CHARLOTTE, N.C.—In a comparison of two bariatric procedures for obesity—endoscopic sleeve gastroplasty and intragastric balloon—patients who underwent ESG had slightly more weight loss, while those undergoing IGB saw a high rate of early balloon removal, translating to somewhat less tolerability.
The comparative study used data from a large database, but follow-up was short.
“What I’d like you to take away from my presentation is that both procedures are safe, with a comparatively low rate of serious adverse events. But the higher rates of dehydration and re-interventions after IGB may suggest that ESG is perhaps better tolerated,” said Anuragh Gudur, MD, a second-year resident at the University of Virginia, in Charlottesville, who presented the study at the 2022 annual meeting of the American College of Gastroenterology (abstract S1067).
“The study is a great glimpse of real-world utilization of both of these procedures,” he commented.
In July, the FDA cleared for marketing the first devices indicated for endoscopic ESG and endoscopic bariatric revision: the Apollo ESG, Apollo ESG Sx, Apollo Revise and Apollo Revise Sx systems (Apollo Endosurgery).
Endoscopic Alternatives to Surgery
“Fewer than 1% of qualified patients actually undergo bariatric surgery, most often due to fears over the operation,” Dr. Gudur said. “Alternatives to surgery are really needed, and endobariatric procedures fulfill that need.”
ESG involves plication of the gastric lumen to restrict its size. Early studies have suggested that ESG may contribute to an approximate total body weight loss of up to 16% in 12 months and sustained weight loss up to 104 weeks, Dr. Gudur noted. In comparison, IGB typically involves placement of a fluid-filled balloon into the gastric lumen to restrict gastric filling, which may result in approximate weight loss of up to 10% in 12 months (Lancet 2022;400[10350]:441-451; Obes Surg 2020;30[8]:3010-3029; Clin Gastroenterol Hepatol 2020;18[5]:1043-1053). The balloon often is removed approximately six months after placement.
Dr. Gudur and his co-investigators compared the short-term safety and efficacy of ESG and IBG using a large bariatric database maintained by the American Society for Metabolic and Bariatric Surgery that includes information from more than 800 international centers. Investigators propensity-matched patients who underwent the two procedures, which included 1,998 undergoing IGB (variety of balloon types) and 1,998 undergoing ESG. There were no significant differences between the groups in baseline characteristics, including comorbidities related to obesity.
Rates of reoperation and readmissions within 30 days were similar, but the ESG group had slightly higher rates of readmission (Table).
| Table. Results of ESG and IGB Bariatric Procedures | |||
| Outcome | IGB (n=1,998) | ESG (n=1,998) | P value |
|---|---|---|---|
| Serious adverse events, % | 0.3 | 0.9 | 0.055 |
| Mean number of days from procedure to discharge | 0.04 | 0.65 | <0.001 |
| Reoperation within 30 days, % | 0.6 | 1.1 | 0.121 |
| Readmission within 30 days, % | 1.5 | 2.8 | 0.004 |
| Intervention within 30 days, % | 4.5 | 1.8 | <0.001 |
| Outpatient treatment for dehydration, % | 4.5 | 2.3 | <0.001 |
| Mean change from pre-op to post-op BMI | –0.95 | –1.51 | <0.001 |
| Mean total body weight loss, % | 2.3 | 3.8 | <0.001 |
| BMI, body mass index; ESG, endoscopic sleeve gastroplasty; IGB, intragastric balloon. | |||
“Notably, patients who underwent [IGB] had more than two times as many re-interventions within 30 days, 80% of which were for early balloon removal,” Dr. Gudur reported. “We also noticed that patients who underwent IGB had more outpatient treatments for dehydration.”
In terms of weight loss, patients undergoing ESG had a slightly higher (statistically significant) mean total body weight loss at 30 days compared with those undergoing IGB, but it’s limited to short-term follow-up. “We do know from other studies that ESG does typically lead to more durable weight loss, often because IGBs are removed after six months and patients can regain the weight,” he said.
Both ESG and IGB demonstrated a low rate of serious adverse events (a composite variable): 0.9% and 0.3%, respectively (P=0.055), a non-significant difference. But the composite variable for this did not capture abdominal pain, dehydration or per-oral intolerance, so it may not reflect the full picture, Dr. Gudur acknowledged.
He also acknowledged that there could be significant variability in the proceduralists’ experience among the participating centers because the data were retrospectively collected across many different institutions.
Data Helpful for Patient Discussions
Dayna Early, MD, a professor of medicine at Washington University in St. Louis and the director of endoscopy at Barnes Jewish Hospital, also in St. Louis, said the study “provides useful insights” into two of the currently available endoscopic therapies for obesity, IGB and ESG. “Since patients have options as to which endobariatric procedure to choose, information regarding weight loss success and complication rates is of utmost importance to assist them in making informed decisions. An advantage of this study is that it incorporated data from a large database of centers specializing in endobariatrics and treatment of obesity,” she said.
“The findings of this study are not unexpected, namely, both interventions are overall well tolerated and successful at achieving weight loss, with IGB patients requiring more re-interventions and ESG patients requiring more re-admissions yet achieving greater weight loss,” Dr. Early noted.
“Despite the limitations described by the authors, the data can be a helpful adjunct in conversations with patients who are considering an endobariatric procedure.”
—Caroline Helwick
Drs. Early and Gudur reported no relevant financial disclosures.
This article is from the February 2023 print issue.