Bariatric Embolization a Future Treatment for Severe Obesity?

Marlene Busko

April 17, 2019

Bariatric embolization — in which one or more arteries to the stomach are blocked with microspheres — led to promising 1-year weight-loss in a pilot study of 20 patients with severe obesity.

In animal studies, this nonsurgical angiographic procedure resulted in decreased levels of the appetite-stimulating hormone ghrelin along with a corresponding reduction in weight.

Now in this proof-of-concept study, patients who had an average of 67 kg (148 pounds) excess weight at baseline lost 11.5% of it 12 months following the procedure.

These findings from the Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) trial were published online April 2 in Radiology by Clifford R. Weiss, MD, Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland, and colleagues.

This initial clinical trial "is a great step forward for this procedure in establishing early feasibility, safety, and early efficacy," said Weiss in a statement by the Radiological Society of North America.

However, "it is important to [state] that bariatric embolization is not proposed as a replacement for bariatric surgery, but as a supplemental method to facilitate weight loss with lifestyle modification," the researchers write.

Bariatric surgery, they note, produces weight loss of up to 19% by gastric banding and 36% by Roux-en-Y gastric bypass, and endoscopically placed gastric balloons produce 34% excess weight loss in 2 years.    

Bariatric embolization, on the other hand, produces weight loss that is "at least as effective as some pharmacotherapies (ie, liraglutide, orlistat, lorcaserin), which induce mean weight loss of 2%–9%."

This minimally invasive procedure was generally well tolerated, and a year later, only three of 20 patients had returned to their initial weight while the rest had lost weight.

Thus, bariatric embolization "may provide needed assistance to patients who are struggling to succeed in lifestyle modification-based weight loss programs," the researchers conclude.

"The reality is that obesity itself is an individualized disease that requires individualized treatments," Weiss added.

The study team included interventional radiologists, gastroenterologists, dietitians, psychologists, hormone experts, bariatric surgeons, and statisticians.

Weiss foresees "a day when there will be a multidisciplinary obesity clinic where six or seven different practitioners get together to treat the patient."

This is already happening at some sites, he notes, "but they are rare and need to be more widespread, like multidisciplinary cancer centers."

A Feasible Way to Cut Appetite, Drop Pounds?

Transarterial embolization of the gastric fundus aims to induce metabolic changes like those induced by bariatric surgery in a safer, less-invasive, more cost-effective way.

The current study was performed under a physician-initiated investigational device exemption from the US Food and Drug Administration.

Participants were recruited from 2014 to 2018, and 15 underwent the procedure at Johns Hopkins and five at Mount Sinai Hospital, New York City.

The patients were mainly women (16 patients), 12 were African American, and eight were white. At baseline, participants were a mean weight of 139 kg (306 pounds) and had a mean body mass index of 45 kg/m2.

Experienced interventional radiologists used a radial or femoral artery approach (six and 14 patients, respectively) and guided fluoroscopy to introduce Embosphere microspheres (Merit Medical) through a catheter to embolize the left gastric and gastroepiploic arteries (16 participants) or just the gastroepiploic artery (four patients). 

On average, the procedure took 32 minutes of fluoroscopy time with a radiation dose of 5255 mGy.

The procedure was performed successfully in all participants.

A month later participants had lost on average 8.2% of their initial excess weight.

At 3 months, 6 months, and 1 year, they had lost 11.5%, 12.8%, and 11.5% of their initial excess weight, respectively.

Patients reported having decreased appetite, with the greatest appetite reduction a month after the procedure. Although appetite then increased, it remained lower than baseline.

Patients also reported better quality of life after the procedure.

Metabolic measures also improved. Levels of total cholesterol, LDL-cholesterol, triglycerides, and HbA1c decreased, and HDL-cholesterol increased.

Eight participants had superficial asymptomatic ulcers that healed by 3 months. One participant had mild gastritis at 3 months. One participant had delayed gastric emptying at 1 month that resolved by 6 months.

There were no major adverse events reported.

As next steps, the team is examining ghrelin changes in these patients and plan to look at longer-term outcomes and effects from a sham procedure.

Weiss has reported receiving financial support Merit Medical and Siemens Healthcare, and material support from Merit Medical and Surefire Medical. The study was also supported by the National Institute of Biomedical Imaging and Bioengineering and TriSalus Life Sciences. Several coauthors have reported receiving grants or payment from Merit Medical. A full list of disclosures is included in the article.

Radiology. Published online April 2, 2019. Full text

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