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.
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.
"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)