lap- Band delivers effective weight loss for adolescents