TY - JOUR
T1 - Radiofrequency Endovenous ClosureFAST versus Laser Ablation for the Treatment of Great Saphenous Reflux
T2 - A Multicenter, Single-blinded, Randomized Study (RECOVERY Study)
AU - Almeida, Jose I.
AU - Kaufman, John
AU - Göckeritz, Oliver
AU - Chopra, Paramjit
AU - Evans, Martin T.
AU - Hoheim, Daniel F.
AU - Makhoul, Raymond G.
AU - Richards, Tim
AU - Wenzel, Christian
AU - Raines, Jeffrey K.
N1 - Funding Information:
This work was supported by VNUS Medical Technologies (San Jose, California).
PY - 2009/6
Y1 - 2009/6
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jvir.2009.03.008
DO - 10.1016/j.jvir.2009.03.008
M3 - Article
C2 - 19395275
AN - SCOPUS:67349155318
SN - 1051-0443
VL - 20
SP - 752
EP - 759
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 6
ER -