implantable cardiac monitor

植入式心脏监护仪
  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:隐源性卒中后,患者通常需要长时间的心脏监测;然而,从长期心律监测获益的患者亚组没有明确定义.
    目标:使用年龄,性别,合并症,基线12导联心电图,短期心律监测和超声心动图数据,我们创建了风险评分,并将其与之前发布的风险评分进行了比较.
    方法:回顾性分析了2017年5月至2022年6月在蒙特菲奥雷医学中心接受的初次诊断为隐源性卒中或TIA的患者,这些患者接受了植入式心脏监护仪的长期节律监测。
    结果:与有临床意义的心房颤动诊断呈正相关的变量包括年龄(p<0.001),种族(p=0.022),糖尿病状态(p=0.026),和COPD状态(p=0.012),心房运行的存在(p=0.003),每24小时心房运行次数(p<0.001),每24小时的心房运行搏动总数(p<0.001)和最长心房运行中的搏动数(p<0.001),LA增大(p=0.007)和至少轻度二尖瓣反流(p=0.009)。我们为我们的人群创建了一个风险分层评分,称为“ACL得分”。“ACL评分显示优于CHA2DS2-VASc评分,并且与C2HEST评分在预测设备检测到的AF方面具有可比性。
    结论:ACL评分使临床医生能够更好地预测哪些患者在隐源性卒中后更有可能被诊断为设备检测到的房颤。
    BACKGROUND: After a cryptogenic stroke, patients often will require prolonged cardiac monitoring; however, the subset of patients who would benefit from long-term rhythm monitoring is not clearly defined.
    OBJECTIVE: The purpose of this study was to create a risk score by identifying significant predictors of atrial fibrillation (AF) using age, sex, comorbidities, baseline 12-lead electrocardiogram, short-term rhythm monitoring, and echocardiographic data and to compare it to previously published risk scores.
    METHODS: Patients admitted to Montefiore Medical Center between May 2017 and June 2022 with a primary diagnosis of cryptogenic stroke or transient ischemic attack who underwent long-term rhythm monitoring with an implantable cardiac monitor were retrospectively analyzed.
    RESULTS: Variables positively associated with a diagnosis of clinically significant AF include age (P <.001), race (P = .022), diabetes status (P = .026), chronic obstructive pulmonary disease status (P = .012), presence of atrial runs (P = .003), number of atrial runs per 24 hours (P <.001), total number of atrial run beats per 24 hours (P <.001), number of beats in the longest atrial run (P <.001), left atrial enlargement (P = .007), and at least mild mitral regurgitation (P = .009). We created a risk stratification score for our population, termed the ACL score. The ACL score demonstrated superiority to the CHA2DS2-VASc score and comparability to the C2HEST score for predicting device-detected AF.
    CONCLUSIONS: The ACL score enables clinicians to better predict which patients are more likely to be diagnosed with device-detected AF after a cryptogenic stroke.
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  • 文章类型: Journal Article
    背景:Brugada综合征(BrS)患者面临室性心律失常和心源性猝死的风险增加。植入式心脏监测仪(ICM)已成为检测BrS心律失常的有效工具。技术进步,包括温度传感器和改进的皮下心电图(subECG)信号质量,有希望进一步提高它们在这一人群中的效用。
    结果:我们介绍了一例40岁男性在12导联心电图上表现出BrS2型模式,谁接受了ICM插入(生物监测器IIIm,BIOTRONIK)由于药物诱导的BrS1型模式和晕厥病史,对编程的心室刺激有负面反应。该设备包含一个集成的温度传感器,可以传输日常生命数据,比如平均心率和体力活动。几个月后,远程警报指示温度升高,以及传播的亚ECG,表明发烧诱发的BrS1型模式。患者被及时建议开始退热治疗。在接下来的几天里,远程监测参数显示平均温度下降,身体活动,和平均心率,无异常亚心电图的进一步复发。
    结论:ICMs在BrS的心律失常检测中提供了有价值的见解。使用嵌入式温度传感器早期检测发热可以改善患者管理,而连续亚ECG形态学分析有可能增强BrS患者的风险分层。
    BACKGROUND: Patients with Brugada syndrome (BrS) face an increased risk of ventricular arrhythmias and sudden cardiac death. Implantable cardiac monitors (ICMs) have emerged as effective tools for detecting arrhythmias in BrS. Technological advancements, including temperature sensors and improved subcutaneous electrocardiogram (subECG) signal quality, hold promise for further enhancing their utility in this population.
    RESULTS: We present a case of a 40-year-old man exhibiting a BrS type 2 pattern on 12-lead ECG, who underwent ICM insertion (BIOMONITOR IIIm, BIOTRONIK) due to drug-induced BrS type 1 pattern and a history of syncope, with a negative response to programmed ventricular stimulation. The device contains an integrated temperature sensor and can transmit daily vital data, such as mean heart rate and physical activity. Several months later, remote alerts indicated a temperature increase, along with transmitted subECGs suggesting a fever-induced BrS type 1 pattern. The patient was promptly advised to commence antipyretic therapy. Over the following days, remotely monitored parameters showed decreases in mean temperature, physical activity, and mean heart rate, without further recurrence of abnormal subECGs.
    CONCLUSIONS: ICMs offer valuable insights beyond arrhythmia detection in BrS. Early detection of fever using embedded temperature sensors may improve patient management, while continuous subECG morphological analysis has the potential to enhance risk stratification in BrS patients.
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  • 文章类型: Journal Article
    心律失常可预测心肌梗死(MI)后的不良预后。我们研究了使用可插入心脏监护仪(ICM)进行心律失常监测是否可以改善治疗和预后。
    BIO|GUARD-MI是一个随机的,具有盲化结果评估的国际开放标签研究。
    三级护理机构监测心律失常,而随访仍由初级保健医生进行。
    ST段抬高(STEMI)或非ST段抬高MI后,射血分数>35%且CHA2DS2-VASc评分≥4(男性)或≥5(女性)的患者。
    除了标准的MI后治疗外,患者被随机分配接受或不接受ICM。设备检测到的心律失常通过远程监测触发了立即指南推荐的治疗变化。
    MACE,定义为心血管死亡或因心血管原因导致的急性计划外住院的复合。
    790名患者(平均年龄71岁,72%男性,计划中的1,400名患者中有51%非STEMI)入组,并随访中位数为31.6个月。在2年,39.4%的装置组和6.7%的对照组对心律失常进行了治疗[风险比(HR)=5.9,P<0.0001]。最常见的心律失常是心房颤动,停顿和心动过缓。使用ICM并没有改善整个队列的结局(HR=0.84,95%-CI:0.65-1.10;P=0.21)。在次要分析中,梗死类型之间的统计学显著交互作用表明,预先指定的非STEMI亚组获益.危险因素分析表明,这可能与非STEMI患者MACE发生率较高有关。
    无症状但可操作的心律失常在梗死后患者中的负担很大。然而,在整个队列中,使用ICM监测心律失常并没有改善结局.事后分析表明,它可能对非STEMI患者或其他高危亚组有益。
    [https://www.clinicaltrials.gov/ct2/show/NCT02341534],NCT02341534。
    UNASSIGNED: Cardiac arrhythmias predict poor outcome after myocardial infarction (MI). We studied if arrhythmia monitoring with an insertable cardiac monitor (ICM) can improve treatment and outcome.
    UNASSIGNED: BIO|GUARD-MI was a randomized, international open-label study with blinded outcome assessment.
    UNASSIGNED: Tertiary care facilities monitored the arrhythmias, while the follow-up remained with primary care physicians.
    UNASSIGNED: Patients after ST-elevation (STEMI) or non-ST-elevation MI with an ejection fraction >35% and a CHA2DS2-VASc score ≥4 (men) or ≥5 (women).
    UNASSIGNED: Patients were randomly assigned to receive or not receive an ICM in addition to standard post-MI treatment. Device-detected arrhythmias triggered immediate guideline recommended therapy changes via remote monitoring.
    UNASSIGNED: MACE, defined as a composite of cardiovascular death or acute unscheduled hospitalization for cardiovascular causes.
    UNASSIGNED: 790 patients (mean age 71 years, 72% male, 51% non-STEMI) of planned 1,400 pts were enrolled and followed for a median of 31.6 months. At 2 years, 39.4% of the device group and 6.7% of the control group had their therapy adapted for an arrhythmia [hazard ratio (HR) = 5.9, P < 0.0001]. Most frequent arrhythmias were atrial fibrillation, pauses and bradycardia. The use of an ICM did not improve outcome in the entire cohort (HR = 0.84, 95%-CI: 0.65-1.10; P = 0.21). In secondary analysis, a statistically significant interaction of the type of infarction suggests a benefit in the pre-specified non-STEMI subgroup. Risk factor analysis indicates that this may be connected to the higher incidence of MACE in patients with non-STEMI.
    UNASSIGNED: The burden of asymptomatic but actionable arrhythmias is large in post-infarction patients. However, arrhythmia monitoring with an ICM did not improve outcome in the entire cohort. Post-hoc analysis suggests that it may be beneficial in non-STEMI patients or other high-risk subgroups.
    UNASSIGNED: [https://www.clinicaltrials.gov/ct2/show/NCT02341534], NCT02341534.
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  • 文章类型: Journal Article
    在临床前研究中评估新药和疗法的安全性时,心律失常检测至关重要。存在许多短期心律失常监测方法,包括非侵入性心电图和动态心电图。然而,没有可靠的,长期的,非侵入性,或用于大型动物心律失常随访的微创方法,允许与同窝动物自由运动。在评估长期药物或治疗的影响时,需要较长的随访时间。比如基因治疗。我们评估了可插入心脏监护仪(ICM)在猪中的可行性和性能,允许自由运动和物种特异性行为的心律失常的长期监测。测试多个植入部位以评估信号质量。ICMs可靠地识别出许多不同的心律失常,但未能检测到单个期外收缩。他们还过度诊断了T波,导致过度感知。动物的肌肉活动和自然惊吓引起了噪音,导致需要记录后评估的异构信号。尽管有这些缺点,ICMs被证明对猪心律的微创长期监测非常有用.
    Arrhythmia detection is essential when assessing the safety of novel drugs and therapies in preclinical studies. Many short-term arrhythmia monitoring methods exist, including non-invasive ECG and Holter. However, there are no reliable, long-term, non-invasive, or minimally invasive methods for cardiac arrhythmia follow-up in large animals that allows free movement with littermates. A long follow-up time is needed when estimating the impact of long-lasting drugs or therapies, such as gene therapy. We evaluated the feasibility and performance of insertable cardiac monitors (ICMs) in pigs for minimally invasive, long-term monitoring of cardiac arrhythmias that allows free movement and species-specific behavior. Multiple implantation sites were tested to assess signal quality. ICMs recognized reliably many different arrhythmias but failed to detect single extrasystoles. They also over-diagnosed T-waves, resulting in oversensing. Muscle activity and natural startles of the animals caused noise, leading to a heterogeneous signal requiring post-recording evaluation. In spite of these shortcomings, the ICMs showed to be very useful for minimally invasive long-term monitoring of cardiac rhythm in pigs.
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  • 文章类型: Journal Article
    植入式心脏监测仪(ICM)提供长期心律失常监测,但是高的错误检测率增加了审查负担。新的“SmartECG”算法可过滤错误检测。使用大型现实世界数据集,我们的目标是量化工作量的减少和这种新算法的任何敏感性损失。
    三个临床项目包括BioMonitorIIIm和任何器械适应症的患者。通过远程监测传输的所有皮下心电图(sECG)被算法分类为“真”或“假”。\"我们量化了工作量的相对减少,假设\"false\"sECGs被忽略。评估了五家医院已建立远程监控程序的远程监控工作量。通过针对三名医生的临床委员会测试2000个sECG的样本来估计灵敏度的损失。
    在我们的368名患者中,42%有晕厥或晕厥前期的指征,31%有隐源性卒中的指征。在418.5患者年的随访中,143,096个远程监控传输包含61,517个sECG。SmartECG将所有sECG的42.8%过滤为“假”,“将每个患者年的人数从147人减少到84人。在五家医院,9名经过培训的审查员平均每工作小时检查105个sECG。这导致每位患者在没有SmartECG的情况下的年度工作时间为83分钟,和48分钟与SmartECG。灵敏度的损失估计为2.6%。在大多数情况下,真正的心律失常被拒绝,SmartECG在错误拒绝sECG之前或之后3天内将相同类型的心律失常分类为“真实”。
    SmartECG提高了使用ICM进行长期心律失常监测的效率。SmartECG减少工作量是有意义的,并且由于算法的不正确过滤而错过相关心律失常的风险是有限的。
    UNASSIGNED: Implantable cardiac monitors (ICMs) provide long-term arrhythmia monitoring, but high rates of false detections increase the review burden. The new \"SmartECG\" algorithm filters false detections. Using large real-world data sets, we aimed to quantify the reduction in workload and any loss in sensitivity from this new algorithm.
    UNASSIGNED: Patients with a BioMonitor IIIm and any device indication were included from three clinical projects. All subcutaneous ECGs (sECGs) transmitted via remote monitoring were classified by the algorithm as \"true\" or \"false.\" We quantified the relative reduction in workload assuming \"false\" sECGs were ignored. The remote monitoring workload from five hospitals with established remote monitoring routines was evaluated. Loss in sensitivity was estimated by testing a sample of 2000 sECGs against a clinical board of three physicians.
    UNASSIGNED: Of our population of 368 patients, 42% had an indication for syncope or pre-syncope and 31% for cryptogenic stroke. Within 418.5 patient-years of follow-up, 143,096 remote monitoring transmissions contained 61,517 sECGs. SmartECG filtered 42.8% of all sECGs as \"false,\" reducing the number per patient-year from 147 to 84. In five hospitals, nine trained reviewers inspected on average 105 sECGs per working hour. This results in an annual working time per patient of 83 min without SmartECG, and 48 min with SmartECG. The loss of sensitivity is estimated as 2.6%. In the majority of cases where true arrhythmias were rejected, SmartECG classified the same type of arrhythmia as \"true\" before or within 3 days of the falsely rejected sECG.
    UNASSIGNED: SmartECG increases efficiency in long-term arrhythmia monitoring using ICMs. The reduction of workload by SmartECG is meaningful and the risk of missing a relevant arrhythmia due to incorrect filtering by the algorithm is limited.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    背景:植入式心脏监护仪(ICM)主要使用皮下心电图(ECG)中的R-R间隔来检测心律失常。因此,ICM对R波振幅的可靠检测至关重要。由于ICM检测到皮下心电图,应评估植入深度的影响.
    结果:本研究调查了ICM深度对ICM(JOTDx;Abbott)产生的ECG的R波(ICM-R)振幅的影响。总的来说,对2022年5月至2023年4月在Kamagaya总医院接受ICM植入的53例患者进行回顾性分析。植入后使用超声成像测量深度位置。ICM的深度与ICM-R振幅没有显示任何相关性(r=-.0141,p=.294)。然而,ICM与心脏表面之间的距离与ICM-R振幅显着相关(r=-.581,p<.001)。体重(r=-.0283,p=.033)和体重指数(r=-.0342,p=.009)与ICM-R振幅相关。V1-导联中的S波也与ICM-R振幅相关(r=.481,p<.001)。经过多变量分析,ICM与心脏表面之间的距离以及V1中的S波是ICM-R振幅的独立决定因素。
    结论:ICM植入越深,ICM-R振幅可能越高。
    Implantable cardiac monitors (ICMs) primarily use R-R intervals in subcutaneous electrocardiograms (ECGs) to detect arrhythmias. Therefore, reliable detection of R-wave amplitude by an ICM is vital. Since ICMs detect subcutaneous ECGs, the impact of the implantation depth should be assessed.
    This study investigated the influence of ICM depth on R-wave (ICM-R) amplitude on an ECG generated by an ICM (JOT Dx; Abbott). Overall, 58 patients who underwent ICM implantation at Kamagaya General Hospital from May 2022 to April 2023 were retrospectively reviewed. The depth-position was measured using ultrasound imaging after implantation. The depth of the ICM did not show any correlation with ICM-R amplitude (r = -.0141, p = .294). However, the distance between the ICM and the heart surface showed a significant correlation with ICM-R amplitude (r = -.581, p < .001). Body weight (r = -.0283, p = .033) and body mass index (r = -.0342, p = .009) were associated with ICM-R amplitude. S wave in the V1 -lead was also associated with ICM-R amplitude (r = .481, p < .001). After multivariate analysis, the distance between the ICM and heart surface and the S wave in V1 were independent determinants for the ICM-R amplitude.
    The ICM-R amplitude may be higher with the ICM implanted deeper.
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  • 文章类型: Journal Article
    心脏可植入电子设备(CIED)远程传输是儿科和成人先天性心脏病(ACHD)患者纵向随访的组成部分。在实施儿科和先天性电生理学会(PACES)赞助的质量改进(QI)项目之前,评估儿科和ACHD中心的baselineCIED远程监测(RM)数据。这是基线EDRM的横断面研究。中心自我报告的基线数据:如果成就>80%,则将单个中心RM依从性定义为高,如果<50%,则定义为低。美国和澳大利亚共有22个儿科中心提交了基线数据。在大多数中心,非医师负责管理RM计划:注册护士(36%),高级实践提供商(27%),合并(23%),和第三方(9%)。15个中心(68%)报告>80%的CIED患者纳入RM,只有两个中心报告<50%参与。36%的患者在植入后14天内报告了器械传播的高依从性,77%的中心报告了在RM中登记的CIED患者的高依从性。实现高依从性的中心数量因设备类型而异:起搏器为36%,ICD的50%,和55%的植入式心脏监护仪(ICM)。所有中心报告至少50%的患者对PM和ICD的建议随访依从性。ICM的依从率低23%。根据对儿科和ACHD中心的横断面调查,符合CIEDRM是次优的。PACES赞助的QI计划将为参与中心提供资源和支持,重复数据将在PDSA周期后进行评估。
    Cardiac implantable electronic device (CIED) remote transmissions are an integral part of longitudinal follow-up in pediatric and adult congenital heart disease (ACHD) patients. To evaluate baseline CIED remote monitoring (RM) data among pediatric and ACHD centers prior to implementation of a Pediatric and Congenital Electrophysiology  Society (PACES)-sponsored quality improvement (QI) project. This is a cross-sectional study of baseline CIED RM. Centers self-reported baseline data: individual center RM compliance was defined as high if there was > 80% achievement and low if < 50%. A total of 22 pediatric centers in the USA and Australia submitted baseline data. Non-physicians were responsible for management of the RM program in most centers: registered nurse (36%), advanced practice provider (27%), combination (23%), and third party (9%). Fifteen centers (68%) reported that > 80% of their CIED patients are enrolled in RM and only two centers reported < 50% participation. 36% reported high compliance of device transmission within 14 days of implant and 77% of centers reported high compliance of CIED patients enrolled in RM. The number of centers achieving high compliance differed by device type: 36% for pacemakers, 50% for ICDs, and 55% for Implantable Cardiac Monitors (ICM). All centers reported at least 50% adherence to recommended follow-up for PM and ICD, with 23% low compliance rate for ICMs. Based on this cross-sectional survey of pediatric and ACHD centers, compliance with CIED RM is sub-optimal. The PACES-sponsored QI initiative will provide resources and support to participating centers and repeat data will be evaluated after PDSA cycles.
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  • 目的:多达20%的缺血性卒中与明显的心房颤动(AF)相关。此外,在CRYSTALAF研究中,1/3的隐源性卒中通过植入式心脏监测仪(ICM)检测到无症状AF.ESC立场文件建议HAVOC评分≥4或BrownESUS-AF评分≥2作为隐源性卒中后ICM植入的标准。但这些标准均未在ICM人群中制定或验证.我们评估了不明来源的栓塞性中风(ESUS)后植入的一组ICM患者的HAVOC和BrownESUS-AF评分。
    方法:回顾性纳入2016年2月至2022年2月在两家法国大学医院植入ESUSICM的所有患者。人口统计数据,心血管危险因素,在审查电子病历后收集临床和生物学数据。计算所有患者的HAVOC和BrownESUS-AF评分。
    结果:在384名患者中,106例(27%)在平均33个月的随访期间发生房颤。随访期间预测AF的得分表现为:HAVOC=AUC:68.5%,C指数:0.662,棕色ESUS-AF=AUC:72.9%,C指数0.712。与CHA2DS2-VASc评分相比,只有BrownESUS-AF评分显示NRI/IDI显著改善.此外,根据建议的HAVOC和BrownESUS-AF阈值对患者进行分类,只有24%和31%的人,分别,会收到ICM,和58(55%)和47(44%)的房颤患者,分别,不会植入ICM.
    结论:HAVOC和BrownESUS-AF评分在预测隐源性卒中后ICM的AF方面显示出接近和中等的表现,严重缺乏敏感性。应在大型ICM队列中开发和验证特定风险评分。
    OBJECTIVE: Up to 20 % of ischemic strokes are associated with overt atrial fibrillation (AF). Furthermore, silent AF was detected by an implantable cardiac monitor (ICM) in 1 in 3 cryptogenic strokes in the CRYSTAL AF study. An ESC position paper has suggested a HAVOC score ≥ 4 or a Brown ESUS-AF score ≥ 2 as criteria for ICM implantation after cryptogenic stroke, but neither of these criteria has been developed or validated in ICM populations. We assessed the performance of HAVOC and Brown ESUS-AF scores in a cohort of ICM patients implanted after embolic stroke of undetermined source (ESUS).
    METHODS: All patients implanted with an ICM for ESUS between February 2016 and February 2022 at two French University Hospitals were retrospectively included. Demographic data, cardiovascular risk factors, and clinical and biological data were collected after a review of electronic medical records. HAVOC and Brown ESUS-AF scores were calculated for all patients.
    RESULTS: Among the 384 patients included, 106 (27 %) developed AF during a mean follow-up of 33 months. The scores performances for predicting AF during follow-up were: HAVOC= AUC: 68.5 %, C-Index: 0.662, and Brown ESUS-AF=AUC: 72.9 %, C-index 0.712. Compared with the CHA2DS2-VASc score, only the Brown ESUS-AF score showed significant improvement in NRI/IDI. Furthermore, classifying patients according to the suggested HAVOC and Brown ESUS-AF thresholds, only 24 % and 31 % of the cohort, respectively, would have received an ICM, and 58 (55 %) and 47 (44 %) of the AF patients, respectively, would not have been implanted with an ICM.
    CONCLUSIONS: HAVOC and Brown ESUS-AF scores showed close and moderate performance in predicting AF on ICM after cryptogenic stroke, with a significant lack of sensitivity. Specific risk scores should be developed and validated in large ICM cohorts.
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