Bariatric Surgery Ruban Nirmalan Medical Director, IUH Arnett Bariatrics
Apr 02, 2015
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
Potential Complications
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
Potential Complications
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 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.
Data on file. Allergan, Inc.
Obesity-Related Comorbidities Reduced in Severely Obese Patients at 48 Weeks
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.
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).
DFU. Allergan, Inc. 2011.
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
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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
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The Physician’s Role (cont’d)
– 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)
The Physician’s Role (cont’d)
• 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.
DFU. Allergan, Inc. 2011.
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.