Dr. Darryl Lamai
The Allurion Intragastric Balloon (formerly Elipse, Allurion Technologies) is a new balloon that is swallowed and does not require surgery or endoscopic placement, with fewer adverse events than reported in other available stomachs. Balloons, meta-analysis show results show high effectiveness in achieving weight loss and improved metabolic profile.
“I believe this analysis is the most comprehensive review. [of the Allurion balloon]Reported Dr. Darryl Lamai, MD, lead author of the University of Utah School of Medicine, Salt Lake City, Department of Gastroenterology and Liver, and a colleague of the study published in the November / December 2021 issue. Journal of Clinical Gastroenterology.
“In our study, Allurion balloons reduced waist circumference and triglyceride levels, [is] It is associated with fewer adverse events when 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, swallowed, and then inflated with 550 mL of liquid through the catheter to create a feeling of fullness and reduce hunger. It will help.
This procedure can be performed outpatiently in about 20 minutes, which may avoid the burden and extra cost of surgery and endoscope placement and removal. After about 4 months, the balloon is designed to be emptied through a valve that opens naturally, and the balloon is passed through the stool.
Currently used worldwide, balloons have not yet been approved by the US Food and Drug Administration (FDA).
A meta-analysis shows an average weight loss of 12.2% across the study
To assess balloon performance, the authors identified seven of the 273 published studies that met the criteria. The study included 2152 patients aged 18 to 65 years with a mean baseline body mass index (BMI) of 32.1 to 38.6 kg / m.2..
All studies were positive and results were reported in 3-4 months when the Allurion balloon normally contracted. Three of the studies were multi-institutional and four were single-institutional.
For improved BMI, the results showed that the pooled mean difference from baseline to the end of the study was 0.88 ().P = .001), and the weighted average percentage of total weight loss during treatment was 12.2% throughout the study.
The average overweight loss for the entire Allurion study was 49.1%.
The analysis was not designed to compare results directly with other balloons, but the authors, for example, ReShape Duo Intragastric Balloons (FDA-approved dual balloon system) were associated with percentages in previous studies. It states that there is a total weight loss of 7.6% in 6 months, compared to 3.6% observed among those who have changed their lifestyle.
However, in another meta-analysis, the pooled percentage of total weight loss when using FDA-approved Orbera balloons was similar to current Allurion analysis, at 12.3% (6 months) 3 months after transplantation. It was shown to be 13.2%). And 11.3% in 12 months).
The analysis further showed that the excessive weight loss due to the Orbera balloon at 12 months was 25.4%.
Other results show that the current meta-analysis also showed a significant improvement with the Allurion balloon with a waist circumference of 0.89 (P = .001) and triglyceride levels of 0.66 (P = .004) vs. baseline.
Previous studies of FDA-approved Ovalon gastric balloons that inflate with gas rather than liquid have shown a significant reduction in waist circumference from 109 cm (± 12.3) to 99 cm (± 10.5) (± 10.5). ((P <.05), and another study, showed that 37.5% of patients receiving Orbera balloons had normalized triglyceride levels after 4 months without combination therapy.
Adverse events appear lower than other balloons
Potential risks associated with Allurion balloons include the possibility of early deflation. However, the pool 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 rates of abdominal pain corresponding to the ReShape Duo and Orbera balloons have been reported to be 54.5% and 57.5%, respectively, and the authors state that the effect is probably due to hyperinflation.
In addition, the rates of vomiting caused by ReShape Duo and Orbera balloons are reported to be much higher at 86.7% and 86.8%, respectively.
Notably, there were no deaths or cases of acute pancreatitis reported in Allurion’s meta-analysis study.
As reported by Medscape Medical NewsSuch concerns have been raised in previous FDA alerts regarding liquid-filled gastric balloons from Orbera and ReShapeDuo.
In the latest update, published in April 2020, the FDA states that it has received reports of 18 deaths worldwide, including eight in the United States, since the approval of the Orbera and ReShape balloons.
Lead author Lamai said concerns about the issue were justified.
“These concerns are valid,” he said. Medscape Medical News.. “Theoretically, because of the short placement time of the Allurion balloon, there are few adverse events, but a comparative study is needed to confirm this.”
Balloons show efficacy in patients suffering from weight loss, metabolic syndrome, and fatty liver disease, but “the type and duration of the gastric balloon needs to be tailored to the patient,” Lamai said. increase.
“The clinician needs to thoroughly discuss the benefits and risks of using an intragastric balloon with the patient,” he added. “In addition, placement of an intragastric balloon should only be attempted by a clinician with expertise in weight loss endoscopy.”
This study is not financially supported.Lamai No relevant financial relationships have been reported.
J Clin Gastroenterol. 2021; 55: 836-841.Overview
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