- Journal of Vascular Surgery: Venous and Lymphatic
Transcrição
- Journal of Vascular Surgery: Venous and Lymphatic
Experimental determination of the best time and duration for endovenous great saphenous vein electrocoagulation Fabio Henrique Rossi, MD, PhD, Camila Baumann Beteli, MD, Mabel Barros Zamorano, MD, Patrick Bastos Metzger, MD, Cybelle Bossolani Onofre Rossi, FACS, Nilo Mitsuru Izukawa, MD, PhD, and Amanda Guerra de Moraes Rego Sousa, MD, PhD, São Paulo, Brazil Objective: Endovenous electrocoagulation provokes immediate selective venous wall necrosis. In this study, we aim to determine the best power and time of electrocoagulation necessary to cause intima and media but not adventitia layer damage in great saphenous vein (GSV) insufficiency treatment. Methods: We studied 100 varicose GSV fragments submitted to endovenous electrocoagulation. The power (60, 90, or 120 W) and time (5, 10, or 15 seconds) were randomly assigned. The fragments were submitted to histopathologic examination to analyze the depth of tissue necrosis. Dose-response models for the analysis of binary data were used to identify the best association between power and the time of electrocoagulation necessary to cause intima and media but not adventitia layer necrosis. We also applied a logistic regression model to investigate the impact of body mass index and GSV diameter on the electrocoagulation effects. Results: The time (odds ratio [OR], 1.26; P [ .0009) was found to be a stronger predictor of the depth of vessel necrosis than the power of electrocoagulation applied (OR, 1.05; P < .0001). The power and time that were most likely to cause intima and media but not adventitia layer destruction were 60.4 W 3 5 seconds, 58.8 W 3 10 seconds, and 8.9 W 3 15 seconds. The initial GSV diameter (median, 5.36 mm; minimum, 2.3 mm; maximum, 10 mm; OR, 0.96; P [ .82) and body index mass (median, 24.7 kg/m2; minimum, 15.6 kg/m2; maximum, 36.2 kg/m2; OR, 1.08; P [ .26) showed a poor correlation with the depth of histologic vessel destruction. Conclusions: The time of electrocoagulation strongly predicts the depth of GSV wall necrosis more than the amount of power applied. Determination of the best time and power of electrocoagulation ratio may help optimize GSV endovenous electrocoagulation closure rates and decrease the complications index. The GSV diameter and body mass index do not influence endovenous electrocoagulation effects. (J Vasc Surg: Venous and Lym Dis 2014;2:315-9.) Chronic venous insufficiency affects 20% of the adult population, with varicosities in the great saphenous vein (GSV) distribution being the most common manifestation. The standard treatment has historically been high GSV ligation and stripping. In recent years, many surgeons have adopted endovascular techniques with good results.1,2 In our prior publications, we have described an endovenous electrocoagulation apparatus and technique that provoke immediate selective venous wall damage in an animal model.3 Furthermore, we demonstrated the same effect in human varicose veins, including the fact that the time of electrocoagulation strongly predicts the depth of vessel wall necrosis more than the power of energy applied.4 In this study, we aim to determine the best power and the time of electrocoagulation necessary to cause intima and media but not adventitia layer damage in lower limb varicose vein treatment. From the Dante Pazzanese Cardiovascular Institute. This article received a research grant from FAPESP. Author conflict of interest: none. Reprint requests: Fabio Henrique Rossi, MD, PhD, Av Dr Dante Pazzanese, 500, Ibirapuera, São Paulo, SP, CEP 04012-909, Brazil (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 2213-333X/$36.00 Copyright Ó 2014 by the Society for Vascular Surgery. http://dx.doi.org/10.1016/j.jvsv.2013.11.001 Clinical Relevance: The successful treatment of lower extremity chronic venous insufficiency includes the elimination of all sources of venous reflux. Endovenous ablation of varicose veins with radiofrequency ablation and endovenous laser therapy has reported advantages over traditional open surgical treatment but is costly. We have described a simple endovenous electrocoagulation apparatus and technique that provoke immediate selective venous wall damage and use a conventional electrosurgical generator as the energy source. In this study, we aim to determine the best power and the time of electrocoagulation necessary to cause intima and media but not adventitia layer damage in lower limb varicose vein treatment. METHODS The study was conducted according to the Helsinki Declaration. The experimental protocol and informed consent were approved by the Institutional Review Board. All the study subjects gave informed consent with local ethical committee approval (IDPC-FMUSP/CEP 3904/2010). We studied 100 varicose vein fragments obtained from 78 patients with clinical, etiologic, anatomic, and pathologic classes 3 to 6; GSV insufficiency with venous diameters between 2.3 and 10 mm (mean, 5.36 mm) was documented by ultrasound examination. Subjects with GSV diameter >12 mm and <2 mm, acute or previous phlebitis, previous surgery or sclerotherapy in the study leg, previous or current 315 316 Rossi et al JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS July 2014 For safety reasons, we checked the best association between power (watts) and the time (seconds) of electrocoagulation necessary to cause intima and media (group A) but not adventitia layer necrosis (group B). Dose-response models for the analysis of binary data were used for this investigation and tolerated the presence of vessel perforation in 10% of the cases. A logistic regression model was applied to investigate the impact of body mass index, saphenous vein initial diameter, and temperature on the depth of vessel wall necrosis caused by the electrocoagulation. The test was considered statistically significant when P < .05. RESULTS Fig 1. Endovenous electrocoagulation apparatus positioned at the proximal portion of the great saphenous vein (GSV). deep venous thrombosis, previous coagulopathy history (congenital or acquired thrombophilia or a prothrombotic state), arterial occlusive disease, active malignant disease, pregnancy, multiple saphenous aneurysms (segmental varicose vein dilatations, two times the adjacent GSV diameters), or congenital malformations were excluded. Patients were submitted to standard surgical groin and ankle GSV dissection. Just before high ligation and stripping of the GSV, an endovenous electrocoagulation apparatus was positioned immediately beneath the superficial epigastric vein (Fig 1). The diameter of this segment was measured in millimeters and submitted to endovenous electrocoagulation with use of the Valleylab FX Electrosurgical Generator (Covidien, Mansfield, Mass) as the energy source. The energy intensity, power, and time of electrocoagulation were determined according to a randomization table. In a previous study, we observed that electrocoagulation with 120 W for 15 seconds could provoke macroscopic GSV shrinkage, induration, and inside carbonization. We fixed this as the highest dose and randomly studied the histologic effects of 60, 90, and 120 W per 5, 10, and 15 seconds4 (Table I). Immediately after the procedure, the temperature adjacent to the vessel was measured (TD-100 thermometer; ICEL, Manaus, Brazil). The venous fragments submitted to electrocoagulation (20 mm) were extracted and fixed by 75% alcohol; the paraffin inclusions were stained with hematoxylin and eosin, crosssectioned, and submitted to light microscopy. Presence of vacuolization, delamination, coagulation, loss of tissue, perforation, nuclear rarefaction and pyknosis with disappearance of the cellular membrane, and cytoplasm fusion due to the coagulation process were investigated and considered signs of electrocoagulation effects.5,6 The damage of the venous wall was then classified according to the depth of appearance of these effects: group A, intima and media necrosis; and group B, intima, media, and adventitia necrosis. In the postoperative period, occurrence of deep venous thrombosis was investigated by duplex scanning done immediately before the patient’s hospital discharge and 30 days after the procedure. The histologic evaluation of the studied fragments showed damage to the intima in all specimens, fullthickness vessel injury in 53 specimens (53%), and perforation in 1 (1%) (Table II). Samplings of the vessel wall circumference damages caused by the electrocoagulation are shown in Fig 2. The temperature reached at the tissue adjacent to the electrocoagulation (median, 51.6 C; minimum, 32 C; maximum, 82.2 C; P ¼ .0006) and the depth of vessel destruction (P < .0005) were correlated to the energy of electrocoagulation applied. The initial GSV diameter (median, 5.36 mm; minimum, 2.3 mm; maximum, 10 mm; odds ratio [OR], 0.96; P ¼ .82) and body index mass (median, 24.7 kg/m2; minimum, 15.6 kg/m2; maximum, 36.2 kg/m2; OR, 1.08; P ¼.26) showed a poor correlation with the depth of histologic vessel destruction. The time of electrocoagulation (OR, 1.26; P ¼ .0009) was found to be a stronger predictor of this phenomenon than the power used (OR, 1.05; P < .0001) (Table III). We fixed the electrocoagulation time and measured what would be the power that minimizes the chances of adventitia layer necrosis and considered that this fact would be tolerable in 10% of the cases. We found that the best power time ratio would be 60.4 W 5 seconds, 58.8 W 10 seconds, and 8.9 W 15 seconds (Fig 3). DISCUSSION Laser and radiofrequency energy causes thermal ablation of the inner layers of the vessel and promotes their Table I. Endovenous electrocoagulation randomization table Group I II III IV V VI VII VIII IX X Energy (J) Power (W) 0 300 600 900 450 900 1350 600 1200 1800 0 60 60 60 90 90 90 120 120 120 Time, seconds 15 5 10 15 5 10 15 5 10 15 JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS Volume 2, Number 3 Table II. Presence of thermal damage found in the intraluminal surface of 100 great saphenous vein (GSV) fragments subjected to endovenous electrocoagulation and examined by light microscopy Circumference No. % Statistical analysis Intima and media (group A) Intima, media, and adventitia (group B) Perforation 100 53 100 53 c2 1 1 P ¼ .0003 occlusion.5,7 Although good clinical results have been shown, the complete mechanism of action of these procedures is still poorly understood.8,9 Few histologic studies have been done of GSV alterations produced by thermal damage.5 In an animal model, we showed that conventional electric energy could selectively cause the destruction of the inner layers of veins.3 Previous studies have demonstrated the applications of electrocoagulation, but inconclusive results and the lack of familiarity with catheterization techniques by the vascular surgeons of the past discouraged its clinical application.10-16 Thermal ablation treatment success depends on high temperatures, but this factor may lead to the injury of structures that are adjacent to the vessel treated. Complications such as pain, skin burns, nerve damage, and deep venous thrombosis may occur. A number of recent studies have tried to reduce these complications by changing the methods of application of the radiofrequency ablation and laser energy,8,9 and others have tried new methods of GSV occlusion with steam17 and glue.18 The heat changes produced by laser energy and radiofrequency ablation on the venous wall are apparently dependent on fluency (F), which represents the result of power expressed in watts multiplied by time (T) of exposure Rossi et al 317 divided by irradiated surface (S) ratio (F ¼ W T/S). This also seems to be true for GSV electrocoagulation, as could be shown in our previous publications. During these experiments, we also found that these parameters were higher than those necessary in laser and radiofrequency thermal ablation.3,4 In bipolar radiofrequency ablation, the energy heats the catheter and is transmitted to the vessel wall by convection (so the tumescence anesthesia is necessary).19 In electrocoagulation, the heat is created at the contact points between the wire and the vessel wall. In conventional monopolar electrosurgery, the active electrode is located in the surgical site; in our method, it is inside the vessel. The patient return electrode is somewhere else on the patient’s body. The current passes through the patient’s body as it completes the circuit from the active electrode to the patient return electrode. Therefore, some energy may be lost during this process. For these reasons, we specifically studied the GSV diameter and the patient’s body mass index and found that these variables did not interfere with the depth of electrocoagulation vessel destruction. The average temperatures observed during endovenous electrocoagulation in this study were lower than those achieved during laser and radiofrequency treatment.20 This suggests that mechanisms other than thermal ablation may be involved. Some authors have found that electric burns cause tissue destruction by thermoelectric and also by electromechanical effectsdthe breakdown of cell membranes by electric and mechanical stress.21 We still do not know if this phenomenon happens during endovenous electrocoagulation, but this could be an advantage, as we know that high temperatures may be also responsible for adjacent tissue complications. Tumescence anesthesia is essential in laser and radiofrequency endovenous ablation. The pressure of the fluid reduces the diameter of the vein, thus optimizing the contact of the fiber with the vein wall. Endovascular Fig 2. Cross-section of great saphenous vein (GSV) proximal fragment taken immediately after endovenous electrocoagulation. Group A: Necrosis (*), loss of substance of the intima (I), and vacuolization of the internal elastic and internal layers of the media (M) are visible. The adventitia layer (A) is intact (hematoxylin and eosin stain, 25). Group B: Vessel full-thickness thermal damage is evident. Necrosis (*), delamination in the intima (I), and delamination and coagulation in the media (M) and adventitia (A) are visible (hematoxylin and eosin stain, 60). JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS July 2014 318 Rossi et al Table III. Predicted odds ratio (OR) for great saphenous vein (GSV) diameter, body index mass, time, and power of the depth of vessel wall damage provoked by endovenous GSV electrocoagulation 95% CI for OR GSV diameter Body index mass Time, seconds Power, W OR Lower Upper P value 0.960 1.080 1.260 1.050 0.680 0.945 1.099 1.029 1.357 1.233 1.446 1.071 .8189 .2590 .0009 <.0001 CI, Confidence interval. electrocoagulation works without tumescent anesthesia, and this can be an advantage, as it simplifies the method. This is possible because its peripheral metal head has a coil effect, and when it leaves the delivery catheter, it opens and stays in contact with the varicose vein wall intima. As the electric current passes through the varicose vein wall layers, it generates heat and cellular necrosis. We previously determined that the time of electrocoagulation is a stronger predictor of varicose vein wall necrosis than the power of energy applied.4 In this study, we decided to fix the electrocauterization time and accepted that a 10% vessel perforation ratio would be tolerable. We found that the best ratio would be 60.4 W 5 seconds, 58.8 W 10 seconds, and 8.9 W 15 seconds. Corcos et al5 studied GSV fragments subjected to endovenous diode 808-nm laser irradiation. The intimal layer appeared to be damaged in all the samples. The frequency of the penetration in the other tissues progressively decreased from the inner to the external layers. A fullthickness thermal damage involving the adventitia was observed in 6 (20.69%) of 29 specimens. In our study, the intima and media layer was damaged in 100% of the cases, whereas the adventitia layer appeared to be involved in 53% of the cases, and perforation was found only in one case. The electrocoagulation apparatus here presented has a low profile, navigates well, and is safe and fully compatible with current endovascular equipment and treatment techniques. The energy source is the electrosurgery equipment present in any surgical center. It may become a less costly and more versatile way of varicose vein thermal ablation. Despite the excellent results presented, this study has some limitations. Electrocoagulation seems to work well and to be safe but was performed in a small venous fragment with maximum 12-mm diameter. The histologic study analyzed only its immediate effects. We do not know yet if these acute alterations would be sufficient to provoke long-term GSV thermal ablation that is necessary for definitive varicose vein treatment. CONCLUSIONS Endovascular electrocoagulation may cause varicose saphenous vein wall destruction. This effect is correlated to power, energy intensity, and duration of application used. The time of application of energy is a stronger predictor of its effects than the power applied. Body mass index and saphenous vein initial diameter did not correlate with the depth of vessel wall damage. Determination of the best time and power of electrocoagulation may help optimize closure rates and the complications index of lower limb endovenous varicose vein treatment. AUTHOR CONTRIBUTIONS Conception and design: FR, NI Analysis and interpretation: FR, CB, MZ, PM Data collection: FR, CB, MZ Writing the article: FR, CR Critical revision of the article: AS, CR, FR Final approval of the article: FR, CB, MZ, PM, CO, NI, AS Statistical analysis: FR Obtained funding: FR Overall responsibility: FR REFERENCES Fig 3. Best time and power of electrocoagulation index necessary to cause intima and media but not adventitia layer necrosis (10% tolerance). 1. Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, et al. 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