Effect of Saphenous Vein Diameter on Closure Rate With ClosureFAST Radiofrequency Catheter

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Abstract
Purpose: Radiofrequency ablation (RFA) of veins >12 mm in diameter has been a controversial subject since the first-generation device was submitted for Food and Drug Administration (FDA) approval. Veins >12 mm were excluded in the initial study. Many insurance carriers used >12 mm size as reason to not approve the procedure. As the concept of tumescent anesthesia was better communicated, RFA was used for large veins. The 12-mm size limit was not used in the studies for the newer ClosureFAST catheter approval, yet remains in force with some insurance companies. Our objective was to determine whether vein diameter >12 mm had effect on closure rates with the Closure-FAST catheter. Methods: ClosureFAST RFA was used to eliminate saphenous reflux in consecutive cases in 1 center. Retrospective analysis was performed on prospectively gathered data. Veins were divided into ≤12 mm diameter (group A) or >12 mm diameter (group B). Duplex scans were scheduled for 2 to 5 days and 6 months postprocedure. Results: A total of 338 great and small saphenous veins were treated, 246 saphenous veins in group A (mean 8 ± 2 mm) and 96 in group B (mean 17 ± 4 mm). Early duplex showed complete closure in 231 veins in group A (94%) and 92 veins in group B (96%; NS). The remaining veins showed partial closure with none showing retrograde flow. Six-month duplex scans were completed in 155 veins. Complete closure was seen in 110 veins in group A (98%) and 43 veins in group B (100%; NS). All veins partially open on early scan had closed by 6 months. The 2 veins open at 6 months in group A were closed on initial scan. Conclusions: Vein diameter >12 mm had no effect on closure rate with the ClosureFAST catheter.