An Overview of Spatz3-The World’s First Adjustable Gastric BalloonAugust 25, 2022
For people who are overweight, but either do not qualify for bariatric surgery or wish to pursue a less invasive approach, the Spatz3 adjustable gastric balloon is a great option. The balloon is saline filled and is inserted with an upper endoscopy under sedation. No incisions, general anesthesia, or a hospital stay is required.
The balloon is indicated for patients with a body mass index (BMI) between 30 and 40. There have been many different gastric balloons in the United States over the years, but this is the first one that is adjustable. The nonadjustable gastric balloon, the Orbera balloon, (as well as the ReShape and Obalon- which are both no longer available in the US) must be removed in six months according to the FDA. The Spatz3 balloon, however, is approved by the FDA to stay in for up to 8 months.
The Spatz3 balloon is only available at specific centers in the US and only under the supervision of a post approval FDA study.
This means that the balloon is fully FDA approved, but they are still collecting a larger set of data (de-identified) before it is available to all surgeons and gastrointestinal doctors. Thus, a physician that is inserting a Spatz3 balloon is an expert in the field! They will do a basic assessment and make sure that a patient meets criteria for the balloon and does not have a contraindication (such as a previous surgery on the stomach like a sleeve gastrectomy or a surgery for acid reflux).
How Do Gastric Balloons Work?
Gastric balloons work in two main ways. The first is that by physically occupying space in the stomach, they help a patient learn portion control. After a balloon is inserted, there is less room in the stomach for food and fluids and the patient feels the full sensation after a smaller meal. The other way they work is that the balloon creates a partial blockage of the stomach, slowing the gastric emptying. This also contributes to a longer period of “feeling full” or satiety.
The goal is for the patient to eat a smaller portion of a well-balanced diet that they can then maintain after the balloon is removed. One of the downsides of balloons, as compared to surgery, is that they are temporary. They are an important tool, and when used in conjunction with intensive nutritional counseling, they can be a huge jump start to major weight loss! The long-term success, however, does still depend on creating healthy habits around food and exercise. This is the piece that the patient will be taught during the 8 months while the balloon is in place.
Down Adjustment To Prevent Early Removal
One of the biggest issues with the previous balloons is that if a patient experiences significant nausea and vomiting or is unable to tolerate the balloon, the only option is to completely remove it. This occurs up to 10% of the time with the nonadjustable balloon! As a result, almost 1 out of every 10 patients does not get the maximum benefit of the balloon. Some patients even have the balloon removed within days or weeks of insertion. With the Spatz3 balloon, those patients now can receive a down adjustment instead of complete removal. This is a major game changer and is why the adjustable nature of the Spatz3 is an excellent design.
The down adjustment procedure is done in an identical manner to the insertion, with an endoscopy under sedation.
What makes the Spatz3 balloon unique is that it has a small piece of tubing attached. So, if a down adjustment is needed, the surgeon or gastrointestinal doctor can take out some of the saline to make the balloon smaller and easier to tolerate. This has been shown to decrease the early removal rate substantially. The majority of patients that require this down adjustment go on to keep the balloon in for the entire treatment period.
Up Adjustment To Enhance Continued Weight Loss
The other major benefit to the Spatz3 balloon, is that at the halfway point, so around month 4, the patient can have an up adjustment if they wish to further their weight loss. This is also done with the endoscope under sedation. Once again, the tubing is used to access the balloon, but this time more saline is instilled into the balloon, making the size of the balloon bigger. This will prevent that stall in weight loss that typically occurs around the 3–4-month time point with the non adjustable gastric balloons.
In the long-term, studies have shown that patients lose almost double the amount of weight with the Spatz3 compared to the other nonadjustable balloons. They also maintain more of that weight loss for a long period of time.
How Much Weight Will I Lose?
The total amount of weight loss is dependent on multiple factors, including the starting weight. For this reason, the amount of weight loss is defined in percentages rather than in the absolute number of pounds. With the Spatz3 gastric balloon, patients can expect to lose up to 10 to 15% of their total body weight. For some patients, this can be upwards of 50-70 lbs!
It is important to note that while gastric balloons are FDA approved; they remain a cash pay procedure, because they are not currently covered under any commercial health insurances. This is true of all nonadjustable balloons and the Spatz3 balloon. Many programs, however, are very comprehensive and include the nutritional support and more! Within the confines of the post approval Spatz3 clinical trial, the patient receives multiple follow-up visits a month and is monitored very closely.
Medications for nausea and other symptoms are prescribed and detailed instructions are given. There are a few things that MUST be avoided while the balloon is in: patients cannot take any non-steroidal anti-inflammatory medications (NSAIDS), like ibuprofen or aspirin, and they cannot smoke or vape nicotine. Female patients of child-bearing age must also agree not to get pregnant and to notify their physician immediately if they do become pregnant as the balloon would need to come out.
Dr. Cynthia Weber is a board certified general and bariatric surgeon at New York Bariatric Group.
ABOUT THE AUTHORDr. Cynthia Weber is a board certified general and bariatric surgeon at New York Bariatric Group. She is a graduate of Northeastern Ohio Universities’ College of Medicine. She completed her general surgery residency at Loyola University Medical Center, dedicating part of her training to research. She completed her fellowship in Bariatric and Minimally Invasive Surgery at the University Hospitals of Cleveland. Dr. Weber has performed hundreds of bariatric operations, advanced foregut surgery and complex endoscopic procedures.