|Year : 2015 | Volume
| Issue : 3 | Page : 96-100
Outcome of Ultrasound Guided Foam Sclerotherapy Treatment for Varicose Veins: Procedure is Standard and Need No Further Study
Akhilesh Kumar Maurya1, Sanjay Singh1, Vikas Sachdeva1, Brajendra Nath2, Sateesh Chandra Verma1, Prashant K Gupta1
1 Department of Surgery, SRN Hospital and MLN Medical College, Allahabad, Uttar Pradesh, India
2 Department of Radiodiagnosis, SRN Hospital and MLN Medical College, Allahabad, Uttar Pradesh, India
|Date of Web Publication||8-Oct-2015|
Akhilesh Kumar Maurya
Department of Surgery, SRN Hospital and MLN Medical College, Allahabad, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Objective: To study the outcomes of the ultrasound guided foam sclerotherapy (UGFS) treatment for superficial venous insufficiency.
Materials and Methods: Selected patients with varicose veins were treated with UGFS using sodium tetradecyl sulfate as sclerosant and followed up to 1-year. Total 148 legs in 123 patients, 98 unilateral limbs, and 25 bilateral limbs were treated by this method.
Results: Out of 148 legs saphenofemoral junction (SFJ) incompetence was found in 42 and sapheno-popliteal junction (SPJ) incompetence in 49, perforator's incompetence in 11, while combination of SFJ and perforators and SPJ and perforators in 16 and 7, respectively. Great saphenous vein varicosity was found in 58, short saphenous vein in 56 and others 34. Twenty-four limbs had recurrent varicose veins previously treated by other modalities, and 124 limbs had primary varicose veins. Fifty-two limbs were treated for complicated varicose veins (CEAP 4-6) and 96 limbs for uncomplicated varicose veins (CEAP 2-3). Early outcome was 100% success rate. No recurrences were noted at 1-year follow-up. Early complications were: Superficial skin necrosis in 4 legs (2.70%), pain at injection sites in 21 legs (14.18%), superficial thrombophlebitis in injected vein in 21 legs (14.18%), bruising in 18 legs (12.16%), superficial vein thrombosis in 10 legs (6.75%), and skin staining around injected veins in 13 legs (8.78%).
Conclusion: UGFS is a safe, good, and effective treatment modality of treatment for patients with varicose veins and found to be associated with significantly less bruising and pain.
Keywords: Foam sclerotherapy, superficial venous insufficiency, ultrasound guided foam sclerotherapy outcome, ultrasound guided sclerotherapy, varicose veins
|How to cite this article:|
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;2:96-100
|How to cite this URL:|
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 [serial online] 2015 [cited 2019 Aug 22];2:96-100. Available from: http://www.indjvascsurg.org/text.asp?2015/2/3/96/166933
| Introduction|| |
Sclerosants cause endothelial damage, which exposes sub-endothelial collagen fibers and activates the intrinsic coagulation pathway. Because of an inflammatory reaction at the vessel wall and thrombus organization in a vessel lumen, fibrosis, and obliteration of the vessel lumen occurs.,,,,
Foams have several benefits over liquid sclerosants: Like a large dose of foam can be used per se ssion, have large surface area leading to greatest efficacy, displaces blood prevents dilution, and inactivation of the sclerosants. Foams are visible on duplex ultrasound, and it is possible to manipulate the foam once it has been injected.
| Materials and Methods|| |
The study carried out at our hospital after taking approval from the ethics committee and obtaining written and informed consents from the patients, between June 2013 and July 2014. Their details are recorded for this new modality of treatment. Every patient referred with varicose vein was explained different modalities of treatments available at the hospital. Only sclerotherapy and invasive surgical methods were available at that time in the hospital. Minimally invasive methods such as subfascial endoscopic perforator ligation surgery, radio frequency ablation (RFA), endovenous laser ablation (EVLA) and endovenous thermal ablation were not available. After a full discussion of the available options and based on their requirements, ultrasound guided foam sclerotherapy (UGFS) tended to be selected by most of the patients, particularly those with strong cosmetic concern and army personnel. Patients included in the study were those having truncal varicose veins, great saphenous vein (GSV), small saphenous vein (SSV), anterior accessory saphenous vein or other recurrent veins with significant incompetent deep venous connection [Figure 1] and [Figure 2].
The full clinical examination was done for every patient undergoing UGFS treatment including palpation of peripheral pulses and classified according to CEAP clinical classification. All patients either have visible varicosities (C2 or C3) or skin complication (C4, C5, or C6). Patients having reticular vein, postthrombotic deep venous occlusion or having deep vein thrombosis (DVT), deep venous insufficiency and A-V malformations, were excluded from the study.
Initial duplex ultrasound assessment
All patients underwent duplex ultrasonography to identify sites of superficial venous reflux and deep venous reflux. Patients were examined in standing posture and sitting on the edge of the examination couch with their legs dependent. In standing posture with their weight on the contra-lateral limb and the leg to be examined kept slightly bent with the heel on the floor to relax the calf muscles. The veins and venous segments were assessed are: Proximal and distal superficial femoral vein, above and below-knee popliteal vein, sapheno-femoral junction (SFJ) and sapheno-popliteal junction (SPJ), the whole length of the GSV, SSV, anterior accessory saphenous vein, and competency of perforators. The diameter and reflux was assessed and was considered pathological when it exceeds 0.5 s.
Cannulation and injection
At the start of treatment, veins are marked with the marker in the standing posture and then cannulated under ultrasound guidance with 18G, 20G, and 22G cannula, depending on the size, depth, and tortuosity. For GSV, cannulation was done just below or above the knee. Other truncal veins including SSV, lower GSV or calf tributary, were cannulated most distally where they can be easily cannulated. The sensitivity of sclerosant was tested. Foam was prepared using a triway, two 5 ml syringes and mixing 1 ml of sodium tetradecyl sulphate with 4 ml of air [Figure 3], leg was elevated about 45° and foam was injected under ultrasound vision until foam was found to reach the SFJ or deep venous junction. Maximum 2 ml of foam was injected per cannula. During injection of foam, the patient was asked to plantar and dorsiflex the ankle to increase the deep venous blood flow and enhance neutralization of any foam that has passed into the deep venous system. Maximum 20 ml foam was used per treatment session.
|Figure 3: Technique of foam preparation using two syringes and one triway|
Click here to view
Bandaging and compression
After completion of foam injection, all cannulas were removed and crepe (elastic) bandage was applied [Figure 4]. Too much pressure use was avoided to prevent any vascular compromise. The bandage was kept in place for 3–5 days and after that bandage removed and examined for residual varicosities and any other complications. Elastic bandages or elastic stockings were advised for 6–8 weeks during walking, standing, and running while limb elevation during sleeping.
All patients treated with UGFS were called for follow-up visit at the completion of 5th day, 6 months, and 1-year. On each follow-up visit, full clinical examination was done and looked for improvement in their symptoms and varicosities, any complications and any signs of DVT. Efficacy of the treatment assessed solely on the basis of improvement in symptoms and disappearance of varicosities. No standard questionnaire or method was used to assess treatment success, symptom relief, and satisfaction.
| Results|| |
Total 148 legs in 123 patients (91 males and 32 females), 98 unilateral limbs, and 25 bilateral limbs were treated by this method for different types of lower limb varicosities [Table 1]. Out of 148 legs SFJ incompetence was found in 42 and SPJ incompetence in 49, perforator's incompetence in 11, while combination of SFJ and perforators and SPJ and perforators in 16 and 7 respectively [Table 2]. The cause of higher incidence of SPJ incompetence in comparison to SFJ incompetence, cannot be explained by this study.
GSV varicosity was found in 58, short saphenous vein in 56 and others 34. 24 limbs had recurrent varicose veins previously treated by other modalities, and 124 limbs had primary varicose veins. Fifty-two limbs were treated for complicated varicose veins (CEAP 4-6) and 96 limbs for uncomplicated varicose veins (CEAP 2-3) [Table 3].
The early outcome was 100% success rate. On first follow-up visit after 3–5 days, all varicosities treated with this method had disappeared. Early outcome was 100%. Early complications were: Superficial skin necrosis in 4 legs at one or two injection sites (2.70%). Pain at injection sites in 21 legs (14.18%), superficial thrombophlebitis in injected vein in 21 of the 148 legs (14.18%), bruising was noted in 18 legs (12.16%), and skin staining around injected veins were found in 13 legs (8.78%).
None of the patients developed any clinical evidence of any DVT. Only 10 of the 148 legs developed superficial vein thrombosis (6.75%), which was treated with analgesics, limb elevation and compression bandage [Table 4]. For all these complications, no treatment was required, and they disappeared without any specific treatment. At the end of 6 months and 1-year, no complications and recurrences were found.
| Discussion|| |
When results of this study are compared with other conventional methods such as saphenous vein stripping, UGFS is found to be associated with lesser pain, very well-tolerated and safe, we found no DVT, allergic reaction, infection, headache, and blurring of vision.
Bruising was noted in 18 legs (12.16%) in this study which was less than other methods like saphenous vein stripping (SVS). The incidence of bruising with SVS was found to be 25–30% reported in different studies., With UGFS treatment bruising and pigmentation was found to be 26–30% in various studies.,,,, After RFA, it is about 13–27%, and after EVLA, it is 11–15%., According to Kalodiki et al. and Shadid et al. surgery is associated with the lesser incidence of pigmentation (5% and 1.1% respectively) in comparison to UGFS (15% and 5.6%, respectively).
Improvements in symptoms and quality of life were 100% in the present study which was found to be similar to other studies. In terms of expectations, one study shows that exceeded in 25% while unmet in 10%.
Recurrences associated with UGFS treatment varies from 4.9% to 40%,,,, but there were no recurrences seen in the present study. Treatment failures associated with UGFS treatment was 2% and 57%, but no failure in the current study.
Anaphylaxis is an established complication of liquid sclerotherapy, but can occur with foam also. No any case of anaphylaxis was recorded in our study like other studies. Bradbury et al. reported allergy to the foam in 0.1% of patients in their study. Scurr et al., Brzoza et al., and Guex et al., each of them reported single case of allergic reactions in their studies.
DVT and thromboembolism after UGFS is a very rare complication and reported in <1% of the patients.,,,, No incidence of DVT was noted in this study and also according to Brunken et al. and Hamahata et al., Figueiredo et al. reported the occurrence of DVT in 9% of their patients. Later on it was found that using foam volume more than 10 ml in single limb resulted in 3-fold chances of DVT  and increased production of endothelin-1 is associated with high chances of DVT. After this study, Breu et al. and Hamel-Desnos et al. uses maximum 10 ml of foam without any incident of DVT.
Superficial thrombophlebitis incidence reported in different studies was found to be <15%.,, One study shows 39% incidence. In our study, it's incidence was about 14.18%.
Other systemic complications associated with UGFS were photopsia, transient blurring of vision, transient ischemic attack, headache, chest tightness, and dry cough has been reported in <1% of the patients.,,, No such complications noted in our study.
Different maneuvers have been described to improve the efficacy and safety of foam sclerotherapy by decreasing the amount of foam entering into the deep venous system and systemic circulation, like leg elevation before foam injection, blocking of SFJ and SPJ before injection.
The weakness of this study is that there is no comparison and randomization between two groups. Only surgeons of our hospital used UGFS as preferred treatment while others used conventional methods of treatment such as SVS, SFJ ligation, SPJ ligation, and perforator ligation. All patients in this study were referred from surgeons of our hospital through a common referral pool. Therefore, there was some clinical or surgeon selection bias.
Another limitation of our study was the size of UGFS cohorts, although this was unlikely to have resulted in any systematic bias. Assessment of complications and outcomes were objective and decided by the therapist. This observer bias could have been improved by subjective assessment of complications and outcome in a follow-up clinic, by using a validated scoring system and questionnaire.
| Conclusion|| |
UGFS was found to be associated with significantly less bruising and pain. The low incidence of complications and recurrence associated with the UGFS gives further evidence of its safety. UGFS is a good and effective treatment modality of treatment for patients with varicose veins because of SFJ incompetence and SPJ incompetence as well as perforator's incompetence.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Kakkos SK, Bountouroglou DG, Azzam M, Kalodiki E, Daskalopoulos M, Geroulakos G. Effectiveness and safety of ultrasound-guided foam sclerotherapy for recurrent varicose veins: Immediate results. J Endovasc Ther 2006;13:357-64.
Coleridge Smith P. Sclerotherapy and foam sclerotherapy for varicose veins. Phlebology 2009;24:260-9.
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;52:939-45.
Darvall KA, Bate GR, Adam DJ, Bradbury AW. Recovery after ultrasound-guided foam sclerotherapy compared with conventional surgery for varicose veins. Br J Surg 2009;96:1262-7.
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 Suppl 2:993-1003.
Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surg 2003;38:207-14.
Subramonia S, Lees T. Sensory abnormalities and bruising after long saphenous vein stripping: Impact on short-term quality of life. J Vasc Surg 2005;42:510-4.
Chapman-Smith P, Browne A. Prospective five-year study of ultrasound-guided foam sclerotherapy in the treatment of great saphenous vein reflux. Phlebology 2009;24:183-8.
Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C. Systematic review of foam sclerotherapy for varicose veins. Br J Surg 2007;94:925-36.
Brunken A, Rabe E, Pannier F. Changes in venous function after foam sclerotherapy of varicose veins. Phlebology 2009;24:145-50.
Blaise S, Bosson JL, Diamand JM. Ultrasound-guided sclerotherapy of the great saphenous vein with 1% vs 3% polidocanol foam: A multicentre double-blind randomised trial with 3-year follow-up. Eur J Vasc Endovasc Surg 2010;39:779-86.
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;26:977-81.
Vasquez MA, Wang J, Mahathanaruk M, Buczkowski G, Sprehe E, Dosluoglu HH. The utility of the Venous Clinical Severity Score in 682 limbs treated by radiofrequency saphenous vein ablation. J Vasc Surg 2007;45:1008-14.
Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: Short-term results. J Vasc Surg 2007;46:308-15.
Christenson JT, Gueddi S, Gemayel G, Bounameaux H. Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up. J Vasc Surg 2010;52:1234-41.
Kalodiki E, Lattimer CR, Azzam M, Shawish E, Bountouroglou D, Geroulakos G. Long-term results of a randomized controlled trial on ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation vs standard surgery for varicose veins. J Vasc Surg 2012;55:451-7.
Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, et al. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg 2012;99:1062-70.
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;53:91-4.
Darvall KA, Bate GR, Sam RC, Adam DJ, Silverman SH, Bradbury AW. Patients' expectations before and satisfaction after ultrasound guided foam sclerotherapy for varicose veins. Eur J Vasc Endovasc Surg 2009;38:642-7.
Hahn M, Schulz T, Junger M. Outcome four years after transcatheter foam sclerotherapy of the greater saphenous vein. Phlebologie 2008;37:237-40.
Leopardi D, Hoggan BL, Fitridge RA, Woodruff PW, Maddern GJ. Systematic review of treatments for varicose veins. Ann Vasc Surg 2009;23:264-76.
Pang KH, Bate GR, Darvall KA, Adam DJ, Bradbury AW. Healing and recurrence rates following ultrasound-guided foam sclerotherapy of superficial venous reflux in patients with chronic venous ulceration. Eur J Vasc Endovasc Surg 2010;40:790-5.
Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011;98:1079-87.
Scurr JR, Fisher RK, Wallace SB, Gilling-Smith GL. Anaphylaxis following foam sclerotherapy: A life threatening complication of non-invasive treatment for varicose veins. Eur J Vasc Endovasc Surg Extra 2007;13:87-9.
Brzoza Z, Kasperska-Zajac A, Rogala E, Rogala B. Anaphylactoid reaction after the use of sodium tetradecyl sulfate: A case report. Angiology 2007;58:644-6.
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 Suppl 2:993-1003.
Myers KA, Jolley D, Clough A, Kirwan J. Outcome of ultrasound-guided sclerotherapy for varicose veins: Medium-term results assessed by ultrasound surveillance. Eur J Vasc Endovasc Surg 2007;33:116-21.
Gillet JL, Guedes JM, Guex JJ, Hamel-Desnos C, Schadeck M, Lauseker M, et al. Side-effects and complications of foam sclerotherapy of the great and small saphenous veins: A controlled multicentre prospective study including 1,025 patients. Phlebology 2009;24:131-8.
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;37:804-9.
Myers KA, Jolley D. Factors affecting the risk of deep venous occlusion after ultrasound-guided sclerotherapy for varicose veins. Eur J Vasc Endovasc Surg 2008;36:602-5.
Frullini A, Felice F, Burchielli S, Di Stefano R. High production of endothelin after foam sclerotherapy: A new pathogenetic hypothesis for neurological and visual disturbances after sclerotherapy. Phlebology 2011;26:203-8.
Breu FX, Guggenbichler S, Wollmann JC. 2nd
European consensus meeting on foam sclerotherapy 2006, Tegernsee, Germany. Vasa 2008;37 Suppl 71:1-29.
Hamel-Desnos C, Allaert FA. Liquid versus foam sclerotherapy. Phlebology 2009;24:240-6.
Islamoglu F. An alternative treatment for varicose veins: Ligation plus foam sclerotherapy. Dermatol Surg 2011;37:470-9.
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;38:758-63.
Guex JJ, Allaert FA, Gillet JL, Chleir F. Immediate and midterm complications of sclerotherapy: Report of a prospective multicenter registry of 12,173 sclerotherapy sessions. Dermatol Surg 2005;31:123-8.
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;34:232-5.
[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4]