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The ClariVein OC endovenous occlusion catheter (Merit Medical) is associated with a good occlusion rate, comparable with other techniques including thermal, without major complications. This is according to a five-year Italian experience with the mechanochemical ablation device, which has been published in the Journal of Vascular Surgery (JVS).1 Another key take-home message from the study is that beginning infusion of the physician-specified agent (PSA) at point of mechanical pullback (protocol 2) produced higher occlusion rates compared to the traditional ClariVein OC technique (protocol 1) with delayed PSA infusion.
The authors, Mattia Mirandola (Ospedale Pederzoli, Verona, Italy) and colleagues explain that mechanochemical endovenous ablation is a non-thermal method to ablate superficial incompetent veins. They note that it was their aim in the JVS paper to assess short-term complications and five-year follow-up outcomes.
This was a retrospective single-centre study of data collected prospectively. “We treated, in an outpatient setting, 395 primary, symptomatic, unilateral, incompetent varicose saphenous veins,” Mirandola et al detail in their methods section. They add that no patients were treated bilaterally in the same session. The majority, the authors continue, were great saphenous veins (92.3%), and the others were small saphenous veins. Procedures were performed with the ClariVein OC catheter and polidocanol 2% in liquid form.
Mirandola and colleagues relay that follow-up was available for 329 patients treated between September 2012 and September 2017 with a mean follow-up time of 20±18 months (range, 6–60 months).
Technical success was achieved in 99.5%, the investigators report in JVS, adding that in two patients they were unable to complete the procedure because of vein spasm leading to catheter damage and inability to infuse the sclerosant. The authors also note that high occlusion rates were recorded for both techniques throughout the study, with a 94–84% rate for protocol 1 and a 95–92% rate for protocol 2.
Communicating further findings, Mirandola et al reveal that the overall survival rate free from recanalisation was 92.4%. In addition, they state that anatomic success was 94% at one year, 91% at two years, 88% at three years, 88% at four years, and 84% at five years. The follow-up at five years, they detail, included 23 patients, five of whom presented with recanalisation. Moreover, the authors note that the veins completely disappeared on duplex ultrasound scan in 36% of cases in this series.
Furthermore, the researchers highlight that, “interestingly,” they did not find a difference in anatomic success in patients with larger vein diameters. They write: “Even though the number of patients with an average diameter >10mm was low in our series, we have not found a significant statistical difference in diameter in the groups with and without revascularisation.”
Speaking to Venous News following publication of these results, Mirandola notes that the JVS paper was the first report showing five-year results for mechanochemical endovenous ablation of great and small saphenous veins.
“ClariVein OC is a non-thermal non-tumescent [NTNT] technique,” Mirandola explains, going on to note that he and his team were the first to use the device in Italy in 2012. At this time, he recalls, there were no guidelines on mechanochemical ablation. Nowadays, however, Mirandola mentions that the National Institute for Health and Care Excellence (NICE) in the UK supports the use of ClariVein OC and the European Society for Vascular Surgery (ESVS) endorses ClariVein OC with a grade II level A recommendation when an NTNT technique is preferred.
Focusing in on the context of their five-year results, Mirandola underlines the fact that the team’s series showed “very similar results at one, two and three years to other studies in the literature”.
“ClariVein OC in our experience is a safe technique and it promises comparable treatment efficacy without the added morbidity associated with high thermal energies,” he continues, commenting on the wider importance of the results. Andreas Griso, another author of the paper comments: “The potential of treating venous reflux in a faster way, without anaesthesia and eliminating the need for tumescent anaesthesia, has changed my approach to superficial venous disease.” Specifically, he remarks on the “great pushability” of the catheter and the importance of its J-shaped tip—both factors that he says are “incomparable” in tortuous veins.
“It has been ages since we started using ClariVein OC and it is now my first choice in very superficial and suprafascial veins, small saphenous veins, and great saphenous veins below the knee,” Mirandola summarises.
Visit the Merit Medical website for more information: ClariVein® OC Infusion Catheter – Maximum Results, Fast Recovery – Merit Medical
- Mirandola M, Griso A, Migliara B, et al. An Italian experience with mechanochemical ablation of the saphenous vein since 2012. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2020 Nov;8(6):999-1005.
Disclaimer: ClariVein OC is not approved, cleared, or available for sale in the USA. Before using any product, refer to the instructions for use (IFU) for indications, contraindications, warnings, precautions, and directions for use.