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Evaluation of the safety, efficacy, and versatility of a new surgical energy device (THUNDERBEAT) in comparison with Harmonic ACE, LigaSure V, and EnSeal devices in a porcine model.

BACKGROUND
THUNDERBEAT™ (TB) (Olympus, Japan) simultaneously delivers ultrasonically generated frictional heat energy and electrically generated bipolar energy. The aim of this study was to evaluate the versatility, bursting pressure, thermal spread, and dissection time of the TB compared with commercially available devices: Harmonic(®) ACE (HA) (Ethicon Endo-Surgery, USA), LigaSure™ V (LIG) (Covidien, USA), and EnSeal(®) (Ethicon).


METHODS
An acute study was done with 10 female Yorkshire pigs (weighing 30-35 kg). Samples 2 cm long of small (2-3 mm)-, medium (4-5 mm)-, and large (6-7 mm)-diameter vessels were created. One end of the sample was sent for histological evaluation, and the other was used for burst pressure testing in a blinded fashion. Versatility was defined as the performance of the surgical instrument based on the following five variables, using a score from 1 to 5 (1=worst, 5=best), adjusted by coefficient of variable importance with weighted distribution: hemostasis, 0.275; histologic sealing, 0.275; cutting, 0.2; dissection, 0.15; and tissue manipulation, 0.1. There were 80 trials per vessel group and 60 trials per instrument group, giving a total of 240 samples.


RESULTS
Versatility score was higher (P<.01) and dissection time was shorter (P<.01) using TB compared with the other three devices. Bursting pressure was similar among TB and the other three instruments. Thermal spread at surgery was similar between TB and HA (P=.4167), TB and EnSeal (P=.6817), and TB and LIG (P=.8254). Difference in thermal spread was noted between EnSeal and HA (P=.0087) and HA and LIG (P=.0167).


CONCLUSION
TB has a higher versatility compared with the other instruments tested with faster dissection speed, similar bursting pressure, and acceptable thermal spread. This new energy device is an appealing, safe alternative for cutting, coagulation, and tissue dissection during surgery and should decrease time and increase versatility during surgical procedures.