Tag Archives: Solitaire

Revolutionizing Ischemic Brain Management, at a Stroke

When Dr. Jeffrey Saver announced last week at the International Stroke Conference that treatment of acute, ischemic stroke patients with the Solitaire retrievable stent produced a 61% rate of complete recanalization, he predicted that this landmark result would quickly propel acute stroke management into a new era.

It sounds a bit audacious for the results of a study with 113 randomized patients to change the face of U.S. management of acute, ischemic stroke patients, but Dr. Saver laid out a compelling scenario at the meeting. In essence, it’s the right result for the right device at the right time.

MRI head scan/courtesy Wikimedia Commons/Ranveig Thattai/creative commons license

Acute stroke care in America is already poised at an important threshold. Last week, The Joint Commission, the U.S. organization responsible for accrediting health-care institutions, announced their newly crafted criteria for credentialing Comprehensive Stroke Centers. By next year, Dr. Saver predicted, 100-200 such centers will have received this designation into the highest tier of acute stroke management. He expects all these locations to treat patients with the Solitaire stent, as well as a few others. “At least 250” U.S. sites should be using it within the next couple of years, he told me. In addition, an emergency-medicine culture already exists to ambulance acute stroke patients to one of the 1,000 Primary Stroke Centers that now exist in America, use imaging to identify the ones who qualify for intravenous lytic therapy with tissue plasminogen activator (t-PA), start administering the drug, and then transfer them to a center that can apply more advanced care, a strategy know as “drip and ship.”

Having the Solitaire device takes this approach a step further, making it “drip, ship, and grip,” he told me, with grip being the step when the thrombus causing the stroke is engaged and removed.

“We stand poised at a new era, our first experience with highly effective cerebral revascularization,” he said at the meeting last week. “The open secret in our field is that t-PA or the devices now available deliver treatment that fails most of the time.” Intravenous t-PA by itself produces full recanalization in about 5% of patients, while existing devices up this to 25%; for Solitaire the rate was 61% in the new randomized study, and the rate of full or partial recanalization was 83%.

This new level of success with Solitaire will make a big difference in how widely the treatment gets used, he told me.

Dr. Jeffrey Saver MITCHEL ZOLER/Zoler/Elsevier Global Medical News

“I think motivations [to use endovascular interventions] will shift with a more reliable device. That will drive wider uptake.” He called it a “paradigm shift” and a “game changer.”

Rapid application of effective endovascular therapy “was the vision of acute stroke care that was a hazy dream when I first became a stroke neurologist 20 years ago,” Dr. Saver said. “I think that in the next few months and years it will become the reality.”

—Mitchel Zoler (on Twitter @mitchelzoler)

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Stents-on-Sticks Score for Acute Stroke

Late yesterday afternoon, I heard about the future of acute stroke treatment: retrieving the culprit blood clot with a removable stent, also known as stent retrievers, stentrievers, and stent-on-a-stick.

stent-on-a-stick; photo by Mitchel Zoler from an image shown by Dr. Aleu

Dr. Aitziber Aleu, an interventional neurologist from Hospital Germans Trias i Pujol near Barcelona, presented the combined experience from three Barcelona-area hospitals using two different brands of stentrievers to treat 89 acute stroke patients during March 2008-December 2010. This was the largest series of stroke patients yet reported who underwent this type of treatment, and a rapt, electrified audience of stroke interventionalists who heard her speak at the International Stroke Conference in Los Angeles kept her on the podium after her talk was over, peppering her with their questions.

Her most notable findings: Using an average of 1.4 passes per patient to remove the clot from a cerebral artery the stentrievers produced good blood flow, TIMI 2 or 3,  in 91% of patient, with hemorrhage occurring in 11% of patients. At 90 days after treatment, 47% had a good outcome, with a modified Rankin scale score of 2 or less, and mortality was 20%. All those numbers were either as good or better than what is routinely achieved with the main clot-removal devices now used, the MERCI clot-spearing device and the Penumbra clot-suction machine. The recannalization rate is better, the procedure time is shorter, the hemorrhage rate about the same.

“The advantage is the stents are very easy to use and they are faster, recannalizing in fewer passes,” Dr. Aleu told me. She said that the self-expanding stent quickly and effectively entangles the clot within its struts so that the clot leaves when the stent is removed.

“Stent retrievers are the next generation of tools,” said the session’s co-chair, Dr. Adnan H. Siddiqui, director of stroke and neurosurgical research at the University of Buffalo. Clot retrieval with an average of 1.4 passes “is incredible,” he said. The approved devices usually require four or five passes. He said that has used one of the two devices now in testing, the Solitaire, on about a dozen patients as part of the 200-patient, U.S.-based  SWIFT trial, which is comparing this stent retriever against the MERCI.  (The other retrievable stent used in Barcelona is the Trevo.) The stent retriever is “more maneuverable and more deliverable” than what’s out there, he told me. And he was thrilled that 47% of patients had good recoveries, with modified Rankin scores of 2 or less.

“The best results now are 40%-45% of patients” reaching this level of stroke recovery. “Fifty percent is the next target,” he said, a goal he hopes will be reached in the SWIFT trial and in other stent retriever studies now underway.

—Mitchel Zoler (on Twitter @mitchelzoler)

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