Lee-Anne Slater, Nandhini Ravintharan, Stacy Goergen, Ronil Chandra, Hamed Asadi, J. Maingard, A. Kuganesan, R. Sum, Sandra Lin, Victor Gordon, Deepa Rajendran, Yenni Lie, Subramanian Muthusamy, Peter Kempster, Thanh G. Phan
Rapid detection of intracranial arterial occlusion in patients with ischemic stroke is important to facilitate timely reperfusion therapy. We compared the diagnostic accuracy of neurologists and radiologists against RapidAI (iSchema View, Menlo Park, CA) software for occlusion detection. Adult patients who presented to a single comprehensive stroke center over a 5‐month interval with clinical suspicion of ischemic stroke and who underwent multimodality imaging with RapidAI interpretation were included. There were 8 assessors: 1 radiologist, 5 neurologists, and 2 radiology trainees. The reference standard was large‐vessel occlusion (LVO) or medium‐vessel occlusion (MVO) diagnosed by a panel of 4 interventional neuroradiologists. Positive likelihood ratio (LR) and negative LR were used to indicate how well readers correctly classified the presence of intracranial occlusions compared with the reference standard. The positive LR and negative LR for each reader were plotted on an LR graph using RapidAI LRs as comparator. The assessors read scans from 500 patients (49.6% men). The positive LR of RapidAI for detection of LVO was 8.49 (95% CI, 5.75–12.54), and the negative LR was 0.41 (95% CI, 0.28–0.58). The positive LR for LVO or MVO for RapidAI was 5.0 (95% CI, 3.28–7.63), and the negative LR was 0.66 (95% CI, 0.56−0.79). Sensitivity for LVO (0.65–0.96) and for LVO or MVO (0.62–0.94) was higher for all readers compared with RapidAI (0.62 and 0.39, respectively). Six of 8 readers had superior specificity to RapidAI for LVO (0.75–0.98 versus 0.93) and LVO or MVO (0.55–0.95 versus 0.92). Experienced readers of acute stroke imaging can identify LVOs and MVOs with higher accuracy than RapidAI software in a real‐world setting. The negative LR of RapidAI software was not sufficient to rule out LVO or MVO.
{"title":"RapidAI\u0000 Compared With Human Readers of Acute Stroke Imaging for Detection of Intracranial Vessel Occlusion","authors":"Lee-Anne Slater, Nandhini Ravintharan, Stacy Goergen, Ronil Chandra, Hamed Asadi, J. Maingard, A. Kuganesan, R. Sum, Sandra Lin, Victor Gordon, Deepa Rajendran, Yenni Lie, Subramanian Muthusamy, Peter Kempster, Thanh G. Phan","doi":"10.1161/svin.123.001145","DOIUrl":"https://doi.org/10.1161/svin.123.001145","url":null,"abstract":"\u0000 \u0000 \u0000 Rapid detection of intracranial arterial occlusion in patients with ischemic stroke is important to facilitate timely reperfusion therapy. We compared the diagnostic accuracy of neurologists and radiologists against\u0000 RapidAI\u0000 (iSchema View, Menlo Park, CA) software for occlusion detection.\u0000 \u0000 \u0000 \u0000 \u0000 \u0000 Adult patients who presented to a single comprehensive stroke center over a 5‐month interval with clinical suspicion of ischemic stroke and who underwent multimodality imaging with\u0000 RapidAI\u0000 interpretation were included. There were 8 assessors: 1 radiologist, 5 neurologists, and 2 radiology trainees. The reference standard was large‐vessel occlusion (LVO) or medium‐vessel occlusion (MVO) diagnosed by a panel of 4 interventional neuroradiologists. Positive likelihood ratio (LR) and negative LR were used to indicate how well readers correctly classified the presence of intracranial occlusions compared with the reference standard. The positive LR and negative LR for each reader were plotted on an LR graph using\u0000 RapidAI\u0000 LRs as comparator.\u0000 \u0000 \u0000 \u0000 \u0000 \u0000 The assessors read scans from 500 patients (49.6% men). The positive LR of\u0000 RapidAI\u0000 for detection of LVO was 8.49 (95% CI, 5.75–12.54), and the negative LR was 0.41 (95% CI, 0.28–0.58). The positive LR for LVO or MVO for\u0000 RapidAI\u0000 was 5.0 (95% CI, 3.28–7.63), and the negative LR was 0.66 (95% CI, 0.56−0.79). Sensitivity for LVO (0.65–0.96) and for LVO or MVO (0.62–0.94) was higher for all readers compared with\u0000 RapidAI\u0000 (0.62 and 0.39, respectively). Six of 8 readers had superior specificity to\u0000 RapidAI\u0000 for LVO (0.75–0.98 versus 0.93) and LVO or MVO (0.55–0.95 versus 0.92).\u0000 \u0000 \u0000 \u0000 \u0000 \u0000 Experienced readers of acute stroke imaging can identify LVOs and MVOs with higher accuracy than\u0000 RapidAI\u0000 software in a real‐world setting. The negative LR of\u0000 RapidAI\u0000 software was not sufficient to rule out LVO or MVO.\u0000 \u0000","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":"58 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139603157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shivani D. Rangwala, Nikita Singh, J. Judge, Christopher Isibor, Craig D. McClain, Laura L. Lehman, A. P. See, D. Orbach, Edward R. Smith
Moyamoya is a rare arteriopathy affecting the intracranial circulation with a risk of stroke in the pediatric population. High‐volume centers provide improved outcomes after surgical revascularization compared with low‐volume centers. However, private insurers are often reluctant to approve care out‐of‐network. We hypothesized that rare diseases that can be treated in a single procedure, such as revascularization for moyamoya, can yield improved clinical outcomes with substantial cost savings to insurance companies when approved for care at high‐volume centers of excellence. Longitudinal deidentified data of pediatric patients undergoing surgical revascularization for moyamoya from January 2018 to December 2020 (N = 125) were obtained from national commercial insurers by an independent third‐party analytics core. Patients were selected according to International Classification of Diseases, Tenth Revision ( ICD‐10 ) diagnosis and procedure codes. For a 9‐month episode, clinical and cost outcome metrics were compared across centers, with patients from the highest volume center designated as the primary cohort. Patients in the primary cohort were on average younger at time of surgery, with greater medical comorbidities, yet exhibited decreased postoperative complications and fewer unplanned readmissions. The primary cohort had an overall 42% lower expense compared with patients treated at other single institution health systems ($89 000 versus $153 000). The primary cohort minimized out‐of‐network costs with implementation of a partnership care model, using local resources for preoperative workup in 68% of episodes, compared with only 8% of episodes at a comparator high‐volume center. Implementation of a partnership model takes advantages of the surgical resources of a high‐volume center while maximizing local resource use for preoperative and postoperative care. Referral to high‐volume centers for pediatric moyamoya revascularization provides both improved outcomes for the patients and substantial cost savings for the insurers. These data suggest the development of high‐volume centers of excellence for select conditions requiring neurosurgical treatment confer benefit to both patients and insurers, even in cases of out‐of‐network care.
{"title":"Referral of Pediatric Moyamoya for Revascularization: Financial and Quality Data Supporting Private Insurer Approval for Out‐of‐Network Care","authors":"Shivani D. Rangwala, Nikita Singh, J. Judge, Christopher Isibor, Craig D. McClain, Laura L. Lehman, A. P. See, D. Orbach, Edward R. Smith","doi":"10.1161/svin.123.001014","DOIUrl":"https://doi.org/10.1161/svin.123.001014","url":null,"abstract":"\u0000 \u0000 Moyamoya is a rare arteriopathy affecting the intracranial circulation with a risk of stroke in the pediatric population. High‐volume centers provide improved outcomes after surgical revascularization compared with low‐volume centers. However, private insurers are often reluctant to approve care out‐of‐network. We hypothesized that rare diseases that can be treated in a single procedure, such as revascularization for moyamoya, can yield improved clinical outcomes with substantial cost savings to insurance companies when approved for care at high‐volume centers of excellence.\u0000 \u0000 \u0000 \u0000 \u0000 Longitudinal deidentified data of pediatric patients undergoing surgical revascularization for moyamoya from January 2018 to December 2020 (N = 125) were obtained from national commercial insurers by an independent third‐party analytics core. Patients were selected according to\u0000 International Classification of Diseases, Tenth Revision\u0000 (\u0000 ICD‐10\u0000 ) diagnosis and procedure codes. For a 9‐month episode, clinical and cost outcome metrics were compared across centers, with patients from the highest volume center designated as the primary cohort.\u0000 \u0000 \u0000 \u0000 \u0000 Patients in the primary cohort were on average younger at time of surgery, with greater medical comorbidities, yet exhibited decreased postoperative complications and fewer unplanned readmissions. The primary cohort had an overall 42% lower expense compared with patients treated at other single institution health systems ($89 000 versus $153 000). The primary cohort minimized out‐of‐network costs with implementation of a partnership care model, using local resources for preoperative workup in 68% of episodes, compared with only 8% of episodes at a comparator high‐volume center.\u0000 \u0000 \u0000 \u0000 Implementation of a partnership model takes advantages of the surgical resources of a high‐volume center while maximizing local resource use for preoperative and postoperative care. Referral to high‐volume centers for pediatric moyamoya revascularization provides both improved outcomes for the patients and substantial cost savings for the insurers. These data suggest the development of high‐volume centers of excellence for select conditions requiring neurosurgical treatment confer benefit to both patients and insurers, even in cases of out‐of‐network care.\u0000","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":"54 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139602582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joo Won Choi, Kirsten Jin, Jessica N. Wilson, Andrew Pham, Tej I. Mehta, S. Tsappidi, Jonathan Y. Zhang, Ferdinand K. Hui, Stacy C. Brown
Dynamic compression of extracranial arteries in the cervicocerebral circulation is a rare phenomenon of ischemic stroke. Retrospective chart review. Here, we present a young fighter pilot who presented with recurrent embolic strokes of undetermined source. He endorsed flying fighter jets for 6 years, during which he was subject to high G‐force loads and extensive in‐flight head maneuvers. Extensive workup identified dynamic arterial compression of his right vertebral artery, which entered the transverse foramen at the C4 level. Dynamic cerebral angiography was used to reveal the specific vessel location and provocative maneuver leading to dynamic occlusion of his right vertebral artery. This case highlights the utility of dynamic cerebral angiography in identifying previously unexplored causes of arteriogenic emboli formation, particularly in patients with predisposing anatomic and clinical risk factors.
颅外动脉对颈脑循环的动态压迫是缺血性中风的一种罕见现象。 回顾性病历审查。 在此，我们介绍一名年轻的战斗机飞行员，他反复出现来源不明的栓塞性中风。他曾在战斗机上服役 6 年，在此期间，他承受了很高的 G 力负荷，并在飞行中做了大量头部动作。广泛的检查发现，他的右侧椎动脉受到动态动脉压迫，在 C4 水平进入横向孔。动态脑血管造影术显示了导致右侧椎动脉动态闭塞的特定血管位置和诱导动作。 本病例凸显了动态脑血管造影术在识别以前未曾探究过的动脉源性栓子形成原因方面的实用性，尤其是在具有易发解剖和临床风险因素的患者中。
{"title":"Fighter Pilot Syndrome: A Bow Hunter Syndrome Variant Identified With Dynamic Cerebral Angiography","authors":"Joo Won Choi, Kirsten Jin, Jessica N. Wilson, Andrew Pham, Tej I. Mehta, S. Tsappidi, Jonathan Y. Zhang, Ferdinand K. Hui, Stacy C. Brown","doi":"10.1161/svin.123.001219","DOIUrl":"https://doi.org/10.1161/svin.123.001219","url":null,"abstract":"\u0000 \u0000 Dynamic compression of extracranial arteries in the cervicocerebral circulation is a rare phenomenon of ischemic stroke.\u0000 \u0000 \u0000 \u0000 Retrospective chart review.\u0000 \u0000 \u0000 \u0000 Here, we present a young fighter pilot who presented with recurrent embolic strokes of undetermined source. He endorsed flying fighter jets for 6 years, during which he was subject to high G‐force loads and extensive in‐flight head maneuvers. Extensive workup identified dynamic arterial compression of his right vertebral artery, which entered the transverse foramen at the C4 level. Dynamic cerebral angiography was used to reveal the specific vessel location and provocative maneuver leading to dynamic occlusion of his right vertebral artery.\u0000 \u0000 \u0000 \u0000 This case highlights the utility of dynamic cerebral angiography in identifying previously unexplored causes of arteriogenic emboli formation, particularly in patients with predisposing anatomic and clinical risk factors.\u0000","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":"38 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139603561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marie K. Luff, A. Sedrakyan, Sameer A. Ansari, Adnan H. Siddiqui, David Liebeskind
Endovascular devices have catalyzed a global industry for advanced technologies such as flow diverters and stent retrievers. Though adoption of these devices has skyrocketed over the past 30 years, the regulatory landscape for real‐world monitoring is constantly under revision. Postmarket surveillance is an area of Medical Device Regulation that monitors how devices perform in the real world after regulatory approval. This area of research is underdeveloped globally, with most surveillance relying on passive adverse event data collection from health care systems. The US Food and Drug Administration has not yet established a comprehensive postmarket surveillance strategy for neuroendovascular devices. Postmarket clinical surveillance data are rare; only 4 mandated 522 postmarket neuroendovascular trials exist, and 4 of 14 endovascular registries have published results per ClinicalTrials.gov. The European Union 2017 Medical Device Regulation describes a comprehensive regulatory strategy to address postmarket surveillance, yet it has faced difficult implementation due to resource constraints and concerns such as increased costs and reliance on foreign devices and regulators. More than 50% of manufacturers are planning portfolio reductions, with 33% of the devices from these manufacturers planned for discontinuation. As of April 2022, >85% of 500 000+ previously certified devices were without new certification. In this article, we describe the current regulatory landscape for postmarket surveillance and support the need for a comprehensive, cost‐efficient postmarket strategy for neurovascular devices while proposing several solutions and considerations. An effective postmarket strategy has numerous benefits, such as promoting patient safety, expanding real‐world data collection, and increased efficiency for approving future devices.
{"title":"Postmarket Surveillance of Neuroendovascular Devices","authors":"Marie K. Luff, A. Sedrakyan, Sameer A. Ansari, Adnan H. Siddiqui, David Liebeskind","doi":"10.1161/svin.123.001081","DOIUrl":"https://doi.org/10.1161/svin.123.001081","url":null,"abstract":"Endovascular devices have catalyzed a global industry for advanced technologies such as flow diverters and stent retrievers. Though adoption of these devices has skyrocketed over the past 30 years, the regulatory landscape for real‐world monitoring is constantly under revision.\u0000 Postmarket surveillance is an area of Medical Device Regulation that monitors how devices perform in the real world after regulatory approval. This area of research is underdeveloped globally, with most surveillance relying on passive adverse event data collection from health care systems. The US Food and Drug Administration has not yet established a comprehensive postmarket surveillance strategy for neuroendovascular devices. Postmarket clinical surveillance data are rare; only 4 mandated 522 postmarket neuroendovascular trials exist, and 4 of 14 endovascular registries have published results per ClinicalTrials.gov. The European Union 2017 Medical Device Regulation describes a comprehensive regulatory strategy to address postmarket surveillance, yet it has faced difficult implementation due to resource constraints and concerns such as increased costs and reliance on foreign devices and regulators. More than 50% of manufacturers are planning portfolio reductions, with 33% of the devices from these manufacturers planned for discontinuation. As of April 2022, >85% of 500 000+ previously certified devices were without new certification.\u0000 In this article, we describe the current regulatory landscape for postmarket surveillance and support the need for a comprehensive, cost‐efficient postmarket strategy for neurovascular devices while proposing several solutions and considerations. An effective postmarket strategy has numerous benefits, such as promoting patient safety, expanding real‐world data collection, and increased efficiency for approving future devices.","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":"55 18","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139385654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"“Resilient Adaptation: Unveiling Healing of the Brain”","authors":"Sandeep Kandregula","doi":"10.1161/svin.123.000904","DOIUrl":"https://doi.org/10.1161/svin.123.000904","url":null,"abstract":"","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":"45 15","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139394887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Endovascular Revascularization of Chronic Cervical Carotid Occlusion","authors":"S. Al kasab, Brian T. Jankowitz","doi":"10.1161/svin.123.001123","DOIUrl":"https://doi.org/10.1161/svin.123.001123","url":null,"abstract":"","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":"11 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139458159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Transcranial Histotripsy Clot and Tissue Ablation for Intracerebral Hemorrhage Evacuation and Other Brain Applications","authors":"Jonathan R. Sukovich, Zhen Xu, Aditya S. Pandey","doi":"10.1161/svin.123.001061","DOIUrl":"https://doi.org/10.1161/svin.123.001061","url":null,"abstract":"","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":"10 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139153490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Rodriguez-Calienes, Fabian Chavez-Ecos, David Espinosa‐Martinez, Diego Bustamante-Paytan, J. Vivanco-Suarez, Nagheli Fernanda Borjas‐Calderón, M. Galecio-Castillo, C. Morán-Mariños, Waldo R. Guerrero, S. Ortega‐Gutierrez
Carotid artery stenting (CAS) has emerged as a viable alternative to carotid endarterectomy for managing carotid artery stenosis in high‐risk patients. Although transfemoral arterial access remains the preferred method, it is associated with inherent limitations and potential complications. Consequently, exploring transradial artery access as a potential option becomes crucial in optimizing patient outcomes and procedural success rates. There are limited data comparing the outcomes of the transradial with the transfemoral approach for CAS. This study aimed to systematically review and meta‐analyze the outcomes and complication rates between transradial and transfemoral access for CAS. A systematic electronic search was conducted in 4 databases. Studies with randomized or nonrandomized designs, involving CAS by the transradial or transfemoral approach, were included. Outcomes of interest were stroke, transient ischemic attack, death, myocardial infarction, and access site complications. A meta‐analysis was performed, analyzing pooled odds ratios (ORs) and 95% CIs to assess the effect size. Six studies with a total of 6917 patients were included, of whom 602 (8.7%) underwent the transradial approach and 6315 (91.3%) the transfemoral approach. The meta‐analysis showed no significant difference in stroke occurrence between the transradial and transfemoral groups (transradial:1.7% versus transfemoral:1.9%; OR = 0.98 [95% CI, 0.49–1.96]; I 2 = 0%). Similarly, no significant difference was found in death (TR:1% versus transfemoral:0.9%; OR = 0.95 [95% CI, 0.38–2.37]; I 2 = 0%), myocardial infarction (transradial:0.2% versus transfemoral:0.3%; OR = 1.53 [95% CI, 0.20–11.61]; I 2 = 0%), transient ischemic attack (transradial:0.4% versus transfemoral:1%; OR = 0.46 [95% CI, 0.11–1.95]; I 2 = 0%), or access site complications (transradial:2.2% versus transfemoral:1%; OR = 0.97 [95% CI, 0.48–1.98]; I 2 = 0%). No significant differences were observed in stroke, death, myocardial infarction, transient ischemic attack, or access site complications on comparing thetransradial and transfemoral approaches for CAS. The transradial approach shows promise as an alternative method for CAS, offering potential benefits without increased risk of complications. However, further studies are needed to confirm these findings.
{"title":"Transradial Access Versus Transfemoral Approach for Carotid Artery Stenting: A Systematic Review and Meta‐Analysis","authors":"A. Rodriguez-Calienes, Fabian Chavez-Ecos, David Espinosa‐Martinez, Diego Bustamante-Paytan, J. Vivanco-Suarez, Nagheli Fernanda Borjas‐Calderón, M. Galecio-Castillo, C. Morán-Mariños, Waldo R. Guerrero, S. Ortega‐Gutierrez","doi":"10.1161/svin.123.001156","DOIUrl":"https://doi.org/10.1161/svin.123.001156","url":null,"abstract":"Carotid artery stenting (CAS) has emerged as a viable alternative to carotid endarterectomy for managing carotid artery stenosis in high‐risk patients. Although transfemoral arterial access remains the preferred method, it is associated with inherent limitations and potential complications. Consequently, exploring transradial artery access as a potential option becomes crucial in optimizing patient outcomes and procedural success rates. There are limited data comparing the outcomes of the transradial with the transfemoral approach for CAS. This study aimed to systematically review and meta‐analyze the outcomes and complication rates between transradial and transfemoral access for CAS. A systematic electronic search was conducted in 4 databases. Studies with randomized or nonrandomized designs, involving CAS by the transradial or transfemoral approach, were included. Outcomes of interest were stroke, transient ischemic attack, death, myocardial infarction, and access site complications. A meta‐analysis was performed, analyzing pooled odds ratios (ORs) and 95% CIs to assess the effect size. Six studies with a total of 6917 patients were included, of whom 602 (8.7%) underwent the transradial approach and 6315 (91.3%) the transfemoral approach. The meta‐analysis showed no significant difference in stroke occurrence between the transradial and transfemoral groups (transradial:1.7% versus transfemoral:1.9%; OR = 0.98 [95% CI, 0.49–1.96]; I 2 = 0%). Similarly, no significant difference was found in death (TR:1% versus transfemoral:0.9%; OR = 0.95 [95% CI, 0.38–2.37]; I 2 = 0%), myocardial infarction (transradial:0.2% versus transfemoral:0.3%; OR = 1.53 [95% CI, 0.20–11.61]; I 2 = 0%), transient ischemic attack (transradial:0.4% versus transfemoral:1%; OR = 0.46 [95% CI, 0.11–1.95]; I 2 = 0%), or access site complications (transradial:2.2% versus transfemoral:1%; OR = 0.97 [95% CI, 0.48–1.98]; I 2 = 0%). No significant differences were observed in stroke, death, myocardial infarction, transient ischemic attack, or access site complications on comparing thetransradial and transfemoral approaches for CAS. The transradial approach shows promise as an alternative method for CAS, offering potential benefits without increased risk of complications. However, further studies are needed to confirm these findings.","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139153860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Czap, A. Alexandrov, May Nour, Jose-Miguel Yamal, Mengxi Wang, Asha P. Jacob, Stephanie A. Parker, Muhammad Bilal Tariq, S. Rajan, A. V. Alexandrov, William J. Jones, B. Navi, Ilana Spokoyny, Jason Mackey, Mackenzie Lerario, Michael O. Gonzalez, Noopur Singh, R. Bowry, J. C. Grotta
The impact of mobile stroke units (MSUs) on outcomes in patients with large vessel occlusions eligible for endovascular thrombectomy (EVT) has yet to be characterized. We completed a prespecified substudy of patients with EVT‐eligible stroke with anterior and posterior circulation large vessel occlusions on computed tomography and/or computed tomography angiography who were enrolled in BEST‐MSU (Benefits of Stroke Treatment using a Mobile Stroke Unit). Primary outcome was 90‐day utility‐weighted modified Rankin scale. Groups were compared using chi‐square or Fisher's exact tests for categorical variables, and 2‐sample t ‐tests for continuous variables. Multiple logistic regression was used to assess the effect of MSU on binary outcomes after adjusting for other baseline factors. Of 1515 trial patients, 293 had large vessel occlusions eligible for EVT: 168 in the MSU group and 125 in the emergency medical services group. Baseline characteristics were comparable, with the exception of baseline National Institutes of Health Stroke Scale score (MSU median 19 [interquartile range 13, 23] versus emergency medical services 16 [11, 20], P = 0.002) and study site. The mean (±SD) score on the utility‐weighted modified Rankin scale at 90 days was 0.63±0.39 in MSU group and 0.51±0.41 in emergency medical services group (mean difference 0.13, 95% CI [0.03–0.22]). After adjustment, MSU had significantly higher odds of functional independence (odds ratio 2.60 [95% CI, 1.45–4.77], P = 0.002). Secondary outcomes also favored MSU: early neurologic recovery (30% improvement in National Institutes of Health Stroke Scale score at 24 hours) 68% versus 52%; adjusted odds ratio 1.98 [95% CI, 1.19–3.33]; time of tissue plasminogen activator bolus from symptom onset 65.0 minutes [50.5–92.0] versus 96.0 [79.3–130.0], P ≤0.001. The groups had similar onset to arterial puncture (169.0 minutes [133.5, 210.0] versus 162.0 [135.0–207.0], P = 0.83). In patients with EVT‐eligible large vessel occlusion stroke, MSU management was associated with better clinical outcomes compared with standard emergency medical services management. MSU management sped thrombolysis but did not expedite EVT treatment times. Future MSU processes should include efforts to capitalize on the potential of MSUs to provide earlier EVT.
{"title":"Impact of Mobile Stroke Units on Patients With Large Vessel Occlusion Acute Ischemic Stroke: A Prespecified BEST‐MSU Substudy","authors":"A. Czap, A. Alexandrov, May Nour, Jose-Miguel Yamal, Mengxi Wang, Asha P. Jacob, Stephanie A. Parker, Muhammad Bilal Tariq, S. Rajan, A. V. Alexandrov, William J. Jones, B. Navi, Ilana Spokoyny, Jason Mackey, Mackenzie Lerario, Michael O. Gonzalez, Noopur Singh, R. Bowry, J. C. Grotta","doi":"10.1161/svin.123.001095","DOIUrl":"https://doi.org/10.1161/svin.123.001095","url":null,"abstract":"\u0000 \u0000 The impact of mobile stroke units (MSUs) on outcomes in patients with large vessel occlusions eligible for endovascular thrombectomy (EVT) has yet to be characterized.\u0000 \u0000 \u0000 \u0000 \u0000 We completed a prespecified substudy of patients with EVT‐eligible stroke with anterior and posterior circulation large vessel occlusions on computed tomography and/or computed tomography angiography who were enrolled in BEST‐MSU (Benefits of Stroke Treatment using a Mobile Stroke Unit). Primary outcome was 90‐day utility‐weighted modified Rankin scale. Groups were compared using chi‐square or Fisher's exact tests for categorical variables, and 2‐sample\u0000 t\u0000 ‐tests for continuous variables. Multiple logistic regression was used to assess the effect of MSU on binary outcomes after adjusting for other baseline factors.\u0000 \u0000 \u0000 \u0000 \u0000 \u0000 Of 1515 trial patients, 293 had large vessel occlusions eligible for EVT: 168 in the MSU group and 125 in the emergency medical services group. Baseline characteristics were comparable, with the exception of baseline National Institutes of Health Stroke Scale score (MSU median 19 [interquartile range 13, 23] versus emergency medical services 16 [11, 20],\u0000 P\u0000 = 0.002) and study site. The mean (±SD) score on the utility‐weighted modified Rankin scale at 90 days was 0.63±0.39 in MSU group and 0.51±0.41 in emergency medical services group (mean difference 0.13, 95% CI [0.03–0.22]). After adjustment, MSU had significantly higher odds of functional independence (odds ratio 2.60 [95% CI, 1.45–4.77],\u0000 P\u0000 = 0.002). Secondary outcomes also favored MSU: early neurologic recovery (30% improvement in National Institutes of Health Stroke Scale score at 24 hours) 68% versus 52%; adjusted odds ratio 1.98 [95% CI, 1.19–3.33]; time of tissue plasminogen activator bolus from symptom onset 65.0 minutes [50.5–92.0] versus 96.0 [79.3–130.0],\u0000 P\u0000 ≤0.001. The groups had similar onset to arterial puncture (169.0 minutes [133.5, 210.0] versus 162.0 [135.0–207.0],\u0000 P\u0000 = 0.83).\u0000 \u0000 \u0000 \u0000 \u0000 In patients with EVT‐eligible large vessel occlusion stroke, MSU management was associated with better clinical outcomes compared with standard emergency medical services management. MSU management sped thrombolysis but did not expedite EVT treatment times. Future MSU processes should include efforts to capitalize on the potential of MSUs to provide earlier EVT.\u0000","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":" 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138962784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mauricio Concha, Lizhen Xu, MacKenzie Horn, Tomoyuki Ohara, J. Nakamya, Jan Beyer‐Westendorf, A. Shoamanesh, Alexander Cohen, Per Ladenvall, Stuart J. Connolly, Andrew M. Demchuk
Andexanet alfa, a specific reversal agent for factor Xa inhibitors, resulted in effective hemostasis in 79% of patients with intracranial bleeding in the ANNEXA‐4 (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) trial (NCT02329327). However, little is known about predictors associated with hematoma expansion in patients with factor Xa inhibitor–associated intracranial hemorrhage (ICrH) receiving andexanet alfa. The ANNEXA‐4 trial was a prospective, single‐arm, open‐label study of andexanet alfa in patients with acute major bleeding within 18 hours after taking a factor Xa inhibitor. Hematoma volumes at baseline and 12 hours after andexanet alfa treatment were measured using a computerized‐assisted volumetric method. Univariable and multivariable logistic regression analyses of clinical and nonclinical parameters were performed to identify factors predictive of different volumes of hematoma expansion. To this end, an ICrH Expansion Scale was developed. Overall, 305 ANNEXA‐4 study patients with baseline and follow‐up imaging were included, 15.7% of whom showed evidence of any ICrH expansion ≥6‐mL. Patients with ≥6‐mL ICrH expansion had a significantly ( P< 0.05) higher proportion of ICrH with multiple compartment involvement (36% versus 14.3%); shorter times from symptom onset to baseline computed tomography (median, 1.6 hours [interquartile range (IQR), 1.2–4.3 hours] versus 3.7 hours [IQR, 1.6–7.0 hours]); lower Glasgow Coma Scale scores (14 [IQR, 12–15] versus 15 [IQR, 14–15]); higher systolic blood pressure 15 minutes before andexanet alfa bolus (mean, 151.6 mm Hg [SD, 24.1 mm Hg] versus 143.3 mm Hg [SD, 22.3 mm Hg]); and larger median baseline ICrH volumes (29.3 mL [IQR, 13.3–50.8 mL] versus 8.6 mL [IQR, 2.1–22.4 mL]). Multivariable analysis confirmed shorter symptom onset‐to‐computed tomography time and larger ICrH volume as independent predictors of ≥6‐mL growth and ICrH Expansion Scale change. Lower Glasgow Coma Scale showed a trend ( P = 0.06) as an independent predictor of ≥6‐mL growth but was an independent predictor of ICrH Expansion Scale change. Shorter time from symptom onset to computed tomography, larger hematoma volumes, and lower Glasgow Coma Scale score at presentation increased the risk of ICrH expansion in patients with factor Xa inhibitor–associated ICrH treated with andexanet alfa.
Andexanet alfa是Xa因子抑制剂的一种特异性逆转剂，在ANNEXA-4（Andexanet Alfa，Xa因子抑制剂抗凝作用的新型解毒剂）试验（NCT02329327）中，79%的颅内出血患者都能有效止血。然而，人们对接受安达赛酮α治疗的Xa因子抑制剂相关颅内出血（ICrH）患者血肿扩大的相关预测因素知之甚少。 ANNEXA-4 试验是一项前瞻性、单臂、开放标签研究，研究对象是服用 Xa 因子抑制剂后 18 小时内发生急性大出血的患者。采用计算机辅助容积测量法测量了基线血肿容积和安达赛酮α治疗后12小时的血肿容积。对临床和非临床参数进行了单变量和多变量逻辑回归分析，以确定不同血肿膨胀体积的预测因素。为此，制定了 ICrH 扩大量表。 总计纳入了 305 名有基线和随访成像的 ANNEXA-4 研究患者，其中 15.7% 的患者有证据显示 ICrH 扩张≥6 毫升。ICrH扩张≥6毫升的患者中，多室受累的ICrH比例明显更高（36%对14.3%）；从症状发作到基线计算机断层扫描的时间更短（中位数，1.6小时[四分位间范围（IQR），1.2-4.3小时]对3.7小时[IQR，1.6-7.0小时]）；格拉斯哥昏迷量表评分较低（14[IQR，12-15]对15[IQR，14-15]）；安体舒通注射前15分钟收缩压较高（平均，151.6 mm Hg [SD, 24.1 mm Hg] 对 143.3 mm Hg [SD, 22.3 mm Hg]）；基线 ICrH 中位体积更大（29.3 mL [IQR, 13.3-50.8 mL] 对 8.6 mL [IQR, 2.1-22.4 mL]）。多变量分析证实，较短的症状发作至计算机断层扫描时间和较大的 ICrH 容量是≥6 mL 生长和 ICrH 扩容量表变化的独立预测因素。较低的格拉斯哥昏迷量表（Glasgow Coma Scale）显示出一种趋势（P = 0.06），可独立预测≥6 毫升的增长，但不能独立预测 ICrH 扩容量表的变化。 从症状出现到接受计算机断层扫描的时间较短、血肿体积较大以及发病时格拉斯哥昏迷量表评分较低，都会增加接受安达信α治疗的Xa因子抑制剂相关ICrH患者ICrH扩大的风险。
{"title":"Predictors of Intracranial Hemorrhage Volume Expansion in Patients Receiving Factor Xa Inhibitors in ANNEXA‐4: Time and Severity Matter Most","authors":"Mauricio Concha, Lizhen Xu, MacKenzie Horn, Tomoyuki Ohara, J. Nakamya, Jan Beyer‐Westendorf, A. Shoamanesh, Alexander Cohen, Per Ladenvall, Stuart J. Connolly, Andrew M. Demchuk","doi":"10.1161/svin.123.000997","DOIUrl":"https://doi.org/10.1161/svin.123.000997","url":null,"abstract":"\u0000 \u0000 Andexanet alfa, a specific reversal agent for factor Xa inhibitors, resulted in effective hemostasis in 79% of patients with intracranial bleeding in the ANNEXA‐4 (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) trial (NCT02329327). However, little is known about predictors associated with hematoma expansion in patients with factor Xa inhibitor–associated intracranial hemorrhage (ICrH) receiving andexanet alfa.\u0000 \u0000 \u0000 \u0000 The ANNEXA‐4 trial was a prospective, single‐arm, open‐label study of andexanet alfa in patients with acute major bleeding within 18 hours after taking a factor Xa inhibitor. Hematoma volumes at baseline and 12 hours after andexanet alfa treatment were measured using a computerized‐assisted volumetric method. Univariable and multivariable logistic regression analyses of clinical and nonclinical parameters were performed to identify factors predictive of different volumes of hematoma expansion. To this end, an ICrH Expansion Scale was developed.\u0000 \u0000 \u0000 \u0000 \u0000 Overall, 305 ANNEXA‐4 study patients with baseline and follow‐up imaging were included, 15.7% of whom showed evidence of any ICrH expansion ≥6‐mL. Patients with ≥6‐mL ICrH expansion had a significantly (\u0000 P<\u0000 0.05) higher proportion of ICrH with multiple compartment involvement (36% versus 14.3%); shorter times from symptom onset to baseline computed tomography (median, 1.6 hours [interquartile range (IQR), 1.2–4.3 hours] versus 3.7 hours [IQR, 1.6–7.0 hours]); lower Glasgow Coma Scale scores (14 [IQR, 12–15] versus 15 [IQR, 14–15]); higher systolic blood pressure 15 minutes before andexanet alfa bolus (mean, 151.6 mm Hg [SD, 24.1 mm Hg] versus 143.3 mm Hg [SD, 22.3 mm Hg]); and larger median baseline ICrH volumes (29.3 mL [IQR, 13.3–50.8 mL] versus 8.6 mL [IQR, 2.1–22.4 mL]). Multivariable analysis confirmed shorter symptom onset‐to‐computed tomography time and larger ICrH volume as independent predictors of ≥6‐mL growth and ICrH Expansion Scale change. Lower Glasgow Coma Scale showed a trend (\u0000 P\u0000 = 0.06) as an independent predictor of ≥6‐mL growth but was an independent predictor of ICrH Expansion Scale change.\u0000 \u0000 \u0000 \u0000 \u0000 Shorter time from symptom onset to computed tomography, larger hematoma volumes, and lower Glasgow Coma Scale score at presentation increased the risk of ICrH expansion in patients with factor Xa inhibitor–associated ICrH treated with andexanet alfa.\u0000","PeriodicalId":21977,"journal":{"name":"Stroke: Vascular and Interventional Neurology","volume":" 20","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138961572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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