Optimal Workflow and Process-Based Performance Measures
for Endovascular Therapy in Acute Ischemic Stroke
Analysis of the Solitaire FR Thrombectomy for Acute Revascularization Study
Bijoy K. Menon, MD; Mohammed A. Almekhlafi, MD, MSc; Vitor Mendes Pereira, MD, MSc;
Jan Gralla, MD; Alain Bonafe, MD; Antoni Davalos, MD; Rene Chapot, MD; Mayank Goyal, MD;
on behalf of the STAR Study Investigators
Downloaded from http://stroke.ahajournals.org/ by guest on June 15, 2017
Background and Purpose—We report on workflow and process-based performance measures and their effect on clinical
outcome in Solitaire FR Thrombectomy for Acute Revascularization (STAR), a multicenter, prospective, single-arm
study of Solitaire FR thrombectomy in large vessel anterior circulation stroke patients.
Methods—Two hundred two patients were enrolled across 14 centers in Europe, Canada, and Australia. The following
time intervals were measured: stroke onset to hospital arrival, hospital arrival to baseline imaging, baseline imaging to
groin puncture, groin puncture to first stent deployment, and first stent deployment to reperfusion. Effects of time of
day, general anesthesia use, and multimodal imaging on workflow were evaluated. Patient characteristics and workflow
processes associated with prolonged interval times and good clinical outcome (90-day modified Rankin score, 0–2)
were analyzed.
Results—Median times were onset of stroke to hospital arrival, 123 minutes (interquartile range, 163 minutes); hospital arrival
to thrombolysis in cerebral infarction (TICI) 2b/3 or final digital subtraction angiography, 133 minutes (interquartile range,
99 minutes); and baseline imaging to groin puncture, 86 minutes (interquartile range, 24 minutes). Time from baseline
imaging to puncture was prolonged in patients receiving intravenous tissue-type plasminogen activator (32-minute mean
delay) and when magnetic resonance–based imaging at baseline was used (18-minute mean delay). Extracranial carotid
disease delayed puncture to first stent deployment time on average by 25 minutes. For each 1-hour increase in stroke onset
to final digital subtraction angiography (or TICI 2b/3) time, odds of good clinical outcome decreased by 38%.
Conclusions—Interval times in the STAR study reflect current intra-arterial therapy for patients with acute ischemic stroke.
Improving workflow metrics can further improve clinical outcome.
Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01327989. (Stroke. 2014;45:2024-2029.)
Key Words: cerebrovascular accident ◼ emergency ◼ stroke
N
ewer mechanical devices have resulted in faster and
better recanalization in patients with acute ischemic
stroke.1–5 This improvement is reflected in better clinical
outcome in studies such as Solitaire With the Intention for
Thrombectomy (SWIFT), Thrombectomy Revascularization
of Large Vessel Occlusions in Acute Ischemic Stroke
(TREVO)-2, and Solitaire FR Thrombectomy for Acute
Revascularization (STAR).6–9 This enthusiasm for newer
mechanical devices is tempered by results of Interventional
Management of Stroke (IMS) 3, Synthesis Expansion:
A Randomized Controlled Trial on Intra-Arterial Versus
Intravenous Thrombolysis in Acute Ischemic Stroke
(SYNTHESIS), and Mechanical Retrieval and Recanalization
of Stroke Clots Using Embolectomy (MR Rescue) that demonstrate no added advantage of endovascular therapy compared with intravenous tissue-type plasminogen activator
(tPA).10–12 Of the many reasons discussed about the inability of these latter trials to show any additional benefit in
the endovascular arm, prolonged time to revascularization
stands out.8,13,14 Time is of critical importance in the management of acute ischemic stroke.15–17 Time saved at every
stage, including reaching the hospital, initial patient evaluation, transfer to imaging, the imaging time, imaging postprocessing and interpretation, and finally initiation of treatment
Received February 4, 2014; final revision received April 16, 2014; accepted April 17, 2014.
From the Department of Clinical Neurosciences, Hotchkiss Brain Institute (B.K.M., M.A.A., M.G.), Department of Radiology (B.K.M., M.A.A.,
M.G.), and Department of Community Health Sciences (B.K.M.), University of Calgary, Calgary, Alberta, Canada; Faculty of Medicine, King Abdulaziz
University, Jeddah, Saudi Arabia (M.A.A.); Department of Neuroradiology, University Hospital of Geneva, Geneva, Switzerland (V.M.P.); Department
for Diagnostic and Interventional Neuroradiology, Inselspital, University of Bern, Bern, Switzerland (J.G.); Department of Neuroradiology, CHU de
Montpellier—Guy de Chauliac, Montpellier, France (A.B.); Department of Neurology, University Hospital Germans Trias i Pujol, Badalona, Barcelona,
Spain (A.D.); and Department of Neuroradiology, Alfred Krupp Krankenhaus, Essen, Germany (R.C.).
Correspondence to Mayank Goyal, MD, Department of Radiology, Seaman Family MR Research Centre, Foothills Medical Centre, 1403-29th St. NW,
Calgary, Alberta T2N 2T9, Canada. E-mail [email protected]
© 2014 American Heart Association, Inc.
Stroke is available at http://stroke.ahajournals.org
DOI: 10.1161/STROKEAHA.114.005050
2024
Menon et al Workflow in the STAR Study 2025
and achieving revascularization, has the potential to improve
clinical outcome.5,18–22 Despite the importance of reducing
time to treatment in improving outcome, inefficiencies continue to exist.22–24 These inefficiencies could be because of
patient, hospital, and health system characteristics and varying physician practices. By recognizing reasons for these
inefficiencies, we can formulate strategies to reduce them.19
The STAR study was an international, prospective, multicenter, single-arm study using stentrievers and conducted in
dedicated high-volume stroke centers with extensive experience on stroke interventions, per-procedural management,
and stroke recovery.9 Using data from this study, we analyze
patient, hospital, health system, and all other characteristics
that are associated with increase in each interval time, focusing our attention on workflow from arrival in hospital to final
digital subtraction angiography (DSA) run or revascularization. Finally, we assess the effect of these various characteristics and interval times on final clinical outcome.
Downloaded from http://stroke.ahajournals.org/ by guest on June 15, 2017
Methods
A total of 202 patients were enrolled in the STAR study across 14
comprehensive stroke centers in Europe, Canada, and Australia.
Patients were eligible if they presented within 8 hours after onset of
an acute ischemic stroke and had a documented proximal intracranial anterior circulation arterial occlusion. Other inclusion criteria
were age (>18 and <85 years), National Institutes of Health Stroke
Scale score of 8 to 30, and a baseline-modified Rankin score <2.
Study methodology is previously published.9 The following time
intervals were measured: stroke onset to hospital arrival, hospital arrival to baseline imaging, baseline imaging to groin puncture, groin
puncture to first stent deployment, and groin puncture to final DSA
or revascularization. Hospital arrival was defined as arrival at the
emergency department of the intra-arterial (IA) facility. Baseline
imaging time was defined as the time of first imaging at any facility after stroke onset. Patients who had imaging in a separate facility and were transferred to the IA facility were excluded from
hospital arrival to baseline imaging analysis. Other data collected
included daytime versus evening/night, weekend versus weekday,
general anesthesia (GA) use, use of multimodal imaging (computed
tomography [CT]±CT perfusion and MRI), and transfer in from a
different facility versus direct referral to IA facility. Successful revascularization was defined as thrombolysis in cerebral infarction
(TICI) 2b/3 revascularization of the target territory with a maximum
of 3 passes of the study device per vessel.
Data Analysis and Statistical Evaluation
Interval times are presented using standard descriptive statistics. We
analyzed the effect of various patient, hospital, and workflow characteristics on the following interval times: hospital arrival to baseline
imaging, baseline imaging to groin puncture, groin puncture to first
stent deployment, and groin puncture to final DSA run (or TICI 2b/3
revascularization) using Student t test for continuous data, Wilcoxon
rank test for nonparametric data, and Fischer’s test for categorical
data. Multivariable linear regression was then used to assess variables
associated with increase in each of the prespecified interval times.
Only those variables considered clinically relevant and statistically
significant (P≤0.05) in univariable analyses were included in these
models. We also did similar analysis on the composite time interval stroke onset to final DSA run (or TICI 2b/3 revascularization).
Finally, we built a multivariable logistic regression model assessing
the effect of time from stroke onset to final DSA (or TICI 2b/3) on
primary clinical outcome (modified Rankin score, 0–2 at 90 days). In
all models, we report main effects after adjustment for other significant variables. Statistical analysis was performed in SAS version 9.3
(SAS Institute, Cary, NC).
Results
Median age was 72 years, 60% were female patients, and the
median National Institutes of Health Stroke Scale score was
17. Other baseline demographics are in the published article.9
CT±computed tomography angiography at baseline was used
in 81 patients, CT perfusion in 67, and MRI in 51 patients.
Distribution of interval times is illustrated in Figure 1. Half of
patients achieved a hospital arrival to baseline imaging time
of 24 minutes, baseline imaging to groin puncture time of 86
minutes, and groin puncture to final DSA (or TICI 2b/3) time
of 34 minutes. Successful revascularization was achieved in
79.2% of patients and good clinical outcome in 57.9%.
Figure 1. Distribution of interval times in
the Solitaire FR Thrombectomy for Acute
Revascularization (STAR) study. CT indicates computed tomography.
2026 Stroke July 2014
Table 1. Final Multivariable Linear Regression Models Reporting Characteristics Associated With Delay
in Each Prespecified Interval Time
Interval Times
Hospital arrival to baseline imaging
Baseline imaging to groin puncture
Significant Variable
Parameter Estimate
(Multivariable)
SE
P Value
Female sex
−10.75
4.25
0.013
Time from stroke onset to hospital arrival (in hours)
−2.44
1.22
0.047
Warfarin use
−53.68
16.76
0.002
Intravenous tissue-type plasminogen activator use
Groin puncture to first stent deployment
31.88
8.73 <0.001
CT±CTP (vs MRI)
−18.06
8.86
0.043
Female sex
−4.92
2.25
0.031
Extracranial carotid disease
24.53
9.99
0.015
Prestroke mRS
3.37
1.54
0.031
GA use
12.54
5.68
0.029
Groin puncture to final DSA (or TICI 2b/3)
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Final multivariable linear regression models reporting characteristics associated with delay in each prespecified interval time.
Negative parameter estimates indicate shorter interval times and positive parameters longer interval times. CT indicates computed
tomography; CTP, CT perfusion; DSA, digital subtraction angiography; GA, general anesthesia; mRS, modified Rankin scale; and TICI,
thrombolysis in cerebral infarction scale.
Discussion
Variables Affecting Interval Times
Using multivariable linear regression, we found that hospital
arrival to baseline imaging time was on average 11 minutes
shorter for women than men (P=0.013). Time from baseline
imaging to groin puncture was on average 32 minutes more in
patients administered intravenous tPA and 54 minutes less in
patients taking warfarin. In multivariable analysis, time from
baseline imaging to groin puncture was on average 18 minutes
less when using CT-based imaging versus MRI. Time from
groin puncture to first stent deployment was on average 25
minutes longer for patients with extracranial carotid disease.
Other variables associated with prolonged groin puncture to
first stent deployment time included male sex and increase in
prestroke modified Rankin score. Time from groin puncture to
final DSA run (or TICI 2b/3) was on average 13 minutes longer in patients who were administered GA. On-hours versus
off-hours presentation and weekday versus weekend presentation did not influence any interval time. Transfer in to the
IA facility from a primary facility (n=29) increased the time
from stroke symptom onset to final DSA run (or TICI 2b/3)
compared with direct transfer (n=157) to IA facility (median
time, 322 versus 276 minutes; P=0.02). In multivariable linear
regression modeling, these variables did not affect any interval
time. Finally, the composite time from stroke onset to final
DSA run (or TICI 2b/3) was on average 71 minutes more in
patients with diabetes mellitus than those without (P=0.001),
73 minutes less in patients taking warfarin (P=0.02), 40 minutes less when GA was used, and 11 minutes less for each
unit increase in Alberta Stroke Program Early CT score on CT
(P=0.03; Table 1).
Data from the STAR study are a reflection of the recent experience (after September 2010) of dedicated high-volume comprehensive stroke centers (across 3 different continents) at IA
therapy using stentrievers.9 We have identified several patient,
hospital, and health system characteristics associated with
delay in workflow/interval times. Among these, intravenous
tPA administration, the modality of imaging at baseline (CT
versus magnetic resonance), and difficulty in endovascular
access could represent opportunities for improvement. We are
also able to show that shorter time from stroke onset to revascularization has a significant effect in improving final clinical
outcome even in this era of stentrievers.
A median door to needle time of <60 minutes is now considered an established metric for which stroke centers aim.25 Similar
metrics have been proposed recently for IA therapy but have not
gained wide acceptance. Based on a widely accepted metric used
in cardiology (door to balloon time <90 minutes), the Society for
Vascular and Interventional Neurology proposed a door to groin
puncture time <90 minutes.26 Other metrics proposed include
baseline imaging to groin puncture (picture to puncture) time
<90 minutes and a door to treatment time <120 minutes.22,27
Our results show that baseline imaging to groin puncture time
Time from stroke onset to final digital
subtraction angiography run (or TICI 2b/3)
in hours
0.62
0.48–0.80 <0.001
Effect of Time on Clinical Outcome
TICI 2b/3 within 3 passes
3
1.11–8.10
Each 1-hour increase in stroke onset to final DSA (or TICI
2b/3) time decreased the odds of good clinical outcome by
38% even after adjusting for reperfusion status, age, baseline
National Institutes of Health Stroke Scale, noncontrast computer tomography Alberta Stroke Program Early CT score,
and other relevant baseline characteristics (Table 2; Figure 2).
Age (every 10 y)
0.49
0.34–0.72 <0.001
Baseline NIHSS
0.92
0.84–1.00
0.04
ASPECTS score on baseline NCCT
1.37
1.05–1.78
0.02
Table 2. Final Multivariable Logistic Regression of Variables
Associated With Good Clinical Outcome (Modified Rankin
Scale, 0–2 at 90 Days)
Variable
Odds Ratio
95% CI
P Value
0.03
ASPECTS indicates Alberta Stroke Program Early CT score; CI confidence
interval; NCCT, noncontrast computer tomography; NIHSS, National Institutes of
Health Stroke Scale; and TICI, thrombolysis in cerebral infarction scale.
Menon et al Workflow in the STAR Study 2027
Figure 2. Estimated probability of good
clinical outcome (modified Rankin score,
0–2 at 90 days) based on time from
stroke onset to final digital subtraction
angiography (DSA) run (or thrombolysis
in cerebral infarction [TICI] 2b/3).
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<90 minutes and a door to treatment time <120 minutes can be
achieved (Figure 3).28 A door to groin puncture time <90 minutes
is, however, difficult to achieve except in a minority of patients.
Unique patient, hospital, health system, and clinical practice variables influence each interval time. Hospital arrival to
imaging time can be reduced if prior information on patient
is available, patient is transferred directly from door to scanner, and a quick, focused clinical assessment is done in parallel.22 Other variables that may affect this interval time are
nonmodifiable and include patient characteristics such as age,
stroke severity, and respiratory and hemodynamic status.29
Interestingly, in the STAR data, hospital arrival to imaging
time is slower, on average, by 13 minutes in men compared
with women; this is possibly because men are sicker at presentation than women. Nonetheless, we did not find a significant
effect of any other patient characteristics on this interval time.
Imaging to groin puncture time could be influenced by
numerous variables. These include the availability and
speed of access to scanner, type of imaging modality used,
efficiency of the picture archival and retrieval system, workflow for intravenous tPA administration, method of activation of neurointerventional team, time of workday (on-hours
versus off-hours or weekday versus weekend), use of GA,
consent for intervention, and so on.5 In addition, this interval
time can be prolonged if the workflow involves imaging at a
primary hospital followed by transfer to the IA facility versus
direct transfer to IA facility. In the STAR data, the variable
that influenced this metric most was workflow around intravenous tPA administration. In many institutions, workflow
around intravenous tPA administration is such that patients
are imaged and administered the drug in a primary care
facility followed by transfer to the IA facility. Even when
directly transported to the IA facility, intravenous tPA is
administered in a dedicated unit away from the angiography
suite and patients assessed for clinical improvement before
being moved to the angiography suite.30 Activation of the
neurointerventional team may also be delayed pending this
assessment. Proponents of this workflow highlight patients
Figure 3. Metrics in the Solitaire FR
Thrombectomy for Acute Revascularization (STAR) trial that are a reflection of
current practice in high-volume comprehensive stroke centers in comparison with
metrics in the Interventional Management
of Stroke (IMS) 3 study.10,28 DSA indicates
digital subtraction angiography; and TICI,
thrombolysis in cerebral infarction.
2028 Stroke July 2014
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who either have no proximal occlusion or have clinically
improved that result in a resource-intensive process such as
IA therapy being mobilized and not used. Nonetheless, the
number of such false-negatives is small in patients with disabling strokes and proximal occlusions; early recanalization
rates with intravenous tPA are also low.31 Moreover, use of
CT angiography at baseline can help identify proximal artery
occlusions.32 A workflow that offers intravenous tPA administration in parallel to rapid activation of the neurointerventional team and transfer to angiography suite has the potential
to reduce time from imaging to groin puncture. Shorter imaging to groin puncture time in patients on warfarin in the STAR
study is also probably because they bypass intravenous tPA.
Use of the appropriate imaging modality is also an important workflow issue.21,22 The STAR data suggest that using
a CT-based paradigm takes less imaging to groin puncture
time compared with a magnetic resonance–based imaging
paradigm without any comparable improvement in clinical
outcome. Making imaging quickly and easily accessible to
the treating physician 24×7 through use of efficient picture
archiving and communication system and simple imaging paradigms is also an important element in improving workflow.
The STAR data suggest that with improvement in the abovementioned processes, a median imaging to puncture time of
60 minutes is an achievable metric (Figure 3).
Groin puncture to first stent deployment and final DSA (or
TICI 2b/3) are indicators of IA procedural efficiency.20 Patient’s
condition (including hemodynamic and respiratory status, state
of agitation or calmness), access issues (at the groin and supraaortic segment including type of arch and large artery tortuosity),
experience and efficiency of the interventional team, and type of
mechanical device all influence this metric.20,33 In the STAR data,
median time from groin puncture to first stent deployment was
23 minutes and to final DSA run (or TICI 2b/3) was 34 minutes.
Nonetheless, presence of carotid disease (access issue) and use
of GA prolonged puncture to final DSA (or TICI 2b/3) time. CT
angiography head and neck at baseline could help the interventionist select beforehand catheters and tools to facilitate access.32
Of note, our results show patients receiving GA had shorter
overall time from stroke onset to final reperfusion, although
these same patients had prolonged time from groin puncture to
final reperfusion. We think this is because some patients were
intubated on route to hospital or at emergency room before
imaging; in such patients, workflow may have improved significantly after intubation. In other patients who were intubated
in the angio-suite to reduce agitation, interval time from groin
puncture to final reperfusion may have increased. We do not
have data on indication and timing of intubation/GA administration to confirm this. Nonetheless, in our opinion, GA use could
be restricted to patients who need it for medical reasons and not
used for reducing patient movement during intervention; in the
latter case, conscious sedation may be tried.20 Finally, teamwork
and familiarity between the interventionist, stroke physician, and
nurses are essential to increase efficiency within the groin puncture to final reperfusion metric. With improvement in efficiency,
a groin puncture to final DSA (or TICI 2b/3) time of <30 minutes is achievable (Figure 3).
The STAR data show that reducing time from stroke
onset to reperfusion improves clinical outcome (Figure 1).
Workflow metrics in the IMS 3 trial show prolonged times
compared with the STAR study (Figure 3).10 This improvement in workflow in the STAR study reflects in an improved
rate of good clinical outcome (modified Rankin score, 0–2 at
90 days) of 57.9% compared with 41% in the endovascular
arm of IMS 3 (with evident proximal occlusion on CT angiography).8–10,34 The use of stentrievers and an effort toward
improvement in workflow metrics across board are anticipated to be key outcome determinants in future trials of endovascular stroke therapy.
Our study has limitations. The STAR registry is a singlearm study. The lack of a randomly assigned control arm raises
concerns of biases that might have influenced the results.
Data on indications for GA, workflow details around intravenous tPA administration, time taken for study consent, and
the nature of difficulty in access to target occlusion was not
available. The small number of patients who were transferred
in from a primary stroke center versus those who were transferred directly to the IA center reflect practice of the enrolling
centers, thus limiting our ability to comment on the relative merits of these paradigms. Nonetheless, the STAR data
shed light on workflow metrics that can be achieved in dedicated stroke centers. In addition, our results show that there
is potential for further improvement in each of these metrics
if workflow is designed in a parallel process framework with
various intermediate steps from patient arrival to final recanalization happening simultaneously whenever possible. Even in
high-volume centers such as those in the STAR study, many
patients did not achieve an imaging to groin puncture time
<90 minutes. Finally, our results show that an improvement
in each metric has a cumulative effect on improving clinical
outcome. A focus on these individual metrics has the potential
to benefit future endovascular trials in addition to improving
efficiency and outcomes in comprehensive stroke centers.
Acknowledgments
We thank Jill Schafer, Senior Statistician, North American Medical
Science Associates (a commercial medical research organization
http://www.namsa.com), for conducting the statistical analyses.
Sources of Funding
Covidien Neurovascular sponsored the STAR study.
Disclosures
Dr Davalos is a consultant for Covidien; Dr Chapot is a consultant
for Covidien, Microvention, and Balt; Dr Gralla, global PI STAR, is
a consultant for Covidien; Dr Pereira, global PI STAR, is a consultant
for Covidien; Dr Goyal is a consultant for Covidien; and the other
authors report no conflicts.
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Downloaded from http://stroke.ahajournals.org/ by guest on June 15, 2017
Optimal Workflow and Process-Based Performance Measures for Endovascular Therapy
in Acute Ischemic Stroke: Analysis of the Solitaire FR Thrombectomy for Acute
Revascularization Study
Bijoy K. Menon, Mohammed A. Almekhlafi, Vitor Mendes Pereira, Jan Gralla, Alain Bonafe,
Antoni Davalos, Rene Chapot and Mayank Goyal
on behalf of the STAR Study Investigators
Stroke. 2014;45:2024-2029; originally published online May 15, 2014;
doi: 10.1161/STROKEAHA.114.005050
Stroke is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231
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