Centrum Oosterwal

ObjectiveThe short-term anatomical success rates of mechanochemical ablation using the Clarivein device (Merit Medical) in the treatment of great saphenous vein (GSV) incompetence are high. However, the anatomical success rates seem to drop over time. The aim of this study was to determine the long-term outcomes of GSV treatment using the Clarivein and to assess whether specific anatomical features better correlate with clinical or quality of life (QoL)-related outcomes. MethodsThis is a single-center, prospective cohort study in follow-up of a multicenter, randomized controlled trial using Clarivein with liquid polidocanol for the treatment of GSV incompetence. The primary outcome was anatomical success (AS), defined as complete occlusion or a recanalized segment, irrespective of reflux, of <10 cm in length. In addition, reflux-free anatomical success (RF-AS) was determined, and defined as complete occlusion or a recanalized segment with <10 cm of reflux. Clinical success was assessed using the Venous Clinical Severity Score (VCSS), and QoL was assessed using the Dutch version of the Aberdeen Varicose Vein Questionnaire (DAVVQ) and the 36-Item Short Form Health Survey (SF-36). Subgroup analyses were performed based on whether AS or RF-AS was achieved or not. ResultsA total of 109 patients (115 limbs) were included. The mean follow-up time was 8.4 ± 0.9 years (range, 5.5-10.3 years). AS was seen in 60.5% of limbs, and RF-AS was seen in 72.8% of limbs. Compared with baseline, the overall mean VCSS improved from 5.3 ± 2.4 to 4.1 ± 2.4, and the overall median DAVVQ score from 13.5 (interquartile range [IQR], 8.7-20.0) to 10.5 (IQR, 5.3-16.2) (P < .001). Improvement in VCSS was only significant in patients with successful treatment: from 5.5 ± 2.7 to 3.7 ± 2.5 (P < .001) if AS was achieved and from 5.0 ± 1.7 to 4.5 ± 1.9 (P = .20) if AS was not achieved. The same results were found for DAVVQ scores: improvement from13.5 (IQR, 8.7-20.6) to 10.3 (IQR, 3.0-14.5) (P < .01) if AS was achieved and from 12.9 (IQR, 8.3-19.3) to 10.8 (IQR, 6.7-18.2) (P = .35) if AS was not achieved. Regarding the overall SF-36 scores, the domains of vitality, mental health, and general health worsened significantly. ConclusionsIn over 8 years of follow-up, the anatomical success rate after the treatment of GSV incompetence using the Clarivein device decreased to 60.5%. However, clinical scores and disease-specific QoL still improved significantly compared with baseline. We found no convincing evidence that the absence of reflux correlates better with clinical and QoL-related outcomes compared with recanalization irrespective of reflux.

ABSTRACTIntroduction: The treatment of incompetent truncal veins has been innovated by the introduction of minimally invasive non-thermal non-tumescent (NTNT) techniques. One of these consists of the use of cyanoacrylate glue to occlude the vein lumen by means of the VenaSeal device.Areas covered: This expert-review aims to evaluate NTNT ablation of incompetent saphenous trunks using the VenaSeal device.Expert commentary: Cyanoacrylate adhesive embolization of incompetent truncal veins using the VenaSeal device is a safe and efficacious innovative technique. Further studies are needed to evaluate anatomical and clinical outcomes at long term.

Less invasive endovenous techniques have been shown to be as effective as open surgery in the treatment of varicose veins. Furthermore, they cause less postoperative bruising and pain and enable early return to normal activities and work. Tumescent anaesthesia is safe and obviates complications of general or spinal anaesthesia. Drawbacks are a steep learning curve and painful administration during treatment. Tumescentless techniques like Clarivein™ or VenaSeal™ Sapheon Closure System are recently under investigation. Short-term results of VenaSeal™ are comparable with thermal ablation. The procedure is safe without serious adverse events. Perioperative pain and patient discomfort with this tumescentless approach is minimal but postoperative recovery is temporarily hindered by thrombophlebitis in 14-15 % of patients. One-year results in a small feasibility study has demonstrated durable closure at this endpoint. No longer-term results are available. A randomized control trial between VenaSeal™ and Covidien ClosureFast™ is in a preparatory phase.

Up to now compression is the best treatment for patients with chronic venous insufficiency.