Long-term results and predictors of failure after mechanochemical endovenous ablation in the treatment of primary great saphenous vein incompetence.

BACKGROUND: Mechanochemical endovenous ablation (MOCA) was introduced to treat superficial venous insufficiency of the lower leg with less pain and haematoma. Long-term outcome is still lacking. The purpose was to report long-term outcome and to analyse possible predictors for failure. METHODS: The study was a retrospective pooled analysis of two prospective cohorts previously reported, but with prolonged long-term outcome up to 5-years follow-up. RESULTS: 163 treated legs were analysed. Mean follow-up was 5.4±0.6 years, in which 33 total failures occurred. Four procedures were partially successful. VCSS improved significantly and remained stable after 1 and 2-years, but significantly rose again after 5-years. AVVQ dropped significantly, but increased after 1 year to 4.3 and 6.1 at 5-years follow-up. CONCLUSION: MOCA was effective with minimal pain perioperative. However, anatomical success deteriorated after 1-year and showed even less results after 5-years, mainly due to partly recanalization, while clinical results were less affected. There were no clear clinical predictors for failure.

Mechanochemical endovenous ablation of saphenous veins using the ClariVein: A systematic review.

Objective To systematically review all available English literature on mechanochemical endovenous ablation and to report on the anatomical, technical, and clinical success. Methods A systematic literature search was performed in PubMed, EMBASE, and the Cochrane Library on mechanochemical endovenous ablation for the treatment of insufficient great and/or small saphenous vein. Methodological quality of the included studies was evaluated using the MINORS score. The primary outcome measure was anatomical success, defined as closure of the treated vein on follow-up duplex ultrasound imaging. Secondary outcomes were technical and clinical success, and major complications defined as deep venous thrombosis, pulmonary embolisms or paresthesia. Results The literature search identified 759 records, of which 13 were included, describing 10 unique cohorts. A total of 1521 veins (1267 great saphenous vein and 254 small saphenous vein) were included, with cohort sizes ranging from 30 to 570 veins. The pooled anatomical success rate after short-term follow up was 92% (95% CI 90-94%) ( n = 1314 veins). After 6 and 12 months these numbers were 92% (95% CI 88-95%) ( n = 284) and 91% (95% CI 86-94%) ( n = 228), respectively. The long-term anatomical success rates at 2 and 3 years were 91% (95% CI 85-95%) ( n = 136) and 87% (95% CI 75-94%) ( n = 48), respectively. Major complications and especially nerve injury were very rare (≤ 0.2%). All studies were of moderate or good quality using the MINORS scoring scale. Conclusions Mechanochemical endovenous ablation using the ClariVein in combination with liquid sclerosant is associated with an anatomical success rate ranging from 87% to 92% and good clinical success. To date, no randomized controlled trials are available studying the anatomical success after mechanochemical ablation, compared to the endothermal ablation. The risk of major complications is very low after the procedure.

Midterm Outcome of Mechanochemical Endovenous Ablation for the Treatment of Great Saphenous Vein Insufficiency.

PURPOSE: To report the midterm results of mechanochemical ablation (MOCA) for treating great saphenous vein (GSV) insufficiency. METHODS: In a 1-year period, 85 consecutive patients (median age 51.4 years; 71 women) undergoing MOCA with polidocanol in 104 limbs were enrolled in a prospective registry. The patients were evaluated at baseline and during follow-up (4 weeks and 1, 2, and 3 years) using duplex ultrasound, the CEAP (clinical, etiologic, anatomic and pathophysiologic) classification, the Venous Clinical Severity Score (VCSS), the RAND Short Form 36-Item Health Survey (RAND-SF36), and the Aberdeen Varicose Vein Questionnaire (AVVQ). Primary outcome measures were clinical and anatomic success. Secondary outcome measures included general and disease-specific quality of life and reinterventions. RESULTS: Technical success (99%) was achieved in all but 1 patient in whom technical problems with the device led to conversion to another method for treatment of 2 limbs. After a median follow-up of 36 months (interquartile range 12.5, 46.3), recanalization occurred in 15 (15%) of 102 successfully treated vein segments. Anatomic success was 92%, 90%, and 87% after 1, 2, and 3 years, respectively. The VCSS improved at all time intervals compared to the preprocedure median. The clinical success at 3 years was 83%. The AVVQ and RAND-SF36 scores showed an improvement at all time intervals compared to baseline values. Between 12 and 36 months, however, a significant deterioration was observed in VCSS, which was accompanied by worsening of disease-specific and general quality of life. CONCLUSION: In the longest follow-up of MOCA to date, this study shows MOCA to be an effective treatment modality for GSV insufficiency at midterm follow-up, but clinical results seem to drop over time.

Mechanochemical Endovenous Occlusion of Varicose Veins Using the ClariVein® Device.

INTRODUCTION: In the last decade, minimally invasive endothermal ablation techniques have replaced surgery for the treatment of superficial venous insufficiency to reduce postoperative complications and recovery time and to improve quality of life. To avoid the risks of nerve damage and need for tumescent anesthesia to improve patient comfort, an alternative heatless technique has been introduced recently. METHODS: Endovenous mechanochemical occlusion using the ClariVein® catheter (Vascular Insights LLC, Quincy, MA) is a new technique combining mechanical injury to the venous endothelium coupled with simultaneous catheter-guided infusion of a liquid sclerosant. This produces irreversible damage to the endothelium resulting in fibrosis of the vein. RESULTS: The technique is related to a low complication rate and a success rate of 96% at two years and sustained quality of life improvement. This closure rate is comparable to endothermal techniques, but significantly less postoperative pain and earlier return to normal activities and work has been reported with endovenous mechanochemical occlusion. CONCLUSION: Mechanochemical occlusion using ClariVein® has proven to be safe and effective and has several advantages compared to endothermal techniques. The possibility of retrograde ablation of distal SSV insufficiency in C6 ulceration is considered a significant advantage. Randomized comparative studies with long-term follow up will continue to define the definite place of mechanochemical occlusion.