Lap-Band Surgery for Adolescents

NYU Medical Center Program for Surgical Weight Loss

George Fielding, MDAssociate Professor of Surgery Evan P. Nadler, MDAssistant Professor of Surgery, Director of Minimally Invasive Pediatric SurgeryChristine Ren, MDAssistant Professor of Surgery

NYU Adolescent Bariatric Experience

Three Phases:Brisbane, Australia (1998-2004) n= 41Off-label experience (2002- 4) n= 41FDA Study (2005) n=17

Brisbane n=41 17.1 YRS ( 12-19)

Y No. Wt (lbs) BMI % EWL0 41 275 431 21 210 32 502 18 200 29 693 16 200 29 704 5 193 29 636 3 171 27 65

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)

NYU Bariatric Program

Largest lap- band experience in worldDedicated to long term follow-upMulti-Disciplinary In-house Nutritional TeamIncludes Pediatric SurgeonPsych care at NYU Child Study Centre

Lap- Band in AdolescentsDemographics n= 58

GenderFemale: 46Male: 12

Age13yrs 514-17 yrs 4018-19 yrs 13

RaceCaucasian 50Hispanic 5African American 3

Pre-OP Co-Morbidities

PreOp Co-MorbiditiesDyslipidemia 22 %

Depression 20 %

Type 2 DM/IGT 20 %

LBP 20 %

OA 17 %

Asthma 17 %

HTN 14 %

PCOS 14 %

GERD 9 %

OSA 7 %

Skin Rashes 6 %

N: 58

Pre-Op Weight and BMI

Pre-OP and OP Data

Average Initial Wt

Average Initial BMI

296.31 lbs 47.43

Average OR Time

AverageLOS

35 mins 24 hrs

Lap BandPeri-operative complications

All patients discharged <24 hrsIncreasing use of same-day approachComplicationsMortality 0PE 0Acute re-op 0Acute readmission <30 days 1

(perforated appendicitis)

Follow Up Weight Loss Report

Avg Initial

Wt

AvgInitialBMI

F/UAvg Wt

Avg BMI

Avg %EWL

N

296 47.43 n/a n/a n/a n/a 58

    3 months 268 42.76 17.79 39

    6 months 252 39.76 34.87 31

    9 months 232 36.91 46.61 29

306 48.53 12 months 218 34.44 57.11 13

343 54.67 18 months 248 39.53 49 6

335 54.36 2 Years 239 38.66 50.2 5

337 55.42 3 Years 249 41.08 42.5 4

356 63 4 Years 170 30 82 1

Post-OP 1 Year Nutritional Panel

Reference Range

Fe 57.5 37-170

Folate 10.9 >2.8

VitB12 419.6 239-931

N: 6

14-17 Years Old n=40

Average OR Time 34

Average LOS 24

Gender

Male 8

Female 32

Race

Caucasian 33

Hispanic 4

African American 3

14-17 Years Old

Age

14 years old 3

15 years old 7

16 years old 11

17 years old 19

Trial

FDA Trial 15

Non FDA Trial 25

Wt Loss & Complications

 AvgWT

AvgBMI

Avg%EWL N Complication

Initial 292.70 46.93 n/a 40 none

3 months 270.85 42.80 19.48 28

1, Perforated Appendicitis and

1, Gastroenteritis

6 months 245.15 38.93 36.42 21 none

9 months 237.66 37.46 47.13 171, Hiatal Hernia and

1, Band Slip

12 months 224.20 35.38 55.50 11 1, Hiatal Hernia

18 months 240.00 36.13 56.00 3 1 Band Slip

2 years 211.33 37.40 51.00 3 none

3 years 223.00 39.43 42.33 3 none

4 years 170.00 30.00 82.00 1 none

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

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.

FDA Trial (Age 14-17)

Patients enrolled : 22 Patients had surgery : 17

GenderFemale: 13Male: 4

Age14 years old: 415 years old: 416 years old: 517 years old: 4

RaceCaucasian: 10

Hispanic: 5African American: 1Native American: 1

Pre-OP and OP Data

N:17

Avg Initial Wt

Avg Initial BMI

Avg OP Time

Avg LOS

293 47.64 30 mins 24 hrs

Pre-Op Co-Morbidities

Pre-OP Co-Morbidities

DM or IGT 37%

Back Pain 37%

Dyslipidemia 37%

Depression 31%

OA 25%

Asthma 19%

GERD 19%

Hypertension 19%

Exertional Dyspnea 19%

Stress Incontinence 6%

Lipid Panel

Lipid Panel

Cholesterol

Triglycerides HDL LDL

CholHDLRatio

Pre-OP(N:17) 163 118 37 99 4.68

Post-OP (N:4)

3 months 159 122 41 94 4.08

Nutritional Panel

  FeFolat

e VitB12VitD

Hydroxy PTHPhos

phorus Mg

Pre-OP(N:17) 60.13 17.05 494.84 24.56 34.57 4.07 4.40

Post-OP(N:4)

3 months 37.25 11.15 530.50 17.25 31.75 3.45 1.98

Post OP Weight Loss

Initial WT(N:17)

Initial BMI(N:17)

3 monthsF/U Wt(N:4)

3 months F/U BMI

(N:4)

3 Month F/U % EBW

(N:4)

293 47.64 274.33 42.92 17.76

Lap Band Surgery for Adolescents

ConclusionsThe surgery is safeThe Lap- Band delivers effective weight

loss for adolescents