A new device adds to the arsenal of Jefferson vascular neurosurgeons – the most experienced and busiest team in the greater Philadelphia region.
After a hot summer day working in the garden at the North Philadelphia boarding house owned by her parents, Belinda Cook lay down for a nap.
Two weeks later she woke up in the hospital. A series of tests at several hospitals revealed what appeared to be an aneurysm in her left internal carotid artery near the ophthalmic artery branch.
Belinda has sickle cell anemia, a condition that increases the risk of aneurysms – bulges in the weakened walls of arteries that can lead to life-threatening ruptures. And in the 56-year-old woman’s case, the aneurysm was also threatening her sight. As it grew in size, the bulging defect in the artery put pressure on her optic nerve.
It was the blurred vision that led Belinda to Jefferson Hospital for Neuroscience. That’s where she came under the care of Jefferson neurosurgeon Fernando Gonzalez, MD.
At Jefferson, new imaging scans revealed that Belinda didn’t have one, but four aneurysms on both her carotid and ophthalmic arteries. One was a massive bulge that was causing her vision problems.
But the locations of the aneurysms precluded an open surgery to repair the arteries. And because of the pressure on her optic nerve, the alternative approach from inside her arteries (endovascular) was also out; using so-called coils and a traditional stent to decrease the blood pressure on the aneurysm would not have solved the issue of the pressure on Belinda’s optic nerve.
Dr. Gonzalez knew of a third option – an unapproved stent – that he had worked with at Barrow Neurological Institute in Phoenix where he was involved in clinical trials for data to submit for U.S. Food and Drug Administration (FDA) approval for use in this country.
But those trials were completed and the new stent was not available. Unlike traditional stents – largely open wire mesh scaffolding structures designed to prop open blood vessels – the Pipeline ™ Embolization Device made by EV3 of Menlo Park, Calif., has much smaller openings to prevent blood from moving through it.
Dr. Gonzalez knew from his experience in Arizona that the Pipeline stent would be ideal for Belinda. It would seal off the four aneurysms from the arterial blood flow, reducing their outward push on the vessel walls and probably decrease the pressure on her optic nerve while preventing a life-threatening rupture.
“I hoped that it would reverse the aneurysms,” Dr. Gonzalez said. At least, he expected that the device would prevent the defects from growing larger and rupturing – a potential deadly outcome.
Belinda had no other options.
Her case was discussed with the other members of the neurovascular team, five experienced vascular neurosurgeons led by Robert H. Rosenwasser, MD, chairman of neurosurgery at Thomas Jefferson University Hospital, who are dedicated exclusively to fixing this type of problem.
The group unanimously concluded that without the Pipeline device, the best case scenario was that the aneurysms would cost the woman her sight in her left eye. The worst case was that untreated, one of the aneurysms would rupture killing the woman.
Dr. Gonzalez filed the necessary paperwork seeking FDA approval for so-called “compassionate use” of the unapproved device in his then 56-year-old patient. Two months later, the federal agency gave its approval.
Belinda Cook, a woman who struggled with sickle cell anemia for her entire life but had that condition controlled with medications, became the first patient in the Philadelphia region to get the Pipeline stent.
Armed with the FDA’s approval, Dr. Gonzalez quickly scheduled Belinda for a procedure in the interventional neuroradiology laboratory at Jefferson Hospital for Neuroscience, the only facility in the region dedicated exclusively to neurology and neurosurgery.
Dr. Gonzalez and his colleague Pascal Jabbour, MD, made a small incision in Belinda’s thigh, just below her groin. The neurosurgeons punctured her femoral artery.
Working together they sent the wire up to the iliac artery to go through the pelvis and into the aorta. They would send the needle-thin wire through 5 feet of blood vessels into Belinda’s head and the four aneurysms.
They continued to steer the guidewire through the arteries from the aorta in the abdomen to the ascending aorta around her heart and finally into the carotid artery in her neck. Then they steered the guidewire onto the left internal carotid where the ophthalmic artery branched off. That’s where the aneurysms were located.
Dr. Gonzalez then began the process of placing a Pipeline stent across the mouth of each of Belinda’s aneurysms. Each stent needed to extend across the area where the arteries bulge outward onto the unaffected artery walls on either side. There, the tubes would block flow of blood into the bulge removing outward pressure and, Dr. Gonzalez hoped, causing the aneurysm to shrink.
After the procedure, Belinda spent the night in the Hospital and was able to go home the next day.
“I felt like a queen,” the smiling woman recalled nearly one year later after a check-up with Dr. Gonzalez.
The neurosurgeon was also pleased with the results. Not only had the aneurysms not grown larger, scans of Belinda’s head showed that the aneurysms had completely disappeared.
“The artery was completely remodeled!” Dr. Gonzalez explained, excitedly showing before and after images. The experience with Belinda Cook reconfirmed what he’d seen in Phoenix working with the Pipeline device: It had the potential to be a powerful life-saving, life-altering tool added to the arsenal of neurosurgeons at Jefferson who are experts at fixing brains from inside tiny blood vessels.
And Dr. Gonzalez and his colleagues at Jefferson had plenty of patients who would benefit – the vascular neurosurgeons at the Hospital are among the busiest in the nation performing both open and endovascular procedures.
While the device awaited FDA approval for use in the U.S., the lengthy process of applying and getting compassionate use exceptions from the agency limited the surgeons’ ability to employ it to help large numbers of patients.
On April 6, the FDA unexpectedly approved the Pipeline device.
Dr. Gonzalez and his Jefferson colleagues were excited. They believe the device better arms them and gives them the ability to ensure that the right approach is employed based on the individual needs of each patient.
Experience matters, particularly with brain surgery, and Jefferson Hospital for Neuroscience is among a handful of institutions in the country with the most experience treating brain aneurysms with open surgery and using endovascular techniques, said Jefferson’s chair of neurosurgery Dr. Rosenwasser.
“The pipeline device is a very good option to treat very large aneurysms, while also preserving the blood vessel,” Dr. Rosenwasser said. “We are the only institution in Pennsylvania, New Jersey and Delaware to have used the device, and because of our experience Dr. Gonzalez and others here will be proctoring neurosurgeons at other institutions to ensure the proper use of this device.”