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It’s Time to Act on Obesity: When Bariatric Surgery Is the Right Choice Presented by: [Surgeon’s Name] A Presentation for Health Care Professionals Treating Obesity This presentation is intended to provide health care professionals with information on obesity and the bariatric surgery treatment option. It is brought to you by Ethicon and is not certified for continuing medical education. 2 Presentation topics • Obesity: An Epidemic • Considering Bariatric Surgery • Identifying Bariatric Surgery Candidates • Understanding the Surgical Options • Patient and Physician Resources • An Important Partnership 3 Obesity: An Epidemic 4 The importance of more aggressive treatment • Obesity is a national disease epidemic1,2 • Obesity is a contributing factor to: – Many serious health conditions and diseases3 – Decreased quality of life4 – Mortality5,6 Figure may require permission. • Obesity can affect every major organ system in the body.7 • Obesity is associated with a 50% to 100% increased risk of death from all causes compared to normal-weight8 • Only ~20% of overweight individuals who attempt to lose weight are successful9 Prevalence† of Self-Reported Obesity Among US Adults by State and Territory in 2014 * Sample size <50 or the relative standard error (dividing the standard error by the prevalence) ≥30%. • The costs to the patient and society are high10 Prevalence estimates reflect Behavioral Risk Factor Surveillance System (BRFSS) methodological changes started in 2011. These prevalence † estimates should not be compared with estimates before 2011. 1. Ogden CL, et al. NCHS Data Brief. 2012;(82):1-8. 2. Centers for Disease Control and Prevention. Obesity prevalence maps. http://www.cdc.gov/obesity/data/prevalence-maps.html. Updated September 11, 2015. Accessed September 23, 2015. 3. Stommel M, et al. Obesity (Silver Spring). 2010;18(9):1821-1826. 4. Guyenet SJ, et al. J Clin Endocrinol Metab. 2012;97(3):745-755. 5. Allison DB, et al. JAMA. 1999; 282(16):1530-1538. 6. Fontaine KR, et al. JAMA. 2003;289(2):187-193.7. Buchwald H. Consensus Conference Statement: Bariatric surgery for morbid obesity: Health implications for patients, health professionals, and third-party payers. ASMBS. Surg Obes Rel Dis. 2004; 1: 371-381. 8. ASMBS. (2013). Fact sheet : Obesity in America. Gainesville, FL: Amber Hamilton. 9. Wing RR, et al. Am J Clin Nutr. 2005;82(suppl 1):222S225S. 10. Cawley J, et al. J Health Econ. 2012;31(1):219-230 5 The consequences of being severely obese are significant • As BMI increases, so does the risk of obesity-related conditions and mortality3,5,6 • Obesity and overweight together are the second leading cause of preventable death in the US, accounting for 300,000 deaths per year. Prevalence of Significant Morbidities Per Weight3 60% Years of Life Lost3 20 49% 50% 45% 15 13 40% 29% 30% 22% 17% 20% 10% 10 8 23% 19% 19% 12% 8% 8% 5 5 4% 1 0% 0 Diabetes BMI 25 Hypertension BMI 30 BMI 40 Arthritis BMI 40+ BMI 25 BMI 35 BMI 40 BMI 40+ BMI=body mass index. 3. Stommel M, et al. Obesity (Silver Spring). 2010;18(9):1821-1826. 5. Allison DB, et al. JAMA. 1999;282(16):1530-1538. 6. Fontaine KR, et al. JAMA. 2003;289(2):187-193. 6 Obesity poses an economic burden to the individual and to society US annual medical cost of obesity (estimated to be $3115 per person) 20.6% $168 billion11* of national health expenditures are spent treating obesity-related illness10 80% Up to 30% greater medical costs for patients with obesity than for normalweight individuals12 higher prescription drug spending for patients with obesity than for normal-weight individuals13 * 2008 dollars. 11. Kaplan LM, et al. Bariatric Times. 2012;9(5):12-13. 10. Cawley J, et al. J Health Econ. 2012;31(1):219-230. 12. Withrow D, et al. Obes Rev. 2011;12(2):131-141. 13. Finkelstein EA, et al. Health Aff (Millwood). 2009;28(5):w822-w831. 7 Considering Bariatric Surgery 8 What is unique about bariatric surgery? Bariatric surgery: • Has a unique mode of action that allows for metabolic change versus caloric restriction, as with dieting11 • Has the greatest weight loss results of any treatment option11 • Has the longest weight loss duration of any treatment option11 A 200-pound patient fighting obesity with diet and exercise alone would only be able to achieve a sustained weight loss of 4 pounds over 20 years16 • Has the ability to reduce or resolve obesityrelated conditions, risks,11 and the need for supplemental medicines14 • Has been shown to significantly improve quality of life15 • May reduce the risk of mortality15 11. Kaplan LM, et al. Bariatr Times. 2012;9(9 suppl C):C12-C13. 14. Schauer PR, et al. N Engl J Med. 2012;366(17):1567-1576. 15 Sjöström L, et al. JAMA. 2012;307(1):56-65. 16. Calle EE, et al. N Engl J Med. 2003;348(17):1625-1638. 9 Physiologic changes induced by bariatric surgery17 Some surgical procedures can uniquely interrupt the metabolic dysregulation cycle17-20 • Stapling procedures (sleeve gastrectomy and gastric bypass)21: – – – Alter the gut hormonal signaling system that affects hunger, satiety, and metabolism Alter signaling processes in a way that supports weight loss Restricts the stomach to reduce calorie intake • Gastric banding22: – Restricts the stomach to reduce calorie intake 17. Chambers AP, et al. Gastroenterology. 2011;141(3):950-958. 18. Shin AC, et al. Endocrinology. 2010;151(4):1588-1597. 19. Peterli R, et al. Ann Surg. 2009;250(2):234-241. 20. Stylopoulos N, et al. Obesity (Silver Spring). 2009;17(10):1839-1847. 21. Brethauer SA. Surg Clin North Am. 2011;91(6):1265-1279. 22. McBride CL, et al. Surg Clin North Am. 2011;91(6):1239-1247. 10 Bariatric surgery results • Bariatric surgery is currently the most effective long-term treatment for obesity11 • Some weight regain is normal23 • Benefits of weight loss and alleviation of obesity-related conditions (even if just for short term) still result in healthier lifestyle23 Treatment Average Weight Loss at 3 Years Average Weight Loss at 5 Years Diet and exercise -0.1%24 -1.6%24 10.7%25,* Not enough data Average Weight Loss at 3 Years Average Weight Loss at 5 Years Gastric bypass 71.2%26 60.5%27 Sleeve gastrectomy 66.0%28 49.0%27 Gastric banding 55.2%26 29.5%27 Drug therapy Surgery * This value represents follow-up of 108 weeks. 11. Kaplan LM, et al. Bariatr Times. 2012;9(9 suppl C):C12-C13. 23. Arterburn DE, et al. Obes Surg. 2013;23(1):93-102. 24. Sjöström L, et al. N Engl J Med. 2004;351(26):2683-2693. 25. Garvey WT, et al. Am J Clin Nutr. 2012;95(2):297-308. 26. Garb J, et al. Obes Surg. 2009;19(10):1447-1455. 27. Brethauer SA, et al. Ann Surg. 2013;258(4):628-636. 28. Himpens J, et al. Obes Surg. 2006;16(11):1450-1456. 11 Identifying Bariatric Surgery Candidates 12 Ensuring that obesity gets diagnosed and treated • Many individuals don’t realize that they have obesity because of the high number of overweight Americans around them. Utilizing BMI data, it needs to be specifically diagnosed with the disease of obesity. • Discussing obesity with a patient must be done in a sensitive way. • Begin the conversation about weight and how it affects their health • Assess the patients efforts to date and readiness to take action • Practice active listening to their concerns and experiences • Focus on the disease of obesity and how to treat it versus how they got there • Provide helpful information on what treatment options can deliver • Discuss support that they have or will need. 13 Society treatment guidelines • Many major medical societies have recognized obesity as a disease and included it in treatment guidelines for excess weight or obesity-related disease reduction or resolution American Heart Association, American College of Cardiology, The Obesity Society (AHA/ACC/TOS) National Heart, Lung and Blood Institute, National Institute of Health (NHLBI/NIH) American Association of Clinical Endocrinologists. American College of Endocrinology (AACE/ACE) Guidelines for: Cardiac Issues and Obesity Obesity Type 2 Diabetes and Obesity Bariatric Surgery Intervention Adults BMI > 40 or BMI > 35 with obesity-related comorbid conditions if did not respond to behavior treatment with or without pharmacotherapy Patients with clinically severe obesity (BMI ≥ 40 or a BMI ≥35 with comorbid conditions) when less invasive methods of weight loss have failed and the patient is at high risk for obesity-associated morbidity or mortality BMI > 35 with comorbidities, adjustable gastric band, gastric sleeve, gastric bypass BMI > 30 with comorbidities, adjustable gastric band BMI=Body mass index. 14 Surgical treatment of patients with obesity29 Who is eligible for surgery? Patients who: • Have a BMI ≥40 kg/m2 or a BMI ≥35 kg/m2 with obesity-related conditions,* such as30: – Type 2 diabetes mellitus – Cardiovascular conditions – Sleep apnea – Fertility-related complications – Orthopedic conditions – Cancer • Are experiencing obesity-related quality-of-life issues Migraines Depression Obstructive sleep apnea High cholesterol Hypertension Asthma GERD Type 2 diabetes Urinary stress incontinence Polycystic ovarian syndrome Osteoarthritis or joint disease Venous stasis disease • Have attempted to lose weight using nonsurgical methods but have not succeeded * Of note, there are >40 documented obesity-related conditions. BMI=body mass index; GERD=gastroesophageal reflux disease. 29. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Bethesda, MD: National Heart, Lung, and Blood Institute; 2000. NIH publication 00-4084. https://www.nhlbi.nih.gov/files/docs/guidelines/prctgd_c.pdf. Accessed September 8, 2015. 30. Obesity in America. American Society for Metabolic and Bariatric Surgery Web site. https://asmbs.org/resources/obesity-in-america. November 2013. Accessed October 16, 2015. 15 Bariatric surgery is a life-changing event Patients should: • Be willing to commit to following dietary restrictions, adhering to an exercise program, taking dietary supplements, and complying with follow-up recommendations • Be well informed and highly motivated • Have a supportive family or social environment • Stay away from smoking or drinking alcohol • Be actively treating severe depression or other mental disease 16 Understanding the Surgical Options 17 Most common bariatric procedures Roux-en-Y Gastric Bypass31 Bypass a portion of the small intestine and create a 15- to 30-cc stomach pouch Sleeve Gastrectomy32 Resect approximately three-fourths of the stomach Laparoscopic Biliopancreatic Adjustable Diversion 22 Gastric Banding (± Duodenal Switch)33 Place implantable device around the uppermost part of the stomach Remove part of the small intestine; performed with or without duodenal switch Less than 2 years after surgery; however, no statistically significant difference between assessments made at ≤2 years and >2 years; At least 3 years after surgery. 31. Powell MS, et al. Surg Clin North Am. 2011;91(6):1203-1224. 32. Brethauer SA. Surg Clin North Am. 2011;91(6):1265-1279. 22. McBride CL, et al. Surg Clin North Am. 2011;91(6):1239-1247. 33. Brethauer S, et al. In: Carey WD, ed. Current Clinical Medicine. 2nd ed. Philadelphia, PA: Saunders Elsevier; 2010:391-396. * † 18 Most common bariatric procedures Treatment Excess Weight Loss How the procedure works Metabolic changes Restriction Roux-en-Y Gastric Bypass ~62%35,* Sleeve Gastrectomy 66%36,† Biliopancreatic Diversion (± Duodenal Switch) ~70%37 Laparoscopic Adjustable Gastric Banding 55%36,† X Less than 2 years after surgery; however, no statistically significant difference between assessments made at ≤2 years and >2 years; At least 3 years after surgery. 35. O’Brien PE, et al. Obes Surg. 2006;16(8):1032-1040. 36. Shi X, et al. Obes Surg. 2010;20(8):1171-1177. 37. Ionut V, et al. J Diabetes Sci Technol. 2011;5(5):1263-1282. * † 19 Disease resolution 20 Tools to consider surgical results • Utilize the online Bariatric Surgery Comparison Tool – Considers a patient’s height, weight, and obesity-related conditions to provide potential outcomes of bariatric surgery based on the experiences of more than 75,000 patients in the United States38 – Can compare potential results between procedures, or versus patients personal experience with non-surgical treatment options. • Order brochures, posters, body mass index cards, and videos that may be helpful for patients • Patients information site at REALIZE.com • HCP information site at ethicon.com/obesity 38. Benoit SC, et al. Obes Surg. 2014;24(6):936-943. 21 Safety profile for bariatric surgery • Clinical evidence shows that the risks associated with morbid obesity outweigh the risks associated with metabolic and bariatric surgery39,† • Most procedures (>90%) are performed laparoscopically40 due to significant advancements in laparoscopic technique41 • Accreditation by the American Society for Metabolic and Bariatric Surgery has resulted in standardization of skills42 Procedure Bariatric surgeries ‡ Other common procedures‡ Complications Mortality Gastric bypass 0.4% 0.2% Gastric banding * * Colectomy 2.4% 0.8% Hysterectomy 0.4% * Cholecystectomy 0.9% 0.9% Hip replacement 1.0% 0.2% 2010 data; * ≤10 cases reported; ‡ Washington State Health Care Authority Heath Technology Assessment. Bariatric Surgery Draft Key Questions: Comment & Response. 2014. http://www.hca.wa.gov/hta/Documents/bariatric_key_qs_comments_response_110714.pdf Last accessed 12/11/2015. 39. Direct Research, LLC, Center for Medicare and Medicaid Services. FY 2010 MedPAR. Medicare Fee-for-Service Inpatient Discharges with Selected Procedures. 40. Seki Y, et al. Surg Technol Int. 2010;20:139-144. 41. Reoch J, et al. Arch Surg. 2011;146(11):1314-1322. 42. Gould J, et al. J Am Coll Surg. 2011;213(6):771-777. † 22 Bariatric surgery: benefits vs risks Benefits of bariatric surgery may include: • Highest level of excess weight loss39 • Strongest obesity-related condition resolution or reduction39 • Reduction in risk of conditions such as cancer15 • Improvement in fertility48 • Improvement in quality of life14 • Reduction in mortality39 • Reduction in patient health care utilization/direct and indirect costs44 Risks39* • Band erosion/slippage/leak/malfunction† • Esophageal spasm/reflux or esophageal/stomach inflammation • Gastric perforation • Outlet obstruction * List is not exhaustive. Risks are in addition to the general risks of surgery. Patient weight, age, and medical history play a significant role in determining specific risks; † Associated with laparoscopic adjustable gastric banding. 39. Direct Research, LLC, Center for Medicare and Medicaid Services. FY 2010 MedPAR. Medicare Fee-for-Service Inpatient Discharges with Selected Procedures. 15. Sjöström L, et al. JAMA. 2012;307(1):56-65. 43. Merhi ZO. Fertil Steril. 2009;92(5):15011508. 14. Schauer PR, et al. N Engl J Med. 2012;366(17):1567-1576. 44 Holtorf AP, et al. In: Huang CK, ed. Advanced Bariatric and Metabolic Surgery. Rijeka, Croatia: InTech; 2012:61-86. 23 Referral considerations Requirements for approval depend on the insurance policy. Most policies require: • Documented history of medical weight loss attempts (3–6 months) • 5-year weight history and medical records • Psychological evaluation • Nutrition counseling A referral for a bariatric surgery consultation is similar to any other specialist referral. The surgeon will examine the patient and determine if surgery is the best option. 24 Postoperative management • Surgery is a tool to help patients lose weight and help keep it off. Diet and exercise are an essential part of the new routine • Recovery takes time and patience • Amount and timing of weight loss will vary • Patients may experience discomfort and pain as their body heals • Diet restrictions should be strict • Additional nutrition screening/supplementation may be required • Medication adjustments may be needed • Length of time to return to normal activities varies • Patients who undergo laparoscopic adjustable gastric banding will require ongoing appointments to assess band restrictiveness and make adjustments 25 Patient and Physician Resources 26 Patient and physician resources • The Obesity Society (TOS) • Strategies to Overcome and Prevent (STOP) Obesity Alliance • Obesity Action Coalition (OAC) • Obesity Action Coalition (OAC) • American Society for Metabolic and Bariatric Surgery (ASMBS) • Ethicon.com/obesity (for HCPs) – Find HCP information and resources – Find a surgeon – Download/order materials • Realize.com/obesity (for patients) – Find a surgeon, find a seminar – Obtain general information – Use the surgery comparison tool • A local Bariatric Surgeon HCPs=health care professionals. 27 An Important Partnership 28 Patient, HCP and surgeon partnership is important • It is essential for the patient, primary healthcare professional or specialist and bariatric surgeon to work together to identify the best treatment for the patient • Surgery is a tool that requires a strong commitment from the patient and treatment team to accommodate the lifestyle changes and the lifetime of follow-up – Bariatric surgery should be synergistic with other therapies – Follow-up care should include managing medications, complications, and patient expectations – Identify and access support groups – Ongoing communication Talk to your patients! Discuss available treatment options If appropriate, refer them to a bariatric surgeon Provide information on local patient seminars 29 Bariatric Surgery Clinical Study Results Results Investigator Study type # of patients Study start year Duration Study publication RCT, single center 80 pts 2002 3 years Obse Surg 43 studies Incl. studies published prior to 2005 10 years Obse Surg O’Brian et al. Systematic review, studies of ≥100 pts and ≥3 yrs. weight loss data Systematic review, studies of ≥100 pts and ≥3 yrs. weight loss data 43 studies Incl. studies published prior to 2005 10 years Obse Surg O’Brian et al. Excess weight loss: 66% Excess weight loss at 3 years, Sleeve Gastrectomy28 62% Excess weight loss at 3 years, Gastric Bypass35 55% Excess weight loss at 3 years, Gastric Band35 Himpens et al. Obesity-related conditions: T2DM: 68% of patients resolved14 STAMPEDE Schauer et al. RCT single center 150 pts 2007 3 years N Engl J Med High blood pressure: 66% of patients resolved45 Tice et al. Systematic review of 14 studies NA Incl. studies published prior to 2007 1 year Am J Med High cholesterol: 94% of patients improved46 Buchwald et al. Systematic review and metaanalysis of 91 studies 22094 pts 2004 NA JAMA Osteoarthritis/degenerative joint disease: 41% of patients resolved47 Schauer et al. Prospective, single center 275 pts 1997 3 years Ann Surg Obstructive sleep apnea: 76% of patients resolved 45 Tice et al. Systematic review of 14 studies NA Incl. studies published prior to 2007 1 year Am J Med Cancer: 38% reduction in incidence of obesity related cancer48 Adams et al. Retrospective, multi center 16038 1984 24 years Obesity 28. Himpens, J. (2006). A Prospective Randomized Study Between Laparoscopic Gastric Banding and Laparoscopic Isolated Sleeve Gastrectomy: Results after 1 and 3 Years. Obes Surg, 16 (11): 1450-1456. 35. O'Brien PE, McPhail T, Chaston TB, et al. Systematic review of medium-term weight loss after bariatric operations. Obes Surg. 2006; 16(8):1032-1040. 14. Schauer P, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. N Engl J Med 2012; 366:1567-1576; April 26, 2012." 45. Tice JA, Karliner L, Walsh J, et al. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med. 2008 Oct;121(10):885-93 46. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37 47. Schauer PR, Ikramuddin S, Gourash W, et al. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg. 2000 30 Oct;232(4):515-29. 48. Adams T, Stroup A, Hunt S et al. Cancer Incidence and Mortality After Gastric Bypass Surgery. Obesity. 2009;17(4):796802. Appendix © 2015 Ethicon US, LLC. All rights reserved. 040042-150909 31 Obesity and cancer Weight loss after bariatric surgery Patient considerations • The risk of developing and dying from many common cancers is increased in individuals with obesity.1 • By 2030, nearly 500,000 Americans are projected to be diagnosed with obesity-associated cancers annually2 – – • In men: may account for 14% of all In women: may account for 20% of all deaths3 Excess weight loss of +25% at 5years.6 • The reduced weight after bariatric surgery may contribute: Men: esophageal cancer (by 52%) and colon cancer (by 24%) 4 Women: endometrial cancer (by 59%), gallbladder cancer (by 59%), and postmenopausal breast cancer (by 12%) 4 Cancers affected by obesity include:1,4 Endometrial cancer, cervical cancer, ovarian cancer, Postmenopausal breast cancer, colorectal cancer, esophageal cancer, pancreatic cancer, gallbladder cancer, liver cancer, kidney cancer, thyroid cancer, prostate cancer, non-hodgkin’s lymphoma, multiple myeloma and leukemia. Mechanism of action • • Each 5-kg/m2 increase in BMI may increase the risk for: ‒ ‒ ‒ deaths3 Research has shown that with weight loss following a sleeve gastrectomy or gastric bypass surgery, the following types of results are seen and may be possible - The function of adipose tissue as an endocrine organ may contribute to cancer risk:5 ‒ Estrogen and adipokines affect biochemical signals and have been linked to some forms of cancer2 ‒ There are increased levels of factors known to be linked to tumor development2 • – a significantly reduced incidence (57% lower risk) of obesity-related cancer in individuals post bariatric surgery compared with no bariatric surgery7 – 80% less likely to develop any cancer compared with their equally overweight counterparts who did not have surgery8 Note: The impact on cancer of weight loss following bariatric surgery may be associated only with cancers that are related to a patient's obesity. According to the American Society of Clinical Oncology, obesity contributes to up to 20% of cancer incidence, linked to poorer cancer outcomes and a risk for the development of comorbid illness in cancer survivors.9 Bariatric surgery is used in morbidly obese adult patients for significant long-term weight loss. Results following bariatric surgery may vary. Bariatric surgery may be appropriate for some patients, and not for others depending on their specific weight, age, and medical history. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed treatment decision. ETHICON manufactures and markets general surgical instruments used in bariatric surgery. The potential benefits discussed are associated with the patient’s weight loss following bariatric surgery, not with the use of the instruments. ETHICON is offering this information in good faith as an educational overview to published literature in this area and a starting point for further research. It is not intended to constitute medical advice or recommendations. BMI=body mass index. 1. Calle EE, Rodriguez C, Walker-Thurmond K. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of adults. N Engl J Med. 2003;348(17):16251638.2. Obesity and cancer risk. National Cancer Institute Web site. http://www.cancer.gov/about-cancer/causes-prevention/risk/obesity/obesity-fact-sheet. Reviewed January 3, 2012. Accessed October 27, 2015. 3. Klein S, et al. In: Melmed S, et al, eds. Williams Textbook of Endocrinology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011:16051632. 4. Renehan AG, et al. Body-mass index and incidence of cancer: a systematic review and meta-analysis of prospective observational studies. Lancet. 2008;371(9612): 569-578. 5. Kershaw EE, et al. Adipose Tissue as an Endocrine Organ. J Clin Endocrinol Metab. 2004;89(6):2548-2556. 6. Brethauer, SA. Can Diabetes Be Surgically Cured? Long-Term Metabolic Effects of Bariatric Surgery in Obese Patients with Type 2 Diabetes Mellitus. Ann Surg 2013;258 (4): 628-636. 7. Yang XW, et al. Effects of Bariatric Surgery on Incidence of Obesity-Related Cancers: A Meta-Analysis. Med Sci Monit. 2015;21:1350-1357. 8. Christou NV, et al. Surgery Decreases Long-term 32 Mortality, Morbidity, and Health Care Use in Morbidly Obese Patients. Surg Obes Relat Dis. 2008;4(6):691-695. 9. Obesity and Cancer: A Guide for Oncology Providers. American Society of Clinical Oncology Website. http://www.asco.org/sites/www.asco.org/files/obesity_provider_guide_final.pdf Accessed January 28, 2016. 043514-151117 Obesity and orthopedic conditions Patient considerations Data has shown• An association may exist between increased BMI and premature lower-extremity degenerative joint diseases, chronic low back pain, and osteoarthritis1 • Men have a higher risk ratio than women for obesity.1 However, women have a 4x greater likelihood of some conditions than normal-weight counterparts.2 Mechanism of action • Increased weight causes extra force through the joints • Increased adipose tissue can contribute to biological changes that can contribute to the degradation of cartilage:3 – High amounts of leptin are proinflammatory and catabolic in cartilage metabolism – Resistin and adiponectin modulate the inflammatory process surrounding osteoarthritis and compound damage to the joints – A disordered state of glucose and lipid metabolism induces collagen stiffness and processes that cause cartilage degradation Weight loss after bariatric surgery Research has shown that post sleeve gastrectomy and gastric bypass surgery there is weight loss that drives health improvements• Weight loss can reduce the odds of developing knee osteoarthritis by 50% among women4 • In most patients, sleeve gastrectomy and gastric bypass surgeries produce excess weight loss of +25% at 5years5 • Weight loss post bariatric surgery has been shown to result in: – Resolution in arthropathy : 91% of patients6 – Decrease in the number of daily medications6 – Reduction in chronic pain: 89% of patients7 According to the American Academy of Orthopaedic Surgeons, obesity is a major contributor to some orthopedic conditions.8 Bariatric surgery is used in morbidly obese adult patients for significant long-term weight loss. Results following bariatric surgery may vary. Bariatric surgery may be appropriate for some patients, and not for others depending on their specific weight, age, and medical history. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed treatment decision. ETHICON manufactures and markets general surgical instruments used in bariatric surgery. The potential benefits discussed are associated with the patient’s weight loss following bariatric surgery, not with the use of the instruments. ETHICON is offering this information in good faith as an educational overview to published literature in this area and a starting point for further research. It is not intended to constitute medical advice or recommendations. BMI=body mass index. 1. Guh DP, et al. BMC Public Health. 2009;9:88. 2. Anderson JJ, et al. Am J Epidemiol. 1988;128(1):179-189. 3. Sowers MR, et al. Curr Opin Rheumatol. 2010;22(5):533-537. 4. Felson DT, et al. Arthritis Rheum. 1998;41(8):1343-1355. 5. Brethauer SA, et al. Ann Surg 2013;258 (4): 628636. 6. Nelson LG, et al. Surg Obes Relat Dis. 2006;2(3):384-388. 7. McGoey BV, et al. J Bone Joint Surg Br. 1990;72(2):322-323. 8. American Academy of Orthopaedic Surgeons. Position Statement 1184. 2015. Retrieved from http://www.aaos.org/CustomTemplates/Content.aspx?id= 22330&ssopc=1. Last accessed February 11, 2016. 043513-151117 33 Obesity and diabetes Patient considerations • • • More than 90% of patients with type 2 diabetes (T2DM) are Research has shown that post sleeve gastrectomy and gastric overweight1, 15% of patients that have obesity have T2DM2 bypass surgery there is weight loss that drives health Diabetes is one of the top ten leading causes of US deaths. 3 improvementsRisk for having T2DM begins at a BMI of 22 kg/m2 and increases by 25% for each additional BMI unit4 • Weight loss after bariatric surgery BMI 25 > 4% incidence of T2DM BMI 30 > 8% BMI 35 > 17% BMI 40 > 22% Age plays a role - In an adult aged 50 years with a BMI of 30 to 35 kg/m2, the incidence of diabetes increases by 750%5 compared to a normal weight individual Mechanism of action • Increased adipose tissue results in higher free fatty acid levels, reducing insulin sensitivity and impairing the function of β-cells in the pancreas6 • Additionally, adiponectin tends to be decreased in patients with obesity, which may also increase insulin resistance6 • Resolved (78.1%) or improved (86.6%) diabetes or obesity-related conditions,7 and reducing the risk of T2DM. • Post surgery there was a reduction of medication for diabetes (down 75% after 12 months)8 and insulin usage (only 1/3 of pre-op insulin takers still taking insulin 5 years post op9) • The Ethicon funded STAMPEDE clinical trial (n=140) showed more effective management of diabetes ( defined as HbA1c <6) in patients with medical therapy following RYGB and SG.10 – 3 years post surgery, glycemic control was achieved in patients undergoing RYGB (38%) and SG (24%) with medical therapy, higher than patients who received medical therapy alone (5%) American Diabetes Association (ADA) Statement: “Bariatric surgery should be considered for adults with BMI ≥ 35 kg/m2 and Type 2 Diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy.”11 BMI=body mass index; RYGB=Roux-en-Y gastric bypass; SG=sleeve gastrectomy; STAMPEDE=Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently. 1. Obesity and overweight. World Health Organization Web site. http://www.who.int/dietphysical activity/media/en/gsfs_obesity.pdf. 2003. Accessed October 27, 2015. 2. Brethauer S, et al. Obesity. In: Carey WD, ed. Current Clinical Medicine. 2nd ed. Philadelphia: Saunders/ Elsevier; 2010. 3. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014. 4. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Bethesda, MD: National Heart, Lung, and Blood Institute; 1998 . NIH publication 98-4083. http://www.nhlbi.nih.gov/files/docs/guidelines/ob_gdlns.pdf. Accessed October 27, 2015. 5. Erixon F, et al. Investing in Obesity Treatment to Deliver Significant Healthcare Savings: Estimating the Healthcare Costs of Obesity and the Benefits of Treatment. Brussels, Belgium: European Centre for International Political Economy; 2014. ECIPE occasional paper 1/2014. http://www.ecipe.org/app/uploads /2014/12/ OCC12014_1.pdf. Accessed October 27, 2015. 6. McKenney RL, et al. Surg Clin North Am. 2011;91(6):1139-1148. 7. Buchwald H, et al. Am J Med. 2009;122(3):248-256. 8. Segal J, et al. Obes Surg. 2009;19:1646-1656. 9. Data on File, Ethicon 2015, Optum Analysis. 10. Schauer PR, et al. N Engl J Med. 2014;370(21): 2002-2013. 11. Handelsman Y, et al. Diabetes Care 2009; 32(S1):S13-S61. Bariatric surgery is used in morbidly obese adult patients for significant long-term weight loss. Results following bariatric surgery may vary. Bariatric surgery may be appropriate for some patients, and not for others depending on their specific weight, age, and medical history. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed treatment decision. ETHICON manufactures and markets general surgical instruments used in bariatric surgery. The potential benefits discussed are associated with the patient’s weight loss following bariatric surgery, not with the use of the instruments. ETHICON is offering this information in good faith as an educational overview to published 34 literature in this area and a starting point for further research. It is not intended to constitute medical advice or recommendations. 043511-151117 Obesity and obstructive sleep apnea Weight loss after bariatric surgery Patient considerations • ~77% of individuals with obesity experience OSA1 ‒ Often underdiagnosed and undertreated1 • The incidence of OSA is 12x to 30x greater in patients who are severely obese2 • In patients with a BMI above 40 kg/m2, OSA occurs in more than 50% of cases3 Mechanism of action • Research has shown that post sleeve gastrectomy and gastric bypass surgery there is weight loss that drives health improvements• In most patients there is excess weight loss of +25% at 5years7 • Improvements in or resolution of sleep apnea occurred in 88.5% of patients8 • Post bariatric surgery with associated weight loss, research shows a decrease in respiratory disturbance index of 89% to 98%9 • Improvement in nocturnal oxyhemoglobin saturation, subjective daytime somnolence, and sleep continuity and architecture, as well as decrease in cardiac dysrhythmias9 may occur post bariatric surgery when there is weight loss Increased throat muscle relaxation and throat closure4: ‒ Change in anatomic factors caused by increased fat mass5 contribute to narrow airways ‒ Reduction in lung volume associated with obesity limits diaphragmatic descent6 ‒ Increased lateral pharyngeal wall thickness and fat deposits in the throat narrow the airway6 Bariatric surgery has been identified by medical societies such as the American Heart Association10 and Academy of Nutrition and Dietetics as the most successful therapy for morbid obesity.11 * Including increased total sleep time, percentage of slow- wave sleep, and percentage of rapid eye movement sleep. BMI=body mass index; OSA=obstructive sleep apnea. 1. Kaul A, et al. Surg Clin North Am. 2011;91(6):1295-1312, ix. 2. Piché MÈ, et al. Can J Cardiol. 2015;31(2):153-166. 3. Resta, O, et al. Int J Obes Relat Metab Disord. 2001;25(5):669-675. 4. Obstructive sleep apnea: causes. Mayo Clinic Web site. http://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/basics/causes/con-20027941. June 15, 2013. Accessed October 27, 2015. 5. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Bethesda, MD: National Heart, Lung, and Blood Institute; 1998. NIH publication 98-4083. http://www.nhlbi.nih.gov/files/docs/guidelines/ob_gdlns.pdf. Accessed October 27, 2015. 6. Dempsey JA, et al. Physiol Rev. 2010;90(1):47-112. 7. Brethauer SA, et al. Ann Surg 2013;258 (4): 628-636. 8. Sarkhosh K, et al. Obes Surg. 2013;23(3):414-423. 9. Koenig SM. Am J Med Sci. 2001;321(4):249-279. 10. Poirier P, Circulation. 2011;123:1683–1701. 11. Hoelscher D, et al. J. Acad. Nutr. Diet. 2013;113(10):1375-1394. Bariatric surgery is used in morbidly obese adult patients for significant long-term weight loss. Results following bariatric surgery may vary. Bariatric surgery may be appropriate for some patients, and not for others depending on their specific weight, age, and medical history. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed treatment decision. ETHICON manufactures and markets general surgical instruments used in bariatric surgery. The potential benefits discussed are associated with the patient’s weight loss following bariatric surgery, not with the use of the instruments. ETHICON is 35 offering this information in good faith as an educational overview to published literature in this area and a starting 043516-151117 point for further research. It is not intended to constitute medical advice or recommendations. Obesity and cardiovascular conditions Effectiveness of weight loss after bariatric surgery Patient considerations With obesity, studies show: • an increased incidence of CV morbidities, such as hypertension, insulin resistance, dyslipidemia, all CV diseases, and all-cause mortality1 • Hypertension is 6x more for patients with morbid obesity (BMI at or above 40 kg/m2) than a normal weight individual, a 52.3% incidence.3 likely2 • there is increased dyslipidemia, increased triglycerides, apolipoprotein B, and LDL/HDL cholesterol levels1 Research has shown that with weight loss following a sleeve gastrectomy or gastric bypass surgery, the following types of results are seen and may be possible • Excess weight loss of +25% at 5years8 • Resolving or reduction of at least one type of CV conditions: – – • A 33% reduction in the relative risk of first-time fatal or nonfatal myocardial infarction or stroke6 • Improved physical function, energy levels, perception of general health, chest pain, and shortness of breath7 • Decreases in medication use for hypertension and hyperlipidemia in diabetic patients —down 45% and 55% at 12 months, respectively 9: Mechanism of action • A high BMI can lead to alterations in cardiac structure and function4 • Studies show an association between obesity and increased sodium retention, increased sympathetic nervous system activity, insulin resistance, and renin– angiotensin system alterations4 Sleeve gastrectomy: 50%5 Gastric bypass: 66%11 The American Heart Association and Academy of Nutrition and Dietetics identified bariatric surgery as the most successful therapy for morbid obesity.10 BMI=body mass index; CV=cardiovascular; HDL=high-density lipoprotein; LDL= low-density lipoprotein. 1. Nader N, et al. In: Bope ET, et al, eds. Conn's Current Therapy 2012. Philadelphia, PA: Elsevier Saunders; 2012:752-757. 2. Poirier, P et al. Bariatric Surgery and Cardiovascular Risk Factors. Circulation. 2011; 123:1684. 3. Nguyen NT, et al. Association of Hypertension, Diabetes, Dyslipidemia, and Metabolic Syndrome with Obesity: Findings from the National Health and Nutrition Examination Survey, 1999 to 2004. J Am Coll Surg. 2008;207(6):928-934. 4. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Bethesda, MD: National Heart, Lung, and Blood Institute; 1998. NIH publication 98-4083. http://www.nhlbi.nih.gov/files/docs/guidelines/ob_gdlns.pdf. Accessed October 27, 2015. 5. Pories W, et al. Who Would Have Thought It? An Operation Proves to Be the Most Effective Therapy for Adult-Onset Diabetes Mellitus. Ann Surg. 1995; 222(3):339-352. 6. Tham JC, et al. Cardiovascular, Renal and Overall Health Outcomes After Bariatric Surgery. Curr Cardiol Rep. 2015;17(5):34. 7. Sjöström L, et al. Bariatric Surgery and Long-term Cardiovascular Events. JAMA. 2012;307(1):56-65. 8. Brethauer, SA. Can Diabetes Be Surgically Cured? Long-Term Metabolic Effects of Bariatric Surgery in Obese Patients with Type 2 Diabetes Mellitus. Ann Surg. 2013;258 (4):628-636. 9. Segal JB, et al. Prompt Reduction in Use of Medications for Comorbid Conditions After Bariatric Surgery. Obes Surg. 2009; 19:16461656. 10. Poirier, P et al. Bariatric Surgery and Cardiovascular Risk Factors. Circulation. 2011; 123:1684; Deanna M, et al. Position of the Academy of Nutrition and Dietetics: Interventions for the Prevention and Treatment of Pediatric Overweight and Obesity. J. Acad. Nutr. Diet. 2013;113 (10): 1375-1394. 11. [EES weighted analysis of data summarized in table 4 of] Brethauer SA,et al. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Rel Dis. 2009;5(4):469-475. Bariatric surgery is used in morbidly obese adult patients for significant long-term weight loss. Results following bariatric surgery may vary. Bariatric surgery may be appropriate for some patients, and not for others depending on their specific weight, age, and medical history. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed treatment decision. ETHICON manufactures and markets general surgical instruments used in bariatric surgery. The potential benefits discussed are associated with the patient’s weight loss following bariatric surgery, not with the use of the instruments. ETHICON is offering this information 36 in good faith as an educational overview to published literature in this area and a starting point for further research. 043515-151117 It is not intended to constitute medical advice or recommendations. Questions? © 2015 Ethicon US, LLC. 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