Gastric Artery Embolization for Weight Loss

by:
Mubin I. Syed, MD, FACR, FSIR
President, Dayton Interventional Radiology
Clinical Associate Professor of the
Radiological Sciences
Wright State University School of Medicine
*Financial Disclosure: Partial funding for above study provided by 2015
SIR Foundation Pilot Research Grant and 2016 RSNA Seed Research
Grant. No other relevant financial relationships.
Mubin Syed, M.D.
• No relevant financial relationship reported
2008: 1.5 billion overweight; 500 million obese
(1 in every 8)
 Major risk factor for diabetes, heart attacks,
stroke, cancer, osteoarthritis
- Increases risk of diabetes 18-fold
 Fifth leading risk for death globally
 Ex. 25 year old morbidly obese loses 12 years
(on average)
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The number of obese people in the world rose
from 105 million in 1975 to 641 million in 2014,
with obesity rates rising from 3 percent to 11
percent among men and from 6 percent to 15
percent among women, the study found.
The researchers added that about one-fifth of
adults could be obese by 2025.
Over the same time, the proportion of
underweight people fell from 14 percent to 9
percent of men and from 15 percent to 10
percent of women, according to the study
HEALTH: http://news.health.com/2016/03/31/more-of-the-worlds-people-are-now-obese-than-underweight/. Accessed April 14, 2016.
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1 in 10 American adults has diabetes (if the
trends continue, the number of people with
diabetes is expected to double or even triple by
2050.
Every 5 minutes, 2 people die from diabetes
and 14 are newly diagnosed.
90% - 95% of all diabetes cases are type 2
86 million adults in the U.S. who had
prediabetes in 2012
http://www.healthline.com/health/diabetes/facts-statistics-infographic#3
Diet / exercise
- Difficult to sustain
 Medications
- Average wt. loss: 6-10lbs
 Surgery…
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Average weight loss: 88lbs (sustained)
Diabetes: 77% resolved
Hypertension: 62% resolved
Sleep apnea: 86%
Hypercholesterolemia: 87% improved
Effects of obesity…
Major Abdominal Surgery
 Mortality: 1-2%
 Wound complications: 7%
 Hernias: 9%
 Esp high risk:
-Extreme obesity
-Co-existing medical conditions
 Need an alternative for surgery!
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Pioneered by Aravind Arepally, MD
Concept: Interventional radiologist can
decrease cells by limiting the blood supply
Most ghrelin secreting cells in the fundus
Interventional radiologist are experts at finding
and targeting specific arteries.
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What is it?
How does it work (metabolism, site of action)?
Where is it produced?
What treatments are currently being developed
to target Ghrelin?
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Vaccine (etc. refer to Monteiro talk)
How would Bariatric embolization work
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40 year old procedure. First described in the early
1970’s.
The left gastric artery is embolized typically with a
“gel-foam slurry” and coils – If necessary.
The procedure is used for life-threatening hemorrhage
from the gastric fundus and gastro esophageal
hemorrhage not controllable by endoscopic
intervention.
Currently is the standard of care as an “on call”
procedure for Interventional Radiology.
Procedure takes 20 minutes.
Safe and effective.
RSNA Press Release - Embolization Procedure
Aids in Weight Loss
• In the retrospective study conducted at Massachusetts
General Hospital in Boston, researchers reviewed the
records of patients who underwent transarterial
embolization for upper gastrointestinal (GI) bleeding. The
study group included 14 patients who underwent
embolization of the left gastric artery, which supplies blood
to the part of the stomach where the hormone ghrelin is
predominantly produced.
• "Ghrelin is the only hormone known to stimulate the
appetite, so it is an intriguing potential target for combating
obesity," said senior researcher Rahmi Oklu, M.D., Ph.D.,
assistant professor of radiology at Harvard Medical School.
"Animal studies have shown that when this artery is
blocked, blood levels of ghrelin decrease and weight loss
occurs."
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The study also included a review of the records of 18 age-matched control patients
who were treated for upper GI bleeding with transarterial embolization of a
different upper gastrointestinal artery. The study group included eight men and
six women with a median age of 66.1 years; the control group included eight men
and 10 women with a median age of 63.5 years.
The researchers found that patients who underwent left gastric artery embolization
lost an average of 7.9 percent of their body weight within three months of the
procedure. Weight loss within the control group was 1.2 percent during the same
time frame.
"Embolizing the left gastric artery may be a potential bariatric treatment for weight
loss and an alternative to other invasive procedures," Dr. Oklu said. "This is an
important data point in the development of a new clinical tool for the treatment of
obesity."
Dr. Oklu pointed out that left gastric artery embolization performed by an
interventional radiologist is low risk when compared to more invasive weight loss
interventions, such as gastric bypass and laparoscopic approaches.
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Kipshidze – "It's a one day surgery. You can do the
procedure on patients in the morning and send them
home in the evening."
The study included just five people. All were obese; the
average body mass index (BMI) was 42.3 kg/m2, with a
range of 33.9 kg/m2 to 52.8 kg/m2. Researchers used
an endoscope to examine each person's esophagus and
stomach before and after the procedure, as well as one
week later. No ulcers or other complications occurred.
Three people had discomfort during the first few hours
after the procedure, but the endoscopy did not show
blockages or other complications.
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One month after bariatric embolization, the
average BMI dropped to 37.9 kg/m2, with an
average weight loss of 29.2 pounds. After three
months, the average BMI was 36.7 kg/m2 and the
average total weight loss was 37 pounds. At six
months, the average BMI was 35.3 kg/m2 and
average total weight loss was 45.1 pounds.
Blood ghrelin levels also dropped. At one month,
levels had fallen 29 percent from baseline (p<0.05).
At three months, they were 36 percent below
baseline (p<0.05). At six months, they were 18
percent below baseline (p>0.5).
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Currently there are 3 active FDA supervised
studies enrolling human patients in the USA
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GET LEAN (Gastric Artery Embolization Trial for the
Lessening of Appetite Nonsurgically), Dayton, Ohio,
300-500 u Beadblock
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BEAT Obesity (Bariatric Embolization of the Arteries
for the Treatment of Obesity), Baltimore, MD and NYC
300-500 u Embospheres
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Albany Study, Albany NY 500-700 u PVA
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Beat Obesity (Bariatric Embolization of the Arteries for
the Treatment of Obesity)-presented by Dr. Clifford
Weiss, Johns Hopkins University SIR 2016
Weight loss at 1 mos
Weight loss at 6 mos
 10.3 lbs
 7.1% EWL
21.0 lbs
13.4% EWL
Weight loss at 3 mos
N=7
 14.8 lbs
 10.1% EWL
 17.5% Ghrelin drop
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300-500 u Embospheres
EWL=(BL-post)/BL-IBW)*100
Devine formula for IBW (1974)
Reprinted with permission from Clifford Weiss,MD
GET LEAN (Gastric Artery Embolization Trial for Lessening of Appetite
Nonsurgically)- PI: Mubin Syed, Dayton Interventional Radiology
Weight loss at 1 mos
 13.5 lbs
 5.3%
 10.6% EWL
 Weight loss at 3 mos
 16.8 lbs
 7.0%
 14.3 % EWL
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Weight loss at 6 mos
 20.25 lbs
 8.5 %
 17.2% EWL
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EWL=(BL-post)/BL-IBW)*100
Devine formula for IBW (1974)
N=4 (300-500 u Beadblock)
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All patients subjectively reported appetite suppression
Kipshidze
University
Hospital
Number
Follow-up
Total
Weight Loss
Mean
Minor
Adverse
Events
Major
Adverse
Events
CV Center,
Frankfurt,
Germany
DIR, Dayton,
OH
John
Hopkins
university
St. Ekaterina
Hospital,
Odessa, Ukraine
Center for Laser
and Interv. Surg.
Beirut,
Lebannon
Total
5
1
4
5
1
12
16
24 mos
20 mos
6 mos
6 mos
2 mos
1-9 mos
224mos
16%
12%
8.5%
8%
9%
1-1.5kg/mos
10%
0
0
3
2
1
2
6(
37.5%)
0
0
0
0
0
0
0
Reprinted with permission
from Nicholas Kipshidze,
MD
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Morbid obesity with a BMI ≥ 40
Age ≥ 22years
Ability to lay supine on an angiographic table
<400lbs due to table weight limits
Appropriate anesthesia risk as determined by certified anesthesia
provider evaluation pre procedure
Subjects who have failed previous attempts at weight loss through
diet, exercise, and behavior modification (as it is recommended that
conservative options, such as supervised low-calorie diets combined
with behavior therapy and exercise, should be attempted prior to
enrolling in this study).
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Major Surgery within the past eight weeks
Previous gastric, pancreatic, hepatic, and/or splenic surgery
Previous radiation therapy to L or R upper quadrant
Previous gastric, hepatic, and/or splenic embolization
Any history of portal venous hypertension
Serum creatinine > 1.8 mg/dL
History of kidney problems
Pregnant or intend to become pregnant within 1 year
History of Severe bleeding (platelet count less than 40,000)
Enrolled in another study
History of allergic reaction to iodinated contrast
Abnormal baseline studies (gastric emptying, CTA, EGD, etc)
Active substance abuse or alcoholism
Hiatal Hernia
Known aortic disease, such as dissection or aneurysm
…
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Defined noncompliance with previous medical care
Subjects with mesenteric atherosclerotic disease or abdominal
angina should be excluded due to safety concerns.
Comorbidity such as cancer, peripheral arterial disease or other
cardiovascular disease
Patients with any abnormality on their baseline EGD
Patients taking anti-coagulants
Patients taking or requiring chronic use of NSAID or steroid
medications
Patients with any history of peptic ulcer disease
Certain psychiatric disorders such as schizophrenia, borderline
personality disorder, and uncontrolled depression, and
mental/cognitive impairment that limits the individual’s ability
to understand the proposed therapy
PLEASE note that GET LEAN does not exclude diabetics and
does not exclude patients with H. Pylori (50% of the population)
and currently does not exclude anatomic variants
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Femoral or radial artery access
Pigtail catheter for flush aortogram
Reverse curve catheter to access celiac artery
followed by the left gastric artery
Coaxial microcatheter for selective left gastric
arteriogram past esophageal branch
Particle embolization using BeadBlock 300-500
micron to stasis (at least 5 cardiac pulsations)
Closure device
60
50
40
30
20
10
0
CH1190
THO6761
CRA1984
ADK1970
60
50
40
Baseline
6 months
30
20
10
0
CH1190 ThO6761 CRA1984 ADK1970
CH1190
THO6761
CRA1984
ADK1970*
Pre
691
543
391
822
1 Week
803
1,046
480
1096
1 Month
822
563
457
813
3 Month
1084
895
331
751
6 Month
961
598
354
668
6 mos %
39.1%
10.1%
-9.5%
-18.7%
939
538
1 Year
CH1190
THO6761
CRA1984
ADK1970*
Pre
22.7
26.7
37.2
17.3
1 Week
12.3
18.6
19.5
15.9
1 Month
7.8
21.7
26.8
10.5
3 Month
7.7
34.7
16.2
13.6
6 Month
7.0
46.8
14.7
10.0
% change
-69.16%
75.28%
-60.48%
-42.20%
All patients who lost weight dropped Leptin levels
1 Year
4.0
CH1190
THO6761
CRA1984
ADK1970*
Pre
80
10
22
66
1 Week
36
107
38
99
1 Month
68
21
47
26
3 Month
88
97
31
38
6 Month
76
20
15
21
% change
-5.00%
100.00%
-31.82%
-68.18%
1 Year
47
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Serum Ghrelin
+8.68%+/- 34.74% at 1 month
-17.49 +/- 29.98% at 3 months
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QOL parameters trend toward improvement
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Hunger appetite scores markedly decreased at
2 weeks post BE and remain suppressed
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GET LEAN study
3 patients with superficial ulcerations by 3 day
endoscopy
 All healed by 30 day endoscopy
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BEAT OBESITY
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3 minor adverse events
 Subclinical transient pancreatitis
 2 patients with superficial ulcerations healed by 2 and 3
weeks respectively
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Maybe: Still in Phase 1 pilot study
Criteria
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Proper patient selection
 Inclusion/exclusion criteria
 Motivation is key
 Ability to exercise and be active post procedure
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BMI range
 Presently BMI >40 in future possibly >35 with
comorbidities similar to bariatric surgery
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Exclusion criteria
 Exclude patients who are depressed or on
antidepressants
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48 lbs lost or
49% EBW
equivalent
to surgical
outcome at
one year
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Radial artery access is feasible and may have huge
potential
Bariatric embolization may have a possible role in morbidly obese
diabetic patients
Normal Hgb A1C-4.5 to 6.0
Prediabetic Hgb A1C- 5.7 to
6.4
Diabetic HgbA1C- >6.5
7.6
7.4
7.2
7
6.8
6.6
ADK1970
6.4
6.2
6
5.8
5.6
Baseline
1 month
3 months
6 months 12 months
All 4 patients were performed in the GET LEAN study at a
free standing center
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Durability not known (possible upregulation in
other parts of stomach and GI tract)
Role of mental component (complexity of human
emotional responses that effect food consumption)
Anatomic variability (size and supply area)
Side effect potential with ghrelin reduction
Ulcer risk with potential for nonhealing (role of H.
Pylori)
Risk of potentially limiting future gastric sleeve
surgery
Ideal patient is not yet defined (BMI etc.)
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Bariatric embolization, or gastric (stomach) artery
embolization promising treatment for obesity
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Can be done outpatient
Potential for major weight loss equal to surgery
Diabetic patients may be candidates
Wrist artery access
Still too early for RCT
Need to improve effectiveness without increasing
risk (lower BMI, and smaller particles)
Procedure is safe is short and intermediate term
Appears to be effective in the short and
intermediate term.
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Continuation of the FDA trial with additional
patients
Including further experience with radial artery
access and diabetic patients
Possible use of alternative embolic agents
(smaller size)
Randomized control trial
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Procedure still experimental
Still in infancy and being done only context of
clinical trials at this stage