|Year : 2016 | Volume
| Issue : 2 | Page : 115-120
Ultrasound-Guided foam sclerotherapy versus surgery for the incompetent great saphenous vein based on vein diameter
Abbas S Kummankandath, Prasad Paul, Karat P.A Ali, Nadakkavil M.R Mujeeb, Sunil Rajendran, Waseem Ahammed
Department of Surgery, MES Medical College, Palachode, Perintalmanna, Kerala, India
|Date of Web Publication||30-Nov-2016|
Karat P.A Ali
Department of Surgery, MES Medical College, Palachode, Perintalmanna - 679338, Kerala
Source of Support: None, Conflict of Interest: None
Background: Varicosities of lower limb is one of the most common medical condition and a lot of treatment modalities are available for the same. However, none of them is superior to the other. We compare the effectiveness of surgery versus foam sclerotherapy in the treatment of varicose veins based on the diameter of the veins.
Patients and Method: One hundred patients with primary great saphenous vein incompetence with treatment over a period of 17 months were included. Depending on the diameter of the vein, they are divided into two groups <5 mm and >5 mm, and then assigned to either ultrasound-guided foam sclerotherapy or surgical stripping with high ligation.
Result: Surgery and sclerotherapy in both groups resulted in reduction in both venous disability score and venous clinical severity score.
Conclusion: In patients with vein diameter <5 mm, foam therapy is as good as surgery, however, in >5 mm, surgery is more effective than sclerotherapy.
Keywords: Foam therapy, great saphenous vein, sclerotherapy, varicose vein, enous clinical severity score, venous disability score
|How to cite this article:|
Kummankandath AS, Paul P, Ali KP, Mujeeb NM, Rajendran S, Ahammed W. Ultrasound-Guided foam sclerotherapy versus surgery for the incompetent great saphenous vein based on vein diameter. Arch Int Surg 2016;6:115-20
|How to cite this URL:|
Kummankandath AS, Paul P, Ali KP, Mujeeb NM, Rajendran S, Ahammed W. Ultrasound-Guided foam sclerotherapy versus surgery for the incompetent great saphenous vein based on vein diameter. Arch Int Surg [serial online] 2016 [cited 2019 Sep 20];6:115-20. Available from: http://www.archintsurg.org/text.asp?2016/6/2/115/194978
| Introduction|| |
Lower limb venous insufficiency is a common medical condition and affects approximately 15% of men and 25% of women. The effect of lower limb venous insufficiency on patient's health-related quality of life is substantial and comparable to other chronic conditions such as diabetes mellitus and cardiovascular diseases. Incompetence of the saphenofemoral junction (SFJ) with reflux of venous blood down the great saphenous vein (GSV) is often the cause of primary varicose veins of the lower limbs. Surgical ligation at the SFJ with stripping of the GSV provides an effective and long-term solution., Open surgery is to date the gold standard in the treatment of lower limb varicose veins. This, however, entails the use of general or regional anesthesia and necessitates a groin incision for surgical dissection of the SFJ. The use of duplex ultrasound in the treatment of varicose veins allows alternative strategies to be used. Nonsurgical treatment options include compression hosiery, radiofrequency ablation, endovenous laser ablation and sclerotherapy. Liquid sclerotherapy was an established method of causing venous occlusion by the injection of sclerosing into the affected veins. Direct contact of sclerosant with the venous endothelium initiates endothelial and contiguous mural injury. A local, wall-adherent thrombus then forms, and subsequent sclerosis transforms the treated vein into a fibrous cord.
The perfect treatment should relieve all physical symptoms, significantly improve the appearance of the leg, be complication-free, allow a fast (immediate) return to normal activities, be inexpensive, and be widely available and applicable to affected patients. Such treatment does not and probably will never exist. Though well aware of the shortcomings of superficial venous surgeries (SVS), clinicians have devoted considerable energies to the development of minimally-invasive alternatives, such as radiofrequency ablation (RFA), endovenous laser ablation (EVLA), and ultrasound-guided foam Sclerotherapy (UGFS).
SVS that aims to remove visible varicosevein (VV) and correct axial superficial and perforator (deep to superficial) incompetence has been considered the “gold standard” for many decades. In patients with GSV incompetence, the SFJ is ligated and the GSV is stripped out from the groin to the knee. However, approximately a quarter of the patients are dissatisfied with their treatment at 5–10-year follow-up., Recurrence is common with reflux demonstrated on duplex ultrasound (DUS) in 13–29% of patients at 2–5 years,,,, and clinical recurrence in up to 37% of patients., SVS also carries with it the risks of wound infection, hematoma, thromboembolism, and cutaneous nerve injury.,,,
Sclerotherapy has been in use for treating varicose vein for over 150 years, but was popularized and over the last few years, surgeons have begun to embrace UGFS, an outpatient procedure under local anesthesia, as an alternative to SVS for truncal varicose veins., Sclerotherapy is the introduction of a substance into the lumen of a vessel with the intention of causing thrombosis and subsequently fibrosis. Sclerosing solutions produce endothelial damage that evolves to fibrosis, with the extent of damage to the blood vessel wall determining the effectiveness of the solution. The use of foamed sclerosant has several important benefits over liquid sclerosant; it displaces blood preventing dilution and inactivation of the sclerosant; it has a much larger surface area incurring greater sclerosing ability; it is possible to manipulate the foam once it has been injected to “steer” the sclerosant in the correct direction; it has a greater volume and therefore fills more of the vein. McAusland first described the use of “froth” that he prepared by shaking a bottle containing sodium morrhuate for the treatment of telangiectasia in 1939. Later, Orbach published a further paper in 1950 describing the use of a foam which he created by “vigorously shaking” a syringe containing air and sclerosant to produce a froth and injected after an “air block.” Currently, Tessari's “Tourbillon technique,” introduced in 2000, is the most commonly used technique of foam production and, as mentioned, is based on the “Irvine technique” but with the use of a three-way tap instead of connection tubing. Sclerosant and air mixture is pumped forwards and backwards approximately 20 times. The liquid: Air ratio varies from 1:3 to 1:4. Several different techniques of delivering the foam to the vein have been described, and none to date has been proven to be better than the other.
In our series, all cases underwent Doppler ultrasound before the treatment and 10 days, 1 month, and 12 months after the treatment. Post-treatment, there were no visible veins or recanalization in surgery and sclerotherapy groups, respectively, in the duplex study performed at 10 days and 1 month. In duplex done at 12 months in <5 mm group, after surgery, residual varicose vein was seen in 4% (1 case) and in 8% (2 cases) after sclerotherapy. Whereas in >5 mm group, although surgery group showed 4% (1 case) treatment failure, it was 16% (4 cases) in case of sclerotherapy. All treatment failures in sclerotherapy were due to partial recanalization with reflux.
| Patients and Methods|| |
This was a cohort longitudinal study. One hundred Patients with primary GSV incompetence with treatment over a period of 17 months were included after taking consent. They were divided into two groups depending on the maximum diameter of the trunk in the thigh measured with the patient standing using Doppler with 10 MgHz linear probe. Diameter was taken as the distance between the two outer walls of the GSV measured 5 cm below the SFJ or 10 cm above the knee joint with minimal probe pressure applied causing very little compression of the vein.
Included in the study were patients with symptomatic lower limb varicose veins and demonstrable incompetent SFJ with reflux down the GSV. Exclusion criteria included recurrent/secondary varicose vein, acute superficial or deep venous thrombosis, bed-ridden patients, and pregnancy.
Depending on the diameter of vein the patients were divided into two groups <5 mm and >5 mm, and then assigned to either UGFS or surgical stripping with high ligation. Patients were provided a pamphlet enlisting the two treatment options (Surgery and UGFS). Informed decision was made by the patient.
Surgery: Conventional surgery includes GSV termination ligation flush to femoral vein plus saphenous trunk stripping. SFJ should be identified and ligated. All the tributaries were identified and ligated. Perforators were also ligated. The vein stripped up to the knee. The treated limbs were bandaged immediately following surgery using elastic bandages (TOPGRIP ™ Bandage) up to the groin for 1 month.
Ultrasound Guided Foam Sclerotherapy: The saphenous trunk is usually treated first, with the patient in the supine position and the leg flat initially. The foam was made from Polidocanol. Tessari's method was used to produce the foam. The following supplies are needed: 25 to 30-gauge needles, two 5-mL Luer-Lock syringes, a three-way stopcock, adhesive tape, roller gauze, and compression bandage. After the treatment area is mapped, access to the first vein to be treated is achieved under ultrasound guidance.
Access is confirmed by the return of blood, and the needle is taped to the patient's leg. The sclerosing agent is prepared by placement of one part Polidocanol in one syringe to 4 parts air in the other syringe. The syringes are attached to the stopcock and closed off. The foam solution is created by rapid mixing of air and chemical back and forth between the two syringes. This rapid movement of solution from one syringe to the other is performed 20 times. After most of the solution is moved to one syringe, the filled syringe is connected to the needle, and intravascular positioning is reconfirmed with the ultrasound. A small amount of foam should be injected initially to confirm needle placement within the vein under ultrasound. The amount of foam delivered is determined during injection with the use of ultrasound to visualize when the targeted vein is filled with foam. Upon completion, 30 to 40-mm Hg full-length graduated compression stockings are applied for 1 month.
Clinical assessment of the two treatment approaches were based on venous disability score (VDS) and venous clinical severity scores (VCSS), taking into consideration the presence of pain, edema, inflammation, hyperpigmentation, and lipodermatosclerosis prior to the procedure ( first assessment) and then 10 days, one month, 1 year after the initial treatment. Duplex ultrasound was also performed after 1 year to assess treatment effectiveness. Assessment carried out 10 days after the procedure also aimed at detecting deep vein thrombosis. Finally, 1 year after the surgery or after the foam sclerotherapy session, a new evaluation was carried out to assess the effectiveness of these procedures.
In the surgery group, failure was defined as the presence of reflux or residual varicose veins in any of the segments assessed. In the foam sclerotherapy group, success was assigned to one of the four grades: (1) Total occlusion; (2) partial recanalization without reflux; (3) partial recanalization with reflux; and (4) total recanalization. The procedure was considered to be successful in cases presenting as total occlusion or partial recanalization without reflux; the two remaining categories were considered to reflect treatment failure.
| Results|| |
A total of 100 limbs were studied and were classified in to various grades of clinical severity based on Clinical, aetiological, anatomical and pathological classification. All 100 limbs had visible varicose veins (C2). Forty four limbs were classified as C4, of which 27 were C4a with pigmentation or eczema, and 17 persons had lipodermatosclerosis (C4b). Seventeen patients had edema (C3) whereas 16 were noted to have telangeictasia or reticular veins. Eleven patients had an active venous ulcer and healed ulcer was noted in 4 of them.
All cases studied were primary, involving the superficial veins with reflux and no obstruction or other venous pathology were identified.
Venous disability score and venous clinical severity score
VDS and VCSS were calculated in these two groups as it subjectively measures the severity of symptoms and disability caused due to the illness. They were measured before commencing the treatment and 10 days, 1 month, and 12 months after the treatment [Figure 1] and [Figure 2]. Surgery and sclerotherapy in both groups resulted in reduction in both VDS and VCSS. In <5 mm group, VDS reduced from a mean of 1.84, and 1.68 to 0.28 and 0.36, respectively, in surgery and sclerotherapy. Mean VCSS changed from 8.84 to 0.72 in both groups. In >5 mm group, VDS reduced from a mean of 1.6, and 1.68 to 0.32 and 0.32, respectively, in surgery and sclerotherapy. Mean VCSS changed from 11.4 to 1 and 1.28 in surgery and sclerotherapy groups.
|Figure 2: Venous disability and venous clinical score after foam therapy|
Click here to view
All cases underwent Doppler ultrasound before the treatment and 10 days, 1 month, and 12 months after the treatment. Post-treatment, there were no visible veins or recanalization in surgery and sclerotherapy groups, respectively, in duplex study performed at 10 days and 1 month. In duplex done at 12 months in <5 mm group, after surgery residual varicose vein was seen in 4% (1 case) and in 8% (2 cases) after sclerotherapy. Whereas in >5 mm group, although surgery group showed 4% (1 case) treatment failure, it was 16% (4 cases) in case of sclerotherapy. All treatment failures in sclerotherapy were due to partial recanalization with reflux.
Statistical testing of hypothesis
The serial measurements were summarized with calculation of the average score over the s change from the baseline score (VDS, VCSS) to those determined 10 days, 1 month, and 12 months of treatment The intergroup comparisons were made with Mann–Whitney U test appropriately.
Hypothesis 1: In vein diameter <5 mm: UGFS and surgery are equally effective [Table 1].
From [Table 1], P value (significance two-tailed) is greater than 0.05, and hence we accept the hypothesis that there is no statistical difference (P value) between the two procedures for veins less than 5 mm, that is UGFS and surgery are equally effective. It is noted that in the case of VDS 10 days, P value is 0.022, which is less than 0.05, and hence it rejects our hypothesis, that is, there is a statistical difference in VDS at 10 days. However, it happened due to increased pain at the region of the ankle for patients who underwent sclerotherapy.
Hypothesis 2. In vein diameter >5 mm: Surgery is more effective than sclerotherapy [Table 2].
From the [Table 2], P value (significance two-tailed) is greater than 0.05, and hence we accept the hypothesis that there is statistical difference (P value) between the two procedures for veins more than 5 mm Hence, surgery is more effective.
| Discussion|| |
The present study is a cohort longitudinal study which included a total of 100 patients who underwent treatment for symptomatic varicose veins of the lower limb from our institute during the period of July 2012–November 2014.
The study was completed with 100 patients allocated to 4 treatment groups. Twenty five patients in each group depending on the maximum size of the GSV underwent either surgery or foam sclerotherapy. Patients in the surgery group underwent flush ligation of the GSV and stripping. They were admitted to the hospital 2 days prior to the procedure for the purpose of preanesthetic evaluation and discharged 1–2 days after the surgery, whereas patients who underwent foam sclerotherapy as an outpatient procedure. Out of the 100 patients, 48 were males and 42 females. In all the 100 cases, treatment was initially successful as there were no residual varicosities noted in the surgery group, and all treated veins were obliterated without any demonstrable reflux in the sclerotherapy group in the first follow-up scan performed on the 10th day after intervention. There were also no cases of deep vein thrombosis among them.
VDS and VCSS reduced in both the surgery and foam sclerotherapy group indicating effective treatment. However, contrary to expectations, the 10th day after the procedure, sclerotherapy (<5 mm) group had slightly increased mean VDS. It may be because of the dull aching pain that the patients complained of at the ankle, where associated short saphenous varicosities were also treated with foam therapy.
Duplex ultrasound was also performed in all patients as part of the follow-up on 10th day, 1 month, and 12 months after the procedure. DUS revealed that post-treatment there were no visible veins or recanalization in surgery and sclerotherapy groups, respectively, in duplex study performed at 10 days and 1 month. In duplex done at 12 months in <5 mm group, after surgery residual varicose vein was seen in 4% (1 case) and in 8% (2 cases) after sclerotherapy. Whereas in >5 mm group, although surgery group showed 4% (1 case) treatment failure, it was 16% (4 cases) in case of sclerotherapy. All treatment failures in sclerotherapy were due to partial recanalization with reflux. The failure rates of sclerotherapy are in accordance with those found in the literature. Cabrera et al. found that 81% of GSV were obliterated with one session of sclerotherapy. In the Monfreux group, immediate success was found in 88.1%. In the Tessari group, they found immediate success in 93.3%. In 2003, Hamel-Desnos et al. reported the outcome of an RCT comparing liquid and foamed 3% polidocanol. In the foam group, 84% of the 45 patients had no residual reflux at 3 weeks. At 6 months, there were two recanalization in the foam group.
This study is the first trial comparing treatment outcome depending on the vein size diameter. Both the procedures were effective in elimination of reflux in treated GSV segments. There were no reported complications in any of the treated patients.
| Conclusions|| |
The present study provides evidence that ultrasound-guided foam sclerotherapy is a safe and clinically effective treatment for primary great saphenous varicosity. It is as effective as superficial vein surgery in treating GSV less than 5 mm. It can be considered as an alternative form of treatment, especially in patients who prefer an outpatient procedure, as well as in patients who are high risk for general or regional anesthesia. However, in GSV more than 5 mm, surgery is more effective than sclerotherapy.
I express my sincere thanks to my colleagues and Departmental Secretary for helping me to collect data and editing the article.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]