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Clinical Investigative Study

Eligibility Determination for Intravenous Thrombolysis Based on


Radiology Interpretation Report of the Head CT Scan in Patients
with Acute Ischemic Stroke
Ameer E. Hassan, DO, Shahram Majidi, MD, Nazli A. Janjua, MD, Saqib A. Chaudhry, MD, Wondwossen G. Tekle, MD,
Mikayel Grigoryan, MD, Adnan I. Qureshi, MD
From the Valley Baptist Brain & Spine Network, Harlingen, TX (AEH, WGT); Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis, MN (SM, SAC,
MG, AIQ); and Long Island College Hospital, Brooklyn, NY (NAJ).

ABSTRACT
OBJECTIVE Keywords: Head CT scan, IV thrombol-
To evaluate the variability of determining eligibility for intravenous thrombolysis (IV ysis, acute ischemic stroke, ICH.
t-PA) by a stroke team interpretation of computed tomographic (CT) scan of the head Acceptance: Received September 19,
versus review of the radiology interpretation (presented in final report) in patients with 2012, and in revised form April 2, 2013.
acute ischemic stroke. Accepted for publication May 7, 2013.
METHODS Correspondence: Address correspon-
We compiled a database of all IV t-PA-treated ischemic stroke patients at our academic dence to Shahram Majidi, Zeenat
institution based on the stroke team’s CT scan interpretation. The CT scan reports of Qureshi Stroke Research Center, De-
171 patients were reviewed by an independent board-certified vascular neurologist who partment of Neurology, University of Min-
nesota, 420 Delaware Street S.E., MMC
was blinded to clinical information except that all patients were being considered for IV
295, Minneapolis, MN 55455. E-mail:
t-PA to determine their eligibility for thrombolysis. The reviewer’s responses were then majidis@gwu.edu.
compared with the treating team’s decision to identify discrepancies, and the impact of the
discrepant decisions on clinical outcome including 24-hour National Institute of Health J Neuroimaging 2014;24:349-353.
stroke Scale (NIHSS) score and discharge modified Rankin scale (mRS), symptomatic DOI: 10.1111/jon.12045
hemorrhage (sICH), and asymptomatic hemorrhage (aICH). We compared the outcomes
of patients who received IV t-PA despite cautionary neuroradiologist interpretation and
placebo-treated patients from NINDS t-PA study.
RESULTS
The independent reviewer decided to treat with IV t-PA 123 patients (72%) after reviewing
the radiology reports. The rate of NIHSS score improvement (52.0% vs. 62.5%, P = .22)
was not different between patients in whom IV t-PA should or should not have been used
based on radiology reports. Favorable clinical outcome defined by mRS of 0-2 at discharge
(50.4% vs. 47.9%, P = .77) and in-hospital mortality (15.6% vs. 12.5%, P = .61) were
similar between the 2 groups. Favorable outcome (discharge or day 7-10 mRS 0-2) was
significantly higher in patients who received t-PA compared with placebo-treated patients
(48% vs. 28%, P = .006).
CONCLUSION
Our study demonstrates that administering IV t-PA to patients based on the stroke team’s
interpretation of the CT scan versus review of the radiology interpretation does not lead
to significant differences in clinical outcome, aICH, or sICH.

Introduction Medicaid reimburses the radiology interpretation of the initial


According to the American Heart Association (AHA) guide- CT scan with the assumption that such interpretation directly
lines, brain imaging is a necessary prerequisite for administer- contributes to treatment. Several institutions experience delay
ing intravenous thrombolysis (IV t-PA) in acute ischemic stroke in receiving the radiology interpretation of the initial CT scan
patients and should be interpreted by a physician with exper- and rely on the vascular neurology interpretation for determin-
tise in reading computed tomographic (CT) scan or magnetic ing IV t-PA eligibility. It remains unclear whether radiology
resonance imaging (MRI) studies of the brain.1 Some institu- interpretation, although less time-efficient, may have resulted
tional protocols require a neuroradiologist’s interpretation to in different and perhaps better treatment choices. In this study,
determine IV t-PA eligibility and the Center for Medicare and we studied the variability in determining eligibility for IV t-PA

Copyright ◦ 2013 by the American Society of Neuroimaging


C 349
by comparing the vascular neurologist’s direct interpretation of withheld based on cautionary neuroradiologist interpretation.
the initial CT scan versus the review of the initial radiology in- We tested this possibility using 2 methods. First, we compared
terpretation (presented in the final impression) among patients the outcomes of patients who received IV t-PA despite caution-
with acute ischemic stroke. ary neuroradiologist interpretation and placebo-treated patients
from NINDS t-PA study.2 The rate of favorable outcome (mRS
score 0-2) was compared between the 2 groups in the univariate
Methods
model and also in the multivariate model using multivariate lo-
We identified all patients who were treated with IV t-PA at
gistic regression model after adjusting for patients’ demograph-
2 comprehensive stroke centers from January 2002 to July
ics and baseline NIHSS score. Second, we used previously val-
2010 with the help of International Classification of Disease,
idated predictive model for patients with acute ischemic stroke.
9th Revision, Clinical Modification (ICD-9-CM) codes where
In this model, Frankel et al3 utilized data from the placebo arm
primary diagnostic codes (433, 434, 436, 437.0, and 437.1) are
of the NINDS t-PA trial to identify the variables that may pre-
used to identify the patients admitted with ischemic stroke and
dict poor outcome, defined as mRS score of >3 at 3 months after
ICD-9-CM procedure 99.10 codes for thrombolytic treatment.
stroke. Patients were randomized within 3 hours of symptom
Clinical records of all identified patients were retrospectively
onset. Variables collected at baseline, 2 and 24 hours, and 7 to
reviewed for accuracy of identification and relevant medical
10 days after stroke were used to identify the predictors of poor
information. We obtained radiology reports (reported by neu-
outcome at 3 months. Their model identified 2 baseline vari-
roradiologist with certificate of added qualification) of the CT
ables, NIHSS score >17 plus atrial fibrillation that predicted
scans for all patients before the thrombolytic treatment that
poor outcome (defined by mRS score >3 at 3 months after
are submitted for reimbursement. For each case, radiology re-
stroke) with a positive predictive value of 96%. We identified
port of the CT scan was printed in 1 page and it was made
patients who had NIHSS >17 and atrial fibrillation among the
clear that patients had arrived within the time window for IV
patients for whom the independent vascular neurologist did not
t-PA with no clinical contraindication for thrombolytic therapy.
agree to give IV t-PA after reviewing CT scan report. Then we
An independent board-certified vascular neurologist blinded to
calculated the rate of poor outcome among the patients in this
thrombolytic treatment reviewed radiology reports and made
group in order to compare with 96% of poor outcome according
the decisions for (or against) treatment using IV t-PA. Patients
to the predictive model.
were divided into those who should and those who should not
receive IV t-PA by the independent vascular neurologist based
Statistical Analysis
on radiology reports.
We collected relevant information for each patient from Descriptive statistics to assess differences in risk factors, sever-
the individual hospital records. Demographic data including ity of disease, and clinical outcome at discharge between pa-
age, sex, and race/ethnicity were collected from patient pro- tients who should and those who should not receive IV t-PA
file documented during admission registration. We collected on the basis of an independent vascular neurologist‘s decision
data regarding stroke risk factors present before onset of using radiology reports by analysis of variance (ANOVA) and
stroke symptoms (as mentioned in the admission and/or dis- χ 2 tests performed using SAS 9.1 software (SAS Institute Inc.,
charge notes), eg, hypertension, dyslipidemia, diabetes melli- Cary, NC). Rates of favorable clinical outcome at discharge and
tus, cigarette smoking, atrial fibrillation, and coronary artery improvement of NIHSS score by 4 points at 24 hours, sICH,
disease. Data regarding severity of stroke and baseline function asymptomatic ICH (aICH) and in-hospital mortality were also
at presentation were obtained by the admission National Insti- compared between the 2 groups. The rate of favorable outcome
tutes of Health stroke scale (NIHSS) score and modified Rankin was compared between placebo-treated patients from NINDS
scale (mRS), respectively. Neurology house staff evaluation of IV t-PA and our patients who received IV rt-PA despite cau-
each patient before and after treatment, and follow-up neuro- tionary neuroradiologist interpretation.
logical exam notes were reviewed during each patient’s hospital
stay; mRS was estimated at discharge after review of functional
status documented in notes by house staff, occupational thera- Results
pist, and/or physical therapist. Occurrence of postthrombolytic There were 171 patients that were treated with IV t-PA during
intracerebral hemorrhage was obtained from the subsequent ra- the study period. The independent vascular neurologist’s deci-
diological reports—symptomatic hemorrhage (sICH) was deter- sion based on radiology reports agreed with the stroke team de-
mined after review of progress notes and documented NIHSS cision on IV t-PA treatment for 123 (71.9%) patients but differed
score for each patient identify neurological deterioration by de- in 48 (27.1%) patients by choosing not to administer throm-
terioration of NIHSS score by 4 points or greater compared bolytic therapy. Important findings in the radiology reports
with the admission assessment. In-hospital mortality included were hyperdense middle cerebral artery sign in 62 (36.25%)
patients who died after being placed on comfort care or sec- patients, loss of gray-white matter differentiation in 50 (29.23%)
ondary to a medical complication following treatment. Favor- patients, and hypodensity in 89 (52.04%) patients. The only
able clinical outcome in our analysis was defined by mRS of reason why the stroke neurologist decided against the initial
0-2 at discharge, or NIHSS score improvement by ≥4 points or decision made by the stroke team was the extent of infarction
0 at 24 hours. qualitatively derived from radiology interpretation. In none of
We evaluated the possibility that whether administration of the patients, the independent stroke neurologist decided against
IV t-PA was beneficial to patients in whom t-PA would be use of IV t-PA due to concerns regarding presence of ICH (see

350 Journal of Neuroimaging Vol 24 No 4 July/August 2014


Table 1. Basic Characteristics and Outcome Variables Stratified by
Decision of Independent Vascular Neurologist Based on
Radiology Reports

Agreed on Not Agreed on P


t-PA Treatment t-PA Treatment Value

Variables 123 48
Age (mean ± SD) 67.5 ± 16.2 65.6 ± 15.3 .4707
Female 55 (44.7) 25 (52.1) .3856
NIHSS score at admission
NIHSS 0-9 56 (45.9) 20 (42.5) .6998
NIHSS 10-19 49 (40.2) 18 (38.3)
NIHSS >20 17 (13.9) 9 (19.2)
Clinical demographics
Hypertension 79 (64.2) 34 (70.8) .4123
Diabetes mellitus 27 (21.9) 16 (33.3) .1232
Coronary artery disease 26 (21.1) 10 (20.8) .965
Hyperlipidemia 39 (31.7) 13 (27.1) .5548
Atrial fibrillation 34 (27.6) 13 (27.1) .9414
Symptomatic ICH 4 (3.45) 1 (2.08) .6836
Asymptomatic ICH 11 (8.94) 2 (4.17) .3209
Outcome at discharge
Clinical improvement by 64 (52.03) 30 (62.50) .2164
≥4 NIHSS score
In-hospital mortality 19 (15.6) 6 (12.5) .6105
Favorable outcome at 62 (50.4) 23 (47.9) .7698
discharge defined
by mRS 0-2

ICH = intracranial hemorrhage; mRS = modified Rankin scale; NIHSS = Na-


tional Institutes of Health Stroke Scale; IV t-PA = intravenous thrombolysis.
Fig 1. Based on radiologist report (provided below), the indepen-
dent vascular neurologist decided on not administering IV t-PA.
Radiologist report: There is loss of the gray-white differentiation at the In our cohort, 7 of 48 patients for whom the independent
level of the left temporal/lateral frontal lobes with mild sulcal efface- vascular neurologist did not agree to give IV t-PA after re-
ment compared to the right. In addition, there is a loss of differentia-
tion of the left basal ganglia. There is no evidence of intraparenchymal
viewing CT scan report had admission NIHSS score >17 plus
hemorrhage. The vessels at the base of the brain appear dense but atrial fibrillation. In those 7 patients, only 3 (39%) had a poor
symmetric. outcome at discharge after IV t-PA treatment. Therefore, con-
sidering the validated predictive model for patients with acute
ischemic stroke, we could expect an increase in rate of poor
outcomes from 39% to 96% in these patients if they had not
Fig 1). There was no difference in the clinical or demographic received IV t-PA based on the neuroradiologist interpretation.
characteristics and admission NIHSS scores between patients
who should and those who should not receive IV t-PA on the
basis of independent vascular neurologist review of radiology Discussion
reports (Table 1). We demonstrated that the decision regarding IV t-PA admin-
The rate of NIHSS score improvement at 24 hours (52.0% istration based on radiology reports may result in prominent
vs. 62.5%, P = .22) was not different between patients who differences in identification of patients who should and those
should and those who should not receive IV t-PA on the basis who should not receive IV t-PA in acute ischemic stroke. Based
of independent vascular neurologist decision based on radi- on the radiology reports provided by a board-certified neuro-
ology reports. Favorable clinical outcome defined by mRS at radiologist, an independent vascular neurologist decided not to
discharge (50.4% vs. 47.9%, P = .77), and in-hospital mortal- treat in almost one-fourth of the patients. Rates of aICH and
ity (15.6% vs. 12.5%, P = .61) was not different between the 2 sICH, in-hospital mortality, and discharge mRS 0-2 did not sig-
groups. There was also no statistically significant difference in nificantly differ between those who received IV t-PA despite
the rates of sICH, aICH, and in-hospital mortality between the ineligibility deemed based on the radiology report. We also
2 groups (Table 1). demonstrated that administration of IV t-PA was beneficial to
Favorable outcome (discharge or day 7-10 mRS 0-2) was patients in whom IV t-PA would be withheld based on caution-
significantly higher in patients who received t-PA compared ary neuroradiologist interpretation.
with placebo-treated patients in NINDS t-PA study (48% vs. It should be noted that in this study we used the interpre-
28%, P = .006). After adjusting for age, gender, and baseline tation provided by a neuroradiologist; though most hospitals
NIHSS score, patients who received IV t-PA despite cautionary do not have and usually rely on a general radiologist read-
neuroradiologist interpretation had lower rates of unfavorable ing brain CT scans. It has been shown in previous studies that
outcomes (OR .49; 95% CI .23-1.03, P = .061). there is a significant lack of agreement even among experienced

Hassan et al: Eligibility Determination for Intravenous Thrombolysis 351


physicians in identifying and quantifying early CT scan changes quality control process of the institution in which the physician
in acute ischemic stroke and that board certification in general practices.
radiology or neurology is insufficient for such a competence.4, 5 Our study has several limitations including its retrospective
Even a neuroradiologist without significant experience in inter- nature and reliance on ICD-9-CM codes to identify the study
pretation of imaging pertaining to stroke may miss hemorrhage population. Second, we used a nonmatched cohort of patients as
in a brain CT scan, and it has been recommended that physi- the control group to compare outcomes. A limitation of the con-
cians highly skilled in identifying intracranial hemorrhage must trol group was that they were treated almost a decade prior to
read and interpret the CT scan.4 Therefore, it is likely that the the IV t-PA-treated patients and may not reflect the reduction in
disagreement would be higher in other settings. death and disability seen with improved stroke care over the last
It has been shown that considerable disagreement between decade.9 Therefore, such a control group selection may have
2 observers may exist even among those with substantial augmented the relative benefit seen in IV t-PA-treated patients.
experience.5, 6 More specific and detailed training in recog- The IV t-PA- and placebo-treated patients were not matched
nizing early CT scan changes was suggested to improve the for individual characteristics and the possibility of bias related
agreement.5 In our study, we believe that the discrepancy be- to certain level of differences between the 2 groups cannot be
tween decision making based on the radiologist report and that excluded. Further understanding of this issue would also be
made by stroke team using self-interpretation of the CT scan is enhanced by not only testing the agreement and difference in
not entirely explained by differences in experience and qualifi- outcome and complications among those patients who received
cation. The knowledge gained by vascular neurologists during IV t-PA but also among those who did not receive IV t-PA be-
patient interview and examination may allow a more balanced cause of initial CT scan findings. The methodology of our study
interpretation of CT scan findings as they pertain to decision does not capture the unofficial report or verbal communication
making. When a neuroradiologist is interpreting a CT scan of between neuroradiologists and ED physicians or stroke neurol-
an acute stroke patient, certain findings may be overempha- ogists. From a legal standpoint, the formal interpretation that
sized and the methodology of interpretation and description is placed in the medical records can form the only verifiable
may ineffectively communicate the findings to another vascular source of discordance between neuroradiologist’s and stroke
neurologist.4 The other aspect that is not addressed by our study neurologist’s interpretations of initial CT scan. The impact of
is the time-efficient aspect of a direct vascular neurologist’s inter- the formal radiology interpretation on decision making in our
pretation. While guidelines recommend door-to-interpretation settings was nonexistent because the decision making was based
time of 45 minutes,1, 7 typically a formal radiologist’s CT scan on stroke neurologist’s interpretations.
interpretation may take longer in most settings.4 Decreasing In conclusion, our result support the validity of the deci-
CT scan interpretation time can have a considerable impact sion to administer IV t-PA based on self-interpretation of CT
on decreasing door-to-needle times in IV t-PA-eligible stroke scan (with or without verbal or unofficial communication with
patients. neuroradiologist) by the treating vascular neurologist prior to
We also have to consider the negative aspects of formal availability of formal radiology reports.
radiology reports for the treating physician. For medicolegal
considerations, the formal radiology report is an official ex-
Dr. Qureshi is supported by National Institute of Neurological Dis-
pert interpretation within the institution. If the treating vascular
eases and Stroke. Principal Investigator, Antihypertensive Treatment
neurologist had already administered IV t-PA prior to formal in Acute Cerebral Hemorrhage (ATACH)-II. RO-1-NS44976-01A2
radiology report, a different (and potentially more valid) in- (medication provided by ESP Pharma), and American Heart Associ-
terpretation later may increase the liability in the event of an ation Established Investigator Award 0840053N, Innovative Strategies
adverse event. The concern is highlighted in the presence of the for Treating Cerebral Hemorrhage.
high rate of incongruence observed in our study. Although the
vascular neurologists are interpreting the emergent CT scan and
making the diagnosis and decisions pertaining to treatment, the
interpretation that is billed for and reimbursed is performed at References
a later interval by radiology. This is similar to the issue that was 1. Adams HP Jr., del Zoppo G, Alberts MJ, et al. Guidelines for
addressed by Health Care Financing Administration (HCFA) the early management of adults with ischemic stroke: a guideline
from the American Heart Association/American Stroke Association
Final Rule (January 1, 1996), which covers interpretations of
Stroke Council, Clinical Cardiology Council, Cardiovascular Radi-
diagnostic studies performed in the emergency department.8 X- ology and Intervention Council, and the Atherosclerotic Peripheral
ray and electrocardiography (EKG) interpretations are included Vascular Disease and Quality of Care Outcomes in Research Inter-
in this rule. HCFA states that they will pay for only 1 interpreta- disciplinary Working Groups: the American Academy of Neurology
tion (can be performed by emergency department physician) of affirms the value of this guideline as an educational tool for neurol-
an x-ray or EKG procedure furnished to an emergency room ogists. Stroke 2007;38:1655-1711.
patient and the reimbursement will be for the interpretation 2. The National Institute of Neurological Disorders and Stroke rt-PA
Stroke Study Group. Tissue plasminogen activator for acute ischemic
and report that directly contributed to the diagnosis and treat-
stroke. N Engl J Med 1995;333:1581-1587.
ment of the individual patient. Similarly, a stroke neurologist 3. Frankel MR, Morgenstern LB, Kwiatkowski T, et al. Predicting
providing contemporaneous interpretation of a diagnostic neu- prognosis after stroke: a placebo group analysis from the National
roimaging study is entitled to reimbursement for such interpre- Institute of Neurological Disorders and Stroke rt-PA Stroke Trial.
tation even if the study is subsequently reviewed as part of the Neurology 2000;55:952-959.

352 Journal of Neuroimaging Vol 24 No 4 July/August 2014


4. Schriger DL, Kalafut M, Starkman S, et al. Cranial computed tomog- 7. Marler JR JP EM. A NINDS Symposium: Improving the Chain of Recovery
raphy interpretation in acute stroke: physician accuracy in determin- for Acute Stroke in Your Community. NINDS Proceedings, Bethesda,
ing eligibility for thrombolytic therapy. JAMA 1998;279:1293-1297. MD. December 12-13, 2002.
5. Grotta JC, Chiu D, Lu M, et al. Agreement and variability in the 8. Health Care Financing Administration (Accessed March 14, 2012, at
interpretation of early CT changes in stroke patients qualifying for http://www.gpo.gov/fdsys/pkg/FR-1995–12–08/html/X95–11208.
intravenous rtPA therapy. Stroke 1999;30:1528-1533. htm)
6. Hassan AE, Zacharatos H, Chaudhry SA, et al. Agreement in en- 9. Qureshi AI, Suri MF, Nasar A, et al. Changes in cost and out-
dovascular thrombolysis patient selection based on interpretation of come among US patients with stroke hospitalized in 1990 to
presenting CT and CT-P changes in ischemic stroke patients. Neur- 1991 and those hospitalized in 2000 to 2001. Stroke 2007;38:2180-
ocrit Care 2012;16:88-94. 2184.

Hassan et al: Eligibility Determination for Intravenous Thrombolysis 353


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