Evaluation of a novel electrosurgical sealing mode in an ex vivo and in vivo porcine model

Abstract

Background

Bipolar vessel sealing has been successfully introduced in a variety of procedures like prostatectomy, hysterectomy, and nephrectomy. In this study, we evaluated a new sealing mode—the thermoSEAL^® mode (TSM)—operated with the VIO3 generator in an ex vivo and in vivo animal study and compared the results with the commercially available BiClamp mode (BCM), operated with the VIO300D generator. Two different instruments were used in combination with both modes, BiCision^® and BiClamp^® 201T (Erbe Elektromedizin GmbH).

Methods

In the ex vivo experiment, the sealing of renal arteries was evaluated using both instruments and modes. For the in vivo study, different types of arteries and veins were sealed using both modes and instruments in a side-by-side comparison for acute complications in a total of four animals.

Results

Mean burst pressure was in all cases significantly above 360 mmHg (p < 0.001). Sealing time during the ex vivo setting was significantly shorter for TSM compared to BCM: BiCision^® (3.7 ± 0.4 vs. 7.1 ± 0.3 s; p < 0.0001); BiClamp^® 201T (3.9 ± 0.3 vs. 5.1 ± 1.1 s; p < 0.0015). Lateral thermal damage was more pronounced for BCM: BiCision^® (TSM 1.4 ± 0.3 mm vs. BCM 1.9 ± 0.2 mm; p < 0.0001); BiClamp^® 201T (TSM 1.9 ± 0.6 mm vs. BCM 3.1 ± 0.6 mm; p < 0.0001). The sealing time during the in vivo study was significantly shorter for TSM in combination with BiCision^® for arteries [TSM 3.0 ± 0.7 s vs. BCM 6.5 ± 1.3 s, (p < 0.0001) and veins 3.2 ± 1.1 vs. 5.8 ± 1.8 s, (p < 0.0001)]. No significant differences were seen for the two modes used with BiClamp^® 201T [artery: TSM 3.3 ± 0.7 s vs. BCM 3.4 ± 0.9 s, (p = 0.891)]. High sealing rates for arteries (100%) and veins (>90%) were noted for both instruments and modes.

Conclusions

While both modes used with two different instruments reveal high safety characterized by a high burst pressure, low thermal damage (ex vivo) zones, and high sealing rates (in vivo), the thermoSEAL^® mode convinces by its fast sealing speed probably helping to reduce operation time.

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