A single-blind, sham procedure randomised trial of transcatheter bariatric embolotherapy (TBE) of the left gastric artery (LGA) in patients with obesity has shown that the procedure is well-tolerated and resulted in effective weight loss at six-month follow-up, compared with the sham control, and the weight loss was sustained at 12 months. The researchers - who reported the outcomes in the paper, ‘Transcatheter Bariatric Embolotherapy for Weight Reduction in Obesity’, published in the Journal of the American College of Cardiology - noted that TBE is a promising, nonsurgical treatment modality for weight loss that might address the treatment gap of BMI ranging between 30-40.
Transcatheter bariatric embolotherapy is a percutaneous procedure involves catheter-directed embolization of the LGA. The LGA provides blood supply to the gastric fundus, which contains the majority of cells that produce ghrelin, the only known orexigenic (appetite stimulating) hormone secreted from the gastrointestinal tract. Previous studies have shown that embolising the LGA can result in weight loss. Therefore, they established the Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial (LOSEIT) to assess the safety and efficacy of TBE in individuals with obesity using an occlusive balloon microcatheter and infusion system designed for this application.
The study was undertaken at the O B Klinka and the Homolka Hospital, Prague, Czech Republic. The primary efficacy endpoints of the study were the differences in TBWL between groups at six and 12 months post-embolization. Success was defined as ≥5% TBWL in the TBE group with statistical superiority to the sham group at six months and ≥5% TBWL in the treatment group at 12 months.
In total, 31 subjects completed 12 months follow-up and at baseline there were no statistically significant differences between the groups. The average age of enrolled subjects was 45.5±9.4 years, with a majority being women (n=36; 81.8%). Their mean weight was 114.5±16.5kg, with a mean BMI of 39.6±3.8kg/m2.
Twenty subjects underwent TBE; there was one inadvertent embolization of the left hepatic artery and another with incomplete LGA stasis. In the TBE group, the most common side effects were nausea (n=7) and vomiting (n=7), compared with the sham control group, nausea (n=4) and epigastric pain (n=3). All side effects were reported within the first two weeks following therapy, without delayed presentation of side effects.
At six months, there were differences between groups in both the absolute TBWL and %TBWL for the intension-to-treat (ITT) population. The mean absolute and percentage weight loss with TBE (7.4kg, 6.4%) was greater than observed with sham (3.0kg, 2.8%; p=0.034, p=0.052, respectively), an additional 3.6% absolute TBWL. In total, 60% of TBE group achieved a ≥5% TBWL, compared with only 12.5% of sham control subjects (p=0.009).
At 12-months, compared with baseline weight, the ITT analysis revealed that the absolute TBWL (7.8 kg) and %TBWL (6.5%) were maintained at 12 months (p=0.0011 and p=0.0008, respectively). In total, 33% of TBE subjects achieved ≥10% TBWL, 27% achieved between 10% and 5% TBWL, and 40% of treated subjects achieved <5% TBWL. One TBE patient gained weight back at 12 months. Two subjects treated with TBE subsequently underwent bariatric surgery approximately 1.5 years later.
Additional outcomes included:
- At 12 months, there was a statistically significant mean decrease of 9.71 ± 15.6 mm Hg in diastolic blood pressure in the TBE group (p=0.02) and a nonsignificant decrease in systolic blood pressure of 1.83±13.1mm Hg (p=0.58)
- Compared with baseline, fewer TBE subjects presented with stage 2 hypertension at 12 months post-procedure (25% vs. 62.5%; p=0.173), so most TBE subjects (56.3%) were in stage 1 hypertension at 12 months
- There were statistically significant improvements in the TBE group in two of five domains, physical function and self-esteem, as well as the overall quality of life; however, none of the changes in the sham group were significant
- The levels of ghrelin decreased in both groups the TBE at six months (p = 0.45) but at 12-month follow up, the TBE group demonstrated a significant median decrease of 15.5% (difference from baseline: p=0.035)
- At six months, the time to achieve satiety in the TBE group decreased by a median of 5 min, compared to a median of 2.5 min in the sham group
- At six months, the TBE group required less volume (mean 5.4% less) to achieve satiety vs. the sham group (mean 5.0% less)
Although the authors acknowledge that little data has been reported on the effect of TBE beyond 12 months, they have extended the follow-up in this study to three years to assess the durability of weight loss and incidence of potentially late adverse events over the longer-term.
“Although a panacea for obesity is unlikely, these data indicate that, if confirmed to be safe and effective in larger future trials, embolotherapy might play an important role in mitigating this global health epidemic,” they concluded.
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