Jefferson Neurosurgeons Using New Liquid Treatment For Wide-Neck Brain Aneurysm
Neurological
surgeons at Jefferson Hospital for Neuroscience are among the first
surgeons in the United States using an FDA-approved liquid system for
treating wide-necked brain aneurysms, which could eventually replace
current treatments.
Principal
investigator Erol Veznedaroglu, M.D., associate professor of
Neurological Surgery and director of the division of Neurovascular
Surgery and Endovascular Neurosurgery, Thomas Jefferson University
Hospital, is one of the few surgeons selected to explore the use of a
liquid embolic (blocking) system to fill wide-neck brain aneurysms,
which have a wide opening where the aneurysm arises from the artery or
blood vessel. A brain aneurysm is a weakness in a major blood vessel
that causes a portion of the vessel wall to balloon out. This
abnormality puts an individual at risk should the aneurysm break open
and bleed.
“A
wide-neck brain aneurysm is relatively uncommon and occurs in about 25
percent of persons with brain aneurysms,” said Dr. Veznedaroglu.
“Wide-neck aneurysms can be difficult to treat both surgically (brain
surgery to clip off the aneurysm) and endovascularly (treatment done
from within the blood vessel), which are methods used to treat other
types of brain aneurysms.”
“The
potential benefit of the liquid embolic system may be the complete or
partial blockage of the blood supply to the aneurysm,” said Deborah L.
August, M.D., MPH, director of Clinical Research in the department of
Neurological Surgery, Jefferson. “It may also help to correct or
lessen some symptoms.”
Current
treatments for brain aneurysms include open brain surgery to clip the
aneurysm and coil embolization or coiling, less–invasive surgical
procedure. For coiling, a catheter is inserted into an artery in the
groin, then advanced into the affected artery in the brain. X-rays are
used to guide the catheter into the artery.
“Coils
are the most commonly used embolization device but some wide-neck
aneurysms have such a large opening that the coils may not stay inside
the aneurysm sac,” said Dr. Veznedaroglu. “In this case, the coils can
fall back into the blood vessel and block or partly block the blood
flow.”
Researchers noted they are not recruiting patients, as this is not a clinical study.
Rather, this is a Humanitarian Use Device which is used to diagnose or treat a disease or condition that affects fewer than
4,000 individuals in the United States per year and for which no comparable device is available.
The
Food and Drug Administration (FDA) allows physicians to use such a
device under a Humanitarian Device Exemption, when a device maker
chooses not to do formal research studies to test a product as it would
be used to treat a smaller population of patients.
“Before
the FDA gave the exemption, it looked at facts given by the maker of
the device and decided that the likely risks of using the system are
within reason, compared to the possible benefits of using this device
and compared to other treatments for a wide neck aneurysm,” said Dr.
August. “Research studies have not been done to show whether this
system works for treating wide-neck aneurysms.”
By filling the aneurysm sac or pocket with the liquid, blood flow into the aneurysm is blocked, helping to prevent the aneurysm
from rupturing or increasing in size.
This
treatment is done endovascularly and essentially consists of inserting
a catheter into the blood vessel to cut off the blood supply. The
material is delivered by slow-controlled injection through a very
micro-size catheter into the aneurysm under x-ray visualization. The
catheter is initially inserted into a vessel in the groin area and
threaded to the vessel where the aneurysm is located. The material
enters the aneurysm as a liquid through the catheter and then begins to
solidify from the outside to the inside with final solidification or
embolization occurring within five minutes.
To be eligible for such a procedure, a patient must 18 years or older, not have an intracranial stent and/or coils or severe
liver or kidney disease. Women who are pregnant or nursing are also not eligible.
Media Only Contact:
Ed Federico
Thomas Jefferson University Hospital
Phone: (215) 955-6300
Published: 1/30/2008