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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

higher the pressure, the greater is the risk of eventual tissue necrosis.(1) 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, (15)

and minimally

invasive perforator therapy, (16) 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:

________ 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?

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

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3. How do you rate the overall presentation material?

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4. Was any commercial bias presented in the material?

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____________________________________________________

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

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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 ___________________________________________________