Richard du Mesnil de Rochemont

Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke

BACKGROUND Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome. METHODS We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 [no symptoms] to 6 [death]). RESULTS The study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P<0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P<0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12). CONCLUSIONS In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days. (Funded by Covidien; SWIFT PRIME ClinicalTrials.gov number, NCT01657461.).

Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis

IMPORTANCE Endovascular thrombectomy with second-generation devices is beneficial for patients with ischemic stroke due to intracranial large-vessel occlusions. Delineation of the association of treatment time with outcomes would help to guide implementation. OBJECTIVE To characterize the period in which endovascular thrombectomy is associated with benefit, and the extent to which treatment delay is related to functional outcomes, mortality, and symptomatic intracranial hemorrhage. DESIGN, SETTING, AND PATIENTS Demographic, clinical, and brain imaging data as well as functional and radiologic outcomes were pooled from randomized phase 3 trials involving stent retrievers or other second-generation devices in a peer-reviewed publication (by July 1, 2016). The identified 5 trials enrolled patients at 89 international sites. EXPOSURES Endovascular thrombectomy plus medical therapy vs medical therapy alone; time to treatment. MAIN OUTCOMES AND MEASURES The primary outcome was degree of disability (mRS range, 0-6; lower scores indicating less disability) at 3 months, analyzed with the common odds ratio (cOR) to detect ordinal shift in the distribution of disability over the range of the mRS; secondary outcomes included functional independence at 3 months, mortality by 3 months, and symptomatic hemorrhagic transformation. RESULTS Among all 1287 patients (endovascular thrombectomy + medical therapy [n = 634]; medical therapy alone [n = 653]) enrolled in the 5 trials (mean age, 66.5 years [SD, 13.1]; women, 47.0%), time from symptom onset to randomization was 196 minutes (IQR, 142 to 267). Among the endovascular group, symptom onset to arterial puncture was 238 minutes (IQR, 180 to 302) and symptom onset to reperfusion was 286 minutes (IQR, 215 to 363). At 90 days, the mean mRS score was 2.9 (95% CI, 2.7 to 3.1) in the endovascular group and 3.6 (95% CI, 3.5 to 3.8) in the medical therapy group. The odds of better disability outcomes at 90 days (mRS scale distribution) with the endovascular group declined with longer time from symptom onset to arterial puncture: cOR at 3 hours, 2.79 (95% CI, 1.96 to 3.98), absolute risk difference (ARD) for lower disability scores, 39.2%; cOR at 6 hours, 1.98 (95% CI, 1.30 to 3.00), ARD, 30.2%; cOR at 8 hours,1.57 (95% CI, 0.86 to 2.88), ARD, 15.7%; retaining statistical significance through 7 hours and 18 minutes. Among 390 patients who achieved substantial reperfusion with endovascular thrombectomy, each 1-hour delay to reperfusion was associated with a less favorable degree of disability (cOR, 0.84 [95% CI, 0.76 to 0.93]; ARD, -6.7%) and less functional independence (OR, 0.81 [95% CI, 0.71 to 0.92], ARD, -5.2% [95% CI, -8.3% to -2.1%]), but no change in mortality (OR, 1.12 [95% CI, 0.93 to 1.34]; ARD, 1.5% [95% CI, -0.9% to 4.2%]). CONCLUSIONS AND RELEVANCE In this individual patient data meta-analysis of patients with large-vessel ischemic stroke, earlier treatment with endovascular thrombectomy + medical therapy compared with medical therapy alone was associated with lower degrees of disability at 3 months. Benefit became nonsignificant after 7.3 hours.

Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial: protocol for a randomized, controlled, multicenter study comparing the Solitaire revascularization device with IV tPA with IV tPA alone in acute ischemic stroke.

Rationale Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions. Aim The aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke. Design The study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled. Procedures Patients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset. Study Outcomes The primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure. Analysis Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0–2).

Practical limitations of acute stroke MRI due to patient-related problems

Patient-related factors may make MRI impractical in an emergency setting. The authors prospectively assessed the limitations on obtaining MRI in 141 consecutive acute stroke patients. MRI was not feasible in 28 (19.9%) patients owing to patient-related issues. Apart from MR contraindications (n = 14; 9.9%), the main factors precluding MRI were a diminished level of consciousness, vomiting, agitation, and hemodynamic compromise. In the subgroup of patients ineligible for MRI because of medical reasons (n = 11), intracerebral hemorrhage was frequent (n = 9; 73%).

Feasibility of Polestar N20, an ultra-low-field intraoperative magnetic resonance imaging system in resection control of pituitary macroadenomas: lessons learned from the first 40 cases.

OBJECTIVETo evaluate the feasibility of PoleStar N20 (Medtronic Surgical Navigation Technologies, Louisville, KY), an ultra-low-field intraoperative magnetic resonance imaging (iMRI) system during resection control of pituitary macroadenomas and to compare intraoperative images with postoperative 1.5-T MRI images obtained 3 months after the procedure. METHODSForty patients with a pituitary macroadenoma (mean size, 26.9 ± 9.1 mm) underwent a surgical procedure to remove the tumor. The iMRI system was implemented in a standardized microsurgical procedure (endonasal, transseptal, transsphenoidal approach) using standard microsurgical instruments. Intraoperative imaging was performed for tumor visualization/navigation and resection control. If an accessible tumor remnant was suspected, surgery was continued for reexploration and, if necessary, continued resection. Total anesthesia time and operation time were compared with a historical cohort of 100 patients who underwent a surgical procedure on pituitary adenomas without iMRI. Sensitivity and specificity of the iMRI to detect residual tumor tissue was assessed in 33 patients (82.5%) after comparison with standard postoperative 1.5-T MRI 3 months after the procedure. RESULTSPreoperative tumor visualization with the ultra-low-field iMRI showed a very good congruency with the preoperative 1.5-T MRI scans. A three-dimensional reconstruction of the coronal scan enabled the surgeon to safely approach the tumor using the integrated navigation system. In seven patients (17.5%), iMRI resection control showed accessible residual tumors leading to further resection. After tumor resection, the final iMRI scan documented adequate decompression of the optic pathway in all patients. Implementation of iMRI led to a significant increase of anesthesia time (246.0 ± 50.7 versus 163.4 ± 41.2 min) and operation time (116.9 ± 43.9 versus 78.2 ± 33.0 min; P < 0.05, t test). Sensitivity of the iMRI was 88.9, 85.7, 93.3, and 100% for the suprasellar, intrasellar, and right and left parasellar regions, respectively, and the specificity was 90.5% in the suprasellar and 100% in the intra- and parasellar regions on both sides. In four patients, the intraoperative interpretation of iMRI was equivocal; thus, it was difficult to distinguish between very small tumor remnants and perioperative changes. CONCLUSIONUltra-low-field 0.15-T iMRI is a safe, helpful, and feasible tool for navigation and tumor resection control in patients with pituitary macroadenomas. Total anesthesia and operation times are prolonged, but iMRI adequately documents the extent of tumor resection. In this series, the PoleStar system increased the rate of resection without disrupting the neurosurgical workflow.

A Simple 3-Item Stroke Scale: Comparison With the National Institutes of Health Stroke Scale and Prediction of Middle Cerebral Artery Occlusion

Background and Purpose— The purpose of the study was to design a simple stroke scale that requires minimal training but reflects initial stroke severity and is predictive of middle cerebral artery (MCA) occlusion. Methods— The new stroke scale assessed 3 parameters: (1) level of consciousness, (2) gaze, and (3) motor function. Each item was graded 0 to 2, where 0 indicated normal findings and 2 severe abnormalities (ie, profound drowsiness or worse, forced gaze deviation, and severe hemiparesis, respectively). During a study period of 11 months, patients presenting with acute stroke symptoms (onset ≤6 hours) were examined by a stroke neurologist assessing the new scale as well as the National Institutes of Health Stroke Scale (NIHSS). In addition, 83 patients received acute magnetic resonance angiography (MRA; as part of an acute stroke protocol). Results— The new stroke scale was strongly associated with the NIHSS. Interobserver reliability of the new scale was high (intraclass correlation coefficient 0.947). Using post hoc analysis, a score of ≥4 predicted proximal vessel occlusion (T-segment or M1-segment occlusion of the MCA on MRA) almost as accurately (overall accuracy 0.86) as an NIHSS score of ≥14 (overall accuracy 0.93). Conclusions— The new stroke scale reflects acute stroke severity well and predicts proximal MCA occlusion with reasonable accuracy. However, the clinical scale needs further evaluation before it can be recommended as a tool for the triage of acute stroke patients.

Treatment related morbidity of unruptured intracranial aneurysms: results of a prospective single centre series with an interdisciplinary approach over a 6 year period (1999–2005)

Objectives: To review the angiographic and clinical outcome of patients with unruptured intracranial aneurysm(s) (UIA) with regard to complications and successful obliteration by surgical clipping or endovascular coiling. Methods: Data were derived from a prospective database of intracranial aneurysms from June 1999 to May 2005. All patients were followed-up for 6 months using the modified Rankin Scale (mRS). Favourable outcome was classified as mRS 0–2. From a total of 691 patients included in the database, 173 harboured 206 UIA of whom 118 patients (133 UIA) were treated. Results: Primary treatment assignment was surgical repair in 91 UIA and endovascular treatment in 42. In 3 UIA (7.1%), endovascular treatment was not feasible and had to be abandoned. Definite treatment was surgery in 94 UIA (81 patients) and endovascular obliteration in 39 UIA (37 patients). There were no deaths related to any treatment. Immediately after treatment, 6.4% of the surgical and 7.7% of the endovascular patients showed new neurological deficits, mainly related to cerebral ischaemia. After 6 months, 3 (2.3%) patients had a treatment related unfavourable outcome, defined as mRS >2, 2 patients after surgical and 1 patient after endovascular aneurysm repair (not statistically different, p = 0.3; Fisher’s exact test). This led to an overall satisfactory outcome in 97.9% of surgically and 97.4% of endovasculary treated UIA. After surgical clipping, complete occlusion of the aneurysm was achieved in 88 (93.6%) and near complete (small residual neck) in 4 (4.3%) of 94 UIA. Two small posterior communicating artery aneurysms with a fetal type posterior communicating artery were wrapped. After endovascular treatment, obliteration was complete in 26 (66.7%). Small residual neck was seen in 13 (33.3%), but none of the UIA showed residual aneurysm filling. Five patients in the endovascular group (13.9%) underwent repeated endovascular treatment after aneurysm recanalisation. Conclusions: If patients are carefully selected and individually assigned to their optimum treatment modality, UIA can be obliterated by surgery or endovascular treatment in the majority of patients, with a low percentage of unfavourable outcomes. In this series, the outcome was not dependent on treatment. However, the rate of recanalisation of UIA is higher after endovascular obliteration. After diagnosis of an UIA, an individual interdisciplinary decision is essential for each patient to provide the optimum management.

Ischemic core and hypoperfusion volumes predict infarct size in SWIFT PRIME

Within the context of a prospective randomized trial (SWIFT PRIME), we assessed whether early imaging of stroke patients, primarily with computed tomography (CT) perfusion, can estimate the size of the irreversibly injured ischemic core and the volume of critically hypoperfused tissue. We also evaluated the accuracy of ischemic core and hypoperfusion volumes for predicting infarct volume in patients with the target mismatch profile.

Cost-Effectiveness of Solitaire Stent Retriever Thrombectomy for Acute Ischemic Stroke: Results From the SWIFT-PRIME Trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke).

Background and Purpose— Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated with stent retriever thrombectomy plus tissue-type plasminogen activator (SST+tPA) compared with tPA. Previous studies suggested that this strategy may be cost-effective, but models were derived from pooled data and older assumptions. Methods— In this prospective economic substudy conducted alongside the SWIFT-PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke), in-trial costs were measured for patients using detailed medical resource utilization and hospital billing data. Utility weights were assessed at 30 and 90 days using the EuroQol-5 dimension questionnaire. Post-trial costs and life-expectancy were estimated for each surviving patient using a model based on trial data and inputs derived from a contemporary cohort of ischemic stroke survivors. Results— Index hospitalization costs were

Perfusion–diffusion mismatch in MRI to indicate endovascular treatment of cerebral vasospasm after subarachnoid haemorrhage

17 183 per patient higher for SST+tPA than for tPA (