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Background The Pipeline Flex Embolization Device (PED) with Shield Technology (PED‐Shield) is a third‐generation flow diverting stents with surface modification designed to reduce platelet adhesion and thrombogenicity. We report the long‐term safety and effectiveness of the PED‐Shield in the treatment of unruptured intracranial aneurysms in an Australian cohort. Methods SCOPE‐AUS (Safety and Clinical Effectiveness Of Pipeline Shield Embolization Device for Treatment of Intracranial Aneurysms in Australia) is a multicenter, single‐arm, retrospective study of patients with unruptured intracranial aneurysms treated with the PED‐Shield flow diverting stents at 3 high‐volume neurointervention centers in Australia between May 1, 2015, and June 30, 2018, evaluating safety and efficacy. The primary outcome was neurologic adverse event or neurologic‐related death at 1 year, and the secondary outcome was long‐term complete aneurysm occlusion. Results A total of 238 patients (mean age 55.8±11.0 years, 73.1% [174/238] female) and 278 aneurysms were treated via 247 procedures. Two (0.7%) aneurysms were retreated during the 18‐month follow‐up. Overall occlusion rates at 18 months or at last follow‐up imaging were 92.5% (233/252). There were 35 (14.7%) total primary end point events. The 12‐month neurologic morbidity and mortality rates were 3.8% (9/238) and 1.3% (3/238), respectively. For the subgroup of internal carotid artery aneurysms, mortality (0.7%) and morbidity (2.0%) rates were low, and the complete occlusion rate was 92.5% (147/155). Conclusions In this multicenter study, which includes a wide variety of both distal bifurcation and proximal unruptured intracranial aneurysms, the occlusion rates and safety outcomes of the PED‐Shield flow diverting stent demonstrate a high proportion of complete aneurysm occlusion, extremely low retreatment rates, and low complication rates.

Intravenous infusion of alteplase is used for thrombolysis before endovascular thrombectomy for ischemic stroke. Tenecteplase, which is more fibrin-specific and has longer activity than alteplase, is given as a bolus and may increase the incidence of vascular reperfusion. METHODS We randomly assigned patients with ischemic stroke who had occlusion of the internal carotid, basilar, or middle cerebral artery and who were eligible to undergo thrombectomy to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or alteplase (at a dose of 0.9 mg per kilogram; maximum dose, 90 mg) within 4.5 hours after symptom onset. The primary outcome was reperfusion of greater than 50% of the involved ischemic territory or an absence of retrievable thrombus at the time of the initial angiographic assessment. Noninferiority of tenecteplase was tested, followed by superiority. Secondary outcomes included the modified Rankin scale score (on a scale from 0 [no neurologic deficit] to 6 [death]) at 90 days. Safety outcomes were death and symptomatic intracerebral hemorrhage. RESULTS Of 202 patients enrolled, 101 were assigned to receive tenecteplase and 101 to receive alteplase. The primary outcome occurred in 22% of the patients treated with tenecteplase versus 10% of those treated with alteplase (incidence difference, 12 percentage points; 95% confidence interval [CI], 2 to 21; incidence ratio, 2.2; 95% CI, 1.1 to 4.4; P=0.002 for noninferiority; P=0.03 for superiority). Tenecteplase resulted in a better 90-day functional outcome than alteplase (median modified Rankin scale score, 2 vs. 3; common odds ratio, 1.7; 95% CI, 1.0 to 2.8; P=0.04). Symptomatic intracerebral hemorrhage occurred in 1% of the patients in each group. CONCLUSIONS Tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset.Copyri

Background and hypothesis: Intravenous thrombolysis with alteplase remains standard care prior to thrombectomy for eligible patients within 4.5 h of ischemic stroke onset. However, alteplase only succeeds in reperfusing large vessel arterial occlusion prior to thrombectomy in a minority of patients. We hypothesized that tenecteplase is non-inferior to alteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. Study design: EXTEND-IA TNK is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint non-inferiority study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale<=3 (no upper age limit), large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal computed tomography and absence of contraindications to intravenous thrombolysis. Patients are randomized to either IV alteplase (0.9 mg/kg, max 90 mg) or tenecteplase (0.25 mg/kg, max 25 mg) prior to thrombectomy. Study outcomes: The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified treatment in cerebral infarction 2 b/3 or the absence of retrievable thrombus. Secondary outcomes include modified Rankin Scale at day 90 and favorable clinical response (reduction in National Institutes of Health Stroke Scale by >=8 points or reaching 0-1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration: ClinicalTrials.gov NCT02388061.Copyright © 2017, © 2017 World Stroke Organization.

Background: Endovascular thrombectomy improves functional outcome in large vessel occlusion ischemic stroke. We examined disability, quality of life, survival and acute care costs in the EXTEND-IA trial, which used CT-perfusion imaging selection. Method(s): Large vessel ischemic stroke patients with favorable CT-perfusion were randomized to endovascular thrombectomy after alteplase versus alteplase-only. Clinical outcome was prospectively measured using 90-day modified Rankin scale (mRS). Individual patient expected survival and net difference in Disability/Quality-adjusted life years (DALY/QALY) up to 15 years from stroke were modeled using age, sex, 90-day mRS, and utility scores. Level of care within the first 90 days was prospectively measured and used to estimate procedure and inpatient care costs (US$ reference year 2014). Result(s): There were 70 patients, 35 in each arm, mean age 69, median NIHSS 15 (IQR 12-19). The median (IQR) disability-weighted utility score at 90 days was 0.65 (0.00-0.91) in the alteplase-only versus 0.91 (0.65-1.00) in the endovascular group (p = 0.005). Modeled life expectancy was greater in the endovascular versus alteplase-only group (median 15.6 versus 11.2 years, p = 0.02). The endovascular thrombectomy group had fewer simulated DALYs lost over 15 years [median (IQR) 5.5 (3.2-8.7) versus 8.9 (4.7-13.8), p = 0.02] and more QALY gained [median (IQR) 9.3 (4.2-13.1) versus 4.9 (0.3-8.5), p = 0.03]. Endovascular patients spent less time in hospital [median (IQR) 5 (3-11) days versus 8 (5-14) days, p = 0.04] and rehabilitation [median (IQR) 0 (0-28) versus 27 (0-65) days, p = 0.03]. The estimated inpatient costs in the first 90 days were less in the thrombectomy group (average US$15,689 versus US$30,569, p = 0.008) offsetting the costs of interhospital transport and the thrombectomy procedure (average US$10,515). The average saving per patient treated with thrombectomy was US$4,365. Conclusion(s): Thrombectomy patients with large vessel

BACKGROUND: Endovascular thrombectomy improves functional outcome in large vessel occlusion ischemic stroke. We examined disability, quality of life, survival and acute care costs in the EXTEND-IA trial, which used CT-perfusion imaging selection. METHODS: Large vessel ischemic stroke patients with favorable CT-perfusion were randomized to endovascular thrombectomy after alteplase versus alteplase-only. Clinical outcome was prospectively measured using 90-day modified Rankin scale (mRS). Individual patient expected survival and net difference in Disability/Quality-adjusted life years (DALY/QALY) up to 15 years from stroke were modeled using age, sex, 90-day mRS, and utility scores. Level of care within the first 90 days was prospectively measured and used to estimate procedure and inpatient care costs (US$ reference year 2014). RESULTS: There were 70 patients, 35 in each arm, mean age 69, median NIHSS 15 (IQR 12-19). The median (IQR) disability-weighted utility score at 90 days was 0.65 (0.00-0.91) in the alteplase-only versus 0.91 (0.65-1.00) in the endovascular group (p = 0.005). Modeled life expectancy was greater in the endovascular versus alteplase-only group (median 15.6 versus 11.2 years, p = 0.02). The endovascular thrombectomy group had fewer simulated DALYs lost over 15 years [median (IQR) 5.5 (3.2-8.7) versus 8.9 (4.7-13.8), p = 0.02] and more QALY gained [median (IQR) 9.3 (4.2-13.1) versus 4.9 (0.3-8.5), p = 0.03]. Endovascular patients spent less time in hospital [median (IQR) 5 (3-11) days versus 8 (5-14) days, p = 0.04] and rehabilitation [median (IQR) 0 (0-28) versus 27 (0-65) days, p = 0.03]. The estimated inpatient costs in the first 90 days were less in the thrombectomy group (average US$15,689 versus US$30,569, p = 0.008) offsetting the costs of interhospital transport and the thrombectomy procedure (average US$10,515). The average saving per patient treated with thrombectomy was US$4,365. CONCLUSION: Thrombectomy patients with large vessel occlus

Background: The use of advanced brain imaging to identify potentially salvageable ischemic penumbra has been controversial. We examined the effect of reperfusion on functional outcome in the EXTEND-IA trial. Method(s): Patients receiving tPA < 4.5 h with major vessel occlusion were randomized to thrombectomy versus tPA-only if CT-perfusion demonstrated mismatch ratio > 1.2 between hypoperfused tissue (Tmax > 6 s) and irreversibly injured ischemic core (relative cerebral blood flow < 30%), absolute mismatch > 10 mL and ischemic core < 70 mL (RAPID software, Stanford University). Reperfusion was defined as >90% reduction in Tmax > 6 s hypoperfusion volume between baseline and 24 h perfusion imaging. Modified Rankin Scale (mRS) was assessed at 90 days. Result(s): There were 70 patients, 35 in each arm, mean age 69, median NIHSS 15. Reperfusion of >90% of the affected territory occurred in 89% endovascular patients and 34% tPA-only patients (p < 0.001). Reperfusion was associated with independence (mRS0-2) in 72% versus 30% nonreperfused patients (p < 0.001). In ordinal analysis which assesses shift between individual levels of the mRS, the unadjusted generalized odds ratio = 4.5, 95%CI 2.2-9.0, p < 0.001 with a 'number needed to reperfuse' of 1.6 patients to achieve at least 1 point improvement on the mRS (OR = 5.1, p < 0.001, adjusted for age and NIHSS). Conclusion(s): In ischemic stroke patients with large vessel occlusion and 'target mismatch' indicating salvageable tissue on CT-perfusion, outcomes are usually unfavorable unless reperfusion is achieved with 70% of patients dead or dependent at 3 months. This is consistent with the penumbral hypothesis that, in the absence of reperfusion, penumbral tissue is recruited into the irreversibly injured infarct over time.

Background: Optimal imaging selection for endovascular therapy for ischemic stroke remains controversial with a range of criteria used in the recent positive trials. Large volume severe hypoperfusion (Tmax > 10 s) is one such criterion, with optimal threshold > 82 mL ('malignant profile'), in a previous study. We examined whether this was associated with poor response to reperfusion in the EXTEND-IA randomized trial, which did not exclude patients on this basis. Method(s): Patients receiving tPA < 4.5 h with major vessel occlusion and favorable CT-perfusion (CTP) were randomized (after written informed consent, IRB-approved) to thrombectomy after tPA versus tPA-alone. CTP eligibility required mismatch ratio > 1.2 between hypoperfused tissue (Tmax > 6 s) and irreversibly injured ischemic core (relative cerebral blood flow < 30%), absolute mismatch > 10 mL, ischemic core <70 mL (RAPID software, Stanford University). Tmax > 10 s volume was calculated and effect on clinical outcomes examined. Result(s): There were 70 patients, 35 in each arm, mean age = 69, median NIHSS = 15. In these patients with ischemic core < 70 mL, median Tmax > 10 s volume was 41 ml with 12/70(17%) > 82 ml, 6/70(8.6%) > 100 ml. Of the 'malignant' patients(Tmax10 s > 82 ml), 6/12(50%) had >90% reperfusion at 24 h (4 endovascular and 2 tPAonly), all of whom had 'early neurological recovery' (>=8 point NIHSS reduction or 0-1 by day 3) and 5/6(83%) had 90 day mRS0-1. No patient with <90% reperfusion had day 90 mRS < 3. Conclusion(s): In ischemic stroke patients <4.5 h after onset, large Tmax > 10 s volume in the absence of a large ischemic core was uncommon. Although the numbers in this study were small, the 83% rate of excellent functional outcome after reperfusion suggests that excluding such patients from therapy may not be justified.

Background: Recent trials have demonstrated improved outcomes with endovascular therapy for ischemic stroke compared with tPA. We examined the effects on resource utilization, length of stay and cost in the EXTEND-IA trial. Method(s): Patients receiving tPA < 4.5 h who had major vessel occlusion and CT-perfusion evidence of salvageable brain tissue were randomized to endovascular thrombectomy after tPA versus tPA-alone. Length of stay in acute inpatient, rehabilitation and nursing care units over the first 3 months and costs were compared between groups (Wilcoxon test) and the mean values were used to calculate costs for the average patient in each treatment group. Result(s): There were 70 patients, 35 in each arm, mean age 69, median NIHSS 15. Endovascular patients had shorter acute inpatient stays (mean 8 versus 12 days, p = 0.04) without increased time in intensive care (9 versus 11 hours, p = 0.51). Survivors spent less time in rehabilitation after endovascular treatment (mean 14 versus 33 days, p = 0.03). The cost of inpatient care in the first 3 months was similar for endovascular and tPA-only patients (mean AU$43,000 versus AU$45,000, respectively), including the AU$20,000 average cost for the thrombectomy. Ongoing nursing care (AU$146,000 p.a.) was required for 5/35 patients (all tPA-only). Conclusion(s): In ischemic stroke patients with large vessel occlusion and salvageable tissue on CT-perfusion, thrombectomy reduced length of stay and was cost neutral compared with tPA-alone over 3months. The healtheconomic benefits would be expected to increase further over time. The magnitude of difference in inpatient care costs suggests this finding would generalize to other health systems.

Background: Trials of endovascular therapy for ischemic stroke have produced variable results. We conducted this study to test whether more advanced imaging selection, recently developed devices, and earlier intervention improve outcomes. Method(s): We randomly assigned patients with ischemic stroke who were receiving 0.9 mg of alteplase per kilogram of body weight less than 4.5 hours after the onset of ischemic stroke either to undergo endovascular thrombectomy with the Solitaire FR (Flow Restoration) stent retriever or to continue receiving alteplase alone. All the patients had occlusion of the internal carotid or middle cerebral artery and evidence of salvageable brain tissue and ischemic core of less than 70 ml on computed tomographic (CT) perfusion imaging. The coprimary outcomes were reperfusion at 24 hours and early neurologic improvement (.8-point reduction on the National Institutes of Health Stroke Scale or a score of 0 or 1 at day 3). Secondary outcomes included the functional score on the modified Rankin scale at 90 days. Result(s): The trial was stopped early because of efficacy after 70 patients had undergone randomization (35 patients in each group). The percentage of ischemic territory that had undergone reperfusion at 24 hours was greater in the endovascular-therapy group than in the alteplase-only group (median, 100% vs. 37%; P<0.001). Endovascular therapy, initiated at a median of 210 minutes after the onset of stroke, increased early neurologic improvement at 3 days (80% vs. 37%, P = 0.002) and improved the functional outcome at 90 days, with more patients achieving functional independence (score of 0 to 2 on the modified Rankin scale, 71% vs. 40%; P = 0.01). There were no significant differences in rates of death or symptomatic intracerebral hemorrhage. Conclusion(s): In patients with ischemic stroke with a proximal cerebral arterial occlusion and salvageable tissue on CT perfusion imaging, early thrombectomy with the Solitaire FR stent retrieve

Background and Hypothesis: Thrombolysis with tissue plasminogen activator is proven to reduce disability when given within 4.5h of ischemic stroke onset. However, tissue plasminogen activator only succeeds in recanalizing large vessel arterial occlusion in a minority of patients. We hypothesized that anterior circulation ischemic stroke patients, selected with 'dual target' vessel occlusion and evidence of salvageable brain using computed tomography or magnetic resonance imaging 'mismatch' within 4.5h of onset, would have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone. Study Design: EXTEND-IA is an investigator-initiated, phase II, multicenter prospective, randomized, open-label, blinded-endpoint study. Ischemic stroke patients receiving standard 0.9mg/kg intravenous tissue plasminogen activator within 4.5h of stroke onset who have good prestroke functional status (modified Rankin Scale <2, no upper age limit) will undergo multimodal computed tomography or magnetic resonance imaging. Patients who also meet dual target imaging criteria: vessel occlusion (internal carotid or middle cerebral artery) and mismatch (perfusion lesion:ischemic core mismatch ratio >1.2, absolute mismatch >10ml, ischemic core volume <70ml) will be randomized to either clot retrieval with the Solitaire FR device after full dose intravenous tissue plasminogen activator, or tissue plasminogen activator alone. Study Outcomes: The coprimary outcome measure will be reperfusion at 24h and favorable clinical response (reduction in National Institutes of Health Stroke Scale by >=8 points or reaching 0-1) at day 3. Secondary outcomes include modified Rankin Scale at day 90, death, and symptomatic intracranial hemorrhage. © 2013 World Stroke Organization.

A qualitative research design and an ethno-nursing research method were used to identify cultural factors influencing Xhosa women's health seeking behaviours associated with breast lumps. Focus group interviews were conducted to obtain data. The research results revealed that these Xhosa women with breast lumps did not disclose some cultural factors which influenced their health seeking behaviours associated breast lumps. Registered nurses, sharing the same culture and language as the Xhosa women, revealed that Xhosa women with breast lumps sought treatment from traditional healers, prior to seeking medical care from the hospital and/or clinics. When they arrive at the hospital/clinics the breast lumps have often progressed to advanced ulcerated breast cancer, with poor prognoses and poor treatment outcomes. Xhosa women lacked knowledge about the management of breast lumps. Health promotion efforts should address this issue at Primary Health Care services in the Eastern Cape.