Stiffness of the Distal Tip of Bipolar Pacing Leads

Authors

  • JIM CAMERON,

    1. The Therapeutic Devices Branch, Therapeutic Goods Administration, Commonwealth Dept. of Community Services and Health, and the Department of Cardiology, Royal Melbourne Hospital, Victoria, Australia
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  • HARRY MOND,

    Corresponding author
    1. The Therapeutic Devices Branch, Therapeutic Goods Administration, Commonwealth Dept. of Community Services and Health, and the Department of Cardiology, Royal Melbourne Hospital, Victoria, Australia
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  • GARY CIDDOR,

    1. The Therapeutic Devices Branch, Therapeutic Goods Administration, Commonwealth Dept. of Community Services and Health, and the Department of Cardiology, Royal Melbourne Hospital, Victoria, Australia
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  • KEITH HARPER,

    1. The Therapeutic Devices Branch, Therapeutic Goods Administration, Commonwealth Dept. of Community Services and Health, and the Department of Cardiology, Royal Melbourne Hospital, Victoria, Australia
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  • JENNIFER MCKIE

    1. The Therapeutic Devices Branch, Therapeutic Goods Administration, Commonwealth Dept. of Community Services and Health, and the Department of Cardiology, Royal Melbourne Hospital, Victoria, Australia
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2 Department of Cardiology, Royal Melbourne Hospital, 3050, Victoria, Australia

Abstract

CAMERON, J., ET AL.: Stiffness of the Distal Tip of Bipolar Pacing Leads. The stiffness of a bipolar pacing lead, particularly between anode and cathode, may be responsible for myocardial penetration and perforation. Following an unprecedented 7% incidence of high threshold exit block with a single model bipolar ventricular endocardial lead, a study was undertaken to compare pacing lead stiffness between anode and cathode of six models of bipolar leads from two manufacturers; Telectronics (T) and Medtronics (M). Four leads had polyurethane insulation; T 030–284 (Laser Dish), T 329–259 (Cordis, Encor), M4012 (Target Tip), and M 4004 (Capsure). Two leads had silicone rubber insulation; M 5026 (Capsure) and M 5024 (Capsure SP). All leads were subjected to two stiffness tests. The Tip Deflection Test involved securing the lead at 45° at the indifferent electrode and applying a force to deflect the tip 5 mm. The three point bending test involved placing the lead over two fixed bars in contact with the anode and cathode. Midway a third bar was pushed onto the lead and the force to deflect the lead 2 mm was recorded. The results showed that pacing leads with polyurethane insulation were much stiffer than those with silicone rubber insulation. The T 030–284 because of its construction was found to be the stiffest. The next stiffest was the M 4012. Both these leads had an unacceptable incidence of high threshold exit block; 7% with the T 030–284 (89 implants) and 3% with the M 4012 (102 implants). No cases of high threshold exit block were documented with the other four pacing leads and in particular the silicone rubber M 5026 (344 implants). It is recommended that bipolar pacing leads with low stiffness between anode and cathode be used and that all new pacing leads be tested for stiffness prior to human implants.

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