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Welcome to the Vein Experts Online Educational CME Program. Original Release Date: 2/1/2013 Termination Date: 1/31/2016 Price: 25.00 for Vein Experts Members & $40.00 for Non-Members Processing/CME Fees Accreditation:

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The University of Toledo and VeinExperts.org. The University of Toledo is accredited by ACCME to provide continuing medical education for physicians. The University of Toledo designates this enduring activity for a maximum of 1.00 AMA PRA Category Credits™. Physicians should claim only credit commensurate with the extent of their participation in the activity. For nurses, we are also able to issue a certificate of attendance stating the course is AMA approved, which may be eligible for credit. Nurses are responsible for submitting the certificate to their board. Please note only one certificate can be issued for each purchase. Disclosure: Ronald Bush, MD, FACS, faculty and planning member discloses he is on the Speaker’s Bureau for Dornier/Refine USA and is employed by Midwest Vein & Laser Center. Richard L. Mueller, MD, faculty and planning member, discloses he receives grant/research support from Vascular Insights, LLC Peggy Bush, APN, planning member, has no disclosures or financial interests and is employed by Midwest Vein & Laser Center. Becky Roberts, planning member, has no financial interest or other relationships with any manufacturer of commercial product or service to disclose. !

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Mission: Our objective is to provide current evidence based information, as well as new technology that is being developed for the treatment of venous disease presented in a virtual format. Target Audience: The target audience for this activity includes physicians and other health care professionals in Cardiology, Dermatology, Interventional Radiology, Phlebology, Surgery, Vascular Surgery, Wound Care Specialists who care for patients with venous disease.

CME Credit Instructions Steps to successfully complete this activity: 1. Register for CME activity & pay your CME fees. 2. Read the Vein Journal entitled ‘Histology of Venous Disease: From Spider Veins to Aneurysms.’ 3. Take the post test (score of 80% or greater must be achieved. (A pdf copy of the exam can be emailed to you if requested). 4. Scan and email post test and evaluation to pbush@veinexperts.org or you can fax completed paperwork to 937-281-0200. 5. You will be contacted by the University of Toledo CME office for instruction of how to sign on and print your certificate. Technical Support Email your questions/concerns to pbush@veinexperts.org or you can call us at 407-900-8346 and we will respond in 24 hours.

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Etiology and Treatment of Venous Ulcers 2/21/13 Ronald Bush, MD, FACS Peggy Bush, APN

Etiology and Treatment of Venous Ulcers This activity describes the cause, treatment, and expected outcome of venous ulcer therapy. Also introduced is a revolutionary technique (TIRS) that rapidly heals venous ulcers in a majority of patients.

Learning Objectives: As a result of this activity, the participant should be able to: 1) Review current treatment of venous ulcers 2) Provide basic knowledge and pathophysiology of venous ulceration 3) Provide a detailed instruction in a technique/procedure to hasten the healing of venous ulcers and prevention of recurrence

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Treating venous leg ulcers is time-consuming and affects patients’ quality of life. Venous ulcers affect approximately 2 percent of the adult population. Millions of dollars are spent each year on the care of venous ulcers. At this time, there is no consensus on the best therapy. Compression therapy has been the main treatment strategy. In this discussion, the etiology from a hemodynamic and cellular aspect will be examined. Adjunctive treatments both medically and surgically will be outlined. Finally, a new treatment option will be introduced known as ‘Terminal Interruption of the Reflux Source,’ (TIRS). This technique was published in Perspectives in Vascular Surgery and Endovascular Therapy, 2010. The common factor for venous ulcers is increased ambulatory venous pressure. A pressure above 45 mmHg increases the risk of ulceration. The (1)

higher the pressure, the greater is the risk of eventual tissue necrosis.

The

increased pressure may be due solely to reflux at some point in the venous system or co-exist with other factors.

(2)

When evaluating a patient with a venous ulcer, an understanding of venous pathophysiology and the complex interaction at the cellular level must be understood. The etiology of the increase venous pressure should be documented. This may be from a superficial, deep, perforating vessel or a

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combination of any of the three. Other contributing factors such as abdominal outflow compression or problems with venous or arterial capacity may be present. The eventual goal if possible is to provide relief of the increased venous pressure. This will ensure the best possible outcome and help reduce further ulcerations. Most therapy is directed at the local level when the patient is first seen in the clinic and this is usually in the form of compression therapy. Compression therapy with either elastic or inelastic dressings has been the historical treatment.

(3) (4)

As compliance increases, so do the healing rates.

Even with compression alone, there is still a high recurrence rate.

(4) (5)

Other adjuncts to improving ulcer healing have been described. Medical therapy has included aspirin, rutosides, and pentoxyphine.

(6) (7) (8)

As always, local wound

care is essential and irrigation and debridement of devitalized tissue is essential. At the ‘Midwest Vein and Laser Center’, Dayton, Ohio, debridement is often carried out using 3 '10cc syringes with saline connected to a 30'gauge needle. This technique in effect directs a high-pressure stream of saline that is directed at the ulcer base. Debridement is very effective and easily tolerated by the patient. Countless dressings have been advocated for ulcers and these range from gauze to impregnated foam dressings. Silver impregnated dressings are used in our clinic when there is evidence of infection locally. However, there is no evidence in the literature of the superiority of one dressing over the other in promoting wound healing.

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Skin grafts have been used as an adjunct in wound healing for venous ulcers. Grafts include full thickness punch grafts, xenografts, or allografts. To date, in an updated review on skin grafting for venous ulcers; bi-layer artificial skin, used in association with compression dressings, increased ulcer healing compared to compression alone.

(10) (11)

In the study by (Falanga et, al, 1998),

healing at 6 months was only 63% with allogenic human skin equivalent compared to a 43% with compression alone.

(10)

Surgical techniques such as, stripping the greater saphenous vein (11), (12), subfascial perforator ligation, (13) endoluminal thermal ablation, invasive perforator therapy,

(16)

(15)

and minimally

have been used as adjuncts in the treatment of

venous ulcers. Non'targeted foam sclerotherapy has also been mentioned as a treatment modality.

(16)(17)

Except for foam sclerotherapy, none of these

procedures have proven to increase the healing rate of venous ulcers. The above adjunctive procedures are mostly directed at preventing future occurrences. Recently, a technique, ‘Terminal Interruption of the Reflux Source (TIRS) has been introduced.

(18)

The TIRS technique targets only those vessels in close

proximity to the venous ulcer (under the ulcer bed). The basis of this theory is that venous ulceration is a local manifestation of a systemic problem. The high venous pressure in a vein or veins draining the ulcer bed, or in some instances a perforator directly in continuity with the ulcer, is responsible for the local phenomena of ulceration. If the venous hypertension is relieved, then healing should accelerate.

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When using the TIRS technique, patients at Midwest Vein and Laser Center had rapid healing of ulcers when compared to compression alone, or compression with other adjunctive procedures. In a series of twenty patients treated with the TIRS technique, healing occurred in ninety percent of patients within 8 weeks. All patients had been compliant with compression for 18-24 months prior to treatment. (Bush, 2010) The exact mechanism of action at the microscopic level is as yet unknown in the TIRS technique. The genesis of ulceration at the microscopic level is generally believed to be an inflammatory response. According to this theory, continuous high pressure leads to eventual necrosis. The necrosis is mediated by complex interaction at the cellular level. Rapid healing observed after occluding these high- pressured venous effluents with foam sclerotherapy must be related to a marked reduction in ambulatory venous pressure at the local level. Unfortunately, there is no reliable means to measure pressures in smaller distal venous channels, or for that fact at the tissue level. Hence an assumption is made that healing is mediated through a local reduction of venous pressure at the ulcer site. The response has been rapid in most patients, however, there may be other mechanisms that are also contributing which as yet are not known. The TIRS technique requires good interpretive ultrasound skills, and the ability to safely deliver the foamed sclerotherapy with the aid of ultrasound guidance. Only the most distal venous branches draining the area of the ulcer are identified. In some patients, especially those with anterior calf ulcers, a perforator leading directly to the ulcer bed may be identified. The proximal source

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of reflux, i.e. saphenous vein, classic posterior tibial perforator, or other source proximally is ignored. Only the distal vessel or vessels are targeted, initially.

Vessels under the ulcer bed, somehow you must get the foam here, by direct puncture or by introducing it through a superior or inferior vessel close to the circumference of the ulcer. When these vessels clot, this equates to an internal compression, which is more effective than external compression. Copyright  2011 by www.bushvenouslectures.com Using ultrasound guidance, these vessels are cannulated with needle penetration through normal skin, as far from the ulcer margin as possible. A 3 cc syringe and a 22'gauge needle are used in our clinic. Cannulation is done superior to the ulcer if chronic skin change exist inferiorly. After penetrating the target vessel, the foam is slowly injected.

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Using ultrasound to demonstrate vessels draining ulcer bed -' Copyright 2011 by www.bushvenouslectures.com

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Local anesthesia to skin delivered with 30-'gauge needle with tumescent solution -' Copyright 2011 by www.bushvenouslectures.com

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Percutaneous puncture of target vessel -' Copyright 2011 by www.bushvenouslectures.com

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Aspirating blood after puncture to confirm needle placement -' Copyright 2011 by www.bushvenouslectures.com

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Injecting Sotradecol  foam -' Copyright 2011 by www.bushvenouslectures.com

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Injecting Sotradecol  foam -' Copyright 2011 by www.bushvenouslectures.com In our clinic, a 4:1 mixture of Sotradecol  and C02 is used. After injecting the foamed solution, compression is applied and local wound care is done. The patient is rescanned at weekly intervals and foam injections are repeated if necessary. A 1 percent concentration is used, unless extenuating circumstances, such as concurrent anticoagulation or high flow exists. A 3 percent foamed solution of Sotradecol is then used. Definitive treatment of the proximal reflux source such as thermal ablation of the saphenous vein or perforator interruption is done at a later date, to help prevent future ulcer occurrences. In some cases, concurrent treatment can be done. However, many times insurance requirements must be addressed and the more definitive procedures are done 6-'8 weeks after the first ultra sound guided !

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treatment. Most patients have had rapid healing by this time and local infection and pain have abated. Venous Ulcers: The TIRS Technique Through a Percutaneous Approach 69- year old male with recurrent venous ulceration right lower leg; the patient had a previous saphenous vein ablation three years ago with foam injection of the ulcer bed 8 weeks before the procedure. The ulcer healed completely before the ablation. Now, presents with recurrent venous ulcer inferior to the old site. Popliteal vein shows no reflux, posterior tibial vein shows no reflux, but there is an incompetent perforator that drains the ulcer bed. This can be seen in figures 1-3. The ulcer bed has been injected once before percutaneously with a 25-gauge needle. This is a quick and relatively painless way to deliver foam into the underlying ulcer bed. In almost all patients, a small superficial venous tributary can be found in close proximity to the ulcer. This has now become my preferred method of performing the TIRS Technique. It is also much more comfortable for the patient. This provides excellent access to the ulcer bed. Make sure there is good blood return in your tubing before injecting the foam. Foam is much safer to inject and much more effective than liquid. This can be seen in Figure 4. Figure 5 shows the foam in the ulcer bed after the percutaneous injection with the 25-gauge needle. The patient should be seen in one week and any patent vessels under the ulcer bed are obliterated with foam. Foam sclerotherapy provides an excellent

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internal compression dressing, reducing ambulatory venous hypertension at the ulcer site. In Fact, this patient had a reduction of one half of the original ulcer size in 2-weeks.

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References 1. Payne S, London N, Newland C, et al. Ambulatory venous pressure: Correlation with skin condition and role in identifying surgically correctible disease. Eur J Vasc Endovasc Surg. 1996;11:195-'200. 2. Raju S, Neglen P, Carr-'White P, et al. Ambulatory venous hypertension: Component analysis in 373 limbs. Vasc Endovascular Surg. 1999;33:257-'266. 3. Fletcher A, Cullum N, Sheldon T. A systematic review of compression treatment for venous leg ulcers. BMJ. 1997;315:576-'580. 4. Erickson C, Lanza D, Karp D, et al. Healing of venous ulcers in an ambulatory care program: the roles of chronic venous insufficiency and patient compliance. J Vasc Surg. 1995;22(5):629-'636. 5. Scriven J, Taylor L, Wood A, et al. A prospective randomized trial of four-'layer versus short stretch compression bandages for the treatment of venous leg ulcers. Ann R Coll Surg Engl. 1998;80:215-'220. 6. Falanga V, Fujitani R, Diaz C, et al. Systemic treatment of venous leg ulcers with high doses of pentoxifylline: Efficacy in a randomized, placebo-' controlled trial. Wound Repair Regen. 1999;7:208-'13. 7. Colgan M, Dormandy J, Jones, P, et al. Oxpentifylline treatment of venous

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ulcers of the leg. BMJ. 1990;300:972-'975. 8. Gohel M, Davies A. Pharmacological agents in the treatment of venous disease: An update of the available evidence. Current Vascular Pharmacology. 7(3):303-'8, 2009 Jul. 9. Jones J, Nelson E. Skin grafting for venous leg ulcers. Cochrane Database Syst Rev.. 2007;18;(2). 10. Falanga V, Margolis D, Alvarez O, et al. Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Arch Dermatol. 1998;134(3):293-'300. 11. Barwell J, Davies C, Deacon J, et al. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR STUDY): Randomized controlled trial. Lancet. 2008;363(9424):1854-'1859. 12. Homans J. The operative treatment of varicose veins and ulcers, based on classification of these lesions. Surg Gynecol Obstet. 1916; 22:143-'158. 13. Pierik E, Van Urk H, Hop W, Wittens C. Endoscopic versus open subfascial division of incompetent perforating veins in the treatment of venous leg ulceration: A randomized trial. J Vasc Surg. 1997;26(6):1049-'1054) 14. Glovicski P, Bergan J, Rhodes J, Canton L, Harmsen S, Ilstrup D. Mid-'term results of endoscopic perforator vein interruption for chronic venous insufficiency: Lessons learned from the North American subfascial

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endoscopic perforator surgery registry. The North American Study Group. J Vasc Surg. 1999;29(3):489-'502. 15. Rautio T, Ohinmaa A, Perala J, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: A randomized controlled trial with comparison of the costs. J Vasc Surg. 2002;35(5):958-'965. 16. Poblete H, Elias S. Venous Ulcers: New options in treatment: Minimally invasive vein surgery. Journal of the Am Coll of Certified Wound Specialists. 2009;1(1):12-'19. 17. Hertzman, P, Owens R. Rapid healing of chronic venous ulcers following ultrasound-'guided foam sclerotherapy. Phlebology. 2007; 22:34-'39. 18. Bush R. Terminal interruption of the reflux source for the treatment of venous ulcers. Presented at the American College of Phlebology. 2009. 19. Bush, R. New technique to heal venous ulcers: Terminal interruption of the reflux source (TIRS). Perspectives in Vascular Surgery and Endovascular Therapy. 2010;22(3).

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Complete the exam & evaluation below and email your results to pbush@veinexperts.org along with your contact information. A score of 80% or greater must be achieved on the post-test and be completed in less than 3 attempts.

Etiology and Treatment of Venous Ulcers 1) The risk for venous ulcers increases with ambulatory venous pressures of: ________ ________ ________

a. 45 mmHg b. >60 mmHg c. Not related to ambulatory pressure

2) Ulcer healing is improved by: ________ ________ ________

a. Saphenous vein stripping b. Compression dressing c. a & b

3) The TIRS Technique: ________

a. Targets the venous complex under the ulcer bed b. Targets the GSV c. Targets only perforator veins d. None of the above

4) The TIRS Technique: ________ ________ ________ ________

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a. Reduces ambulatory pressure locally b. Can only be done early in ulcer formation c. Requires higher external compression d. None of the above

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Evaluationჼჼ ჼ 1. How well did this activity present the objectives? Excellent

Good

Satisfactory

Poor

2. How do you rate the overall usefulness of the online material to meeting your needs? Excellent

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3. How do you rate the overall presentation material? Excellent

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4. Was any commercial bias presented in the material? No

Yes (Please explain)

____________________________________________________ 5. I will be able to change my clinical practice as a result of participating in this activity. Yes

No

6. What topics about venous disease would you like to hear about in the future? ____________________________________________________ 7. Additional comments/recommendations: ____________________________________________________ ____________________________________________________

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Contact Information Name & Credentials_______________________________________________ Address ________________________________________________________ Phone Number ___________________________________________________ Email address ___________________________________________________

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Chapter 1 Etiology and Treatment of Venous Ulcers