Maurizio De Luca MD

  Department of Surgery – Regional Hospital of Vicenza – ItalyDepartment of Surgery – Regional Hospital of Vicenza – Italy

 

XXI Congresso Nazionale SICOb

Cagliari, 25-27 Aprile 2013

Controversie in Chirurgia Bariatrica

Chirurgia Bariatrica con BMI compreso tra 30 e 35: perchè, quando, come?

Pro

Maurizio De Luca

1. Patients in age group from 18 to 60 years2. With BMI ≥ 40 kg/m2

3. With BMI 35-40 kg/m2  with comorbidity in which surgically induced weight loss is expected to improve the disorder:

a. metabolic disordersb. cardio-respiratory diseasec. severe joint diseased. obesity-related severe psychological problems

4.     Current BMI or documented previous BMI of this severity    a. Weight  Loss  as  a  result  of  intensified  treatment before  surgery  is  not  a     

contraindication for the planned bariatric surgeryb. Bariatric Surgery is indicated in Patients who exhibited substantial weight loss in 

a  conservative treatment but started to gain weight again5.     Failed to  lose weight or to maintain  long-term weight  loss, despite appropriate non-surgical 

medical care6.     Compliance with medical appointments

NIH Conference: Gastrointestinal Surgery for Severe Obesity. Consensus Development Conference Panel.Ann Intern Med 1991; 115; 956-961

Ridley N: Expert Panel on Weight Loss Surgery – Executive ReportObes Res 2005; 13:206-226

Indication For Bariatric Surgery NIH 1991

Maurizio De Luca

BMI - International Guidelines for  eligibility to bariatric surgery

NIH. Gastrointestinal Surgery for Severe Obesity. National Institutes of Health. Consensus Development Conference Statements. Am J Clin  Nutr 1992; 55: 615S-9S.

NHMRC Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults. Canberra: National Health and Medical Research Council; 2003

NICE. Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children.. London: National Institute for Health and Clinical Excellence: 2006

European. Inter-disciplinary European Guidelines on surgery of severe obesity. Int J Obes London 2007; 31: 569-677

ADA Standards of Medical Care in Diabetes. 2010 Diabetes Care, 33, S11-61

SIGN. Management of Obesity: Summary of SIGN Guideline. BMJ 2010; 340,154.

NIH (USA) NHMRC (Australia) NICE (UK) European ADA (USA) SIGN (Scotland)

Year 1991 2003 2006 2007 2010 2010

BMI >4035-40 with 1 serious weight loss responsive comorbidity

>4035-40 with 1 serious weight loss responsive comorbidity

>4035-40 with disease that improve weight loss

>4035-40 with 1 weight loss responsive comorbidity

>4035-40 if control of diabetes or comorbidity is difficult

>4035-40 with 1 serious weight loss responsive comorbidity

Medicare NCD (National Coverage Determinations) 2004 removed “serious”BMI 30-35

Recognise use BMI <35

Weight loss pre-surgery does not change eligibility

BMI < 35 insufficient evidence to date

Maurizio De Luca

Randomized Trials and Meta-analysis of bariatric surgery including Patients with BMI < 35

Maurizio De Luca

Study Type BMI range N Duration FU Weight Loss BMI change Health outcomes

Observational studies of bariatric surgery including Patients with BMI < 35

Maurizio De Luca

Observational studies of bariatric surgery including Patients with BMI < 35

Maurizio De Luca

2009Cochrane Review stated that Bariatric Surgery resulted in greater weight  loss than conventional  treatment  in  Obese  Class  I  (BMI 30-35)  accompanied  by improvements in comorbidities such as Type 2 Diabetes, Hypertension, OSAS,  and improvements in health related quality of life.

Colquitt JL, Pico J, Loveman E, Surgery for Obesity. Cochrane Database Syst Rev 2009 CD003641

BMI 30-35

Maurizio De Luca

Bariatric Surgery in Low BMI

BMI 32-35

1.Indication  for  bariatric  surgery  in  Patients  with  BMI  32-35  should  be  considered individually

2.Strongly discouraged for age > 60 years, absolutely contraindicated for age <18

3.Main Comorbidities which indicate surgery BMI 32-35:a) Severe degree of diabetes (Hgb A1c>9 on maximal medical therapy)b) Hypertensionc) Severe sleep apnead) Venous stasis diseasee) Severe degree of joint painf) Impaired Quality of Life

Fried M, et al: Inter-disciplinary European Guidelines on Surgery of Severe ObesityInt J Obes 2007;31:569-77

Yermilov I, Mcgory M, Shekelle P: Appropriate Criteria for Bariatric Surgery: Beyond the NIH Guidelines Obesity, 1-7, 78, 2009

(Evidence Level C, D)

Maurizio De Luca

Bariatric Surgery in Low BMI

BMI 30-32

1.Indication for bariatric surgery in Patients with BMI 30-32 is strongly restricted

2.Absolute contraindication for age < 18 and > 60 years(Evidence Level C,

D)

3.    Operation  on  these  individuals  should  be  conducted  within  clinical  trials,  such  as  for those with diabetes

Fried M, et al: Inter-disciplinary European Guidelines on Surgery of Severe ObesityInt J Obes 2007;31:569-77

Yermilov I, Mcgory M, Shekelle P: Appropriate Criteria for Bariatric Surgery: Beyond the NIH Guidelines Obesity, 1-7, 78, 2009

Maurizio De Luca

Italian Society of Bariatric Surgery and Metabolic Disorders (SICOb) Position Statement (2008)

Bariatric  Surgery BMI 30-35 in case of:

a) Diabetes, Type IIb) Sleep Apnoea Syndromec) Hypertensiond) GERDe) Degenerative arthritis

P.S. : Diabetes: > 3 years, HgA1c > 7.5%, Failure prevoius medical treatment

Bariatric Surgery in Pts with BMI 30-35

Maurizio De Luca, Luca Busetto, Luigi Angrisani and SICOB Executive Board

Maurizio De Luca

International Guidelines for  eligibility for bariatric surgery

FDA expands use of banding system for weight loss. Patients with BMI 30-35 now qualify

The U.S. Food and Drug Administration has expanded the use of Allergan’s LAP-BAND Adjustable Gastric Banding System, a device implanted around the upper part of the stomach to limit the amount of food that can be eaten at one time.

The February 16, 2011, approval expands the use of the LAP-BAND to include obese individuals with a BMI of 30 to 35 who also have an existing condition related to their obesity.

The FDA approved the LAP-BAND in 2001 for use in severely obese patients with a body mass index (BMI) of at least 40, those with a BMI of at least 35 and who also have an existing severe condition related to their obesity, such as heart disease or diabetes, or those who are at least 100 pounds overweight. BMI is a general measure of body fat based on an individual’s weight and height.

Friday, February 16, 2011

Maurizio De Luca

1) 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

2) The existing cutoff of BMI, which excludes those with Class I Obesity, was established arbitrarly nearly 20 years ago

3) There is no current justification on ground of evidence, of clinical effectiveness, cost-effectiveness, ethics, or equity, that this group of patients (30-35) should be excluded from life-saving treatment.

SOARD (9) 2013: ASMBS Statements and Guidelines

Maurizio De Luca

American Association of Clinical Endocrinologists (AACE)The Obesity Society (TOS)American Society of Metabolic and Bariatric Surgery (ASMBS)

Patients offered bariatric surgery:

1)Grade A Best Evidence Level 1 for BMI > 35 target of weight control and improved of biochemical markers of CVD risk

2) Grade B Best Evidence Level 2 for BMI > 30 target of weight control and improved of biochemical markers of CVD risk

3) Grade C Best Evidence Level 3 for BMI > 30 target of glycemic control in T2D and improved of biochemical markers of CVD risk

AACE/TOS/ASMBS Guidelines 2013

Endocrine Practice Vol 19 No 2 March/April 2013

Maurizio De Luca

Bariatric Surgery Controversies (BMI 30-35)

CONCLUSION

1. Class I Obesity is a disease thae causes multiple other diseases, decreas the duration of life, desreases QoL.

1. Current option in nonsurgical treatment for Class I obesity are not generally effective in achieving a substantial and durable weight reduction

1. For Patients with BMI 30-35 who do not achieve substantial and durable weight and comorbidity improvement with non-surgical methods, bariatric surgery is an available option.

1. Bariatric Surgery has been shown in randomized, controlled trials, to be a safe and effective treatment for patients with BMI 30-35

Maurizio De Luca

Bariatric Surgery Controversies (BMI 30-35)

Thank You for your attention