Prospective randomised comparative study of visual foam sclerotherapy alone or in combination with ultrasound-guided foam sclerotherapy for treatment of superficial venous insufficiency: preliminary report

ObjectiveThe aim of the study is to compare ultrasound-guided foam sclerotherapy (UGFS: injection of foam sclerosant under ultrasound guidance) of the great saphenous vein (GSV) combined with visual foam sclerotherapy (VFS: injection of foam sclerosant under visual control) for varicose tributary veins and VFS alone in the treatment of GSV reflux.Design and methodsA total of 133 limbs in 97 patients with GSV reflux were randomised to receive either VFS alone or VFS combined with UGFS. In both groups, 1% polidocanol foam was used. Assessments included duplex ultrasonography, evaluation of Venous Clinical Severity Scores (VCSS) and CEAP (clinical, etiologic, anatomic, and pathophysiologic) scores. Ultrasonographic inspection of the foam in the GSV was carried out during 5 min before compression was applied. The primary ‘end’ point of the study was obliteration of the GSV at 6 months.ResultsA total of 51 limbs in 48 patients were treated with UGFS + VFS and the remaining 52 limbs in 49 patients were treated with VFS alone. There were no significant inter-group differences in patient age, male: female ratio, height, weight, body mass index, CEAP clinical scores or VCSS. The GSV diameter was 6.0 ± 1.7 mm (median ± interquartile range) in the UGFS + VFS group and 5.7 ± 1.6 mm in the VFS group (p = 0.419). The mean injected volume of foam for varicose tributary veins was 4 ± 2 ml in the UGFS + VFS group and 6 ± 2 ml in the VFS group, a significantly higher amount of foam being used in the latter (p < 0.001). However, the mean total amount of foam was greater in limbs treated with UFGS + VFS than in those treated with VFS alone (p = 0.017). Ultrasonographic inspection revealed complete vasospasm of the GSV in 37 (72.5%) limbs in the UGFS + VFS group and 29 (55.8%) in the VFS group during sclerotherapy (p = 0.097). At 6-month follow-up, complete occlusion was found in 23 limbs (45.1%) treated with UGFS + VFS and in 22 limbs (42.3%) treated with VFS. The difference between the two groups was not significant (p = 0.775). Reflux was absent in 30 limbs (58.8%) treated with UGFS + VFS and in 37 (71.2%) treated with VFS (p = 0.190). There was no inter-group difference in post-treatment VCSS (p = 0.223).ConclusionsThese results show that UGFS + VFS and VFS are equally effective for the treatment of GSV reflux, despite the lower volume of foam used for VFS alone.     

Healing and Recurrence Rates Following Ultrasound-guided Foam Sclerotherapy of Superficial Venous Reflux in Patients with Chronic Venous Ulceration

ObjectivesTo determine healing and recurrence rates following ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR) in patients with healed (clinical, etiologic, anatomic and pathophysiologic (CEAP) classification, C5) and open (C6) chronic venous ulceration (CVU).MethodsBetween 1 March 2005 and 31 December 2009, 130 consecutive patients (132 limbs, 49 CEAP C5, 83 C6) of median age 70 (interquartile range (IQR) 56–76) years underwent UGFS as part of their treatment for CVU.ResultsThe median (IQR) follow-up time was 16 (12–32) months. One C6 patient moved abroad 1 week after UGFS and was lost to follow-up. Healing was observed in 67/82 (82%) remaining C6 patients at a median (IQR) of 1 (1–2) month following their first UGFS treatment. In 49 limbs originally treated for C5 disease, and in 67 limbs treated for C6 that healed following UGFS, there were five recurrent ulcers during the follow-up period, giving a 4.9% Kaplan–Meier estimate of recurrence at 2 years. In legs treated for C6 and C5 disease, the median (IQR) ulcer-free periods were 22 (IQR 9–32) and 14 (IQR 8–36) months, respectively.DiscussionHealing rates following UGFS for CVU are comparable to those reported after surgery but recurrence may be lower. UGFS is a safe, clinically effective and, thus, highly attractive minimally invasive alternative to surgery in patients with C5 and C6 disease.     

Ultrasound-guided foam sclerotherapy for the treatment of varicose veins

BACKGROUND: The aim was to assess the early efficacy and complications of ultrasound-guided foam sclerotherapy (UGFS) in a cohort of patients with varicose veins. METHODS: Of 192 consecutive patients referred with varicose veins over 15 months, only 11 chose surgery; the rest underwent UGFS treatment. Polidocanol was foamed 1 : 3 with air. Under ultrasound control via butterfly or Seldinger cannulation, 1 per cent foam was injected into superficial veins and 3 per cent foam into saphenous trunks, up to a total volume of 14 ml. Outcome was defined as complete when occlusion of the saphenous trunk and/or over 85 per cent of the varicosities was achieved, and partial closure when less. RESULTS: In 163 legs, complete occlusion occurred after one intervention, a further 32 after a second, and one after a third (overall 91 per cent). Of the remainder, all other legs achieved partial occlusion after up to three interventions, apart from two legs with great saphenous vein (GSV) incompetence, which failed. All 23 legs with small saphenous veins had complete occlusion after one intervention compared with 64 of 97 legs with GSV incompetence (P < 0.010). Occlusion rates were also higher when the GSV was cannulated directly: 56 of 70 versus 8 of 27 (P < 0.001). CONCLUSIONS: UGFS achieved early complete occlusion safely in over 90 per cent of legs with varicose veins.     

Blocking the Saphenofemoral Junction During Ultrasound-Guided Foam Sclerotherapy – Assessment of a Presumed Safety-measure Procedure

ObjectivesUltrasound-guided foam sclerotherapy (UGFS) is a technique in which a mixture of sclerosing drug and gas is used to treat varicose veins. Several authors have demonstrated transient systemic effects after UGFS. These effects are not well understood but probably originate from a systemic distribution of the sclerosing foam. Therefore, safety measures have been developed to prevent foam from flowing into the deep venous system. The aim of the study is to evaluate whether blockage of the saphenofemoral (SF) junction by either manual compression or surgical ligation prevents microbubbles from leaking into the deep venous circulation.MethodsTo detect the distribution of microbubbles, radioactive pertechnetate (^99mTcO₄^?) was added to the foam solution. Initially, in vitro trials were performed in the laboratory to investigate the effect of ^99mTc on foam stability. The time taken for foam to liquefy was measured for foam alone and for the mixture with ^99mTc. In subsequent research, eight varicose great saphenous veins (GSVs) were treated by UGFS. In three patients, this treatment was preceded by surgical ligation of the SF junction. In three patients, the groin was manually compressed during UGFS. In two patients, UGFS was performed without compression of the groin.ResultsIn vitro, ^99mTc did not influence foam stability; after 2.6 min all foam had reduced to liquid, regardless of whether ^99mTc had been added or not. In vivo trials showed that all patients showed a decrease in the cumulative amount of ^99mTc detected in the GSV following polidocanol-^99mTc mixture injection. However, the decrease of radioactivity was slightly reduced when compression or ligation of the SF junction was performed.ConclusionsBlocking the SF junction during UGFS using either manual compression or ligation does not prevent, but may reduce the flow of foam into the femoral vein.     

Validation of a new duplex derived haemodynamic effectiveness score, the saphenous treatment score, in quantifying varicose vein treatments

ObjectivesTo evaluate a duplex-derived score for varicose vein treatments using numerical values of haemodynamic effectiveness.DesignThe saphenous treatment score (STS) was developed prospectively to compare the effect of endovenous treatments on reflux within saphenous segments.PatientsSixty-six patients were randomised to endovenous laser ablation (EVLA) or ultrasound-guided foam sclerotherapy (UGFS) to the great saphenous vein (GSV).MethodsAssessments included the Aberdeen varicose vein severity score (AVVSS), the venous clinical severity score (VCSS), the venous filling index (VFI) and the STS.ResultsA mean STS of 5.70 decreased to 3.30, P < .0005, post-treatment. The median (IQR) AVVSS, VCSS and VFI (ml/sec) decreased from 21.52(15.48) to 18.86(11.27), P = .14, from 6(4) to 3(4), P < .0005 and from 7.1(6.9) to 1.9(.9) P < .0005, respectively. In 15 patients requiring additional UGFS the mean STS values decreased from 5.8 to 4.13 and then to 2.6 P < .0005, respectively. The individual above and below knee mean treatment differences in STS on 38 EVLA and 28 UGFS patients were 1.92 and .87 (EVLA) compared to 1.57and .29 (UGFS) P = .001, respectively.ConclusionsThe STS has been shown to grade the haemodynamic effects of different treatments as well as ongoing treatments on the GSV.     

Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial.

AIM: To assess the safety and efficacy of sclerotherapy of the great saphenous vein (GSV) comparing standardised polidocanol foam to liquid polidocanol in a randomised controlled trial (RCT). METHODS: A multicentre randomised controlled clinical trial was carried out in which saphenous trunks were treated by sclerotherapy. 106 patients with primary varicose veins due to an incompetent GSV were treated with either standardised 3% polidocanol foam or 3% liquid polidocanol. The primary efficacy criterion was elimination of reflux (<0.5 sec) measured 3 cm below the sapheno-femoral junction (SFJ) by duplex ultrasonography 3 months after the last injection. RESULTS: A significantly greater number of patients were successfully treated by foam sclerotherapy resulting in 69% elimination of reflux compared to 27% patients treated with liquid sclerosant. The secondary endpoints of vein occlusion, reflux time, refilling time and patient satisfaction also improved significantly more in the foam group. The mean number of treatment sessions was 1.3 in the foam group compared to 1.6 in the liquid group. Differences between study centres occurred with a mean of 96% reflux elimination in 6 centres versus 39% in 4 other centres. Centres with a high response rate injected a higher mean volume (4.3 vs. 3.6 ml) in the first session in a vein with a smaller diameter (7.5 mm vs. 8.4 mm). No difference in adverse drug reactions was observed between treatment groups. CONCLUSIONS: Standardised 3% polidocanol foam is more efficient and equally safe compared to 3% liquid polidocanol for treatment of GSV. In comparison to other studies a relatively small volume was injected into relatively large veins.     

Endovenous laser ablation: Does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial

BACKGROUND: Following above-knee (AK) great saphenous vein (GSV) endovenous laser ablation (EVLA) 40% to 50% patients have residual varicosities. This randomized controlled trial (RCT) assesses whether more extensive GSV ablation enhances their resolution and influences symptom improvement. METHOD: Sixty-eight limbs (65 patients) with varicosities and above and below-knee GSV reflux were randomized to Group A: AK-EVLA (n = 23); Group B: EVLA mid-calf to groin (n = 23); and Group C: AK-EVLA, concomitant below-knee GSV foam sclerotherapy (n = 22). Primary outcomes were residual varicosities requiring sclerotherapy (6 weeks), improvement in Aberdeen varicose vein severity scores (AVVSS, 12 weeks), patient satisfaction, and complication rates. RESULTS: EVLA ablated the treated GSV in all limbs. Sclerotherapy requirements were Group A: 14/23 (61%); Group B: 4/23 (17%); and Group C: 8/22 (36%); chi2 = 9.3 (2 df) P = .01 with P(A-B) = 0.006; P(B-C) = 0.19; P(A-C) = 0.14. AVVSS scores improved in all groups as follows: A: 14.8 (9.3-22.6) to 6.4 (3.2-9.1), (P < .001); B: 15.8 (10.2-24.5) to 2.5 (1.1-3.7), (P < .001); and C: 15.1 (9.0-23.1) to 4.1 (2.3-6.8), (P < .001) and P(A-B) = 0.011, P(A -C) = 0.042. Patient satisfaction was highest in Group B. BK-EVLA was not associated with saphenous nerve injury. CONCLUSIONS: Extended EVLA is safe, increases spontaneous resolution of varicosities, and has a greater impact on symptom reduction. Similar benefits occurred after concomitant BK-GSV foam sclerotherapy.     

Great Saphenous Vein Diameter at the Saphenofemoral Junction and Proximal Thigh as Parameters of Venous Disease Class

BackgroundGreat saphenous vein (GSV) incompetence is involved in the majority of cases of varicose disease. Standardised pre-interventional assessment is required to analyse the relative merit of treatment modalities. We weighed GSV diameter measurement at the sapheno-femoral junction (SFJ) against measurement at the proximal thigh 15 cm distal to the groin (PT), established a conversion factor and applied it to selected literature data.MethodsLegs with untreated isolated GSV reflux and varices limited to its territory and control legs were studied clinically, with duplex ultrasound and photoplethysmography. GSV diameters were measured at both the SFJ and the PT. A conversion factor was calculated and used to compare published data.ResultsOf 182 legs, 60 had no GSV reflux (controls; group I), 51 had above-knee GSV reflux only (group II) and 71 had GSV reflux above and below knee (group III). GSV diameters in group I measured 7.5 mm (±1.8) at the SFJ and 3.7 mm (±0.9) at the PT. In groups II and III, they measured 10.9 mm (±3.9) at the SFJ and 6.3 mm (±1.9) at the PT (p < 0.001 each). Measurement at the PT revealed higher sensitivity and specificity to predict reflux and clinical class. Good correlation between sites of measurement (r = 0.77) allowed a conversion factor (SFJ = 1.767 * PT, PT = 0.566*SFJ) to be applied to pre-interventional data of published studies.ConclusionsGSV diameter correlates with clinical class, measurement at the PT being more sensitive and more specific than measurement at the SFJ. Applying the conversion factor to published data suggests that some studies included patients with minor disease.     

Closure of the Greater Saphenous Vein with Endoluminal Radiofrequency Thermal Heating of the Vein Wall in Combination with Ambulatory Phlebectomy: 50 Patients with More Than 6-Month Follow-up

BACKGROUND: Incompetence of the saphenofemoral junction (SFJ) with reflux into the greater saphenous vein (GSV) is one cause of chronic venous hypertension that may lead to the development of varicose and telangiectatic leg veins. OBJECTIVE: To evaluate with long-term follow-up a novel method for closing the incompetent GSV at its junction with the femoral vein through an endoluminal approach. METHODS: Fifty patient legs with reflux at the SFJ into the GSV were treated with radiofrequency (RF) heating of the vein wall through an endoluminal catheter. Patients were evaluated at 6, 9, 12, and 18-24 months to determine treatment efficacy as well as adverse sequelae. RESULTS: Nine patients could not return for evaluation after 3 months. The remaining 41 patient legs were evaluated. Sixty-eight percent of treated legs achieved complete closure of the SFJ and GSV. Twenty-two percent of legs had an open GSV without reflux. Three patients (four legs) (10%) had an open and refluxing GSV. Three of 41 legs had recurrent varicose veins. Only 1 of 41 legs had recurrent symptoms. Complete treatment took an average of 20 minutes. Adverse sequelae were minimal, with 28 legs showing purpura less than 2 weeks, 5 legs with erythema less than 1 week, and 8 legs with an indurated fibrous cord lasting for up to 6 months posttreatment. CONCLUSION: Endoluminal RF thermal heating of an incompetent GSV has been shown to be easily accomplished and efficacious throughout the 24-month-follow-up period.     

Comparison of 1% and 3% polidocanol foam in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, double-blind trial with 2 year-follow-up. "The 3/1 Study".

OBJECTIVES: To compare 1% and 3% POL foam in treating the great saphenous vein (GSV) by ultrasound guided sclerotherapy. DESIGN: Multicentre, prospective, randomised, double-blind trial with 2 year-follow-up. PATIENTS AND METHODS: 148 patients with GSV reflux (saphenous trunk diameter 4-8 mm) were randomised to undergo ultrasound guided foam sclerotherapy using either 1% or 3% POL foam in a single session. Foam production was standardised using a sterile disposable syringe kit including sterile air and the Turbofoam machine. Duplex ultrasonography was used to assess the outcome at 3 weeks, 6 months, 1 year, 18 months and 2 years. The main criterion of success was the disappearance of the venous reflux. The length of occlusion of the vein (only measured at 3 week-echography assessment) was a secondary criterion. Side effects were assessed. RESULTS: 74 patients were included in each group. The mean volume of foam injected was 4.4 ml for the 3% group and 4.6 ml for the 1% group. After 3 weeks, reflux was abolished in 96% (71 patients) of the 3% group and 88% (68 patients) of the 1% group (NS). The mean occlusion length of the vein was 38 cm for the 3% group and 34 for the 1% group (NS). After 2-years, reflux was absent in 69% of the 3% group and 68% of the 1% group (NS). 14 patients were lost to follow-up at 2 years. CONCLUSION: This study demonstrates equivalent efficacy for 1% POL and 3% POL foam in sclerotherapy of the GSV where the trunk is less than 8 mm in diameter. These data obtained two years of follow-up confirm our previously reported 6 month-follow-up data published in 2005.     

Ultrasound Guided Foam Sclerotherapy: Factors Associated with Outcomes and Complications

ObjectivesIn recent years ultrasound guided foam sclerotherapy (UGFS) has become an increasingly popular treatment for varicose veins. Although many published series detail the results of UGFS, little is known about the factors which are associated with outcomes and complications. The aim of this study was to identify these factors.DesignA review of a prospectively collected database of UGFS which commenced in July 2007.MethodsA successful outcome was defined as complete occlusion of the target vein on duplex scanning at follow-up. Eight factors were assessed to determine whether they were associated with outcomes and complications. These factors were age, gender, compliance with post-procedure compression hosiery, previous varicose vein surgery, single or multiple sites of injection, concentration of sclerosant, volume of sclerosant and pre-procedure severity score.ResultsBetween July 2007 and July 2009, a total of 126 patients (60 men, 66 women) attended follow-up visits and had a post-procedure duplex scan. Targets for UGFS included the great saphenous vein (n = 75), small saphenous vein (n = 13) and anterior accessory great saphenous vein (n = 8). The remainder of procedures involved other veins or more than a single target vein. The median timing of follow-up was 3 months (range 1.5–14 months) with duplex scans revealing complete occlusion of the target vein in 79% of patients. The only factor associated with a successful outcome was compliance with post-procedure compression hosiery (p < 0.05). The most frequently encountered complications following UGFS were skin staining (28%), superficial thrombophlebitis (18%) and pain (14%). The only factor associated with post-UGFS complications was female gender (p < 0.05). When complications were analysed in isolation female gender was also significantly associated with skin staining (p < 0.05), but no other complication.ConclusionsThese data suggest that compliance with post-procedure compression hosiery and gender are important factors associated with a successful outcome and reported complications following UGFS, respectively.     

Clinical and hemodynamical findings in legs with previous surgery of the great saphenous vein: role of the small saphenous vein

AIM: To assess the role of small saphenous vein (SSV) reflux in patients with a long history of varicose disease and previous stripping of the great saphenous vein (GSV). METHODS: Consecutive patients with a history of GSV stripping 5-19 years earlier were enrolled in this prospective clinical study. A total of 101 legs of 75 consecutive patients fulfilled the study criteria: previous stripping of GSV from ankle to groin at least 5 years earlier, no history of thromboembolism and no previous surgery of deep veins or SSV. All patients were studied clinically using standardized classifications: clinical class, clinical disability score (CDS) and venous clinical scoring system (VCSS). Colour flow duplex imaging (CFDI) was used to assess reflux in deep and superficial veins. Details of prior surgery were evaluated. RESULTS: Overall, SSV reflux was noted in 28 (28%) of the legs, recurrent GSV (rGSV) in the thigh in 41 (41%), reflux in tributaries alone in 28 (28%) and a combination of SSV and rGSV reflux in 4 (3%). Segmental deep reflux was measured in 23 (23%) of the legs; the prevalence of deep reflux was significantly higher in complicated than in uncomplicated legs (12% versus 47%; P<0.05). Deep reflux was more frequently associated with SSV reflux than with rGSV reflux (50% versus 22%; P<0.05). The prevalence of SSV with or without deep reflux increased from 17% to 50% (P<0.05) when uncomplicated (C2-3) and complicated (C4-6) legs were compared. A similar increase was not seen in the legs with rGSV (39% versus 44%; P>0.05). SSV reflux without deep reflux was observed in 25% of the legs with complicated (C4-6) disease, whereas the prevalence of SSV reflux was low (9%) in uncomplicated (C2-3) legs. VCSS was higher in the legs with SSV reflux than in those with rGSV reflux. CDS scores tended to be higher in the SSV reflux group than in the legs with rGSV reflux or tributary reflux alone. After exclusion of deep reflux, the results remained at the same level. CONCLUSION: Small saphenous vein (SSV) reflux is common in legs with recurrent varicose veins and previous stripping of the GSV. SSV reflux alone is frequent in complicated legs, and SSV reflux is typically associated with segmental deep reflux. Clinical and hemodynamical findings stress the role of SSV reflux in this selected venous population.     

Fate and clinical significance of saphenofemoral junction tributaries following endovenous laser ablation of great saphenous vein

BACKGROUND: Unlike surgery, endovenous laser ablation (EVLA) abolishes great saphenous vein (GSV) reflux but does not specifically interrupt the GSV tributaries at the groin. The fate and clinical significance of these tributaries were assessed in a prospective study. METHODS: Eight-one legs (70 patients) underwent colour flow duplex ultrasonography 12 months after GSV ablation for primary varicose veins. Saphenofemoral junction (SFJ) reflux, tributary patency, and recurrent or residual varicosities were recorded, and Aberdeen Varicose Vein Severity Scores (AVVSS) were compared with pretreatment values. RESULTS: The GSV had recanalized without evidence of reflux in two patients. None of the 81 legs showed SFJ reflux although one or more patent tributaries were visible in 48 (59 per cent); all were competent. In 32 legs (40 per cent) there was flush GSV occlusion with the SFJ and no tributaries were detectable. One leg showed evidence of neovascularization in the groin. AVVSS values were similar in groups with or without visible tributaries, both before and after EVLA: median (interquartile range) 13.9 (7.6-19.2) before EVLA and 2.9 (0.6-4.8) at follow-up in patients with visible tributaries, and 14.9 (9.2-20.2) and 3.1 (0.8-5.1) respectively in those without. Recurrent varicosities were present in one leg only, due to an incompetent mid-thigh perforating vein. CONCLUSION: Persistent non-refluxing GSV tributaries at the SFJ did not appear to have an adverse impact on clinical outcome 1 year after successful EVLA of the GSV.     

Ultrasound-guided foam sclerotherapy as a therapeutic modality in venous ulceration

ObjectivesThe objective of this systematic review and meta-analysis was to evaluate rates of ulcer healing following ultrasound-guided foam sclerotherapy (UGFS).MethodsThe MEDLINE, CENTRAL and Embase databases were used to search for relevant studies using the terms ' (sclerotherapy AND ulcer) OR (vein AND ulcer) OR (sclerotherapy AND vein)'. Heterogeneity between studies was quantified using the I² statistic. A random effects model was used to calculate risk ratios where substantial heterogeneity was found.ResultsThe initial search yielded 8266 articles. 8 studies were included in the qualitative synthesis and 3 in the meta-analysis. Superior complete ulcer healing rates were noted in patients treated with foam sclerotherapy versus compression therapy alone (pooled OR 6.41, 95% CI = 0.3–148.2, p = 0.246, random effects method). A marked degree of heterogeneity was observed between studies (I² = 81%).ConclusionA prospective, trial is warranted in order to determine the true merits of UGFS in the setting of venous ulceration.     

Venenoperation in Kombination mit Sklerotherapie

Background

Treatment of primary varicosis of the great saphenous vein (GSV) with reflux of the total GSV (down to the ankle or Hach grade 4) by the modified Babcock operation may lead to damage of the saphenous nerve. We combined high saphenofemoral ligation and partial stripping with sclerotherapy of incompetent veins and perforators of the lower leg.

Population and method

A total of 129 legs were treated first by high ligation and partial stripping, 6 weeks postoperatively by sclerotherapy of the remaining incompetent parts of the GSV and incompetent perforators of the lower legs. Before surgery (A), 6 weeks after the operation (before sclerotherapy B) and 9 months after completion of sclerotherapy (C) the venous refilling time (T0) and venous ejection fraction (V0) were evaluated and Duplex scanning performed. The subjective intensity of 7 different complaints of the legs was assessed.

Results

The T0 was highly significantly prolonged from 13.3?s?±?3.8 to 27.0?s?±?4.9 by the operation (B) and again highly significantly to 32.4?s?±?7.6 at (C). At (C) six legs (4.7%) had refluxes in the groin and in five lower legs (3.9%) recurrent incompetent perforators. At (B) there were sensory neurologic deficits in four legs and at (C) in none. All seven assessed complaints improved significantly from point A to B as well as from B to C.

Conclusions

Sclerotherapy significantly improves hemodynamic parameters and subjective complaints compared to operative treatment alone and minimizes the risk of saphenous nerve injury.     

Comparisons of side effects using air and carbon dioxide foam for endovenous chemical ablation

OBJECTIVE: This clinical study evaluated prospectively adverse events immediately following ultrasound-guided foam sclerotherapy (UGFS) for the treatment of lower extremity venous valvular insufficiency. Incidence of side effects associated with carbon dioxide (CO(2)) foam was compared with a historical control using air-based foam. The literature on the subject was reviewed. METHODS: Vital signs were monitored during and immediately after UGFS, and adverse events were recorded for 24 hours following the procedure. The air-based foam group had 49 patients: 44 women and 5 men. The CO(2)-based foam group had 128 patients: 115 women and 13 men. CEAP class was C2EpAsPr, describing varicose veins, primary etiology, and saphenous reflux. UGFS followed thermal ablation of the great saphenous vein. Foam was prepared using the three-way tap technique to mix gas with 1% polidocanol in a 4:1 ratio. Segments of the great and small saphenous veins and their tributaries were treated with UGFS. Foam volumes injected were 27 +/- 10 (SD) (6-46 range) and 25 +/- 12 (6-57 range) mL for air- and CO(2)-based foams respectively (P = .39). Incidence of adverse events was compared by chi(2) statistics. Vital signs were compared by paired t test. RESULTS: During the procedure, the average heart rate decreased by less than 5 bpm for both groups (P < .001), and blood pressure decreased by less than 3 mm Hg in the CO(2) group (P < .02). Respiratory rate, electrocardiogram, and pulse oxymetry did not change significantly in both air- and CO(2)-foam series (P > .05). Visual disturbances were experienced by 3.1% (4/128) and 8.2% (4/49) patients in the CO(2) and air groups respectively (P = .15). Respiratory difficulties or circumoral paresthesia each occurred in 0.8% (n = 1) of the CO(2) patients. Incidence of chest tightness (3.1% vs 18%), dry cough (1.6% vs 16%), or dizziness (3.1% vs 12%) were significantly lower in the CO(2) vs air groups (P < .02). Nausea occurred in 2% and 4% of the CO(2) and air-based foam groups (P = .53). Overall, the proportion of patients describing side effects decreased from 39% (19/49) to 11% (14/128) as CO(2) replaced air for foam preparation (P < .001). Similar findings were described in the literature of air-based foam but data on the use of physiological gas were rare. CONCLUSIONS: Side effects decreased significantly if CO(2) rather than air was employed to make the sclerosing foam for chemical ablation of superficial veins of the lower extremity.     

Varicose vein surgery with preservation of the saphenous vein: A comparison between high ligation-avulsion versus saphenofemoral banding valvuloplasty-avulsion

Purpose: Surgical treatment of varicose veins with preservation of the greater saphenous vein (GSV) was studied.Methods: Patients with reflux at the saphenofemoral junction and grossly normal GSV were treated with two different surgical techniques: perivalvular banding valvuloplasty (PVBV-A) of the saphenous valve, wherein the diameter of the uppermost saphenous valve was narrowed by Dacron-reinforced silicone band (12 patients, 15 extremities); and high ligation (HL-A) of the saphenous vein, wherein the GSV was ligated flush with the femoral vein (14 patients, 16 extremities). Both groups also had varicose tributaries of GSV avulsed through multiple stab incisions.Results: In the HL-A group two GSV (13%) remained completely patent, 10 GSV (62.5%) thrombosed partially, and the remaining four GSV (25%) had complete thrombosis. In the PVBV-A group 12 GSV (80%) remained completely patent and without reflux, one GSV (7%) remained patent but showing reflux. Two GSV (13%) thrombosed completely. There were no surgical complications or recurrences (mean follow-up was 9.4 months for PVBV-A and 9.5 months for HL-A), and the postoperative recovery time was similar for both groups.Conclusions: Both techniques are equally effective in the early elimination of varicosities. Preservation of the saphenous vein is significantly better after PVBV-A (p < 0.01). A prospective randomized trial with long-term follow-up is required. (J VASC SURG 1994;20:684-7.)     

Photoplethysmographic Venous Refilling Times Following Ultrasound Guided Foam Sclerotherapy for Symptomatic Superficial Venous Reflux: Relationship with Clinical Outcomes

IntroductionDigital photoplethysmography (PPG) provides an inexpensive, reproducible, quantitative, non-invasive assessment of lower limb venous function.AimTo examine the relationship between venous refilling time (VRT) and severity of venous disease, and also between changes in VRT and symptomatic improvement after ultrasound guided foam sclerotherapy (UGFS) for symptomatic superficial venous reflux (SVR).MethodsPrior to and 6 months after UGFS, 246 patients (317 limbs) completed a symptom questionnaire, underwent duplex ultrasonography and clinical assessment, and VRT measurement by digital PPG. Health related quality of life (HRQL) questionnaires were also completed.ResultsMedian VRT improved from 11 to 31 s (P < 0.0005, Wilcoxon Signed Ranks). Abnormal VRT (<20 s) correlated well with the presence of SVR on duplex (sensitivity 75%, specificity 94%). Pre-treatment there was a significant relationship between reducing VRT and increasing CEAP clinical grade (P < 0.0005, χ²), extent of SVR on duplex (P < 0.0005) and a non-significant relationship with overall increasing symptom severity (P = 0.097). Relief of all symptoms was more likely when there was normalisation of VRT after treatment (80% vs. 65%, P < 0.0005, χ²). Pre-treatment VRT correlated with both generic physical (r = 0.428, P = 0.002) and disease-specific (r = ?0.413, P = 0.003, Spearman's rank) HRQL.ConclusionsUGFS for SVR improves VRT measured by digital PPG and that improvement correlates with symptom relief.     

导管引导下泡沫硬化剂疗法治疗大隐静脉曲张

目的 探讨导管引导下的泡沫硬化剂疗法治疗下肢静脉曲张的临床效果.方法 选择2008年4月至8月间有微创治疗意愿的30例(条)中重度下肢静脉曲张患者.其中男性11例,女性19例;年龄34-85岁,平均年龄52岁.病史2～30年,平均20年.对其进行导管引导下患肢大隐静脉主干内注射1%聚桂醇泡沫硬化剂,观察大隐静脉主干的闭合情况.结果 30条患肢均在导管引导下成功注射硬化剂,平均每条患肢应用6.2 ml泡沫硬化剂,27条(90%)大隐静脉主干治疗后即刻可见反流消失.术后早期大隐静脉走行轻微浅静脉炎5例(条),2周内自行缓解,无严重的并发症发生.平均随访3个月,27例患者下肢活动后酸胀、乏力感消失,下肢明显的曲张畸形静脉消失;27条患肢(90%)于治疗后2周、3个月后复诊血管超声时大隐静脉主干闭塞.4例(条)患者(15%)仅有小腿局限的轻度曲张.结论 导管引导的泡沫硬化剂疗法治疗下肢静脉曲张的大隐静脉主干闭合率较高,是微创治疗下肢静脉曲张有效的新方法.     

Comparative Study of Outcome of Duplex Ultrasound-Guided,Catheter-Directed Foam Sclerotherapy and Radio-frequency Ablation in the Management of Great Saphenous Varicose Veins

Chronic venous insufficiency of lower limbs is a common problem in adults. We compared the two modalities, namely duplex ultrasound-guided, catheter-directed foam sclerotherapy (UGFS) and radio-frequency ablation (RFA), in the management of great saphenous varicose veins using clinical assessment (Venous Clinical Severity Score, Venous Disability Score) and duplex imaging. Patients presenting with great saphenous vein (GSV) varicosity due to incompetent saphenofemoral junction (SFJ) were selected and randomly assigned in each arm, i.e., duplex UGFS group and RFA group. Patients were assessed on days 7, 30, and 90 both clinically and sonologically. Clinical assessment was based on the Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS). Obliteration of the treated GSV segment was noted in all the limbs of the RFA group (31/31) on duplex sonography on days 7, 30, and 90, while in the UGFS group, out of 30 limbs, obliteration was successful in 28 (28/30) and 2 had treatment failure. However, outcome of both the groups were statistically comparable (P value?>?0.05). After the procedure, improvement in the VCSS was noted in both the study arms in every follow-up and both the modalities were found to be equally effective. Improvement in the Venous Disability Score was there on every follow-up, but maximum improvement was seen on the second visit, i.e., post-treatment day 30. Improvement was statistically significant and equal in both arms after the initial 1 week. Foam sclerotherapy, especially catheter-directed, is as effective as radio-frequency ablation in achieving anatomical obliteration and yielding relief in clinical signs and symptoms in patients with GSV varicosity with SFJ incompetence.