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BACKGROUND: CEREBRAL ANEURYSMS
| Cerebral aneurysms are present in one to six percent of the American population. They pose a health risk because of their potential to rupture and bleed into the brain. Industry sources estimate that 30,000 patients are diagnosed with ruptured cerebral aneurysms each year in the United States. Embolic coiling is currently being used to treat approximately 30% of patients diagnosed with cerebral aneurysms in the United States. Industry sources also indicate that a significant percentage of patients diagnosed with cerebral aneurysms in European countries are treated using embolic coiling procedures and we believe that embolic coiling procedures can be used to treat a similar percentage of patients with cerebral aneurysms in the United States as awareness grows among patients and physicians of the advantages of embolic coiling. |
 |
Since the early 1990's cerebral aneurysms have been treated using an endovascular
technique. In this procedure, an interventional radiologist guides a catheter
from the femoral artery, up through the aorta, and into the cerebral vasculature
either via the carotid or vertebral artery until it reaches the aneurysm.
Coils are threaded through the catheter until the aneurysm is packed with
enough coils to prevent blood flowing into it. This
process is called embolization.
There
has now been a significant series of published journal articles written by
medical experts regarding the use, safety, efficacy and complications relating
to treatment of cerebral aneurysms using endovascular techniques to place
embolic coils1,2,3,4,5,6,7,8,9,10,11,12,13. The use of detachable embolic coils in the
treatment of aneurysms has been specified to have a low incidence of complications10, and have a comparable
patient outcome to surgical methods13.
This is not, however, to mean that the procedure is without reported risk
or complication. The following surgical complications were reported: Incomplete
occlusion of the aneurysm4,5,7,8,9,13, re-rupture of the aneurysm during placement
of the coils5,6,7,9,12, thromboembolism4,5,6,7,9,12,
vasospasm3,12, requirement for additional patient interventions
at a later date6,8,13, and re-bleeding at a future date4. The complications related to thromboembolism
may be explained by the hypercoagulable state of patients who are in acute
subarachnoid hemorrhage12.
In no instances did the authors consider decreased use of embolic coiling
for the treatment of aneurysms due to surgical or post-surgical risks or complications.
On the contrary, all authors reported on the potential benefit of this treatment,
especially for patients who were not candidates for surgery. It appeared to
be the belief of all that endovascular coiling to treat aneurysms would be
expanded due to the positive patient outcomes, the strong potential benefits
to the patient, and the low or acceptable level of risk.
(to view complete list of references click here )
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