Research Project
6792895
DESCRIPTION (provided by applicant): Advancements in the understanding of Congestive Heart Failure and the cardiac pacing technology has expanded the indications for bi-ventricular pacing. Although 95 % of all leads are currently placed transvenously, placement of leads into the left ventricle pose significantly higher risks for this approach. Hence, there is a greater need for more advanced myoepicardial lead designs as well as tools for placement of these devices into the left ventricle through a thoracotomy or sub-xyphoid approach. Because of the much greater mechanical strain on these leads, the fixation mechanism must be very secure until chronic tissue fixation, due to tissue in-growth, is complete. Lead dislodgement and/or migration remain a leading cause of pacing failure. Threshold rise in the first few weeks post implantation can lead to premature battery depletion, unnecessarily high voltage thresholds, or may even require lead replacement. Steroid eluting leads have become standard practice but a less traumatic insertion system and more biocompatible lead would offer much longer term potential. A high impedance electrode with sensing capabilities combined with these attributes would be a great advance for epicardial lead placement and treatment. The research will focus on the development and implementation of a new epicardial lead fixation system and a "smart pacing electrode". The approach will utilize advanced mechanical designs along with new material technology to provide an atraumatic insertion and fixation lead. Coupled with anti-scarring/anti-inflammatory drug therapy, this novel lead system will allow lower pacing thresholds leading to more efficient power use and longer battery life. The major aim will be to develop a retractable and repositionable passive fixation system utilizing innovative new technology. This fixation system will employ new hydrophilic polymer drug delivery systems to provide both a hydrodynamic seal as well as deliver anti-inflammatory drugs to the implantation site. Additionally, MEMS technology will be employed to develop a high impedance electrode that provides a platform for integration of new sensors to respond to changes in cardiac activity. A high impedance, low threshold epicardial lead, with a novel new passive fixation mechanism will be developed to advance treatment for patients requiring left ventricular pacing.
