Disclosures. What is a Specialty Vein Clinic? Prevalence of Venous Disease. Management of Venous Disease: an evidence based approach.

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1 Management of Venous Disease: an evidence based approach Disclosures Ed Boyle, MD Andrew Jones, MD Dr. Ed Boyle and Dr. Andrew Jones disclose Grants/research support: Medtronic, BTG International, Clearflow, VenX What is a Specialty Vein Clinic? Prevalence of Venous Disease Varicose Veins 20+ million Swollen Leg 6 million Skin Changes 1 million Skin Ulcer 500,000

2 Swelling Management Vascular Diagnostics Rule out DVT SVT DVT Diagnosis and Management The Old Paradigm Traditional Surgical Practice Venous Stasis Lymphedema Swelling Managment DVT Diagnosis and Management Comprehensive Vein Care Vascular Diagnostics Swelling Management Modern Minimally Invasive Surgical Practice Venous ThromboEmbolism (VTE) Includes both deep vein thrombosis (DVT) and pulmonary embolism (PE) Common, lethal disorder that affects hospitalized and nonhospitalized patients

3 Statistics from the CDC Statistics from the CDC 300,000 to 600,000 affected by VTE each year Estimates suggest that 60, ,000 Americans die of DVT/PE annually 10% to 30% of people will die within one month of diagnosis. Sudden death is the first symptom in about one-quarter (25%) of people who have a PE. Source - Among people who have had a DVT, one-half will have long-term complications (post-thrombotic syndrome) such as swelling, pain, discoloration, and scaling in the affected limb. One-third (about 33%) of people with DVT/PE will have a recurrence within 10 years. Approximately 5 to 8% of the U.S. population has one of several genetic risk factors for developing VTE Source - Considerations in the Outpatient Diagnosis of DVT What causes DVT Acquired Hypercoagulabilty Proximal vs Distal Low volume vs high volume of clot Symptoms vs no symptoms Able to initiate anticoagulation Ambulatory vs Non Ambulatory Can they wear compression Personal and Family History Cancer Trauma Catheters Surgery Pregnancy Estrogen Ability to follow up

4 What causes DVT Inhereted Hypercoagulabilty Who is at Risk? Factor V Leiden mutation Prothrombin gene mutation Protein S deficiency Protein C deficiency Antithrombin deficiency Dysfibrinogenemia DVT Most Common in Outpatients Outpatient Management Nearly 2/3 of VTEs occur in the outpatient setting DVTs still occur in patients that received prophylaxis within 30 days before diagnosis. Death occurs in 6% of DVT cases and 12% of PE cases within 1 month of diagnosis. Outpatient management of DVT has been shown to be safe and effective Major costs savings Patients must be have stable hemodynamics Goldhaber, American Journal of Cardiology: Volume 93, Issue 2, 15 January 2004, Pages Spencer FA; Arch ntern Med, 2007, 167: Jul 23;167(14): Koopman MM, N Engl J Med. 1996;334(11):682.

5 Treatment Pathway Fully Accredited Vascular Diagnostic Laboratory Leg Pain and Swelling? Refer for Venous US Study Positive Negative Consult? Education Initiation of Anticoagulation Fitting and counseling for Graded Compression Hose Coordination with other Health Care Providers Management per Guidelines Short and Long Term Follow Up Patient Characteristics in an Outpatient Vascular Laboratory to R/O DVT Isolated calf vein thrombosis The most common presenting symptoms were pain (40%), edema (28%), and pain and edema (27%). Duplex scans were abnormal in 22%, 2/3 acute DVT, and 1/3 chronic DVT In the acute DVT, 40% were above knee DVT s and 60% were ICVT Physician specialty was family medicine (40%), followed by orthopedics (33%) and internal medicine specialties (19%) Most DVTs start in the calf Options: Stockings +/- Anticoagulation ~1 out of 10 have clot propagation Short interval follow up PE still a consideration Education very important Gibson K, JVS, 2011;53(1),260-1

6 If not anticoagulated, surveillance with serial ultrasound Anticoagulation options Patients at high risk of bleeding or those with a preference to avoid anticoagulation If extension does not occur within two weeks, it is unlikely to occur Compression helps the pain and swelling considerably Historical standard has been immediate initiation of LMWH and Warfarin Patient administered injections Requires frequent monitoring Relatively inexpensive Oral factor Xa inhibitors The factor Xa inhibitors rivaroxaban (Xeralto) and apixaban (Eliquis) have been approved by regulators agencies as monotherapy for DVT Require normal renal function Willing to accept the risk of bleeding on an irreversible agent Expensive and not approved by all insurance providers Long Term Follow Up Doc: What s wrong with my leg?

7 Post Thrombotic Syndrome (PTS) Presentation Long-term complication of DVT 1 in 3 patients develop PTS Compression stockings MAY significantly reduces PTS Once PTS is diagnosed, compression is very important 1 Brandjes DP, et. al. Lancet 1997 ² 2008 ACCP Guidelines ³Journal of Thromb. Haemost. L.W. Tick, et.al, October 4, 2008 Risk factors for post thrombotic syndrome in patients with a first time DVT Symptoms Pain (an aching or cramping feeling) Heaviness/Tiredness Burning or tingling sensations Swelling/Throbbing Tender areas around the veins Complications Inflammation (phlebitis) Blood clots (e.g., DVT) Ankle sores or skin Symptoms ulcers can progress to complications Bleeding Saphenofemoral Reflux and Ambulatory Venous Hypertension Ultrasound Diagnostic Study Must be performed to determine the sources of reflux. Evaluate for venous occlusion or thrombus Map the course of the incompetent superficial veins Localize sites for treatment with minimally invasive techniques VN20-52-A 12/04

8 What about Compression? Fit and Style Important Degree of Compression Endovenous Ablation Class I 20 to 30 mmhg aching, swelling small varicose vein changes Class II 30 to 40 mmhg symptomatic Varicose veins, Chronic venous insufficiency, post ulcer Class III 40 to 50 mmhg Chronic venous insufficiency, post ulcer, lymphedema Class IV 50 to 60 mmhg (same as III)

9 GSV Ablation GSV Ablation before 2 weeks after before 2 weeks after Ambulatory Phlebectomy OLD Technique Micro Technique Old Type Incisions Typical of Vein Stripping Modern Microphlebectomy Incisions used at Inovia How Big are the Incisions Using Modern Techniques?

10 Phlebectomy Pre Surgery Ambulatory Phlebecomy 3 months Post Op Before 2 weeks later Anesthesia Delivery Initial Topical cream Outpatient vs Inpatient Surgery? Followed by Tummescent

11 Foam Sclerotherapy Spider Vein Treatment Sclerotherapy Allows tracking on Ultrasound Holds the sclero agent in the treated vein longer Allows less concentrated solutions at lower volumes to be used Before After Venous stasis ulcer management (ESCHAR TRIAL): randomized controlled trial First, rule out any associated arterial, immunologic, endocrine, or other systemic causes for leg/foot ulceration Venous ultrasound to evaluate for axial vein and perforator vein reflux Exudative venous ulcers need multilayer compression dressings and appropriate antibiotics if infection exists Frequent debridement and frequent objective evaluation for ulcer area with each office visit Comparison of surgery and compression with compression alone in chronic venous ulceration Healing rates were similar in the compression and surgery and compression alone groups (65% in both groups) 12-month ulcer recurrence rates were significantly reduced in the compression vs surgery group (12% vs 28%, p<0.0001) Most patients with chronic venous ulceration will benefit from the addition of simple venous surgery plus compression.

12 Venous stasis ulcer management What is New? Compression-Compression- Compression! Superficial vein ablation as indicated Follow Up for Recurrence Recurrent venous ulcers at the same location may be associated with venous outflow obstruction FDA Clears Medtronic s VenaSeal for Varicose Veins (Feb 20, 2015) FDA Approves Varithena (Polidocanol Injectable Foam) for the Treatment of Patients with Varicose Veins (2014) Our Specialty Niche VTE DVT Therapeutic PE Prophylaxis Outpatient Inpatient Chronic Acute Primary Care - Surgical Specialists Hematology - Coag Clinc - Urgent Care/ER

13 Isolated calf vein clot algorithm Checklist Assigns responsibility Creates a reproducible process Helpful for teaching new staff Quality assurance Vascular Quality Initiative Public Awareness Collaboration between American Venous Forum and The Society for Vascular Surgery Patient Safety Organization Allows for benchmark comparisons with other regional and national centers Quality Committee will analyze and compare different treatments for different types of veins, and recommend optimal treatment Regional quality group meetings to develop quality improvement projects 74% of adults have little or no awareness of DVT 57% are unable to name any common risk factors or pre-existing conditions that could lead to the development of DVT 95% report that their physician had never discussed this medical condition with them. 1 APHA Deep-Vein Thrombosis Omnibus Survey. Conducted by Wirthlin Worldwide 2002