Gerardo Ruiz-Ares

Comparison of Safety and Clinical and Radiographic Outcomes in Endovascular Acute Stroke Therapy for Proximal Middle Cerebral Artery Occlusion With Intubation and General Anesthesia Versus the Nonintubated State

Background and Purpose— There is considerable heterogeneity in practice patterns between sedation in the intubated state vs nonintubated state during endovascular acute stroke therapy. We sought to compare clinical and radiographic outcomes between these 2 sedation modalities. Methods— Consecutive patients with acute stroke due to middle cerebral artery–M1 segment occlusion treated with endovascular therapy between January 2006 and July 2009 were identified in our interventional acute stroke database. Level of sedation was determined as intubated (IS) vs nonintubated (NIS) state. Final infarct volumes on follow-up imaging and clinical outcomes at 3 to 6 months were obtained. Results— A total of 126 patients were included (73 [58%] NIS vs 53 [42%] IS). In IS patients, intensive care unit length of stay was longer (6.5 vs 3.2 days, P=0.0008). Intraprocedural complications were lower in NIS patients compared with IS patients (5/73 [6%] vs 8/53 [15%], respectively), but the difference was not significant (P=0.13). In univariate and multivariate analyses, NIS was significantly associated with in-hospital mortality (odds ratio=0.32, P=0.011), good clinical outcome (odds ratio=3.06, P=0.042), and final infarct volume (odds ratio=0.25, P=0.004). Conclusion— In endovascular acute stroke therapy, treatment of patients in NIS appears to be as safe as treatment in IS and may result in more favorable clinical and radiographic outcomes. Our preliminary observations derived from this retrospective study await confirmation from prospective trials.

Manual Aspiration Thrombectomy: Adjunctive Endovascular Recanalization Technique in Acute Stroke Interventions

Background and Purpose— We evaluated recanalization rates, clinical outcomes, and safety when manual aspiration thrombectomy is used in conjunction with other thrombolytic modalities in a consecutive case series of patients with large vessel intracranial occlusion. Methods— We conducted a retrospective review of a prospectively acquired acute endovascular stroke database. Manual aspiration thrombectomy was carried out with Distal Access and Penumbra reperfusion catheters of different sizes placed in the thrombus and aspirated with a syringe. Results— We identified 191 patients: Occlusion locations were as follows: M1% to 50%, M2% to 10%, internal carotid artery terminus 25%, and vertebrobasilar 15%. Median treatment duration was 90 minutes. Recanalization results were Thrombolysis in Myocardial Ischemia 2/3 93%, Thrombolysis in Myocardial Ischemia 3 27%, Thrombolysis In Cerebral Infarction 2a/2b/3 91%, Thrombolysis In Cerebral Infarction 2b/3 71%, and Thrombolysis In Cerebral Infarction 3 25%. Larger catheters were associated with higher recanalization rates. Parenchymal hematoma rate was 13.6%. The favorable outcome (90-day modified Rankin Scale ⩽2) rate was 54%. Mortality at 90 days was 25%. Conclusions— Manual aspiration thrombectomy is a useful addition to the armamentarium of endovascular treatment modalities for acute stroke.

Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem cells from adipose tissue: a safety assessment: a phase II randomized, double-blind, placebo-controlled, single-center, pilot clinical trial.

BACKGROUND Few studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke. Intravenous administration of allogeneic mesenchymal stem cells (MSCs) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair, consequently supporting better functional recovery. We aim to assess the safety and efficacy of MSC administration and evaluate its potential as a treatment for cerebral protection and repair. MATERIALS A Phase IIa, prospective, randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. Twenty patients presenting acute ischemic stroke will be randomized in a 1:1 proportion to treatment with allogeneic MSCs from adipose tissue or to placebo (or vehicle) administered as a single intravenous dose within the first 2 weeks after the onset of stroke symptoms. The patients will be followed up for 2 years. Primary outcomes for safety analysis: adverse events (AEs) and serious AEs; neurologic and systemic complications, and tumor development. Secondary outcomes for efficacy analysis: modified Rankin Scale; NIHSS; infarct size; and biochemical markers of brain repair (vascular endothelial growth factor, brain-derived neurotrophic factor, and matrix metalloproteinases 9). RESULTS AND CONCLUSIONS To our knowledge, this is the first, phase II, pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic MSCs from adipose tissue within the first 2 weeks of stroke. In addition, its results will help us define the best criteria for a future phase III study.

Futile Interhospital Transfer for Endovascular Treatment in Acute Ischemic Stroke The Madrid Stroke Network Experience

Background and Purpose— The complexity of endovascular revascularization treatment (ERT) in acute ischemic stroke and the small number of patients eligible for treatment justify the development of stroke center networks with interhospital patient transfers. However, this approach might result in futile transfers (ie, the transfer of patients who ultimately do not undergo ERT). Our aim was to analyze the frequency of these futile transfers and the reasons for discarding ERT and to identify the possible associated factors. Methods— We analyzed an observational prospective ERT registry from a stroke collaboration ERT network consisting of 3 hospitals. There were interhospital transfers from the first attending hospital to the on-call ERT center for the patients for whom this therapy was indicated, either primarily or after intravenous thrombolysis (drip and shift). Results— The ERT protocol was activated for 199 patients, 129 of whom underwent ERT (64.8%). A total of 120 (60.3%) patients required a hospital transfer, 50 of whom (41%) ultimately did not undergo ERT. There were no differences in their baseline characteristics, the times from stroke onset, or in the delays in interhospital transfers between the transferred patients who were treated and those who were not treated. The main reasons for rejecting ERT after the interhospital transfer were clinical improvement/arterial recanalization (48%) and neuroimaging criteria (32%). Conclusions— Forty-one percent of the ERT transfers were futile, but none of the baseline patient characteristics predicted this result. Futility could be reduced if repetition of unnecessary diagnostic tests was avoided.

Validation of the FOUR Score (Spanish Version) in Acute Stroke: An Interobserver Variability Study

Background: Methods to assess impaired consciousness in acute stroke typically include the Glasgow Coma Scale (GCS), but the verbal component has limitations in aphasic or intubated patients. The FOUR (Full Outline of UnResponsiveness) score, a new coma scale, evaluates 4 components: eye and motor responses, brainstem reflexes and respiration. We aimed to study the interobserver variability of the FOUR score in acute stroke patients. Methods: We prospectively enrolled consecutive patients with acute stroke admitted from February to July 2008 to the stroke unit of our Neurology Department. Patients were evaluated by neurology residents and nurses using the FOUR score and the GCS. For both scales, we obtained paired and total weighted kappa values (Kw) and intraclass correlation coefficients (ICC). NIH stroke scale was also recorded on admission. Results: We obtained a total of 75 paired evaluations in 60 patients (41 cerebral infarctions, 15 cerebral hemorrhages and 4 transient ischemic attacks). Thirty-three (55%) patients were alert, 17 (28.3%) drowsy and 10 (16.7%) stuporous or comatose. The overall rater agreement was excellent in the FOUR score (Kw 0.93; 95% CI 0.89–0.97) with an ICC of 0.94 (95% CI 0.91–0.96) and in the GCS (Kw 0.96; 95% CI 0.94–0.98) with an ICC of 0.96 (95% CI 0.93–0.97). A good correlation was found between the FOUR score and the GCS (ρ 0.83; p < 0.01) and between the FOUR score and the NIH stroke scale (ρ –0.78; p < 0.001). Conclusions: The FOUR score is a reliable scale for evaluating the level of consciousness in acute stroke patients, showing a good correlation with the GCS and the NIH stroke scale.

Efficacy of intravenous thrombolysis according to stroke subtypes: the Madrid Stroke Network data

To identify possible differences in the early response to intravenous thrombolysis (IVT) or in stroke outcome at 3 months, based on stroke subtype in patients with acute ischaemic stroke (IS).

Treatment with statins and ischemic stroke severity: Does the dose matter?

Objective: To examine the effects of pretreatment with statins at high doses (40 mg of rosuvastatin or 80 mg of any other statin) and low to moderate doses (<40 mg of rosuvastatin or <80 mg of any other statin) on ischemic stroke (IS) severity in clinical practice. Methods: Observational study of IS admissions to our stroke unit over a 3-year period (2008–2010). Mild stroke severity was defined as NIH Stroke Scale score ≤5 on admission. Multivariable regression models and matched propensity score analyses were used to quantify the association of statin pretreatment at high and low to moderate doses with mild stroke severity. Results: Of the 969 IS patients, 23% were taking low to moderate doses and 4.1% were taking high doses of statins prior to the stroke. Statins were associated with lower NIHSS scores on admission (median [interquartile range] 4 [9] for nonstatin patients, 4 [9] for low to moderate doses of statins, and 2 [4] for high doses of statins; p = 0.010). After multivariable adjustment, pretreatment with statins was associated with a higher probability of mild stroke severity in the unmatched analysis (odds ratio [OR] = 1.637, 95% confidence interval [CI] 1.156–2.319 for the low to moderate doses and OR = 3.297, 95% CI 1.480–7.345 for the high doses of statins) as well as in the propensity score matched analysis (OR = 2.023, 95% CI 1.248–3.281 for the low to moderate doses and OR = 3.502, 95% CI 1.477–8.300 for the high doses of statins). Conclusion: Pretreatment with statins is associated with lower stroke severity, at high as well as at low to moderate doses.

Questionable reversal of anticoagulation in the therapeutic management of cerebral haemorrhage associated with vitamin K antagonists

Reversal of anticoagulation is recommended to correct the international normalised ratio (INR) for patients with intracranial haemorrhage (ICH) associated with vitamin K antagonists (VKA). However, the validity of such treatment is debated. We sought to identify, prospectively, the prognostic effect of VKA-ICH treatment in a cohort of patients (n=71; median age 78 years, range 20-89; 52% males). Data collated were: baseline characteristics, treatments, baseline and post-treatment INR, haematoma volume, and haematoma enlargement. Treatment effects and prognostic factor assessment were in relation to mortality and functional outcomes. On admission, the patients had a median score of 9 [p25; p75 of 5; 20] on the National Institute of Health Stroke Scale (NIHSS) and a mean INR of 2.7 (range: 0.9 - 10.8). Haematoma volume (34.6 cm³; SD: 24.9) correlated with NIHSS (r = 0.55; p<0.001) but not with INR. Anticoagulation reversal treatment was administered in 83% of patients. INR <1.5 was achieved in 60.7% of cases. Death or dependency at three months was 76%. Neither baseline INR, anticoagulation reversal nor haematoma enlargement were related to mortality or functional outcome. The only independent prognostic factor was clinical severity on admission. Baseline NIHSS predicted mortality (OR: 1.18; 95%CI: 1.09-1.27), independence (OR: 0.83; 95%CI: 0.74-0.94) and neurological recovery (NIHSS 0-1) (OR: 0.83; 95%CI: 0.73-0.95). The data indicate that VKA-ICH had a poor prognosis. Treatment and INR correction did not appear to affect outcomes.

Atrial fibrillation in young stroke patients: do we underestimate its prevalence?

The prevalence of atrial fibrillation (AF) in young stroke patients has rarely been reported and is considered an uncommon ischaemic stroke (IS) aetiology. Our objective was to analyse the prevalence of AF in IS patients up to 50 years of age and its relationship with stroke severity and outcomes.

A Prediction Model for Unstable Carotid Atheromatous Plaque in Acute Ischemic Stroke Patients: Proposal and Internal Validation

The aim of this prospective study was to analyze the utility of a gray-scale median (GSM) system for identifying unstable plaques and to design and validate a prediction model for unstable plaques in symptomatic atheromatous carotid arteries. Fifty-two patients with non-cardioembolic cerebral infarction were included in the study. The receiver operating characteristic analysis revealed 76% sensitivity and 82% specificity for a GSM of 29 (p < 0.001) as a cutoff point for unstable plaques. A logistic regression model indicated that a GSM <29, male gender and not having been treated with angiotensin-converting enzyme inhibitors were independently associated with an unstable plaque classification. A probability model for unstable plaques was achieved by combining the strength of each variable (high blood pressure, hypercholesterolemia, smoking, previous stroke, anti-hypertensive drugs, calcium channel blockers, intima-media thickness). The model was tested with receiver operating characteristic curve analysis (p < 0.001) and validated by the leave-one-out cross-validation method (p < 0.001). The prediction model based on a GSM <29, male gender and not having been treated with angiotensin-converting enzyme inhibitors resulted in a probable unstable plaque assessment.