1. Surgical Intervention Including Devices Victor F Garcia MD

2. Various procedures and relevant anatomy Outcomes Safety Effectiveness What are the advantages of doing bariatric surgery in this population? What are the concerns & issues about doing bariatric surgery in this population? Surgical Weight Loss Procedures

3. Distal gastric bypass Bilio-pancreatic diversion Malabsorptive Intragastric balloon Gastric stimulator Sleeve gastrectomy Adjustable Gastric Band Vertical Banded Gastroplasty Restrictive Roux-Y Gastric bypass Restrictive + Malabsorptive Surgically Induced Weight Loss

4. New-Branch Vertical banded gastroplasty New-Branch Adjustable gastric band New-Branch Sleeve gastrectomy Restrictive

5. New-Branch Bilio-pancreatic diversion Distal gastric bypass Malabsorptive Procedures 250cm 100cm

6. 2 New-Branch 1 Intragastric Balloon & Implanted Gastric Stimulator %EWL 23% (40%) %EWL 33%

7. Most Common Procedures Which is the best operation?

8. Lap Roux Y Gastric Bypass

9. Lap Adjustable Gastric Band

10. Weight Changes bjects in the SOS Study over a 10-Year Period Sjostrom, L. et al. N Engl J Med 2004;351:2683-2693 Swedish Obese Subjects Study

11. Lifestyle, Diabetes, and Cardiovascular Risk Factors 10 Years after Bariatric Surgery Study Overview The Swedish Obese Subjects Study: obese subjects treated with gastric surgery and contemporaneously matched, conventionally treated obese controls Surgically treated subjects enrolled for at least 2 years (4047 subjects) or 10 years (1703 subjects) had a lower incidence of diabetes, hypertriglyceridemia, and hyperuricemia; differences in the incidence of hypercholesterolemia and hypertension were not significant Bariatric surgery resulted in long-term weight loss, improved lifestyle, and amelioration of some risk factors

12. Meta-Analysis: Surgical Treatment of Obesity

15. proceduremorbiditymortality % EWL AGB10%.05-0.1%47% RYGBP27%0.5%62% BPD30%1-3%70% SLEEVE1%0%30-40% BALLOON4%.03%40% IGS1%0%23-40% Bariatric Surgery Outcomes

16. Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients. Christou, Ann Surg. 2004 Bariatric surgery resulted in significant reduction in mean percent excess weight loss (67.1%, P < 0.001). Bariatric surgery patients had significant risk reductions for developing cardiovascular, cancer, endocrine, infectious, psychiatric, and mental disorders compared with controls. The mortality rate in the bariatric surgery cohort was 0.68% compared with 6.17% in controls (relative risk 0.11, 95% confidence interval 0.04- 0.27), a reduction in the relative risk of death by 89%.

17. Comprehensive Weight Management Program Cincinnati Children’s 2001- First children’s hospital based bariatric surgery program 63 adolescents Mean age 17.5 years (13-23) Mean BMI 58.1 (44-85)

18. Complications (n=36) 22 (61%) had no complications 9 had minor complications 4 had moderate complications 2 had severe complications Beri-beri with sequelae over 2 months Death (@ 9 months post-op, due to colitis developed while getting rehabilitation for osteoarthritis)

19. Body Composition After Gastric Bypass in Adolescents 13 patients: DEXA at 3,6,12 months - weight, fat and lean mass Results Mean BMI 60 (pre op), @ baseline 45% fat/ 55% LM Mean BMI 38 (12 mo post op) 3 mos:↓ fat -19% (p=.001);↓ lean mass -17% (p=.001) 3-12 mos: ↓ fat -40% (p=.0005);↓ lean mass -.6% (NS)

20. Bariatric Surgery Reverse Adolescent OSAS 34 patients (19 with PSG post op) OSA AHI  5 per hr of sleep in 55% OSA either resolved or improved after bariatric surgery in 100%; AHI improved by nearly 20 fold compared to only 3-5 fold in adults. Surgical weight loss in adolescence may result in more complete reversal

21. Left Ventricular Hypertrophy Reverses Five patients with pre & post operative echocardiograms Left ventricular wall thickness decreased by 13% Ventricular mass decreased by 23.4% over 6 months. One adult study found only 14.5% decrease in left ventricular mass after surgical weight loss.

22. Improved Metabolic Profile Insulin resistance (HOMA-IR) elevated in 64% of patients preoperatively while postoperatively it decreased by 78% overall and completely normalized in all but one. Nearly 2 fold improvement in beta cell function. Significant decrease in triglyceride levels

23. Patient factors/outcomes & resolution ImprovedResolvedp value Number33158<0.001 Age (yrs)48.247.80.724 Pre op BMI51500.270 Post op BMI 37330.002 %EWL4262<0.001 Duration Diabetes 10.74.1<0.001

24. Surgery as an Effective Early Intervention for Diabesity Why the reluctance? Dixon et al Diabetes Care 28:472-474, 2005 early intervention in the management of severely obese subjects with type 2 diabetes if intensive lifestyle interventions fail to achieve and maintain significant weight loss. Remission was predicted by greater weight loss and a shorter history of diabetes (pseudo r2 = 0.44, P < 0.001). improvement in insulin sensitivity following surgery was best predicted by the extent of weight loss. Improvement in ß-cell function, however, was predicted by a shorter history of diabetes

25. Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the metabolic syndrome. The mean excess body weight loss at time of second biopsy was 59% +/- 22%; time interval between biopsies was 15 +/- 9 months. There was a reduction in prevalence of MS, from 70% to 14% (P < 0.001), and a marked improvement in liver steatosis (from 88% to 8%), inflammation (from 23% to 2%), and fibrosis (from 31% to 13%; all P < 0.001). Inflammation and fibrosis resolved in 37% and 20% of patients, respectively, corresponding to improvement of 82% (P < 0.001) in grade and 39% (P < 0.001) in stage of liver disease. Mattar et al, Ann Surg. 2005 Oct

26. Timing of Surgical Treatment Attained physiological and skeletal maturation Physiological/sexual maturation- Tanner 3 or 4 Skeletal maturation- age 13-14 girls; 15-16 boys or have attained mid parental height; bone age if there is doubt Stage of cognitive development Acquired formal operations- thinking about possibilities, consequences Psychological health and weight related quality of life

27. Advantages of Surgical Intervention in Adolescence Procedure related Safe and effective long term weight loss if compliant Co morbidity Resolution or amelioration of most if not all; function of duration of disease Reduces the incidence of co-morbidities Improved quality of life Survival Increased survival compared to medical management - SOS Study, Flum et al, & Christou et al

28. Metabolic Bone Disease Gastric bypass surgery for morbid obesity leads to an increase in bone turnover and a decrease in bone mass. Markers of bone turnover were significantly elevated in patients post LRGB (urinary N-telopeptide cross- linked collagen type 1 and osteocalcin) at 3 months & 9 months. Bone mineral density decreased significantly at the total hip, trochanter, and total body with significant decreases in bone mineral content at these sites. the longer term. Coates, J Clin Endocrinol Metab. 2004 Mar;89(3):1061-5.

29. Nutritional Deficiencies more common with bypass procedures protein deficiency rare after RYGBP <150cm iron deficiency anemia (6-33%); restrictive & malabsorptive B12 (37%) & folate deficiency (22%) Vitamin B12 deficiency associated with low breast- milk vitamin B12 concentration in an infant following maternal gastric bypass surgery. Thiamine (.0002%) beriberi; Acute Wernicke's encephalopathy;peripheral polyneuropathy

30. Laparoscopic Operations Degree of Difficulty (1-10) Gall Bladder 3 Appendectomy 3 Hernia 5 Lap band 5-6 Nissen 7 Spleen 8 Adrenal 8 Colon 9 Esophagectomy 9.5 Gastric bypass 9.5

31. BMI Guidelines For Adolescent Bariatric Surgery BMI 40/50 Pediatrics, 2004 Obes Research, 2005 BMI 35/40 JACS, 2005 J Clin Endocrin Metab, 2005 “Conservative” “NIH Adult Threshold”

32. What Should We Mean By “Conservative” Guidelines for Adolescent Bariatric Surgery? Offer a complex procedure, with defined procedure-related risks when the risk of complications is lowest, when medical therapy is ineffective and its continuation may be detrimental, when the outcomes are likely to be the best possible when the likelihood of recidivism is the lowest.

33. Superobesity & Weight Loss Related Outcomes BMI >50 Mason, 1987, Benotti, 1989, Sugerman, 1989, Yale, 1989, MacLean, 1990, Brolin, 2002 Lose significantly lower percentage of their excess weight despite losing a significantly greater quantity of weight compared to lighter patients. Likelihood of successful weight loss is significantly lower after conventional RYGBP; stabilize at a significantly greater percentage over IBW than morbidly obese patient. Must lose more weight to achieve a level that would represent a valid reduction in actuarial risk. A prospective randomized study reported recidivism among the superobese is common after 4 -5 years (Brolin, 1992)

34. BMI and Procedure-related Risks Fernandez et al. Ann Surg. 2004. Multivariate analysis of risk factors for death following gastric bypass for treatment of morbid obesity. independent risk factors associated with perioperative death included leak, pulmonary embolus, preoperative weight, and hypertension Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Regan al, Obes Surg. 2003. surgical management of the supersuper obese patient BMI =/> 60 is associated with higher morbidity, mortality, and long term weight loss failure.

35. Probable Consequences of a Higher BMI Threshold Increased risk for procedure related complications and death for all procedures Increased risk of weight regain Higher final BMI Greater & longer duration of disease burden

36. Experience Matters Transforming Health Care, Harvard Business Review adolescent bariatric surgery

37. Washington State Comprehensive Healthcare Abstract Reporting System Results 66,109 3,328 underwent gastric bypass 250% increase in frequency of procedure after 1996 (IRR 2.5 95% CI 2.4-2.7) 1.02% (34) in hospital mortality 30 day mortality of 1.9% (64) Within surgeons first 19 cases the odds of a 30 day death were 4.7 times higher

38. Regionalizing Complex Procedures For certain complex procedures patient outcomes are directly related to surgeon & hospital volume Birkmeyer, J.D. and J.B. Dimick, Potential benefits of the new Leapfrog standards: effect of process and outcomes measures. Surgery, 2004. 135(6): p. 569-75. Finlayson, E.V., P.P. Goodney, and J.D. Birkmeyer, Hospital volume and operative mortality in cancer surgery: a national study. Arch Surg, 2003. 138(7): p. 721-5; discussion 726 Birkmeyer, J.D., E.V. Finlayson, and C.M. Birkmeyer, Volume standards for high-risk surgical procedures: potential benefits of the Leapfrog initiative. Surgery, 2001. 130(3): p. 415-22. Gordon, T.A., et al., Statewide regionalization of pancreaticoduodenectomy and its effect on in-hospital mortality. Ann Surg, 1998. 228(1): p. 71-8.

39. Adolescent Obesity Centers an obesity center for every 500,000-person population 500-1000 operations per year Life long follow up Lars Sjostrom, Swedish Obesity Subjects Study

40. Attributes of a Bariatric Surgery Program for Adolescents Based on ‘best practices’ treating other adolescent chronic diseases (diabetes, cystic fibrosis, liver transplantation, oncology) A multidisciplinary team providing Comprehensive evaluation Standard of care surgical intervention Postoperative medical, psychological, and surgical surveillance tailored for the adolescent age group Peer and parent support groups!

41. Essential part of good clinical trials practice is maximal retention of study participants The ability to draw definitive conclusions about the absolute & relative efficacy and safety of bariatric surgery is limited by the large percentage lost to follow up Complete evaluation of enrolled patients is a critically important aspect of any clinical trial bariatric surgery in adolescents The Need for Complete Data in Studies of Surgical Weight Loss

42. We are well into the adolescent RCT between Lap Band and "optimal" non-surgical therapy. However we have no data from that study so far. On compliance of adolescent: Awful. Much worse than the adults. It may be just because they are adolescents. It may be that they don't sense the severity of the problem as do adults. It may be that they are always dependent on Mum or Dad bringing them along and so the logistics catches them out. For whatever reason, I would guess they would score about 3-4 out of 10 on a compliance test score whereas our adult patients would probably average around 7-8. Effectiveness: Good if they attend. Better rate of weight loss than the adults Bad habits: They are probably more susceptible to peer pressure than the adults and so have episodes of social eating and drinking which destroy the good results so quickly. Also, with lack of attention to the eating rules with eating too much,too fast, the incidence of prolapse is likely to be greater. Clearly there is a need for a carefully done randomized controlled clinical trial. Let's hope our data show a clear picture one way or the other at the end of the trial. Sorry to be so lacking in data at this stage. Best of luck Paul O’Brien

43. Adolescent Compliance Surgeon/ Hospital Volume Success with Adolescent Bariatric Surgery Choice of Operation Blue Ocean Strategy

44. Imperatives In the absence of robust evidence of the long term outcome of bariatric surgery in adolescents, the context for adolescent bariatric surgery should be strictly defined--the process deliberate, the follow up & outcome evaluation better than that of the pediatric long term cancer study Adolescent bariatric surgery should be performed by experienced bariatric surgeons & regionalized to select centers of excellence committed to systematically and programmatically optimizing compliance, follow up, and assessing the outcomes of surgical weight loss on adolescents Centers must maintain and report long term, detailed follow up, data collection and submission into a national database/registry.

45. Acknowlegements Thomas Inge Comprehensive Weight Management Team