Description: Background and Purpose— In previous studies, the Totaled Health Risks in Vascular Events (THRIVE) score has shown broad utility, allowing prediction of clinical outcome, death, and risk of hemorrhage after tissue-type plasminogen activator (tPA) treatment, irrespective of the type of acute stroke therapy applied to the patient. Methods— We used data from the Virtual International Stroke Trials Archive to further validate the THRIVE score in a large cohort of patients receiving tPA or no acute treatment, to confirm the relationship between THRIVE and hemorrhage after tPA, and to compare the THRIVE score with several other available outcome prediction scores. Results— The THRIVE score strongly predicts clinical outcome (odds ratio, 0.55 for good outcome [95% CI, 0.53–0.57]; P 〈0.001), mortality (odds ratio, 1.57 [95% confidence interval, 1.50–1.64]; P 〈0.001), and risk of intracerebral hemorrhage after tPA (odds ratio, 1.34 [95% confidence interval, 1.22–1.46]; P 〈0.001). The relationship between THRIVE score and outcome is not influenced by the independent relationship of tPA administration and outcome. In receiver operator characteristic curve analysis, the THRIVE score was superior to several other available outcome prediction scores in the prediction of clinical outcome and mortality. Conclusions— The THRIVE score is a simple-to-use tool to predict clinical outcome, mortality, and risk of hemorrhage after thrombolysis in patients with ischemic stroke. Despite its simplicity, the THRIVE score performs better than several other outcome prediction tools. A free Web calculator for the THRIVE score is available at http://www.thrivescore.org .

Description: Background and Purpose— Several outcome prediction scores have been tested in patients receiving acute stroke treatment with previous generations of endovascular stroke treatment devices. The TREVO-2 trial was a randomized controlled trial comparing a novel endovascular stroke treatment device (the Trevo device) to a previous-generation endovascular stroke treatment device (the Merci device). Methods— We used data from the TREVO-2 trial to validate the Totaled Health Risks in Vascular Events (THRIVE) score in patients receiving treatment with a third-generation endovascular stroke treatment device and to compare THRIVE to other predictive scores. We used logistic regression to model outcomes and compared score performance with receiver operating characteristic curve analysis. Results— In the TREVO-2 trial, the THRIVE score strongly predicts clinical outcome and mortality. The relationship between THRIVE score and outcome is not influenced by either success of recanalization or the type of device used (Trevo versus Merci). The superiority of the Trevo device to the Merci device is evident particularly among patients with a low-to-moderate THRIVE score (0–5; 53.8% good outcome with Trevo versus 27.5% good outcome with Merci). In receiver operating characteristic curve analysis, the THRIVE score was comparable or superior to several other outcome prediction scores (HIAT, HIAT-2, SPAN-100, and iScore). Conclusions— The THRIVE score strongly predicts clinical outcome and mortality in the TREVO-2 trial. Taken together with THRIVE validation data from patients receiving intravenous tissue-type plasminogen activator or no acute treatment, the THRIVE score has broad predictive power in patients with acute ischemic stroke, which is likely because THRIVE reflects a set of strong nonmodifiable predictors of stroke outcome. A free Web calculator for the THRIVE score is available at http://www.thrivescore.org .

Description: Background and Purpose— Observational studies indicate that outpatient cardiac monitoring detects previously undiagnosed atrial fibrillation (AF) in 5% to 20% of patients with recent stroke. However, it remains unknown whether the yield of monitoring exceeds that of routine clinical follow-up. Methods— In a pilot trial, we randomly assigned 40 patients with cryptogenic ischemic stroke or high-risk transient ischemic attack to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days or to receive routine follow-up alone. After thorough investigation, we excluded patients with documented AF or other apparent stroke pathogenesis. We contacted patients and their physicians at 3 months and at 1 year to ascertain any diagnoses of AF or recurrent stroke or transient ischemic attack. Results— The baseline characteristics of our cohort broadly matched those of previous observational studies of monitoring after stroke. In the monitoring group, patients wore monitors for 64% of the assigned days, and 25% of patients were not compliant at all with monitoring. No patient in either study arm received a diagnosis of AF. Cardiac monitoring revealed AF in zero patients (0%; 95% confidence interval, 0%–17%), brief episodes of atrial tachycardia in 2 patients (10%; 95% confidence interval, 1%–32%), and nonsustained ventricular tachycardia in 2 patients (10%; 95% confidence interval, 1%–32%). Conclusions— In the first reported randomized trial of cardiac monitoring after cryptogenic stroke, the rate of AF detection was lower than expected, incidental arrhythmias were frequent, and compliance with monitoring was suboptimal. Our findings highlight the challenges of prospectively identifying stroke patients at risk for harboring paroxysmal AF and ensuring adequate compliance with cardiac monitoring. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique Identifier: NCT00715533

Description: Background— The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation). Methods and Results— This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were met: The 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was 〉90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock. Conclusions— The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01064076.

Description: We aimed to prospectively examine the association between the glycemic index and glycemic load of foods consumed and the dietary intakes of carbohydrates, sugars, fiber, and principal carbohydrate-containing food groups (eg, breads, cereals, and sugary drinks) with changes in blood pressure during adolescence. A total of 858 students aged 12 years at baseline (422 girls and 436 boys) were examined from 2004–2005 to 2009–2011. Dietary data were assessed from validated semiquantitative food frequency questionnaires. Blood pressure was measured using a standard protocol. In girls, after adjusting for age, ethnicity, parental education, parental history of hypertension, baseline height, baseline blood pressure, change in body mass index, and time spent in physical and sedentary activities, each 1-SD (1-SD=7.10 g/d) increase in baseline dietary intake of total fiber was associated with a 0.96-, 0.62-, and 0.75-mmHg decrease in mean systolic ( P =0.02), diastolic ( P =0.01), and arterial blood pressures ( P =0.002), respectively, 5 years later. In girls, each 1-SD increase in dietary glycemic index, glycemic load, carbohydrate, and fructose was concurrently related to increases of 1.81 ( P =0.001), 4.02 ( P =0.01), 4.74 ( P =0.01), and 1.80 mm Hg ( P =0.03) in systolic blood pressure, respectively, 〉5 years. Significant associations between carbohydrate nutrition variables and blood pressure were not observed among boys. Excessive dietary intake of carbohydrates, specifically from high glycemic index/glycemic load foods, could adversely influence blood pressure, particularly in girls, whereas fiber-rich diets may be protective against elevated blood pressure during adolescence.

Description: Background and Purpose— Computed tomography angiography is an accurate noninvasive method to diagnose intracranial steno-occlusive disease (ICAD) at initial presentation for stroke. We aimed to identify features of computed tomography angiography associated with unfavorable outcome. Methods— We identified patients with ICAD in the Screening Technology and Outcomes Project in Stroke Study, a prospective imaging-based study of stroke outcomes, in consecutive patients with ischemic stroke or transient ischemic attack (TIA) presenting to 2 academic medical centers. All patients underwent computed tomography angiography, which were graded by 2 neuroradiologists independently. Univariate and multiple logistic regression was used to evaluate predictors of favorable outcome at 6 months, defined as a modified Rankin Scale ≤2. Results— Among 539 patients that met study entry criteria, ICAD was identified in 212 patients (39%); 116 patients (22%) had concurrent extraintracranial lesions, and 66 patients (12%) had multiple sites of ICAD. Patients with ICAD had more severe stroke (median National Institutes of Health Stroke Scale, 9 versus 3; P 〈0.001), worse outcomes at 6 months (modified Rankin Scale, 0–2; 57% versus 73%; P 〈0.001), and higher mortality (18% versus 8%; P =0.001). In the multivariate model, age (odds ratio [OR], 0.75 per decade; 95% confidence interval [CI], 0.65–0.87), female sex (OR, 0.49; 95% CI, 0.32–0.73), multiple sites of ICAD (OR, 0.53; 95% CI, 0.29–0.97), complete occlusion (OR, 0.42; 95% CI, 0.25–0.72), and concurrent extraintracranial lesions (OR, 0.51; 95% CI, 0.31–0.84) negatively predicted favorable outcome. Conclusions— Findings of multiple sites of ICAD from computed tomography angiography, concurrent extraintracranial lesions, and complete occlusion are independent predictors of unfavorable outcome at 6 months.

Description: Background and Purpose— Can lysability of large vessel thrombi in acute ischemic stroke be predicted by measuring clot density on admission nonenhanced CT (NECT), postcontrast enhanced CT, or CT angiogram (CTA)? Methods— We retrospectively studied 90 patients with acute large vessel ischemic strokes treated with intravenous (IV) tPA, intra-arterial (IA) tPA, and/or mechanical thrombectomy devices. Clot density [in Hounsfield unit (HU)] was measured on NECT, postcontrast enhanced CT, and CTA. Recanalization was assessed by the Thrombolysis in Cerebral Infarction grading system (TICI) on digital subtraction angiography. Results— Thrombus density on preintervention NECT correlated with postintervention TICI grade regardless of pharmacological (IV tPA r =0.69, IA tPA r =0.72, P 〈0.0001) or mechanical treatment ( r =0.73, P 〈0.0001). Patients with TICI≥2 demonstrated higher HU on NECT (mean corrected HU IV tPA=1.58, IA tPA=1.66, mechanical treatment=1.7) compared with patients with TICI〈2 (IV tPA=1.39, IA tPA=1.4, mechanical treatment=1.3) ( P =0.01, 0.006, 〈0.0001 respectively). There was no association between recanalization and age, sex, baseline National Institute of Health Stroke Scale, treatment method, time to treatment, or clot volume. Conclusions— Thrombi with lower HU on NECT appear to be more resistant to pharmacological lysis and mechanical thrombectomy. Measuring thrombus density on admission NECT provides a rapid method to analyze clot composition, a potentially useful discriminator in selecting the most appropriate reperfusion strategy for an individual patient.

Description: Background and Purpose— To determine the effect of intravenous tissue plasminogen activator (IV-tPA) on outcomes in patients with severe major anterior circulation ischemic stroke. Methods— Prospectively, 649 patients with acute stroke had admission National Institutes of Health stroke scale (NIHSS) scores, noncontrast computed tomography (CT), CT angiography (CTA), and 6-month outcome assessed using modified Rankin scale. IV-tPA treatment decisions were made before CTA, at the time of noncontrast CT scanning, as per routine clinical protocol. Severe symptoms were defined as NIHSS〉10. Poor outcome was defined as modified Rankin scale 〉2. Major occlusions were identified on CTA. Univariate and multivariate stepwise-forward logistic regression analyses of the full cohort were performed. Results— Of 649 patients, 188 (29%) patients presented with NIHSS〉10, and 64 out of 188 (34%) patients received IV-tPA. Admission NIHSS, large artery occlusion, and IV-tPA all independently predicted good outcomes; however, a significant interaction existed between IV-tPA and occlusion ( P 〈0.001). Of the patients who presented with NIHSS〉10 with anterior circulation occlusion, twice the percentage had good outcomes if they received IV-tPA (17 out of 49 patients, 35%) than if they did not (13 out of 77 patients, 17%; P =0.031). The number needed to treat was 7 (95% confidence interval, 3–60). Conclusions— IV-tPA treatment resulted in significantly better outcomes in patients with severely symptomatic stroke with major anterior circulation occlusions. The 35% good outcome rate was similar to rates found in endovascular therapy trials. Vascular imaging may help in patient selection and stratification for trials of IV-thrombolytic and endovascular therapies.

Description: Background and Purpose— The goal of the Stroke Treatment Academic Industry Roundtable (STAIR) meetings is to advance the development of stroke therapies. At STAIR VIII, consensus recommendations were developed for clinical trial strategies to demonstrate the benefit of endovascular reperfusion therapies for acute ischemic stroke. Summary of Review— Prospects for success with forthcoming endovascular trials are robust, because new neurothrombectomy devices have superior reperfusion efficacy compared with earlier-generation interventions. Specific recommendations are provided for trial designs in 3 populations: (1) patients undergoing intravenous fibrinolysis, (2) early patients ineligible for or having failed intravenous fibrinolysis, and (3) wake-up and other late-presenting patients. Among intravenous fibrinolysis–eligible patients, key principles are that CT or MRI confirmation of target arterial occlusions should precede randomization; endovascular intervention should be pursued with the greatest rapidity possible; and combined intravenous and neurothrombectomy therapy is more promising than neurothrombectomy alone. Among patients ineligible for or having failed intravenous fibrinolysis, scientific equipoise was affirmed and the need to randomize all eligible patients emphasized. Vessel imaging to confirm occlusion is mandatory, and infarct core and penumbral imaging is desirable in later time windows. Additional STAIR VIII recommendations include approaches to test multiple devices in a single trial, utility weighting of disability end points, and adaptive designs to delineate time and tissue injury thresholds at which benefits from intervention no longer accrue. Conclusions— Endovascular research priorities in acute ischemic stroke are to perform trials testing new, highly effective neuro thrombectomy devices rapidly deployed in patients confirmed to have target vessel occlusions.