Percutaneous epicardial placement of a prototype miniature pacemaker under direct visualization: An infant porcine chronic survival study.

Abstract

Pacemaker implantation in infants typically consists of surgical epicardial lead placement with an abdominal generator. Here, we describe the chronic performance of our minimally invasive prototype miniature pacemaker implanted under direct visualization in an immature porcine model. Twelve piglets underwent miniature pacemaker implantation. A self-anchoring two-channel access port was inserted into a 1cm incision in the subxiphoid space, and a thoracoscope was inserted into the main channel to visualize the thoracic cavity under insufflation. The pacemaker leadlet was inserted through a sheath via secondary channel and affixed against the epicardium using a helical side-biting electrode. The miniature pacemaker was tucked into the incision, which was sutured closed. Ventricular sensing, leadlet impedance, and capture thresholds were measured biweekly. A limited necropsy was performed after euthanasia. Nine piglets were followed for a median of 78 (IQR 52-82) days and gained 6.6 ± 3.2kg. Three animals were censored from the analysis due to complications unrelated to the procedure. Capture thresholds rose above maximal output after a median of 67 (IQR 40-69) days. At termination, there was a significant decrease in R-wave amplitude (P=.03) and rise in capture thresholds at 0.4ms (P=.01) and 1.0ms pulse widths (P=.02). There was no significant change in leadlet impedance (P=.74). There were no wound infections. There were no infections following minimally invasive implantation of our prototype miniature pacemaker. Improvements to epicardial fixation are necessary to address diminished leadlet efficacy over time.