Bariatrics: : The Next Five Years

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Bariatrics: : The Next Five Years Kent C. Sasse, M.D., MPH, F.A.C.S, Medical Director Western Bariatric Institute Founder, International Metabolic Institute Reno, NV

A Revolution In The Making Author: The Sasse Guide To Outpatient Weight Loss Surgery www.sasseguide.com Books available on www. Amazon.com and everywhere.

What Is Dr. Sasse Going To Say? An Epidemic of Obesity is Here A Weight Loss Revolution Has Arrived Outpatient Weight-Loss Surgery Is The Future You Hold the Keys to: Better Patient Outcomes Effective Community Service Building a Larger Client base Great ASC Profits

What Is Dr. Sasse Going To Say? Who will be having Weight-loss surgery? Does it work? What Are The Risks and Rewards? What Are the Keys to Success? What Will The Next Five Years Bring?

The Obesity Epidemic is Here 60% of Americans are overweight 20-30 million Americans are morbidly obese ASCs positioned to dominate weight-loss surgery in the future Obese patients need many surgical services 70 million Americans have pre-diabetes

Morbid Obesity: A Major Health Problem Diabetes Mellitus Hypertension GERD Urinary Incontinence Pickwickian Respiratory Syndrome Obstructive Sleep Apnea

1985 Obesity* Trends Among U.S. Adults *BMI > 30 or ~ 30 lbs overweight for 5 4 5 person No Data <10% 10% 14% Source: BRFSS, CDC

1991 Obesity* Trends Among U.S. Adults *BMI > 30 or ~ 30 lbs overweight for 5 4 5 person No Data <10% 10% 14% 15% 19% Source: BRFSS, CDC

1993 Obesity* Trends Among U.S. Adults *BMI > 30 or ~ 30 lbs overweight for 5 4 5 person No Data <10% 10% 14% 15% 19% Source: BRFSS, CDC

1996 Obesity* Trends Among U.S. Adults *BMI > 30 or ~ 30 lbs overweight for 5 4 5 person No Data <10% 10% 14% 15% 19% Source: BRFSS, CDC

1999 Obesity* Trends Among U.S. Adults *BMI > 30 or ~ 30 lbs overweight for 5 4 5 person No Data <10% 10% 14% 15% 19% 20 Source: BRFSS, CDC

2002 Obesity* Trends Among U.S. Adults *BMI > 30 or ~ 30 lbs overweight for 5 4 5 person No Data <10% 10% 14% 15% 19% 20% 24% 25% Source: BRFSS, CDC

2004 Obesity* Trends Among U.S. Adults *BMI > 30 or ~ 30 lbs overweight for 5 4 5 person No Data <10% 10% 14% 15% 19% 20% 24% 25% Source: BRFSS, CDC

Obesity Trends Among U.S. Adults 2006 No Data <10% 10% 14% 15% 19% 20% 24% 25% 29% 30% 14

Obesity Trends Among U.S. Adults 2007 No Data <10% 10% 14% 15% 19% 20% 24% 25% 29% 30% 15

What Defines Obesity? Doctors usually use body mass index (BMI) to determine obesity BMI 25-29.9 29.9 (Overweight) BMI 30-34.9 34.9 (Mild to Moderate Obesity) BMI 35-39.9 39.9 (Obese) BMI 40 or greater (Severely Obese) Current NIH, ASMBS, and Medicare criteria: BMI over 35 with comorbid condition

Clinically Severe Obesity A life-threatening condition Associated with comorbidities Shortens life expectancy The diseases associated with morbid obesity markedly reduce the odds of attaining an average life span and raise annual mortality tenfold or more. American College of Surgeons

Obesity Comorbidities Heart Disease Type 2 Diabetes Mellitus Hypertension Strokes Certain Types of Cancer Endometrial Breast Prostate Colon Dyslipidemia Gallbladder disease Sleep Apnea Asthma Reduced Fertility Osteoarthritis

FACT Only one in eleven people who are 100lbs overweight lives to age 65. New England Journal of Medicine

Kids Face a New Challenge Childhood Obesity One-third of kids Diabetes, asthma, and depression. Poor school performance. Low Pay.

Accelerating Worldwide Problem

Conclusion Only surgery has proven effective over the long term for most patients with clinically severe obesity -1991 National Institutes of Health Consensus Conference Statement Endorsed by: National Institutes of Health (NIH) American Heart Association (AHA) American Medical Association (AMA) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) American Association of Family Practitioners (AAFP)

30-70 million People Need a Solution. A Revolutionary One Must Be: Effective Durable Minimally Invasive Affordable Low Risk Discreet

Weight Loss Surgery: A New Era

The Revolution Has Arrived Weight Loss Surgery Works Minimally Invasive Highly Effective Safe Low Risk Outpatient Options

Weight Loss Surgery: the New Standard

Annual Number of Bariatric Operations in the U.S. 250000 200000 150000 100000 Bariatric Operations 50000 0 2000 2002 2004 2006 2008

What is Gastric Banding? A form of restrictive weight loss surgery (bariatric) Soft silicone-based polymer #1 surgical procedure for weight loss in Europe and Australia

The LAP-BAND System Band is placed around the upper part of the stomach. A small pouch is created Causes satiety Less than 1 hour spent in surgery. Same-day release (95%) or overnight hospital stay. Return to work in less than 1 week. Evaluated every 6-86 8 weeks for gradual adjustments.

LAP-BAND Adjustability Unfilled Band Filled Band

Body Mass Index vs Time After LAP-BAND Placement BMI (kg/m 2 ) 45 43 41 39 37 35 33 31 29 27 25 0 3 6 9 12 18 24 36 48 60 72 Months After LAP-BAND System Surgery Obesity Surgery, Volume 12, 2002 O Brien et al

Who Will Be Having Weight-loss Surgery Expect BMI 30 to become the new standard Many, many studies support this Future FDA approval at BMI 30? Shift to preventing disease More vanity surgery Result: Expand pool to 70+ million Americans eligible, more cash pay outpatient procedures

Weight Loss Surgery Makes National Headlines Weight-Loss Surgery Cuts Death Rate August 23, 2007, 8:23 am Posted by Jacob Goldstein Posted August 23 rd on the Wall Street Journal website Weight-loss surgery cuts the mortality rate for obese people, according to two studies published in this week s New England Journal of Medicine. The stomach surgery has clearly been shown as a way to help people lose weight, but the question of whether it extends life had not clearly been answered. The author of an NEJM editorial that accompanied the research told the WSJ that the studies are analogous to the statin trials that showed the drugs reduced death rates and not just cholesterol trials that prompted sales of the drugs to skyrocket. The surgery already has been gaining popularity quickly, and is now being studied as a possible treatment for diabetes. One of the new studies, conducted in Sweden, randomly assigned just over 4,000 people to either surgery or conventional treatment. During a follow-up period of about 11 years, those who received surgery were 29% less likely to die than those who received conventional treatment. The other study did not randomly assign people to one group or another, but compared roughly 8,000 people who had surgery with an identical number of people of similar age, sex, and body-mass index who did not have surgery. During a follow-up period of about seven years, those who had surgery were 40% less likely to die than those who did not.

Our Experience Surgery Center of Reno 17,000 square feet 5 O.R. s 450 total cases per month 10-15 15 Lap Band cases per month, 1 RYGB per month Western Bariatric Institute, a Center of Excellence St. Mary s s Regional Medical Center, a partner

WBI: Gender 100% 80% 60% 40% 20% 0% Female Male n=3428

WBI Patient Weight Loss Results Average Weight 350 300 250 Weight 200 150 100 50 0 Pre-Op Weight Post-Op weight 1 Post-Op weight 3 Post-Op weight 6 Post-Op weight 12 Post-Op weight 24 288 lbs n=1928 Source: Western Bariatric Institute gastric bypass and Lap-Band patients through 2006

Average OR Minutes minutes 100 80 60 40 20 91.6 mins 88.9 mins 70 mins 56.7 mins 0 2003 2004 2005 2006

Co-morbidity comparison in bariatric surgery Wittgrove & Clark Condition GERD Hypercholesterol Hypertriglyceride Diabetes Glucose Intolerance Stress Incontinence Sleep Apnea Hypertension Arthritis (symptomatic) Pre-Op 269 275 158 85 50 201 225 118 371 Post-Op 4 8 1 1 0 6 5 10 36

Change in Quality of Life Greatly Improved Improved 58% 37% No Change 5% Diminished Greatly Diminished 0 0 Life Changing

What is The Future of Weight Loss Surgery? Laparoscopic Roux-en-Y Gastric Bypass and Adjustable Band Long term weight loss Long term health improvement Metabolic complications now on the radar Rarer surgical complications mortality 0.001-0.4% Schauer PR Annals of Surgery 2000, 232(4)515.

Instrumentation Advances Three Row Articulating Gastric Stapler - Endo GIA* Intracorporeal Suturing - EndoStich* Atraumatic access devices - Step* Trocars

National Bariatric Surgery Trends and Projections - A fast growing service - Number of Cases 400,000 300,000 200,000 100,000 0 1990 1995 2000 2005 2010 2015 Source: American Society for Bariatric Surgeons (ASBS): Innovations Future Center Database

Our Story: Western Bariatric Institute Past 15% growth rate 80% bypasses 2% cash pay No Insurance for Complications Future 750 cases/yr 65% LapBands 10% cash pay More Affordable Comprehensive Insurance for Complications

Outpatient LapBand The New Standard 60-80% of cases 95% stay 4-64 6 hours <1 week recovery

Outpatient Gastric Sleeve A New Option Durability being tested No anastamosis rapid recovery

What Is Gastric Bypass? The Gastric Bypass procedure is designed to limit the amount of food eaten. This is done by: Dividing the stomach through the use of staples to create a small pouch. The pouch is 5-10% 5 of the size of the old stomach, therefore holds less food.

Outpatient Gastric Bypass Challenging Highly Selected cases All stay overnight Higher risk of complications and admission

What a difference a year makes

Resolution of Co morbidities Co morbidity % Improved % Resolved Diabetes 18% 82% Sleep Apnea 19% 74% Gout 14% 72% GERD 24% 72% Hypertension 18% 70% Hyperlipidemia 33% 63% Source: Schauer et al, Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Annals of Surgery, 2000

Who qualifies for surgery? Classification Healthy Weight Overweight Obese Class I Obese Class II Obese Class III 18.5 24.9 25 29.9 30 34.9 35 39.9 > 40 BMI A BMI of 35 39 with comorbid condition A BMI of 40 or higher alone Emerging Standard: BMI >30

Trends: Why Is Bariatric Surgery Growing? It Works. The #1 most effective intervention for obesity The #1 most effective treatment for diabetes Minimally Invasive Outpatient Surgery Highly Durable Recent Large Multicenter Study: 89% of patients maintain their weight loss at 10 years follow up.

Future Trends Increased Volume of Outpatient Cases Greater demand Publicity BMI 30 Diabetes, even non-obese obese Increased Cash-pay customers (ASC fee $9500) Price of Lap Band to fall, J&J band arrived 08 More Insurance hurdles

Future Trends Price Competition Mexico LapBands 7K Holy Grail: U.S. LapBand 10K Concentrate experience with best surgeons and practices Best long term results=best advertisement Fewer complications Wider mission to combat obesity

It Starts With All of Us Talking to Kids and Parents: Obesity Prevention Foundation

What Services are Needed? Advanced Laparoscopic Skills Training & Fellowship Medical Director ASCs should only choose the best surgeons Comprehensive pre-operative program Post Operative program committed to the success of their patients Band fills, counseling, support groups

What is the Future of Bariatric Surgery? More Comprehensive Long term approach Pre-Op Post-Op Non-Op Surgery Concentrated at Excellent centers Integration with medical arm Maintenance, plateaus, and relapses Band Adjustments Metabolic and late surgical complications

WBI: Reoperation within 30 days of Surgery % Yearly 25% 23% % Reop 20% 16% 15% % 10% 7% 5% 0% 2002 2003 2004 2005 n=266 n=288 n=256 n=447 1% Emphasis on Quality

WBI: % Readmission within 30 days 7% 6% 5% 4% 3% 2% 1% 0% 2002 2003 2004 2005 n=266 n=288 n=256 n=447 % Readmission Emphasis on Quality

What Did We Need at Western Bariatric Institute? Bariatric Medical Component Preop Program for High Risk Patients Weight Loss Program for Non-Surgical patients Postoperative programs for plateaus and relapses Long Term Follow Up Data Collection Great ASC Partner

Formation of imetabolic Medical Weight Loss MDs PhD Psychologists Health Coaches Fitness Trainers Dietary Counselors Chef and Meals Augment any bariatric practice

Formation of imetabolic Medical Solutions for any bariatric practice anywhere Separate Entity Cash, vs. insurance Separate facility Warm, less medical Develop Programs Marketing Outreach Product and Fulfillment

Pre-Operative Program A clear patient pathway to surgery & supportive staff members Insurance & Authorizations Specialists Patient Education 2-44 week liquid diet recommendations A trend toward 3-63 6 month medically supervised

Western Bariatric Institute Post Operative Program Follow up appointments 1 week, 1 month, 3 months, every 6 months Nutritional Support Group Classes One on one evaluations and plans Support Group Program Fitness Component Tracking of data & outcomes Practical for most Surgeons?

Increasingly Stringent Insurance Requirements for Surgery Must meet criteria and prove medical necessity Letter of support from primary care physician H&P and work up from surgeon Nutritional evaluation Psychological evaluation 5 year diet history Medically Supervised weight loss program

imetabolic

imetabolic

Special Considerations for Obesity Surgery Patients Sensitivity training for ASC staff Morbidly Obese vs. Seriously Overweight Understanding the shift in emphasis to customer service

Post Operative Considerations Vitamin Deficiencies & Monitoring B12, Iron, Calcium, Vit D, B complex, Anemia Anatomical Bowel Obstructions Gastric Ulcers (No NSAIDS!) Band Slips or Erosions Port Site Flips Insurance Package for Complications: BLIS

Food Solutions for Surgical Patients Preop liquid meal replacements Basic 800 kcal LCD for 2-42 4 weeks Postop initial 8 weeks Meal replacements Liquid and chewable multivitamins Postop Long term Surgery-friendly meals

Introducing our own Chef Dave Fouts Designer of the imetabolic Meals To Go Great health begins with great nutrition. Whether you are a post Bariatric Bypass or Lapband patient, an individual on achieving or maintaining a weight loss goal through healthier eating habits, or a nutritionally conscious family on the go; imeals To Go is a great choice for everyone. Together with Chef Dave Fouts, imetabolic has created a menu of nutritious and delicious meals. From free range chicken, to beef tenderloin, to fresh grilled salmon and crisp tender vegetables, each meal has been crafted with the healthiest, balanced ingredients. We take the stress out of making healthy eating decisions! All meals are based on a 1200 calorie a day diet and extreme care has been given to insure that every meal is moist, tender, and tastes just as good as it looks. Welcome To The New You!

Summary: How Outpatient Surgery Is Revolutionizing Weight Loss Voting with their feet, weight-loss surgery on the rise Safe, effective, minimally invasive solution Procedure is effective, durable, and safe At ASCs,, procedure is affordable and discreet

Summary: What Did Dr. Sasse Say? Who Is A Candidate for Weight Loss Surgery? BMI greater than 30 Does Weight Loss Surgery Work? Yes! Highly Effective, durable. What Are Risks And Rewards? Surgical risks, nutritional concerns vs. life expectancy The Keys to Weight Loss Success Excellent surgeons and programs, patient education

Bariatrics: : The Next Five Years Huge increase in patients/volume Shift to ASCs Dominance of LapBand procedure Vanity Procedure More cash-pay Downward Price competition Insurance products needed for complications

Make a Difference Start Today! www.obesitypreventionfoundation.org (775) 789-9198 9198

Thank You! Kent C. Sasse, M.D., MPH, FACS Author: The Sasse Guide To Outpatient Weight Loss Surgery www.sasseguide.com