Consider the impact of Venous Disease Review elements in the workup and diagnosis of Venous Disease Review treatment considerations

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1 Gregory Bohn, MD FACS Clinical Symposium on Advances in Skin and Wound Care September 9-12, 2011 Gaylord National Washington, DC Consider the impact of Venous Disease Review elements in the workup and diagnosis of Venous Disease Review treatment considerations Bard Hernia Training Center for Laproscopic and Kugel techniques Bard Training Center for Laproscopic Antireflux Procedures and Hiatal Hernia Repair Speaker for Pfizer on Surgical Infections Medical Advisory Panel Diversified Clinical Services 1

2 Affects 2-5 % of the population 24 Million have some form of Varicose Vein Disease or Venous Insufficiency 6 Million develop skin Changes of Chronic Venous Insufficiency 1 Million to 500,000 affected with Venous Ulcers Account for 70% - 80% of all vascular ulcers treated Brown KE, Chronic Venous Insufficiency; emedicine.medscape.com/article/ overview May 11, 2009 Of the ulcers that heal, as many as 72% may recur at one year Improving clinical outcomes is important Costs of treatment are considerable Cost of Venous disease $ billion Cost per case approximately $40,000 Cost of Days lost of work Quality of life issues Brown KE, Chronic Venous Insufficiency; emedicine.medscape.com/article/ overview May 11, 2009 Not just a disease of the elderly Over 40% report their first ulcer by age 50 13% of patients with Chronic Venous Insufficiency had their first ulcer by age 30 Brown KE, Chronic Venous Insufficiency; emedicine.medscape.com/article/ overview May 11,

3 Deep System Anterior Tibial Vein Posterior Tibial Vein Peroneal Vein Popliteal Vein Femoral Vein Iliac Vein Superficial System: Greater Saphenous Lesser Saphenous Branch Veins superficial Connected to the deep system by a series of perforator veins in the leg Joins the Deep System at the foramen ovale in the groin. Healthy leg/vein Standing Approximately 80 mm Hg Supine Approximately 10mm Hg Blood Flow is uni-directional back to heart Valves open with high pressure and close with low pressure 3

4 Calf Muscle Pump augments the return of blood from the leg As the foot is dorsiflexed, the calf compresses the deep veins creating a pressure up to 250 mm Hg Blood propelled cephlad towards the heart When the foot is flexed, the pressure drops and flow from the superficial system through the perforators is augmented Valves close to prevent the back flow of blood Damage to the valves leads to increased venous pressures Without a competent valve, the blood becomes a column of water with high pressure at the bottom of the column Superficial Veins become varicose 4

5 As the calf muscle pump activates, the high pressure from the deep system is transmitted to the superficial system Increased pressure in the superficial system leads to increasing dilation of the veins thinning the vessel walls Increasing pressure in the vessels leads to leakage of fluid and protein from the capillaries into the tissues Hydrostatic Pressure overcomes the osmotic tissue gradient in the dermal capillaries Immobility / Prolonged Standing or Sitting Obesity Pregnancy Smoking Thrombophlebitis Deep Vein Thrombosis Hip or knee replacement Abdominal surgery Hyper coagulable states Cancer DVT and DVT Valve and Damage valve damage results results in Chronic in Chronic Venous Venous Insufficiency Insufficiency 5

6 Water Protein rich Red blood cells Cause Hemosiderin deposition and staining WBCs become activated and release proteolytic enzymes MMPs Becomes Exudative when inflamation ensues Edema Usually insidious in onset Resolves with leg elevation Progressive over time below the knee Aching discomfort relieved with leg elevation as in bed rest Varicosities worsen as does edema Edema worsens and impacts oxygenation by increasing diffusion distance from capillaries and cells Hyperpigmentation Gaiter distribution Hemosiderin Staining extravisated blood with edema Blood cells lyse and release hemosiderin ( iron containing pigment) and melanin Progressive hyperpigmentation with fibrosis and chronic inflammation 6

7 Ulceration Trauma to legs that are compromised Fail orderly healing process Medial Malleolus most common Lateral Tibial Calf Irregular borders with flat wound bed Wound bed friable congested Pain usually relieved with elevation Surrounding skin changes Lipodermatosclerosis History important in diagnosis DVT Trauma Joint replacement hip or knee Standing long hours Morbid obesity Pregnancy CHF Immobility Danielsson, et al; 272 patients; 401 lower extremities Mean age 60 yrs (range 14-90) Mean body mass index 28.9 (+/- 7.76) 167 patients overweight (BMI > 25kg/m 2 Positive correlation Between BMI and Clinical Severity of Disease (p<.001) After adjustments for peak reversal of flow and total reflux score (p<.001) Overweight patients were significantly more likely to have skin changes and ulceration (p<.001) Overweight is a separate risk factor for skin change and ulceration in patients with Chronic Venous Disease Danielsson G, Eklof B, et al The influence of obesity on chronic venous disease. Vasc Endovascular Surg 2002 Jul-Aug; 36(4) :

8 ABI: Correlates with normal perfusion Correlates with adequate perfusion Correlates with significant arterial occlusive disease > 1.2 Non Compressible External Compression to counter act the venous hypertension Augments calf muscle pump Initial 86% Data healing Evaluation with compression* mmhg compression preferred 4 Week VLU VLU ABI typically tolerate Evaluation mm HG <10 cmcompression 2 >10 ( cm Multilayer 2 VLU VLU or 2 layer system ) < 12 ABI 0.9 > > 30% < 30% compression of mm Hg ( Lite months compression months Closure Closure wraps ) Cochrane Review : Multi layer long stretch more effective than inelastic systems Cochrane Database Sys Review 2009 Jan 21(1) CD Kantor and Margolis 104 patients Wounds measured weekly Wound that decreases by > 30% in first 4 weeks has 68% probability to heal at 24 weeks Wound that failed to demonstrate 30% improvement 74.7% probability to fail to heal at 24 weeks Kantor J, Margolis DJ ; A multicenter study of percentage change in venous leg ulcer area as a prognostic index of healing at 24 weeks, Brit J Dermatol 2000; 142:

9 Confirm diagnosis R/O DVT or other clot Compression? Treat with anticoagulants Dressing choice not shown to affect ulcer healing Cochrane Review Sequential Compression Pumps Sequential and gradient cyclical compression Mechanical augmentation of edema control and return Improves healing of ulcer over no compression Once healing continued use of compression needed to augment the calf muscle pump Class of Compression: Class Ankle Pressure I mm Hg II mm HG III mm Hg IV > 60 mm Hg 9

10 Hosiery Compression Therapy No compression associated with a higher rate of recurrence High compression hosiery (40mmHg) better than medium compression Compliance better with medium compression hosiery than high compression Cochrane Database Syst Review 2000 (4) cd How often should patients bee seen? Does what we do in the Wound Center make a difference? I heal 85% of my patients, I m doing great! Observed rate of healing 85.6% Benchmark 87% Evaluated the current treatment algorithm Weekly visits for dressing change and compression Wilcox, JR The Art and the Evidence of Healing Venous Stasis Ulcers. Monograph 2006 with permission 10

11 Main Entry: 1 bi week ly Pronunciation: \(ˌ)bī-ˈwē-klē\ Function: adjective Date: :occurring twice a week 2:occurring every two weeks : fortnightly usage see bi- biweekly adverb Examined their methodology for treating Venous Stasis ulcers and their outcomes Single layer vs Multi Layer Length of compression Frequency of Change James Wilcox RN, ACHRN, DAPWCA Clinical Impressions: Compression dressings don t last seven (7) days Multi layer compression works better Single layer compression should not be used if less than 15 o dorsiflexion Wound Dressings don t last seven (7) days 11

12 2 year evaluation (2002 & 2003) Looked at 250 Patients Used multilayer wrap and Unna boot applied weekly over 6 months Then compared to bi-weekly changes (twice a week) for 6 months James Wilcox RN, ACHRN, DAPWCA Weekly with Profore Multi layer wrap healed 87.5% Weekly wrap with Unna Boot single layer healed 89% Switched to Bi-weekly (twice a week compression) healed 96.1% Improved healing rate by 8.6% We prospectively reviewed a series of patients who underwent treatment following Clinical Practice Guidelines during 2009 and Centers were selected based on overall frequency of visits. The frequency of visits was broken down into two groups (Weekly vs. bi-weekly Visits). The Weekly Group included centers that were seeing patients on a weekly basis and in some cases more frequently during the early stages of care. The second group was made up of centers that were seeing patients Bi-weekly more than 10 days apart with the max time between visits being 30 days. 12

13 Methods This was a retrospective study of 215 patients with venous stasis ulcers in the lower extremities collected from 9 wound care centers from 6 states during 2009/2010. The analysis was limited to wounds 5 x 5 cm, and depth of 0.2 cm. The goal of the study was to analyze time to heal based on visit frequency. Group 1 had biweekly visits, which had to be > 10 days between visits in the first 4 weeks, while Group 2 had weekly visits, which could be more than once a week but at least once a week. 13

14 Positive Prognostic Indicators Ulcer size < 10cm 2 Ulcer duration < 12 Months Absence of PAD ABI >0.8 Negative Prognostic Indicators Ulcer size > 10cm 2 Ulcer duration > 12 months Presence of PAD ABI <0.8 81% chance to heal at 24 weeks 22% chance to heal at 24 weeks 30 Day review Healing > 30% Predicts Healing 30 Day review Healing < 30% Predicts Non Healing Living Skin Equivalent (Apligraf) Iowa LCD by Wisconsin Physician Service VSU of 3months duration failed treatment for 2 months 3 applications per ulcer No fewer than 2 weeks in between applications 2 applications are indicated with a 3 rd application if 50% or more healing noted 14

15 Graft meshed 1.0 : 1.5 Placed oriented keratinocyte side up Fixed with Transforming Powder Left in place 2 week global? Simplify placement Improve efficacy by managing wound environment Improve delivery of growth factors Improve cell viability Falanga : 275 venous ulcer patients Failed on previous treatments Median duration 1 yr Median Size 400mm 2 Weekly Visits for 8 weeks Up to 5 applications in first 3 weeks Control n= 129 Treatment n= 146 Patients placed in multilayer compression wraps for 8 wks up to 6 months Placed in elastic stockings after 8 wks Falanga V, Et al Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Arch Dermatol (3) Results: 275 patients 100% closure at 6 months 63% in LSE group 48% in standard care P=0.02 LSE Median 61 days to heal Standard care 181 days to heal P=0.003 > 6 months to complete healing LSE 92 days Standard Care 190 days P=0.001 Falanga V, Et al Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Arch Dermatol (3)

16 Venous ablation can reduce recurrence rates Goal is to re-direct blood flow to deep System Traditional vein stripping effective but has morbidity Endovascular ablation is as effective with less morbidity from wounds and hematoma ESCHAR study: 500 patients Healing at 24 wks no difference (65% vs. 65%) Healing at 3 years Compression 89% Compression and surgery 93% (P=0.73) Recurrence at 12 months: Compression 28% recurrence Compression and surgery 12% recurrence (P < ) Recurrence at 4 years Compression 56% Compression Surgery 31% Barwell JR, et al; Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomized controlled trial. Lancet 2004 Jun 5;363 : Zamboni randomized 80 patients: Surgical group healing was 100% (31 days) Compression group 96% (63 days) (p<0.02). The recurrence rate 9% in the surgical 38% in the compression group (p<0.05). Surgical group plethysmographic parameters except ejection fraction, had improved significantly at 6 months at 3 years residual volume fraction remained in the normal range. Quality of life significantly improved in the Surgery group. Follow-up of 3 years Zamboni P, Minimally invasive surgical management of primary venous ulcers vs. compression treatment a randomized clinical trial. Eur J Vasc Endocvas Surg 2003 apr 25 (

17 Surgical group plethysmographic parameters except ejection fraction, had improved significantly at 6 months at 3 years residual volume fraction remained in the normal range. Quality of life significantly improved in the Surgery group. Zamboni P, Minimally invasive surgical management of primary venous ulcers vs. compression treatment a randomized clinical trial. Eur J Vasc Endocvas Surg 2003 apr 25 ( Viarengo compared treatment to compression 52 patients 25 compression alone 27 endo vascular Laser plus compression Healed Rate at 12 months Surgical/compression 81.5% Compression alone 24% Recurrence Rate 44% recurred in compression group 0 % recurred in the endo ablation group compression Viarengo LM, et al; endovenous Laser treatment for varicose veins in patients with active ulcers:measurement of intravenous and perivenous temperatures during the procedure. Dermatologic Surg. 33(10) Patients treated 938 limbs 53% of limbs had nonthrombotic compression lesions (defined as no history of DVT and no venographic or ultrasound findings indicating previous DVT) 40% had post-thrombotic obstruction 7% had a combined etiology Site of obstructive lesion Common iliac vein 36% External iliac vein in 18% Both sites in 46% of symptomatic limbs Neglen P, Chronic Venous Obstruction and Iliac Stenting: Etiology of an Obstructive Lesion. Vascular. 2007;15(5):

18 Chronic Venous Insufficiency (CVI) 17% of may be candidates for stenting Obstruction of the iliac vein Primary Secondary compression of the iliac vein Right Iliac artery on Left Iliac Vein (May-Thurner Syndrome) Secondary to previous deep venous thrombosis (DVT) Benign or malignant tumors Pelvic irradiation Retroperitoneal fibrosis Aneurysmal compression Raju S, Owen S, Jr, Neglen P. The clinical impact of iliac venous stents in the management of chronic venous insufficiency. J Vasc Surg 2002;35:8-15. Neglén, et al reported 447 limbs with non malignant obstruction Patients with obstruction and reflux had more severe disease (p<0.001) Patients had relief of Pain (P<0.001) Swelling (P<0.001) Ulcer Healing (55%) with stenting alone Iliac obstructive Disease may be overlooking in treatment of difficult to heal patients. Neglén P, Thrasher TL, Raju S ; Venous outflow obstruction: an underestimated contributor to chronic venous disease. J Vasc Surg 38(5) Nov 2003 p Right Iliac Artery compresses the Left Iliac Vein Increases the risk of DVT in left extremity Leads to Venous hypertension and reflux 18

19 ` Linton Procedure SEPS smaller incisions Ligates the perforating veins Performed on recalcitrant ulcers after stripping or ablation Venous Hypertension results from valve insufficiency Edema and lipodermatosclerosis results Trauma leads to ulceration that is difficult to heal Compression essential to healing Weekly visits matters Twice weekly appointments improves healing Monitor progress or lack there of Implement Advanced technology in a timely fashion Consider obstructive pathologies 19

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