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Slide 2 Luigi Angrisani Director - General and Endoscopic Surgery Unit S.Giovanni Bosco Hospital, Naples, Italy Efficacia della terapia chirurgica sulle complicanze cardiovascolari nel diabete mellito tipo 2 Slide 3 DIABETE MELLITO: COMPLICANZE CRONICHE Microangiopatia Retinopatia Nefropatia Neuropatia Macroangiopatia Macroangiopatia Coronarica Cerebrale Periferica Microangiopatia Retinopatia Nefropatia Neuropatia Macroangiopatia Macroangiopatia Coronarica Cerebrale Periferica Slide 4 Diabete 2-4 volte rischio di CAD 2-4 volte rischio di PAD 3 volte rischio di ictus Prima causa di cecit Prima causa di IRC 2 volte mortalit per IMA a 5a. 20 volte rischio di amputazioni Restenosi dopo rivascol. Diabete mellito e complicanze croniche Slide 5 Il diabete una malattia cardiovascolare che si diagnostica misurando la glicemia Y. Yarvinen Slide 6 Macro-vascular Complications Ischemic heart disease Cerebrovascular disease Peripheral vascular disease Diabetic patients have a 2 to 6 times higher risk for development of these complications than the general population Slide 7 Macro vascular Complications Slide 8 J Am Coll Surg. 2013 Apr;216(4):545-56 Slide 9 Bariatric surgery (BAR) has been established as an effective treatment for type 2 diabetes mellitus (T2DM) in obese patients. Few studies have examined the mid- to long-term outcomes of bariatric surgery in diabetic populations. No comparative studies have broadly examined major macrovascular and microvascular complications in bariatric surgical patients vs similar, nonbariatric surgery controls. BACKGROUND Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56 Slide 10 STUDY DESIGN Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56 Large, population-based, retrospective cohort study of adult obese patients with T2DM, from 1996 to 2009. Eligible patients undergoing bariatric surgery (BAR [n=2,580]) were compared with nonbariatric surgery controls (CON [n=13,371]) for the outcomes of any first - major macrovascular event (myocardial infarction, stroke, or all- cause death) or - microvascular event (new diagnosis of blindness, laser eye or retinal surgery, nontraumatic amputation, or creation of permanent arteriovenous access for hemodialysis), assessed in combination and separately - other vascular events (carotid, coronary or lower extremity revascularization or new diagnosis of congestive heart failure or angina pectoris). Slide 11 Bariatric surgery is associated with a 60% to 70% reduction in the hazard of any major macro- or microvascular complication of T2DM in moderately to severely obese patients free of advanced cardiovascular and microvascular disease at baseline. Macrovascular, microvascular, and other vascular events were all shown to be substantially reduced in the Bariatric Surgery patients vs Controls. The magnitude of the estimated risk reductions ranged between 60% and 80% for all study outcomes and suggests that bariatric surgery may significantly reduce the burden of end-stage diabetes related complications for at least the first 5 to 10 years after surgery. Although the preponderance of available data is limited by a lack of level 1 evidence, bariatric surgery appears to be emerging as one of the most effective treatments for ameliorating the excess cardiovascular disease burden imparted by T2DM and obesity. Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56 RESULTS Slide 12 PATHOPHYSIOLOGY Weight loss likely plays an important role in the long-term durability of diabetes remission among bariatric patients, who exhibit improved remission rates for at least 10 years after surgery compared with control patients receiving optimal medical therapy or usual care. Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56 Slide 13 STUDYS LIMITATIONS Retrospective nature Lack of information on body weight and markers of glycemic control preclude analysis of the proposed mechanisms for the observed risk reductions. Lack of information on duration and severity of diabetes at the time of study inclusion Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56 Slide 14 AuthorsArticle type Relative risk reduction of CV disease Percentage of diabetic patients Heneghan HM et al. Am J Cardiol 2011 Systematic review 40%28% Scott JD et al. Surg Obes Relat Dis 2013 Retrospective cohort study 25-50%40% Sjostrom L JAMA 2012 Prospective matched cohort study 33%*15% Cardiovascular risk reduction and bariatric surgery *47 % in diabetic subgroup Slide 15 CONCLUSIONS Bariatric surgery is associated with a 65% reduction in major macrovascular and microvascular events in moderately and severely obese patients with T2DM. Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56 Slide 16 Micro vascular Complications Slide 17 Diabetic Retinopathy (DR) DR is the leading cause of blindness in the working population of the Western world The prevalence increase with the duration of the disease (few within 5 years, 80 100% will have some form of DR after 20 years) Maculopathy is most common in type 2 patients and can cause severe visual loss Slide 18 Slide 19 Rapid and significant improvement in diabetes control is known to worsen diabetic retinopathy (DR). 38/ 119 patients had surgeries T2DM preoperatively. - 9% new DR after surgery - 9% progression of pre-existent DR after surgery - 59% no DR before and after surgery - 14% stable DR through surgery. - 9% regression of DR after surgery. Changes in DR are unpredictable after bariatric surgery. A small but significant proportion (18%) of patients with diabetes and bariatric surgery tended to develop new DR or worsen their retinopathy. Slide 20 Slide 21 Diabetic Nephropathy (DN) Diabetes has become the most common cause of end stage renal failure in the US and Europe About 20 30% of patients with diabetes develop evidence of nephropathy The prevalence of DN is higher in Black Americans than in Whites (Figures for South Africa is not available) Slide 22 Slide 23 Conclusions Bariatric surgery reduces overall mortality in obese subjects Bariatric surgery reduces cardiovascular events in non- diabetic population Bariatric surgery can provide a significative percentage of treated patients with prolonged remission of T2DM Bariatric surgery seems to be associated with a significant reduction in major macrovascular and microvascular events in moderately and severely obese subjects with T2DM. Angrisani 2013 Slide 24 Slide 25 SICOB National Registry Pts BMI < 35 (1998 2012) Slide 26 Slide 27 ANGRISANI 2013 Naples, Italy Slide 28 93 Bariatric Procedures in 70 Obese Type 2 Diabetics General and Endoscopic Surgery Unit S. Giovanni Bosco Hospital - Naples - Italy Director: Luigi Angrisani Slide 29 CHIRURGIA DEL DIABETE Lefficacia delle tecniche chirurgiche inversamente proporzionale al BMI di partenza Tra le tecniche chirurgiche (BPD, bypass gastrico, sleeve gastrectomy, bendaggio gastrico) quelle pi complesse sono anche le pi efficaci (e nello stesso tempo rischiose) Il meccanismo fisiopatologico sostanzialmente basato sul calo ponderale. Angrisani 2013 Slide 30 Slide 31 STAMPEDE trial: conclusions Slide 32 Slide 33 Schauer PR et al NEJM 2012 Slide 34 STAMPEDE trial Slide 35 Slide 36 Slide 37 Slide 38 Slide 39 Slide 40 Slide 41 Slide 42 Bariatric surgery is associated with a 60% to 70% reduction in the hazard of any major macro- or microvascular complication of T2DM in moderately to severely obese patients free of advanced cardiovascular and microvascular disease at baseline. Macrovascular, microvascular, and other vascular events were all shown to be substantially reduced in the Bariatric Surfgery patients vs Controls. The magnitude of the estimated risk reductions ranged between 60% and 80% for all study outcomes and suggests that bariatric surgery may significantly reduce the burden of end-stage diabetes related complications for at least the first 5 to 10 years after surgery. Although the preponderance of available data is limited by a lack of level 1 evidence, bariatric surgery appears to be emerging as one of the most effective treatments for ameliorating the excess cardiovascular disease burden imparted by T2DM and obesity. Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56 Slide 43 Slide 44 Slide 45 Slide 46 Slide 47 CHIRURGIA BARIATRICA E COMPLICANZE DEL DIABETE