Introduction

There are two main groups of methods for the treatment of lower extremity varicosities: endothermal techniques, comprising laser, radiofrequency and steam ablations, and non-thermal methods, comprising liquid and foam sclerotherapy, mechanical occlusion chemically assisted endovenous ablation and endovenous application of the cyanoacrylate glue [1–4]. At the moment, thermal methods are preferred, considering more clinical data on their long-term efficacy. Still it is known that these procedures can be complicated by an injury to the adjacent nerves [5–7]. It is also known that chemical ablations, primarily foam sclerotherapy, are less efficient in comparison with thermal methods. Closure of varicose veins with the cyanoacrylate glue is a relatively new method. Although it has been demonstrated that such treatments are safe and efficient [8–15], data regarding its use concern small and medium-sized varicosities. Published evidence on the use of glue ablation for large varicosities is quite scarce. This retrospective analysis presents results of the treatment for large varicose veins with the use of a hybrid technique: the cyanoacrylate glue injection and foam sclerotherapy, during the same procedure, using the sandwich technique [16–18].

Material and methods

It is a retrospective analysis of the results of treatment for large varicose veins with the use of a novel technique: the cyanoacrylate glue injection combined with foam sclerotherapy, using the sandwich technique. This method was used for the treatment of varicose veins if an incompetent interfascial segment was wider than 6 mm, thus unsuitable for standard foam sclerotherapy, due to the high risk of failed closure or recurrence. This hybrid method allows for substantial reduction of the amount of glue needed for the vein closure, and minimizes the risk of granuloma formation and other allergic reaction related to the epifascial administration of cyanoacrylate. Technical details of the procedure have been described in our previous paper [18]. In brief, after mapping the incompetent superficial veins, the cyanoacrylate glue (Venex, Vesta Medical Devices, Ankara, Turkey) was injected in the area 2–4 cm distally from the saphenofemoral junction and in the most critical locations, like the dilatations of the saphenous vein or connection of the interfascial segment of the incompetent saphenous vein with an epifascial dilatated tributary. The glue was administered from a 1 ml tuberculin syringe in small drops, 0.1–0.2 ml each, under ultrasound control (8–11 MHz linear probe), through the direct puncture, using a 25G (0.50 mm) needle. Maximal volume of the glue administered during the procedure was 1.0 ml. Remaining unclosed segments of the target vein and epifascially located varicosities were managed with foam sclerotherapy. For this purpose we used 1–3% polidocanol (Aethoxysklerol, Kreussler Pharma, Wiesbaden, Germany) mixed with room air in a 1 : 4 ratio, using the standard Tessari method to obtain the sclerosing foam. Foam was firstly administered in 0.5–1.0 ml boluses between previously injected drops of the cyanoacrylate glue. All foam injections were performed under ultrasound control, using a 26G (0.40 mm) needle.

Here, early results of this particular ablation procedure for the closure of large varicose veins are presented. We have performed the closure of varicose veins using the aforementioned hybrid approach in 125 patients. Out of them, 17 (13.6%) presented with large varicose veins, which was defined as the presence of an enlarged interfascial segment of the incompetent saphenous vein (the great saphenous vein, the small saphenous vein or the anterior accessory saphenous vein), which in the standing position was 15 mm or wider. In this group, there were 15 female and 2 male patients. The maximum diameter of the target veins revealed by ultrasound in this patient series varied 15–20 mm, median 18 mm. In this group there were 13 large great saphenous veins and 4 large anterior accessory saphenous veins. There were 8 large varicose veins of the right lower extremity, and 9 on the left side. In 2 patients there was also another incompetent interfascial vein, which also required ablation. One patient presented with a large great saphenous vein and a smaller incompetent small saphenous veins, and the other presented with a large anterior accessory saphenous vein and a smaller incompetent great saphenous vein. In this group of patients presenting with large varicose veins, the volume of injected glue was 0.8–1.0 ml. Depending on the diameter and topography of incompetent superficial veins, foam sclerotherapy was performed using either 2% or 3% polidocanol; maximum volume of the sclerosing foam was 10 ml.

For the closure of these large varicosities, the above-described sandwich technique was modified in order to facilitate complete ablation. After injection of the glue in the proximity of the saphenofemoral junction, foam sclerotherapy of below-the-knee varicosities was performed, an elastic bandage was put on the lower leg. Thereafter, the closure of incompetent superficial veins located above the knee was completed. This strategy was adopted from the hemodynamic surgical procedures, particularly from the CHIVA-2 method. The whole treatment for large varicose veins using this modified sandwich technique can be divided into 4 consecutive steps:

1. Deposition of the glue in the proximity of the saphenofemoral junction (or the junction of the anterior accessory saphenous vein with the femoral vein, for the incompetent anterior accessory saphenous vein), which reduces inflow to the incompetent saphenous vein from the femoral vein;
2. Sclerotherapy of incompetent below-the-knee varicosities, followed by external compression of the lower leg by an elastic bandage, which reduces inflow to the incompetent saphenous vein from the periphery;
3. After these two steps, the femoral part of the incompetent saphenous vein usually shrinks, which is visible in ultrasound (of note, it may take some minutes until such a shrinking begins);
4. Complete closure of the shrunken femoral segment of the incompetent saphenous vein, with the glue and/or sclerosing foam.

Results

In all 17 patients presenting with large varicosities, the procedure was uneventful. There were neither acute glue-associated allergic reactions, severe pain associated with the punctures, bleeding, nor other intraprocedural adverse events. Similarly, there were no complications associated with foam sclerotherapy, including the neurologic sequelae. Immediately after the procedure all target interfascial veins were contracted, filled with the glue and/or
sclerosing foam. Deep veins of the managed extremity were patent, with no signs of thrombosis or protrusion of the glue into them. The technical success rate, defined as a complete closure of the target veins immediately after the procedure, revealed by ultrasound, was 100%.

All 17 patients showed at the follow-up visit, which was scheduled 2–3 weeks after the procedure. During the first follow-up visit, in all these patients ultrasound examination did not reveal deep vein thrombosis, a protrusion of injected glue into the deep veins, or other procedure-related complications. Patients did not report any serious adverse events occurring between the procedure and the first post-procedural follow-up visit, except for mild or moderate pain at the site of the managed veins, which was controllable with mild analgesics. There was neither severe phlebitis associated with sclerotherapy, nor inflammatory skin reactions suggesting hypersensitivity to the injected cyanoacrylate. In 15 cases at the first post-procedural follow-up visit, the target interfascial veins were completely closed. Thus, the primary success rate was 88.2%. The remaining two patients underwent additional closures of patent venous segments: one patient was managed with an additional cyanoacrylate glue injection, and one with foam sclerotherapy. At the second follow-up visit, all these patients had their target veins completely closed – the assisted primary success rate was 100%. In 3 patients (17.6%) an additional foam sclerotherapy of the remaining epifascial varicosities was performed. There were no serious adverse events related to these complementary procedures.

Discussion

Although chemical ablation of varicose veins can be efficiently done with cyanoacrylate glue, even if the incompetent saphenous vein is as large as 20 mm, this technique is rather recommended for the treatment of smaller varicosities, and most clinical trials included patients presenting with varicose veins of 4–14 mm in diameter [4, 19–23]. It is generally considered that the treatments for large diameter incompetent veins are associated with a higher rate of recurrence. This problem is also seen after thermal methods. Besides, ablation of a large-diameter incompetent vein requires quite a lot of glue, which, at least theoretically, may be associated with a higher risk of glue-related allergic reactions and other adverse events [24–26]. Moreover, a higher cost associated with an additional volume of the glue cannot be neglected. During thermal ablations of large-diameter incompetent venous segments, these veins can be compressed by an injected tumescent anesthetic fluid, which facilitates their effective closure.

However, in a case of chemical ablation there is no need for anesthesia. Theoretically, a tumescent anesthetic fluid could also be applied, even in patients managed with chemical methods. Yet, the sandwich technique, which was used in this patient series, requires precise injections of small droplets of the glue through direct punctures in the desired locations. Unlike glue ablation through a catheter, prior injection of the tumescent anesthetic fluid would make such precise injections challenging or even impossible. Hence, the hemodynamic approach aimed at shrinking the target vein was used, instead of an external compression by the injected fluid.

This patient series demonstrates that even in a case of large varicosities, hybrid chemical ablation of varicose veins using the sandwich technique can be safe and efficient. Early primary and assisted primary success rates were similar to those of smaller varicosities [18]. Moreover, a hemodynamic approach allows for reduction of the glue volume used. It was possible to ablate even large incompetent saphenous veins using such a small amount of glue as 1 ml maximum. Although an association between glue volume and adverse events is rather based on expert opinions, it is generally accepted that a risk of serious adverse events following cyanoacrylate glue treatments is primarily related to large volumes of injected glue, an extravasal injection of the cyanoacrylate, and glue embolization of the epifascial varicose veins. Of course, known hypersensitivity to cyanoacrylate is the obvious contraindication to such a chemical ablation, still in clinical settings it is rarely the case. Using the above-presented technique, a risk of all these complications could be minimized, since the glue volume was small and the epifascial incompetent veins were closed with foam sclerotherapy instead of cyanoacrylate.

Limitations

There are some limitations of this study that should be acknowledged. It was a retrospective survey of the patient series. Also, early results of the treatments were assessed, therefore a prospective study would be required to assess the long-term results of this procedure.

Conclusions

The treatment for varicose veins, using the sandwich technique, which combines the cyanoacrylate glue injection and foam sclerotherapy, can be safe and efficient, even if the varicosities are very large.

Disclosures

1. Institutional review board statement: Not applicable.
2. Assistance with the article: None.
3. Financial support and sponsorship: None.
4. Conflicts of interest: None.

References