216-41: Electrocautery compared to electrical plasma surgery in patients undergoing device generator replacement - A prospective randomized study

Abstract

Background: As the number of cardiac implantable electronic devices is constantly growing, the need for generator replacement surgeries increases. Generator replacement is associated with surgical complications such as pocket hematoma, infections and lead damages. Conventional electrocautery has been shown to bear the potential of lead insulation damage by focal heating. Recently a novel electrical plasma surgery tool (PEAK PlasmaBladeTM, Medtronic Inc., Minneapolis, MN, USA) has been introduced. This tool works at lower peak temperature levels and is able to cut wet tissue as well. The aim of this prospective randomized single center study was to compare effectiveness and safety of the electrical plasma surgery tool with a conventional electrocautery tool in device generator replacement surgeries. Methods: After randomization, 78 patients undergoing device generator replacement were treated either with a conventional radiofrequency electrocautery tool (Vio 100C, Erbe Elektromedizin GmbH, Tübingen, Germany; n = 38) or the electrical plasma surgery tool (n = 40). The primary endpoint was the duration from skin incision to generator enucleation. Secondary endpoints were procedural durations, incidence of pocket hematoma, device infections and lead damages. Results: The duration to generator enucleation was significantly shorter in the plasma surgery group [8 ± 5 min. vs 13 ± 10 min.; p = 0.002]. Secondary endpoints did not significantly differ between the two groups. In two patients a cross over from the conventional treatment group to the plasma surgery group was necessary due to severe fibrotic adhesions. Conclusion: Application of an electrical plasma surgery tool for generator replacement surgery leads to a significant shortening of duration to generator enucleation whereas complication rates did not significantly differ.