STANFORD, Calif.— If Barbara Maluo's brain aneurysm had been
discovered a few months ago, she would have had few viable treatment
options. She was one of the 10 to 15 percent of brain aneurysm
patients diagnosed each year with aneurysms so large and wide that
they cannot be reliably treated using conventional methods of treatment.
Fortunately, time was on Maluo's side. The discovery of a bulge in
her carotid artery came after the Food and Drug Administration
fast-tracked approval of a brand-new intracranial device called the
Pipeline stent. This week, Stanford
Hospital became the first hospital in Northern California—and one
of only two in the state—qualified to offer the Pipeline treatment
without restrictions. Maluo was one of Stanford's first Pipeline patients.
The FDA has limited the Pipeline for use on aneurysms in the
internal carotid artery, the major blood vessel supplying blood to the
front of the brain. "We know that the device is safe in certain
anatomy, like the carotid," said Michael Marks,
MD, chief of Stanford's Interventional
Neuroradiology Department. "The carotid is also one of the
most common sites for these large aneurysms to occur. As we learn
more, there may be additional applications for a device like this. But
our focus right now is treating those patients that we've had no good
Maluo was first diagnosed with the aneurysm after going to a
hospital in Hilo, Hawaii. She had reacted badly to some pain
medication and was so "loopy," she said, that doctors did a
quick brain scan on her. That's when they discovered the large bulge
in her carotid artery. Maluo's doctor sent her angiogram images by
iPhone to Marks, who examined them and realized she would be good
candidate for the Pipeline.
A few days later, Maluo was at Stanford Hospital, ready for her
procedure. Through a small incision in her groin, Marks threaded in a
catheter along a path through Maluo's blood vessels to help carry the
Pipeline to her brain.
Aneurysms occur when blood vessel walls weaken, causing them to
balloon out. People may walk around with brain aneurysms for years
without symptoms. The threat is that they will burst; the bleeding
that follows can be lethal. An estimated 6 million people in the
United States (about one in 50) have a brain aneurysm. Some 25,000 to
30,000 people every year experience hemorrhages from a burst aneurysm;
about 40 percent do not survive.
Some aneurysms are small and can be treated either by filling them
up with coils inserted through a catheter in a minimally invasive
procedure, or through neurosurgery that opens the skull, clamping them
off with clips. Some smaller aneurysms with wider necks can also be
treated with coils and stents developed especially to keep the coils
from falling into the main artery.
Others, like Maluo's, are so big and wide that coils and standard
stents are not adequate. In such cases, these traditional procedures
carry a higher risk and have a lower chance of success.
At first glance, the Pipeline looks like a standard intracranial
stent used with coils, but its distinctive design eliminates the need
for coils, which are used to fill a brain aneurysm to block blood
flow. The Pipeline's netting is braided, with 48 strands interlocked
into a dense weave. Introduced into the artery through a microcatheter
less than 0.027 inches in diameter, the Pipeline is placed to
precisely expand and cover over the neck or opening of the aneurysm.
Its braided walls diminish the flow of blood into the aneurysm,
sealing it off while still allowing blood to flow freely through the
healthy part of the artery.
The blood in the aneurysm clots, blocking the aneurysm's ability to
expand or rupture. The Pipeline allows all the blood vessels in the
area to remain functional. "You really don't want to sacrifice a
major blood vessel," Marks said.
The new device was originally developed by a Menlo Park-based
company, and its clinical success won FDA approval after just a year's
use in Europe. "It was a very fast turnaround," Marks said.
"This stent was recognized as a treatment for a group of patients
who did not have any good treatment options".
Maluo was out of the hospital quickly. "It's kind of amazing to
know that they were in there working on your brain and you're out in
two days," she said. "I am just overjoyed to get it treated
so quickly." She has since returned to Hawaii, her
life-threatening aneurysm safely sidelined.
By Sara Wykes