UPDATE: SAPHENOUS TREATMENTS. Pauline Raymond-Martimbeau Dallas Non Invasive Vascular Laboratory Vein Institute of Texas Dallas, Texas, USA

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1 UPDATE: SAPHENOUS TREATMENTS Pauline Raymond-Martimbeau Dallas Non Invasive Vascular Laboratory Vein Institute of Texas Dallas, Texas, USA

2 DISCLOSURE No financial conflicts of interest to disclose Off-label medication & Non-FDA products may be discussed

3 Saphenous vein incompetence is common. GREAT AND SMALL SAPHENOUS VEINS Untreated saphenous incompetence may result in chronic venous insufficiency (CVI). Labropoulos N, Tiongson J, Pryor L, et al. Definition of venous reflux in lowerextremity veins. J Vasc Surg 2003;38: /S (03)

4 CHRONIC VENOUS INSUFFICIENCY CVI is a significant public health problem in the United States. Traditionally treated with high ligation and stripping, minimally invasive techniques have evolved. Non-thermal and thermal procedures are used to treat refluxing saphenous veins.

5 THE CARE OF PATIENTS WITH VARICOSE VEINS AND ASSOCIATED CHRONIC VENOUS DISEASES: CLINICAL PRACTICE GUIDELINES The Society for Vascular Surgery (SVS, the American Venous Forum (AVF) and the American College of Phlebology (ACP) have developed clinical practice guidelines. For treatment of the incompetent great saphenous vein (GSV), they recommend endovenous thermal ablation (radiofrequency or laser) rather than high ligation and inversion stripping of the saphenous vein to the level of the knee (GRADE 1B). They recommend phlebectomy or sclerotherapy to treat varicose tributaries (GRADE 1B) and suggest foam sclerotherapy as an option for the treatment of the incompetent saphenous vein (GRADE 2C). Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011;53:2S-48S /j.jvs Khilnani NM, Grassi CJ, Kundu S, D'Agostino HR, Khan AA, McGraw JK. Multi-society consensus quality improvement guidelines for the treatment of lower-extremity superficial venous insufficiency with endovenous thermal ablation from the Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology and Canadian Interventional Radiology Association. J Vasc Interv Radiol Jan. 21(1):14-31

6 CLINICAL PRACTICE GUIDELINES ACP and other associations suggest Mechanical/chemical ablation (Clarivein Device) may also be used to treat truncal venous reflux. GRADE 2B (2) GSV and SSV must have a reflux time > 500 msec, regardless of the reported vein diameter (GRADE 1A).

7 People who lose their relevance get stuck in the past because they re no longer in the present moment. Marc Benioff

8 NON THERMAL ABLATION Ultrasound guided foam sclerotherapy (UGFS) Polidocanol injectable foam (Varithena) Mechanochemical endovenous ablation (MOCA), (ClariVein) Cyanoacrylate adhesive (Venaseal) Ambulatory phlebectomy Powered phlebectomy (TriVex) V-block VeinOff Balloon sclerotherapy Leopardi D, Hoggan BL, Fitridge RA, Woodruff PW, Maddern GJ. Systematic review of treatments for varicose veins. Ann Vasc Surg Mar. 23(2):

9 THERMAL ABLATION Radiofrequency ablation (RFA) Endovenous laser (ELA) Steam vein ablation or sclerosis (SVS) Endovenous Microwave ablation (EMA) Sadick NS. Advances in the treatment of varicose veins: ambulatory phlebectomy, foam sclerotherapy, endovascular laser, and radiofrequency closure. Dermatol Clin Jul. 23(3):443-55, vi.

10 Pregnancy, Breast feeding Obstructed deep venous system inadequate to support venous return Allergy Liver dysfunction or allergy making it impossible to use a local anesthetic, sclerosant Severe uncorrectable coagulopathy Severe hypercoagulability syndromes Inability to adequately ambulate after the procedure Infectious disease Systemic disease Co-morbidities CONTRAINDICATIONS

11 ULTRASOUND-GUIDED FOAM SCLEROTHERAPY

12 UGFS UGFS uses a detergent sclerosant (sodium tetradecyl sulfate, polidocanol) mixed with air or gas (CO2, CO2/O2) to produce foam. Foam injected intravenously using ultrasound imaging to monitor its progress. Endothelial inflammation, fibrosis and sclerosis occur. European consensus recommended not injecting more than 10 ml per session. Post-injection compression bandages are recommended Rabe E, Breu FX, Cavezzi A, Coleridge Smith P, Frullini A, Gillet JL, et al. European guidelines for sclerotherapy in chronic venous disorders. Phlebology Jul. 29 (6):338-54

13 TESSARI METHOD: 3-WAY VALVE

14 Female-Female connector DSS METHOD: CONNECTOR

15 MARTIMBEAU METHOD: 2ML VIAL WITH A FILTER

16 FOAM INJECTION 16 Direct Injection Butterfly Injection

17 CATHETER

18 Mario Sica, Guide pratique UGFS ENPOINT Vasospam No return of blood Foam moving to proximal vein No systemic side effects

19 FOAM INJECTION

20 POST CARE

21 POLIDOCANOL INJECTABLE FOAM Patent- protected drug/device combination, uniform gas CO2/O2

22 ELA& RFA

23 MECHANISM OF ACTION ELA: Endothelial and vein wall shrinkage by nonspecific heating of the vessel. RFA: Thermal destruction using electrical energy passing through tissue in the form of high-frequency alternating current. Sadek M, Kabnick LS, Berland T, et al. Update on endovenous laser ablation: Perspect Vasc Surg Endovasc Ther Dec. 23(4):233-7.

24 ELA EQUIPMENT ELA can be performed using any of the following wavelengths. Hemoblobin specific: 810 nm (AngioDynamics) 940 nm (Dornier MedTech Americas) 980 nm (Biolitec) 1064 nm (Sharplan) Water specific: 1320 nm (CoolTouch) 1470 nm (Biolitec, Angiodynamics)

25 ELA Different laser fiber can be used. Bare-tip fibers, jacket-tip fibers, radial fibers. At this point, there are no conclusive data demonstrating a superiority of a given fiber, wavelength and energy deposition combination, efficacy, significant adverse effects, or complications as metrics for comparison. Kabnick LS, Caruso JA. EVL Ablation Using Jacket-Tip Laser Fibers. Endovasc Today July

26 RFA Radiofrequency energy is delivered through a special catheter with deployable electrodes at the tip; the electrodes touch the vein walls and deliver energy directly into the tissues without coagulating blood. The newest system, called ClosureFast, delivers infrared energy to vein walls by directly heating a catheter tip with radiofrequency energy. Weiss, M, James WD, Radiofrequency Ablation Therapy for Varicose Veins, Feb. 2016, Medscape

27 TECHNIQUE Leg prepared and draped, and a local anesthetic agent is used for site of cannulation. Entire procedure performed under US guidance: Needle puncture of the vessel Seldinger technique used to place a guidewire into the vessel, and an introducer sheath is passed over the guidewire, which is removed. RF catheter or the laser fiber is passed through the sheath, and the tip is advanced to 2 cm below the SF junction, caudal to the epigastric vein. Anesthetic is injected along the entire course of the vein.

28 TUMESCENT ANESTHESIA IN PERIVENOUS SPACE Although 35 mg/kg with epinephrine has been reported as safe FDA recommends a maximum dose of 5 mg/kg without and 7 mg/kg with epinephrine

29 ANESTHESIA Dilute tumescent anesthetic solution of lidocaine and sodium bicarbonate 0.1% lidocaine w or w/out epinephrine, 5-10 ml/cm of treated vein Used as local anesthetic Used to empty the vein to maximize the contact of the thermal device and the vein wall Protective heat sink around the treated vein to minimize heating of adjacent structures.

30 RESULTS Clinical trials which have compared surgery, foam sclerotherapy, laser ablation and RF ablation have found that the outcomes are clinically assessed and patient reported outcomes are similar. At 1year, all treatments were efficacious. The technical failure rate was highest after foam sclerotherapy, but both radiofrequency ablation and foam were associated with a faster recovery and less postoperative pain than endovenous laser ablation and stripping. Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br. J. Surg. 98(8), (2011) Nesbitt C, Eifell RK, Coyne P, Badri H, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional surgery for great saphenous vein varices. Cochrane Database Syst. Rev. (10),CD (2011).

31 OUTCOMES RFA The ClosureFast catheter has been shown in a prospective, international multicenter study to be 93% effective at three years using Kaplan Meier analysis At 5-year follow-up, radiofrequency segmental thermal ablation remained a successful treatment for over 90% of patients who underwent the therapy for incompetent great saphenous veins. The vein occlusion rate was 91.9% at last follow-up, with the Venous Clinical Severity Score changing from 3.9 at baseline to 0.6 at 1 year, 0.9 at 3 years, and 1.3 at 5 years Proebstle TM, Alm BJ, Gockeritz O, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Br J Surg Feb. 102 (3):212-8.

32 RECURRENCE A study by Bush et al indicated that perforating veins are the most frequent cause of recurrent varicose veins after radiofrequency or laser ablation. Recanalized great saphenous vein: 29% Recanalized small saphenous vein reflux: 15% Bush RG, Bush P, Flanagan J, et al. Factors associated with recurrence of varicose veins after thermal ablation: results of the recurrent veins after thermal ablation study. ScientificWorldJournal :

33 UGFS COMPLICATIONS All treated veins contain some extent of thrombus after treatment. Local superficial phlebitis and secondary telangiectasia with symptoms of discomfort and discoloration. The thrombus usually begins to liquefy within 1 2 weeks of injection and should be drained (after 3 weeks) if there is visible trapping of blood within the vein or if the patient complains of discomfort.

34 UGFS COMPLICATIONS Postsclerotherapy hyperpigmentation is common, with reported incidences ranging from 2% to 80%, and appears to depend upon the choice and concentration of sclerosant solution, vessel size, injection technique, and postprocedure care. More worrisome is the possibility of inadvertent injection of sclerosant into an arteriole. This rare complication may result in areas of ischemia. Anaphylactic choc DVT, PE

35 UGFS COMPLICATIONS There have been a few reports of patients experiencing transient scotoma. The etiology of this experience is unclear, but it may be due to small amounts of foam crossing a clinically silent atrial septal defect. Stroke is very rare and it is more likely associated with injection of large volume, co-morbidities and a large PFO.

36 POLIDOCANOL INJECTABLE FOAM COMPLICATIONS Proximal DVT: 1.7% Dist CFV extension 2.9% Distal DVT 1.1% Isolated gastrocnemius/soleal phlebitis 1.4% No PE No cerebrovascular neurological AE

37 ELA/RFA COMPLICATIONS Ecchymosis over the treated segment frequently occurs and normally lasts for 7-14 days. Treated vein tightness Superficial phlebitis is another uncommon side effect of ELA, being reported after about 5% of treatments. plasticsurgerykey.com

38 Dexter D, Kabnick L, Berland T, et al. Complications of endovenous lasers. Phlebology 2012;27 Suppl 1: /phleb S18 ELA/RFA COMPLICATIONS More significant adverse events reported following ELA include neurologic injuries, skin burns, and DVT. The nerves at highest risk include the saphenous nerve and the sural nerve Paresthesia (0-10%) or dysesthesia, most of which is transient. A rare complication after thermal ablation is formation of an arteriovenous fistula. Rajpal

39 ELA/RFA COMPLICATIONS DVT following ELA is unusual. Endovenous heat induced thrombosis (EHIT) can occur as an extension of thrombus (1%) from the treated truncal vein across the junctional connection into the femoral or popliteal veins.

40 MOCA Mechanochemical endovenous ablation (MOCA) (ClariVein ) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant.

41 MOCA A study from Steve Elias & al in 2012 on Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial Thirty GSVs in 29 patients were treated. All patients have reached sixmonth follow-up; the average number of postoperative days is 260. No adverse events have been reported. The Primary Closure Rate is 96.7% A study from Tang :Early results in 2016 from a large single-centre series of mechanochemical endovenous ablation for varicose veins 300 patients were treated. The 3year success rate is 86%

42 MOCA VS RFA

43 CYANOACRYLATE SUPER GLUE

44 CYANOACRYLATE When introduced into a vessel: cyanoacrylate (VenaSeal )creates inflammatory reaction Polymerization damages the endothelium and induces immunological responses Results: 1 year 92% occlusion Volume 1.3 ml

45 CYANOACRYLATE VS RFA Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Morrison N. GibsonK, Mc Enroe S, Goldman M, King T, Weiss R, Cher D, Jones A, J Vasc Surg 2015 Apr: 61 (4): CAE was proven to be noninferior to RFA for the treatment of incompetent GSVs at month 3 after the procedure.

46 STEAM ABLATION

47 STEAM ABLATION Steam works by supplying approximately 60 joules/cm per pulse of steam to the vein, which is in the same range as radiofrequency or laser ablation. Van de Bos and al. reported the excellent initial results of steam ablation in Subsequent authors have also documented its efficacy. Randomized clinical trial of endovenous laser ablation versus steam ablation for great saphenous veinsvan den Bos RR, Malskat WS, De Maeseneer MG, de Roos KP, Groeneweg DA, Kockaert MA, Neumann HA, Nijsten T.Br J Surg Aug;101(9): doi: /bjs Epub 2014 Jun 30. Erratum in: Br J Surg Oct;101(11):1484.

48 V-BLOCK

49 V-BLOCK V-Block (VVT Medical Ltd). The technique involves the release of an occlusion device at the SFJ and installation of a liquid sclerosant through a dual-syringe system A preclinical study in sheep was recently reported. Initial trial results in humans were reported by Dr. Ralf Kolvenbach at the 2013 VEITHsymposium and show similar results with early occlusion rates > 90%. Farber A, Belenky A, Malikova M, et al. The evaluation of a novel technique to treat saphenous vein incompetence: preclinical animal study to examine safety and efficacy of a new vein occlusion device. Phlebology. 2014;29:16-24

50 IN SUMMARY Non thermal and thermal minimally invasive percutaneous procedures can replace traditional surgery with less complications, shorter recovery time and excellent results demonstrated by Steve Elias. NTNT are gaining popularity.

51 CONCLUSION Several procedures are safe and effective to treat saphenous vein incompetence with QOL parameters improved on all patients. Large, prospective, randomized trials with long term follow-up are required to obtain unbiased evaluations for some of the procedures.