Physicians Regional finding success with new treatment for aneurysms
NORTH NAPLES (February 25, 2012 by Naples Daily News) -- Deborah Abraham spent what seemed like years coping with excruciating headaches.
Today she's got her life back, after becoming the first patient at Physicians Regional Medical Center-Pine Ridge, to undergo a new treatment for large and wide-necked brain aneurysms.
Until now, large aneurysms that are wide at the opening have defied conventional methods of treatment. That leaves patients at risk for rupture and can lead to debilitating strokes or death.
The new treatment, called Pipeline embolization, received U.S. Food and Drug Administration approval last year.
Dr. Brian Mason, an endovascular surgeon at Physicians Regional, has been trained in using the Pipeline device, marketed by Covidien, based in Mansfield, Mass."The Pipeline has been in use in Europe for two years," Mason said.
Physicians Regional spent $5 million to build a hybrid operating room for its Neurovascular and Stroke Institute. Mason is the institute's medical director.
The hybrid operating room is for endovascular procedures, like the Pipeline, which can be converted without delay if the surgeon has to switch to a traditional craniotomy to access the brain, said Taylor Hamilton, Physicians Regional's spokeswoman.
"You don't have to lose any time," she said.
In its list of top game-changing medical technologies for 2012, Cleveland Clinic Ohio includes the Pipeline device although the medical center doesn't specifically name it. Cleveland Clinic describes it as a "remarkable" new device.
"It's been estimated that over the next five years, approximately one fourth of worldwide aneurysm treatment procedures could be eligible for treatment with this device," according to a Cleveland Clinic publication for an upcoming conference in October.
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Abraham, of Port Charlotte, spent several years, with fruitless results, to get treatment for her headaches.
"It was intense throbbing, the whole right side of my face would get numb," she said. "The pain was in the back of my eye. It felt like there was glass in my eye."
In 2005, tests showed she had an aneurysm, a weak spot in the wall of a vessel where a sac or pouch forms.
An estimated six million Americans have an unruptured brain aneurysm, or one in 50 people, according to the Brain Aneurysm Foundation, located in Hanover, Mass. Ruptured brain aneurysms are fatal in about 40 percent of the cases.
Traditional "open" surgery was ruled out for Abraham because of the aneurysm's location. A coil embolization to prevent blood flow to the aneurysm didn't work.
That's a catheter-based technique to deploy soft platinum coils in the aneurysm to prevent blood flow into it.
"The neck of the aneurysm was so large," she said. "The coil, it spit it right out."
She and her husband, Lew, were at a loss.
"We did not know if it was going to burst," he said.
Abraham was referred to specialists at Shands Hospital at the University of Florida in Gainesville with no luck. After the couple moved to Virginia, she went to specialists at the University of Virginia in Charlottesville.
"There was so much swelling in my head, they couldn't see anything," she said of the doctors at Virginia. "It looked like my aneurysm had grown."
After the couple moved back to Port Charlotte last year, they learned about Mason. Then her appendix burst and she spent six days in the hospital.
By last fall, she'd had enough of the headaches and made the appointment with Mason.
"The headache attacks would last for hours and the next day I was still sore," she said.
Mason performed the Pipeline embolization on Jan. 11. It's a catheter-based treatment similar to coil embolization but instead of soft platinum coils, the Pipeline device is a braided tube mesh device.
"It looks like a Slinky," he said, referring to the child's toy.
The Pipeline is placed across the aneurysm neck so blood flow is diverted away from the aneurysm.
"The aneurysm clots up and shrinks," Mason said. "For eight weeks to six months, we keep the patient on a blood thinner."
Abraham's procedure took about an hour; she was sedated and spent one night in the hospital.
"It is just another thing we have in our arsenal for patients who can't be treated with coils," he said.
There are limitations; the Pipeline cannot be used on ruptured aneurysms."Pipeline is for elective procedures now," he said.
Covidien, the manufacturer, reported during a clinical trial with 108 patients that its success rate was 82 percent with complete occlusion after six months.
The device is for adults only for large and wide-necked aneurysms in the internal carotid artery, said David Young, spokesman for Covidien Vascular Therapies. To date, 130 physicians in the U.S. have started using it.
So far, Mason has done a handful of Pipeline embolizations at Physicians Regional since the beginning of the year.
Abraham still has some residual pain. Mason has told her the pain should go away.
"I feel great," she said. "I know it is not growing.
"I just feel the other doctors were stumped," she added. "Nobody knew what to do with me. Without this Pipeline, I don't know what they could have done."