SAVE LIMBS SAVE LIVES! Endovenous Ablation for Chronic Wounds

SAVE LIMBS SAVE LIVES! Endovenous Ablation for Chronic Wounds Frank J. Tursi, DPM, FACFS Clinical Associate Professor, University of Pennsylvania/Presbyterian Foot and Ankle Consultant, Philadelphia Flyers, Tampa Bay Lightning Chief of Podiatry, Division of General Surgery Our Lady Of Lourdes Medical Center, Camden, NJ tursimd@aol.com www.footandanklesj.com

Epidemiology: Prevalence More than 30 million Americans suffer from varicose veins or a more serious form of venous disease called Chronic Venous Insufficiency (CVI). 1 CVI Prevalence *,1,2 30,000,000+ Of the over 30 million Americans affected: Only 1.9 million seek treatment annually 1,2 While the vast majority remain undiagnosed and untreated Seek Treatment *2 1,900,000 Treated 447,0002 (Table 30) *Statistics based on individuals over the age of 40 1. Gloviczki P, et al. The care of patients with varicose veins and associated chronic diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. JVS; May 2011. 2. Lee, A. US markets for varicose vein treatment devices 2011. Millennium Research Group, Inc. (A Decision Resource, Inc. Company), www.mrg.net, May 2011.

Epidemiology: Risk Factors Many factors contribute to the presence of venous disease and CVI including 1,2,3,4,5 : Gender Age Family history Standing occupation Obesity Prior injury or surgery Multiple pregnancy 1. "Chronic Venous Insufficiency." Vascular Web. Society For Vascular Surgery, Jan. 2011. Web. 17 Aug. 2011. http://www.vascularweb.org/vascularhealth/pages/chronic-venous-insufficiency.aspx. 2. Maurins U, Hoffmann BH, Lösch C, Jöckel KH, Rabe E, Pannier F. Distribution and prevalence of reflux in the superficial and deep venous system results from the Bonn vein study, Germany. J Vasc Surg.2008;48:680-87. 3. Criqui MH et al. Epidemiology of chronic peripheral venous disease; JJ Bergan Editor, The Vein Book, Elsevier Academic Press.(2007):30. 4. Chiesa R, Marone EM, Limoni C, Volonte M, Schaefer E, Petrini O. Chronic venous insufficiency in Italy: the 24-cities cohort study. Eur J Vasc Endovasc Surg. 2005;30:422-429. 5. Rabe E, Pannier F. Epidemiology of chronic venous disorders; P. Glovicki, Editor, Handbook of venous disorders (3rd edition), Hodder Arnold.(2009);109.

Anatomy: Venous System Venous blood flows from the capillaries to the heart Flow occurs against gravity Muscular compression of the veins Negative intrathoracic pressure Calf muscle pump Low flow, low pressure system

Etiology & Pathophysiology Healthy veins, with competent vein valves, keep blood moving in one direction back to the heart Diseased veins, with damaged vein valves, cause blood to move in both directions, elevating venous pressure

Anatomy: Perforators Perforator valves maintain one-way flow from superficial to deep veins Perforator valve failure causes: Higher venous pressure and GSV/branch dilation Increasing pressure results in GSV valve failure Additional vein branches become varicose Further GSV incompetence and dilation NOTE: The SVS/AVF Guideline Committee definition of pathologic veins includes those with outward flow of 500 ms, with a diameter of 3.5 mm, located beneath a healed or open venous ulcer 1 1. Gloviczki P, et al. The care of patients with varicose veins and associated chronic diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. JVS; May 2011.

Prevalence of Venous Leg Disease Edinburgh Vein Study 1 Duplex Scanning was Conducted in Men & Women Age 18-64 35% of Subjects without Evidence of Venous Disease had Significant Reflux in 1 of 8 Venous Segments Bochum Studies Venous Reflux may occur in Teenage Years 12.3 % of the 14-16 year olds had Saphenous Reflux 2 1. Evans CJ, Fowkes FGR, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population. J Epidemiol Comm Health 1999; 53: 149-53. 2. Schultz-Ehrenburg U, Weindorf N, Matthes U, Hirche H. New epidemiological findings with regard to initial stages of varicose veins (Bochum Study I-!!!). In Phlebologie 92. 1992: 234-36. Cross. Prepare. Remove... Preserve

Prevalence of Venous Leg Ulcers Prevalence of open and healed Venous Ulcers is ~1% of the Total Population Above Age 60, Prevalence Increases with Age in Both Men & Women 2-3 X More Common in Females Prognosis of Healing Poor-50% Healing in 4 Months Evans CJ, Fowkes FGR, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population. J Epidemiol Comm Health 1999; 53: 149-53. Cross. Prepare. Remove... Preserve

Etiology & Pathophysiology: Symptoms Patients who suffer from venous disease or CVI may present symptoms of 1 : Varicose veins Burning or itching of the skin Leg pain, aching, or cramping Leg or ankle swelling Leg heaviness and fatigue Skin changes Restless legs Lower leg ulcers 1. Gloviczki P, et al. The care of patients with varicose veins and associated chronic diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. JVS; May 2011.

Etiology & Pathophysiology: CEAP C 0 : Asymptomatic. No visible or palpable signs of venous disease C 1 : Spider veins, reticular veins, telangiectasias C 6 : Open Skin Ulcers C 5 : Healed Skin Ulcers C 4 : Pigmentation, Lipodermatosclerosis C 2 : Varicose Veins C 3 : Edema Increased Pain and Reduced Quality of Life Photos courtesy of Rajabrata Sarkar, MD PhD

Patient Assessment & Diagnosis Patient Assessment Current general health condition Past medical history Symptoms Physical exam Ultrasound Diagnostic Study Required in order to determine the source of reflux Evaluate for venous occlusion or thrombus Map the course of the incompetent superficial veins

Treatment Options Conservative Therapies: Exercise Leg elevation Compression Stockings Unna Boot NOTE: These therapies treat the symptoms, not the underlying cause Non-Surgical Treatments: Surgical Treatments: Vein Stripping & Ligation Endovenous thermal ablations Radiofrequency ablation Laser ablation

Systemic Reflux in Venous Ulceration Sources of Reflux in Venous Ulcer Patients 1 Superficial Perforating Deep 79% 63% 49.5% Photo courtesy of David MacMillian MD Incompetent perforators found in 66.3% of venous ulcer patients 1 1. Hanrahan L. et al. Distribution of valvular incompetence in patients with venous stasis ulceration. JVS 13,6, 805-812 June 1991

Improved Clinical Outcomes Minimally invasive treatments may be available to aid ulcer healing in patients with chronic venous insufficiency that did not experience ulcer healing using compression therapy alone 1. 1. Harlander-Locke, et al. The impact of ablation of incompetent superficial and perforator veins on ulcer healing rates, J Vasc Surg 55:458-64(2012)

Improved Clinical Outcomes (cont d.) N = 500 Compared to compression therapy alone, surgical treatments (such as the ClosureFAST procedure) addressing the underlying cause of venous ulcers may: reduce ulcer recurrence 1 improve quality of life 2 1. Gohel MS, Barwell Jr et. Al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomized controlled trial. BMJ. 2007 Jul 14; 335(7610):83 2. Zamboni P. Cisno F. et al. Minimally invasive surgical management of primary venous ulcers vs. compression treatment: A randomized clinical trial. Eur J Vasc Endovasc Surg 25, 313-318 (2003)

RF Ablation Technique

RF Ablation Module

The Venefit Procedure with the ClosureRFS Stylet Single puncture percutaneous access under ultrasound guidance Temperature controlled 85 C heating at or below deep fascia Endovenous ablation specifically indicated to treat incompetent perforator veins

The ClosureFast catheter Safety Summary INDICATIONS: The ClosureFast catheter is intended for endovascular coagulation of blood vessels in patients with superficial venous reflux. CONTRAINDICATIONS: Patients with thrombus in the vein segment to be treated. Caution: The vein wall may be thinner in an aneurysmal segment. To effectively occlude a vein with an aneurysmal segment, additional tumescent infiltration may be needed over the aneurysmal segment, and the treatment of the vein should include segments proximal and distal to the aneurysmal segment. Caution: No data exists regarding the use of this catheter in patients with documented peripheral arterial disease. The same care should be taken in the treatment of patients with significant peripheral arterial disease as would be taken with a traditional vein ligation and stripping procedure. POTENTIAL COMPLICATIONS: Potential complications include, but are not limited to, the following: hematoma, vessel perforation, thrombosis, pulmonary embolism, phlebitis, infection, adjacent nerve injury, skin burn or discoloration. Note: This is only a summary; please refer to instructions for use included with product.

Venous Ulcer Patient Outcomes Non-healing venous ulcer Healed 8 weeks after the Venefit procedure* A prospective study 2 has shown that 76% of ulcers were healed within 6 months after the Venefit TM procedure 1. In a separate study, 95% of ulcers remained healed at 18 months 2. *Individual results may vary. Photos courtesy of David MacMillian, MD 1. Harlander-Locke, et al. The impact of ablation of incompetent superficial and perforator veins on ulcer healing rates, J Vasc Surg 55:458-64(2012) 2. Harlander-Locke, et al. Combined treatment with compression therapy and ablation of incompetent superficial and perforating veins reduces ulcer recurrence in patients with CEAP 5 venous disease, J Vasc Surg 55:446-50(2012

Endovenous Laser Ablation The underlying goal for all thermal ablation procedures is to deliver sufficient thermal energy to the wall of an incompetent vein segment to produce irreversible occlusion, fibrosis, and ultimately disappearance of the vein. The mechanism of vein wall injury after ELA is controversial. It has been postulated to be mediated both by direct effect and indirectly via laser-induced steam generated by the heating of small amounts of blood within the vein. Proebstle TM, Sandhofer M, Kargl A, Gul D, Rother W, Knop J. Thermal damage of the inner vein wall during endovenous laser treatment: key role of energy absorption by intravascular blood. Dermatol Surg. Jul 2002;28(7):596-600.

Endovenous Laser Ablation Adequately damaging the vein wall with thermal energy is imperative to obtain effective ablation. Some heating may occur by direct absorption of photon energy (radiation) by the vein wall, as well as by convection from steam bubbles and conduction from heated blood. However, these later mechanisms are unlikely to account for most of the impact on the vein.

Endovenous Laser Ablation Endovenous laser wavelengths commercially available include: 810 nm (AngioDynamics Queensbury, NY) 940 nm (Dornier MedTech Americas, Inc, Kennesaw, Ga) 980 nm (Biolitec, Inc, East Longmeadow, Mass) 1064 nm (Sharplan, Inc., NJ) 1320 nm (CoolTouch, Roseville, Calif) 1470 nm (Biolitec, Angiodynamics)

Before & After Ablation

Closing Remarks / Thank You

Thank You! 32