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The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins
ARTICLE IN PRESS The Egyptian Journal of Radiology and Nuclear Medicine (2015) xxx, xxx–xxx
Egyptian Society of Radiology and Nuclear Medicine
The Egyptian Journal of Radiology and Nuclear Medicine www.elsevier.com/locate/ejrnm www.sciencedirect.com
ORIGINAL ARTICLE
The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins Nasr Mohamed M. Osman a,*,1, Ahmed Ali A. Hameed Moustafa Abdel Fatah El Sherief b,1 a b
a,1
,
Department of Radiology, Minia University Hospital, Minia, Egypt Department of Surgery, Minia University Hospital, Minia, Egypt
Received 14 January 2015; accepted 5 June 2015 Available online xxxx
KEYWORDS US; Sclerotherapy; Varicose veins
Abstract Objective: The aim of this study was to evaluate the role of ultrasound guided foam sclerotherapy in the treatment of lower limb truncal varicose veins. Subjects and methods: The study included 30 patients (9 males and 21 females) ranging from 20 to 40 y, with various degrees of varicose veins chosen from the vascular surgery department from April 2013 to April 2014. All patients are evaluated with color Doppler ultrasound system. Results: The study included nine males (30%) and 21 females (70%) with various degrees of varicose veins. Each case had foam injection under duplex guidance. All patients suffered from cosmetic disfigurement, whereas 24 patients (80%) complained of leg pain. In the first phase (after 2 weeks) 28 patients (93.3%) showed complete clinical improvement of the pre-interventional symptoms, while only 2 patients (6.7%) showed no improvement. Four patients (13.3%) suffered from complications in the form of thrombophlebitis. The 2nd phase follow up demonstrated the final patient’s outcomes. 86.7% of the subjected sample (26 patients) showed further improvement. Conclusion: Foam sclerotherapy is an effective, simple and safe technique for the treatment of truncal varicose veins with minimal complications. Ó 2015 The Authors. The Egyptian Society of Radiology and Nuclear Medicine. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
1. Introduction Abbreviations: GSV, great saphenous vein; SSV, short saphenous vein; DVT, deep venous thrombosis * Corresponding author at: El Minia University, El Minia, Egypt. Tel.: +20 1005039104. 1 All authors have appraised the article and actively contributed in the work. Peer review under responsibility of Egyptian Society of Radiology and Nuclear Medicine.
Varicose veins are elongated, tortuous, and dilated superficial veins of the lower limbs with deficient valves. The World Health Organization (WHO) defines varicose veins as saccular dilatation of the veins which are often tortuous (1). They are classified etiologically into primary and secondary varicose veins. Secondary varicose veins almost always follow
http://dx.doi.org/10.1016/j.ejrnm.2015.06.001 0378-603X Ó 2015 The Authors. The Egyptian Society of Radiology and Nuclear Medicine. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001
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a change in the deep venous system function whether outflow obstruction or pump failure or both. The precise cause of primary varicose veins remains unknown (2). Sclerotherapy is a minimally invasive technique uses an injection of a special chemical (sclerosant) into a varicose vein to damage and scar the inside lining of the vein (3,4). Foam sclerotherapy is performed under ultrasound control. The foam solution causes intense spasm of the vein and a greater volume can be injected without using too much of the STD solution (5,6). The initial results with foam sclerotherapy are very promising and this method of treatment offers a possible alternative to surgery. Surgery carries a risk of general anesthesia and the time of work off. Surgery is not more effective than foam sclerotherapy for primary truncal saphenous vein treatment (7,8). The complications of foam sclerotherapy include brown pigmentation of the skin, deep venous thrombosis (DVT), skin ulceration, scar and allergic reaction (9,10). 2. Aim of the work The aim of this study is to evaluate the role of ultrasound guided foam sclerotherapy in the treatment of truncal varicose veins. 3. Patients and methods This study was approved by the ethics committee of our institution during the period between April 2013 and April 2014. The study group included 30 patients (9 were males and 21 females) ranging from 20 to 40 y with a mean age 30 y, with various degrees of varicose veins chosen under umbrella of the study criteria from vascular surgery department. All patients were evaluated with color Doppler ultrasound system (Logic 5 Pro, General Electric Medical System, GE Healthcare, Milwaukee, WI, USA) Ultrasound 5–10 MHz for the deep and superficial venous system. The exclusion criteria were as follows: Pregnancy, breast feeding, DVT, known allergy to polidocanol solution (Aethoxysclerol) and lack of mobility. Inclusion criteria for the study were truncal incompetence in the great saphenous veins as defined by a reflux of more than 0.5 s documented by duplex scan. The chosen patients underwent ultrasound guided foam sclerotherapy with early follow up 1–3 days postinjection and long follow up to 6 months. A Tessari micro-foam technique was done using 2 mm Aethoxysclerol 2% to 8 ml sterile air with triple way cannula. Using sonar guidance the cannula is placed inside the truncal vein and injection of the foam inside the vein done. Patients are treated at the operating room in the radiology department which is equipped with a color duplex ultrasound and an adjustable examination board. 3.1. Instruction given for patient immediately post procedure
To walk for at least half hour. To have plenty of fluids. To maintain external compression for 4 days. Given anti-inflammatory medication with strict follow up.
3.2. Every patient is advised to (1) Avoid straining, strenuous physical activity or Valsalva maneuver for the first month because they may contribute to early recanalization.(2) Avoid prolonged car or plane travel of more than 4 h during the first month after treatment to decrease the incidence of the thromboembolic events. 4. Results Thirty patients were selected to fulfill the aims and objectives of this study, nine (30%) males and 21 females (70%), with various degrees of varicose veins, chosen under umbrella of study criteria. Each case had single injection with foam under duplex guidance and the varicosities are assessed after injection and any complications were observed. Venous reflux before interventional techniques presented in 27 patients (90%) along the long saphenous vein (Figs. 1B and 2C), 5 patients (16.7%) had refluxing short saphenous vein. Sixteen patients (53.3%) had refluxing saphenofemoral junction, whereas 2 patients (6.7%) had refluxing saphenopopliteal junction (Table 1). All subjected individuals suffered from cosmetic disfigurement, whereas 24 patients (80%) complained of leg pain. Twenty-one patients (70%) suffered from limb heaviness, and 5 patients (16.7%) complained of itching. The follow up regimen was subdivided into two phases: The first phase describes the patient’s manifestation and complications after 2 weeks of interventional therapy (Figs. 1E and 2A and B), while the second phase demonstrates the final patient’s outcomes after 3 months of interventional therapy. The first phase (after 2 weeks) found that 28 patients (93.3%) showed complete clinical improvement of the pre-interventional symptoms (Table 2), while 2 patients (6.7%) showed no improvement in his symptoms (Table 3). Four patients (13.3%) suffered from complications in the form of thrombophlebitis. The 2nd phase follow up demonstrated the final patient’s outcomes. 86.7% of the subjected sample (26 patients) showed further improvement in the symptoms. Thrombophlebitis, developed in 2 patients (6.7%) (see Fig. 3). 5. Discussion Sclerotherapy refers to the method of varicose veins interventional treatment, where a chemical substance is introduced into the lumen of a vein to cause endothelial necrosis and subsequent fibrosis. Apart from reducing the size of the vein to a small fibrous cord, effective sclerotherapy also eliminates the physiopathological reflux associated with varicose veins. It can be effective for all types of pathological venous dilatations from major truncal varicose veins to the finest telangiectases (11). Foam sclerotherapy has several advantages from liquid form; a smaller quantity of sclerosing agent is to be injected, no dilution with blood and it ensures homogenous effect along the injected vein, provided the diameter remains reasonable (11). A detailed review of the outcomes of ultrasound guided foam sclerotherapy has been published recently. Cabrera et al. (12) has published a clinical series of 500 legs treated by foam sclerotherapy. He reported that after three or more
Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001
ARTICLE IN PRESS The role of ultrasound guided foam sclerotherapy
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Fig. 1 A female patient complaining from heaviness of leg pain slightly decreases but preserved with leaning down and wearing an elastic stock, on regular regimen of venotonics but with no appreciable improvement. (A) Before injection showing multiple dilated tributaries at the back of the lower thigh. (B) Color Doppler showing refluxing SSV and refluxing tributaries on application of color Doppler. (C) Demonstrating injection of the tributaries. Needle seen in dilated tributaries. (D) Foam material (white with posterior acoustic shadowing) in SSV and tributaries after injection. (E) Post injection; sclerotherapy made and the prominent varicose veins literally vanish.
years 81% of the treated great saphenous trunks remained occluded and 97% of superficial varices had disappeared. This required one session of sclerotherapy in 86% of patients, two in 11% and three sessions in 3% of patients. No DVT or pulmonary embolism was encountered in this series. Subsequently, a number of authors have published clinical series based on this technique including Frullini and Cavezzi (13) who reported a series of 453 patients, and Barrett et al. (14) who reported a series of 100 limbs. Cavezzi et al. (15) have subsequently published a detailed analysis of the efficacy of foam sclerotherapy in 194 patients, reporting a good outcome in 93% of patients. In fact, this technique has become widely used in southern Europe, Australia, New Zealand, South America and the USA. The relative efficacy of foam and liquid sclerotherapy has been investigated in a detailed study. 33 patients with truncal saphenous incompetence were injected with either 2–2.5 mL of 3% POL liquid or foam into the GSV under ultrasound guidance, on only one occasion. Obliteration of saphenous incompetence was obtained in 35% of liquid-treated patients and 85% of foam-treated patients after three months. A new treatment for primary varicose veins should be minimally invasive and capable of being used on primary and recurrent varicose veins so that it can be repeated as required. There should be few significant complications and the treatment should have good efficacy in abolishing venous reflux in saphenous trunks, perforating veins and varices (16). The 1st phase follow up represented 2 weeks after foam sclerotherapy and the 2nd phase demonstrated final patient’s outcomes after 1.5 months of injection. Jean-Jerome et al. (17), Arends et al. (18) and Smith (19) also aimed to study
the efficacy and safety of foam sclerotherapy in treating primary venous insufficiency, while Creton and Uhl (20) aimed to study the short term results of combined peroperative foam sclerotherapy and surgical treatment for recurrent varicose veins and Figueredo (21) aimed to compare venous clinical severity scores in patients with healed venous ulcers due to varicose veins of the lower limbs treated by saphenous stripping and phlebectomy or by ultrasound-guided foam sclerotherapy. In the current study, ultrasound guided foam sclerotherapy was done by delivering fresh foam (prepared by Tessari method) into the refluxing veins through cannula while the patient in supine position, then applying compression tools post procedure. 1 and 2% concentrations of polidocanol were used. Jean-Jerome and Arends et al. (17,18) adopted the same technique. Figueredo (21) adopted the same technique but with injecting the patient in standing position and then placing him in Trendelenburg’s position. Smith (19) used 1% polidocanol, 1% sodium tetradecyl and 3% sodium tetradecyl as sclerosing agents while we used 2% polidocanol in our study. Creton and Uhl (20) applied the same technique, but using 1% polidocanol. Regarding the clinical issue, leg pain, heaviness, disfigurement, visible varicosities and skin itching were reviewed as improved or not improved. Firstly, this study achieves high patient satisfaction with the improvement of the quality of life and a high rate of closure of the saphenous trunks and visible varicosities with foam sclerotherapy. The demographic features of this study included 30 patients, 9 males (30%) and 21 females (70%) with lower limb varicosities. Age ranged from 620 to P40 years (mean age 32.96 and SD 10.4 years), with 5 patients less than 20 years
Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001
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Fig. 2 Male patient with GSV incompetence, Color Doppler was done and injection recommended. Injection of GSV done and good patient satisfaction obtained. (A and B) Pre- and post injection; sclerotherapy made these prominent varicose veins (GSV) literally vanish. (C) Refluxing GSV seen with duplex examination. (D) Foam seen filing the veins note also the needle itself within the vein. (E) Post injection 1.5 months showing thrombosed GSV and its caliber is also reduced.
Table 1 Describe pre-interventional patient’s frequency distribution according to venous reflux by Doppler.
Table 2 Describe post-interventional improvement upon radiological basics after the 1st phase.
Venous refluxing
Frequency
%
Frequency
Long saphenous V. Short saphenous V. Giacomine V. Sapheno-femoral junction Sapheno-popliteal junction
27 5 4 16 2
90 16.7 13.3 53.3 6.7
Patient’s outcomes (radiological success) (1st phase follow up)
Percent (%)
Full V. Obliteration Partial V. Obliteration with reflux Partial V. Obliteration without reflux No obliteration
25 3 2 0
83.3 10 6.7 0
Total
30
100
old (16.7%), 7 patients in the 3rd decade (23.3%), 14 patients in the 4th decade (46.7%) and 4 patients more than 40 years old (13.3%). Another study by Creton and Uhl (20) was done upon 129 patients; 19% of them were males and 81% were females with average age 55 years, while in Arends et al. (18) the study was done upon 1252 patients, 55.4% were males and 64.6% were females with average age 53 years. By reviewing the Doppler sonographic findings in preinterventional assessment, venous reflux was presented in 27 limbs (90%) along the long saphenous vein, 5 limbs (16.7%)
along the short saphenous vein. The study conducted by Arends et al. (18) showed similar results, where 1031 limbs (82.3%) showed reflux in GSV, 248 limbs (19.8%) showed reflux in SSV, 3 limbs (0.2%) showed refluxing Giacomini vein. In the study conducted by Smith, there were 766 limbs (699%) with refluxing GSVs alone, 223 limbs (20%) with refluxing SSVs alone, while there were 120 limbs (11%) with refluxing both GSV and SSVs. In the study conducted by Creton and Uhl (20), 100 limbs showed reflux in GSV (77.5%) while 29 limbs showed reflux in SSV.
Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001
ARTICLE IN PRESS The role of ultrasound guided foam sclerotherapy
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Table 3 Describe post-interventional patient’s outcomes along the 2nd phase of follow up according to the degree of radiological success. Patient’s outcomes (radiological success) (2nd phase)
Frequency
Percent (%)
Full V. Obliteration Partial V. Obliteration with reflux Partial V. Obliteration without reflux No obliteration
24 2 3 1
80 6.7 10 3.3
Total
30
100
reported 5% thrombophlebitis. Thrombophlebitis can be avoided by occluding the connection of the varicosities with the truncal veins or the tributaries using various methods of compression such as applying elastic bandage over the condyles. No major systemic complication such as anaphylaxis or stroke occurred in the current study. No deep venous thrombosis occurred and this is in agreement with Arends et al. (18), while Creton and Uhl (20) (2 reported cases), Smith (19) (10 reported cases). This may be explained as in our study we sent the patient immediately after the procedure for ambulation (15 min walking), while in Creton and Uhl study (20), the patients did not get up and walk immediately post procedure. Also, Creton and Uhl (20) used low concentration polidocanol (1%) as a sclerosing agent for injection which necessitates the injection of higher volumes of polidocanol, thus promoting the extension of foam bubbles into the deep system and raising the risk of DVT. 6. Conclusion Foam sclerotherapy is effective for treatment of truncal varicose veins. 93.3% of the treated patients showed complete clinical improvement of the pre-interventional symptoms following first phase follow up with further improvement after the 2nd phase follow up. The technique is simple and can be repeated as required with minimal complications. The technique should be considered as a new treatment for varicose veins.
Fig. 3 Describe post-interventional improvement upon radiological basics after the 1st phase.
As regards the position of the Saphenopopliteal junction, this study is in agreement with Vasdekis et al. (22) as 18 cases (60%) show that the SSV is seen extending up to the thigh (with high up SPJ), 9 cases (30%) show that SSV joins GSV at the level of the thigh, 3 cases (10%) show that the SSV is ended before reaching the pop fossa (end in the calf region). In the 1st phase follow up (two weeks post injection), most of the patients (86.9%) showed improvement of symptoms with minimal complications in the form of thrombophlebitis. Reassessment of the patients after 3 months revealed that the majority showed further improvement in the symptoms with complete absence of the complications, and persistence of high percentage of radiological and clinical success of the procedure. Jean-Jerome (17) showed a radiological and clinical success of about 80% after the first session. Arends et al. (18) showed a success rate of about 84.4% and Ouvry et al. (23) showed 85% success rate. Our study showed similar results (86.9% success rate), while Creton and Uhl (20) the success rate 92%. The differences in success rates between our study and Creton and Uhl (20) studies were due to Creton and Uhl (20) underwent multiple sessions of foam sclerotherapy, while, in the current study, we initially underwent a single session technique, in addition to the learning curve in this study. Also these differences may be due to that Creton and Uhl (20) underwent combined surgical treatment and foam sclerotherapy, while in this study. In this study, 2 limbs (6.6%) developed thrombophlebitis, in agreeing with studies done by Smith (19), where they
Disclosure No disclosure of funding received for this work from any organization. Conflict of interest None declared. References (1) Abramson DL. Vascular disorders of the extremities. 9th ed. Hagerstown, Maryland: Harper and Row; 1991. (2) Clarke GH, Vasdekis SN, Hobbs JT, Nicolaides AN. Venous wall function in the pathogenesis of varicose veins. Surgery 1992;111:402. (3) Ackroyd JS, Pattison M, Browse NL. New instruments for varicose vein surgery. J Cardiovasc Surg 1993;11:65. (4) Aloi et al. Microfoam ultrasound-guided sclerotherapy treatment for varicose veins in a sub-group with diameters at the junction of 10 mm or greater compared with a subgroup of less than 10 mm. Dermatol Surg 2011;30:1386–90. (5) Belcaro G, Nicole Ides AV, Veller M. Venous disorders. A manual of diagnosis and treatment 1995; 25–49. (6) Bergan JJ, Kistner RL. Surgery for primary venous insufficiency: overview and commentary. In: Bergan JJ, Kistner RI, editors. Atlas of venous surgery. Philadelphia (PA): W.B. Saunders Co.; 1992. p. 33–9. (7) Geroulakos G. Foam therapy for those with varicose vein. Dermatol Surg 2005;50:89–94. (8) Frullini Alessandro. Foam sclerotherapy a review. Phlebo Lymphogr 2003;40:125–9.
Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001
ARTICLE IN PRESS 6 (9) Caggiati A, Bergan JJ, Gloviczki P, et al. Nomenclature of the veins of the lower limbs: an international interdisciplinary consensus statement. J Vasc Surg 2002;36:416–22. (10) Caggiati A, Ricci S. The long saphenous vein compartment. Phlebology 1997;12:107–11. (11) Rao J, Wildemore JK, Goldman MP. Double blind prospective comparative trial between foamed and liquid polidocanol and sodium tetradecylsulphate in the treatment of varicose and telangiectatic leg veins. Dermatol Surg 2005;31:631–5. (12) Cabrera Cabrera, Garcia-Olmedo, Ominguez MA. Treatment of varicose vein with sclerosant in microfoam form: long term outcomes. Phlebology 2000;15:19–23. (13) Frullini A, Cavezzi A. Sclerosing foam in the treatment of varicose veins and telangiectases: history and analysis of safety and complications. Dermatol Surg 2002;28:11–5. (14) Barrett LM, Frazegp, Bruce Allen, et al. Guidelines of sclerotherapy. Dermatol Surg 2004;82:1291–301. (15) Cavezzi A, Frullini A, Ricci S, Tessari L. Treatment of varicose veins by foam sclerotherapy: two clinical series. Phlebology 2002;17:13–8. (16) Tessari L, Cavezzi A, Frullini A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatol Surg 2000;27:58–60.
N.M.M. Osman et al. (17) Jermi Jean, Cabrera J, Cabrera Jr J, Garcia-Olmedo MA. Treatment of varicose long saphenous veins with sclerosant in microfoam form: long term outcomes. Phlebology 2000;15:19–23. (18) Arends L, van den Bos R, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities are at least as effective as surgical stripping or foam sclerotherapy: metaanalysis and meta-regression of case series and randomized clinical trials. J Vasc Surg 2009;49:230–9. (19) Coleridge Smith P. Chronic venous disease treated by ultrasound guided foam sclerotherapy. Eur J Vasc Endovasc Surg 2006;32:577–83. (20) Creton D, Uhl JF. Foam sclerotherapy combined with surgical treatment for recurrent varicose veins: short term results. Eur J Vasc Endovasc Surg 2007;33:619–2424. (21) Figueredo M. Results of surgical treatment compared with ultrasound – guided foam sclerotherapy in patients with varicose veins. Eur J Endovasc Surg 2009:1–623. (22) Ncolaides A, Christopoulos D, Vasdekis S. Progress in the investigation of chronic venous insufficiency. Ann Vasc Surg 1989 [El Sevier]. (23) Ouvry P, Allaert FA, Desnos P, Hamel-Desnos C. Efficacy of the great saphenous vein: a multicentre randomised controlled trial with a 2-year follow-up. Eur J Vasc Endovasc Surg 2008;36:366–70.
Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001
Egyptian Society of Radiology and Nuclear Medicine
The Egyptian Journal of Radiology and Nuclear Medicine www.elsevier.com/locate/ejrnm www.sciencedirect.com
ORIGINAL ARTICLE
The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins Nasr Mohamed M. Osman a,*,1, Ahmed Ali A. Hameed Moustafa Abdel Fatah El Sherief b,1 a b
a,1
,
Department of Radiology, Minia University Hospital, Minia, Egypt Department of Surgery, Minia University Hospital, Minia, Egypt
Received 14 January 2015; accepted 5 June 2015 Available online xxxx
KEYWORDS US; Sclerotherapy; Varicose veins
Abstract Objective: The aim of this study was to evaluate the role of ultrasound guided foam sclerotherapy in the treatment of lower limb truncal varicose veins. Subjects and methods: The study included 30 patients (9 males and 21 females) ranging from 20 to 40 y, with various degrees of varicose veins chosen from the vascular surgery department from April 2013 to April 2014. All patients are evaluated with color Doppler ultrasound system. Results: The study included nine males (30%) and 21 females (70%) with various degrees of varicose veins. Each case had foam injection under duplex guidance. All patients suffered from cosmetic disfigurement, whereas 24 patients (80%) complained of leg pain. In the first phase (after 2 weeks) 28 patients (93.3%) showed complete clinical improvement of the pre-interventional symptoms, while only 2 patients (6.7%) showed no improvement. Four patients (13.3%) suffered from complications in the form of thrombophlebitis. The 2nd phase follow up demonstrated the final patient’s outcomes. 86.7% of the subjected sample (26 patients) showed further improvement. Conclusion: Foam sclerotherapy is an effective, simple and safe technique for the treatment of truncal varicose veins with minimal complications. Ó 2015 The Authors. The Egyptian Society of Radiology and Nuclear Medicine. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
1. Introduction Abbreviations: GSV, great saphenous vein; SSV, short saphenous vein; DVT, deep venous thrombosis * Corresponding author at: El Minia University, El Minia, Egypt. Tel.: +20 1005039104. 1 All authors have appraised the article and actively contributed in the work. Peer review under responsibility of Egyptian Society of Radiology and Nuclear Medicine.
Varicose veins are elongated, tortuous, and dilated superficial veins of the lower limbs with deficient valves. The World Health Organization (WHO) defines varicose veins as saccular dilatation of the veins which are often tortuous (1). They are classified etiologically into primary and secondary varicose veins. Secondary varicose veins almost always follow
http://dx.doi.org/10.1016/j.ejrnm.2015.06.001 0378-603X Ó 2015 The Authors. The Egyptian Society of Radiology and Nuclear Medicine. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001
ARTICLE IN PRESS 2
N.M.M. Osman et al.
a change in the deep venous system function whether outflow obstruction or pump failure or both. The precise cause of primary varicose veins remains unknown (2). Sclerotherapy is a minimally invasive technique uses an injection of a special chemical (sclerosant) into a varicose vein to damage and scar the inside lining of the vein (3,4). Foam sclerotherapy is performed under ultrasound control. The foam solution causes intense spasm of the vein and a greater volume can be injected without using too much of the STD solution (5,6). The initial results with foam sclerotherapy are very promising and this method of treatment offers a possible alternative to surgery. Surgery carries a risk of general anesthesia and the time of work off. Surgery is not more effective than foam sclerotherapy for primary truncal saphenous vein treatment (7,8). The complications of foam sclerotherapy include brown pigmentation of the skin, deep venous thrombosis (DVT), skin ulceration, scar and allergic reaction (9,10). 2. Aim of the work The aim of this study is to evaluate the role of ultrasound guided foam sclerotherapy in the treatment of truncal varicose veins. 3. Patients and methods This study was approved by the ethics committee of our institution during the period between April 2013 and April 2014. The study group included 30 patients (9 were males and 21 females) ranging from 20 to 40 y with a mean age 30 y, with various degrees of varicose veins chosen under umbrella of the study criteria from vascular surgery department. All patients were evaluated with color Doppler ultrasound system (Logic 5 Pro, General Electric Medical System, GE Healthcare, Milwaukee, WI, USA) Ultrasound 5–10 MHz for the deep and superficial venous system. The exclusion criteria were as follows: Pregnancy, breast feeding, DVT, known allergy to polidocanol solution (Aethoxysclerol) and lack of mobility. Inclusion criteria for the study were truncal incompetence in the great saphenous veins as defined by a reflux of more than 0.5 s documented by duplex scan. The chosen patients underwent ultrasound guided foam sclerotherapy with early follow up 1–3 days postinjection and long follow up to 6 months. A Tessari micro-foam technique was done using 2 mm Aethoxysclerol 2% to 8 ml sterile air with triple way cannula. Using sonar guidance the cannula is placed inside the truncal vein and injection of the foam inside the vein done. Patients are treated at the operating room in the radiology department which is equipped with a color duplex ultrasound and an adjustable examination board. 3.1. Instruction given for patient immediately post procedure
To walk for at least half hour. To have plenty of fluids. To maintain external compression for 4 days. Given anti-inflammatory medication with strict follow up.
3.2. Every patient is advised to (1) Avoid straining, strenuous physical activity or Valsalva maneuver for the first month because they may contribute to early recanalization.(2) Avoid prolonged car or plane travel of more than 4 h during the first month after treatment to decrease the incidence of the thromboembolic events. 4. Results Thirty patients were selected to fulfill the aims and objectives of this study, nine (30%) males and 21 females (70%), with various degrees of varicose veins, chosen under umbrella of study criteria. Each case had single injection with foam under duplex guidance and the varicosities are assessed after injection and any complications were observed. Venous reflux before interventional techniques presented in 27 patients (90%) along the long saphenous vein (Figs. 1B and 2C), 5 patients (16.7%) had refluxing short saphenous vein. Sixteen patients (53.3%) had refluxing saphenofemoral junction, whereas 2 patients (6.7%) had refluxing saphenopopliteal junction (Table 1). All subjected individuals suffered from cosmetic disfigurement, whereas 24 patients (80%) complained of leg pain. Twenty-one patients (70%) suffered from limb heaviness, and 5 patients (16.7%) complained of itching. The follow up regimen was subdivided into two phases: The first phase describes the patient’s manifestation and complications after 2 weeks of interventional therapy (Figs. 1E and 2A and B), while the second phase demonstrates the final patient’s outcomes after 3 months of interventional therapy. The first phase (after 2 weeks) found that 28 patients (93.3%) showed complete clinical improvement of the pre-interventional symptoms (Table 2), while 2 patients (6.7%) showed no improvement in his symptoms (Table 3). Four patients (13.3%) suffered from complications in the form of thrombophlebitis. The 2nd phase follow up demonstrated the final patient’s outcomes. 86.7% of the subjected sample (26 patients) showed further improvement in the symptoms. Thrombophlebitis, developed in 2 patients (6.7%) (see Fig. 3). 5. Discussion Sclerotherapy refers to the method of varicose veins interventional treatment, where a chemical substance is introduced into the lumen of a vein to cause endothelial necrosis and subsequent fibrosis. Apart from reducing the size of the vein to a small fibrous cord, effective sclerotherapy also eliminates the physiopathological reflux associated with varicose veins. It can be effective for all types of pathological venous dilatations from major truncal varicose veins to the finest telangiectases (11). Foam sclerotherapy has several advantages from liquid form; a smaller quantity of sclerosing agent is to be injected, no dilution with blood and it ensures homogenous effect along the injected vein, provided the diameter remains reasonable (11). A detailed review of the outcomes of ultrasound guided foam sclerotherapy has been published recently. Cabrera et al. (12) has published a clinical series of 500 legs treated by foam sclerotherapy. He reported that after three or more
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Fig. 1 A female patient complaining from heaviness of leg pain slightly decreases but preserved with leaning down and wearing an elastic stock, on regular regimen of venotonics but with no appreciable improvement. (A) Before injection showing multiple dilated tributaries at the back of the lower thigh. (B) Color Doppler showing refluxing SSV and refluxing tributaries on application of color Doppler. (C) Demonstrating injection of the tributaries. Needle seen in dilated tributaries. (D) Foam material (white with posterior acoustic shadowing) in SSV and tributaries after injection. (E) Post injection; sclerotherapy made and the prominent varicose veins literally vanish.
years 81% of the treated great saphenous trunks remained occluded and 97% of superficial varices had disappeared. This required one session of sclerotherapy in 86% of patients, two in 11% and three sessions in 3% of patients. No DVT or pulmonary embolism was encountered in this series. Subsequently, a number of authors have published clinical series based on this technique including Frullini and Cavezzi (13) who reported a series of 453 patients, and Barrett et al. (14) who reported a series of 100 limbs. Cavezzi et al. (15) have subsequently published a detailed analysis of the efficacy of foam sclerotherapy in 194 patients, reporting a good outcome in 93% of patients. In fact, this technique has become widely used in southern Europe, Australia, New Zealand, South America and the USA. The relative efficacy of foam and liquid sclerotherapy has been investigated in a detailed study. 33 patients with truncal saphenous incompetence were injected with either 2–2.5 mL of 3% POL liquid or foam into the GSV under ultrasound guidance, on only one occasion. Obliteration of saphenous incompetence was obtained in 35% of liquid-treated patients and 85% of foam-treated patients after three months. A new treatment for primary varicose veins should be minimally invasive and capable of being used on primary and recurrent varicose veins so that it can be repeated as required. There should be few significant complications and the treatment should have good efficacy in abolishing venous reflux in saphenous trunks, perforating veins and varices (16). The 1st phase follow up represented 2 weeks after foam sclerotherapy and the 2nd phase demonstrated final patient’s outcomes after 1.5 months of injection. Jean-Jerome et al. (17), Arends et al. (18) and Smith (19) also aimed to study
the efficacy and safety of foam sclerotherapy in treating primary venous insufficiency, while Creton and Uhl (20) aimed to study the short term results of combined peroperative foam sclerotherapy and surgical treatment for recurrent varicose veins and Figueredo (21) aimed to compare venous clinical severity scores in patients with healed venous ulcers due to varicose veins of the lower limbs treated by saphenous stripping and phlebectomy or by ultrasound-guided foam sclerotherapy. In the current study, ultrasound guided foam sclerotherapy was done by delivering fresh foam (prepared by Tessari method) into the refluxing veins through cannula while the patient in supine position, then applying compression tools post procedure. 1 and 2% concentrations of polidocanol were used. Jean-Jerome and Arends et al. (17,18) adopted the same technique. Figueredo (21) adopted the same technique but with injecting the patient in standing position and then placing him in Trendelenburg’s position. Smith (19) used 1% polidocanol, 1% sodium tetradecyl and 3% sodium tetradecyl as sclerosing agents while we used 2% polidocanol in our study. Creton and Uhl (20) applied the same technique, but using 1% polidocanol. Regarding the clinical issue, leg pain, heaviness, disfigurement, visible varicosities and skin itching were reviewed as improved or not improved. Firstly, this study achieves high patient satisfaction with the improvement of the quality of life and a high rate of closure of the saphenous trunks and visible varicosities with foam sclerotherapy. The demographic features of this study included 30 patients, 9 males (30%) and 21 females (70%) with lower limb varicosities. Age ranged from 620 to P40 years (mean age 32.96 and SD 10.4 years), with 5 patients less than 20 years
Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001
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N.M.M. Osman et al.
Fig. 2 Male patient with GSV incompetence, Color Doppler was done and injection recommended. Injection of GSV done and good patient satisfaction obtained. (A and B) Pre- and post injection; sclerotherapy made these prominent varicose veins (GSV) literally vanish. (C) Refluxing GSV seen with duplex examination. (D) Foam seen filing the veins note also the needle itself within the vein. (E) Post injection 1.5 months showing thrombosed GSV and its caliber is also reduced.
Table 1 Describe pre-interventional patient’s frequency distribution according to venous reflux by Doppler.
Table 2 Describe post-interventional improvement upon radiological basics after the 1st phase.
Venous refluxing
Frequency
%
Frequency
Long saphenous V. Short saphenous V. Giacomine V. Sapheno-femoral junction Sapheno-popliteal junction
27 5 4 16 2
90 16.7 13.3 53.3 6.7
Patient’s outcomes (radiological success) (1st phase follow up)
Percent (%)
Full V. Obliteration Partial V. Obliteration with reflux Partial V. Obliteration without reflux No obliteration
25 3 2 0
83.3 10 6.7 0
Total
30
100
old (16.7%), 7 patients in the 3rd decade (23.3%), 14 patients in the 4th decade (46.7%) and 4 patients more than 40 years old (13.3%). Another study by Creton and Uhl (20) was done upon 129 patients; 19% of them were males and 81% were females with average age 55 years, while in Arends et al. (18) the study was done upon 1252 patients, 55.4% were males and 64.6% were females with average age 53 years. By reviewing the Doppler sonographic findings in preinterventional assessment, venous reflux was presented in 27 limbs (90%) along the long saphenous vein, 5 limbs (16.7%)
along the short saphenous vein. The study conducted by Arends et al. (18) showed similar results, where 1031 limbs (82.3%) showed reflux in GSV, 248 limbs (19.8%) showed reflux in SSV, 3 limbs (0.2%) showed refluxing Giacomini vein. In the study conducted by Smith, there were 766 limbs (699%) with refluxing GSVs alone, 223 limbs (20%) with refluxing SSVs alone, while there were 120 limbs (11%) with refluxing both GSV and SSVs. In the study conducted by Creton and Uhl (20), 100 limbs showed reflux in GSV (77.5%) while 29 limbs showed reflux in SSV.
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Table 3 Describe post-interventional patient’s outcomes along the 2nd phase of follow up according to the degree of radiological success. Patient’s outcomes (radiological success) (2nd phase)
Frequency
Percent (%)
Full V. Obliteration Partial V. Obliteration with reflux Partial V. Obliteration without reflux No obliteration
24 2 3 1
80 6.7 10 3.3
Total
30
100
reported 5% thrombophlebitis. Thrombophlebitis can be avoided by occluding the connection of the varicosities with the truncal veins or the tributaries using various methods of compression such as applying elastic bandage over the condyles. No major systemic complication such as anaphylaxis or stroke occurred in the current study. No deep venous thrombosis occurred and this is in agreement with Arends et al. (18), while Creton and Uhl (20) (2 reported cases), Smith (19) (10 reported cases). This may be explained as in our study we sent the patient immediately after the procedure for ambulation (15 min walking), while in Creton and Uhl study (20), the patients did not get up and walk immediately post procedure. Also, Creton and Uhl (20) used low concentration polidocanol (1%) as a sclerosing agent for injection which necessitates the injection of higher volumes of polidocanol, thus promoting the extension of foam bubbles into the deep system and raising the risk of DVT. 6. Conclusion Foam sclerotherapy is effective for treatment of truncal varicose veins. 93.3% of the treated patients showed complete clinical improvement of the pre-interventional symptoms following first phase follow up with further improvement after the 2nd phase follow up. The technique is simple and can be repeated as required with minimal complications. The technique should be considered as a new treatment for varicose veins.
Fig. 3 Describe post-interventional improvement upon radiological basics after the 1st phase.
As regards the position of the Saphenopopliteal junction, this study is in agreement with Vasdekis et al. (22) as 18 cases (60%) show that the SSV is seen extending up to the thigh (with high up SPJ), 9 cases (30%) show that SSV joins GSV at the level of the thigh, 3 cases (10%) show that the SSV is ended before reaching the pop fossa (end in the calf region). In the 1st phase follow up (two weeks post injection), most of the patients (86.9%) showed improvement of symptoms with minimal complications in the form of thrombophlebitis. Reassessment of the patients after 3 months revealed that the majority showed further improvement in the symptoms with complete absence of the complications, and persistence of high percentage of radiological and clinical success of the procedure. Jean-Jerome (17) showed a radiological and clinical success of about 80% after the first session. Arends et al. (18) showed a success rate of about 84.4% and Ouvry et al. (23) showed 85% success rate. Our study showed similar results (86.9% success rate), while Creton and Uhl (20) the success rate 92%. The differences in success rates between our study and Creton and Uhl (20) studies were due to Creton and Uhl (20) underwent multiple sessions of foam sclerotherapy, while, in the current study, we initially underwent a single session technique, in addition to the learning curve in this study. Also these differences may be due to that Creton and Uhl (20) underwent combined surgical treatment and foam sclerotherapy, while in this study. In this study, 2 limbs (6.6%) developed thrombophlebitis, in agreeing with studies done by Smith (19), where they
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Please cite this article in press as: Osman NMM et al., The role of ultrasound guided foam sclerotherapy in treatment of truncal varicose veins, Egypt J Radiol Nucl Med (2015), http://dx.doi.org/10.1016/j.ejrnm.2015.06.001