|Year : 2021 | Volume
| Issue : 6 | Page : 137-141
Catheter-directed foam sclerotherapy in chronic venous insufficiency patients with active ulcer single-center experience
Department of Vascular and Endovascular Surgery, Assiut University Hospitals, Asyut, Egypt
|Date of Submission||03-May-2021|
|Date of Decision||29-May-2021|
|Date of Acceptance||31-May-2021|
|Date of Web Publication||20-Jan-2022|
Department of Vascular and Endovascular Surgery, Assiut University Hospitals, Asyut
Source of Support: None, Conflict of Interest: None
Introduction: Varicose vein and chronic venous insufficiency (CVI) is one of the most prevalent health problems in Europe and the United States; in some studies, it may reach 60% of population. Patients and Methods: This prospective study involving on 51 patients (C6) is to assess the efficacy and tolerance of sclerotherapy foam in the treatment of great saphenous vein incompetence and ulcer healing in CVI patients at 6 and 12 months and to report our experience regarding the diagnosis and treatment of CVI by catheter directed sclerotherapy (CDS). Results and Conclusion: In our experience, CDS safely can contribute to good ulcer healing rate up to 73% at 6 months for a reasonable cost of money and time which might be considered an attractive strategy for providing efficient vascular service in clinical practice.
Keywords: Catheter-directed foam, chronic venous insufficiency, duplex guided, sclerotherapy
|How to cite this article:|
Shahat M. Catheter-directed foam sclerotherapy in chronic venous insufficiency patients with active ulcer single-center experience. Indian J Vasc Endovasc Surg 2021;8, Suppl S2:137-41
|How to cite this URL:|
Shahat M. Catheter-directed foam sclerotherapy in chronic venous insufficiency patients with active ulcer single-center experience. Indian J Vasc Endovasc Surg [serial online] 2021 [cited 2022 Jul 4];8, Suppl S2:137-41. Available from: https://www.indjvascsurg.org/text.asp?2021/8/6/137/336021
| Introduction|| |
Catheter-directed foam sclerotherapy (FS) is considered a safe cost-effective measure that can be held on outpatient procedure under local or tumescent anesthesia around the targeted vein. The efficacy of this method to ablate the reflux of the treated venous segment may reach 80% after 1–2 years in some researches.
The main indicator of success is the diameter of the vein. Best results are achieved with 5 mm diameter. The larger the diameter, the more amount of foam in higher concentration is needed. We usually do not exceed 10 ml of sclerosing material per session.,
By increasing more than the indicated amount, side effects such as hyperpigmentation, eczema, and even ulceration appear and also risk of inflammation and thromboembolic risk increase.,
Some authors considering local tumescence anesthesia decrease amount needed and increase contact of the venous wall with the foam and also decrease the side effects such as pain inflammation and skin ulceration. It also decreases vein diameter to make more contact of foam with sclerosing material.
The aim of the study was to assess the efficacy and tolerance of sclerotherapy foam in the treatment of great saphenous vein (GSV) incompetence and to report our experience regarding the diagnosis and treatment of chronic venous insufficiency (CVI) by catheter-directed sclerotherapy (CDS).
The primary objective was the efficacy of abolition of venous reflux at 6 months. The secondary outcomes include evaluation of side effects, durability of FS, patient satisfaction with treatment, and symptom severity. All data were assessed 1, 6, and 12 months after treatment.
| Patients and Methods|| |
This study was conducted prospectively on 51 patients (with 52 limbs) who presented to the Department of Vascular Surgery of Assiut University Hospitals with CVI manifestations from March 2014 to March 2015 inclusion and exclusions criteria in [Table 1]. All patients underwent detailed history taking, and data were collected on age, sex, and cardiovascular risk factors such as diabetes mellitus, hypertension, ischemic heart disease, allergy to sclerotherapy, previous deep vein thrombosis, pulmonary embolism, and peripheral artery disease. In addition, history of previous venous surgery. Patients then went complete clinical examinations.
The patient went to make complete blood count, prothrombin time, and platelet count. Venous duplex scanning was performed on all patients to assess reflux and/or obstruction in the superficial, perforator, and deep veins using compression release and/or Valsalva to induce reflux. Computed tomography venography may be needed in patients in whom deep venous system obstruction is suspected.
The treatments were performed in equipped theater under complete aseptic condition in outpatient bases. The patient was placed supine position. A 6F sheath is then introduced into the GSV below the knee under US guidance. Local and in some cases tumescent anesthesia was used. Then, the catheter was advanced and positioned approximately 2 cm distal to the saphenofemoral junction (SFJ) (inflow to the deep system) distal to superficial epigastric vein visualized by duplex. [Figure 1] and [Figure 2].
|Figure 1: Catheter advancement inside great saphenous vein lumen (image from one case done in Assiut University Hospitals)|
Click here to view
|Figure 2: Great saphenous vein with catheter inside it 2 cm away from saphenofemoral junction (Image from one case done in Assiut University Hospitals)|
Click here to view
Using a modified method of Tessari, 10-ml sclerosing foam was made by mixing 2-ml ethanolamine oleate and 8-ml air using two syringes and a three-way connector. The vein was compressed with the US probe proximal to the catheter, to prevent inflow of foam to the deep system. Then, the foam was delivered along the vein while the catheter was steadily withdrawn. Approximately 10 ml of foam was delivered. The SFJ and site of puncture were compressed for 5 min, and the extension of the vein was massaged to migrate foam in distal direction.
Immediately after the procedure, the patients were mobilized. All patients had continuous compression therapy immediately postoperative.
Statistical analysis was performed using SPSS (23 SPSS Inc., Chicago, Illinois, USA). Descriptive statistics were used, with continuous variables expressed as mean ± standard deviation and categorical data expressed as percentages.
| Results|| |
Between March 2014 and March 2015, 51 patients (52 limbs) underwent CDS for venous leg ulcers. The median age was 43.5 years (range, 24–65), 30 men and 21 women. All patients had active venous ulcers. The studied population were categorized as C6, Ep, As, and Pr according to clinical, etiological, anatomical, pathological (CEAP) classification. Of the 52 limbs, 32 had insufficiency of the GSV and 8 insufficiency of the short saphenous vein (SSV). Twelve patients had insufficiency in both GSV and SSV, and only one patient had bilateral ulcers and saphenous insufficiency [Table 2].
Six patients had recurrent varicose veins after previous venous surgery. No patient had an ankle-brachial index <0.8 or insufficiency in the deep venous system. Foam delivery along the vein was technically successful in 100%. In all veins, 10 ml of foam was used. The GSVs were punctured just above the knee. Access to SSV was achieved by an antegrade puncture in the proximal part of the calf or achieved by a retrograde puncture.
The clinical and instrumental examination always revealed a reduction of symptoms and manifestations of CVI and decreased CEAP. The complications were reported in our study during and after intervention. These complications and details of follow-up visits are listed in [Table 3] and [Table 4].
Twelve months after treatment, patients in the CDS rated their satisfaction with the procedure as 4.5 on a scale of 1 (very unsatisfied) to 5 (very satisfied). The overall combined rating of satisfied and very satisfied was 95% in the catheter directed foam sclerotherapy (CDFS) at 12-month follow-up.
SCALE: 1 – very unsatisfied, 2 – unsatisfied, 3 – moderately satisfied, 4 – satisfied, and 5 – very satisfied.
At 1-month follow-up, patients in the CDS reported pain during and after treatment (4 – on average) on a scale of 1 (not tolerable) to 5 (no pain).
Visual analog score: 1 – nontolerable pain, 2 – painful, 3 – moderate pain, 4 – mild pain, and 5 – no pain.
| Discussion|| |
About one-third of the population aged between 18–60 years suffer from varicose veins or manifestation of CVI. The expenditure among this entity of disease is huge and represents one of the major obstacles in the face of the resources of the health system, especially in the developing countries. Chronic venous ulcer requires huge health-care resources, acting approximately 1%–1.5% of the adult Western population, and is estimated to 1% of total health cost.,
Many modalities are now used for management of this entity. in the last decade the surgery was the only line, then the endovenous ablation procedures developed like radiofrequency laser ablation, which still have high cost and really no suitable for all sectors special in developing countries. So emerged midway solution that has cost effectiveness of surgery and minimal invasiveness of endovenous ablation. Liquid sclerotherapy and FS with comparable result to the previous two modalities.
CDS is a technique used to deliver the sclerosing foam along the incompetent vein through a catheter. This is a safe and simple technique of distributing foam directly to the intended site.
This study reported healing rates comparable with other studies, both after surgical correction of superficial venous incompetence (65%–83%) and after CDS (79%–83%). The recurrence rate is comparable with those reported after CDS (4.9%–17%) and slightly better than after surgery (12%–22%)., A few studies reported higher healing rates after CDS in addition to compression therapy, but they are small and their follow-ups are short.
CDS has a better safety than US-guided sclerotherapy. Once access to GSV, there is no extravasation risk or risk of accidental intra-arterial injection. There is no risk of vein wall perforation, which occurs with laser. When our procedure compared with RF it has much less pain much less time consuming and less amount of tumescent is needed. Furthermore, there is no bruising after intervention. The most difficult step and painful part of the intervention is GSV puncture.
There is increasing concern about higher incidence of femoral vein thrombosis from leakage of sclerosant material through thigh perforators. We compress to occlude SFJ, hence the foam is pushed down through the perforators and then to the femoral vein. We can avoid this by decreasing the volume of foam below 10 mL of foam.
Digital compression is not an effective method and may lead to spillage of sclerosant material to the deep system. Some used a method of wire embolectomy catheter balloon to avoid the need for digital compression the need for digital compression and assure lengthy contact of the foam with the vein. Others used clipping the perforators before CDS to minimize the chance of foam escaping into deep system and give chance to lengthy contact with the endothelium.
This study has only included patients suffering from venous ulcers not responding intensive compression therapy. Differences in the study population might explain why the healing rate is lower than in some studies. The elimination of superficial venous insufficiency seems to initiate a quick ulcer healing in many patients.
As shown here, many ulcers were healed at the first follow-up 4 weeks after CDS and all of the healed ulcers did so within 3 months. This phenomenon has been reported in other studies.
At the 1-year follow-up, 16 patients (16 limbs), including two recurrences, had active ulcers. Of those never healed, three patients were diagnosed with arterial insufficiency and their ulcers were considered as mixed ulcers. This might have affected their healing ability. However, the treatment had improved their ulcer status, and none of these patients had experienced any complication related to the CDS. Mixed ulcers benefit from eliminating the superficial venous insufficiency in addition of correcting the arterial component. For these patients, compression is not advisable.
Our study showed a total ulcer healing rate after 1 month, 51.9% of patients, while after 1-year follow-up, 69.2% did not have active ulcers Williamsson et al. reported a total ulcer healing rate after 3 months of 71% (22/31) of the studied limbs or 70% (21/30) of the patients. At 1 year, 65% (20/31) limbs did not have active ulcers after 1-year follow-up.
Duplex follow-up in our study after 1 month showed 94.2% totally occluded and 3.8% partly occluded with no reflux. After 1-year follow-up, the current study showed complete occlusion in 75%, 15.4% partly occluded with no reflux, 7.7% partly occluded with reflux, and 1.9% were recanalized.
Those results are in line with earlier results shown by Williamsson et al. They found occlusion in 70% after 1 year, 14% were partly occluded, and 15% were recanalized.
Regarding side effects, in our study, thrombophlebitis was reported in four patients (7.6%), hyperpigmentation was reported in three patients (5.7%), and only one patient developed deep venous thrombosis (1.9%). Serious side effects of foam-sclerosing agent are estimated to be between 0% and 5.7%. In a meta-analysis of 69 studies of treatment by sclerotherapy for venous insufficiency systematic review of FS, Jia et al. calculated a median incidence of 4.4% (range, 0%–10.3%) for thrombophlebitis and 31.6% (range, 7.8%–55.1%) for matting/skin pigmentation. Studies performing CDFS of the GSV reported similar results. Kölbel et al. diagnosed thrombophlebitis in 3/53 patients and Williamsson et al. in 2/91 patients after CDFS of the GSV.
The limitations of this study are the small patient sample and the lack of surveillance of the compression treatment. All patients received the same treatment, i.e., there is not a control group of compression alone. In addition, the possible effect of different compression systems is not evaluated.
| Conclusion|| |
CDS is an effective endovenous treatment modality for management of varicose vein with good ulcer healing rate in CVI patients with C6 and accepted patient satisfaction, being an attractive strategy to provide dedicated vascular service.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Rathbun S, Norris A, Stoner J. Efficacy and safety of endovenous foam sclerotherapy: Meta-analysis for treatment of venous disorders. Phlebology 2012;27:105-17.
Subramonia S, Lees TA. The treatment of varicose veins. Ann R Coll Surg Engl 2007;89:96-100.
Rabe E, Breu FX, Cavezzi A, Coleridge Smith P, Frullini A, Gillet JL, et al.
European guidelines for sclerotherapy in chronic venous disorders. Phlebology 2014;29:338-54.
Eckmann DM. Polidocanol for endovenous microfoam sclerosant therapy. Expert Opin Investig Drugs 2009;18:1919-27.
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.
Parsi K. Catheter-directed sclerotherapy. Phlebology 2009;24:98-107.
Brodersen JP, Geismar U. Catheter-assisted vein sclerotherapy: A new approach for sclerotherapy of the greater saphenous vein with a double-lumen balloon catheter. Dermatol Surg 2007;33:469-75.
Xu J, Wang YF, Chen AW, Wang T, Liu SH. A modified Tessari method for producing more foam. Springerplus 2016;5:129.
Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health 1999;53:149-53.
Beale RJ, Gough MJ. Treatment options for primary varicose veins – A review. Eur J Vasc Endovasc Surg 2005;30:83-95.
Nelzèn O. Leg ulcers: Economic aspects. Phlebology 2000;15:110-4.
Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser treatment for varicose veins. Br J Surg 2005;92:1189-94.
Williamsson C, Danielsson P, Smith L. Catheter-directed foam sclerotherapy for insufficiency of the great saphenous vein: Occlusion rates and patient satisfaction after one year. Phlebology 2013;28:80-5.
Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, et al.
Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): Randomised controlled trial. Lancet 2004;363:1854-9.
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.
Bergan J, Pascarella L, Mekenas L. Venous disorders: Treatment with sclerosant foam. J Cardiovasc Surg (Torino) 2006;47:9-18.
Goldman MP, Mauricio M, Rao J. Intravascular 1320-nm laser closure of the great saphenous vein: A 6- to 12-month follow-up study. Dermatol Surg 2004;30:1380-5.
Bidwai A, Beresford T, Dialynas M, Prionidis J, Panayiotopoulos Y, Browne TF. Balloon control of the saphenofemoral junction during foam sclerotherapy: Proposed innovation. J Vasc Surg 2007;46:145-7.
Treiman GS, Copland S, McNamara RM, Yellin AE, Schneider PA, Treiman RL. Factors influencing ulcer healing in patients with combined arterial and venous insufficiency. J Vasc Surg 2001;33:1158-64.
Devereux N, Recke AL, Westermann L, Recke A, Kahle B. Catheter-directed foam sclerotherapy of great saphenous veins in combination with pre-treatment reduction of the diameter employing the principals of perivenous tumescent local anesthesia. Eur J Vasc Endovasc Surg 2014;47:187-95.
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.
Kölbel T, Hinchliffe RJ, Lindblad B. Catheter-directed foam sclerotherapy of axial saphenous reflux: Early results. Phlebology 2007;22:219-22.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]