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Prospective, double-blind, randomized controlled trial comparing electrocoagulation and radiofrequency in the treatment of patients with great saphenous vein insufficiency and lower limb varicose veins.
J Vasc Surg Venous Lymphat Disord. 2018 03; 6(2):212-219.JV

Abstract

OBJECTIVE

Thermoablation has been replacing conventional surgery in the surgical treatment of great saphenous vein (GSV) reflux in patients with lower limb varicose veins; however, thermoablation is expensive. Intravenous electrocoagulation (EC) may, selectively and safely, cause necrosis of the GSV wall, but the clinical results have never been studied. The objective of this study was to compare EC and radiofrequency ablation (RFA) in the treatment of GSV insufficiency, considering efficacy, complications, and effect on quality of life.

METHODS

This was a prospective, double-blind, randomized clinical trial. Patients with lower limb varicose veins and GSV reflux confirmed by duplex ultrasound were randomized into two treatment groups: EC and RFA. Patients were followed up at 1 week, 3 months, and 6 months after the procedure. Occlusion of the GSV confirmed by duplex ultrasound was considered the primary outcome, and the rate of complications and improvement in quality of life, using the Aberdeen Varicose Vein Questionnaire score, were the secondary outcomes.

RESULTS

Fifty-seven patients were included, with a total of 85 treated GSVs; 43 were treated with RFA and 42 with EC. There was no statistically significant difference between the groups regarding age (P = .264), sex (P = .612), Aberdeen Varicose Vein Questionnaire score (P = .054), and diameter (P = .880) and depth (P = .763) of the treated GSV. In the intraoperative period, immediately after thermoablation, all GSVs treated with EC presented no flow and incompressibility in the treated segment, whereas 12 limbs still had flow in the treated GSV (P < .001) and 9 veins showed compressibility (P < .001) when treated with RFA. The main postoperative complication was paresthesia; however, there was no statistical significance between the groups (P = .320) regarding its presence. Time to return to routine activities was lower in the EC group than in the RFA group (P = .026). There was no difference between the groups at the 3-month (P = .157) and 6-month (P = .157) follow-up in occlusion of the GSV and improvement of the quality of life score (P = .786 and P = .401, respectively).

CONCLUSIONS

EC has been shown to be an effective method for ablation of the GSV, with venous occlusion rate, occurrence of complications, and effect on quality of life similar to those with RFA.

Authors+Show Affiliations

Dante Pazzanese Institute of Cardiology, São Paulo, Brazil. Electronic address: camilabaumann@yahoo.com.br.Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.Unilago University School of Medicine, São Paulo, Brazil.Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.Dante Pazzanese Institute of Cardiology, São Paulo, Brazil.Department of Radiology, Arizona Heart Hospital, Phoenix, Ariz.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29229466

Citation

Beteli, Camila Baumann, et al. "Prospective, Double-blind, Randomized Controlled Trial Comparing Electrocoagulation and Radiofrequency in the Treatment of Patients With Great Saphenous Vein Insufficiency and Lower Limb Varicose Veins." Journal of Vascular Surgery. Venous and Lymphatic Disorders, vol. 6, no. 2, 2018, pp. 212-219.
Beteli CB, Rossi FH, de Almeida BL, et al. Prospective, double-blind, randomized controlled trial comparing electrocoagulation and radiofrequency in the treatment of patients with great saphenous vein insufficiency and lower limb varicose veins. J Vasc Surg Venous Lymphat Disord. 2018;6(2):212-219.
Beteli, C. B., Rossi, F. H., de Almeida, B. L., Izukawa, N. M., Onofre Rossi, C. B., Gabriel, S. A., Kambara, A. M., de Moraes Rego Sousa, A. G., & Thorpe, P. (2018). Prospective, double-blind, randomized controlled trial comparing electrocoagulation and radiofrequency in the treatment of patients with great saphenous vein insufficiency and lower limb varicose veins. Journal of Vascular Surgery. Venous and Lymphatic Disorders, 6(2), 212-219. https://doi.org/10.1016/j.jvsv.2017.09.010
Beteli CB, et al. Prospective, Double-blind, Randomized Controlled Trial Comparing Electrocoagulation and Radiofrequency in the Treatment of Patients With Great Saphenous Vein Insufficiency and Lower Limb Varicose Veins. J Vasc Surg Venous Lymphat Disord. 2018;6(2):212-219. PubMed PMID: 29229466.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective, double-blind, randomized controlled trial comparing electrocoagulation and radiofrequency in the treatment of patients with great saphenous vein insufficiency and lower limb varicose veins. AU - Beteli,Camila Baumann, AU - Rossi,Fábio Henrique, AU - de Almeida,Bruno Lorenção, AU - Izukawa,Nilo Mitsuru, AU - Onofre Rossi,Cybelle Bossolani, AU - Gabriel,Sthefano Atique, AU - Kambara,Antônio Massamitsu, AU - de Moraes Rego Sousa,Amanda Guerra, AU - Thorpe,Patricia, Y1 - 2017/12/09/ PY - 2017/07/22/received PY - 2017/09/21/accepted PY - 2017/12/13/pubmed PY - 2018/10/10/medline PY - 2017/12/13/entrez SP - 212 EP - 219 JF - Journal of vascular surgery. Venous and lymphatic disorders JO - J Vasc Surg Venous Lymphat Disord VL - 6 IS - 2 N2 - OBJECTIVE: Thermoablation has been replacing conventional surgery in the surgical treatment of great saphenous vein (GSV) reflux in patients with lower limb varicose veins; however, thermoablation is expensive. Intravenous electrocoagulation (EC) may, selectively and safely, cause necrosis of the GSV wall, but the clinical results have never been studied. The objective of this study was to compare EC and radiofrequency ablation (RFA) in the treatment of GSV insufficiency, considering efficacy, complications, and effect on quality of life. METHODS: This was a prospective, double-blind, randomized clinical trial. Patients with lower limb varicose veins and GSV reflux confirmed by duplex ultrasound were randomized into two treatment groups: EC and RFA. Patients were followed up at 1 week, 3 months, and 6 months after the procedure. Occlusion of the GSV confirmed by duplex ultrasound was considered the primary outcome, and the rate of complications and improvement in quality of life, using the Aberdeen Varicose Vein Questionnaire score, were the secondary outcomes. RESULTS: Fifty-seven patients were included, with a total of 85 treated GSVs; 43 were treated with RFA and 42 with EC. There was no statistically significant difference between the groups regarding age (P = .264), sex (P = .612), Aberdeen Varicose Vein Questionnaire score (P = .054), and diameter (P = .880) and depth (P = .763) of the treated GSV. In the intraoperative period, immediately after thermoablation, all GSVs treated with EC presented no flow and incompressibility in the treated segment, whereas 12 limbs still had flow in the treated GSV (P < .001) and 9 veins showed compressibility (P < .001) when treated with RFA. The main postoperative complication was paresthesia; however, there was no statistical significance between the groups (P = .320) regarding its presence. Time to return to routine activities was lower in the EC group than in the RFA group (P = .026). There was no difference between the groups at the 3-month (P = .157) and 6-month (P = .157) follow-up in occlusion of the GSV and improvement of the quality of life score (P = .786 and P = .401, respectively). CONCLUSIONS: EC has been shown to be an effective method for ablation of the GSV, with venous occlusion rate, occurrence of complications, and effect on quality of life similar to those with RFA. SN - 2213-3348 UR - https://www.unboundmedicine.com/medline/citation/29229466/Prospective_double_blind_randomized_controlled_trial_comparing_electrocoagulation_and_radiofrequency_in_the_treatment_of_patients_with_great_saphenous_vein_insufficiency_and_lower_limb_varicose_veins_ DB - PRIME DP - Unbound Medicine ER -