Contro G. Nanni (Vercelli)

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1 Contro G. Nanni (Vercelli)
controversie in chirurgia bariatrica Chirurgia bariatrica con BMI compreso tra 30 e 35: perchè, quando e come? Pro M. De Luca (Vicenza) Contro G. Nanni (Vercelli) Giacinto Nanni U.O. Chirurgia Generale Casa di Cura Sant’Anna, Casale M.to (AL)

2 POSITION STATEMENT Written description of the objectives of a positioning strategy. It states (1) how the firm defines its business or how a brand distinguishes itself, (2) how the customers will benefit from its features, and (3) how these benefits or aspects will be communicated to the intended audience. LINEA GUIDA Insieme di raccomandazioni sviluppate sistematicamente, sulla base di conoscenze continuamente aggiornate e valide, redatto allo scopo di rendere appropriato, e con un elevato standard di qualità, un comportamento desiderato. Sono una base di partenza per l'impostazione di comportamenti e modus operandi condivisi in organizzazioni di ogni genere (sia private, sia pubbliche) nel campo sociale, politico, economico, aziendale, medico e così via. Prevalentemente non si tratta di procedure obbligatorie (in questo caso si parla di protocollo, di codice o procedura). RACCOMANDAZIONE, Anche: consiglio, proposta, suggerimento, segnalazione ... suggestion, recommendation ...

3 perchè JAMA, January 4, 2012, Vol 307, No. 1 Can J Surg, Vol. 56, No. 1, February 2013 Journal of Internal Medicine, 2013, 273; 219–234 Long-term cardio-vascular risk and coronary events in morbidly obese patients treated with laparoscopic gastric banding Luca Busetto, Fabio De Stefano, Sabrina Pigozzo, Gianni Segato, Maurizio De Luca, Franco Favretti Surgery for Obesity and Related Diseases, Articles in Press, 01 April 2013

4 perchè

5 Sleeve gastrectomy and type 2 diabetes mellitus: a systematic review
Diabetes remission and reduced cardiovascular risk after gastric bypass in Asian Indians with body mass index <35 kg/m2 Shashank S. Shah, Jayashree S. Todkar, Poonam S. Shah, David E. Cummings Surgery for Obesity and Related Diseases, Vol 6, Issue 4, Pages , July 2010 Sleeve gastrectomy and type 2 diabetes mellitus: a systematic review Richdeep S. Gill, Daniel W. Birch, Xinzhe Shi, Arya M. Sharma, Shahzeer Karmali, et al Surgery for Obesity and Related Diseases , Vol 6, Issue 6,, Pages , November 2010 Metabolic surgery for type 2 diabetes: efficacy and risks Halperin Florencia, Goldfine Allison B Current Opinion in Endocrinology, Diabetes & Obesity, April 2013, Volume 20 - Issue 2 - p 98–105 Bariatric surgery to treat type 2 diabetes: what is the recent evidence? Van Gaal, Luc F.; De Block, Christophe E.M. Current Opinion in Endocrinology, Diabetes & Obesity. 19(5): , October 2012. Role of Bariatric-Metabolic Surgery in the Treatment of Obese Type 2 Diabetes with Body Mass Index <35 kg/m2: A Literature Review Caio E.G. Reis, Jacqueline I. Alvarez-Leite, Josefina Bressan, and Rita C. Alfenas. Diabetes Technology & Therapeutics. April 2012, 14(4):

6 Outcomes of bariatric surgery in patients with body mass index <35 kg/m2
Gianos M, Abdemur A, Fendrich I, Gari V, Szomstein S, Rosenthal RJ Surgery for Obesity and Related Diseases, Vol 8, Issue 1, Pages 25-30, January 2012 Comment on: Outcomes of bariatric surgery in patients with BMI less than 35 kg/m Surg Obes Relat Dis.,2013, 9: John Morton, M.D., M.P.H., F.A.S.M.B.S. Minimally Invasive and Bariatric Surgery Stanford, California Given our knowledge regarding the harmful effect of class 1 obesity, should patients with a BMI 30–35 kg/m2 be deferred treatment until their disease has advanced? The Food and Drug Administration has also agreed that gastric band treatment of patients with a BMI of 30–35 kg/m2 should not be deferred and is appropriate. This report demonstrates that co-morbidity remission in this patient population is at least equivalent to the high level of improvement that other higher weight bariatric surgical patients currently enjoy. The authors also show that these lower weight BMI patients did not lose too much weight, with a 1-year postoperative BMI of kg/m2, roughly the median BMI in the United States. Additional investigation of this population is desirable to identify the most appropriate candidates for surgical intervention, particularly from a disease perspective. As our society’s name implies, we are more than bariatric or weight loss surgeons: we are metabolic surgeons as well. Although more research is needed, it is apparent that class 1 obese patients will benefit from earlier bariatric surgery referral.

7 Consensus Development Conference Panel
Consensus Development Conference Panel. Gastrointestinal surgery for severe obesity: Consensus Development Conference statement. Ann Intern Med. 1991:115: National Institutes of Health. National Heart, Lung and Blood Institute: Clinical Guidelines on the Identification, Evaluation and Treatment of Overweight and Obesity in Adults. The Evidence Report. June 1998 International Journal of Obesity (2007) 31, 569–577 2008 EDISES s.r.l. – Napoli 2011 quando

8 3. Recommendations 3.1 Management of Diabetes 3.1.1 Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity (BMI equal to or greater than 35) not achieving recommended treatment targets with medical therapies, especially where there are other obesity related co-morbidities. Under some circumstances people with a BMI should be eligible for surgery. 3.1.2 It is up to each health system to determine whether bariatric surgery with its support services is economically appropriate. 3.1.3 Surgery should be considered as complementary to medical therapies to reduce micro-vascular and cardiovascular risk. 2011 3.2 Research Recommendations 3.2.1 Studies are needed to establish more robust criteria than BMI for predicting benefit from surgery and define which patients benefit most from which procedures. 3.2.2 Studies are needed to establish the benefit of surgery for persons with diabetes and BMI < 35. 3.2.4 Studies are required to document the course of complications after surgery obtain evidence that surgery stabilises and ideally improves microvascular complications. 3.2.5 Studies are needed to establish the duration of the benefit of surgery. 3.2.6 Studies are needed to establish the mechanisms of the success of surgery and the mechanisms associated with recurrence. 3.2.7 Studies are needed to establish the long term complications of surgery. It will be important to phenotype candidates for surgery to define what will be the most appropriate bariatric procedure for persons with diabetes in different age groups, different duration of diabetes etc. Randomised controlled trials are needed to evaluate and compare different bariatric procedures for the treatment of diabetes between themselves as well as emerging non-surgical therapies.

9 criteri di selezione per la chirugia dell'obesità
Eating Weight Disord. 15: 1-31, ©2010, Editrice Kurtis criteri di selezione per la chirugia dell'obesità Indice di Massa Corporea superiore a 40 o compreso tra 35 e 40 se in presenza di altre patologie associate che possono beneficiare del calo ponderale (ipertensione arteriosa, diabete, insufficienza respiratoria o sindrome delle apnee ostruttive, dolori osteo-articolari causati da un’artrosi documentata radiologicamente, ...); età compresa tra i 18 e i 60 anni; obesità di durata superiore a 5 anni; precedente fallimento del trattamento medico dietetico protratto per almeno 1 anno; capacità di comprendere la procedura e volontà di aderire alle regole comportamentali richieste; assenza di dipendenza da alcool o droghe; assenza di sindromi endocrinometaboliche, di patologie intestinali in fase attiva, di ulcera peptica, di reflusso gastresofageo, di cirrosi epatica; rischio operatorio accettabile.

10 (Livello della Prova IV, Forza della Raccomandazione C).
La percentuale di remissione del diabete nel breve-medio termine è risultata buona nei pazienti con BMI kg/m2 e meno brillante nei pazienti con BMI kg/m2. Questa tendenza e stata recentemente confermata da Scopinaro et al. in uno studio prospettico condotto con Diversione Biliopancreatica. Non vi sono comunque al momento dati a lungo termine sul rapporto rischio/beneficio della chirurgia bariatrica nel paziente con obesità lieve-moderata (con o senza diabete) e in questo gruppo va considerato con maggiore cautela il rischio rappresentato dall’induzione di un livello eccessivo di calo ponderale. La sessione degli standard di cura del diabete riservata alla chirurgia bariatrica nel 2009 dall’ADA concludeva che, sebbene piccoli trials di terapia chirurgica avessero dimostrato un beneficio nel paziente con diabete tipo 2 e BMI 30–35 kg/m2, le evidenze non erano sufficienti a raccomandare la chirurgia in questo tipo di pazienti al di fuori di protocolli di ricerca. Una posizione di maggiore apertura è stata recentemente assunta dall’IDF, che suggerisce la possibilita di trattare chirurgicamente pazienti diabetici tipo 2 con BMI 30–35 kg/m2 in caso di mancato controllo metabolico nonostante terapia medica ottimale, in particolare nel caso il peso sia in aumento o altre comorbosità correlate all’obesità non siano controllate dalle terapia convenzionale. Non vi sono al momento evidenze sufficienti a consigliare in termini generali l’applicazione della chirurgia bariatrica nel paziente con BMI inferiore rispetto a quello considerato soglia di indicazione dalle linee guida correnti. Rimane aperta la possibilita che questa opzione terapeutica possa risultare efficace in termini di rapporto rischio beneficio nel paziente con BMI 30‑35 kg/m2 e comorbosita severa non sufficientemente controllata da terapia medica ottimale, con particolare riferimento al paziente diabetico. E in ogni caso opportuno che questa ipotesi venga esplorata solo nell’ambito di studi controllati di lungo periodo. (Livello della Prova IV, Forza della Raccomandazione C).

11 POSITION STATEMENT SICOB
I) La SICOB, quindi: 1. considerata la recente revisione dello stato dell’arte della chirurgia bariatrica italiana 2. considerata l’evidente riduzione che il trattamento chirurgico determina sul peso 3. analizzato il miglioramento che il trattamento di chirurgia bariatrica determina nelle suddette comorbidità (diabete, sindrome delle apnee notturne, ipertensione arteriosa, artropatia da carico reflusso gastroesofageo) 4. rilevando l’inefficacia del trattamento dietologico-comportamentale e/o farmacologico sul mantenimento del calo ponderale a lungo termine e sulle riduzioni delle suddette comorbidità a lungo termine in pazienti con BMI tra 30 e 35 supporta la indicazione al trattamento chirurgico per Pazienti con BMI tra 30 e 35 + una delle seguenti comorbidità: diabete, sindrome delle apnee notturne, ipertensione arteriosa, artropatia da carico, reflusso gastroesofageo SICOB Consiglio Direttivo SICOb ( ) III) La SICOB raccomanda, infine: 1. che la indicazione al trattamento chirurgico per Pazienti con BMI tra 30 e 35 + una comorbidità: diabete (come indicato nelle premesse che sono parte integante dello Statement), sindrome delle apnee notturne, ipertensione arteriosa, artropatia da carico e reflusso gastroesofageo sia approvata in ambito multidisciplinare (dietologo, internista, psicologo, chirurgo) 5. che i pazienti trattati vengano inseriti in studi clinici in grado di valutare l’effetto dell’intervento di chirurgia bariatrica sulle comorbidità, sulla perdita di peso e sulla sicurezza in pazienti con BMI tra 30 e 35 + una comorbidità (diabete, sindrome delle apnee notturne, ipertensione arteriosa, artropatia da carico, reflusso gastroesofageo).

12 Summary and recommendations
Surgery for Obesity and Related Diseases Vol 9, Issue 1, Pages e1-e10, January 2013 Summary and recommendations 1.Class I obesity is a well-defined disease that causes or exacerbates multiple other diseases, decreases the duration of life, and decreases the quality of life. The patient with class I obesity should be recognized as deserving treatment for this disease. 2.Current options of nonsurgical treatment for class I obesity are not generally effective in achieving a substantial and durable weight reduction. 3.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 for suitable individuals. The existing cutoff of BMI, which excludes those with class I obesity, was established arbitrarily nearly 20 years ago. There is no current justification on grounds of evidence of clinical effectiveness, cost-effectiveness, ethics, or equity that this group should be excluded from life-saving treatment. 4. Gastric banding, sleeve gastrectomy, and gastric bypass have been shown in RCTs to be well-tolerated and effective treatment for patients with BMI 30–35 in the short and medium term.

13 American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice are systematically developed statements to assist health-care professionals in medical decision making for specific clinical conditions. Most of the content herein is based on literature reviews. In areas of uncertainty, professional judgment was applied. These guidelines are a working document that reflects the state of the field at the time of publication. Because rapid changes in this area are expected, periodic revisions are inevitable. We encourage medical professionals to use this information in conjunction with their best clinical judgment. The presented recommendations may not be appropriate in all situations. Any decision by practitioners to apply these guidelines must be made in light of local resources and individual patient circumstances. Copyright © 2013 AACE.

14 The development of these updated guidelines was commissioned by the AACE, TOS, and ASMBS Board of Directors and adheres to the AACE 2010 protocol for standardized production of clinical practice guidelines (CPG). Each recommendation was re-evaluated and updated based on the evidence and subjective factors per protocol. Examples of expanded topics in this update include: the roles of sleeve gastrectomy, bariatric surgery in patients with type-2 diabetes, bariatric surgery for patients with mild obesity, copper deficiency, informed consent, and behavioral issues. There are 74 recommendations (of which 56 are revised and 2 are new) in this 2013 update, compared with 164 original recommendations in 2008. There are 403 citations, of which 33 (8.2%) are EL 1, 131 (32.5%) are EL 2, 170 (42.2%) are EL 3, and 69 (17.1%) are EL 4. There is a relatively high proportion (40.4%) of strong (EL 1 and 2) studies, compared with only 16.5% in the 2008 AACE- TOS-ASMBS CPG. These updated guidelines reflect recent additions to the evidence base. Bariatric surgery remains a safe and effective intervention for select patients with obesity. A team approach to perioperative care is mandatory with special attention to nutritional and metabolic issues.

15 Q1. Which patients should be offered bariatric surgery? (R1-3)
2(2/3)-r. Patients with a BMI ≥35 kg/m2 and 1 or more severe obesity-related co-morbidities, including T2D, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life, may also be offered a bariatric procedure. Patients with BMI of kg/m2 with diabetes or metabolic syndrome may also be offered a bariatric procedure, although current evidence is limited by the number of subjects studied and lack of longterm data demonstrating net benefit. Grade A, BEL 1 for BMI ≥35 kg/m2 and therapeutic target of weight control and improved biochemical markers of cardiovascular disease [CVD] risk Grade B, BEL 2 for BMI ≥30 kg/m2 and therapeutic target of weight control and improved biochemical markers of CVD risk Grade C, BEL 3 for BMI ≥30 kg/m2 and therapeutic target of glycemic control in T2D and improved biochemical markers of CVD risk 3(4)-r. There is insufficient evidence for recommending a bariatric surgical procedure specifically for glycemic control alone, lipid lowering alone, or cardiovascular disease risk reduction alone, independent of BMI criteria (Grade D).

16 come

17 Gli interventi chirurgici attualmente suffragati da dati di letteratura comprendenti casistiche sufficientemente ampie e con follow-up adeguatamente prolungato sono i seguenti: 1. Interventi che limitano l’introduzione del cibo: a) ad azione prevalentemente meccanica (interventi restrittivi): - bendaggio gastrico regolabile; - gastroplastica verticale; - sleeve gastrectomy; b) ad azione prevalentemente funzionale: - bypass gastrico e varianti. 2. Interventi che limitano l’assorbimento dell’energia: - diversione biliopancreatica sec. Scopinaro - DBP con duodenal switch. (Livello di prova V; Forza della Raccomandazione B). 2008 EDISES s.r.l. – Napoli Non abbiamo al momento dati basati sull’evidenza tali da permettere di avviare ogni singolo paziente ad una particolare procedura bariatrica. I fattori che possono risultare utili per la scelta dell’intervento sono relativi al paziente (età; sesso; sovrappeso e distribuzione del grasso; composizione del corpo e consumo energetico; complicanze e condizioni morbose associate con particolare riferimento al diabete tipo 2; spettanza e qualità di vita; livello socio-economico e culturale; motivazione e capacità collaborativa; supporto familiare ed ambientale e distanza geografica dal luogo di cura), alla metodica (esecuzione tecnica; risultati; complicanze specifiche, immediate e tardive) ed al chirurgo (capacità tecnica; cultura ed esperienza, generica e specifica; struttura e sistema sanitario). (Livello di prova VI; Forza della raccomandazione B).

18 Surgery for Obesity and Related Diseases
Vol 9, Issue 1, Pages e1-e10, January 2013 …. Gastric banding, sleeve gastrectomy, and gastric bypass have been shown in RCTs to be well-tolerated and effective treatment for patients with BMI 30–35 in the short and medium term …. .... Laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (RYGB), and laparoscopic biliopancreatic diversion BPD, BPD/duodenal switch (BPD-DS), or related procedures are primary bariatric and metabolic procedures that may be performed in patients requiring weight loss and/or metabolic control ….

19 Long-term outcomes of laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass in the United States. Spivak H, Abdelmelek MF, Beltran OR, Ng AW, Kitahama S Surg Endosc, 2012 Jul;26(7): CONCLUSIONS: Over the long term, LRYGB had an approximate reduction of 15 kg/m(2) BMI and 60% EWL, a significantly better outcome than LAGB patients experienced with band intact. The main issue with LAGB was its 50% failure rate in the long term, as defined by poor weight loss and percentage of band removal. Nevertheless, LAGB had a remarkably safe course, and it may therefore be considered for motivated and informed patients Long-term results of adjustable gastric banding in a cohort of 186 super-obese patients with a BMI≥ 50 kg/m2. Arapis K, Chosidow D, Lehamann M, Bado A, Polanco M, Kamoun-Zana S, Pelletier AL, Kousouri M, Marmuse JP Journal of Visceral Surgery, 149: Apr pg e143-52 At ten years, only 11% of patients have successful bariatric results (%EWL>50%) and we were forced to remove the gastric band in 52.2% of patients because of complications, regardless of the initial operative technique used. Given these results, AGB gastroplasty is not a recommended method for super-obese patients and we believe that a BMI greater or equal to 50 kg/m(2) is a contra-indication for this procedure.

20 WHY THE GASTRIC BAND FAILS
Manuel E. Castro, MD, PhD, FACS Baylor University Medical Center Methodist Dallas Medical Center Dallas, TX Rapid Improvement of Diabetes After Gastric Bypass Surgery Is It the Diet or Surgery? Ildiko Lingvay, MD, MPH, MSCS, Eve Guth, MD, Arsalla Islam, MD and Edward Livingston, MD Diabetes Care, March 25, 2013 Published online before print March 25, 2013, CONCLUSIONS Glucose homeostasis improved in response to a reduced caloric diet, with a greater effect observed in the absence of surgery as compared with after RYGB. These findings suggest that reduced calorie ingestion can explain the marked improvement in diabetes control observed after RYGB.

21 OBES SURG (2012) 22:1521–1526 Conclusion Following bariatric/metabolic surgery, a minority of patients did not show the expected metabolic health benefits. There is no correlation between inadequate weight loss and metabolic nonresponse. Age and a long history of preoperative diabetes mellitus, high preoperative HbA1c levels, and a preoperative multi-drug diabetes medication can be assumed to be negative predictors for metabolic (diabetes) failure in the early postoperative course.

22 OBES SURG, published online 22 March 2013
DOI /s Abstract Is bariatric surgery as primary therapy for type 2 diabetes mellitus (T2DM) with body mass index (BMI) <35 kg/m2 justified? Open-label studies have shown that bariatric surgery causes remission of diabetes in some patients with BMI <35 kg/m2. All such patients treated had substantial weight loss. Diabetes remission was less likely in patients with lower BMI than those with higher BMI, in patients with longer than shorter duration and in patients with lesser than greater insulin reserve. Relapse of diabetes increases with time after surgery and weight regain. Deficiencies of data are lack of randomized long-term studies comparing risk/benefit of bariatric surgery to contemporary intensive medical therapy. Current data do not justify bariatric surgery as primary therapy for T2DM with BMI <35 kg/m2. Until we have such data, which will take many years to obtain, what should be our current position regarding metabolic surgery as a treatment for type 2 diabetes in patients with BMI <35 kg/m2? Since diabetes regulation and cardiovascular risk factor reductions respond well to bariatric surgery in patients with type 2 diabetes with BMI ≥27 and <35 kg/m2, it should be considered as an option in those patients that cannot be adequately controlled on intensive medical therapy. The more obese the type 2 diabetic patient is, the more likely the potential benefit that can be obtained with metabolic surgery. The less overweight the patient, the less likely that there will be a meaningful benefit. In any event, a thorough discussion with the patient about the risks as well as the potential benefits needs to be discussed. Metabolic surgery is not a benign procedure and should only be undertaken if adequate intensive medical therapy is failing.

23 Original Article/ ONLINE FIRST
Impact of Bariatric Surgery on Health Care Costs of Obese Persons: A 6-Year Follow-up of Surgical and Comparison Cohorts Using Health Plan Data Jonathan P. Weiner, DrPH; Suzanne M. Goodwin, PhD; Hsien-Yen Chang, PhD, MHS; Shari D. Bolen, MD, MPH; Thomas M. Richards, MSEE; Roger A. Johns, MD, MHS; Soyal R. Momin, MS, MBA; Jeanne M. Clark, MD, MPH JAMA Surg. 2013;():1-8. doi: /jamasurg Published online February 20, 2013 As evidence has accumulated to support the health benefits of bariatric surgery, the number of procedures has increased dramatically, reaching 220,000 annually as of Additionally, numerous studies have suggested that bariatric surgery reduces healthcare costs by improving patients' health and well-being. Design Longitudinal analysis of claims data comparing a bariatric surgery cohort with a matched nonsurgical cohort. Results Total costs were greater in the bariatric surgery group during the second and third years following surgery but were similar in the later years. However, the bariatric group's prescription and office visit costs were lower and their inpatient costs were higher. Those undergoing laparoscopic surgery had lower costs in the first few years after surgery, but these differences did not persist. Conclusions and Relevance: Bariatric surgery does not reduce overall health care costs in the long term. Also, there is no evidence that any one type of surgery is more likely to reduce long-term health care costs. To assess the value of bariatric surgery, future studies should focus on the potential benefit of improved health and well-being of persons undergoing the procedure rather than on cost savings. The primary outcome was standard costs and adjusted ratios of the surgical patients' healthcare costs as compared with those of the matched nonsurgical group.

24 Is Bariatric Surgery Worth It?
Consistent with bariatric surgery clinical experience, women accounted for 80% of the patients included in the study; 54% of the patients were ages 45 to 64 and 37% were 30 to 44. About half the patients in both groups had hypertension, and 25% to 30% had type 2 diabetes. The two groups had comparable healthcare costs in the year prior to date of the surgical patients' procedures: $8,850 in the surgical cohort and $9,590 for the comparison group. The standardized cost of surgery was $29,517, including the surgery and 30-day follow-up period. In the first year after surgery, healthcare costs averaged $8,905 in the surgery cohort and $9,908 in the comparison group. During year 2, total healthcare costs in the surgical cohort peaked at $9,908, whereas costs in the comparison group decreased to $9,264. Costs in the surgery cohort exceeded those of the comparison group for 3 of the next 4 years: Year 3 -- $9,211 versus $9,041 Year 4 -- $9,051 versus $9,232 Year 5 -- $9,386 versus $8,966 Year 6 -- $9,259 versus $8,714 Bariatric surgery patients had lower costs for prescriptions and clinic visits but higher costs for inpatient care compared with the comparison group. In a critique of the study, JAMA deputy editor Edward H. Livingston, MD, said bariatric surgery clearly benefits a subgroup of patients who have a complication or condition known to improve dramatically with weight loss, such as diabetes and osteoarthritis. Reducing body mass index should not be the exclusive indication for the surgery. "Bariatric surgery has dramatic short-term results, but on a population level, its outcomes are far less impressive," Livingston wrote. "In this era of tight finances and inevitable rationing of healthcare resources, bariatric surgery should be viewed as an expensive resource that can help some patients. Those patients should be carefully vetted and the operations offered only if there is an overwhelming probability of long-term success." February 20, 2013 Is Bariatric Surgery Worth It?

25 International Journal for Equity in Health 2012, 11:54
Conclusions: The proportion of bariatric surgery-eligible Canadians that undergo publicly funded bariatric surgery is very low. There are notable differences in sociodemographic profiles and prevalence of comorbidities between surgery-eligible subjects and surgical recipients.

26 Pitfalls in using BMI as a selection criterion for bariatric surgery
Livingston, Edward H Current Opinion in Endocrinology, Diabetes & Obesity October Volume 19 - Issue 5 - p 347–351 Purpose of review: Because obesity was thought to be an important independent predictor for mortality, the eligibility criteria for bariatric procedures are all indexed to some minimum level of BMI. Recent evidence suggests that BMI is a poor correlate of mortality, suggesting that BMI should not serve as the basis for bariatric surgery approval. Recent findings: Longevity studies of patients who have undergone bariatric operations have shown either a little or no improvement in survival. The distribution of fat is a far greater predictor of complications of obesity then the degree of obesity itself. When excessive amounts of calories are deposited into muscle it causes insulin resistance and diabetes. Consequently, weight loss induced by any means is an extremely effective treatment for obesity-related diabetes. Summary: BMI is used as a criterion for bariatric surgery because it was thought that weight loss would be associated with greater longevity. This is not been the case and BMI should no longer be used to select patients for bariatric procedures. Bariatric operations should be offered to patients with complications of obesity that would be expected to resolve with weight loss such as diabetes.

27 Curr Opin Endocrinol Diabetes Obes 2012, 19:339–340
... one unifying answer is that we need to rethink our approach. Calculating the BMI can be useful, however, important clinical decisions for the individual patient may be better served by consideration of overall risks, independent of the BMI. Moreover, it is now incumbent upon our governments to incorporate these ideas into new policies that are not based solely on numbers. In addition, our food supply is changing so fast that we cannot say with certainty what we are eating anymore.What this has done to our risk of obesity and comorbidities as well as cancers has yet to be elucidated completely. Legislation should be ready to make adjustments as data surfaces. Continued research on prevention and treatment of obesity should be paving the way for better outcomes. The health of our future generations rides on it.

28 The Edmonton obesity staging system
A proposed clinical staging system for obesity A M Sharma and R F Kushner International Journal of Obesity (2009) 33, 289–295; published online 3 February 2009 Current classifications of obesity based on body mass index, waist circumference and other anthropometric measures, although useful for population studies, have important limitations when applied to individuals in clinical practice. Thus, these measures do not provide information on presence or extent of comorbidities or functional limitations that would guide decision making in individuals. In this paper we review historical and current classification systems for obesity and propose a new simple clinical and functional staging system that allows clinicians to describe the morbidity and functional limitations associated with excess weight. It is anticipated that this system, when used together with the present anthropometric classification, will provide a simple framework to aid decision making in clinical practice. The Edmonton obesity staging system Stage 0. No apparent risk factors (e.g., blood pressure, serum lipid, and fasting glucose levels within normal range), physical symptoms, psychopathology, functional limitations, and/or impairment of wellbeing related to obesity Stage 1. Presence of obesity-related subclinical risk factors (e.g., borderline hypertension, impaired fasting glucose levels, elevated levels of liver enzymes), mild physical symptoms (e.g., dyspnea on moderate exertion, occasional aches and pains, fatigue), mild psychopathology, mild functional limitations, and/or mild impairment of well-being Stage 2. Presence of established obesity-related chronic disease (e.g., hypertension, type 2 diabetes, sleep apnea, osteoarthritis), moderate limitations in activities of daily living, and/or well-being Stage 3. Established end-organ damage such as myocardial infarction, heart failure, stroke, significant psychopathology, significant functional limitations, and/or impairment of well-being Stage 4. Severe (potentially end-stage) disabilities from obesity-related chronic diseases, severe disabling psychopathology, severe functional limitations, and/or severe impairment of well-being

29 Appl Physiol Nutr Metab, 2011, 36:570–576
We sought to determine whether the Edmonton Obesity Staging System (EOSS), a newly proposed tool using obesity-related comorbidities, can help identify obese individuals who are at greater mortality risk. Data from the Aerobics Center Longitudinal Study (n = 29 533) were used to assess mortality risk in obese individuals by EOSS stage (follow-up (SD), 16.2 (7.5) years). The effect of weight history and lifestyle factors on EOSS classification was explored. Obese participants were categorized, using a modified EOSS definition, as stages 0 to 3, based on the severity of their risk profile and conditions (stage 0, no risk factors or comorbidities; stage 1, mild conditions; and stages 2 and 3, moderate to severe conditions). Compared with normal-weight individuals, obese individuals in stage 2 or 3 had a greater risk of all-cause mortality (stage 2 hazards ratio (HR) (95% CI), 1.6 ( ); stage 3 HR, 1.7 ( )) and cardiovascular-related mortality (stage 2 HR, 2.1 ( ); stage 3 HR. 2.1 ( )). Stage 0/1 was not associated with higher mortality risk. Lower self-ascribed preferred weight, weight at age 21, cardiorespiratory fitness, reported dieting, and fruit and vegetable intake were each associated with an elevated risk for stage 2 or 3. Thus, EOSS offers clinicians a useful approach to identify obese individuals at elevated risk of mortality who may benefit from more attention to weight management. Further research is necessary to determine what EOSS factors are most predictive of mortality risk, and whether these findings can be generalized to other obese populations.

30 OBES SURG (2011) 21:1947–1949 The progressively increasing population of obese individuals is an ongoing global epidemic. Bariatric surgical intervention remains the only evidence-based approach to produce marked sustainable weight loss in severely obese patients. However, with limited health-care resources, it remains an important challenge to determine which patients will benefit most. The EOSS may be an important tool to redefine indications for bariatric surgery in obese individuals. Further research to determine how to incorporate the EOSS into clinical bariatric practice is needed. CMAJ, October 4, 2011, 183(14) The Edmonton obesity staging system independently predicted increased mortality even after adjustment for contemporary methods of classifying adiposity. The Edmonton obesity staging system may offer improved clinical utility in assessing obesity related risk and prioritizing treatment.

31 • Access to bariatric surgery is often limited.
CMAJ • November 24, 2009, 181(11) Key points • Bariatric surgery is indicated for medically refractory patients with severe obesity or with moderate obesity plus a major medical comorbidity. • Bariatric surgery substantially improves obesity-related comorbidities, survival and quality of life, but carries a significant risk of perioperative death and a 20% chance of chronic gastrointestinal symptoms. • Access to bariatric surgery is often limited. • In Canada, the demand exceeds capacity by nearly 600-fold. • Governments and administrators need to recognize the immense need that exists.

32 considerazioni La scelta del BMI come indicazione alla Chirurgia Bariatrica (> 40 o > 35 se presenti co-morbosità, NIH 1991, e segg.) ha determinato un grande incremento degli interventi chirurgici, non accompagnato dalla reale dimostrazione della riduzione della mortalità e dei costi, collegata alla semplice perdita di peso. Anche l’estensione della terapia chirurgica ai BMI < 35 con comorbosità ha contribuito a questa situazione. Di conseguenza, la stima della necessità di interventi bariatrici, sulla base del solo criterio BMI, fa prevedere un volume di attività irreale, non solo per l’impossibilità materiale di effettuarla, ma anche, e soprattutto, per l’impraticabile spesa sanitaria relativa, sia pubblica che privata. Questo pone un problema di duplice tipo: economico-gestionale e etico-sanitario. I budget contrattati con il SSN con i tetti di spesa e la valutazione di quali pazienti operare o no e quali priorità individuare potrebbero non poter risolvere le modalità con cui si potrà affrontare davvero l’epidemia obesità. Anche il numero delle complicazioni e delle recidive da trattare sarebbe, in termini assoluti, eccessivo. Attualmente, presso molte istituzioni pubbliche e private già si è condizionati da controlli preventivi o consuntivi di Commissioni di controllo che avallano o bocciano la programmazione di interventi bariatrici: ad es., sono ancora valide e seguite le linee guida nazionali/internazionali e non si accettano in molti casi, o si accettano dopo approfondimento collegiale caso per caso, le position statements delle Società Scientifiche. E’ evidente che è una mera operazione economica, ma sta iniziando anche nel nostro paese quanto già in corso in altri stati con un servizio sanitario nazionale o pubblico o con assicurazioni private (ad es., il Canada e gli USA con Medicare e Medicaid).

33 La Chirurgia dell’Obesità dovrebbe essere considerata terapeutica, cioè indicata quando si associno malattie importanti e il paziente sia critico, e non preventiva delle co-morbosità e dei presunti alti costi dell’assistenza all’obeso: ciò eviterebbe la troppo lunga attesa dei pazienti più gravi e più urgenti, e conterrebbe la spesa sanitaria. Tra l’altro, il fallimento in alta percentuale di alcuni tipi di interventi bariatrici vanifica l’ipotetico effetto di prevenzione delle malattie associate rilevanti. Sembra quindi indispensabile selezionare i pazienti da avviare alla chirurgia sulla base di altri fattori, che comprendano, oltre al BMI, l’età e le patologie associate, soprattutto metaboliche, cardiovascolari e respiratorie, considerando che il BMI non riflette la reale condizione clinica del paziente. La classificazione secondo i Criteri di Edmonton identifica il rischio di mortalità nei grandi obesi, essendo gli stadi 0 e 1 a basso rischio se confrontati con gli stadi 2, 3 e 4. Gli stadi sono caratterizzati dalla presenza e dalla gravità delle co-morbosità. Lo stadio 4 è caratterizzato da co-morbosità gravi in fase terminale. Varie esperienze confermano come sia possibile sottoporre a intervento bariatrico i pazienti più gravi con ottimi risultati in termini di mortalità e risoluzione delle co-morbosità. La scelta dei pazienti dello stadio 2 e 3 di Edmonton appare strategica per ottenere il massimo successo della cura: un reale vantaggio in termini di costo-efficacia e di mortalità. Tale scelta si deve riflettere sulla formazione delle liste d’attesa, affinché privilegino i pazienti per i quali non è etico, a causa del deterioramento clinico, procrastinare per mesi o anni l’intervento, soprattutto se preceduti da pazienti che non siano nell’imminenza di grave malattia.

34 Quindi .... non pro o contro BMI < 35 o qualsiasi altro schema in dipendenza dal BMI, .... ma, attraverso studi controllati, prospettici e multicentrici di analisi costo-efficacia che dovrebbero confermare il reale impatto della chirurgia sulla risoluzione dei gravi problemi clinici del paziente obeso, i criteri di Edmonton potrebbero essere scelti o tenuti in considerazione come base per l’indicazione chirurgica. Inoltre, la possibilità di elaborare un indice che possa sostituire le indicazioni del NIH 1991 e i successivi passaggi con position statements, raccomadazioni e linee guida porterebbe a diffondere criteri di scelta univoci e condivisi, anche da chi gestisce il SSN. Grazie