Article Archive
January/February 2013

Promising Intervention for Stroke Patients

By Lindsey Getz
Aging Well
Vol. 6 No. 1 P. 10

Although stroke is the fourth leading cause of death and a common cause of long-term disability in the United States, there have been few proven treatment options until recently. A new FDA-approved device developed at the UCLA Stroke Center has shown significant success in limiting disability in this patient population and may eventually impact the grim stroke-related statistics.

The Device
The SOLITAIRE Flow Restoration Device is a self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia. In the recent Solitaire With the Intention for Thrombectomy (SWIFT) study, SOLITAIRE dramatically outperformed the standard mechanical treatment achieved with the Merci Retrieval System device.

“Pulling clots out is not a new idea,” says Reza Jahan, MD, an associate professor of radiology at UCLA and the study’s principal neurointerventional investigator, who also led the preclinical studies. “There have been clot grabbers in the past that have used the same general concept, but this device just does it so much better. When we tested against the Merci device, it was a significant difference.”

Compared with the Merci device, “Initial treatment with the SOLITAIRE device is associated with more frequent reperfusion, less symptomatic intracranial hemorrhage, reduced mortality, and increased good final neurologic outcome three months after stroke,” says Jeffrey L. Saver, MD, lead study author and a professor of neurology and the director of the Stroke Center at UCLA’s Geffen School of Medicine.

Study Success
In fact, the effectiveness of the SOLITAIRE device resulted in the premature end of the SWIFT study. Stroke patients in the study were randomly assigned to be treated with either the SOLITAIRE or the Merci device. Only 2% of SOLITAIRE-treated patients had symptoms of bleeding in the brain compared with 11% of Merci patients. And 58% of SOLITAIRE-treated patients had good mental/motor functioning at a 90-day follow-up compared with 33% of Merci patients.

When used as the first treatment approach, the SOLITAIRE device opened more vessels, necessitating fewer subsequent intervention attempts with other devices or drugs. Therefore, at the suggestion of a safety monitoring committee, the trial was ended nearly a year earlier than planned due to significantly better outcomes.

“What is unique about this device is that when you deploy it, it compresses the clot, immediately reestablishing blood flow,” Jahan explains. “None of the other devices do that. As you unsheathe the device from the catheter it is confined in, it will expand to its diameter, which is a maximum of 4 mm. The fact that blood flow can be established immediately may be beneficial in ultimately improving patient outcomes. The SOLITAIRE device has the ability to reopen clogged arteries fast, and when it comes to a stroke patient, time is critical. Once the device is expanded and compresses the clot, it will also dig into it, grabbing on to it and allowing the physician to then pull it out.”

Jahan says the device also is easy to use. The SOLITAIRE device is inserted into a blocked artery using a thin catheter and, as it travels through the artery, compresses and traps the clot through its self-expanding, stentlike design. The clot is then removed when the device is withdrawn, reopening the blocked blood vessel.

“The device is easy to use because the principles of use are identical to other devices that physicians have used, although for different reasons,” Jahan explains. “For example, this is essentially stent technology, and we’ve been doing stenting in the brain for years. Physicians are already familiar with the technology of putting a stent across the narrowing of a blood vessel in the brain. The technique is identical except that you’re deploying the stentlike device to remove a clot.”

Identifying Appropriate Patients
While there isn’t much doubt that the device is easy to use and superior to previous devices, the big question remains: Which patients are the best candidates for its use? “You’d think the answer would be everybody, but the truth is there are patients who haven’t gotten to us in a reasonable amount of time who will not benefit from reopening the clogged artery,” Jahan says.

“The damage is already done, and you are not helping anything by reopening that clogged artery, which is already dead,” he says. “So the controversy right now is who to treat—and who not to treat—and we’re currently doing a follow-up trial to best answer that question. The SWIFT PRIME study will determine which patients can be best treated by SOLITAIRE and will also take a closer look at the financial benefit of treating patients with the device. We have to assume that getting arteries unclogged faster and producing a better outcome will also bring cost savings, but we’re going to take a closer look at that with this new study.”

The SOLITAIRE device has repeatedly been called a game changer. Saver told Neurology Reviews that the device will save lives. “For the first time, we have a highly effective recanalization device, similar to what the cardiologists are able to do for acute myocardial infarctions,” he said.

“We’re really excited about this,” Jahan adds. “Even though the device is pretty new, I can’t imagine physicians going back to the old device once they’ve used this. Studies have proven it’s far better, and there’s no reason to use something else.”

While the device’s initial release was limited to ensure physicians were comfortable with its use, it is being manufactured and is now available.

“Whenever you have a new device, there are three key questions to ask: Does it do what it’s supposed to do? Is it safe? And is it easy to use?” Jahan says. “With the SOLITAIRE device, the answer to all of those questions is yes. It’s a superior product that does a better job of removing clots, has far less complications than the old device, and is very easy to use. This is a game changer for stroke patients.”

— Lindsey Getz is a freelance writer based in Royersford, Pennsylvania.