Cover Story

Bariatric Endoscopy: Growing Awareness in a Dynamic Field

Before 2015, managing obesity was the realm of other specialties. Although gastroenterologists have traditionally dealt with some of the comorbidities of obesity, they were not in position to target the root cause and provide relief in the form of weight management. That changed with the clinical introduction and FDA approval of several devices and procedures for the endoscopic management of obesity and metabolic disease, putting GIs right in the middle of the obesity epidemic.

“What became clear over the past few years as we understand the disease state of obesity and the pathophysiology of the disease, is that the gastrointestinal tract is really front and central in this disease process,” Barham K. Abu Dayyeh, MD, MPH, director of advanced endoscopy and associate professor of medicine in the department of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota, told Healio Gastroenterology and Liver Disease. “The signals originate from the GI tract, whether from the stomach or the small intestine. These are critical for communicating with the central nervous system, pancreas, liver, adipose tissue and peripheral muscle, to regulate body weight, energy expenditure and key metabolic processes such as blood sugar levels and the rate of fatty acids deposition into organs such as the liver.”

Endoscopic bariatric procedures have been a hot topic in gastroenterology ever since. However, lack of insurance reimbursement remains a significant hurdle to their widespread adoption in the United States.

Abu Dayyeh and other experts told Healio Gastroenterology and Liver Disease it is going to take a concentrated effort from GIs, professional societies and patients to get adoption of these procedures to the levels where they will be able to chip away at the treatment gap in the management of obesity.

“Every therapy needs to be considered on an individual basis,” Austin Chiang, MD, MPH, of Jefferson Health, said. “Some people may be more suited for bariatric surgery or might be more suited for endoscopy.”
“Every therapy needs to be considered on an individual basis,” Austin Chiang, MD, MPH, of Jefferson Health, said. “Some people may be more suited for bariatric surgery or might be more suited for endoscopy.”
Source: Jefferson Health.

The Procedures

The world of obesity management in gastroenterology has shifted rapidly in the 4 years since the first FDA approvals for endoscopic bariatric devices. Now, there are devices and procedures that target several different pathways of the disease, as well as procedures designed to manage other metabolic diseases linked with obesity.

“It’s very dynamic,” Austin Chiang, MD, MPH, director of bariatric endoscopy at Jefferson Health in Philadelphia, said. “That’s what is so exciting about something as novel and innovative as this area.”

A GI’s obesity management tools can be broken down into procedures that work on the stomach and procedures that work on the small intestine.

Shelby Sullivan, MD
Shelby Sullivan

Among the stomach procedures, the intragastric balloon was among the first endoscopic devices approved for the management of obesity. These space occupying devices help provide about 10% total body weight loss (TBWL) and are typically removed after about 6 months. The trick, according to Shelby Sullivan, MD, director of the gastroenterology metabolic and bariatric program at the University of Colorado School of Medicine, is keeping the weight off once the balloon comes out.

“Long-term, without continued therapy, there is very likely some weight regain that occurs with balloons,” Sullivan said. “Additional therapies, including continued behavioral modification or weight loss medication or repeated balloon therapy, are really required in order to maintain all of the weight loss in the majority of the patients after balloons come out.”

However, Sullivan said balloons are a good choice for patients who do not want to make changes to the anatomy of their GI tract.

Also, in the area of stomach-targeted therapies is endoscopic sleeve gastroplasty, which has shown 18% to 20% TBWL within 2 years and about 15% within 5 years. Devices like the TransPyloric Shuttle (Baranova) and AspireAssist (Aspire Bariatrics) have also received approval from the FDA.

Gastroenterologists can target intestinal pathways with devices like EndoBarrier (duodenal-jejunal bypass liner, GI Dynamics), which helps improve glycemic control and insulin resistance in patients with type 2 diabetes.

“It is for diabetics who have been on too many medications and are almost on their way to insulin,” Chiang said. “This is really to see if we can harness some of the physiology of gastric bypass and help patients drive diabetes back into remission.”

Barham K. Abu Dayyeh, MD, MPH
Barham K. Abu Dayyeh

There are even more devices in the pipeline that Abu Dayyeh said could become available in the coming years, including the Full Sense Device (BFKW, LLC), magnetized balloons and a group of devices that work on small intestinal pathways targeting diabetes and fatty liver disease.

“We are going to have better intestinal bypass, devices and tools that could recreate the single anastomosis gastric bypass procedure, which is a very successful surgical procedure for the management of obesity and type 2 diabetes by creating endoscopic anastomosis bypass of the stomach and proximal small intestines,” Abu Dayyeh said.

Adoption

Although endoscopic bariatric procedures have caught on worldwide, their adoption in the United States has been a bit slower despite being an upcoming and rapidly evolving field.

Timeline of FDA-Approved Weight-Loss and Weight-Management Devices
To view an enlarged image, click on the image.

“It hasn’t grown in the way people had expected and the primary driver for that is lack of insurance coverage,” Sullivan said. “There are a number of things that I think are getting in the way of insurance coverage. Insurance companies want additional, long-term data, which we certainly have been collecting. ... The other thing is that we have to get CPT codes. There is a process for getting a CPT code for these procedures.”

Sullivan believes that these procedures have the potential to be popular among patients because although they do not provide as much weight loss as traditional bariatric surgery, they come with significantly less risk. While surgical techniques are permanent, bariatric devices, like the intragastric balloon or aspiration therapy, are reversible.

As more data emerge showing the benefits of endoscopic bariatric techniques and metabolic therapies, Abu Dayyeh said desire for them among patients will only grow higher.

“Clinical trials studying these devices and techniques recruit rapidly because there are no issues of coverage,” he said. “The actual clinical adaptation has been slower because of the lack of appropriate CPT codes and coverage. However, globally in the world, these procedures have seen wide adaptation and are being used at significant volume outside the U.S.”

Endoscopic techniques bring the possibility of expanding the options for patients in need of weight management or treatment for metabolic disease. Not everyone can undergo bariatric surgery, but those patients might still need more help losing weight and keeping it off.

“Every therapy needs to be considered on an individual basis,” Chiang said. “Some people may be more suited for bariatric surgery or might be more suited for endoscopy. Some patients, especially patients without any options in terms of being a poor surgical candidate or not meeting whatever criteria to undergoing bariatric surgery an endoscopic option might be more desirable.”

Hurdles

Awareness is an obstacle to adopting endoscopic bariatric and metabolic therapies. In the realm of weight management, they are still relatively unknown to a large part of the population.

“In certain parts of the country, there are not necessarily people performing these procedures yet or driving these cases through insurance companies,” Chiang said. “I can say from here in Philadelphia, when I approach insurers, many don’t know what I’m talking about.”

Without a solid understanding among insurers and patients, Sullivan said GIs who offer these procedures might have a hard time getting their bariatric endoscopy practice off the ground. The easy part is adapting to the procedures, which involves a lot of techniques and skills a GI will likely be accustomed to. The hard part is putting in the work to get the attention of patients.

“There isn’t a referral source,” she said. “Patients don’t know about it. You have to put so much more time and effort into advertising your practice, which a gastroenterologist might not be doing.”

Gastroenterologists need to make the case to insurers, Sullivan said, that these procedures are less risky and less expensive in the long run because they help improve the comorbidities associated with obesity, as well as the weight itself.

“They would see financial benefit because of other medications that patients would be able to stop because of significant weight loss,” she said.

The experts believe the best way to advance toward widespread adoption is to generate codes that will facilitate a pathway to reimbursement. That eventual coverage will allow future research to explore the true benefits of these procedures outside the realm of data that are available strictly in clinical trials.

Abu Dayyeh said GI, endoscopic and surgical societies need to concentrate their efforts to push for these codes. Just like any other new medical device, a lot of work must be done before they are used in common practice.

“Once we get the codes and the pathway for reimbursement, more studies will evaluate the real-life performance of these procedures and develop pathways to incorporate them into management plans of obesity and metabolic disease,” he said. “Cardiac stents didn’t just come. A similar story has to come for these endoscopic procedures.”

Patients will have to play a part in this process as well.

“We just need to keep getting the message out there and letting patients know that they need to communicate with their insurance companies that this is something that they want,” Chiang said.

Optimism

Obesity is a massive, worldwide health epidemic considering there were more than 650 million adults with a BMI greater than 30 kg/m2 in 2016, according to the World Health Organization. Obesity presents significant costs, both medical costs related to comorbidities, as well as other challenges it causes for patients because of those medical problems as well as physical indications related to obesity.

“It also has financial costs in terms of how much it costs to treat those other obesity-related comorbidities,” Sullivan said. “So, it’s really important that gastroenterologists embrace the treatment of obesity even more.”

Sullivan was optimistic about the prospects of eventually getting insurance reimbursement that will ultimately allow for bariatric endoscopy to become more widespread in the U.S.

“There are definite benefits to having procedures that have less risk,” she said. “Again, there is less weight loss associated with them, but they may still have enough medical benefits weight loss in terms of reduction of other costly medications and procedures, that they would be worth it for insurance companies.”

Chiang said these techniques will not be some magic bullet that will solve the obesity crisis over night. Instead, they have to be part of an integrated plan to provide tailored treatment for the individual patient.

“There has to be a coordinated effort with dietary and lifestyle modification and other types of potential treatments,” he said. “If we think of it all as a multifaceted approach, the patients will be able to have the most optimal outcome possible. I tell the patients this is only one piece of the puzzle, but we are able to offer this as an additional option on top of everything else. The more options the better, but we have to integrate everything all together.”

Adding additional tools to help manage obesity is crucial from Abu Dayyeh’s perspective, who said there is a critical gap that must be addressed.

“Despite all our efforts, we are actually failing to manage this gap,” he said. “We need to expand the toolbox with lifestyle, behavioral, medical, endoscopic and surgical options in order to effectively manage this disease. These should not work in silos. They should be integrated with each other in order to manage the patient rather than focus on a particular technology or technique.” – by Alex Young

Disclosures: Abu Dayyeh reports receiving research support from Apollo Endosurgery, GI Dynamics, Spatz medical and USGI. He also reports being a speaker for Johnson & Johnson, Medtronics and Olympus. Chiang reports previously consulting for Obalon Therapeutics. Sullivan reports financial ties to Aspire Bariatrics, BARONova, Elira Therapeutics, GI Dynamics, Obalon, Spatz FGIA and USGI Medical.

Before 2015, managing obesity was the realm of other specialties. Although gastroenterologists have traditionally dealt with some of the comorbidities of obesity, they were not in position to target the root cause and provide relief in the form of weight management. That changed with the clinical introduction and FDA approval of several devices and procedures for the endoscopic management of obesity and metabolic disease, putting GIs right in the middle of the obesity epidemic.

“What became clear over the past few years as we understand the disease state of obesity and the pathophysiology of the disease, is that the gastrointestinal tract is really front and central in this disease process,” Barham K. Abu Dayyeh, MD, MPH, director of advanced endoscopy and associate professor of medicine in the department of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota, told Healio Gastroenterology and Liver Disease. “The signals originate from the GI tract, whether from the stomach or the small intestine. These are critical for communicating with the central nervous system, pancreas, liver, adipose tissue and peripheral muscle, to regulate body weight, energy expenditure and key metabolic processes such as blood sugar levels and the rate of fatty acids deposition into organs such as the liver.”

Endoscopic bariatric procedures have been a hot topic in gastroenterology ever since. However, lack of insurance reimbursement remains a significant hurdle to their widespread adoption in the United States.

Abu Dayyeh and other experts told Healio Gastroenterology and Liver Disease it is going to take a concentrated effort from GIs, professional societies and patients to get adoption of these procedures to the levels where they will be able to chip away at the treatment gap in the management of obesity.

“Every therapy needs to be considered on an individual basis,” Austin Chiang, MD, MPH, of Jefferson Health, said. “Some people may be more suited for bariatric surgery or might be more suited for endoscopy.”
“Every therapy needs to be considered on an individual basis,” Austin Chiang, MD, MPH, of Jefferson Health, said. “Some people may be more suited for bariatric surgery or might be more suited for endoscopy.”
Source: Jefferson Health.

The Procedures

The world of obesity management in gastroenterology has shifted rapidly in the 4 years since the first FDA approvals for endoscopic bariatric devices. Now, there are devices and procedures that target several different pathways of the disease, as well as procedures designed to manage other metabolic diseases linked with obesity.

“It’s very dynamic,” Austin Chiang, MD, MPH, director of bariatric endoscopy at Jefferson Health in Philadelphia, said. “That’s what is so exciting about something as novel and innovative as this area.”

A GI’s obesity management tools can be broken down into procedures that work on the stomach and procedures that work on the small intestine.

Shelby Sullivan, MD
Shelby Sullivan

Among the stomach procedures, the intragastric balloon was among the first endoscopic devices approved for the management of obesity. These space occupying devices help provide about 10% total body weight loss (TBWL) and are typically removed after about 6 months. The trick, according to Shelby Sullivan, MD, director of the gastroenterology metabolic and bariatric program at the University of Colorado School of Medicine, is keeping the weight off once the balloon comes out.

“Long-term, without continued therapy, there is very likely some weight regain that occurs with balloons,” Sullivan said. “Additional therapies, including continued behavioral modification or weight loss medication or repeated balloon therapy, are really required in order to maintain all of the weight loss in the majority of the patients after balloons come out.”

PAGE BREAK

However, Sullivan said balloons are a good choice for patients who do not want to make changes to the anatomy of their GI tract.

Also, in the area of stomach-targeted therapies is endoscopic sleeve gastroplasty, which has shown 18% to 20% TBWL within 2 years and about 15% within 5 years. Devices like the TransPyloric Shuttle (Baranova) and AspireAssist (Aspire Bariatrics) have also received approval from the FDA.

Gastroenterologists can target intestinal pathways with devices like EndoBarrier (duodenal-jejunal bypass liner, GI Dynamics), which helps improve glycemic control and insulin resistance in patients with type 2 diabetes.

“It is for diabetics who have been on too many medications and are almost on their way to insulin,” Chiang said. “This is really to see if we can harness some of the physiology of gastric bypass and help patients drive diabetes back into remission.”

Barham K. Abu Dayyeh, MD, MPH
Barham K. Abu Dayyeh

There are even more devices in the pipeline that Abu Dayyeh said could become available in the coming years, including the Full Sense Device (BFKW, LLC), magnetized balloons and a group of devices that work on small intestinal pathways targeting diabetes and fatty liver disease.

“We are going to have better intestinal bypass, devices and tools that could recreate the single anastomosis gastric bypass procedure, which is a very successful surgical procedure for the management of obesity and type 2 diabetes by creating endoscopic anastomosis bypass of the stomach and proximal small intestines,” Abu Dayyeh said.

Adoption

Although endoscopic bariatric procedures have caught on worldwide, their adoption in the United States has been a bit slower despite being an upcoming and rapidly evolving field.

Timeline of FDA-Approved Weight-Loss and Weight-Management Devices
To view an enlarged image, click on the image.

“It hasn’t grown in the way people had expected and the primary driver for that is lack of insurance coverage,” Sullivan said. “There are a number of things that I think are getting in the way of insurance coverage. Insurance companies want additional, long-term data, which we certainly have been collecting. ... The other thing is that we have to get CPT codes. There is a process for getting a CPT code for these procedures.”

Sullivan believes that these procedures have the potential to be popular among patients because although they do not provide as much weight loss as traditional bariatric surgery, they come with significantly less risk. While surgical techniques are permanent, bariatric devices, like the intragastric balloon or aspiration therapy, are reversible.

As more data emerge showing the benefits of endoscopic bariatric techniques and metabolic therapies, Abu Dayyeh said desire for them among patients will only grow higher.

“Clinical trials studying these devices and techniques recruit rapidly because there are no issues of coverage,” he said. “The actual clinical adaptation has been slower because of the lack of appropriate CPT codes and coverage. However, globally in the world, these procedures have seen wide adaptation and are being used at significant volume outside the U.S.”

Endoscopic techniques bring the possibility of expanding the options for patients in need of weight management or treatment for metabolic disease. Not everyone can undergo bariatric surgery, but those patients might still need more help losing weight and keeping it off.

“Every therapy needs to be considered on an individual basis,” Chiang said. “Some people may be more suited for bariatric surgery or might be more suited for endoscopy. Some patients, especially patients without any options in terms of being a poor surgical candidate or not meeting whatever criteria to undergoing bariatric surgery an endoscopic option might be more desirable.”

PAGE BREAK

Hurdles

Awareness is an obstacle to adopting endoscopic bariatric and metabolic therapies. In the realm of weight management, they are still relatively unknown to a large part of the population.

“In certain parts of the country, there are not necessarily people performing these procedures yet or driving these cases through insurance companies,” Chiang said. “I can say from here in Philadelphia, when I approach insurers, many don’t know what I’m talking about.”

Without a solid understanding among insurers and patients, Sullivan said GIs who offer these procedures might have a hard time getting their bariatric endoscopy practice off the ground. The easy part is adapting to the procedures, which involves a lot of techniques and skills a GI will likely be accustomed to. The hard part is putting in the work to get the attention of patients.

“There isn’t a referral source,” she said. “Patients don’t know about it. You have to put so much more time and effort into advertising your practice, which a gastroenterologist might not be doing.”

Gastroenterologists need to make the case to insurers, Sullivan said, that these procedures are less risky and less expensive in the long run because they help improve the comorbidities associated with obesity, as well as the weight itself.

“They would see financial benefit because of other medications that patients would be able to stop because of significant weight loss,” she said.

The experts believe the best way to advance toward widespread adoption is to generate codes that will facilitate a pathway to reimbursement. That eventual coverage will allow future research to explore the true benefits of these procedures outside the realm of data that are available strictly in clinical trials.

Abu Dayyeh said GI, endoscopic and surgical societies need to concentrate their efforts to push for these codes. Just like any other new medical device, a lot of work must be done before they are used in common practice.

“Once we get the codes and the pathway for reimbursement, more studies will evaluate the real-life performance of these procedures and develop pathways to incorporate them into management plans of obesity and metabolic disease,” he said. “Cardiac stents didn’t just come. A similar story has to come for these endoscopic procedures.”

Patients will have to play a part in this process as well.

“We just need to keep getting the message out there and letting patients know that they need to communicate with their insurance companies that this is something that they want,” Chiang said.

Optimism

Obesity is a massive, worldwide health epidemic considering there were more than 650 million adults with a BMI greater than 30 kg/m2 in 2016, according to the World Health Organization. Obesity presents significant costs, both medical costs related to comorbidities, as well as other challenges it causes for patients because of those medical problems as well as physical indications related to obesity.

“It also has financial costs in terms of how much it costs to treat those other obesity-related comorbidities,” Sullivan said. “So, it’s really important that gastroenterologists embrace the treatment of obesity even more.”

Sullivan was optimistic about the prospects of eventually getting insurance reimbursement that will ultimately allow for bariatric endoscopy to become more widespread in the U.S.

PAGE BREAK

“There are definite benefits to having procedures that have less risk,” she said. “Again, there is less weight loss associated with them, but they may still have enough medical benefits weight loss in terms of reduction of other costly medications and procedures, that they would be worth it for insurance companies.”

Chiang said these techniques will not be some magic bullet that will solve the obesity crisis over night. Instead, they have to be part of an integrated plan to provide tailored treatment for the individual patient.

“There has to be a coordinated effort with dietary and lifestyle modification and other types of potential treatments,” he said. “If we think of it all as a multifaceted approach, the patients will be able to have the most optimal outcome possible. I tell the patients this is only one piece of the puzzle, but we are able to offer this as an additional option on top of everything else. The more options the better, but we have to integrate everything all together.”

Adding additional tools to help manage obesity is crucial from Abu Dayyeh’s perspective, who said there is a critical gap that must be addressed.

“Despite all our efforts, we are actually failing to manage this gap,” he said. “We need to expand the toolbox with lifestyle, behavioral, medical, endoscopic and surgical options in order to effectively manage this disease. These should not work in silos. They should be integrated with each other in order to manage the patient rather than focus on a particular technology or technique.” – by Alex Young

Disclosures: Abu Dayyeh reports receiving research support from Apollo Endosurgery, GI Dynamics, Spatz medical and USGI. He also reports being a speaker for Johnson & Johnson, Medtronics and Olympus. Chiang reports previously consulting for Obalon Therapeutics. Sullivan reports financial ties to Aspire Bariatrics, BARONova, Elira Therapeutics, GI Dynamics, Obalon, Spatz FGIA and USGI Medical.