Intragastric Balloon

Excerpt

Since the beginning of the 1980s, the worldwide prevalence of obesity has doubled. An estimated 1 in 3 adults is categorized as overweight or obese, equating to greater than 1.4 billion adults. Given the epidemic rates of obesity and the subsequent rise in the prevalence of obesity-related health conditions and comorbidities, there is a global need for effective and safe treatment of this disease. Comorbidities include hypertension, hyperlipidemia, cardiovascular disease, diabetes mellitus, orthopedic conditions, gastroesophageal reflux disease, metabolic dysfunction, psychiatric disorders, obstructive sleep apnea, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, and cancers.

While bariatric surgery is considered the most effective treatment modality for morbid obesity, there are restrictions for a patient to be a candidate for surgical intervention. Bariatric surgeries, which range from Roux-en-Y gastric bypass, duodenal switch, laparoscopic sleeve gastrectomy, to name a few, require a body mass index (BMI) greater than 35 kg/m² with associated comorbidities or meeting the BMI criteria for severe obesity with a BMI greater than 40 kg/m². With the parameters mentioned above to meet preoperative criteria, this leaves an intermediate group of patients who are not candidates for surgery but have also failed or not responded well to medical therapies. These patients are also looking for a safe and effective weight-loss therapy that is minimally invasive, like the intragastric balloon. Current treatment modalities for obese patients include lifestyle modifications, pharmacotherapy, bariatric surgery, and endoscopic applications, of which the intragastric balloon is the most widely used.

Intragastric balloon therapies are a minimally invasive and temporary methodology to induce weight loss in obese patients. The soft saline or an air-filled balloon is placed into the stomach, typically in an endoscopic fashion. The balloon is a restrictive mechanism and promotes the feeling of satiation as it is a space-occupying device. The average gastric capacity is approximately 1200 mL, but an obese patient can stretch this volume threefold. A balloon volume of 400 mL or higher is enough to induce the feeling of satiation. A proposed mechanism of action is the delayed gastric emptying process, which can serve as a contributing weight-loss factor. Importantly, as with all bariatric procedures, a patient must comply with lifestyle modifications to achieve and maintain meaningful weight loss before and after any intervention.

History

The study of intragastric restriction dates back to 1939, with the investigation of gastric bezoars by Michael DeBakey. His analysis concluded that approximately 30% of patients with gastric bezoars and concretions had experienced weight loss. Patients analyzed suffered from gastrointestinal symptoms, most commonly nausea and vomiting, and did not necessarily lose weight. The first intragastric balloon introduced in 1985 was created by husband-and-wife gastroenterologists Lloyd Garren and Mary Garren. This balloon was introduced in the United States and was called the Garren-Edwards Gastric Bubble (GEGB). The GEGB was a cylindrical, “tin can” shape with a central, hollow channel for insertion and retrieval in an endoscopic fashion. This balloon was filled with approximately 200 mL of room air and placed in the stomach for 4 months. This intragastric balloon received approval from the Food and Drug Administration (FDA) but was withdrawn from the market in 1992 due to severe side effects. Complications included gastric ulcers, Mallory-Weiss tears, small bowel obstructions, and gastric erosion. There was also insufficient efficacy in weight loss with patients using these devices.

The failures of the GEGB promoted the 1987 conference titled Obesity and the Gastric Balloon: A Comprehensive Workshop. This obesity congress included 75 international experts from gastroenterology, surgery, nutrition, behavioral medicine, and obesity specialists. This meeting aimed to develop a consensus on the technology of intragastric balloons and treatment options. The ideal balloon characteristics should include high efficacy, radiopaque markers, adjustability to a variety of sizes between 400 and 500 mL, low ulcer and obstructive potential, absence of edges or sharp ridges, the composition of materials that last for long periods, made to maximize both weight-loss and limit the amount of food intake. According to this conference, the usage of intragastric balloon therapy was for patients whose BMI did not qualify for operative bariatric procedures but desired to improve an obesity-associated condition or to lose excess weight. The intragastric balloons could also be utilized for patients with an extremely high BMI who are either unfit for bariatric surgery or to reduce body weight before bariatric surgery.

Using the characteristics and conclusions from the Obesity and the Gastric Balloon conference, a balloon was developed in 1991 by the BioEnterics Corporation. This balloon contained a saline and methylene blue mixture and would remain in the stomach for 6 months. Initially, this balloon was used outside North America in Asia, South America, Europe, and the Middle East. The balloon, called Orbera, eventually received FDA approval in the United States in 2015. Since 2015, different intragastric balloon systems have been introduced to the United States and European markets. The usage of these balloons ranges from primary weight loss, a bridging therapy for bariatric surgery, and a weight-loss solution for high-risk patients. Attracting factors to intragastric balloons include the little to noninvasive nature, limited to a specific time frame, and reversible. The intragastric balloon also preserves the anatomy of the stomach. It is important to note that weight loss is not comparable to that expected from a surgical procedure. Intragastric balloons can be used as a weight-loss tool but are ineffective for weight maintenance. The advantages and disadvantages must be analyzed individually when making a medical therapy decision with a patient.