Bariatric Surgery Ruban Nirmalan Medical Director, IUH Arnett Bariatrics

Bariatric Surgery

Ruban Nirmalan

Medical Director, IUH Arnett Bariatrics

Disclosures

• None

04/11/23 2

• Impact of Obesity

• Weight Loss Makes a Difference

• Surgical Options for Weight Loss

• Safety and Effectiveness of Adjustable Gastric Banding System vs. Other Surgical Options

• Adjustable gastric band Is Effective in Obese and Moderately Obese Patients

• Gradual Weight Reduction With Gastric Band Results in Better Quality of Weight Loss

Review of Today’s Topics

3

Impact of Obesity

04/11/23 4

Disease Risk*

― Increased High Very high Extremely high

*Disease risk for type 2 diabetes, hypertension, and cardiovascular disease (CVD), relative to normal weight and waist circumference.

1. National Institutes of Health/National Heart, Lung and Blood Institute. NIH Publication 98-4083, Rockville, MD: September 1998. 2. US Department of Health and Human Services. The Surgeon General’s Call to Action to Prevent and Decrease Overweight and Obesity; Rockville, MD: 2001.

NorNormal1Weight1 (BMI 18.5 to 24.9)

Overweight1

(BMI 25 to 29.9) Obese1

(BMI 30 to 34.9)

Class I Obesity

Moderate Obesity1 (BMI 35 to 39.9 )

Class II Obesity

Morbid Obesity1

(BMI 40 or more)

Class III Obesity

Classification of Overweight and Obesity by Body Mass Index (BMI), Waist Circumference and Associated Disease Risk*

• Additional Risks:– Large waist circumference (men >40 in; women >35 in)1

– Weight gain of as little as 11 pounds increases risk of developing type 2 diabetes2

– Specific races and ethnic groups1

5

Pulmonary disease•Abnormal function•Obstructive sleep apnea•Hypoventilation syndrome

Nonalcoholic fatty liver disease•Steatosis•Steatohepatitis•Cirrhosis

Coronary heart disease•Diabetes•Dyslipidemia•Hypertension

Gynecologic abnormalities•Abnormal menses•Infertility•Polycystic ovarian syndrome

Osteoarthritis

Skin problems

Gall bladder disease

Cancer•Breast, uterus, cervix, colon, esophagus, pancreas, kidney, prostate

Phlebitis•Venous stasis

Gout

Medical Complications of Obesity1

Idiopathic intracranial hypertension

Stroke

Cataracts

Severe pancreatitis

1. Bhoyrul S, Lashock J. JMCM. 2008:11(4):10-17.

6

Widely Accepted That Obesity Is Associated With Increased Morbidity

18%

2%

9%

29%

4%

18%

39%

6%

21%

48%

10%

21%

Hypertension Type 2 Diabetes DyslipidemiaAxis Title

National Health and Nutrition Examination Survey (NHANES) 1999-2004Prevalence of Hypertension, Type 2 Diabetes, and Dyslipidemia by BMI

18-24.9 kg/m2 ≥25-29.9 kg/m2 ≥30-34.9 kg/m2 ≥35-39.9 kg/m2

Nguyen NT et al. J Am Coll Surg. 2008;207(6):928-934.

7

Hypertension Type 2 Diabetes

Dyslipidemia

Pre

vale

nce

(%

)

Weight gain of 11 pounds or more has been shown to increase the risk of developing Type 2 Diabetes.

*BMI ≥30 or about 30 lbs overweight for 5’4” person. Includes gestational diabetes.

1. CDC US Obesity Trends. http://www.cdc.gov/obesity/data/trends.html. Accessed January 13, 2011; 2. World Health Organization, the Economist Intelligence Unit, BCG Analysis.

Behavioral Risk Factor Surveillance System, 1990, 1995, 2000, 2005, and 20081

Obesity Trends* Among Adults

No Data <10% 10%-14% 15%-19% 20%-24% 25%-29% ≥30%

20082005

• From 1990 to 2000, morbid obesity (BMI ≥40 kg/m2) nearly tripled from 0.8% to 2.2%3

• Between 2005 and 2015, the US obese population is expected to increase 59% to 140 MM2

8

1990 1995 2000

BMI vs. Mortality

16 19 22 25 28 31 34 37 40 45

0

50

100

150

200

250

300

350

400

Rel

ativ

e M

orta

lity

Rat

e p

er 1

00,0

00

BMI (kg/m2)

Exponential Increase in Risk

High risk

Medium risk

Low risk

Data based on BMI distribution from the Third NHANES (NHANES III)—a 6-year study from 1988-1994.

Fontaine KR et al. JAMA. 2003;289(2):187-193.

For adults with a BMI >45, life expectancy decreases by up to 20 years1

9

Costs Associated With Obesity1

14.5%

Impact of Obesity: Social and Economic Effects

• Social Impact– Getting a job, making a good

impression– Dealing with judgmental behavior– Compromising health and

premature aging

• Economic Impact*1-6

– As weight increases, so does medical spending in the health care system

– $139 billion in direct and indirect costs annually

– Annual costs for obesity are ~15× greater than those for being overweight

– Increased personal spending on prescriptions, weight-loss products

– By 2030, health care costs attributable to overweight/obesity could account for 16% to 18% of total US health care costs

*Regression approach using data from 1998 Medical Expenditure Panel Survey and the 1996-97 National Health Interview Surveys. N=9867 adults. Percent of increase is significant across all payors (P<.05).

†Value of years of life lost measured by the dollar value of a quality-adjusted life year.

1. Dor A et al. September 21, 2010. www.gwumc.edu/sphhs/departments/healthpolicy/pdf/HeavyBurdenReport.pdf. Accessed February 15, 2011; 2. Finkelstein EA et al. Health Aff. 2003; doi10.1377/hthaff.w3.219; 3. Finkelstein EA et al. Obes Res. 2004;12(1):18-24; 4. Sturm R. Health Aff. 2002;21(2):245-253; 5. Warner J. Web MD: November 8, 2004; 6 Wang Y et al. Obesity. 2008;16(10):2323-2330.

10

†

Weight Loss Makes a Difference

04/11/23 11

Plasma Lipids Improve With Weight Loss: Meta-analysis of 70 Clinical Trials1

*P ≤.05

LDL-C=low-density lipoprotein cholesterol; HDL-C=high-density lipoprotein cholesterol; TG=triglycerides.

1. Dattilo AM et al. Am J Clin Nutr. 1992;56(2):320-328.

-0.06

-0.04

-0.02

0.00

0.02

TotalCholestero

l LDL-C TG

HDL-C(weight stable) HDL-C

(actively losing)

m

mol/

L p

er

kg

of

Weig

ht

Loss

m

g/d

L p

er k

g o

f Weig

ht

Loss

*

**

*

*

0.5

0.0

-0.5

-1.0

-1.5

-2.0

-2.5

12

Disease Resolution With Weight Loss

Weight Loss: Effect on Comorbidities

Comorbidity ∆Weight ∆Effect

Type 2 diabetes1 >13.6 kg>10%

A1C by 2.6A1C by 1.6

High blood pressure2 8.8 kgDiastolic: -7.0 mm HgSystolic: -5.0 mm Hg

Heart disease3 2.25 kg -48% risk factor sum

Sleep apnea4 10% 20%

-26% AHI-48% AHI

AHI=apnea hypopnea index (apnea events + hypopnea events per hour of sleep)1. Wing RR et al. Arch Intern Med. 1987;147(10):1749-1753; 2. Stevens VJ et al. Ann Intern Med. 2001;134(1):1-11; 3. Wilson PW et al. Arch Intern Med. 1999;159(10):1104-1109; 4. Peppard PE et al. JAMA. 2000;284(23):3015-3021.

13

Obesity can lead to resistance against insulin and leptin, which are two hormones that work to regulate metabolism and appetite in the body.

Current Obesity Treatment Guide

National Institutes of Health. National Heart, Lung and Blood Institute. NIH Publication No. 00-4084. October 2000. www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed January 13, 2011.

BMI Category (kg/m2)

Treatment 25-26.9 27-29.9 30-34.9 35-39.9

Diet, exercise, behavior therapy

With comorbidities

With comorbidities + +

Pharmacotherapy With comorbidities + +

SurgeryWith

comorbidities

14

Major US Commercial Weight Loss Programs Aren’t Effective Long Term for Most Patients

1. Tsai AG et al. Ann Intern Med. 2005;142(1):56-66; 2. Copeland PM. Nat Clin Pract Endocrinol Metab. 2006;2(12):658-659; 3. Truby H et al. BMJ. 2006;332(7553)1309-1314; 4. Gold BC et al. Obesity. 2007;15(1):155-164.

Treatment Weight Change (%) Attrition Rate (%)

Short Term Long Term Initial Long Term

TOPS®1

Nutrition and behavior therapy, therapist-2.3 to 0.4 at 12 weeks -3.2 – 1.6 at 1 year Not given 38 to 67 at 1 year

Health Management Resources®1

Very low calorie diet (VLCD) using meal replacements with or without usual foods

-15.3 – 14.1 at 12 weeks -8.4 at 1 year 0 – 2.5 7.5 at 1 year

Optifast®1 Group counseling and 12-week VLCD -21.8 at 26 weeks -9.0 at 1.5 years 45 57 at 1.5 years

Weight Watchers®1

Weight Watchers, groupSelf-help with 2 visits and a dietician

5.3 at 26 weeks1.5 at 26 weeks

3.2 at 2 years0 at 2 years

18 at 1 year18 at 1 year

27 at 2 years27 at 2 years

Slim-Fast®2,3

Meal replacement, support pack (self-help) -6.8 at 6 months -11.4 at 1 year Not given Not given

Vtrim®4

Internet-based behavioral intervention -7.3 at 6 months -5.5 at 1 year 18 at 6 months 35 at 12 months

eDiets®4

Internet-based, self-help program -3.6 at 6 months -2.8 at 1 year 19 at 6 months 23 at 12 months

15

Why Current FDA-Approved Weight-Loss Drugs May Not Work

• May not sustain long-term weight loss in most patients1,2,3

– Average weight loss with medication is only 5% to 10%1,4

– Obesity is a complex condition with multiple underlying causes– Medication may not be targeting all the mechanisms driving hunger and cravings

• Hunger is not the only trigger for eating– Other powerful forces drive eating – comfort eating, social eating– Food is not used solely for nutritional reasons– Genetics and impaired metabolism

• Side effects can interfere with compliance and increase dropout rates

– Cause insomnia, drowsiness, irritability, or depression1

– Fat absorption drugs can cause muscle cramping, diarrhea, flatulence, and intestinal discomfort1

– Consuming excess amounts of fat while taking those drugs may cause greater intestinal discomfort

1. Abbott Laboratories. Prescribing Information. Meridia Capsules; 2006; 2. Ioannides-Demos LL et al. Pharmacotherapy for obesity. Drugs. 2005;65(10):1391-418; 3. Li Z et al. Ann Intern Med. 2005;142(7):532-546; 4. Roche Laboratories. Prescribing Information. Xenical Capsules; 2007

Still… benefits may outweigh risks when evaluating weight-loss programs and pharmacotherapy

16

Surgical Options for Weight Loss

04/11/23 17

Trends in Bariatric Surgery

Data on file. Allergan, Inc. Total Procedures – ASMBS 2002-2007, AGN Estimates 2008-2010; Banding 2002-2008 – LAP-BAND® Sales; Total Banding/Bypass/Sleeve Procedures – AGN Estimates.

2002 2003 2004 2005 2006 2007 2008 2009

0

50,000

100,000

150,000

200,000

250,000

300,000

Bari

atr

ic P

roced

ure

s (

No.)

0

20

40

60

80

100

Pro

ced

ure

Sh

are

(%)

Banding ShareBypass Share Sleeve ShareTotal Procedures

18

15 MM surgery candidates… only 1% (177 K) had surgery in 2009/2010.

Bariatric Surgical Options: How They Work

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)1

Laparoscopic Adjustable Gastric Banding

(LAGB)1,2

Laparoscopic Sleeve Gastrectomy3

1. Needleman BJ. Surg Clin North Am. 2008;88(5):991-1007; 2. Dixon JB et al. Arch Intern Med. 2001;161(1):102-106; 3. Weiner RA et al. Obes Surg. 2007;17(10):1297-1305.

19

Roux-en-Y Gastric Bypass

04/11/23

Advantages• Rapid initial weight loss• No implant required

Disadvantages• Stomach stapling and

intestinal rerouting• Non-adjustable and

virtually non-reversible• Higher complication rates

after surgery• Dumping syndrome

possible• Vitamin deficiencies

possible

04/11/23

Potential Complications

Sleeve Gastrectomy

04/11/23

Advantages• Rapid initial weight loss• No implant required

Disadvantages• Stomach stapling• Complications possible• Non-adjustable• Non-reversible • Longer hospital stay and

recovery

04/11/23


Laparoscopic Gastric Banding Surgery

04/11/23

Advantages

• No stapling of the stomach

• Gradual, healthy weight loss

• Long-term weight loss

Disadvantages

• Requires adjustments by your surgeon

• Lose one to two pounds per week

04/11/23


Overall, Bariatric Surgery Has a Proven Safety and Low Mortality Rate

26

1. Flum DR et al. N Engl J Med. 2009;361(5):445-454; 2. DeMaria EJ et al. Ann Surg. 2007;246(4):578-582; 3. Buchwald H et al. JAMA. 2004;292(14):1724-1737; 4. US Department of Health & Human Services. AHRQ. http://hcupnet.ahrq.gov. Accessed January 13, 2011.

Drug Eluding Stent4

Mortality Rate

Lap Cholecystectomy40.00

0.50

1.00

2.00

Rate

(%

)

Appendectomy4

GI Obstru

ction4

CABG w/ cath4

Carotid Stent4

Hernia4

Flum1

DeMaria2

Buckwald3

HHS4

1.50

Coronary Heart Disease (CHD) Risk Is Significantly Reduced After Bariatric Surgery

27

Vogel JA et al. Am J Cardiol. 2007;99(2):222-226.

Men Women2

4

6

8

10

12

10-y

ear

CH

D R

isk

(%

)

P<.0001

P=.002

Men Women-80

-60

-40

-20

0

20

Ab

solu

te m

g/d

L C

han

ge

P<.0001 for all pairwise changes from baseline

Chol LDL-C HDL-C TGBefore Surgery After Surgery

Change in mean lipid values for men and women. Chol = total cholesterol; HDL-C = high-density lipoprotein cholesterol; LDL-C = low density lipoprotein cholesterol; TG = triglycerides.

10-year predicted CHD risk before (blue bars) and after (amber bars) bariatric surgery for men and women.

Remission or Improvement of Type 2 Diabetes Often Occurs After Bariatric Surgery

28

1. Pontiroli AE et al. Diabetes Care. 2005;28(11):2703-2709; 2. Spivak H et al. Am J Surg. 2005;189(1):27-32; 3. Ponce J et al. Obes Surg. 2004;14(10):1335-1342; 4. Dixon JB, O’Brien PE. Diabetes Care. 2002;25(2):358-363; 5. Torquati A et al. J Gastrointest Surg. 2005;9(8):1112-1116; 6. Skroubis G et al. Obes Surg. 2006;16(4):488-495; 7. Pories WJ et al. Ann Surg. 1995;222(3):339-350.

45%

66%

80%

64%

74%70%

83%

0

20

40

60

80

100

Imp

rove

me

nt o

r Re

mis

sio

no

f Dia

be

tes

(%)

Study

LAGB RYGB

Pontiroli1n=73

Spivak2n=163

Ponce3n=35

Dixon4n=50

Torquati5

n=117Skroubis6n=10

Pories7n=121

Safety and Effectiveness of Surgical Options

04/11/23 29

14.5%

• Prospective, multicenter, observational study of 30-day outcomes in patients undergoing bariatric surgical procedures at 10 clinical sites in the United States from 2005 through 2007

• Within 30 days after surgery, 0.3% of the patients died

– 0%, 0.2%, and 2.2% of patients died after LAGB, laparoscopic RYGB, and open RYGB, respectively

• The composite end point of death, deep-vein thrombosis or venous thromboembolism, reintervention, or failure to be discharged by 30 days after surgery occurred in 4.1% of patients

Low Incidence of Complications With LAGB:Longitudinal Assessment of Bariatric Surgery (LABS)

30

Flum DR et al. N Engl J Med. 2009;361(5):445-454.

Data based on interim analysis of ongoing LAP-BAND AP® Experience (APEX) Study.

A multicenter (44 sites), prospective, open-label, 5-year evaluation of 500 severely obese patients undergoing LAP-BAND AP® System surgery. BMI of at least 40 or with a BMI of at least 35 with one or more severe comorbid conditions, or at least 100 lbs over estimated ideal body weight.

52% Mean EWL at 96 Weeks With Adjustable Gastric Banding in Severely Obese Patients

31

9.512.7

17.622.5

27.030.8

33.738.2

40.644.0

46.151.0 51.7

0

10

20

30

40

50

60

2 (n=439)

4 (n=444)

8 (n=429)

12 (n=409)

16 (n=396)

20 (n=392)

24 (n=396)

30 (n=380)

36 (n=370)

42 (n=364)

48 (n=371)

72 (n=274)

96 (n=159)

EW

L (

%)

APEX Trial

Week

34%

46%

52%

APEX Trial

42.541.8

41.1

40.039.4

38.738.2

37.3 37.036.2 35.9

34.7 34.6

33.0

35.0

37.0

39.0

41.0

43.0

45.0

2 (n=439)

4 (n=444)

8 (n=429)

12 (n=409)

16 (n=396)

20 (n=392)

24 (n=396)

30 (n=380)

36 (n=370)

42 (n=364)

48 (n=371)

72 (n=274)

96 (n=159)

Mea

n B

MI

Week

Average 19% Mean BMI Loss at 96 Weeks WithAdjustable Gastric Banding in Severely Obese Patients

32

.



Data on file. Allergan, Inc.

Obesity-Related Comorbidities Reduced in Severely Obese Patients at 48 Weeks



Data on file. Allergan, Inc.

33

33%24%

69%

18% 16%31%

55%57%

24%

51% 59% 26%

0

20

40

60

80

100

Diabetes Hypertension GERD Sleep Apnea Osteoarthritis Hyperlipidemia

Imp

rov

em

en

t/R

em

iss

ion

(%

)

48-week data on comorbiditieswith the LAP-BAND®

Remission Improved(n= 75) (n=142) (n=112) (n=72) (n=44) (n=54)

Adjustable Gastric Banding Is Also Effective in Obese and Moderately Obese Patients

04/11/23 34

Early Intervention Data(LBMI-001)

More Than 82% of Patients Achieved at Least 30% EWL at 12 Months

35

Error bars represent the 95% confidence interval.

Data on file. Allergan, Inc., LBMI-001.

% o

f P

ati

en

ts A

ch

ievin

g

30%

EW

L

Baseline BMI <35 kg/m2

n=62

Baseline BMI≥35 kg/m2

n=81

PrimaryEndpointThreshold

Mean 65% EWL at 12 Months

36

Error bars denote 95% CI, which cannot be used to evaluate differences between time points.

Data on file. Allergan, Inc. LBMI-001.

Mean

% E

WL

N=143

Baseline Month2

Month4

Month6

Month8

Month10

Month12

Weight Loss With LAGB Is Associated With Positive Changes in Cardiovascular Laboratory Values

37

Treatment NScreening Lab

Value

Change From Screening to

Month 12

Lab Test Mean Mean

Cholesterol (mg/dL) 143 204.5 -13.7

HDL (mg/dL) 143 55.7 5.8

LDL (mg/dL) 143 121.3 -13.4

Triglycerides (mg/dL) 143 137.2 -30.7

Fasting glucose (mg/dL) 145 93.4 -3.6

HbA1c (%) 145 5.4 -0.1

SBP (mm Hg) 142 127.6 -8.1

DBP (mm Hg) 142 79.1 -3.1

DFU. Allergan, Inc. 2011.

*P<.0001.

Weight on IWQOL-lite total score was also improved (P<.0001) at 12 months (62.8 at baseline vs 90.6 at 12 months).


Significant Improvement in Quality of Life (QOL) Measures (100-Point Scale)

38

61

44

66

79 76

93

81

8997 96

0

20

40

60

80

100

Physical Function Self-Esteem Sexual Life Public Distress Work

Me

an

Sc

ore

Baseline 12 Months*

**

**

(n=142) (n=143) (n=143)(n=141) (n=139)

Weight Loss Sustained Into the Second Year

39

Year 1N=143*

Year 2N=128

Primary endpoint:% patients achieving 30% EWL

83.9 85.9

Mean % EWL 64.5 70.4

Mean % total weight loss 18.3 20.1

*Evaluable population.

Data on file. Allergan, Inc. LBMI-001.

Year 2 data is from an interim analysis before all patients had reached their Month 24 visit.

Gradual Weight Reduction With LAGB Results in Better Quality of Weight Loss

04/11/23 40

Comparable Effectiveness Between Banding and Bypass at 3 Years and Thereafter

41

*LAGB using the LAP-BAND® System and another adjustable gastric band. Comparison was based on pooled data from 43 peer-reviewed reports involving at least 100 patients at entry and providing at least 3 years of postoperative data.1

The LAP-BAND® System was approved in the United States on the basis of a nonrandomized, single-arm study (N=299). Significant improvements in percent of EWL vs baseline were achieved at 12 months (34.5%), 24 months (37.8%), and 36 months (36.2%). DFU. Allergan, Inc. 2011.

O’Brien P et al. Obes Surg. 2006;16;(8)1032-1040.

0

10

20

30

40

50

60

70

80

0 12 24 36 48 60

EW

L (

%)

Time After Surgery (Months)

RYGB

LAGB

58.2%(N=176)

55.2%(N=640)

Gradual weight losswith gastric banding

• Healthy weight loss

• Similar to diet and exercise

• Excess fat is lost

Gastric Banding Often Enables a Healthy Rate of Weight Loss

42

Chaston TB et al. Int J Obes (Lond). 2007;31(5):743-750.

Rapid weight losswith gastric bypass

• Excess fat lost

• Muscle, bone and necessary fat lost

• Nutrients and minerals lost

• Nutrient supplementation is necessary to prevent other health problems

Importance of Fat-Free Mass Loss (FFML)• Fat-free mass plays an important role in preservation and

regulation of the body.– Preserves skeletal integrity and quality of life as the body

ages, and maintains resting metabolic rate, as well as regulates core body temperature

• With significant weight loss, patients may lose fat-free mass such as bone or muscle mass, nutrients or necessary fat.

• Certain bariatric surgical methods can cause malabsorption and malnutrition, which influence fat-free mass loss.

• Nondiversionary LAGB surgery generally preservesa favorable amount of fat-free mass.

43

Chaston TB et al. Int J Obes (Lond). 2007;31(5):743-750.

Gastric Band: Lower FFML Than RYGB*

44

*The mean %FFML was calculated for all male subjects and all female subjects on dietary and behavioral weight loss interventions. Where studies reported a mean of male subjects and female subjects, the cutoff was adjusted in proportion to the ratio of female subjects to male subjects in the study.†Average FFML was defined by the mean %FFML of subjects on dietary and behavioral weight loss interventions.

Chaston TB, Dixon JB et al. Int J Obes (Lond). 2007;31(5):743-750.

LAGB RYGB

Patients (n=400) lost a median of

17.5%fat-free mass

Patients (n=87) lost a median of

31.3% fat-free mass

8% of cohort (n=400)

experienced above-average FFML†

100% of cohort (n=87)

experienced above-average FFML†

LAGB Is More Cost-effective Than LRYGB

• The modeled cost-effectiveness analysis showed that both operative interventions for morbid obesity, LAGB and LRYGB, were cost-effective at $25,000 and that LAGB was more cost-effective than LRYGB for all base-case scenarios.

45

*2004 US dollars, adjusted for inflation, based on public data sources.

Salem L et al. Surg Obes Relat Dis. 2008;4(1):26-32.

Probabilities and Cost for 3 Years

LAGB LRYGB

EWL % (range) 55 (38-64) 71 (59-89)

Cost* $16,200 $27,560

Adjustments $150 NA

Perioperative mortality % (range)

0.5 (0-1) 1 (0.5-2)

Revisions % (range) 5 (2-7) 5 (1-10)

Revision cost $5,000 $10,000

LAGB Is Cost Effective in the Long-Term Using Claims Analysis

• US health care claims data for 7000 LAGB patients were used to quantify the costs and potential cost savings resulting from LAGB

• Including the related medical payments in the 90 days before and after the procedure, the mean cost of LAGB was approximately $20,000

• The net cost of coverage for LAGB was reduced to 0 by approximately 4 years after band placement in the general population

• For those with diabetes, the net costs resulting from LAGB were reduced to 0 in just 2 years

Finkelstein EA et al. Surg Obes Relat Dis. 2010. In Press.

Amanda’s Success Story

47

www.lapband.com/en/success_stories/patient_stories. Accessed January 13, 2011.

“After years of yo-yo dieting, gaining back even more weight every time I quit, I gave up. At 304 lbs, I thought I was out of weight loss options. Then I learned about the LAP-BAND® System weight loss surgery and I knew right away it was the best choice for me. Since my surgery in 2003, I've gone from a size 30 dress down to a size 14. I feel so great about my decision, my positive lifestyle changes, and even better about my results. Best of all, I look like a new woman and I'm in control of my life!”

Before After

Duane’s Success Story

48

www.lapband.com/en/success_stories/patient_stories. Accessed January 13, 2011.

“My moment of truth was when I hit 303 pounds. I knew right then I had to do something or I wasn’t going to be around to see my girls grow up. Now I get to have fun and my kids love it. The greatest feeling I ever had was when my kids could come up to me and put their arms completely around me for the first time. A year ago we had a class reunion and nobody knew who I was. That was cool. I had this one girl say “Duane, you look hot.” And I said, “why didn’t you think that 30 years ago?” Getting the LAP-BAND® System surgery was the greatest decision I ever made in my life.”

Before After

The Role of the Primary Care Physician

04/11/23 49

The Physician’s Role

• Diagnose– Recognize patients at risk– Calculate BMI, which may be estimated to be lower than

actual value

• Educate about obesity– Inform patients of health risks and medical hazards

associated with severe obesity– If lifestyle recommendations are not able to be

consistently followed, then one should consider a bariatric procedure

– Describe impact of weight loss on comorbidities and mortality

– Communicate weight loss results and importance of long-term follow-up

50

The Physician’s Role (cont’d)

• Motivate patients to address obesity– Describe tangible options available to patients– Share success stories

• Explain surgical options– LAGB has a lower rate of complications

compared to other bariatric procedures1,2

– LAGB is effective for weight loss with data out to 5 years3

• Lower FFML compared with RYGB (17.5% vs 31.3%)4

04/11/23 51


– Weight loss with LAGB often improves major cardiovascular risk factors as well as other comorbidities5

•Hypertension •Hyperlipidemia•Type 2 diabetes•Asthma•GERD•Obstructive sleep apnea

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1. Parikh MS et al. J Am Coll Surg. 2006;202(2):252-261; 2. Weiner RA et al. Obes Surg. 2007;17(10):1297-1305; 3. O’Brien P et al. Obes Surg. 2006;16;(8)1032-1040; 4. Chaston TB, Dixon JB et al. Int J Obes (Lond). 2007;31(5):743-750; 5. Data on file. Allergan, Inc. (APEX Study)


• Refer patient to better understand surgical options– Important to select an experienced surgeon in a

comprehensive, weight loss center with competed support staff, able to care for patients afflicted with obesity.

Aftercare management– To enhance the transition to life after bariatric surgery and

to prevent weight regain and nutritional complications, all patients should receive care from a multidisciplinary team including an experienced primary care physician, endocrinologist or gastroenterologist and consider enrolling postoperatively in a comprehensive program for nutrition and lifestyle management.1

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1. Heber D et al. J Clin Endocrin Metab. 2010;95(11):4823-4843.

Bariatric Surgery Guidelines Support Your Referrals

• Nonsurgical treatments ineffective for most morbidly obese patients1

• The American Academy for Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery have recommended that morbidly obese patients (BMI >40 or BMI >35 with a obesity related comorbidity) should be offered bariatric surgery.2

– 15 million individuals meet the criteria for morbid obesity3

• American Diabetes Association: Bariatric surgery should be considered for adults with BMI of 35 and type 2 diabetes, especially if the diabetes is difficult to control with lifestyle and pharmacologic therapy.4

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1. Fontaine KR et al. JAMA. 2003;289(2):187-193; 2. Mechanick JI et al. Endocr Pract. 2008;14(suppl 1):1-83; 3. ASMBS Fact Sheet. www.asbs.org/Newsite07/media/asmbs_fs.pdf. Accessed January 13, 2011; 4. American Diabetes Association. http://care.diabetesjournals.org/content/32/Supplement_1/S3.full.pdf+html. Accessed January 13, 2011.

Current Selection Criteria for Bariatric Surgery in Adults1

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Factor Criteria

Weight (adults) • BMI ≥40 with no comorbidities • BMI ≥35 with one or more severe obesity-associated comorbidity

Weight loss history • Failure of previous nonsurgical attempts at weight reduction, including nonprofessional programs (for example, WeightWatchers®)

Commitment • Expectation that patient will adhere to postoperative care• Follow-up visits with physician(s) and team members• Recommended medical management• Instructions regarding any recommended procedures or tests

Exclusion • Reversible endocrine disorders or other disorders that cause obesity• Current drug or alcohol abuse• Uncontrolled, severe psychiatric illness• Unable to comprehend

– Risks, benefits, expected outcomes, alternatives, and required lifestyle changes

• Not a complete list of exclusion criteria for bariatric surgery

1. Mechanick JI et al. Surg Obes Relat Dis. 2008;4(5 suppl):S109-S184.

Consider Early Intervention

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• Early intervention with the Band System in obese and moderately obese patients has recently been approved by the FDA.

• The gastric band has been shown to be safe and effective in individuals with a BMI of 30 to 40 with obesity-related comorbidity.

• Majority of patients (>80%) achieved >30% EWL– Mean 65% EWL at 1 year

• Laboratory values improved

• Quality of life measures were significantly improved

• New data supports the need for primary care physicians to refer obese and moderately obese individuals who fail other forms of weight loss management for bariatric surgery.


Summary

• Fewer complications compared with gastric bypass reported in 1 study1

– 9% (LAP-BAND®, n=480) vs 23% (RYGB, n=235)

• Comparable weight loss to gastric bypass after 5 years2

– 55% (LAP-BAND® , n=640) vs 58% (RYGB, n=176)

• More cost-effective than gastric bypass3

– Payers estimated to fully recover the costs of laparoscopic bariatric surgeries after 2 ¼ years in patients with diabetes and after 4 years in the entire surgical population4

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The gastric band is a safe and effective option for your obese to

morbidly obese patients whose weight is affecting their health

1. Parikh MS et al. J Am. College Surgeons. 2006;202(2):252-261; 2. O’Brien PE et al. Obes Surg. 2006;16(8):1032-1040; 3. Salem L et al. Surg Obes Relat Dis. 2008;4(1):26-32; 4. Finkelstein EA et al. Surg Obes Relat Dis. 2010. In Press.

Documents

Bariatric Surgery Ruban Nirmalan Medical Director, IUH Arnett Bariatrics