Tobias Struffert

The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe

Background and purpose The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. Methods A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. Results A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Conclusion Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

Efficient drug-delivery using magnetic nanoparticles — biodistribution and therapeutic effects in tumour bearing rabbits

UNLABELLED To treat tumours efficiently and spare normal tissues, targeted drug delivery is a promising alternative to conventional, systemic administered chemotherapy. Drug-carrying magnetic nanoparticles can be concentrated in tumours by external magnetic fields, preventing the nanomaterial from being cleared by metabolic burden before reaching the tumour. Therefore in Magnetic Drug Targeting (MDT) the favoured mode of application is believed to be intra-arterial. Here, we show that a simple yet versatile magnetic carrier-system (hydrodynamic particles diameter <200nm) accumulates the chemotherapeutic drug mitoxantrone efficiently in tumours. With MDT we observed the following drug accumulations relative to the recovery from all investigated tissues: tumour region: 57.2%, liver: 14.4%, kidneys: 15.2%. Systemic intra-venous application revealed different results: tumour region: 0.7%, liver: 14.4 % and kidneys: 77.8%. The therapeutic outcome was demonstrated by complete tumour remissions and a survival probability of 26.7% (P=0.0075). These results are confirming former pilot experiments and implying a milestone towards clinical studies. FROM THE CLINICAL EDITOR This team of investigators studied drug carrying nanoparticles for magnetic drug targeting (MDT), demonstrating the importance of intra-arterial administration resulting in improved clinical outcomes in the studied animal model compared with intra-venous.

Flat Detector CT in the Evaluation of Brain Parenchyma, Intracranial Vasculature, and Cerebral Blood Volume: A Pilot Study in Patients with Acute Symptoms of Cerebral Ischemia

BACKGROUND AND PURPOSE: The viability of both brain parenchyma and vascular anatomy is important in estimating the risk and potential benefit of revascularization in patients with acute cerebral ischemia. We tested the hypothesis that when used in conjunction with IV contrast, FD-CT imaging would provide both anatomic and physiologic information that would correlate well with that obtained by using standard multisection CT techniques. MATERIALS AND METHODS: Imaging of brain parenchyma (FD-CT), cerebral vasculature (FD-CTA), and cerebral blood volume (FD-CBV) was performed in 10 patients. All patients also underwent conventional multisection CT, CTA, CTP (including CBV, CTP-CBV), and conventional catheter angiography. Correlation of the corresponding images was performed by 2 experienced neuroradiologists. RESULTS: There was good correlation of the CBV color maps and absolute values between FD-CBV and CTP-CBV (correlation coefficient, 0.72; P < .001). The Bland-Altman test showed a mean difference of CBV values between FD-CT and CTP-CBV of 0.04 ± 0.55 mL/100 mL. All vascular lesions identified with standard CTA were also visualized with FD-CTA. Visualization of brain parenchyma by using FD-CT was poor compared with that obtained by using standard CT. CONCLUSIONS: Both imaging of the cerebral vasculature and measurements of CBV by using FD-CT are feasible. The resulting vascular images and CBV measurements compared well with ones made by using standard CT techniques. The ability to measure CBV and also visualize cerebral vasculature in the angiography suite may offer significant advantages in the management of patients. FD-CT is not yet equivalent to CT for imaging of brain parenchyma.

Flat-panel detector volumetric CT for visualization of subarachnoid hemorrhage and ventricles: preliminary results compared to conventional CT

IntroductionThe aim of this study was to compare flat-panel volumetric CT (VCT) to conventional CT (cCT) in the visualization of the extent of subarachnoid hemorrhage (SAH) and the width of the ventricles in patients with acute SAH.MethodsIncluded in the study were 22 patients with an acutely ruptured cerebral aneurysm who received VCT during coil embolization. VCT image quality, the extent of SAH (using a modified Fisher score and total slice number with SAH visible) and the width of the ventricles (Evans index) were evaluated by two experienced neuroradiologists (RAD1 and RAD2) and compared to the findings on cCT. Ten patients undergoing VCT for reasons other than SAH served as negative controls.ResultsInterobserver agreement in rating image quality was excellent for cCT (Kendall W value 0.94) and good for VCT (0.74). SAH was identified by RAD1 and RAD2 on VCT images in all patients. The modified Fisher scores underestimated the extent of SAH on VCT images in comparison with cCT images. Pearson’s correlation coefficient (r) regarding the number of image slices with SAH visible on cCT images compared with the number on VCT images was 0.85 for RAD1 and 0.84 for RAD2. The r value for the degree of interobserver agreement for the number of slices with SAH visible was 0.99 for cCT, and 0.95 for VCT images (n = 19), respectively. The width of the ventricles measured in terms of the Evans Index showed excellent concordance between the modalities (r = 0.81 vs. 0.82).ConclusionOur preliminary results indicate that VCT is helpful in evaluating SAH in the angiography suite. Additionally, reliable evaluation of ventricle width is feasible. However, there are limitations with regard to the visibility of SAH on VCT images in comparison to cCT images.

Flat Panel Detector Angiographic CT for Stent-Assisted Coil Embolization of Broad-Based Cerebral Aneurysms

BACKGROUND AND PURPOSE: The purpose of this work was to evaluate angiographic CT (ACT) in the combined application of a self-expanding neurovascular stent and detachable platinum coils in the management of broad-based and fusiform intracranial aneurysms. MATERIALS AND METHODS: Eleven patients harboring wide-necked intracranial aneurysms were treated with a flexible self-expanding neurovascular stent and subsequent aneurysm embolization with platinum microcoils. ACT was performed after the interventional procedure to analyze stent position and the relationship of coils to the stent. Postprocessing included multiplanar reconstructions (MPRs) and maximum intensity projections (MIPs). ACT volume datasets were postprocessed for soft tissue visualization. RESULTS: Accurate stent placement with subsequent coil occlusion of the aneurysms was feasible in all of the patients. Similar to nonsubtracted digital subtraction angiography (DSA) images, radiopaque platinum stent markers showed excellent visibility in ACT as well. The stent struts themselves, hardly visible in nonsubtracted DSA, were visible in MPRs and MIPs of ACT in all of the patients. In aneurysms larger than 10 mm in diameter, accurate stent assessment at the level of the coils was limited due to beam hardening artifacts. Postprocedural ACT in all of the patients did not reveal any evidence of procedure-related intracranial hemorrhage. CONCLUSION: ACT provides cross-sectional, 3D visualization of endovascular stents otherwise hardly visible with plain fluoroscopy. ACT enables us to accurately determine stent position, which may be helpful in complex stent-assisted aneurysm coiling procedures. However, in aneurysms larger than 10 mm in diameter, beam hardening artifacts caused by the endoaneurysmal coil package impair visibility of the stent. Further data are necessary to evaluate the usefulness of ACT in stent-assisted aneurysm coiling.

Intraventricular Fibrinolysis and Lumbar Drainage for Ventricular Hemorrhage

Background and Purpose— Both intraventricular fibrinolysis (IVF) and lumbar drainage (LD) may reduce the need for exchange of external ventricular drainage (EVD) and shunt surgery in patients with intracerebral hemorrhage and severe intraventricular hemorrhage. We investigated the feasibility and safety of IVF followed by early LD for the treatment of posthemorrhagic hydrocephalus. Methods— This prospective study included patients with spontaneous ganglionic intracerebral hemorrhage and severe intraventricular hemorrhage with acute obstructive posthemorrhagic hydrocephalus who received an EVD (n=32). The treatment algorithm started with IVF (4 mg recombinant tissue plasminogen activator every 12 hours) until clearance of the third and fourth ventricles from blood. Thereupon, EVD was clamped and if clamping was unsuccessful, communicating posthemorrhagic hydrocephalus was assumed and LD placed. EVD was removed if there was neither an increase of intracranial pressure nor ventricle enlargement on CT. A ventriculoperitoneal shunt was indicated if “LD weaning” was unsuccessful for >10 days. Outcome was assessed at 90 and 180 days using the modified Rankin Scale. Results— IVF resulted in fast clearance of the third and fourth ventricles (73±50 hours). However, early EVD removal was only possible in 4 patients. The remaining 28 patients developed communicating posthemorrhagic hydrocephalus. In all of these patients, early LD was capable to replace EVD. EVD exchange was not necessary and EVD duration was 105±59 hours. Only one patient required a ventriculoperitoneal shunt. At 180 days, 20 (62.5%) patients had a good (modified Rankin Scale 0 to 3) outcome and 5 (15.6%) patients had died. One patient had asymptomatic ventricular rebleeding. Conclusions— In patients with secondary intraventricular hemorrhage and posthemorrhagic hydrocephalus, the combined treatment approach of IVF and early LD is safe and feasible, avoids EVD exchange, and may markedly reduce the need for shunt surgery.

Safety and Outcome after Thrombolysis in Stroke Patients with Mild Symptoms

Background: Thrombolytic therapy is frequently withheld in patients with minor stroke symptoms. However, recent studies demonstrate that a substantial proportion of these patients dies or remains permanently disabled because of underestimation of symptom severity at baseline or secondary deterioration. We aimed to assess the safety and outcome of thrombolysis therapy in patients with minor but disabling stroke symptoms. Methods: 32 patients presenting with mild symptoms were treated with intravenous recombinant tissue-type plasminogen activator between April 2006 and April 2008. Data were extracted from a prospectively collected database. Baseline demographic data, and clinical, laboratory and imaging findings were analyzed. Outcome was assessed using the modified Rankin Scale (mRS) score at 3 months and was dichotomized into favorable (mRS 0–1) versus unfavorable (mRS 2–6). Results: In the majority of patients, the left hemisphere was affected, with aphasia representing the most common symptom leading to treatment decision. The frequency of perfusion lesion (46%) and vessel occlusion (35%) at baseline was high but had no effect on the outcome at 3 months in our series of treated patients. Outcome was favorable in 94% of patients, and 47% recovered without any persisting symptom. Only one asymptomatic and no symptomatic hemorrhage was observed. Conclusion: Our data support current guidelines and international licenses which give no lower National Institutes of Health Stroke Scale (NIHSS) limit for intravenous thrombolysis (IVT). Considering the accumulating evidence that the natural course in patients with mild symptoms is not as favorable as often assumed and taking the low risk of bleeding in those patients into account, patients with mild but disabling symptoms should be treated with IVT regardless of their baseline NIHSS score.

Metal Artifact Reduction for Clipping and Coiling in Interventional C-Arm CT

BACKGROUND AND PURPOSE: Metallic implants induce massive artifacts in CT images which deteriorate image quality and often superimpose structures of interest. The purpose of this study was to apply and evaluate a dedicated MAR method for neuroradiologic intracranial clips and detachable platinum coiling events. We here report the first clinical results for MAR in FDCT. MATERIALS AND METHODS: FDCT volume scans of several patients treated with endovascular coiling or intracranial clipping were corrected by using a dedicated FDCT MAR correction algorithm combined with an edge-preserving attenuation-normalization method in the projection space. Corrected and uncorrected images were compared by 2 experienced radiologists and evaluated for several image-quality features. RESULTS: After application of our algorithm, implant delineation and visibility were highly improved. CT values compared with values in metal artifact−unaffected areas showed good agreement (average correction of 1300 HU). Image noise was reduced overall by 27%. Intracranial hemorrhage in the direct surroundings of the implanted coil or clip material was displayed without worrisome metal artifacts, and our algorithm even allowed diagnosis in areas where extensive information losses were seen. The high spatial resolution provided by FDCT imaging was well preserved. CONCLUSIONS: Our MAR method provided metal artifact−reduced images in every studied case. It reduced image noise and corrected CT values to levels comparable with images measured without metallic implants. An overall improvement of brain tissue modeling and implant visibility was achieved. MAR in neuroradiologic FDCT imaging is a promising step forward for better image quality and diagnosis in the presence of metallic implants.

Visualisation of intracerebral haemorrhage with flat-detector CT compared to multislice CT: results in 44 cases

The aim of the study was to test the reliability of intracerebral haemorrhage (ICH) detection with C-arm-mounted flat-detector computed tomography (FD-CT) in the angio suite as compared to multislice CT (MSCT). In this study 44 patients with 45 ICH were included. All patients were investigated with MSCT and FD-CT during angiographic evaluation. As a control group we included 16 patients without ICH. In each haematoma we assessed volumetric data of the ICH and counted the numbers of ICH-positive slices. Using interobserver ratings, we additionally investigated the potential of FD-CT to serve as a diagnostic tool to detect ICH. In FD-CT three haematomas were not detected because of motion and beam-hardening artefacts in the region close to the skull base. The r value for the degree of interobserver agreement for the number of slices was 0.95 for MSCT and 0.94 for FD-CT. Measurements of the area and the calculated volume of the ICH showed high inter- and intraobserver agreement. Our results indicate that FD-CT is a helpful tool in the daily emergency management of ICH patients as detection of ICH was found to be nearly as reliable as in MSCT. Limitations of this technology are motion and beam-hardening artefacts that may mask small haematomas located in the posterior fossa or the skull base.

Endovascular treatment of unruptured intracranial aneurysms: occurrence of thromboembolic events.

OBJECTIVE:The purpose of this study was to evaluate the frequency and causes of thromboembolic events associated with endovascular embolization of asymptomatic aneurysms. Correlations between radiological findings (aneurysm size, localization, embolization time, number of coils used, as well as patient age) were evaluated with the occurrence of thromboembolic events and clinical findings. METHODS:Sixty-eight patients treated for unruptured intracranial aneurysms (mean age, 49 yr) were evaluated. Hyperintense lesions on diffusion weighted imaging were analyzed in 50 patients. Aneurysm size was 3 to 15 mm. RESULTS:Complete occlusion of the aneurysms was achieved in 55 of 68 (82%). One patient had a transient paresis. There was one infarction and one aneurysm rupture during the procedure with no consecutive neurological symptoms. We found new hyperintense lesions in 21 of 50 (42%) diffusion weighted imaging studies. In 43% of these, there was only one lesion smaller than 2 mm. In 33%, there was more than one lesion less than 2 mm; in 19%, we found a lesion of 2 to 10 mm in size. In one case, a lesion greater than 10 mm occurred. There was no correlation between aneurysm location and the occurrence of lesions or among the number of coils used, the size of the aneurysm, patient age, or embolization time. Mortality rate was 0%, morbidity 4.0%. If the 18 aneurysms where no diffusion weighted imaging was obtained are included, morbidity is 2.9%. CONCLUSION:The high rate of thromboembolic events suggests that heparin is not sufficient to prevent ischemic lesions. An antiplatelet therapy, started before or during intervention, might diminish thrombus formation.