Early Results With a New Endovenous Radiofrequency Ablation Catheter, Venclose®

Abstract

Endovenous Radio-frequency Ablation (RFA) has become a common treatment for chronic venous insufficiency. The Medtronic® Closurefast catheter was previously the only RFA catheter approved for use in this procedure. In 2018 VenClose® Company's new device was approved. As there has been little literature on this new device, we examined our results with this new alternative. Patients with symptomatic venous insufficiency had their lower extremities mapped via ultrasound. If superficial reflux (>.5 s) was found the patients were recommended a 6-week conservative course of compression stockings, elevation, and NSAIDs. If conservative treatment failed, the patient was scheduled for an RFA. The procedure was done at the outpatient clinic, instructions were given to return for follow-up in 3-5days, and every 3months thereafter for the first year. 1032 procedures were performed over 14months. We had 503 patients, 69% female, mean age 54 ± 12. Under the CEAP system, clinical manifestation portion, the majority of our limbs were class C3 and class C4. The majority of veins closed were GSV above knee and SSV. Follow-up duration ranged from 1 to 276days (Mean (M) = 10 SD: 20days). Our success rate was 99.32% at initial follow-up. We observed EHITs in 12 cases (1.16%), 8 of which were class I, 2 of which were class II, and 2 of which were class III. We noted SVTs of proximal varicose veins in 40 cases (3.88%) and SVT of distal GSV in 4 cases (.38%). There were 4 (.38%) cases of DVT, 3 in calf muscular veins (.29%), and one in a perforator vein (.09%). We observed two cases of puncture abscess (.193%), 8 cases of infection at the puncture site (.77%), with 8 infections occurring at locations other than the puncture site and not as a result of the procedure. These preliminary results indicate that this new machine and catheter are promising with low rates of EHIT, recanalizations, and other complications. It is important to research this catheter and further studies should continue to follow up to examine recanalization rates over a more long-term follow-up.