A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial)

2020 ◽  
pp. 026835552095169
Author(s):  
Juliana Puggina ◽  
Igor Rafael Sincos ◽  
Walter Campos ◽  
Rina Maria P Porta ◽  
Jorgete Barreto dos Santos ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Venous Ulcer ◽  
Clinical Severity ◽  
Ulcer Recurrence ◽  
Venous Leg Ulcer ◽  
Open Label ◽  
Perforating Veins ◽  
Venous Clinical Severity Score ◽  
Endovenous Ablation ◽  
Group 2

Objectives To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence. Method This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS). Results Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT). Conclusions RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome. Registration: Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.

Superficial vein ablation for the treatment of primary chronic venous ulcers

2011 ◽  
Vol 26 (7) ◽  
pp. 301-306 ◽  
Author(s):  
S Sufian ◽  
S Lakhanpal ◽  
J Marquez
Keyword(s):  
Ulcer Healing ◽  
Ulcer Recurrence ◽  
Superficial Vein ◽  
Recurrence Rates ◽  
Perforating Veins ◽  
Venous Ulcers ◽  
Endovenous Ablation ◽  
Ceap Classification ◽  
Small Ulcer

Objective This retrospective study was undertaken to review our experience with ablation of superficial veins with significant reflux, using VNUS ClosureFAST RF (radiofrequency) or laser 980 nm, in patients with primary chronic venous ulcers, and also determine its effects in ulcer healing and ulcer recurrence. Method Included were 25 limbs (18 patients with chronic primary venous ulcers (clinical, aetiological, anatomical and pathological elements [CEAP] classification C6), who underwent endovenous ablation with RF for the axial veins or laser for the perforating veins during a two-year period. Results Of the 18 patients, there were eight men and 10 women. The median age of the group was 68 (range 37–89) years. The number of ablations done in each leg with an ulcer varied from one to eight, with a median of three. During a follow-up period of 6–12 months, one patient failed ulcer healing despite sequential ablations of refluxing veins. There was one case that developed recurrence of a small ulcer after six months and was successfully treated with a perforator ablation. Conclusion Endovenous ablation of incompetent superficial veins improves the healing of chronic primary venous ulcers and decreases the recurrence rates.

Influence of perforating vein surgery in patients with venous ulceration

2013 ◽  
Vol 30 (2) ◽  
pp. 127-132 ◽  
Author(s):  
WB van Gent ◽  
CHA Wittens
Keyword(s):  
Ulcer Healing ◽  
Controlled Trial ◽  
Clinical Importance ◽  
Compression Therapy ◽  
Venous Ulcer ◽  
Ulcer Recurrence ◽  
Recurrence Rates ◽  
Venous Ulceration ◽  
Perforating Veins ◽  
Perforating Vein

Objectives The exact role of perforating vein surgery is still unclear. The aim of this study is to analyze the influence of perforating vein surgery in patients with venous ulceration. Methods This study was part of a randomized controlled trial in which conservative and surgical treatment of venous ulceration was compared. It is a secondary analysis of prospectively gathered data. Ninety-seven active leg ulcers were surgically treated with a subfascial endoscopic perforating vein surgery (SEPS) procedure. Concomitant superficial venous incompetence was treated with flush saphenopopliteal ligation and/or saphenofemoral ligation and limited stripping of the great saphenous vein. All patients were also treated with ambulatory compression therapy. Ulcer healing and recurrences are described in detail. To measure the completeness of the SEPS procedure duplex ultrasonography was performed on each patient before and 6 weeks and 12 months after surgery. Also newly formed perforators after surgery were scored and their influence was analyzed. Results Analyses were performed on 94 ulcerated legs with a mean follow-up of 29 months. In all treated legs, only 45% all perforators were treated. In 55% one (29%) or more (26%) perforators were missed. Healing was not significantly influenced by the number of remaining incompetent perforating veins, but recurrence was significantly higher in patients who had incomplete SEPS procedure ( p = 0.007 log-rank). New incompetent perforating veins did not affect ulcer healing or recurrence. The plotted location of new perforators did not show a pattern. Deep vein incompetence and treatment of superficial venous incompetence had no significant influence on healing or recurrence rates in a complete or incomplete SEPS procedure. Conclusion In this series a well-performed SEPS procedure lowers the venous ulcer recurrence rate significantly, indicating the clinical importance of incompetent perforating veins in patients with an active venous ulcer.

Surgical methods and clinical results of subfascial endoscopic perforator surgery in Japan

2018 ◽  
Vol 33 (10) ◽  
pp. 678-686 ◽  
Author(s):  
Hitoshi Kusagawa ◽  
Naoki Haruta ◽  
Ryo Shinhara ◽  
Yuji Hoshino ◽  
Atsushi Tabuchi ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Healing Rate ◽  
Clinical Results ◽  
Clinical Severity ◽  
Ulcer Recurrence ◽  
Surgical Methods ◽  
Venous Clinical Severity Score ◽  
Ulcer Healing Rate ◽  
Subfascial Endoscopic Perforator Surgery

Objectives To clarify the surgical methods and the clinical results of subfascial endoscopic perforator surgery in Japan. Methods This study included 1287 limbs of 1091 patients who underwent subfascial endoscopic perforator surgery in 14 hospitals. Simultaneous saphenous vein treatment was performed in 1079 limbs (83.8%), and 118 limbs (9.2%) had deep venous lesions. The venous clinical severity score was calculated before and 6 to 12 months after surgery. The ulcer healing rate and ulcer recurrence rate were calculated cumulatively. Results Preoperative venous clinical severity score was significantly decreased from 10.0 ± 6.6 to 3.1 ± 3.4 ( P < .0001) postoperatively. The primary ulcer healing rate was 96.2% (332/345 C6 limbs) at an average follow-up of 47.7 months, and the ulcer recurrence rate was 12.0% (49/393 C5, C6 limbs) at the average follow-up of 46.0 months after the ulcer healed. Conclusion These results indicate that subfascial endoscopic perforator surgery is an alternative to improve the long-lasting disease severity and/or clinical outcome.

Venous Leg Ulcer Healing: A Randomized Prospective Study of Long-Stretch versus Short-Stretch Compression Bandages

1998 ◽  
Vol 13 (2) ◽  
pp. 59-63 ◽  
Author(s):  
L. Danielsen ◽  
S. M. Madsen ◽  
L. Henriksen
Keyword(s):  
Ulcer Healing ◽  
Venous Ulcer ◽  
Positive Influence ◽  
Compression Bandage ◽  
Leg Ulcers ◽  
Venous Leg Ulcer ◽  
Venous Leg Ulcers ◽  
Area Reduction ◽  
Compression Bandages ◽  
Table Analysis

Objective: To compare the efficacy of a long-stretch bandage with that of a short-stretch compression bandage. Design: Prospective evaluation of healing of venous leg ulcers in blindly randomized groups of patients. Setting: Bispebjerg Hospital, Copenhagen, Denmark. Patients: Forty-three patients with venous leg ulcers were included. Forty legs in 40 patients were evaluated at 1 month (34 patients), 6 months (32 patients) or 12 months (27 patients). Interventions: Both types of bandage were used at a width of 10 cm and applied using the same spiral bandaging technique. Main outcome measures: Ulcer healing and ulcer area reduction. Results: Healed ulcers after 1 month were observed in 27% of the long-stretch group and in 5% of the short-stretch group ( p = 0.15); after 6 months the corresponding figures were 50% and 36% ( p = 0.49) and after 12 months 71% and 30% ( p = 0.06). Using life-table analysis the predicted healing rate in the long-stretch group after 12 months was 81% and for the short-stretch group 31% ( p = 0.03). The mean of relative ulcer areas at 1 month was 0.45 for the long-stretch group and 0.72 for the short-stretch group ( p = 0.07), at 6 months the corresponding figures were 0.81 and 0.60 ( p = 0.25) and at 12 months 0.25 and 0.95 ( p = 0.01). Conclusions: The present study appears to indicate a Positive influence of the elasticity of a compression bandage on venous ulcer healing.

Subcutaneous fasciotomy and eradication of superficial venous reflux for chronic and recurrent venous ulcers: mid-term results

2011 ◽  
Vol 26 (5) ◽  
pp. 197-202 ◽  
Author(s):  
J T Christenson ◽  
C Prins ◽  
G Gemayel
Keyword(s):  
Ulcer Healing ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Subcutaneous Tissue ◽  
Skin Grafting ◽  
Venous Ulcer ◽  
Venous Disease ◽  
Ulcer Recurrence ◽  
Venous Ulcers ◽  
Mid Term Results

Objective Increased intramuscular and subcutaneous tissue pressures are often found in patients with severe chronic venous insufficiency venous ulcer disease. Additional subcutaneous para-tibial fasciotomy promotes early ulcer healing. This study evaluates the mid-term effect of eradication of superficial reflux with additional fasciotomy in patients with increased tissue pressures. Method Between January 2006 and June 2009, 58 patients underwent fasciotomy. Tissue pressures (intramuscular and subcutaneous) were measured. Sixty-nine limbs with 91 venous ulcers were treated. Mean duration of the venous ulcer was 3.4 years. Underlying disease was post-thrombotic syndrome (PT) in 19 patients (33%, 24 limbs, 27 ulcers) and non-post-thrombotic (non-PT) severe chronic venous insufficiency in 39 (67%, 45 limbs, 64 ulcers). All patients were C6 at the time of surgery. Preoperative tissue pressures were 23.5 ± 6.1 mmHg (intramuscularly) and 9.8 ± 3.2 mmHg (subcutaneously). Results Ninety ulcers (99%) healed postoperatively (42 with and 48 without skin grafting). Tissue pressures significantly decreased following surgery and remained low at three months postoperatively. Ten ulcers in six patients recurred six to 20 months postoperatively (11%), resulting in 86.4 actuarial freedom from venous ulcer recurrence at three years following surgery. Four patients (1 non-PT and 3 PT) had re-fasciotomy; all healed initially but two ulcers (2 patients, PT) recurred at 11 and 12 months. Those patients underwent re-fasciotomy, one healed and one recurred six months later. Conclusion Eradication of superficial reflux with additional subcutaneous fasciotomy for chronic and recurrent venous ulcer improves ulcer healing or success of skin grafting. Mid-term results are excellent particularly in patients with non-PT disease. Recurrence is more frequently seen in patients with PT syndrome. In patients with ulcer recurrence and high tissue pressures, re-fasciotomy can be helpful to promote healing, particularly in patients with primary venous disease.

Correlation between GSV diameter and varicose clinics

Phlebologie ◽  
2016 ◽  
Vol 45 (01) ◽  
pp. 29-35 ◽  
Author(s):  
F. Amsler ◽  
E. Kalodiki ◽  
E. Mendoza
Keyword(s):  
Varicose Veins ◽  
Clinical Severity ◽  
Venous Disease ◽  
Published Data ◽  
Mean Values ◽  
Venous Clinical Severity Score ◽  
The Mean ◽  
Group 2 ◽  
Disease Stratification ◽  
Group 1

Summary Background Great saphenous vein (GSV) incompetence is involved in the majority of cases of varicose disease. Stratification of venous disease severity is still difficult. This study aims to correlate GSV diameters with C of CEAP and the venous clinical severity score (VCSS). Methods Legs without GSV reflux (Control legs, Group 1) and legs with untreated isolated GSV reflux and varicose veins limited to the GSV territory (Group 2) were studied clinically and with duplex ultrasound in a prospective study. The GSV diameters were measured both next to the saphenofemoral junction (SFJ) and at proximal thigh (PT) and correlated to the C of CEAP and VCSS. Results The control legs-group 1 were: n=33, 6 male, mean age 53, mean BMI 26.The legs with reflux-group 2 were: n=78, 16 male, mean age 54, mean BMI 27.The mean diameters for the SFJ ( ± SD) for groups 1 and 2 were 6.4 ± 1.8 and 9.9 ± 3.4. For PT they were 3.6 ± 0.9 and 5.9 ± 1.8 respectively. In legs with reflux the SFJ diameter correlates strongly with the PT diameter (r=0.69) and moderately with the C of CEAP and VCSS; 0.42 and 0.45 respectively. The PT diameter correlates slightly better with the C of CEAP and VCSS than the SFJ diameter (0.55 and 0.57). The mean values of VCSS for groups 1 and 2 were 0.70. and 4.69. The C of CEAP and VCSS show a strong correlation among them with r=0.79 in group 2 and 0.80 in the whole sample. Conclusion The GSV diameters next to the SFJ and particularly at the PT in patients having reflux correlate strongly with both the C of CEAP and VCSS. Recording the GSV diameters at the SFJ and PT in a standardized way may improve comparison of published data and contribute to choice of treatment in the future.

Use of the VENOVO™ and Sinus Obliquus™ venous stents in the treatment of non-thrombotic or post-thrombotic iliac vein lesions – Short-term results from a multi-centre Asian cohort

2020 ◽  
pp. 026835552094621
Author(s):  
Tjun Y Tang ◽  
Mervin HH Lim ◽  
Karthikeyan Damodharan ◽  
Charyl JQ Yap ◽  
Shaun QW Lee ◽  
...  
Keyword(s):  
Clinical Improvement ◽  
Ulcer Healing ◽  
Iliac Vein ◽  
Interquartile Range ◽  
Clinical Severity ◽  
Venous Disease ◽  
Short Term ◽  
Venous Clinical Severity Score ◽  
Venous Stents

Objectives Deep venous stenting with intravascular ultrasound (IVUS) guidance is gaining favour as the treatment modality of choice for symptomatic ilio-femoral venous occlusive disease. The aim was to determine the short-term patency and symptomatic relief gained using the Bard Venovo™ and Optimed Sinus Obliquus™ stents in the endovascular treatment of non-thrombotic iliac vein lesions (NIVL) and post-thrombotic venous obstruction (PTO) from two Asian tertiary vascular centres. Methods Sixty patients (males = 21/60 (35.0%); median age 67 years (interquartile range 54–77)) who underwent IVUS interrogation and ilio-femoral stenting (June 2018–May 2019) in two Asian centres were prospectively followed. Clinical improvement was determined by the revised Venous Clinical Severity Score (rVCSS), pain using the Visual Analogue Scale (VAS) and ulcer healing rate. Patency rates were evaluated using Duplex ultrasound and computer tomography venogram. Results Seventy-one legs were interrogated and stented; 11/60 (18.3%) patients had a bilateral procedure. Indications for surgery were PTO ( n = 11/71 (15.5%)) and NIVL ( n = 60/71 (84.5%)). Twenty-seven of 71 (38.0%) patients had CEAP 6 disease. The median follow-up was 283 (interquartile range 211–370) days. Technical and procedural success was both 100%. Twenty-one of 71 (29.6%) legs had a combination of Venovo™ and Sinus Obliquus™ stents inserted for concurrent ilio-caval and iliac lesions. There were no major post-operative complications. Six-month primary, assisted primary and secondary patency rates were 94.1, 97.1 and 100%, respectively. There were no stent fractures. Mean rVCSS and VAS improved from 12.26 (±3.31) to 4.33 (±2.78) and 6.97 (±1.38) to 2.03 (±1.65), respectively, at three months (p < 0.01). Complete ulcer healing was seen in 27/27 (100%) patients at three months. Conclusion Use of Venovo™ and Sinus Obliquus™ stents for symptomatic ilio-femoral venous disease showed excellent six-month primary patency rate with no stent fractures. There were significant clinical improvement and low-device-related complications. Longer follow-up is awaited to see how these dedicated venous stents perform.

scholarly journals MECHANISMS OF DEVELOPMENT OF INCOMPETENT PERFORATING VEINS IN PATIENTS WITH VARICOSE VEIN DISEASE OF LOWER LIMBS

2015 ◽  
Vol 174 (3) ◽  
pp. 15-19
Author(s):  
B. S. Sukovatych ◽  
M. B. Sykovatykh
Keyword(s):  
Varicose Vein ◽  
Venous Insufficiency ◽  
Lower Limbs ◽  
Clinical Severity ◽  
Direct Relation ◽  
Perforating Veins ◽  
Venous Clinical Severity Score ◽  
Ceap Classification ◽  
Mechanisms Of Development ◽  
Vein Disease

An analysis of the results of complex examination and treatment of 181 patients with varicose vein disease (according to CEAP classification C3-C6) was made. Patients were divided into 2 groups. The first group included 106 (58,6%) patients with venous clinical severity score C3 and the second group - 75 (41,4%) patients with score C4-C6. An ultrasonic scintiangiography was used to determine the localization, intensity and length of blow-out in venous system of affected limb. The study found out 2 mechanisms of development of incompetent perforating veins. A superficial blood reflux influenced on the progress of venous insufficiency in 41 (38,7%) patients of the first group. The superficial and deep blood refluxes facilitated to development of the disease and were detected in 67 (89,4%) patients of the second group. It was stated, that there is a direct relation of perforating blood reflux rate with the level of intensity of superficial and deep blood reflux. The more expression of the refluxes took place, the more cases of incompetent perforating veins.

Daflon 500 mg and Venous Leg Ulcer: New Results From a Meta-Analysis

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S33-S39 ◽  
Author(s):  
Philip Coleridge Smith
Keyword(s):  
Ulcer Healing ◽  
Conventional Therapy ◽  
Conventional Treatment ◽  
Oral Treatment ◽  
Meta Analysis ◽  
Venous Ulcer ◽  
Leg Ulcer ◽  
Venous Leg Ulcer ◽  
Type 1 Error ◽  
Randomized Controlled Studies

The objective of this study was to assess the effect of oral treatment with Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) on leg ulcer healing. This study was conducted as a meta-analysis of randomized prospective studies using Daflon 500 mg as an adjunct to conventional treatment. Medical literature databases and the manufacturer’s records were searched for relevant clinical trials. Five prospective, randomized, controlled studies in which 723 patients with venous ulcers were treated between 1996 and 2001 were identified. Conventional treatment (compression and local care) in addition to Daflon 500 mg 2 tablets daily was compared with conventional treatment plus placebo in two studies (n=309), or with conventional treatment alone in three studies (n=414). The primary end point was complete ulcer healing at 6 months. The results are expressed as a reduction in the relative risk (RRR) of healing with 95% confidence intervals (CI). Since, in the present case, the desired treatment effect is increased ulcer healing, RRR should be positive to indicate a benefit of adjunctive Daflon 500 mg over conventional therapy alone. Type 1 error was set at 5%. At 6 months, the chance of ulcer healing was 32% better in patients treated with adjunctive Daflon 500 mg than in those managed by conventional therapy alone (RRR, 32%; 95% CI, 3% to 70%). This difference was present from month 2 (RRR, 44%; 95% CI, 7% to 94%), and was associated with a shorter time to healing (16 weeks vs 21 weeks; p=0.0034). The benefit of Daflon 500 mg was found in the subgroup of ulcers between 5 and 10 cm2 in area (RRR, 40%; 95% CI, 6% to 87%), as well as in patients with ulcers of 6 to 12 months’ duration (RRR, 44%; 95% CI, 6% to 97%). These results confirm that venous ulcer healing is accelerated by Daflon 500 mg treatment. Daflon 500 mg might be a useful adjunct to conventional therapy in large and longstanding ulcers that might be expected to heal slowly.

Mid-term results in the treatment of varicose veins with N-butyl cyanoacrylate

2017 ◽  
Vol 32 (10) ◽  
pp. 665-669 ◽  
Author(s):  
Erdinc Eroglu ◽  
Alptekin Yasim ◽  
Murat Ari ◽  
Hasan Ekerbicer ◽  
Aydemir Kocarslan ◽  
...  
Keyword(s):  
Saphenous Vein ◽  
Varicose Veins ◽  
Good Method ◽  
Clinical Severity ◽  
Venous Clinical Severity Score ◽  
Long Term Follow Up ◽  
Endovenous Ablation ◽  
Mid Term Results

Aim To present mid-term results of patients with varicose veins treated with N-butyl cyanoacrylate (VariClose®), a nontumescent endovenous ablation technique. Patients and method Endovenous ablation was performed on 180 patients with saphenous vein incompetence between May and October 2014. One hundred sixty-eight subjects capable of being followed-up for 30 months were included. Patients’ pre- and postoperative data were recorded. Results Procedures were performed on the great saphenous vein in 159 patients and on the small saphenous vein in nine patients. Saphenous vein diameters ranged between 5.5 mm and 14 mm. Full ablation was achieved in all patients following the procedure. No complications were encountered. Patients were monitored for 30 months. Ablation rates were 100% at the 3rd month, 98.3% at the 6th month, 96.6% at 1 year, and 94.1% at 30 months. Mean venous clinical severity score was 10.2 before procedures, decreasing to 3.9 at 3 months, 4.2 at 6 months, 2.9 at 12 months, and 2.7 at 30 months ( p = 0.000). Conclusion Due to its high success rate, absence of complications, no tumescent anesthesia requirement and high patient satisfaction, endovenous ablation with N-butyl cyanoacrylate is a good method. However, long-term follow-up results are now needed.

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