Obesity Clinical Trial
Official title:
Transradial Selective Catheterization of the Celiac Artery in Obese Patients: A Pilot Study
BACKGROUND:
- Obesity, with its associated comorbidities, is set to become a major risk factor for
cardiovascular disease in the 21st century. To this day, diet and medical therapy have
proven only limited efficacy and bariatric surgery remains the last resort for many
severely obese patients who wish to lose weight, modify their cardiovascular risk
factors and ultimately modify their long-term prognosis. However, bariatric surgery
remains associated with significant procedural morbidity and many patients are not
eligible for such a surgery procedure as the risk-benefit ratio of bariatric surgery in
severe obese patients with coronary artery disease is not yet well known.
- Recently, percutaneous left gastric artery embolization has been reported as a promising
technique leading to a body weight loss that is equivalent to bariatric surgery.
- In the context of an endovascular procedure in obese patients, vascular access is a
major concern. Transradial access (or radial artery approach) has been consistently
associated with significant reductions in access-site related vascular complications and
peri-procedural bleeding compared to the standard transfemoral access (or femoral artery
approach). This is particularly evident in patients with severe obesity.
- Visceral arteries most often have an acute angulation with the aorta which makes them
more easily cannulated from above (transradial access) compared to below (transfemoral
access). Preliminary experience has shown that cannulation of the celiac artery is
feasible from transfemoral and transradial access, the latter being associated with
shorter procedural time and less contrast agent use. To date, several pilot studies have
reported successful percutaneous embolization of the left gastric artery with
biodegradable microspheres. This appears to be a promising technique to reduce weight in
severely obese patients.
- Prior to launching a randomized trial, further study is warranted regarding the
feasibility and safety aspects of transradial angiography of the celiac artery.
RATIONALE:
- A significant proportion of patients referred to IUCPQ-UL catheterization laboratory are
overweight (body mass index >25 kg/m²).
- Ongoing research and early clinical experience suggest that embolization of the left
gastric artery could drastically reduce ghrelin levels and be associated with
significant weight loss.
- In obese patients, catheterization using femoral artery access is associated with higher
risks of vascular complications and peri-procedural bleeding compared to a radial artery
approach.
- Given the anatomy (angle) of the celiac artery, selective catheterization of the celiac
and left gastric arteries remains challenging, especially in obese patients.
- Before studying the effects of bariatric embolization, more data regarding the access of
the left gastric artery is necessary.
HYPOTHESES:
- Transradial angiography of the celiac artery/left gastric artery is feasible and safe.
- Given the angulation of celiac artery, catheterization through a radial approach could
be simpler.
- Selective angiography of the celiac artery and the left gastric artery can be performed
in the setting of uncomplicated coronary angiography/percutaneous coronary intervention
(PCI).
- Detailed anatomy of the celiac artery and its branches can be visualized by selective
transradial angiography.
OBJECTIVES:
- The primary objective is to demonstrate the feasibility and safety of performing
selective angiography of the celiac artery using a transradial approach in obese
patients referred for diagnostic coronary angiography and/or PCI.
- The secondary objective is to observe anatomical variations of the celiac artery and the
left gastric artery.
STUDY DESIGN:
➢ A prospective pilot study performed at Quebec Heart & Lung Institute (Institut
Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval; IUCPQ-UL).
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