Most recent update: Sunday, April 29, 2018 - 14:56

You are here

NICE approves endovenous mechanochemical ablation

Printer-friendly version

The National Institute for Health and Care Excellence (NICE) has issued approval via Interventional Procedure Guidance IPG557 for endovenous mechanochemical ablation for the treatment of varicose veins in the United Kingdom.  The NICE guidelines provide evidence-based guidance and advice on a range of health topics and conditions. This move places endovenous mechanochemical ablation on standard arrangements for the treatment of varicose veins.

In its updated guidance, published May 2016, NICE Guidance reported: “Current evidence on the safety and efficacy of endovenous mechanochemical ablation for varicose veins appears adequate to support the use of this procedure, provided that standard arrangements are in place for consent, audit, and clinical governance.”

A NICE guideline describes recommendations for the diagnosis and management of varicose veins. Many people have varicose veins that do not cause any symptoms or need treatment on medical grounds. However, some people will need treatment for the relief of symptoms or if there is evidence of skin discoloration, inflammation or ulceration. Treatment options include endothermal ablation, ultrasound-guided foam sclerotherapy and surgery (usually stripping and ligation of the great and small saphenous veins, and phlebectomies).

Endovenous mechanochemical ablation for varicose veins combines mechanical ablation with the use of sclerosing agents to close veins without the need for tumescent anaesthesia (infusion of a large volume of dilute local anaesthetic around and along the entire length of vein to be treated).

The procedure is carried out using local anaesthesia at the catheter insertion site. Ultrasound imaging is used to identify the target vein, its diameter and the length of the section of vein to be treated. An infusion catheter with a motor drive is introduced percutaneously into the distal end of the target vein and, in the case of the great saphenous vein, the catheter tip is advanced to the saphenofemoral junction. A dispersion wire that extends through the catheter lumen is rotated to damage the epithelium and a sclerosant is infused simultaneously as the catheter is slowly pulled back through the vein. Patients are advised to wear compression stockings for about two weeks after the procedure.

The NICE approval found that in a randomised controlled trial (RCT) of 117 patients with great or small saphenous vein incompetence treated by mechanochemical ablation or radiofrequency ablation, mean pain scores (measured on a visual analogue scale, 0–100) during the procedure were 13.4±16.0mm and 24.4±18.0mm respectively (p=0.001). In a non-randomised comparative study of 68 patients with great saphenous vein incompetence treated by mechanochemical ablation or radiofrequency ablation, mean pain scores (measured on a visual analogue scale, 0–100) during the procedure were 22.0±16.0mm and 27.0±15.0mm respectively (p=0.16).

At three days after the procedure, mean pain scores were 6.2±9.2mm and 20.5±25.5mm respectively (p=0.004) and the mean postoperative pain scores per day over the first 14 postoperative days were 4.8±9.7mm and 18.6±17.0mm respectively (p<0.001). In a non-randomised comparative study of 147 patients treated by mechanochemical ablation, radiofrequency ablation or endovenous laser therapy, median pain scores (measured on a visual analogue scale) during the procedure were one, five and six respectively (p<0.01).

In the RCT of 117 patients treated by mechanochemical ablation or radiofrequency ablation, complete occlusion rates were 83% and 92% (absolute numbers not reported) respectively at 1‑month follow‑up (p=0.79). In a case series of 449 patients (570 veins), occlusion rates were 89% for the great saphenous vein and 81% for the small saphenous vein (absolute numbers not reported) at 3‑month follow‑up. In a case series of 92 patients (106 legs) with great saphenous vein insufficiency, 88% (90/102) of veins treated were obliterated at one-year follow‑up. In a case series of 63 patients (73 treated legs), occlusion rates were 94% (68/72), 95% (61/64) and 95% (40/42) at six, 12 and 24-month follow-up respectively. In a case series of 50 patients with small saphenous vein insufficiency, the occlusion rate was 94% (44/47) at one year follow-up.

This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not identify any additional anecdotal adverse events. They considered that the following were theoretical adverse events: vein perforation, migraine, visual disturbance and stroke.

To access the NICE Guidance, please click here