WASHINGTON — Endoscopic sleeve gastroplasty – or ESG – successfully treated obesity in a new study showing its efficacy, safety and reproducibility outside the centers that launched the procedure years ago, according to research presented during Digestive Disease Week 2018.
“This international multicenter study demonstrates consistent efficacy and safety of ESG as a treatment for obesity across our study centers. Thus, we believe ESG is a safe and effective endoscopic bariatric procedure with generalizability and reproducibility,” Vivek Kumbhari, MBChB, assistant professor of medicine at Johns Hopkins Medicine, said during his presentation. “Considering the significant weight loss observed, reproducibility of the results among independent centers, variation of follow up protocols, absence of intraprocedural events and low prevalence of major adverse events and complications, ESG appears to be a feasible, effective and safe treatment for obesity. The procedure, in its current form, is thus suitable for incorporation into clinical practice.”
Kumbhari introduced the concept that ESG has only been studied at three pioneering centers, with this study being the first published outside of those centers.
“It’s very hard for widespread adoption of a technique when it’s only reported in three centers,” he said.
In this study, Kumbhari and colleagues looked at consecutive ESG patients undergoing ESG with the Apollo OverStitch device (Apollo Endosurgery) from February 2016 through May 2017 at three centers: The BMI Clinic in Australia and Johns Hopkins and UT Health in the U.S. Outcomes included weight change at 6 months post-procedure, adverse events and complications. Kumbhari noted that patients were offered ESG, but also intragastric balloons and bariatric surgery as appropriate. This study looked at those that chose ESG, he said.
Although this is an endoscopic procedure, the baseline BMI for the group was 37.9 and 33.9% of the patients had BMI greater than 40 kg/m2, making them surgical candidates, Kumbhari said. He explained that 30.4% had reflux, which contributed to their choice to avoid surgery and choose ESG. Additionally, 8.9% previously had an intragastric balloon.
Kumbhari showed that across the study, there was an average weight loss of 16.4 kg at 6 months and a decrease in BMI of 5.6 kg/m2. That translated into a 14.9% total body weight loss (TBWL) at 6 months and excess weight loss in 50.3% of the study population. At 3 months post-ESG, 62.2% of the study population reached 10% or more TBWL. At 6 months post-ESG, that percentage rose to 81%.
“That’s quite robust outcomes,” Kumbhari said. “Our findings were similar between the three centers. ... The baseline BMIs were very similar, and history of obesity-related chronic disease was also similar amongst the group. This is a reproducible therapy and does appear to be generalizable.”
A higher baseline BMI was positively correlated with absolute weight loss, but negatively associated with excess weight loss, Kumbhari said. Being male was also a consistent determinant of greater absolute weight loss and change of BMI. Unfortunately, he said previously having an intragastric balloon was associated with less weight loss.
“The results were somewhat disappointing,” Kumbhari said. “The outcomes were poorer in those who had a previous intragastric balloon across all BMI cohorts. Particularly at 6 months, the TBWL was almost half in those who had a prior intragastric balloon as opposed to those who had no balloon.”
Kumbhari reported that although there were two post-procedural severe adverse events due to bleeding from ulcerations along the suture line, there were no intraprocedural complications.
“This procedure may be safe to be performed in outpatient or surgical centers,” he said. “We report comparable and consistent findings despite our experience with the suturing system being far less.” – by Katrina Altersitz
Kumbhari V, et al. Abstract 2160. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.
Sartoretto A, et al. Obes Surg. 2018;doi:10.1007/s11695-018-3135-x.
Disclosures: Kumbhari reports acting as a consultant for Apollo Endosurgery, Boston Scientific, Reshape Medical and Medtronic. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.