Showing papers by "Peter D. Schellinger published in 2011"
TL;DR: The trial met its primary safety end point but not its primary efficacy end point, and signals of treatment effect were suggested on all-cause mortality, in patients presenting early, older than age 70 years, or with moderate strokes, but these require confirmation.
Abstract: Background and Purpose—Fewer than 5% of patients with acute ischemic stroke are currently treated, and there is need for additional treatment options. A novel catheter treatment (NeuroFlo) that increases cerebral blood flow was tested to 14 hours. Methods—The Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke trial is a randomized trial of the safety and efficacy of NeuroFlo treatment in improving neurological outcome versus standard medical management. The primary safety end point was the incidence of serious adverse events through 90 days. The primary efficacy end point on a modified intent-to-treat population was a global disability end point at 90 days. Secondary end points included mortality, intracranial hemorrhage, modified Rankin scale score outcome of 0 to 2, and modified Rankin scale shift analysis. Results—Between October 2005 and January 2010, 515 patients were enrolled at 68 centers in 9 countries. The primary efficacy end point did not reach statistical significance (OR, 1.17; CI, 0.81...
95 citations
TL;DR: By applying a standardized and diligently monitored thrombolysis protocol, carried out by a specialized stroke team within a neurological emergency room, in-hospital delays can be minimized and improvement of door-to-needle times irrespective of the time to arrival and treatment during off-hours is allowed.
Abstract: BackgroundIntravenous thrombolysis for acute stroke is more efficient the earlier the treatment is initiated. In-hospital delays account for a significant proportion of avoidable time loss before t...
79 citations
TL;DR: A lower age, lower National Institutes of Health Stroke Scale score on admission, and smaller pretreatment diffusion-weighted imaging lesion volume were found to be associated with a favorable outcome after treatment with IV-tPA.
Abstract: Background and Purpose—Stroke magnetic resonance imaging with perfusion and diffusion weighting has shown its potential to select patients likely to benefit from intravenous thrombolysis with tissue-type plasminogen activator (IV-tPA). We aimed to determine the predictors of favorable outcome in magnetic resonance imaging–selected, acute stroke patients treated with IV-tPA. Methods—We analyzed the data of acute ischemic stroke patients from a prospective, multicenter, observational study of magnetic resonance imaging–based IV-tPA treatment initiated ≤6 hours from symptom onset. Neurologic deficit on admission was assessed by the National Institutes of Health Stroke Scale. Clinical outcome was assessed after 90 days according to the modified Rankin Scale. Favorable outcome was defined as a modified Rankin Scale score of 0 to 1. Patients were compared regarding baseline parameters. Multivariate regression analysis was used to identify predictors of favorable outcome. Results—Of 174 patients, 83 (48%) reache...
57 citations
TL;DR: Partial aortic occlusion as an adjunct to thrombolysis in the treatment of acute stroke appears safe and studies aimed at determining the efficacy of this therapeutic approach are warranted.
Abstract: Background and Purpose—Collateral flow augmentation using partial aortic occlusion may improve cerebral perfusion in acute stroke. We assessed the safety and feasibility of partial aortic occlusion immediately after intravenous tissue plasminogen activator. Methods—We conducted an open-label pilot study of partial aortic occlusion after thrombolysis. The primary end point was all serious adverse events within 30 days of treatment. Results—None of the 22 patients enrolled developed symptomatic parenchymal hemorrhages. Asymptomatic hemorrhagic transformation occurred in 9 patients. Procedure-related adverse events were limited to groin complications (n=13). Seventy-seven percent of patients experienced neurological improvement (≥4-point improvement of the National Institutes of Health Stroke Scale score). Conclusions—Partial aortic occlusion as an adjunct to thrombolysis in the treatment of acute stroke appears safe. Studies aimed at determining the efficacy of this therapeutic approach are warranted. Clini...
34 citations
TL;DR: Rapid complete recovery can be achieved in up to a fifth of acute stroke patients treated with thrombolysis, and these patients are younger and have milder strokes, less often with cardioembolic origin.
Abstract: Background: Recombinant tissue plasminogen activator (rt-PA) is the only approved specific therapy for acute ischemic stroke. This study analyzes demographic and clinical characteristics of patients with early complete neurological recovery after thrombolysis. Methods: Data of 320 consecutive patients treated with rt-PA within 3 h of stroke onset at our facility between April 2006 and March 2009 were extracted from our prospective institutional stroke and thrombolysis database. Baseline demographic parameters, risk factors, clinical characteristics as well as neuroradiologic findings of patients with complete recovery 24 h after treatment and at hospital discharge were analyzed. Outcome was evaluated using the modified Rankin Scale at 90 days. Results: Thirty patients (9.4%) were asymptomatic 24 h after thrombolysis and 70 (22%) at hospital discharge. Patients with complete recovery were younger, more often male, had milder stroke symptoms, less often cardioembolic strokes, fewer bleeding complications and more often normal follow-up imaging. In addition, in-hospital time was shorter and these patients retained a better functional outcome at 90 days. Only 1 patient who had completely recovered at hospital discharge died during the follow-up time. In multivariate regression analysis, only the National Institute of Health Stroke Score (NIHSS) on admission was predictive for complete recovery at both examined time points. Conclusion: Rapid complete recovery can be achieved in up to a fifth of acute stroke patients treated with thrombolysis. These patients are younger and have milder strokes, less often with cardioembolic origin. Better outcome and lower mortality are sustained at 3 months.
31 citations
TL;DR: It is unrealistic to expect primary intraarterial revascularisation to be any better than systemic plasminogen activator within the 3-h time window, and patients treated with systemic thrombolysis achieved better functional outcomes likely due to earlier treatment initiation.
Abstract: BackgroundAn uncontrolled clinical study of the Penumbra™ system showed high rates of recanalisation and relatively poor functional outcomes that were inadequately compared with historic controls. We aimed to compare the findings in Penumbra with intravenous tissue plasminogen activator trials that determined recanalisation (Combined Lysis Of Thrombus in Brain ischaemia using transcranial Ultrasound and Systemic tissue plasminogen activator and Transcranial Ultrasound in Clinical Sonothrombolysis).MethodsControl patients treated with intravenous tissue plasminogen activator and intermittent ultrasound surveillance had National Institutes of Health Stroke Scale scores >7. The Penumbra trial definition of symptomatic intracranial haemorrhage was used. Revascularisation was defined using thrombolysis in brain ischaemia scores predictive of thrombolysis in myocardial infarction flow grades and compared with thrombolysis in myocardial infarction data from Penumbra. Favourable functional outcomes was defined as...
13 citations
TL;DR: In this article, a number of such Grenzsituationen aufgedeckt and diskutiert are discussed, e.g., the Thrombolyse auserhalb geltender Zulassungskriterien (z.b. B. Vorhofflimmern and frischer Stent), or haufig diskuterten Risikokonstellationen (Demenz, Anamnese fur Sturze, Zustand nach intrazerebraler Blutung).
Abstract: Bei der Behandlung von Schlaganfallpatienten ist fur eine Vielzahl der therapeutischen Entscheidungen im Alltag die medizinische Evidenz begrenzt oder nicht vorhanden. Dies betrifft Behandlungssituationen sowohl in der Akuttherapie als auch in der Sekundarpravention. In diesem Beitrag werden solche Grenzsituationen aufgedeckt und diskutiert. Beispiele sind die Thrombolyse auserhalb geltender Zulassungskriterien (z. B. hohes Alter, orale Antikoagulation) und die Sekundarpravention bei Patienten mit konkurrierenden Behandlungsindikationen (z. B. Vorhofflimmern und frischer Stent) oder haufig diskutierten Risikokonstellationen (Demenz, Anamnese fur Sturze, Zustand nach intrazerebraler Blutung). Neben der Diskussion der aktuellen Datenlage werden eigene Erfahrungen berichtet und konkrete Empfehlungen zum Vorgehen gegeben.
2 citations