Leadless epicardial pacing at the left ventricular apex: an animal study

Abstract

Aims State-of-the-art pacemaker implantation technique in infants and small children consists of pace/sense electrodes attached to the epicardium and a pulse generator in the abdominal wall with a significant rate of dysfunction during growth, mostly attributable to lead failure. In order to overcome lead-related problems, feasibility of epicardial implantation of a leadless pacemaker at the left ventricular apex in a growing animal model was studied. Methods and results Ten lambs (median body weight 26.8 kg) underwent epicardial implantation of a Micra transcatheter pacing system (TPS) pacemaker (Medtronic Inc., Minneapolis, USA). Using a subxyphoid access, the Micra was introduced through a short, thick-walled tube to increase tissue contact and to prevent tilting from the epicardial surface. The Micra's proprietary delivery system was firmly pressed against the heart, while the Micra was pushed forward out of the sheath allowing the tines to stick into the left ventricular apical epimyocardium. Pacemakers were programmed to VVI 30/min mode. Pacemaker function and integrity was followed for 4 months after implantation. After implantation, median intrinsic R-wave amplitude was 5 mV [interquartile range (IQR) 2.8–7.5], and median pacing impedance was 2235 Ω (IQR 1725–2500), while the median pacing threshold was 2.13 V (IQR 1.25–2.9) at 0.24 ms. During follow-up, 6/10 animals had a significant increase in pacing threshold with loss of capture at maximum output at 0.24 ms in 2/10 animals. After 4 months, median R-wave amplitude had dropped to 2.25 mV (IQR 1.2–3.6), median pacing impedance had decreased to 595 Ω (IQR 575–645), and median pacing threshold had increased to 3.3 V (IQR 1.8–4.5) at 0.24 ms. Explantation of one device revealed deep penetration of the Micra device into the myocardium. Conclusion Short-term results after epicardial implantation of the Micra TPS at the left ventricular apex in lambs were satisfying. During mid-term follow-up, however, pacing thresholds increased, resulting in loss of capture in 2/10 animals. Penetration of one device into the myocardium was of concern. The concept of epicardial leadless pacing seems very attractive, and the current shape of the Micra TPS makes the device unsuitable for epicardial placement in growing organisms.

New Guidelines of Pediatric Cardiac Implantable Electronic Devices: What Is Changing in Clinical Practice?

“…New approaches to pacemakers or ICDs and lead placement are ongoing [130][131][132][133]. Leadless pacemakers are promising systems that should minimize complications related to lead and pocket [134,135], although the large size of venous introducers limits their pediatric use.…”