Exploring the Power of Weight Loss Balloon and Endoscopic Interventions

A Weight Loss Balloon or intragastric balloon is one of the FDA-approved non-surgical methods of weight loss.

Endoscopic placement of an Intragastric balloon for the treatment of obesity is a rapidly evolving method that is becoming safer, cheaper, and more effective day by day as new highly efficient balloons are prepared and used.

Role of Endoscopic Procedures in the Management of Obesity in 2023:

With the new weight loss medicines, the competition between Bariatric surgery (weight loss surgery), Endoscopic procedures including intragastric balloons, and weight loss medicines is getting tougher.

Unless newer more effective and safer weight loss balloons are available, people may opt for weight loss pills rather than balloons.

The estimated weight loss after 6 months to one year with the newer weight loss medicines Semaglutide (Wegovy, Ozempic, and Rybelsus), Liraglutide (Saxenda and Victoza), and the dual GLP-1 and GIP analog Tirzepatide (Mounjaro) exceeds the estimated weight loss of most endoscopic procedures.

The table above shows the average weight loss with endoscopic procedures vs FDA-approved weight loss medicines.

Except for the endoscopic sleeve gastroplasty or gastric sleeve plication and endoscopic gastric bypass (Endobarrier) which are associated with significant weight loss, the weight loss associated with other procedures are just comparable to weight loss medicines.

Endoscopic Options Available for Weight Loss:

A few endoscopic procedures have been approved by the FDA for the treatment of obesity. Broadly, these procedures can be divided into three categories based on their mechanism of action:

• Intragastric Weight Loss Balloons
• Stomach modifying procedures
• Aspire Assist Device

Intragastric Weight Loss Balloons:

Currently, there are three types of weight loss balloons that have been approved by the FDA for the treatment of obesity.

These include:

1. Single balloon system
2. Double balloon system, and
3. Obalon balloon

The single and double weight loss balloon systems are placed in the stomach via an endoscope and filled with saline fluid.

Examples of single and double balloon systems are Orbera and ReShape intragastric balloons respectively. The double balloon system is connected with a middle tube (R shape-integrated dual balloon system).

The Obalon weight loss balloon system is a little different from the single and double gastric balloon systems as it does not require endoscopic placement.

The Obalon balloon is swallowed by the patient. This is a multiple balloon system, so every 4-weekly, the balloon has to be ingested with a total of 3 balloons. These are filled with nitrogen gas.

All the weight loss balloons have to be removed via an endoscope after six months. The estimated weight loss with the endoscopic gastric balloon is approximately 10% – 20%.

Stomach Modifying Procedures:

Stomach modifying procedures are essentially similar to bariatric surgical procedures, however, they are performed via the help of an endoscope.

There are two stomach-modifying procedures that are being practiced worldwide:

• Endoscopic Sleeve Gastroplasty also called Endoscopic Gastric Plication
• Endoscopic Gastric Bypass via Endobarrier method.

Endoscopic Sleeve Gastroplasty is an FDA-approved procedure, however, Endoscopic Gastric Bypass is currently being practiced outside the US.

The endoscopic Sleeve Gastroplasty procedure is performed by modifying the stomach contour so as to accommodate less amount of food.

On the other hand, the Endoscopic Gastric Bypass is a combination of Sleeve Gastroplasty and placement of an Endobarrier that inhibits the absorption of food in the first part of the small intestine.

Endoscopic Sleeve Gastroplasty or gastric plication:

In this procedure, an endoscope-guided suturing of the stomach wall is performed reducing the stomach volume. These include the Apollo endosurgery and overstitch procedures [Ref].

The volume of the stomach is reduced to 30% of its original volume (70% is stitched), leaving a banana shape tube of greater curvature for food retention.

People with hiatal hernia or those with gastritis are not candidates for endoscopic sleeve gastroplasty.

Sleeve Gastroplasty is associated with an estimated weight loss of about 10 – 20% after six months to one year. It is similar to Laparoscopic Sleeve Gastrectomy.

Endoscopic Gastric Bypass Procedures:

The second endoscopic stomach modifying procedure has not been approved by the FDA but is available outside the United States.

This procedure (Endobarrier, GI dynamics) is performed by an endoscopist (gastroenterologist) and an interventional radiologist.

This procedure is similar to gastric bypass procedures. It is a combination of sleeve gastroplasty and placement of an Endobarrier that inhibits food absorption in the first part of the duodenum.

In this procedure, about 65 cm of the small gut from the duodenum to the proximal jejunum is bypassed by using a barrier device called Endobarrier.

The barrier device is fitted into the first part of the small intestine and fixed via a hook in the stomach wall. This barrier device inhibits the absorption of food that enters the small intestine.

The barrier device also prevents food from mixing biliary and pancreatic juices similar to gastric bypass surgeries.

Thus, it helps a person lose weight and simultaneously cures diabetes, fatty liver, dyslipidemia, and sleep apnea.

It has been estimated to cause a weight loss of about 22 kg over one year.

The Aspire Assist Device:

This is another technique primarily aimed at obesity management. In this procedure, a device is placed endoscopically in the stomach.

It is connected by a valve that is placed outside the body. After 30 minutes of a meal, the valve of the device is opened and the food that has been eaten comes out of the stomach via the tube.

This allows the emptying of the stomach after each meal and is controlled by the patient. It allows approximately 30% of the calories to be lost.

The FDA has approved the Aspire Assist device in patients who are at least 22 years of age and have a BMI of 35 to 55 kg/m² despite low-calorie restriction and exercise [Ref].

It should not be placed in patients with eating disorders such as Bulimia Nervosa, Binge eating disorder, nighttime eating disorder, pregnancy, and lactating women, patients with inflammatory bowel disease, and those with previous abdominal surgeries.

The Aspire Assist Device is associated with approximately 12.1% of weight loss [Ref]

Weight Loss Balloon: Pros and Cons

Weight loss balloon procedures are non-surgical techniques and hence less invasive compared to bariatric surgical procedures.

In addition, the anatomy of the stomach is maintained. Thus, it is similar to physiological weight loss methods such as calorie restriction.

Gastric balloons make a person feel full all the time and delay the gastric emptying of food into the intestines.

In addition, gastric balloons are easy to place, have fewer side effects, and have no major risks as bariatric surgical procedures.

However, on the other hand, it has its own drawbacks. These are listed below:

Cons of weight loss balloon Placement:

• This is not a permanent solution. The balloons are allowed for a maximum of 6 months in the stomach after which they are removed.
• Most patients need another method for effective weight reduction since the weight loss associated with these procedures is modest and transient.
• Some patients may not tolerate it because they develop stomach pain, bloating, and heartburn. Patients who are intolerant may opt for early removal of the balloon.

Complications of Weight Loss Balloon Placement:

• Nausea
• Vomiting
• Abdominal pain

In 90% of patients, these symptoms will resolve with time and the balloons can be tolerated. Air-filled balloons have fewer of these complications than saline-filled balloons.

Serious complications of Intragastric Balloons:

• Migration of the balloon to the small gut may lead to intestinal obstruction. In addition, this may also lead to gut perforation.
• Intractable reflux
• Hyperinflation may be one of the reasons for the immediate removal of the balloon
• There is an increased risk of pancreatitis.

Until now, only 7 deaths have been reported with the use of intragastric balloon placement.

Short and Long-Term Efficacy of Weight Loss Balloon:

The results of short-term weight loss are approximated to be around 10 to 20%. However, since these balloons have to be removed after one year, they are not effective on a long-term basis.

A meta-analysis conducted by the American Society of Gastroenterology concluded the short-term efficacy of a single balloon system with weight loss of 13% in 6 months. The weight loss was maintained for almost 1 year.

Another study showed a weight loss of approximately 11-15% at 6 months duration and maintenance of 1 year.

All the FDA-approved balloon systems showed similar results with an average weight loss of 11% at 6 months and weight maintenance at one year in about 70% of the patients.

The long-term efficacy of weight loss balloons has not been studied. However, weight loss beyond one year is not expected.

Who is a candidate for the Weight loss balloon:

• Patients with a BMI of 30-40 kg/m²
• Committed and compliant with aggressive changes in lifestyle.

Who should not have a weight loss balloon placed?

• Previous upper gastrointestinal surgery
• Inflammatory bowel disease
• A hiatal hernia of more than 3 cms

New research in endoscopic weight loss interventions:

Currently, for long-term use, a new adjustable balloon system is under experimentation.

This has an adjustable volume, which is better for patients who cannot tolerate previously designed systems.

This system will be able to stay in the stomach for a longer time of 8 to 12 months compared to previous systems available which were to stay for 6 months only.

Recently, another new technique of duodenal resurfacing has been experimented with. The basic theme of this technique is after duodenal ablation regrowth of duodenal mucosal has improved metabolic parameters.