The early results obtained using this new minimally invasive technique that uses both coil embolization and foam as a sclerosing agent were published in the journal Phlebology in December 2014. The study shows that the technique, which associates a mechanical interruption of the sapheno-femoral junction to classic sclerotherapy with no need for surgery or anaesthesia, is effective, nearly painless and appears cost-effective in a small group of patients with short follow-up.
As reported in the journal, the amount of foam used is similar to scleroembolization, but the passage of foam in the femoral vein during its injection is considerably reduced, due to the coil positioned previously. The technique allows an immediate closure of the saphenous vein trunk.
Marco P Viani, Vascular Surgery Unit, Azienda Ospedaliera Fatebenefratelli, Milan, Italy and colleagues reported the results obtained with nine patients (two women, seven men; mean age 63.5 years). While six patients presented with simple varicose veins, the other three presented with healed venous ulcers.
The technique first uses echocardiography in order to identify the sapheno-femoral junction. For five patients, the physicians inserted a straight 5F catheter (Boston Scientific) at the knee in the great saphenous vein shaft using a 5F introducer. In the other four patients, the great saphenous vein was isolated at the knee and the 5F catheter was inserted into the vein shaft without using an introducer. The next step involved placement of a standard platinum coil (0.035” fibered platinum coil, Boston Scientific) 1mm wider than the calibre of sapheno-femoral junction in standing position, under echographic control. The coil was placed 1cm below the origin of the epigastric vein, and caused the prompt occlusion of the terminal portion of the great saphenous vein, according to the authors. The last step of the single-session procedure involved scleroembolisation of the great saphenous vein with lauromacrogol 2% foam carried out through the 5-French catheter under echographic control.
Viani, the inventor of the technique, told Interventional News:”The rationale behind this new technique is analogous to radiofrequency ablation or foam sclerotherapy, which are routinely used by our group. The mechanical interruption of the saphenous shaft improves the results of simple scleroembolisation, thus abolishing venous reflux. The technique might prove useful because it reproduces a surgical vein ligation with no need of surgical incision and anaesthesia. Nevertheless, further studies are necessary to demonstrate the effectiveness and real advantages of one shot scleroembolization. Right now, we are trying to modify the technique by optimising the mechanical interruption of the saphenous shaft, avoiding the use of a coil.”
The researchers note that this technique allows for the treatment of varicose veins without surgery and general, spinal or tumescent anaesthesia. “Only a small amount of local anaesthetic is needed to allow the positioning of the 5-French introducer or the surgical isolation of the great saphenous vein at the knee,” they report in the paper.
The researchers compressed the patients’ legs at the end of the procedure with an elastic bandage and all patients were discharged after a short medical observation (mean time 5h). They also recommended a 30-minute walking restriction post-procedure.
“Postoperative compression was maintained until the following day. Afterwards, the patient was instructed to wear compression stockings with a class I pressure gradient (20–30 mmHg) for 15 days. All patients underwent echographic control one day, seven days, one month and three months after the procedure,” the authors wrote.
Viani et al reported that occlusion of the great saphenous vein trunk was immediately obtained in all patients. The procedure was almost painless, the only pain being due to the local anaesthesia to allow access to the vein. The symptoms of varicose vein disease were resolved in every patient. At the end of the procedure all patients improved their condition. There were also no perioperative complications observed.
They further reported that the mean follow-up was three months and at this time point, complete occlusion of the great saphenous vein was maintained in eight out of nine cases. There was a recanalisation of the saphenous shaft in one patient one week after treatment and this was successfully treated with a foam injection. There were no instances of coil migration or compression of the common femoral vein at three months follow-up using ultrasonography. The follow-up also included an echographic evaluation of the deep venous system and no deep vein thromboses were observed.
Viani et al write that the costs are significantly lower with one-shot scleroembolization when compared to other endoluminal techniques, such as radiofrequency, laser ablation or other minimally invasive mechanical treatments, the mean cost of a coil being US$120.