The Allurion Intragastric Balloon (formerly Elipse, Allurion Technologies), a new balloon that is swallowed, requiring no surgery or endoscopic placement, shows high efficacy in achieving weight loss and an improved metabolic profile, with less adverse events than those reported with other available gastric balloons. balloons, results of a meta-analysis show.
“We believe this analysis is the most comprehensive review [of the Allurion balloon]“, reports first author Daryl Ramai, MD, of the Division of Gastroenterology and Hepatology, University of Utah School of Medicine, Salt Lake City, and colleagues of the research published in the November issue/ December 2021 from Journal of Clinical Gastroenterology.
“Our study showed that the Allurion Ball reduces waist circumference and triglyceride levels and [is] associated with fewer adverse events compared to other intragastric balloons,” the authors conclude.
Unlike other balloons, the Allurion Gastric Balloon is compressed into a small capsule connected to a thin catheter and, once swallowed, is then inflated with 550ml of liquid through the catheter to create a feeling of satiety and help control gastric hunger.
The procedure can be performed on an outpatient basis in approximately 20 minutes, potentially avoiding the additional burden and cost of surgery or endoscopic placement and removal. After about 4 months, the balloon is designed to empty through a valve that opens spontaneously, and the balloon is then passed in the stool.
Although currently in use around the world, the ball has not yet received approval from the United States Food and Drug Administration (FDA).
Meta-analysis shows average weight loss of 12.2% across all studies
To assess ball performance, the authors identified seven of 273 published studies that met the review criteria. The studies included 2152 patients, aged 18 to 65, with a mean baseline body mass index (BMI) of 32.1 to 38.6 kg/m2.
All studies were prospective, with results reported at 3 to 4 months, when the Allurion balloon typically deflates. Three of the studies were multicentre, while four were single centre.
In terms of improvement in BMI, the results showed that the pooled mean difference between the baseline and the end of the studies was 0.88 (P = 0.001), and the weighted mean percent total body weight loss during treatment across all studies was 12.2%.
The average excess body weight loss in the Allurion studies was 49.1%.
The analysis was not designed to directly compare results with other balloons, but the authors note, for example, that the ReShape Duo intragastric balloon (an FDA-cleared dual balloon system) has been reported in a previous study as being associated with a percentage total body weight loss of 7.6% at 6 months, compared to 3.6% seen in people who made lifestyle changes.
However, a separate meta-analysis showed that the combined percentage of total body weight loss with the FDA-cleared Orbera balloon was about the same as the current Allurion analysis, at 12.3% at 3 months post-test. implantation (follow-up of 13.2% at 6 months and 11.3% at 12 months).
This analysis further showed that the excess body weight loss with the Orbera balloon at 12 months was 25.4%.
In other results, the current meta-analysis also showed significant improvements with the Allurion Ball in waist circumference of 0.89 (P = 0.001) and triglyceride levels of 0.66 (P = 0.004) relative to baseline.
Previous research involving the FDA-approved Obalon intragastric balloon, which is inflated with gas rather than liquid, has shown a significant reduction in waist circumference from 109 cm (± 12.3) to 99 cm (± 10.5 ) (P
Adverse events appear lower than other bubbles
Potential risks associated with the Allurion balloon include the potential for early deflation; however, the combined rate of early balloon deflation observed in the meta-analysis was relatively low at 1.8%.
Other adverse events reported with the Allurion balloon were abdominal pain (37.5%), vomiting (29.6%), diarrhea (15.4%) and small bowel obstruction (0.5 %).
The corresponding rates of abdominal pain with the ReShape Duo and Orbera balloons were reported as 54.5% and 57.5%, respectively, with the effects possibly due to overinflation, the authors note.
And vomiting rates with the ReShape Duo and Orbera balloons were reported to be much higher, at 86.7% and 86.8%, respectively.
It should be noted that no deaths or cases of acute pancreatitis were reported in the meta-analysis studies of Allurion.
As reported by Medscape Medical News, such concerns have been raised in previous FDA alerts regarding Orbera and ReShape Duo liquid-filled intragastric balloons.
In the latest update, published in April 2020, the FDA described receiving reports of 18 deaths that have occurred worldwide since Orbera and ReShape balloons were approved, including eight in the United States.
First author Ramai noted that concern over the issues was warranted.
“These concerns are valid,” he said. Medscape Medical News. “Theoretically, since the Allurion balloon is placed over a shorter period, it is conceivable that there are fewer adverse events. However, comparative trials are needed to confirm this.”
Although balloons show efficacy in patients with weight loss, metabolic syndrome and fatty liver disease, “the type and duration of intragastric balloons should be tailored to the patient,” Ramai said.
“Clinicians should thoroughly discuss with their patients the benefits and risks of using an intragastric balloon,” he added. “Furthermore, placement of intragastric balloons should only be attempted by clinicians with expertise in bariatric endoscopy.”
The study received no financial support. Ramai has did not report any relevant financial relationships.
J Clin Gastroenterol. 2021;55:836-841. Summary
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