|Year : 2020 | Volume
| Issue : 1 | Page : 43-48
Use of a low thermal injury dissection device reduces local tissue temperature change in a cadaveric model of anterior lumbar interbody fusion
Michael A Gallizzi1, Brandon T Garland2, Darvin J Griffin3, Joshua G Vose3, Mark M Guirguis3
1 Anterior Spine Institute for Research and Education (ASPIRE), Denver; Skyridge Medical Center, Lone Tree, CO, USA
2 Skyridge Medical Center, Lone Tree, CO, USA
3 Anterior Spine Institute for Research and Education (ASPIRE), Denver, CO, USA
|Date of Submission||19-May-2020|
|Date of Decision||12-Jun-2020|
|Date of Acceptance||22-Sep-2020|
|Date of Web Publication||21-May-2021|
Dr. Michael A Gallizzi
10107 RidgeGate Pkwy, Evergreen Bldg Suite 370, Lone Tree, CO
Source of Support: None, Conflict of Interest: None
Background Context: Local temperature change and thermal injury from electrosurgical instruments may be a source of complications in anterior lumbar interbody fusion (ALIF).
Purpose: To determine if use of a low-thermal injury electrosurgical device affected changes in tissue temperature, depth of thermal injury, and incidence of electrical coaptations (arcs) in a cadaveric model of ALIF, compared to traditional electrosurgery.
Study Design/Setting: Basic research study.
Methods: Fiber optic temperature sensors were positioned percutaneously at the iliac artery, iliolumbar vein, sympathetic plexus, psoas muscle, illac vein, and aorta of four fresh, room temperature, cadaveric lumbar spine specimens. Traditional electrosurgery (ES) or a low thermal injury device (LTD) was used to perform a standard ALIF dissection. Change in tissue temperature at each anatomic point and the number of electrosurgical arcs to nearby retractors were recorded. Tissue samples at the temperature-monitoring points were harvested for histological analysis and measurement of depth of acute thermal injury.
Results: Compared to electrosurgery, use of the LTD resulted in a meaningful and statistically significant reduction in temperature change at all anatomic measurement points except the aorta, and an overall 52% decrease in mean depth of thermal injury (0.14 ± 0.86 mm vs. 0.29 ± 0.17 mm, respectively; P = 0.0003). There were 95% fewer electrical arcs between LTD and retractors compared to ES (1 vs. 18 events; P = 0.0002).
Conclusions: In a cadaveric model of ALIF, use of a low-thermal-injury electrosurgical device reduced local temperature change, depth of thermal injury, and the number of electrosurgical arcs compared to traditional electrosurgery.
Keywords: Anterior lumbar interbody fusion, electrosurgery, radiofrequency, thermal tissue damage
|How to cite this article:|
Gallizzi MA, Garland BT, Griffin DJ, Vose JG, Guirguis MM. Use of a low thermal injury dissection device reduces local tissue temperature change in a cadaveric model of anterior lumbar interbody fusion. Duke Orthop J 2020;10:43-8
|How to cite this URL:|
Gallizzi MA, Garland BT, Griffin DJ, Vose JG, Guirguis MM. Use of a low thermal injury dissection device reduces local tissue temperature change in a cadaveric model of anterior lumbar interbody fusion. Duke Orthop J [serial online] 2020 [cited 2022 May 28];10:43-8. Available from: https://www.dukeorthojournal.com/text.asp?2020/10/1/43/316556
| Introduction|| |
Electrosurgical dissection near critical anatomy is commonplace during surgery. However, heat transfer from electrosurgical instruments to adjacent tissue results in acute thermal injury and introduces the risk of inadvertent damage to local vessels and nerves.,,, Furthermore, tissue necrosis at the wound edge secondary to thermal injury impairs wound healing, increases inflammation, and may lead to adverse clinical sequelae. For these reasons, surgical procedures such as anterior cervical discectomy and fusion (ACDF) and anterior lumbar interbody fusion (ALIF), where the concentration of critical anatomy in and around the spinal column is high, represent a unique intersection of technological and anatomic risk.
Monopolar electrosurgical instruments have been widely used for dissection and bleeding control since introduction in the 1920s, and their utility and limitations have been well described.,,, Further, their widespread use has inspired a number of technological advances, including closed-loop feedback generators, bipolar instruments, and radiofrequency energy coupled with continuous irrigation to improve device performance and minimize thermal injury. Nevertheless, despite these advances, inadvertent electrosurgical injury has remained a challenge.,,,,,,,,,, While the majority of published research regarding the adverse effects of electrosurgery has been in the areas of general, laparoscopic, and gynecologic surgery, it is reasonable to speculate that these effects, including injury to adjacent nerves from lateral thermal spread, and burns secondary to direct or capacitive coupling, may pose relevant risks during spinal procedures. Accordingly, there remains a knowledge gap regarding the selection of devices that may confer a clinical benefit through limiting the impact of local, microscopic thermal injury associated with electrosurgical dissection in spine surgery.
Previously, a cadaveric study of ACDF dissection examined changes in tissue temperature and depth of thermal injury when the procedure was performed using a low thermal injury device (”LTD,” PEAK PlasmaBlade, Medtronic plc., Minneapolis, MN) or a representative traditional electrosurgical device. In the experiment, fiberoptic temperature probes were placed at critical anatomic points encountered during ACDF, including the carotid sheath, esophagus, trachea, and longus coli; temperature change during dissection and depth of thermal injury were recorded. Use of the LTD resulted in more than a 50% reduction in temperature change at numerous anatomical points and significantly less thermal injury to adjacent critical tissues compared to traditional electrosurgical dissection.
The present study was designed to expand upon that work by examining change in tissue temperature, extent of thermal damage, and incidence of electrosurgical arcs (sometimes colloquially referred to as coaptations) associated with the LTD compared to a traditional electrosurgical device during ALIF dissection in a cadaveric model of the lumbar spine.
| Methods|| |
Study design and objective
This was an on-label, non-GLP, controlled research evaluation conducted at Medtronic Physiological Research Laboratories (Minneapolis, MN). The objective was to determine if use of the LTD could reduce tissue temperature change and depth of thermal injury at critical anatomic points during representative ALIF procedures, as well as incidence of unintentional direct coupling (arcing) between the surgical electrode and nearby retractors when compared to a traditional electrosurgical device, in human cadavers.
The LTD test article for this study (PEAK PlasmaBlade 3.0S and AEX generator, Medtronic, plc., Minneapolis, MN USA) uses brief, precise pulses of radiofrequency energy in concert with a proprietary blade insulation technology to minimize energy transfer during use. Prior research has demonstrated equivalent healing to scalpel of cutaneous and fascial incisions created by the LTD.,,
The control article was a representative, single-use electrosurgical device (”ES,” ValleyLab™ Electrosurgery Pencil Model E2450H with Edge™ coated electrode Model E2516 and Model E1502, 13 cm reusable straight electrode extension, Medtronic, plc., Minneapolis, MN, USA) powered by a representative RF generator (ValleyLab Force FX generator, Medtronic, plc. Minneapolis, MN, USA).
Human cadaveric spines
Four human cadaveric cervical spines (adult; L4 to L5 or S1; maximum 120 h postmortem) were obtained from Anatomy Bequest Program at the University of Minnesota. Adjacent soft tissues of the lumbar region were left intact, and none of the specimens had history of prior spine surgery or musculoskeletal disease.
Tissue temperature sensor
The temperature probes used in this study were the Reflex™ fiber optic temperature sensor (model T1C-02-B30; Qualitrol, Québec City, Québec, Canada). This is a multipurpose, fiberoptic, 4-channel temperature thermometer specifically designed for recording accurate temperature measurements during industrial and laboratory processes as well as medical research (for example, in tissue ablation studies).,
The system operates by sending an excitatory pulse of light of predefined intensity through the fiber optic cable to the crystalline probe, which reflects light in a temperature-dependent manner. By measuring the intensity of the reflected light, these probes provide real-time, continuous temperature measurement that is not susceptible to RF interference. They are considered to be the industry standard for temperature measurement in energy-based applications and systems.
On the day of the experiment, the spinal specimens were acclimated to room temperature (22°C –23°C) and prepped in standard fashion. Individual temperature probes were positioned at or within 8–10 mm of the critical structures (iliac artery, iliac vein, aorta, iliolumbar vein, sympathetic plexus, and psoas muscle) in the plane of dissection.
ALIF procedures were carried out on each spine specimen using a fresh dissection device; the dissection devices were randomly assigned to each specimen prior to the procedure. Device settings were chosen as representative of surgical practice for both the LTD (Cut 7) and ES (35 W) devices. The ALIF retroperitoneal approach was performed in standard fashion according to surgeon's practice, with all dissection performed with the respective energy device. The anterior spine retractor, (MARS™ Anterior Retractor, Globus Medical, Audubon, PA), was placed in a standard fashion by a vascular and spine surgeon, BTG and MAG. Tissue temperature at the probe sites was recorded at baseline and continuously in real time as the procedure was performed.
The occurrence of direct coupling between the dissection device electrode and any nearby metal retractors, often referred to colloquially as “electrosurgical coaptation,” was measured as the number of observed electrical arcs and recorded using a high-resolution (1920 × 1080 pixels), high-speed (120 frames per second), digital camera (DSC-RX100M5 Cyber-Shot, Sony Corp., Tokyo, JP) mounted to a lighting fixture and positioned to visualize the operative field. Videos were recorded from beginning to end of each procedure to ensure capture of arc events (limit of resolution for event duration, 8.3 ms). The number of events, noted as bright white or yellow pixels spanning between the device tip and the retractor, was recorded during frame-by-frame, postprocedure review of the videos by the authors using commercially available analysis software (Lightworks ver. 14.0, EditShare, Watertown, MA USA).
When the dissection was complete, tissue samples (2 cm long by 4 mm thick) at the position of the temperature probes were excised, labeled, and fixed in 10% neutral buffered formalin for a minimum of 24 h and then processed for histopathology.
Formalin-fixed specimens were embedded in paraffin, sectioned, and stained with hematoxylin and eosin to determine tissue structure and depth of thermal injury in the plane of dissection. Depth of thermal injury (in mm) was calculated as the maximal perpendicular distance from the treated surface to interface of injured and healthy tissue. The maximum, minimum, and median depth of effect was averaged to determine the total depth of effect for each anatomical location.
The primary endpoint of this study was mean change in temperature at critical anatomic points during ALIF with the LTD or ES device. The secondary endpoints were depth of thermal injury and number of electrical arcs during dissection.
The mean change in temperature was calculated relative to baseline and compared between the ES and LTD groups. All quantified values are presented as mean ± standard deviation. For comparisons between groups, statistical significance was calculated by the F-test, then by a two-sided t-hypothesis test for equal or unequal variance with two-tailed distribution; error bars represent 95% confidence intervals. P < 0.05 were considered statistically significant.
| Results|| |
On the day of procedure, the calibrated, fiberoptic temperature probes were successfully positioned within 8–10 mm of predetermined critical structures (iliac artery, iliolumbar vein, sympathetic plexus, psoas muscle, iliac vein, and aorta) as planned in four human cadaveric spines (range of postmortem interval, 78–108 h).
The ALIF dissection procedure was successful in all specimens. With the exception of the aorta, there was a statistically significant reduction in the mean change in temperature at all anatomic points with the LTD compared to ES [Table 1].
|Table 1: Mean maximal temperature change at specific anatomical sites during anterior lumbar interbody fusion, by device|
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Histopathological assessment demonstrated that use of ES resulted in significantly greater depth of thermal damage compared to LTD at all anatomical locations except for the aorta [Figure 1] and [Table 2]. Overall, the mean depth of tissue damage was 0.29 ± 0.17 mm for ES versus 0.14 ± 0.86 mm for LTD (P = 0.0003).
|Figure 1: Hematoxylin and Eosin staining at low magnification (×20) showing depth of effect at six critical anatomic points. The thermal depth effect is indicated by the double headed arrow|
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|Table 2: Summary of depth of effect measurements and average depth of treatment effect for all lesions|
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The data file from one high-speed digital video, taken during an ES dissection, became corrupted prior to analysis and could not be viewed. Of the remaining seven videos (3 ES and 4 LTD), 1 electrical arc was observed in the LTD treatment group and 19 in the ES group, representing a 95% difference in the observable incidence of direct coupling [P = 0.0002, [Table 3]].
|Table 3: Direct coupling during anterior lumbar interbody fusion procedures|
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| Discussion|| |
In this study, dissection using the LTD reduced temperature change at critical structures adjacent to the ALIF procedure and depth of acute thermal tissue injury at the site of dissection. These results are consistent with prior research, which has demonstrated that use of the LTD device yields reduced thermal injury depth, inflammatory response, and scar width with wound healing equivalent to a cold scalpel.,,,,
Performed in the lumbar spine, ALIF commonly involves the L4 through L5 or L5 through S1 segments, as those are most likely to exhibit degenerative loss of disc height with age. The purpose of the procedure is to restore disc height, minimize or eliminate foraminal stenosis, restore functional anatomy, and eliminate pain. ALIF may be performed for other indications and may be performed by or in combination with a posterior approach, if added stability is necessary.
The standard ALIF surgical approach involves an abdominal incision to address the spine anteriorly by mobilizing and retracting major muscles, organs, and vascular structures away from the area to be fused. Typical anatomy encountered via the anterior approach includes the aorta, lilac artery, iliac vein, iliolumbar vein, sympathetic plexus, bladder, and the psoas muscles. After partial or complete removal of the degenerated disc (s), the remaining space is filled with bone graft or substitute to promote fusion. Finally, local anatomy is returned to normal position and the abdominal incision is closed.
Comparatively, the anterior approach has been associated with relatively high complication rates compared to nonanterior approach procedures, including posterior and transverse techniques (26.88% vs. 9.6%). However, the anterior approach provides excellent visualization of the ventral aspect of the lumbar spine without the associated risk of spinal cord manipulation, which allows for optimal disc decompression. As a complex procedure, the reported complications associated with ALIF are numerous, including: vascular and visceral injuries, infection and wound complications, retrograde ejaculation, sympathetic dysfunction, failure of fusion, bladder and bowel problems, and paralysis.,,,,,,,, These adverse events may be transient or permanent in nature depending upon the severity of injury.
With respect to procedure instrumentation, specifically, it is known that unintended thermal spread from electrosurgical dissection causes tissue damage and may jeopardize nearby blood vessels and nerves, potentially causing transient and permanent injury.,,,,,,,,,,,, Accordingly, a number of methodological approaches, as well as electrosurgical device innovations, have been used to minimize overall operative risk. However, little preclinical research at the intersection of these two influences has been conducted to substantiate choice of dissection instrument. The use of devices that minimize temperature change and depth of thermal injury may influence the incidence of complications related to electrosurgical injury in ALIF.
In addition to measuring direct thermal injury to tissue, in this experiment, we also assessed the incidence of unintentional direct coupling (electrical arcs) between the dissection device and nearby surgical retractors that are commonly used to improve surgical-site access. Such arcs, which may manifest as sparks but are often too brief to visualize, represent a rapid, highly localized discharge of current between the electrode and an object outside of the intended current path. This discharge of electricity is associated with temperatures extreme enough to ionize air and vaporize water—indeed, current flow from the electrode to the target tissue is fundamental to the operating mechanism of traditional ES.,,, Such unintentional and uncontrolled direct coupling represents a potential source of additional heat damage, collateral tissue damage, poor healing and potential infection.
In our study, the LTD was associated with a statistically significant and clinically meaningful 95% reduction in incidence of observed electrical discharges between the electrode and nearby surgical retractors. This is not unexpected, given that the LTD operates by a fundamentally different mechanism than traditional ES, and because the LTD electrode is highly insulated, greatly reducing its exposed surface area.
There are a number of limitations to this study. First, as a cadaveric model, the tissues tested were not perfused, which could have affected temperature change and thermal injury compared to living tissues. As such, the results of this experiment may represent the upper bound for dissection instrument risk in this procedure. Importantly, however, the thermal injury results of this experiment were consistent with previous studies in living clinical (human) and preclinical (animal) models, as well as in vitro experiments, and the comparator arm provided an essential control. Second, the sample size of this experiment was small due to the difficulty of obtaining fresh human cadaveric specimens. The small sample size may affect overall statistical power of the results, however not the directional trends. Finally, there was fairly wide variation in the recorded temperature change data, which we believe is due to the different methods of applying energy by each surgeon. Even with such difference in technique, statistical analysis confirmed that there were clear differences between results from the control and test devices.
| Conclusion|| |
In this cadaveric model of soft-tissue electrosurgical dissection during ALIF, use of a low thermal injury electrosurgical device reduced temperature change at important anatomic locations, depth of acute thermal injury in adjacent tissues, and direct electrical coupling compared to traditional electrosurgery. In the future, a formal, prospective clinical study may be useful to investigate if these improved preclinical results translate to clinical outcomes.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]