TREATMENT OF VARICOSE VEINS: CAN IT BE IMPROVED BY MECHANOCHEMICAL ABLATION USING THE CLARIVEIN DEVICE?
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1 TREATMENT OF VARICOSE VEINS: CAN IT BE IMPROVED BY MECHANOCHEMICAL ABLATION USING THE CLARIVEIN DEVICE? Michel MJP Reijnen Rijnstate Hospital, Arnhem The Netherlands
2 Disclosures Consultancy and research funding W.L. Gore and associates Vascular Insights LLC Atrium Maquet Getinge Group
3 Current ablative techniques Need for tumescence Risk for thermal injury Postoperative pain Hardware
4 Mechanochemical endovenous ablation MOCA Mechanism of action: Combination: Mechanical damage + Sclerotherapy Mechanical: rotating wire intimal / cellular damage and spasm of the vein Pharmacotherapy: sclerosans penetrates vessel wall scar formation MOCA is NOT a variation on foam sclerosing
5 Mechanochemical endovenous ablation MOCA
6 MOCA : The Clarivein catheter 4 Fr. micropuncture sheath Small caliber catheter (2.7 Fr) Soft, flexible infusion catheter Rotating wire included in the catheter Bended tip facilitates catheterization
7 Initial trials U.S.A. 30 GSV Sotradecol Mean diameter GSVs Mean length GSVs GSV treatment time Treatment time 8 mm 36 cm 5 min 14 min Elias S, Raines, JK. Mechanochemical tumiscentless endovenous ablation: Final Results of the initial clinical trial. Phlebology Phlebology Feb;27(2):67-72.
8 Initial trials U.S.A. Obliteration 1 month: 30/30 6 months: 29/30 12 months: 20/20 3 patients with ecchymoses (side branches?) Elias S, Raines, JK. Mechanochemical tumiscentless endovenous ablation: Final Results of the initial clinical trial. Phlebology Phlebology Feb;27(2):67-72.
9 Initial trials Netherlands Polidocanol 1.5% 30 GSV in 25 patients M:F = 7:18 GSV diameter GSV length 6.1 ±2.1 mm 40.0±6.6 cm Treatment time 20±4.8 min van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther Jun;18(3):
10 Initial trials Netherlands No nerve injury No DVT No skin injury No neurological or vision disturbances 9 (30%) minor haematoma 4 (13%) induration van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther Jun;18(3):
11 Initial trials Netherlands 6 weeks follow-up (n = 30) 29/30 (97%) obliterated 1 recanalization 3 patients proximal open segment (>4 cm) GSV Anatomical success 87% Fine tuning of technique VCSS: 3.0 (IQR ) to 1.0 (IQR ) Improvement also in group with open proximal segment van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther Jun;18(3):
12 Final results of Clarivein registry study Polidocanol 2.0% (2mL) and 1.5% 105 GSV 2 Dutch centers Primary endpoints Anatomical success at 12 months Clinical success at 12 months Secondary endpoints Complications QOL; SF-36 and AVVQ
13 Final results of Clarivein registry study Inclusion criteria C2-C6 Insufficient GSV Suitable for endovenous treatment (>3mm, tortuosity) Age > 18 years Signed informed consent Exclusion criteria Vein > 12mm Pregnancy and lactation Allergy Polidocanol Previous treatment of ipsilateral leg History of deep venous thrombosis Use of anticoagulant
14 Final results of Clarivein registry study M:F 3:7 CEAP C2 37 C3 36 C4 34 C5 32 C6 2 VCSS 4 (IQR 3-5) GSV diameter 6.0 ±1.8 mm GSV length 45 ±8 cm
15 Final results of Clarivein registry study Treatment time Volume polidocanol 11 ±3 min 5.4 ± 1.4 ml Complications: No nerve injury, DVT, neurological or vision disturbances 3 (3%) phlebitis 8 (8%) minor hematoma 11 (10%) induration Patient satisfaction: 8.8 ± 1.1
16 Final results of Clarivein registry study 6 months 12 months Clinical success 94% Clinical success 95% Improvement 94% Improvement 95% Deterioration 0% Deterioration 1% Identical 6% Identical 4% VCSS 1 (IQR 0-2) VCSS 1 (IQR 0-1)
17 Final results of Clarivein registry study 6 months 12 months 102 patients 100 patients Anatomical success 93% Anatomical success 88% 3 open GSV 5 open GSV 4 proximal open segment 7 proximal open segment
18 Final results of Clarivein registry study Aberdeen Varicose Vein Questionaire Instrument which measures HR-QOL in patients with whole spectrum of venous disease (C1-C6) Pre-operative 11.1 (IQR ) One-year 2.2 (IQR )
19 Postoperative pain and early QOL after MOCA and ClosureFast of incompetent GSV Non-randomised cohort study N=34 in each group Endpoints Postoperative pain Use of pain medication Resumption of normal activities and work VCSS QOL (AVVQ, RAND 36) Van Eekeren RRJP, Boersma D, Konijn V, De Vries JPPM, Reijnen MMPJ. Postoperative pain and early quality of life after radiofrequency and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg 2012 Nov 7. [Epub ahead of print].
20 Postoperative pain and early QOL after MOCA and ClosureFast of incompetent GSV Complication rate, clinical outcome and postoperative QOL identical MOCA : Less postoperative pain Less days of pain medication Earlier resumption of normal activities Earlier resumption of work Van Eekeren RRJP, Boersma D, Konijn V, De Vries JPPM, Reijnen MMPJ. Postoperative pain and early quality of life after radiofrequency and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg 2012 Nov 7. [Epub ahead of print].
21 MOCA of the short saphenous vein Incidence sural nerve injury 1.3% -11% First 50 consecutive patients Technical success 100% No major complications, especially no nerve injury or DVT 1-year anatomical success 94% VCSS pre-treatment 3.0 (IQR 2-5) 6 weeks 1.0 (IQR 1-3) 1 year 1.0 (IQR 1-2) P < Boersma D, Van Eekeren RJA, Werson, DAB, Van der Waal RIF, Reijnen MMPJ, De Vries JPPM. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein device: One-year results of a prospective series. Eur J Vasc Endovasc Surg, in press.
22 Duplex during follow-up Early postoperative period: no flow but often a compressible vein At 6 months: Vein is visible, but not compressible At 1 year: Vein often not visible anymore
23 Histology 1-year after MOCA Circumferential disappearance of the endothelial layer Considerable damage to the tunica media in an inhomogeneous pattern The original lumen is organized with complex structure of collagen fibers and fibroblasts
24 Conclusions MOCA is a fast and safe technique for GSV and SSV insufficiency The early results are promising with acceptable closure rates MOCA is related to a very low incidence of major complications Learning curve, less forgiving than laser / RFA
25 Critical issues Polidocanol versus sotradecol Optimal dose and pull-back rate Long-term and comparative data Maradona trial randomizing MOCA to ClosureFast for GSV insufficiency
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