Advancements in Obesity Treatment for the Low BMI Patient Population: Part 1

| November 2, 2014

This column investigates current research in the surgical and clinical aspects of obesity treatment and educates bariatric care professionals on the most up-to-date information on emerging technologies in the field.

Part 1: The United States Perspective

An Interview with

Natan Zundel, MD, FACS, FASMBS
Vice-Chairman, Department of Surgery, Florida International University, Miami, Florida, United States

Vafa Shayani, MD, FACS
Chairman, Department of Surgery; Bariatric Medical Director, Adventist Bolingbrook Hospital, Bolingbrook, Illinois, United States

Financial disclosures: Dr. Zundel is a consultant for Apollo Endosurgery, Inc., Ethicon, Inc., Olympus, and Applied Medical. Dr. Shayani is a paid consultant for Apollo Endosurgery, Inc.

Bariatric Times interviewed Drs. Zundel and Shayani, bariatric surgeons practicing in the United States. Here, they share their perspectives on obesity treatment, especially in the low BMI patient population in the United States. They discuss the potential and near future of minimally invasive treatment modalities, such as adjustable gastric banding, endoscopic suturing, and intragastric balloons, in helping to treat this vast patient population. Part 1 focuses on the United States perspective and Part 2 will describe the outside of the United States experience.

Q1: With the World Health Organization’s latest projections indicating that approximately 2.3 billion adults will be overweight and more than 700 million will be obese by 2015,1 Do you think we are effectively treating the obesity epidemic as a group of clinicians and engaging patients early enough to prevent obesity? Are you seeing a different patient mix visiting your practice (e.g., low BMI, patients previously resistant to undergoing surgery)?   

Dr. Zundel: No, I do not believe we are effectively treating the obesity epidemic. The only way to treat it is through prevention, which means engaging patients early before they become morbidly obese. We have treatment via weight loss surgery (e.g., Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, and biliopancreatic diversion/duodenal switch, but most insurance companies will only cover these procedures when a patient becomes morbidly obese. When a patient presents for surgery, he or she is already morbidly obese with multiple comorbidities, such as type 2 diabetes mellitus (T2DM), obstructive sleep apnea (OSA), and hypertension. I have even had patients ask me how much weight they need to gain in order to receive treatment, which is very sad. Now, other operations that may be or become a solution to help patients at low BMIs. For example, we can offer patients treatment with the LAP-BAND® System (Apollo EndoSurgery, Austin, Texas, United States) and endoscopic suturing procedures that are less invasive than other operations. These operations may become a solution for us to begin effectively treating the obesity epidemic because they can be employed earlier and thus help patients get back on track to better health earlier. I am seeing more patients with lower BMIs requesting treatment.

Dr. Shayani: The numbers speak for themselves and show that we are barely making a dent in treating the obese population in the United States. Although there are currently efforts being made to prevent obesity, such as First Lady Michele Obama’s initiatives, we will not see the effects immediately. They will be visible in 10, 15, and 20 years, but I believe things will get worse before they get better. Until our preventive measures lead to meaningful results, we have no choice but to treat morbid obesity after it is diagnosed and unfortunately this is what the insurance companies dictate. This means that we are reserving treatment for patients who are already morbidly obese. The other members of our community that fall in the low BMI category are not being attended to which makes for a short-sighted approach to solving the obesity epidemic.

In my practice, I primarily offer adjustable gastric banding  to my patients who are surgical candidates, and I have not seen a different mix of patients present for treatment. I am already treating the lower BMI patients with the LAP-BAND® System. I have observed an increased level of awareness among patients and find that they are self-educating on the less invasive options, both those that are already available in the U.S. and other technologies that will become available in the future. Patients are interested, but I think cost plays a big role in the decision to undergo treatment. I am not seeing many patients pay out of pocket and I think it is directly correlated to the United States’ economy. People do not have the financial means to pay for their treatment themselves. Additionally, although adjustable gastric banding is covered, there are still limitations. For low BMI patients, they must also have major comorbidities (e.g., T2DM, OSA, hypertension, arthritis) to be considered for coverage of weight loss surgery. Again, this is a short-sighted approach because it prevents us from reaching patients before they experience major comorbidities.

Q2: 40 million potential patients in the U.S. alone is a large number of people who could benefit from less invasive therapies. Additionally, the invasiveness of existing procedures has been cited as the key reason for this lack of penetration. Do you find patients are more receptive to undergoing less invasive treatment (e.g., endoscopic suturing, band, gastric balloon) when offered as an option next to traditional surgery? How might you encourage patients to be open to new therapies?

Dr. Zundel: I find that some patients are scared of surgery that is permanent or too aggressive (i.e., LSG, RYGB, and BPD-DS). They are more receptive to less invasive therapies and I find that patients come into the office having already researched these therapies.
They are very aware of products and procedures that are in trial and may be available soon, such as intragastric ballooning. I also find that they understand a weight loss procedure is only a small percentage of the process of losing weight and keeping it off. They are responsible for adhering to proper diet and exercise routines and staying engaged with the multidisciplinary care team. I would encourage patients to be open to new therapies by explaining what they are, how they work, and why they would be a a good option for that particular patient under the right circumstances.

Dr. Shayani: Undoubtedly. There is no question that the medical community and patients demand less invasive approaches, not just to treat obesity, but also other major diseases. For instance, coronary artery disease used to be treated with open-heart surgery. Today, we are able to perform catheter-based procedures that are better tolerated, can be easily repeated, and result in quicker recovery. Another example of the medical community moving to less invasive therapies can be seen in bariatric surgery, which went from open to laparoscopic approach with much success. As long as the risk of complication isn’t increased, there is no question that we will continue to seek out less invasive technology to offer to our patients.

I do find that patients are more receptive to minimally invasive options:  LAGB does not  involve removal of a portion of the stomach like in LSG or re-routing of the gastrointestinal tract like RYGB and BPD-DS. Traditional weight loss procedures scare many patients. In the near future, I hope  to be able to offer endoscopic procedures and devices to my less severely obese patients . As for encouraging patients to embrace new therapies, I believe that patients should be treated like knowledgeable professionals. The more information we provide, the more likely they will make an educated decision that would be ideal for them.

Q3: The list of newer, less invasive technologies that are safe and effective ways for Lower BMI patients is growing. What does that mean for such a large part of the U.S. population with a Lower BMI that is looking for medical intervention?

Dr. Zundel: It means that we can increase the number of patients that we are reaching and treating, especially earlier in their struggle with obesity. That is where even more minimally invasive therapies come into play. When patients cross the obesity line, whether by a little or a lot, they need treatment. By treating the United States population with low BMI, we can prevent them from rising to even higher BMI and the increased morbidity and mortality that comes with higher categories of obesity. We can prevenhelp them move to the other side of the health equation and get them back on track. There is no better health service than that.

Dr. Shayani: The fact that treatment for the low BMI patient population is growing  forces us to do the work to make sure the treatments are safe, effective, and durable. We need to be open and honest about data and in the process, provide the patients  with the confidence they need in whatever modality of treatment they choose. If they believe the procedure is efficacious and durable, they will be more motivated to do their role of adhering to diet and exercise regimens and following up with the multidisciplinary team. Additionally, new modalities will likely offer a  different risk/benefit ratio when compared with traditional bariatric surgery:  the lower the risk of the procedure and the better it is tolerated by the patients,  the more appropriate it is to offer it early. The low BMI patient who doesn’t have comorbidities is more likely to accept a minimally invasive therapy because relative to the benefits provided, the risk might be much lower.

Q4: What does this mean for the surgical community? What barriers might exist in the surgical community to adopt device therapy technologies and treat the population? How might you encourage the surgical community to be open to new therapies?

Dr. Zundel: This means that the surgical community can not only treat more patients, but also treat them earlier. As surgeons and health care providers, we need to make sure that the therapies are done safely. We also need to make sure new procedures are performed when they  are a good option for a patient’s particular circumstances.

There are barriers. For instance, who will pay for these therapies? Patients always have the option to pay out of pocket, but many are not able to do so. As a surgical community, we need to make sure the insurance companies understand minimally invasive therapies for obesity and see the safety and efficacy through our data. We need to make sure that any personnel involved in the treatment of patients with low BMI are adequately educated and trained.

I would encourage the surgical community to be open to these new therapies by first addressing their concerns. A surgeon might be concerned that their surgical cases will go somewhere else. I would reassure him or her that these new therapies are not a threat, but rather another tool they can offer to their patients. I would also encourage them to not be scared of undergoing new training to learn these procedures. If they are open to the new therapies and learn to do them safely and effectively, they will find they can see and treat more patients. In implementing new therapies, encouraging the surgical community is important because if we do not embrace it, another discipline might. If we all make sure that we understand these new therapies once they are proven safe and effective and we embrace them, only good things will come for our patients and for us.

Dr. Shayani: For the surgical community, this means that we need to do more work to show not only good short-term results for low BMI patients, but also reasonable long-term results. This will help with promoting patient access. Although on the surface it might appear that treating more patients would result in an increase in cost, in reality, we could argue that by preventing comorbidities, we would see a decrease in cost of care and thus a better return on our investment over time. In the long run, treating obesity early would save our society money.
One barrier that might exist in surgeons adopting new therapies is the concern that there would be loss of revenue in performing less invasive procedures. I would encourage the surgical community as a whole to put individual needs and desires aside and look at the bigger picture. At the end of the day, we have to say, “What would we want for ourselves or our own family member.” I hope that the medical community would not abandon new technology because revenue generation is not  competitive. It would be unfortunate if cost was the only driving force, however, I do acknowledge that there is a financial component to medicine like other professions.

Another barrier is the availability of space and time. If we were to substantially increase the number of procedures performed, we may encounter  difficulty in finding enough qualified facilities. This limitation might result in delay in care (recognizing the elective nature of most bariatric procedures), something that is common in other developed countries but not familiar to us in the United States.
Lastly, as mentioned previously, cost to the patient and insurance coverage may be a barrier.

Q5: In order for the integration of less invasive interventions to be successful will there be a need for other disciplines (e.g., dietitians, gastroenterologists) to join the multi-disciplinary care team? In your experience, are other disciplines (e.g., dietitians, gastroenterologists) receptive to the new modalities?

Dr. Zundel: Yes, implementing these therapies in a multidisciplinary environment is critical. If you don’t include the support of a dietitian, exercise coach, psychologist, and others it would just be a procedure. If the procedure goes well, but the patient does not have guidance on diet, exercise, and managing emotional struggles, they will gain weight.

In my experience, I find that other disciplines are receptive to the new modalities. Our gastroenterologists and dietitians are embracing new technologies and are already educating themselves on treating patients who undergo them. The dietitians want to be prepared, so they are learning the differences and difficulties in patients undergoing RYGB versus endoscopic suturing procedures. The gastroenterologists already understand RYGB and LSG and are learning how a procedure like the intragastric balloon is different. They are excited for these new therapies and want to be part of the multidisciplinary team. I find that other disciplines involved in caring for patients with obesity are educating themselves on new modalities by looking at international data, attending meetings, and learning about therapies for low BMI.

Dr. Shayani: I see the future of bariatric surgery including more than one discipline. For example, vascular procedures are shared by at least four disciplines. The same may happen in bariatric surgery with bariatric surgeons collaborating with gastroenterologists. I do not think there is anything wrong with gastroenterologists offering endoscopic weight loss procedures, as long as they demonstrate adequate expertise. A multidisciplinary care team will be needed in order to successfully integrate new therapies because we need the different skill sets to work together. For instance, bariatric surgeons and gastroenterologists might work closely together and learn from one another. The surgical community should respect the skills of gastroenterologists and gastroenterologists should in turn recognize their limitations and the need to have appropriate back up from the bariatric surgeon when performing endoscopic procedures. This collaboration will result in the best outcomes for patients. As for other medical disciplines, such as dietitians, exercise coaches, and mental health professionals, they are already a part of bariatric patient care. They will undoubtedly embrace and be involved in new therapeutic modalities.

Q6: Beyond demonstrating the safety and clinical efficacy of the new treatment options, what work will need to be completed among the clinicians, societies, and payors to make these emerging technologies available to the general population?

Dr. Zundel: First, we will need to demonstrate to clinicians and societies that these new therapies are safe and effective. We need their support and then we need to make sure clinicians understand when such procedures are indicated. Next, we will need to work for patient access by explaining not only the safety and efficacy, but also the benefits of early and successful treatment to the insurance companies. Payors will need to understand that if you prevent the patient population with low BMI from gaining more weight, it is better in the long term because it means a reduction in comorbidities and less expense to them in the long term. These new therapies can not only save patients, they can also save money.

Dr. Shayani: As clinicians and scientists, we start by focusing  on safety and efficacy. However, we also need to pay attention to “durability” of the procedures we offer. I believe we need to do a better job of providing long-term data. I feel that as a community, bariatric surgeons have been settling for short-term results with very few studies adequately addressing the longer term outcomes. If you examine research in other diseases, especially cancer, you find that the length of time in studies keeps extending. For instance, for treatment of many malignancies, reporting 10 year results are considered the minimum requirement. We need to start to focus on much longer results than our current reports.
Next, much work will need to be done to convince payers to cover these new treatment modalities. Currently, some insurance companies allow employers to pick and choose what is covered for their employees. With this “dealer’s choice” approach, treatment of obesity is often excluded. I think it is unfortunate that obesity doesn’t receive the same respect as cancer care and dialysis. I would like to see more pressure on legislation to not exclude obesity intervention as it is a real dis-service to many people. Nobody should be told that their insurance doesn’t cover obesity treatment and it is my hope that in the next few years those exclusions will be eliminated.

Q7: What is your outlook for 2015 and beyond in terms of patient mix and the number of available less invasive treatment options?

Dr. Zundel: In 2015, I think we will see intragastric balloon devices approved by the FDA. I also think we will see a significant increase in patients with low BMI presenting for treatment and seeking these new therapies.

Dr. Shayani: Personally, I have been performing LAGB procedures since 2001 and have observed a lot of success in my patients. In most instances, patients come in seeking LAGB. If I see patients who are likely to benefit more from stapling procedures, I prefer to refer them to a high volume center with a significant experience with such procedures. In 2015, I anticipate many patients presenting and asking about new therapeutic options including endoscopic suturing or intragastic balloon.

Q8: What interventions will be in your armentarium for the treatment of obesity and related conditions?

Dr. Zundel: My armentarium for the treatment of obesity and related conditions will include the following:
1.    Endoluminal devices (intragastric ballon, EndoBarrier, if aproved)
2.    Endoluminal procedures (pouch dilation, anastomosis dilation, gastroplasty)
3.    Other devices (LAP-BAND)
4.    Traditional bariatric procedures (RYGB, LSG)

In surgery as in life, we are always moving forward. We have moved from open to laparoscopic. These less invasive treatments are a new step forward. I am excited to see new treatment options coming for my patients.

Dr. Shayani: In 2015, I anticipate to continue to offer LAGB as the first line treatment option to my obese and morbidly obese patients and to offer endoscopic procedures to the lower BMI (overweight and obese) population.

References
1.    NMH Fact Sheet. Unhealthy Diets and Physical Activity. World Health Organization. 2009.
Funding: No funding was provided in the preparation of this manuscript.

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