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A review of the extravascular implantable cardioverter-defibrillator system: technology, development, clinical outcomes, and global experience. 血管外植入式心律转复除颤器系统综述:技术、发展、临床结果和全球经验。
Q4 Medicine Pub Date : 2025-12-01 Epub Date: 2025-11-11 DOI: 10.1007/s00399-025-01121-6
Christopher Shepley, Stephen Allen, Vibeke Andersen

This article provides a comprehensive overview of the AuroraTM extravascular implantable cardioverter-defibrillator (EV-ICD) system for the treatment of potentially fatal ventricular arrhythmias. It details its hardware design, including the device and the lead, and examines software features such as antitachycardia pacing (ATP) and the suite of enhanced discriminators specifically designed to address potential sensing challenges with an anterior mediastinal lead. The report includes clinical data from the primary acute human studies, the Pivotal EV-ICD study, and the updated Enlighten Post-Approval Registry, highlighting safety and efficacy. The EV-ICD system represents a step toward minimizing transvenous lead-related complications while maintaining effective arrhythmia detection and therapy, offering a promising alternative for a broad spectrum of patients at risk of sudden cardiac death.

本文全面介绍了用于治疗潜在致命性室性心律失常的AuroraTM血管外植入式心律转复除颤器(EV-ICD)系统。详细介绍了其硬件设计,包括设备和导联,并检查了软件功能,如抗心动过速起搏(ATP)和专门设计用于解决前纵隔导联潜在传感挑战的增强型鉴别器套件。该报告包括来自主要急性人类研究、Pivotal EV-ICD研究和最新的enlightenment批准后注册的临床数据,强调了安全性和有效性。EV-ICD系统在最大限度地减少经静脉铅相关并发症的同时,保持有效的心律失常检测和治疗,为广泛的有心源性猝死风险的患者提供了一个有希望的替代方案。
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引用次数: 0
[ICD electrode implantation for left bundle branch area pacing]. [ICD电极植入左束支区起搏]。
Q4 Medicine Pub Date : 2025-12-01 Epub Date: 2025-11-11 DOI: 10.1007/s00399-025-01117-2
G Imnadze, K Harutyunyan, T Eitz, T Fink, Y Bocchini, M Didenko, E Akkaya, P Sommer

We are entering a new era of physiological pacing with left bundle branch area pacing (LBBAP), which is becoming an increasingly common in clinical routine. LBBAP has clear advantages over right ventricular (RV) and biventricular (BVP) pacing. Another option is to combine LBBAP and BVP, known as left bundle branch optimized (LOT) cardiac resynchronization therapy (CRT), which shortens the QRS duration more effectively than LBBAP and BVP alone. Implanting LOT CRT in patients with an ICD indication is particularly complicated. In this case, four leads are generally required. Additionally, the ICD device must have DF1/IS1 ports. Placing the ICD lead in the LBBAP position helps to eliminate the aforementioned problem and enables LOT CRTD to be performed with three leads. Furthermore, with an optimally stimulated QRS complex, CRTD therapy can be performed using two leads and a dual-chamber ICD device. With a VDD ICD lead, this therapy can be performed using just one lead and a VVI ICD device. To date, only a few publications have appeared on the implantation of ICD leads in the LBBAP position. Experience with the permanent implantation of standard ICD leads in the LBBAP position showed high implantation success rates and acceptable procedure and fluoroscopy durations. Most cases showed optimal ECG findings, such as shortened QRS duration, V6‑R wave peak time (V6RWPT) and/or V6-V1 interpeak interval. Defibrillation testing was successful in all but one of the patients published to date. To further develop this promising therapy, we need sheaths that have been developed and tested for this purpose (made from new materials and with different curves), as well as leads with fixed helixes and true bipolar sensing (to avoid atrial oversensing). Ideally, the new leads should have a narrow diameter, and the coils should be short yet sufficiently dimensioned. A VDD variant could also be an interesting option. Current ICD devices also need to be modernized to include the possibility of unipolar stimulation. From a clinical perspective, we should observe more patients over a longer period of time and focus on critical points.

左束支区起搏(LBBAP)正在进入一个新的生理起搏时代,在临床常规中越来越普遍。LBBAP比右心室(RV)和双心室(BVP)起搏有明显的优势。另一种选择是联合LBBAP和BVP,称为左束分支优化(LOT)心脏再同步化治疗(CRT),它比单独LBBAP和BVP更有效地缩短QRS持续时间。在有ICD指征的患者中植入LOT CRT尤其复杂。在这种情况下,通常需要四根引线。此外,ICD设备必须具有DF1/IS1端口。将ICD引线置于LBBAP位置有助于消除上述问题,并使LOT CRTD能够使用三引线进行。此外,有了最佳刺激的QRS复合物,CRTD治疗可以使用双导联和双腔ICD装置进行。使用VDD ICD导联,这种治疗可以只使用一根导联和一个VVI ICD装置进行。到目前为止,关于在LBBAP位置植入ICD引线的报道很少。在LBBAP位置永久植入标准ICD引线的经验表明,植入成功率高,操作程序和透视时间可接受。大多数病例的心电图表现最佳,如QRS持续时间缩短,V6- R波峰值时间(V6RWPT)和/或V6- v1峰间间隔。除一例患者外,除颤试验均成功。为了进一步发展这种有前途的疗法,我们需要为此目的开发和测试的护套(由新材料制成,具有不同的曲线),以及具有固定螺旋和真正的双极感应的引线(以避免心房过度感应)。理想情况下,新的引线应该有一个狭窄的直径,线圈应该短但足够的尺寸。VDD变体也是一个有趣的选择。目前的ICD设备也需要现代化,以包括单极增产的可能性。从临床角度来看,我们应该观察更多的患者,观察更长的时间,关注关键点。
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引用次数: 0
[Update device therapy]. [更新设备疗法]。
Q4 Medicine Pub Date : 2025-12-01 Epub Date: 2025-11-10 DOI: 10.1007/s00399-025-01123-4
Carsten W Israel, Christian Butter
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引用次数: 0
Cardiac contractility modulation: an update. 心脏收缩性调节:最新进展。
Q4 Medicine Pub Date : 2025-12-01 Epub Date: 2025-10-30 DOI: 10.1007/s00399-025-01118-1
Jürgen Kuschyk, Javed Butler, Timothy Fendler, Niraj Varma

Cardiac contractility modulation (CCM) represents an innovative device-based therapy for patients with heart failure (HF) who remain symptomatic despite optimal guideline-directed medical therapy (GDMT). It delivers biphasic, non-excitatory electrical signals during the absolute refractory period, enhancing myocardial contractility and relaxation. It improves calcium cycling and facilitates diastolic calcium reuptake. Therapeutic effects from key clinical studies and real-world experiences in HF with reduced ejection fraction (HFrEF) are reviewed and the safety profile is examined. The design and objectives of the ongoing AIM HIGHer clinical trial in HF patients with mildly reduced (HFmrEF) or preserved (HFpEF) ejection fraction are summarized. The design of the next-generation device combining CCM with defibrillator functionality (CCM-D) is presented. The objectives of the ongoing clinical study with CCM‑D, INTEGRA‑D, are discussed in detail.

心脏收缩性调节(CCM)是一种创新的基于设备的治疗心力衰竭(HF)患者,尽管有最佳的指导药物治疗(GDMT),但仍有症状。它在绝对不应期传递双相非兴奋性电信号,增强心肌收缩性和舒张性。它能改善钙循环,促进舒张期钙的再吸收。本文回顾了主要临床研究和实际经验对心力衰竭伴射血分数降低(HFrEF)的治疗效果,并检查了安全性。本文总结了正在进行的AIM HIGHer临床试验在射血分数轻度降低(HFmrEF)或保持(HFpEF)的HF患者中的设计和目标。介绍了结合CCM和除颤器功能(CCM- d)的下一代设备的设计。正在进行的CCM - D (INTEGRA - D)临床研究的目标进行了详细讨论。
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引用次数: 0
[Comment on the European Society of Cardiology (ESC) Clinical Consensus Statement on the indication for conduction system pacing]. [对欧洲心脏病学会(ESC)关于传导系统起搏适应症的临床共识声明的评论]。
Q4 Medicine Pub Date : 2025-12-01 Epub Date: 2025-09-22 DOI: 10.1007/s00399-025-01106-5
Carsten W Israel

The Clinical Consensus Statement of the European Society of Cardiology (ESC) updates expert opinions on conduction system pacing (CSP). It does not represent a focused update of the ESC pacemaker guidelines of 2021 since that would require the publication of new results of randomized trials. But an official statement became necessary because at the time of preparing the ESC guidelines on pacing and cardiac resynchronization, only very limited data on left bundle branch pacing were available rendering this form of pacing almost completely ignored in the recommendations. Second, daily implantation practice has changed substantially worldwide since the advent of CSP. Third, basically all international heart rhythm societies apart from the ESC have published new guidelines on the use CSP in 2023 which differ significantly from the European recommendations. The Clinical Consensus Statement on CSP of the ESC differs from the 2021 ESC guidelines only in nuances since ESC statutes do not allow that an ESC expert opinion paper substantially contradict current ESC guidelines. However, it is important for daily practice that CSP be recommended as a potential alternative to right ventricular pacing in patients with good left ventricular function or rare ventricular pacing is expected. Similarly, CSP is recommended as an alternative to biventricular pacing (BiVP) in reduced left ventricular function, in context with ablation of the atrioventricular node, in heart failure with wide QRS complex and for upgrading in pacing-induced cardiomyopathy. Finally, CSP is recommended in nonresponders to BiVP.

欧洲心脏病学会(ESC)的临床共识声明更新了传导系统起搏(CSP)的专家意见。它并不代表2021年ESC起搏器指南的重点更新,因为这需要发表随机试验的新结果。但是官方声明是必要的,因为在准备ESC关于起搏和心脏再同步的指南时,只有非常有限的关于左束支起搏的数据,使得这种起搏形式在建议中几乎完全被忽略。其次,自CSP出现以来,全球范围内的日常植入实践发生了重大变化。第三,除了ESC之外,基本上所有国际心律学会都在2023年发布了关于使用CSP的新指南,这与欧洲的建议有很大不同。关于ESC CSP的临床共识声明与2021年ESC指南仅在细微差别上有所不同,因为ESC法规不允许ESC专家意见文件与当前ESC指南存在实质性矛盾。然而,在日常实践中,推荐CSP作为左心室功能良好或罕见心室起搏的患者右心室起搏的潜在替代方案是很重要的。同样,在左心室功能减退、房室结消融、伴有宽QRS复合物的心力衰竭和起搏性心肌病升级时,CSP被推荐作为双室起搏(BiVP)的替代方案。最后,推荐对BiVP无反应的患者使用CSP。
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引用次数: 0
Erratum zu: Kabellose Herzschrittmacher. “无线心脏起搏器”。
Q4 Medicine Pub Date : 2025-11-17 DOI: 10.1007/s00399-025-01125-2
Arian Sultan, David Duncker, Henning Jansen, Micaela Ebert, Victoria Johnson, Till Althoff, Tillmann Maurer, Sascha Rolf, Christian Heeger, Heidi Estner, Andreas Rillig, Philipp Sommer, Leon Iden, K R Julian Chun, Sonia Busch, Roland Tilz, Tillmann Dahme, Daniel Steven
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引用次数: 0
[What to do with device-detected atrial fibrillation? : Executive summary of the position paper of the German Society of Cardiology]. 如何处理设备检测到的心房颤动?[德国心脏病学会立场文件的执行摘要]。
Q4 Medicine Pub Date : 2025-10-29 DOI: 10.1007/s00399-025-01112-7
Tobias Tönnis, Nina Becher, Ralf Birkemeyer, David Duncker, Lars Eckardt, Klaus Gröschel, Dominik Linz, Christian Meyer, Florian Straube, Arian Sultan, Rolf Wachter, Maura Zylla, Paulus Kirchhof

Device-detected atrial fibrillation (DDAF), like clinical atrial fibrillation (AF), is also associated with an increased risk of thromboembolic events, although the risk appears to be significantly lower. The efficacy and safety of oral anticoagulation in DDAF were investigated in two large randomized trials (NOAH-AFNET 6 and ARTESIA [13, 19]). They showed a low rate of ischemic strokes without anticoagulation (about 1% per year). This risk can still be reduced by therapeutic anticoagulation, but the risk of severe bleeding increases. In the recently published position paper [36] of the German Society of Cardiology, the current study situation was presented and expert recommendations were given on how to deal with DDAF.

器械检测心房颤动(DDAF)与临床心房颤动(AF)一样,也与血栓栓塞事件的风险增加相关,尽管风险似乎明显较低。两项大型随机试验(NOAH-AFNET 6和ARTESIA[13,19])研究了口服抗凝治疗DDAF的疗效和安全性。结果显示,没有抗凝治疗的缺血性中风发生率很低(每年约1%)。这种风险仍然可以通过抗凝治疗来降低,但严重出血的风险会增加。在最近发表的德国心脏病学会(German Society of Cardiology)立场文件[36]中,介绍了目前的研究现状,并就如何应对DDAF给出了专家建议。
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引用次数: 0
[Vascular closure following electrophysiological procedures-a practical guide]. [电生理手术后血管闭合-实用指南]。
Q4 Medicine Pub Date : 2025-10-06 DOI: 10.1007/s00399-025-01108-3
Christian-Hendrik Heeger, Henning Rolfes

The proposed introduction of outpatient electrophysiological procedures challenges physicians with the task of safely discharging patients after only a few hours of monitoring. Despite the widely established use of ultrasound-guided vascular access in many centers, access-site complications remain the most common complications associated with electrophysiological interventions. Modern vascular closure devices have made postprocedural care safer and more comfortable. Nevertheless, the traditional Z‑suture continues to play an important role, particularly in cases of individual anatomical challenges or as a fallback option in the event of device failure. The choice of the closure method should always be made on an individual basis, taking into account vascular access, patient safety, available resources, and physician expertise. This review article focuses on techniques and systems for the periprocedural management of vascular access in electrophysiology.

建议引入门诊电生理程序,挑战医生的任务,安全出院患者后,只有几个小时的监测。尽管超声引导血管通路在许多中心得到了广泛的应用,但通路部位并发症仍然是与电生理干预相关的最常见并发症。现代血管闭合装置使术后护理更安全、更舒适。尽管如此,传统的Z形缝线仍然发挥着重要作用,特别是在个体解剖困难的情况下,或者在设备发生故障时作为备选方案。闭合方法的选择应始终以个人为基础,考虑血管通路、患者安全、可用资源和医生专业知识。本文综述了电生理学血管通路围手术期管理的技术和系统。
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引用次数: 0
[Modern WPW-syndrome treatment: from ECG via double-check-mapping to ablation]. 【现代www综合征的治疗:从心电图双检测到消融】。
Q4 Medicine Pub Date : 2025-09-01 Epub Date: 2025-07-24 DOI: 10.1007/s00399-025-01093-7
Harilaos Bogossian, Nana-Yaw Bimpong-Buta, Sebastian Robl, Konstantinos Iliodromitis
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引用次数: 0
Management of channelopathies in children. 小儿经络病的治疗。
Q4 Medicine Pub Date : 2025-09-01 Epub Date: 2025-08-05 DOI: 10.1007/s00399-025-01098-2
Ulrich Krause

Cardiac channelopathies are a group of hereditary diseases that expose affected children and adolescents to an increased risk of syncope and sudden cardiac death (SCD) due to malignant ventricular tachyarrhythmias. Although cardiac channelopathies are rare, with an estimated prevalence of 1:2000-1:10,000, early recognition in order to start treatment and prevent SCD is warranted. The following article provides an overview of current recommendations and facts on the diagnosis and treatment of cardiac channelopathies in children and adolescents. The most commonly encountered cardiac channelopathies during childhood and adolescence include long QT syndrome (LQTS), catecholaminergic polymorphic ventricular tachycardia (CPVT), Brugada syndrome (BrS) and short QT syndrome (SQTS). While subjects with LQTS and CPVT commonly respond well to β‑blocker medication, and flecainide is an additional option in patients with CPVT, no such highly effective drug therapy exists for the treatment of patients with BrS or SQTS. Left cardiac sympathetic denervation is an additional treatment option in subjects with LQTS or CPVT. Implantable cardioverter-defibrillator implantation is indicated in patients with channelopathies and life-threatening ventricular tachyarrhythmias despite adequate antiarrhythmic medication.

心脏通道病变是一组遗传性疾病,使受影响的儿童和青少年因恶性室性心动过速导致晕厥和心源性猝死(SCD)的风险增加。虽然心脏通道病变是罕见的,估计患病率为1:2000-1:10 000,早期识别以开始治疗和预防SCD是有必要的。以下文章概述了目前关于儿童和青少年心脏通道病变的诊断和治疗的建议和事实。儿童期和青春期最常见的心脏通道病变包括长QT综合征(LQTS)、儿茶酚胺能多形性室性心动过速(CPVT)、Brugada综合征(BrS)和短QT综合征(SQTS)。虽然LQTS和CPVT患者通常对β受体阻滞剂药物反应良好,并且flecainide是CPVT患者的额外选择,但BrS或SQTS患者的治疗还没有这种高效的药物治疗方法。左心交感神经去支配是LQTS或CPVT患者的额外治疗选择。植入式心律转复除颤器植入术适用于有通道病变和危及生命的室性心动过速的患者,尽管有足够的抗心律失常药物。
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引用次数: 0
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Herzschrittmachertherapie und Elektrophysiologie
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