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Treatment of Thrombus Formation Associated With the MicroMed DeBakey VAD Using Recombinant Tissue Plasminogen Activator
- Markus Rothenburger,
- Markus J. Wilhelm,
- Dieter Hammel,
- Christoph Schmidt,
- Tonny D. T. Tjan,
- Dirk Böcker,
- Hans H. Scheld and
- Christof Schmid
Circulation Volume 106, Issue 12_suppl_124 September 2002

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Background The latest generation of left ventricular assist devices consists of nonpulsatile impeller pumps. In these small pumps, thrombus formation inside the device does not lead to thromboembolic end-organ dysfunction but may dramatically impair pump flow. We report on our experience with thrombus-related pump dysfunctions of the MicroMed DeBakey left ventricular assist device and its treatment.Methods Eight of 22 patients with a MicroMed DeBakey VAD presented with a critically reduced pump flow. In 7 cases, an increased power demand indicative of progressive thrombus formation associated with the device was evident, whereas 1 case presented with thrombus formation within the inflow conduit associated with a very low power demand. Brief spontaneously resolving pump stops had been noted in 6 patients. All 8 patients were treated with 100 mg of recombinant tissue plasminogen activator (rt-PA), administered via an IV line.Results Rt-PA lysis led to an increase of pump flow along with a reduction of power demand within a short time in all patients. No severe bleeding complications occurred. However, 4 patients experienced transient epistaxis. All patients could be discharged from intensive care immediately after discontinuation of thrombolytic therapy.Conclusion Rt-PA lysis is a very effective tool for thrombus-related pump dysfunction in patients with impeller pumps, which renders emergency surgical exchange unnecessary in most cases.
Morning Resistance to Thrombolytic Therapy
- Eugene Braunwald
Circulation Volume 91, Issue 51 March 1995

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Toward a New Frontier in Myocardial Reperfusion Therapy : Emerging Platelet Preeminence
- Eric J. Topol
Circulation Volume 97, Issue 220 January 1998

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Can Transcranial Ultrasonication Increase Recanalization Flow With Tissue Plasminogen Activator?
- Toshihiro Ishibashi,
- Masahiko Akiyama,
- Hisashi Onoue,
- Toshiaki Abe and
- Hiroshi Furuhata
Stroke Volume 33, Issue 51 May 2002

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Background and Purpose— In thrombolytic therapy for acute ischemic stroke, it is essential to obtain rapid thrombolysis before ischemic neuronal injury occurs. To develop a new technique of thrombolysis for acute ischemic stroke, the effect of transcranially applied ultrasound (TUS) on thrombolysis was examined.Methods— An occlusion model of rabbit femoral artery was produced with thrombin after establishment of stenotic flow and endothelial damage. After stable occlusion was confirmed, monteplase (mtPA) was administered intravenously, and ultrasound (490 kHz, 0.13 W/cm²) was applied through a piece of temporal bone (TUS group; n=9). The control group received mtPA alone (tissue plasminogen activator [tPA] group; n=12). To verify the efficacy of TUS, femoral artery flow was measured during the procedure.Results— The recanalization ratio was 16.7% (2 of 12) in the tPA group and 66.7% (6 of 9) in the TUS group. The recanalization ratio in the TUS group was higher than that in the tPA group (P=0.03). Patency flow ratio, which was defined as recanalization flow divided by baseline flow, of the TUS group (44.6±13.9%) was significantly greater than that of the tPA group (9.9±6.8%) at 60 minutes (P=0.025). Patency flow ratio became higher in the TUS group than in the tPA group between 20 and 30 minutes from the start of thrombolysis.Conclusions— Low-frequency and low-intensity TUS enhanced thrombolysis by mtPA in a rabbit femoral artery occlusion model. This technique should be clinically useful for thrombolysis in acute ischemic stroke.
Acute Basilar Artery Occlusion Treated With Combined Intravenous Abciximab and Intra-arterial Tissue Plasminogen Activator: Report of 3 Cases
- Bernd Eckert,
- Christoph Koch,
- Götz Thomalla,
- Joachim Roether and
- Herrmann Zeumer
Stroke Volume 33, Issue 51 May 2002

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Background— Acute vertebrobasilar occlusion remains a disease with a high mortality even after treatment by local intra-arterial fibrinolysis. Adjunctive treatment with platelet glycoprotein IIb/IIIa receptor inhibitors such as abciximab may facilitate recanalization and improve the neurological outcome. Results after treatment of 3 patients by combined intravenous abciximab and local intra-arterial tissue plasminogen activator (tPA) are reported.Case Descriptions— Treatment was performed within 6 hours of stroke onset. Angiography revealed embolic occlusion of the basilar artery in 2 patients and atherothrombotic occlusion at the vertebrobasilar junction in 1 patient. Therapy consisted of intravenous abciximab bolus administration (0.25 mg/kg) followed by 12-hour infusion therapy (0.125 μg/kg per minute) and local intra-arterial thrombolysis with tPA (10 mg/h). Heparin was only applied for catheter flushing (500 IU/h). The patient with the atherothrombotic occlusion was treated with additional percutaneous transluminal angioplasty and stenting. Complete recanalization of the basilar artery occurred in 2 patients, whose conditions improved clinically to functional independence. In the third patient only partial recanalization was seen, with only slight clinical improvement. This patient died of cardiac failure 2 months later. Besides a subtle subarachnoid hemorrhage (n=1), no intracranial or extracranial bleeding complication was observed.Conclusions— The combination of glycoprotein IIb/IIIa receptor inhibitor with local intra-arterial tPA might be a promising therapy for patients with acute vertebrobasilar occlusion. Further studies are necessary to define the clinical benefit and the bleeding rate of this new pharmacological approach.
Early Dramatic Recovery During Intravenous Tissue Plasminogen Activator Infusion: Clinical Pattern and Outcome in Acute Middle Cerebral Artery Stroke
- Robert A. Felberg,
- Nicholas J. Okon,
- Ashraf El-Mitwalli,
- W. Scott Burgin,
- James C. Grotta and
- Andrei V. Alexandrov
Stroke Volume 33, Issue 51 May 2002

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Background and Purpose— Acute-stroke patients receiving standard intravenous tissue plasminogen activator (tPA) have been noted to experience early dramatic recoveries. The prevalence, clinical characteristics, and outcome of patients experiencing dramatic recovery is not well described.Methods— We prospectively studied all patients presenting with acute middle cerebral artery (MCA) stroke syndromes and transcranial Doppler (TCD) evidence of an MCA obstruction. All patients received intravenous tPA per the National Institute of Neurological and Communicative Disorders and Stroke protocol, with serial National Institutes of Health Stroke Scale (NIHSS) scores and continuous TCD monitoring. Dramatic recovery was defined as an improvement of ≥10 NIHSS points or a decrease to an NIHSS score of ≤3 by the end of infusion. Outcome at the end of infusion, at 24 hours, and at long-term follow-up were obtained. The timing and pattern of deficit recovery during dramatic recovery was also studied.Results— Dramatic recovery occurred in 22% of all patients. Compared with patients who did not experience dramatic recovery, those patients who did had significantly lower end-infusion NIHSS (median 2 and range 0 to 16 for dramatic-recovery patients versus median 17 and range 6 to 35 for non–dramatic-recovery patients, P<0.01) and 24-hour NIHSS (median 2 and range 0 to 16 for dramatic-recovery patients versus median 13 and range 2 to 35 for non–dramatic-recovery patients, P<0.01). A long-term modified Rankin Score benefit was noted (median 1 and range 0 to 6 for dramatic-recovery patients versus median 4 and range 0 to 6 for non–dramatic-recovery patients, P<0.01). Baseline clinical characteristics were similar. The only difference was improved TCD-determined flow values at the end of infusion (normal restoration of flow was 58% in dramatic-recovery patients versus 14% in non–dramatic-recovery patients, P<0.01). A characteristic pattern of recovery of deficit was noted.Conclusions— Early dramatic recovery in acute MCA stroke patients treated with intravenous tPA is relatively frequent. The benefit of dramatic recovery is maintained at 24 hours and over the long term. TCD monitoring suggests that dramatic recovery is a result of early restoration of MCA flow during the tPA infusion. The consistent pattern of early clinical recovery may help explain the mechanisms by which thrombolysis improves outcome and could suggest targets for enhancing the therapeutic effect of intravenous tPA.
Intra-Arterial Thrombolysis in 100 Patients With Acute Stroke Due to Middle Cerebral Artery Occlusion
- Marcel Arnold,
- Gerhard Schroth,
- Krassen Nedeltchev,
- Thomas Loher,
- Luca Remonda,
- Frank Stepper,
- Matthias Sturzenegger and
- Heinrich P. Mattle
Stroke Volume 33, Issue 71 July 2002

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Background and Purpose— The purpose of this study was to evaluate the safety and efficacy of local intra-arterial thrombolysis (LIT) using urokinase in patients with acute stroke due to middle cerebral artery (MCA) occlusion.Methods— We analyzed clinical and radiological findings and functional outcome 3 months after LIT with urokinase of 100 consecutive patients. To measure outcome, the modified Rankin scale (mRs) score was used.Results— Angiography showed occlusion of the M₁ segment of the MCA in 57 patients, of the M₂ segment in 21, and of the M₃ or M₄ segment in 22. The median National Institutes of Health Stroke Scale (NIHSS) score at admission was 14, and, on average, 236 minutes elapsed from symptom onset to LIT. Forty-seven patients (47%) had an excellent outcome (mRs score 0 to 1), 21 (21%) a good outcome (mRs score 2), and 22 (22%) a poor outcome (mRs score 3 to 5). Ten patients (10%) died. Excellent or good outcome (mRs score ≤2) was seen in 59% of patients with M₁ or M₂ and 95% of those with M₃ or M₄ MCA occlusions. Recanalization as seen on angiography was complete (thrombolysis in myocardial infarction [TIMI] grade 3) in 20% of patients and partial (TIMI grade 2) in 56% of patients. Age <60 years (P<0.05), low NIHSS score at admission (P<0.00001), and vessel recanalization (P=0.0004) were independently associated with excellent or good outcome and diabetes with poor outcome (P=0.002). Symptomatic cerebral hemorrhage occurred in 7 patients (7%).Conclusions— LIT with urokinase that is administered by a single organized stroke team is safe and can be as efficacious as thrombolysis has been in large multicenter clinical trials.
Rapid Breakdown of Microvascular Barriers and Subsequent Hemorrhagic Transformation After Delayed Recombinant Tissue Plasminogen Activator Treatment in a Rat Embolic Stroke Model
- Rick M. Dijkhuizen,
- Minoru Asahi,
- Ona Wu,
- Bruce R. Rosen and
- Eng H. Lo
Stroke Volume 33, Issue 81 August 2002

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Background and Purpose— Thrombolytic therapy with recombinant tissue plasminogen activator (rtPA) after stroke increases risk of hemorrhagic transformation, particularly in areas with blood-brain barrier leakage. Our aim was to characterize acute effects of rtPA administration on the integrity of microvascular barriers.Methods— Stroke was induced in spontaneously hypertensive rats by unilateral embolic middle cerebral artery occlusion. Six hours after stroke, rtPA was intravenously administered (n=10). Controls received saline (n=4). Extravasation of the large-diameter contrast agent monocrystalline iron oxide nanocolloid (MION) was assessed with susceptibility contrast-enhanced MRI during rtPA injection. In addition, we performed perfusion MRI and diffusion-weighted MRI. After MRI, 2 hours after rtPA treatment, intracerebral hemorrhage was quantified with a spectrophotometric hemoglobin assay.Results— Late rtPA treatment resulted in increased hemorrhage volume (8.4±1.7 versus 2.9±0.9 μL in controls; P<0.05). In MION-injected animals, during rtPA administration, transverse relaxation rate change (ΔR₂*) increased from 12.4±6.0 to 31.6±19.2 s⁻¹ (P<0.05) in areas with subsequent hemorrhage. Significant ΔR₂* changes were absent in nonhemorrhagic areas, in animals without injected MION, and in saline-treated animals. Thrombolytic therapy did not improve perfusion in regions with hemorrhagic transformation (cerebral blood flow index was 22.8±19.7% [of contralateral] at 0.5 hours before and 22.4±18.0% at 1 hour after rtPA administration).Conclusions— The ΔR₂* changes during rtPA delivery in MION-injected animals indicate extravasation of MION, which reflects increased permeability of the blood-brain barrier. This implies that late rtPA treatment rapidly aggravates early ischemia-induced damage to microvascular barriers, thereby enhancing hemorrhagic transformation.
Comparison of Admission Perfusion Computed Tomography and Qualitative Diffusion- and Perfusion-Weighted Magnetic Resonance Imaging in Acute Stroke Patients
- M. Wintermark,
- M. Reichhart,
- O. Cuisenaire,
- P. Maeder,
- J.-P. Thiran,
- P. Schnyder,
- J. Bogousslavsky and
- R. Meuli
Stroke Volume 33, Issue 81 August 2002

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Background and Purpose— Besides classic criteria, cerebral perfusion imaging could improve patient selection for thrombolytic therapy. The purpose of this study was to compare quantitative perfusion CT imaging and qualitative diffusion- and perfusion-weighted MRI (DWI and PWI) in acute stroke patients at the time of their emergency evaluation.Methods— Thirteen acute stroke patients underwent perfusion CT and DWI or PWI on admission. The size of infarct and ischemic lesion (infarct plus penumbra) on the admission perfusion CT was compared with that of the MR abnormalities as shown on the DWI trace and on the relative cerebral blood volume, cerebral blood flow, time to peak, and mean transit time maps calculated from PWI studies.Results— The most significant correlation was found between infarct size on the admission perfusion CT and abnormality size on the admission DWI map (r=0.968, P<0.001). A significant correlation was also observed between the size of the ischemic lesion (infarct plus penumbra) on the admission perfusion CT and the abnormality size on the mean transit time map calculated from admission PWI (r=0.946, P<0.001). Information about cerebral infarct and total ischemia (infarct plus penumbra) carried by both imaging techniques was similar, with slopes of 0.913 and 0.905, respectively.Conclusions— An imaging technique may be helpful in the identification of cerebral penumbra in acute stroke patients and thus in the selection of patients for thrombolytic therapy. Perfusion CT and DWI/PWI are equivalent in this task.
Microplasmin: A Novel Thrombolytic That Improves Behavioral Outcome After Embolic Strokes in Rabbits
- Paul A. Lapchak,
- Dalia M. Araujo,
- Steve Pakola,
- Donghuan Song,
- Jiandong Wei and
- Justin A. Zivin
Stroke Volume 33, Issue 91 September 2002

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Background and Purpose— It has been proposed that the novel thrombolytic microplasmin may be useful in the treatment of ischemic stroke. In the present study the effects and safety profile of microplasmin were evaluated in 2 rabbit embolic stroke models that have been used successfully to develop tissue plasminogen activator (tPA) as the only Food and Drug Administration-approved treatment for stroke. The rabbit small clot embolic stroke model (RSCEM) and rabbit large clot embolic stroke model (RLCEM) were used to determine the potential neuroprotective properties and safety profile of microplasmin, respectively, after an embolic stroke.Methods— Rabbits were embolized by injecting small blood clots (RSCEM) or large blood clots (RLCEM) into the cerebral circulation. For the RSCEM, 126 rabbits were included, with behavioral analysis conducted 24 hours later, allowing for determination of the effective stroke dose (ES₅₀) or clot amount (milligrams) that produces severe neurological deficits in 50% of rabbits. For RLCEM safety study analysis, 47 rabbits were included, with postmortem analyses consisting of assessment of hemorrhage and infarct rate and size. In test animals microplasmin was infused intravenously 60 minutes after embolization, whereas control rabbits were given infusions of the saline/Plasma-Lyte vehicle with all assessments performed in a blinded fashion.Results— In the RSCEM, a drug is considered neuroprotective if it significantly increases the ES₅₀ compared with the vehicle-treated control group. The ES₅₀ of the vehicle-treated control group 24 hours after embolization was 1.36±0.42 mg (n=38). Microplasmin, infused starting 60 minutes after embolization, increased the ES₅₀ to 2.32±0.57 (n=21), 1.89±0.48 (n=21), 2.81±0.55 (n=22), and 1.89±0.28 mg (n=24) for the 1-, 2-, 4-, and 8-mg/kg doses, respectively. There was a statistically significant behavioral improvement in the 4-mg/kg dose arm (P=0.040). The microplasmin dose of microplasmin that was statistically significant (4 mg/kg) was subsequently determined to be safe in the RLCEM because it did not increase the incidence of hemorrhages (56%) compared with vehicle-treated rabbits (63%), nor did it significantly alter hemorrhage volume, infarct rate, or infarct volume.Conclusions— The present study shows that microplasmin improves behavioral rating scores in the RSCEM when administered 60 minutes after embolization, at a dose that does not increase hemorrhages in the RLCEM. This is in contrast to tPA, which significantly enhances the hemorrhage rate in the RLCEM.
Effect of Intravenous Thrombolysis on MRI Parameters and Functional Outcome in Acute Stroke <6 Hours
- J. Röther,
- P.D. Schellinger,
- A. Gass,
- M. Siebler,
- A. Villringer,
- J.B. Fiebach,
- J. Fiehler,
- O. Jansen,
- T. Kucinski,
- V. Schoder,
- K. Szabo,
- G.J. Junge-Hülsing,
- M. Hennerici,
- H. Zeumer,
- K. Sartor,
- C. Weiller,
- W. Hacke
Stroke Volume 33, Issue 101 October 2002

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Background and Purpose— The goals of this study were to examine MRI baseline characteristics of patients with acute ischemic stroke (AIS) and to study the influence of intravenous tissue plasminogen activator (tPA) on MR parameters and functional outcome using a multicenter approach.Methods— In this open-label, nonrandomized study of AIS patients with suspected anterior circulation stroke, subjects received a multiparametric stroke MRI protocol (diffusion- and perfusion-weighted imaging and MR angiography) within 6 hours after symptom onset and on follow-up. Patients were treated either with tPA (thrombolysis group) or conservatively (no thrombolysis group). Functional outcome was assessed on day 90 (modified Rankin Score; mRS).Results— We enrolled 139 AIS patients (no thrombolysis group, n=63; thrombolysis group, n=76). Patients treated with tPA were more severely affected (National Institutes of Health Stroke Scale score, 10 versus 13; P=0.002). Recanalization rates were higher in the thrombolysis group (Thrombolysis in Myocardial Infarction criteria 1 through 3 on day 1; 66.2% versus 32.7%; P<0.001). Proximal vessel occlusions resulted in larger infarct volumes and worse outcome (P=0.02). Thrombolysis was associated with a better outcome regardless of the time point of tPA treatment (≤3 hours or 3 to 6 hours) (univariate analysis: mRS ≤2, P=0.017; mRS ≤1, P=0.023). Age (P=0.003), thrombolytic therapy at 0 to 6 hours (P=0.01), recanalization (P=0.016), lesion volume on day 7 (P=0.001), and initial National Institutes of Health Stroke Scale score (P=0.001) affected functional outcome (mRS on day 90) positively (multivariate analysis). The time point of tPA therapy affected the recanalization rate (P=0.024) but not final infarct volume.Conclusions— In this pilot study, tPA therapy had a beneficial effect on vessel recanalization and functional outcome. Multiparametric MRI delineates tissue at risk of infarction in AIS patients, which may be helpful for the selection of patients for tPA therapy. tPA therapy appeared safe and effective beyond a 3-hour time window. This study delivers the rationale for a randomized, MR-based tPA trial.
Thrombolytic Treatment of Clot Embolism in Rat: Comparison of Intra-arterial and Intravenous Application of Recombinant Tissue Plasminogen Activator
- Frank Niessen,
- Thomas Hilger,
- Mathias Hoehn and
- Konstantin-A. Hossmann
Stroke Volume 33, Issue 121 December 2002

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Background and Purpose— We sought to test the hypothesis that intra-arterial recombinant tissue plasminogen activator (rtPA) treatment of thromboembolic stroke is more efficient than intravenous application.Methods— Rats were embolized by intracarotid injection of autologous fibrin-rich blood clots. One hour later rtPA (10 mg/kg) was infused either intravenously (n=8) or intra-arterially (n=8). Control rats (n=8) received intra-arterial infusion of saline. Treatment was monitored by MR perfusion-weighted imaging and apparent diffusion coefficient (ADC) imaging, and outcome was evaluated by comparing incidence of hemorrhages and lesion volumes of ATP and pH.Results— Clot embolism led to a decline of perfusion-weighted imaging signal intensity in the middle cerebral artery territory to <40% of control. Both intra-arterial and intravenous treatment significantly improved blood flow in cerebral cortex but not in caudate putamen. In untreated animals, ATP and pH lesion volumes were 510.3±94.5 and 438.6±39.2 mm³ at 7 hours after clot embolism, respectively. Both intravenous and intra-arterial rtPA treatment produced hemorrhagic complications but reduced ATP lesion size to 296.2±136.1 and 370.3±103.7 mm³ and reduced pH lesion size to 263.3±114.6 and 303.3±103.0 mm³, respectively (P<0.05 for untreated versus treated rats; no difference between intravenous and intra-arterial treatment). ADC imaging revealed that lesion reduction was due to inhibition of infarct growth but not to reversal of primary injury.Conclusions— This study documents reduction of injury by rtPA treatment but does not reveal a difference between intra-arterial and intravenous application. Our data do not support an advantage of intra-arterial thrombolysis.
Analysis of the Safety and Efficacy of Intra-Arterial Thrombolytic Therapy in Ischemic Stroke
- Rejane C. Lisboa,
- Borko D. Jovanovic and
- Mark J. Alberts
Stroke Volume 33, Issue 121 December 2002

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Background and Purpose— Intra-arterial thrombolytic therapy (IAT) may be a treatment option for patients with ischemic stroke. We analyzed the safety and efficacy of IAT on the basis of published data.Methods— We searched computerized databases for studies using IAT in ≥10 patients with ischemic stroke. Some studies had control patients for comparison. Data were collected on age, stroke territory, time to treatment, medication, site of arterial occlusion and recanalization on angiogram, outcomes, and symptomatic intracranial hemorrhage (SICH).Results— The analysis included 27 studies with 852 patients who received IAT and 100 control subjects. There were more favorable outcomes in the IAT than in the control group (41.5% versus 23%, P=0.002), with a lower mortality rate for IAT (IAT, 27.2%; control group, 40%, P=0.004). The IAT group had an odds ratio of 2.4 (95% CI, 1.45 to 3.85) for favorable outcome. SICH was more frequent in the IAT group compared with the control group (9.5% versus 3%, P=0.046). The subgroup of patients receiving a combination of intravenous thrombolytic therapy and IAT had more favorable outcomes than the IAT alone subgroup, but this trend did not reach statistical significance (53.6% versus 41.5%, P=0.1). Among the patients treated with IAT, those who had supratentorial strokes were more likely to have favorable outcomes than those with infratentorial strokes (42.2% versus 25.6%; P=0.001; odds ratio, 2.0; 95% CI, 1.33 to 3.0).Conclusions— IAT for ischemic stroke appears efficacious but carries an increased risk of SICH. Further prospective studies are needed to prove the safety and efficacy of IAT in stroke.
Plasma Metalloproteinase-9 Concentration Predicts Hemorrhagic Transformation in Acute Ischemic Stroke
- Mar Castellanos,
- Rogelio Leira,
- Joaquín Serena,
- José M. Pumar,
- Ignacio Lizasoain,
- José Castillo and
- Antoni Dávalos
Stroke Volume 34, Issue 11 January 2003

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Background and Purpose— Matrix metalloproteinase-9 (MMP-9) activity has been associated with hemorrhagic transformation (HT) in experimental models of cerebral ischemia. Our aim was to investigate the relationship between MMP-9 concentrations in blood within 24 hours of stroke onset and subsequent HT of cerebral infarction.Methods— We studied 250 patients with a hemispheric ischemic stroke of 7.8±4.5 hours’ duration. Early CT signs of cerebral infarction were evaluated on admission. The HT and infarct volume were analyzed from the CT performed on days 4 through 7. MMP-9 levels were determined by enzyme-linked immunosorbent assay in blood samples obtained on admission.Results— HT was observed in 38 patients (15.2%): 24 (63.2%) had a hemorrhagic infarction, and 14 (36.8%) had a parenchymal hematoma. A total of 108 patients (43%) received anticoagulants before the second CT scan. Systolic and diastolic blood pressures, body temperature, frequency of early CT signs of ischemia (92% versus 22%), and treatment with anticoagulants (79% versus 37%) were significantly higher in the group with HT (P<0.001). Mean infarct volume was 126±60 cm³ in the HT group and 90±68 cm³ in the group without HT (P=0.003). Median (quartiles) plasma MMP-9 concentrations were higher in the HT group (193 [163, 213] versus 62 [40, 93] ng/mL, P<0.001), even in the 24 patients seen within 3 hours of symptom onset (P=0.014). MMP-9 levels ≥140 ng/mL had a positive and negative predictive value of HT of 61% and 97%, respectively. MMP-9 ≥140 ng/mL was associated with HT (odds ratio, 12; 95% confidence interval, 3 to 51; P<0.001) after adjustment for potential confounders and final infarct volume.Conclusions— High plasma MMP-9 concentration in the acute phase of a cerebral infarct is an independent biochemical predictor of HT in all stroke subtypes.
Establishing Data Elements for the Paul Coverdell National Acute Stroke Registry: Part 1: Proceedings of an Expert Panel
- Wendy A. Wattigney,
- Janet B. Croft,
- George A. Mensah,
- Mark J. Alberts,
- Timothy J. Shephard,
- Philip B. Gorelick,
- David S. Nilasena,
- David C. Hess,
- Michael D. Walker,
- Daniel F. Hanley,
- Patti Shwayder,
- Meighan Girgus,
- Linda J. Neff,
- Janice E. Williams,
- Darwin R. LaBarthe and
- Janet L. Collins
Stroke Volume 34, Issue 11 January 2003

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Background and Purpose— Stroke is the third-leading cause of death and a leading cause of disability in adults in the United States. In recent years, leaders in the stroke care community identified a national registry as a critical tool to monitor the practice of evidence-based medicine for acute stroke patients and to target areas for continuous quality of care improvements. An expert panel was convened by the Centers for Disease Control and Prevention to recommend a standard list of data elements to be considered during development of prototypes of the Paul Coverdell National Acute Stroke Registry.Methods— A multidisciplinary panel of representatives of the Brain Attack Coalition, professional associations, nonprofit stroke organizations, and federal health agencies convened in February 2001 to recommend key data elements. Agreement was reached among all participants before an element was added to the list.Results— The recommended elements included patient-level data to track the process of delivering stroke care from symptom onset through transport to the hospital, emergency department diagnostic evaluation, use of thrombolytic therapy when indicated, other aspects of acute care, referral to rehabilitation services, and 90-day follow-up. Hospital-level measures pertaining to stroke center guidelines were also recommended to augment patient-level data.Conclusions— Routine monitoring of the suggested parameters could promote community awareness campaigns, support quality improvement interventions for stroke care and stroke prevention in each state, and guide professional education in hospital and emergency system settings. Such efforts would reduce disability and death among stroke patients.
Imaging-Based Decision Making in Thrombolytic Therapy for Ischemic Stroke: Present Status
- Peter D. Schellinger,
- Jochen B. Fiebach and
- Werner Hacke
Stroke Volume 34, Issue 21 February 2003

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Background— Thrombolysis is the treatment of choice for acute stroke within 3 hours after symptom onset. Treatment beyond the 3-hour time window has not been shown to be effective in any single trial; however, meta-analyses suggest a somewhat lesser but still significant effect within 3 to 6 hours after stroke. It seems reasonable to apply improved selection criteria that allow differentiation between patients with and without a relevant indication for thrombolytic therapy.Summary of Review— The present literature on imaging in stroke has been thoroughly reviewed, covering Doppler ultrasound (DU), arteriography, CT, and MRI and including modern techniques such as perfusion CT, diffusion- and perfusion-weighted MRI (DWI, PWI), CT angiography and MR angiography (CTA, MRA), and CTA source image analysis (CTA-SI). The authors present their view of a comprehensive diagnostic approach to acute stroke, which challenges the concept of a rigid therapeutic time window.Conclusions— Information about the presence or absence of a vessel occlusion, whether by means of DU, CTA, or MRA, is essential before recombinant tissue plasminogen activator is given in the 3- to 6-hour time window. Clear demarcation of the irreversibly damaged infarct core and the ischemic but still viable and thus salvageable tissue at risk of infarction as seen on DWI/PWI/MRA or alternatively CT/CTA/CTA-SI should be obtained before thrombolysis is initiated within 3 to 6 hours. Once these advanced techniques are used, the therapeutic time window can be extended with acceptable safety. However, comprehensive informed consent is mandatory, especially when thrombolytic therapy is considered beyond established time windows.
Are Some Patients Likely to Benefit From Recombinant Tissue-Type Plasminogen Activator for Acute Ischemic Stroke Even Beyond 3 Hours From Symptom Onset?
- David M. Kent,
- Robin Ruthazer and
- Harry P. Selker
Stroke Volume 34, Issue 21 February 2003

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Background and Purpose— Recombinant tissue plasminogen activator (rtPA) has been demonstrated to improve outcomes in acute ischemic stroke when delivered within 3 hours of symptom onset. However, the Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke (ATLANTIS B) trial, in which patients were treated mostly between 3 and 5 hours after symptom onset, found no overall benefit from rtPA. We hypothesized that a subgroup of patients at low risk for thrombolysis-related intracranial hemorrhage, identifiable on the basis of pretreatment clinical variables, may benefit even when treated after 3 hours, despite the overall results of the trial.Methods— Using an independently derived multivariate model that predicts the risk of thrombolysis-related intracranial hemorrhage in patients receiving tPA for acute myocardial infarction (based on 6 easily obtainable clinical characteristics), we stratified patients in the ATLANTIS B trial into low-, intermediate-, and high-risk tertiles. We examined outcomes in the prespecified low-risk subgroup using a global test of significance across 4 outcome scales.Results— Despite having a similar average baseline stroke severity and median time to treatment (270 minutes), patients in the prespecified low-risk group (n=194) were significantly less likely to have a symptomatic intracranial hemorrhage than other patients in the trial (2.2% versus 9.2%, P=0.03). Although there was no treatment effect for rtPA in the overall trial, a consistent trend favoring rtPA therapy (a 5% to 12% absolute treatment benefit) was found across 4 different stroke scales in the prespecified low-risk group (P=0.10). The treatment-benefit-by-risk interaction was significant (P=0.03).Conclusions— Use of a multivariate index based on clinical variables is a promising approach to assist in the selection of patients with a favorable risk-benefit profile for thrombolytic therapy beyond 3 hours.
Serial FLAIR Imaging After Gd-DTPA Contrast: Pitfalls in Stroke Trial Magnetic Resonance Imaging
- Helmut Rumpel and
- Ling Ling Chan
Stroke Volume 34, Issue 31 March 2003

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Background— Most MRI protocols for stroke trials comprise 2 successive fluid-attenuated inversion-recovery (FLAIR) imaging acquisitions in which the first scan is done pre–Gd-DTPA contrast while the second is within the contrast clearance window.Summary of Report— A 68-year-old male was diagnosed as having hyperacute right middle cerebral artery infarct and a subacute chronic small left occipital cortical infarct. The latter turned from hypointense to strikingly hyperintense on the second FLAIR image, resembling the picture of an acute-on-chronic infarction or hemorrhage. However, the second DWI and CT refuted either of these.Conclusions— Image contrast using FLAIR in acute stroke trial imaging may also be affected by T1 effects of Gd-DTPA in chronic infarcts.
Quality Improvement and Tissue-Type Plasminogen Activator for Acute Ischemic Stroke: A Cleveland Update
Stroke Volume 34, Issue 31 March 2003

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Background and Purpose— A systematic audit of intravenous tissue-type plasminogen activator (tPA) use and stroke outcomes in Cleveland, Ohio, during 1997–1998 demonstrated higher rates of symptomatic intracranial hemorrhage (ICH) than reported in the National Institute of Neurological Disorders and Stroke (NINDS) trial. We now report updated results of intravenous tPA use in the Cleveland Clinic Health System (CCHS).Methods— A stroke quality improvement program was initiated in the 9-hospital CCHS in 1999. A retrospective chart review for all stroke patients with primary International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes 434 and 436 admitted to the 9 hospitals from June 1999 to June 2000 was used to determine outcomes of patients treated with intravenous tPA.Results— Intravenous tPA was given to 18.8% of patients arriving within 3 hours of symptom onset. Protocol deviations occurred in 19.1% of patients given intravenous tPA. The symptomatic ICH rate was 6.4%.Conclusions— Since 1997, intravenous tPA use has increased, while the rates of symptomatic ICH and protocol deviations have decreased in the CCHS. The CCHS symptomatic ICH rate is now similar to that reported in the NINDS trial. These improvements occurred after initiation of a stroke quality improvement program.
Telemedicine for Acute Stroke: Triumphs and Pitfalls
- Marian P. LaMonte,
- Mona N. Bahouth,
- Peter Hu,
- Mohammed Y. Pathan,
- Karen L. Yarbrough,
- Ruwani Gunawardane,
- Patrick Crarey and
- Wesley Page
Stroke Volume 34, Issue 31 March 2003

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Background and Purpose— Telemedicine is emerging as a potential timesaving, efficient means for evaluating patients experiencing acute stroke. In areas where local stroke care specialists are not available, telemedicine can link an emergency department physician with a specialist in a stroke treatment center. This consultation provides an opportunity for administration of thrombolytic drugs within the short therapeutic time window associated with ischemic stroke. Here, we describe our stroke treatment center experiences and report safe administration of recombinant tissue plasminogen activator (rtPA) during telemedicine consultation.Methods— The University of Maryland Medical Center uses a triplexed integrated services digital network line providing a 30–frames-per-second video link to St Mary’s Hospital >100 miles away. The system uses a pan, tilt, and zoom camera with remote site control, allowing 2-way, real-time, audiovisual communication and CT image transfer. We retrospectively reviewed all acute stroke consultations provided to St Mary’s Hospital between 1999 and 2001.Results— We reviewed 50 consultations. Of the 50, 23 were attempted through telemedicine linkage, and 27 were by traditional telephone conversation, followed by transfer. Of the 23 telemedicine consultations, 2 were aborted because of technical difficulties. Of the patients evaluated by traditional means, 1 of 27 (3.8%) received intravenous rtPA; 5 of 21 (23.8%) received rtPA after telemedicine consultation. No patients experienced complications.Conclusions— Telemedicine consultation provided treatment options not previously available at the remote hospital. Administration of rtPA during telemedicine consultation was feasible and safe, and the system was well received. Lack of reimbursement for telemedicine services will hinder widespread adaptation of this promising technology for remote acute stroke treatment.

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