Cyanoacrylate adhesive embolization using the VenaSeal Sapheon Closure System (Venaseal) of the incompetent great saphenous veins offers several advantages over endothermal ablation including not requiring tumescent anasthaesia and use of compression stockings after the intervention. Endothermal ablation can also cause paresthesia in 5–10% of patients.
A European multicentre study has shown that transcatheter endovenous cyanoacrylate embolization for closure of insufficient great saphenous veins has proved feasible, safe and effective without the use of sedation, tumescent anesthesia or compression stockings at one year. The study was presented at the European Venous Forum (26–28 June, Paris, France).
“The side-effects seen with the procedure were mild and in particular, paresthesia was not observed,” said Thomas Proebstle, Department of Dermatology, University of Mainz, Germany, lead author of the study.
The prospective, multicentre cohort study was conducted in seven European centres (Germany, UK, Denmark and The Netherlands) from December 2011 to July 2012. Seventy patients with incompetent great saphenous veins received endovenous embolization with a unique endovenous cyanoacrylate adhesive implant. Varicose tributaries remained untreated for three months. The investigators carried out duplex ultrasound and clinical examination at two days and after one, three and six months, which was the primary endpoint of the study.
Proebstle and colleagues treated 70 incompetent great saphenous veins and followed the patients up for six months. At the second day follow-up, 69 of 70 patients (98.6%) showed complete occlusion. Partial recanalisations were observed at three months in two more cases and in one additional case at six months follow-up. Life-table occlusion rates were 98.6% at the second day follow-up, 95.7% at three months and 94.3 % at six months. Standard error was below 0.028 at all times.
Speaking on the complications that occurred, Proebstle said: “Phlebitis occurred in six cases (8.7%), five of whom received non-steroidal anti-inflammatory drugs for an average of seven days, and no serious adverse events were observed. Average Venous Clinical Severity Score (VCSS) improved from 4.3+/-0.3 at baseline to 1.3+/-0.16 at six months follow-up.
Another study reported at the European Venous Forum, by Nick Morrison from the Morrison Vein Institute, Scottsdale, USA, showed that cyanoacrylate embolization as compared to radiofrequency ablation demonstrates similar closure at three months (non-inferiority p-value <0.0001). VCSS scores were significantly improved in both groups, indicating the expected clinical response to treatment.
Morrison was reporting the results of a randomised, controlled, non-inferiority study comparing the safety and efficacy of cyanoacrylate adhesive embolization to radiofrequency ablation for closure of incompetent great saphenous veins.
“From March 2013 to September 2013, 222 patients with symptomatic great saphenous veins reflux at 10 US clinical sites were randomly assigned to treatment with either cyanoacrylate adhesive embolization using the VenaSeal Sapheon Closure System or radiofrequency ablation with the ClosureFast System (Covidien). “Follow-up visits were arranged on the third day after the procedure, and at one and three months. Adjunctive procedures were not allowed until after the three-month visit,” Morrison said.
The primary efficacy endpoint was complete closure of the symptomatic great saphenous veins at three months as measured by Doppler ultrasound and assessed by an independent core laboratory. The investigator at each site recorded CEAP classification at screening and three-month follow-up and VCSS at baseline, day three, and one and three months. Pre-specified procedure-related adverse events and patient-reported adverse events were recorded.
The great saphenous vein closure results as judged by each site investigator were reported. “Final data will be assessed by independent vascular ultrasound core laboratory,” Morrison clarified. There were 108 veins that were embolized. At one month 105 were evaluated and 100% showed complete closure (complete vein closure was defined as closure along the entire treated vein segment with no patency >5cm). At three months, 104 patients were evaluated and 103 (99%) were completely closed. In the group that received radiofrequency ablation, 114 veins were treated. At one month, 109 were evaluated and 94 showed complete closure (86.2%). At three months, 108 patients were evaluated and 103 (95.4%) showed completely closed. In both instances the non-inferiority p value (hypothesis 10%) was <0.0001. The VCSS was not significantly different for both groups at all the time points during follow-up. The incidence of procedure-related adverse events and other adverse events throughout the study was similar between groups.