Pacemaker and Defibrillator Lead Tip Interactions in Porcine Cardiac Tissue and Tissue Substitute on the Bench¹

Pacemakers and implantable cardioverter defibrillators (ICDs), used to treat cardiac arrhythmias, typically consist of a pulse generator and at least one lead that attaches to the heart wall with an active (helix) or passive (tines) mechanism. Perforation of the lead tip through the heart wall can be a serious complication which may occur during implantation or some time thereafter. Even though the percent incidence of reported perforations is low, cardiac rhythm management devices are prevalent medical interventions with over 300,000 procedures every year, such that as many as 15,000 patients each year may be affected by some form of perforation [1,2]. Therefore, the mechanical interactions between the lead tip and the cardiac tissue need to be more fully understood to reduce adverse events in pacemaker and ICD patients. As a first step toward this goal, we developed a unique experimental system incorporating test parameters that simulate...