|Year : 2019 | Volume
| Issue : 4 | Page : 1234-1238
Evaluation of foam sclerotherapy in treatment of lower limbs – primary varicose veins
Ahmed T Gafar1, Walid M Omran2, Yahia M Alkhateep2, Ayman A Albatanony3
1 Department of General Surgery, Ministry of Health, Menshawy Hospital, Gharbeya, Egypt
2 Department of General and Vascular Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt
3 Department of General Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt
|Date of Submission||12-Apr-2018|
|Date of Decision||18-May-2018|
|Date of Acceptance||21-May-2018|
|Date of Web Publication||31-Dec-2019|
Ahmed T Gafar
Tanta, Gharbeya 31511
Source of Support: None, Conflict of Interest: None
The aim was to evaluate the efficacy of foam sclerotherapy for treating primary varicose veins.
Foam sclerotherapy is a standard method of treatment of primary varicose veins. It is a less invasive method, simple, effective, and can be done in outpatient.
Materials and methods
This is a prospective study on 50 consecutive patients who were diagnosed to have clinical and radiological evidence of primary varicose veins in the Department of Vascular Surgery Unit in Menoufia University hospitals from February 2017 to February 2018. Local ethics committee's approval and a written consent were obtained. The foam was generated by Tessari method.
Fifty lower limbs of 50 patients were presented with primary varicose veins and competent saphenofemoral junction. There were 35 (70%) females and 15 (30%) males with mean age of 35.4 ± 10.125 years (range: 22–55 years). Fifty limbs included 20 (40%) right limbs and 30 (60%) left limbs. Twenty-five (50%) patients complained of disfigurement, 30 (60%) patients of pain, 30 (60%) patients of heaviness, and 35 (70%) patients of swelling. The complications were pain at injection sites in 32 (64%) patients, itching in four (8%) patients, ecchymosis in 18 (36%) patients, and superficial thrombophelibitis in eight (16%) patients.
Foam sclerotherapy is safe, effective, and less complicated in treating primary varicose veins.
Keywords: foam sclerotherapy, varicose veins, venous insufficiency
|How to cite this article:|
Gafar AT, Omran WM, Alkhateep YM, Albatanony AA. Evaluation of foam sclerotherapy in treatment of lower limbs – primary varicose veins. Menoufia Med J 2019;32:1234-8
|How to cite this URL:|
Gafar AT, Omran WM, Alkhateep YM, Albatanony AA. Evaluation of foam sclerotherapy in treatment of lower limbs – primary varicose veins. Menoufia Med J [serial online] 2019 [cited 2020 Apr 4];32:1234-8. Available from: http://www.mmj.eg.net/text.asp?2019/32/4/1234/274217
| Introduction|| |
Varicose veins of the lower limbs are the most common presentation of chronic venous insufficiency, influencing 75% of the patients. Primary varicose veins are associated with a normal deep venous system and hardly progress to more advanced venous disease, when compared to secondary . Sclerotherapy is a medical technique used to remove the varicose veins. It includes an injection of a solution directly into the vein. The sclerosant material disturbs the lining wall of the blood vessel, leading to swelling and sticking together, and blood clot formation . Foam is produced by mixing sclerosants in the detergent class with a gas. The most usually utilized sclerosing agents are hypertonic saline, sodium tetradecyl sulfate, and polidocanol . Orbach was the first person who published utilization of foam in sclerotherapy via air block technique in 1944 . Foams have several advantages over liquid sclerosants: as a large dose of foam can be utilized per session, have large surface area leading to greatest efficacy, displaces blood prevents dilution, and inactivation of the sclerosants. Foams are visible on duplex ultrasound . The aim of this study was to evaluate the efficacy of foam sclerotherapy for treating primary varicose veins.
| Materials and Methods|| |
This prospective study was conducted on 50 consecutive patients who were diagnosed to have clinical and radiological evidence of lower extremities, primary varicose veins, in the Department of Vascular Surgery Unit in Menoufia University hospitals from February 2017 to February 2018. Local ethics committee's approval and written consent were obtained.
Patient's ages range between 21 and 60 years, patients with primary varicose veins, and competent saphenofemoral junction (as the best treatment for incompetent saphenofemoral junction is surgical treatment, whereas patients with competent saphenofemoral junction are best treated with foam sclerotherapy), and patients suffering from residual varicose veins after surgery.
Pregnancy, allergy to sclerosing agent, deep venous thrombosis (DVT), patients with absent pedal pulses, mental or psychiatric disturbance, patients with combined varicose veins and lymphedema.
An informed consent before admission preserving all ethical considerations of the patients. Medical history, clinical examination of every patient according to clinical, anatomical, etiological, pathological (CEAP) clinical classification, duplex ultrasound on venous system of lower limbs to confirm the primary nature of varicose veins (duplex showed primary varicosities are seen, great saphenous vein is patent, compressible with no evidence of thrombosis, saphenofemoral valve is competent, no DVT, normal arterial system with adequate blood flow till the peripheral arteries), explanation of foam sclerotherapy steps for the patients.
Preparation of the foam
The foam was generated by Tessari method by using a triple way and two 5 ml syringes by mixing 1 ml sclerosing agent poliodicanol (Aethoxysklerol 2%, Lauromacrogolum 400, 40 mg–2 ml; Kreussler Pharma, Wiesbaden, Germany) in one syringe, 4 ml of air in the other syringe, connect to stopcock, apply 20 alternative movements from one syringe to the other through the stopcock and 5 ml of foam will be available [Figure 1].
Mapping and drawing the venous network on skin choose the site(s) of injection in standing posture, preparing the skin, patient in supine position, placing a needle or butterfly canula into vein. Preparing the foam (we used 2–4 ml of aethoxysclerol 2% for each patient), injecting progressively the sclerosing foam, check the foam fills all the desired veins then venous spasm and disappearance of veins. Removing needle, place a ball of cotton then applying a creep bandage. The bandage is kept for 2–3 days. Elastic stocking is advised for 6–8 weeks during walking.
Evaluation and follow-up
All patients were being evaluated 1 week after injection then after 1, 3, and 12 months. Patients who were being evaluated by clinical assessment, looked for improvement in their symptoms and duplex study to detect any complications.
The results had been collected, evaluated, calculated, tabulated, and statistically analyzed by using a computer statistical package (IBM SPSS statistics for Windows, version 21.0; IBM Corp., Armonk, New York, USA). Descriptive statistics were used in the form of number and percentage.
| Results|| |
Fifty patients with 50 lower limbs were presented with primary varicose veins and competent saphenofemoral junction. There were 35 (70%) females and 15 (30%) males with mean age 35.4 ± 10.125 years (range: 22–55 years). Fifty limbs included 20 (40%) right limbs and 30 (60%) left limbs. The clinical presentations of patients were (C1, C2, and C3): 25 (50%) patients complained of disfigurement, 30 (60%) patients of pain, 30 (60%) patients of heaviness, and 35 (70%) patients of swelling [Table 1]. The complications with foam sclerotherapy treatment were: pain at injection sites in 32 (64%) patients, itching in four (8%) patients, ecchymosis in 18 (36%) patients, and superficial thrombophelibitis in eight (16%) patients. None of the patients developed DVT or skin ulcer [Table 2]. The superficial thrombophelibitis, ecchymosis, and pain were treated with analgesics, anti edematous, limb elevation, and compression bandage. A total of 35 (70%) patients underwent one session, nine (18%) patients underwent two sessions and six (12%) patients underwent more than two sclerotherapy sessions [Table 3]. Patient satisfaction after the injection was assessed using post-treatment questionnaire after 1 month of administration of the injection (excellent means disappearance of all varicosities after one session of injection, very good means disappearance after two sessions, good means disappearance after three sessions, fair means very weak response to the injection, poor means failure of injection), 35 (70%) patients were excellent, eight (16%) patients were very good, and seven (14%) patients were good [Table 4]. All (100%) patients reported improvement during the first 3 months of follow-up during which compression stockings were used regularly, all varicosities treated with this method had disappeared, we continued the follow-up for 12 months to detect any recurrence of varicosities [Figure 2].
| Discussion|| |
Varicose veins of the lower limbs are the most wide presentation of chronic venous insufficiency. The varicosities derived from the reflux of the great saphenous vein, making it the most influenced vessel in the wide clinical range of chronic venous insufficiency . Surgery has been the best and standard treatment for a long time, but the operation may be related to serious complications as bleeding, groin infection, thrombophlebitis, saphenous nerve injury or even life-threatening conditions. In recent years many less invasive methods of endovenous treatments of varicose veins, such as sclerotherapy, radiofrequency, and laser have been introduced. The least invasive, among mentioned ways of treatment is the foam sclerotherapy . Sclerotherapy is a medical technique used to remove varicose veins and spider veins by injection of a solution directly into the vein. The solution irritates the lining of the blood vessel and damages it . Foam sclerotherapy has several advantages from liquid form, such as a little amount of sclerosing agent is needed to be injected; no dilution with blood and it ensures homogenous effect along the injected vein . Smith  also reported that foam sclerotherapy as a relatively easy to perform procedure and that it can be done as outpatient basis. The decision of a better treatment option depends on different factors: stage of the venous disease according to CEAP classification, site of the lesion, complaints and return to work, preference against some strategies of treatment or their complications. Foam sclerotherapy is safe, rapid, and is less expensive than surgery and other treatment choice for varicose veins . Rasmussen et al.  demonstrated that stripping of great saphenous vein is as costly as endovenous laser ablation. The time taken for daily activities and to resume work was the longest after surgery when compared to endovenous laser ablation, radiofrequency ablation, and foam sclerotherapy. Ultrasound-guided foam sclerotherapy was the least expensive and the most advantageous method of treatment of varicose veins. These authors, however, recognized this strategy as the least traumatic, the cheapest, and easy to repeat . In our study the compression was left without change for ∼2–3 days. Such duration of initial compression is also suggested by Rasmussen et al. . During the Second European Meeting on foam Sclerotherapy in Tegernsee in 2006 the majority of experts recognized the necessity of compression after intravenous foam administration . The Cochrane review, has compared the results of sclerotherapy and surgery, and showed that sclerotherapy was very much superior to surgery in a year's span . This study included 50 patients with 50 legs; all patients were presented with primary varicose veins and 100% of patients with competent saphenofemoral junction. There were 70% females and 30% males, as the varicose veins were more common in females than males, Gamal et al. , which included 80 patients, 65% females and 35% males. In this study 50 affected limbs were included 40% right limbs and 60% left limbs, as varicose veins are common in the left lower limbs. In this study, the clinical presentation of patients was 50% with disfigurement, 60% with pain, 60% with heaviness, and 70% with swelling. There were no patients with skin ulcer or skin change. Our patients were 100% with competent saphenofemoral junction and 0% obstruction. A total of 35 (70%) patients needed one session of foam sclerotherapy, nine (18%) patients needed two sessions to remove their varicose veins, and six (12%) patients needed three sessions to remove all varicose veins. In comparison to other study as Figueiredo et al. , 27 patients underwent foam sclerotherapy, three (11.11%) patients underwent one session, 19 (70.37%) underwent two sessions and five (18.5%) patients underwent three sclerotherapy sessions. Follow-up examinations were planned to assess the efficacy of the therapy and detection of any complications. Patients were followed up at a week, and then 1, 3, and 12 months after the treatment. Similar follow-up has also been suggested by several other authors as Ouvry et al. . Improvements in clinical presentation were 100% in this study, which came in agreement with other studies as Tan et al. . An ultrasound examination performed a week after therapy proved correct obliteration of the treated vein in 100% of cases and additionally did not reveal signs of DVT, this agree with Zimmet  and Desnos et al. . In this study we used 2% of sclerosant agent (aethoxysclerol 2%), this agree with Desnos et al.  performed sclerotherapy with 1 and 2% drug concentration, whereas the majority of authors used 1 or 3% of foamy sclerosant. The superficial thrombophlebitis in this study was present in eight (16%) patients. The incidence of phelibitis in different studies was found to be less than 15% as Brunken et al. . Figueiredo et al.  reported that incidence of phelibitis was 39%. Inadequate compression could be one of the main cause of increased incidence of thrombophlebitis in these patients, so the importance of compression therapy after foam sclerotherapy was recognized in the second European meeting on foam sclerotherapy in Tegernsee in 2006 . Some authors claim that more concentrated sclerosants can also increase the frequency of phlebitis as Cavezzi . In this study the ecchymosis was reported in 18 (36%) patients in 2 weeks after the procedure. It faded with time and a year after the procedure was completely disappeared. The ecchymosis and pigmentation was found to be 26–30% in various studies as Chapman–Smith and Browne  and Jia et al. . In this study, there was pain at the sites of injection in 32 (64%) patients, which gradually decreased, responded to analgesic, and completely disappeared after a month. Recurrences associated with foam sclerotherapy treatment varies from 4.9 to 40% according to Han et al.  and Rasmussen et al. , but there were no recurrences seen in this study because our study continued for 1 year on 50 patients, so the recurrence may appear after 1 year. Treatment failures associated with foam sclerotherapy treatment was 2% according to Chapman–Smith and Browne , but no failure is seen in this study. Anaphylaxis is one of the complications in liquid sclerotherapy, but can occur with foam also. Not any case of anaphylaxis was recorded in this study. Bradbury et al.  reported allergy to the foam in 0.1% of patients in their study. Brzoza et al.  and Guex et al.  each of them reported single case of allergic reactions in their studies. DVT after foam sclerotherapy is a very rare complication and is reported in less than 1% of the patients according to Bradbury et al. , Chapman–Smith and Browne , and Jia et al. . No incidence of DVT was noted in this study and also by Brunken et al. . According to Hamahata et al. , Figueiredo et al.  reported the occurrence of DVT in 9% of their patients. According to Myers and Jolley , it was found that using foam volume more than 10 ml in single limb resulted in threefold chances of DVT, and increased production of endothelin-1 is associated with high chances of DVT. Other systemic complications associated with foam sclerotherapy were transient blurring of vision, transient ischemic attack, headache, chest tightness, and dry cough, which has been reported in less than 1% of the patients, according to Bradbury et al. , Chapman–Smith and Browne , and Jia et al. . No such complications were noted in this study. Different maneuvers have been described to improve the efficacy and safety of foam sclerotherapy as leg elevation before foam injection, blocking the saphenofemoral junction and saphenopopliteal junction before injection . This study achieved high patient satisfaction with the improvement in clinical presentation and the high rate of closure of the visible varicosities with the foam. The limitation of this study is that there is no comparison and randomization between two groups.
| Conclusion|| |
Foam sclerotherapy is simple, safe, effective, and a more satisfactory procedure for treating of small, residual, and recurrent varicose veins.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Piers MFB, Nogueira RF, Navarro TP. Chronic venous disease and varicose veins. In: Navarro T, Dardik A, Junqueira D, Cisneros L, editors. Vascular diseases for the non-specialist
. Cham: Springer; 2017. 167–181.
Gamal WM, Mohamed AS. Color duplex ultrasound-guided foam sclerotherapy: an approach in the management of patients with superficial varicosities of lower extremity. J Vasc Med Surg 2016; 4
Gibson K. Sclerotherapy. In: Chaar C, editor. Current management of venous diseases
. Cham: Springer; 2018. 153–166.
Madhu BS, Shashi Kumar HB, Naveen Kumar Reddy M, Kalabhairav S, Abilash Reddy V. Efficacy and safety of ultrasound guided foam sclerotherapy with sodium tetradecyl sulphate for residual and minor varicosities. Int Surg J 2017; 4
Maurya AK, Singh S, Sachdeva V, Nath B, Verma SC, Gupta PK. Outcome of ultrasound guided foam sclerotherapy treatment for varicose veins: procedure is standard and need no further study. Indian J Vasc Endovasc Surg 2015; 2
Kurnicki J, Osęka M, Tworus R, Gałązka Z. Ultrasound-guided foam sclerotherapy of great saphenous vein with 2% polidocanol – one-year follow-up results. Wideochir Inne Tech Maloinwazyjne 2016; 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
Smith CP. Chronic venous disease treated by ultrasound guided foam sclerotherapy. Eur J Vasc Endovasc Surg 2006; 32
Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and urgical stripping for great saphenous varicose veins. Br J Surg 2011; 98
Breu FX, Guggenbichler S, Wollmann JC. 2nd
European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa, 2008; 37 Suppl 71. 1–30.
Rigby KA, Palfreyman SJ, Beverley C. Surgery versus sclerotherapy for the treatment of varicose veins. Cochrane Database Syst Rev 2004; CD004980.
Figueiredo M, Araújo S, Barros N
Jr, Miranda F
Jr. Results of surgical treatment compared with ultrasound-guided foam sclerotherapy in patients with varicose veins: a prospective randomised study. Eur J Vasc Endovasc Surg 2009; 38
Ouvry P, Allaert FA, Desnos P, Desnos C. Efficacy of polidocanol foam versus liquid in sclerotherapy of the great saphenous vein: a multicenter randomized controlled trial with a 2-year follow up. Eur J Vasc Endovasc Surg 2008; 36
Tan VK, Abidin SZ, Tan SG. Medium term results of ultrasonography guided catheter assisted foam sclerotherapy of the long saphenous vein for treatment of varicose veins. Singapore Med J 2012; 53
Zimmet SE. Sclerotherapy treatment of telangiectasias and varicose veins. Tech Vasc Interv Radiol 2003; 6
Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins randomized controlled trial with or without compression. Eur J Vasc Endovasc Surg 2010; 39
Brunken A, Rabe E, Pannier F. Changes in venous function after foam sclerotherapy of varicose veins. Phlebology 2009; 24
Cavezzi A. Invited commentary re: comparison of 1% and 3% polidocanol foam in ultrasound guided sclerotherapy of the great saphenous vein: a randomized, double-blind trial with 2 year follow-up. 'The 3/1 study'. Eur J Vasc Endovasc Surg 2007; 34
Chapman-Smith P, Browne A. Prospective five-year study of ultrasound-guided foam sclerotherapy in the treatment of great saphenous vein reflux. Phlebology 2009; 24
Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C. Systematic review of foam sclerotherapy for varicose veins. Br J Surg 2007; 94
Han M, Schulz T, Junger M. Outcome four years after transcatheter foam sclerotherapy of the greater saphenous vein. Phlebologie 2008; 37
Bradbury AW, Bate G, Pang K, Darvall KA, Adam DJ. Ultrasound guided foam sclerotherapy is a safe and clinically effective treatment for superficial venous reflux. J Vasc Surg 2010; 52
Brzoza Z, Kasperska-Zajac A, Rogala E, Rogala B. Anaphylactoid reaction after the use of sodium tetradecyl sulfate: a case report. Angiology 2007; 58
Guex JJ, Schliephake DE, Otto J, Mako S, Allaert FA. The French polidocanol study on long-term side effects: a survey covering 3,357 patient years. Dermatol Surg 2010; 36
Hamahata A, Yamaki T, Sakurai H. Outcomes of ultrasound-guided foam sclerotherapy for varicose veins of the lower extremities: a single center experience. Dermatol Surg 2011; 37
Figueiredo M, de Araujo SP, Figueiredo MF. Late follow up of saphenofemoral junction ligation combined with ultrasound-guided foam sclerotherapy in patients with venous ulcers. Ann Vasc Surg 2012; 26
Myers KA, Jolley D. Factors affecting the risk of deep venousocclusion after ultrasound-guided sclerotherapy for varicoseveins. Eur J Vasc Endovasc Surg 2008; 36
O'Hare JL, Earnshaw JJ. The use of foam sclerotherapy for varicose veins: a survey of the members of the Vascular Society of Great Britain and Ireland. Eur J Vasc Endovasc Surg 2007; 34
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]