RECOGNITION AND ENDOVASCULAR TREATMENT OF CHRONIC VENOUS INSUFFICIENCY

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1 RECOGNITION AND ENDOVASCULAR TREATMENT OF CHRONIC VENOUS INSUFFICIENCY Paul Kramer, MD, FACC, FSCAI Liberty Cardiovascular Specialists Liberty Regional Heart and Vascular Center

2 DISCLOSURES NONE

3 Venous Reflux Disease What Is It? Venous valve becomes incompetent Superficial vein >> deep vein Increases weight of column of blood on adjacent, inferior valve, which is then more likely to fail Blood return from the deep venous system refluxes down the incompetent superficial veins ( ASD of the leg ) Such venous hypercirculation may lead to deep venous valve failure Upright venous pressure at the ankle ultimately increases due to uninterrupted, unsupported column of blood and may exceed 80 mmhg

4 Scope of the Problem Approximately 25 million Americans suffer from venous reflux It is estimated that in America, 72% of women and 42% of men will experience varicose veins by the time they are in their 60 s Prevalence is highly correlated to age and gender Risk factors: Multiple pregnancies Family history Obesity Standing profession ~50,000 vein stripping and high ligation procedures performed annually in U.S.

5 Anatomy Review Deep Venous System Common femoral vein Femoral vein Popliteal vein Gastrocnemius veins Tibial veins

6 Anatomy Review Superficial Venous System Lies between muscle-surrounding fascia and the skin, usually in its own fascial envelope Great saphenous vein (GSV) Saphenofemoral junction tributaries Anterior Accessory Saphenous Vein (AASV) previously known as Anterior Lateral Tributary Posterior Accessory Saphenous Vein (PASV) previously known as Posterior Medial Tributary Superficial epigastric vein Small saphenous vein (SSV) Perforators - connect the superficial system to the deep system

7 Overview of Venous Anatomy

8 Lesser (Short) Saphenous Vein

9 Saphenofemoral Junction(SFJ) Tributaries SCI: SE: SEP: AL: PM: Superficial Circumflex Iliac Superficial Epigastric Superficial External Pudendal Anterior Lateral (aka, Anterior Accessory Saphenous) Posterior Medial (aka, Posterior Accessory Saphenous)

10 Consequences Ambulatory venous hypertension is the unifying underlying etiology of Spider veins Reticular veins Varicose veins Edema Leg fatigue, heaviness, and pain Lipodermatosclerosis Recurrent or nonhealing ulcers

11 Spectrum of Venous Reflux Disease Varicose Veins 20+ million Swollen Leg 6 million Skin Changes 1 million Skin Ulcer 500,000

12 Diagnosis of Venous Reflux Disease Consider the diagnosis Edema Leg fatigue, heaviness Spider/reticular veins Varicose veins Lipodermatosclerosis/ulcer Duplex ultrasound Supine and upright Augmentation by Valsalva, compression

13 Venous Insufficiency Exam Baseline Cephalad flow direction (Blue) Valsalva Reversal of flow direction (Red) Duplex images demonstrating reflux in the GSV

14 Venous Insufficiency Exam Image courtesy of Gerald Neidzwiecki, MD GSV Distal thigh--reflux after augmentation

15 Treatment Options Ignore or dismiss The most common option Diuretics, fluid and salt restriction Minimal effect on venous pressure at the ankle Compression hose Partial counterforce to venous hypertension Doesn t impact underlying pathophysiology High ligation and stripping of the GSV Endovascular ablation of the GSV Radiofrequency ablation Laser

16 High Ligation and Stripping Traditionally viewed as the gold standard Inpatient procedure General anesthesia required Initial failure due to Stripping of wrong vein (medial or lateral accessory) Failure to strip all large, incompetent veins Late failure (35-50%) due to development of neovascular venous clusters and re-creation of original pathophysiology ~ one third of patients require a second surgical procedure

17 Randomized Trials Radiofrequency Ablation vs Surgery 3 randomized trials comparing RFA to surgery RFA was superior to vein stripping in every statistically significant outcome 2 less postoperative pain less bruising quicker recovery higher quality of life scores 81% of RFA patients returned to normal activities within 1 day vs 47% of vein stripping patients 2 RFA patients returned to work more than 1 week sooner than vein stripping patients 2 2 Lurie, F, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study), J Vasc Surg 2003; 38(2):

18 HOW DOES IT WORK? RF energy delivery via 7 cm heating element, resulting in: Direct vein wall heating ( o C) Endothelial denudation Collagen contraction Fibrotic sealing Goat saphenous vein 12 wks post-ablation

19 Radiofrequency Ablation Mechanism of Action Temperature controlled direct heating of vein wall Vein wall collagen contraction Endothelial cell denudation Inflammatory swelling of vein wall Fibrotic seal of vein lumen Acute result

20 Endovenous Laser Therapy FDA Approval History Diomed Jan 02 Biolitech Jun 02 Angiodynamics Nov 02 Dornier Nov 02 Vascular Solutions Nov 03 CoolTouch Sept 04 Sciton April 06

21 Method of Action Comparison: Radiofrequency Ablation vs Laser RFA EVLT Before Before After After Direct heating via continuous physical contact with RFA heating element Laser boils blood results in indirect heating; fiber contact with vein may creates perforations, pain, and extravasation

22 RF vs. Laser Ablation RFA 48 Hours Post-Op Laser Adverse effects in all 26 (EVL) patients were ecchymoses and palpable induration along the thrombotically occluded GSV that lasted for 2 to 3 weeks.

23 IDENTIFICATION OF GSV

24 ULTRSASOUND-GUIDED NEEDLE ACCESS

25 ACCESSING THE VEIN mpg

26 Catheter Advancement and Positioning Obtain longitudinal view of SFJ. Advance catheter into CFV Withdraw catheter tip 2-3 cm distal to SEV entry Preserve SEV patency Note: Catheter position may shift during tumescent infiltration Image courtesy of Joseph Smith, MD

27 POSITIONING THE CATHETER

28 Tumescent Anesthesia Compresses and exsanguinates treatment segment Heat sink thermally insulates vein from adjacent tissues Skin Muscle Fat Lymphatics Provides effective anesthesia

29 TUMESCENT ANESTHESIA

30 TUMESCENT ANESTHESIA

31 Treatment 1. Apply external compression; deliver two 20-second RF cycles to segment closest to SFJ 2. Repeat withdrawal, compression and treatments until desired length treated Aneurysmal segments and areas with large tributaries or perforators may benefit from two treatment cycles

32 FINAL DUPLEX IMAGE

33 Potential Complications Potential complications include, but are not limited to: Vessel perforation Thrombosis Pulmonary embolism Phlebitis Hematoma Infection Paresthesia Skin burn Loss of GSV availability for bypass graft

34 Adjunctive Procedures Spider and Reticular Vein Sclerotherapy

35 Adjunctive Procedures Spider and Reticular Vein Sclerotherapy Blanching of spider vein after sclerosant injection

36 Adjunctive Procedures Spider and Reticular Vein Sclerotherapy Final Result

37 Adjunctive Procedures Ambulatory Phlebectomy

38 Summary Radiofrequency venous ablation is a simple, office-based procedure that, compared to hospital-based vein stripping Has greater durability Has a very short recovery time Is less costly Results in higher patient satisfaction

39 WHAT IS REQUIRED TO MANAGE VENOUS INSUFFICIENCY? Knowledge of vascular (venous) anatomy Understanding of hemodynamics, hydraulics, flow physiology Familiarity with vascular duplex imaging Skills in percutaneous vascular intervention (access, wires, catheters) Integration of 2D image with endovascular device manipulation SOUND FAMILIAR?

40 WHY SHOULD CARDIOLOGISTS BE INVOLVED IN THE MANAGEMENT OF CHRONIC VENOUS INSUFFICIENCY? Seriously unrecognized but disabling disease There are about 50,000 vein stripping surgeries performed annually in the U.S. Percutaneous treatment is rapidly and appropriately replacing surgery Impact on quality of life is substantial Endovascular specialists possess most of the technical skills required Provision of vein treatment services is another reason for patients to be referred to your practices

41 Thank You! Image courtesy of Robert Merchant, MD Image courtesy of Robert Merchant, MD Pre-treatment *Individual results may vary 2 weeks post-rfa