The Health Institute Carlos III (ISCIII) in Spain analyzed the effectiveness and safety of the endovenous ablation of varicose saphenous veins with cyanoacrylate closure system in patients with moderate to severe chronic venous insufficiency compared to surgical procedures, as of saphenous vein stripping, and other endovenous ablation techniques. In the report, published on the website in 2020, it was outlined that despite the limitations found in selected studies, intravenous sealing with cyanoacrylates seems to be a promising alternative to existing treatments, especially in terms of less use of anesthesia and compression bandage, as well as shorter recovery time.
The following outcomes were selected for the assessment: effectiveness, safety, length of the intervention, need for admission, use of anesthesia, compression bandage, and return time to work activity/recovery since the intervention. The systematic review of the scientific literature was performed to assess the effectiveness and safety of the technology. The assessment included 11 studies: a randomized controlled trial, a non-randomized controlled trial, and nine case series studies. The randomized controlled trial compares the Venaseal® closure system with radiofrequency ablation (RFA) and presents a moderate quality of evidence. The non-randomized controlled trial compares the cyanoacrylate systems VariClose® with endovenous laser ablation (EVLA) and presents a high risk of bias and low quality of evidence.
- There is no significant difference in the closure rate between the cyanoacrylate closure system (CAC) and RFA groups, or in CAC and EVLA after one year of follow-up. The occlusion rates were 96.8% and 95.8% in the CAC groups, 95.9% in the RFA group and 92.2% in the EVLA group;
- There is no significant difference in the recanalization-free survival rate. The rates were for CAC - 96.8% respect to 90.7% of the RFA group and 97.9% respect of 95% of the EVLA group;
- The improvement of the clinical severity score for CAC is similar to the improvement of this score for RFA and EVLA;
- Improvements were observed in the quality of life measured by EQ5D Scale after the intervention, with similar results for the CAC group and the RFA group. This variable was not measured in the study that compared CAC with EVLA. The quality of life, measured by the AVVQ scale, improved after the intervention in a similar degree with compared technologies (CAC, RFA, EVLA);
- No serious adverse effects and complications were observed in the compared techniques. Mild thrombosis and ecchymosis were significantly lower in the case of CAC versus RFA, as well as paresthesia and ecchymosis that were significantly lower for CAC versus EVLA;
- The mean time of intervention was significantly less for CAC than RFA or EVLA. The CAC does not require tumescent anesthesia, either compressive bandages after the intervention, against other types of interventions. The recovery time with the CAC intervention was one day, as with the time observed in EVLA.
- There is low evidence on the effectiveness and safety of endovenous cyanoacrylate closure system for chronic venous insufficiency;
- Concerning effectiveness, results are initially positive. The occlusion rate after CAC treatment is 97%, the recanalization rate is 4.5%, and the quality of life improves after the intervention in all patients. The mean time of intervention, the time to total recovery, the need for anesthesia and the need for compressive bandages are more favorable than in regular interventions for chronic venous insufficiency treatment;
- Regarding safety, the procedure has a low rate of deep vein thrombosis, cerebrovascular complications, or death. The adverse effects (phlebitis, ecchymosis, paraesthesia, pain, etc.) are similar or have lower rates than those of other reference treatments (EVLA, RFA or surgery);
- Despite the limitations found on selected studies, intravenous sealing with cyanoacrylates seems to be a promising alternative to existing treatments, especially in terms of less use of anesthesia and compression bandage, as well as a shorter recovery time;
- Randomized and controlled studies would be important in obtaining information on the quality of intravenous cyanoacrylate sealing. Finally, studies assessing effectiveness and safety for long-term follow-up are required, especially concerning occlusion rates and the absence of recanalization.
The full details in Spanish can be found here.
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