Modulation Scheme Analysis for Low-Power Leadless Pacemaker Synchronization Based on Conductive Intracardiac Communication.

Conductive intracardiac communication (CIC) has been demonstrated as a promising concept for the synchronization of multi-chamber leadless cardiac pacemakers (LLPMs). To meet the 2-5 µW power budget of a LLPM, highly specialized CIC-transceivers, which make optimal use of the cardiac communication channel, need to be developed. However, a detailed investigation of the optimal communication parameters for CIC-based LLPM synchronization is missing so far. This work analyzes the intracardiac communication performance of two low-power modulation techniques, namely On-Off-Keying (OOK) and Manchester-encoded baseband transmission (BB-MAN), as a function of the transmitted bit-energy. The bit error rate (BER) of a prototype dual-chamber LLPM was determined both in simulation and in-vitro experiments on porcine hearts. A BER of 1e -4 was achieved with a median bit-energy in the range of 3-16 pJ (interquartile range: 4-15 pJ) for data rates from 75-500 kbps and a receiver input noise density of 7 nV/ √{Hz}. Both modulation schemes showed comparable performance, with BB-MAN having a slight bit-energy advantage (1-2 dB at 150-500 kbps) under equalized transceiver characteristics. This study demonstrates that reliable CIC-based LLPM synchronization is feasible at transmitted power levels 10 nW under realistic channel conditions and receiver noise performance. Therefore, modulation techniques such, as BB-MAN or OOK, are preferable over recently proposed alternatives, such as pulse position modulation or conductive impulse signaling, since they can be realized with fewer hardware resources and smaller bandwidth requirements. Ultimately, a baseband communication approach might be favored over OOK, due to the more efficient cardiac signal transmission and reduced transceiver complexity.

Leadless cardiac resynchronization therapy: An in vivo proof-of-concept study of wireless pacemaker synchronization.

BACKGROUND: Contemporary leadless pacemakers (PMs) only feature single-chamber ventricular pacing. However, the majority of patients require dual-chamber pacing or cardiac resynchronization therapy (CRT). Several leadless PMs implanted in the same heart would make that possible if they were able to synchronize their activity in an efficient, safe, and reliable way. Thus, a dedicated ultra-low-power wireless communication method for PM synchronization is required. OBJECTIVE: The purpose of this study was to develop a leadless CRT system and to evaluate its function in vivo. METHODS: Device synchronization was implemented using conductive intracardiac communication (CIC). Communication frequencies were optimized for intracardiac device-device communication. Energy consumption, safety, and reliability of the leadless PM system were tested in animal experiments. RESULTS: We successfully performed CRT pacing with 3 independent devices synchronizing their action using CIC. No arrhythmias were induced by the novel communication technique. Ninety-eight percent of all communication impulses were transmitted successfully. The optimal communication frequency was around 1 MHz, with a corresponding transmitted power of only 0.3 µW at a heart rate of 60 bpm. CONCLUSION: Leadless PMs are able to synchronize their action using CIC and may overcome the key limitation of contemporary leadless PMs.

An Intracardiac Flow Based Electromagnetic Energy Harvesting Mechanism for Cardiac Pacing.

Contemporary cardiac implantable electronic devices such as pacemakers or event recorders are powered by primary batteries. Device replacement due to battery depletion may cause complications and is costly. The goal of energy harvesting devices is to power the implant with energy from intracorporeal power sources such as vibrations and blood flow. By replacing primary batteries with energy harvesters, reinterventions can be avoided and the size of the total device might be reduced. This paper introduces a device with a lever, which is deflected by the blood stream within the right ventricular outflow tract (RVOT), an attractive site for cardiac pacing. The resulting torque is converted to electrical energy by an electromagnetic mechanism. The blood flow harvester weighs 6.4 g and has a volume of 2 cm3, making the harvester small enough for catheter implantation. It was tested in an experimental setup mimicking flow conditions in the RVOT. The blood flow harvester generated a mean power of 14.39 ± 8.38 µW at 60 bpm (1 Hz) and up to 82.64 ± 17.14 µW at 200 bpm (3.33 Hz) during bench experiments at 1 m/s peak flow velocity. Therefore, it presents a viable alternative to power batteryless and leadless cardiac pacemakers.

Fundamental Characterization of Conductive Intracardiac Communication for Leadless Multisite Pacemaker Systems.

OBJECTIVE: A new generation of leadless cardiac pacemakers effectively overcomes the main limitations of conventional devices, but only offer single-chamber pacing, although dual-chamber or multisite pacing is highly desirable for most patients. The combination of several leadless pacemakers could facilitate a leadless multisite pacemaker but requires an energy-efficient wireless communication for device synchronization. This study investigates the characteristics of conductive intracardiac communication between leadless pacemakers to provide a basis for future designs of leadless multisite pacemaker systems. METHODS: Signal propagation and impedance behavior of blood and heart tissue were examined by in vitro and in vivo measurements on domestic pig hearts and by finite-element simulations in the frequency range of 1 kHz to 1 MHz. RESULTS: A better signal transmission was obtained for frequencies higher than 10 kHz. The influence of a variety of practical parameters on signal transmission could be identified. A larger distance between pacemakers increases signal attenuation. A better signal transmission is obtained through larger inter-electrode distances and a larger electrode surface area. Furthermore, the influence of pacemaker encapsulation and relative device orientation was assessed. CONCLUSION: This study suggests that conductive intracardiac communication is well suited to be incorporated in leadless pacemakers. It potentially offers very low power consumption using low communication frequencies. SIGNIFICANCE: The presented technique enables highly desired leadless multisite pacing in near future.

Endocardial Energy Harvesting by Electromagnetic Induction.

OBJECTIVE: cardiac pacemakers require regular medical follow-ups to ensure proper functioning. However, device replacements due to battery depletion are common and account for ∼25% of all implantation procedures. Furthermore, conventional pacemakers require pacemaker leads which are prone to fractures, dislocations or isolation defects. The ensuing surgical interventions increase risks for the patients and costs that need to be avoided. METHODS: in this study, we present a method to harvest energy from endocardial heart motions. We developed a novel generator, which converts the heart's mechanical into electrical energy by electromagnetic induction. A mathematical model has been introduced to identify design parameters strongly related to the energy conversion efficiency of heart motions and fit the geometrical constraints for a miniaturized transcatheter deployable device. The implemented final design was tested on the bench and in vivo. RESULTS: the mathematical model proved an accurate method to estimate the harvested energy. For three previously recorded heart motions, the model predicted a mean output power of 14.5, 41.9, and 16.9 µW. During an animal experiment, the implanted device harvested a mean output power of 0.78 and 1.7 µW at a heart rate of 84 and 160 bpm, respectively. CONCLUSION: harvesting kinetic energy from endocardial motions seems feasible. Implanted at an energetically favorable location, such systems might become a welcome alternative to extend the lifetime of cardiac implantable electronic device. SIGNIFICANCE: the presented endocardial energy harvesting concept has the potential to turn pacemakers into battery- and leadless systems and thereby eliminate two major drawbacks of contemporary systems.

Leadless Dual-Chamber Pacing: A Novel Communication Method for Wireless Pacemaker Synchronization.

Contemporary leadless pacemakers only feature single-chamber pacing capability. This study presents a prototype of a leadless dual-chamber pacemaker. Highly energy-efficient intrabody communication was implemented for wireless pacemaker synchronization. Optimal communication parameters were obtained by in vivo and ex vivo measurements in the heart and blood. The prototype successfully performed dual-chamber pacing in vivo. The presented wireless communication method may in the future also enable leadless cardiac resynchronization therapy.

Towards Batteryless Cardiac Implantable Electronic Devices-The Swiss Way.

Energy harvesting devices are widely discussed as an alternative power source for todays active implantable medical devices. Repeated battery replacement procedures can be avoided by extending the implants life span, which is the goal of energy harvesting concepts. This reduces the risk of complications for the patient and may even reduce device size. The continuous and powerful contractions of a human heart ideally qualify as a battery substitute. In particular, devices in close proximity to the heart such as pacemakers, defibrillators or bio signal (ECG) recorders would benefit from this alternative energy source. The clockwork of an automatic wristwatch was used to transform the hearts kinetic energy into electrical energy. In order to qualify as a continuous energy supply for the consuming device, the mechanism needs to demonstrate its harvesting capability under various conditions. Several in-vivo recorded heart motions were used as input of a mathematical model to optimize the clockworks original conversion efficiency with respect to myocardial contractions. The resulting design was implemented and tested during in-vitro and in-vivo experiments, which demonstrated the superior sensitivity of the new design for all tested heart motions.