Effect of a single element subcutaneous array electrode added to a transvenous electrode configuration on the defibrillation field and the defibrillation threshold.

Even with the use of biphasic shocks, up to 5% of patients need an additional subcutaneous lead to obtain a defibrillation safety margin of at least 10 J. The number of patients requiring additional subcutaneous leads may even increase, because recent generation devices have a < 34 J maximum output in order to decrease their size. In 20 consecutive patients, a single element subcutaneous array lead was implanted in addition to a transvenous lead system consisting of a right ventricular (RV) and a vena cava superior lead using a single infraclavicular incision. The RV lead acted as the cathode; the subcutaneous lead and the lead in the subclavian vein acted as the anode. The biphasic defibrillation threshold was determined using a binary search protocol. Patients were randomized as to whether to start them with the transvenous lead configuration or the combination of the transvenous lead and the subcutaneous lead. In addition, a simplified assessment of the defibrillation field was performed by determining the interelectrode area for the transvenous lead only and the transvenous lead in combination with the subcutaneous lead from a biplane chest X ray. The intraoperative defibrillation threshold was reconfirmed after 1 week, after 3 months, and after 12 months. The mean defibrillation threshold with the additional subcutaneous lead was significantly (P = 0.0001) lower (5.7 +/- 2.9 J) than for the transvenous lead system (9.5 +/- 4.6 J). With the subcutaneous lead, the impedance of the high voltage circuit decreased from 48.9 +/- 7.4 omega to 39.2 +/- 5.0 omega. In the frontal plane, the interelectrode area increased by 11.3% +/- 5.5% (P < 0.0001) and in the lateral plane by 29.5% +/- 12.4% (P < 0.0001). The defibrillation threshold did not increase during follow-up. Complications with the subcutaneous electrode were not observed during a follow-up of 15.8 +/- 2 months. The single finger array lead is useful in order to lower the defibrillation threshold and can be used in order to lower the defibrillation threshold.

RCT Entities:   Population Interventions Outcomes