4 Efficacy

4 Efficacy

This section describes efficacy 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.

4.1 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±16.0 mm and 24.4±18.0 mm 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±16.0 mm and 27.0±15.0 mm respectively (p=0.16). At 3 days after the procedure, mean pain scores were 6.2±9.2 mm and 20.5±25.5 mm respectively (p=0.004) and the mean postoperative pain scores per day over the first 14 postoperative days were 4.8±9.7 mm and 18.6±17.0 mm 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 1, 5 and 6 respectively (p<0.01).

4.2 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 1‑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 6‑, 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 1‑year follow‑up.

4.3 In the RCT of 117 patients treated by mechanochemical ablation or radiofrequency ablation, similar venous clinical severity scores (VCSS) were reported in the 2 groups at 1‑month follow‑up (2.12 and 2.96 respectively, p=0.22, compared with 6.5 and 5.6 respectively at baseline, p=0.086). In the non‑randomised comparative study of 68 patients treated by mechanochemical ablation or radiofrequency ablation, there were statistically significant improvements in VCSS from baseline in both treatment groups at 6‑week follow‑up (from 3.0 to 1.0 and from 4.0 to 3.0 respectively, p<0.001 for both groups). In the case series of 92 patients (106 legs), median VCSS improved from 4.0 at baseline to 1.0 at 1‑year follow‑up (p<0.001).

4.4 In the RCT of 117 patients treated by mechanochemical ablation or radiofrequency ablation, there were improvements in the Aberdeen Varicose Vein Questionnaire (AVVQ) in both groups at 1‑month follow‑up (12.7 and 15.5 respectively, p=0.41, compared with 22.6 and 22.7 respectively at baseline, p=0.97). In the non‑randomised comparative study of 68 patients treated by mechanochemical ablation or radiofrequency ablation, there were statistically significant improvements in AVVQ scores from baseline in both treatment groups at 6‑week follow‑up (from 7.1 to 5.0, p=0.006, and from 9.5 to 4.5, p=0.002 respectively). In the case series of 92 patients (106 legs), median AVVQ improved from 11.1 at baseline to 2.4 at 1‑year follow‑up (p<0.001). In the case series of 50 patients, median patient satisfaction score (scale 0–10) was 8 (interquartile range, 8–9) at 6‑week follow‑up.

4.5 In the RCT of 117 patients treated by mechanochemical ablation or radiofrequency ablation, the mean times to return to usual activities were 3.5 days and 4.8 days respectively (p=0.235). In the case series of 92 patients (106 legs), the median time to return to usual activities was 1.0 day (interquartile range, 0.0–1.0).

4.6 The specialist advisers listed the following key efficacy outcomes: successful closure, ideally after 1‑year minimum follow‑up; quality of life (specific and generic); postoperative pain; and resolution of symptoms relating to venous incompetence.

4.7 Thirty commentaries from patients who had experience of this procedure were received, which were discussed by the committee.

  • National Institute for Health and Care Excellence (NICE)