Functional repair of the great saphenous vein by external valvuloplasty reduces the vein's diameter: 6-month results of a multicentre study.

OBJECTIVES: External valvuloplasty (eVP) is a reconstructive surgical method to repair the function of the terminal and preterminal valves. We evaluated the 6-month outcomes of eVP regarding the diameter of the great saphenous vein (GSV). METHODS: Patients from five vein centres were included in this observational study. Follow-up involved detailed duplex sonography of the GSV. The venous clinical severity score (VCSS) and the C class of the clinical, aetiologic, anatomic and pathophysiologic (CEAP) classification were recorded. RESULTS: We enrolled 210 patients, with a follow-up rate of 58%; eVP was sufficient in 95.24% of the patients. The GSV diameters decreased significantly from 4.4 mm (standard deviation (SD): 1.39) to 3.9 (SD: 1.12), 4 cm distal to the saphenofemoral junction (SFJ); from 3.7 mm (SD: 1.10) to 3.5 mm (SD: 1.02) at the mid-thigh; from 3.6 mm (SD: 1.14) to 3.3 mm (SD: 0.94) at the knee and from 3.1 mm (SD: 0.99) to 2.9 mm (SD: 0.78) at the mid-calf. VCSS decreased significantly from 4.76 (SD: 2.13) preoperatively to 1.77 (SD: 1.57) 6 months postoperatively. CONCLUSIONS: GSV function can be restored by eVP; diameters over the total length of the GSV decreased significantly.

External valvuloplasty of the saphenofemoral junction in insufficient great saphenous veins - six weeks results of a prospective multicentre trial.

Background: Varicosis of the great saphenous vein (GSV) is a common disease. Most of the therapeutic concepts attempt to remove or destroy the truncal vein. However, the absence of the GSV could be harmful for further treatments of artherosclerotic disease as the GSV is often used as bypass graft in lower extremity or coronary artery revascularisations. External valvuloplasty (EV) is one of the vein-sparing treatment options. The aim of this clinical study was to describe the outcome, safety and complications of this procedure in a prospective multicentre trial. Patients and methods: The function of the terminal and preterminal valve was restored by external valvuloplasty. Furthermore, multiple phlebectomies of tributaries were performed. Patients were reinvestigated six weeks after surgery. Primary endpoint was the function of the external valvuloplasty measured by diameter of the GSV and the prevalence of reflux in the GSV. The eligibility of the vein as a potential bypass graft was noticed. CEAP class and VCSS scores were analysed. Results: A total of 359 patients were included in the study. After six weeks 297 patients could be reinvestigated. The function of the external valvuloplasty was sufficient in 284 patients (95.6%). Treatment failed in 8 patients (2.6%) due to an occlusion or junctional reflux despite valvuloplasty. The GSV was estimated as suitable as a bypass graft in 261 patients (87.8%). Reflux at the saphenofemoral junction was significantly reduced after treatment and the diameter of the GSV near the saphenofemoral junction significantly decreased from 4.4 mm to 3.8 mm (p < 0.05). The VCSS was significantly reduced from 4.6 preoperatively to 2.6 postoperatively. Conclusions: External repair of the great saphenous vein can reduce venous symptoms and may preserve the great saphenous vein as a bypass graft. Nevertheless, this treatment option is only suitable for a limited number of patients.

Genome-wide association analysis for chronic venous disease identifies EFEMP1 and KCNH8 as susceptibility loci.

Chronic venous disease (CVD) is a multifactorial condition representing one of the most common disorders among populations of Western countries. The heritability of about 17% suggests genetic risk factors in CVD etiology. However, so far the genetic causes are unknown. We undertook the hitherto first genome-wide association study (GWAS) for CVD, analyzing more than 1.93 M SNPs in 4,942 German individuals, followed by replication in two independent German data sets. The combined analysis of discovery and replication stages (2,269 cases and 7,765 controls) yielded robust associations within the two genes EFEMP1 and KCNH8 (rs17278665, rs727139 with P < 5 × 10-8), and suggestive association within gene SKAP2 (rs2030136 with P < 5 × 10-7). Association signals of rs17278665 and rs727139 reside in regions of low linkage disequilibrium containing no other genes. Data from the ENCODE and Roadmap Epigenomics projects show that tissue specific marks overlap with the variants. SNPs rs17278665 and rs2030136 are known eQTLs. Our study demonstrates that GWAS are a valuable tool to study the genetic component of CVD. With our approach, we identified two novel genome-wide significant susceptibility loci for this common disease. Particularly, the extracellular matrix glycoprotein EFEMP1 is promising for future functional studies due to its antagonistic role in vessel development and angiogenesis.

Comparable effectiveness of endovenous laser ablation and high ligation with stripping of the great saphenous vein: two-year results of a randomized clinical trial (RELACS study).

OBJECTIVE: To compare the clinical efficacy and safety of endovenous laser treatment (EVLT) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) insufficiency. DESIGN: Two-center randomized controlled trial with 2-year follow-up. SETTING: Interventions were performed on ambulatory and hospitalized patients at 2 vein centers, a university dermatology department (EVLT-treated group), and a specialized vein clinic (HLS-treated group). PATIENTS: Random sample of 400 patients with GSV insufficiency. INTERVENTIONS: Patients were assigned (1:1) to EVLT or HLS of the GSV from September 2004 through March 2007; 185 and 161 patients (limbs), respectively, were treated per protocol. MAIN OUTCOME MEASURES: Clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), duplex-detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), hemodynamics (venous refilling time), quality of life (Chronic Venous Insufficiency Questionnaire 2), adverse effects, and visual analog scale-based evaluations of patients' satisfaction. RESULTS: Clinically recurrent varicose veins after surgery were similarly observed in both groups: 16.2% (EVLT-treated group) vs 23.1% (HLS-treated group); P = .15. Duplex-detected saphenofemoral refluxes occurred significantly more frequently after EVLT (17.8% vs 1.3%; P < .001). Both treatments equally improved medical condition (Homburg Varicose Vein Severity Score) and disease-related quality of life. Endovenous laser treatment caused more adverse effects (phlebitic reaction, tightness, dyspigmentation) but revealed advantages concerning hemodynamics, recovery, and cosmetic outcome. CONCLUSIONS: Both EVLT and HLS are comparably safe and effective procedures to treat GSV incompetence. The significantly higher rate and the course of duplex-detected saphenofemoral recurrences after EVLT remain a matter of further investigations. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN18322872.

Construction and evaluation of a multidimensional score to assess varicose vein severity - the Homburg Varicose Vein Severity Score (HVVSS).

To evaluate a novel score (HVVSS) for varicose vein patients combining subjective symptoms, clinical findings and functional data of venous insufficiency. 91 patients (118 legs) with primary varicose veins of the great, small or accessory anterior saphenous vein were treated with conventional surgery. HVVSS was assessed pre- and 3 months postoperatively. The data were compared with established clinical and disease-related life quality scores (VCSS, AVVQ, CIVIQ). Test responsiveness, validity and reliability were determined using correlations with CEAP stage and venous refilling time as hemodynamic parameter, and inter-observer variability was assessed. All scores were highly responsive to varicose vein surgery (p<0.001). HVVSS(0-100) decreased from 34.1 ± 13.0 to 9.6 ± 6.9 postoperatively. The relative score change of HVVSS was superior to VCSS (69.5% vs. 58.8%, p=0.005). HVVSS revealed highly significant correlations with the clinical CEAP stage and was exclusively able to differentiate mild from severe disease as defined by venous refilling time (p=0.009). Inter-observer reliability of HVVSS was confirmed by correlation coefficients of 0.977 and 0.950 pre- and postoperatively (p<0.001). HVVSS is a suitable and reliable tool to assess disease severity in varicose vein patients and to quantify therapeutic effects of varicose vein treatment.

Venoarterial flow index steadily improves after endovenous laser treatment of the great saphenous vein.

BACKGROUND: Endovenous laser treatment (EVLT) is a minimally invasive procedure to ablate varicose veins. The venous arterial flow index (VAFI) represents a quantitative duplex ultrasound parameter to characterize venous hemodynamics, which has not been investigated in EVLT so far. OBJECTIVE: To analyze the hemodynamic improvement of EVLT of the great saphenous vein (GSV) according to VAFI measurement. MATERIALS AND METHODS: One hundred thirty-three participants with complete GSV insufficiency were treated with 810-nm EVLT. VAFI as a ratio of venous and arterial flow volumes of the common femoral vessels and digital photoplethysmography (DPPG) were assessed before and 3 (n=129) and 12 months (n=71) after EVLT. RESULTS: EVLT was performed with an energy fluence of 22.5 J/cm², resulting in an occlusion rate of 98.4%. Duplex recurrence rates were 9.4% at 3-month and 15.5% at 12-month follow-up. VAFI significantly improved from 1.395 to 1.242 and 1.167 (p<.001) 3 and 12 months after EVLT. Venous refilling time (DPPG) accordingly increased from 20.0 to 36.9 seconds (p<.001) 3 months postoperatively. CONCLUSION: EVLT improves hemodynamic alterations in people with incompetent GSVs as demonstrated using VAFI and DPPG. VAFI might be a suitable diagnostic tool to quantify venous hemodynamics in people with varicose veins. The authors have indicated no significant interest with commercial supporters.

Heritability of chronic venous disease.

Varicose veins without skin changes have a prevalence of approximately 20% in Northern and Western Europe whereas advanced chronic venous insufficiency affects about 3% of the population. Genetic risk factors are thought to play an important role in the aetiology of both these chronic venous diseases (CVD). We evaluated the relative genetic and environmental impact upon CVD risk by estimating the heritability of the disease in 4,033 nuclear families, comprising 16,434 individuals from all over Germany. Upon clinical examination, patients were classified according to the CEAP guidelines as either C2 (simple varicose veins), C3 (oedema), C4 (skin changes without ulceration), C5 (healed ulceration), or C6 (active ulcers). The narrow-sense heritability (h2) of CVD equals 17.3% (standard error 2.5%, likelihood ratio test P = 1.4 x 10(-13)). The proportion of disease risk attributable to age (at ascertainment) and sex, the two main risk factors for CVD, was estimated as 10.7% (Kullback-Leibler deviance R2). The heritability of CVD is high, thereby suggesting a notable genetic component in the aetiology of the disease. Systematic population-based searches for CVD susceptibility genes are therefore warranted.