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Effect of Transluminal Injection of Foam Sclerotherapy Combined with Endovenous Thermal Ablation of Varicose Veins

Open AccessPublished:January 13, 2020DOI:https://doi.org/10.1016/j.ejvssr.2019.12.001

      Highlights

      • Stab avulsion tends to result in incomplete avulsions.
      • Ultrasound-guided foam sclerotherapy also tends to result in non-sclerotic vessels.
      • Foam sclerosing agent injected via the sheath covers the whole varicose vein.
      • Transluminal foam sclerotherapy improves VCSS and reduces additional interventions.

      Objective

      The combination of endovenous therapies with stab avulsion or ultrasound guided foam sclerotherapy is widely performed. However, these conventional techniques tend to result in incomplete avulsions or persistent varicosities.

      Methods

      One hundred and thirteen legs in 97 consecutive patients who underwent 1470 nm laser ablation for great saphenous varicose veins were enrolled. The foam sclerosing agent was injected via the sheath after endovenous laser ablation (EVLA). Patients were divided into two groups: EVLA only group (Control; n = 50) and EVLA and transluminal injection of foam sclerotherapy (TLFS) group (SCL; n = 63).

      Results

      At three month follow up, reflux was abolished throughout all treated great saphenous veins (GSVs) when assessed with Duplex ultrasound. Thrombophlebitis was observed in two patients in the SCL group (p = .13). Additional second stage sclerotherapy was needed in the Control group (n = 33, 66%) vs. SCL group (n = 2, 3%; p < .0001). The venous clinical severity score (VCSS) was significantly improved in the SCL group (changes of VCSS, Control −3.3 ± 1.7 and SCL -4.4 ± 1.0; p < .0001). Univariable and multivariable analyses revealed that, among age, sex, Clinical-Etiology-Anatomy-Pathophysiology classification, linear endovenous energy density, and TLFS, TLFS was the only significant factor of improved VCSS (hazard ratio = −0.96; 95% confidence interval = −1.4 to −0.58; p < .0001).

      Conclusions

      TLFS combined with EVLA may be an easy, safe, and effective procedure with acceptable complications vs. EVLA alone and reduces additional second stage interventions.

      Keywords

      INTRODUCTION

      Endovenous varicose vein therapies are now the preferred treatment option vs. traditional surgical procedures and are currently considered as the first choice. Stab avulsion (SA) or ultrasound guided foam sclerotherapy (UFS) combined with endovenous laser ablation (EVLA) also is performed widely. However, these conventional techniques tend to result in incomplete avulsions or persistent varicosities regardless of the amount of effort or time put into the procedure. Previously reported extended EVLA of great saphenous vein (GSV) and above knee EVLA with below knee foam sclerotherapy via the endovenous catheter is safe and effective.
      • Theivacumar N.S.
      • Dellagrammaticas D.
      • Mavor A.I.
      • Gough M.J.
      Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial.
      In this study, an endovenous catheter was inserted via a sheath; and thus it could be considered whether a transluminal injection of foam sclerotherapy (TLFS) via this sheath might cover the whole varicose vein vs. local SA/UFS. The aim of this study was to assess the short term efficacy, patient satisfaction, and effects on venous clinical severity score (VCSS) of TLFS in the treatment of GSV varicose veins.

      METHODS

      Patients

      From March 2017 to March 2019, 99 consecutive patients with 113 legs were enrolled in the study. Eligible patients had a diagnosis of unilateral/bilateral GSV varicose veins, with clinical class C2–C6 disease according to the Clinical-Etiology-Anatomy-Pathophysiology classification. Great saphenous insufficiency was defined as reflux >0.5 s using colour duplex ultrasound along with the Valsalva method or the lower extremity milking method. The indication for EVLA was a symptomatic primary varicose vein. Exclusion criteria were (1) recurrent varicose veins following previous surgery, EVLA, or UFS; (2) sclerosant hypersensitivity; (3) serious systemic diseases, such as deep vein thrombosis (DVT) and chronic obstructive pulmonary disease; (4) serious lower limb ischaemic disease (lower extremity arteriosclerosis obliterans, thromboangiitis obliterans, acute arterial embolism, Raynaud's syndrome); (5) coagulation disorder; and (6) simultaneous EVLA for both great and small saphenous veins. Patients were divided into a conventional EVLA only group (Control; n = 50; March–November 2017) and a combined TLFS group (SCL; n = 63; December 2017–March 2019). This study was approved by the Ethics Committee. All patients provided written informed consent.

      Procedure

      The GSV at the lower end of reflux or upper third of the calf was punctured under 1% lidocaine local anaesthesia and under ultrasound guidance. A 6 Fr 15/25 cm introducer sheath (Radifocus™ Introducer II H; Terumo Co., Ltd., Tokyo, Japan) was inserted. Finally, through the introducer sheath, a laser catheter using a 1470nm diode laser [(LEONALD1470; Biolitec, Bonn, Germany) with a radial 2ring fibre ELVeS Radial 2ring™ fibre; Biolitec] was inserted. EVLA was performed from a point just distal to the saphenofemoral junction under tumescent local anaesthesia (0.9% saline 500 mL, 2% lidocaine 30 mL, 0.1% adrenaline 1 mL, 7% sodium bicarbonate 20 mL). The laser fibre was pulled back at 2 mm/s with 8W.

      TLFS

      Sclerosing foam was prepared using the previously described Tessari method.
      • Tessari L.
      • Cavezzi A.
      • Frullini A.
      Preliminary experience with a new sclerosing foam in the treatment of varicose veins.
      EVLA was temporarily stopped 2–4 cm proximal to the targeted tributary vein (TV). The tip of the introducer sheath was placed 1–2 cm proximal to the targeted TV. Then, sclerosing foam was injected via the side port while compressing the GSV above the targeted TV (Fig. 1A). After injecting the sclerosant, EVLA was restarted. Ultrasound was used to check that the sclerosant was in the targeted TV. If needed, sclerosing foam was injected into the next target by a similar method (Fig. 1B). When the targeted TV was located below the insertion site, sclerosing foam was injected just before removing the sheath. The maximum dose was 2 mL of 1% polidocanol with 4–6 mL air. After the procedure, patients were encouraged to wear compression stockings during the first 24 hours and advised to continue wearing them for one month but only during the daytime.
      Figure 1
      Figure 1(A) EVLA temporarily stopped at 2–4 cm proximal to targeted TV (red line; EVLA site). Simultaneously, the tip of the sheath was placed 1–2 cm proximal to targeted TV. Then, sclerosing foam was injected via the side port (green arrow). (B) Sclerosing foam was injected into the next target by a similar method.

      Assessment of outcome

      Before the procedure, VCSS were recorded. A post-interventional check up took place one day, one month, and three months after the procedure. Patients were asked about their recovery status and complications. Also, persistent varicosities, DVT, and endovenous heat induced thrombosis were checked for visually and by ultrasound. Finally, after three months, VCSS were recorded.

      Statistical analysis

      Continuous variables were presented as mean ± standard deviation. Categorical variables were presented as numbers (percentages). Student's t-test was used to test for between group differences in independent continuous parametric and non-parametric variables. Chi-square test was used to test for differences between categorical variables. Logistic regression analysis was conducted to identify the predictors of improved VCSS. Candidate predictors were selected based on clinical importance and special interests associated with EVLA.

      RESULTS

      There were no significant differences between the groups in the baseline patient characteristics (Table 1). EVLA was technically successful in all cases. No major complications were observed during follow up. Thrombophlebitis was observed in two patients in the SCL group (p = .13). Additional second stage sclerotherapy was required significantly more often in the Control group (n = 33, 66%) than the SCL group (n = 2, 3%; p < .0001).
      Table 1Results.
      Variable, n (%)ControlSCLp value
      n=50 (44%)n=63 (56%)
      Age, years66±1267±12.64
      Gender (female)34 (68%)40 (63%).62
      CEAP classification
      C210 (20%)7 (11%)
      C32 (4%)4 (6%)
      C4a26 (52%)41 (65%)
      C4b6 (12%)6 (10%)
      C54 (8%)5 (8%)
      C62 (4%)0 (0%)
      All patients: Etiologic classification, Primary (Ep); Anatomic classification, Superficial (As); Pathophisiologic classification, Reflux (Pr)
      EVLA procedure
      Target GSV (left/right)21/2931/32
      Target GSV diameter, mm7.9±1.98.0±1.2.76
      Procedure success50 (100%)63 (100%)
      Ablation length, cm42±941±7.59
      Total laser energy, J1322±5221276±316.57
      LEED, J/cm31±1231±5.79
      Major complications0 (0%)0 (0%)
      Thrombophlebitis0 (0%)2 (3%).12
      Additional sclerotherapy33 (66%)2 (3%)<.0001
      Assessment of VCSS
      Pre-procedure VCSS10.4±2.711.2±2.3.07
      Post-procedure VCSS7.1±3.56.8±2.5.63
      Changes in VCSS (Post-Pre value)−3.3±1.7−4.4±1.0<.0001
      Data are presented as mean ± standard deviation (SD) or number of patients (%). CEAP = Clinical-Etiology-Anatomy-Pathophysiology; EVLA = endovenous laser ablation; GSV = great saphenous vein; LEED = linear endovenous energy density; VCSS = venous clinical severity score.
      There was no significant difference in the pre-procedure VCSS between the groups (10.4 ± 2.7 vs. 11.2 ± 2.3, p = .07). Changes in VCSS (post-pre values) were significantly larger in the SCL group vs. the Control group (−3.3 ± 1.7 vs. −4.4 ± 1.0, p < .0001) (Table 1).
      Univariable (p < .0001) and multivariable [HR = −0.96 (95% CI; −1.4 – −0.58), p < .0001] analyses revealed that TLFS was the only significant factor for improved VCSS (Table 2).
      Table 2Univariable and multivariable predictors affecting the changes of VCSS.
      VariableUnivariateMultivariatep value
      p valueHR (95% CI)
      Age.36NA
      Gender (female).33NA
      CEAP classification.25NA
      TLFS<.0001−0.96 (−1.4 to −0.58)<.0001
      LEED.16NA
      CEAP = Clinical-Etiology-Anatomy-Pathophysiology; CI = confidence interval; HR = hazard ratio; LEED = linear endovenous energy density; TLFS = transluminal injection of foam sclerotherapy; VCSS = venous clinical severity score.

      DISCUSSION

      It remains undefined whether EVLA alone is better than EVLA+SA/UFS. A previous study reported that combined EVLA plus phlebectomy improved clinical outcomes and reduced the need for further procedures.
      • Lane T.R.
      • Kelleher D.
      • Shepherd A.C.
      • Franklin I.J.
      • Davies A.H.
      Ambulatory varicosity avulsion later or synchronized (AVULS): a randomized clinical trial.
      On the other hand, several investigators have also claimed that concomitant phlebectomy could be omitted because EVLA improved the symptoms.
      • Schanzer H.
      Endovenous ablation plus microphlebectomy/sclerotherapy for the treatment of varicose veins: single or two-stage procedure?.
      Because of the use of conventional hooks, only superficial varicose veins near the incision site could be avulsed. Numerous additional incisions would be needed to remove all the varicosities. The number of stab wounds tends to increase once the vein is torn and retracts under the skin, as it becomes difficult to re-grasp and a new incision is often required. There are some complications that are directly related to SA, such as bleeding, nerve damage, and infection. Therefore, many patients could avoid unnecessary scars, extra pain as a result of phlebectomy, and complications by undergoing TLFS. If phlebectomy is still needed after TLFS, this often allows for a smaller second stage procedure.
      UFS+EVLA is also widely performed and is less invasive and more acceptable not only to patients but also to the operator. Wang et al. demonstrated that simultaneous tributary UFS with truncal EVLA is a promising, feasible, and safe treatment approach vs. tributary EVLA with truncal EVLA.
      • Wang J.C.
      • Li Y.
      • Li G.Y.
      • Xiao Y.
      • Li W.M.
      • Ma Q.
      • et al.
      A comparison of concomitant tributary laser ablation and foam sclerotherapy in patients undergoing truncal endovenous laser ablation for lower limb varicose veins.
      Theivacumar et al. showed that EVLA down as far as the lowest point of GSV reflux also resulted in shrinkage of the majority of varicose veins, making delayed sclerotherapy unnecessary.
      • Theivacumar N.S.
      • Dellagrammaticas D.
      • Mavor A.I.
      • Gough M.J.
      Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial.
      However, previous clinical studies have not fully reviewed TLFS. For TLFS, an adequate length of sheath must be selected according to the location of the targeted TV.
      • Cavezzi A.
      • Labropoulos N.
      • Partsch H.
      • Ricci S.
      • Caggiati A.
      • Myers K.
      • et al.
      Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs-UIP consensus document. Part II. Anatomy.
      In the present study, ultrasound checks were made to see whether the sclerosant stayed in the vein. The method was based on the goal that the sclerosant should fill into the distal end of the targeted vein. Interestingly, there were few complications related to foam sclerotherapy. Thrombophlebitis was observed in only two patients, as the total sclerosant volume was relatively small.
      This study has several limitations: it was (1) prospective but not randomised and controlled, (2) limited by its single centre design and relatively small number of patients, and (3) long term follow up is needed for further studies.
      TLFS+EVLA may be an easy, safe, and effective procedure, with acceptable complications vs. EVLA alone and may also reduce additional second stage interventions.

      CONFLICT OF INTEREST

      None.

      FUNDING

      None.

      References

        • Theivacumar N.S.
        • Dellagrammaticas D.
        • Mavor A.I.
        • Gough M.J.
        Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial.
        J Vasc Surg. 2008; 48: 173-178
        • Tessari L.
        • Cavezzi A.
        • Frullini A.
        Preliminary experience with a new sclerosing foam in the treatment of varicose veins.
        Dermatol Surg. 2001; 27: 58-60
        • Lane T.R.
        • Kelleher D.
        • Shepherd A.C.
        • Franklin I.J.
        • Davies A.H.
        Ambulatory varicosity avulsion later or synchronized (AVULS): a randomized clinical trial.
        Ann Surg. 2015; 261: 654-661
        • Schanzer H.
        Endovenous ablation plus microphlebectomy/sclerotherapy for the treatment of varicose veins: single or two-stage procedure?.
        Vasc Endovasc Surg. 2010; 44: 545-549
        • Wang J.C.
        • Li Y.
        • Li G.Y.
        • Xiao Y.
        • Li W.M.
        • Ma Q.
        • et al.
        A comparison of concomitant tributary laser ablation and foam sclerotherapy in patients undergoing truncal endovenous laser ablation for lower limb varicose veins.
        J Vasc Interv Radiol. 2018; 29: 781-789
        • Cavezzi A.
        • Labropoulos N.
        • Partsch H.
        • Ricci S.
        • Caggiati A.
        • Myers K.
        • et al.
        Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs-UIP consensus document. Part II. Anatomy.
        Eur J Vasc Endovasc Surg. 2006; 31: 288-299

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