Physician Information
1. Clinical Indications
Obesity is a chronic condition in which an individual has an excess amount of body fat compared to body type and size. Medical professionals utilize a number of measures to determine if an individual is underweight, normal, overweight, obese, or morbidly obese. For epidemiological studies, Body Mass Index (BMI) is a commonly used measure and includes the following groups.[1]
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less than 18.5 is underweight
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18.5 - 24.9 is normal weight
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25.0 - 29.9 is overweight
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30.0 kg/m2 to 34.9 kg/m2 is Class I Obese
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35.0 kg/m2 to 39.9 kg/m2 is Class II Obese
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>40 kg/m2 is Class III Obese
Obesity is defined as a body mass index (BMI) of 30 kg/m2 or greater. Individuals whose BMI falls between 25 kg/m2 and 29.9 kg/m2 are considered overweight. Other indicators such as skin fold, waist circumference, and waist-to-hip ratio measurements are believed to provide a better estimate than BMI alone especially when determining health risks and other associated health problems.[2], [3].
2. Etiology
In most cases, obesity is a primary disease in which no obvious cause exists, except for the imbalance of energy intake and expenditure. While we do not know all of the underlying causes for the disease, its negative health effects are highly visible and often can develop into other diseases or comorbidities, or obesity can be aggravated by additional comorbidities. Research has shown that obesity is a disease that is linked to virtually every aspect of human life, including social status, education, genetics, race, gender, and economic status. Any number of factors can contribute to the disease, but, in almost all cases, obesity is a result of consuming more calories than are expended on a consistent basis.
3. Health consequences & comorbidities
For people whose nutritional health has become severely imbalanced, virtually every aspect of their life is impacted in a negative way. The further a patient is from their ideal weight, the more pronounced these negatives impacts are likely to be. Many obese people face health issues, social isolation, financial challenges, and family problems on a daily basis. Left untreated, the health and well being of people suffering from obesity can spiral downward and, in many cases, can lead to premature death.
Often obese people suffer in silence because of the social stigma attached to their disease despite that fact that there are more than 300,000,000 people in the US, Canada, and
Europe who are either overweight or obese. On a global scale, it is estimated that over 1.7 billion people are overweight or obese.[4]
Despite the treatment options available obesity is now the second leading cause of preventable death in the
United States claiming up to 400,000 lives annually.[5]
Some of the most common comorbidities associated with obesity includes:
- heart disease
- diabetes
- high blood pressure
- high cholesterol
- certain types of cancer
- gallbladder disease
- gout
- osteoarthritis
- respiratory disease
4. Socio-economic consequences
Because obesity has such a profound impact on so many aspects of life the socioeconomic burden is quite high for the individual, their family, employers and the overall healthcare system. From a microeconomic perspective, people who suffer from obesity can face decreased wages, increased medical expenses, premature retirement, unemployment, and have a higher dependence on social services.[6] Employers also bear a significant burden. Studies indicate that overweight and obese employees take more sick leave than non-obese employees, are twice as likely to have seven or more absences due to illness during the past six months and one-and-a-half times more likely to have three to six absences due to illness during the past six months.[7]
In the U.S., the direct and indirect costs associated with obesity is estimated at more that $117 billion.[8] According to the Center's for Disease Control approximately half of these costs are covered by Medicaid and Medicare.
5. Continuum of care
Obesity and its comorbidities can be halted and reversed at virtually every stage of the disease. Typically, the initial treatment algorithm involves nutrition, behavior therapy, physical activity, and, in some cases drugs. If a patient is unable to lose weight through these methods a surgical solution may be an option.
Along the continuum of care, bariatric surgery is an option for patients whose obesity has progressed to where their quality of life has diminished significantly or is potentially life threatening, and where less drastic measures have failed. Research has shown that for these patients, bariatric surgery greatly improves their quality of life and reduces or eliminates many serious, often life threatening obesity related health problems.
In 2004, the American Society for Bariatric Surgery established guidelines to inform patients and physicians about the continuum of care with the main goal of finding the best solution for each individual suffering from obesity. A surgical option is available for patients who have a BMI greater than 35 (Class II) and have obesity related health problems or comorbidities, or have a BMI greater than 40 (Class III) without obesity related health problems and failed to lose wight upon dietary changes.[9] In addition, bariatric surgical centers follow strict inclusion and exclusion criteria to protect the health of the patient, maximize the efficacy of the procedure, and in accordance with government regulation.
In addition to the BMI requirement a patient must:
- have attempted and failed other more conservative approaches to weight loss (including diet and exercise)
- show a commitment to losing weight
- have an understanding of how this surgery will dramatically impact his or her life
- pass a psychological evaluation
- meet other conditions as required
5.1 Nutrition
From a prevention standpoint, good nutrition is critical to long-term health and wellness. Bad nutritional behaviors are believed to be a major hurdle in combating obesity. It is important to facilitate a weight loss program before and after surgery because patients who are unable to change their diet after surgery typically regain much of their excess weight.
5.2 Physical activity
The growing trend of reduced participation in or lack of physical activity throughout the day for both adults as well as for children appears to be as significant as a lack of good nutrition. A lack of physical activity is a growing problem in almost every developed country and is the result of our changing culture. By working with a nutritionist, trainer, or medical professional many people can benefit from a time replacement plan for replacing television watching with an activity like walking, running, or biking.
5.3 Behavior therapy
Many psychological and biological mechanisms leading to obesity are just beginning to be understood. In addition, as our understanding of the connection between obesity and behavior has grown over the past 40 years, medical professionals have discovered various treatment options for curbing behaviors resulting in obesity. Counseling, group therapy, and in-patient and out-patient treatment resources can be effective in treating obesity. Behavior therapy involves changing diet and physical activity patterns and learning to replace old habits with new behaviors that promote a healthy lifestyle. Behavioral therapy is effective for some patients and is required for any patient seeking a surgical treatment option.
5.4 Pharmaceuticals
Through pharmacological research and clinical studies, we have gained important insights into the biochemical relationship between the human body and food. Individuals who suffer from obesity have psycho-physiological factors that override their internal metabolic system and drive them to over consume.[10]
There are a variety of pharmacological therapies available for the treatment of obesity. While research has indicated that a pharmacological approach, combined with co-interventions including diet and exercise, does result in weight loss while taking the medication the long term efficacy and safety of these medications is unknown. [1] Some medications, especially amphetamines, pose serious health risks and are addictive. Drug therapy is recommended as a treatment option for persons with a Body Mass Index (BMI) > 30 with no obesity-related conditions or a BMI of > 27 with two or more obesity-related conditions.
5.5 Surgery
According to the American Society for Bariatric Surgery (ASBS), bariatric surgery is the most effective therapy for morbid obesity and can result in significant improvement to or complete resolution of obesity health risks.[8] Despite the successes of bariatric surgery and despite of the fact that most bariatric procedure are now being performed laparoscopically, these procedures are still risky procedures and are usually only an option after considerable steps have been taken to ensure that other less invasive options have been explored and that the patient is prepared to accept the risks, costs, and benefits of a surgical solution.
6. Surgical solutions
Gastric bypass surgery is the gold standard in the
United States for surgical weight loss procedures. Many studies on gastric bypass surgery report that between 50-80 % of excess weight is lost over the 24 month period following surgery [11]. Longitudinal studies indicate weight loss surgery is effective as a long-term, even life-long solution. Failure to achieve or maintain adequate weight loss, or weight regain, after gastric bypass has been reported to be as high as 25-30% depending heavily on the type of procedure selected and the ability of the patient to adhere to post-operative lifestyle changes.[11]Weight regain after gastric bypass is usually multi-factorial. Psychological, dietary, and medical follow up is very important for long-term weight loss success. Once these factors have been ruled out as the cause for weight regain, surgical re-evaluation is warranted.
Bariatric surgeries involve either a ‘restrictive' and/or a ‘malabsorptive' approach. Restrictive means the size of the stomach is restricted, so that less food can be eaten before the patient feels full. This involves stapling off and/or removing a significant part of the stomach. Malabsorptive approaches involve bypassing large portions of the stomach and intestines and shortening the absorptive surface in the bowel. This may result in more or less severe deficiency of vitamins, minerals and other nutritions, essential for a healthy body.
There are four main bariatric surgical procedures commonly performed in the United States and
Europe :
- Gastric Banding (Restrictive)
- Gastric Sleeve resection (Restrictive)
- Gastric Bypass including Vertical Banded Gastroplasty variation (Malabsorptive & Restrictive)
- Biliopancreatic Diversion with Duodenal Switch (Malabsorptive and Restrictive)
- While there are multiple variations and techniques used to perform each procedure, each surgeon standardizes their own techniques to improve efficacy and patient safety.
6.1 Gastric Bypass
Gastric Bypass surgery is the most popular procedure performed in North America and the second most common in
Europe. There are two generally accepted gastric bypass techniques, stapling (Gastric Sleeve) with vertical division (Roux-en-Y) or vertical division alone. Both procedures can be performed open or laparoscopically.
Gastric Bypass involves creating a small pouch of approximately 30 cubic centimeters (cc) at the top of the stomach. An anastomotic outlet is created and the distal end of the Roux limb, created from part of the jejunum (upper small intestine), is attached to the anastomotic outlet. The proximal end is reconnected near the ileocoecal valve (the valve between the small and large intestine). The length of the Roux limb determines the level of malabsorption achieved. Because the stomach is smaller, about the size of an egg, patients often experience satiety after eating only small amounts of food. The anastomotic outlet allows food to enter the Roux limb gradually and in small amounts, bypassing the distal stomach, duodenum, and much of the jejunum, allowing limited absorption.
6.2 Bilio-Pancreatic Diversion with Duodenal Switch
Biliopancreatic Diversion with Duodenal Switch (BPD-DS) is more commonly performed in Europe than in the
United States . This procedure involves a partial gastrectomy (the restrictive component) and the construction of a long Roux-en-Y limb that bypasses the small intestine (the malabsorptive component). BPD typically produces the greatest excess weight loss but it is also the most complex and can be done by experienced surgeons only.
The main advantage of this procedure is that BPD patients can continue to eat large meals without gaining weight. Complications include loose stools, stomal ulcers, offensive body odor and foul smelling stools and flatus. More serious complications include protein malnutrition associated with hypoalbuminemia, anemia, edema, asthenia, and alopecia. These complications can be life threatening and often result in hospital stays of two to three weeks. In addition BPD patients need to take a lifelong regime of supplements including calcium, Vitamin D, and others as prescribed.
6.3 Gastric Banding
Gastric Banding is the most popular bariatric procedure in Europe, Australia, and
South America . Considered a less invasive surgical option than gastric bypass, gastric banding includes two derivations: Adjustable Silicone Gastric Banding (ASGB) and the Vertical Banded Gastroplasty (VBG). Both can be done through laparoscopic or open surgery, although most procedures are done laparoscopically today.
ASGB involves the placement of an adjustable silicone band around the top of the stomach while VBG involves the placement of gastric staples and a band. Both ASGB and VBG create a restrictive pouch. This small stomach pouch (30cc) allows patients to achieve early satiety after eating only a small amount of food. Because banding does not involve malabsorption there is little risk of malnutrition thereby reducing the risk of vitamin, mineral, and protein deficiency.[12]
7. EndoGastric Solutions' endoluminal research
Bariatric surgery has rapidly evolved since it was first introduced as a solution to morbid obesity in the 1950's. As advances in surgical techniques and procedures have improved safety and efficacy, more and more people who suffer from obesity are able to find a permanent solution to their life long struggle with weight. EndoGastric SolutionsTM is committed to providing innovative procedures for treating patients who suffer from being overweight and/or obese. These options are being designed not only to reduce excess weight but also to decrease the health problems associated with obesity.
We believe that novel minimally invasive surgical solutions will help provide more options to patients and physicians so that anatomical changes can be achieved less invasively and more safely and that the benefits will be enjoyed by a larger portion of those in need of significant intervention.
Currently, EndoGastric SolutionsTM is working on developing devices and procedures to implement some of the proven rationales of established bariatric procedures in ways that could be beneficial in overweight or obese patients.
References:
1 Meta-Analysis: Pharmacologic Treatment of Obesity. Zhaoping Li, MD, PhD; Margaret Maglione, MPP; Wenli Tu, MS; Walter Mojica, MD; David Arterburn, MD, MPH; Lisa R. Shugarman, PhD; Lara Hilton, BA; Marika Suttorp, MS; Vanessa Solomon, MA; Paul G. Shekelle, MD, PhD; and Sally C. Morton, PhD., W-92 5 April 2005 Annals of Internal Medicine Volume 142, Number 7
2 Abdominal obesity is associated with increased risk of acute coronary events in men. H.-M. Lakka, T. A. Lakka, J. Tuomilehto and J. T. Salonen. European Heart Journal (2002) 23, 706-713
3 Waist circumference and not body mass index explains obesity related health risk. Ian Janssen, Peter T Katzmarzyk, and Robert Ross, American Journal of Clinical Nutrition, (2004) p 379-385
4 NIH
5 Annual Deaths Attributable to Obesity in the United States. Allison DB, Fontaine KR, Manson JE, Stevens J, VanItallie TB 1999. JAMA 82:1530-1538
6 Epidemiologic and Economic Consequenses of the Global Epidemics of Obesity and Diabetes. Yach, Derek, David Stuckler, and Kelly D. Brownell, Nature Medicine, V. 12 No. 1 pg 62-66, January 2006
7 Obesity and absenteeism: an epidemiologic study of 10,825 employed adults. Tucker LA, Friedman GM. American Journal of Health Promotion, 1998:12:202-207
8 U.S. Department of Health and Human Services 2001 The Surgeon General's call to action to prevent and decrease overweight and obesity. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Office of the Surgeon General
9 2004 ASBS Consensus Conference. Henry Buchwald, M.D., Ph.D., F.A.C.S. Consensus Conference Statement Bariatric surgery for morbid obesity: Health implications for patients,health professionals, and third-party payers. Surgery for Obesity and Related Diseases 1 (2005) 371-381
10 Similarity Between Obesity and Drug Addiction as Assessed by Neurofunctional Imaging: A Concept Review. Gene-Jack Wang, MD, Nora D. Volkow, MD, Panayotis K. Thanos, PhD, Joanna S. Fowler, PhD, Journal of Addictive Diseases, Vol. 23, No. 3, 2004, pp. 39-53
11 An Overview of Obesity and Weight Loss Surgery, Thomas L. O'Connell, MD, Clinical Diabetes, Volume 22, Number 3, 2004
12 Laparoscopic Adjustable Silicone Gastric Banding Versus Vertical Banded Gastroplasty in Morbidly Obese Patients Surgical Clinics of North America. Philip R. Schauer MD, Sayeed Ikramuddin MD, Volume 81, Number 5, October 2001
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