Why the study?
Device replacements carry potential risks including complications and lead damage, and it is uncertain if the PEAK PlasmaBlade™ reduces these risks and procedure times compared to conventional methods.
Does the PEAK PlasmaBlade reduce procedure time and complications compared to conventional electrocautery in patients undergoing cardiac device replacement?
Cohort (n=611)
Does the PEAK PlasmaBlade reduce procedure time and complications compared to conventional electrocautery in patients undergoing cardiac device replacement?
Absolute Event Rate: 28.4% vs 47.5%
p-value: p=<0.001
The use of an electrical plasma surgery tool for cardiac device replacement significantly reduces procedure time, hospital stay, and lead damage compared to conventional electrocautery, resulting in cost savings.
May support PlasmaBlade use in device replacement; hypothesis-generating and requires RCTs before practice change.
BACKGROUND: Device replacements bear many potential risks for patients. Electrocautery should be used cautiously because of heating of the cautery tip which may lead to insulation melting. The PEAK PlasmaBlade™ (Medtronic Inc., Minneapolis, MN, USA) uses a novel technology to cut tissue. The objective of this study was to evaluate if this instrument is less destructive and can decrease complications and shorten procedure times. METHODS AND RESULTS: Two groups were compared: in group 1, surgery was done with scissors and conventional electrocautery, whereas the PEAK PlasmaBlade™ was used in group 2. Procedure time and complication rates were retrospectively investigated. Group 1 comprised 509 patients, while group 2 consisted of 102 patients. Procedure time in group 2 was significantly shorter with 28.4 ± 8.9 minutes than in group 1 with 47.5 ± 24.5 minutes (P < 0.001). The hospital stay was also reduced (2.1 ± 2.2 days versus 3.1 ± 2.4 days, P < 0.001). One major complication occurred in only 2.4% (two patients) of group 2 and in 6.9% (35 patients) of group 1. There were no damaged leads in group 2 compared to 5.7% in group 1 (P = 0.008). Cost analyses showed that the use of The PEAK PlasmaBlade™ instead of conventional electrocautery resulted in cost savings of €120/patient. CONCLUSION: Device replacement is associated with a notable complication risk. Our investigation showed that a new device for generator replacement resulted in significantly reduced procedure time and length of hospital stay while completely avoiding lead damage, which translated into considerable cost savings in a real world setting.
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Kypta et al. (2014) conducted a cohort in Device replacement (n=611). PEAK PlasmaBlade vs. scissors and conventional electrocautery was evaluated on Procedure time (p=<0.001).
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