脳卒中急性期の理学療法におけるロボットスーツHAL導入の効果

Section Editors: Marc Fisher MD Antoni Davalos MD The Food and Drug Administration (FDA) evaluates applications for new human drugs, biologics, and complex medical devices. Companies must obtain FDA approval to legally market these products. In August, the FDA gave Concentric Medical clearance to market its Merci Retriever system to “remove blood clots from the brain in patients experiencing an ischemic stroke.” Given that the FDA is charged with “protecting the public health by assuring the safety, efficacy, and security of… biological products and medical devices…, ” “advancing public health by helping to speed innovations that make medicines … more effective, safer, and more affordable,” and “helping the public get the accurate, science-based information they need to use medicines … to improve their health,”1 the FDA’s decision to approve the Merci Retriever system is of concern. The pathways to approval are reviewed by Felten et al in the accompanying article and are outlined in Figure 1. Figure 1. Potential pathways for device approval. The decision to approve the Merci Retriever was based on data from the MERCI (Mechanical Embolus Removal in Cerebral Ischemia) Trial; the approval was granted through the 510(k) process. The Merci Retriever system includes a flexible nickel titanium (nitinol) wire that obtains a helical shape once it is passed through the tip of the guidance catheter. In practice, the catheter/wire is passed distal to the thrombus, the catheter is removed, and the helical configuration assumed by the wire; the clot is then trapped in the helix and withdrawn from the vasculature (Figure 2). The 510(k) clearance means that the Merci Retriever was felt to be substantially equivalent to a predicate device. In this case, the predicate device was the Concentric Retriever, which itself received 510(k) clearance by the FDA in May 2001 for “use in …

BackgroundLimitations in physicians’ knowledge regarding fibrinolytic therapy for acute ischemic stroke may contribute to low rate of fibrinolytic therapy in China. Here physicians’ knowledge was surveyed on intravenous fibrinolytic therapy for acute ischemic stroke.MethodsNeurologists (n = 175) from 27 major general hospitals in Shanxi province, P. R. China, were invited to complete questionnaires regarding their basic knowledge of intravenous fibrinolytic therapy for acute ischemic stroke. The questionnaire contained 12 multiple-choice questions. One point was assigned for a correct answer and zero point for a false or unanswered question.ResultsOne hundred and thirty-one neurologists (74.9%) responded to the questionnaires. The mean accuracy rate of 12 questions was 54.9 ± 25.01% (range 0.8–96.2%). The mean total score for respondents was 6.59 ± 2.03 (range 2–11). More years of experience and higher academic degrees were independent factors related to the total scores (P = 0.000 and P = 0.004, respectively).ConclusionsThe neurologists in this study were knowledge deficient in the area of intravenous fibrinolytic therapy for acute ischemic stroke. This partially accounts for the low rate of fibrinolytic therapy in China.

The effort to develop effective therapies for acute ischemic stroke achieved several important successes during the past decade, but also many disappointing failures. The 2 primary successes were related to thrombolysis. The first was the NINDS rt-PA (National Institute of Neurological Disorders and Stroke Recombinant Tissue-Type Plasminogen Activator) trial reported in 1995. This study demonstrated that initiation of intravenous (IV) rt-PA within 3 hours after the onset of acute ischemic stroke significantly improved outcome at 3 months. 1 This study led to the approval of rt-PA initiated within 3 hours of stroke onset as the only currently available acute stroke therapy. The second major success was the demonstration that intra-arterial prourokinase initiated within 6 hours of stroke onset in patients with angiographically documented proximal middle cerebral artery (MCA) occlusion also improved outcome at 3 months. 2 A third marginally positive acute stroke trial used ancrod, a defibrinogenating agent derived from Malaysian pit vipers. 3 Ancrod initiated within 3 hours after stroke onset also improved 3-month outcome but to a lesser degree than either rt-PA initiated within 3 hours or prourokinase initiated within 6 hours. These successful acute stroke therapy trials were outweighed by a large number of neuroprotective trial failures. Currently, not one of many purported neuroprotective therapies assessed in pivotal clinical trials has demonstrated unequivocal, statistically significant improvement in clinical outcome. 4 The neuroprotective trials all included patients who presented with a stroke 3 hours after onset, and the therapies used for each patient failed for myriad reasons that will be explored in detail. In this overview of the current status and future direction of acute stroke therapy, we will discuss in detail the current situation of thrombolytic therapy for acute ischemic stroke, reviewing the results of published clinical trials, postmarketing experience with rt-PA given within the 3-hour window, and future directions of how to potentially expand this window for IV thrombolytic therapy. The status of various neuroprotective therapies for acute ischemic stroke will be reviewed and potential new neuroprotective strategies previewed. Last, we attempt to envision likely approaches toward multiple therapeutic interventions, a treatment strategy likely to lead to maximal improvement in the greatest number of stroke patients.

BackgroundHigh on-treatment platelet reactivity (HOTPR) may undermine the efficacy of antiplatelet therapy in acute stroke. This study aimed to assess platelet reactivity and HOTPR status during the acute phase of ischaemic stroke following antiplatelet initiation, and to determine their associations with stroke outcomes in a Malaysian cohort.MethodsThis prospective, observational study enrolled patients with acute ischaemic stroke at Sarawak General Hospital. Platelet reactivity was measured at baseline and on Days 1 and 3 post-antiplatelet therapy using Multiplate® Analyser. HOTPR was defined by ASPItest (> 30 U) or ADPtest (> 46 U) values. The primary outcome was recurrent stroke at one year, while secondary outcomes included early neurological deterioration (END), poor functional outcome (mRS ≥ 2) at three months, and all-cause mortality at one year. Cox and logistic regression models adjusted for clinical covariates were used, with Firth’s correction applied for rare events and model non-convergence.ResultsA total of 198 participants were enrolled, with a mean age of 59.8 years; 66.7% were male. At one year, 9.1% experienced recurrent stroke, 9.6% had died, 9.2% experienced END during admission, and 21.6% had mRS ≥ 2 at three months. HOTPR rates decreased by Day 3 (aspirin: Day 1 20.0% to Day 3 6.6%; clopidogrel: 50.5–28.0%), with persistent HOTPR in 11.8% (aspirin) and 39.2% (clopidogrel). Some initially normal responders developed HOTPR by Day 3 (aspirin 5.4%, clopidogrel 16.3%). Platelet reactivity and HOTPR status on Days 1 and 3 were not significantly associated with recurrent stroke at one year or END. However, higher ADPtest values on Day 1 [OR 1.05 (95% CI 1.00, 1.09), p = 0.037], clopidogrel HOTPR on Days 1 and 3 [OR 20.99 (95% CI 1.53, 7089.91), p = 0.017; OR 16.58 (95% CI 1.57, 24326.82), p = 0.017], and persistent clopidogrel HOTPR on both days [OR 45.25 (95% CI 2.34, 21861.76), p = 0.007] were significantly associated with poor functional outcomes.ConclusionPlatelet reactivity and HOTPR status were not associated with recurrent stroke and END. However, higher ADPtest values and clopidogrel-related HOTPR were associated with poor functional outcomes. Further studies are needed to evaluate the clinical utility of platelet reactivity monitoring in acute stroke management.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12883-025-04396-x.

An apparatus for producine rotation by the use of sound waves : G. Hippe. ( Ann. d. Phys., No. 2, 1927.)

Background: Symptomatic intracerebral hemorrhage (SICH) following thrombolytic therapy for acute ischemic stroke is associated with a high rate of morbidity and mortality. Knowledge of the risk factors associated with SICH following thrombolyitc therapy may provide insight into the pathophysiological mechanisms underlying the development of SICH, lead to the development of treatments that reduce the risk of SICH and have implications for the design of future stroke trials. Methods: Relevant studies were identified through a search in Pubmed. Included studies used multivariate analyses to identify independent risk factors for SICH following thrombolytic therapy. For each variable that was found to have a significant association with SICH, a secondary literature search was conducted to identify additional reports on the specific relationship between that variable and SICH. Summary of Review: Twelve studies met inclusion criteria for the systematic review. Extent of hypoattenuated brain parenchyma on pretreatment CT and elevated serum glucose or history of diabetes were independent risk factors for thrombolysis-associated SICH in six of the twelve studies. Symptom severity was an independent risk factor in three of the studies and advanced age, increased time to treatment, high systolic blood pressure, low platelets, history of congestive heart failure and low plasminogen activator inhibitor levels were found to be independent risk factors for SICH in a single study. Although these data should not alter the current guidelines for the use of rt-PA in acute stroke, they may help develop future strategies aimed at reducing the rate of thrombolysis-associated SICH.

Background and Purpose: Prehospital notification of patients with suspected acute stroke by emergency medical services (EMS) personnel is recommended to reduce delays in time-dependent management such as thrombolytic therapy. We developed ” the Brain Saver”, which is a smartphone-assisted prenotification system using mobile application platform, and evaluated preliminarily the effects of this system on improving quality indicator for thrombolysis therapy in acute ischemic stroke. Methods: Through the Brain Saver, the EMS personnel sent the clinical information, such as age, sex, time of symptom onset, expected arrival time, neurological symptom of the patient with suspected acute stroke in the field, so that the stroke team prepared to prioritize the hospital resources such as computerized tomography (CT) and various laboratory test for suspected stroke patients. On arrival at emergency room, patients were transferred directly from triage onto the CT room on the ambulance stretcher, and the stroke team meet patient. Between September 2014 and July 2015, we compared quality indicators including door-to-needle time (DNT), door-to-imaging time (DIT) of patients with intravenous tissue plasminogen activator (tPA) with prenotification to those without prenotification. Results: During study period, time of onset to arrival in patients with prenotification using the Brain Saver was similar in those without. However, compared with tPA patients who arrived without prenotification, the median (interquartile range) DNT decreased from 55 (42-92) to 36 (32-42) minutes (p=0.003) and DIT was reduced from 11 (7-15) to 3 (2-6) minutes (p<0.0001). Conclusions: The Brain Saver was the efficient tool to communicate between EMS personnel and the stroke team for the prenotification of patients with acute stroke. The prenotification improved quality indicator of in-hospital stroke management by reducing time delay in thrombolytic therapy.

A multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke caused by proximal arterial occlusion in the anterior circulation.

There have been major advances during the past decade in stroke diagnosis, prevention, and treatment. Of these, intravenous tissue plasminogen activator (tPA) is currently the only approval medical therapy for acute ischemic stroke within a 3-hour window (1,2) , and is recommended by most acute stroke treatment guidelines, including Taiwan Guidelines for the Management of Stroke (3) . Postmarketing surveys have demonstrated that intravenous tPA can be administered appropriately in a wide variety of hospitals setting. Recently, a large observational study (SITS-MOST) showed that intravenous tPA is safe and effective in routine clinical use for acute ischemic stroke within 3 hours, even by hospitals with little previous experience of thrombolytic therapy for acute ischemic stroke

Emergency physician attitudes toward thrombolytic therapy in acute stroke

Uric acid, a powerful and potent antioxidant. Effect of uric acid in acute stroke was a controversy. Chronic hyperuricemia is atherogenic. But in recent days various articles were published about the antioxidant and the beneficial effects of uric acid due to cerebral antioxidant effect. In this article, we had reviewed various articles which discuss the major beneficial and deleterious effect of uric acid in neurological diseases to conclude the effect of uric acid in the scenario of acute ischemic stroke. This review was conducted through an Internet search on a public access website like PubMed, Google Scholar, Cochrane library, ProQuest and Medline databases until 2019. Keywords utilized included uric acid (UA), Acute ischemic stroke, neuroprotection, stroke therapy, and vasculoprotection. Total of 10 article from literature was reviewed, the major exclusion criteria were the studies that included patients which coronary artery disease, chronic kidney disease, Metabolic syndrome and patients who are taking drugs that influencing the uric acid levels. Chronic hyperuricemia is atherogenic and it had a negative impact on outcome in stroke, but in acute setting resent days various papers had been published about the beneficial effect of uric acid due to its antioxidants property. This was further supported by the co administration of Intravenous uric acid along with thrombolysis for acute ischemic stroke. Hence, we had concluded that, uric acid had a beneficial effect in a setting of acute ischemic stroke.

Outcomes of Intravenous Thrombolytic Therapy for Acute Ischemic Stroke With an Integrated Acute Stroke Referral Network: Initial Experience of a Community-Based Hospital in a Developing Country

Background: Recent studies have shown that intra-arterial recanalization therapy (IAT) for acute ischemic stroke (AIS) is associated with worse clinical outcomes when performed under general anesthesia (GA) compared to local anesthesia, with or without conscious sedation. The reasons for this association have not been systematically studied. Methods: We retrospectively reviewed 190 patients who underwent IAT for anterior circulation AIS from January 2008 to December 2012 at our institution. Baseline demographics, vessels involved, acute stroke treatment including intravenous tissue type plasminogen activator (tPA) use, use of GA vs. monitored anesthesia care (MAC), location of thrombus, recanalization grade, radiologic post-procedural intracerebral hemorrhage, and 30-day outcomes were collected. Relevant clinical time points were recorded. Detailed intra-procedural hemodynamics including maximum/minimum heart rate, systolic blood pressure (BP), diastolic BP, mean BP, use of pressors and episodes of hypotension were collected. Our study's outcomes were as follows: in-hospital mortality, 30-day good outcome (mRS ≤2), successful recanalization and radiologic post-procedural intracerebral hemorrhage. Results: Ninety-one patients received GA and 99 patients received MAC. There was no significant difference in the NIHSS score between the two groups but the GA group had a higher number of ICA occlusions (31.9 vs. 18.2%, p = 0.043). The time from the start of anesthesia to incision (23.0 ± 12.5 min vs. 18.7 ± 11.3 min, p = 0.020) and the time from the start of anesthesia to recanalization (110 ± 57.2 vs. 92.3 ± 43.0, p = 0.045) was longer in the GA group. The time from incision to recanalization was not significantly different between the two groups. mRS 0-2 was achieved in 22.8% of patients in the MAC group compared to 14.9% in GA (p = 0.293). Higher mortality was seen in the GA group (25.8 vs. 13.3%, p = 0.040). Successful recanalization (TICI 2b-3) was similar between the GA and MAC (57.8 vs. 48.5%, p = 0.182) groups, but GA had a higher number of parenchymal hematomas (26.3 vs. 10.1%, p = 0.003). There was no difference in the intra-procedural hemodynamic variables between the GA and MAC groups. Anesthesia type was an independent predictor for mortality (along with age and initial NIHSS), and the only independent predictor for parenchymal hematomas, with MAC being protective for both. Conclusion: Our study has confirmed previous findings of GA being associated with poorer outcomes and higher mortality in patients undergoing IAT for AIS. Detailed analysis of intra-procedural hemodynamics did not reveal any significant difference between the two groups. Parenchymal hematoma was the major driver of the difference in outcomes.

See related article, pages 1826–1830. The goal of acute stroke evaluation is to determine not only stroke type (ischemic versus hemorrhagic) and localization (anatomical and vascular), but perhaps more importantly, to determine reversibility (presence of an ischemic penumbra that may be salvaged with acute therapy). Traditionally, neurologists have relied on history and neurological examination to provide much of this information. However, long experience has demonstrated that the neurological examination is imperfect at best in determining lesion localization and grossly limited in its ability to provide insights into the presence of penumbral tissue. This is evidenced by the only modest correlations between National Institutes of Health Stroke Scale (NIHSS) score and perfusion-weighted imaging lesion volume.1,2 The last decade has seen a striking growth in neuroimaging techniques that provide important real-time information about acute stroke pathophysiology. In the mid-1990s the advent of diffusion-weighted imaging revolutionized the role of MRI in acute stroke evaluation. Not …

Cardioembolic infarction accounts for one quarter of all cerebral infarcts and is the most severe subtype of ischemic stroke. The rate of in-hospital death may be as high as 27% and a few patients are symptom-free at discharge from the hospital. Major cardiac sources of embolism are well-established and cardioembolic stroke is largely preventable. However, once stroke due to cardiac embolism has occurred, the likelihood of recurrence is relatively high (up to 10% for early embolic recurrence). Therefore, efforts at primary prevention for major-risk cardioembolic sources and secondary prevention of recurrence are very important. Although large series of patients with cardioembolic infarction have been reported in the literature, some clinical aspects of the natural course of the disease are still poorly defined. The objective of this supplement is to present an update review of relevant aspects related to clinical manifestations, biological characteristics, prognostic implications and treatment of cardioembolic stroke, in order to contribute to improve the quality of care and outcome of acute stroke patients. The most relevant aspects of cardioembolic infarction are discussed in the following 11 chapters: 1)epidemiology and risk factors of cerebral ischemia and ischemic heart diseases: similarities and differences; 2) clinical and prognostic features of cardioembolic stroke; 3) patent oval foramen in cerebral infarction; 4) cardiac workup of ischemic stroke; 5) complex atheromatosis of the aortic arch in cerebral infarction; 6) blood biomarkers in cardioembolic stroke; 7) heart failure in acute ischemic stroke; 8) cerebrovascular disease as a complication of cardiac transplantation; 9) antithrombotic therapy in cardiac embolism; 10) thrombolytic therapy in acute stroke; and 11) angiogenesis, neurogenesis and neuroplasticity in ischemic stroke. Cerebral cardioembolism is an important topic in the frontier between cardiology and vascular neurology, occurs frequently in daily practice, and has a high impact for patients, health care systems and society. It is for all these reasons that an update on cardioembolic infarction is now fully justified. It is worth mentioning that a team of excellent professionals belonging to the Expert Committee on Cerebrovascular Diseases of the Catalonian Society of Neurology and with proven experience in the field have contributed to the different chapters. My gratitude to all contributors for their support of this project and particularly to Dr. Jianyi Zhang, Editor-in-Chief of the Current Cardiology Reviews series. We hope that clinicians involved in the care of patients with cardioembolic infarction and interested in this topic will profit this publication and find this resource valuable and useful.