Safety and Efficacy of Transcatheter Bariatric Embolotherapy for Weight Loss

Transcatheter bariatric embolotherapy (TBE) of the left gastric artery is a safe and effective modality for weight loss in obese patients, according to study results published in the Journal of the American College of Cardiology.

Earlier studies suggested that TBE of the left gastric artery can assist in patients’ efforts to lose weight by reducing ghrelin, an appetite-stimulating hormone secreted from the gastric fundus. The current study aimed at determining the safety and efficacy of TBE for weight reduction.

The single blind study included patients with obesity (body mass index, 35-55 kg/m²). The participants were randomized to either sham (control group) or TBE of the left gastric artery using an occlusion balloon microcatheter to administer 300 to 500 µm embolic beads (intervention group). The primary outcome was total body weight loss at 6 months.

The study sample included 44 patients (mean age, 45.5 years; 36 women) and after 4 participants withdrew consent at the baseline visit, 20 subjects were allocated to transcatheter bariatric embolization and 20 subjects were allocated to sham control.

At 6 months, the mean absolute and percentage weight loss in the intention-to-treat analysis was significantly greater among participants in the intervention group compared with the control group (7.4 kg vs 3.0 kg, P =.034, and 6.4% vs 2.8%, P =.052, respectively).

Similarly, the mean absolute and percentage weight loss in the per-protocol analysis was also significantly greater following TBE (9.4 kg vs 1.9 kg, P =.0002, and 8.3% vs. 1.8%, P = .0011, respectively). A total of 60% of TBE subjects achieved a total body weight loss of 5% or more compared with 12.5% of those in the control group (P =.009).

At 12-months, the absolute and percentage weight loss was maintained in the intention-to-treat (7.8 kg and 6.5%, respectively) and in the per-protocol (9.3 kg and 9.3%, respectively) analyses.

Ghrelin levels decreased in the intervention group at 6- and 12-month follow-up (12.2% and 15.5%, respectively). In addition, the time to achieve fullness was 1.7 minutes less for the TBE group, on average.

The most common adverse events following the intervention were mild and included nausea and vomiting (7 cases each), and epigastric pain (4 cases). In the control group, nausea (4 cases) and epigastric pain (3 cases) were reported.

Endoscopy following TBE revealed 5 cases of asymptomatic ulcers. There was only 1 serious adverse event in the study, and it was deemed unrelated to the intervention.

The study had several limitations, including lack of a control group after 6 months, no data on the effect of weight loss on cardiovascular outcomes, and data collection from only 2 centers in Europe.  

“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,” wrote the researchers.

Disclosure: This clinical trial was supported by Endobar Solutions. Please see the original reference for a full list of authors’ disclosures.

Reference

Reddy VY, Neužil P, Musikantow D, et al. Transcatheter bariatric embolotherapy for weight reduction in obesity. J Am Coll Cardiol. 2020;76(20):2305-2317. doi:10.1016/j.jacc.2020.09.550