Abstract 144: Quality Assurance Measurement of St Jude/Abbott Tendril Pacemaker Leads in Veterans

Abstract

Background: St Jude/Abbott 1688TC and 2088TC Tendril Pacemaker Leads with a silicone-polyurethane copolymer insulation have been reported to have failure rates as high as 5.7% and 5.2%. The VA National Cardiac Surveillance Program (NCDSP) monitors 45,000 Veterans; many have St Jude/Abbott Leads. Objective: Examine the survival rate of the 1688TC and 2088TC Tendril Pacemaker Leads in the VA database as an ongoing QA measure. Method: Model and serial numbers, dates of implant, and out of service (OOS) dates among other variables are listed. Records of OOS leads were analyzed for the OOS reason, and the cause of lead failure: noise, fracture, malfunction, insulation breaks, dislodgement and significant changes in impedance and threshold. Results: There were 5,550 1688TC Tendril pacemaker leads implanted in 4,140 veterans, for an average of 83 (0-199) months; 185 (3.33%) leads were OOS at an average of 58 (0-152) months. Reasons for OOS were: failures in 69 (1.24%), system upgrades in 51 (0.92%), infections in 55 (0.99%), and other reasons in 10 (0.18%). Of 11,587 2088TC Tendril pacemaker leads implanted in 8,147 veterans for an average of 46 (0-108) months; 224 (1.93%) leads were OOS at an average of 29 (0-92) months. Lead failures occurred in 67 (0.58%), system upgrades in 85 (0.73%), infections in 64 (0.55%), and other reasons in 8 (0.07%). The graph shows the survival rate of the 1688TC and 2088TC Tendril pacemaker leads after implant (excluding upgrades, infections, and other reasons). Conclusion: At 108 months follow-up, both leads had comparable survival. Lead failure was found in 1.05% of the 1688TC and 0.58% of the St Jude/Abbott 2088TC Tendril pacemaker leads implanted in veterans, much lower than that in other published reports.