AMERICAN PODIATRIC MEDICAL ASSOCIATION

AMERICAN PODIATRIC MEDICAL ASSOCIATION

THE NATIONAL ANNUAL SCIENTIFIC MEETING Friday, July 13 th 2018 Washington, D.C.

CHRONIC VENOUS INSUFFICIENCY OF THE LOWER EXTREMITIES Clinical Pearls for the Podiatrist

PRESENTED BY: ROBERT D. STOFFEY, D.O. RVT, RPHS, RVS, DABR, DAOBR The Center for Vein Restoration

GOALS: To Describe Anatomy, Physiology, and Pathophysiology of the Venous System of the Bilateral Lower Extremities To Describe the Clinical Assessment of, the Diagnosis of, and the Treatment of Incompetent, Refluxing Superficial Veins which Contribute to Chronic Venous Insufficiency To Emphasize the Role of the Podiatrist in Suspecting that his/her Patient has Chronic Venous Insufficiency and to Emphasize the Important Role that the Podiatrist has in initiating Conservative Treatment and when indicated Referring your Podiatry Patient to a Full Service Vein Care Center or similar treatment facility

PHLEBOLOGY The medical specialty devoted to the diagnosis, treatment, and follow up care of patients with venous disorders

GENERAL CONCEPTS: THE VENOUS SYSTEM OF THE LOWER EXTREMITY

LOWER EXTREMITY VENOUS SYSTEM General Functions: Returns Deoxygenated Blood to the Heart Blood Pressure Regulation Thermoregulation Nutritive Support Wound Repair

LOWER EXTREMITY VENOUS SYSTEM Requirements for a Normally Functioning Venous System: Must be Unobstructed and without Significant Reflux Must Maintain a Low Pressure Environment Have a Functional Calf-Muscle Pump

VENOUS ANATOMY OF THE LOWER EXTREMITY Deep Venous System Perforating Veins Superficial Venous System Countless Tributaries

THREE VENOUS SYSTEMS Deep venous system: the channel through which 90% of venous blood is pumped out of the legs Superficial venous system: drains blood from the skin, act as a transient collecting system. Superficial veins are located outside of muscular fascia Perforating veins: the conduits for blood to travel from the superficial to the deep veins, provide for one-way flow

REVIEW OF NORMAL FUNCTIONING VEINS:

GREAT SAPHENOUS VEIN Great saphenous vein The Longest Vein in the Body runs from dorsum of foot medially up leg Joins with the Common Femoral Vein(of the deep venous system) at the Saphenofemoral Junction site of highest pressure usually at the saphenofemoral junction, but may begin with perforating or pelvic vein

GREAT SAPHENOUS VEIN

SMALL SAPHENOUS VEIN Small saphenous vein runs from lateral foot up posterior calf variations in termination(behind the knee) most commonly joins the Popliteal Vein(of the deep venous system) at the Saphenopopliteal Junction like the GSV, the SSV is a common source of Superficial Venous Reflux

SMALL SAPHENOUS VEIN

PERFORATING VEINS Connect the Deep Venous System with the Superficial Venous System In Healthy Individuals, the Perforating Veins, with their one-way valves, direct blood from the Superficial Venous System to the Deep Venous System From Superficial to Deep From Distal to Proximal

CALF-MUSCLE PUMP Foot and calf muscles act to squeeze the blood out of the deep veins One way valves allow only upward and inward flow, in normal physiologic conditions During muscle relaxation, blood is drawn inward through perforating veins into the deep venous system Calf-Muscle Pump assists in returning deoxygenated blood from lower extremities to the right-side of the heart.

CALF-MUSCLE PUMP

THE FUNCTION OF ONE-WAY VENOUS VALVES Valve leaflets allow unidirectional flow, inward & upward From Superficial Veins to Deep Veins(via perforators) From Distal to Proximal Dilation of vein wall prevents opposition of valve leaflets, resulting in pathologic venous reflux Valvular fibrosis, destruction, or agenesis also results in venous reflux

VENOUS VALVULAR FUNCTION

NORMAL UNIDIRECTIONAL VENOUS BLOOD FLOW

ABNORMAL VENOUS BLOOD FLOW: BIDIRECTIONAL FLOW/VENOUS REFLUX

REVIEW OF NORMAL FUNCTIONING VEINS:

DILATED SUPERFICIAL VEINS DUE TO CHRONIC VENOUS REFLUX

CHRONIC VENOUS INSUFFICIENCY Reflux and/or obstruction leads to congestion and dilatation of the walls of the veins of the superficial system Symptoms, such as aching, pain, burning, throbbing, tiredness, itching, cramping, numbness and heaviness are worsened with prolonged standing or sitting, heat, & hormonal influences such as pregnancy Symptoms are improved with graduated compression stockings, leg elevation, exercise but CVI is not cured by these techniques and venous disease progresses

CHRONIC VENOUS INSUFFICIENCY (CHRONIC VENOUS HYPERTENSION) The Result of Retrograde Flow of Venous Blood primarily due to incompetent venous valves, valve destruction, and/or obstruction of the venous system of the lower extremities. The Most Common Vascular Disease affecting more then 30 million Americans 4-5 time more common than Arterial Disease The most common cause of leg swelling in adults Patient with Varicose Veins have and Increased Risk of DVT (5.6% versus 0.9%). 70% of Leg Ulcers are due to Chronic Venous Insufficiency

CHRONIC VENOUS INSUFFICIENCY Amongst the US Adult Population: The Prevalence of CVI: Females: 25% & Males: 15% For US Adults age 50 & Older: Females: 50% & Males: 30% Adults with Severe Venous Insufficiency: Healed Ulcers:1-2% & Active Ulcers:0.3%

CHRONIC VENOUS INSUFFICIENCY Nearly 2 Million Working Days Lost per Year in US Labor $3 Billion estimated Annual US Cost for Vein Disease Ass d with Reduced Quality of Life, Pain, Inactivity, Limited Activity Ass d with Social Isolation, Depression, Stigma Cost to Society & Individuals and their families has helped to prompt some of the advanced treatments available today

PATHOPHYSIOLOGY Reflux & Obstruction: REFLUX: Dilatation of vein wall leads to valve insufficiency Monocytes may destroy vein valves Retrograde flow results in distal venous hypertension OBSTRUCTION: Thrombosis and subsequent fibrosis obstruct venous outflow Damage to vein valves may also cause reflux Both contribute to venous hypertension *** Far Worse if Both Reflux and Obstruction is Present

PREVALENCE OF CHRONIC VENOUS DISEASE 1 in 22 or 4.5% or 12.2 million people in the USA are affected by varicose veins Incidence increases with age and is more common in women with over 40% of women in their 50 s suffering from some sort of venous disorder Across all ages and gender, 60% of Americans suffer from venous disease and its sequelae

CHRONIC VENOUS INSUFFICIENCY In U.S. Adult Population: Most Common Cause of Leg Edema 25 Million+ Adults, perhaps much more 20% of Adult Population(25% Female, 15% Men) Adults Over the Age of 50, CVI affects: ½ of all Women and 1/3 of all Men Aging U.S. Population will Surely Result in More Chronic Venous Disease, which is often not diagnosed or under diagnosed

RISK FACTORS FOR DEVELOPING CHRONIC VENOUS INSUFFICIENCY Non-Controllable Risk Factors: Age Female, Pregnancy History of DVT or SVT Controllable Risk Factors: Weight Amount of Physical Activity Smoking Amount of Prolonged Standing / Sitting

ELABORATION ON PROLONGED SITTING &/OR STANDING Often Occupationally-Related 2,854 Factory Workers with Varicose Veins: 64.5% had jobs standing in one place 29.2% had jobs requiring prolonged periods of sitting 6.3% had jobs requiring, - allowing - them to walk during their shift

VARICOSE VEINS ARE 3 TIMES MORE COMMON IN WOMEN THAN MEN Each Pregnancy Worsens Chronic Venous Disease 405 women with varicose veins 13% had one pregnancy 30% had two pregnancies 57% had three pregnancies

HISTORY History of problem: onset, pregnancies, prior DVT, immobilization, family history of varicose veins Associated symptoms and relationship to heat, menses, exercise and compression Current medications Family history Previous treatment and result Goals of patient Be Reasonable in yours and your patient s Expectations!

PHYSICAL EXAMINATION Examine patient in the standing position, from the groin to the ankle Inspect and palpate for varicose and telangiectatic veins Check the medial and lateral malleolar areas for skin changes suggestive of chronic venous insufficiency (e.g., corona phlebectasica) Edema often identified sooner from behind the ankles Inspect the pelvis & abdomen for enlarged superficial veins, esp. if ilio-femoral thrombosis is suspected

TELANGIECTASIAS Also known as spider veins Measure less than 1 mm Very common, especially in women Increase in frequency with age 85% of patients are symptomatic **** May indicate more extensive venous disease: Tip of the Iceberg

TELANGECTASIAS

RETICULAR VEINS Enlarged, greenish-blue appearing veins Measure 1-3 mm Frequently associated with clusters of telangiectasias May be symptomatic, especially in dependent areas of leg

RETICULAR VEINS

CLASSIC APPEARING VARICOSE VEINS (MEASURE GREATER THAN 3 MM)

VENOUS ULCERS Over 50% of patients have only superficial venous disease; superficial venous disease may be primary factor in 50-85% of patients * <10% have only deep venous disease Results from ambulatory venous hypertension, which leads to WBC activation, TCpO2, local release of proteolytic enzymes

VENOUS ULCER

ULCERS: VENOUS VS. ARTERIAL Venous ulcers are significantly more common Venous ulcers are above medial malleoli vs. arterial ulcers are in areas of chronic pressure or trauma Arterial ulcers usually have a more necrotic base and are more painful S/S of CVI (pigmentation, etc.) or ischemia (absent pulses, hair loss, etc.) are present

CHRONIC VENOUS INSUFFICIENCY PRESENTING SYMPTOMS: Lower Extremity Symptoms are Worsened by Prolonged Standing, Prolonged Sitting, Warmer Weather, Hormonal Changes, Pregnancy, Weight Gain, Sedentary Lifestyle. Lower Extremity Symptoms are Relieved to Some Degree by Walking and Exercising, both of which initiate the Calf Muscle Pump, Elevation of the Legs, Graduated Compression Stockings, Weight Loss. While Symptoms may be relieved, Chronic Venous Disease Progresses.

PRESENTING SYMPTOMS OF CHRONIC VENOUS DISEASE ** Very Likely will be Diagnosed by the Patient s Podiatrist if he/she is looking for Chronic Venous Insufficiency Aching, Itching Fatigue, heaviness in legs Pain: throbbing, burning, stabbing Cramping Swelling (peripheral edema) Restless Leg Syndrome-type Symptoms Numbness

SPECTRUM OF CHRONIC VENOUS DISEASE

CHRONIC VENOUS INSUFFICIENCY DIAGNOSIS: Key Role of the Podiatrist to Obtain a Thorough H&P to include the Lower Extremities and to Suspect C.V.I. Duplex Ultrasound is Performed to Map the Veins of Both Legs to include a Comprehensive Assessment of all Major Veins of the Deep and Superficial Venous System as well as their major accessory and tributary veins. Perforating Veins are also assessed, particularly in patients with Venous Ulcers.

DUPLEX ULTRASOUND DEMONSTRATING ABNORMAL VENOUS REFLUX

CHRONIC VENOUS INSUFFICIENCY GRADING, ASSESSING SEVERITY CEAP: Clinical Etiology Anatomy Pathophysiology

C.E.A.P. CEAP Grading Scale is used for initial diagnosis, to formulate therapeutic options, and to follow prognosis of and response to treatment. C Clinical: Based on Outward signs which your patient is presenting with.

CEAP C0 C6: C0: C-Zero: No Clinically Visible or Palpable Signs of Venous Disease. However Patient can have Heaviness, Itchiness, and Leg Cramps. Key Clinical Pearl: Podiatrist Must be Aware of & Cognizant of Venous Disease C1: Spider or Reticular Veins(less than 1 mm) C2: Varicose Veins(greater than 3 mm) C3: Edema. Swelling at the Ankles, best visualized from the back of the feet.

CEAP C0 C6: C4: C4A: Hyperpigmentation & Eczema C4: C4B: Lipodermatosclerosis & Atrophie Blanche C5: Healed Venous Ulcer C6: Active Venous Ulcer

CVI: ASSESSING SEVERITY VCSS: VENOUS CLINICAL SEVERITY SCORE A Clinical System utilized to grade the level of venous disease. Used in Conjunction with the CEAP Classification VCSS is More Dynamic than CEAP VCSS can be assessed on each patient visit and temporal changes can be documented

TREATMENT OF CHRONIC VENOUS INSUFFICIENCY The Podiatrist should be Cognizant of the Relatively Large Proportion of Adults who have Undiagnosed Lower Extremity Chronic Venous Disease When the Podiatrist Suspects or Determines that his/her Patient has CVI Consider: Referral to a Full Service Vein Care Center A Complete, Bilateral Lower Extremity Duplex Ultrasound Venous Mapping would be performed on your patient This would evaluate the deep and superficial venous system, as well as the perforating veins

TREATMENT OF C.V.I. TWO MAJOR CATEGORIES: - Conservative Treatment - Minimally-Invasive Interventions

CONSERVATIVE TREATMENT Compression Therapy Graduated Compression Stockings: Provides a gradient of pressure, highest at the ankle, decreasing as it moves up the leg Reduces reflux of blood Improves venous outflow Increases velocity of blood flow to reduce the risk of blood clots **** PCP: Do NOT Rx GCS if patient has or is suspected of having PAD treat the Peripheral Arterial Disease First.

GRADUATED COMPRESSION STOCKING

GRADUATED COMPRESSION STOCKING

INELASTIC COMPRESSION

COMPRESSION THERAPY Reduces symptoms of aching, fatigue, pain, and swelling Increases fibrinolytic activity Increases TCpO2 Mainstay of treatment for venous ulcers NOTE: Graduated compression therapy and wound care will heal venous stasis ulcers. Elimination of the reflux will reduce the recurrence.

COMPRESSION - GCS 8-15 mmhg Indications: Leg fatigue, mild swelling 15-20 mild aching, swelling ** 20 30 aching, pain, swelling, mild varicose veins 30-40 aching, pain, swelling, mild varicose veins, POST ULCER Prophylactic 40-50-60: Recurrent Ulceration, Lymphedema

EXERCISE ANOTHER FORM OF CONSERVATIVE THERAPY Reduces symptoms such as aching and pain Reduces ulcer recurrence Speeds resolution of superficial phlebitis and DVT 30 minutes daily is best Lower extremity exercise is helpful (stay away from heavy weight-lifting or other strenuous activity)

CONSERVATIVE APPROACH TO TREATING CHRONIC VENOUS REFLUX Begin with Conservative Measures: Weight Loss Exercise, Stretching, Walking Graduated Compression Stocking: 20-30 mmhg Goal is Overall Improvement of the Patient s Health Physical, Mental, Psychosocial & their Family s'

MINIMALLY-INVASIVE PROCEDURES TO TREAT CVI Most patients have a combination of varicose veins, reticular veins, and telangiectasias Different treatment methods may be best for each type of vein involved, or for different sized veins Therefore, more than one treatment method typically will be required for most patients In general, varicose veins and any associated reflux are treated prior to treatment of telangiectasias / spider veins

MINIMALLY INVASIVE PROCEDURES Outpatient Procedures, lasting 30 minutes to just over an hour Avoids Surgery, Suturing, General Anesthesia, Hospitalization Rapid if Not Immediate Recovery Rapid Return to Normal Activities of Daily Living Minimal Complication Rate(EHIT, DVT, PE, Infection) Covered by Medicare and Most Private Medical Insurance

TREATMENT OF CHRONIC VENOUS INSUFFICIENCY Modern, State-of-the-Art Vein Care Centers Outpatient Venous Ablation Procedures on Incompetent, Refluxing Superficial Veins All Work Performed on an Outpatient Basis Minimally Invasive, Same Day Procedures Patients are able to drive to/from the center and Quickly Resume their Usual Activities

TREATMENT OF CHRONIC VENOUS INSUFFICIENCY Minimally Invasive Procedures: Thermal Ablation: 2 Endovenous Techniques: Radiofrequency Ablation or Laser Ablation Non-Thermal Ablation: Mechanical Occlusion &/or Chemical Ablation Sclerotherapy Micro- or Ambulatory Phlebectomy

TREATMENT OF CHRONIC VENOUS INSUFFICIENCY Sclerotherapy: Intravenous Administration of an FDAapproved Chemical Irritant which results in intentional inflammation, fibrosis, and subsequent obliteration of the non-functioning, refluxing vein. Can be administered Visually or with the assistance of Ultrasound Guidance Can be administered in liquid form or as a Foam, mixed with room air or medical-grade Carbon Monoxide or a combination thereof.

VISUAL SCLEROTHERAPY Sclerotherapy most effective Laser may be helpful Multiple treatments usually required Reduces SYMPTOMS in 85% of patients Improves quality of life Injection of sclerosant solution causes damage to endothelium which leads to fibrosis of vein

SCLEROTHERAPY: VISUAL OR U/S-GUIDED Sclerotherapy works by injecting a pharmaceutical agent into the lumen of the vein which causes the vein to collapse and fibrose. Can be done visually or with the assistance of real-time ultrasound Can be injected in liquid form or in a foam form, the latter form displaces blood increasing the efficiency of the sclerosant, prolonging contact with the vein wall

VISUAL SCLEROTHERAPY

VISUAL SCLEROTHERAPY BEFORE AFTER

USGFS: ULTRASOUND-GUIDED FOAM SCLEROTHERAPY Variable-sized vein can be treated Needle lumen location inside vein, as well as movement of echogenic sclerosant and response of vein (spasm) visible allow ultrasound visualization Efficacy enhanced with foamed sclerosant

USGFS USGFS: Ultrasound Guided Foam Sclerotherapy Detergent Sclerosants such as Polidoconal or STS Ideal for Small and Tortuous Vessels Ultrasound Needed as these superficial veins are frequently not visible on the skin surface Potential Complications: Phlebitis, SVT extending to DVT or even PE

USGFS: REAL-TIME VISUALIZATION OF THE VEIN USING ULTRASOUND

USGFS BEFORE AFTER

THERMAL ABLATION OF REFLUXING SUPERFICIAL VEINS Endovenous Thermal Ablation of Insufficient SUPERFICIAL Veins FDA approved since 1999 Small Radiofrequency Ablation Catheter or Laser Fiber Catheter placed within the vein to be treated Perivenous Tumescent Anesthesia administered around the vein Real-Time Ultrasound Guidance is Utilized

RADIOFREQUENCY ABLATION (RFA) Outpatient procedure approximately 60 min. long Local tumescent Temperature at vein wall controlled >95+% closure at 2 years FDA-approved for RX of Great Saphenous Vein

RADIOFREQUENCY ABLATION

RFA: RADIOFREQUENCY ABLATION RFA: Heats vein from inside to 120 degrees Celsius for 20 seconds for each 7 cm treatment segment Very High Closure Rates of Treated Veins at 2 and 5 years (in excess of 95+ percent) Catheter is removed at conclusion of treatment Nothing remains in the patient at end of study

ENDOVENOUS LASER ABLATION Outpatient procedure approximately 60 min long Only local anesthesia required Continuous pullback Closure of >95+% Great Saphenous Veins at 2 years FDA-approved

ENDOVENOUS LASER ABLATION Endovenous Laser Treatment of a Refluxing Incompetent Superficial Vein is similar to RFA in that Heat Energy is Delivered to the Inner Aspects of the Vein resulting in intended Iatrogenic endothelial denudation, collagen contraction, and fibrosis. Blood Returning from the feet and lower extremities is diverted to other functioning superficial veins and then to the perforating veins and the deep venous system to the IVC and ultimately to the right side of the heart.

NON-RFA, NON-LASER HORIZON TREATMENT OPTIONS Non-Thermal, Non-Tumescent Treatment of CVI MOCA: Mechanical Obstruction & Chemical Ablation Performed endovenously (similar to RFA/Laser) Small Catheter with a Hockey Stick end piece Simultaneous Agitation of the Venous Endothelium along with Administration of a liquid form of FDA approved Detergent type of Sclerosant Agent (STS)

NON-THERMAL / NON-TUMESCENT TREATMENTS MOCA(CLARIVEIN) Mechanical (agitator) & Chemical (STS) Scleroscant High-Success Rate No Thermal Energy No Tumescent Anesthesia VENASEAL Cyanoacrylate( Super Glue ) High Success Rate No Thermal Injury No Tumescent Anesthesia No Compression Stockings Foreign Body(Glue) remains in body

DISTAL TIP OF CLARIVEIN DEVICE

PHLEBECTOMY: MICRO- AMBULATORY- STAB- OUTPATIENT

PHLEBECTOMY Very esthetic method of removing varicose veins Usually requires only local anesthetic Especially useful for tributaries of GSV, SSV

PHLEBECTOMY Useful to Remove Visual Varicosity Excellent Esthetic Effects Used on Superficial Non-Truncal Tributary Veins Microincision made over or adjacent to Varicose Vein Phlebectomy Hook & Hemostat Teases & Removes Vein Unsightly Vein is Removed or Interrupted

PHLEBECTOMY

PHLEBECTOMY

PHLEBECTOMY

PHLEBECTOMY BOFORE & AFTER:

CHRONIC VENOUS INSUFFICIENCY & THE CRITICAL ROLE THAT THE PODIATRIST PLAYS: The Podiatrist should have a good understanding of the etiology, presenting signs and symptoms, and treatment options, for their patients with chronic venous insufficiency due to incompetent refluxing &/or obstructed superficial veins Patients may very likely present to their Podiatrist for reasons other than CVI and the Podiatrist must be aware of the possibility of Chronic Venous Insufficiency.

QUESTIONS? Comments? Suggestions?

THANK YOU FOR ALLOWING ME TO JOIN YOU FOR TODAY S CME PRESENTATIONS!!!!! Robert.Stoffey@CenterForVein.com www.centerforvein.com