Rav Acha Moshe, Soifer Elina, Hasin Tal
Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Hebrew University, Jerusalem 910000, Israel.
Vectorious Medical Technologies, Tel Aviv 610000, Israel.
Micromachines (Basel). 2020 Sep 29;11(10):902. doi: 10.3390/mi11100902.
Advancement in the miniaturization of high-density power sources, electronic circuits, and communication technologies enabled the construction of miniaturized electronic devices, implanted directly in the heart. These include pacing devices to prevent low heart rates or terminate heart rhythm abnormalities ('arrhythmias'), long-term rhythm monitoring devices for arrhythmia detection in unexplained syncope cases, and heart failure (HF) hemodynamic monitoring devices, enabling the real-time monitoring of cardiac pressures to detect and alert for early fluid overload. These devices were shown to prevent HF hospitalizations and improve HF patients' life quality. Pacing devices include permanent pacemakers (PPM) that maintain normal heart rates, defibrillators that are capable of fast detection and the termination of life-threatening arrhythmias, and cardiac re-synchronization devices that improve cardiac function and the survival of HF patients. Traditionally, these devices are implanted via the venous system ('endovascular') using conductors ('endovascular leads/electrodes') that connect the subcutaneous device battery to the appropriate cardiac chamber. These leads are a potential source of multiple problems, including lead-failure and systemic infection resulting from the lifelong exposure of these leads to bacteria within the venous system. One of the important cardiac innovations in the last decade was the development of a leadless PPM functioning without venous leads, thus circumventing most endovascular PPM-related problems. Leadless PPM's consist of a single device, including a miniaturized power source, electronic chips, and fixating mechanism, directly implanted into the cardiac muscle. Only rare device-related problems and almost no systemic infections occur with these devices. Current leadless PPM's sense and pace only the ventricle. However, a novel leadless device that is capable of sensing both atrium and ventricle was recently FDA approved and miniaturized devices that are designed to synchronize right and left ventricles, using novel intra-body inner-device communication technologies, are under final experiments. This review will cover these novel implantable miniaturized cardiac devices and the basic algorithms and technologies that underlie their development. Advancement in the miniaturization of high-density power sources, electronic circuits, and communication technologies enabled the construction of miniaturized electronic devices, implanted directly in the heart. These include pacing devices to prevent low heart rates or terminate heart rhythm abnormalities ('arrhythmias'), long-term rhythm monitoring devices for arrhythmia detection in unexplained syncope cases, and heart failure (HF) hemodynamic monitoring devices, enabling the real-time monitoring of cardiac pressures to detect and alert early fluid overload. These devices were shown to prevent HF hospitalizations and improve HF patients' life quality. Pacing devices include permanent pacemakers (PPM) that maintain normal heart rates, defibrillators that are capable of fast detection and termination of life-threatening arrhythmias, and cardiac re-synchronization devices that improve cardiac function and survival of HF patients. Traditionally, these devices are implanted via the venous system ('endovascular') using conductors ('endovascular leads/electrodes') that connect the subcutaneous device battery to the appropriate cardiac chamber. These leads are a potential source of multiple problems, including lead-failure and systemic infection that result from the lifelong exposure of these leads to bacteria within the venous system. The development of a leadless PPM functioning without venous leads was one of the important cardiac innovations in the last decade, thus circumventing most endovascular PPM-related problems. Leadless PPM's consist of a single device, including a miniaturized power source, electronic chips, and fixating mechanism, implanted directly into the cardiac muscle. Only rare device-related problems and almost no systemic infections occur with these devices. Current leadless PPM's sense and pace only the ventricle. However, a novel leadless device that is capable of sensing both atrium and ventricle was recently FDA approved and miniaturized devices designed to synchronize right and left ventricles, using novel intra-body inner-device communication technologies, are under final experiments. This review will cover these novel implantable miniaturized cardiac devices and the basic algorithms and technologies that underlie their development.
高密度电源、电子电路和通信技术的小型化取得进展,使得能够构建直接植入心脏的小型电子设备。这些设备包括用于预防心率过低或终止心律异常(“心律失常”)的起搏装置、用于在不明原因晕厥病例中检测心律失常的长期心律监测装置以及心力衰竭(HF)血流动力学监测装置,后者能够实时监测心脏压力以检测并警示早期液体过载。这些设备已被证明可预防心力衰竭住院,并改善心力衰竭患者的生活质量。起搏装置包括维持正常心率的永久性起搏器(PPM)、能够快速检测并终止危及生命的心律失常的除颤器以及改善心脏功能和心力衰竭患者生存率的心脏再同步装置。传统上,这些设备通过静脉系统(“血管内”)植入,使用将皮下设备电池连接到适当心脏腔室的导体(“血管内导线/电极”)。这些导线是多种问题的潜在来源,包括导线故障以及由于这些导线长期暴露于静脉系统内的细菌而导致的全身感染。过去十年中重要的心脏创新之一是开发了无需静脉导线的无导线PPM,从而规避了大多数与血管内PPM相关的问题。无导线PPM由单个装置组成,包括小型化电源、电子芯片和固定机构,直接植入心肌。这些装置仅出现罕见的与设备相关的问题,几乎不会发生全身感染。目前的无导线PPM仅能感知和起搏心室。然而,一种能够同时感知心房和心室的新型无导线装置最近已获得美国食品药品监督管理局(FDA)批准,并且使用新型体内设备内通信技术设计用于使左右心室同步的小型化装置正在进行最终实验。本综述将涵盖这些新型可植入小型化心脏装置以及作为其发展基础的基本算法和技术。高密度电源、电子电路和通信技术的小型化取得进展,使得能够构建直接植入心脏的小型电子设备。这些设备包括用于预防心率过低或终止心律异常("心律失常")的起搏装置、用于在不明原因晕厥病例中检测心律失常的长期心律监测装置以及心力衰竭(HF)血流动力学监测装置,后者能够实时监测心脏压力以检测并警示早期液体过载。这些设备已被证明可预防心力衰竭住院,并改善心力衰竭患者的生活质量。起搏装置包括维持正常心率的永久性起搏器(PPM)、能够快速检测并终止危及生命的心律失常的除颤器以及改善心脏功能和心力衰竭患者生存率的心脏再同步装置。传统上,这些设备通过静脉系统("血管内")植入,使用将皮下设备电池连接到适当心脏腔室的导体("血管内导线/电极")。这些导线是多种问题的潜在来源,包括导线故障以及由于这些导线长期暴露于静脉系统内的细菌而导致的全身感染。过去十年中重要的心脏创新之一是开发了无需静脉导线的无导线PPM,从而规避了大多数与血管内PPM相关的问题。无导线PPM由单个装置组成,包括小型化电源、电子芯片和固定机构,直接植入心肌。这些装置仅出现罕见的与设备相关的问题,几乎不会发生全身感染。目前的无导线PPM仅能感知和起搏心室。然而,一种能够同时感知心房和心室的新型无导线装置最近已获得美国食品药品监督管理局(FDA)批准,并且使用新型体内设备内通信技术设计用于使左右心室同步的小型化装置正在进行最终实验。本综述将涵盖这些新型可植入小型化心脏装置以及作为其发展基础的基本算法和技术。