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Venous Ablation Therapy: When and How?

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Presentation on theme: "Venous Ablation Therapy: When and How?"— Presentation transcript:

1 Venous Ablation Therapy: When and How?
Keith M Horton, MD Medstar Washington Hospital Center Clinical Assistant Professor Radiology, Georgetown University Hospital The information contained in this presentation includes content on VNUS Closure treatment. It is not intended to serve as an exclusive education or guide to patient treatment.

2 Keith M. Horton, MD I/we have no real or apparent conflicts of interest to report. Off-Label: Foam Sclerotherapy: can be produced only with detergents: sodium tetradecyl sulfate (STS) which is FDA-approved as Sotradecol™, and polidocanol ( POL) which is not yet FDA-approved.

3 It may seem that I am glossing over a lot of the details” and I am” but a lot of what I will be talking about you can find in this article written and in the Journal of interventional radiology Journal of Vascular and Interventional Radiology, January 2010 Vol. 21, Issue 1, Pages 14-31

4 U.S. Epidemiology and Prevalence
Venous reflux disease is 2x more prevalent than coronary heart disease (CHD) and 5x more prevalent than peripheral arterial disease (PAD)1 Of the estimated 25 million people with symptomatic superficial venous reflux1: Only 1.7 million seek treatment annually2 Over 23 million go untreated Since I’m in a roomful of cardiologists I will try to explain this to you but maybe next familiar to you The prevalence of venous reflux is actually twice as high as coronary heart disease and five times higher than peripheral arterial disease, though far fewer patients actually receive treatment Statistics show that of the 25 million people in the U.S. who suffer from symptomatic reflux, only about 5% seek treatment annually; 2/3 of patients who do seek treatment have saphenous reflux Sources: American Heart Association, SIR, Brand et al. “The Epidemiology of Varicose Veins: The Framingham Study” US Markets for Varicose Vein Treatment Devices 2006, Millennium Research Group 2005.

5 Prevalence by Age and Gender
Female Male 8% 1% 41% 24% 72% 43% With advancing age, especially with females, the prevalence of venous disease grows The typical female patient is in her 40’s and has had multiple pregnancies Coon WW, Willis PW, Keller JB: Venous thromboembolism and other venous disease in the Tecumseh Community Health Study Circulation 1973;48:

6 Risk Factors Gender Age Heredity Pregnancy Standing occupation Obesity
Prior injury or surgery Sedentary lifestyle I have Already mentioned gender and age is a risk factors additional risk factors include Gender: Approximately four times as many women as men are affected by varicose veins, suggesting that female hormones may be a risk factor. Age: Generally, most elderly individuals show some degree of varicose vein occurrence. Heredity: Weak vein walls and valves, as well as shortage of vein valves, seem to be inherited characteristics, and may play a role in determining who develops varicose veins and at what age Pregnancy is associated with an increase in blood volume. Also, added pressure on the veins in the legs by the weight of the growing uterus and the relaxation effects of the hormones estrogen and progesterone on the vein walls contribute to the development of varicose veins during pregnancy. Standing or prolonged sitting: causes a great amount of pressure to develop in the leg veins. The calf muscles are inactive and therefore can’t help push venous blood back up to the heart. This causes blood to pool in the veins, thus resulting in increased pressure on the vein walls. Prior trauma or surgery to the leg could cause interruption of the normal blood flow channels.

7 Vein Valves Blood propelled by calf muscle pump opens the valve in one direction Blood moving with gravity closes the normal valve With properly functioning valves, the blood has only one direction in which to go – toward the heart. Image source:

8 Vein Valve Failure Normal vein: valve open and closed
The incompetent valves are most often found in the great saphenous vein (GSV) or small saphenous vein (SSV) or in their tributaries. Until recently, the main treatment strategy for incompetence in these veins was to remove them. Endovenous thermal ablation (EVTA) of the saphenous veins has been used by physicians since the late 1990s as an alternative to surgical removal. Normal vein: valve open and closed Dilated vein with non-functioning valve

9 With time these veins dialate, become tortuous and eventually and bulge and become visable..

10

11 Venous Reflux: A Serious Progressive Disease
Skin Ulcers Skin Damage Leg Swelling 500K 2-6 Million Symptomatic Patients1 Varicose Veins 1White JV, Ryjewski C. Chronic venous insufficiency. Perspect Vasc Surg Endovasc Ther 2005;17:319-27 2Image courtesy of Paul McNeill, MD 3Image courtesy of Rajabrata Sarkar, MD 4Photo source: missinglink.ucsf.edu/.../stasis_dermatitis.html 5Photo source: Amor Khachemoune, Catharine Lisa Kauffman: Management Of Leg Ulcers. The Internet Journal of Dermatology Volume 1 Number 2. 20 Million Increased pain and reduced quality of life Serial testing of children over an 8 year period revealed abnormal venous flow and symptoms predated the appearance of varicosities Progression of venous abnormalities goes from reticular veins to incompetent perforators to truncal varicosities Patients with varicose veins are usually symptomatic- even if they are not fully aware. A good history and physical will detect problems secondary to the veins >7 million Americans with highly symptomatic disease: - Swollen limbs can be secondary to venous hypertension and sedentary lifestyles - Progression of venous stasis hypertension affects the skin and appendages, and are a precursor to ulceration - Venous stasis ulceration is the most common cause of lower extremity ulceration Overall, as the severity of the disease progresses, quality if life decreases

12 Duplex Ultrasound All patients should have Clinical and US
Must be familiar with Duplex US Knowledge can be Acquired in many ways All patients with CVD should undergo a complete clinical and duplex US evaluation before being considered a candidate for EVTA. This evaluation and subsequent treatment should be performed by a physician who is appropriately trained in the care of patients with venous disorders. The body of knowledge required by such a physician includes a thorough understanding of the anatomy, physiology, pathophysiology, and clinical course pertaining to these conditions. The physician should be experienced in the performance and interpretation of duplex US of the venous system as well as conservative, medical, and procedural approaches for treating venous disorders. The requisite knowledge, clinical, and procedural experience required to care for patients with venous disorders can be acquired in a number of ways. Many physicians will acquire the necessary knowledge and skills through continuing medical education and/or mentored clinical experiences (11) after their postgraduate medical training. The knowledge and skills can also be obtained through postgraduate medical training in an Accreditation Council for Graduate Medical Education–recognized (or approved) postgraduate training program.

13 The Great Saphenous Vein
Images courtesy of Olivier Pichot, MD GSV within the fascial envelope Note the superficial or saphenous fascia above the vessel and the deep or muscular fascia below the vessel Shown here is the GSV within the saphenous compartment – commonly referred to as the “saphenous eye”

14 Saphenofemoral Junction
Image courtesy of Gerald Niedzwiecki, MD The GSV terminates in the Common Femoral Vein at the Saphenofemoral Junction One to three sub terminal valves in the GSV: usually just one within one cm of the SFJ There are generally 5 tributaries at the SFJ: - AL = Anterolateral - SCI = Superficial circumflex iliac - SE (SEV) = Superficial epigastric - SEP = Superficial external pudendal - PM = Posteromedial SFJ image source: Chandler JG et al. Defining the role of extended saphenofemoral junction ligation: A prospective comparative study. JVS 2000;32:941-53

15 Superficial System Exam: Great Saphenous Vein
Image courtesy of Gerald Niedzwiecki, MD Image courtesy of Gerald Niedzwiecki, MD Here we see pulsed wave Doppler images of a normal and refluxing great saphenous vein. Normal valve closure time of <0.5 sec Reflux of approximately 1.5 seconds

16 Reflux Assessment: Deep System Exam
Assess deep venous system and rule out DVT using compression, color flow and augmentation Note areas of deep system incompetence at this time Image courtesy of Gerald Niedzwiecki, MD Vein in compression The insufficiency study starts with assessment of the deep venous system. Color and pulsed-wave Doppler, and maneuvers such as compression and augmentation, are used to determine the presence of obstruction and reflux Although most radiologists are familiar with duplex ultrasound (DUS) imaging of the deep system, DUS evaluation of the superficial venous system is seldom performed properly. In addition to its undeniable diagnostic value, DUS is also a critical part of treatment of venous reflux. Experienced practitioners may recognize common clinical patterns of venous disease; however, DUS will more reliably and accurately map out all of the underlying sources of reflux. Treatment plans based solely on physical examination will often result in inadequate elimination of incompetent pathways or removal of normal veins. Therefore, it is strongly recommended that all patients undergoing evaluation for varicose veins, edema or venous skin changes (CEAP clinical stage 2-6) undergo DUS of the superficial venous system prior to initiating treatment. Normal flow in deep vein after augmentation

17 Treatment for Venous Insufficiency
First line is conservative management What patient can do Exercise daily Elevate legs often Wear medical grade compression stockings 1 2 3 Leg elevation helps to drain the excess blood that pools in the calf and ankle area Exercise and compression stockings assist the function of the calf muscle pump Image sources: 1: 2: 3:

18 Compression Therapy for Venous Insufficiency
First step in management of SVI Payors usually require several weeks or even months Doesn’t alter anatomy of venous insufficiency patient; treats symptoms but is not curative Accelerates venous return Compression reduces lumen diameter of superficial and deep veins Helps calf muscle pump work more effectively Underlying cause must still be addressed Very useful in post-treatment regimens SVI = Superficial venous insufficiency Compression stockings can relieve symptoms while worn but are not curative

19 Indications For Endovenous Procedure
Failed conservative therapy Signs and symptoms of venous insufficiency Impact of symptoms on ADLs often not realized until after problem corrected Reflux proven by duplex scan Anatomic defect that will lead to worsening of natural history Should be corrected on its own merit Document the signs and symptoms via history and physical Prescribe conservative therapy and document results Refer the patient to a physician with a vein practice or a laboratory for a duplex work-up ADL’s: activities of daily living Venous hypertension caused by incompetent valves in the superficial veins is by far the most common cause of this condition. The incompetent valves are most often found in the great saphenous vein (GSV) or small saphenous vein (SSV) or in their tributaries.

20 Traditional Therapy For SVI
GSV stripping and ligation Groin incision to ligate and divide GSV tributaries and SFJ at CFV Stripper passed through GSV at groin, retrieved at knee incision Stripper pulled from groin to knee, stripping vein and avulsing branches Significant morbidity associated with vein avulsion There are variations to this basic method; however, the steps generally include: - Groin incision - Tributary ligation and division Physical removal of the saphenous vein Until recently, the main treatment strategy for incompetence in these veins was to remove them. Endovenous thermal ablation (EVTA) of the saphenous veins has been used by physicians since the late 1990s as an alternative to surgical removal. This document will review the appropriate means by which the ablative techniques are to be used to maximize benefit and mini- Image source: Goldman MP, et al eds. Varicose veins and telangiectasias: Diagnosis and treatment. 2nd ed. St. Louis: Quality Medical Publishing, Inc.; 1999.

21 Modern Therapy For SVI Endovenous ablation Radiofrequency or laser
Great and small saphenous veins Accessory saphenous veins Giacomini or Thigh Extension veins Perforators Modern Therapy: Address pathophysiology without the disfigurement and trauma associated with traditional surgery Throughout this document, the procedure under discussion will be referred to as EVTA for incompetent truncal (ie, saphenous) veins. This procedure is used to ablate incompetent truncal veins in patients with SVI. The underlying mechanism of this procedure is to deliver sufficient thermal energy to the wall of an incompetent vein segment to produce irreversible occlusion, fibrosis, and ultimately resorption of the vein. The currently available devices used to accomplish this have been evaluated and approved by the Food and Drug Administration of the United States and use radiofrequency (RF) or laser energy (of a variety of different wavelengths) to deliver the required thermal dose. The thermal energy is delivered by a RF catheter or a laser fiber inserted into the venous system, either by percutaneous access or by open venotomy.

22 Radiofrequency Ablation
RF generator heats catheter tip coil, which conducts heat into vein wall Denudes intimal lining Collagen molecules contract Acute inflammatory response leads to eventual fibrotic occlusion of vessel Treatment temperature at 120C System uses least amount of energy necessary to maintain temperature Continuous system feedback ensures adequate thermal dose Throughout this document, the procedure under discussion will be referred to as EVTA for incompetent truncal (ie, saphenous) veins. This procedure is used to ablate incompetent truncal veins in patients with SVI. The underlying mechanism of this procedure is to deliver sufficient thermal energy to the wall of an incompetent vein segment to produce irreversible occlusion, fibrosis, and ultimately resorption of the vein. The currently available devices used to accomplish this have been evaluated and approved by the Food and Drug Administration of the United States and use radiofrequency (RF) or laser energy (of a variety of different wavelengths) to deliver the required thermal dose. The thermal energy is delivered by a RF catheter or a laser fiber inserted into the venous system, either by percutaneous access or by open venotomy.

23 Endovenous Laser Laser generator and generic diode laser fiber
Peak treatment temperature reaches ~700C Heated blood in vein generates steam bubble which indirectly heats vein wall, causing thrombotic occlusion Image source:

24 Anatomy GSV 70-80% SSV 10-20% Non Saph 10-15% Anatomy
Superficial veins.—The veins of the lower extremity that are superficial to the fascia surrounding the muscular compartment are considered the superficial veins. These include innumerable venous tributaries known as collecting veins, as well as the GSV and SSV and their major named tributaries (Fig). Deep veins.—The deep veins are those that are found deep to the muscular fascia. These include the tibial, peroneal, popliteal, femoral, and iliac veins, as well as the intramuscular sinusoidal and perforating veins. GSV.—An important component of the superficial venous system, the GSV begins on the dorsum of the foot and ascends along the medial aspect of the leg to ultimately drain into the femoral vein near the groin crease. This vein resides in a space deep to the superficial and superficial to the deep fascia. This location is known as the saphenous space. The word “great” replaces “greater” or “long” by international consensus (1,2; Fig). SSV.—Another important superficial vein, the SSV begins on the lateral aspect of the foot and ascends up the midline of the calf. In as many as two thirds of cases, it drains into the popliteal vein, and in at least one third of cases more cephalad into the posterior thigh. The SSV also resides in the saphenous space. The word “small” replaces “lesser” or “short” by international consensus (1,2; Fig). Anterior and posterior accessory GSVs.— The anterior and posterior accessory GSVs are located in the saphenous space and travel parallel and anterior or posterior to the GSV. The anterior accessory GSV is much more common (Fig). Giacomini vein.—This intersaphenous Giacomini vein is a communication between the GSV and SSV. It represents a form of SSV thigh extension that connects the SSV with the posterior circumflex vein of the thigh, a posterior tributary of the proximal GSV (Fig). Truncal veins.—This term “truncal veins” refers to the saphenous veins and their intrafascial straight primary tributaries (Fig). CVD.—CVD is the clinical entity that results from chronic venous hypertension (3). The overwhelming majority of patients with stigmata of venous hypertension have primary (or idiopathic) disease of the vein wall with resultant valvular dysfunction in the superficial veins, which leads to reflux (4). This subset of CVD is known as SVI. Pathophysiologically significant reflux in the GSV or one of its primary tributaries is present in 70%–80% of patients with CVD. SSV reflux is found in 10%–20% of patients and nonsaphenous superficial reflux is identified in 10%–15% of patients (5,6). Venous obstruction, deep vein reflux, muscular pump failure, and congenital anomalies are much less common causes. Venous obstruction is the most common of these other causes of CVD and is almost always the result of prior deep vein thrombosis (DVT). It is initially an obstructive disease but usually progresses to a combination of obstruction and superficial and deep reflux (7). Reflux or outflow vein obstruction leads to an increase in pressure in the veins. The veins themselves can dilate if unconstrained, and the pressure causes stretching of receptors in the vein wall that leads to discomfort to the patient. The pressure itself can adversely affect local tissues and metabolic processes, leading to damage in the vein wall, the skin, and subcutaneous tissues.

25 Pre-op Mapping & Marking
Significant anatomy to note: Depth of vein from skin surface Maximum vein diameter Duplicate saphenous system Areas with: Tortuous and aneurysmal segments Tributaries, branches and perforators Potential vein access sites Nitropaste Image courtesy of Joseph Smith, MD The treatment vein anatomy should be assessed pre-operatively and the following factors evaluated and noted: The depth of the vein from the skin surface Vein diameter Duplicate system Significant anatomy such as tortuous or aneurysmal segments, duplicate systems, and tributaries, perforators, or large branches Potential vein access sites should be identified

26 Tilt table Ultrasound machine Warming blanket

27 RF machine Laser Klein Pump Pandora

28 Vein Access Treatment vein accessed percutaneously under ultrasound guidance or with small cut down Needle Image courtesy of Darcy Kessler, RVT Most often, a percutanous approach is used to access the vein, though a small cut down incision may be used with good cosmetic result.

29 Vein Access Vein access achieved percutaneously or through small cutdown An introducer sheath is placed in vein Image courtesy of Joseph Smith, MD The vein is accessed percutaneously with ultrasound guidance or through a small cutdown The optimal vein access site is close to the surface of the skin, free from any branches or tortuosity, and at least 4mm in diameter. An introducer sheath is placed in the vein, through which the catheter will be inserted Image courtesy of Joseph Smith, MD

30 Catheter Tip Position Catheter tip is positioned 2.0cm distal to the SFJ to Avoid heating too close to deep venous system Preserve epigastric vein patency SEV Catheter CFV SFJ Image courtesy of Thomas Proebstle, MD Careful measurement of the distance from the catheter tip to deep system is performed to ensure that heating will not occur too close to the deep system

31 Indexing and Treatment
1. Apply external compression and deliver energy to vein segment; two 20-second RF cycles delivered at segment closest to SFJ Withdraw catheter to next shaft marker, apply compression and deliver energy The sequence of indexing and treatment is as follows: Apply external compression and deliver energy to the vein segment then Index the catheter to the next shaft marker, re-apply compression and deliver energy Remember that there is a 0.5cm treatment overlap between segments Repeat catheter indexing, compression, and treatment until the last treatment segment is reached 3. Repeat withdrawal, compression and treatments until desired length treated Note: Aneurysmal segments and areas with large tributaries or perforators may benefit from two treatment cycles

32 Perivenous Tumescent Infiltration
Dilute local anesthetic infiltrated into saphenous compartment (perivenously) using duplex imaging Infiltration of a dilute lidocaine solution begins at the access site and advances proximally toward the sahenofemoral junction. The goal is to inject into the saphenous compartment very close to the vein and create a 360 degree fluid halo around the vein. The halo appears black because fluid is a poor reflector of ultrasound transmission, as is blood in a normal patent vein. At the SFJ, a sufficient volume of fluid should be infiltrated to thoroughly compress the vein around the heating element. Perivenous infiltration technique: note 360 “halo” of fluid around vein

33 Tumescent Infiltration
Dilute local anesthetic infiltrated around treatment vein under ultrasound imaging Catheter A dilute local anesthetic is infiltrated into the saphenous compartment to encircle the treatment vein to protect surrounding soft tissue from thermal injury, compress the vein around the catheter, and provide patient comfort Image courtesy of Michael Vasquez, MD Note fluid encircling vein

34 Tip Position Verification
Catheter tip is positioned 2.0cm distal to SFJ under ultrasound guidance Image courtesy of Joseph Smith, MD The final tip position of the catheter should be confirmed with duplex ultrasound to ensure the device is not in the deep venous system. The correct catheter tip position is 2 centimeters from the saphenofemoral junction A longitudinal or oblique view of the common femoral vein, saphenofemoral junction, and great saphenous vein provides the most accurate visualization of the tip placement. Because there are no expanding electrodes as a landmark it is important to perform a secondary verification of tip position by scanning from proximal thigh to SFJ in transverse to detect the true distal end of the catheter and see the transition where the catheter disappears from the image. Once proper catheter tip placement is confirmed, tumescent fluid is injected around the SFJ.

35 Compression and Exsanguination
Just prior to treatment, vein is compressed around catheter using combination of: Tumescent infiltration Trendelenburg position External compression

36 Radiofrequency Ablation Procedure Video
Radiofrequency Ablation of GSV: Vein is accessed near the knee No groin incision SFJ tributaries are left intact The procedure is generally performed on an ambulatory basis with local anesthetic and typically requires no sedation. The patients are fully ambulatory following treatment and the recovery time is short.

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38 Post-Ablation US Follow-up
Follow duplex performed w/in 72 hours Rule out DVT Assess vessel occlusion Periodic duplex follow up of the patient recommended The patient returns for a duplex study within 72 hours after the procedure to rule out the presence of DVT and assess the occlusion status of the treated vessel In our practice, the patient also returns for follow up ultrasound scans at __ week(s), __ months, and annually thereafter for longer term tracking of treatment results

39 Post-Ablation Duplex Assessment
Image courtesy of Michael Vasquez, MD No flow present Thickened vein walls This image represents a typical acute post-op result. There is flow present from the superficial epigastric vein but no flow seen in the proximal GSV. Additionally, the vein walls are very thick, indicating the inflammatory response to treatment which will lead to eventual fibrotic occlusion and sonographic disappearance

40 Summary Can’t underestimate the value of Duplex
WHEN is much more important than HOW!!

41 Summary Anyone can drill a Well
It’s where you drill it that makes the difference!!!


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