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

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.

Transvenous and non-transvenous implantable cardioverter-defibrillators in children, adolescents, and adults with congenital heart disease: who is at risk for appropriate and inappropriate shocks?

AIMS: Non-transvenous implantable cardioverter-defibrillators (ICDs) as used in small patients and in patients with congenital heart disease (CHD) have not been compared with transvenous systems with respect to safety and efficacy yet. Aim of the present study was to describe the prevalence of and to identify contributing factors for appropriate and inappropriate ICD discharges in patients with non-transvenous and transvenous ICD. METHODS AND RESULTS: Single centre analysis of all paediatric and CHD patients who had received an ICD since 1995. One hundred and ninety-five patients were included. A transvenous system had been implanted in 153 (78%) subjects, the remaining 42 (22%) individuals received an extracardiac (EC)-ICD system. During mean follow-up of 4.5 years appropriate ICD shocks were noted in 32 (16%) individuals, whereas inappropriate shocks occurred in 22 (11%) patients. Appropriate shocks were more frequent in patients with an EC-ICD than in individuals with transvenous systems (29% vs. 13%, P = 0.02). Rapidly conducted atrial tachycardia (AT) was the most common reason for inappropriate shocks (76%). Rate of inappropriate shocks was not different between EC and transvenous systems (12% vs. 11%, P = 0.26). Lead failure was more prevalent in subjects with an EC-ICD (29% vs. 7%, P = 0.001). CONCLUSION: Individuals with EC-ICD systems were particularly prone to experience appropriate shocks. As rapidly conducted AT was the most common reason for inappropriate ICD shocks, rigorous treatment of these arrhythmias and proper ICD programming are mandatory. Though lead failure was of concern in EC-ICD patients, EC-ICD systems were not inferior with respect to inappropriate shocks.