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Minimally invasive vein therapy and treatment options for endovenous heat-induced thrombus
Krista Frasier, BS, RVT, and Victoria Latessa, MSN, ANP, ACNP, C
Radiofrequency ablation and endovenous laser therapy are types of minimally invasive techniques that have been used in the treatment of chronic venous insufciency. In both procedures, high-intensity heat via thermal energy is produced and delivered via an endovenous catheter placed in the saphenous vein. This results in changes that therapeutically induce closure of the vein by denaturing the vessel wall with subsequent thrombus formation. Patients undergo ultrasound 48 to 72 hours postprocedure to conrm vessel occlusion and assess for possible extension of thrombus into the deep venous system. Thrombus is frequently visualized with the procedure in the tributaries, the venous dilations, and at times the saphenofemoral junction. In any other setting, thrombus at the saphenofemoral junction would warrant anticoagulation. However, the characteristics, composition, and behavior of endovenous heat-induced thrombus are different than de novo thrombosis. This postprocedure endovenous heat-induced thrombus is considered a normal consequence of the procedure and does not require traditional anticoagulation in most cases, depending on the location. (J Vasc Nurs 2008;26:53-57)

The purpose of this article is to increase nursing knowledge regarding vein ablation performed by minimally invasive endovenous techniques and to recognize the pathophysiologic responses to thermal-induced treatment, analyze postprocedure complications regarding venous thrombosis, and recognize the different stages of endovenous heat-induced thrombus (EHIT) based on a protocol developed by Kabnick et al.1 The use of this protocol allows the vascular nurse and/or practitioner to individualize treatment with specic regard to anticoagulation, as well as document and track outcomes to contribute to evidence-based practice.

the femoral, popliteal, and crural (paired) veins, and the supercial system is composed of the great and short saphenous veins. The supercial venous system drains into the deep system via the venous conuence (anatomic area where ow comes together, as in where veins converge) found at the saphenofemoral junction (SFJ) and saphenopopliteal junction (SPJ) (Figure 1A); these junctions are anatomically located in the groin and behind the knee, respectfully. These deep and supercial systems are connected by perforating veins that allow one-way ow from the supercial vein to the deep veins (Figure 1B).

SIGNIFICANCE
Venous insufciency is a common disorder affecting 25% of women and 15% of men in the United States.2,3 It has been estimated that varicose veins affect 50% of the population by the age of 50 years3 and 75% of women by age 70 years.4 Approximately 2% of the health care budget is spent on the treatment of chronic venous disease.4 The most signicant form of chronic venous disease is chronic venous insufciency, which is the seventh leading cause of debilitating disease in the United States.5

CAUSE OF VARICOSE VEINS

According to the class, cause, anatomy, and pathophysiology classication of venous disease, there are three types of disease: congenital, which accounts for a small number of venous diseases; primary, which accounts for the majority of venous diseases; and secondary, in which the presence of venous disease is the result of a previous event, for example, an episode of deep venous thrombosis (DVT).6 Little is known about the cause of venous disease, although valvular insufciency and weakening in the vessel wall are components.7 The disease affects more women than men and is worse with recurrent pregnancies. Weight and employment environment may also contribute to the distribution of the disease.8

ANATOMY
The venous anatomy of the lower extremity consists of the deep and supercial systems. The deep system is composed of
From Staten Island University Hospital, Staten Island, New York; and the Lenox Hill Hospital, New York, New York. Corresponding author: Victoria Latessa, MSN, ANP, ACNP, C, Lenox Hill Hospital, 130 E. 77th St., 13th Floor, New York, NY 10021. The authors hold no nancial interest in any product or manufacturer mentioned in this article. 1062-0303/2008/$34.00 Copyright 2008 by the Society for Vascular Nursing, Inc. doi:10.1016/j.jvn.2008.03.002

CLINICAL MANIFESTATIONS
Clinical manifestations of chronic venous disease can range from mild to severe. The most common symptoms include varicose veins, aching, swelling, burning, itching, feelings of heaviness, and night cramps.8 Symptoms are usually progressive and worsen by the end of the day, particularly for those who must stand or sit with legs dependent for prolonged periods of time. As veins become larger and more dilated, one is at risk for bouts of supercial thrombophlebitis.8 Historically, the treatment of choice for venous insufciency consisted of vein stripping with high ligation.3,5,9 This treatment

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Figure 2. Venous incompetence as demonstrated by spectral Doppler. Figure 1. Venous conuence and Perforator vein location.

consisted of the removal of the great saphenous vein after ligation and division of the SFJ.10 The procedure was hospital based and required general or regional anesthesia and 1 to 2 weeks of recovery time with a gradual return to normal activities. Common complications included bruising, hematoma, bleeding, pain, and paresthesia. There was also a signicant recurrence rate as high as 28.8% at 5 years.11

ENDOVENOUS ABLATION
Minimally invasive techniques in vein therapy have evolved in the past decade and have revolutionalized vein care.12 The modality of choice is endovenous ablation (EVA) using either laser or radiofrequency energy to heat the vein. Laser ber demographics cited in this article are from the EVLT by Diomed Holdings, Inc. (Andover, MA) and the VNUS Closure radiofrequency device by VNUS Medical Technologies, Inc. (San Jose, CA). The reported success rate for both thermal and laser ablation is approximately 95%,13 with a long-term recurrence rate of less than 7% when using the EVLT.14 The procedure is easily performed in an ofce setting, and discomfort is mild. With experienced operators, side effects and complications are few.15 EVA is performed by obtaining percutaneous access to the vein under ultrasound guidance at a location typically between the distal thigh and the proximal calf. The RF catheter or laser ber is then advanced to the groin (SFJ), over which the selected catheter is passed.12,16 A tumescent solution consisting of 400 mL of normal saline, 4 mL of 8.4% sodium bicarbonate, and 40 mL of 1% lidocaine is then infused (injected) around the incompetent vein deep to the subfascial vein or in the subcutaneous space, depending on the location. If the vein is supercial, then an attempt must be made to inject adequate tumescent to achieve a vein depth of more than 1 cm. The use of tumescent anesthesia or the placement of large volumes of dilute anesthesia in a perivascular position under ultrasound guidance serves the following purposes:17

2. Decreases the diameter of the treated vein (by external compression, improved wall apposition), thus allowing for greater energy absorption. 3. Provides safe and effective anesthesia. The position of the catheter should be conrmed just distal to the inferior epigastric branch of the saphenous vein. It is recommended that the tip should be placed 1 to 2 cm distal to the SFJ.18 For radiofrequency ablation, treatment is temperature controlled and begun at 85 C to 90 C using a 6F catheter (RFAc), withdrawing at a rate of 2 to 3 cm per minute, or 120 C using a 7F catheter (RFAf) and treating 7-cm segments for 20 seconds.19 The actual ablation occurs from a heat-induced spasm of the vessel that results in collagen shrinkage of the vessel wall with radiofrequency ablation. When using the laser, the ablation of the vessel is the result of tissue damage caused by high-intensity thermal heating of the blood and vessel.20 Laser heating is more intense than radiofrequency at 70 J/cm with a pullback rate of 1 mm/sec the rst 10 to 15 cm of treatment and 2 mm/sec for the remaining segment of vein to be treated.16 Patients are sent home the same day wearing 20 to 30 mm Hg compression stockings, which support the procedure and controls bruising.

DUPLEX ULTRASOUND
Before, during, and after the procedure, patients are studied with a color ow duplex ultrasound system with a 7 to 5-MHz linear array probe (ultrasound images obtained using iU22; Philips Medical Systems, N.A., Bothell, WA). Patients are placed in a supine position with reverse Trendelenburg of approximately 30%.

Pre-procedure
When patients are evaluated for reux, the examination should be performed in the standing position. Venous insufciency that leads to venous pathology can be reliably documented in this position. The examination begins at the SFJ. The relationship of the greater saphenous vein to any abnormal veins is assessed by tracing its course and the course of any tributaries

1. Protects the perivascular tissue from heat generated by laser or radiofrequency (protects from burns and paresthesia).

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Figure 3. Classes of EHIT as noted by location of thrombus as compared to the common femoral vein.

Figure 5. Stage 1/class 1 EHIT. Figure 4. Endovenous heat induced thrombus.

curred at a much earlier time (110 days) compared with de novo DVT (36 weeks) (Figure 4).1

that might lead to the abnormal veins. The deep veins are also assessed. Venous reux can be easily documented by looking at normal antegrade ow followed by retrograde ow of more than 0.5 seconds with a quick, rm compression of the distal segment of the veins. The diameter of the reuxing vessel should also be obtained (Figure 2).

DISCUSSION
As with any new therapy, a set of indications, guidelines, contraindications, and complications unique to the particular intervention are encountered. One such complication is DVT. The percentage of DVT post-EVA ranges from 0.5% to 7.7%.11,17,18,21,22 Although DVT is not a new complication, the majority of DVT occurring post-EVA is actually an extension of supercial thrombophlebitis occurring in the treated saphenous vein.21 The normal endothelial surface is maintained in a thromboresistant state by several mechanisms under basal conditions.23 The de novo venous thrombi are formed in regions of static blood ow and composed predominantly of red cells entrapped within an extensive brin meshwork, with relatively few platelets intermixed.23 After heat is introduced into the vein, the intimal layer of the vessel is destroyed. The heat-induced thrombus is inltrated by macrophages, neutrophils, and eosinophils followed by broblasts that migrate from the adventitia. Collagen secreted by the broblasts leads to the formation of a matrix almost identical to

Postprocedure
The protocol includes, but is not limited to, the conrmation of vessel occlusion status post-EVA. One must also conrm the patency of the deep venous system. Compression maneuvers and augmentations are performed throughout the extremity to assess great saphenous patency and rule out DVT. In the presence of EHIT, ultrasound characteristics include increased echogenicity, less movement than de novo thrombosis consistent with adherence to vessel wall, and retraction of thrombus noted relatively quickly. Conrm the location of the thrombus to the SFJ and the common femoral vein for proper classication (Figure 3). Additional follow-up duplex ultrasound should note aging (echogenicity) of the thrombus. EHIT chronicity changes oc-

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TABLE I ENDOVENOUS ABLATION: POSTPROCEDURE INSTRUCTIONS Activity Resume walking today for at least 15 min and then 30 min every day thereafter. In the initial 48 hours following the procedure avoid prolonged sitting and walk frequently. Progress to normal activities during next few days. No running, aerobics, or heavy lifting for 2 wk. You may drive 24 h after the procedure Medications Resume all preoperative medications. Use extra-strength acetaminophen (Tylenol; McNeil-PPC, Inc., Fort Washington, PA) or ibuprofen for pain, following package directions. An ice pack may be applied to any sore, throbbing area. Care Precautions

Keep your ace bandages on Call our ofce immediately for 24 h. for severe or unusual pain After 24 h, remove ace not relieved by acetaminobandages, shower, and phen (Tylenol) or ibuproapply support hose. fen, or unusual redness or Support hose must be worn swelling of the operative for the next 2 wk, removleg. ing only at bedtime. Please make a follow-up It is normal to feel tugging, appointment for ultrapulling, or a rm rope-like sound 48-72 h after vein in the treated area. procedure. We will then see you in follow-up at 1 and 3 mo, and annually.

that of a scar formation.23 Dilations, varicose tributaries, and the SFJ are susceptible to the formation of EHIT. The resultant EHIT is of concern when it is in close proximity to the SFJ or when it extends into the deep venous system (common femoral vein).1 The question becomes whether or not to anticoagulate, and if so, for what length of time. According to Kabnick et al.,1 a classication of EHIT has been developed to grade the extent of the thrombus and to correlate ultrasound ndings with a treatment plan (Figure 3, shown in longitudinal view).

CASE STUDY
A 47-year-old woman had gross bulging varicosities of the left lower extremity that throbbed and ached. The patients history was unremarkable for previous episodes of DVT or supercial thrombophlebitis. The patient underwent EVA of the great saphenous vein with the VNUS ClosureFast (VNUS Medical Technologies, Inc.). The position of the catheter was conrmed to be just distal to the inferior epigastric branch of the saphenous vein. An approximately 7-cm segment of vein was treated with double 20second cycles, and the remaining segment of vein to the proximal calf was treated with single 20-second cycles. The procedure was unremarkable, and duplex ultrasound conrmed saphenous ablation postprocedure and common femoral vein patency. Duplex ultrasound performed 96 hours after ablation demonstrated the presence of EHIT in the SFJ. EHIT was categorized as Class 1 (saphenous thrombus in close proximity to the junction). The patient was not anticoagulated but was followed closely by duplex ultrasound to monitor changes to the thrombosis. Follow-up duplex ultrasound performed 48 hours later found no evidence of propagation of thrombus. At 1-month follow-up, duplex ultrasound noted complete resolution of EHIT (Figure 5).

 Class 1: EHIT is in close proximity to the SFJ or SPJ.  Class 2: EHIT extends beyond the SFJ or SPJ into the common femoral vein, inhabiting a space of less than 50% when measured in cross-section.  Class 3: EHIT extends beyond the SFJ or SPJ into the common femoral vein, inhabiting a space of more than 50% when measured in cross-section.  Class 4: EHIT of the common femoral vein is totally occlusive. Patients who t the criteria of class 1 do not require anticoagulation. The brous thrombus is stable and regresses within a short period of time. This class requires close observation and follow-up at regular short intervals until resolution. Class 2 patients can be treated with low-molecular-weight heparin until the thrombus can be reclassied by duplex ultrasound as class 1. This usually takes place in 7 to 10 days. In both class 3 and 4, one should consider conventional anticoagulation. Treatment should start with low-molecular-weight heparin for 48 hours before starting with warfarin to avoid a hypercoagulable state.22 In class 4, anticoagulation should continue for 3 to 6 months with follow-up ultrasound before discontinuation.

NURSING IMPLICATIONS
As the number of patients who undergo EVA increase; the more likely we are to see EHIT on postprocedural ultrasound. Because most procedures are ofce based, treatment takes place in the outpatient setting. Therefore, the initial assessment is critical. It is important to conrm that the patient has no contraindication to the initial procedure, such as pregnancy, breastfeeding, deep vein thrombosis, unable to ambulate, or absent distal pulses.3

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Second, for those patients who are in the class I category and not anticoagulated, it is imperative that they realize the importance of follow-up in 48 to 72 hours for repeat ultrasound. They also need to be appraised of symptoms that would warrant immediate attention, such as shortness of breath, chest pain, and increased pain, erythema, or swelling in the leg. Third, for those patients who require short-term anticoagulation with low-molecular-weight heparin, the nurse must make sure the patient has access to the medication and can successfully administer it; if not, admission may be required. If possible, the rst dose can be given or self-administered in the ofce under medical supervision. Not all pharmacies stock this medication, and the low-molecular-weight heparin is expensive;. Always make sure that the patient has the means by which to obtain the medication (Table I). EVA continues to evolve and provides an opportunity for vascular nurses to increase their knowledge base, develop collaborative relationships with vascular technologists, and serve as educators to other allied health professionals.

CONCLUSIONS
EVA is a widely accepted alternative to varicose vein ligation and stripping. The complications are usually minor and rare. DVT or EHIT is a rare complication that may be seen on ultrasound postprocedure. The cause and pathology of EHIT are different than de novo thrombus and may not require anticoagulation. According to Kabnick et al.,1 EHIT is different than de novo DVT and therefore should be treated differently depending on the proximity of the thrombus to the SFJ, although it is not certain whether this is true. However, close observation and monitoring with ultrasound are mandatory in all cases of EHIT until there is resolution or regression of thrombus in or near the deep venous system.

REFERENCES
1. Kabnick LS, Ombrellino M, Agis H, et al. Endovenous heat induced thrombus (EHIT) following endovenous vein obliteration: to treat or not to treat? A new thrombotic classication. 18th Annual Meeting American Venous Forum. February 23, 2006, Miami Florida. 2. Callam R. Epidemiology of varicose veins. Br J Surg 1994; 81:167-73. 3. Min R, Zimmett S, Isaacs M, Forrestal M. Endovenous laser treatment of the incompetent greater saphenous vein. J Vasc Interv Radiol 2001;12:1167-71. 4. Naom JJ, Hunter GC. Pathogenesis of varicose veins and implications for clinical management. Vascular 2007;15:242-9. 5. Meissner MH, Gloviczki P, Bergan J, et al. Primary chronic venous disorders. J Vasc Surg 2007;46(Suppl S):54-67. 6. Labropoulos N, Tassiopoulos AK. Etiology and anatomic distribution of venous disease in patients with venous ulcers. Perspect Vasc Surg 2000;12:117-26.

7. Elsharawy MA, Naim MM, Abdelmaguid EM, AlMulhim AA. Role of saphenous vein wall in the pathogenesis of primary varicose veins. Interact Cardiovasc Thorac Surg 2007;6:219-24. 8. Eberhardt RT, Raffetto JD. Chronic venous insufciency. Circulation 2005;111:2398-409. 9. Merchant RF, Pichot O; Closure Study Group. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reux as a treatment for supercial venous insufciency. J Vasc Surg 2005;42:502-9. 10. Bergan JJ, Kumis NH, Owens EL, Sparks SR. Surgical and endovascular treatment of lower extremity venous insufciency. J Vasc Interv Radiol 2002;13:563-8. 11. Dwerryhouse S, Davies B, Harradine K, Earnshaw JJ. Stripping the long saphenous vein reduces the rate of reoperation for recurrent varicose veins: ve-year results of a randomized trial. J Vasc Surg 1999;29:589-92. 12. Elias SM, Frasier KL. Minimally invasive vein surgery. Mt Sinai J Med 2004;71:42-6. 13. Mozes G, Kalra M, Carmo M, Swenson L, Gloviczki P. Extension of saphenous thrombus into the femoral vein: a potential complication of new endovenous ablation techniques. J Vasc Surg 2005;41:130-5. 14. Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reux: Long-term results. J Vasc Interv Radiol 2003;14:991-6. 15. Kalra M, Gloviczki P. Fifteen years ago laser was supposed to open arteries, now it is suppose to close veins: what is the reality behind the tool? Perspect Vasc Surg Endovasc Ther 2006;18:3-10. 16. Min RJ, Khilnani NM. Endovenous laser ablation of varicose veins. J Cardiovasc Surg 2005;46:395-405. 17. Munavalli G, Weiss R. Lower extremity venous disease and advances in techniques for endovenous ablation. Skin Aging 2007;64-70. 18. Merchant RF, Pichot O. RF obliteration of saphenous reux for treating supercial venous insufciency. Endovasc Today 2007;(suppl):19-21. 19. Frasier K, Giangola G. Endovenous radiofrequency ablation: a novel treatment of venous insufciency in Klippel-Trenaunay patients. J Vasc Surg 2008;47:1344-50. 20. Puggioni A, Kalra M, Carmo M, Mozes G, Gliviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: analysis of early efcacy and complications. J Vasc Surg 2005;42:488-93. 21. Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reux: a multicenter study. J Vasc Surg 2002;35:1190-6. 22. Perrin M. Endoluminal treatment of lower-limb varicose veins by radiofrequency and endovenous laser. Endovasc Today 2007;(Suppl):22-4. 23. Millenson MM, Bauer KA. Pathogenesis of thromboembolism. In: Hull R. Pineo G, eds. Disorders of thrombosis. Philadelphia: W.B. Saunders; 1996, p 175-87.