Letters to the Editor

| December 23, 2010

Goodbye to the BMI

Dear Bariatric Times Editor:
At last—we finally have federal recognition that access to bariatric surgery should no longer be limited by an arbitrary body mass index (BMI=kg/m2)! On December 6, 2010, the United States Food and Drug Administration (FDA) advisory panel voted 8 to 2 in favor of approving an expanded indication for an implantable adjustable gastric band (Lap-Band Adjustable Gastric Banding System, Allergan, Inc., Irvine California) to be used for weight reduction in patients with a BMI of at least 30kg/m2 and less than 40kg/m2.

The process was badly flawed and, curiously, the flaws led to the correct decision for several reasons.  The panel (and in full disclosure, I served on the panel) noted that the BMI was not an appropriate metric for the selection of patients and that the assessment of severe obesity should be based on the level of metabolic disease rather than height and weight. In spite of Allergan’s rigorous adherence to the FDA-approved protocol, the investigators were able to identify only 14 subjects with a BMI >30kg/m2, documenting that patients may have life-threatening comorbidities of obesity with BMIs less than 35kg/m2. They also found that the extent of comorbidities was not directly related to height and weight alone. Further, the great majority of the entire cohort of patients with BMIs of 30 to 40kg/m2 had good to excellent outcomes. Finally, the studies were sharply limited by the lack of quantification measures of the comorbidities of metabolic failure.

The basic flaw is that the BMI is not the right measure. While it is, without question, a superb tool for studies of epidemiology and the national distribution of obesity, it is an inappropriate and cruel index to decide whether a patient with a fatal disease should be denied the only effective treatment.

The application of the BMI to clinical practice is badly misguided. For starters, the BMI is unigender. Some years ago, after our human performance laboratory at East Carolina University (ECU) weighed over 2,000 volunteers and patients under water to determine the relationships of body composition to the BMI, I hurried home to show my wife that we obtained two very different curves for men and women. Her tart response: “You had to drown over 2,000 people to learn that men and women are different?”

The unigender failure of the BMI is not its only flaw. The BMI also fails to allow for fitness, age, body fat distribution in terms of subcutaneous versus visceral fat, the severity of the comorbidities, or for racial differences. For example, one of our volunteer subjects at ECU was a chap who was 5’8” (1.72m) tall and weighed 308 pounds (140kg) with a BMI of 47.3kg/m2—easily within the guidelines for bariatric surgery. We did not operate on him; he would have been hard to catch. His body composition studies reflected a seven-percent fat mass, not surprising since he was the fastest running back in the history of our school. Similarly, when I was activated in the first Gulf War, we were cautioned about sending troops with BMIs greater than 35kg/m2 overseas—a rule that we followed for a few weeks until it became apparent that our fittest soldiers had BMIs in the high range. The BMI also fails to take into consideration the increased fat deposits that occur with aging and growth in children and teenagers, the variation in the size of the fat deposits in visceral wersus peripheral stores, and the severity of the comorbidities.

The most serious flaw of the BMI for the selection of patients is its discrimination against individuals of African American and Asian descent. Comparisons of fat distribution and comorbidities between Caucasians and other groups document that the prevalence of diabetes and hypertension in Caucasian women with a BMI of 35kg/m2 occur in African American and Asian women with BMIs of 32kg/g2. With the “BMI 35 rule,” the Caucasian women have access to bariatric surgery while women in other races, equally ill but lighter, are denied coverage.

Before we assign blame for the unfortunate use of the BMI, we have to admit that we, the bariatric surgeons, played a major role in setting the rules. Twenty years ago, the challenge, superbly managed by Drs. Sugerman, Buchwald, and Kral, was to convince carriers that bariatric surgery offered effective, durable, and safe treatment. It was a hard sell. Accordingly, when the panel on the National Institute of Health Consensus Conference on Gastrointestinal Surgery for Severe Obesity met on March 25–27, 1991, the first challenge was to gain official agreement that diets, exercise, behavioral modification, and drugs were not effective treatments for severe obesity. That was the easy part. The next question was when could surgery be considered a reasonable alternative. Since the BMI, a measure of height and weight, appeared to be a reasonable decision point, the panel accepted the arbitrary proposal that patients could be considered for surgery if they had a BMI≥40kg/m2. With the recognition that the comorbidities might be more important than height and weight, a BMI≥35 with comorbidities could also be considered.
It was a great victory two decades ago but it is time to move on. We have a lot more data, and the quality and safety of the surgery has improved exponentially. The current approach in which 99 percent of eligible patients are denied access is not clinically or morally acceptable. What if a pill were available that could produce durable weight loss greater than 100 pounds (45.5kg) with simultaneous and safe control of diabetes, sleep apnea, and hypertension, and a reduction in mortality by 80 percent? Would the American public accept its limitation to one percent of those who could benefit?

This FDA decision is our call to arms. Instead of focusing on obesity, we should focus on the central issue of “metabolic failure” (“MF” as a new mnemonic?), a disease in which increased weight is only one of the expressions. We should offer our colleagues a replacement for the BMI, a “metabolic index” that, similar to the Glasgow Scale, summarizes our patients’ illnesses in a concise and credible manner. Most importantly, we must educate our colleagues, our public, our legislators, our employers, and our carriers that denial of the only effective treatment is not only cruel, but also much more expensive.

Flawed process? You betcha. Given the faulty premise that the treatment of disease should be governed by height and weight, the FDA panel’s decision was pre-ordained. However, it was also wise and clearly exposed our society’s dreadful attitude toward some of our sickest citizens.

Sincerely,

Walter J. Pories, MD, FACS, FASMBS
Professor of Surgery, Biochemistry, Sport and Exercise Science, Brody School of Medicine, East Carolina University, Greenville, North Carolina

References
1.    Pories WJ, Dohm LG, Mansfield CJ. Beyond the BMI: The search for better guidelines for bariatric surgery.” Obesity. 2010;18(5): 865–871.

Original cartoon 1

Bariatric Center Finds Early Ambulation Competition Successful in Motivating Postoperative Patients to Get Moving

Dear Bariatric Times Editor:
Motivating patients to be ambulatory after surgical procedures is never an easy situation. Ambulation decreases the risk of postoperative pneumonia, speaks the return of postoperative ileus, decreases the rate of pressure ulcer formation, and improves circulation. It is this last benefit that is so critical to patients with morbid obesity because the leading cause of death after all weight loss surgeries is from pulmonary embolism. Many different methods have been approached to decrease the risk of pulmonary embolism, including vena caval filters and postoperative anticoagulants, but early ambulation has been shown to be the most critical. At Kennedy University Hospital, Stratford, New Jersey, we approached early ambulation in a unique way and would like to share our methods and success with your readership.

Over a period of three months, all preoperative patients were required to undergo a preoperative class held by our bariatric coordinator. All aspects of the patients’ upcoming hospital admissions were reviewed including the requirement for early ambulation. A competition of “Who can ambulate the most the night after their surgery” was offered to the patients. The winners received a certificate and had their names posted on the wall of the hospital floor. The competition was reviewed with the medical/surgical nursing staff and the nurse manager. The plan was to total how many “laps” a patient did around the nursing floor, which totals 300 feet. Winners were posted on postoperative Day 1 and a tally was followed from week to week.

Very rapidly, news of the competition spread. The first outstanding performance came from a 52-year-old male pateint who ambulated 10 times around the nursing station the night after his laparoscopic Roux-en-Y gastric bypass (RYGB). He received his certificate and his name went up on the wall. News of his accomplishment spread. Shortly thereafter, another weight loss surgery patient felt inspired and ambulated 17 times around the nursing floor the night after her weight loss surgery. She received her certificate, and her name replaced that of the first winner. News continued to spread, and the competition grew. Patients now were motivated to get out of bed for all the right reasons, as well as to get their certificate and replace the name on the wall as the new winner of the competition. The competition reached a zenith when a patient, the wife of the first winner, arrived to have her laparoscopic gastric bypass performed. The procedure went uneventfully. The night following her surgery, she and her husband started to make their laps. They started slowly, but deliberately. They had made it 10 times by 6pm, when the postoperative check was performed. By the time she finally laid down to go to sleep, she had accomplished the unheard of 40 laps around the nursing floor! The next day, the nurse manager, surgeon, and bariatric coordinator met. Pleased with themselves about the early ambulation, they decided that 40 times was a little too much. The patient received her certificate, her name went on the wall, and it was determined that there would be monthly winners from that point forward.

This story, while remarkable, is illustrative of a very clever way to approach the difficult task of ambulating patients after weight loss surgery. Informed preoperatively of its importance, and of a competition with a potential reward, patients pushed themselves to get out of bed and ambulate. By including patients in a competition, we improved their own care. We offer this as an idea for other bariatric programs. Our only recommendation before implementing this is to check the cardiac condition of your medical/surgical nurses—they may not be able to keep up with the postoperative patients.

Sincerely,

Lisa Shaw, RN, CMSRN, CBN, Bariatric Program Coordinator
William Quick, RN, BSN, Nurse Manager of Bariatric Unit
Louis Balsama, DO, FACS, Bariatric Surgeon
Marc A. Neff, MD, FACS, Medical Director Bariatric Program

All from Kennedy University Hospital, Stratford, New Jersey

Category: Letters to the Editor, Past Articles

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