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Background: In the SPOTLIGHT trial (Spot Sign Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy), patients with a computed tomography (CT) angiography spot-sign positive acute intracerebral hemorrhage were randomized to rFVIIa (recombinant activated factor VIIa; 80 μg/kg) or placebo within 6 hours of onset, aiming to limit hematoma expansion. Administration of rFVIIa did not significantly reduce hematoma expansion. In this prespecified analysis, we aimed to investigate the impact of delays from baseline imaging to study drug administration on hematoma expansion. Methods: Hematoma volumes were measured on the baseline CT, early post-dose CT, and 24 hours CT scans. Total hematoma volume (intracerebral hemorrhage+intraventricular hemorrhage) change between the 3 scans was calculated as an estimate of how much hematoma expansion occurred before and after studying drug administration. Results: Of the 50 patients included in the trial, 44 had an early post-dose CT scan. Median time (interquartile range) from onset to baseline CT was 1.4 hours (1.2–2.6). Median time from baseline CT to study drug was 62.5 (55–80) minutes, and from study drug to early post-dose CT was 19 (14.5–30) minutes. Median (interquartile range) total hematoma volume increased from baseline CT to early post-dose CT by 10.0 mL (−0.7 to 18.5) in the rFVIIa arm and 5.4 mL (1.8–8.3) in the placebo arm ( P =0.96). Median volume change between the early post-dose CT and follow-up scan was 0.6 mL (−2.6 to 8.3) in the rFVIIa arm and 0.7 mL (−1.6 to 2.1) in the placebo arm ( P =0.98). Total hematoma volume decreased between the early post-dose CT and 24-hour scan in 44.2% of cases (rFVIIa 38.9% and placebo 48%). The adjusted hematoma growth in volume immediately post dose for FVIIa was 0.998 times that of placebo ([95% CI, 0.71–1.43]; P =0.99). The hourly growth in FFVIIa was 0.998 times that for placebo ([95% CI, 0.994–1.003]; P =0.50; Table 3). Conclusions: In the SPOTLIGHT trial, the adjusted hematoma volume growth was not associated with Factor VIIa treatment. Most hematoma expansion occurred between the baseline CT and the early post-dose CT, limiting any potential treatment effect of hemostatic therapy. Future hemostatic trials must treat intracerebral hemorrhage patients earlier from onset, with minimal delay between baseline CT and drug administration. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01359202.

Introduction: Decisions to transport patients from primary to comprehensive stroke centre would be influenced by info on likelihood/timing of spontaneous or IV tPA recanalization (recan). We examined recan rates by time for a wide range of occlusion sites in the INTERRSeCT multicenter prospective cohort study. Methods: Acute stroke patients consented/enrolled at 12 centers/5 countries if intracranial occlusion present on baseline CTA; eGFR≥60 ml/min. CTA was repeated 2-6 hrs later for recan unless patient taken for EVT (first run of angio used instead). Primary outcome was successful recan (rAOL scale score 2b/3) interpreted by central core lab. Results: 619 patients enrolled, 81.6% received IV tPA. 59.9% recan by follow-up CTA and 40.1% by first run angio. Median baseline NIHSS 14 (IQR 11); mean age 70.1 yrs (SD 13); median onset to baseline CTA 115 mins (IQR 108). Recan assessment imaging median 162 mins (IQR 198) from IV tPA bolus or baseline CTA (if no IV tPA). Successful recan (rAOL 2b-3) rates comparing baseline to repeat imaging shown in Figure 1a (IV tPA red; no IV tPA blue). IV tPA had much higher recan than non-IV tPA group (30.5% vs 11%, p Conclusions: Early recan rates were low across all occlusion sites. Beyond 6 hrs post tPA, recan rates approached EVT levels except for ICA. Imaging factors such as residual flow may further refine transport/triage decisions.

Objective: We explore relationships amongst known and novel clot characteristics identified on CTA and early recanalization with IV tPA using classification and regression tree analysis (CART). Methods: Data is from patients presenting with acute ischemic stroke and proximal anterior circulation occlusions from the Calgary CTA database (2003-2012) and the Keimyung Stroke Registry (2005-2009). Patients who received IV t-PA followed by endovascular therapy were included. Clot location, clot length, residual flow through clot, ratio of contrast HU pre/post clot (cirHU) and distance of clot from M1 origin (for M1 MCA occlusions), were assessed on baseline CT-angio using OsiriX (Fig 1). Early recanalization (TICI 2a, 2b & 3) with IV t-PA was assessed on DSA first run. Results: We identified 228 patients (50.4% male, median age 69 yrs, median baseline NIHSS 17) who fulfilled inclusion criteria. Median symptom onset to IV t-PA time was 120 mins (IQR=70 mins) and median IV t-PA bolus to first angio run time was 70.5 mins (IQR=62 mins). Patients with residual flow within clot are five times more likely to recanalize than those without. Patients with residual flow within clot and a shorter clot length (≤15mm) were the most likely to recanalize(70.6%). Patients without residual flow with a carotid T/L occlusion rarely recanalized (1.7%). Patients without residual flow in M1 clots recanalized more if they were distal and had a cirHU < 2 (36.8%). (Fig 2). Inter-rater reliability for these clot characteristics was good to excellent. Conclusion: Clot characteristics on CTA could help physicians estimate early recanalization rates with IV tPA for proximal clots ranging from 0% to more than 80%.

Background: We aimed to see if antegrade flow observed on CT Perfusion Source Images (CTPSi) across an intracranial occlusion correlated with first run of DSA and predicted recanalization on DSA or repeat CTA. Methods: Patients with acute ischemic stroke and large vessel intracranial occlusion on CTA who had a CT Perfusion study followed by DSA or repeat CTA 4-6 hours later were included. CT Perfusion parameters were 8 cm coverage in static mode, acquisitions at 5 mm thickness, 5 seconds delay after contrast & 24 passes over 66 seconds. Antegrade flow was defined as the presence of ‘clot enhancement’ sign on the 1st pass of CTPSi and increasing density of contrast permeating the clot and filling the vessel distal to the occlusion on the 2nd and 3rd passes of CTPSi (Fig 1 & 2). This was correlated with the first run of DSA and recanalization was assessed on DSA (Group 1) or repeat CTA (Group 2). Results: Total 56 patients were included. In group 1(n=35), antegrade flow on CTPSI was present in 14/35 patients (40%). All these patients had antegrade flow on DSA and 12 of them showed early recanalization (TICI 2a, 2b or 3). IV t-PA was received by 29/35 patients. The sensitivity and specificity of CTPSi to predict antegrade flow when compared to DSA was 86.7% (95% CI, 59.5 - 98.3) and 95% (95% CI, 75.1 - 99.9) respectively. In Group 2 (n=21), antegrade flow was seen on CTPSI in 13 patients (62%) and all of them recanalized with IV t-PA. Six out of 8 patients without antegrade flow on CTPSi did not recanalize. Conclusion: Antegrade flow across an occlusion can be reliably assessed on initial passes of CTPSi and it predicts recanalization with IV t-PA.

Background and Purpose— Carotid angioplasty and stenting (CAS) has a higher incidence of periprocedural stroke compared with endarterectomy. Identifying CAS steps with the highest likelihood of embolization may have important implications. We evaluated CAS safety by correlating the findings of procedural transcranial Doppler with postprocedure diffusion-weighted imaging (DWI) lesions. Methods— In this prospective study, transcranial Doppler monitoring was performed during CAS procedures, which were divided into 11 steps. Embolic signals on transcranial Doppler were counted and classified based on the relative energy index of microembolic signals into microemboli ≤1 or malignant macroemboli >1. Poststenting MRI was performed in all cases. A negative binomial regression model was used to evaluate the predictive value of transcranial Doppler emboli for new DWI lesions. Results— Thirty subjects were enrolled. Seven of 30 subjects (23.3%) were asymptomatic. The median embolic signal count was 212.5 (108 microemboli and 80 malignant macroemboli). Stent deployment phase showed the highest median embolic signals count at 58, followed by protection device deployment at 30 ( P =0.0006). Twenty-four of 30 (80%) had new DWI lesions on post-CAS MRI. The median DWI count was 4 (interquartile range 7). Two of 30 (6.7%) had new or worsening clinical deficits post-CAS. For every malignant embolus, the expected count of DWI lesions increases by 1% ( 95% confidence interval, 0%–2%; P =0.032). Conclusions— We observed a high incidence of embolic signals during CAS procedure, especially, when devices were deployed. Most subjects developed new DWI lesions, but only 6.7% had deficits. Malignant macroemboli predicted new DWI lesions.

BACKGOUND: We evaluated the safety of the steps during carotid stenting. METHODS: This was a prospective single-arm study. Cases were monitored by TCD during the stenting procedure. The time of each of 11 steps was recorded and noted during TCD interpretation. Post stenting MRI was done in all patients. Emboli on TCD were classified based on the relative energy index of microemboli (REIM) method into microemboli (REIM ≤ 1) or malignant (REIM >1). Medians were compared using Mann-Whitney test. A negative binomial model was used to investigate the predictive value of TCD findings on new DWI hits. RESULTS: We enrolled 30 subjects. The median age was 70.5 years and 23.3% were asymptomatic. The median count of embolic signals was 212.5 (108 microemboli, 80 malignant). Stent deployment had the highest median count 58 (31 microemboli, 20 malignant) followed by protection device deployment 30 (21 microemboli, 10 malignant, (p value 0.0006)) “Figure”. On post stenting MRI, 80% had new DWI hits. The median DWI count was 4 (range 0-33). The median volume of DWI hits was 0.4 ml (range 0 - 6.1 ml). 63% of patients had a total volume under 1 ml. Only 2 patients (6.7%) had new deficits post stenting. The median DWI volume in those patients was 3.0 ml compared to 0.6 ml in asymptomatic cases (p 0.037). Median emboli count in those with vs. without new deficits was not different (p 0.87) Total TCD emboli count did not predict DWI hits, adjusting for age and symptoms’ status (p 0.25). Malignant emboli predicted new DWI hits (p 0.044). For every malignant embolus, the expected count of DWI hits increases by 1% (CI95 0-2%). There was no relation between total or malignant emboli with the DWI volume. CONCLUSIONS: In this prospective study, we observed a high incidence of emboli on TCD during stenting, especially when stent and protection device were deployed. Most patients developed new DWI hits but only 6.7% had new deficits. The combined DWI volume was less than 1.0 ml in most cases. Only malignant emboli predicted new DWI hits.