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The Bariatrics Lounge - The Bariatric Surgery Blog
Jan 06, 2016 04:03AM
As you may know, the standard recommendation has been that bariatric surgery is indicated for BMI 35 or above, in the presence of at least 1-2 comorbidities. In the US, patients whose BMI is between 30 and less-than-35 have hard time being accepted for weight loss surgery and, by and large, have had no surgical option.
One bariatric surgery, adjustable gastric band placement, involves the placement of a device that is produced by Allergan (Lap Band). In an Allergan News Release, the U.S. Food and Drug Administration (FDA) approved the expanded use of the LAP-BANDŽ System, Allergan?s gastric band, for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition. The LAP-BANDŽ System study, initiated by Allergan, Inc., is a prospective, single-arm, non-randomized, multi-center five year-study. The study was initiated in 2007, and included 149 patients. The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month time point, where clinically meaningful weight loss was defined as at least 30% Excess Weight Loss (EWL).
The 12-month results showed that almost 84% of the patients lost at least 30% of their excess weight at one-year. In terms of improvement in comorbid conditions of dyslipidemia, Type 2 diabetes, and hypertension, 22-33% of patients with those conditions, saw their conditions resolved after one year.
Comparing the Lap Band with non-surgical weight loss (which has very low success rates), and setting the threshold of "success" to the level of losing 30% excess weight, allowed those results to shine. However, if those were compared to sleeve gastrectomy (1-2 year average excess weight loss of 60-68%, and 5 year average loss of 50% excess weight) such a standard for success would not be met by the Lap Band. But the sleeve gastrectomy is a surgical procedure, not involving the implantation of a device. Therefore, there is no basis for FDA to have any saying about the sleeve gastrectomy or gastric bypass. It is safe to say that the improvement in comorbidities is, on the average, much better with the sleeve gastrectomy than the adjustable gastric band.
Will bariatric surgeons become more encouraged to apply the same BMI guideline of 30 for other bariatric surgeries (instead of 35) based on the FDA approval of the Lap Band? Would they be supported by the American Society of Bariatric Surgery if they do so? Will insurance companies change their coverage criteria based on that? So many questions. But it is a good start.
Swedish researchers published in the British Medical Journal (BMJ) a study that aimed to examine how change in level of physical activity after middle age influences mortality and to compare it with the effect of smoking cessation. Researchers surveyed 2205 men aged 50 in 1970-3, then re-examined them at ages 60, 70, 77, and 82 years. They found that mortality was lowest among the most active men. Men who increased their activity level from low/moderate to high between the ages of 50 and 60 saw a drop in mortality after an initial period of 10 years. Before 10 years, no survival advantage was observed. An increase in physical activity has the same impact on lowering mortality rate in the long term as smoking cessation.
Total mortality after changes in leisure time physical activity in 50 year old men: 35 year follow-up of population based cohort.
Byberg L, Melhus H, Gedeborg R, Sundström J, Ahlbom A, Zethelius B, Berglund LG, Wolk A, Michaëlsson K. BMJ. 2009 Mar 5;338:b688. (Free Full Article)
The Body Mass Index (BMI) is one way of assessing weight categories. According to a study published online by the medical journal Lancet, high and Low BMIs were associated with increased mortality risk.
This large research examined data from 57 prospective studies with 894,576 participants, mostly in western Europe and North America. Mortality was lowest among those associated with BMIs in the range of 22.5 to 25 kg/m2. Above 25, every 5-unit increase in BMI translated to a serious 40% higher risk for death from ischemic heart disease or stroke and 10% increased risk for cancer-related deaths.
The authors commented "Although other anthropometric measures (eg, waist circumference, waist-to-hip ratio) could well add extra information to BMI, and BMI to them, BMI is in itself a strong predictor of overall mortality both above and below the apparent optimum of about 22.5?25 kg/m2."
Even though the "normal" BMI range is usually quoted to start from BMI of 18.5, the study showed that adults whose BMI was below 22.5 were also at higher risk for death. However, such a higher mortality was mainly, but not entirely, due to smoking-related lung diseases and cancer.
This important study was funded by UK Medical Research Council, British Heart Foundation, Cancer Research UK, EU BIOMED programme, US National Institute on Aging, and Clinical Trial Service Unit (Oxford, UK).
Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Prospective Studies Collaboration. Lancet. 2009 Mar 28;373:1083-1096.
(How to use the doi system?)