Ventricular Fibrillation

心室颤动
  • 文章类型: Case Reports
    This study investigates the cardiac safety concerns related to TASER discharges centering on a pivotal case that marked the first TASER-related fatality in South Korea. Employing Pratt et al.\'s theoretical framework, the research evaluates the potential for ventricular fibrillation (VF) from these discharges. The methodology incorporated a high-resolution waveform analysis using sophisticated equipment and considered specific incident details, including dart impact locations verified through a forensic examination. A human body impedance of 500 Ω, chosen based on empirical studies and coupled with non-inductive resistance for high-voltage handling, was utilized in the model. By applying a heart-current factor from IEC 60479 standards, the study found a VF risk of up to 5% depending on the impact location and current pathways. In this specific case, although the calculated risk did not exceed critical thresholds, the VF risk was high enough to suggest that TASER discharges played a role in the fatal outcome. This study underscores the importance of dart impact location in TASER safety evaluations, contributing to a broader understanding of TASER cardiac risks and providing a basis to advocate for rigorous safety protocols.
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  • 文章类型: Journal Article
    这项研究涉及自动体外除颤器(AED)在早期治疗再纤颤中的早期治疗,旨在评估院外心脏骤停(OHCA)患者在胸部按压(CC)期间新的电击咨询系统(SAS)的性能。
    这项工作的重点是AEDSAS性能,作为DEFI2022临床前瞻性研究的次要结果,其中包括首次分析的可电击OHCA患者。SAS采用分析同时压缩(AWC)算法,通过在存在或不存在胸部按压的情况下进行两阶段ECG分析的有条件操作,与心肺复苏(CPR)和电击建议进行交互。AWC由第一波建议触发。然后,心肺复苏后1分钟,CC期间的ECG分析在两种治疗方案之间做出决定。对于重新纤颤的患者,暂停CPR以进行即时确认分析和休克建议。对于有不可电击节律的患者,CPR持续2分钟直至标准分析。
    在AEDs(DEFIGARDTOUCH7,SchillerMédical)的首次分析中,来自285名建议休克的OHCA患者的临床数据包括576项标准分析,2011年CC期间的分析,577在没有CC的情况下进行确认分析。全球AEDSAS表现符合心律失常分析敏感性(94.9%)和特异性(>99.3%)的标准建议。AWC通过在大多数心室纤颤(92.9%)中提前2分钟停止CPR,提供了可电击节律的创新治疗,而大多数非电击患者(86.5-95.2%)受益于至少2分钟的连续CPR。
    这项研究为OHCA早期治疗中的急救者在CPR期间常规使用AED和AWC集成算法进行ECG分析提供了积极证据。临床试验注册:注册号:NCT04691089,试验注册:ClinicalTrials.gov。
    UNASSIGNED: This study involving automated external defibrillators (AEDs) in early treatment of refibrillation aims to evaluate the performance of a new shock advisory system (SAS) during chest compressions (CC) in out-of-hospital cardiac arrest (OHCA) patients.
    UNASSIGNED: This work focuses on AED SAS performance as a secondary outcome of DEFI 2022 clinical prospective study, which included first-analysis shockable OHCA patients. SAS employs the Analyze Whilst Compressing (AWC) algorithm to interact with both cardiopulmonary resuscitation (CPR) and shock advice by conditional operation of two-stage ECG analysis in presence or absence of chest compressions. AWC is triggered by the first-shock recommendation. Then, after 1 min of CPR, ECG analysis during CC decides between two treatment scenarios. For patients with refibrillation, CPR is paused for immediate confirmation analysis and shock advice. For patients with non-shockable rhythms, CPR is continued for 2 min until standard analysis.
    UNASSIGNED: Clinical data from 285 OHCA patients with shock recommendation at the first-analysis by AEDs (DEFIGARD TOUCH7, Schiller Médical) consisted of 576 standard analyses, 2011 analyses during CC, 577 confirmation analyses in absence of CC. Global AED SAS performance meets the standard recommendations for arrhythmia analysis sensitivity (94.9%) and specificity (>99.3%). AWC provided innovative treatment of shockable rhythms by stopping CPR earlier than 2 min in most ventricular fibrillations (92.9%), while most non-shockable patients (86.5-95.2%) benefitted from continuous CPR for at least 2 min.
    UNASSIGNED: This study provides positive evidence for routine use of AEDs with AWC-integrated algorithm for ECG analysis during CPR by first-responders in early OHCA treatment.Clinical Trial Registration: Registration number: NCT04691089, trial register: ClinicalTrials.gov.
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  • 文章类型: Journal Article
    持续的室性心动过速(VT)在心脏淀粉样变性中并不常见,导管消融的基质和结果未定义。
    我们纳入了22名连续患者(平均年龄,68±10岁;男性,91%)伴有心脏淀粉样变性(ATTR[转甲状腺素蛋白],n=16;轻链,n=6)在2013年至2023年之间进行了室性心动过速/室颤(VF)的导管消融,观察,国际研究。主要疗效结果是随访期间复发性VT/VF,而主要安全性终点包括主要手术相关的不良事件.
    消融指征为药物难治性室性心动过速17例(77%),5例患者(23%)的室性早搏引起的多形性VT/VF。使用心内膜(n=17.77%)或心外膜内入路(n=5.23%)进行导管消融。17例(77%)和10例(45%)患者获得了左心室和右心室的完整心内膜电解剖电压图,分别。每个病人都有低电压区域的证据,最常累及室间隔(n=16);16例(73%)患者记录了晚期电位.每位患者可诱导1(1-2)VT的中位数;26个可映射VT中的12个(46%)来自室间隔。16例患者(73%)获得了完整的手术成功,4例(18%)主要手术相关不良事件。在中位随访32(14-42)个月后,9例患者(41%)出现持续VT/VF复发;36个月随访时,无VT/VF复发生存率为56%(95%CI,36%-86%),大多数患者仍然服用抗心律失常药物。在消融术后6个月期间,每位患者植入式心律转复除颤器治疗显著减少(前:6[4-9]与后:0[0-0];P<0.001)。在多变量分析中,完整的手术成功与复发性VT/VF的风险降低相关(风险比,0.002;P=0.034)。
    导管消融术可以在超过一半的心脏淀粉样变性患者中控制复发性VT/VF,消融后室性心动过速/室性心动过速负荷的减少可能与生活质量相关。室间隔基质和手术相关并发症的风险挑战了心脏淀粉样变性和VT/VF患者的成功治疗。
    UNASSIGNED: Sustained ventricular tachycardia (VT) in cardiac amyloidosis is uncommon, and the substrate and outcomes of catheter ablation are not defined.
    UNASSIGNED: We included 22 consecutive patients (mean age, 68±10 years; male sex, 91%) with cardiac amyloidosis (ATTR [transthyretin], n=16; light chain, n=6) undergoing catheter ablation for VT/ventricular fibrillation (VF) between 2013 and 2023 in a retrospective, observational, international study. The primary efficacy outcome was recurrent VT/VF during follow-up, while the primary safety end point included major procedure-related adverse events.
    UNASSIGNED: The indication for ablation was drug-refractory VT in 17 patients (77%), and premature ventricular complex-initiated polymorphic VT/VF in 5 patients (23%). Catheter ablation was performed using endocardial (n=17.77%) or endo-epicardial approaches (n=5.23%). Complete endocardial electroanatomical voltage maps of the left and right ventricles were obtained in 17 (77%) and 10 (45%) patients, respectively. Each patient had evidence of low-voltage areas, most commonly involving the interventricular septum (n=16); late potentials were recorded in 16 patients (73%). A median of 1 (1-2) VT was inducible per patient; 12 of the 26 mappable VTs (46%) originated from the interventricular septum. Complete procedural success was achieved in 16 patients (73%), with 4 (18%) major procedure-related adverse events. After a median follow-up of 32 (14-42) months, sustained VT/VF recurrence was observed in 9 patients (41%); survival free from VT/VF recurrence was 56% (95% CI, 36%-86%) at 36-month follow-up, and most patients remained on antiarrhythmic drugs. A significant reduction in per patient implantable cardioverter defibrillator therapies was noted in the 6-month period after ablation (before: 6 [4-9] versus after: 0 [0-0]; P<0.001). In multivariable analysis, complete procedural success was associated with reduced risk of recurrent VT/VF (hazard ratio, 0.002; P=0.034).
    UNASSIGNED: Catheter ablation can achieve control of recurrent VT/VF in more than half of patients with cardiac amyloidosis, and the reduction in VT/VF burden post-ablation may be relevant for quality of life. Septal substrate and risk of procedure-related complications challenge successful management of patients with cardiac amyloidosis and VT/VF.
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  • 文章类型: Journal Article
    目的:可穿戴式心脏复律除颤器(WCD)适用于有心脏骤停风险的患者,这些患者不是植入式除颤器治疗的直接候选者。现有WCD的局限性包括差的顺应性和高的误报率。Jewel是一种新颖的补丁WCD(P-WCD),通过基于粘合剂的近乎连续磨损设计和旨在最大程度减少不适当检测的机器学习算法来解决这些限制。这是在电生理(EP)实验室中对JewelP-WCD进行的首次人体研究,以确定该装置在单次电击终止室性心动过速/室颤(VT/VF)方面的安全性和有效性。目的是使用JewelP-WCD评估单次电击终止VT/VF的安全性和有效性。
    结果:这是人类的第一次,prospective,单臂,单中心研究针对计划进行EP手术的患者,其中预期VT/VF自发发生或诱发。JewelP-WCD被放置在同意的患者身上;在确认VT/VF后,一个单一的冲击(150J)是通过装置交付。使用一组序贯设计和Pocockalpha支出函数来测量成功的VT/VF单次电击终止的观察比例。如果置信下限超过62%的性能目标,则达到终点。使用单边较低的97.4%的精确置信区间。在18个合格科目中,16(88.9%,97.4%置信界限:65.4%)通过单次电击成功除颤,超过主要终点表现目标,无不良事件。
    结论:对JewelP-WCD的首次人类评估证明了终止VT/VF的安全性和有效性。
    背景:URL:https://clinicaltrials.gov/;唯一标识符:NCT05490459。
    OBJECTIVE: Wearable cardioverter-defibrillators (WCDs) are indicated in patients at risk of sudden cardiac arrest who are not immediate candidates for implantable defibrillator therapy. Limitations of existing WCDs include poor compliance and high false alarm rates. The Jewel is a novel patch-WCD (P-WCD) that addresses these limitations with an adhesive-based design for near-continuous wear and a machine learning algorithm designed to minimize inappropriate detections. This was a first-in-human study of the Jewel P-WCD conducted in an electrophysiology (EP) lab to determine the safety and effectiveness of the device in terminating ventricular tachycardia/ventricular fibrillation (VT/VF) with a single shock. The aim was to evaluate the safety and effectiveness of terminating VT/VF with a single shock using the Jewel P-WCD.
    RESULTS: This was a first-in-human, prospective, single-arm, single-centre study in patients scheduled for an EP procedure in which VT/VF was expected to either spontaneously occur or be induced. The Jewel P-WCD was placed on consented patients; upon confirmation of VT/VF, a single shock (150 J) was delivered via the device. A group sequential design and Pocock alpha spending function was used to measure the observed proportion of successful VT/VF single-shock terminations. The endpoint was achieved if the lower confidence limit exceeded the performance goal of 62%, using a one-sided lower 97.4% exact confidence bound. Of 18 eligible subjects, 16 (88.9%, 97.4% confidence bound: 65.4%) were successfully defibrillated with a single shock, exceeding the primary endpoint performance goal with no adverse events.
    CONCLUSIONS: This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF.
    BACKGROUND: URL: https://clinicaltrials.gov/; Unique identifier: NCT05490459.
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  • 文章类型: Journal Article
    背景:复苏期间肺动脉压(PAP)升高。这减少了左心室充盈,导致血流量减少。吸入一氧化氮(iNO)产生选择性肺血管舒张。我们假设iNO会在复苏期间降低PAP,从而增加生存率。
    方法:30只猪(40公斤)在左前降支冠状动脉闭塞和室颤引起的心肌缺血后进行心脏骤停9.5分钟。在复苏期间,这些猪被随机分配给40ppmiNO或安慰剂.主要结果是自发循环恢复(ROSC)。实现ROSC的猪接受4小时强化护理。
    结果:对照组的ROSC率为9/14(64%),iNO组为11/16(69%)(OR1.295CI[0.3;5.6],p>0.99)。舒张主动脉压/PAP比值无差异(平均差-0.99[95%CI:-2.33-0.36],p=0.14)。ROSC后60分钟和120分钟,iNO组的平均肺动脉压较低(平均差:-12.18mmHg[95CI:-16.94;-7.43]p<0.01和-5.43[95CI:-10.39;-0.46]p=0.03)。ROSC后60和120分钟,iNO组的肌钙蛋白I水平显着升高(平均差:266105ng/l[95CI:6356;525855]p=0.045和420049ng/l[95CI:136779;703320],p=0.004)。对照组的心脏风险面积为33%(SD1),iNO组为34%(SD1)。梗死面积除以危险面积在对照组中为55%(SD3),在iNO组中为86%(SD1)。p=0.01。
    结论:应用iNO并没有改善ROSC率或血流动力学功能,但增加了心肌损伤。
    BACKGROUND: During resuscitation pulmonary artery pressure (PAP) increases. This reduces left ventricular filling, leading to decreased blood flow. Inhaled nitric oxide (iNO) produces selective pulmonary vasodilation. We hypothesized that iNO would lower PAP during resuscitation resulting in increased survival.
    METHODS: 30 pigs (40 kg) were subjected to cardiac arrest for 9.5 min after myocardial ischemia induced by coronary artery occlusion of the left anterior descending artery and ventricular fibrillation. During resuscitation, the pigs were randomized to 40 ppm iNO or placebo. The primary outcome was return of spontaneous circulation (ROSC). Pigs achieving ROSC underwent 4-hours intensive care.
    RESULTS: The ROSC rate was 9/14 (64%) in the control group and 11/16 (69%) in the iNO group (OR 1.2 95%CI [0.3;5.6], p > 0.99). There was no difference in diastolic aorta pressure/PAP ratio (mean difference -0.99 [95% CI: -2.33-0.36], p = 0.14). Mean pulmonary artery pressure was lower in the iNO group 60 and 120 min after ROSC (mean difference: -12.18 mmHg [95%CI: -16.94; -7.43] p < 0.01 and -5.43 [95%CI: -10.39; -0.46] p = 0.03). Troponin I levels in the iNO group were significantly higher 60 and 120 min after ROSC (mean difference: 266105 ng/l [95%CI: 6356; 525855] p = 0.045 and 420049 ng/l [95%CI: 136779; 703320], p = 0.004). The area at risk of the heart was 33% (SD 1) in controls and 34% (SD 1) in the iNO group. The infarct size divided by the area at risk was 55% (SD 3) in controls and 86% (SD 1) in the iNO group, p = 0.01.
    CONCLUSIONS: Application of iNO did not improve the rate of ROSC or hemodynamic function but increased myocardial injury.
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  • 文章类型: Journal Article
    背景:WCD适用于有心脏骤停风险的患者,这些患者不是植入式除颤器治疗的直接候选人。现有WCD的局限性包括差的顺应性和高的误报率。Jewel是一种新颖的补丁WCD(P-WCD),通过基于粘合剂的近乎连续磨损设计和旨在最大程度减少不适当检测的机器学习算法来解决这些限制。这是在电生理(EP)实验室中对JewelP-WCD进行的首次人体研究,以确定该设备在单次电击终止VT/VF时的安全性和有效性。
    目的:使用JewelP-WCD评估单次电击终止VT/VF的安全性和有效性。
    方法:这是首次在人类,prospective,单臂,单中心研究针对计划进行EP手术的患者,其中预期VT/VF自发发生或被诱导。JewelP-WCD被放置在同意的患者身上;在确认VT/VF后,一次电击(150J)通过该装置进行。使用一组序贯设计和Pocockalpha支出函数来测量成功的VT/VF单次电击终止的观察比例。如果置信下限超过62%的性能目标,则达到终点。使用单边较低的97.4%的精确置信区间。
    结果:在18个符合条件的受试者中,16(88.9%,97.4%置信界限:65.4%)通过单次电击成功除颤,超过主要终点表现目标,无不良事件。
    结论:对JewelP-WCD的首次人类评估证明了终止VT/VF的安全性和有效性。
    背景:URL:https://www。clinicaltrials.gov/;唯一标识符:NCT05490459。
    OBJECTIVE: Wearable cardioverter-defibrillators (WCDs) are indicated in patients at risk of sudden cardiac arrest who are not immediate candidates for implantable defibrillator therapy. Limitations of existing WCDs include poor compliance and high false alarm rates. The Jewel is a novel patch-WCD (P-WCD) that addresses these limitations with an adhesive-based design for near-continuous wear and a machine learning algorithm designed to minimize inappropriate detections. This was a first-in-human study of the Jewel P-WCD conducted in an electrophysiology (EP) lab to determine the safety and effectiveness of the device in terminating ventricular tachycardia/ventricular fibrillation (VT/VF) with a single shock. The aim was to evaluate the safety and effectiveness of terminating VT/VF with a single shock using the Jewel P-WCD.
    RESULTS: This was a first-in-human, prospective, single-arm, single-centre study in patients scheduled for an EP procedure in which VT/VF was expected to either spontaneously occur or be induced. The Jewel P-WCD was placed on consented patients; upon confirmation of VT/VF, a single shock (150 J) was delivered via the device. A group sequential design and Pocock alpha spending function was used to measure the observed proportion of successful VT/VF single-shock terminations. The endpoint was achieved if the lower confidence limit exceeded the performance goal of 62%, using a one-sided lower 97.4% exact confidence bound. Of 18 eligible subjects, 16 (88.9%, 97.4% confidence bound: 65.4%) were successfully defibrillated with a single shock, exceeding the primary endpoint performance goal with no adverse events.
    CONCLUSIONS: This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF.
    BACKGROUND: URL: https://clinicaltrials.gov/; Unique identifier: NCT05490459.
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  • 文章类型: Journal Article
    心房颤动(AF)是心脏手术后最常见的心律失常,引起一系列临床症状和治疗,约三分之一的冠状动脉搭桥手术患者出现。我们旨在评估胺碘酮预防冠状动脉搭桥手术患者心律失常的效果。
    在这项双盲随机临床试验中,纳入60例18岁以上的冠状动脉搭桥手术患者,随机分为两组,在松开主动脉前接受胺碘酮(3mg/kg)10分钟(在100cc生理盐水中)输注,和一个对照组,在松开主动脉前10分钟接受100cc的盐水。病人的人口统计,临床特征,并记录医院和临床病程。
    手术后,22例(36.67%)患者发生心律失常。胺碘酮组显着降低再灌注心室纤颤(RVF)率(26.7%vs.70%;p=.001)和房颤发生率(13.3%vs.60%;p<.001)与安慰剂组相比,在手术后的最初24小时内。在移除主动脉钳后需要D/C休克方面,两组之间没有显着差异。(p=.117)此外,胺碘酮组的重症监护病房住院时间明显低于对照组(2.43vs.3.07天;p=.013)。
    在松开主动脉前10分钟单次静脉注射低剂量胺碘酮的预测特性可以显着降低冠状动脉旁路移植术后的RVF和AF的发生率,同时也减少了住院时间。
    UNASSIGNED: Atrial fibrillation (AF) is the most frequent arrhythmia after cardiac surgery causing a range of clinical symptoms and treatments that develop in around one-third of coronary artery bypass surgery patients. We aimed to evaluate the effect of Amiodarone in preventing arrhythmia in patients undergoing coronary artery bypass surgery.
    UNASSIGNED: In this double-blind randomized clinical trial, 60 patients candidate for coronary artery bypass surgery above the age of 18 were included and randomly divided into two groups of intervention, receiving an infusion of Amiodarone (3 mg/kg) 10 min (in 100 cc Normal saline) before declamping of the aorta, and a control group, receiving 100 cc of saline 10 min before declamping of the aorta. The patient\'s demographic, clinical features, and hospital and clinical course were recorded.
    UNASSIGNED: After undergoing operation, 22 (36.67%) of patients were developed arrhythmia. The Amiodarone group demonstrated significantly lower reperfusion ventricular fibrillation (RVF) rates (26.7% vs. 70%; p = .001) and AF occurrence (13.3% vs. 60%; p < .001) during the initial 24 h after surgery compared to the placebo group. There was no significant difference between the two groups regarding the need for D/C shock after removing the aortic clamp. (p = .117) Furthermore, the intensive care unit stay among the amiodaron group was significantly lower than the control group (2.43 vs. 3.07 days; p = .013).
    UNASSIGNED: The predictive properties in the administration of single intravenous low-dose Amiodarone 10 min before the declamping of the aorta can significantly lower the rates of RVF and AF after coronary artery bypass grafting, while also decreasing hospitalization duration.
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  • 文章类型: Journal Article
    目标:院外心脏骤停(OHCA)期间,自动体外除颤器(AED)每两分钟分析一次心律;然而,80%的再纤颤发生在休克后的第一分钟内。我们已经实现了一种在执行胸部按压(AWC)的同时分析心律的算法。当AWC检测到可电击的节奏时,它将分析之间的时间缩短到一分钟。我们调查了AWC对心肺复苏质量的影响。
    方法:在这项横断面研究中,我们比较了2022年使用AWC治疗的患者,从2017年开始的历史队列。纳入标准是在第一次分析时具有可电击节律的OHCA患者。主要终点是胸部按压分数(CCF)。次要终点是心律演变和生存率,包括非预设亚组的生存分析。
    结果:在2017年和2022年,355和377个OHCA符合纳入标准,我们分析了每个队列中第一个连续的285例病例。与2017年相比,2022年CCF增加(77%[72-80]对72%[67-76];P<0.001),VF复发更迅速(53s[32-69]对117s[90-132])。2017年和2022年之间的生存率没有差异(调整后的风险比0.96[95%CI,0.78-1.18]),但是在2022年发生在公共场所的OHCA亚组中,从呼叫到AED接通的短时间内,该比例更高(调整后的风险比0.85[0.76-0.96])。
    结论:用AWC治疗的OHCA患者有更高的CCF,在心室纤颤中花费的时间更短,但没有生存差异,干预时间短的公共场所发生的OHCA除外。
    OBJECTIVE: During out-of-hospital cardiac arrest (OHCA), an automatic external defibrillator (AED) analyzes the cardiac rhythm every two minutes; however, 80% of refibrillations occur within the first minute post-shock. We have implemented an algorithm for Analyzing cardiac rhythm While performing chest Compression (AWC). When AWC detects a shockable rhythm, it shortens the time between analyses to one minute. We investigated the effect of AWC on cardiopulmonary resuscitation quality.
    METHODS: In this cross-sectional study, we compared patients treated in 2022 with AWC, to a historical cohort from 2017. Inclusion criteria were OHCA patients with a shockable rhythm at the first analysis. Primary endpoint was the chest compression fraction (CCF). Secondary endpoints were cardiac rhythm evolution and survival, including survival analysis of non-prespecified subgroups.
    RESULTS: In 2017 and 2022, 355 and 377 OHCAs met the inclusion criteria, from which we analyzed the 285 first consecutive cases in each cohort. CCF increased in 2022 compared to 2017 (77% [72-80] vs 72% [67-76]; P < 0.001) and VF recurrences were shocked more promptly (53 s [32-69] vs 117 s [90-132]). Survival did not differ between 2017 and 2022 (adjusted hazard-ratio 0.96 [95% CI, 0.78-1.18]), but was higher in 2022 within the sub-group of OHCAs that occurred in a public place and within a short time from call to AED switch-on (adjusted hazard ratio 0.85[0.76-0.96]).
    CONCLUSIONS: OHCA patients treated with AWC had higher CCF, shorter time spent in ventricular fibrillation, but no survival difference, except for OHCA that occurred in public places with short intervention time.
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  • 文章类型: Journal Article
    背景:院外心脏骤停(OHCA)并发难治性室颤(VF)与不良预后相关。β-1受体选择性阻断可能克服难治性VF并提高生存率。该试验研究了院前兰地洛尔在OHCA和难治性VF中的疗效和安全性。
    方法:在本随机分组中,双盲,安慰剂对照试点试验,OHCA和复发性或难治性VF患者(至少3次除颤尝试和最后一次节律可电击),用肾上腺素和胺碘酮预处理,被分配接受兰地洛尔或安慰剂的附加治疗。兰地洛尔以20mg推注的形式给予。主要疗效结果是从试验药物输注到持续恢复自主循环(ROSC)的时间。安全性结果包括心动过缓和心搏停止的发作。
    结果:共纳入36例患者,将19个分配给兰地洛尔组,将17个分配给安慰剂组。从试验药物输注到持续ROSC的时间在治疗组之间相似(39分钟[兰地洛尔]对41分钟[安慰剂])。与安慰剂组相比,兰地洛尔组的持续ROSC在数值上较低(7例患者[36.8%]与11例患者[64.7%],分别)。与安慰剂组相比,兰地洛尔组的试验药物输注后15分钟内的心搏停止发生率明显更高(7例患者[36.8%]和0例患者[0.0%],分别)。
    结论:在接受肾上腺素和胺碘酮预处理的OHCA和难治性VF患者中,与安慰剂相比,连续推注兰地洛尔20mg并没有缩短维持ROSC的时间.兰地洛尔可能与心动过缓和心搏停止有关。
    BACKGROUND: Out-of-hospital cardiac arrest (OHCA) complicated by refractory ventricular fibrillation (VF) is associated with poor outcome. Beta-1-receptor selective blockade might overcome refractory VF and improve survival. This trial investigates the efficacy and safety of prehospital landiolol in OHCA and refractory VF.
    METHODS: In this randomized, double-blind, placebo-controlled pilot trial, patients with OHCA and recurrent or refractory VF (at least 3 defibrillation attempts and last rhythm shockable), pretreated with epinephrine and amiodarone, were allocated to receive add-on treatment with landiolol or placebo. Landiolol was given as a 20 mg bolus infusion. The primary efficacy outcome was time from trial drug infusion to sustained return of spontaneous circulation (ROSC). Safety outcomes included the onset of bradycardia and asystole.
    RESULTS: A total of 36 patients were enrolled, 19 were allocated to the landiolol group and 17 to the placebo group. Time from trial drug infusion to sustained ROSC was similar between treatment groups (39 min [landiolol] versus 41 min [placebo]). Sustained ROSC was numerically lower in the landiolol group compared with the placebo group (7 patients [36.8%] versus 11 patients [64.7%], respectively). Asystole within 15 min of trial drug infusion occurred significantly more often in the landiolol group than in the placebo group (7 patients [36.8%] and 0 patients [0.0%], respectively).
    CONCLUSIONS: In patients with OHCA and refractory VF who are pretreated with epinephrine and amiodarone, add-on bolus infusion of landiolol 20 mg did not lead to a shorter time to sustained ROSC compared with placebo. Landiolol might be associated with bradycardia and asystole.
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  • 文章类型: Journal Article
    背景:植入式心脏复律除颤器的使用寿命更长,并且对具有针对性的引线放置的可靠引线的兴趣正在增长。OmniaSecure除颤导线是一种新颖的,小直径,导管输送导线设计用于有针对性的放置,基于已建立的SelectSecureSureScanMRI3830型无腔起搏导线平台。
    目的:本试验评估了OmniaSecure除颤导线的安全性和有效性。
    方法:全球LEADR关键临床试验招募了需要重新植入一级或二级预防的植入式心律转复除颤器或心脏再同步治疗除颤器的患者,所有这些人都得到了研究的线索。主要疗效终点是按照方案植入时成功除颤。主要的安全终点是在6个月时没有研究引线相关的主要并发症。如果双侧95%可信区间的下限>88%和>90%,则满足主要疗效和安全性目标。分别。
    结果:总计,643名患者成功接受了研究引导,505例患者完成了12个月的随访。99.5%的患者将导线放置在所需的右心室位置。119例患者在植入时完成除颤测试,成功率为97.5%。Kaplan-Meier估计在第6个月和第12个月时与研究导线相关的主要并发症的发生率为97.1%。该试验超过了主要疗效和安全性目标阈值。在整个平均随访12.7±4.8个月(平均值±SD)期间,研究导线断裂为零,电气性能稳定。
    结论:OmniaSecure导线在安全性和有效性方面超过了预设的主要终点性能目标,显示高除颤成功率和低发生率与零导线骨折的导线相关的主要并发症。
    BACKGROUND: Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure™ defibrillation lead is a novel small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform.
    OBJECTIVE: This trial assessed safety and efficacy of the OmniaSecure defibrillation lead.
    METHODS: The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead-related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively.
    RESULTS: In total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead-related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD).
    CONCLUSIONS: The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.
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