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Expert discusses potential of bariatric embolization, metabolic interventions

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HOLLYWOOD, Fla. — Bariatric embolization and metabolic interventions may be the “next revolution” in endovascular medicine, according to a speaker at the International Symposium on Endovascular Therapy.

Obesity is a growing issue worldwide. More than one-third of U.S. adults have obesity, according to the CDC. On a larger scale, more than 1.5 billion adults worldwide are overweight and more than 500 million are obese, according to WHO estimates.

A number of bariatric surgery options for obesity have grown in popularity in recent years, all of which are associated with significant weight loss, but also with cons such as reoperation and nutritional deficit.

However, a “treatment gap” in bariatric surgery remains, according to Nicholas Kipshidze, MD, PhD, of New York Cardiovascular Research and N. Kipshidze Central University Hospital in Tbilisi, Georgia, said during a presentation. Diet and lifestyle alone is not effective enough for many overweight or obese people, but there is a gap between that and bariatric procedures, which may be too risky for many people, he said.

Bariatric embolization as another option

“Bariatric procedures affect the gastric fundus, the main source of ghrelin production, and may share common mechanisms of action with bariatric embolization,” Kipshidze said.

Ghrelin is a hormone produced mainly by P/D1 cells lining the fundus of the human stomach and epsilon cells of the pancreas that stimulate hunger. Ghrelin is “the most potent appetite stimulant,” he said, as ghrelin levels rise before meals, fall after eating and decrease with dieting.

Kipshidze proposed a transcatheter approach in the left gastric artery using a commercially available catheter.

“Ninety percent of ghrelin is produced in the stomach fundus. The left gastric artery is the principal source of arterial supply to the gastric fundus. Arterial embolization procedures are well-characterized and safe,” he said. “Left gastric artery embolization can reduce ghrelin production, potentially leading to weight loss.”

The concept of bariatric embolization has transitioned from a theory to practice over the years. According to Kipshidze, the role of the ghrelin hormone was first described in 2002. Thereafter, other researchers reported significant weight loss after gastric embolization for bleeding in patients, experimental animals and Kipshidze and colleagues performed a first-in-man study of bariatric surgery in Georgia and Germany, in which weight loss was sustained through 2 years (mean percent weight loss from baseline, 16%). In the past 3 years, a number of U.S. physician-sponsored Investigational Device Exemption studies of left gastric artery embolization for weight loss have begun or are in planning stages, he said.

Early lessons

Kipshidze told the audience at ISET 2017 that bariatric embolization is technically feasible and effective. Ghrelin suppression and weight reduction have been demonstrated extensively, he said.

In early stages, the concept of bariatric embolization for weight loss was first validated in animals. However, he said, significant side effects such as ulceration and gastritis emerged in animals. Concern over non-target embolization and the high level of the FDA-required safety profile limits generalization of the procedure with off-the-shelf devices, he said.

Additionally, the use of embolic spheres and particles is more clinically relevant, as size and location are “critical to procedural effectiveness,” Kipshidze said.

“Clinical generalization of bariatric embolization requires the development of a dedicated micro-catheter and infusion system,” he said.

Future directions

Future research goals include evaluation of bariatric embolization in patients with diabetes, Kipshidze said.

He noted that it will also be important to perform a randomized trial using a dedicated bariatric embolization device.

Creation of a multidisciplinary obesity team, including interventional radiologists, cardiologists, bariatric surgeons, endocrinologists, gastroenterologists, nutritionists, and others will be vital in the future, he said.

Moreover, Kipshidze announced the launch of the OUS clinical study in February 2017, designed to evaluate safety and efficacy of left gastric artery embolization with the EndoBar robotic catheter infusion system (IntelliFusion). The study will enroll patients with a BMI greater than 35 kg/m². Target enrollment is 40 participants, who will be randomly assigned in a 1:1 fashion, with crossover to therapy for a sham group. The primary endpoints are safety (gastroscopy at 7 days) and weight loss at 6 and 12 months. Secondary endpoints include ghrelin and glucagon-like peptide 1 concentrations, oral glucose tolerance, insulin sensitivity, change in eating behavior, hunger scores and gastric motility. – by Katie Kalvaitis

Reference:

Kipshidze N. Concurrent Session VI: Late-Breaking Trials and Hot Topics. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.

Disclosure: Kipshidze reports founding and holding equity in EndoBar Solutions LLC.