Factors affecting the frequency of subcutaneous lead usage in implantable defibrillators.

Subcutaneous leads (SQ) add complexity to the defibrillation system and the implant procedure. New low output devices might increase the requirement for SQ arrays, although this might be offset by the effects of active can and biphasic technology. This study sought to assess the impact of these technologies on SQ lead usage, and to determine if clinical variables could predict the need for an SQ lead. Patients receiving nonthoracotomy systems (n = 554) at our institution underwent step-down-to-failure DFT testing with implant criteria of a 10-J safety margin. SQ leads were used only after several endovascular configurations failed. Use of biphasic waveforms significantly lowered the frequency of use of SQ leads from 48% to 3.7% (P < 0.000001). SQ leads were required in 4.4% of patients with cold can devices and 2.6% of patients with active can devices (P = NS). There was no increase in SQ lead usage with low energy (< 30-J delivered energy) devices. Clinical variables (including EF, heart disease, arrhythmia, and prior bypass) did not predict the need for an SQ lead. The implant DFT using SQ arrays (14.5 +/- 6.5 J) was not significantly lower than that for SQ patches (16.6 + 6.0 J). We conclude that biphasic waveforms significantly reduce the need for SQ leads. Despite this reduction, 3.7% of implants still use an SQ lead to achieve adequate safety margins. The introduction of lower output devices has not increased the need for SQ leads, and when an SQ lead is required, there is not a significant difference in the implant DFT of patches versus arrays. Clinical variables cannot predict which patients require SQ leads.