35 kg/m 2 Surgery for Obesity and Related Diseases

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)
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 ...
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
perchè
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 332-338, 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 707-713, 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):352-358, 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): 365-372
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, 9:149-150
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 27. 9 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.
Consensus Development Conference Panel. Gastrointestinal surgery for severe obesity:
Consensus Development Conference statement.
Ann Intern Med. 1991:115:956-961
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
3. Recommendations
3.1 Management of Diabetes
2011
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 comorbidities. Under
some circumstances people with a BMI 3035 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.
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.
3.2.10 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.
3.2.11 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.
Eating Weight Disord.
15: 1-31, 2010 ©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.
La percentuale di remissione del diabete nel breve-medio termine è risultata buona nei pazienti con BMI 30-35
kg/m2 e meno brillante nei pazienti con BMI 25-30 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).
POSITION STATEMENT SICOB
I) La SICOB, quindi:
SICOB
Consiglio
Direttivo SICOb
(2008-2010)
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
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).
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.
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.
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.
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 30-34.9 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).
come
2008 EDISES s.r.l. – Napoli
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).
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).
Surgery for Obesity
and Related Diseases
Vol 9, Issue 1, Pages e1e10, 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 ….
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):1909-19
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, 149:2 2012 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 superobese patients and we believe that a BMI greater or equal to 50 kg/m(2) is a
contra-indication for this procedure.
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.
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.
OBES SURG, published online 22 March 2013
DOI 10.1007/s11695-013-0907-1
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
should be considered as an
option in those patients that cannot be adequately controlled on intensive medical therapy.
respond well to bariatric surgery in patients with type 2 diabetes with BMI ≥27 and <35 kg/m2, it
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.
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:10.1001/jamasurg.2013.1504.
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 2009. Additionally, numerous studies have suggested that bariatric surgery reduces
healthcare costs by improving patients' health and well-being.
Design Longitudinal analysis of 2002-2008 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.
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.
February 20, 2013
Is Bariatric
Surgery Worth It?
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."
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.
Pitfalls in using BMI as a selection criterion for bariatric surgery
Livingston, Edward H
Current Opinion in Endocrinology, Diabetes & Obesity
October 2012 - 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.
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.
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
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 (1.3-2.0); stage 3 HR, 1.7 (1.4-2.0)) and cardiovascular-related
mortality (stage 2 HR, 2.1 (1.6-2.8); stage 3 HR. 2.1 (1.6-2.8)). 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.
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.
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.
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).
La Chirurgia dell’Obesità dovrebbe essere considerata terapeutica, cioè indicata
quando si associno malattie importanti e il paziente sia critico, e non preventiva delle comorbosità 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.
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.