1. Maurizio De Luca MD Department of Surgery – Regional Hospital of Vicenza – Italy Department of Surgery – Regional Hospital of Vicenza – Italy XXI Congresso Nazionale SICOb Cagliari, 25-27 Aprile 2013 Controversie in Chirurgia Bariatrica Chirurgia Bariatrica con BMI compreso tra 30 e 35: perchè, quando, come? Pro

2. Maurizio De Luca 1.Patients in age group from 18 to 60 years 2.With BMI ≥ 40 kg/m 2 3.With BMI 35-40 kg/m 2 with comorbidity in which surgically induced weight loss is expected to improve the disorder: a. metabolic disorders b. cardio-respiratory disease c. severe joint disease d. obesity-related severe psychological problems 4. Current BMI or documented previous BMI of this severity a. Weight Loss as a result of intensified treatment before surgery is not a contraindication for the planned bariatric surgery b. Bariatric Surgery is indicated in Patients who exhibited substantial weight loss in a conservative treatment but started to gain weight again 5. Failed to lose weight or to maintain long-term weight loss, despite appropriate non-surgical medical care 6. Compliance with medical appointments NIH Conference: Gastrointestinal Surgery for Severe Obesity. Consensus Development Conference Panel. Ann Intern Med 1991; 115; 956-961 Ridley N: Expert Panel on Weight Loss Surgery – Executive Report Obes Res 2005; 13:206-226 Indication For Bariatric Surgery NIH 1991

3. Maurizio De Luca BMI - International Guidelines for eligibility to bariatric surgery NIH. Gastrointestinal Surgery for Severe Obesity. National Institutes of Health. Consensus Development Conference Statements. Am J Clin Nutr 1992; 55: 615S-9S. NHMRC Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults. Canberra: National Health and Medical Research Council; 2003 NICE. Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children.. London: National Institute for Health and Clinical Excellence: 2006 European. Inter-disciplinary European Guidelines on surgery of severe obesity. Int J Obes London 2007; 31: 569-677 ADA Standards of Medical Care in Diabetes. 2010 Diabetes Care, 33, S11-61 SIGN. Management of Obesity: Summary of SIGN Guideline. BMJ 2010; 340,154. NIH (USA)NHMRC (Australia)NICE (UK)EuropeanADA (USA)SIGN (Scotland) Year19912003200620072010 BMI>40 35-40 with 1 serious weight loss responsive comorbidity >40 35-40 with 1 serious weight loss responsive comorbidity >40 35-40 with disease that improve weight loss >40 35-40 with 1 weight loss responsive comorbidity >40 35-40 if control of diabetes or comorbidity is difficult >40 35-40 with 1 serious weight loss responsive comorbidity Medicare NCD (National Coverage Determinations) 2004 removed “serious” BMI 30-35 Recognise use BMI <35 Weight loss pre- surgery does not change eligibility BMI < 35 insufficient evidence to date

4. Maurizio De Luca Randomized Trials and Meta-analysis of bariatric surgery including Patients with BMI < 35

5. Maurizio De Luca Study Type BMI range N Duration FU Weight Loss BMI change Health outcomes Observational studies of bariatric surgery including Patients with BMI < 35

6. Maurizio De Luca Observational studies of bariatric surgery including Patients with BMI < 35

7. Maurizio De Luca 2009 Cochrane Review stated that Bariatric Surgery resulted in greater weight loss than conventional treatment in Obese Class I (BMI 30-35) accompanied by improvements in comorbidities such as Type 2 Diabetes, Hypertension, OSAS, and improvements in health related quality of life. Colquitt JL, Pico J, Loveman E, Surgery for Obesity. Cochrane Database Syst Rev 2009 CD003641 BMI 30-35

8. Maurizio De Luca Bariatric Surgery in Low BMI BMI 32-35 1.Indication for bariatric surgery in Patients with BMI 32-35 should be considered individually 2.Strongly discouraged for age > 60 years, absolutely contraindicated for age <18 3.Main Comorbidities which indicate surgery BMI 32-35: a)Severe degree of diabetes (Hgb A1c>9 on maximal medical therapy) b)Hypertension c)Severe sleep apnea d)Venous stasis disease e)Severe degree of joint pain f)Impaired Quality of Life Fried M, et al: Inter-disciplinary European Guidelines on Surgery of Severe Obesity Int J Obes 2007;31:569-77 Yermilov I, Mcgory M, Shekelle P: Appropriate Criteria for Bariatric Surgery: Beyond the NIH Guidelines Obesity, 1-7, 78, 2009 (Evidence Level C, D)

9. Maurizio De Luca Bariatric Surgery in Low BMI BMI 30-32 1.Indication for bariatric surgery in Patients with BMI 30-32 is strongly restricted 2.Absolute contraindication for age 60 years (Evidence Level C, D) 3. Operation on these individuals should be conducted within clinical trials, such as for those with diabetes Fried M, et al: Inter-disciplinary European Guidelines on Surgery of Severe Obesity Int J Obes 2007;31:569-77 Yermilov I, Mcgory M, Shekelle P: Appropriate Criteria for Bariatric Surgery: Beyond the NIH Guidelines Obesity, 1-7, 78, 2009

10. Maurizio De Luca Italian Society of Bariatric Surgery and Metabolic Disorders (SICOb) Position Statement (2008 ) Bariatric Surgery BMI 30-35 in case of: a) Diabetes, Type II b) Sleep Apnoea Syndrome c) Hypertension d) GERD e) Degenerative arthritis P.S. : Diabetes: > 3 years, HgA1c > 7.5%, Failure prevoius medical treatment Bariatric Surgery in Pts with BMI 30-35 Maurizio De Luca, Luca Busetto, Luigi Angrisani and SICOB Executive Board

11. Maurizio De Luca International Guidelines for eligibility for bariatric surgery FDA expands use of banding system for weight loss. Patients with BMI 30-35 now qualify The U.S. Food and Drug Administration has expanded the use of Allergan’s LAP-BAND Adjustable Gastric Banding System, a device implanted around the upper part of the stomach to limit the amount of food that can be eaten at one time. The February 16, 2011, approval expands the use of the LAP-BAND to include obese individuals with a BMI of 30 to 35 who also have an existing condition related to their obesity. The FDA approved the LAP-BAND in 2001 for use in severely obese patients with a body mass index (BMI) of at least 40, those with a BMI of at least 35 and who also have an existing severe condition related to their obesity, such as heart disease or diabetes, or those who are at least 100 pounds overweight. BMI is a general measure of body fat based on an individual’s weight and height. Friday, February 16, 2011

12. Maurizio De Luca 1) For Patients with BMI 30-35 who do not achieve substantial and durable weight and co-morbidity improvement with nonsurgical methods, bariatric surgery should be an available option 2) The existing cutoff of BMI, which excludes those with Class I Obesity, was established arbitrarly nearly 20 years ago 3) There is no current justification on ground of evidence, of clinical effectiveness, cost-effectiveness, ethics, or equity, that this group of patients (30-35) should be excluded from life-saving treatment. SOARD (9) 2013: ASMBS Statements and Guidelines

13. Maurizio De Luca American Association of Clinical Endocrinologists (AACE) The Obesity Society (TOS) American Society of Metabolic and Bariatric Surgery (ASMBS) Patients offered bariatric surgery: 1)Grade A Best Evidence Level 1 for BMI > 35 target of weight control and improved of biochemical markers of CVD risk 2) Grade B Best Evidence Level 2 for BMI > 30 target of weight control and improved of biochemical markers of CVD risk 3) Grade C Best Evidence Level 3 for BMI > 30 target of glycemic control in T2D and improved of biochemical markers of CVD risk AACE/TOS/ASMBS Guidelines 2013 Endocrine Practice Vol 19 No 2 March/April 2013

14. Maurizio De Luca Bariatric Surgery Controversies (BMI 30-35) CONCLUSION 1.Class I Obesity is a disease thae causes multiple other diseases, decreas the duration of life, desreases QoL. 1.Current option in nonsurgical treatment for Class I obesity are not generally effective in achieving a substantial and durable weight reduction 1.For Patients with BMI 30-35 who do not achieve substantial and durable weight and comorbidity improvement with non-surgical methods, bariatric surgery is an available option. 1.Bariatric Surgery has been shown in randomized, controlled trials, to be a safe and effective treatment for patients with BMI 30-35

15. Maurizio De Luca Bariatric Surgery Controversies (BMI 30-35) Thank You for your attention