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B. Karenko, DO January 25, 2014

B. Karenko, DO January 25, 2014. Pathophysiology & Treatment of Chronic Venous Insufficiency. Disclosures. I have no financial disclosures. Topics. Epidemiology and prevalence Pathophysiology Clinical classifications of venous disease Anatomy Treatment Options.

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B. Karenko, DO January 25, 2014

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  1. B. Karenko, DOJanuary 25, 2014 Pathophysiology & Treatment of Chronic Venous Insufficiency

  2. Disclosures • I have no financial disclosures

  3. Topics • Epidemiology and prevalence • Pathophysiology • Clinical classifications of venous disease • Anatomy • Treatment Options

  4. Venous Reflux Epidemiology • It is estimated that in America, 72% of women and 42% of men will experience varicose veins by the time they are in their 60s.1 • Prevalence is highly correlated to age and gender • Risk factors: • Multiple pregnancies • Family history • Obesity • Standing profession 1 Data on file 2 Ruckley CV. Socioeconomic impact of chronic venous insufficiency and leg ulcers. Angiology. 1997;48:67-9. 3 McGuckin M, Waterman R, et al. Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg. 2002;183:132-7.

  5. Annual U.S. Incidence U.S. Prevalence Prevalence and Etiology of Venous Insufficiency Venous reflux disease is 2x more prevalent than coronary heart disease (CHD) and 5x more prevalent than peripheral arterial disease (PAD)1 Millions

  6. What is Venous Reflux Disease? • Progressive condition caused by poor return of blood to heart • Symptoms include: • Pain • Varicose veins • Leg heaviness & fatigue • Swollen limbs • Skin changes and skin ulcers • Risk factors • Multiple pregnancies • Family history • Obesity • Standing profession

  7. Normal Venous System • Venous blood flows from capillaries to heart • Flow occurs against gravity with no pump and relies on: • Muscular compression of veins • Healthy vein valves • Negative intrathoracic pressure • Low flow, low pressure system

  8. Venous System Abnormalities • Increased pressure in large veins (e.g., from obesity or pregnancy) • Sequential valve failure (e.g., post-DVT) • Dilation of peripheral veins (varicose veins) • Increased venous capillary pressure (with long standing chronic venous insufficiency) • Inflammatory and ischemic injury (discolored, thickened skin) • May result in venous ulceration

  9. Calf Muscle Pump • Calf muscle contraction propels venous blood upward toward heart • Calf muscle pump dysfunction associated with venous hypertension • Deficiency is significant to severity of venous ulceration Image source: http://www.rebuildermedical.com/images/muscle_pump.jpg

  10. Dilated Vein Normal Vein Head Foot Valve Open Valve Closed Leaky Valve How Venous Reflux Occurs • Vein valves fail • Results in reflux and poor venous drainage • Column of blood increases pressure in leg veins • Increased pressure causes surface veins to become varicose

  11. Venous Reflux Incompetent valves allow reverse flow, known as reflux Venous reflux can lead to varicose veins and other more severe signs and symptoms Image source: http://www.veininnovations.com/varicose_veins_faqs.html

  12. Spectrum of Venous Disease Varicose Veins Swollen Leg Skin Changes Skin Ulcer

  13. CEAP Clinical Classification Class 0: Asymptomatic; no visible or palpablesigns 1: Spider veins, reticular veins, telangiectasias 2: Varicose veins 3: Edema 4a: Skin changes with hyperpigmentation and eczema 4b: Skin changes with lipodermatosclerosis and atrophie blanche 5: Healed ulcer 6: Active ulcer

  14. CEAP Clinical ClassificationsClinical Etiology Anatomy Pathophysiology Skin Ulcer CEAP 6 Varicose Veins CEAP 2 Swelling CEAP 3 Skin Changes CEAP 4

  15. CEAP Class 2: Varicose Veins • Dilated, frequently tortuous veins with thickened walls • Cause: incompetent valves • Primary • Majority of varicose veins • Originate in superficial system • Secondary • Originate in deep system • Deep venous insufficiency • Deep vein obstruction (DVT) CEAP 2 Image source: http://www.pyroenergen.com/articles07/varicose-veins.htm

  16. CEAP Class 3: Edema • Untreated, venous insufficiency may result in edema • Venous hypertension forces fluid into lymphatic & interstitial spaces • Leg swells due to poor venous return • Pain and discomfort, especially in distal calf and ankle • May include incompetence in deep, superficial, and perforating veins CEAP 3 Image source: RajabrataSarkar, MD

  17. CEAP Class 4: Skin Changes • In addition to varicose veins and edema, these patients present with: • Class 4a: • Hyperpigmentation (especially in distal and medial calf) • Stasis dermatitis (venous eczema) • Class 4b: • Lipodermatosclerosis • Atrophie blanche CEAP 4a Image source: http://www.visualdxhealth.com/adult/stasisDermatitis.htm

  18. CEAP 5: Healed Venous Ulcer • All venous systems may be involved • Persistent reflux & venous hypertension results in microcirculatory changes in skin • Eventually leads to ulceration CEAP 5 Image source: http://gensurg.co.uk/vv%20-%20classification_of_venous_problem.htm

  19. CEAP 6: Active Ulcer • Most severe stage of venous disease • Involves superficial, deep, and perforating veins • Persistent venous hypertension results in microcirculatory and inflammatory changes to skin CEAP 6 Image source: http://www.cambridgeveins.co.uk/venous-ulcers/

  20. Venous Anatomy

  21. Deep Venous System • Common Femoral Vein (CFV) • Femoral Vein (FV) • Popliteal Vein (PV) • Gastrocnemius Veins • Tibial Veins Image source: Weiss RA, et al eds. Vein diagnosis and treatment: A comprehensive approach. McGraw-Hill Companies, Inc.; 2001.

  22. Superficial Venous System

  23. CFV SFJ Great Saphenous Vein (GSV) • Courses from medial ankle to groin • Joins Common Femoral Vein (CFV) proximally at Saphenofemoral Junction (SFJ) Image source: Fundamentals of Phlebology: Venous Disease for Clinicians. Illustration by Linda S. Nye. American College of Phlebology 2004.

  24. Images courtesy of Olivier Pichot, MD Greater Saphenous Vein • Bound anteriorly by superficial fascia & posteriorly by deep fascia • Often called “saphenous eye” Fascial layers creating “saphenous eye”

  25. SFJ Tributary Veins • SCI: Superficial Circumflex Iliac • SE: Superficial Epigastric • SEP: Superficial External Pudendal • AASV: Anterior Accessory Saphenous • PASV: Posterior Accessory Saphenous Image adapted from: Chandler JG et al. Defining the role of extended saphenofemoral junction ligation: A prospective comparative study. JVS 2000;32:941-53

  26. AASV Anterior Accessory Saphenous Vein • Connects SFJ with lateral venous system • Important source of varicose veins • Relatively high incidence of AASV reflux in patients with GSV reflux • Common source of recurrence after vein stripping surgery Image adapted from: Thorisson HM et al. The role of ultrasound in the diagnosis and treatment of chronic venous insufficiency. Ultrasound Quarterly 2007;23:137-50.

  27. PASV Posterior Accessory Saphenous Vein • PASV incompetence less common than AASV Image adapted from: Thorisson HM et al. The role of ultrasound in the diagnosis and treatment of chronic venous insufficiency. Ultrasound Quarterly 2007;23:137-50.

  28. Small Saphenous Vein (SSV) • Courses from lateral ankle up posterior calf • Terminates in popliteal fossa at Saphenopopliteal Junction (SPJ) • Variable confluence with Popliteal Vein (PV) • Proximal portion lies between superficial & deep fascial layers SPJ Pop V SSV Figure adapted from: Weiss RA, et al eds. Vein diagnosis and treatment: A comprehensive approach. McGraw-Hill Companies, Inc.; 2001.

  29. Venous Disease Summary • Despite high prevalence, a very low percentage of patients seek treatment • Vein valve failure creates column of venous hypertension • Left untreated, severity of disease increases • Knowing relevant anatomy is critical to identifying proper treatment pathway

  30. Conservative Treatments • Leg elevation • Compression stockings • Conservative treatments often have poor patient compliance because they: • are difficult for patients to integrate into daily routine • are uncomfortable • require lengthy (lifelong) treatment • do not cure the underlying problem (pathology)

  31. Treatment Options Cont. • Traditional Vein Stripping • Outdated technique • Long recovery • High recurrence rates • Endovenous Ablation • Minimally invasive • Office based procedure • Fast, mild recovery • Over 95% efficacy at 5 years

  32. Radio Frequency ablation using the ClosureFAST™ Catheter

  33. Related and Complementary Procedures • Sclerotherapy • External lasers and intense pulsed light • Used to treat small superficial or “spider” veins Image courtesy of Robert A. Weiss, MD Image courtesy of Robert A. Weiss, MD

  34. Related and Complementary Procedures • Phlebectomy • Removal of diseased veins through a series of small incisions and use of specialized hooks to treat visible varicose veins Images courtesy of Kenneth Harper, MD Images courtesy of Kenneth Harper, MD

  35. Post-Procedure Instructions • Ambulate frequently, a minimum of 30 minutes daily • Avoid heavy/strenuous exercise for a few days • Avoid prolonged sitting or standing • Wear compression stockings for up to 2 weeks • Patient should return for duplex scan within 72 hours

  36. Endovenous Ablation Results Pre-Treatment One Week Post-Op

  37. Results Cont. Before After

  38. Efficacy at 3 years A multicenter prospective study has shown 93% occlusion at 3 years post-treatment.1 • Using the ClosureFast catheter with the 7 cm heating element • . • Dietzek A, Current Data on Radiofrequency Ablation With The ClosureFAST Catheter, 37th Annual Veith Symposium, November 17th, 2010 New York

  39. Efficacy at 5 Years 1 1. Proebstle, T. American College of Phlebology Annual Congress, November 2012

  40. CEAP Classification 1. Proebstle, T. American College of Phlebology Annual Congress, November 2012

  41. Rasmussen Randomized Clinical Trial1*** *n is the number of patients who returned for follow-up **In the 10-day period post-procedure Note: The ClosureFastTM Catheter was used in this study 1. L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof, Randomized Clinical Trial Comparing Endovenous Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. British Journal of Surgery Society Ltd., Wiley Online Library, www.bjs.co.uk, March 15, 2011

  42. Systemic Reflux in Venous Ulceration Incompetent perforators found in 66.3% of venous ulcer patients1 Photo courtesy of David MacMillian MD • Hanrahan L. et al. Distribution of valvular incompetence in patients with venous stasis ulceration. JVS 13,6, 805-812 June 1991

  43. 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 ulcer1 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.

  44. A Review of Select Perforator Vein Treatment Options • Subfascial Endoscopic Perforator Surgery • Less invasive than open surgery • Access issues by medial malleolus1 • Percutaneous Radiofrequency Ablation • Minimally Invasive outpatient • Access not limited by PV location 1. Elias S, Peden E, Ultrasound-Guided Percutaneous Ablation for the Treatment or Perforating Vein Incompetence. Vascular, Vol. 15, No.5. pp.281-289, 2007, The International Society for Vascular Surgery, ISSN: 1708-5381, DOI: 10.2310/6670. 2007

  45. Radiofrequency Ablation with 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

  46. Improved Clinical Outcomes • 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)

  47. Improved Clinical Outcomes N = 500 • 1. Gohel MS, BarwellJr 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 VascEndovascSurg 25, 313-318 (2003)

  48. References • American Heart Association, SIR, Brand et al. “The Epidemiology of Varicose Veins: The Framingham Study” • US Markets for Varicose Vein Treatment Devices 2006, Millennium Research Group 2005. • Coon WW, Willis PW, Keller JB: Venous thromboembolism and other venous disease in the Tecumseh Community Health Study Circulation 1973; 48:839-846. • Barron HC, Ross BA. Varicose Veins: A guide to prevention and treatment. NY, NY: Facts on File, Inc. [An Infobase Holdings Company]; 1995;vii. • White JV, Ryjewski C. Chronic venous insufficiency. PerspectVascSurgEndovascTher 2005;17:319-27 • Dietzek A, Two-Year Follow-Up Data From A Prospective, Multicenter Study Of The Efficacy Of The ClosureFAST Catheter, 35th Annual Veith Symposium. November 19, 2008. New York. • Almeida JI. Lessons Learned After 2000 Endovenous Ablations. 34thVeith Symposium. Nov 14-18, 2007. New York • Hanrahn L. et al. Distribution of valvular incompetence in patients with venous stasis ulceration. JVS 13,6, 805-812 June 1991 • Jamie R Barwell, Colin E Davies,Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomized controlled trial,THE LANCET, Vol 363, June 04 • Nelzen O. Fransson I. True long-term healing and recurrence of venous leg ulcers following SEPS combined with superficial venous surgery: a prospective study. Eur J VascEndovascSurg 34, 605-612 (2007)

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