Transcript: Shumei Man, MD, PhD, on Shortening Door-to-Needle Times in Acute Ischemic Stroke

Christina Vogt: Hello everyone, and welcome back to another podcast. I’m Christina Vogt, associate editor of the Consultant360 Specialty Network. Today, I’m joined by Dr Shumei Man, who is a neurologist at the Cleveland Clinic in Ohio. Thank you for joining me today, Dr Man.

Dr Man: Thank you for inviting me.

Christina Vogt: Today, we’ll be discussing her recent study, “Association Between Thrombolytic Door-to-Needle Time and 1-Year Mortality and Readmission in Patients With Acute Ischemic Stroke,” which was recently published in JAMA. So first, what prompted you to conduct this study on the association between thrombolytic door-to-needle time and 1-year mortality and readmission among patients with acute ischemic stroke?

Dr Man: Thank you for the question. First, thank you for the interest and giving us the opportunity to talk about this study. Where we designed this project, we realized that it remains a knowledge gap and an important question whether shorter door-to-needle times for intravenous thrombolytic therapy translates to better long-term outcomes.

Randomized clinical trials have shown that intravenous thrombolytic therapy if administered within 4.5 hours of stroke onset can improve functional outcomes at 3 months. Earlier administration of tPA was associated with reduced in-hospital mortality and better functional outcomes at discharge and 90 days. So how to provide faster thrombolytic treatments–we cannot control when the stroke happens and when the patient can be noticed to have a stroke. Door-to-needle time is directly under the control of the stroke care teams and has been used as a target for quality improvement by the American Heart Association/the American Stroke Association Target Stroke National Quality Initiatives.

However, it remains unclear whether shorter door-to-needle times translates to better long-term outcomes and survival benefits. In order to address this question, we designed this study to examine the association of door-to-needle times for IV tPA with all-cause mortality, all-cause readmission, the composite of mortality and readmission and the cardiovascular readmission at 1 year after acute ischemic stroke. To do so, we had to link Get With the Guidelines Stroke Registry with Medicare files.

Christina Vogt: The results of your study showed that shorter door-to-needle times were associated with lower all-cause readmission and lower all-cause mortality at 1 year in the study population. What are some potential efforts or interventions that could help shorten door-to-needle times?

Dr Man: Well, historically, up until 2010, only a quarter of IV tPA was given within 60 minutes of hospital arrival, meaning door-to-needle times less than 60 minutes. So, for the past many years, people and institutions across the country involved in caring for stroke patients and organizing stroke systems of care have been putting out tremendous efforts to shorten door-to needle times. The most well-designed and carried out national effort is Target Stroke quality initiative. That was launched in January 2010 by the American Heart Association/American Stroke Association, which came with both strategies and award system.

The initial goal of Target Stroke was for participating hospitals to achieve door-to-needle times within 60 minutes in at least 50% of their patients. To achieve these goals, Target Stroke provided participating hospitals with best practice strategies, supporting tools, and educational resources necessary to improve the timelines of tPA administration to eligible patients.

An expert working group performed a systematic review of the published data on improving door-to-needle times and identified the 10 best practice strategies that could be very rapidly, feasibly, and cost-effectively adopted by participating hospitals. The initial strategies included advanced hospital notification by emergency medical service, rapid triage protocol and stroke team notification, single call activation system, specific script protocols and tools, rapid acquisition and the interpretation of brain imaging, rapid laboratory testing, rapid access to tPA, pre-mixing TPA ahead of time, a team-based approach, and providing prompt feedback to the stroke team on performance.

With the success of the first stage of Target Stroke, the AHA launched Target Stroke phase 2 in April 2014 to continue improving door-to-needle times. The primary goal of Target Stroke phase 2 was for hospitals to achieve door-to-needle times within 60 minutes in at least 70% of patients treated with IV tPA, and door-to-needle times within 45 minutes in at least 50% of patients. The Target Stroke phas 2 identified and disseminated new strategies for more rapid in-hospital management in our patients receiving tPA.

So, Target Stroke has helped hospitals nationwide achieving improved stroke outcomes. So, reduced door-to-needle times for eligible patients. Hospitals across the country have been utilizing these strategies to create, exam, and improve their unique process and best practice strategies to shorten door-to-needle time. Mobile stroke units also created an innovative pathway to deliver IV tPA onsite with further accelerating thrombolytic treatment timelines. This is an achievement, as well as an opportunity. Previous studies have shown that there are still opportunities in implementing the strategies that were most strongly associated with shorter door-to-needle times such as direct transport to CT or MRI scanner by EMS, pre-mix of tPA ahead of time, protocol for routine for remixing of tPA, initiation of tPA in the brain imaging fluid, CT scannesr physically located in the ER and a timer or clock attached to track time.

Christina Vogt: What key takeaways do you hope to leave with neurologists on this topic?

Dr Man: The key takeaway is that the effort in shortening door-to-needle times pays off in the form of reducing death and readmission, in addition to improving functional outcomes for stroke patients. Ischemic stroke patients treated with IV tPA with door-to-needle times of 45 minutes and less had a lower all-cause mortality and all-cause hospital admission than patients with door-to-needle times longer than this target. This study supports further effort to shorten door-to-needle times.

Christina Vogt: What is the next step in terms of future research in this area?

Dr Man: There are still many important questions in stroke management that need to be addressed by research and high-quality data. Some of them can be and need to be addressed by clinical trials, but many questions cannot be answered by clinical trials, like the current study. So, an accurate and well-validated real-world database is irreplaceable, along with a well-designed and non-biased analysis. It can answer many clinical questions in a timely and cost-effective fashion that otherwise cannot be answered by clinical trials. I think we should continue to improve the utilization of real-world data.

We are fortunate to have the national stroke registry Get With the Guidelines Stroke, an ongoing registry that collects patient-level clinical data, including demographics, medical history, acute stroke treatment and complications, and in-hospital outcomes of patients with acute ischemic stroke or TIA.

In order to obtain longitudinal outcomes after the hospital discharge, my colleagues at Get With the Guidelines Stroke and Duke Clinical Research Institute have successfully linked Get With the Guidelines Stroke with Medicare files, as have been used in this project. This resource is invaluable for stroke research and quality improvement because it allows us to study the longitudinal outcomes years after stroke hospitalization, even home times, across functional outcomes. Because both Get With the Guidelines Stroke Medicare database are an ongoing data collection, we can study the most concurrent practice and treatment. However, Medicare only covers patients aged 65 years and older. The results in older patients may not apply to younger patients.

We have seen a decrease in stroke incidence among elderly, but up to a 45% increase among young patients. In order to conduct longitudinal studies or younger stroke patients, we need post-discharge data from other sources. Younger patients tend to use commercial insurance, but we have not been able to acquire a commercial insurance database that we can link with Get With the Guidelines Stroke. I think that question needs to be solved in the future, too.

Christina Vogt: Thanks again for joining me today. Dr Man.

Dr Man: Thank you for inviting me.

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