In Vivo Durability of Polyurethane Insulated Implantable Cardioverter Defibrillator (ICD) Leads

Abstract

The 6935M Sprint Quattro Secure S and 6947M Sprint Quattro Secure are high voltage leads designed to administer a maximum of 40 joules of energy for terminating ventricular tachycardia or ventricular fibrillation. Both leads utilize silicone insulation and a polyurethane outer coating. The inner coil is shielded with polytetrafluoroethylene (PTFE) tubing, while other conductors are enveloped in ethylene tetrafluoroethylene (ETFE), contributing to the structural integrity and functionality of these leads. Polyurethane is a preferred material for the outer insulation of cardiac leads due to its flexibility and biocompatibility, while silicone rubber ensures chemical stability within the body, minimizing inflammatory or rejection responses. Thirteen implantable cardioverter defibrillator (ICD) leads were obtained from the Wright State University Anatomical Gift Program. The as-received devices exhibited varied in vivo implantation durations ranging from less than a month to 89 months, with an average in vivo duration of 41 ± 27 months. Tests were conducted using the Test Resources Q series system, ensuring compliance with ASTM Standard D 1708-02a and ASTM Standard D 412-06a. During testing, a load was applied to the intact lead, with careful inspection for surface defects before each test. Results of load to failure, percentage elongation, percentage elongation at 5 N, ultimate tensile strength, and modulus of elasticity were calculated. The findings revealed no significant differences in these parameters across all in vivo exposure durations. The residual properties of these ICD leads demonstrated remarkable stability and performance over a wide range of in vivo exposure durations, with no statistically significant degradation or performance changes observed.

Keywords

• polyurethane
• lead insulation
• ICD leads
• failure analysis
• in vivo environment
• cardiac diseases