Surgical Intervention Including Devices

Surgical Intervention Including Devices

Victor F Garcia MD

Various procedures and relevant anatomy

Outcomes

Safety

Effectiveness

What are the advantages of doing bariatric surgery in this population?

What are the concerns & issues about doing bariatric surgery in this population?

Surgical Weight Loss Procedures

Surgical Weight Loss Procedures

Distal gastricbypass

Bilio-pancreaticdiversion

Malabsorptive

Intragastric balloon

Gastricstimulator

Sleeve gastrectomy

AdjustableGastric Band

Vertical Banded Gastroplasty

Restrictive

Roux-YGastric bypass

Restrictive +MalabsorptiveSurgically

InducedWeight Loss

New-BranchVertical bandedgastroplasty

New-Branch

New-BranchAdjustablegastric band

New-BranchSleevegastrectomy

Restrictive

New-BranchBilio-pancreaticdiversion

Distalgastric bypass

Malabsorptive Procedures

250cm

100cm

2 New-Branch

1

Intragastric Balloon & ImplantedGastric Stimulator

%EWL23% (40%)

%EWL33%

Most Common Procedures

Which is the best operation?

Lap Roux Y Gastric Bypass

QuickTime™ and aSorenson Video 3 decompressorare needed to see this picture.

Lap Adjustable Gastric Band

Weight Changes bjects in the SOS Study over a 10-Year Period

Sjostrom, L. et al. N Engl J Med 2004;351:2683-2693

Swedish Obese Subjects Study

Lifestyle, Diabetes, and Cardiovascular Risk Factors 10 Years after Bariatric Surgery

Study Overview• The Swedish Obese Subjects Study: obese subjects treated

with gastric surgery and contemporaneously matched, conventionally treated obese controls

• Surgically treated subjects enrolled for at least 2 years (4047 subjects) or 10 years (1703 subjects) had a lower incidence of diabetes, hypertriglyceridemia, and hyperuricemia; differences in the incidence of hypercholesterolemia and hypertension were not significant

• Bariatric surgery resulted in long-term weight loss, improved lifestyle, and amelioration of some risk factors

Meta-Analysis: Surgical Treatment of Obesity

Meta-Analysis: Surgical Treatment of Obesity

procedureprocedure morbiditymorbidity mortalitymortality % EWL% EWL

AGB 10% .05-0.1% 47%

RYGBP 27% 0.5% 62%

BPD 30% 1-3% 70%

SLEEVE 1% 0% 30-40%

BALLOON 4% .03% 40%

IGS 1% 0% 23-40%

Bariatric Surgery OutcomesBariatric Surgery Outcomes

Surgery decreases long-term mortality, morbidity, and health care use in morbidly obese patients.

Christou, Ann Surg. 2004 • Bariatric surgery resulted in significant reduction in

mean percent excess weight loss (67.1%, P < 0.001).

• Bariatric surgery patients had significant risk reductions for developing cardiovascular, cancer, endocrine, infectious, psychiatric, and mental disorders compared with controls.

• The mortality rate in the bariatric surgery cohort was 0.68% compared with 6.17% in controls (relative risk 0.11, 95% confidence interval 0.04-0.27), a reduction in the relative risk of death by 89%.

Comprehensive Weight Management Program

Cincinnati Children’s

Comprehensive Weight Management Program

Cincinnati Children’s

2001- First children’s hospital based bariatric surgery program

63 adolescents

Mean age 17.5 years (13-23)

Mean BMI 58.1 (44-85)

Complications (n=36)Complications (n=36)

22 (61%) had no complications

9 had minor complications

4 had moderate complications

2 had severe complications

Beri-beri with sequelae over 2 months

Death (@ 9 months post-op, due to colitis developed while getting rehabilitation for osteoarthritis)

Body Composition After Gastric Bypass in Adolescents

Body Composition After Gastric Bypass in Adolescents

13 patients: DEXA at 3,6,12 months - weight, fat and lean mass

Results

Mean BMI 60 (pre op), @ baseline 45% fat/ 55% LM

Mean BMI 38 (12 mo post op)

3 mos:↓ fat -19% (p=.001);↓ lean mass -17% (p=.001)

3-12 mos: ↓ fat -40% (p=.0005);↓ lean mass -.6% (NS)

Bariatric Surgery Reverse Adolescent OSAS

Bariatric Surgery Reverse Adolescent OSAS

34 patients (19 with PSG post op)

OSA AHI ≥ 5 per hr of sleep in 55%

OSA either resolved or improved after bariatric surgery in 100%; AHI improved by nearly 20 fold compared to only 3-5 fold in adults.

Surgical weight loss in adolescence may result in more complete reversal

Left Ventricular Hypertrophy ReversesLeft Ventricular Hypertrophy Reverses

Five patients with pre & post operative echocardiograms

Left ventricular wall thickness decreased by 13%

Ventricular mass decreased by 23.4% over 6 months.

One adult study found only 14.5% decrease in left ventricular mass after surgical weight loss.

Improved Metabolic ProfileImproved Metabolic Profile

Insulin resistance (HOMA-IR) elevated in 64% of patients preoperatively while postoperatively it decreased by 78% overall and completely normalized in all but one.

Nearly 2 fold improvement in beta cell function.

Significant decrease in triglyceride levels

Patient factors/outcomes & resolution

Improved Resolved p valueNumber 33 158 <0.001Age (yrs) 48.2 47.8 0.724Pre op BMI

51 50 0.270

Post op BMI

37 33 0.002

%EWL 42 62 <0.001Duration Diabetes

10.7 4.1 <0.001

Surgery as an Effective Early Intervention for Diabesity

Why the reluctance?

Dixon et al Diabetes Care 28:472-474, 2005

Surgery as an Effective Early Intervention for Diabesity

Why the reluctance?

Dixon et al Diabetes Care 28:472-474, 2005

early intervention in the management of severely obese subjects with type 2 diabetes if intensive lifestyle interventions fail to achieve and maintain significant weight loss.

Remission was predicted by greater weight loss and a shorter history of diabetes (pseudo r2 = 0.44, P < 0.001).

improvement in insulin sensitivity following surgery was best predicted by the extent of weight loss.

Improvement in ß-cell function, however, was predicted by a shorter history of diabetes

Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the

metabolic syndrome.

Surgically-induced weight loss significantly improves nonalcoholic fatty liver disease and the

metabolic syndrome.

The mean excess body weight loss at time of second biopsy was 59% +/- 22%; time interval between biopsies was 15 +/- 9 months.

There was a reduction in prevalence of MS, from 70% to 14% (P < 0.001), and a marked improvement in liver steatosis (from 88% to 8%), inflammation (from 23% to 2%), and fibrosis (from 31% to 13%; all P < 0.001).

Inflammation and fibrosis resolved in 37% and 20% of patients, respectively, corresponding to improvement of 82% (P < 0.001) in grade and 39% (P < 0.001) in stage of liver disease.

Mattar et al, Ann Surg. 2005 Oct

Timing of Surgical TreatmentTiming of Surgical Treatment

Attained physiological and skeletal maturation

Physiological/sexual maturation- Tanner 3 or 4

Skeletal maturation- age 13-14 girls; 15-16 boys or have attained mid parental height; bone age if there is doubt

Stage of cognitive development

Acquired formal operations- thinking about possibilities, consequences

Psychological health and weight related quality of life

Advantages of Surgical Intervention in Adolescence

Advantages of Surgical Intervention in Adolescence

Procedure related

Safe and effective long term weight loss if compliant

Co morbidity

Resolution or amelioration of most if not all; function of duration of disease

Reduces the incidence of co-morbidities

Improved quality of life

Survival

Increased survival compared to medical management - SOS Study, Flum et al, & Christou et al

Metabolic Bone DiseaseMetabolic Bone Disease

Gastric bypass surgery for morbid obesity leads to an increase in bone turnover and a decrease in bone mass.

Markers of bone turnover were significantly elevated in patients post LRGB (urinary N-telopeptide cross-linked collagen type 1 and osteocalcin) at 3 months & 9 months.

Bone mineral density decreased significantly at the total hip, trochanter, and total body with significant decreases in bone mineral content at these sites. the longer term.

Coates, J Clin Endocrinol Metab. 2004 Mar;89(3):1061-5.

Nutritional DeficienciesNutritional Deficiencies

more common with bypass procedures

protein deficiency rare after RYGBP <150cm

iron deficiency anemia (6-33%); restrictive & malabsorptive

B12 (37%) & folate deficiency (22%)

Vitamin B12 deficiency associated with low breast-milk vitamin B12 concentration in an infant following maternal gastric bypass surgery.

Thiamine (.0002%) beriberi; Acute Wernicke's encephalopathy;peripheral polyneuropathy

Laparoscopic OperationsDegree of Difficulty (1-10)Laparoscopic Operations

Degree of Difficulty (1-10)

Gall Bladder 3

Appendectomy 3

Hernia 5

Lap band 5-6

Nissen 7

Spleen 8

Adrenal 8

Colon 9

Esophagectomy 9.5

Gastric bypass 9.5

BMI Guidelines For Adolescent Bariatric Surgery

BMI Guidelines For Adolescent Bariatric Surgery

BMI 40/50

Pediatrics, 2004

Obes Research, 2005

• BMI 35/40JACS, 2005J Clin Endocrin Metab,

2005

“Conservative” “NIH Adult Threshold”

What Should We Mean By “Conservative” Guidelines for Adolescent Bariatric Surgery?

What Should We Mean By “Conservative” Guidelines for Adolescent Bariatric Surgery?

Offer a complex procedure, with defined procedure-related risks

when the risk of complications is lowest,

when medical therapy is ineffective and its continuation may be detrimental,

when the outcomes are likely to be the best possible

when the likelihood of recidivism is the lowest.

Superobesity & Weight Loss Related Outcomes

BMI >50

Superobesity & Weight Loss Related Outcomes

BMI >50

Mason, 1987, Benotti, 1989, Sugerman, 1989, Yale, 1989, MacLean, 1990, Brolin, 2002

Lose significantly lower percentage of their excess weight despite losing a significantly greater quantity of weight compared to lighter patients.

Likelihood of successful weight loss is significantly lower after conventional RYGBP; stabilize at a significantly greater percentage over IBW than morbidly obese patient.

Must lose more weight to achieve a level that would represent a valid reduction in actuarial risk.

A prospective randomized study reported recidivism among the superobese is common after 4 -5 years (Brolin, 1992)

BMI and Procedure-related RisksBMI and Procedure-related Risks

• Fernandez et al. Ann Surg. 2004. Multivariate analysis of risk factors for death following gastric bypass for treatment of morbid obesity.

independent risk factors associated with perioperative death included leak, pulmonary embolus, preoperative weight, and hypertension

• Early experience with two-stage laparoscopic Roux-en-Y gastric bypass as an alternative in the super-super obese patient. Regan al, Obes Surg. 2003.

surgical management of the supersuper obese patient BMI =/> 60 is associated with higher morbidity, mortality, and long term weight loss failure.

•

Probable Consequences of a Higher BMI Threshold

Probable Consequences of a Higher BMI Threshold

Increased risk for procedure related complications and death for all procedures

Increased risk of weight regain

Higher final BMI

Greater & longer duration of disease burden

Experience MattersExperience Matters

TransformingHealth Care,

Harvard Business Review

adolescentbariatricsurgery

Washington State Comprehensive Healthcare Abstract Reporting System

Washington State Comprehensive Healthcare Abstract Reporting System

Results

66,109

3,328 underwent gastric bypass

250% increase in frequency of procedure after 1996 (IRR 2.5 95% CI 2.4-2.7)

1.02% (34) in hospital mortality

30 day mortality of 1.9% (64)

Within surgeons first 19 cases the odds of a 30 day death were 4.7 times higher

Regionalizing Complex Procedures Regionalizing Complex Procedures

For certain complex procedures patient outcomes are directly related to surgeon & hospital volume

Birkmeyer, J.D. and J.B. Dimick, Potential benefits of the new Leapfrog standards: effect of process and outcomes measures. Surgery, 2004. 135(6): p. 569-75.

Finlayson, E.V., P.P. Goodney, and J.D. Birkmeyer, Hospital volume and operative mortality in cancer surgery: a national study. Arch Surg, 2003. 138(7): p. 721-5; discussion 726

Birkmeyer, J.D., E.V. Finlayson, and C.M. Birkmeyer, Volume standards for high-risk surgical procedures: potential benefits of the Leapfrog initiative. Surgery, 2001. 130(3): p. 415-22.

Gordon, T.A., et al., Statewide regionalization of pancreaticoduodenectomy and its effect on in-hospital mortality. Ann Surg, 1998. 228(1): p. 71-8.

Adolescent Obesity CentersAdolescent Obesity Centers

an obesity center for every 500,000-person population

500-1000 operations per year

Life long follow up

Lars Sjostrom, Swedish Obesity Subjects Study

Attributes of a Bariatric Surgery Program for Adolescents

Attributes of a Bariatric Surgery Program for Adolescents

Based on ‘best practices’ treating other adolescent chronic diseases (diabetes, cystic fibrosis, liver transplantation, oncology)

A multidisciplinary team providing

Comprehensive evaluation

Standard of care surgical intervention

Postoperative medical, psychological, and surgical surveillance tailored for the adolescent age group

Peer and parent support groups!

Essential part of good clinical trials practice is maximal retention of study participants

The ability to draw definitive conclusions about the absolute & relative efficacy and safety of bariatric surgery is limited by the large percentage lost to follow up

Complete evaluation of enrolled patients is a critically important aspect of any clinical trial bariatric surgery in adolescents

The Need for Complete Data in Studies of Surgical Weight

Loss

The Need for Complete Data in Studies of Surgical Weight

Loss

We are well into the adolescent RCT between Lap Band and "optimal" non-surgical therapy. However we have no data from that study so far.

On compliance of adolescent: Awful. Much worse than the adults. It may be just because they are adolescents. It may be that they don't sense the severity of the problem as do adults. It may be that they are always dependent on Mum or Dad bringing them along and so the logistics catches them out. For whatever reason, I would guess they would score about 3-4 out of 10 on a compliance test score whereas our adult patients would probably average around 7-8.

Effectiveness: Good if they attend. Better rate of weight loss than the adults

Bad habits: They are probably more susceptible to peer pressure than the adults and so have episodes of social eating and drinking which destroy the good results so quickly. Also, with lack of attention to the eating rules with eating too much,too fast, the incidence of prolapse is likely to be greater.

Clearly there is a need for a carefully done randomized controlled clinical trial. Let's hope our data show a clear picture one way or the other at the end of the trial.

Sorry to be so lacking in data at this stage.

Best of luck

Paul O’Brien

Adolescent Compliance

Surgeon/ Hospital Volume

Success with AdolescentBariatric Surgery

Success with AdolescentBariatric Surgery

Choice of Operation

Blue Ocean Strategy

Imperatives Imperatives In the absence of robust evidence of the long term outcome of bariatric surgery in adolescents, the context for adolescent bariatric surgery should be strictly defined--the process deliberate, the follow up & outcome evaluation better than that of the pediatric long term cancer study

Adolescent bariatric surgery should be performed by experienced bariatric surgeons & regionalized to select centers of excellence committed to systematically and programmatically optimizing compliance, follow up, and assessing the outcomes of surgical weight loss on adolescents

Centers must maintain and report long term, detailed follow up, data collection and submission into a national database/registry.

Acknowlegements

Thomas Inge

Comprehensive Weight Management Team