First- and second-generation drug-eluting balloons for femoro-popliteal arterial obstructions: update of technique and results

Item does not contain fulltextThe use of drug-eluting balloons for treatment of long-segment femoropopliteal artery obstructions has become widespread in recent years. The possibility to deliver a drug into the arterial wall with sustained antiproliferative effects, without leaving behind metal scaffolding, seems very promising. The current generation of drug-eluting balloons differs in the formulation of the drug (usually paclitaxel), technique of coating, and the elution excipients. Results of published randomized trials are reviewed in this report. A new innovative coating technique has been introduced recently. The PRIMUS(R) coronary drug-eluting balloon and the Legflow(R) peripheral drug-eluting balloon consist of paclitaxel nanoparticles that are embedded underneath the surface of the balloon as well as inside a new shellolic acid drug-release matrix. Risk for dislodgement of the paclitaxel particles is minimized in the newest generation of drug-eluting balloons. Short-term in vitro and in vivo results of this stable, coated balloon are promising, and large randomized trials have been started recently to gather more long-term and robust clinical data

Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study

Item does not contain fulltextPURPOSE: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. In a pilot study, 30 limbs in 25 patients (18 women; mean age 52 years) with GSV incompetence were treated with MOCA using polidocanol at 2 centers. Initial technical success, complications, patient satisfaction, and classification by venous clinical severity score (VCSS) were assessed 6 weeks after the treatment. RESULTS: Initial technical success of MOCA was 100%. There were no major adverse events. Minor complications consisted of 9 local ecchymoses at the puncture site and superficial phlebitis that resolved within a week in 4 limbs. Duplex ultrasonography at 6 weeks showed 26 (87%) of 30 veins were completely occluded; 3 veins showed partial recanalization in the proximal (n = 2) and distal GSV. One patient had full segment recanalization and was successfully retreated. The VCSS significantly improved at 6 weeks (p < 0.001). Patient satisfaction was high, with a median satisfaction of 8.8 on a 0-10 scale. CONCLUSION: This study showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of GSV incompetence. Larger studies with a prolonged follow-up are indicated to prove the efficacy of this technique in terms of obliteration rates