Safety of clinical irreversible electroporation

Abstract

Irreversible electroporation (IRE) for focal tumor control has developed since early human studies in 2009 to a point where it is now a useful part of the tumor eradication algorithm. While animal studies provided some basis for confidence that delivery of high voltage pulses via needle electrodes would be well tolerated and effective, there were anxieties about the effects on cardiac activity, particularly in patients with pacemakers, when the IRE was planned to be close to the heart itself. The early clinical experience of IRE in the chest, abdomen, and pelvis shows that these electrical effects are extremely well tolerated particularly if cardiac-gated delivery is used. The sum of this experience also shows that, provided the total amount of energy delivered is within reasonable limits, no thermal effects are to be expected and the IRE effect does not damage collagenous support structures, blood vessels, nerves, and bile ducts. IRE of brain tumors is the final frontier where although it appears animals are able to tolerate IRE to their cerebral tissue, to date no human study has been completed.