Bariatric surgery is expanding its indication from serving primarily as an option for obese patients to being considered an indication for some patients with type 2 diabetes. One prominent surgeon suggests the clinical data will help move it towards mainstream acceptance and resolve any reimbursement issues.

By: John Parkinson, Clinical Content Coordinator, DiabetesCare.net

At the 2nd World Congress on International Therapies for Type 2 Diabetes, held in New York City this past March, the International Diabetes Federation (IDF) held a concurrent press conference during the World Congress, announcing its position statement recommending the indication for surgical intervention for people who suffer from type 2 diabetes and have a body mass index (BMI) of 35 or greater as another treatment modality. The IDF officially recommended 2 bariatric procedures: the Roux-en Y Gastric Bypass (RYGB) and Laparoscopic Adjustable Gastric Banding (LAGB).

Bruce M. Wolfe (pictured), MD, FASMBS, president of the American Society for Metabolic and Bariatric Surgery (ASMBS) was one of a group of IDF panelists that helped write the recommendations. ASMBS had three other surgeons represented on the panel including John Dixon, MD, Francesco Rubino, MD, director of the World Congress and a member of IDF’s taskforce and Philip Schauer, MD, past president of ASMBS.

Dr. Wolfe believes strongly that the data will move bariatric surgery along as another viable modality within the diabetes realm and serve as one more tool in practitioners’ armamentariums that can be utilized in qualified patients.

DiabetesCare.net talked with Dr. Wolfe recently about which bariatric procedures may be better suited for the morbidly obese patients who have diabetes, and about the role bariatric surgery will play in diabetes care overall. Here are some of the highlights from the conversation:

DiabetesCare.net: With the news earlier this year that the IDF is recommending bariatric surgery as an indication for patients with type 2 diabetes who are unable to maintain control through other therapies, does ASMBS have an official position itself for the same indication for type 2 diabetes patients?

Dr. Wolfe: ASMBS has not taken an official position. We have as a field supported bariatric surgery in patients with a BMI greater than 35 in the presence of co-morbidities including type 2 diabetes for many years. The NIH conference in 1991 made that clear. I suppose our society never felt the need to duplicate that recommendation.

DiabetesCare.net: Bariatric surgery has had some access barriers in terms of reimbursement and insurers’ requirements for patients including undergoing a weight loss program prior to a procedure. Will the IDF’s position on bariatric surgery for patients with type 2 diabetes help to change some of these challenges?

Dr. Wolfe: The access and application of bariatric surgery among type 2 diabetics involves many factors. My own personal opinion is that as the intervention becomes more standard and more commonly applied in medicine as recommended to primary care and diabetes doctors, that the reimbursement and insurers will get onboard.

It is a little unfair to say the barrier is all due to insurance requirements. If the data supports it and the medical community approves it and feels this treatment should be made available, I expect the insurance companies to follow suit. I don’t think they are the obstructionists they are made out to be.

One problem we hope to see addressed by healthcare reform is what is known as adverse selection, wherein patients migrate toward a single insurance company that covers a service such as bariatric surgery if they need the surgery.

The data showing the benefits for bariatric surgery in diabetes, continues to expand. And as it does, it becomes a stronger justification for our position that bariatric surgery should be made available to people. The outcomes data regarding bariatric surgery for obese diabetics is consistently positive and supportive and is what stimulated IDF to write the position statement.

DiabetesCare.net: As the data does appear to be very strong and there does not appear to be any obstacles in terms of what you are seeing, have we reached a critical mass with bariatric surgery for patients with type 2 diabetes?

Dr. Wolfe: There are some academics and healthcare planners who insist that the quality of the data would be stronger if it involved randomized clinical trials, which they prefer to see prior to effecting a major change in how medicine is practiced. Thus, we don’t have as much randomized clinical trial data as healthcare planners and insurers would like to see. It takes a fair amount of momentum, education, and time to effect substantial changes in the practice of medicine, but the change does appear to be occurring. The benefits of weight loss have been so well demonstrated by observational trials that the NIH Consortium rejected a randomized, clinical trial with BMI greater than 35 for bariatric surgery as unnecessary and inappropriate.

DiabetesCare.net:
There has been some variability about BMI and what the measurement should be in indicating bariatric surgery for interventional therapy for patients with type 2 diabetes. Does ASMBS have an official position or recommendation on BMI?

Dr. Wolfe: We as a society don’t have an official position. The reason BMI has persisted as a standard metric is that it is readily available and easy to measure in primary practices. However, there are limitations to BMI to the extent of which diabetes and other health effects vary with the same BMI and different populations, like the Asian populations for example.

BMI has proven to be a very functional tool that we need for prescribing these procedures. We categorize a BMI greater than 35 with co-morbidity as severe obesity, indicating surgery. Hopefully in time, research will identify subpopulations with refined or specific criteria indicating surgery.

DiabetesCare.net: In a patient who may be coming under a BMI of 35. How much of the clinician’s experience plays a role in what he or she will recommend in terms of surgery in these patients?


Dr. Wolfe: The problem is that the individual practitioner is not going to have much experience because the population with a BMI of less than 35 has not been taken as a standard or accepted indication for bariatric surgery and insurance coverage. So, the number of patients who undergone surgery with diabetes with the lower BMI is a smaller group.

The IDF and American Diabetes Association and the American Heart Association, all have statements stating that the data or evidence supporting a clinical recommendation for surgery in patients with a BMI less than 35 is insufficient to justify routine recommendation or consideration of surgery. In medicine, we are moving past the personal experience of the practitioner and more towards global, evidence-based practice. Practitioners should be guided by what the overall evidence shows and what guidelines we can provide to these practitioners so they will have appropriate treatment protocols.

DiabetesCare.net: There are some emerging surgical procedures within the bariatric field. Is there one specific type of surgery that has shown to be more effective and should be specifically indicated for diabetes patients?

Dr. Wolfe: The observation has been made that there is special effect in improving or inducing the removal of type 2 diabetes in the procedures that rearrange the GI tract. That would be the gastric bypass (roux-en-y procedure) and a much less commonly done procedure called the duodenal switch (gastric reduction duodenal switch ).

Definitive long-term data regarding the importance of weight loss versus rearranging the intestines and GI tract is not available yet. Gastric bypass does appear to be superior to procedures on the stomach alone, but the weight loss is also superior with the gastric bypass, so we don’t want to ignore the benefits of the weight loss.

When you get into the less-severely obese, the superiority of gastric bypass over gastric banding is less clear. We need better research to identify candidates for gastric bypass when the indication for the surgery is more the diabetes than the obesity.

The laparoscopic adjustable gastric banding procedures have their place because they are less severe operations and presumably as a result have less complications, at least in the short term.

DiabetesCare.net:
Whether a patient has a more comprehensive gastric bypass or the laparoscopic adjustable gastric banding procedure, is the post-operative treatment the same or approached differently when it comes to eating?

Dr. Wolfe: If you distill down what exactly we do in bariatric surgery, we aid the patient in achieving a reduction in how much they eat. Bariatric surgery is a practical solution to a life-threatening problem. If the patients are going to have success there must be changes in their habits, including what they eat and how much they eat. Dietary instruction is a substantial part of the intervention. There are some differences in this instruction for gastric banding patients as opposed to gastric bypass.

DiabetesCare.net: There is the changing of the stomach’s physiology and quick weight-loss associated with these procedures. Is there anything else from a physiological standpoint that patients who undergo this procedure need to consider will happen to them post-operatively?

Dr. Wolfe: The management of the diabetes requires careful monitoring because requirements for medications changes very rapidly. It is not unusual for patients who are on insulin to never have to take insulin after a gastric bypass. They need to be alert for glucose monitoring. The effects for banding procedure patients are slower than gastric bypass.

In terms of the requirements in preparations for the changes they make, we have to be on the lookout for patients who expect the surgery to solve their problems in and of itself, which isn’t the proper frame of mind or what we do.

DiabetesCare.net: Does ASMBS plan to do any outreach to the medical community at large about bariatric surgery as it pertains to patients with type 2 diabetes?

Dr. Wolfe: Education is a major thrust of ASMBS including the annual meeting. The first half of our meeting is devoted to post-graduate courses to educate our members and other health professionals who may attend. Our job is to make sure that information gets to the hands of the practitioners and health planners.

The second component of the ASMBS education program is to educate legislators and their staff, other government officials, insurance companies, medical practitioners, and the public at large regarding the detrimental health effects of obesity and the benefits of weight loss, whether accomplished by surgery or other means.

DiabetesCare.net: As the annual ASMBS conference is approaching, do you expect the IDF position statement and the bariatric surgery for patients with type 2 diabetes to be a major topic of discussion?

Dr. Wolfe: Diabetes and other co-morbidities have been themes the last three to four meetings. The research has been steadily evolving and those of us involved in it are making every effort to present the results.

One interesting finding that was presented at the New York meeting (World Congress) was from Sweden. They found that elevated insulin among the obese predicted a better survival rate following bariatric surgery than any other parameter. It was an observation that is not yet published, but out in the public domain. We will certainly pass that information along to those who attend our meeting.

The benefits of weight loss after bariatric surgery reduce the risk of long-term cardiovascular disease, cancer and other co-morbidities. Thus, it takes several years for the benefits of improved survival to become apparent.

This is also important because most people can lose weight short term, so if the surgery doesn’t produce superior long-term weight loss and benefit then the basis is diminished greatly.

 

Originally posted by DiabetesCare.net on June 17, 2011.