Comment to: Great saphenous vein ablation with steam injection: results of a multicentre study by Milleret R, Huot L, Nicolini P, Creton D, Roux AS, Decullier E, Chapuis FR, Camelot G. Eur J Vasc Endovasc Surg 2013;45:391-6.
Stefano Ricci
Abstract
This open multicentre prospective cohort study carried out in four French centers report the obliteration rate of the great saphenous vein (GSV) in 75 patients treated using the steam vein sclerosis (SVS) system with high energy levels.
Inclusion criteria were reflux at the sapheno-femoral junction (SFJ) and/or from the sub-terminal valve of the GSV of more than 0.5 s, vein diameter of between 4 and 13 mm (measured 3 cm distal to the SFJ) and a CEAP from C2 to C5.
After pre-operative duplex ultrasound scan tumescent anesthesia was administered around the previously marked vein, in between the fascias, using a 21 gauge needle to inject a solution of 1.4% bicarbonate 500 mL, plus 20 mL 1% lidocaine with adrenaline. This was also performed in patients undergoing general anesthesia or loco-regional spinal anesthesia to provide a heat sink and protect the saphenous nerve.
Access to the GSV under the knee was made through surgical incision or echo-guided percutaneous puncture placing a 16 G infusion catheter. Then, a flexible stainless steel SVS catheter covered with Teflon and with a diameter of 1.2 mm was inserted through the infusion catheter to a level of 2 and 3 cm below the SFJ.
The SVS generator was calibrated to emit one pulse of steam with 60 J of energy every 1.8 s. The steam temperature delivered at the tip was 120°C. Two (for up to 7 mm) or three (for over 7 mm) or four (for large trunks over 12 mm) pulses were emitted for every cm of vein treated with the catheter stationary. Post-operative treatment consisted of 2 weeks of compression by class II stockings worn during the day and pain-killers (ibuprofen) at the patient’s discretion. Patients were then followed up at 1, 6 and 12 months with clinical examination, duplex ultrasound scanning, quality of life and safety assessments. A total of 75 patients (88 limbs-13 bilateral) underwent surgery with a median treatment time of 35 min (range 12-85) including patient preparation time; the median length of vein treated was 42 cm (range 15-57 cm). At 6-month visit the obliteration rate was 96% [95% CI: 89-99] at 12 months was 92% [95% CI: 83-97]. Vein diameter improved at 6 months from a median of 8 mm (range: 4-12 mm) to 1 mm (range: 0-9 mm) at mid-thigh. There were no adverse events either during or after the surgical procedure. The majority of adverse events occurred by day 8, the most common being ecchymosis at the entry site and pain in seven patients. At 1 month, inflammation of the venous pathway occurred in two patients and hypoesthesia in one patient. One protrusion of thrombus in the femoral vein (less than 1 cm) occurred fully resolved in 8 days under treatment by low molecular weight heparin. An ongoing study is focused on the treatment of tributaries. This could be a significant improvement as it allows an all-in-one endovenous procedure.
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Comment by Stefano Ricci
Interesting preliminary results of another system other than laser, RF and chemical sclerotherapy to achieve saphenous stem closure. Twelve-month obliteration at 92% is comparable to the other heat based systems and better than sclerotherapy reports, probably with fewer adverse effects. The flexible nature of the steel catheter that not needs a guide wire is particularly interesting. When a new system is suggested to the medical community, its success is ligated to its advantage in relation to the already acquired methods, in particular if the same methods surprisingly obtain good results. In the case of SVS, as the obliteration results are similar to what achieved by other methods, only the possible lower cost would correspond to an advantage. It will be important to know something about. The possible good outcome on tributaries treatment for an all-in-one procedure, now in study, could represent another advantage over the alternatives in use, even if laser tributary treatment has been favorably indicated in a recent study by Myers et al.1
Reply by the Authors
Thank you for your interest.
Your review and comments are quite good, I agree with them.
As you suggested the main advantage of steam is the treatment of large tortuous varices, I plan to write a paper on this application for your journal during the quiet period in August.
References
1. Myers KA, Clough A, Tilli H. Endovenous laser ablation for major varicose tributaries. Phlebology 2013;28:180-3.[PubMed]
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