Comparison of two ablation procedures combined with high ligation and foam sclerotherapy and compression therapy for patients with venous leg ulcers

Figures & data

Figure 1. Flowchart detailing inclusion of study patients.

Table 1. Baseline Characteristics in the EMA+HL-FS-CT and EVLA+HL-FS-CT groups.

Mean ± SD or n (%)	EMA+HL-FS-CT (n = 134)	EVLA+HL-FS-CT （n = 167）	P-value
Limbs	146	183	NA
Gender			0.537^§
Male	73(54.5)	85(50.9)
Female	61(45.5)	82(49.1)
Age (y)	61.7 ± 8.9	60.5 ± 10.5	0.299*
Occupation			0.480^§
Manual worker	84 (62.7)	98 (58.7)
Mental worker	50 (37.3)	69 (41.3)
Course of varicose vein (y, IQR)	19.3(12.0–25.0)	20.2(12.0–30.0)	0.733^†
Ulcer duration (mo)	22.9 ± 68.1	26.0 ± 72.6	0.709*
Ulcer area (cm^2)	12.2 ± 25.0	12.9 ± 24.3	0.816*
Reflux time of the GSV^‡			0.745^§
<1.0s	3 (2.1)	7 (3.8)
1.0–2.0s	41 (28.1)	56 (30.6)
2.0–5.0s	45 (30.8)	53 (29.0)
>5s	57 (39.0)	67 (36.6)
No. of perforators			0.120^§
>2perforators/limb	81 (55.5)	117 (63.9)
≤2perforators/limb	65 (44.5)	76 (36.1)
The baseline VCSS (IQR)	12.6 (11.0–14.0)	12.6 (10.0–15.0)	0.743^†
The baseline AVVQ	52.9(46.2–59.0)	52.5 (43.6–59.0)	0.645^†

*Independent-sample t-test, ^§Pearson Chi-Square, ^†Mann – Whitney U test. ^‡The reflux time of the great saphenous vein was measured at the saphenous-femoral vein junction [15].

Abbreviations: EMA+HL-FS-CT, endovenous microwave ablation+high ligation-foam sclerotherapy-compression therapy; EVLA+HL-FS-CT, endovenous microwave ablation+high ligation-foam sclerotherapy-compression therapy; y, year; IQR, interquartile range; mo, month; GSV, great saphenous vein; VCSS, Venous Clinical Severity Score; AVVQ, Aberdeen Varicose Veins Questionnaire, SSV Small saphenous vein.

Figure 2. Ulcer healing time of the two groups.

Table 2. The follow-up outcomes in the EMA and EVLA groups.

	EMA (n = 146 limbs)	EVLA (n = 183 limbs）	P-value
Time to ulcer healing (mo, IQR)	1.45 (0.75–1.5)	1.86 (0.5–2.5)	0.141^†
Recurrence of ulcer
6mo (%)	1 (0.7)	1 (0.5)	0.747^§
12mo (%)	6 (4.1)	7 (3.8)	0.936^§
Recanalization of the GSV
1mo (%)	0 (0.0)	0 (0.0)	Null
6mo (%)	0 (0.0)	1 (0.6)	1.000^&
12mo (%)	6 (4.4)	8 (4.6)	0.918^§
VCSS (IQR)
1mo	9.0 (7.0–11.0)	9.9 (7.0–13.0)	0.029^†
6mo	2.4 (1.0–3.0)	2.7 (1.0–3.0)	0.368^†
12mo	1.7 (0.0–3.0)	2.3 (1.0–3.0)	0.008^†
AVVQ (IQR)
1mo	25.0 (15.4–35.9)	28.0 (15.4–38.5)	0.082^†
6mo	5.1 (0.0–7.7)	7.0 (2.6–7.7)	0.009^†
12mo	3.7 (0.0–5.1)	5.3 (0.0–7.7)	0.001^†

*Independent-sample t-test, ^§Pearson Chi-Square, ^&Fisher’s Exact Test, ^†Mann – Whitney U test. Significant values are in bold.

Abbreviations: EVLA, endovenous laser ablation; EMA, endovenous microwave ablation; IQR, interquartile range; GSV, great saphenous vein; VCSS, Venous Clinical Severity Score; IQR, interquartile range; AVVQ, Aberdeen Varicose Veins Questionnaire.

Table 3. The procedure-related outcomes in the EMA and EVLA groups.

	EMA (n = 146 limbs)	EVLA (n = 183 limbs)	P-value
Time of procedure (min)	80.4 ± 12.8	74.3 ± 11.8	0.001*
Amount of sclerosing agent (ml)	9.6 ± 0.7	9.7 ± 0.7	0.592*
Number of GSV occlusions	146 (100)	183 (100)	Null
Prophylactic antibiotics	13 (8.9)	19 (10.4)	0.653^§

*Independent-sample t-test, ^§Pearson Chi-Square. Significant values are in bold.

Abbreviations: EVLA, endovenous laser ablation; EMA, endovenous microwave ablation; GSV, great saphenous vein.

Table 4. The incidence of complications in the EMA and EVLA groups.

	EMA (n = 146 limbs)	EVLA (n = 183 limbs)	P-value
Numbness
1mo (%)	17 (11.6)	25 (13.7)	0.586^§
6mo (%)	4 (2.7)	8 (4.4)	0.433^§
Skin burns (%)	7 (4.8)	11 (6.0)	0.630^§
EHIT	0 (0)	0 (0)	Null
DVT (%)	1 (0.7)	1 (0.5)	0.872^§
Ecchymosis (%)	6 (4.1)	8 (4.4)	0.909^§
Thrombophlebitis (%)	6 (4.1%)	10 (5.5%)	0.570^§
Groin infection (%)	3 (2.1)	2 (1.1)	0.479^§
Death	0	0	Null

^§Pearson Chi-Square.

Abbreviations: EVLA, endovenous laser ablation; EMA, endovenous microwave ablation; EHIT, endothermal heat induced thrombosis; DVT Deep vein thrombosis.

Figure 3. VCSS of the two groups at different time.

Figure 4. AVVQ of the two groups at different time.

Jeanneret C, Labs KH, Aschwanden M, et al. Physiological reflux and venous diameter change in the proximal lower limb veins during a standardised valsalva manoeuvre. Eur J Vasc Endovasc Surg. 1999;17(5):398–403. doi: 10.1053/ejvs.1998.0797

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Data availability statement

The data that support the findings of this study are available on request from the corresponding author XCL. The data are not publicly available due to the containing information that could compromise the privacy of research participants.