Intracranial Embolism

颅内栓塞
  • 文章类型: Journal Article
    目的:本研究旨在分析术前感染性脑栓塞对感染性心内膜炎(IE)瓣膜手术患者术后早期和晚期结局的影响。
    方法:基于德国感染性心内膜炎临床多中心分析项目(CAMPAIGN)注册的回顾性多中心研究,包括1994年至2018年在德国六个中心接受瓣膜手术的IE患者。根据术前有无脓毒性脑栓塞分为两组进行统计学比较。进行倾向评分匹配,以调整术后结果的比较。主要结果是30天死亡率和估计的5年生存率。
    结果:共4917例患者纳入分析,3909例(79.5%)患者术前无脓毒症脑栓塞和1008例(20.5%)患者。术前感染性脑栓塞患者有更多的基线合并症。二尖瓣心内膜炎(44.1%vs.33.0%p<0.001),大植被>10mm(43.1%vs.30.0%,p<0.001),和葡萄球菌感染(42.3%vs.21.3%,p<0.001)在脑栓塞组中更常见。在术前脑栓塞患者中,286例(28.4%)患者无卒中征象(无声卒中)。匹配后(1008个匹配对),30日死亡率无统计学显著差异(20.1%.vs.22.8%;p=0.14)和5年生存率(47.8%vs.49.1%;术前有无脑栓塞的患者分层log-rankp=0.77),分别。
    结论:对于需要进行瓣膜手术的感染性心内膜炎患者,术前败血症脑栓塞不会对早期或晚期死亡率产生负面影响。因此,它不应该在决定是否进行手术方面发挥重要作用。
    OBJECTIVE: This study aimed to analyse the impact of preoperative septic cerebral embolism on early and late postoperative outcomes in patients with infective endocarditis undergoing valve surgery.
    METHODS: Retrospective multicentric study based on the Clinical Multicentric Project for Analysis of Infective Endocarditis in Germany (CAMPAIGN) registry comprising patients with infective endocarditis who underwent valve surgery between 1994 and 2018 at 6 German centres. Patients were divided into 2 groups for statistical comparison according to the presence or absence of preoperative septic cerebral embolism. Propensity score matching was performed for adjusted comparisons of postoperative outcomes. Primary outcomes were 30-day mortality and estimated 5-year survival.
    RESULTS: A total of 4917 patients were included in the analysis, 3909 (79.5%) patients without and 1008 (20.5%) patients with preoperative septic cerebral embolism. Patients with preoperative septic cerebral embolism had more baseline comorbidities. Mitral valve endocarditis (44.1% vs 33.0% P < 0.001), large vegetations >10 mm (43.1% vs 30.0%, P < 0.001), and Staphylococcus species infection (42.3% vs 21.3%, P < 0.001) were more frequent in the cerebral embolism group. Among patients with preoperative cerebral embolism, 286 (28.4%) patients had no stroke signs (silent stroke). After matching (1008 matched pairs), there was no statistically significant difference in 30-day mortality (20.1% vs 22.8%; P = 0.14) and 5-year survival (47.8% vs 49.1%; stratified log-rank P = 0.77) in patients with and without preoperative cerebral embolism, respectively.
    CONCLUSIONS: Preoperative septic cerebral embolism in patients with infective endocarditis requiring valve surgery does not negatively affect early or late mortality; therefore, it should not play a major role in deciding if surgery is to be performed.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    背景:支架辅助颈动脉血管重建术采用手术切除经颈入路和动态血流逆转(TCAR)的方法越来越受欢迎。TCAR,尽管术中大脑保护最大化,在症状性与无症状的狭窄。TCAR常规单层支架(游离细胞面积5.89mm2)无法密封栓塞性病变可能在血流逆转神经保护终止后特别相关。
    方法:我们评估了TCAR的围手术期和30天主要不良脑和心脏事件(MACCE)(ENROUTE,SilkRoadMedical)与MicroNET覆盖的神经保护支架(CGuard,InspireMD)在连续患者中,经股/经radial滤器保护支架置入术的并发症风险升高(病变相关和/或通路相关风险增加)。CGuard(MicroNET游离细胞面积≈0.02-0.03mm2)具有1级证据,可以减少和消除手术后病变相关的脑栓塞。
    结果:106名高风险患者(年龄72[61-76]岁,中位数[Q1-Q3];60.4%有症状,49.1%糖尿病患者,36.8%的妇女,61.3%的左侧索引病变)在三个血管外科中心登记。血管造影狭窄严重程度为81(75-91)%,病变长度21(15-26)mm,病变风险增加的特征为87.7%。研究支架使用率为100%(无其他支架类型)。74.5%的病灶扩张前;扩张后发生率为90.6%。流动逆转持续时间为8(5-11)分钟。在建立神经保护之前,无症状患者发生了一次中风(0.9%)(使用护套插入线的索引病变破坏);没有其他围手术期MACCE。30天后没有发生进一步的不良事件。30天的支架通畅率为100%,速度正常,并且通过Duplex多普勒没有任何支架内材料。
    结论:尽管本研究中增加的病变和有临床症状的患者比例很高,使用MicroNET覆盖的抗栓塞支架的TCAR显示30天MACCE率<1%。这表明通过动态血流逆转最大限度地预防脑栓塞与抗栓塞支架预防围手术期和术后脑栓塞相结合的临床作用(TOPGUARDNCT04547387)。
    BACKGROUND: Stent-assisted carotid artery revascularization employing surgical cutdown for transcervical access and dynamic flow reversal (TCAR) is gaining popularity. TCAR, despite maximized intra-procedural cerebral protection, shows a marked excess of 30-day neurologic complications in symptomatic vs. asymptomatic stenoses. The TCAR conventional single-layer stent (free-cell area 5.89mm2) inability to seal embologenic lesions may be particularly relevant after the flow reversal neuroprotection is terminated.
    METHODS: We evaluated peri-procedural and 30-day major adverse cerebral and cardiac events (MACCE) of TCAR (ENROUTE, SilkRoad Medical) paired with MicroNET-covered neuroprotective stent (CGuard, InspireMD) in consecutive patients at elevated risk of complications with transfemoral/transradial filter-protected stenting (increased lesion-related and/or access-related risk). CGuard (MicroNET free cell area ≈0.02-0.03 mm2) has level-1 evidence for reducing intra- and abolishing post-procedural lesion-related cerebral embolism.
    RESULTS: One hundred and six increased-risk patients (age 72 [61-76] years, median [Q1-Q3]; 60.4% symptomatic, 49.1% diabetic, 36.8% women, 61.3% left-sided index lesion) were enrolled in three vascular surgery centers. Angiographic stenosis severity was 81 (75-91)%, lesion length 21 (15-26)mm, increased-risk lesional characteristics 87.7%. Study stent use was 100% (no other stent types). 74.5% lesions were predilated; post-dilatation rate was 90.6%. Flow reversal duration was 8 (5-11)min. One stroke (0.9%) occurred in an asymptomatic patient prior to establishing neuroprotection (index lesion disruption with the sheath insertion wire); there were no other peri-procedural MACCE. No further adverse events occurred by 30-days. 30-day stent patency was 100% with normal velocities and absence of any in-stent material by Duplex Doppler.
    CONCLUSIONS: Despite a high proportion of increased-risk lesions and clinically symptomatic patients in this study, TCAR employing the MicroNET-covered anti-embolic stent showed 30-day MACCE rate <1%. This suggests a clinical role for combining maximized intra-procedural prevention of cerebral embolism by dynamic flow reversal with anti-embolic stent prevention of peri- and post-procedural cerebral embolism (TOPGUARD NCT04547387).
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  • 文章类型: Journal Article
    脑栓塞对运动和神经功能的恢复提出了重大挑战。早期综合康复治疗(EIRT)已被提出作为一种有益的方法,然而,它的疗效需要彻底的评估。这项回顾性研究,从2020年1月至2023年1月进行,涉及117名患者的脑栓塞后,分为接受EIRT的EIRT组(n=56)和接受标准护理的对照组(n=61)。Fugl-Meyer评估(FMA)和美国国立卫生研究院卒中量表(NIHSS)用于评估运动和神经功能,而肌肉力量从0级(完全瘫痪)到V级(正常力量)来评估身体恢复。资格集中在确认的脑栓塞诊断上,卒中后入院时间,和基线功能状态。这项研究坚持严格的道德标准,获得所有参与者的知情同意。与对照组相比,EIRT组的FMA和NIHSS评分均有显著改善,表明更好的运动和神经恢复。治疗后FMA(P<.01)和NIHSS评分(P<.01)差异有统计学意义。肌肉力量分析进一步证实了EIRT的积极影响,EIRT组中更多的患者在出院时达到更高水平的肌肉力量。该研究表明EIRT可显著改善患者脑栓塞后的运动和神经系统预后。观察组的显着改善表明,应考虑将EIRT更广泛地应用于中风康复中,以增强康复并改善生活质量。
    Cerebral embolism presents a significant challenge for recovery of motor and neurological function. Early integrated rehabilitation therapy (EIRT) has been proposed as a beneficial approach, yet its efficacy requires thorough evaluation. This retrospective study, conducted from January 2020 to January 2023, involved 117 patient\'s post-cerebral embolism, divided into an EIRT group (n = 56) receiving EIRT and a control group (n = 61) receiving standard care. The Fugl-Meyer Assessment (FMA) and the National Institutes of Health Stroke Scale (NIHSS) were used to evaluate motor and neurological functions, while muscle strength was categorized from Level 0 (complete paralysis) to Level V (normal strength) to assess physical recovery. Eligibility centered on confirmed cerebral embolism diagnosis, timing of poststroke admission, and baseline functional status. The study adhered to strict ethical standards, with informed consent obtained from all participants. The EIRT group showed substantial improvements in both FMA and NIHSS scores compared to the control group, indicating better motor and neurological recovery. Significant differences were found in the posttreatment FMA (P < .01) and NIHSS scores (P < .01). Muscle strength analysis further confirmed the positive impact of EIRT with more patients in the EIRT group achieving higher levels of muscle strength at discharge. The study demonstrates the potential of EIRT to significantly improve motor and neurological outcomes for patient\'s post-cerebral embolism. The marked improvements in the observation group suggest that EIRT should be considered for broader application in stroke rehabilitation to enhance recovery and improve quality of life.
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  • 文章类型: Journal Article
    许多缺血性中风被诊断为不明来源的栓塞性中风(ESUS)。最近的证据表明,非狭窄颈动脉斑块(nsCP)可能是ESUS风险的重要原因。我们旨在调查ESUS中与nsCP相关的危险因素概况和定义的卒中病因。
    在这项回顾性病例对照研究中,我们调查了由ESUS引起的急性缺血性卒中的连续患者,小血管疾病,或磁共振成像证实的心脏栓塞。血管危险因素的关联年龄,动脉高血压,糖尿病,异常脂蛋白血症,身体质量指数,酒精消费,烟草使用,肾衰竭,使用二元logistic回归分析对存在nsCP的卒中病史进行调查,并进一步按卒中病因和性别进行分层.
    总共,609名患者(中位年龄,76岁;46%的女性)从2018年到2020年接受治疗的人被认为是。在ESUS患者中,与明确的病因相比,性别对nsCP的患病率起更重要的作用.与ESUS的男性患者相比,ESUS的女性患者显示nsCP的几率较低(调整后的优势比,0.36[95%CI,0.15-0.86])。在ESUS的男性患者中,我们观察到年龄(每10年增加调整后的赔率比,2.55[95%CI,1.26-5.17])和高血压(调整后的比值比,2.49[95%CI,0.56-11.1])是nsCP的主要危险因素,而在ESUS女性患者中,烟草使用也特别相关(调整后的比值比,3.71[95%CI,0.61-22.5])。这些结果与位于梗死同侧的nsCP的敏感性分析一致。
    性别差异在ESUS患者的nsCP患病率中起重要作用。这些发现可能对ESUS后有针对性的二级预防管理具有重要意义。
    Many ischemic strokes are diagnosed as embolic strokes of undetermined source (ESUS). Recent evidence suggests that nonstenotic carotid plaque (nsCP) may be a substantial contributor to the risk for ESUS. We aimed to investigate the risk factor profile associated with nsCP in ESUS and defined stroke etiologies.
    In this retrospective case-control study, we investigated consecutive patients with acute ischemic stroke due to ESUS, small-vessel disease, or cardioembolism proven by magnetic resonance imaging. The association of vascular risk factors age, arterial hypertension, diabetes, dyslipoproteinemia, body mass index, alcohol consumption, tobacco use, kidney failure, and history of stroke with the presence of nsCP was investigated using binary logistic regression analysis and further stratified by stroke etiology and sex.
    In total, 609 patients (median age, 76 years; 46% women) who were treated from 2018 to 2020 were considered. In patients with ESUS, sex played a more important role for the prevalence of nsCP than in defined etiologies. Female patients with ESUS had lower odds of exhibiting nsCP compared with male patients with ESUS (adjusted odds ratio, 0.36 [95% CI, 0.15-0.86]). In male patients with ESUS, we observed that age (adjusted odds ratio per 10-year increase, 2.55 [95% CI, 1.26-5.17]) and hypertension (adjusted odds ratio, 2.49 [95% CI, 0.56-11.1]) were the main risk factors for nsCP, whereas in female patients with ESUS also tobacco use was particularly relevant (adjusted odds ratio, 3.71 [95% CI, 0.61-22.5]). These results were in line with a sensitivity analysis in nsCP located ipsilateral to the infarct.
    Sex differences play an important role in nsCP prevalence in patients with ESUS. These findings may have important implications for the management in targeted secondary prevention following ESUS.
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  • 文章类型: Journal Article
    关于新发房颤(AF)与缺血性卒中之间的时间关系及其对患者临床特征和死亡率的影响的数据有限。
    基于人群的注册链接数据库包括2007年至2018年芬兰所有新发房颤患者。与房颤时间相关的缺血性卒中(ISTAF)定义为在首次房颤诊断后±30天内发生的缺血性卒中。用logistic回归和Cox比例风险分析研究与ISTAF相关的临床因素。
    在229565例新发房颤患者中(平均年龄,72.7岁;50%为女性),204774(89.2%)没有经历缺血性卒中,12209(5.3%)在房颤前30天超过缺血性卒中,和12582(5.8%)有ISTAF。2007年至2018年,房颤患者中ISTAF的年度比例从6.0%降至4.8%。与ISTAF呈正相关的因素是年龄较高,教育水平较低,和酒精使用障碍,而血管疾病,心力衰竭,慢性肾脏病癌症,ISTAF不太可能出现精神疾病。与无缺血性卒中患者和既往有缺血性卒中患者相比,ISTAF与≈3倍和1.5倍的死亡风险相关(调整后的风险比,2.90[95%CI,2.76-3.04]和1.47[95%CI,1.39-1.57],分别)。ISTAF患者的90天生存概率从2007年的0.79(95%CI,0.76-0.81)增加到2018年的0.89(95%CI,0.87-0.91)。
    ISTAF描绘了围绕AF诊断的缺血性中风的突出时间聚类。尽管合并症较少,ISTAF患者情况更糟,虽然有所改善,生存率高于有或无缺血性卒中病史的患者。
    URL:https://www。clinicaltrials.gov;唯一标识符:NCT04645537。URL:https://www.encepp.eu;唯一标识符:EUPAS29845。
    Limited data exist on the temporal relationship between new-onset atrial fibrillation (AF) and ischemic stroke and its impact on patients\' clinical characteristics and mortality.
    A population-based registry-linkage database includes all patients with new-onset AF in Finland from 2007 to 2018. Ischemic stroke temporally associated with AF (ISTAF) was defined as an ischemic stroke occurring within ±30 days from the first AF diagnosis. Clinical factors associated with ISTAF were studied with logistic regression and 90-day survival with Cox proportional hazards analysis.
    Among 229 565 patients with new-onset AF (mean age, 72.7 years; 50% female), 204 774 (89.2%) experienced no ischemic stroke, 12 209 (5.3%) had past ischemic stroke >30 days before AF, and 12 582 (5.8%) had ISTAF. The annual proportion of ISTAF among patients with AF decreased from 6.0% to 4.8% from 2007 to 2018. Factors associated positively with ISTAF were higher age, lower education level, and alcohol use disorder, whereas vascular disease, heart failure, chronic kidney disease cancer, and psychiatric disorders were less probable with ISTAF. Compared with patients without ischemic stroke and those with past ischemic stroke, ISTAF was associated with ≈3-fold and 1.5-fold risks of death (adjusted hazard ratios, 2.90 [95% CI, 2.76-3.04] and 1.47 [95% CI, 1.39-1.57], respectively). The 90-day survival probability of patients with ISTAF increased from 0.79 (95% CI, 0.76-0.81) in 2007 to 0.89 (95% CI, 0.87-0.91) in 2018.
    ISTAF depicts the prominent temporal clustering of ischemic strokes surrounding AF diagnosis. Despite having fewer comorbidities, patients with ISTAF had worse, albeit improving, survival than patients with a history of or no ischemic stroke.
    URL: https://www.clinicaltrials.gov; Unique identifier: NCT04645537. URL: https://www.encepp.eu; Unique identifier: EUPAS29845.
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  • 文章类型: Journal Article
    背景:脑边界区梗死(BZIs)是急性缺血性卒中的一种亚型,发生在两个主要脑动脉区域之间的交界处。内部和外部BZI是基于脑磁共振成像(MRI)中的已知模式来定义的。然而,这两种类型的BZI的病因和病理生理学仍存在争议。本研究旨在确定两种BZI的病因学差异,以指导为这些患者制定适当的治疗策略。方法:在这项前瞻性研究中,BZIs患者来自大不里士医学院附属医院的急性缺血性卒中患者,大不里士,伊朗,从2017年到2019年。根据Org10172在急性中风治疗(TOAST)分类系统中的试验,进行了适当的临床和实验室检查以确定缺血性中风的可能病因。结果:该研究包括106例BZI患者,每组53例。两种类型的BZI在男性中更常见。然而,关于性别的两种类型之间没有显着差异,年龄,以及主要卒中危险因素的概况。结果显示BZI类型与血流动力学因素之间无相关性(P=0.086)。然而,大动脉粥样硬化(LAA)是BZI各亚型中最常见的病因;内部LAA(P=0.016)和外部BZI的心源性栓塞(P=0.046)是脑梗死的更常见的病因亚型。结论:LAA可能是脑内外BZIs最常见的病因。心栓塞可能在外部亚型中具有更重要的病因作用。
    Background: Cerebral border zone infarctions (BZIs) are a subtype of acute ischemic stroke that occur at the junction between two major cerebral arterial territories. Internal and external BZIs are defined based on the known patterns in brain magnetic resonance imaging (MRI). However, the etiology and pathophysiology of these two types of BZI are still debated. This study aimed to determine the etiologic differences of two types of BZI to guide tailor appropriate treatment strategies for these patients. Methods: In this prospective study, patients with BZIs were enrolled from patients with acute ischemic stroke admitted to the hospitals affiliated with Tabriz University of Medical Sciences, Tabriz, Iran, from 2017 to 2019. Appropriate clinical and laboratory workups were applied to determine possible etiologies of ischemic stroke according to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification system. Results: The study included 106 patients with BZI, 53 patients in each group. Both types of BZI were more frequent in males. However, there was no significant difference between the two types concerning sex, age, and profile of major stroke risk factors. The results showed no correlation between the type of BZI and hemodynamic factors (P = 0.086). However, large artery atherosclerosis (LAA) was the most frequent etiology within each subtype of BZI; LAA in internal (P = 0.016) and cardioembolism (P = 0.046) in external BZI were more frequent etiologic subtypes of cerebral infarction. Conclusion: LAA might be the most common etiology for internal and external cerebral BZIs. Cardioembolism might have a more important etiologic role in the external subtype.
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  • 文章类型: Randomized Controlled Trial
    背景:高功率短持续时间(HPSD)消融策略已成为治疗心房颤动(AF)的流行方法,具有较短的消融时间。利用的智能触摸环绕流(STSF)导管,电极周围有56个孔,降低电极组织温度和血栓风险。因此,我们进行了这个预测,与传统的SmartTouch(ST)导管方法相比,在房颤消融术中采用STSF导管的HPSD策略是否能降低无症状脑栓塞(SCE)的风险。
    方法:从2020年6月至2021年9月,将100例房颤患者以1:1的比例随机分为使用STSF导管的HPSD组(功率设定为50W)或使用ST导管的常规组(功率设定为30至35W)。所有患者均行肺静脉隔离术,操作员自行决定是否有额外的病变。在消融前和消融后24-72h进行切片厚度为1mm的高分辨率脑弥散加权磁共振成像(hDWI)。新的围手术期SCE的发生率被定义为主要结果。使用蒙特利尔认知评估(MoCA)测试评估认知表现。
    结果:所有入选房颤患者(中位年龄63岁,60%为男性,59%阵发性房颤)成功消融。术后hDWI在42例入选患者中发现106个病灶(42%),HPSD组22例(44%)有55个病灶,常规组20例(40%)有51个病灶(p=0.685)。两组间平均病变数无显著差异(p=0.751),最大病变直径(p=0.405),和每位患者的总病变体积(p=0.669)。通过多变量回归分析,在房颤消融术期间,持续性房颤和CHA2DS2-VASc评分被确定为SCE决定因素。SCE患者和无SCE患者之间的MoCA评分没有显着差异,术后即刻(p=0.572)和3个月随访时(p=0.743)。
    结论:涉及100例房颤患者的小样本,这项研究揭示了房颤消融术中SCE的相似发生率,将使用STSF导管的HPSD策略与使用ST导管的常规方法进行比较。
    背景:Clinicaltrials.gov:NCT04408716。AF=心房颤动,DWI=磁共振扩散加权成像,HPSD=高功率短持续时间,ST=智能触摸,STSF=智能触摸环绕流。
    High-power short-duration (HPSD) ablation strategy has emerged as a popular approach for treating atrial fibrillation (AF), with shorter ablation time. The utilized Smart Touch Surround Flow (STSF) catheter, with 56 holes around the electrode, lowers electrode-tissue temperature and thrombus risk. Thus, we conducted this prospective, randomized study to investigate if the HPSD strategy with STSF catheter in AF ablation procedures reduces the silent cerebral embolism (SCE) risk compared to the conventional approach with the Smart Touch (ST) catheter.
    From June 2020 to September 2021, 100 AF patients were randomized 1:1 to the HPSD group using the STSF catheter (power set at 50 W) or the conventional group using the ST catheter (power set at 30 to 35 W). Pulmonary vein isolation was performed in all patients, with additional lesions at operator\'s discretion. High-resolution cerebral diffusion-weighted magnetic resonance imaging (hDWI) with slice thickness of 1 mm was performed before and 24-72 h after ablation. The incidence of new periprocedural SCE was defined as the primary outcome. Cognitive performance was assessed using the Montreal Cognitive Assessment (MoCA) test.
    All enrolled AF patients (median age 63, 60% male, 59% paroxysmal AF) underwent successful ablation. Post-procedural hDWI identified 106 lesions in 42 enrolled patients (42%), with 55 lesions in 22 patients (44%) in the HPSD group and 51 lesions in 20 patients (40%) in the conventional group (p = 0.685). No significant differences were observed between two groups regarding the average number of lesions (p = 0.751), maximum lesion diameter (p = 0.405), and total lesion volume per patient (p = 0.669). Persistent AF and CHA2DS2-VASc score were identified as SCE determinants during AF ablation procedure by multivariable regression analysis. No significant differences in MoCA scores were observed between patients with SCE and those without, both immediately post-procedure (p = 0.572) and at the 3-month follow-up (p = 0.743).
    Involving a small sample size of 100 AF patients, this study reveals a similar incidence of SCE in AF ablation procedures, comparing the HPSD strategy using the STSF catheter to the conventional approach with the ST catheter.
    Clinicaltrials.gov: NCT04408716. AF = Atrial fibrillation, DWI = Diffusion-weighted magnetic resonance imaging, HPSD = High-power short-duration, ST = Smart Touch, STSF = Smart Touch Surround Flow.
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  • 文章类型: Journal Article
    目的:心房颤动(AF)成功导管消融后的长期口服抗凝药物(OAC)仍存在争议。前瞻性数据缺失。ODIN-AF研究旨在评估OAC对中度至高度栓塞事件风险患者无症状脑栓塞事件和临床相关心脏栓塞事件发生率的影响。肺静脉隔离(PVI)后无房颤。
    方法:这种前瞻性,随机化,多中心,开放标签,盲性终点介入试验纳入了计划接受PVI治疗阵发性或持续性房颤的患者.PVI六个月后,无房颤患者随机接受持续接受达比加群的OAC或不接受OAC。主要终点是与基线相比,在随访12个月时在脑MRI上检测到的新的无症状微栓塞性和大栓塞性病变的发生率。安全分析包括出血,临床上明显的心脏栓塞,严重不良事件(SAE)。
    结果:在2015年至2021年之间,200名患者被随机分为2个研究组(OAC:n=99,OAC:n=101)。12个月后,OAC上和OAC下臂之间新的脑微病变的发生没有显着差异[2(2%)对0(0%);P=0.1517]。MRI显示没有新的宏观栓塞性病变,两组均未出现临床上明显的卒中.SAE在OAC臂中更频繁[OACn=34(31.8%),OACn=18(19.4%);P=0.0460];出血没有差异。
    结论:在12个月的随访后,与继续OAC相比,成功PVI后停止OAC未发现与脑栓塞事件的风险升高相关。
    OBJECTIVE: Long-term oral anticoagulation (OAC) following successful catheter ablation of atrial fibrillation (AF) remains controversial. Prospective data are missing. The ODIn-AF study aimed to evaluate the effect of OAC on the incidence of silent cerebral embolic events and clinically relevant cardioembolic events in patients at intermediate to high risk for embolic events, free from AF after pulmonary vein isolation (PVI).
    METHODS: This prospective, randomized, multicenter, open-label, blinded endpoint interventional trial enrolled patients who were scheduled for PVI to treat paroxysmal or persistent AF. Six months after PVI, AF-free patients were randomized to receive either continued OAC with dabigatran or no OAC. The primary endpoint was the incidence of new silent micro- and macro-embolic lesions detected on brain MRI at 12 months of follow-up compared to baseline. Safety analysis included bleedings, clinically evident cardioembolic, and serious adverse events (SAE).
    RESULTS: Between 2015 and 2021, 200 patients were randomized into 2 study arms (on OAC: n = 99, off OAC: n = 101). There was no significant difference in the occurrence of new cerebral microlesions between the on OAC and off OAC arm [2 (2%) versus 0 (0%); P = 0.1517] after 12 months. MRI showed no new macro-embolic lesion, no clinical apparent strokes were present in both groups. SAE were more frequent in the OAC arm [on OAC n = 34 (31.8%), off OAC n = 18 (19.4%); P = 0.0460]; bleedings did not differ.
    CONCLUSIONS: Discontinuation of OAC after successful PVI was not found to be associated with an elevated risk of cerebral embolic events compared with continued OAC after a follow-up of 12 months.
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  • 文章类型: Journal Article
    背景:在经导管主动脉瓣置换术(TAVR)后的早期,卒中和其他有临床意义的栓塞并发症已得到充分证实。CAPTIS装置是一种栓塞保护系统,旨在通过偏转碎片远离大脑的循环来提供神经血管和全身保护,捕获碎片,从而避免全身栓塞。
    目的:我们旨在研究TAVR期间CAPTIS完整脑和全身栓塞保护系统的安全性和可行性研究。
    方法:一项首次人体研究调查了安全性,TAVR期间CAPTIS的可行性和碎片捕获能力。患者随访30天。主要终点是72小时的装置安全性和脑血管事件。
    结果:20例患者使用球囊扩张或自扩张瓣膜系统进行TAVR。CAPTIS已成功交付,定位,部署,并在所有情况下检索到,成功完成TAVR,无器械相关并发症.未观察到脑血管事件。所有患者都捕获了大量的碎片颗粒。
    结论:在TAVR期间使用CAPTIS全身栓塞保护系统是安全的,它捕获了大量的碎片颗粒。没有患者发生脑血管事件。有必要进行随机临床试验以证明其有效性。
    BACKGROUND: Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain\'s circulation, capturing the debris and thus avoiding systemic embolisation.
    OBJECTIVE: We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR.
    METHODS: A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours.
    RESULTS: Twenty patients underwent TAVR using balloon-expandable or self-expanding valve systems. CAPTIS was successfully delivered, positioned, deployed, and retrieved in all cases, and TAVR was successfully completed without device-related complications. No cerebrovascular events were observed. High numbers of debris particles were captured in all patients.
    CONCLUSIONS: The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event. A randomised clinical trial is warranted to prove its efficacy.
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