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Luigi AngrisaniDirector - General and Endoscopic Surgery UnitS.Giovanni Bosco Hospital, Naples, Italy

Efficacia della terapia chirurgica sulle complicanze cardiovascolari nel diabete mellito tipo 2DIABETE MELLITO: COMPLICANZE CRONICHE Microangiopatia Retinopatia Nefropatia Neuropatia Macroangiopatia Coronarica Cerebrale Periferica2Diabete 2-4 volte rischio di CAD 2-4 volte rischio di PAD 3 volte rischio di ictusPrima causa di cecitPrima causa di IRC 2 volte mortalit per IMA a 5a. 20 volte rischio di amputazioniRestenosi dopo rivascol.Diabete mellito e complicanze croniche3Il diabete una malattia cardiovascolare che si diagnostica misurando la glicemiaY. YarvinenMacro-vascular ComplicationsIschemic heart diseaseCerebrovascular diseasePeripheral vascular disease

Diabetic patients have a 2 to 6 times higher risk fordevelopment of these complications than thegeneral population

Macro vascular Complications

J Am Coll Surg. 2013 Apr;216(4):545-56

7Bariatric 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.BACKGROUNDJohnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56STUDY DESIGNJohnson 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).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):545-56RESULTSPATHOPHYSIOLOGYWeight 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):545-56STUDYS LIMITATIONSRetrospective 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):545-56AuthorsArticle typeRelative risk reduction of CV disease Percentage of diabetic patients Heneghan HM et al.Am J Cardiol 2011

Systematic review40%28%Scott JD et al.Surg Obes Relat Dis 2013Retrospective cohort study25-50%40%Sjostrom LJAMA 2012Prospective matched cohort study33%*15%Cardiovascular risk reduction and bariatric surgery*47 % in diabetic subgroupCONCLUSIONSBariatric surgery is associated with a 65% reduction in major macrovascular and microvascular events in moderatelyand severely obese patients with T2DM.Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56Micro vascular ComplicationsDiabetic Retinopathy (DR)DR is the leading cause of blindness in the working population of the Western worldThe 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

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.

Diabetic Nephropathy (DN)Diabetes has become the most common cause of end stage renal failure in the US and EuropeAbout 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)

ConclusionsBariatric 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

SICOB National RegistryPts BMI < 35 (1998 2012)

SICOB National RegistryPts BMI < 35 (1998 2012)

ANGRISANI 2013 Naples, Italy

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93 Bariatric Procedures in 70 Obese Type 2 DiabeticsGeneral and Endoscopic Surgery UnitS. Giovanni Bosco Hospital - Naples - ItalyDirector: Luigi AngrisaniCHIRURGIA DEL DIABETELefficacia 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

STAMPEDE trial: conclusions

Schauer PR et al NEJM 2012

STAMPEDE trialSTAMPEDE trial

The combined end point of myocardial infarction and stroke, whichever came first, with fatal cardiovascular events and total (fatal and nonfatal) cardiovascular events are shown. The incidence data are based on observations until December 31, 2009. Follow-up time is truncated at 18 years, because number of persons at risk beyond this point was low. All persons are included in the calculation of hazard ratios (HRs). The incidence rates per 1000 person-years for fatal cardiovascular events were 0.9 (95% CI, 0.6-1.3) in the surgery group and 1.7 (95% CI, 1.3-2.2) in the control group; and for total cardiovascular events, 6.9 (95% CI, 6.0-8.0) and 8.3 (95% CI, 7.3-9.4), respectively. Y-axis regions shown in blue indicate range from 0 to 0.035.

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Data shown for controls obtaining usual care and for surgery patients obtaining banding, vertical banded gastroplasty, or gastric bypass at baseline. Percentage weight changes from the baseline examination and onward are based on data available on July 1, 2011. Error bars represent 95% CIs.

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Cardiovascular events include fatal and nonfatal myocardial infarction and stroke events combined. Error bars represent 95% CIs. BMI indicates body mass index (calculated as weight in kilograms divided by height in meters squared). For the 5 quintiles (26.3 mU/L) of interaction between control and surgery groups for baseline insulin, the mean values were 8.3, 12.9, 17.0, 22.6, and 38.0 mU/L, respectively. To convert insulin to pmol/L, multiply by 6.945. For the 5 quintiles (44.8) of interaction between control and surgery groups for baseline BMI, the mean values were 35.3, 38.7, 40.8, 43.1, and 48.3, respectively.

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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

Johnson et al. J Am Coll Surg. 2013 Apr;216(4):545-56CHIRURGIA BARIATRICA E COMPLICANZE DEL DIABETE

46Grafico18139022227692357

Serie 1LAGB813 (74%)Bypass gastrico 90 (8%)Bypass biliointestinale2 (0%)Gastroplastica Verticale22 (2%)Diversione Biliopancreatica27 (2%)Sleeve gastrectomy69 (6%)Long Magenstrasse23 (2%)BIB57 (5%)

Foglio1Serie 1Colonna1LAGB81374%1103bypass gastrico908%Bypass biliointestinale20%Gastroplastica Verticale222%Diversione Biliopancreatica272%Sleeve gastrectomy696%Long Magenstrasse232%Palloni575%

Grafico14118114792110139118131144152991

Serie 1Cases/year1.103 CASES

Foglio1Serie 1prima del 20004120011820021120034720049220051102006139200711820081312009144201015220119920121Per ridimensionare l'intervallo di dati del grafico, trascinare l'angolo inferiore destro dell'intervallo.

Grafico134451045924495100

SleeveANTI -OBESITY PROCEDURES n= 1932 Jan 1996 - Dec 201232651045924495

Grafico141464231181031816429322

Diabetic PtsTotal41464

Foglio1Diabetic PtsTotalGBP41464Sleeve23118Band10318BIB16429BPD/DS322Per ridimensionare l'intervallo di dati del grafico, trascinare l'angolo inferiore destro dell'intervallo.