Lap-Band Surgery for Adolescents

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/m2 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 AdolescentsDemographics 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 N: 58

8. Pre-Op Weight and BMI • Pre-OP and OP Data

9. Lap BandPeri-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

11. Post-OP 1 Year Nutritional Panel

12. 14-17 Years Old n=40

13. 14-17 Years Old

14. Wt Loss & Complications

15. Lap – Band ComplicationsReflux (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. N:17 Pre-OP and OP Data

19. Pre-Op Co-Morbidities

20. Lipid Panel

21. Nutritional Panel

22. Post OP Weight Loss

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