It's now my pleasure to welcome Caitlin Cookson. She's going to present an update on endoscopic bariatric therapy. Caitlin's a physician assistant specializing in gastroenterology at UC Health Digestive Health Center. She's also an instructor at the University of Colorado. Caitlin, take it away. All right, so today we'll be talking about endoscopic bariatric therapies that are available. I'd like to start by thanking Dr. Shelby Sullivan. She is our bariatric endoscopist at University of Colorado. She was a big help in allowing me to use some of her slides and get this talk together for us today. Today we are going to quickly review lifestyle interventions, pharmacotherapy, and surgical options for weight loss. We'll identify endoscopic interventions for weight loss, including the use of intergastric balloons and overstitch techniques. Then we'll also understand the selection process for appropriate patients for those common adverse events and their management. This is data from 2020. It's a nice chart that allows us to visualize the amount of patients that have elevated BMI or obesity, which is BMI greater than 30, as well as their often associated comorbidities. Of those, you see that 24 million adults are currently experiencing severe obesity. When we look at how we treat this, previous studies have demonstrated low uptake of anti-obesity medications anywhere from 1% to 2%, although with semaglutide, this is likely higher. Then only 1% of patients who qualify for bariatric surgery are actually getting bariatric surgery per year. There's a large amount of adults in the United States experiencing obesity that really aren't getting treated. This is where some endoscopic options may be a good choice for them. To quickly hit on lifestyle modifications, I will say our center specifically, we work with a whole other clinic that really focuses on these patients. If that is something that's available, I think that's a great thing for these patients to have in addition to their endoscopic options. To go over what they talk about, self-monitoring, having patients record intake and activities, problem solving, identifying barriers and finding solutions, stimulus control, avoiding triggers to eating and slowing the rate of eating, social support, recruiting friends and family, and this includes clinic visits with a provider, cognitive restructuring, thinking positively, and then relapse prevention, managing episodes of overeating and weight gain. In addition to diet, exercise is always a wonderful addition to lifestyle modifications. This was an interesting study that demonstrated that, of course, exercise is important for weight loss, but we really need to be counseling our patients that exercise is also important for weight maintenance. The CDC currently recommends 150 minutes per week of moderate intensity exercise, but the study demonstrated that 200 or more is really likely what patients need to be achieving to help maintain weight loss. Then in regards to pharmacotherapy, when you're going to initiate pharmacotherapy for a patient, you first want to review medication lists and stop any medications that can be causing weight gain. You want to identify patients that will benefit. Generally, this is people that have a BMI over 30 or a BMI of 27 or greater with at least one obesity-associated co-morbidity. Other patients that may benefit from this are patients that have a device removed and they would like to prevent weight regain for patients who have not achieved targeted weight loss after endoscopic or bariatric surgery. You want to choose a weight loss medication, and then you want to determine if you should continue that medication. You would hope to see at least a 5% total body weight loss by three months with no significant side effects and ensure that the cost is acceptable to the patient. This slide is just a reference slide of FDA approved weight loss medications. I am in no way an expert on prescribing these, but I wanted you to have this resource. One thing I do want to point out is a lot of these medications really are intended to be used in the long term. It's not necessarily a quick fix. Patients need to recognize that when we're starting them on this, we would expect them to be on it for an extended period of time. In conclusion, for lifestyle therapy and medications, lifestyle therapy includes diet, exercise, and behavioral modifications. Self-monitoring is one of the most important pillars of that behavior modification. Exercise helps with weight loss, but it is more important for weight loss maintenance. There are several steps to obesity pharmacotherapy, and then there are multiple medications that can be used for weight loss. Semaglutide is the most effective for now, although there are certainly drugs in the pipeline that will also have likely even higher efficacy, but they are expensive and other weight loss medications may be available, may work for your patient, and they may be more cost effective. Then I also quickly want to review bariatric surgery options for our patients. I wanted to pay special attention to the sleeve gastrectomy and the Roux-en-Y gastric bypass because we have some endoscopic options for these patients after their surgeries. The sleeve gastrectomy and Roux-en-Y gastric bypass are by far the most prevalent, have a similar weight loss profile. The gastric band is falling out of favor, and then the single anastomosis duodenal ileal bypass and sleeve gastrectomy as well as the biliopancreatic diversion with duodenal switch are both very effective for weight loss, but we see more complications with these procedures and higher risks of micronutrient deficiencies after these procedures, and they're not as common. So going on to the actual bariatric endoscopy portion, we have two approaches for bariatric endoscopy. One is space occupying devices. These include intragastric balloons. Some are fluid-filled and endoscopically placed. Others are gas-filled and swallowable, and then we have overstitch, which includes an endoscopic sleeve gastroplasty, which is a primary procedure, and then revision of bariatric surgery for patients that have already undergone Roux-en-Y gastric bypass or sleeve gastrectomy. So a balloon overview here. There's four at market. Three of them are fluid-filled, endoscopically placed. SPATS-3 is in post-marketing trials right now, not commercially available, and then Reshape and Ovalon are actually also not available only because, not because they've lost FDA approval, but the company has stopped producing them. So the only one available right now for patients is the Olbera. They have good profiles on total body weight loss, around 12 to 15 percent. The Ovalon's a little bit less at 10 percent. Of note, patients typically have to pay for these out of pocket, so cost is something that needs to be determined. Obviously, there's a wide variety of cost given the location as well as the setting in which these endoscopies are done, but best kind of range I could find was anywhere from $69,000 for these balloons. So patient selection for the balloons. You want them to have failed lifestyle therapy. FDA labeling is from 30 to 40 BMI, but there's no difference in safety or percentage total body weight loss outside of that range. Patients need to be interested in a removable device, willing to abstain from NSAIDs, willing to take a PPI for the entire duration of balloon implantation, and willing to participate in ongoing lifestyle therapy. Contraindications for balloons include prior foregut surgery, cirrhosis, esophageal stricture, large hiatal hernia, need for anticoagulation, and history of peptic ulcer disease with unknown cause. You want to use caution in using these balloons in patients with gastroparesis or poorly controlled GERD. There are more accommodative symptoms with the fluid-filled balloons, with the gas-filled balloons, but as I just mentioned, the gas-filled is not currently available. To speak to the adverse events, they are very common. We see accommodative symptoms very commonly in patients after they're placed. Patients need to be counseled on this and to expect that. You can see how high vomiting, nausea, and abdominal pain, how frequently reported it is for all of our balloons. Patients need to be aware that this is likely to happen and that we do our best to manage these symptoms with medical management. The other high adverse event I wanted to point out was GERD. You really do want to be cautious in using these in patients with the diagnosis of GERD because it is likely to increase that. As far as medical management of these symptoms, one week prior to placing the balloon, we will start patients on high-dose PPI therapy as well as hyoscyanine. We will do this for seven days after the procedure as well. Then we have our typical antiemetics. Peri-procedurally in non-diabetic patients, we will offer dexamethasone to help with nausea as well. Then adherence to the diet is also very important. Of course, they have to be NPO for the procedure. Then 24 to 48 hours, clear liquids, days three through 10, a full liquid or PRA diet, and day 11 through 14, soft food. Then after two weeks, if all of their accommodative symptoms have resolved, they can advance to a low-calorie diet. I think I mentioned typically those symptoms are worse in the first week. Then after that, patients start to see an improvement. Then moving on to our primary overstitch technique, endoscopic sleeve gastroplasty. This is an endoscopic placement of sutures in an effort to decrease the overall stomach volume. It opposes the posterior greater curvature and anterior wall to create a tube-like shape, kind of similar to the shape you see after a sleeve gastrectomy. We are stitching the stomach actually together to decrease the entire volume. Patients that are a good option for this, they will also have to have failed lifestyle therapy. FDA labeling is for BMI between 30 to 50. They need to be interested in a semi-permanent procedure. I say semi-permanent as some of those stitches that are placed are likely to come undone, but overall this does change the shape of the stomach permanently for the patient. They need to be willing to comply with the post-procedure diet and willing to participate in ongoing lifestyle therapy and be able to abstain from NSAIDs and anticoagulation during the post-op period. Contraindications for sleeve gastroplasty include cirrhosis, esophageal stricture, large hiatal hernia, or need for surveillance of gastric mucosa. As we do stitch that down, we're not ever going to be able to surveil that part. This includes a history of advanced dysplasia or gastric cancer or genetic diseases. We want to use caution in offering this to patients with gastroparesis, poorly controlled FERD, or a strong family history of gastric cancer. Again, because we won't be able to assess the entire gastric mucosa. Considerations, there are less accommodative symptoms with this procedure than the endoscopically placed fluid-filled balloons. This study looked at efficacy as well as adverse events associated with the endoscopic sleeve gastroplasty. 92% of patients did report non-serious adverse events, but most of those were related to accommodative symptoms. When you break that down here, you see that the majority of patients had mild to moderate abdominal pain, nausea, and vomiting, most in that first week. Then we see a really pretty decent improvement. Again, mostly mild as time goes on and as patients heal from the procedure. This is looking at efficacy. This was ultimately a two-year trial. You can see that patients had near 15% total body weight loss, and that was maintained to the two-year mark. This study did look at serious adverse events. 2% required endoscopic or surgical treatment. Then 4% of patients required hospitalization for treatment of accommodative symptoms. This graphic compares the endoscopic sleeve gastroplasty to the laparoscopic sleeve gastrectomy. This looks at weight loss at three years. You see that the sleeve gastrectomy may be a little bit more effective with total body weight loss at 19% compared to 14%. We see really similar profiles in comorbidity remission as well as adverse events. 28 people, or about 1%, did require repeat ESG. The total of 2.7% of patients actually advanced to a sleeve gastrectomy after the endoscopic gastroplasty. The other overstitch technique we have available is revision of bariatric surgery. This is something that we can offer both Roux-en-Y gastric bypass patients and patients that have had sleeve gastrectomies. We can use it to help with weight regain. We can also use it for some adverse events we commonly see in patients that have had Roux-en-Y gastric bypass, including candy cane syndrome as well as dumping syndrome. I'm going to focus on weight regain here. The pathophysiology of weight regain after a Roux-en-Y gastric bypass is likely multifactorial, but it has been demonstrated in the literature that the diameter of the gastrogynostomy does correlate with weight regain. We use 30 millimeters as the cutoff of what is greater than 30 millimeters. We really start seeing an increase in weight gain. Modalities for treatment of a dilated gastrogynostomy include APC alone or endoscopic transoral outlet reduction or TOR. This is done with suturing of the anastomosis with or without the gastric pouch to reduce the diameter, typically done with APC or with modified ESD. APC alone use low flow, high watts. Two to three rings are applied on the gastric side of the anastomosis. These patients need to be on high-dose PPI therapy as well as sucralafate and a liquid diet for 45 days after procedure. You repeat this procedure every eight to 10 weeks until the stoma size is reduced. Picture A here is the dilated gastrogynostomy before treatment. B is right after treatment with the APC. C is our final result. You can see a really nicely narrowed down gastrogynostomy there. Then the TOR technique utilizes APC or ESD to prep the gastric side of the mucosa and then moves forward with suturing down the gastrodegeneral anastomosis, utilizing either interrupted or purse-string sutures. This is a video here of the procedure. Dr. Sullivan here is applying APC on the gastric side. She did two rings there. Then she does a dilated gastrogynostomy. She does purse-string suturing here with 11 bites. This patient had a 30-millimeter gastrogynostomy in a pouch that was 6 centimeters long. Final measurements after this procedure was a GJ of 8 millimeters and then the pouch length of only 3 centimeters. This patient did experience an adverse event of intermittent vomiting with meat that required a modified diet for six months. They had great total body weight loss at 12 and the 23-month mark of 19 and 18 percent. You can see here at the end of the video that that greatly reduced diameter of that gastrodigidostomy. Patient selection for the TOR procedure or APC alone, you want to assume that they have a weight loss failure, which we define as a weight regain of at least 20 percent of the weight they had lost or less than 50 percent excess weight loss from the time of surgery. You need to be interested in a permanent procedure, willing to comply with the post-procedure diet, willing to participate in ongoing lifestyle therapies, and be able to abstain from NSAIDs and anti-coagulation during the post-op period. Procedures contraindicated in cirrhosis, esophageal stricture, and large tidal hernia. You want to use caution in patients with poorly controlled GERD. You want to make sure that you address any medical issues that may need to be evaluated in the small bowel or the remnant stomach before this revision, as once you narrow that down, it'll be much more difficult to evaluate that area. Management of symptoms associated with TOR, we want to do high-dose PPI therapy one week before, and then for six weeks, as well as to proliferate for six weeks, and then utilize our anti-emetics to help with any type of nausea they may be experiencing. In regard to diet, we recommend 72 hours of clear liquids after this procedure. Days 3-42, they can be on a full liquid diet. Savory options can often help with nausea. Then week 6-8, a PRA diet, and then after week 8, they can slowly advance to a low-calorie diet from there. It's certainly an intensive and long diet that they have to follow after the procedure. This study compared the surgical revision of a dilated gastrointestinaloscopy to endoscopic revision. You can see here that there was a higher total body weight loss achieved with surgical revision. Although I will point out that the endoscopic revision also maintained over five years. What I did want to point out here though, is if you look at the adverse event profile, there was only two non-serious adverse events reported in the endoscopic arm. The surgical arm had 15, six of which were serious. While it may be a little bit less effective than overall total body weight loss percentage, it is very safe. In conclusion, bariatric therapies are safe and effective treatments for obesity and metabolic disease. Our currently available primary procedures include the fluid-filled intragastric balloon, as well as endoscopic sleeve gastroplasty. Bariatric surgery is safe and effective, but we should be prepared for adverse events, and we can manage those in our clinics or an endoscopy. Weight regain after 5-10 years after a ruined my gastric bypass, or a sleeve gastrectomy is relatively common. Endoscopic revision is safe and effective with fewer adverse events compared with surgical revision.

Caitlin Cookson

physician assistant

UC Health Digestive Health Center

endoscopic bariatric therapies

intragastric balloons

endoscopic sleeve gastroplasty