First-in-man clinical implantation and acute pacing performance of a novel subxiphoidal pacemaker system.

Abstract

Intravascular cardiac pacemakers are an established therapy for bradycardic indications. Recently, a new class of leadless pacemakers have mitigated some of the complications related to pacemaker leads. In this study, we evaluate the implantation and performance of a novel extravascular technology that delivers epicardial pacing through a subxiphoidal approach. Fifteen patients undergoing non-emergent open-heart surgery were enrolled. A midline incision was made just below the xiphoid process, and substernal tunneling was used to create a pocket for the device and to access the anterior pericardium over the right ventricle. The test device (Calyan Technologies, Oakdale, MN) was temporarily inserted underneath the ribcage and clipped to the xiphoid process. The sensing and pacing electrode (FlexArm) was positioned on the anterior pericardium. Ventricular sensing and pacing capture thresholds were measured. The test device was successfully implanted in all 15 patients. There were no device or procedure-related adverse events. The first five implanted patients had no pacing capture at maximum stimulation intensity. Design changes were made to the device, including different electrode size and shape, and successful ventricular capture was achieved in 9 of the subsequent 10 patients. In these patients, pacing threshold was 3.8 ± 1.6mA with a pulse width of 0.5 ms. All devices were successfully explanted at the end of the procedure. In a first-in-human experience with a novel extravascular pacemaker, this study demonstrated the feasibility of pericardial ventricular pacing via a subxiphoidal approach. Further chronic studies are required to evaluate the safety and performance of this novel pacing technology.