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Spectrum of neurologic events following cardiac transplantation.
- C A Sila
Stroke Volume 20, Issue 111 November 1989

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Pulsatile tinnitus.
- C A Sila,
- A J Furlan and
- J R Little
Stroke Volume 18, Issue 11 January 1987

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Pulse-synchronous tinnitus suggests a vascular etiology and is deemed rare by the otologic literature. During the period 1978-1985 we evaluated 20 patients with the sole or initial complaint of pulsatile tinnitus. Fourteen patients had objective pulsatile tinnitus, perceived by the patient and the examiner alike, and 6 had subjective pulsatile tinnitus, perceived by the patient only. Angiographic findings in patients with objective pulsatile tinnitus included dural or pial arteriovenous malformations, occlusive disease of the intra- or extracranial carotid arteries from atherosclerosis or dissection, panarterial ectasia, and venous sinus thrombosis. Most of the patients with subjective pulsatile tinnitus had normal evaluations, but other possible causes of subjective pulsatile tinnitus included a carotid occlusion and pseudotumor cerebri. Pulsatile tinnitus is an uncommon symptom produced by a variety of causes. Given the abnormalities present in our series, we would recommend intraarterial digital subtraction angiography or conventional angiography in the evaluation of objective pulsatile tinnitus and intravenous digital subtraction angiography for subjective pulsatile tinnitus. Increased intracranial pressure must also be considered.
Community Use of Intravenous Tissue Plasminogen Activator for Acute Stroke : Results of the Brain Matters Stroke Management Survey
- Irene L. Katzan,
- Cathy A. Sila and
- Anthony J. Furlan
Stroke Volume 32, Issue 41 April 2001

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Background and Purpose—Little is known of neurologists’ viewpoints regarding intravenous tPA use or institutional readiness to evaluate potential thrombolytic candidates.Methods—Surveys were distributed at the Brain Matters Stroke Management Workshops held in 16 cities in the United States.Results—Intravenous tPA was administered by 46.9% of responding neurologists. Almost 30% (29.9%) of surveyed neurologists were “very convinced” of its efficacy, whereas 61.6% were “very concerned” about the risk of intracranial hemorrhage. Only half of the respondents believed their institutions could meet all NINDS-recommended stroke-evaluation time targets.Conclusions—Neurologists’ enthusiasm for the efficacy of intravenous tPA is tempered by their concern about intracranial hemorrhage. Institutional readiness for evaluating acute stroke patients is not optimized.
Abstract TP45: Promoting High Value Care For Stroke Patients Within A Stroke System Of Care: Reducing Unnecessary Hospital Transfers For Patients Not Taken For Thrombectomy
- Kelsey R Duncan,
- Julie M Fussner,
- Kelly M MONTGOMERY and
- Cathy A SILA
Stroke Volume 53, Issue Suppl_11 February 2022

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Introduction: High value care aims to provide the best patient outcomes while avoiding defects and waste. Our previous work determined that 39% of patients transferred for possible thrombectomy based on clinical criteria and CT only did not have a large vessel occlusion (LVO) which led to a health system-wide guideline to improve transfer selection by adding criteria for emergent CT angiography. This study aims to describe the impact of that guideline and reanalyze the reasons why patients transferred for consideration of thrombectomy do not receive the procedure.Methods: All patients transferred from within and outside of the health system as a potential thrombectomy candidate between 1/1/19- 6/30/21 were reviewed for reasons why thrombectomy was not pursued.Results: Over 30 months, 316 patients transferred for possible thrombectomy were not taken to the angio suite primarily due to absence of LVO on vessel imaging (26.3%), lack of suspicion of LVO on assessment (18%) and significant improvement in clinical symptoms (12%). Other reasons included too large of core infarct (13.3%), CT head ASPECT score (8.2%), lack of perfusion imaging mismatch (6.3%), poor baseline functional status (4.7%), lesion too distal (3.8%), ICH (3.2%), time since last known well (1.9%), chronic ICA occlusion preventing access to acute lesion (1.9%), and medically unstable (0.3%).Conclusions: Despite the institution of a system-wide protocol for acute CTA imaging to guide patient selection, the major reason for not proceeding to thrombectomy was still absence of LVO, some of which was related to out-of-system hospital transfers. Drawbacks of unnecessary patient transfer include increased cost of care, moving patients farther away from their home and family, and non-essential use of tertiary hospital bed space, particularly in the setting of a pandemic. Given the prevalence of potentially preventable unnecessary transfers, protocols that support in-the-field triage and transport based on clinical criteria alone, without CT or CTA, are destined to worsen health system efficiency and decrease the value of care for patients with major acuteischemic stroke.
Abstract WP34: Bed Ahead Process Avoids The Thrombectomy Patient Boarding In Emergency Department
- Kelly M MONTGOMERY,
- Julie M Fussner,
- Chase Vlad,
- Riley Grosso and
- Cathy A SILA
Stroke Volume 53, Issue Suppl_11 February 2022

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Background: University Hospitals Comprehensive Stroke Center (UH CSC) is an academic medical center with a dedicated 19 bed Neuroscience Intensive Care unit (NSU). As the only comprehensive stroke center in a 22 hospital system, the majority of ischemic stroke patients requiring a mechanical thrombectomy procedure are transferred to the UH CSC. A post thrombectomy patient requires intensive monitoring to assess for complications and is best cared for by highly trained neuro nurses in an intensive care environment. Lack of available NSU beds often resulted in these patients returning to the high volume emergency department with less than ideal staffing. The request for a NSU bed was not initiated until the thrombectomy procedure began delaying the chain of events that lead to an available NSU bed.Hypothesis: A proactive process that would initiate obtaining a NSU bed sooner would avoid these patients from boarding in the emergency department.Methods: Key stake holders from the stroke program, neurocritical care, emergency medicine, neuro interventional and the transfer center met in early 2019 to review data and quality concerns. An algorithm was developed and shared with all staff. Once the stroke faculty accepts a transfer of a potential thrombectomy patient, the new process includes notifying the NSU fellow and charge nurse to initiate making an open bed before the patient arrives to UH CSC.Results: In 2018, 48% of patients that underwent a mechanical thrombectomy returned to the emergency department. After the implementation of the new process the percentage of patients returning to the emergency department declined to 28% in 2019. In 2020 only 8% returned to the emergency department. The number of quality concerns significantly decreased.Conclusion: The bed ahead process initiated before a thrombectomy patient arrives at the comprehensive stroke center has been successful in avoiding returns to the emergency department and meeting our goal to achieve high quality patient outcomes and improve care efficiency.
Patent foramen ovale and brain infarct. Echocardiographic predictors, recurrence, and prevention.
- J P Hanna,
- J P Sun,
- A J Furlan,
- W J Stewart,
- C A Sila and
- M Tan
Stroke Volume 25, Issue 41 April 1994

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Paradoxical embolism through a patent foramen ovale is a recognized cause of stroke, but clinical predictors, recurrence rate, and prevention of brain infarcts in patients with patent foramen ovale have not been determined. We reviewed transesophageal echocardiographic records to ascertain echocardiographic predictors and optimal prophylaxis for patent foramen ovale-related infarcts.A patent foramen ovale was identified in 74 patients during 615 transesophageal echocardiograms by color Doppler or saline contrast during a 60-month period. On the basis of final clinical situation, the patients were divided into the following groups: group 1, infarct with patent foramen ovale a likely cause (n = 16); group 2, infarct with patent foramen ovale an unlikely cause (n = 23); and group 3, no infarct (n = 35). Transesophageal echocardiograms were reviewed to assess patent foramen ovale characteristics and associated cardio-embolic sources without knowledge of clinical details or group assignment. Follow-up after a patent foramen ovale-related infarct was obtained by telephone or written correspondence in 15 of 16 group 1 patients.Atrial septal aneurysms were more common in group 1 (38%) compared with group 2 (10%) and group 3 (8%) (P = .02). Contrast right-to-left shunting occurred in 88% of group 1 (P = .06) and 86% of group 2 (P = .07) compared with 60% of group 3. Prevention of recurrence in subjects with presumed patent foramen ovale-related brain infarcts varied. Aspirin was usually chosen after initial brain ischemia. Warfarin and patent foramen ovale closure were usually reserved for subjects with symptoms of brain ischemia while taking aspirin or those who required warfarin or cardiac surgery for other indications. No recurrent infarcts occurred in 15 patients during a mean follow-up period of 28 months.Atrial septal aneurysm and right-to-left shunt may be predictive of a patent foramen ovale that predisposes a patient to stroke. Aspirin may provide sufficient infarct prophylaxis after initial ischemia. Warfarin and surgical correction should likely be reserved for those in whom aspirin is not effective or those who require warfarin or cardiac surgery for other reasons until prospective studies are available.
Cuyahoga County Operation Stroke Speed of Emergency Department Evaluation and Compliance With National Institutes of Neurological Disorders and Stroke Time Targets
Stroke Volume 34, Issue 41 April 2003

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Background and Purpose— Although the National Institutes of Neurological Disorders and Stroke (NINDS) has established time targets for the evaluation of acute stroke patients, little is known about how often these targets are met in the community. To track compliance with NINDS guidelines, Cuyahoga County Operation Stroke implemented a countywide data collection process that provides comparative reporting of hospital performance.Methods— Data on the emergency department evaluation of stroke patients have been retrospectively collected since January 2000 by hospitals participating in Cuyahoga County Operation Stroke. All hospitals used a 1-page form that includes NINDS time target information.Results— Median time to emergency department arrival for the 1003 patients in this cohort was 115 minutes; 382 patients (38%) arrived in <3 hours; 506 (50%) arrived in <6 hours. After arrival, median time to physician contact was 12 minutes, time to CT was 65 minutes, and time to imaging results was 105 minutes. Earlier arrival intervals after symptom onset were independently associated with shorter evaluation times. All time targets were met in patients receiving intravenous tissue plasminogen activator.Conclusions— A countywide data collection system for acute stroke evaluation is feasible. In the Cleveland metropolitan area, time to physician contact is close to the recommended NINDS target. Time to CT and time to imaging results are substantially longer than recommended. However, there was wide variation between hospitals. The association between time to arrival, speed of evaluation, and administration of intravenous tissue plasminogen activator suggests that community physicians selectively accelerate the evaluation and management of potential thrombolysis candidates.
Abstract 133: Over Estimation Of Percent Stenosis By Physician Operators May Lead To Carotid Stent Over Utilization
- Francis Jareczek,
- Mary B FARRELL,
- Erik Lehman,
- Cathy A Sila,
- John Terry,
- DAVID SACKS,
- Paul Kalapos,
- Scott Simon and
- Kevin M Cockroft
Stroke Volume 54, Issue Suppl_11 February 2023

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Introduction: Based largely on the inclusion criteria of clinical trials, the degree of cervical carotid artery stenosis is often used as an indication for stent placement in the setting of carotid atherosclerotic disease. However, the rigor and consistency with which such stenosis is measured outside of clinical trials is unclear. We compared the percent stenosis as measured by real world physician operators to that measured by independent expert reviewers.Hypothesis: We hypothesized that the documented degree of stenosis, termed operator-reported stenosis (ORS), from real world facilities performing carotid stent placement would be larger than the reviewer-measured stenosis (RMS) as assessed by clinicians experienced in treating carotid artery disease.Methods: Images were selected from patient cases used for carotid stenting facility accreditation. Data collected included demographics, National Institutes of Health Stroke Scale, modified Rankin Score, and the documented degree of stenosis (ORS). The ORS was compared to the RMS, derived from a panel of expert clinicians.Results: A total of 68 angiograms were reviewed from 39 symptomatic and 29 asymptomatic patients. The RMS values demonstrated excellent agreement with an intra-class correlation of 0.80. The median ORS was 90.0% (IQR 80.0, 90.0) versus a median RMS of 61.1% (IQR 49.8, 73.6), with a median difference of 21.8% (IQR 13.7, 34.4), p < 0.001. This discrepancy persisted within several subpopulations and was larger among asymptomatic patients and those treated at facilities granted delayed accreditation. Based on RMS values, 72% of symptomatic patients and only 10% of asymptomatic patients would meet the Centers for Medicare and Medicaid Services criteria for carotid stent placement.Conclusions: Real world operators tend to overestimate cervical carotid artery stenosis compared to external expert reviewers. Since decisions regarding carotid revascularization are often based at least partially on percent stenosis, such measuring discrepancies inevitably lead to a higher volume of procedures, which may in turn represent a degree of procedural over utilization.
Comparison of the ABC/2 Estimation Technique to Computer-Assisted Volumetric Analysis of Intraparenchymal and Subdural Hematomas Complicating the GUSTO-1 Trial
- James M. Gebel,
- Cathy A. Sila,
- Michael A. Sloan,
- Christopher B. Granger,
- Joseph P. Weisenberger,
- Cindy L. Green,
- Eric J. Topol and
- Kenneth W. Mahaffey
Stroke Volume 29, Issue 91 September 1998

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Background and Purpose—The volume of an intracerebral hemorrhage has been shown to be an important independent predictor of mortality in several reports.¹²³⁴⁵ A technique for estimating hematoma volume, known as the ABC/2 method, has been proven a reliable, simple bedside technique for the volume measurement of intraparenchymal intracerebral hemorrhage.⁶⁷⁸ Subdural hematomas also carry a significant mortality risk but are more amenable to surgical evacuation. A reliable, simple bedside measurement of subdural hematoma volume may prove a valuable tool in prognostication and management of patients with this entity.Methods—Computed tomographic (CT) brain scans of 244 patients suffering from intracranial hemorrhage in the GUSTO-1 trial were systematically reviewed. The volumes of 298 intraparenchymal hematomas were measured by the ABC/2 technique, and the volumes of 44 subdural hematomas were measured by an adaptation of this technique and compared to computer-assisted volumetric analysis.Results—Excellent correlation between the techniques were achieved for both subdural (r=0.842; slope, 0.982) and intraparenchymal hematoma volume measurements (r=0.929; slope, 1.11).Conclusions—The ABC/2 method is a simple and accurate technique for the measurement of intraparenchymal hematoma volume, and a simple adaptation allows for a similarly accurate measurement of subdural hematoma volume as well.
Cooling for Acute Ischemic Brain Damage (COOL AID): An Open Pilot Study of Induced Hypothermia in Acute Ischemic Stroke
- Derk W. Krieger,
- Michael A. De Georgia,
- Alex Abou-Chebl,
- John C. Andrefsky,
- Cathy A. Sila,
- Irene L. Katzan,
- Marc R. Mayberg and
- Anthony J. Furlan
Stroke Volume 32, Issue 81 August 2001

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Background and Purpose— Hypothermia is effective in improving outcome in experimental models of brain infarction. We studied the feasibility and safety of hypothermia in patients with acute ischemic stroke treated with thrombolysis.Methods— An open study design was used. All patients presented with major ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score >15) within 6 hours of onset. After informed consent, patients with a persistent NIHSS score of >8 were treated with hypothermia to 32±1°C for 12 to 72 hours depending on vessel patency. All patients were monitored in the neurocritical care unit for complications. A modified Rankin Scale was measured at 90 days and compared with concurrent controls.Results— Ten patients with a mean age of 71.1±14.3 years and an NIHSS score of 19.8±3.3 were treated with hypothermia. Nine patients served as concurrent controls. The mean time from symptom onset to thrombolysis was 3.1±1.4 hours and from symptom onset to initiation of hypothermia was 6.2±1.3 hours. The mean duration of hypothermia was 47.4±20.4 hours. Target temperature was achieved in 3.5±1.5 hours. Noncritical complications in hypothermia patients included bradycardia (n=5), ventricular ectopy (n=3), hypotension (n=3), melena (n=2), fever after rewarming (n=3), and infections (n=4). Four patients with chronic atrial fibrillation developed rapid ventricular rate, which was noncritical in 2 and critical in 2 patients. Three patients had myocardial infarctions without sequelae. There were 3 deaths in patients undergoing hypothermia. The mean modified Rankin Scale score at 3 months in hypothermia patients was 3.1±2.3.Conclusion— Induced hypothermia appears feasible and safe in patients with acute ischemic stroke even after thrombolysis. Refinements of the cooling process, optimal target temperature, duration of therapy, and, most important, clinical efficacy, require further study.
Decreased Perihematomal Edema in Thrombolysis-Related Intracerebral Hemorrhage Compared With Spontaneous Intracerebral Hemorrhage
- James M. Gebel,
- Thomas G. Brott,
- Cathy A. Sila,
- Thomas A. Tomsick,
- Edward Jauch,
- Shelia Salisbury,
- Jane Khoury,
- Rosemary Miller,
- Arthur Pancioli,
- John E. Duldner,
- Eric J. Topol and
- Joseph P. Broderick
Stroke Volume 31, Issue 31 March 2000

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Background and Purpose—Intracerebral hemorrhage (ICH) is a highly morbid disease process. Perihematomal edema is reported to contribute to clinical deterioration and death. Recent experimental observations indicate that clotting of the intrahematomal blood is the essential prerequisite for hyperacute perihematomal edema formation rather than blood-brain barrier disruption.Methods—We compared a series of patients with spontaneous ICH (SICH) to a series of patients with thrombolysis-related ICH (TICH). All patients were imaged within 3 hours of clinical onset. We reviewed relevant neuroimaging features, emphasizing and quantifying perihematomal edema. We then analyzed clinical and radiological differences between the 2 ICH types and determined whether these factors were associated with perihematomal edema.Results—TICHs contained visible perihematomal edema less than half as often as SICHs (31% versus 69%, P<0.001) and had both lower absolute edema volumes (0 cc [25th, 75th percentiles: 0, 6] versus 6 cc [0, 13], P<0.0001) and relative edema volumes (0.16 [0.10, 0.33] versus 0.55 [0.40, 0.83], P<0.0001). Compared with SICHs, TICHs were 3 times larger in volume (median [25th, 75th percentiles] volume 69 cc [30, 106] versus 21 cc [8, 45], P<0.0001), 4 times more frequently lobar in location (62% versus 15%, P<0.001), 80 times more frequently contained blood-fluid level(s) (86% versus 1%, P<0.001), and were more frequently multifocal (22% versus 0%, P<0.001).Conclusions—The striking qualitative and quantitative lack of perihematomal edema observed in the thrombolysis-related ICHs compared with the SICHs provides the first substantial, although indirect, human evidence that intrahematomal blood clotting is a plausible pathogenetic factor in hyperacute perihematomal edema formation.
Abstract W P172: Baseline Quality of Life and Risk of Stroke in the Antihypertensive and Lipid Lowering to Prevent Heart Attack (ALLHAT) Trial
- Tanzila Shams,
- Alexander P Auchus,
- Suzanne Oparil,
- Clinton Wright,
- Jackson Wright,
- Anthony J Furlan,
- Cathy A Sila,
- Barry Davis,
- Sara Pressel,
- Jose-Miguel Yamal,
- Paula Einhorn,
- Jeff Cutler and
- Alan J Lerner
Stroke Volume 46, Issue suppl_11 February 2015

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Background: Quality of Life (QoL) is an integrative health status measure that may predict medical outcomes. No prospective study assessed relationship between QoL, subsequent stroke risk, and post-stroke outcome.Objective: Determine how baseline QoL predicted non-fatal stroke, as well as the impact of stroke risk factors on QoL in ALLHAT using visual analogue scale (VAS) – a validated QoL tool. Methods: ALLHAT randomized hypertensive patients to Chlorthalidone (C), Amlodipine (A) or Lisinopril (L), and used VAS to measure global QoL (0.00 -1.00) at baseline, 2, 4, and 6 yrs. QoL values underwent statistical Torrance transformation (TQoL). Mean QoL and TQoL pre (baseline) and post non-fatal stroke were analyzed. Hazard ratios (HR) and Kaplan-Meier curves for each quartile of baseline QoL were calculated. Baseline QOL, TQoL, and stroke risk factors were used in a multiple linear regression model to predict post-stroke QoL. QoL changes were examined by study arm, age, gender, and race.Results: 28,534 (86%) participants completed at least one VAS. Of the 1,517 strokes; 22% (n=322) were fatal. QoL and TQoL results were similar. Patients who experienced in-trial stroke in C and A arms had lower baseline QoL than those who did not (HR =.71 vs .74, p<0.001and .71 vs .74, p=0.004, respectively), but not in L (HR=.73 vs .74, p=0.24). A 10% increment in baseline QoL or TQoL was associated with 5% and 7% reduction in the risk of stroke respectively (adjusted HR; 95% CI = .95; .91 -.99) and .93; .89 –.98). In risk factor adjusted models, lowest baseline QoL quartile had a 20% higher stroke risk (HR =1.20; 95% CI: 1.00-1.44) than highest quartile. QoL worsened post stroke, dropping most in elderly >75 yrs (-.08 units, p<0.0001), compared to groups 55-64 (-.04, p<0.05) and 65-75 yrs, (-.07, p <0.0001), and in A arm (-.09 units, p<0.0001) compared with C (-.05, p=0.0006) and L (-.07, p< 0.0001), but did not differ by gender or race. In a multiple linear regression model, baseline QoL predicted post-stroke QoL.Conclusions: Lower baseline QoL was associated with higher stroke risk. Qol was lower post stroke. Baseline QoL was the only factor predicting post stroke QoL, and QoL change increased with age. Investigation of factors determining QoL may be fertile ground for stroke risk reduction.
Abstract WP56: Improvement In Motor And Language Domains Mediates Most Of The Effect Of 24h NIHSS Improvement On Functional Independence
- Deep Pujara,
- Leonid Churilov,
- Ameer E Hassan,
- Michael G Abraham,
- clark sitton,
- Kelsey R Duncan,
- Faisal Al-Shaibi,
- Faris Shaker,
- Sophia Sundararajan,
- Cathy A Sila,
- Gregory W Albers,
- Bruce Campbell and
- Amrou Sarraj
Stroke Volume 54, Issue Suppl_11 February 2023

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Introduction: Improvement in NIH stroke scale scores on 24h follow-up is considered a key prognostic element after endovascular thrombectomy (EVT). We aimed to evaluate the proportion of effect of 24h NIHSS improvement on mRS 0-2 at 90d mediated through improvement in motor and language domains.Methods: From SELECT study, EVT patients with detailed NIHSS components on presentation and 24h follow-up as well as complete mRS on discharge and 90d were selected. Motor improvement was defined as ≥2 point in cumulative arms and legs score or 0 score at 24h and language improvement was defined as ≥1 point in cumulative aphasia and dysarthria scores at 24h. Mediation analysis framework using 4-step method (Figure 1a) was used to evaluate the effect of 24h NIHSS improvement mediated through improvement in motor and language scores.Results: Of 192 eligible EVT patients, 176 demonstrated motor deficits and 187 demonstrated language deficits. 24h NIHSS improvement was significantly associated with mRS 0-2 (aOR:1.15[1.07-1.23], p<0.001) - step 1. 24h NIHSS improvement was also significantly associated with motor (aOR:1.77[1.48-2.12],p<0.001) and speech improvement (aOR:1.25[1.16-1.36],p<0.001) - step 2. In the full model, motor (aOR:3.00[1.07-8.46],p=0.037) and speech improvement (aOR:3.15[1.37-7.27],p=0.007) were significantly associated with mRS 0-2, whereas 24h NIHSS improvement was no longer a significant predictor (aOR:1.05[0.96-1.15],p=0.33) - step 3 of figure 1a. Motor improvement mediated 68% and speech improvement mediated 27% of the association of 24h NIHSS improvement with mRS 0-2 (Figure 1b) - step 4.Conclusions: Almost all (~95%) of the effect of 24h NIHSS improvement on functional independence (mRS 0-2) was mediated through specific improvement in motor and language domains, suggesting a large role of improvement in motor and language domains in achieving better functional independence. Further studies are needed to confirm the findings.
Extended-Release Niacin Therapy and Risk of Ischemic Stroke in Patients With Cardiovascular Disease: The Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcome (AIM–HIGH) Trial
- Koon K. Teo,
- Larry B. Goldstein,
- Bernard R. Chaitman,
- Shannon Grant,
- William S. Weintraub,
- David C. Anderson,
- Cathy A. Sila,
- Salvador Cruz-Flores,
- Robert J. Padley,
- William J. Kostuk and
- William E. Boden
and on behalf of the AIM-HIGH Investigators

Stroke Volume 44, Issue 101 October 2013

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Background and Purpose—In Atherothrombosis Intervention in Metabolic Syndrome with low HDL/High Triglycerides: Impact on Global Health Outcomes (AIM-HIGH) trial, addition of extended-release niacin (ERN) to simvastatin in participants with established cardiovascular disease, low high-density lipoprotein cholesterol, and high triglycerides had no incremental benefit, despite increases in high-density lipoprotein cholesterol. Preliminary analysis based on incomplete end point adjudication suggested increased ischemic stroke risk among participants randomized to ERN.Methods—This final analysis was conducted after complete AIM-HIGH event ascertainment to further explore potential relationship between niacin therapy and ischemic stroke risk.Results—There was no group difference in trial primary composite end point at a mean 36-month follow-up among 3414 patients (85% men; mean age, 64±9 years) randomized to simvastatin plus ERN (1500–2000 mg/d) versus simvastatin plus matching placebo. In the intention-to-treat analysis, there were 50 fatal or nonfatal ischemic strokes: 18 (1.06%) in placebo arm versus 32 (1.86%) in ERN arm (hazard ratio [HR], 1.78 [95% confidence interval {CI}, 1.00–3.17; P=0.050). Multivariate analysis showed independent associations between ischemic stroke risk and >65 years of age (HR, 3.58; 95% CI, 1.82–7.05; P=0.0002), history of stroke/transient ischemic attack/carotid disease (HR, 2.18; 95% CI, 1.23–3.88; P=0.0079), elevated baseline Lp(a) (HR, 2.80; 95% CI, 1.25–6.27 comparing the middle with the lowest tertile; HR, 2.31; 95% CI, 1.002–5.30 comparing the highest with the lowest tertile; overall P=0.042) but a nonsignificant association with ERN (HR, 1.74; 95% CI, 0.97–3.11; P=0.063).Conclusions—Although there were numerically more ischemic strokes with addition of ERN to simvastatin that reached nominal significance, the number was small, and multivariable analysis accounting for known risk factors did not support a significant association between niacin and ischemic stroke risk.Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00120289.
Baseline Quality of Life and Risk of Stroke in the ALLHAT Study (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial)
- Tanzila Shams,
- Alexander P. Auchus,
- Suzanne Oparil,
- Clinton B. Wright,
- Jackson Wright,
- Anthony J. Furlan,
- Cathy A. Sila,
- Barry R. Davis,
- Sara Pressel,
- Jose-Miguel Yamal,
- Paula T. Einhorn and
- Alan J. Lerner
and for the ALLHAT Collaborative Research Group

Stroke Volume 48, Issue 111 November 2017

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Background and Purpose—The visual analogue scale is a self-reported, validated tool to measure quality of life (QoL). Our purpose was to determine whether baseline QoL predicted strokes in the ALLHAT study (Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial) and evaluate determinants of poststroke change in QoL. In the ALLHAT study, among the 33 357 patients randomized to treatment arms, 1525 experienced strokes; 1202 (79%) strokes were nonfatal. This study cohort includes 32 318 (97%) subjects who completed the baseline visual analogue scale QoL estimate.Methods—QoL was measured on a visual analogue scale and adjusted using a Torrance transformation (transformed QoL [TQoL]). Kaplan–Meier curves and adjusted proportional hazards analyses were used to estimate the effect of TQoL on the risk of stroke, on a continuous scale (0–1) and by quartiles (≤0.81, >0.81≤0.89, >0.89≤0.95, >0.95). We analyzed the change from baseline to first poststroke TQoL using adjusted linear regression.Results—After adjusting for multiple stroke risk factors, the hazard ratio for stroke events for baseline TQoL was 0.93 (95% confidence interval, 0.89–0.98) per 0.1 U increase. The lowest baseline TQoL quartile had a 20% increased stroke risk (hazard ratio=1.20 [95% confidence interval, 1.00–1.44]) compared with the reference highest quartile TQoL. Poststroke TQoL change was significant within all treatment groups (P≤0.001). Multivariate regression analysis revealed that baseline TQoL was the strongest predictor of poststroke TQoL with similar results for the untransformed QoL.Conclusions—The lowest baseline TQoL quartile had a 20% higher stroke risk than the highest quartile. Baseline TQoL was the only factor that predicted poststroke change in TQoL.Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000542.
Cryptogenic Stroke in Relation to Genetic Variation in Clotting Factors and Other Genetic Polymorphisms Among Young Men and Women
- Harland Austin,
- Marc I. Chimowitz,
- Holly A. Hill,
- Seemant Chaturvedi,
- Lawrence R. Wechsler,
- Robert J. Wityk,
- Elizabeth Walz,
- Janet L. Wilterdink,
- Bruce Coull,
- Cathy A. Sila,
- Panos Mitsias,
- Bruce Evatt,
- W. Craig Hooper
Stroke Volume 33, Issue 121 December 2002

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Background and Purpose— The purpose of the present study was to compare the prevalences of genetic polymorphisms in persons with cryptogenic stroke with those among stroke patients with evidence of large-artery occlusive disease or an unequivocal cardioembolic source (noncryptogenic stroke).Methods— We compared the prevalences of genetic polymorphisms thought to be related to thrombi formation in young stroke patients with evidence of large-artery occlusive disease or an unequivocal cardioembolic source (noncryptogenic stroke; controls; n=79) with those in young stroke patients without such sources (cryptogenic stroke; cases; n=67). Common variations in the genes encoding factor V, prothrombin, angiotensin I–converting enzyme, 5,10-methylenetetrahydrofolate reductase, endothelial cell nitric oxide synthase, tissue plasminogen activator, plasminogen activator inhibitor–1, and fibrinogen were evaluated. We also compared the allele prevalence of these genes among all stroke patients with those among a large pool of historical controls assayed for these genes.Results— None of these genetic polymorphisms was statistically significantly related to cryptogenic stroke. With respect to a comparison of all ischemic stroke with historical controls, only the prevalence of tissue plasminogen activator D allele among stroke subjects was statistically significantly higher than that of the historical controls (P=0.0014).Conclusions— These findings generally do not support the hypothesis that genes associated with a prothrombotic state are risk factors among a subgroup of young people with stroke of undetermined cause. Except for the D tissue plasminogen activator allele, the findings also indicated that these genetic factors are unrelated, or only weakly related, to all ischemic stroke.
Abstract 208: No Independent Association Between Extended-Release Niacin (ERN) Therapy and Ischemic Stroke in Patients with Established Cardiovascular Disease: A Detailed Analysis from the AIM HIGH Trial
- Koon Teo,
- Larry B Goldstein,
- Bernard R Chaitman,
- Shannon Grant,
- William S Weintraub,
- David C Anderson,
- Cathy A Sila,
- Salvador Cruz-Flores,
- Robert J Padley,
- William J Kostuk,
- Todd J Anderson and
- William E Boden
Stroke Volume 44, Issue suppl_11 February 2013

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Background: Statins reduce cardiovascular (CV) events and stroke by 20-25% in both patients with established cardiovascular disease (CVD) and in asymptomatic patients at high risk for CVD. Meta-analyses also show that niacin reduces major CV events by 25% and stroke by 27%. In AIM HIGH, which evaluated the addition of extended-release niacin (ERN) to simvastatin in patients with established CV disease and low baseline levels of HDL-C, we observed an unexpected increased rate of ischemic stroke in those randomized to ERN. The present analysis explores possible reasons for the observed numerical excess of ERN-associated stroke.Methods and Results: Among 3,414 patients (85% male; mean age: 64±9 years) randomized to simvastatin + ERN (1,500-2,000mg/day or matching placebo to achieve an on-treatment LDL-C target of 40-80mg/dL), there was no difference in the trial’s composite primary endpoint at a mean 36-month follow-up. This included 50 fatal or non-fatal ischemic strokes, of which 18 (1.85%) occurred in the placebo arm and 32 (2.3%) in the niacin arm (age-adjusted HR 1.78; 95% CI 1.00-3.17, p=0.050). Multivariate step-wise analyses showed strong associations between ischemic stroke risk and age > 65 (HR 3.60 95% CI 1.83-7.09, p=0.0002) and history of stroke/TIA/carotid disease (HR 2.19 95% CI 1.23-3.90, p=0.0075), a moderate association with Lp(a) (HR 2.80, 95%CI 1.25 - 6.27, p=.012 comparing the middle to the lowest tertile), but an insignificant association between ischemic stroke and ERN (HR 1.74 95% CI .97-3.11, p=0.063).Conclusion: Although there was a numerical excess in ischemic strokes associated with the addition of ERN to simvastatin, the number of events was small and multivariable analysis accounting for known risk factors revealed no significant association between niacin treatment and subsequent ischemic stroke risk.
Thrombolysis-Related Intracranial Hemorrhage : A Radiographic Analysis of 244 Cases From the GUSTO-1 Trial With Clinical Correlation
Stroke Volume 29, Issue 31 March 1998

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Background and Purpose—Intracranial hemorrhage (ICH) is a serious complication of thrombolytic therapy. We systematically reviewed the radiographic features of 244 cases of symptomatic ICH complicating thrombolysis for acute myocardial infarction in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-1) trial, correlated these observations with clinical data, and speculated on hemorrhage pathogenesis.Methods—CT scans from 244 patients suffering symptomatic ICH were systematically reviewed for selected radiographic features, including ICH type, location, hematoma characteristics, mass effect features, hydrocephalus, and preexisting lesions. Hematoma volume was estimated by computer-assisted volumetric analysis. Data from this analysis were correlated with clinical data including hypertension, anticoagulation, age, thrombolytic regimen, and ICH timing.Results—Most hemorrhages were large (median [25th, 75th percentile] volume, 72 mL [39, 118]), solitary (66%), lobar (77%), confluent (80%), and intraparenchymal (82%) with a blood/fluid level (82%) and little edema (median [25th, 75th percentile] volume, 9 mL [5, 16]). Hydrocephalus (P<.001), any one mass effect feature (P<.001), intraventricular hemorrhage (P=.022), mottled hematoma appearance (P=.050), and hematoma blood/fluid level (P<.001) were associated with higher hemorrhage volume in the radiographic analysis, as were older age (P=.005), treatment with combined streptokinase and tissue plasminogen activator (P=.034), and hemorrhage onset 8 to13 hours after treatment (P=.008) in the clinical analysis. Subdural hemorrhage was a high-volume subgroup whose risk increased with antecedent trauma (P=.026) or syncope (P=.006). Deep intraparenchymal hemorrhage was associated with hypertension (P=.016), and multifocal ICH occurred significantly earlier after treatment (P=.002).Conclusions—Although the majority of postthrombolytic ICH are large, solitary, and supratentorial, the spectrum is diverse. Features of mass effect reflected the large volumes, and hematoma characteristics of mottling and blood/fluid levels were frequent. Thrombolysis-related coagulopathy and age appear to be the most important identifiable factors in the genesis of postthrombolytic ICH, but the hemorrhage subtype seen may reflect an interaction with other factors such as hypertension, ICH timing, antecedent head trauma, and syncope.
Prediction of 30-Day Mortality Among Patients With Thrombolysis-Related Intracranial Hemorrhage
Circulation Volume 98, Issue 146 October 1998

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Background—Limited information exists on risk factors for mortality after thrombolysis-related intracranial hemorrhage. We wished to determine the characteristics associated with 30-day mortality after thrombolysis-related intracranial hemorrhage.Methods and Results—We performed an observational analysis within a randomized trial of 4 thrombolytic therapies, conducted in 1081 hospitals in 15 countries. Patients presented with ST-segment elevation within 6 hours of symptom onset. Our population was composed of the 268 patients who had primary intracranial hemorrhage after thrombolysis. With univariable and multivariable analyses, we identified clinical and brain imaging characteristics that would predict 30-day mortality among these patients. CT or MRI were available for 240 patients (90%). The 30-day mortality rate was 59.7%. Glasgow Coma Scale score, age, time from thrombolysis to symptoms of intracranial hemorrhage, hydrocephalus, herniation, mass effect, intraventricular extension, and volume and location of intracranial hemorrhage were significant univariable predictors. Multivariable analysis of 170 patients with complete data, 98 of whom died, identified the following independent, significant predictors: Glasgow Coma Scale score (χ², 19.3; P<0.001), time from thrombolysis to intracranial hemorrhage (χ², 15.8; P<0.001), volume of intracranial hemorrhage (χ², 11.6; P<0.001), and baseline clinical predictors of mortality in the overall GUSTO-I trial (χ², 10.3; P=0.001). The final model had a C-index of 0.931.Conclusions—This model provides excellent discrimination between patients who are likely to live and those who are likely to die after thrombolytic-related intracranial hemorrhage; this may aid in making decisions about the appropriate level of care for such patients.
Predictors of Ischemic Stroke in the Territory of a Symptomatic Intracranial Arterial Stenosis
Circulation Volume 113, Issue 431 January 2006

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Background— Antithrombotic therapy for intracranial arterial stenosis was recently evaluated in the Warfarin versus Aspirin for Symptomatic Intracranial Disease (WASID) trial. A prespecified aim of WASID was to identify patients at highest risk for stroke in the territory of the stenotic artery who would be the target group for a subsequent trial comparing intracranial stenting with medical therapy.Methods and Results— WASID was a randomized, double-blinded, multicenter trial involving 569 patients with transient ischemic attack or ischemic stroke due to 50% to 99% stenosis of a major intracranial artery. Median time from qualifying event to randomization was 17 days, and mean follow-up was 1.8 years. Multivariable Cox proportional hazards models were used to identify factors associated with subsequent ischemic stroke in the territory of the stenotic artery. Subsequent ischemic stroke occurred in 106 patients (19.0%); 77 (73%) of these strokes were in the territory of the stenotic artery. Risk of stroke in the territory of the stenotic artery was highest with severe stenosis ≥70% (hazard ratio 2.03; 95% confidence interval 1.29 to 3.22; P=0.0025) and in patients enrolled early (≤17 days) after the qualifying event (hazard ratio 1.69; 95% confidence interval 1.06 to 2.72; P=0.028). Women were also at increased risk, although this was of borderline significance (hazard ratio 1.59; 95% confidence interval 1.00 to 2.55; P=0.051). Location of stenosis, type of qualifying event, and prior use of antithrombotic medications were not associated with increased risk.Conclusions— Among patients with symptomatic intracranial stenosis, the risk of subsequent stroke in the territory of the stenotic artery is greatest with stenosis ≥70%, after recent symptoms, and in women.

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