Dr. Cori McBride reviews the safety and efficacy of bariatric surgery for shared decision making and presents the tools and resources available to patients and physicians.
I'm very excited to introduce our next speaker, Dr Corey Mcbride. She is the chief of minimally invasive and bariatric surgery at the University of Nebraska Medical Center. She is a professor of surgery and the vice chair of surgical informatics in the department of Surgery and the chair of the clinical governance committees and bylaws committee. She is particularly well qualified to speak on the subject of bariatric surgery because she's actually had surgery herself. So dr Mcbride, please go ahead. Well, thank you very much for that nice introduction. And for the entire program committee for asking me to talk on this topic which I am incredibly passionate about. I have no financial disclosures, little impact what I'm talking about today and I don't think I'm planning on talking about any off label indications. But I do hold several leadership positions in some of the major organizations that impact bariatric surgery and I want to make it clear I'm speaking as an individual and not necessarily for any of those organizations. My goals today are to really try to make clear some of the relationship between obesity diabetes and the other weight related comorbidities and really help share with you some of the the demonstrated efficacy, a bariatric surgery on these weight related comorbidities and then share with you some of the tools that we have available but for patients and physicians to look at the safety and efficacy to try to help patients really understand of surgery is right for them. And then once they make that decision that yes, they need a stronger tool like surgery to help them on their weight loss journey. Which operation might be best as we are moving more and more in medicine to this concept of a shared decision making model. Many people have seen a cartoon something like this, looking at the obesity comorbidities and um she shows up a lot in my presentations because what it really shows us is there really is not an organ system in the human body that is not affected by obesity all the way from the brain to the spinal cord to the heart, the lungs, the liver, the pancreas, the intestines, the bladder, the joints, um across the board Now they're not all affected equally and they're not all affected through the same mechanisms. Some of them are direct impact of weight on the organ itself. And we can imagine that very clearly when we think about the joints, some of that is because of actual fat deposition within the organ, the liver, the heart and some of it is the actual neuro endocrine effects which is very clear to you as people who work in the endocrine field. But as she gets skinnier after bariatric surgery and this is why I really love what I do is all of the um impacts of bariatric a of wait on all of these organ systems either improve or the disease is resolved to some degree. Now how much they resolve or improve does vary based on the disease. The actual operation they get and the duration of time that they had the disease in some cases. Now gird it doesn't matter. It doesn't matter if you had good for six months or 10 years if you have bariatric surgery. The resolution rate is about the same. But it definitely matters when you're talking about something like diabetes. There is good evidence that the longer you have been an insulin dependent diabetic when you finally get bariatric surgery will impact the resolution rate of um your operation. And so there is a time crunch if a patient really is an insulin controlled diabetic to think about sending them for bariatric surgery. But part of the reason I really love what I do is the two boxes at the bottom. It's the improved quality of life. I love the six month and 12 month follow up appointment where I can sit there and talk to patients about what they can do that they couldn't do before. And it's rarely about their medical comorbidities because that's old news to them. It's about tying their shoelaces without getting short of breath. It's getting down on the floor and talk and playing with their kids and their grandkids. It's about flying without the seat belt extension that makes them gloriously happy and why I love to do what I do and the mortality benefits. We help them extend their lives by decreasing their oncology risks, particularly breast and colon cancers and the reduction in the major adverse cardiac events. Bariatric surgery and its relationship to Type two diabetes has been published and talked about since 95 by Dr Perry's in his group. And they noticed that in 100 and 65 diabetic patients who had an open gastric bypass, 88% of them had normal fasting blood glucose and hemoglobin A one CS at a year. And by a few years after that there were enough publications that a meta analysis could be performed that again showed 76% of resolution. Now I think we'd refer to it as uh conversion to a diet controlled diabetic or improvement. However, all all of those studies were based on retrospective data and we really like prospective randomized controlled trials in medicine. And so several of those really started to be constructed in the 2000s. Probably one of the best known was the stampede trial out of the Cleveland clinic where dr Schauer and his colleagues took 100 and 50 patients and randomized them in a 1 to 1 to one fashion between intensive medical therapy, gastric bypass and sleeve gastrectomy. Now you do have to take these this study with a little bit of a grain of salt because they did have a very narrow B. M. I. Cohort of only 27 to 43 which means there was a significant number of these patients that got bariatric surgery that would not be considered. Bariatric surgery candidates under most insurance companies criteria and by using a BME cut off of 43. I don't know that. We can say that the intensive medical therapy that was used here is necessarily applicable to our BMS of 45 50 60 across the board. But it is an interesting study. They released their data at one years, three years and five years. And I'm showing you the five year data today. Their primary endpoint was hemoglobin. A one C. Is less than six without medications. And clearly at five years the surgery arms did better than the medical arm with a significantly higher percentage of their patients that were off all of medications and still had a normal hemoglobin A one C. But you can also see that a large number of the patients went from being insulin dependent. Which is this this light blue bar here and it's a dramatically fewer number of patients were still requiring insulin at five years. So the medication shift was really across the board as far as secondary in endpoints. They tracked hemoglobin a one C for this entire six year period and the surgery arms did better than the medical arm. As far as weight and body mass index. As expected, the surgical patients lost significantly more and the weight loss was durable out to five years. But as I mentioned earlier, the quality of life part is really what energizes me and why I love going to work every day as you would expect from a prospective randomized trial. All three groups scored approximately the same on the quality of life indices early on When they checked them though are we questioned them at five years. What they actually found and the way this they used the ran 36 for this. So lower numbers are worse. Higher numbers are better. The medical therapy group was essentially the same for the cohorts of social fund. The ones here on the side on this side and this side, but actually physical functioning and role limitations due to emotional problems. Actually, the numbers had gotten lower. So basically being morbidly obese or I'm sorry I guess 27-43 means you're severely obese but being obese for five more years worsens how you feel physically and emotionally, which probably doesn't come as a surprise. But they actually had to spell that out. On the other hand, the surgical arms. Their numbers all went up the circles got bigger. They felt better and had higher qualities of life. Now the stampede trial is not the only prospective randomized trial. And by 2013 we were able to get a meta analysis of just prospective randomized trials and for weight. All of the trials favor bariatric surgery. For remission of type two diabetes, all of them favor bariatric surgery and for improvement in metabolic syndrome. All of them favor bariatric surgery. But just like many of the medication trials for diabetes initially just looked at the outcome of our their labs better. And now, most of the trials look at how are we impacting mortality and major adverse cardiovascular outcomes are bariatric surgery literature is doing the same thing. It's no longer good enough to publish a study and say we've controlled your hemoglobin a one C. Now, what we're really looking at is what are the major, what are the impacts on mortality At five years, 10 years? What are the impacts on major adverse cardiac outcomes? Because we really want to not just impact them for a year. We want to impact them for five years, 10 years, 20 years. And that's sorry. That's exactly what the Cleveland clinic did here. They took over 2000 of their metabolic and bariatric patients and matched them 1 to 5 with nonsurgical patients. So they ended up with over 11,000 controls. And they looked at the mace now for the primary endpoint, absolutely. Surgical patients still had major adverse cardiac events, As did the nonsurgical groups. But when you look at it, the absolute risk difference was almost 17% between the two groups. And when you look at them individually, what you see, the mortality difference breaks as early as one year and they continue to separate out to the eight years. And it is statistically significant. The same with heart failure. The same with coronary artery disease. And therefore apathy were all statistically significant by eight years. The only two that didn't reach statistical significance were cerebral vascular event or disease and atrial fibrillation. But even though these did not reach statistical significance, you can see a clinical significance here now showing graphs like that is sometimes hard for patients to understand. So this Cleveland clinic, working with the american society of metabolic and Bariatric surgery put these together in both websites and apps that you can use to actually talk to patients about this on the A. S. M. B. S website. It's under the campaign of the escape diabetes campaign. And Cleveland clinic also has it in the app that you can download on your phone or you can see it on their website and basically, you put in demographics and I literally, the day I was starting to craft this talk, I went into my clinic, I found an average patient and I plugged her in. So you put in demographics, you put in medical history, you put in their most recent clinical labs, you put in the medications they're taking and you clip find my risk And it will show you the current 10 year risk if they do not have bariatric surgery, their current tenure risk, if they have bariatric surgery and what is the relative risk production. So this makes it very clear, surgery is not going to fix everything. We are not going to take them from a 32% mortality to zero. Some of the damage has been done. And so they do still have a mortality risk. But the relative risk reduction drops to buy 43% similarly, very impressive reduction in their chance of developing heart failure, coronary artery disease and kidney disease. Now the patient Isil I selected for this had already had A T. I. A. So he didn't tell me about cerebral vascular disease but I went ahead and re ran her unclip king that box. And so if she had never had a stroke, it would have told me what the risk of her having a tia or stroke was. Part of the reason I like doing this on the A. S. M. B. S. Website is though they will also give you an infographic on this. And the patients really seem to like the visual of these um smiley faces. So again, unfortunately a certain number of patients will still die after surgery By the end of 10 years and that's the yellow frowny faces. But they understand this concept of the Teal Smiley faces. The patients that should have died by 10 years but didn't because they had bariatric surgery and it will show you one for each of the risks that we were talking about. But obviously as a surgeon, my job is not just to talk about the good things that can happen with surgery for a balanced informed consent conversation. We have to talk about the risks versus the benefits. And that's a huge part of what I do is educating patients and their families about why I do what I do and what are the pros and cons But again, there's a study that helps me have that conversation. So um this study but Dr Armenian looked at how safe is metabolic and bariatric surgery specifically in type two diabetic patients. And using the knees quick database. He pulled all of the patients with type two diabetes who had a lap gastric bypass and compared them to the top seven next, the next most common seven Operations that they'd had. And he looked at their 30 day complication rate and the 30 day mortality. So this is their 30 day more complication of those seven other operations and this is their mortality. So I'm going to pause for a second and I want you to mentally think about where in these rank lists, you would put a laparoscopic gastric bypass and then I'm going to show you where it goes and we'll see if you're surprised. Okay, this is where they fall on those rank lists. And this surprises a lot of people because what this is really saying is a lab gastric bypass is safer than laparoscopic gallbladder surgery. It's safer than a laparoscopic appendectomy. It's safer than the knee replacement that many of these patients want a need. It's probably not fair to compare it to a heart bypass because that's an emergency procedure. But still um so when I give this talk to like the family medicine department at my hospital. The question I asked them is if you have a patient in front of you who has symptomatic gallbladder disease, would you send them for a lap cole? If the answer is yes. And they also have symptomatic obesity then you should be sending them for bariatric surgery. So once you send them to me it's my job to talk to them again about should you be thinking about surgery based on your weight based on your comorbidities. And then we have to pick the exact operation and you know talking about the pros and cons of the different operations is another complete talk on its own. But there is again for this concept of shared decision making. There is a calculator that we can use. That will help us make that decision and is sponsored by um the american College of Surgeons and the N. B. S. A. Q. I. P. Which is basically the certifying agency for our Centers of Excellence. And it takes all of the data that is submitted by every center of excellence and puts it into a database and then it has this risk benefit calculator that I and I put in exactly the same patient I showed you before and I put in her demographic data I can just I can check off which operations she and I are considering as well as the different comorbidities that she has that they track against. And then I can look and it will display for me her risk of a 30 day complication including mortality risks any complication, anything from a minor wound infection or an outpatient U. T. I. To um a serious complication including readmissions, trip to the emergency room, re operations, endoscopy, these leaks bleeding wound infections that require debridement etcetera. And we can look at it for each operation that she and I are considering. It also has the ability to show us. And I'm sorry it displays this way. But the first one was B. M. I. So we can look and say at every month what should your B. M. I. B. And where should it be at the end of the year? How much weight would you expect to lose by the end of the year. Both in pounds and by percent total change. And we can look at all of this and make decisions because it's not just, oh goodness sorry. Um Well that was the end of the slides but I feel like I'm missing something but okay um you know it's not just about weight if all I cared about was weight and the cosmos missus of that way would be a plastic shirt and I'm not a plastic surgeon. I'm a metabolic and bariatric surgeon. It is about the weight and how that is impacting their health. Their quality of life. Their longevity. It is about that ability to get them off the medicines they don't need anymore because those health and problems problems have improved or resolved, but um and I'm I'm sorry the slides are no longer there. The other question that comes up a lot when I talked to practitioners though, while many studies show incredible durability in bariatric surgery, bariatric surgery works. We used to think bariatric surgery was almost purely restrictive, meaning it made your stomach smaller, which we can all conceptualize and when your stomach is smaller, you just can't eat as much food. But most of you have probably met someone who's had bariatric surgery at this point and they can now eat more than they used to be able to eat. And they're convinced their stomach has stretched out in some way. But if we actually do um upper jeez that um look at pouch size or stomach size, the stomach is usually the size we want it to be. And so you've had some fascinating talks already today that really do talk about um how obesity really is a neuro endocrine and hormonal issue. And that's why these medications work and bariatric surgery is really the same way. The more we learn about bariatric surgery. What we are learning is that surgery works because it is working on these same neuro endocrine pathways that the medicines work on, they decrease, they increase. Um sorry, it's a little harder to do this without the slide in front of me, but, you know, it decreases the grille in it um impacts GOP one. It impacts leptin levels, But sometimes for some patients it only really does that for a year to 18 months and then they start to drift back to their normal amounts. And that's why many of our patients actually need some of these same medications that your previous speaker talked about because they need things to be reset back to where they were Within that 1st 6-9 months after surgery. So I actually had to learn a lot about this despite having been a bariatric surgeon for almost 18 years. And so I started going to the same obesity conferences that as medicine doctors do and I got my A. B. O. M certification um about 18 months ago because I use all these same medications in our post bariatric patients to help them maintain the weight loss if they start struggling. I think let's go ahead and wind this up and go ahead and move to questions. Thank you so much Corey. That was so informative and even taught me so many new things. Um I think you are so highly qualified to talk about. I didn't even know you were certified in obesity medicine. I think it's so rare to see surgeons who are actually using medications for the post op weight regain. So I think that's that's incredible. So we do have some questions. Um oftentimes with patients when approaching the topic, they will say things like surgery is taking the easy way out. I want to do it myself. How do you approach patients who have that type of resistance to surgery? I hear that all the time. And um, what I really try to point out to them is medications are a tool and this is just one more tool. Surgery helps patients not be hungry, get small, get full on a small amount of food. It makes the food sit there long enough for the hormonal feedback to get back to the brain to say you're full. You don't need the last five bites that are sitting on your plate. You don't need to come back for seconds. You don't need to eat again in 30 minutes, which is what many of the medications that we prescribe are aiming to do is impacting those same neural hormonal pathways and that's what we expect. That's what we want surgery to do. It's just some time for most patients. It is a much stronger tool than any of the surgery. You know, we didn't have a speaker on the program today because there just wasn't the time to talk about. Um you know, there are some endoscopic options that are kind of part way between the medications and surgery. There are now the inter gastric balloons, there are endoscopic sleeves and sometimes um I find it's helpful to talk to patients about the endoscopic therapies because sometimes in their heads they can conceptualize how that's a tool. Oh, you would put a balloon in, it would be full, It will make me feel full and they can kind of get over it. Well, maybe I need something then when they realize insurance is not going to pay for that balloon. But insurance might pay for surgery and sometimes they have to think about it for a couple of weeks. They realize how the sleeve surgery we've been talking about really is just a more dramatic tool than the endoscopic therapy. And I'm not slamming endoscopic therapies at all. I think they have their role and they have their niche. But until we get insurance coverage for them, they really are just out of the price point for the majority of my patients because they just can't afford a self pay anything That's several $1,000. Of course, yeah, that's definitely cost limiting. I mean, speaking of that in terms of insurance and coverage and cost, I don't know what type of population you're working with but is that a barrier for you as well? Oh, absolutely. There are and there's multiple barriers on multiple levels. So the um, with the affordable Care Act, one of the things that came with the affordable Care Act was that bariatric surgery, each state got to decide whether bariatric surgery would be in the essential benefits package. So I think it's either 30 or 31 states decided to put it in the essential benefits package. So when I talk to friends and colleagues around the country that are in those states, it's now required to be in every insurance plan. But unfortunately, what the majority of those insurance plans did was they set the bar really high. You've got to work with a dietitian for a year, you've got to do drug testing, you've got so they they put all of these obstacles in patients way That have no basis in evidence-based medicine that they predict success with the tool of bariatric surgery. And it's 100% that they are trying to get the patients to drop out in the States. And Nebraska happens to be one of them. They did not add it to the essential benefits plan. So it is not required to be on every insurance. And so um we have many insurance that just don't cover it and you know, and it's unfortunate because they come in and they think that if I just write the best letter in the world, their insurance will cover it and I, you know, God can write them a letter and they're still not going to get it if it's an exclusion up there with cosmetic dentistry and you know, infertility treatments or whatever is on their exclusions, it's not going to get covered. Um but we continue to fight the fight and we continue to submit, you know data to their HR departments trying to get it covered and then we try and we do the best we can. Um I see several questions on here about long term complications and I was going to say briefly because I realized it and I don't want to throw your timetable off. You know, The version of the gastric bypass we are doing right now is very different than the one we were doing 2030 years ago. And so in fact it's almost unfortunate. We still call ourselves the gastric bypass. It almost would have been better if we renamed the operation so that it was a break and we called it something else. Because what they were doing back then is very different as far as how much bowel is bypassed. And if you remember your med school anatomy of a ruin, why there's a biliary limb and there's a roux limb and there's a common channel. And the proportions of that are just very different now than they were back then. But the other thing that's really different is back then. They did not do nearly as good a job as we do now in education and counseling of patients. Um, and back then they didn't have bariatric specific vitamins, you know, everybody was told take two flint stones and and chew on tom's and that will be enough. We now have bariatric specific vitamins. Um and there are several brands that have gotten it down to a once a day capsule and that is probably the cheapest, most efficient way that you can get a bariatric vitamin. So the compliance is really good and on bariatric specific vitamins that are designed for the capsule to be broken down with a minimal amount of stomach acid and with the actual formulations of the vitamins that are also designed to not need allies stomach acid. Most patients do pretty well. Sometimes we have to give a lot of vitamins to meet to sort of fill the tank as it were. And then getting them on a bariatric specific multivitamin will maintain them sufficiently moving forward. So getting them in to see a bariatric dietitian or into a bariatric program that can get them on bariatric specific vitamins is probably the best thing you could do. Um I don't know if we publish our email addresses but I'm happy. So mine is cl mcbride at U N M C dot E D U. Actually, I can put it in the chat here in a second while the next speaker is talking and if people want to email me, I'm happy to send them then there's there's two now and I have no financial relationship with either company um that I'm happy to send you that are the two that we recommend that are once a day um or some of the other companies that are more often but people really like the taste of um that could be helpful. Perfect. Thank you. We will make sure your contact information is available. Thank you so much. That was really fabulous
