Eberhard Rabe

Revision of the venous clinical severity score: Venous outcomes consensus statement: Special communication of the American Venous Forum Ad Hoc Outcomes Working Group

In response to the need for a disease severity measurement, the American Venous Forum committee on outcomes assessment developed the Venous Severity Scoring system in 2000. There are three components of this scoring system, the Venous Disability Score, the Venous Segmental Disease Score, and the Venous Clinical Severity Score (VCSS). The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. However, as a descriptive instrument, the CEAP classification responds poorly to change. The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment. Based on initial experiences with the VCSS, an international ad hoc working group of the American Venous Forum was charged with updating the instrument. This revision of the VCSS is focused on clarifying ambiguities, updating terminology, and simplifying application. The specific language of proven quality-of-life instruments was used to better address the issues of patients at the lower end of the venous disease spectrum. Periodic review and revision are necessary for generating more universal applicability and for comparing treatment outcomes in a meaningful way.

Distribution and prevalence of reflux in the superficial and deep venous system in the general population--results from the Bonn Vein Study, Germany.

OBJECTIVE Venous diseases are among the most frequent diseases in the general population of industrialized countries. The aim of this article is to investigate the population-based prevalence of pathologic reflux in superficial and deep leg veins, taking into account factors as gender, age, and clinical classification of venous disease. METHODS In a population-based cross-sectional study, 3072 subjects aged 18 to 79 years (1350 male, 1722 female, response 59%) were enrolled from October 2000 through November 2001. A standardized interview was conducted to document phlebological history and clinical examinations including duplex sonography of selected superficial and deep leg veins. Pathological reflux was defined as being >500 ms. All participants where classified according to the CEAP classification. RESULTS Using the highest clinical stage per participant, 9.6% where classified C0, 59.0% C1, 14.3% C2, 13.5% C3, 2.9% C4, and 0.7% C5-C6. A pathological reflux (>500 ms) was found in 35.3% (95% confidence interval [CI] 33.6-37.1) of subjects with 21.0% (95% CI 19.5-22.5) showing reflux in at least one superficial vein and 20.0% (95% CI 18.6-21.5) showing reflux in at least one deep vein. We observed significantly higher reflux prevalence for the superficial veins in women while for the deep veins reflux prevalence were significantly higher in men. Prevalence of reflux in the superficial veins markedly increases with age. In the deep venous system, no clear changes in reflux prevalence with age can be observed. For superficial veins, reflux prevalence is markedly higher with higher C-stages. For the deep veins, the proportion of refluxes is relatively constant in stages C0-C3 with a distinct increase of prevalence from stage C4 onward. CONCLUSION Our results show a high prevalence of reflux both for the superficial and the deep venous system. Reflux prevalence is associated with gender, age, and the clinical stage as measured by the CEAP classification. Further longitudinal studies are needed to clarify the relevance of pathological reflux in subjects with otherwise healthy veins.

First results with a new 1470-nm diode laser for endovenous ablation of incompetent saphenous veins

Introduction Most of the published EVLA data concern 810, 940, 980 nm diode lasers and 1064 or 1320 nm Nd:Yag laser systems. Major side effects are postoperative pain and bruising. The aim of this study was to show the outcome one year after EVLA of incompetent saphenous veins with a 1470 nm Diode laser (Ceralas E, biolitec). Patients and method Between December 2006 and February 2007, 134 saphenous veins (108 GSV, 26 SSV) in 117 legs of 100 consecutive patients where treated by EVLA for GSV and SSV incompetence. All patients were examined clinically and with duplex by an experienced phlebologist prior to intervention, and at the follow-up visits for complications, occlusion, flow and reflux in the treated vein segment. The clinical evaluation included clinical CEAP and the presence of recurrent varicose veins. Patient satisfaction was assessed by a 0 to 4 scale. Results After a mean follow-up period of 184 days (SD 27) 127 treated veins (102 GSV, 25 SSV) of 111 limbs in 94 patients and after 329 days (SD 14) 105 treated veins (94 GSV, 21 SSV) of 105 limbs in 83 patients were reinvestigated. Six patients were lost to follow up after six months and an additional 11 patients after one year. Up to one year follow-up all treated veins remained occluded. At six months, one new insufficient anterior accessory saphenous vein (AASV) and after 12 months, three new insufficient AASV occurred. After one year 45 patients were very satisfied with the method, 34 were satisfied, three were fairly and one was not satisfied. The mean of all answers was 0.5 (SD 0.5). In three cases phlebitic reactions after 10 days, but no severe complications such as deep vein thrombosis occured. After six months in 9.5% of the legs paresthesia was present in the treated area which reduced to 7.6% after one year. Intake of painkillers was mean 6.7 tablets (SD 3.5). When we compared GSV legs treated with LEED below or above 100 J/cm, the paresthesia rate was significantly lower in the first group with 2.3% compared to 15.5 % in the higher LEED group. The differences for number of days with analgesic intake and for the paraesthetic area were significant. Discussion In this prospective follow-up study with 100 consecutive patients and 134 treated saphenous veins a high occlusion rate of 100% could be demonstrated one year after treatment. However, with LEED > 100 J/cm in this study, the incidence of paresthesia rose significantly. Therefore it seems adequate to stay below 100 J/cm in the future as the occlusion rate was the same below and above 100 J/cm. Conclusion EVLA of GSV and SSV with a 1470 nm diode laser is a minimally invasive, safe and efficient therapy option with a high success rate.

Primary chronic venous disorders

Primary chronic venous disorders, which according to the CEAP classification are those not associated with an identifiable mechanism of venous dysfunction, are among the most common in Western populations. Varicose veins without skin changes are present in about 20% of the population while active ulcers may be present in as many as 0.5%. Primary venous disorders are thought to arise from intrinsic structural and biochemical abnormalities of the vein wall. Advanced cases may be associated with skin changes and ulceration arising from extravasation of macromolecules and red blood cells leading to endothelial cell activation, leukocyte diapedesis, and altered tissue remodeling with intense collagen deposition. Laboratory evaluation of patients with primary venous disorders includes venous duplex ultrasonography performed in the upright position, occasionally supplemented with plethysmography and, when deep venous reconstruction is contemplated, ascending and descending venography. Primary venous disease is most often associated with truncal saphenous insufficiency. Although historically treated with stripping of the saphenous vein and interruption and removal of major tributary and perforating veins, a variety of endovenous techniques are now available to ablate the saphenous veins and have generally been demonstrated to be safe and less morbid than traditional procedures. Sclerotherapy also has an important role in the management of telangiectasias; primary, residual, or recurrent varicosities without connection to incompetent venous trunks; and congenital venous malformations. The introduction of ultrasound guided foam sclerotherapy has broadened potential indications to include treatment of the main saphenous trunks, varicose tributaries, and perforating veins. Surgical repair of incompetent deep venous valves has been reported to be an effective procedure in nonrandomized series, but appropriate case selection is critical to successful outcomes.

Cost-of-illness of chronic leg ulcers in Germany

Chronic wounds are important because of their frequency, their chronicity and high costs of treatment. However, there are few primary data on the cost‐of‐illness in Germany. The aim was to determine the cost‐of‐illness of venous leg ulcers (VLU) in Germany. Prospective cost‐of‐illness study was performed in 23 specialised wound centres throughout Germany. Direct, medical, non medical and indirect costs to the patient, statutory health insurers and society were documented. Thereover, health‐related quality of life (QoL) was recorded as intangible costs using the Freiburg quality of life assessment for wounds (FLQA‐w, Augustin). A total of 218 patients (62.1% female) were recruited consecutively. Mean age was 69.8 ± 12.0 years. The mean total cost of the ulcer per year and patient was €9569, [€8658.10 (92%) direct and €911.20 (8%) indirect costs]. Of the direct costs, €7630.70 was accounted for by the statutory health insurance and €1027.40 by the patient. Major cost factors were inpatient costs, outpatient care and non drug treatments. QoL was strikingly reduced in most patients. In Germany, VLU are associated with high direct and indirect costs. As a consequence, there is a need for early and qualified disease management. Deeper‐going cost‐of‐illness‐studies and cost‐benefit analyses are necessary if management of chronic wounds is to be improved.

European guidelines for sclerotherapy in chronic venous disorders

Aim Sclerotherapy is the targeted chemical ablation of varicose veins by intravenous injection of a liquid or foamed sclerosing drug. The treated veins may be intradermal, subcutaneous, and/or transfascial as well as superficial and deep in venous malformations. The aim of this guideline is to give evidence-based recommendations for liquid and foam sclerotherapy. Methods This guideline was drafted on behalf of 23 European Phlebological Societies during a Guideline Conference on 7–10 May 2012 in Mainz. The conference was organized by the German Society of Phlebology. These guidelines review the present state of knowledge as reflected in published medical literature. The regulatory situation of sclerosant drugs differs from country to country but this has not been considered in this document. The recommendations of this guideline are graded according to the American College of Chest Physicians Task Force recommendations on Grading Strength of Recommendations and Quality of Evidence in Clinical Guidelines. Results This guideline focuses on the two sclerosing drugs which are licensed in the majority of the European countries, polidocanol and sodium tetradecyl sulphate. Other sclerosants are not discussed in detail. The guideline gives recommendations concerning indications, contraindications, side-effects, concentrations, volumes, technique and efficacy of liquid and foam sclerotherapy of varicose veins and venous malformations.

Efficacy and tolerability of an ulcer compression stocking for therapy of chronic venous ulcer compared with a below-knee compression bandage: results from a prospective, randomized, multicentre trial

SUMMARY Objective: To investigate the possibility of improving healing rates in ulcus cruris venosum by using an ulcer compression stocking (U-Stocking) (Venotrain* ulcertec) as compared to compression bandages. Research design and setting: Prospective, multicentre, open-labelled, randomized, active-controlled study with blinded assessment of the primary endpoint. Sixteen phlebology outpatient clinics in Germany or the Netherlands or German medical practices specialized in phlebology. Patients and methods: 134 patients with venous leg ulcers entered the study. Among others, patients with infected ulcer or obesity were excluded. 121 patients were eligible for primary efficacy analyses. U-Stocking or bandages applied for at least eight hours per day and for up to 12 weeks. The primary endpoint was the healing rate after 12 weeks as assessed by planimetric measures. The secondary outcome variables were time to healing, changes in ulcer size (planimetry), experience of use and patient compliance. Main outcome measures: Therapy with the U-Stocking produced a significantly higher rate of complete healing of 47.5% (29/61) versus 31.7% (19/60) with bandages, 1-sided p = 0.0129 [CI: 95% for differences: 4.3% to 28.5%]. Mean time to healing was 46 days in both groups. Time required for application of the U-Stocking was a mean of 5.4 min (SD 5.4) versus 8.5 min (SD 6.5) for bandages, p = 0.0001. Around three patients in each treatment group were affected by serious adverse events. All treatment-related adverse events are known for compression therapy. Conclusions: The U-Stocking was superior to bandages in compression therapy for venous ulcer. This is of significance to new treatment standards as well as to future studies of longer term therapy (> 12 weeks) for unhealed ulcers or prevention of recurrence.

Endovenous laser ablation of great saphenous veins using a 1470 nm diode laser and the radial fibre – follow-up after six months

Background Endovenous laser ablation (EVLA) is an efficient method to treat insufficient great saphenous veins (GSV) with high occlusion rates.1–5 Most studies used 810, 940 or 980 nm diode lasers and a bare fibre.1,2,6 Moderate postoperative pain and bruising are frequent findings.2,6 Laser systems with higher wavelengths like 1470 nm with a higher absorption in water show less pain and bruising after the procedure.7–9 A newly-developed fibre (radial fibre, Biolitec) emits the laser energy radially around the tip directly into the venous wall contrary to the bare fibre.9 The aim of this study was to demonstrate the outcome and side-effects after EVLA of GSV with a 1470 nm diode laser (Ceralas E, Biolitec) by using the radial fibre. Methods Non-randomized, prospective study including 50 unselected limbs of 50 patients with a duplex sonographically verified incompetent GSV. EVLA was performed with a 1470 nm diode laser (Ceralas E, Biolitec) and a radial fibre. In the same session all insufficient tributaries were treated by phlebectomy. Tumescent local anaesthesia with 0.05% lidocaine was applied perivenously. Laser treatment was carried out in a continuous mode with a power of 15 W. Compression stockings (30 mmHg) were applied for one month. Postinterventional checkups took place one, 10, 30 days and six months after the procedure. Results Three patients were lost to follow-up. The average linear endovenous energy density (LEED) was 90.8 J/cm vein (SD 35.3). At the six month follow-up all treated veins remained occluded and no new reflux in the treated segments occurred. No recurrent varicose veins had occurred so far. No severe complications such as deep venous thrombosis could be detected. In four patients at 30 days and three patients at six months local paresthesia occurred in the region of EVLA. Forty-four percent of patients did not have any pain after the treatment and 50% did not take any analgesic tablets at any time after the procedure. Postoperative ecchymoses in the track of the treated GSV was rare. In 80% of the limbs, no ecchymoses was observed after the treatment. Conclusion EVLA of GSV with a radially emitting laser fibre by using a 1470 nm diode laser is a safe and efficient treatment option.

Associated factors and comorbidities in patients with pyoderma gangrenosum in Germany: a retrospective multicentric analysis in 259 patients

BackgroundPyoderma gangrenosum (PG) is a rarely diagnosed ulcerative neutrophilic dermatosis with unknown origin that has been poorly characterized in clinical studies so far. Consequently there have been significant discussions about its associated factors and comorbidities. The aim of our multicenter study was to analyze current data from patients in dermatologic wound care centers in Germany in order to describe associated factors and comorbidities in patients with PG.MethodsRetrospective clinical investigation of patients with PG from dermatologic wound care centers in Germany.ResultsWe received data from 259 patients with PG from 20 different dermatologic wound care centers in Germany. Of these 142 (54.8%) patients were female, 117 (45.2%) were male; with an age range of 21 to 95 years, and a mean of 58 years. In our patient population we found 45.6% with anemia, 44.8% with endocrine diseases, 12.4% with internal malignancies, 9.3% with chronic inflammatory bowel diseases and 4.3% with elevated creatinine levels. Moreover 25.5% of all patients had a diabetes mellitus with some aspects of potential association with the metabolic syndrome.ConclusionsOur study describes one of the world’s largest populations with PG. Beside the well-known association with chronic bowel diseases and neoplasms, a potentially relevant new aspect is an association with endocrine diseases, in particular the metabolic syndrome, thyroid dysfunctions and renal disorders. Our findings represent clinically relevant new aspects. This may help to describe the patients’ characteristics and help to understand the underlying pathophysiology in these often misdiagnosed patients.

Societal costs of chronic venous disease in CEAP C4, C5, C6 disease:

Active venous ulcers are present in 0–0.5% of the adult Western population; 0.6–1.4% have healed ulcers. The socioeconomic importance of chronic venous insufficiency (CVI) is due to the large number of patients concerned to the cost of investigations and management and to the deterioration of the quality of life (QoL) and loss of working days. The magnitude of these costs depends on the severity of the venous disease. As the prevalence of CVI increases with age, societal costs also increase with age of the involved population. In clinical stages C4–C6, direct costs include treatment of skin changes, prevention of ulcer development and recurrence as well as ulcer treatment. Direct costs include medical and nursing manpower, cost of investigations and of treatment. These costs can appear in hospitals or in outpatient care. There are also indirect costs related to loss of working days. Reimbursement of costs for venous diseases differs widely in different countries and is affected by government policies.