SAFETY AND FEASIBILITY OF MECHANO-CHEMICAL ABLATION OF VARICOSE VEINS: INITIAL RESULTS

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1 SAFETY AND FEASIBILITY OF MECHANO-CHEMICAL ABLATION OF VARICOSE VEINS: INITIAL RESULTS Michel M.P.J. Reijnen, M.D., Ph.D. Jean-Paul P.M. de Vries, M.D., Ph.D. Rijnstate Hospital, Arnhem, The Netherlands St Antonius Hospital, Nieuwegein, The Netherlands

2 Venous insufficiency 120 million people in North America / Western Europe Edinburg Vein Study: Incidence saphenous varicose veins: 40% male 32% female Incidence telangiectasias or reticular veins: 80% Bonn Vein Study: Only 9.6% of the population (13.6% men, 6.4% women) had no signs of venous disorders 1. Evans CJ et al. J Epidemiol Community Health. 1999;53: Rabe E et al. Phlebologie. 2003;32:1-14.

3 US varicose vein procedures Surgery RF Laser Source: Millennium Research Group, Nov 2005 & MedTech Insight, Oct 7, 2005

4 Current endovenous techniques Catheter based Need for tumescence (sedation) Risk for thermal injury Postoperative pain Hardware Energy source / generator

5 Mechano-Chemical Endovenous Ablation (MOCA ) Mechanism of action: Combination: Mechanical damage + Sclerotherapy Mechanic: rotating wire intimal/ cellular damage and spasm of the vein Sclerotherapy: penetrates vessel wall scar formation MOCA is NOT a variation on foam sclerosing

6 Mechano-Chemical Endovenous Ablation MOCA

7 Mechano-Chemical Endovenous Ablation MOCA Advantages: No tumescence No heating Quick procedure / comfortable for patient No hardware In-office procedure

8 MOCA : Clarivein Catheter 4 Fr. micropuncture sheath Small caliber (2.7 Fr) Soft, flexible infusion catheter Rotating wire included in the catheter Bended tip faciliates catheterisation

9 Mechano-Chemical Endovenous Ablation (MOCA ) Patient in horizontal position Start rotating first to creat spasm Pullback rate of 7 sec per cm Inject sclerosans slowly during pullback Compression stockings first 24 hrs continuously and 2 weeks during daytime Full activity immediately

10 Mechano-Chemical Endovenous Ablation (MOCA ) Courtesy Steve Elias, Mount Sinai NY and Englewood NJ Hospitals

11 Results Courtesy Steve Elias, Mount Sinai NY and Englewood NJ Hospitals 30 GSV, Sotradecol Mean diameter GSVs 8 mm Mean length GSVs 36 cm GSV treatment time 5 min Treatment time 14 min Elias S. Mechano-chemical endovenous ablation (ClariVein TM ) Final Results of the first clinical trial. American College of Phlebology 24 th Annual Congress, Florida. November 3, 2010

12 Results Courtesy Steve Elias, Mount Sinai NY and Englewood NJ Hospitals Obliteration 1 month: 30/30 6 months: 29/30 12 months: 20/20 3 patients with ecchymoses (side branches?) Elias S. Mechano-chemical endovenous ablation (ClariVein TM ) Final Results of the first clinical trial. American College of Phlebology 24 th Annual Congress, Florida. November 3, 2010

13 Results: safety study Rijnstate, Arnhem and St.Antonius, Nieuwegein series Polidocanol 30 GSV in 25 patients M:F = 7:18 GSV diameter 6.1 ±2.1 mm GSV length 40.0±6.6 cm Treatment time 20±4.8 min

14 Results: safety study Rijnstate, Arnhem and St.Antonius, Nieuwegein series No nerve injury No DVT No skin injury No neurological or vision disturbances 9 (30%) minor haematoma 4 (13%) induration

15 Results: safety study Rijnstate, Arnhem and St.Antonius, Nieuwegein series Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Visual analogue scale for pain

16 Results: safety study Rijnstate, Arnhem and St.Antonius, Nieuwegein series 6 weeks follow-up (n = 30) 29/30 (97%) obliterated 1 recanalisation 3 patients proximal open segment (>4 cm) GSV Technical succes 87% Fine tuning of technique VCSS: 3.0 (IQR ) to 1.0 (IQR ) Improvement also in group with open proximal segment

17 Results: Pivotal trial Rijnstate, Arnhem and St.Antonius, Nieuwegein series 97 patients treated (GVS 77, SSV 15, ALB 5) SSV/GSV diameter SSV/GSV length 7.0 ±2.4 mm 34.7±10.9 cm 6 wks follow-up (n = 97) 97/97 (100%) obliterated 3 patients open proximal segment (>4 cm) GSV Technical success: 97% versus 87% in safety study Learning curve!! 6 months results?

18 Results: Pivotal trial Rijnstate, Arnhem and St.Antonius, Nieuwegein series No nerve injury No DVT No skin injury No neurological or vision disturbances 26 (27%) minor haematoma 21 (22%) induration 13 (13%) pain/discomfort > 1 week

19 Conclusions Fast and simple technique Very comfortable for patient No tumescent or hardware No major complications Learning curve

20 Perspectives Fine tuning of the technique Start device 0.5 cm below SFJ Optimal dose sclerosans Pull back speed, monitoring Diameter GSV (>12 mm?) Long-term data necessary Safety study (submitted); Procedure is safe and feasable Multi-centre registries (GSV, SSV) (ongoing) Randomized trials (ethical approval)

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