Thermal spread with Voyant 5 mm Fusion versus LigaSure 5 mm Blunt Tip Devices

doi:10.21203/rs.3.rs-2106048/v1

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Thermal spread with Voyant 5 mm Fusion versus LigaSure 5 mm Blunt Tip Devices

https://doi.org/10.21203/rs.3.rs-2106048/v1

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Thermal spread is an unavoidable side-effect of electrocautery, however limiting it is important for minimizing damage to surrounding tissues. LigaSure 5 mm Blunt Tip has been in use since 2009 while Voyant 5 mm Fusion has only been FDA approved since 2018. Our hospital, a rural academic tertiary care center, recently moved to purchasing Voyant because of cost concerns. We aimed to compare the thermal spread of the two tools on raw pork meat at two different cut depths and on both right and left sides. The LigaSure device had significantly less thermal spread than Voyant across all measurements. Based on our data, the LigaSure device should be chosen for use despite the increased cost.

A variety of surgical devices have been developed for electrocautery vessel sealing.(1) These tools are useful for decreasing operative time and lowering blood loss.(2) One of the downsides of these tools is the thermal spread that can damage surrounding structures.(3) LigaSure 5 mm Blunt Tip has been in use since 2009, while Voyant 5 mm Fusion has only been FDA approved for market sales since 2018.(4) At the time of this writing, our purchasing department reported paying $325 for each Voyant 5 mm x 37 cm Fusion Device, while the LigaSure 5 mm x 37 cm Blunt Tip Device is $607.

Thermal spread is an unavoidable side-effect of using electrocautery, however it damages surrounding tissues. Limiting thermal spread is an important goal of device manufacturers. Minimizing it is especially important when working with small vessels in tight spaces, such as in a thyroidectomy or esophagectomy.(5–7)

Our hospital, a rural academic tertiary care center, has recently moved to purchasing Voyant due to its lower cost. We aimed to compare the thermal spread of the tools at two different cut depths and on both right and left sides.

The data consisted of 224 measurements of thermal spread taken with digital caliper after activations from the Voyant 5 mm Fusion and LigaSure 5 mm Blunt Tip devices at cut-depths of 4mm and 8mm on the left and right sides on raw pork meat. This analysis compares the thermal spread of the two devices at the two sites (left and right), and the analysis is repeated for both cut-depths. A third analysis compares the sum of the thermal spread at the two sites by cut-depth.

In all three analyses the distribution of thermal spread is analyzed using two-way factorial analysis of variance (ANOVA). This approach tests whether there are significant differences between the thermal spreads by device and by side (left or right). It also tests for an interaction between the two, which would occur if the difference between devices was greater on one side compared to the other. The steps taken to conduct the ANOVA are (1) view the data graphically to determine evidence for device differences or an interaction, (2) conduct the statistical tests based on the ANOVA, and (3) if there is a significant interaction, determine which side shows the larger effect of the device.

7mm Analysis

Figure 1 shows the distributions of thermal spread by side and device. The figure shows that the mean is greater on both sides for the Voyant device (${M}_{\text{right}}=2.54$, ${M}_{\text{left}}=2.32$) than it is for the LigaSure device (${M}_{\text{right}}=1.58$, ${M}_{\text{left}}=1.49$). In addition, the lines connecting the means for each side are roughly parallel. If an interaction were present, such that the devices differed more for one side than the other, these lines would not be parallel. No such evidence for an interaction is present in the figure.

Table 1 gives the results of the two-way factorial ANOVA. The ANOVA confirms that that the interaction between side and device is not significant ($p=0.73$). The main effect of device is statistically significant (p < 0.001), which indicates a significant difference in between the Voyant and LigaSure devices. The main effect of side is not significant (p = 0.06).

Table 1

ANOVA Results (Cut-Depth: 7mm)
Term	SS: Type III	DF	F Statistic	P Value
Device	20.20	1	205.85	< 0.001
Side	0.35	1	3.53	0.063
Interaction	0.01	1	0.12	0.734
Residuals	10.60	108

4mm Analysis

Figure 2 shows the distributions of thermal spreads of the LigaSure and Voyant devices. The mean LigaSure thermal spread is slightly greater on the right side than on the left (${M}_{\text{right}}=1.56$, ${M}_{\text{left}}=1.52$), while the left side is slightly greater than the right side for Voyant (${M}_{\text{right}}=2.26$, ${M}_{\text{left}}=2.35$). The lines connect the sides between the two devices cross, suggesting the possibility of an interaction, although the slopes for each line do not appear to be very distinct.

Table 2 shows the result of the ANOVA for the cut-depth of 4mm. Despite the evidence in the figures above that there may be an interaction between the factors of side and device, the interaction effect is not significant in the ANOVA results ($p=0.23$). The main effect of device is once again significant at the $\alpha =0.05$ level ($p<0.001$), but the main effect of side is not ($p=0.68$).

Table 2

ANOVA Results (Cut-Depth: 4mm)
Term	SS: Type III	DF	F Statistic	P Value
Device	16.28	1	182.37	< 0.001
Side	0.02	1	0.17	0.682
Interaction	0.13	1	1.43	0.235
Residuals	9.64	108

Combined Analysis

The third analysis combines the left and right thermal spread measure into a single “total” measure of thermal spread, or the sum of the left and right measures. This analysis treats cut-depth (4mm and 7mm) as an independent variable along with the device type.

Figures 3 shows that the thermal spread for the Voyant device is greater than the thermal spread of the LigaSure device for both cut-depths. While the LigaSure device has a consistent distribution at both cut-depths (${M}_{\text{4mm}}=3.08$, ${M}_{\text{7mm}}=3.07$), the Voyant device has a larger mean thermal spread at 7mm (${M}_{\text{7mm}}=4.77$) than it does at 4mm (${M}_{\text{4mm}}=4.61$).

Table 3 shows the ANOVA results for the total thermal spread show that there is no interaction between the factors of cut-depth and device (p = 0.27). The type of device again has a significant main effect (p < 0.001), while the cut-depth does not (p = 0.34).

Table 3

ANOVA Results (Total Thermal Spread)
Term	SS: Type III	DF	F Statistic	P Value
Device	72.76	1	415.41	< 0.001
Cut-Depth	0.16	1	0.90	0.344
Interaction	0.21	1	1.21	0.274
Residuals	18.92	108

LigaSure is an established surgical tool, while Voyant is newer. Previous studies have examined LigaSure versus Harmonic (8), however literature on Voyant is scant. Voyant has become popular because it is more cost effective. Our data suggests that while the side-to-side and cut depth do not impact the thermal spread for either device, LigaSure has significantly less spread overall. This has surgical implications, suggesting that, despite the cost savings posed by Voyant, LigaSure is the preferred instrument.

Previous work demonstrated some differences between the LigaSure 5 mm Blunt Tip and Voyant 5 mm Fusion. Wille et al investigated bursting pressure, sealing time, tissue fusion, thermal spread and radiation, and jaw force for the LigaSure and Voyant 5 mm devices. T-tests were used for analysis and found no difference in bursting pressure, thermal spread, or quality of luminal fusion. Additionally, they report that LigaSure had a faster vessel sealing time, higher jaw force, and lower maximal temperature. (9) Our investigation of thermal spread varies from theirs, and here we report significantly increased thermal spread with the Voyant tool. This difference may be the result of their use of isolated porcine vessels versus our choice of raw pork muscle. Our material was chosen to mimic bowel mesentery. Porcine tissue is commonly used for studying electrocautery. (10) This represents a notable limitation of our study. Future studies could examine human tissues or use appropriate settings by asking the companies to program the devices for the specific tissue being used.

Decreasing thermal spread is important for minimizing damage to surrounding tissues.(3) The current literature on Voyant products is severely lacking compared to literature on LigaSure. We suggest discontinuing use of the 5 mm Voyant Fusion device at our institution, despite the cost savings, until it can be conclusively demonstrated to be at least equal to the LigaSure 5 mm Blunt Tip.

Data Availability

All data generated or analyzed during this study are included in this published article in the supplementary files.

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No competing interests reported.

VoyantvsLigasure11.xlsx

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Version 1

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Thermal spread with Voyant 5 mm Fusion versus LigaSure 5 mm Blunt Tip Devices

Status:

Version 1

Abstract

Figures

Introduction

Methods

Results

7mm Analysis

4mm Analysis

Combined Analysis

Discussion

Declarations

Data Availability

References

Additional Declarations

Supplementary Files

Status:

Version 1