Objectives 8/2/2017. Definitions: Pediatric. Definitions: Adult

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Update on Bariatric Surgery for the Treatment of Morbid Obesity in Adolescents and Teenagers Faisal G. Qureshi MD, MBA Associate Professor, Pediatrics and Surgery Associate Chief, Pediatric Surgery University Texas Southwestern Medical Center Children s Medical Center Objectives No Disclosures Discuss current trends in adult and childhood obesity in the US. Evaluate the choices for a surgical procedure. Discuss expected outcomes for surgical interventions. Discuss program development Questions. Definitions: Adult Definitions: Pediatric Overweight: BMI between 25-29.9 or defined as a BMI at or above the 85th percentile and lower than the 95th percentile for children of the same age and sex. Obese: BMI greater than 30 or BMI above the 95th percentile for children of the same age and sex EWL%-Excess weight loss % from Ideal Body Weight EBL%-Excess BMI Loss % from BMI of 25 3 Poverty Genetics Race Education http://abcpediatricclinic.com/images/viciouscycle-of-childhood-obesity.jpg Access Role of Fructose 5 6 1

My Patients Obesity Rates The S sisters 17 and 18 325 and 350 pounds BMI 50 and 55 JD and pseudotumor cerebri KS 16 year old female PCOS BMI 42 (*BMI 30, or about 30 lbs. overweight for 5 4 person) 1990 1999 2009 No Data <10% 10% 14% 15% 19% 20% 24% 25% 29% 30% Prevalence of Self-Reported Obesity Among U.S. Adults by State and Territory, BRFSS, 2012 Prevalence of Self-Reported Obesity Among U.S. Adults by State and Territory, BRFSS, 2013 *Sample size <50 or the relative standard error (dividing the standard error by the prevalence) 30%. *Sample size <50 or the relative standard error (dividing the standard error by the prevalence) 30%. Prevalence of Self-Reported Obesity Among U.S. Adults by State and Territory, BRFSS, 2014 Prevalence of Self-Reported Obesity Among U.S. Adults by State and Territory, BRFSS, 2015 *Sample size <50 or the relative standard error (dividing the standard error by the prevalence) 30%. *Sample size <50 or the relative standard error (dividing the standard error by the prevalence) 30%. 2

Obesity and Ethnicity 2014 White Black Global Problem Hispanic 13 Global Issue 16 Pediatric Obesity Rate Childhood Obesity Rates Race/Gender 18 3

2011 Data-10-17 Year olds High School Student Obesity 2015 20 Texas Data Texas Data Obesity 30.9% in 2013. Dallas is ranked 130 of 232 counties Obesity, physical inactivity and access to exercise opportunities 15.6% of high school students in Texas are overweight 19.1% of 10-17 year olds in Dallas Metro are either overweight or obese. County Health and RoadMaps RWJ foundation 2013 Dallas Metro Area Total population:6.5 million Under 19 population is 24%: 1.6 million 300,000 young people are overweight or obese Impact of Obesity 70-80% chance of becoming overweight or obese adults. 2 X non-obese adolescents to die prematurely, before age 55, of illness or self-inflicted injury Face a 10-20 year shorter life span Less Education Lower rates of being married Lower Household income 24 Gortmaker et al, NEJM 1993 4

Impact of Obesity: Medical Metabolic Syndrome PCOS and other Endocrine NAFLD Cardiovascular Disorders Joint and Skin Disorders Malignancy Obesity Facts Approximately 17% (or 12.5 million) of children and adolescents aged 2 19 years are obese. (CDC) Nearly 33% of children are overweight or obese. (IOM) Obesity-related illness carries an annual cost of $190.2 billion. (IOM) Costs So What is the Solution? Non-Surgical Interventions None Societal Medical Mechanical Diet and behavior modification can help a minority of obese adolescents, the vast majority of these patients go on to become obese adults. Freedman DS et al., Pediatrics. 2001. Surgical: Which Procedure? Gastric Bypass Banding Sleeve Gastrectomy Biggest Loser Biggest Gainer Medications Approved for Chronic Weight Management: STOP 29 5

Other Management Strategies Reshape Balloon: FDA Approved for Adults Orbera Balloon: FDA warnings pancreatitis/overinflation BMI 30-40 Endoscopic placement and removal, Ulcers and migration issues No Pediatric approval FDA application in Process only for adults 31 32 1991 NIH Guidelines for Surgery BMI > 40 kg/m2 -OR- BMI > 35 kg/m2 and co-morbid illness -AND- Failed to have sustained weight loss on supervised weight-reduction programs(6 months) 33 Best Practices Gastric Bypass (RYGB) Most common bariatric procedure in U.S. Restrictive Malabsorptive 65-70% EWL @ 2yrs 0.5-1% mortality ~10% complications Many severe Lowest failure rate Pratt J,. Best practice updates for pediatric/adolescent weight loss surgery. Obesity (MGH) 6

RYGB in Adolescents Overall complication rate 39%,16% of patients had moderate or severe sequelae. One patient with beriberi and one death. Lawson ML et al. J PediatrSurg. 2006 Major complications-8%, minor complications-15% Inge et al. JAMA Pediatr, 2013 Adjustable Gastric Banding (LAGB) ~50% EWL @ 2yrs Meticulous follow-up ~0.1% mortality ~10% complications ~20% failure rate National trend against its use (4% of cases in 2012) Nguyen N et al. J Am Coll Surg. 2013 LABG in Adolescents Some long term data. Silberhumer et al. Surg Endosc. 2011 More modest %EWL. Holterman et al. J PediatrSurg. 2010 Significant lean mass loss. Nadler et al. J Am CollSurg, 2009 Falling out of favor for adults. Sleeve Gastrectomy(LSG) Stand alone procedure since 2009 Increasing share of cases (49% in 2015) Surg Obes Relat Dis.2015 50-70% EWL @ 2yrs <0.5% mortality ~2-3% complications Nguyen et al. J Am CollSurg, 2013 LSG in Adolescents TEEN-LABS Relatively safe and effective. Alqahtani et al. Ann Surg. 2012 First US adolescent only cohort. Nadler et al. Surgery2012 German cohort. Lennerzet al. IntJ Obes, 2013 Nothing longer than 2 year follow up. Adolescents/Teenagers low numbers, poor data collection Cincinnati, Houston, Columbus, Pittsburgh, Birmingham, NIH Prospectively collected data 2007-2011 JAMA 42 2014 7

TEEN-LABS Update TEEN-LABS 242 patients November 2015 43 44 TEEN-LABS Periop Complications Post op Complication < 30 days 45 46 TEEN-LABS Bottom Line 47 48 8

Sleeve Gastrectomy Safer Shorter Operative Time No rearrangement of intestinal tract Fewer nutritional deficiencies Can be converted to bypass if needed Nearly similar weight loss profile 49 50 Dallas Program Jan 2016 Total Referrals/Operations 171 Referrals, 28 procedures, 20 pending Age at Surgery 16.1 ± 1.06 (range 15-19) Female 78% Race/Ethnicity 50% C: 32% AA: 18% H: Length of Stay (days) 1.7 ±0.9 Surgical complications Other re-admissions 1 Bleedtakeback POD1 1 Thrombophebitis 2 protracted emesisegd 1 emesis IVF 1 dehydration 1 vasovagal episode 51 52 Dallas Program--Outcomes # Weight KG EWL% BMI Kg/m 2 EBL% DOS 28 137±20 NA 49±7 NA 3 months 20 116±20 23±19 43±7 21±7 6 months 15 111±21 26±21 43±7 24±7 1 year 4 103±6 34±6 40±3 39±3 EWL% Excess Weight Loss EBL% Excess BMI Loss *Dark outlines represent Dallas and Plano Regions Source: Alliance 53 54 9

Comorbid Conditions Weight Change Over Time Comorbid Conditions Preop Resolved/Time Diabetes 34% 55% (<2 months) HTN 31% 88% (<3 months) OSA 46% Retesting at 1 yr 200 180 160 140 120 100 80 60 0.00 1 MONTH 3 MONTHS 6 MONTHS 9 MONTHS 12 MONTHS 55 56 BMI Change Over Time So Surgery for Obese Children? 70 65 60 55 50 45 40 35 30 25 20 0 1 MONTH 3 MONTH 6 MONTH 9 MONTH 12 MONTH Obesity Increasing No Good Alternatives Good data and good safety profile Exponential Growth in availability of procedure.. 57 58 Trends in Adolescent Surgery 2012 698 1100 No change between 2006-2012 Comorbidities increased, Length of stay diminished Lack of sufficient evidence base. Bariatric Surgery- ~20,000 references Adolescent Bariatric Surgery- ~2500 Complication rates and risks remain undefined Long term >10 yrs data unclear 59 60 10

Why is there no change in numbers? Position Paper JAMA 2011 An increasing proportion of US children are so severely obese as to be at immediate risk for life-threatening complications including type 2 diabetes. >45% Do not measure BMI <10% refer for weight loss surgery Cost risk Complication risk no indication in pediatrics 27% did not know surgery was an option 66% would like to attempt non-surgical intervention first Younger physicians more likely to refer Obesity is a social problem not a disease Child protective services typically provide intermediate options such as in-home social supports, parenting training, counseling, and financial assistance, that may address underlying problems In some instances, support services may be insufficient to prevent severe harm, leaving foster care or bariatric surgery as the only alternatives. Although removal of the child from the home can cause families great emotional pain, this option lacks the physical risks of bariatric surgery 61 62 Why is there no change in numbers? So What is the Solution? Perceptions Education Significant ethical concerns Societal 43% reduction in obesity in 2-5 year old What about the currently obese generation? Currently the only solution is surgery. 63 Keys to Success Multidisciplinary Team Multidisciplinary Team (UTSW and CMC) Volume Institutional support and infrastructure Education and Research Opportunities On Protocol for long term follow up Contribute to TEEN-LABS Adult program in place Surgeon (2-3 Visits) Obesity Clinic (medical management) Endocrinologist Designated Advanced Practice Providers Cardiologist Psychologist Social Work Dietitian Anesthesia Team GI Specialist Pulmonology/Sleep Specialist Research Coordinators 65 11

Stakeholders SWOT Analysis UTSW Surgery Pediatric Surgery Anesthesia Bariatric Surgical Center Research Funding Agencies Strengths: Historical success in program development at institutional and personal level Patient volume is high, so surgical program will have ready customers Access to adult surgical program for expertise and when patients age out they will have adequate resources Strong medical obesity program Weaknesses: Inconsistent support of surgical procedure amongst medical practitioners Institutional structural reconfiguration for obese patients and their often obese families Need for special operating room tools and equipment across the institution Patients and Families Payers Referring Physicians Medical Obesity Program UTSW Pediatrics Endocrinology Cardiology Strong Children s support at administrative and faculty level Surgical Expertise Opportunities: Strong research history at university Unique opportunity to collaborate between divisions within institution Can become one of a handful bariatric programs for children in the nation Can become single full service obesity program in the city Improve lives of young people in the city Expansion to other campuses Special training for operating room staff, recovery room and surgical floor nurses Threats: Failure of institutional support Failure of collaboration between medical and surgical groups Failure of collaboration between research programs Surgical complications Entry of adult surgeons into bariatrics for children at other institutions Entry of other children s hospitals into this space External Regulators Children s Medical Center Board, Executives, Nursing Nutrition, Psychology 67 68 Patient Characteristics Preoperative Evaluation Age over 14 6 months attempt at weight loss Multidisciplinary evaluation Can assent No weight loss required Preoperative Liquid diet Radiology as indicated Cardiology as indicated Sleep study as indicated Average time to OR 6 months MichalskyMP Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience. SeminPediatrSurg. 2014 Infrastructure needed Preoperative Checklist Free Standing Children s Institute Bariatric Furniture in waiting room, clinic and inpatient Appropriate Toilet Fixtures Appropriate weight limit and size table in OR CT scan 300kg Fluoroscopy 250kg (usually upright) Multidisciplinary Team Required 12

Post Operative Diet Diet Advancement Post Operative Supplements Pre and Post Operative Nutrition Surveillance MechanickJI, Clinical practice guidelines for the peri-operative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient 2013 update:. Endocr Pract. 2013 Multidisciplinary Team Required My Patients Baseline BMI and Weight Loss Surgery The S sisters 17 and 18 325 and 350 pounds BMI 50 and 55 KS 16 year old female PCOS BMI 42 JD and pseudotumor cerebri Who is a Better Candidate? Inge et al, J Peds2010 78 13

My Patients Summary The S sisters 17 and 18 325 and 350 pounds BMI 50 and 55 BMI now 40 and 42 Asymptomatic but still obese KS 16 yrold female PCOS BMI 42 BMI now 29 A generation (or two) with obesity No effective non surgical therapy Not enough reports Not Enough procedures Belief systems Access No FDA approval for new devices 80 Absolutely but with: Age > 14, Weight >95 th percentile BMI >35 with comorbid, BMI > 40 without Earlier referral, healthy obese Willing to make behavioral changes. Multidisciplinary evaluation Standardized protocol Complete support of institution 81 82 Faisal.qureshi@utsouthwestern.edu EPIC referral to bariatrics Miraset al, Nat Rev 2013 83 84 14

The Future 85 86 Personal Thoughts Surgery is only a tool Not of last resort Patients have to do the hard work There is a tipping point Aha moment 88 Conclusion-No Adolescents Unless Cost savings Multidisciplinary evaluation Pratt et al. Obesity 2009 Standardized protocol with intent to follow patients for 5 years and publish data. Cost made up within 5 years in UK study But recent Swedish and VA study did not show cost benefits Michalsky et al. Surg Obes Relat Dis. 2012 Mental health provider and dietician with pediatric expertise/training. Zeller et al. Surg Obes Relat Dis. 2011 15

Primary Care Medical or Surgical Management Reset your internal criteria Review your own practice statistics Start documenting BMI Start documenting efforts at weight control Evaluate for complications of obesity Critical partners for co-morbidity resoluton Reach out often Mean age 44, BMI 48, 88% female, 412 patients 1.5 kg loss for wait listed 4 kg loss for medical management 22 EWL Surgical Comorbid conditions improved dramatically with Surgery 226 patients, 14.4+- 4 (5-21) 50% females 33% <12 51% 13-17 93 Saudi Experience Saudi Experience 16

Kuwait Experience 135 Patients 72% female Median age 19, (12-21) No complications reported 17