Abstract
Endovenous laser ablation of the great saphenous vein comparing 1920-nm and 1470-nm diode laser
D Mendes-Pinto, P Bastianetto, L Cavalcanti Braga Lyra, et al.
Int Angiol 2016; 35: 599–604.
The aim of this study was to compare venous occlusion rates at a one-year follow-up comparing 1920-nm versus 1470-nm endolaser.
The authors in a randomized prospective trial compared the 1470-nm (42 limbs) to the 1920-nm (48 limbs) wavelength with regard to safety and efficacy. There were no differences in relation to age, CEAP (Clinical, Etiologic, Anatomical and Pathological Classification), VCSS (Venous Clinical Severity Score) and saphenous diameter. The resulting LEED in 1920-nm group was 17.8 ± 0.6 J/cm and vs. 24.7 ± 0.8 J/cm in 1470-nm group (P < 0.01). Closure rates were lower for the 1920-nm group: 90.9% vs. 96.8% (P = 0.06) at 30 days, 87.5% vs. 96.3% at six months (P = 0.03), and 87.5% vs. 94.7% (P = 0.05) at one year. The 1920-nm group had less ecchymosis (18.7% vs. 52.4%), induration (12.4% vs. 38.1%) and days of analgesic use (1.4 ± 0.2 vs. 2.4 ± 0.4). CEAP and VCSS were reduced over time in both groups.
The authors concluded that the treatment with endolaser 1920-nm was feasible and with reduced complications. The use of low endoluminal energy resulted in decreased vein occlusion rates in comparison to the 1470-nn laser. Clinical outcome scores were similar between wavelengths.
Treatment modalities for small saphenous vein insufficiency: Systematic review and meta-analysis
D Boersma, VN Kornmann, RR van Eekeren, et al.
J Endovasc Ther 2016; 23: 199–211.
The authors studied the efficacy and safety, paresthesia and deep vein thrombosis (DVT) for small saphenous vein treatment by endovenous laser ablation (EVLA), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy (UGFS), steam ablation, mechanochemical endovenous ablation (MOCA), and surgery using PUBMED, EMBASE, and Cochrane Library. The combined anatomical efficacy was 58.0% (95% CI 40.9% to 75.0%) for surgery in 798 SSVs, 98.5% for EVLA in 2950 SSVs, 97.1% to 99.9% for RFA in 386 SSVs, and 63.6% for UGFS in 494 SSVs. One study reported results of MOCA, with 94% closure rate. Neurologic complications were most frequently reported after surgery (mean 19.6%) and thermal ablation (EVLA: mean 4.8%; RFA: mean 9.7%). Deep venous thrombosis rate was 0% to 1.2%.
The authors concluded that thermal ablation (EVLA/RFA) should be preferred to surgery and foam sclerotherapy in the treatment of SSV incompetence.
After superficial ablation for superficial reflux associated with primary deep axial reflux, can variable outcomes be caused by deep venous valve anomalies?
O Maleti, M Lugli, M Perrin.
Eur J Vasc Endovasc Surg 2016 [Epub ahead of print] pii: S1078-5884(16)30541-X. DOI: 10.1016/j.ejvs.2016.10.009.
The authors in 21 patients in a retrospective study to attempted to identify deep venous valve anomalies (reflux) in patients who underwent great saphenous vein ablation without improvement. In 17/21 patients, the deep reflux was not abolished. In this subgroup, surgical exploration of the deep valve was performed using venotomy for possible valve repair. Among the 17 subgroup patients, four post-thrombotic lesions were discovered intra-operatively in four patients; they underwent different surgical procedures. In 13 of the subgroup patients, primary valve incompetence was confirmed intra-operatively. In 11 cases, the leaflets were asymmetrical and in only two were they symmetrical. After valvuloplasty, deep reflux was abolished in all 13 patients. Clinical improvement was obtained in 12/13 patients (92%). It is noteworthy that abolition of deep reflux was associated with significant improvement in air plethysmography data as well as with improvement in clinical status measured on CEAP class, VCSS and the SF-36 questionnaire.
The authors concluded that failure to correct deep axial reflux by superficial ablation in patients with superficial and associated primary deep axial reflux may be related to asymmetry in the valve leaflets.
Post-operative benefit of compression therapy after endovenous laser ablation for uncomplicated varicose veins: A randomized clinical trial
K Ye, R Wang, J Qin, et al.
Eur J Vasc Endovasc Surg 2016; 52: 847–853.
The authors studied utilizing a randomized trial of C2 patients treated with EVLA at a single institution from January 2012 to November 2013. Before EVLA, patients were randomized into two groups based on whether or not (control group) they wore an elastic compression stocking (ECS group) post-operatively. The primary end point was the pain score (visual analog scale [VAS], range from 0 to 10), while secondary end points included the severity of operation-related complications, the quality of life (Aberdeen Varicose Vein Symptoms Severity Score, AVVSS), and the mean time to return to work. A total of 400 patients (200 patients in each group) were included. In the first week after EVLA, patients in the ECS group experienced less pain (p < 0.001) and edema (p = 0.01), but by two weeks there was no difference between groups. There were no differences in the quality of life or in the mean-time to return to work.
The authors concluded that use of an elastic compression stocking does not prove to be a sustainable benefit.
Surgical management of iliofemoral vein thrombosis during pregnancy and the puerperium
P Dueppers, K Grabitz, Y Li, et al.
J Vasc Surg: Venous and Lym Dis 2016; 4: 392–399.
Between 1996 and 2016, all women who received venous thrombectomy (VT) for pregnancy-related deep venous thrombosis were included. Retrospective data were combined with a current follow-up. The study included 82 women with a mean age of 29 years (17–38 years). An additional arteriovenous fistula was performed in 79 and planned simultaneous cesarean section in 13 patients. Neither pulmonary emboli nor fetal complications occurred during surgery, and perioperative and postoperative mortality was 0%. Operative revision was required in 38% mainly for rethrombosis (24%) and bleeding (12%). One fetus died two months after VT of unrelated causes. After a mean of 83 months, complete venous recanalization was seen in 88%, venous valve sufficiency in 90%, and PTS in 31% without any ulcers. At 10 years, PTS incidence rose to reach 50% with limited statistical significance because of the number of patients reaching long-term follow-up. The authors concluded that iliofemoral venous recanalization during pregnancy can be performed safely in a specialized center, with lower PTS rates than in historical controls.
In vitro evaluation of clot capture efficiency of an absorbable vena cava filter
SJ Dria, MD Eggers.
J Vasc Surg: Venous and Lym Dis 2016; 4: 472–478.
Conceptually, an absorbable inferior vena cava filter constructed from a flexible polymer is clinically appealing because it obviates filter retrieval and is unlikely to perforate the inferior vena cava and to impale neighboring organs. A recent in vivo study demonstrated that the investigational absorbable filter retained sufficient mechanical strength to function for the indicated prophylactic period with no migration, caval penetration, or tilt >15degrees. This study assessed clot capture efficiency for the absorbable filter vs. the Greenfield stainless steel filter as an indication of the filter’s efficacy at preventing pulmonary embolism before commencement of human studies.
Investigational absorbable and Greenfield filters were challenged with polyacrylamide clot surrogates ranging from 3 × 5 to 10 × 24 mm (diameter × length) in a flow loop simulating the venous system. Filters were challenged with clots until clot capture efficiency (CCE) standard error of 5%, or less was achieved under binomial statistics. Pressure gradients across the filters were measured for the largest size clot, enabling calculation of forces on the filter. The in vitro CCE of the absorbable IVCF was statistically similar to that of the Greenfield filter for all clot sizes apart from the 3 × 10-mm clot, for which there was statistically significant difference between filter CCEs (absorbable filter, 59%; Greenfield filter, 31%; P = 0.0001). CCE ranged from an average 32% for the 3 × 5-mm clot to 100% for 7 × 10-mm and larger clots for the absorbable IVCF. Pressure gradient across the absorbable filter with 10 × 24-mm clot averaged 0.14 mmHg, corresponding to a net force on the filter of 2.1 × 10−3 N, compared with 0.39 mmHg or 5.8 × 10−3 N (P < 0.001) for the Greenfield filter. The investigators concluded that CCE of the absorbable filter was statistically similar to or an improvement on that of the Greenfield stainless steel filter for all clot sizes tested. CCE of the Greenfield filter in this study aligned with data from previous studies. Given the efficacy of the Greenfield filter in attenuating the risk of pulmonary embolism, the current study suggests that the absorbable filter may be a viable candidate for subsequent human testing.
Endovenous ablation therapy (laser or radiofrequency) or foam sclerotherapy versus conventional surgical repair for short saphenous varicose veins
SC Paravastu, M Horne, PD Dodd.
Cochrane Database Syst Rev 2016; 11: CD010878.
To compare the effectiveness of endovenous laser ablation (EVLA), radiofrequency ablation (RFA) and ultrasound-guided foam sclerotherapy (UGFS) versus conventional surgery in the treatment of Short (or small) saphenous vein (SSV) varices the Cochrane Vascular Information Specialist searched the Specialised Register (last searched 17 March 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2). All randomised controlled trials (RCTs) comparing EVLA, endovenous RFA or UGFS with conventional surgery in the treatment of SSV varices were considered for inclusion and independently reviewed. Trials that met the inclusion criteria were assessed; any disagreements were resolved by discussion. Data were extracted; the Cochrane’s tool for assessing risk of bias was used – the authors performed either fixed-effect meta-analyses with odds ratios (ORs) and 95% confidence intervals (CIs) or random-effects meta-analyses where there was moderate to significant heterogeneity. The authors identified three RCTs, all of which compared EVLA with surgery; one also compared UGFS with surgery. There were no trials comparing RFA with surgery. The EVLA versus surgery comparison included 311 participants: 185 received EVLA and 126 received surgery. In the UGFS comparison, each treatment group contained 21 subjects. For several outcomes in the EVLA comparison, only a single study provided relevant data; as a result, the current review is limited in its ability to demonstrate meaningful results for some planned outcomes. The quality of evidence according to GRADE was moderate to low for the outcome measures in the EVLA versus surgery comparison, but low for the UGFS versus surgery comparison. Reasons for downgrading in the EVLA versus surgery comparison were risk of bias (for some outcomes, the outcome assessors were not blinded; and in one study, the EVLA-surgery allocation of 2:1 did not appear to be prespecified); imprecision (data were only available from a single small study, and the CIs were relatively wide); indirectness (one trial reported results at six months rather than one year and was inadequately powered for SSV varices-only analysis). Reasons for downgrading in the UGFS versus surgery comparison were imprecision (only one trial offered UGFS, and several participants were missing from the analysis) and a limitation in design (the study was inadequately powered for SSV participants alone). For the EVLA versus surgery comparison, recanalization or persistence of reflux at six weeks occurred less frequently in the EVLA group than in the surgery group (OR 0.07, 95% CI 0.02 to 0.22; I2 = 51%; 289 participants, 3 studies, moderate-quality evidence). Recurrence of reflux at one year was also less frequent in the EVLA group than in the surgery group (OR 0.24, 95% CI 0.07 to 0.77; I2 = 0%; 119 participants, 2 studies, low-quality evidence). For the outcome clinical evidence of recurrence (i.e. presence of new visible varicose veins) at one year, there was no difference between the two treatment groups (OR 0.54, 95% CI 0.17 to 1.75; 99 participants, 1 study, low-quality evidence). Four participants each in the EVLA and surgery groups required reintervention due to technical failure (99 participants, 1 study, moderate-quality evidence). There was no difference between the two treatment groups for disease-specific quality of life (QoL) (Aberdeen Varicose Veins Questionnaire) either at six weeks (mean difference (MD) 0.15, 95% CI −1.65 to 1.95; I2 = 0%; 265 participants, 2 studies, moderate-quality evidence), or at one year (MD −1.08, 95% CI −3.39 to 1.23; 99 participants, 1 study, low-quality evidence). Main complications reported at six weeks were sural nerve injury, wound infection and deep venous thrombosis (DVT) (one DVT case in each treatment group; EVLA: 1. For the UGFS versus surgery comparison, there were insufficient data to detect clear differences between the two treatment groups for the two outcomes recanalization or persistence of reflux at six weeks (OR 0.34, 95% CI 0.06 to 2.10; 33 participants, 1 study, low-quality evidence), and recurrence of reflux at one year (OR 1.19, 95% CI 0.29 to 4.92; 31 participants, 1 study, low-quality evidence). No other outcomes could be reported for this comparison because the study data were not stratified according to saphenous vein.
The authors concluded that moderate- to low-quality evidence exists to suggest that recanalization or persistence of reflux at six weeks and recurrence of reflux at one year are less frequent when EVLA is performed, compared with conventional surgery. For the UGFS versus conventional surgery comparison, the quality of evidence is assessed to be low; consequently, the effectiveness of UGFS compared with conventional surgery in the treatment of SSV varices is uncertain. Further RCTs for all comparisons are required with longer follow-up (at least five years). In addition, measurement of outcomes such as recurrence of reflux, time taken to return to work, duration of procedure, pain, etc., and choice of time points during follow-up should be standardized such that future trials evaluating newer technologies can be compared efficiently.
Value of delayed duplex ultrasound assessment after endothermal ablation of the great saphenous vein
EJ Ryer, JR Elmore, RP Garvin, et al.
J Vasc Surg 2016; 64: 446–451.
Endothermal ablation (ETA) of the great saphenous vein (GSV) is associated with a small but definite risk of endothermal heat-induced thrombosis (EHIT) extending into the common femoral vein. This was a retrospective review of consecutive ETA GSV procedures from 2007 to 2014. All patients were evaluated with duplex ultrasound imaging on postprocedure day 1, and 79% of patients underwent a second ultrasound assessment one week postprocedure. EHIT was considered present when proximal GSV closure progressed to level ≥4, based on a six-tier classification system. A total of 842 patients underwent GSV ETA. Patients with EHIT were more likely to have had a prior deep venous thrombosis (DVT; P = 0.002) and a larger GSV (P = 0.006). Forty-three procedures (5.1%) were classified as having EHIT requiring anticoagulation, based on a level ≥4 proximal closure level. Of the 43 patients with EHIT, 20 (47%) were found on the initial ultrasound assessment performed 24 h post-procedure, but 19 patients (44%) with EHIT would not have been identified with a single postoperative ultrasound scan performed 24 h after intervention. These 19 patients had a level ≤3 closure level at the duplex ultrasound scan performed 24 h post-procedure and progressed to EHIT on the delayed duplex ultrasound scan. Lastly, thrombotic complications in four patients (9%), representing three late DVT and one DVT/pulmonary embolism presenting to another hospital, would not have been identified regardless of the postoperative surveillance strategy. Maximum GSV diameter was the only significant predictor of progression to EHIT on multivariate analysis (P = 0.007). Based on 2014 United States dollars, the two-ultrasound surveillance paradigm is associated with health care charges of $31,109 per identified delayed venous thromboembolism event. In conclusion, delayed duplex ultrasound assessment after ETA of the GSV comes with associated health care costs but does yield a significant number of patients with progression to EHIT. Better understanding of the timing, risk factors, and significance of EHIT is needed to cost-effectively care for patients after ETA for varicose veins.