Laparoscopic Sleeve Gastrectomy Recent Literature Review Surgeon Date

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Laparoscopic Sleeve Gastrectomy Recent Literature Review Surgeon Date

Laparoscopic Sleeve Gastrectomy Recent Literature Review Surgeon Date

Agenda • Introduction • Review of Bariatric Surgery • Weight Loss for Sleeve Gastrectomy

Agenda • Introduction • Review of Bariatric Surgery • Weight Loss for Sleeve Gastrectomy • Comparative Studies • Case Studies • Complications for Sleeve Gastrectomy • Obesity Related Disease Outcomes for Sleeve Gastrectomy • Comparative Studies • Case Studies • Implementation of Sleeve Gastrectomy as a Covered Procedure 2 | January 28, 2010 |

John Doe, M. D. , F. A. C. S. • Titles Disclosures • Consulting

John Doe, M. D. , F. A. C. S. • Titles Disclosures • Consulting • Research • Stock 3 | January 28, 2010 |

Sleeve Gastrectomy 1 Bariatric procedure originally as part of Biliopancreatic Diversion and Duodenal Switch

Sleeve Gastrectomy 1 Bariatric procedure originally as part of Biliopancreatic Diversion and Duodenal Switch (BPDDS) Remove part of stomach, creating a sleeve from antrum to esophagus. A bougie or nasogastric tube is used to size the sleeve 2 3 Utilizes same instrumentation as other bariatric procedures Surgeon Training Programs Fellowships Resident Training CME courses Clinical Immersion 4 4 | January 28, 2010 |

Bariatric Surgery Adjustable Gastric Banding (AGB) Mechanism of Action Benefits % of Cases In

Bariatric Surgery Adjustable Gastric Banding (AGB) Mechanism of Action Benefits % of Cases In 2008 Sleeve Gastrectomy (SG) Roux-en-Y Gastric Bypass (RNYGB) Biliopancreatic Diversion/Duoden al Switch (BPDDS) • Malabsorptive • Hormonal • Restrictive • Best Weight Loss • Restrictive • Malabsorptive • Hormonal • Low Complications • Good Weight Loss • Continuous GI Tract • Reduces Hunger • Better Weight Loss • Early Effect on Diabetes 40% 5% 45% 5% ASMBS, Rational for Bariatric Surgery, http: //www. asbs. org/Newsite 07/patients/resources/asbs_rationale. htm 5 | January 28, 2010 |

Two Year Excess Weight Loss Two Year Weight Loss and Mortality 100% Switch Roux-en-Y

Two Year Excess Weight Loss Two Year Weight Loss and Mortality 100% Switch Roux-en-Y 50% Banding 10% 0. 01 0. 1 1 10 30 Day Mortality (log scale %) Adapted from Buchwald H, et al, Bariatric surgery, a systematic review and meta-analysis, JAMA. 2004; 292: 1724 -1737 and Maggard M, et al, Meta-Analysis: Surgical Treatment of Obesity, Ann Intern Med. 2005; 142: 547 -559. 6 | January 28, 2010 |

Two Year Excess Weight Loss Two Year Weight Loss and Mortality 100% Switch Roux-en-Y

Two Year Excess Weight Loss Two Year Weight Loss and Mortality 100% Switch Roux-en-Y Gastrectomy 50% Banding 10% 0. 01 0. 1 1 10 30 Day Mortality (log scale %) Adapted from Buchwald H, et al, Bariatric surgery, a systematic review and meta-analysis, JAMA. 2004; 292: 1724 -1737 and Maggard M, et al, Meta-Analysis: Surgical Treatment of Obesity, Ann Intern Med. 2005; 142: 547 -559 and Brethauer et al Systematic review of sleeve gastrectomy as staging and primary bariatric procedure SOARD 2009; 5. 7 | January 28, 2010 |

Safety of Bariatric Surgery Mortality Rate (%) 2. 00% 1. 50% 1. 00% UP

Safety of Bariatric Surgery Mortality Rate (%) 2. 00% 1. 50% 1. 00% UP 4 HC hw Bu c a 2 ari De M LA BS 1 0. 00% ald 3 0. 50% 1) LABS Reporting Group N Engl J Med 2009; 361: 445 -54 2) De. Maria et al Ann Surg. 2007 Oct; 246(4): 578 -82 3) Buchwald et al JAMA. 2004; 292: 1724 -1737 4) AHRQ, Healthcare Cost and Utilization Project (HCUP), http: //hcupnet. ahrq. gov/ accessed 01/13/10, 2007 data DRG 288 8 | January 28, 2010 |

Safety of Surgery Mortality Rate (%) 2. 00% 1. 50% 1. 00% pe nd

Safety of Surgery Mortality Rate (%) 2. 00% 1. 50% 1. 00% pe nd ec tom GI y 6 O bs tru cti on 7 Ch ole La cy p ste CA c BG tomy 8 Dr w ug / c ath 9 El ud ing St en 1 t 0 Ca rot id Ste nt 11 He rni a 5 UP 4 HC hw Bu c a 2 ari De M LA BS 1 0. 00% ald 3 0. 50% Ap 1) LABS Reporting Group N Engl J Med 2009; 361: 445 -54 2) De. Maria et al Ann Surg. 2007 Oct; 246(4): 578 -82 3) Buchwald et al JAMA. 2004; 292: 1724 -1737 4) AHRQ, Healthcare Cost and Utilization Project (HCUP), http: //hcupnet. ahrq. gov/ accessed 01/13/10, 2007 data DRG 288 5) Ibid 2007 data DRG’s 161 and 162 6) Ibid 2007 data DRG’s 166 and 167 7) Ibid 2007 data DRG’s 180 and 181 8) Ibid 2007 data DRG’s 493 and 494 9) Ibid 2007 data DRG’s 547 and 548 10) Ibid 2007 data DRG’s 557 and 558 11) Ibid 2007 data DRG 577 9 | January 28, 2010 |

Cost of Obesity Lost Work Days, Claims, per 100 FTE's 200 $70, 000 180

Cost of Obesity Lost Work Days, Claims, per 100 FTE's 200 $70, 000 180 $60, 000 Days and Number of Claims 160 $50, 000 140 120 $40, 000 100 $30, 000 80 60 Claims Lost Workdays Medical Claims Cost Indemnity Claims Cost $20, 000 40 $10, 000 20 0 $<18. 5 (Underweight) 18. 5 -24. 9 25 -29. 9 30 -34. 9 (Obesity 35 -39. 9 (Obesity>40 (Obesity class (Recommended (Overweight) class II) III) weight) Obesity Class Ostbye T et al. Obesity and workers' compensation: results from the Duke Health and Safety Surveillance System. Arch Intern Med. 2007 Apr 23; 167(8): 766 -73. 10 | January 28, 2010 |

Annual Per Capita Cost of Obesity Percapita Healthcare Spend (2008 Dollars) by BMI $6,

Annual Per Capita Cost of Obesity Percapita Healthcare Spend (2008 Dollars) by BMI $6, 000 $5, 341 Per Capita Spend ($) $5, 000 $4, 380 $3, 273 $3, 248 $3, 601 $3, 000 $2, 000 $1, 861 Women $3, 382 $2, 616 $1, 837 $4, 648 $2, 798 Men $2, 099 $1, 000 $- <18. 5 (Underweight) 18. 5 -24. 9 (Recommended weight) 25 -29. 9 (Overweight) 30 -34. 9 (Obesity class I) 35 -39. 9 (Obesity class II) >40 (Obesity class III) BMI (Obesity Class) Adjusted annual expenditures according to body mass index (BMI [kg/m 2]), for a typical White man or woman, aged 35 to 44 years, who is a high school (but not a college) graduate, has private insurance coverage, and resides in a metropolitan setting in the South. Wee et al. Health care expenditures associated with overweight and obesity among US adults: importance of age and race. Am J Public Health. 2005 Jan; 95(1): 159 -65. 11 | January 28, 2010 |

Return on Intervention Months to Recoup Intervention Costs 70 ROI driven by • Cost

Return on Intervention Months to Recoup Intervention Costs 70 ROI driven by • Cost of surgery • Comorbidities prior to surgery • Weight Loss 60 Time (months) Surgical costs recovered in 13 to 60 months 50 Finklestein 1 40 Crémieux 2 30 Sampalis 3 20 Gallagher 4 10 0 Laparoscopic Bariatric Surgery 1) Finkelstein and Brown Am J Manag Care. 2005; 11: 641 -646. 2) Cremieux et al. Am J Manag Care 2008; 14: 589 -596 3) Sampalis et al Obes Surg 2004; 14: 939 -947 4) Gallagher et al Obes Surg 2003; 13: 245 -248. 12 Open Bariatric Surgery Type of Surgery | January 28, 2010 |

Why Coverage for Sleeve Gastrectomy • Category 1 CPT Code 43775 Laparoscopy, surgical, gastric

Why Coverage for Sleeve Gastrectomy • Category 1 CPT Code 43775 Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (ie, sleeve gastrectomy) effective January 1, 2010 • Estimated 10, 000 procedures in 2008 • 70 peer reviewed articles have been published since 2006 on Sleeve Gastrectomy that show similar results to other covered Bariatric Procedures for – Weight loss, as measured by excess BMI loss (39) – Comorbidity resolution (19) – Complication rates (16) 13 | January 28, 2010 |

Comparative Weight Loss Evidence • Published since 2006 • Sleeve Gastrectomy compared to other

Comparative Weight Loss Evidence • Published since 2006 • Sleeve Gastrectomy compared to other bariatric procedure(s) • Greater than 12 Month Follow-up • BMI reported pre-op and at follow-up • Excess BMI Loss calculated 1 Where EBMLI = Excess BMI Loss BMI 0 = Pre-operative BMIt = BMI at time of follow-up 6 papers meet the above criteria 1 Deitel et al Reporting Weight Loss 2007, editorial Obes Surg 2007; 17: 565 -568 14 | January 28, 2010 |

Comparative Weight Loss Evidence Duration (months) Control Year Author 2006 Himpens 80 (40) 24

Comparative Weight Loss Evidence Duration (months) Control Year Author 2006 Himpens 80 (40) 24 LAGB Single Center Prospective Randomized 2008 Karamanako s 32 (16) 12 RYGBP Single Center Prospective Randomized 2008 Vidal 91 (39) 12 RYGBP Single Center Case Matched Strain 121 (30) 21 LAGB, RYGBP, SWITCH Single Center Prospective Cohort Study 2007 Lee 846 (216) 36 LAGB, RYGBP, SWITCH Single Center Prospective Cohort Study 2009 Wong 94 (30) 24 LAGB, RYGBP Single Center Prospective Cohort Study 2009 15 N Total (SG) Study | January 28, 2010 |

Himpens et al. Prospective Randomized Study Between Laparoscopic Gastric Banding and Laparoscopic Isolated Sleeve

Himpens et al. Prospective Randomized Study Between Laparoscopic Gastric Banding and Laparoscopic Isolated Sleeve Gastrectomy: Results after 1 and 3 Years EBMIL 100% 80% EWL (BMI(25)) • Single Center Randomized Trial (40/40) • More loss of hunger in Sleeve Gastrectomy group 90% 70% Sleeve Gastrectomy 60% Adjustable Gastric Band 50% 40% 30% 20% 10% 0% 0 10 20 30 Time (Mo) 40 50 Himpens et al. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg 2006; 16: 1450– 6. 16 | January 28, 2010 | 60

Vidal et al. 1 and Karamanakos et al. 2 EBMIL EWL (BMI(25)) • Vidal

Vidal et al. 1 and Karamanakos et al. 2 EBMIL EWL (BMI(25)) • Vidal – Single center case matched comparison • Vidal - Similar weight loss and diabetes resolution • Karamanakos- Single center randomized study • Karamanakos – Better weight loss and reduced ghrelin levels with SG 100% 90% Sleeve Gastrectomy 2 80% Roux en Y Gastric Bypass 2 70% Roux en Y Gastric Bypass 1 60% Sleeve Gastrectomy 1 50% 40% 30% 20% 10% 0% 0 10 20 30 Time (Mo) 40 50 1) Vidal et al. Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese subjects. Obes Surg 2008; 18: 1077– 82. 2) Karamanakos et al. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann Surg 2008; 247: 401– 7. 17 | January 28, 2010 | 60

Lee et al. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year

Lee et al. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results EBMIL Biliopancreatic Diversion and Duodenal Switch Sleeve Gastrectomy 100% 90% Roux en Y Gastric Bypass 80% EWL (BMI(25)) • Single Center Cohort Study (846 patients) • All laparoscopic procedures • SG patients had higher pre-op BMI but similar EBMIL to Roux en Y and BPPDS patients 70% Adjustable Gastric Band 60% 50% 40% 30% 20% 10% 0% 0 10 20 30 Time (Mo) 40 50 Lee et al. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc 2007; 21: 1810– 6. 18 | January 28, 2010 | 60

Strain et al. Comparison of weight loss and body composition changes with four surgical

Strain et al. Comparison of weight loss and body composition changes with four surgical procedures EBMIL 100% 90% 1 2 80% EWL (BMI(25)) • Single Center Cohort Study (121 patients) • All laparoscopic procedures • Sleeve Gastrectomy and Biliopancreatic Diversion (BPDDS) patients had higher pre-op BMI’s 2 70% Biliopancreatic Diversion and Duodenal Switch 1 Roux en Y Gastric Bypass 1 Sleeve Gastrectomy 60% 50% 1 40% Adjustable Gastric Band 30% 20% 10% 0% 0 10 20 30 Time (Mo) 40 50 1) Strain et al. Comparison of weight loss and body composition changes with four surgical procedures. Surg Obes Relat Dis. 2009 Sep-Oct; 5(5): 582 -7. Epub 2009 Apr 14. 2) Strain et al. Comparison of effects of gastric bypass and biliopancreatic diversion with duodenal switch on weight loss and body composition 1 -2 years after surgery. Surg Obes Relat Dis. 2007 Jan-Feb; 3(1): 31 -6. Epub 2006 Nov 20. 19 | January 28, 2010 | 60

Wong et al. Laparoscopic bariatric surgery: a five-year review EBMIL 100% 80% EWL (BMI(25))

Wong et al. Laparoscopic bariatric surgery: a five-year review EBMIL 100% 80% EWL (BMI(25)) • Single Center Cohort Study (94 patients) • All laparoscopic procedures • Roux en Y patients had higher pre-op BMI’s 90% 70% Roux en Y Gastric Bypass 60% 50% Sleeve Gastrectomy 40% Adjustable Gastric Band 30% 20% 10% 0% 0 10 20 30 Time (Mo) 40 50 Wong et al. Laparoscopic bariatric surgery: a five-year review. Hong Kong Med J. 2009 Apr; 15(2): 100 -9. 20 | January 28, 2010 | 60

Case Study Weight Loss Evidence • • Published since Dec 2005 Greater than 10

Case Study Weight Loss Evidence • • Published since Dec 2005 Greater than 10 Patients BMI reported pre-op and at follow-up Excess BMI Loss calculated 1 Where EBMLI = Excess BMI Loss BMI 0 = Pre-operative BMIt = BMI at time of follow-up 39 papers meet the above criteria 1 Deitel et al Reporting Weight Loss 2007, editorial Obes Surg 2007; 17: 565 -568 21 | January 28, 2010 |

Case Study Weight Loss Evidence Follow Up Time t (months) 22 Pre-Op 6 12

Case Study Weight Loss Evidence Follow Up Time t (months) 22 Pre-Op 6 12 18 24 36 Total Number of Patients at Time t 2660 96 1770 245 451 98 Total Number of Studies 39 4 21 5 5 4 Average BMI at Time, BMIt (kg/m 2) 47. 9 33. 3 33. 9 35. 3 33. 7 30. 9 | January 28, 2010 |

Case Study Weight Loss Evidence Excess BMI Loss 100% 90% 80% 95% Confidence interval

Case Study Weight Loss Evidence Excess BMI Loss 100% 90% 80% 95% Confidence interval BMI EWL (%) 70% 60% 50% 40% 30% 20% 10% 0% 0 10 20 30 Time (Mo) 40 50 60 Weighted Analysis of longitudinal Excess BMI Loss from 39 papers on previous slide 23 | January 28, 2010 |

Sleeve Gastrectomy Weight Loss Compared to Roux en Y Bypass and Adjustable Gastric Banding

Sleeve Gastrectomy Weight Loss Compared to Roux en Y Bypass and Adjustable Gastric Banding Excess BMI Loss 100% 90% Roux en Y Gastric Bypass 1 80% Roux en Y Gastric Bypass 2 70% BMI EWL (%) Adjustable Gastric Band 1 60% Sleeve Gastrectomy 50% Adjustable Gastric Band 2 40% 30% 20% 10% 0% 0 10 20 30 Time (Mo) 40 50 60 1)Christou et al. Five-year outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass in a comprehensive bariatric surgery program in Canada, Can J Surg, Vol. 52, No. 6, December 2009 E 249 -258 2)Angrisani et al. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5 -year results of a prospective randomized trial, Surg Obes Rel Dis 2007; 3: 127 -133 24 | January 28, 2010 |

Safety of Bariatric Surgery and Gastrectomy Mortality Rate (%) 2. 00% 1. 50% Bariatric

Safety of Bariatric Surgery and Gastrectomy Mortality Rate (%) 2. 00% 1. 50% Bariatric Surgery 1. 00% Sleeve Gastrectomy Br eth au Sa er 5 nc he z-S an tos 6 ev iew UP 4 Ca se R HC hw Bu c a 2 ari De M LA BS 1 0. 00% ald 3 0. 50% 1) LABS Reporting Group N Engl J Med 2009; 361: 445 -54 2) De. Maria et al Ann Surg. 2007 Oct; 246(4): 578 -82 3) Buchwald et al JAMA. 2004; 292: 1724 -1737 4)AHRQ, Healthcare Cost and Utilization Project (HCUP), 2007 data DRG 288 http: //hcupnet. ahrq. gov/ 5) Brethouer et all Surg Obes Rel Diseas 2009; 5: 469 -475 6) Sanchez-Santos et al Obes Surg, 2009 19 459 -467 25 | January 28, 2010 |

Aggregate Perioperative Complications 2005 to present N greater than 100 patients 16 Studies Case

Aggregate Perioperative Complications 2005 to present N greater than 100 patients 16 Studies Case Review (N= 2936) Spanish Registry 1 (n=504) Comp Total Frequency Mortality 8 0. 27% 2 0. 36% Staple Line 69 2. 4% 11 2. 0% Wound Site 18 0. 6% 1 0. 2% Bleeding 21 0. 7% 6 1. 1% Other 14 0. 5% 5 0. 9% Stricture 13 0. 4% 1 0. 2% Respiratory 8 0. 3% 1 0. 2% Thrombosis 7 0. 2% 1 Sanchez-Santos et al. Short- and Mid-term Outcomes of Sleeve Gastrectomy for Morbid Obesity: The Experience of the Spanish National Registry, Obes Surg 2009; 19 : 1203– 1210 26 | January 28, 2010 |

Aggregate Perioperative Complications 2006 to present N greater than 100 patients 16 Studies Comp

Aggregate Perioperative Complications 2006 to present N greater than 100 patients 16 Studies Comp Case RNY 1 BPDDS 1 AGB 1 SG 2 Staple Line 2. 4% 2. 2% 1. 8% Bleeding 0. 7% 2. 0% 0. 2% 0. 3% 1. 0% 1. 6% 4. 2% 7. 7% 1. 8% Reoperation 2. 7% 1) Maggard M, et al, Meta-Analysis: Surgical Treatment of Obesity, Ann Intern Med. 2005; 142: 547 -559 2) Brethauer et al Systematic review of sleeve gastrectomy as staging and primary bariatric procedure SOARD 2009; 5. 27 | January 28, 2010 |

Reinsurance for Private Pay Patients Personal Communication, BLIS Inc, Copyright © 2010 BLIS Inc.

Reinsurance for Private Pay Patients Personal Communication, BLIS Inc, Copyright © 2010 BLIS Inc. Used with permission. 28 | January 28, 2010 |

Comparative Studies – Obesity Related Comorbidity Outcomes 29 Year Author 2006 Himpens N Total

Comparative Studies – Obesity Related Comorbidity Outcomes 29 Year Author 2006 Himpens N Total (SG) Duration (months) Control 80 (40) 24 LAGB Appetite suppression greater in SG group Outcomes 2008 Karamanakos 32 (16) 12 RYGBP For both groups, glucose and triglycerides significantly decreased Appetite suppression greater in SG group 2008 Vidal 91 (39) 12 RYGBP 84. 6% T 2 DM resolution rates for both groups 2009 Strain 121 (30) 21 LAGB, RYGBP, SWITCH Outcomes not reported 2007 Lee 846 (216) 36 LAGB, RYGBP, SWITCH Outcomes not reported 2009 Wong 94 (30) 24 LAGB, RYGBP Surgery improved hypertension, diabetes and dislipidemia | January 28, 2010 |

Case Study Obesity Related Comorbidity Outcomes • Published since 2006 • Greater than 10

Case Study Obesity Related Comorbidity Outcomes • Published since 2006 • Greater than 10 Patients • BMI reported pre-op and at follow-up 30 Number of patients in Subgroup # of Studies Showing results Total 1754 19 Type 2 Diabetes 397 18 95% Hypertension 428 14 88% Hyperlipidemia 189 11 73% Sleep Apnea 234 10 91% Degenerative joint disease/ joint pain 210 6 70% % Resolved or Improved | January 28, 2010 |

2010 HEDIS Measurements that are affected by Gastrectomy • Adult BMI Assessment • Comprehensive

2010 HEDIS Measurements that are affected by Gastrectomy • Adult BMI Assessment • Comprehensive Diabetes Care -Hb. A 1 c control (<7. 0%) and Poor Control (>9%) • Relative Resource Use for People With Diabetes • Relative Resource Use for People With Uncomplicated Hypertension National Committee for Quality Assurance (NCQA), Healthcare Effectiveness Data and Information Set (HEDIS) 2010 Measures, http: //www. ncqa. org/Portals/0/HEDISQM/HEDIS 2010/2010_Measures. pdf 31 | January 28, 2010 |

Bariatric Surgery Procedures Excess Weight Loss 100% Switch Roux-en-Y Gastrectomy 50% Banding 10% 0.

Bariatric Surgery Procedures Excess Weight Loss 100% Switch Roux-en-Y Gastrectomy 50% Banding 10% 0. 001 0. 1 1 10 30 Day Mortality Adapted from Buchwald H, et al, Bariatric surgery, a systematic review and meta-analysis, JAMA. 2004; 292: 1724 -1737 and Maggard M, et al, Meta-Analysis: Surgical Treatment of Obesity, Ann Intern Med. 2005; 142: 547 -559 and Brethauer et al Systematic review of sleeve gastrectomy as staging and primary bariatric procedure SOARD 2009; 5. 32 | January 28, 2010 |

Bariatric Surgery Procedures Diabetes Resolution Rate Excess Weight Loss 100% Switch Roux-en-Y Gastrectomy 50%

Bariatric Surgery Procedures Diabetes Resolution Rate Excess Weight Loss 100% Switch Roux-en-Y Gastrectomy 50% Banding 10% 0. 001 0. 1 1 10 30 Day Mortality Adapted from Buchwald H, et al, Bariatric surgery, a systematic review and meta-analysis, JAMA. 2004; 292: 1724 -1737 and Maggard M, et al, Meta-Analysis: Surgical Treatment of Obesity, Ann Intern Med. 2005; 142: 547 -559 and Brethauer et al Systematic review of sleeve gastrectomy as staging and primary bariatric procedure SOARD 2009; 5. 33 | January 28, 2010 |

Bariatric Surgery Procedures Diabetes Resolution Rate 100% Switch Roux-en-Y Gastrectomy 50% Banding 10% 0.

Bariatric Surgery Procedures Diabetes Resolution Rate 100% Switch Roux-en-Y Gastrectomy 50% Banding 10% 0. 001 0. 1 1 10 30 Day Mortality Adapted from Buchwald H, et al, Bariatric surgery, a systematic review and meta-analysis, JAMA. 2004; 292: 1724 -1737 and Maggard M, et al, Meta-Analysis: Surgical Treatment of Obesity, Ann Intern Med. 2005; 142: 547 -559 and Brethauer et al Systematic review of sleeve gastrectomy as staging and primary bariatric procedure SOARD 2009; 5. 34 | January 28, 2010 |

Society Support Societies that endorse Sleeve Gastrectomy • American Society for Metabolic and Bariatric

Society Support Societies that endorse Sleeve Gastrectomy • American Society for Metabolic and Bariatric Surgery • Society of American Gastrointestinal and Endoscopic Surgery • American College of Surgeons 35 | January 28, 2010 |

Blue Distinction Centers for Bariatric Surgery Offering Sleeve Gastrectomy Hospital Surgeon (* Author) University

Blue Distinction Centers for Bariatric Surgery Offering Sleeve Gastrectomy Hospital Surgeon (* Author) University of Alabama Hospital E. E. Frezza*, M. D UC Irvine Medical Center N. Nguyen*, M. D Yale-New Haven Hospital R. Bell*, M. D Cleveland Clinic Hospital, FL R. Rosenthal*, M. D University of Chicago Medical Center Chicago V. Prachand*, M. D North Shore University Health. System (Evanston) C. Frantzides, MD Clarian North Medical Center S. Mattar*, M. D Johns Hopkins Bayview Medical M. Schweitzer, M. D Massachusetts General Hospital J Pratt, M. D University of Minnesota Medical Center S. Ikramuddin, MD Atlantic City Medical Center A Onopchenko, MD Lenox Hill Hospital M. Roslin, MD Cleveland Clinic Hospital, OH P. Schauer*, MD Blue Distinction Centers for Bariatric Surgery, http: //www. bcbs. com/innovations/bluedistinction/blue-distinctionbariatric/bluedistinctionbariatric. pdf 36 | January 28, 2010 |

Sleeve Gastrectomy Patient Characteristics • BMI greater than 40 kg/m 2 • BMI greater

Sleeve Gastrectomy Patient Characteristics • BMI greater than 40 kg/m 2 • BMI greater than 35 kg/m 2 with significant obesity related comorbidities • Participate multidisciplinary Center of Excellence program • Model medical profile – NSAID use – Prior surgery – Large ventral hernia – Revisions – Need to reduce comorbidities prior to planned operation – Earlier intervention 37 | January 28, 2010 |

Professional Education • Surgeon Training – CME – Fellowships – Residency – Clinical Immersion

Professional Education • Surgeon Training – CME – Fellowships – Residency – Clinical Immersion • Staff Training – Patient Education – Perioperative Management – Follow-up • Patient Pathways 38 | January 28, 2010 |

Sleeve Gastrectomy Advantages • No anastomoses • Continuity of gastrointestinal tract – Functional pylorus

Sleeve Gastrectomy Advantages • No anastomoses • Continuity of gastrointestinal tract – Functional pylorus – Does not bypass duodenum • Reduces hunger • No implanted device • Follow up visits to adjust device not needed 39 | January 28, 2010 |

Conclusions • Weight loss drives obesity related comorbidity resolution • Sleeve Gastrectomy has better

Conclusions • Weight loss drives obesity related comorbidity resolution • Sleeve Gastrectomy has better weight loss than Adjustable Gastric Banding • Sleeve Gastrectomy has fewer complications than Roux en Y Gastric Bypass or Biliopancreatic Diversion and Duodenal Switch • Mid term data to 3 years tracks with other covered bariatric procedures • Sleeve Gastrectomy is as effective as other covered procedures • Sleeve Gastrectomy should be covered as a medically necessary treatment for Morbid Obesity and Related Diseases 40 | January 28, 2010 |

Questions 41 | January 28, 2010 |

Questions 41 | January 28, 2010 |

References Slide # 6, 7, 8, 25, 32, 33, 34 42 In order of

References Slide # 6, 7, 8, 25, 32, 33, 34 42 In order of appearance Reference Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004; 292: 1724 -37. Buchwald Abstract Buchwald PDF 6, 7, 32, 33, 34 Maggard MA, Shugarman LR, Suttorp M et al, Meta-Analysis: Surgical Treatment of Obesity, Ann Intern Med. 2005; 142: 547 -559 Maggard Abstract Maggard PDF 7, 25, 32, 33, 34 Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis 2009; 5: 469 -75. Brethauer Abstract 8, 9, 25 Longitudinal Assessment of Bariatric Surgery (LABS) Consortium et al, Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30; 361(5): 445 -54. LABS Abstract LABS PDF 8, 9, 25 De. Maria EJ, Murr M, Byrne TK, et al Validation of the obesity surgery mortality risk score in a multicenter study proves it stratifies mortality risk in patients undergoing gastric bypass for morbid obesity. Ann Surg. 2007 Oct; 246(4): 578 -82; discussion 583 -4. 8, 9, 25 AHRQ, Healthcare Cost and Utilization Project (HCUP), http: //hcupnet. ahrq. gov/ accessed 01/13/10, 2007 data http: //hcupnet. ahrq. gov 10 Ostbye T, Dement JM, Krause KM. Obesity and workers' compensation: results from the Duke Health and Safety Surveillance System. Arch Intern Med. 2007 Apr 23; 167(8): 766 -73. Ostbye Abstract Ostbye PDF 11 Wee CC, Phillips RS, Legedza AT, et al. Health care expenditures Wee Abstract associated with overweight and obesity among US adults: importance of age Wee PDF and race. Am J Public Health. 2005 Jan; 95(1): 159 -65 12 Finkelstein E and Brown DS, A cost-benefit simulation model of coverage for Finkelstein bariatric surgery among full-time employees. Am J Manag Care. 2005; 11: Abstract 641 -646 Finkelstein PDF De. Maria Abstract | January 28, 2010 |

References Slide # In order of appearance Reference 12 Cremieux PY, Buchwald H, Shikora

References Slide # In order of appearance Reference 12 Cremieux PY, Buchwald H, Shikora SA, Ghosh A, Yang HE, Buessing M. A study on the economic impact of bariatric surgery. Am J Manag Care 2008; 14: 589 -96. Cremieux Abstract Cremieux PDF 12 Sampalis JS, Liberman M, Auger S, Christou NV. The impact of weight reduction surgery on health-care costs in morbidly obese patients. Obes Surg 2004; 14: 939 -47. Sampalis Abstract 12 Gallagher SF, Banasiak M, Gonzalvo JP, et al. The impact of bariatric surgery on the Veterans Administration healthcare system: a cost analysis. Obes Surg 2003; 13: 245 -8. Gallagher Abstract 14, 21 43 Deitel M, Gawdat K, Melissas J. Reporting weight loss 2007. Obes Surg 2007; 17: 565 -8. 16 Himpens J, Dapri G, Cadiere GB. A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years. Obes Surg 2006; 16: 1450 -6. Himpens Abstract 17 Vidal J, Ibarzabal A, Romero F, et al. Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese subjects. Obes Surg 2008; 18: 1077 -82. Vidal Abstract 17 Karamanakos SN, Vagenas K, Kalfarentzos F, Alexandrides TK. Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Ann Surg 2008; 247: 401 -7 Karamanakos Abstract 18 Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in Lee Abstract 216 patients: report of two-year results. Surg Endosc 2007; 21: 1810 -6. Lee PDF | January 28, 2010 |

References Slide # Reference 19 Strain GW, Gagner M, Pomp A, et al. Comparison

References Slide # Reference 19 Strain GW, Gagner M, Pomp A, et al. Comparison of weight loss and body composition changes with four surgical procedures. Surg Obes Relat Dis 2009; 5: 582 -7. 20 Wong SK, Kong AP, Mui WL, et al. Laparoscopic bariatric surgery: a fiveyear review. Hong Kong Med J 2009; 15: 100 -9. Wong Abstract Wong PDF 24 Christou N, Efthimiou E. . Five-year outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Ygastric bypass in a comprehensive bariatric surgery program in Canada, Can J Surg, Vol. 52, No. 6, December 2009 E 249 -258 Christou Abstract Christou PDF 24 Angrisani L, Lorenzo M, Borrelli V. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5 -year results of a prospective randomized trial, Surg Obes Rel Dis 2007; 3: 127 -133 25, 26 31 44 In order of appearance Sanchez-Santos R, Masdevall C, Baltasar A, et al. Short- and mid-term outcomes of sleeve gastrectomy for morbid obesity: the experience of the Spanish National Registry. Obes Surg 2009; 19: 1203 -10. National Committee for Quality Assurance (NCQA), Healthcare Effectiveness Data and Information Set (HEDIS) 2010 Measures, Strain Abstract Angrisani Abstract Sanchez-Santos PDF | January 28, 2010 |