Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-blinded, Randomized Study (RECOVERY Study)
| Autor: | Paramjit S. Chopra, Raymond G. Makhoul, Jeffrey K. Raines, Christian Wenzel, Tim Richards, Jose I. Almeida, Daniel F. Hoheim, John A. Kaufman, Martin T. Evans, Oliver Göckeritz |
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| Rok vydání: | 2009 |
| Předmět: |
Male
medicine.medical_specialty Ecchymosis Comorbidity law.invention Varicose Veins Randomized controlled trial Quality of life law medicine Humans Single-Blind Method Radiology Nuclear Medicine and imaging business.industry Great saphenous vein Reflux Middle Aged medicine.disease United States Surgery Tenderness Treatment Outcome Venous Insufficiency Catheter Ablation Female Laser Therapy medicine.symptom Cardiology and Cardiovascular Medicine business After treatment |
| Zdroj: | Journal of Vascular and Interventional Radiology. 20:752-759 |
| ISSN: | 1051-0443 |
| Popis: | Purpose The present study was designed to address the hypothesis that radiofrequency (RF) thermal ablation, as represented by the ClosureFAST system, is associated with improved recovery and quality-of-life (QOL) parameters compared with 980-nm endovenous laser (EVL) thermal ablation of the great saphenous vein (GSV). Materials and Methods Eighty-seven veins in 69 patients were randomized to ClosureFAST or 980-nm EVL treatment of the GSV. The study was prospective, randomized, single-blinded, and carried out at five American sites and one European site. Primary endpoints (postoperative pain, ecchymosis, tenderness, and adverse procedural sequelae) and secondary endpoints (venous clinical severity scores and QOL issues) were measured at 48 hours, 1 week, 2 weeks, and 1 month after treatment. Results All scores referable to pain, ecchymosis, and tenderness were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. Minor complications were more prevalent in the EVL group ( P = .0210); there were no major complications. Venous clinical severity scores and QOL measures were statistically lower in the ClosureFAST group at 48 hours, 1 week, and 2 weeks. Conclusions RF thermal ablation was significantly superior to EVL as measured by a comprehensive array of postprocedural recovery and QOL parameters in a randomized prospective comparison between these two thermal ablation modalities for closure of the GSV. |
| Databáze: | OpenAIRE |
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