insertable cardiac monitor

插入式心脏监护仪
  • 文章类型: Journal Article
    目的:指南推荐可插入心脏监测仪(ICM)在评估不明原因晕厥(US)晕厥的早期阶段,当怀疑心律失常病因时。我们检查了上一代ICM(LG-ICM)的诊断产量,以建立US的原因,通过评估在临床实践中的发病率:相关的心律失常诊断,晕厥复发和CM引导心脏电子设备(CIED)植入。我们还调查了与相关心律失常和晕厥复发风险增加相关的基线患者特征。
    方法:分析了2020年11月至2023年1月在我们机构接受LG-ICM进行美国或晕厥前期调查的连续患者的前瞻性数据。
    结果:共109名患者(平均年龄64.4±16.1岁,40.4%的女性)患有美国或晕厥前发作的女性接受了LG-ICM的植入。在平均11.7±8.1个月的随访中,LG-ICM诊断产率为42%。特别是,LG-ICM在29名(27%)患者中检测到心律失常(其中6名在晕厥复发期间),并在另外19名(17%)患者中排除了晕厥的心律失常起源。LG-ICM引导16例(15%)美国患者植入aCIED,由于诊断为心搏停止或严重的心动过缓。年龄≥65岁(p=0.012)和房性心律失常病史(p=0.004)是LG-ICM进行心律失常诊断的重要独立预测因子,而CAD是晕厥复发的预测因子(接近统计意义,p=0.056)。
    结论:LG-ICM在美国晕厥中的诊断率与ILR和上一代ICM相当。应在管理ICM数据所需的较低医院工作量中寻求LG-ICM的优势。年龄≥65岁和房性心律失常史是ICM检测到的显著心律失常的独立预测因子。
    OBJECTIVE: Guidelines recommend insertable cardiac monitor (ICM) in the early phases of the evaluation of unexplained syncope (US) syncope, when an arrhythmic etiology is suspected. We examined the diagnostic yield of the last generation ICM (LG-ICM) to establish the causes of US, by assessing in the clinical practice the incidence of: relevant arrhythmia diagnosis, syncope recurrences and CM-guided cardiac electronic device (CIED) implantation. We investigated also baseline patient characteristics associated to an increased risk of relevant arrhythmias and of syncope recurrence.
    METHODS: Data prospectively collected from consecutive patients receiving LG-ICM for investigation of US or presyncope in our institution between November 2020 and January 2023 were analyzed.
    RESULTS: A total of 109 patients (mean age 64.4 ± 16.1 years, 40.4% women) with US or pre-syncope episodes underwent implantation of the LG-ICM. During a mean follow-up of 11.7 ± 8.1 months, LG-ICM diagnostic yield was 42%. In particular, LG-ICM detected cardiac arrhythmias in 29 (27%) patients (in 6 out of them during a syncope recurrence) and to exclude the arrhythmic origin of the syncope in additional 19 (17%) patients. LG-ICM guided the implantation of a CIED in 16 (15%) US patients, due to the diagnosis of asystole or severe bradycardia. Age ≥ 65 years (p = 0.012) and atrial arrhythmia history (p = 0.004) are significant independent predictors of arrhythmic diagnoses performed by LG-ICM, while CAD is predictor of syncope recurrence (bordering on statistical significance, p = 0.056).
    CONCLUSIONS: The diagnostic yield of LG-ICM in US syncope is comparable to those of ILR and previous generation ICM. The advantages of LG-ICM should be sought in lower hospital workload necessary to manage ICM data. Age ≥ 65 years and atrial arrhythmia history are independent predictors of significant ICM-detected arrhythmias.
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  • 文章类型: Case Reports
    插入式心脏监护仪(ICM),用于长期心律监测,经常经历诊断挑战,如T波过度感知,导致误报。此病例报告提出了一种新的方法来纠正ICM植入中的T波过度感知。在这种情况下,我们正在分享一名38岁女性,患有复发性晕厥发作,她接受了ICM植入(LUX-Dx™,ICM-波士顿科学公司,马尔伯勒,美国)。植入后,检测到T波过感测。而不是通常的重新调整或重新插入,我们采用了一种非侵入性方法,通过现有切口将ICM以45度角向心脏右侧重新定位.这有效地解决了过感测问题,而没有并发症或需要新的切口。ICM在将症状与心律失常联系起来方面至关重要,特别是在标准诊断工具不足的情况下。尽管他们的效用,由于皮下放置,ICM易受T波过感测的影响。我们的案例展示了一个成功的替代方法来解决这个问题,在没有侵入性程序的情况下提高ICM的诊断准确性。这个案例凸显了将ICM重新定位为简单,克服T波过感测问题的非侵入性解决方案。它呼吁医学界进一步研究和讨论,以探索其更广泛的适用性,从而提高ICM在临床实践中的疗效。在三个月的随访中,患者在适当的感知下没有出现并发症,在类似情况下,验证这种方法是可行的选择。
    Insertable cardiac monitor (ICM), used for long-term heart rhythm monitoring, often experiences diagnostic challenges such as T-wave oversensing, leading to false positives. This case report presents a novel approach to rectifying T-wave oversensing in ICM implantations. In this case, we are sharing a 38-year-old female with recurrent syncopal episodes who underwent ICM implantation (LUX-Dx™, ICM-Boston Scientific, Marlborough, United States). Post-implantation, T-wave oversensing was detected. Instead of the usual readjustment or reinsertion, we employed a non-invasive method of repositioning the ICM at a 45-degree angle toward the right side of the heart through the existing incision. This effectively resolved the oversensing issue without complications or the need for a new incision. ICMs are vital in linking symptoms to arrhythmias, especially in cases where standard diagnostic tools fall short. Despite their utility, ICMs are susceptible to T-wave oversensing due to subcutaneous placement. Our case demonstrates a successful alternative approach to address this, enhancing ICM\'s diagnostic accuracy without invasive procedures. This case highlights the potential of repositioning ICMs as a simple, non-invasive solution to overcome T-wave oversensing issues. It calls for further research and discussion within the medical community to explore its wider applicability, thereby improving ICM efficacy in clinical practice. The patient experienced no complications following the procedure during the three-month visit with appropriate sensing, validating this approach as a feasible option in similar cases.
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  • 文章类型: Case Reports
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  • 文章类型: Journal Article
    背景:LUX-Dx™是自2022年10月以来引入欧洲市场的新型可插入心脏监护仪(ICM)。
    目的:本研究的目的是全面描述ICM在欧洲商业使用初期的植入经验。
    方法:该系统包括切口工具和预加载有小ICM的单件式插入工具。植入手术包括切口,创建一个设备口袋,插入ICM,传感验证,和切口闭合。患者会收到带有预装App的移动设备,连接到他们的ICM并将数据传输到管理系统。在植入时和患者出院前分析在欧洲中心收集的数据。
    结果:在23个中心共进行了368次植入手术。晕厥(235,64%)和隐源性中风(34,9%)是ICM最常见的适应症。大多数程序(338,92%)在电生理实验室进行。所有ICM均成功植入左胸骨旁区域,323名(88%)患者朝向45°。在对9例(2%)患者进行感知验证后,需要重新定位。未报告手术并发症,从皮肤切口到缝合的中位时间为4分钟(第25-75百分位数2-7)。在植入时,平均R波振幅为0.39±0.30mV,P波能见度为91±20%.传感参数保持稳定,直到出院前,并且不受患者特征或适应症的影响。程序时间很快,在患者组中表现出一致性,并在初步使用该系统后进行了改进。操作员对系统的反馈是积极的。患者报告说,使用App非常方便,植入后的不适程度很低。
    结论:LUX-Dx™植入看起来既有效又简单,具有良好的植入后感知值,并与操作员和患者的积极反馈相关。
    BACKGROUND: The LUX-Dx™ is a novel insertable cardiac monitor (ICM) introduced into the European market since October 2022.
    OBJECTIVE: The aim of this investigation was to provide a comprehensive description of the ICM implantation experience in Europe during its initial year of commercial use.
    METHODS: The system comprises an incision tool and a single-piece insertion tool pre-loaded with the small ICM. The implantation procedure involves incision, creation of a device pocket, insertion of the ICM, verification of sensing, and incision closure. Patients receive a mobile device with a preloaded App, connecting to their ICM and transmitting data to the management system. Data collected at European centers were analyzed at the time of implantation and before patient discharge.
    RESULTS: A total of 368 implantation procedures were conducted across 23 centers. Syncope (235, 64%) and cryptogenic stroke (34, 9%) were the most frequent indications for ICM. Most procedures (338, 92%) were performed in electrophysiology laboratories. All ICMs were successfully implanted in the left parasternal region, oriented at 45° in 323 (88%) patients. Repositioning was necessary after sensing verification in 9 (2%) patients. No procedural complications were reported, with a median time from skin incision to suture of 4 min (25th-75th percentiles 2-7). At implantation, the mean R-wave amplitude was 0.39 ± 0.30 mV and the P-wave visibility was 91 ± 20%. Sensing parameters remained stable until pre-discharge and were not influenced by patient characteristics or indications. Procedural times were fast, exhibited consistency across patient groups, and improved after an initial experience with the system. Operator Operator feedback on the system was positive. Patients reported very good ease of use of the App and low levels of discomfort after implantation.
    CONCLUSIONS: LUX-Dx™ implantation appears efficient and straightforward, with favorable post-implantation sensing values and associated with positive feedback from operators and patients.
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  • 文章类型: Journal Article
    背景:长期心律监测(LTRM)可以检测有房颤和卒中风险的患者的未诊断房颤(AF)。循环微小RNA(miRNA),已被证明在心房电和结构重塑中起作用,可以帮助选择最受益于LTRM的患者。这项研究的目的是调查糖尿病(DM)和高血压以及使用可插入心脏监护仪(ICM)筛查检测到的亚临床AF(SCAF)的患者是否具有显着不同的血浆基线水平的五个选定的miRNA在调节心房电和结构重塑(miR-21-5p,miR-29b-3p,miR-150-5p,miR-328-3p,和miR-432-5p)与没有SCAF的那些相比。方法:本研究于2013年12月-2015年11月在某二级学术教学医院门诊进行。符合条件的患者年龄≥65岁,患有DM和高血压,但没有已知的心脏病。所有患者均接受ICM。在ICM植入当天,抽取用于测量5种miRNA血浆水平的血样。在这个事后分析中,我们通过逆转录-定量聚合酶链反应研究了它们的表达。比较了有和没有新检测到SCAF的患者的miRNA血浆水平。结果:我们纳入了82例连续患者(中位年龄71.3岁(IQR67.4-75.1)),平均随访588天(IQR:453-712天).17名患者(20.7%)患有ICM检测到的SCAF。miR-328-3p的血浆水平,miR-29b-3p,miR-21-5p,miR-432-5p,与未发生SCAF的患者相比,miR-150-5p略有差异,但无显着差异。结论:在高血压和DM患者中,新检测到的SCAF与miR-21-5p表达水平的变化没有显着相关,miR-29b-3p,miR-150-5p,miR-328-3p,和miR-432-5p。
    Background: Long-term rhythm monitoring (LTRM) can detect undiagnosed atrial fibrillation (AF) in patients at risk of AF and stroke. Circulating microRNAs (miRNAs), which have been shown to play a role in atrial electrical and structural remodelling, could help to select patients who would benefit most from LTRM. The aim of this study was to investigate whether patients with diabetes mellitus (DM) and hypertension and screen-detected subclinical AF (SCAF) using an insertable cardiac monitor (ICM) have significantly different plasma baseline levels of five selected miRNAs playing a role in the modulation of atrial electrical and structural remodelling (miR-21-5p, miR-29b-3p, miR-150-5p, miR-328-3p, and miR-432-5p) compared to those without SCAF. Methods: This study was performed at the outpatient clinic of a secondary academic teaching hospital between December 2013 and November 2015. Eligible patients were ≥65 years of age with DM and hypertension but without known heart diseases. All patients received an ICM. On the day of ICM implantation, blood samples for the measurement of plasma levels of the five miRNAs were drawn. In this post hoc analysis, we investigated their expression by reverse transcription-quantitative polymerase chain reaction. MiRNA plasma levels in patients with and without newly detected SCAF were compared. Results: We included 82 consecutive patients (median age of 71.3 years (IQR 67.4-75.1)), who were followed for a median of 588 days (IQR: 453-712 days). Seventeen patients (20.7%) had ICM-detected SCAF. Plasma levels of miR-328-3p, miR-29b-3p, miR-21-5p, miR-432-5p, and miR-150-5p were slightly but not significantly different in patients with incident SCAF compared with patients without. Conclusions: In patients with hypertension and DM, newly detected SCAF was not significantly associated with changes in expression levels of miR-21-5p, miR-29b-3p, miR-150-5p, miR-328-3p, and miR-432-5p.
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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
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  • 文章类型: Journal Article
    由于其阵发性性质,未确定来源的栓塞性中风(ESUS)患者的房颤(AF)检测具有挑战性。我们试图使用可插入心脏监护仪(ICM)评估房颤检测,并在ESUS后对各种房颤监测策略进行成本分析。我们将此成本分析建模应用于最近发表的卒中房颤和PerDiem试验。
    对出院前放置ICM的ESUS连续住院患者进行回顾性图表回顾。利用ICM检测到的AF和医疗保险平均支付率,我们对ESUS患者在出院前立即插入ICM与使用可穿戴监护仪后再插入ICM的30天/患者诊断成本进行了建模,从医疗保险和患者自付的角度来看。将类似的建模策略和成本分析应用于中风AF和PerDiem试验。
    在192名ESUS患者中,房颤检测随着监测时间的延长而增加:14天时为7.3%,30天的9.4%,中位数约6个月(189天)后为17.2%。成本模型预测,与可穿戴到ICM的策略相比,立即ICM导致每位患者的Medicare付款减少3683-4070美元,患者的自付费用减少1425-1503美元。在PERDIEM和STROKEAF试验中使用类似的建模,从付款人的角度来看,30天ELR至ICM策略的附加成本为$3786-$3946,从患者自付角度来看,为$1472-$1503.
    与可穿戴到ICM策略相比,在ESUS节省成本后立即使用ICM,由于短期可穿戴心脏监测的成本和低诊断率。
    UNASSIGNED: Detection of atrial fibrillation (AF) in patients with embolic stroke of undetermined source (ESUS) is challenging due to its paroxysmal nature. We sought to assess AF detection with an insertable cardiac monitor (ICM) and to perform cost analysis for various AF monitoring strategies post-ESUS We applied this cost analysis modeling to recently published Stroke AF and Per Diem trials.
    UNASSIGNED: Retrospective chart review was performed in consecutive hospitalized patients with ESUS who had ICM placed prior to discharge. Utilizing rate of ICM-detected AF and Medicare average payments, we modeled 30-day per-patient diagnostic costs of Immediate ICM insertion prior to discharge versus using a wearable monitor followed by ICM in patients with ESUS, from Medicare and patient out-of-pocket perspectives. Similar modeling strategy and cost analysis was applied to the Stroke AF and Per Diem trials.
    UNASSIGNED: In 192 ESUS patients, AF detection increased with length of monitoring: 7.3 % at 14 days, 9.4 % at 30 days, and 17.2 % after a median ~ 6 months (189 days). Cost modeling predicted that immediate ICM leads to $3683-$4070 lower Medicare payments per-patient and $1425-$1503 lower patient out-of-pocket costs compared to Wearable-to-ICM strategies. Using similar modeling in the PER DIEM and STROKE AF trials, the additive costs of the 30-day ELR to ICM strategy ranged from $3786-$3946 from a payer perspective and $1472-$1503 from a patient out-of-pocket perspective.
    UNASSIGNED: Use of ICM immediately after ESUS is cost-saving compared to Wearable-to-ICM strategies, due to the cost and low diagnostic yield of short-term wearable cardiac monitoring.
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  • 文章类型: Case Reports
    植入式环路记录仪(ILR)在马心脏病学中越来越多地用于在塌陷的情况下检测心律失常,表现不佳或监测心房颤动(AF)复发。然而迄今为止,ILR从未与马的远程监控功能一起使用,因此,只有当临床医生使用专用设备询问ILR时,才会发现心律失常,这可能会延迟诊断和干预。此病例报告描述了在复发性AF的马匹中使用具有远程监控功能的ILR。远程监控包括位于稳定的传输设备,允许每天将心律失常记录和功能消息传输到在线服务器,可供临床医生在没有专门设备的情况下进行评估。ILR在植入后约3个月检测到阵发性房颤发作。植入后七个月,在ILR错误分类为心动过缓的发作中出现持续性房颤,马退休了。本报告显示了远程监控马匹ILR的可行性和好处,同时也是目前马心电图解读算法的不足。
    Implantable loop recorders (ILRs) are increasingly used in equine cardiology to detect arrhythmias in the context of collapse, poor performance or monitoring for recurrence of atrial fibrillation (AF). However to date, the ILR has never been reported to be used with a remote monitoring functionality in horses, therefore the arrhythmia is only discovered when a clinician interrogates the ILR using dedicated equipment, which might delay diagnosis and intervention. This case report describes the use of an ILR with remote monitoring functionality in a horse with recurrent AF. The remote monitoring consisted of a transmission device located in the stable allowing daily transmission of arrhythmia recordings and functioning messages to an online server, available for the clinician to evaluate without specialised equipment. The ILR detected an episode of paroxysmal AF approximately three months after implantation. Seven months after implantation, initiation of persistent AF was seen on an episode misclassified by the ILR as bradycardia, and the horse was retired. This report shows the feasibility and benefits of remote monitoring for ILRs in horses, but also the shortcomings of current algorithms to interpret the equine electrocardiogram.
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  • 文章类型: Case Reports
    可插入心脏监护仪(ICM)是皮下植入的小型心电图,可在晕厥患者中检测到心律失常时自动记录心电图。如果ICM错过了严重的心律失常,它可能会延迟心律失常性晕厥的诊断,并使患者处于危险之中。在这里,我们描述了ICM患者未发现的心脏骤停病例。一名87岁晕厥男子入院。经过8天的监测,原因无法确定,植入了ICM.植入后九小时,患者出现心肺骤停.尽管体表心电图显示心室平坦线和纤颤,ICM记录失败。记录失败的原因被认为是ICM的R波振幅的波动和噪声过度感知。总之,尽管很少,ICM可能忽略危及生命的心律失常。即使在ICM未能检测到与症状相匹配的心律失常的情况下,完全排除心律失常的存在可能是不可行的。
    可插入心脏监测仪(ICM)用于诊断心律失常性晕厥。然而,极不经常,ICM可能无法记录危及生命的心律失常。由于诸如所记录的R波的低振幅和噪声之类的因素的不幸组合,可能发生无法捕获心律失常。即使在ICM未检测到符合症状的心律失常的情况下,完全排除心律失常的存在可能是不可行的.
    Insertable cardiac monitors (ICMs) are small electrocardiographs implanted subcutaneously to automatically record electrocardiograms when arrhythmia is detected in patients with syncope. If the ICM misses a significant arrhythmia, it may delay the diagnosis of arrhythmogenic syncope and put the patient at risk. Herein, we describe a case of undetected cardiac arrest in a patient with ICM. An 87-year-old man with syncope was admitted to the hospital. After 8 days of monitoring, the cause could not be determined, and an ICM was implanted. Nine hours after implantation, the patient experienced cardiopulmonary arrest. Despite a body surface electrocardiogram showing ventricular flatline and fibrillation, the ICM failed to record. The cause of failure to record was considered to be the fluctuation in the R-wave amplitude of the ICM and noise oversensing. In conclusion, albeit infrequently, ICMs might overlook life-threatening arrhythmias. Even in cases where the ICM fails to detect an arrhythmia matching the symptoms, it may not be feasible to entirely rule out the presence of arrhythmias.
    UNASSIGNED: Insertable cardiac monitors (ICMs) are used to diagnose arrhythmogenic syncope. However, extremely infrequently, ICM may fail to record life-threatening arrhythmias. Failure to capture arrhythmias can happen due to an unfortunate combination of factors such as a low amplitude of the recorded R wave and noise. Even in cases where the ICM does not detect an arrhythmia that matches the symptoms, it may not be feasible to completely exclude the presence of arrhythmias.
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