Benchmarks for Endovascular Stroke Therapy Get Their First Update in 5 Years

The last time a multisociety consensus statement setting quality metrics for endovascular therapy for acute ischemic stroke was published—in 2013—the field had not yet seen definitive evidence that the approach improved patient outcomes over standard care. But that ambiguity has since changed in a big way, triggering an update to those standards.

MR CLEAN, published at the end of 2014, was the first of several randomized trials demonstrating the safety and efficacy of endovascular therapy—typically with stent retrievers—when added to usual care that included IV thrombolysis in eligible patients. That flood of new data established endovascular therapy as the standard of care when it’s available and changed practice guidelines.

Because of advancements in the field over the last several years, there was a need to update the quality metrics, according to David Sacks, MD (Reading Hospital and Medical Center, West Reading, PA), lead author of the latest consensus statement crafted by the Society of Interventional Radiology (SIR) and 11 other professional societies.

“The devices have improved, the processes of care have improved, and we felt that it was appropriate to revise our prior quality benchmarks to reflect the new data that was available from multiple trials and multiple registries,” he told TCTMD.

Some of the expectations [are] aspirational, but we expect that they will be achieved by most places over time with attention, with work. David Sacks

Published in the April issue of the Journal of Vascular and Interventional Radiology, the document details 15 metrics covering indications for treatment, data collection, time intervals, procedural success, postprocedural imaging, and clinical outcomes.

As in the 2013 document, the key clinical outcome metric is a goal for at least 30% of treated patients to be functionally independent (modified Rankin Scale score 0-2) at 90 days.

“That number sounds low, and it is lower than in the trials and the registries, but it was based on an expectation that the procedure has become so effective that it’s going to be used to treat patients who would otherwise not qualify for the trials,” Sacks explained.

The recent randomized trials have informed changes to the key time intervals included in the consensus statement. “We now know that these patients can be treated quite fast,” said Sacks. “So we have faster expectations for the time that it takes from [when] the patient arrives in the emergency room to the time that you should be accessing the artery and the time that it takes to get the artery open. And we have higher expectations for the success rate of removing the clot and having the artery be opened.”

For example, 75% of patients being evaluated for revascularization should have imaging started within 30 minutes of arriving at the emergency department, although that time is expected to be 12 minutes at the top centers. The same proportion of patients treated with endovascular therapy should have imaging-to-puncture times no greater than 110 minutes, with the expectation that the best centers can achieve times of 50 minutes or less.

Sacks said he hopes that the benchmarks will be adopted at least in part for use in certifying stroke centers, adding that even if that doesn’t happen, individual facilities can use them to improve their processes of care and be accountable to these expectations.

“Our document would really be very well designed to be imported into accreditation programs, and I think that will improve quality of care because facilities will now know what their goals are and what they need to improve to achieve these,” he said.

“That has been a very effective approach in the speed with which interventional procedures have been performed for heart attacks, and I think that we are adopting a very similar model by letting people know what the expectations are,” he continued. “Some of the expectations [are] aspirational, but we expect that they will be achieved by most places over time with attention, with work.”

Along with SIR, the organizations involved in creating the consensus statement were the American Association of Neurological Surgeons, the American Society of Neuroradiology, the Cardiovascular and Interventional Radiology Society of Europe, the Canadian Interventional Radiology Association, the Congress of Neurological Surgeons, the European Society of Minimally Invasive Neurological Therapy, the European Society of Neuroradiology, the European Stroke Organisation, the Society for Cardiovascular Angiography and Interventions, the Society of NeuroInterventional Surgery, and the World Stroke Organization.