Ultrasound-guided foam sclerotherapy for chronic venous disease with ulcer. A prospective multiple outcome cohort study

Abreu, Guilherme Camargo Gonçalves de; Camargo Jr., Otacílio de; Abreu, Márcia Fayad Marcondes de; Aquino, José Luis Braga de

doi:10.1590/1677-5449.180108

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Brasil

Jornal Vascular Brasileiro

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ORIGINAL ARTICLE • J. Vasc. Bras. 19 • 2020 • https://doi.org/10.1590/1677-5449.180108 copy

Ultrasound-guided foam sclerotherapy for chronic venous disease with ulcer. A prospective multiple outcome cohort study^* * The article was based on dissertation approved by the Programa de Pós-graduação em Ciências da Saúde, PUC-Campinas (2017), and was presented at the XIV Pan-american Congress of Vascular and Endovascular Surgery (2016).

Escleroterapia ecoguiada com espuma para doença venosa crônica com úlcera: coorte prospectiva de múltiplos desfechos

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Background

Chronic Venous Disease (CVD) is the main cause of chronic leg ulcers. Varicose veins are the most frequent cause of venous leg ulcers (VLU). 50.9% of Brazilian women have varicose veins and ulcer prevalence is as high as 4%. Ultrasound-guided foam sclerotherapy (UGFS) is a low-cost treatment option for varicose veins.

Objectives

To analyze UGFS outcomes in patients with VLU.

Methods

Prospective consecutive single center cohort study. Patients with great saphenous vein (GSV) reflux and VLU were treated and followed-up for 180 days. The following were studied: quality of life (QoL), disease severity, healing, and elimination of GSV reflux. The Aberdeen questionnaire, a venous clinical severity score, and Duplex scanning (DS) results were analyzed.

Results

22 patients aged 35 to 70 years were treated. There was improvement in quality of life, disease severity reduced, and ulcer diameter reduced (p < 0.001; ANOVA). 77.27% of VLU healed completely (95%CI: 59.76-94.78%). The dimensions of 20/22 VLU reduced (90.91%; 95%CI: 78.9-100%). GSV reflux was eliminated in 63.64% (95%CI: 43.54-83.74%). Men had greater QoL benefit and women had more complications. There were no severe complications. The VLU that had healed completely at the end of the study were smaller at baseline than those that did not completely heal. The GSV that were completely occluded at the end of the study were smaller at baseline than those that were not completely occluded (p < 0.05; Mann-Whitney).

Conclusion

The results suggest that most patients benefited from UGFS.

Keywords:
varicose ulcer; leg ulcer; varicose veins; sclerotherapy; ultrasonography; quality of life

Patient (%)	Number of administrations	Total administrations
8 (36.4%)	1	8
10(45.5%)	2	20
2 (9.1%)	3	6
2 (9.1%)	4	8
22 (100%)		42

Variable	Mean	Sd ^§§ §§ standard deviation	Min	Median	Max
Administrations (n)	1.91	0.92	1.00	2.00	4.00
Age (years)	56.05	10.46	35.00	58.50	70.00
Schooling (years)	6.36	4.39	0.00	6.00	15.00
Baseline AQ^* * Aberdeen venous questionnaire;	47.05	12.17	21.70	45.00	74.20
Day 60 AQ*	23.96	10.29	6.30	21.20	48.20
Day 180 AQ*	16.99	9.58	0.00	16.40	37.00
Baseline VCSS^† † Venous clinical severity score;	18.64	3.03	14.00	19.00	24.00
Day 60 VCSS†	10.09	4.76	3.00	9.00	20.00
Day 180 VCSS†	6.73	3.61	1.00	6.00	16.00
VU^‡ ‡ Larger venous ulcer diameter; baseline diameter (cm)	4.11	3.40	1.00	3.00	14.00
VU‡ day 60 diameter (cm)	1.15	2.52	0	0	8.0
VU‡ day 180 diameter (cm)	1.18	2.65	0	0	10.0
GSV^‡‡ ‡‡ Great saphenous vein; baseline diameter (mm)	12.00	3.62	5.50	11.05	21.00
BMI^§ § Body mass index; (kg/m²)	30.2	5.4	23.1	30.3	44.7

Adverse Effect	n	Patient with AE (n)
Phlebitis with pain	4	3, 13, 15, 19 (4)
Phlebitis without pain	2	2, 4 (2)
Skin staining	3	4, 12, 15* (3)
Local pain	1	22*
Local cellulitis	1	16* (1)
Total AE	11	2, 3, 4, 12, 13, 15, 16, 19,22* (9)

Ulcer healing	n	% (95%CI†)
Day 60
Complete	15	68.18 (48.72-87.64%)
Incomplete	07	31.82 (12.36-52.28%)
Failure	0	0
Day 180
Complete	17	77.27 (59.75-94.79%)
Incomplete	03	13.64 (0-27.98%)
Failure	02	9.09 (0-21.10%)

Variable	Interaction	p-value
BMI^* * Body mass index;	0.5877	0.2897
GSV^† † Great saphenous vein. reflux pattern	0.4524	0.3242
GSV† diameter	0.9529	0.8751
Reflux in perforating veins	0.1991	0.2858
Reflux in deep veins	0.3636	0.2322
Number of applications	0.6992	0.9772
Gender	0.1002	0.0801
Age (years)	0.2449	0.1497
Comorbidity	0.2292	0.2243
Side affected by ulcer	0.9873	0.6225
Schooling (years)	0.5385	0.5509
Occupation	0.3349	0.1305

Time	n	Average	Sd ^* * Standard deviation.	Min.	Median	Max
Baseline	22	4.11	3.4	1.00	3.00	14.00
Day 60	22	1.15	2.52	0.00	0.00	8.00
Day 180	22	1.18	2.65	0.00	0.00	10.00

VU healing	n (%)	Mean	Sd ^* * Standard deviation.	min	median	max	p-value
Healing at day 60
Complete	15 (68.18%)	2.93	1.58	1.00	3.00	5.00	0.0336
Incomplete	7 (31.82%)	6.86	4.88	1	5.00	14.00
Healing at day 180
Complete	17 (77.27%)	2.94	1.64	1.00	3.00	5.00	0.0115
Incomplete	5 (22.73%)	8.4	4.83	3.00	9.00	14.00

	Partial Occlusion	Total Occlusion	p-value
Baseline diameter Mean Sd (n)	13.8 ± 3.0 (n=12)	9.6 ± 2.8 (n=10)	0.003
Baseline diameter Median (min – max)	13.7 (1.7-21)	10.5 (5.5-14.8)

	Partial Occlusion	Total Occlusion	p-value
Baseline diameter Mean Sd (n)	13.22± 3.2(n=15)	9.4 ± 3.3 (n=7)	0.01
Initial diameter Baseline (min – max)	12.4 (8.7-21)	10.7 (5.5-14.8)

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[1] Conflicts of interest: No conflicts of interest declared concerning the publication of this article.