UPDATED Preliminary Program: MGB-OA Consensus Conference

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UPDATED Preliminary Program:  
MGB-OA Consensus Conference
*** Optional ***  Added Saturday LIVE Surgery
UPDATED Preliminary Program (Shortened link = http://wp.me/s2Dmx-mccp2 )

** Oct 18: Thursday morning : PUBLISHED DATA ON MGB

–      ***Hand out Voting Questionnaire for Consensus Voting***

–      Pr. JM Chevallier Charge to the Meeting; Listen, Learn, Discuss, Vote, Plan
Time: 8 min
Objectives:
1. Why Are We Here: MGB Excellent Therapy – Not Widely Recognized
2. Report of MGB Series: Is MGB Excellent/Best Practice Treatment for Obesity/Metabolic Disease
3. Technical Details of Best Performance of MGB
4. Plan for Adoption and Improvement of MGB around the World

Questions and Answers and Votes from Floor
Time: 8 min
1. Why is MGB not used by everyone
2. What are the Results of MGB
3. What are the Technical Details (Critical Success Factors of the MGB)
4. What Should Be the Next Steps in Adoption of MGB

–      Intro Safwan A Taha; Bariatric Surgery, Where are We Now and Where are We Going
Time: 8 Min
1. 2 min JIB, VBG, RNY, Band, Sleeve, Plication
2. 2 min History of Failure
3. 2 Min Rise of the MGB
4. 2 Min The Future

–      Kamal Mahawar & Dr P Lointer, MGB: Review of Literature on MGB
Time: 8 min
Objectives:
1. Literature Results Non-MGB
2. Review of MGB Series
3. Conclusion of Literature Review
4. Recommendations Based Upon Literature Review

Questions and Answers and Votes from Floor
Time: 8 min
1. Results of Non-MGB Bariatric Surgery is Not Ideal
2. Ideal Bariatric Surgery
3. Results of MGB
4. Recommendations based upon Literature review of MGB

–      Special Guest Presentations:
Dr. Narwaria  Former President Obesity Surg Soc India
My Journey to the MGB / MGB-In India
Time 8 min
1. Who Am I: Successful International leader in Bariatric Surgery
2. Initial Skepticism of MGB
3. Initial Results with MGB
4. Insights into the Mind of an MGB Skeptic

–      Pr. JM Chevallier President Obesity Surg Soc France:
What I know about MGB: 7 years experience
Time 8 min
1. Who Am I: Successful International leader in Bariatric Surgery
2. Initial Skepticism of MGB
3. Initial Results with MGB
4. Insights into the Mind of an MGB Skeptic

Questions and Answers and Votes from Floor
Time: 8 min
1. Why Should Presently Successful Bariatric Surgeons Choose MGB
2. Skepticism of MGB
3. Results of MGB
4. Response to MGB Skeptics

–     Michal Cierny          The Czech Experience (Ulcer & MGB)
Time: 8 min
1. Ulcer after MGB vs RNY
2. PreOp and Post Op Management Prevention
3. Treatment of Gastritis / Ulcer
4. No NSAIDs, Rx H.Pylori, Anti-Acids (PPI’s, H2 Blockers), Bismuth subsalicylate, Yogurt, No Smoking!!, Soda, Coffee, Etoh, Green Tea, Meat, Hand washing, Careful food prep, Safe water source

–     R Weiner :       MGB Results in Germany
Time 8 min
1. Bile Reflux Ulcer after MGB vs RNY
2. PreOp and Post Op Management / Prevention
3. Treatment of Gastritis / Ulcer
4. No NSAIDs, Rx H.Pylori, Anti-Acids (PPI’s, H2 Blockers), Bismuth subsalicylate, Yogurt, No Smoking!!, Soda, Coffee, Etoh, Green Tea, Meat, Hand washing, Careful food prep, Safe water source, *** Endoscopy ***, *** Surgery Revision ***

–      R Rutledge : Rational Choices in Bariatrics, Fear of Gastric Cancer/Marginal Ulcer
Time: 8 min
1. Performance Assessment Tool (What are the criteria of ideal weight loss / metabolic surgery, MGB Nearest to Ideal
2. Confused Surgeons; It is not the Bile that is feared but the Consequences (Cancer, Gastritis, Ulcer)
3. Fear Gastric Cancer
I. Unfounded
II. Fear Held by those with the LEAST Knowledge
4 Ulcer MGB = RNY

Questions and Answers and Votes from Floor
Time: 8 min
1. Ulcers / Gastritis in MGB
2. Ulcers / Gastritis Prevention
3. Ulcers / Gastritis Treatment
4. Surgery for Ulcers / Gastritis

–     Manuel Garcia Caballero:    One Anastomosis Gastric Bypass, Critical Advantages
Time 8 min
1. Bile Reflux After Billroth II
2. Caballero/Carbajo Anti-Reflux Stitch
3. 11 yr Results with OAB
4. Fear Bile Reflux => Do OAB

Questions and Answers and Votes from Floor
Time: 8 min
1. Bile Reflux After MGB
2. Anti-Reflux Stitch (OAB)
Sometimes / Always / Never
3. Rate of bile reflux After MGB
4. Management of Bile Reflux After MGB

–      Mario Musella          The Italian Experience; Technical Details of MGB Best Practice
Time: 8 min
1. Caliber & Length of sleeve
2. Length of Bypass
3. Anastomosis (hand-sewn, mechanical, side to side, end to side,linear stapler, circular stapler, Reinforcement of the staple gastric sleeve line, Reinforcement of the gastric remnant staple line, (seam-guard, peri-strip, fibrin glue, other sealant…) Closure of the stapler access (single layer, double layer, mechanical continuous suture, manual continuous suture, mechanical interrupted stitches, manual interrupted stitches…)
4. Only ONE WAY or Multiple Equally Good Ways to Perform MGB

–     C Peraglie
Time: 8 min
1. Caliber & Length of sleeve
2. Length of Bypass
3. Anastomosis (hand-sewn, mechanical, side to side, end to side,linear stapler, circular stapler, Reinforcement of the staple gastric sleeve line, Reinforcement of the gastric remnant staple line, (seam-guard, peri-strip, fibrin glue, other sealant…) Closure of the stapler access (single layer, double layer, mechanical continuous suture, manual continuous suture, mechanical interrupted stitches, manual interrupted stitches…)
4. Only ONE WAY or Multiple Equally Good Ways to Perform MGB

Questions and Answers and Votes from Floor
Time: 8 min
1. MGB; Technical Details; Critical Success Factors
2. MGB-Sleeve
3. MGB Bypass
4. MGB-Gastro-Jejunostomy

–      Rui Ribeiro              Portugal Experience: Technical Details II: MGB Part 1: Gastric Pouch
Time 8 min

1. Surgeon/Patient Position, Ports Position/Placement,

2. Location of pouch initiation, Skeletonization of lesser curve,

3. Creation of the pouch:

Use of the staple gun, Covidien/Ethicon: Pros & Cons,

Location and angle of first staple cartridge

Cartridge selection: White/Blue/Gold/Green,

Delays: Before and During Staple Gun Firing

4. Wisdom of Old Men:

Fear “Thickness”,

Fear The Tube/Bougie/NC tube

Fear the angle of His

–     Jan Apers                Dutch experience with MGB
Time 8 min
1. Dutch Experience with MGB
2. Running the Bowel, Distance of the bypass, Tailoring the length bypass
3. Leaks after MGB
4. Managing Leaks

Directed Discussion:  Agreements and Controversies
–     Panel: Chevalier, Caballero, Tacchino, Kular, Peraglie, Nawaria, Weiner
–     Moderator/Floor Person: Rutledge
–     Recorders: Musella, Van Den Bossche,

** Thursday afternoon : LONG TERM STUDIES AND OTHER TOPICS

–      Sandeep Aggarwal   Role of MGB vs Other Surgery
Time 8 min
1. Band vs MGB
2. BPD vs MGB
3. RNY vs MGB
4. Sleeve vs MGB

– Dr Jean Cady   : MGB as Rescue for Failed Band
Time 8 min
1. Band is Good choice?
2. Failure Rate (Weight Regain, Reflux) and Leak Rate
3. FU Band and MGB, complications and Weight Loss
4. Band vs MGB;  50% vs 90% Success

–      K S Kular:                 MGB vs Sleeve; A comparison and Prediction of the Future
Time 8 min
1. Sleeve is Good choice for Many
2. Failure Rate (Weight Regain, Reflux) and Leak Rate
3. 3 yr FU Sleeve and MGB, Pouch Dilation and Weight Loss
4. Lee; Sleeve vs MGB,  50% vs 90% Success

–     R Tacchino : MGB and BPD; compare and contrast
Time 8 min
1. BPD is Good choice for Many
2. Failure Rate (Weight Regain, Reflux) and Leak Rate
3. 3 yr FU BPD and MGB, Pouch Dilation and Weight Loss
4. BPD, Band, Sleeve, MGB My Advice and Perspective

–     Dr. Atul N.C Peters   MGB compared to RYGB
Time 8 min
1. RNY is Good choice for Many
2. Failure Rate (Weight Regain, Reflux) and Leak Rate
3. FU RNY and MGB, Bowel Obstruction and Weight Regain
4. RNY, BPD, Band, Sleeve, MGB My Advice and Perspective

– Questions and Answers and Votes from Floor
Time: 8 min
1. Long Term Expectations and Predictions of Band, Sleeve, RNY, BPD Outcomes
2. Long Term MGB Outcomes
3. Band, Sleeve, RNY, BPD vs. MGB Recommendations
Always Choose MGB (Rutledge Doctrine)
Always Choose Band, Sleeve, RNY, BPD
Tailored Approach
When to choose Band, Sleeve, RNY, BPD
When to choose MGB
4. BPD vs. MGB Need for Further Study

–      Emilio Manno,     Long term experience, Complications and Management
1. Italian Experience of MGB
2. Anemia
3. Ulcer
4. Inadequate / Excess Weight Loss / Other Complications

–    Michael Van den Bossche; UK experience with MGB; Complications and Management

Time 8 min

1. UK Experience of MGB
2. Anemia
3. Ulcer
4. Inadequate / Excess Weight Loss / Other Complications

** Friday morning : TIPS and Tricks , COMPLICATIONS and risks

–     K S Kular: How I Came to the MGB; My Path Cannot Be Your Path
Time 8 min
1. Background Leading to Consideration of MGB
2. Data Supporting My Decision to Choose MGB 5 years Ago
3. Struggle to Offer MGB
4. Advice from My Experience

–     Karl-Peter.Rheinwalt Germany Starting/Integrating New MGB Program
Time 8 min
1. Background Leading to Consideration of MGB
2. Data Supporting My Decision to Choose MGB 5 years Ago
3. Struggle to Offer MGB
4. Advice from My Experience

–     Maurizio De Luca   Complication of mini-gastric bypass
Time 8 min
1. My Consideration of MGB
2. My Results of MGB
3. Complications and Outcomes
4. Advice from My Experience

Voting CONSENSUS : QUESTIONS AND ANSWERS
Questionnaire and the answers of the floor
Plans for Future
— IFSO European Chapter
— IFSO 2013 1 day MGB Interest Group
— Paris Oct 2013?
— Excess Funds from Meeting? Use
— International Collaboration and Assistance / Organization and Founding Members and Officers

Bold Database Interface

Optional ADDED Saturday LIVE Surgery
4 Select Surgeons Invited to View Live Surgery in Paris with Dr Jean Cady/DrRutledge
Surgeons and 20 Other Slots Added to Watch Live Streaming Surgery
Meet Following Surgery for Group Discussion
Possible Dinner Meeting to Follow

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Declining Interest in the Band in Europe

In Europe, the preference for gastric band has declined in favor of Roux-Y-gastric bypass.

After LAGB, band removal was necessary for complications or insufficient weight loss in 24% of patients.

Only half of the patients achieved a more than 50% EWL,

The failure in one out of four patients does not allow proposing the Band as a first-line option for the treatment of obesity.

Amplify’d from www.ncbi.nlm.nih.gov
Obes Surg. 2011 May;21(5):582-7.

Long-term results of a prospective study on laparoscopic adjustable gastric banding for morbid obesity.

Source

Department of Gastrointestinal Surgery, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium. yves.van.nieuwenhove@ugent.be

Abstract

BACKGROUND:

The objective of this study was to study the long-term outcome of adjustable gastric banding in the treatment of morbid obesity. In Europe, the preference for gastric band has declined in favor of Roux-Y-gastric bypass.

METHODS:

This is a follow-up of a prospective study on a large cohort of patients after laparoscopic gastric banding (LAGB) for morbid obesity.

RESULTS:

Complete data were collected on 656 patients (88%) from a cohort of 745 patients. After a median follow-up of 95 months (range 60-155), the mean BMI dropped from 41.0 ± 7.3 to 33.2 ± 7.1 kg/m², with a 46.2 ± 36.5% excess weight loss (EWL). A more than 50% EWL was achieved in 44% of patients. The band was still in place in 77.1% of patients; conversion to gastric bypass after band removal was carried out in 98 (14.9%) patients, while a simple removal was done in only 52 (7.9%) patients. Band removal was more likely in women and patients with a higher BMI.

CONCLUSIONS:

After LAGB, band removal was necessary for complications or insufficient weight loss in 24% of patients. Nearly half of the patients achieved a more than 50% EWL, but in 88%, a more than 10% EWL was observed. LAGB can achieve an acceptable weight loss in some patients, but the failure in one out of four patients does not allow proposing it as a first-line option for the treatment of obesity.

Read more at www.ncbi.nlm.nih.gov

 

Faint Praise for the MGB from RNY Surgeon

“This is an interesting report, because it delineates a longitudinal experience with the mini-gastric bypass in Asian patients. Not too long ago, the bariatric community questioned the role of the mini-gastric bypass and its appropriateness as a durable operation for obesity. The experience of Lee et al. with a large cohort suggests some answers.”
;-)

Now 14 years later; the MGB appears on the threshold of vindication….

Surg Obes Relat Dis. 2010 Oct 30.Revisional surgery for laparoscopic mini-gastric bypass. Lee WJ, Lee YC, Ser KH, Chen SC, Chen JC, Su YH.
Department of Surgery, Min-Sheng General Hospital, National Taiwan University, Taipei, Taiwan.

“Of the 1322 Mini-Gastric Bypass patients, ** 23 (1.7%) ** had undergone revision surgery during a follow-up of 9 years.”

Amplify’d from www.soard.org
« BackSurgery for Obesity and Related Diseases
Article in Press

Editorial comment

published online 13 December 2010.
Corrected Proof

Article Outline

 

This is an interesting report, because it delineates a longitudinal experience with the mini-gastric bypass in Asian patients. Not too long ago, the bariatric community questioned the role of the mini-gastric bypass and its appropriateness as a durable operation for obesity. The experience of Lee et al. with a large cohort suggests some answers. Although the report is focused on the small percentage of patients who underwent revisional surgery, the data fall short of reporting the incidence of weight gain, bile reflux, and anastomotic complications in the patients who did not undergo revisional surgery. Moreover, the question that comes to mind is whether the mini-gastric bypass is more suitable in Asian patients. The Journal continues to commit to open, spirited, and balanced discussions that are supported by data and withstand the test of common sense.

PII: S1550-7289(10)00804-X

doi:10.1016/j.soard.2010.12.001

Refers to article:

  • Revisional surgery for laparoscopic minigastric bypass

    Corrected Proof, 01 November 2010

    Wei-Jei Lee, Yi-Chih Lee, Kong-Han Ser, Shu-Chun Chen, Jung-Chien Chen, Yen-How Su

    Surgery for Obesity and Related Diseases
    DOI: 10.1016/j.soard.2010.10.012

« BackSurgery for Obesity and Related Diseases

Read more at www.soard.org

 

Level I: Evidence; Controlled Prospective Trial; MGB vs RNY

Laparoscopic Roux-en-Y Versus Mini-Gastric Bypass for the Treatment of Morbid Obesity
A Prospective Randomized Controlled Clinical Trial

The Mini-Gastric Bypass is a ** simpler ** and ** safer ** procedure that has
** no disadvantage ** compared with RnY Gastric Bypass

Evidence-based medicine (EBM) or evidence-based practice (EBP) aims to apply the best available evidence gained from the scientific method to clinical decision making.[

Level I: Evidence obtained from at least one properly designed randomized controlled trial. Provides the “current best evidence in making decisions about the care of individual patients”

Amplify’d from www.ncbi.nlm.nih.gov
Laparoscopic Roux-en-Y Versus Mini-Gastric Bypass for the Treatment of Morbid Obesity
A Prospective Randomized Controlled Clinical Trial
Wei-Jei Lee, MD, PhD,* Po-Jui Yu, RN, Weu Wang, MD,* Tai-Chi Chen, MD,* Po-Li Wei, MD,* and Ming-Te Huang, MD
Abstract
Objectives:
This prospective, randomized trial compared the safety and effectiveness of laparoscopic Roux-en-Y gastric bypass (LRYGBP) and laparoscopic mini-gastric bypass (LMGBP) in the treatment of morbid obesity.
Summary Background Data:
LRYGBP has been the gold standard for the treatment of morbid obesity. While LMGBP has been reported to be a simple and effective treatment, data from a randomized trial are lacking.
Methods:
Eighty patients who met the NIH criteria were recruited and randomized to receive either LRYGBP (n = 40) or LMGBP (n = 40). The minimum postoperative follow-up was 2 years (mean, 31.3 months). Perioperative data were assessed. Late complication, excess weight loss, BMI, quality of life, and comorbidities were determined. Changes in quality of life were assessed using the Gastro-Intestinal Quality of Life Index (GIQLI).
Results:
There was one conversion (2.5%) in the LRYGBP group. Operation time was shorter in LMGBP group (205 versus 148, P < 0.05). There was no mortality in each group. The operative morbidity rate was higher in the LRYGBP group (20% versus 7.5%, P < 0.05). The late complications rate was the same in the 2 groups (7.5%) with no reoperation. The percentage of excess weight loss was 58.7% and 60.0% at 1 and 2 years, respectively, in the LPYGBP group, and 64.9% and 64.4% in the LMGBP group. The residual excess weight <50% at 2 years postoperatively was achieved in 75% of patients in the LRYGBP group and 95% in the LMGBP group (P < 0.05). A significant improvement of obesity-related clinical parameters and complete resolution of metabolic syndrome in both groups were noted. Both gastrointestinal quality of life increased significantly without any significant difference between the groups.
Conclusion:
Both LRYGBP and LMGBP are effective for morbid obesity with similar results for resolution of metabolic syndrome and improvement of quality of life. LMGBP is a simpler and safer procedure that has no disadvantage compared with LRYGBP at 2 years of follow-up.

Read more at www.ncbi.nlm.nih.gov

 

Interrupting the vagus nerve: the majority of patients report less "hunger" and lose weight.

In aggregate, the preponderance of evidence supported by laboratory and clinical mechanistic studies interrupting abdominal bi-directional vagal transmission demonstrates that the majority of patients report less “hunger” and lose weight.

Amplify’d from www.ncbi.nlm.nih.gov

World J Surg. 2009 Oct;33(10):1995-2006.

Vagal nerve function in obesity: therapeutic implications.

Kral JG, Paez W, Wolfe BM.

Department of Surgery, State University of New York Downstate Medical Center, 450 Clarkson Avenue, Box 40, Brooklyn, NY, 11203, USA. jkral@downstate.edu

Abstract

The primal need for nutrients is satisfied by mechanisms for sensing internal stores and detecting food; ATP is the most primitive signal. With increasing density of sensory neurons and glia (the primordial brain) and the emergence of autonomic neural activity throughout the endoderm, transmitters and other signaling molecules enable alimentation before the appearance of innate storage functions. Memory and, ultimately, cognition are prerequisites for processing and producing food to facilitate assimilation and safeguard the supply of nutrients. The gut-brain-gut axis via the vagus nerve is the autonomic neurohumoral pathway integrating these elements of energy homeostasis. Humans uniquely override obligate nutrient needs, eating in the absence of deprivation, resulting in pathological chronic overnutrition arising from dysautonomia. Obesity surgery circumvents powerful redundant mechanisms of alimentation and reduces excess stores of body fat from chronic overnutrition while preventing re-accumulation of fat. All bariatric operations, whether purely restrictive, maldigestive and malabsorptive, or combinations, rely on regulatory mechanisms related to autonomic nervous system function and the brain-gut axis. We review the functional anatomy and the importance of the vagus nerve for maintaining maladaptive chronic overnutrition and describe interventions to abrogate its effects. In aggregate, the preponderance of evidence supported by laboratory and clinical mechanistic studies interrupting abdominal bi-directional vagal transmission demonstrates that the majority of patients report less “hunger” and lose weight.

PMID: 19618240 [PubMed – indexed for MEDLINE]

Read more at www.ncbi.nlm.nih.gov

 

The Lap Band: "Not Very Good if You're Very Heavy"

“If you don’t need it it will work great.”

and

Only “50 to 100% complication rates by 10 years”…

and

Finally the Lap Band is a “disservice”

FDA Weighs Lowering the Bar for Bariatric Surgery


November 23rd, 2010 by MorganDowney


Leave a reply »

On December 3, 2010, an Food and Drug Administration Advisory Committee will consider a change affecting which patients would be eligible for Lap-Band(R) surgery. The current standard is a Body Mass Index of 35 with comorbid conditions (See Health section). The proposal from Allergan Inc. would lower it a BMI of 30 with comorbid conditions. This is a good idea. See my written comments below for why it should be approved.

 

 

 

 

 I would like to submit the following comments for the Advisory Committee reviewing the application of Allergan Inc. to expand the indication for Lap-Band surgery to a lower Body Mass Index. I am the Editor and Publisher of the DowneyObesityReport.com and have worked in obesity advocacy since 1996 as executive director of the American Obesity Association and later as the executive vice president of The Obesity Society. I consult with a number of organizations, including the sponsor, on obesity policy and patient issues.

A. Background

The original Food and Drug Administration (FDA) labeling for patient selection for the Lap-Band of a Body Mass Index (BMI) 35 with cormorbid conditions criteria was taken from a 1991 National Institutes of Health consensus statement which is out-of-date and was not, and is not, based on scientific evidence. BMI is one of several alternative tools to measure obesity. However, it lacks reliability in key populations, such as women, African-Americans, Hispanics and persons of Asian ancestry. The BMI cutoff points are subject to change according to scientific evidence.  For most people, weight gain is incremental over many years. By the time a person reaches a BMI of 30, many adverse co morbid conditions are already well established. Weight loss resolves most but not all comorbid conditions. Surgery achieves the highest degree of weight loss compared to pharmaceutical products and lifestyle interventions. Changing the FDA labeling would allow physicians and patients to assess the appropriateness of LAGB without unnecessary and unsupported constraints which discriminate against a significant number of Americans.

A national goal has been established to reduce the prevalence and health effects of obesity. For certain patients at a BMI of 30 and above  with co morbidities, a LAGB procedure will allow earlier and more effective protection against future weight gain, adverse health effects and increased costs. Conversely, maintaining the current labeling will force patients wishing to have bariatric surgery to undergo gastric bypass (open or laparoscopic) since such surgeries are not limited by FDA labeling. Requiring obese patients to take a higher risk procedure when a safer and equally effective alternative is available cannot be considered sound medical practice nor ethically justified.

Leading medical opinion seeks ways to intervene earlier and more aggressively given the limitations in contemporary treatments for cancer, heart disease, type 2 diabetes and mental illness.

B. Origin of the current patient selection criteria

When the Lap-Band was approved by the Food and Drug Administration, bariatric surgery was regarded as a dangerous operation which should be reserved only for the most severe cases of obesity. There being no professionally recognized standards for patient selection of Lap-Band at the time (2001), the FDA and the sponsor company (then Inamed Inc.) agreed to follow the recommendations of the National Institutes of Health promulgated in 1991. The NIH guidelines (hereafter “Guidelines)” were the product of a consensus development conference and were titled, “Gastrointestinal Surgery for Severe Obesity.”

The Guidelines now appear on the NIH website with the following prominent disclaimer:

This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong.

(Accessed June 9, 2010 at http://consensus.nih.gov/1991/1991GISurgeryObesity084html.htm)

A review of the Guidelines (now nearly 20 years old) quickly brings out several points:

a. the purpose of the consensus conference was standards for surgery for severe obesity, a BMI of 40 or greater. The lower BMI discussion is almost an afterthought;

b. there was no scientific evidence discussed which weighed the BMI of 35 criteria against a BMI of 30;

c. there was no anticipation of the radical changes coming to bariatric surgery within ten years, namely the introduction of laparoscopic procedures in general and adjustable gastric bypass in particular; and

d. the description of the limitations of non-surgical interventions for severe obesity is not different from a description offered today.

The Guidelines’ discussion of these operations at BMI levels of 40 follows:

In certain instances less severely obese patients (with BMI’s between 35 and 40) also may be considered for surgery. Included in this category are patients with high-risk comorbid conditions such as life-threatening cardiopulmonary problems (e.g., severe sleep apnea, Pickwickian syndrome, and obesity-related cardiomyopathy) or severe diabetes mellitus. Other possible indications for patients with BMI’s between 35 and 40 include obesity-induced physical problems interfering with lifestyle (e.g., joint disease treatable but for the obesity, or body size problems precluding or severely interfering with employment, family function, and ambulation).

Obviously, what is said of patients between BMI of 35 and 40 can also be true of patients between BMI of 30 to 40. There is no further discussion of why a BMI of 35 was chosen as a cutoff. This is unfortunate because this Guideline is the only guideline which uses a BMI of 35. The United States Government and the World Health Organization use cutoffs points of 30 for obesity and 40 for severe obesity. The Food and Drug Administration uses a BMI of 30 or BMI of 27 with comorbid conditions for reviewing pharmaceutical products for the treatment of obesity.

It would appear that the NIH Guidelines, on which the FDA relied for its initial approval of the Lap-Band, were sui generis, not based on scientific evidence and not the objective of the consensus conference which produced them. It seems reasonable, then, to ask if the same measurement tool (the BMI) and the same cutoff (35) would be proposed today for LAGB.

The rapid technological changes in bariatric surgery have preceded changes in treatment guidelines. The original NIH Guidelines for bariatric surgery were promulgated in 1991. In 1994, Clark and Wittgrove showed that gastric bypass could be performed safely laproscopically. Laparoscopic Gastric Bypass, Roux-en-Y: Preliminar… [Obes Surg. 1994] – PubMed result The Lap-Band was approved by the FDA in 2001. In 1995, Poires et al showed bariatric surgery provided durable weight loss and significant improvement in comorbidities, including type 2 diabetes and an overall reduction in mortality over 14 years. Who would have thought it? An operation proves to … [Ann Surg. 1995] – PubMed result

Reflecting on the technological changes, as well as on studies by Sjostrom and Adams on reductions in mortality for patients undergoing bariatric surgery (see below), Dr. George Bray wrote in a New England Journal of Medicine editorial in 2007, “Has the time come to reconsider BMI guidelines for bariatric surgery? In addition to the improvement in the risk of diabetes, the reduction in deaths from cancer may also argue in this direction. Sjostrom et al, and Adams et al show that weight loss saves lives in obese patients. Thus, the question as to whether intentional weight loss improves life span has been answered, and the answer appears to be a resounding yes.” The missing link – lose weight, live longer. [N Engl J Med. 2007] – PubMed result

C. The Body Mass Index as the Measurement for Obesity

Obesity is universally recognized as a major health problem because of its impact on mortality and morbidity. But what exactly is “obesity.” Obesity refers to excess body fat mass or adipose tissue. Adipose tissue is a normal component of the human body. So, the concern is about “excess” adipose tissue. Body fat can be measured in many ways including skinfold thickness, hydrostatic weighing, air displacement, dual energy X-ray absorptiometry and bioelectrical impedance.

The Body Mass Index does not measure excess adipose tissue. It is a formula combining height and weight (weight in kg/height in meters, squared). The Body Mass Index has been shown to correlate very highly with excess adipose tissue, especially at a population level. At the level of specific groups, more variation is seen. At the individual level, reliance on the BMI alone may be unwarranted. The BMI can overestimate excess adipose tissue in younger or more muscular persons as well as in persons with edema. The BMI can also underestimate excess adipose tissue, especially in the elderly who have lost lean body mass.

 Waist Circumference has been discussed alone or in connection with the BMI to identify obesity related health risks in general, Waist circumference and not body mass index explai… [Am J Clin Nutr. 2004] – PubMed result   and for type 2 diabetes and cardiovascular disease risk in particular. Does Waist Circumference Predict Diabetes and Cardiovascular Disease Beyond Commonly Evaluated Cardiometabolic Risk Factors? — Diabetes Care

BMI in specific populations

Not all adipose is created equal. Visceral adipose tissue or VAT is more metabolically active than other adipose tissue sites and appears to contribute to many metabolic abnormalities associated with excess body weight. VAT is measured by waist circumference or waist-hip ratio. Some research suggests that BMI and waist circumference do not adequately measure visceral fat in different racial and ethnic groups. Visceral fat, waist circumference, and BMI: impact… [Obesity (Silver Spring). 2008] – PubMed result

The BMI is highly useful for population studies but it does not measure fat mass or percentage of fat mass for which there are no clearly defined cutoffs. In a recently published study, Okorodudu et al performed a meta-analysis of the correlation of BMI with body fat percentage. They found that commonly used BMI cutoffs to diagnose obesity have high specificity but low sensitivity to identify excess adiposity as they failed to identify half of the people with excess body fat percentage. Diagnostic performance of body mass index to ident… [Int J Obes (Lond). 2010] – PubMed result

Indeed, there is a population of normal weight but metabolically obese individuals, mainly women, who have normal BMIs but whose metabolic parameters are similar to that of persons with obesity, referred to a MONW, metabolically obese normal weight. They display high insulin sensitivity, high abdominal and visceral fat, higher blood pressure and lower physical activity. Characteristics of metabolically obese normal-weig… [Appl Physiol Nutr Metab. 2007] – PubMed result

Women

The BMI failed to identify nearly half of the reproductive-age women who met the criteria for obesity by percent body fat. Accuracy of current body mass index obesity classi… [Obstet Gynecol. 2010] – PubMed result

DeLorenzo and colleagues found in a study comparing BMI with percent of body fat and found a significant of both males and females with excess body fat percentage would not be considered obese by BMI alone. How fat is obese? [Acta Diabetol. 2003] – PubMed result

Minority Populations

The reliability of the BMI to identify cases of excess adipose tissue has been disputed in studies involving Mexicans (Diabetes and hypertension increases in a society w… [Public Health Nutr. 2005] – PubMed result), Hispanic-Americans (Interethnic differences in the accuracy of anthrop… [Int J Obes (Lond). 2009] – PubMed result (in which the BMI was described as being “almost uninformative.)”.

Also, the BMI’s reliability is questionable among several Asian heritage populations Are Asians at greater mortality risks for being ov… [Public Health Nutr. 2009] – PubMed result. Particular populations affected include: 

Alternatives

Many clinicians and researchers recommend evaluating overweight not solely by BMI but including other the presence of other diseases, smoking, blood pressure, glucose intolerance and fat distribution. Human variation and body mass index: a review of t… [J Physiol Anthropol. 2007] – PubMed result or elevated fasting triglyceride concentration. Abdominal obesity and the metabolic syndrome: cont… [Arterioscler Thromb Vasc Biol. 2008] – PubMed result

While the BMI has well-known limitations, it continues to be widely used because of its convenience, overall reliability and the lack of a widely-accepted, validated alternative. However, its limitations indicate that it is one of several tools to evaluate excess adipose tissue and it should be employed for clinical decision-making with some flexibility. Its employment as a barrier to access to a safe and effective treatment, such as LAGB, should therefore be subject to significant scrutiny.

It should be noted that the FDA’s use of the BMI threshold for bariatric surgery has created a Catch-22 for many surgical candidates. Many insurers require that candidates for bariatric surgery undergo 6-12 months of non-surgical weight loss program before being approved for surgery. Those who fall below a BMI of 35 are then rejected for surgery because the insurer claims it is not necessary, even though weight regain is very common. Those who do not fall below a BMI of 35 are also not approved because they are deemed “non-compliant.”

D. Adverse Health Effects begin in Overweight and continue into Obese BMI Categories

Despite the limitations of the BMI, there is a close relationship between it and the incidence of several chronic diseases caused by excess fat, including type 2 diabetes, hypertension, coronary heart disease and cholelithiasis. All risks are greatly increased for subjects with a BMI of over 29, independent of gender. Guidelines for healthy weight. [N Engl J Med. 1999] – PubMed result 

In a recent meta-analysis, Guh et al found overweight to be statistically significant for type 2 diabetes, breast cancer, endometrial cancer, ovarian cancer, colorectal cancer, esophageal cancer, kidney cancer, pancreatic cancer, prostate cancer, hypertension, stroke, coronary artery disease (but not congestive heart failure), asthma, chronic back pain, osteoarthritis, pulmonary embolism, and gallbladder disease. The incidence of co-morbidities related to obesity… [BMC Public Health. 2009] – PubMed result   (NB: review did not include sleep apnea, dyslipidemia,)

In a recent article in The Lancet, researchers examining 57 studies encompassing 900,000 adults found a BMI 22.5-25 was optimal for longevity. At a BMI of 30-35, median survival is reduced by 2-4 years. Body-mass index and cause-specific mortality in 90… [Lancet. 2009] – PubMed result. Adams et al found in an analysis of BMI at age 50, among non-smokers, the risk of death increased 20% to 40% among overweight persons and by 2 to at least 3 times among obese persons. Overweight, obesity, and mortality in a large pros… [N Engl J Med. 2006] – PubMed result

From Obesity to type 2 diabetes to cardiovascular disease

Many components of the physiological processes leading from excess adipose tissue to type 2 diabetes to cardiovascular diseases are still topics of active research. However, the progression from overweight to obese to diabetic is clear. The linkage between excess body fat (and central obesity) is probably high concentrations of free fatty acids, altered adipokine expression and low grade inflammation which contribute to B-cell failure leading to insulin resistance and type 2 diabetes. Persons with obesity with depressed insulin-mediated glucose can recover after weight loss. The road from obesity to type 2 diabetes. [Angiology. 2008 Apr-May] – PubMed result

E. Bariatric Surgery achieves superior weight loss and duration

Buchwald et al published a review and meta-analysis of type 2 diabetes after bariatric surgery covering 134 studies including 22, 094 patients from January 1990 to June 5, 2003. They found that bariatric surgery is followed by resolution of type 2 diabetes in 48% of patients who underwent laparoscopic adjustable gastric banding, 84% of patients who underwent gastric bypass, and 98% of patients with biliopancreatic diversion/duodenal switch. Caution is in order in assuming a causal link. 10% of diabetic patients are normal weight and ¾ of morbidly obese patients are not diabetic. Evidence has been mounting that changes in gut hormones may be important factors. Weight and type 2 diabetes after bariatric surgery… [Am J Med. 2009] – PubMed result

An earlier meta-analysis by Buchwald found bariatric surgery successful in resolving wholly or partially hypertension, type 2 diabetes, hyperlipidemia, and, obstructive sleep apnea. Bariatric surgery: a systematic review and meta-an… [JAMA. 2004] – PubMed result

The positive impact of bariatric surgery on survival of persons with morbid obesity has been documented in the Swedish Obesity Study Effects of bariatric surgery on mortality in Swedi… [N Engl J Med. 2007] – PubMed result and by other researchers Long-term mortality after gastric bypass surgery. [N Engl J Med. 2007] – PubMed result.             

LAGB is an elective procedure. Nearly 80% of patients pay out-of-pocket as health insurance reimbursement is limited. (See AHRQ HCUP Statistical Brief #23).  So which patients might select a hospital-based surgical procedure with some risks? There are several medical categories of patients who have failed at lifestyle modifications and are at elevated risks if their weight is not brought under control.

A. Cancer patients who are overweight and obese have increased risk of developing one of several cancers. Less recognized is that obesity is also associated with poorer outcomes in resected colon cancer patients and in prostrate cancer patients. Obese cancer patients are at increased risk for problems following cancer surgery, including would complication, lymphedema, second cancers as well as obesity-related comorbidities. Weight loss has been recommended for obese cancer survivors who are otherwise healthy. Obesity and cancer: the risks, science, and potent… [Oncology (Williston Park). 2005] – PubMed result 

B. Type 2 diabetics with high insulin resistance who are unresponsive to other treatment.

C. Coronary heart disease patients who are overweight or  obese patients may demonstrate increases in weight, not decreases.   Management of overweight and obese patients with c… [Eur J Cardiovasc Prev Rehabil. 2010] – PubMed result For such patients, more intensive interventions may be necessary to achieve an optimal weight. LAGB as well as LGB have been shown to be effective in reducing biochemical markers of coronary heart disease. One year improvements in cardiovascular risk facto… [Obes Surg. 2010] – PubMed result.  Livingston et al have suggested changing the NIH obesity surgery patient selection criteria if patients have risk factors for cardiovascular disease. Do current body mass index criteria for obesity su… [Surg Obes Relat Dis. 2007 Nov-Dec] – PubMed result

D. Smokers

It is well known that cessation of smoking has an effect of increasing body weight. This is often a deterrent to smokers to discontinue their habit.  The French Observational Cohort of Usual Smokers (… [BMC Public Health. 2010] – PubMed resultPsychosocial factors associated with weight contro… [J Natl Med Assoc. 2009] – PubMed result  Assuming a smoker might have also failed at attempts to change lifestyle factors such as diet and exercise, an alternative intervention of LAGB could encourage smoking cessation and achieve significant weight loss, thereby meeting two important public health goals.

F. Modern Medicine intervenes too late with too little

While medicine has improved in a great many areas, obesity has seen little in the way of the development of new therapeutic approaches, save for LABG. The frustration in related areas of medicine with contemporary approaches to type 2 diabetes and cardiovascular disease is apparent.

In a multi-center study of 5, 535 patients with coronary heart disease, De Bacquer and others observed,

Overweight and obese patients had more frequently raised blood pressure and elevated cholesterol after adjustment for age, gender, education, diabetes, and centre. In patients using blood pressure lowering agents, 56% of obese and 51% of overweight patients were still having raised blood pressure compared to 42% in normal weight patients. A similar result was observed for the therapeutic control of total cholesterol. In the period between coronary event and interview, body weight had increase with at least five kilograms in a quarter of all patients. Overweight and obesity in patients with established coronary heart disease: Are we meeting the challenge? — Eur Heart J

Dr. Thomas A. Buchanan of the Keck School of Medicine at the University of Southern California, after reviewing the limitations of current therapies to address the tidal wave of type 2 diabetes and accompanying cardiovascular disease, wrote:

So where does all this leave us regarding prevention and early treatment of type 2 diabetes? Basically, we need to get real about what we are up against. Losing a little weight or taking a relatively weak medication such as metformin will do little more than buy some time. Even the use of more potent medications, e.g. thiazolidinediones, will arrest disease progression in only a subset of individuals. We must apply some “big guns,” and they should be pointed at obesity. Those guns can be big in the public health sense: aiming at the development of population-based approaches to improve nutrition and reduce obesity. They must also be big in the individual sense – they must be truly effective in reducing obesity among individuals who become obese and begin to manifest B-cell failure. The implementation of lifestyle interventions in such individuals  – with the intensity used in the DPP and the Finnish Diabetes Prevention Study – is definitely a good idea, but we must keep in mind that most of these individuals will continue to progress toward diabetes even if they “lose a little weight.”

 

People who continue to progress in the face of whatever lifestyle changes they can make are logical candidates for medications that either promote weight loss or change fat biology. It seems prudent at present to use those medications very early in the course of diabetes, before the B-cell “horse” is completely out of the bar. But again, many people will continue to manifest rising glucose levels, reflecting failing B-cell function. This is where I believe we need to change our views about the use of bariatric surgery for hyperglycemia. Currently, the most effective and impressive surgeries involve both restrictive and malabsorptive components. They are very invasive and are generally reserved for people who are already at the end stages of obesity and B-cell failure. That approach seems appropriate to me. But I believe that less invasive restrictive surgeries, such as gastric banding, may have an important role earlier in the evolution of obesity and hyperglycemia.

 

The steepest dose-response curve between obesity and insulin resistance occurs across the range of BMI that encompasses overweight and moderate obesity. This is the range that is characteristic of many individuals with prediabetes and early type 2 diabetes. Although their glucose levels and risk of long-term diabetic complications are not yet high, their insulin resistance and B-cell function are already very bad. More important, the only real hope of preventing further deterioration is through is through potent weight loss. Gastric banding and other restrictive bariatric approaches may be well suited for this stage of disease.  These procedures lead to weight loss that is greater and longer-lasting than can be achieved with lifestyle interventions alone. The resulting unloading of B-cells is likely to be much more than we can achieve with lifestyle changes or available medications alone. Theoretically, such weight loss could provide long-term stabilization or even reversal of the B-cell disease that underlies prediabetes and type 2 diabetes.  

 

The epidemic of hyperglycemia that is currently sweeping across the globe is very clearly related to obesity. The most logical direct approach to stemming the epidemic is to strike hard at obesity. This should include public health measures to minimize the development of obesity in everyone. It should include more focused lifestyle interventions and targeted pharmacological approaches in individuals who manifest rising glycemia. But if we stop there, the available evidence is pretty clear: we will lost the battle against type 2 diabetes. We need very potent tools to reverse obesity and its metabolic effects if we are to win this battle. Modestly invasive bariatric approaches must be studies in this context to determine their impact on insulin resistance and the B-cell disease that leads to type 2 diabetes. Stemming the tide of type 2 diabetes: bring on the… [Obesity (Silver Spring). 2010] – PubMed result 

 

G. Conclusion

The current BMI threshold for patient selection for Lap-Band is not based on a sound scientific basis. The limitations of the BMI itself should limit its use as a “hard” measure of excess adiposity because several populations are not well identified using the BMI. This has led to a phenomenon of treating the BMI, not the patient. Reducing the BMI threshold will give patients and physicians more freedom to decide appropriate courses of action for long term weight reduction.

Sincerely,

Morgan Downey

Editor and Publisher

Read more at www.downeyobesityreport.com

 

Coenzyme Q10 protects from the Negative effects of Fructose

Diabetes and obesity are metabolic disorders induced by an excessive dietary intake of fat, usually related to inflammation and oxidative stress.

CoQ10 supplementation decreased the global expression of inflammatory and metabolic stresses markers

Amplify’d from www.ncbi.nlm.nih.gov

Biochem Pharmacol. 2009 Dec 1;78(11):1391-400. Epub 2009 Jul 23.

Coenzyme Q10 supplementation lowers hepatic oxidative stress and inflammation associated with diet-induced obesity in mice.

Sohet FM, Neyrinck AM, Pachikian BD, de Backer FC, Bindels LB, Niklowitz P, Menke T, Cani PD, Delzenne NM.

Louvain Drug Research Institute, Nutrition and Metabolism Research Group, Université Catholique de Louvain, Brussels, Belgium.

Abstract

BACKGROUND: Diabetes and obesity are metabolic disorders induced by an excessive dietary intake of fat, usually related to inflammation and oxidative stress.

AIMS: The aim of the study is to investigate the effect of the antioxidant coenzyme Q10 (CoQ10) on hepatic metabolic and inflammatory disorders associated with diet-induced obesity and glucose intolerance.

METHODS: C57bl6/j mice were fed for 8 weeks, either a control diet (CT) or a high-fat diet plus 21% fructose in the drinking water (HFF). CoQ10 supplementation was performed in this later condition (HFFQ).

RESULTS: HFF mice exhibit increased energy consumption, fat mass development, fasting glycaemia and insulinemia and impaired glucose tolerance. HFF treatment promoted the expression of genes involved in reactive oxygen species production (NADPH oxidase), inflammation (CRP, STAMP2) and metabolism (CPT1alpha) in the liver. CoQ10 supplementation decreased the global hepatic mRNA expression of inflammatory and metabolic stresses markers without changing obesity and tissue lipid peroxides compared to HFF mice. HFF diets paradoxically decreased TBARS (reflecting lipid peroxides) levels in liver, muscle and adipose tissue versus CT group, an effect related to vitamin E content of the diet.

CONCLUSION: In conclusion, HFF model promotes glucose intolerance and obesity by a mechanism independent on the level of tissue peroxides. CoQ10 tends to decrease hepatic stress gene expression, independently of any modulation of lipid peroxidation, which is classically considered as its most relevant effect.

Read more at www.ncbi.nlm.nih.gov