Abstract
The effect of wavelength on endothermal heat-induced thrombosis incidence after endovenous laser ablation (EVLA)
WP Shutze, K Kane, T Fisher, et al.
J Vasc Surg Venous Lymphat Disord 2016; 4: 36–44
Retrospective review of EVLA from 2005 to 2014 with an 810-nm (hemoglobin-specific) or 1470-nm (water-specific) laser. Age, sex, body mass index, Clinical, Etiologic, Anatomic, and Pathophysiologic (CEAP) class, vein diameter, vein(s) treated, adjunctive phlebectomy, energy delivered, laser pullback times, and EHIT (closure level ≥3) development were included in the review. The Fisher exact test and Pearson χ2 test were used to evaluate the association between EHIT and the categoric variables. Logistic regression was used to evaluate the relationship between EHIT and the continuous variables. There were 1439 veins ablated in 1109 patients (769 females, 340 males). The great saphenous vein (GSV) was treated in 1332, the small saphenous vein (SSV) in 78, and both in 29 (22 procedures on accessory veins were excluded). The CEAP C class for these patients was 1 in 0, 2 in 616, 3 in 522, 4 in 150, 5 in 51, and 6 in 98, and was not recorded in 2. EHIT occurred in 76 cases (5.28%), in 73 after GSV ablation and in 3 after SSV ablation. The 810-nm laser was used in 1144 procedures, and EHIT developed in 69 patients (6.0%). The 1470-nm laser was used in 295 procedures, with EHIT developing in seven patients (2.4%; p = .0122). The average energy delivered to the EHIT group (3517 ± 1998.1 J) was higher than for the non-EHIT group (2825.1 ± 1491.2 J; p = .0002). The average vein diameter was larger in the EHIT group (9.3 ± 3.8 mm) than in the non-EHIT group (7.2 ± 3.3 mm; p = .0001). EHIT occurred in 59 of 837 cases (6.6%) undergoing simultaneous stab phlebectomy compared with 17 of 525 cases (3.1%) undergoing only EVLA (p = .0049). Statistical analysis confirmed that the association between EHIT and CEAP class was significant (p = .0001). No differences were seen for age, body mass index, sex, combined bilateral, and multiple or simultaneous GSV and SSV ablations between the two groups. A multivariate analysis confirmed that CEAP class, vein diameter, adjunctive phlebectomy, and 810 laser wavelength were indeed risk factors for post-EVLA EHIT and that energy delivered and pullback time were not.
Prevalence of non-thrombotic iliac vein lesions in patients with unilateral primary varicose veins
Ł Dzieciuchowicz, R Krzyżański, Ł Kruszyna, et al.
EJVS 2016; 51: 429–433
The authors investigated the association between the presence of non-thrombotic iliac lesions (NIVLs), using intravascular ultrasound, and primary varicose veins (PVVs) and the frequency of NIVLs in asymptomatic and PVV limbs. Thirty-three patients with unilateral PVV and great saphenous vein incompetence who were qualified for surgical treatment were analyzed. Fifty-seven percent of patients presented with varicose veins on the right side. During varicose vein surgery, IVUS of the bilateral common iliac veins (CIVs), bilateral external iliac veins (EIVs), and the inferior vena cava was performed. In both the CIVs and the EIVs, the minimal and reference lumen areas were measured, and the percentage stenosis was calculated. The minimal lumen area (MLA) was smaller, and the stenosis of the CIV was greater on the left side than the right: median 57 and 108 mm2 (p = 0.001) and 69 and 34% (p < 0.001), respectively. However, when the PVV and non-PVV sides were compared, no statistically significant differences of MLA or stenosis of the CIV were found: 88 and 67 mm2 (p = 0.38) and 44% and 51% (p = 0.40), respectively. With regard to EIVs, no statistically significant differences in either MLA or stenosis between the left and right and PVV and non-PVV sides were found. The frequency of ≥50% stenosis of CIV and EIV in the PVV limbs and the non-PVV limbs was 42% and 48% and 51% and 39%, respectively.
The authors concluded that NIVLs are not associated with the presence of ipsilateral PVV.
Randomized clinical trial of 940- versus 1470-nm endovenous laser ablation for great saphenous vein incompetence
WS Malskat, J Giang, MG De Maeseneer, et al.
Br J Surg 2016; 103: 192–198
Patients with great saphenous vein incompetence were randomized to receive 940- or 1470-nm EVLA. The primary outcome was pain at 1 week. Secondary outcomes were patient satisfaction, duration of analgesia use and time without normal activities assessed at 1 week; HRQoL after 12 weeks; treatment success after 12 and 52 weeks; change in Venous Clinical Severity Score (VCSS) after 12 weeks; and adverse events at 1 and 12 weeks. A total of 142 legs were randomized (940-nm EVLA, 70; 1470-nm EVLA, 72). Patients in the 1470-nm laser group reported significantly less pain on a visual analogue scale than those in the 940-nm laser group: median (i.q.r.) score 3 (2–7) versus 6 (3–8) (p = 0·004). Duration of analgesia use was significantly shorter after 1470-nm EVLA: median (i.q.r.) 1 (0–3) versus 2 (0–5) days (p = 0·037). HRQoL and VCSS improved equally in both groups. There was no difference in treatment success rates. Complications were comparable in both groups, except for more superficial vein thrombosis one week after 1470-nm EVLA. The authors concluded that EVLA using a 1470-nm wavelength fibre was associated with improved postoperative pain and a reduction in analgesia use in the first week after surgery compared with use of a 940-nm fibre. Treatment success and adverse event rates were similar.
The use of the VEINES-QOL/Sym questionnaire in patients operated for varicose veins
Ł Migdalski and Kuzdak K.
Pol Przegl Chir 2015; 87: 491–498
As a result of no data available concerning the use of VEINES to assess patients after varicose vein (VV) surgery, the authors studied the change in quality of life (QOL) after VV surgery and verified the usefulness of VEINES in a venous practice. Sixty-nine patients (CEAP class C2-C3) indicated for VV surgery were studied. The patients responded 2 h before surgery and after 3 months. Patients were differentiated into several categories according to CEAP stage, age, sex, BMI, the use/lack of compression therapy, and education level. The QOL increased significantly in C3 patients, patients over the age of 50, and all patients regardless of education. There were no differences between groups differentiated according to sex, the use or lack of compression therapy, or BMI.
The authors concluded that VEINES-QOL/Sym questionnaire is reliable and valid to be used in a daily venous practice to assess patients before and after venous intervention.
A systematic review of endovenous stenting in chronic venous disease secondary to iliac vein obstruction
MJ Seager, A Busuttil, B Dharmarajah, et al.
Eur J Vasc Endovasc Surg 2016; 51: 100–120
This report aimed to produce a systematic review and meta-analysis of the available data reported to the Preferred Reporting Items for Systematic reviews and meta-analyses guideline. MEDLINE, EMBASE, and the Cochrane Central Register for Controlled Trials databases and key references were searched. Sixteen studies were included (14 before-and-after studies, 1 controlled before-and-after study, and 1 case series) encompassing successful deep venous stenting in 2373 and 2586 post-thrombotic or non-thrombotic limbs and patients, respectively. The data were too heterogeneous to perform a meta-analysis. There were significant improvements in validated measures of the severity of CVD and venous disease-specific quality of life. Persistent ulcer healing rates ranged from 56 to 100% in limbs that had often already failed conservative management. Primary and secondary stent patency ranged from 32 to 98.7% and 66–96%, respectively. The major complication rate ranged from 0 to 8.7% per stented limb. A GRADE assessment demonstrated the quality of the evidence for five outcomes to be “Very Low” and one to be “Low” (ulcer healing). The investigators concluded that quality of evidence to support the use of deep venous stenting to treat obstructive CVD is currently weak. The treatment does, however, appear promising and is safe and should therefore be considered as a treatment option, while the evidence base is improved.
A meta-analysis of low-molecular-weight heparin to prevent pregnancy loss in women with inherited thrombophilia
L Skeith, M Carrier, R Kaaja, et al.
Blood, Epub ahead of print, 2 February 2016
The authors studied, using a meta-analysis method, whether the use of low-molecular-weight heparin (LMWH) to prevent pregnancy loss with inherited thrombophilia was appropriate. Using randomized controlled trials comparing LMWH versus no LMWH in women with inherited thrombophilia and prior late (≥10 weeks) or recurrent early (<10 weeks) pregnancy loss, 8 trials and 483 patients met inclusion criteria. There was no significant difference in live birth rates with the use of LMWH compared to no LMWH (RR 0.81, 95% CI, 0.55 to 1.19, p = 0.28).
The authors concluded that the meta-analysis suggested no benefit of LMWH in preventing recurrent pregnancy loss in women with inherited thrombophilia.
Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): An international, prospective, non-interventional study
W Ageno, LG Mantovani, S Haas, et al.
Lancet Haematol 2016; 3: e12–e21
XA inhibition with rivaroxaban for long term and initial anticoagulation in venous thromboembolism (XALIA) was a multicentre, international, prospective, non-interventional study of patients with deep-vein thrombosis, done in hospitals and community care centres in 21 countries. The study investigated the safety and effectiveness of rivaroxaban compared with standard anticoagulation therapy (initial treatment with unfractionated heparin, low-molecular-weight heparin, or fondaparinux, usually overlapping with and followed by a vitamin K antagonist) for at least three months. Eligible patients were adults (aged ≥18 years) with an objectively confirmed diagnosis of deep-vein thrombosis, and an indication to receive anticoagulation treatment for at least three months. Following approval of rivaroxaban for the pulmonary embolism indication, patients with deep-vein thrombosis and concomitant pulmonary embolism were also eligible; however, those with isolated pulmonary embolism were not included. Type, dose, and duration of therapy for each patient were at the physician's discretion. The primary effectiveness and safety outcomes were major bleeding, recurrent venous thromboembolism, and all-cause mortality. Propensity score-adjusted analyses were done to account for potential imbalances between groups. Between 26 June 2012 and 31 March 2014, 5142 patients were enrolled. The safety population (all patients who received at least one dose of the anticoagulant of interest) comprised 2619 patients in the rivaroxaban group and 2149 in the standard anticoagulant therapy group. Patients in the rivaroxaban group were younger and fewer had active cancer or concomitant pulmonary embolism than those in the standard anticoagulation group. In the propensity score-adjusted population, the frequency of major bleeding was 0.8% (19/2505) in the rivaroxaban group and 2.1% (43/2010) in the standard anticoagulation group, with a propensity score-adjusted hazard ratio (HR) of 0.77 (95% CI 0.40–1.50, p = 0.44). The frequency of recurrent venous thromboembolism was 1.4% (36/2505) in the rivaroxaban group and 2.3% (47/2010) in the standard anticoagulation group (propensity score-adjusted HR 0.91 (95% CI 0.54-1.54, p = 0.72). The all-cause mortality frequency was 0.4% (11/2505) in the rivaroxaban group and 3.4% (69/2010) in the standard anticoagulation group (propensity score-adjusted HR 0.51 (95% CI 0.24–1.07, p = 0.074). The incidence of treatment-emergent adverse events in the safety population was similar between the two groups (944 (36.0%) of 2619 in the rivaroxaban group vs. 805 (37.5%) of 2149 in the standard anticoagulation group). The study concluded that in routine clinical practice, rivaroxaban-treated patients had a lower risk profile at baseline than those treated with standard anticoagulation. Propensity score-adjusted results confirm that rivaroxaban is a safe and effective alternative to standard anticoagulation therapy in a broad range of patients. Rates of major bleeding and recurrent venous thromboembolism were low in rivaroxaban-treated patients and consistent with phase 3 findings.
Low-molecular-weight heparin plus aspirin versus aspirin alone in pregnant women with hereditary thrombophilia to improve live birth rate: Meta-analysis of randomized controlled trials
AL Areia, E Fonseca, M Areia, et al.
Arch Gynecol Obstet 2016; 293: 81–86.
The investigators used a meta-analysis of randomized controlled trials evaluating LMWH (low-molecular-weight heparin) + ASA compared to ASA in pregnant women with hereditary thrombophilia in order to improve live birth rate. Live birth rate was the primary outcome measure. Secondary outcomes included rates of first-trimester miscarriage, prematurity, pre-eclampsia, and low birth weight for gestational age babies.
Four trials were included in the quantitative synthesis in a total of 222 randomized women. Effect of LMWH + ASA versus ASA with regard to live births was evaluable in all four randomized controlled trials with a similar overall treatment effect for the therapies OR 1.7 (95% CI 0.72–4.0) and without heterogeneity (I (2) = 0 %). No significant differences or heterogeneity were observed between groups for secondary outcomes, namely first-trimester miscarriages OR 0.69 (0.22–2.16), prematurity OR 0.99 (0.4–2.08), pre-eclampsia OR 1.49 (0.63–3.5), and small for gestational age babies OR 2.08 (0.96–4.47).
The authors concluded that there were no significant differences in live birth weight and other pregnancy outcomes between LMWH + ASA vs. ASA. In addition, the authors stated that these findings were based on a paucity of trials presenting methodological limitations; therefore, there is no evidence to support any incremental benefit of adding LMWH to ASA alone in women with inherited thrombophilia.
Microwave ablation versus laser ablation in occluding lateral veins in goats
XH Wang, XP Wang, WJ Su, et al.
J Huazhong Univ Sci Technol Med Sci 2016; 36: 106–110
These investigators studied endovenous microwave ablation (EMA), a technique for truncal thermal ablation not widely studied, in the goat model using endovenous laser ablation (EVLA) as the standard. Twelve animals were randomized into two groups: with six treated with EMA (EMA group) and six with EVLA (EVLA group). Results of coagulation including coagulation, fibrinolysis and platelet activation were assessed at three or four different time points: before, immediately after, 24 h (and 48 h) after ablation. The length of the ablated vein and preoperative average diameter were comparable between the two groups. In both EMA and EVLA groups, several coagulation parameters, fibrinolysis and platelet activation parameters only underwent slight changes. Ultrasound imaging displayed that the diameter reduction of the veins treated by EMA was significantly larger than by EVLA. Microscopic examination revealed necrosis and thickening of the vein wall and occlusion of the lumen within three months after ablation in both EMA and EVLA groups.
The authors concluded that EMA is a minimally invasive therapy, which appears to be safe and effective for treatment of lateral veins in goats.