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Sandwich Laser Foam (SALF) an Easy Feasible Endoluminal Proposal of two Combined Methods por Treatment of Severe Dilated Saphenous Vein Incompetence

Cesar Carmelino MD1, Hugo Navas MD2 , Collaboration; Juan Flores MD1
Correspondence address; ccarmelino@hotmail.com, navashugo@gmail.com
1. VENOCENTRO-CLINICA MIRAFLORES; LIMA-PERU
2. HOSPITAL DE CLINICAS CARACAS-VENEZUELA

Abstract
Endoluminal laser and foam sclerotherapy each constitute excellent alternatives for the treatment of insufficient saphenous veins. Over the last decade, multiple studies have been published comparing different methods for endovascular ablation of the saphenous veins, including several meta-analysis, in which one may behold very solid, long-term occlusion rates with laser and lower rates with foam sclerotherapy.

It has been established that the results with laser are highly satisfactory with veins that measure less than 1 cm in diameter, at the saphenofemoral junction or at the saphenopopliteal; results show that the higher the diameter, the higher recanalization rates, and many groups prefer recurring to conventional saphenectomy, disconnection of the saphenofemoral or saphenopopliteal junction or by applying sclerotherapy or complementary laser for such complex cases.

We propose a new technique which combines the benefits of laser and foam Sandwich Ablation Laser Foam (SALF) in the same procedure, with more benefits and less complications, with high occlusion rates for saphenous veins measuring more than 1cm. Mainly for those which are highly dilated and hold the presence of aneurysmatic dilatations in its trunk, without having to significantly increase the amount of necessary energy to achieve an effective laser ablation, nor excessive quantities of sclerosant.

Introduction
Over the past 15 years, an important change has been developing in the search for the venous insufficiency treatment, through the quest of a less invasive and more effective surgery, with less complication rates and fewer long-term recurrences. Thus appearing thermal ablations through laser treatment, with Boné’s published papers1-3 and radiofrequency, more recently with water steam.

Chemical ablation through foam sclerotherapy and new methods developed in the past few years, such as cyanoacrylate 4,5 or the use of a catheter, allowing to damage the endothelium through rotation while performing liquid sclerotherapy (Clarivein ®), have been Non-Thermal ablation alternatives. These positive results have encouraged continuing research and innovation on procedures that will be each time less aggressive.

There have been many publications oriented toward thermal ablation and chemical ablation, however, these have always shown very similar results in all series and meta-analysis 6,7 exhibiting a superiority at length of thermal over chemical ablation treatments, due to its higher long-term recanalization. In addition, there is a certain consensus in order to choose alternatives for conventional procedures for saphenous vein removal, or by foam when the patient carries large dilatations in the saphenous vein, or when the proximal segments of saphenous veins are highly dilated. There is a consensus to choose stripping, disconnections followed by thermal or chemical ablation, or the use of foam as a sole treatment, with the inherent risks of lower rate, long-term occlusion.

In this sense, it can be observed in our work that patients recanalize with greater ease when the GSV or LSV is greatly dilated, or when dilated sectors are present, especially when they are near the entering of the deep venous system, (SFJ or SPJ) and when large tributaries are present. We believe that if we can combine the advantages that each method holds separately within the same procedure, we may be able to go beyond increasing the benefits, and achieve a rise in the success rate, as well as decrease long-term complications.

Inclusion Criteria
We have considered for this series patients diagnosed with chronic venous disease, with CEAP of 2 to 6, symptomatics, and ecographics findings of the saphenofemoral junction superior to 1 cm of diameter or saphenopopliteal junction superior to 0.8 cm. Also, presence of aneurysmatic dilatations in the saphenous vein trunk larger than 1 cm diameter without placing a limit to the dilatation of the SFJ or SPJ, neither in the saphenous trunk. In our series, the maximum diameter of the saphenofemoral junction reached has been 28 mm.

Model case in which it is opted for SALF combined technique
Table 1
Table 2

Operational Technique
Preparation and selection of the patient is always done with exhaustive clinical testing, evaluating arterial integrity, clinical background and CEAP classification, mapping is proceeded with ecodoppler color, deep venous system permeability is evidenced, escape points, reentry points, incompetent perforators veins, diameter of great or small saphenous vein in all its trunk. A particular emphasis is placed in determining these findings in order to include the patients in our series:
– Diameter of Saphenofemoral junction (SFJ) greater than 12 mm and saphenopopliteal junction (SPJ) superior to 0.8mm.
– Dilatations in the trunk of the great or small saphenous vein that exceed 1 cm.

When we observe in our patient these two aspects of dilatation in saphenous junctions and saphenous vein trunk, we proceed to decide the combined procedure (SALF). We carry out strict photographic documentation (mapping) through skin-marking of the patient standing and lying down, according to the eco-graphic report for areas of greater dilatations of the saphenous vein, with the aid at all time of the venoscope and the augmented reality visualization system (vein viewer®), in our office and at room temperature in order to avoid venous spasm.

Once the patient is in the OR, a routine takes place in all cases: cardiovascular monitoring, pulse oximetry and IV line. We then proceed to cannulate percutaneously under ultrasound control the dilated saphenous vein in the patellar region using the Seldinger technique; the tip of the laser fiber (radial) was positioned at 2 cm from SFJ or SFP. Most of the procedures were performed under local anesthesia (lidocaine) and endovenous sedation.

Laser 1470nm and radial emission fiber was used in all cases, starting with the thermal ablation in the proximal segment of saphenous vein, implementing a variable energy according to the case, starting with 8 watts and for a time varying from 5 to 15 seconds, observing the formation of intraluminal images that initially go in proximal direction and then change direction. Once we observe the formation of a white line, ultrasound examination of the closure and the draining of the epigastric vein were confirmed.

The energy implemented in this phase varies, depending on each patient’s ultrasound examination, we can observe varying values from 48 to 120 Joules/cm. Immediately after verifying the proximal occlusion, we continue the saphenous ablation for the following 3 to 5 centimeters of length, at which point we culminate the first part, leaving the fiber positioned in place. Verifying that there is no displacement during the following phase, and using the accessory way with 7 FR introducer, we aspire the blood and then injected 3 cc of 3% polidocanol FOAM in the GSV, or 3 cc of 1% polidocanol FOAM in the case of a SSV.

We can observe the passage of the foam, with a uniform and total diffusion in the saphenous vein trunk, witnessing a highly marked spasm in the entire vein and observing foam bubble being retained in a 5 centimeter of the SFJ or SPJ. We carry on with laser ablation of the saphenous vein in a continuous form with LEEDS measures of 30 to 40 Joules/centimeter. Lastly, we make the necessary ultrasound verifications and complete the procedure with the removal of the varicose vein cluster.

Results
In a period from December 2014 to October 2015 (10 months,) we have been operating on 36 patients with this SALF technique (30 cases carried out in Lima, 6 cases carried out in Caracas), corresponding to 49 inferior members that were operated under this technique (13 cases of bilateral procedures). 25 of the patients were female and 11 were male, all cases were performed under local anesthesia and endovenous sedation.

The average age of the patients was 56.8 years (ages ranged from 37-74 years). 28 were great saphenous veins (15 right, 13 left), and 11 were small saphenous veins (6 left, 5 right), as well as two anterior accessory saphenous veins that were also operated. The most frequent functional classification was CEAP 3 and 4 which both make up a 63% of the cases, 3 patients were operated in the functional stage of CEAP 6 (table 1 and 2)

The results from the six-month monitoring was 100% occlusion in all saphenous veins treated, we have not found recanalizations nor greater complications in the procedure to the present day. Tolerance has been adequate in all patients. Monitoring of patients has been carried out through at the first week and month ultrasound controls, in addition to the three months and six months following the operation; yearly control for long-term monitoring has been arranged to continue.

Table 3
Table 4

Discussion
Some years ago, a technique named LAFOS (Laser Assisted Foam Sclerotherapy), was introduced by Frullini and Fortuna 8 in which a Holmium YAG of 2100nn laser equipment is used to deliver a sort of coarctation of the saphenous vein, then proceeding to sclerosis with 3% polidocanol for the greater saphenous vein, and 2% for the smaller saphenous vein. What is striking about this is that according to the group, when the diameter of saphenous vein is reduced, it is done at the expense of the retraction of middle layer collagen, without damaging the endothelium.
For such, they use a maximum emission of 5 watts with fluence of 250 mili Joules and at 10 Joules per centimeter, with 10 short discharges per second in the form of micro-pulses; aiming to reduce the saphenous vein diameter to proceed to a more efficient application of the sclerosant, so that the reduction of the diameter will allow optimizing the effect of the latter (the main objective is to achieve a more effective sclerotherapy by reducing the caliber of the saphenous vein through the use of laser).

The main objective of the Frullini study was not ablation, but thermal reduction of the size of the saphenous vein in order to optimize sclerotherapy. In our work, we obtain the initial thermal ablation of the proximal saphenous vein followed by the potentiated and doubled ablation of the saphenous vein, with an increased effect by means of foam sclerosis and laser ablation, with fluences ranging from 30 to 40 Joules per centimeter.

Large aneurysmatic dilatation of Saphenofemoral junction perfectly occluded by SALF combined technique

This new combined technique that we set out is oriented toward the cases where there is much controversy in the appropriate therapeutic option, such as a great saphenous vein with a diameter superior to 1 centimeter, a saphenous vein with severe dilatations during its trunk, or the presence of venous aneurysms near the saphenofemoral or the saphenopopliteal junction; furthermore, fears of a recurrences or deep vein thrombosis have led many surgeons to perform a crossectomy.

We consider that the safety provided by an initial occlusion of the proximal and trunk of saphenous vein can ensure avoiding propagation of foam in the deep venous system. We can observe initially an intense spasm following the application of foam, however, the echogenic image shown after the application of the laser subsequent to the foam, shows a highly severe spasm with the formation of a very dense, white hyperechogenic line in the entire saphenous vein trunk; which is not usually visible in either method separately.

Certain benefits can be obtained from requiring a smaller quantity of energy. Just by finding a distinctly marked spasm in the saphenous vein trunk, its diameter is already decreased, thus allowing a better contact of the optic fiber with the venous walls, performing a faster laser ablation procedure with less demand of energy to destroy the endothelium, noting during the ablation a considerable resistance of the optic fiber in the saphenous vein during the discharge; additionally, we can observe fewer possibility of microperforation and ecchymosis. We diminish the risk of embolization of foam particles when a seal marking the junction of the saphenous vein through laser treatment is executed, for which reason we have not observed a single patient with adverse effects attributable to foam.

The presence of a perforator vein in the thigh would not constitute a contradiction in a strict sense, just as the foam technique for saphenous veins does not exclude it, due to the fact that the sclerosant has little passage to the deep system from an insufficient perforator vein, and the amount that could pass through is quickly diluted in the bloodstream. Moreover, the use of smaller amounts of sclerosant than the exclusively foam ablation, could diminish the risk of embolization and adverse effects.

Image of intraoperative surgery: moment of proximal post closure – previous to injecting foam

As to the recurrences, Brittenden 9 exhibits by comparing foam, stripping, and laser, similar six-month results with fewer complications in the group of laser treatment. Different types of complications have been reported, being deep vein thrombosis the most feared, followed by fistulas and aneurysm of the residual stump 10-13. As to the possibility of a recurrence, we can currently observe the perfect closure of all cases, without finding a re-canalization in this initial series of patients during monitoring period; all with severe saphenous veins pathology.

This makes us believe that the strengthened effect of combining two methods implemented with excellent results, will allow a lower relapse rate in comparison to the use of a single method. It is always a matter of controversy the best method for severely dilated saphenous veins, including SFJ flush ligation plus laser treatment, versus pure endovenous laser treatment. In a moderated and high fluence 14,15 better results are visible using a greater quantity of energy that go up to 150 Joules/cm.

We can observe the benefit regarding a greater spasm and occlusion of difficult and highly dilated areas, just by using foam it favors a total spasm of the vein, allowing it to reach areas of marked dilatations and aneurysms, in which usually there would be a possibility that the fiber will not get to make contact with the totality of the wall. In this way, foam succeeding to occupy the whole area, will produce an evident and immediate puncture of the occlusion.

As we continue with laser, we can see that the spasm is so marked that it practically wraps with the optic fiber. The heat generated by laser can possibly be strengthening the foam effect by the increase of foam temperature; although it has not yet been described, it may be possible that foam in a higher temperature will have a better effect, considering that we witnessed in the laser emission the formation of boiling bubbles, which would be incrementing foam temperature and perhaps incrementing its ability to cause endothelial injury.

We can see (table 3) by comparing the same patient, the amount of energy applied using Laser+Foam (SALF), in contrast with just Laser; they are quite similar, considering that the average saphenous vein ablated by laser has an exclusive, discrete tendency to receive greater amounts of energy, even though they are of a smaller diameter than those treated through the combined form.

When we take 10 random patients that have been treated by SALF with greatly dilated saphenous veins, and compare them with control cases made up of 10 patients treated with laser for insufficient saphenous veins without serious dilatations; we can see the energy applied is practically the same, which shows that highly dilated saphenous vein with the use of foam requires a lower quantity of energy in order to complete the procedure, independently from the greater aneurysmatic dilatations along the saphenous trunk (table 4.)

In conclusion, evolution is constant and has many options that could come up in the future 16-17. However, we believe the “SALF method” is effective, easy to deliver, and allows an excellent control of the procedure on physical and chemical ablation of the saphenous vein. Thus strengthening the effect, as well as permitting the treatment of more dilated, tortuous saphenous veins, or with aneurysms, while using less amount of energy, and possibly better long-term results than with other methods implemented in a single form. Long-term results could lay out the implementation of this method as an easy mechanism to address very complex cases, fulfilling results in the long run similar to those reported in simple saphenous vein pathology.

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