Abstract

Background: Recently introduced leadless cardiac pacemakers effectively overcome all lead-related limitations of conventional pacemaker systems. However, these devices only feature single-chamber pacing capability although dual-chamber pacing is highly desirable due to physiologic reasons. Implanting a leadless pacemaker into the right atrium and a second one into the right ventricle would enable leadless dual chamber pacing but requires wireless communication for device synchronization. Conventional radiofrequency telemetry is not suitable for this purpose due to its high energy consumption. Thus, an ultra-low power wireless communication method is crucial to preserve the pacemaker’s longevity (modern pacemakers consume only 5-10 µW of power). Purpose: Dual-chamber pacing capability for leadless pacemakers. Methods: Two pacemakers were developed that feature bidirectional wireless communication. Intra-body communication was implemented as communication method. This method uses the electrical conductivity of blood and tissue: the data from one device is modulated and applied as a small alternating current signal to the myocardial tissue and blood via electrodes. The signal is registered almost simultaneously by the other device. The communication frequency is ~100 kHz and therefore does not influence the heart’s functioning. The pacemakers feature an electrode pair for bipolar stimulation, the communication is performed over the same electrodes. The pacemakers were tested in an acute in-vivo trial on a 60 kg domestic pig. One pacemaker paced the right atrium, the other one the right ventricle. The atrial pacemaker served as master device and dictated the actual pacing rate, the atrioventricular (AV) pacing delay and pacing activity to the ventricular pacemaker in a wireless manner. Results: The pacemakers successfully performed dual-chamber pacing (D00) with wireless intra-body communication using the myocardium and blood as transmission path. No interference with the cardiac function was observed. The ECG sequence in Figure 1 shows the onset of leadless dual-chamber pacing recorded during the in-vivo trial: the atrial (A) and ventricular (V) pacing spikes are indicated by the arrows. The pacing rate was set to 120 bpm and the AV delay to 50 ms. Less than 1 µW average power was applied to the tissue for wireless communication. Conclusion: To our knowledge, this is the first report on successful leadless dual-chamber pacing during an in-vivo trial. Intra-body communication was integrated into a pacemaker system and has proven to be a promising, power-efficient wireless communication method for leadless dual-chamber pacemakers.

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