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GACE treatment

Bariatric embolisation offers “an alternative to surgery”

Weight loss in all patients at one month follow up
Additional studies recruiting larger number of patients is underway

Gastric artery chemical embolisation can be a safe and effective alternative to bariatric surgery, according to the results from the first human study to assess the procedure.

The outcomes of the Endovascular Treatment of Obesity: Early Results from First in Man Study, which were presented at the annual meeting of the American College of Cardiology in San Francisco, reported weight loss in all patients at one month follow up with mean initial weight falling from 128.12±24.4kg to 114.86±21.3kg and mean initial BMI decreasing from 42.26±6.8 to 37.86±5.7.

"If a large, randomised study shows similar results, this may be a very simple method and an alternative to bariatric surgery," said lead researcher Dr Nicholas Kipshidze, general director, Republican Hospital, Tbilisi, Georgia.

It has been previously reported that the embolisation procedure can suppress the hormone ghrelin.

Technique

Patients had a catheter placed in their groin, which was threaded through an artery until it reached the gastric fundus. BeadBlock Embolic Bead 300–500μm microspheres (Biocompatibles Ltd.) were then run through the catheter to block the artery.

The researchers noted that although blood flow to the stomach is reduced, the risk of part of the stomach dying from lack of blood is small, because these tissues get blood from other blood vessels.

To rule out significant initial gastritis, ulcer or any worsening after the procedure, they performed a gastroscopy on all patients before and after the procedure and one after the operation.

They researchers reported no peri-procedural complications. During the first few hours after the procedure, three patients complained of a slight pain in the epigastrium, but controlled gastroscopy did not reveal any impairments.

Blood ghrelin level was also measured before the procedure as well as at one, two, three and four weeks post-operation.

Results

In the first days after procedure, all patients reported significantly decreased appetite. After a month, patients lost on average 29lbs, at three months they had lost an average of 37lbs pounds and at six months the average weight loss was 45lbs.

There was also a marked reduction in ghrelin levels: at one month they had fallen 29% and by 36% at three months. However, at six months, ghrelin levels were only 18% below where they had been before the procedure. Ghrelin levels and patients' weight will continue to be monitored until 12 months.

The researchers said that the new study did not address lifestyle factors and they did not instruct patients to change their diets or exercise.

Kipshidze said that this procedure has several advantages over current weight-loss procedures, including reduced hospital stays and recovery times.

Embolisation using the BeadBlock microspheres has been used for years to treat bleeding in the intestines, reduce side effects from chemotherapy for advanced liver cancer and to treat uterine fibroids.

“Ghrelin is one of many hormones known to influence hunger and appetite, and in every prior attempt to change long-term weight outcomes by manipulating one hormone, we found compensatory mechanisms that kick in over time and the benefits tend to wear off,” said Dr David Katz, director of the Yale University Prevention Research Center. “So [the new procedure] is unlikely to prove to be an alternative to the lifestyle approaches, namely eating well and being physically active.”

Kipshidze is planning larger clinical trials where some patients - including some with diabetes - will undergo the procedure while others will have a sham procedure. In all, they plan to recruit 30 patients to ensure that the procedure is safe and effective. The procedure is also being refined with new equipment and techniques.

"The question is, will this thing work in a lot of people over a long period of time, and what's the complication rate and what's the mortality with it," said Dr Stephen Green, associate chairman of the department of cardiology at North Shore University Hospital, NY. "If this works it would be fantastic - it would be a game changer - but this is not ready for prime time."

 

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