Use of the LAP-BAND ® in Adolescents: A Discussion with the Experts

The epidemic of pediatric obesity is a significant health concern. Children with obesity experience comorbid conditions that are typically thought of as adult conditions, and the psychosocial and societal issues these children face because of excessive weight are substantial and very challenging for the developing child or adolescent to cope with. Because childhood obesity is viewed as a disease that is not going to get better without intervention, adolescents are now being considered for surgical intervention.

The participants in this roundtable session are members of a five-year longitudinal FDA Investigational Device Exemption study. This study aims to investigate the safety and efficacy of the adjustable gastric-band device in morbidly obese adolescents.

Dr. Seidl: We are delighted to have the opportunity to discuss the study with this panel and hear about their experiences to date. Could each member of the panel please introduce him or herself?

Dr. Browne: I am Dr. Allen Browne and I, along with Dr. Mark Holterman and Dr. Ai-Xuan Holterman, established the New Hope Pediatric and Adolescent Weight Management Program at the University of Illinois in Chicago and Investigational Device Exemption (IDE) #1 with the FDA to start research in the United States into the adjustable gastric band as an aid to help kids who are morbidly obese.

Dr. Reichard: I am Dr. Kirk Reichard, the Surgical Director of the Bariatric Surgery Program at the Alfred I DuPont Hospital in Wilmington, Delaware. I am responsible for Investigational Device Exemption #4, which we wrote nearly four years ago. We have to date enrolled 100 patients, of whom 44 or 45 have received the device. We recently requested a variance to enroll up to 75 surgical patients because we have lots of patients who are still waiting for the data of the four independent trials and the Allergan trial to be presented to the FDA.

Dr. Datto: I am Dr. George Datto, and I am Dr. Reichard's associate. I have been Medical Director of the Bariatric Program at DuPont since its inception in 2007.

P. Karpink: I am Peggy Karpink and I am the Clinical Research Coordinator at the Alfred I DuPont Hospital.

C. Clarahan: I am Christine Clarahan, the nutritionist at DuPont. I recently joined this program, but I previously helped develop an adult program. I am responsible for seeing the children both pre- and post-op.

Dr. Turner: I am Dr. Larry Turner, a licensed clinical psychologist at the University of Illinois specializing in children and adolescents. I am also a registered nurse. I have also worked at the New Hope Clinic in Chicago.

A. Phipps: I am Amy Phipps, a nurse practitioner for the New Hope program that Dr. Browne and Dr. Turner referenced at the University of Illinois Medical Center in Chicago.

Dr. Seidl: I would like to set the stage for the readership. Can you describe for us the overall multi-site trial? How many sites are there? How many targeted patients? How many have been enrolled?

Dr. Reichard: Starting with Dr. Allen Browne, Dr. Mark Holterman, and Dr. Ai-Xuan, Holterman IDE #1 was approved in 2004. This grew to a total of four IDEs, including ours. These were independent institutions working independently with the FDA with no support from industry. Subsequent to that, there has been an industry-supported study funded by the Allergan Corporation. The independent groups have by my count somewhere in the range of 200 to 250 patients with adjusted gastric bands on now. That independent group of those four IDEs is one of the largest groups of pediatric gastric-band participants in the world under a protocol.

Dr. Seidl: Can you provide an overall description of the weight-loss outcomes you have seen so far in these 200 to 250 patients?

Dr. Browne: I can speak for the Chicago experience up to about two years ago. I left Chicago at that time, but the results we were seeing were very similar to the results seen in adults. With proper preparation of the patients and the families and then good support after the band is placed, you will see about 50% or 60% of the kids that will go on a nice, steady weight-loss schedule that will result at least in a year at 30% to 40% of their excess weight being lost. The band is a long-term project. I just need to insert that because as you look at the results in the adults, you are not finished with your weight loss in many adults until three years. The data that we have so far are somewhat short term.

A. Phipps: I worked with Dr. Browne in Chicago and we did 33 bands on the FDA protocol. We had about 18 patients who really lost well, and we had about 10 who sort of floated but did not gain. We had about five who regained. The struggle that we have had with them is keeping them active in an unfunded study. That has been tough. But as far as their outcomes of weight loss, what Dr. Browne was saying is right. About half of them have lost really well.

Dr. Browne: IDE #2 was at New York University in New York City and they put on 50 bands and had results quite similar to ours at University of Illinois Chicago (UIC) with about a 50% good response rate. Then with the other 50% of the kids, you have things like Amy mentioned, with a not so good response rate or initial response where they regain and that kind of thing.

IDE #3 is from Morgan Stanley Children's Hospital in New York City and Dr. Jeff Zitsman. Jeff is up to 120 enrolled, so he has had great success at recruiting, figuring out how to pay for it, and with the FDA. All of our results are similar.

Dr. Seidl: One of the things mentioned is that children with obesity are experiencing some of the comorbidities that we typically see in adults. I am wondering if you have seen improvements in comorbidities such as hypertension, diabetes, dyslipidemia, any respiratory symptoms such as sleep apnea or asthma? If so, how soon after surgery are you seeing these improvements occur?

Dr. Browne: What we are really doing, at least in the Chicago group, is monitoring the kids for the different comorbidities on different schedules—the blood sugar and insulin levels and looking at insulin requirements and repeating a sleep study, say, at six months or a year. I cannot really tell you how fast it is happening per se, but Dr. Ai-Xuan Holterman has published a couple of papers that demonstrate improvement. She has published data about comorbidities, insulin levels, and fasting glucose. We had a small group in Chicago where we performed liver biopsies when they had their surgery, which showed NASH, non-alcoholic steatohepatitis, and then we were able to talk some of those kids into getting another liver biopsy a year or more later and we showed that it improved. We also did repeat quality of life questionnaires in Chicago and results showed improvement. So over the study period of roughly two years for most of the kids, you can see improvements in comorbidities, not only quality of life comorbidities, but also the clinical comorbidities.

Dr. Seidl: Dr. Reichard, do you want to describe any of the weight-loss outcomes so far in the patients you have seen and in the time frame that you have seen them?

Dr. Reichard: At one year, we are seeing about a 65-pound weight loss, which is durable and progressive at two years to 80 to 85 pounds. More importantly, we are seeing a 75% resolution in metabolic syndrome in kids who are out at least six months [post-surgery]. This finding is durable out at least a year, which means that co-morbidities such as hyperinsulinism, hypercholesterolemia, and hypertension are improving with this therapy. Even though they are not necessarily losing 100% of their excess weight, they are definitely healthier than they were when they entered. We presented these findings in June 2010.

Dr. Seidl: Dr. Browne, you mentioned quality-of-life co-morbidities. What are the psychosocial outcomes you have observed in these adolescents, whether they are measured specifically with some instrument or whether they are just anecdotal comments?

Dr. Browne: The other psychosocial aspect observed in Chicago has been the Beck Depression Score that we had used—which, by the way, is really not appropriate for teenagers—demonstrated improvement.

Dr. Turner: Initially when we screened the adolescents, we used the quality-of-life scale and the Beck Depression Inventory. We used interviewing techniques to get some more perspective. Regardless of their weight, which is an added burden on them, they had some of the same issues as all adolescents, a very challenging time. Of those who had previous psychological issues, we referred some to see a therapist, depending on where they lived. With others, we helped them to work through it.

At the Chicago site, there was a lot of education prior to being selected for surgery. They were selected by a team, not just one person. As a group, they verbalized that they understood. But just like all normal teenagers, initially they think that the LAP-BAND^® is a miracle. But when the weight does not come off, they return to old dietary habits—double cheeseburgers and everything—and they become a bit disappointed.

A lot of it really depended upon the support that they had within the clinic and with their families. Some of them had some severe family issues that helped to sabotage them, and some of the kids were quite mature because of those traumas and were able to maneuver their way right on through the process. It was case by case with the children who were in our study.

Dr. Seidl: Does anyone have any other comments about the psychosocial outcomes they have observed?

Dr. Datto: We have our psychologist screen all kids at study entry both by clinical interview and standardized testing. We are using both a quality-of-life and Behavioral Assessment System for Children (BASC) score. From a clinical interview perspective, we are seeing high rates of pre-morbid Axis I conditions, such as depression and anxiety. About a third of our kids present already on a psychotropic medication. The majority of kids come from families that do not have two parents residing in the house, and often times those parents have their own significant psychosocial or psychiatric issues. These adolescents come from psychosocially challenging home environments.

In addition, about 25% of the kids are home schooled. Because of the challenges that they face, both from a weight and a psychological standpoint, they are not in that school environment, which is a supportive one often for other adolescents who do not have severe morbid obesity. Uniformly I think that they all benefit from having a psychologist on the team to work with them both preoperatively and postoperatively.

Our psychologist is more involved preoperatively in assuring that we screen kids appropriately. We do not put bands on those kids who are not able to understand the procedure and process, or those who do not have the family support necessary to come to visits, make follow-up appointments, and change the home living environment.

Many times we see improvements preoperatively in depression and anxiety, as the big carrot is to get the band; they are able to change behaviors, at least in the short-term, to meet that goal of getting surgery. The challenges they face preoperatively often come back postoperatively, so to have a place where these kids can get ongoing care for these psychological issues that generally do not resolve just because of the band is also important.

We have seen improvements in quality of life, depression, and anxiety in kids both preoperatively and postoperatively with the band. But our experience would strongly support the need for a psychologist or someone specifically trained in that area to be working with the kids both preoperatively and postoperatively to ensure good outcomes and also for continued care of their premorbid psychological and family issues. That is our psychological experience here [at DuPont].

Dr. Browne: You bring up a very important issue. They work themselves up to the band because they want it. They have unrealistic expectations of what it is going to do, but they want it. Then after they get the band on, reality hits. They have the band on, and now they have to learn how to use the band. They have to learn how to take advantage of the band. That is the real reality and gut check for them. We had patients who took a year before they would successfully start sorting it out. There certainly are a lot of those issues that have to be recognized both during preparation for the band and then the ongoing care of their obesity, which includes using the band.

Dr. Seidl: Three or four times I have heard the mention of “family” in this discussion of how the adolescents are coping. Is there anything more specific you can say about families in terms of the role that they play before, during, and after surgery, or any examples of what you are experiencing with the adolescents' family members?

Dr. Datto: Obesity is as much an environmental disease as anything. This is where these kids spend most of their time—in their family environment. Those families that see it as their responsibility to help the child do better—that is, bringing the kids to their visits, making sure the food environment is not horrendous in the house, making sure the kids get to school, making sure the kids take their medicine—they are going to do better. Unfortunately, sometimes families think when the kid hits a magical age, 16 or 17, they should be flying by themselves. That uniformly is a setup for failure. We have screened more than 100 kids and performed 40 surgeries, so 60 kids have not made it to surgery. That is the number-one reason why kids who enter the presurgical program do not make it to surgery—because of a lack of family support.

Dr. Turner: You are absolutely correct on that. LAP-BAND^® in one sense can be viewed as a family surgery because everyone is going to be impacted by it. Mom has to change the way she shops and change the way she cooks. The whole family has to change. You cannot just hide the snacks because the kid will find them. You have got to get rid of them and that means changes for everyone. It really, really works a lot better when the family works as a unit, whether it is a single parent or not.

Then there are the emotional issues because sometimes the kids know how to really get to mom: “Oh, just one ice cream,” “Oh, just one bag of cookies,” and that type of thing. It is about relationships, and the whole idea of LAP-BAND^® and dealing with adolescents and kids is a family issue. You have to have the family onboard.

A. Phipps: You are talking about a time of transition and turmoil anyway and you add a chronically strained relationship around food into that mix. I think it is really key for the people who are working with the kids to recognize the developmental transition to accountability, which naturally we want to happen in the teenage years, and support that both from the parents' side and the kid's side. As Dr. Turner mentioned, there are times when there are certain roles for each person, so we try to work with both the parents and the adolescent to establish support from the family. But accountability [must develop] from the kid's side in this time of transition, when the kid is moving from more dependent care to more self-care and ultimately independence. There is a lot of change that occurs naturally, and it just requires even more intervention with everyone involved.

Dr. Datto: There is no perfect family and there is no ideal family situation. The mean BMI in our kids is 53, at a mean age of 16. What has been previously offered to this population hasn't worked. We need to develop different strategies in order to get the best outcomes.

Dr. Browne: There is an irony in this word “adolescent” and this age group of 14, 15, 16, and 17 that, through some heavy negotiations, we worked it out with the FDA so they would allow us to study that age group. The 14- and 15-year-old is not a 16- and 17-year-old. It is a dynamic time. They are moving through different stages. As you take care of them and you watch them go along, you realize that a whole lot of things are changing. One is who they are and how they interact with their families. It does not decrease the importance of their families, but [rather] how they interact with the families, the amount of independence they have, the amount of mobility that they have—all those things make it a continuously moving target as they move through the age group.

Dr. Seidl: It sounds as if you have divided the adolescents into two age groups, 14- and 15-year-olds, and 16- and 17-year-olds. Do the two “groups” look different in terms of outcomes or do they look different in terms of the psychosocial family support that is needed?

Dr. Browne: I do not think we have numbers big enough to be able to analyze that. Good question.

A. Phipps: Anecdotally, there are a lot of kids that we see at 17 that got their band at 14 who say, “Oh, my gosh. I use it so much better now than I did at that time.” Even the kids are commenting that they are glad they got it at that young age and they had more support from the parents at that time, but they do kind of move into a comfortable place as the maturity comes. That makes [the band] an even better tool that can be used to help them.

Dr. Reichard: While we enter kids in the study at ages 14 and 15, many of those kids take a long time until they really are ready for the band. We have kids who get their bands and do not do terribly well for a year or so, and we have had some enter college and then return with an incredible amount of success. In some of the kids, it is just a matter of further maturation.

A. Phipps: That also brings up one of the questions: should we do it that young? What I see in our kids in Chicago is that even in the kids who are not losing a miraculous amount of weight right away, those kids are able to maintain their weight, which is something they frequently had not been able to do up until this point. I would still argue that doing it young is not a bad thing. You may not see a quick response.

Dr. Reichard: That is our experience, too, as Dr. Datto said. Our mean BMI at age 16 is 53, so they are gaining an enormous amount of weight every year before they come to see us. We have had no kids gain weight after they have gotten the band. Everybody has lost; a few have regained some of their weight. Many of them continue to lose weight, but we have had nobody to this point, in 45 kids, who weigh equal to or more than what they did at surgery. That, at a year, is better than where they would have been had we not put on the bands; they could have been 40 or 50 pounds heavier. I still argue for doing them when they are younger [because] even if they are not losing a lot of weight, they are not gaining it.

Dr. Browne: I think in this age group the definition of success is a little different than it might be for an adult.

Dr. Reichard: These kids are getting a metabolic benefit even if they are not losing a lot of weight. We are looking now at the comorbidities that we know are risk factors for cardiovascular disease later in life; even if they are not losing a lot of weight, they are getting benefits in terms of their triglycerides and their cholesterol, of their insulin resistance and glucose intolerance. These are getting better even in the absence of enormous weight loss.

Dr. Seidl: Because adolescents are still growing and have specific caloric and nutritional needs, what are you tracking from a nutritional standpoint and what do results show so far? Is there any concern at this point for long-term nutritional consequences?

C. Clarahan: We look at all of the lab values. Fortunately with nutrition, labs and weight are things we can track. The best benefit of the band in terms of nutrition is that it is a purely restrictive procedure; it is not malabsorptive. We do know that there are common vitamin deficiencies in general in obese adolescents, so we closely monitor those. We have not had any significant vitamin deficiencies, but from the first day that I see them, we start them on a complete multivitamin and calcium supplement, which we separate by two hours because of the iron and calcium competing in the body. We have not had any significant deficiencies whatsoever.

A. Phipps: Same for Chicago; the only deficiency we have really been finding is vitamin D, but as far as the nutritional deficiencies that would be related to the surgery [we haven't seen them]. The kids are taught nutrition basics and working with the band.

C. Clarahan: About a year or so ago, some of the dietitians who have worked with the pediatric band patients from Texas Children's Hospital, Cincinnati Children's, the Nationwide Children's Hospital, Hopkins, and Seattle Children's met and developed guidelines for pediatric bariatric surgery patients. We do set some calorie goals for them as well. Because you are restricted, it is important that they take the supplements as we recommend them.

Dr. Seidl: With any surgical procedure, you want to make sure that the benefits outweigh the risks. What are some of the potential or actual risks that you have experienced in your time working with these adolescents, and do you feel that, with this procedure, the benefits outweigh the risks?

Dr. Reichard: I think that our biggest concern is doing any operation on a morbidly obese kid. This is something about which I have worked long and hard with our anesthesiologists to address. We operate on kids who weigh 400 pounds for gallstones, for torsed ovaries, for hip disease, knee disease. We perform tonsillectomies on morbidly obese kids with severe sleep apnea. Data are emerging to suggest that morbidly obese kids have silent myocardial dysfunction and ischemia. We have seen a couple of children develop life-threatening pulmonary emboli after orthopedic procedures. I think the largest risks are cardiorespiratory complications and venous thromboembolism. We have not personally seen anything like this in our bariatric patients and work diligently to screen in order to prevent.

The technical risks from doing a LAP-BAND^® are pretty unusual. Intraoperative problems such as injury to the stomach or the esophagus, intraoperative bleeding, postoperative infections are relatively uncommon, and in our experience, we have not seen them.

The other complication that can occur is dislocation or slippage of the band, which I think is not so much of a technical problem as it is nutrition and teaching problem in kids who either overfill their pouch postoperatively or who think the band needs to be tightened more aggressively. Band erosion has also become quite uncommon. We have not had any re-operations in our series. Our stance at this point is that the technical, intraoperative, and perioperative risks are quite low. We worry the most about the comorbid conditions and what effect those have on a safe anesthetic.

Dr. Browne: I think the Chicago experience is quite similar in that there is a lot of fuss about complications of bariatric surgery, but that is not related to LAP-BAND^® surgery. It is not related to adjustable-gastric-band surgery; it is related to other types of bariatric surgery. The actual complications related to the adjustable-gastric-band surgery are minor wound infections. I had one kid whose band was defective; it had a hole in it so we could not fill it up. It took us a while to figure that one out and we had to replace it.

These kids probably do better with anesthesia because they are scheduled. As Dr. Reichard points out, we still operate on these kids for emergency issues. Then the anesthesiologist does not know they are coming. They are high risk for anesthesia and they have to be watched for cardiorespiratory emboli issues. When they are in a bariatric program, they are marked, and they go through a strict protocol. That is why the results are uniformly quite good in terms of the perioperative period. Whereas when these same kids come in with gallbladder, appendicitis, or other surgical emergencies, people do not look at them the same way, and general anesthesia is more dangerous for them—even though it is the same process. That is something that has to be tackled educationally in the healthcare system.

The risk/benefit, once you start putting the band on, you learn how to work with the children and their families, and you live with these patients, is not an argument. They are so much better off after having what, in the surgical world, is really a pretty small procedure. Nothing is without risk, but especially over time as we better document the resolution of comorbidities, the improvement in their quality of life, the resolution of their psychosocial issues, the scale is going to lean very, very heavily to the benefit side. The real pressure is going to be on how to develop programs that help the kids and the families take advantage of the band, because having a band is far safer than being obese.

Dr. Reichard: There is really little debate among the colleagues in our program at this point, although there was a great deal of debate when I first brought up the idea of doing bariatric surgery. I find that some of my medical colleagues are actually pushing me to do more and more aggressive things, if you will, in terms of banding kids who weigh more, kids who have hypothalamic obesity. Again, while these operations are not risk-free, I do a large volume of complex laparoscopic surgery than LAP-BAND^® insertion in kids who are sicker than this. I think the risk/benefit is low, but I think the important thing is that they are done in a setting that is designed to care for kids and adolescents.

Dr. Seidl: Do you think that only pediatric surgeons should be doing these procedures? And if so, what are the advantages of a pediatric-focused bariatric program?

Dr. Browne: Actually you asked two questions. Because putting the band on is one thing; it is an interaction with the patient for 45 minutes. They probably stay overnight and then they go home. The surgeon has this little brief interaction and interlude with the patient and then the adjustments may or may not be done by the surgeon or the nurse practitioner. That is one issue—who puts on the band. As long as they are technically proficient at putting on the band it does not make any difference whether they are adult bariatric surgeons or pediatric surgeons trained in doing this.

The real crux of the matter is the pediatric program and the program having resources that care for the kids and the families. That is what separates it out.

Dr. Seidl: Thank you for that clarification. It is an excellent point. Dr. Reichard?

Dr. Reichard: I am involved now in a national effort to begin talking about credentialing adolescent programs. This argument comes up a lot. There are not enough pediatric surgeons interested in bariatric surgery to care for all the morbidly obese teenagers in the country. I think that the focus should be on the program and not on the surgeon. In the adult bariatric world, the focus is very much on the surgeon and his or her program is secondary. The surgeon applies for center-of-excellence designation. The surgeon is the one who does the primary application.

The pediatric program, as we have envisioned it, is focused around the pediatric medical director who will apply for a center-of-excellence designation. Then the questions will not necessarily focus on how many lap bands has Dr. Reichard done, as long as it is a safe number; the questions will be: do you have the nutritionists onboard who know how to deal with adolescents and their quirks? Do you have the behavioral health specialists who specialize in the special needs of adolescents? Do you have exercise people who know how to deal with adolescents? And do you have the kind of program that can deal with these kids long term in order to really get the best outcomes.

I do not think that you can have a surgeon working in isolation without a program like that. If those adolescent weight-management programs want to affiliate with adult bariatric surgeons in their community, if that is the appropriate thing, I am 100% in favor of that. If you have a couple of pediatric surgeons like Dr. Browne and I, who have an interest in it and who are affiliated with programs such as the ones with which we are affiliated, I think that is a great way to do it.

Dr. Browne: As we approach a time when the FDA may be approving the band for use in adolescents, 14 through 17 years old, one of the things that has to be guarded against is anybody putting a band on a kid when the kid and the family are not in a pediatric-focused program. That is dead flat wrong, immoral, and unethical. There is no justification for that. We have to figure out some way to protect the kids and their families. They are a very susceptible group. They will buy a ticket to Mexico, go down there, and get a band placed. They do it every day. But when they come back, they have had no prep and they have no ongoing care. It is wrong.

Dr. Reichard: And I think the onus is on us, not only as pediatric surgeons but pediatric providers. The adult group is very much onboard; the Society for Bariatric Surgery is grappling with this issue right now. How do we make certain that the adolescents are receiving the kind of care that we all believe they need to receive with these operations? It is not really going to be a conversation about who the technicians are. That is really the bottom line.

A. Phipps: This is an amazingly powerful time to give kids the opportunity to change their self-esteem and their destiny. It can change the trajectory of their future, when they feel confidence that they have been able to manage this thing that has been a problem for them their whole lives. I think that this timing is so perfect, because it is a time of transition, maturity, and change, and it allows the kids to step forward on a different foot than they have had in the past. It really does impact every level, certainly the biologic issues, but socially and emotionally and psychologically. It is a very powerful thing for these kids at this time of change.

Dr. Seidl: Well said, Amy. I think that is the perfect statement to end our discussion here today. Thank you again to all of our participants. You have made this a great discussion.