BARIATRIC SURGERY AND TREATMENT OF TYPE 2 DIABETES Bradley Schwack, MD Assistant Professor, Surgery...

BARIATRIC SURGERY AND TREATMENT OF TYPE 2

DIABETES

BARIATRIC SURGERY AND TREATMENT OF TYPE 2

DIABETES

Bradley Schwack, MD

Assistant Professor, Surgery

NYU School of Medicine

NYU Weight Management Program

Bradley Schwack, MD

Assistant Professor, Surgery

NYU School of Medicine

NYU Weight Management Program

BARIATRIC SURGERYBARIATRIC SURGERY

Definition of obesityDefinition of obesity

determined by height and weight

Body Mass Index (BMI)= kg/m2

100 lbs overweight

determined by height and weight

Body Mass Index (BMI)= kg/m2

100 lbs overweight

Degrees of Obesity Degrees of Obesity

NORMAL BMI 18.5 – 24.9

OVERWEIGHTBMI 25 – 29.9

OBESEBMI 30 – 34.9

SEVERE OBESEBMI 35 – 39.9

MORBIDLY OBESE

BMI 40

What does it mean to be obese?What does it mean to be obese?

hypertension hyperlipidemia diabetes mellitus respiratory

insufficiency obesity-

hypoventilation sleep apnea asthma

cardiomyopathy/MI GERD PE/DVT

hypertension hyperlipidemia diabetes mellitus respiratory

insufficiency obesity-

hypoventilation sleep apnea asthma

cardiomyopathy/MI GERD PE/DVT

CVA stress incontinence DJD wt-bearing joints low back pain venous stasis/ulcers cholelithiasis amenhorrhea infertility problems skin

infections/inflammation accident proneness

cancer (uterus, breast, colon, prostate)

CVA stress incontinence DJD wt-bearing joints low back pain venous stasis/ulcers cholelithiasis amenhorrhea infertility problems skin

infections/inflammation accident proneness

cancer (uterus, breast, colon, prostate)

Medical Implications:

Obesity is a U.S. public health epidemic: 64% Americans overweight 30% Americans obese 10% morbidly obese

400,000 deaths /year from obesity related causes

[90,000 deaths/yr from colon + breast ca]

#2 cause of preventable deaths #1 is smoking

Obesity is a U.S. public health epidemic: 64% Americans overweight 30% Americans obese 10% morbidly obese

400,000 deaths /year from obesity related causes

[90,000 deaths/yr from colon + breast ca]

#2 cause of preventable deaths #1 is smoking

Bariatric SurgeryBariatric Surgery

Bariatrics: The study of Obesity and its Treatments

Surgery: The science of operations

Bariatric surgery: A therapeutic intervention to understand and treat the cause and sequelae of morbid obesity.

Bariatrics: The study of Obesity and its Treatments

Surgery: The science of operations

Bariatric surgery: A therapeutic intervention to understand and treat the cause and sequelae of morbid obesity.

Rising Use of Weight Loss SurgeryRising Use of Weight Loss Surgery

Steinbrook, N Engl J Med, 2004Steinbrook, N Engl J Med, 2004

Bariatric Surgery and DiabetesBariatric Surgery and Diabetes

Meta-analysis (Buchwald et al – 2009) Overall remission rate of 78%

< 2 years since surgery 80% >2 years since surgery 75% Results seen with all operations, yet most dramatic

with the gastric bypass Not much data beyond 5 years

**If treated within 5 years of DM diagnosis—higher long term remission rates (Brethauer et al, 2013) – possible progressive loss of beta cell function

Meta-analysis (Buchwald et al – 2009) Overall remission rate of 78%

< 2 years since surgery 80% >2 years since surgery 75% Results seen with all operations, yet most dramatic

with the gastric bypass Not much data beyond 5 years

**If treated within 5 years of DM diagnosis—higher long term remission rates (Brethauer et al, 2013) – possible progressive loss of beta cell function

Bariatric Surgery and DiabetesBariatric Surgery and Diabetes

International Diabetes Federation (2011) Journal of Diabetes (3(2011): 261-264) “Bariatric surgery is an appropriate treatment

of people with T2D and obesity who are not achieving recommended treatment targets with existing medical therapies, especially in the presence of other major comorbidities”

<1% of those eligible actually have WLS for diabetes

International Diabetes Federation (2011) Journal of Diabetes (3(2011): 261-264) “Bariatric surgery is an appropriate treatment

of people with T2D and obesity who are not achieving recommended treatment targets with existing medical therapies, especially in the presence of other major comorbidities”

<1% of those eligible actually have WLS for diabetes

What do you do when you have 100 lbs to lose?

What do you do when you have 100 lbs to lose?

1991 NIH Consensus StatementBariatric Surgery

At BMI 40: risk of surgery < risk of morbid obesity

1991 NIH Consensus StatementBariatric Surgery

At BMI 40: risk of surgery < risk of morbid obesity

CONSENSUS STATEMENT* Bariatric Surgery for Morbid Obesity: Health Implications for

Patients, Health Professionals, and Third-Party Payers

H. Buchwald, J Am Coll Surg 2005; 200:593

Criteria for surgeryCriteria for surgery

BMI > 40 kg/m2

-OR- BMI > 35 kg/m2 and major medical

complications of obesity

-AND- Failure of other approaches to long-term

weight loss no substance abuse, psychoses or

uncontrolled depression

BMI > 40 kg/m2

-OR- BMI > 35 kg/m2 and major medical

complications of obesity

-AND- Failure of other approaches to long-term

weight loss no substance abuse, psychoses or

uncontrolled depression

How does surgery work?How does surgery work?

Restrictive - restrict amount of food ingested Decreases appetite/hunger Early satiety Behavior modification

Gastric Banding (Lap Band) Roux-en Y Gastric bypass (RYGB) Sleeve Gastrectomy

Malabsorptive- limits digestion and absorption Decreases length of intestine exposed to digested food 25% of fat is absorbed Behavior modification

Biliopancreatic Diversion, Duodenal Switch (BPD/DS)

All operations can be performed open or laparoscopically

Restrictive - restrict amount of food ingested Decreases appetite/hunger Early satiety Behavior modification

Gastric Banding (Lap Band) Roux-en Y Gastric bypass (RYGB) Sleeve Gastrectomy

Malabsorptive- limits digestion and absorption Decreases length of intestine exposed to digested food 25% of fat is absorbed Behavior modification

Biliopancreatic Diversion, Duodenal Switch (BPD/DS)

All operations can be performed open or laparoscopically

Laparoscopic Roux en Y Gastric Bypass

Laparoscopic Roux en Y Gastric Bypass

Laparoscopic Roux en Y Gastric Bypass

Laparoscopic Roux en Y Gastric Bypass

1960s invented by Drs. Mason and Ito Restrictive: small gastric pouch (15-20cc) Intestinal anatomy:

Redirect the alimentary tract so that the gastric contents are directed 75-150cm distal to the ligament of Treitz .

Redirection of intestines has 2 fold impact: Avoid the reflux of bile and pancreatic juices into the gastric

pouch Variable malabsorbtive effect.

1960s invented by Drs. Mason and Ito Restrictive: small gastric pouch (15-20cc) Intestinal anatomy:

Redirect the alimentary tract so that the gastric contents are directed 75-150cm distal to the ligament of Treitz .

Redirection of intestines has 2 fold impact: Avoid the reflux of bile and pancreatic juices into the gastric

pouch Variable malabsorbtive effect.

-Gastric pouch: 15-20 ml•Food bypasses 95% stomach and duodenum•2 anastomoses•12 mm stoma•Inaccessible gastric remnant•Require life-long vitamin supplements•Side effects:

•dumping, •stomal stricture•Deficiencies- iron, calcium

•Theoretically reversible, but very difficult.

Gastric BypassGastric Bypass

The gastric bypass has been a recognized treatment of morbid obesity for over 40 years.

Laparoscopic: 1994 Wittgrove and Clark 5-6 small abdominal incisions (0.5-2.0cm) Inflate the peritoneal cavity with gas to create space to work Reduces trauma, operative exposure, surgical insult, and post-

operative pain. Proven an equally safe and effective means of weight loss. Level of comfort with procedure is a matter of surgeon opinion,

training, and experience.Wittgrove et al. 1994

Higa et al., 2001. Lugan et al, 2004.

The gastric bypass has been a recognized treatment of morbid obesity for over 40 years.

Laparoscopic: 1994 Wittgrove and Clark 5-6 small abdominal incisions (0.5-2.0cm) Inflate the peritoneal cavity with gas to create space to work Reduces trauma, operative exposure, surgical insult, and post-

operative pain. Proven an equally safe and effective means of weight loss. Level of comfort with procedure is a matter of surgeon opinion,

training, and experience.Wittgrove et al. 1994

Higa et al., 2001. Lugan et al, 2004.

Gastric BypassGastric Bypass

Gastric BypassGastric Bypass

1.5-2 years 60-68% excess weight loss Majority of weight loss in first 9 months Plateau at 1.5 years

5 years may regain 15%-20% excess wt

1.5-2 years 60-68% excess weight loss Majority of weight loss in first 9 months Plateau at 1.5 years

5 years may regain 15%-20% excess wt

Gastric Bypass ComplicationsGastric Bypass Complications

PneumoniaBlood clots in legsBleedingInfection

Perotinitis intestinal leakage (2-3%)Popped staples

Death: 1 in 200

Nutritional RisksNutritional Risks

Lifelong vitamins (Calcium, Fe, B-12) Daily multivitamin Bi-annual labs Watch for anemia Wait >18months before pregnancy Dehydration

Lifelong vitamins (Calcium, Fe, B-12) Daily multivitamin Bi-annual labs Watch for anemia Wait >18months before pregnancy Dehydration

Bypass and DiabetesBypass and Diabetes

Pories et al (1995)-Greenville, NC (ECU) >600 patients 83% w/ T2DM—normal glc, HbA1c, insulin 99% w/ glc intolerance—normal “No other therapy has produced such durable

and complete control of diabetes mellitus.” Ann Surg (1995; 222: 339-52)

Pories et al (1995)-Greenville, NC (ECU) >600 patients 83% w/ T2DM—normal glc, HbA1c, insulin 99% w/ glc intolerance—normal “No other therapy has produced such durable

and complete control of diabetes mellitus.” Ann Surg (1995; 222: 339-52)

Bypass and DiabetesBypass and Diabetes

Bypass shows more promising resolution of diabetes than the sleeve or band.

Parikh et al (2013)—Meta-analysis (1389pts) Remission rates (1 year):

33% Lap band 54% Sleeve 64% Gastric Bypass

Buchwald et al (2009) Resolution of T2DM

57% Lap band patients 80% Gastric bypass patients

Bypass shows more promising resolution of diabetes than the sleeve or band.

Parikh et al (2013)—Meta-analysis (1389pts) Remission rates (1 year):

33% Lap band 54% Sleeve 64% Gastric Bypass

Buchwald et al (2009) Resolution of T2DM

57% Lap band patients 80% Gastric bypass patients

Bypass and DiabetesBypass and Diabetes

Unique to bypass—DM resolution can come before weight loss

Rubino et al (2006) – animal studies Bypassing a short segment of proximal intestine

directly ameliorates T2DM, independent of food intake, body weight, etc.

Potentially undiscovered factors from proximal small bowel contributing to pathophysiology of DM

Unique to bypass—DM resolution can come before weight loss

Rubino et al (2006) – animal studies Bypassing a short segment of proximal intestine

directly ameliorates T2DM, independent of food intake, body weight, etc.

Potentially undiscovered factors from proximal small bowel contributing to pathophysiology of DM

Bypass and DiabetesBypass and Diabetes

Theories as to “why” (and factors unique to bypass?) Weight loss Ghrelin suppression (bypassed stomach) Metabolic due to exclusion of the proximal

small intestines (unsure of reasons why)

Theories as to “why” (and factors unique to bypass?) Weight loss Ghrelin suppression (bypassed stomach) Metabolic due to exclusion of the proximal

small intestines (unsure of reasons why)

Sleeve GastrectomySleeve Gastrectomy

Sleeve GastrectomySleeve Gastrectomy

Purely restrictive Partial gastrectomy of

greater curvature Leaves tube of

stomach sized to 32 French Bougie

No long term data

Purely restrictive Partial gastrectomy of

greater curvature Leaves tube of

stomach sized to 32 French Bougie

No long term data

Sleeve GastrectomySleeve Gastrectomy

1-2% risk of leak at upper stomach from staple line Possible re-operation Death Lengthy hospitalization

Possible re-operation for completion Gastric bypass or malabsorbtive procedure Lap Band Re-sleeve gastrectomy

1-2% risk of leak at upper stomach from staple line Possible re-operation Death Lengthy hospitalization

Possible re-operation for completion Gastric bypass or malabsorbtive procedure Lap Band Re-sleeve gastrectomy

Sleeve Gastrectomy and DiabtesSleeve Gastrectomy and Diabtes

“New Kid on the Block” Mechanism most likely related to acute

weight loss ? Ghrelin suppression No part of GI tract is bypassed

“New Kid on the Block” Mechanism most likely related to acute

weight loss ? Ghrelin suppression No part of GI tract is bypassed

Sleeve Gastrectomy and DiabetesSleeve Gastrectomy and Diabetes

Sleeve has been done as a primary operation for a few years

Small studies showing improvement of diabetes with weight loss

Some show equal remission to and some show a bit less remission than with bypass Factors may be higher vs lower BMI Insulin insensitivity vs low insulin production

Sleeve has been done as a primary operation for a few years

Small studies showing improvement of diabetes with weight loss

Some show equal remission to and some show a bit less remission than with bypass Factors may be higher vs lower BMI Insulin insensitivity vs low insulin production

The Laparoscopic Adjustable Gastric Band System

The Laparoscopic Adjustable Gastric Band System

A silicone band is placed around the upper part of the stomach

A small pouch is created Slows down gastric pouch

emptying Early feeling of satiety Surgical appetite suppressant

Purely restrictive Quick recovery Adjustable restriction

through mediport Reversible (if necessary)

Depends on surgeon and patient commitment (much f/u)

A silicone band is placed around the upper part of the stomach

A small pouch is created Slows down gastric pouch

emptying Early feeling of satiety Surgical appetite suppressant

Purely restrictive Quick recovery Adjustable restriction

through mediport Reversible (if necessary)

Depends on surgeon and patient commitment (much f/u)

LAP-BAND AdjustabilityLAP-BAND Adjustability

Unfilled Band Filled Band

Adjustments are made in the officeAdjustments are made in the office

% Excess Weight Loss% Excess Weight Loss

0

10

20

30

40

50

60

70

80

90

0 1 yr 2 yrs 3 yrs 4 yrs 5 yr

LapBandGBBPD

0

10

20

30

40

50

60

70

80

90

0 1 yr 2 yrs 3 yrs 4 yrs 5 yr

LapBandGBBPD

1 Pories 1995

2 Marceau, 1998; Hess 1998; Scopinaro 1998

3 O’Brien 1999; Cadiere 2000; Fielding1999; Dargent 1999; Belachew 1998

%E

WL

AdvantagesAdvantages

No intestinal surgery

No stapling/cutting of stomach

No nutritional risks

Adjustable

Reversible

Safe

No intestinal surgery

No stapling/cutting of stomach

No nutritional risks

Adjustable

Reversible

Safe

Foreign body Frequent follow-up

visits Needs more

commitment Easy to cheat

Foreign body Frequent follow-up

visits Needs more

commitment Easy to cheat

DisadvantagesDisadvantages

Complications of the BandComplications of the Band Slippage (5%)—gastric prolapse

Need reoperation laparoscopically Erosion (0.1%)—band erodes into lumen

Need laparoscopic removal Tubing breakage (1%)

Replace in day surgery Port infection (0.5%)

Antibiotics Weight loss failure (5%)

Remove laparoscopically and do a RNY Death: 1 in >3000

Slippage (5%)—gastric prolapse Need reoperation laparoscopically

Erosion (0.1%)—band erodes into lumen Need laparoscopic removal

Tubing breakage (1%) Replace in day surgery

Port infection (0.5%) Antibiotics

Weight loss failure (5%) Remove laparoscopically and do a RNY

Death: 1 in >3000

LAGB and DiabetesLAGB and Diabetes

Dolan and Fielding. Obes Surg, 2004 88 patients, BMI 45, Type II DM 2 years after surgery

51% EWL 65% patients off all medications (insulin, oral)

30% EWL by 6 months after surgery--> more likely to be off all DM medications

Dolan and Fielding. Obes Surg, 2004 88 patients, BMI 45, Type II DM 2 years after surgery

51% EWL 65% patients off all medications (insulin, oral)

30% EWL by 6 months after surgery--> more likely to be off all DM medications

Lap Band and DiabetesLap Band and Diabetes

Sultan et al (2010: SOARD 6:373-376.) 102 patients LAGB (5 year mean EWL 48.3%) 88% preop on meds for DM, 46.5% on @5yrs 14.9% preop on insulin for DM, 8.5% @ 5yrs HbA1c: 7.53 avg preop; 6.58 avg 5 yrs later DM resolved—no meds, glc, HbA1c—in 40% of

LAGB 5 years out Combined improvement/remission rate was 80%

at 5 years

Sultan et al (2010: SOARD 6:373-376.) 102 patients LAGB (5 year mean EWL 48.3%) 88% preop on meds for DM, 46.5% on @5yrs 14.9% preop on insulin for DM, 8.5% @ 5yrs HbA1c: 7.53 avg preop; 6.58 avg 5 yrs later DM resolved—no meds, glc, HbA1c—in 40% of

LAGB 5 years out Combined improvement/remission rate was 80%

at 5 years

Lap Band and DiabetesLap Band and Diabetes

Dixon et al (2012: Obesity Reviews 13:57-67) Remission improvement rates varied from 53-

70% within 2 years after LAGB placement Look at success of weight loss in lap band

populations as well Varied results

Dixon et al (2012: Obesity Reviews 13:57-67) Remission improvement rates varied from 53-

70% within 2 years after LAGB placement Look at success of weight loss in lap band

populations as well Varied results

Surgery Deters Progression of IllnessSurgery Deters Progression of Illness

8

1

24

7

2924

49

41

22

8

27

17

05

101520253035404550

Incidence (%)

2 YR 10 YR 2 YR 10 YR 2 YR 10 YR

DM HTN TG

ControlSurgery

8

1

24

7

2924

49

41

22

8

27

17

05

101520253035404550

Incidence (%)

2 YR 10 YR 2 YR 10 YR 2 YR 10 YR

DM HTN TG

ControlSurgery

SjSjööstrströöm et al., NEJM 2004,352:2683m et al., NEJM 2004,352:2683

StudyMortality

with SurgeryMortality

without Surgery

MacDonald, 1997 9% 28%

Christou, 2004 0.7% 6.1%

O’Brien, 2006 0.3% 10.6%

Surgery Decreases Long-term Mortality

Surgery Decreases Long-term Mortality

Restrictive Bariatric SurgeryRestrictive Bariatric Surgery

A tool against obesity Not a magic bullet Patient follow up and compliance is

necessary

A tool against obesity Not a magic bullet Patient follow up and compliance is

necessary

Restrictive Bariatric Procedures and Diabetes

Restrictive Bariatric Procedures and Diabetes

BARIATRIC PROCEDURES HAVE BEEN SHOWN TO BE SUPERIOR TO CONSERVATIVE THERAPY IN THE MANAGEMENT OF TYPE 2 DIABETES

Schauer et al (2012: N Engl J Med 366: 1567-1576)

Dixon et al (2011: SOARD 7: 433-447) “Internation Diabetes Federation taskforce”

BARIATRIC PROCEDURES HAVE BEEN SHOWN TO BE SUPERIOR TO CONSERVATIVE THERAPY IN THE MANAGEMENT OF TYPE 2 DIABETES

Schauer et al (2012: N Engl J Med 366: 1567-1576)

Dixon et al (2011: SOARD 7: 433-447) “Internation Diabetes Federation taskforce”

The Conclusion. . . .?The Conclusion. . . .?

Type 2 Diabetes BMI < 35 Moderate response to

conservative/medical treatment Will Bariatric Surgery be a treatment

option and will insurance companies cover such a procedure??

Type 2 Diabetes BMI < 35 Moderate response to

conservative/medical treatment Will Bariatric Surgery be a treatment

option and will insurance companies cover such a procedure??

This is not necessarily the goal of Bariatric Surgeon

This is not necessarily the goal of Bariatric Surgeon

The Goal is to be HealthyThe Goal is to be Healthy

55 – 70% of the excess weight off Feeling less tired and sick Off high blood pressure meds Control and possible remission of

Diabetes

55 – 70% of the excess weight off Feeling less tired and sick Off high blood pressure meds Control and possible remission of

Diabetes