Retrospective analysis of routine use of a double heat cycle (DHC) during radiofrequency segmental ablation (ClosureFAST(™) ) of saphenous veins.

BACKGROUND: Recent experimental evidence suggests that increasing energy delivered during radiofrequency segmental ablation (RFSA) of varicose veins might further improve outcomes. OBJECTIVES: To evaluate occlusion rates and safety of the routine use of double heat cycle (DHC) during RFSA of incompetent saphenous veins up to 3 years after the initial treatment. METHODS: Retrospective review of prospectively collected duplex ultrasound (DUS) and complication rate data of successive patients from the Viennese, Lower Austrian and Slovenian regions treated for incompetent saphenous veins, followed up on a yearly basis for up to 3 years after the procedure. RESULTS: Between 2007 and 2011, 258 patients (389 veins; 322 great saphenous veins (GSV)] had been treated with DHC ClosureFast. Patients' return was 46% (122 subjects) 3 years after RFSA [140 GSV and 31 small saphenous veins (SSV)] with a mean follow-up time of 24.93 ± 11.77 months. At 36 months Kaplan-Meier survival analysis showed the occlusion probability of 98.6% (95% CI: 1.005-0.966). All SSV were closed. Except for three cases of dysaesthesia which disappeared within a year, there have not been major side-effects. CONCLUSIONS: Results of the retrospective analysis indicate that the routine use of DHC during RFSA for incompetent saphenous veins is equally safe but potentially more efficacious considering mid-term venous closure rates.

Early granulomatous foreign body reactions to a novel alginate dermal filler: the system's failure?

BACKGROUND: Cutaneous granulomas after a soft filler injection represent one of the worst scenarios for both patient and injector. OBJECTIVES: To present clinical and histopathological features of granulomatous nodular reactions induced by a new alginate-based dermal filler (Novabel(®)), and put it in context of the process of injectable soft tissue fillers approval and promotion in the EU. METHODS: A case series of four patients injected with Novabel(®) for volume restoration of the face and hands, who developed severe foreign body reactions. RESULTS: Four patients injected with Novabel(®) into tear troughs and/or dorsa of hands developed severe granulomatous reactions within months after injections. As we injected with the new filler into a total of 10 patients, a high incidence of 40% of the disfiguring adverse effect was observed. The inadequate response of manufacturer to our reporting the side-effects along with the available data on registration process of dermal fillers confirmed that the area is not well-regulated. CONCLUSIONS: The status of dermal fillers as class III medical devices, and the process of their approval and marketing in the EU need to be seriously reconsidered to avoid unnecessary and serious adverse reactions.

[Endovenous thermal ablation of saphenous varicosis]. / Endovenöse Thermoablation der Stammvarikose.

Endoluminal catheter-based procedures enable venous reflex in varicose saphenous veins to be eliminated. The catheter tip is positioned in the sapheno femoral or popliteal junction under ultrasound guidance. The energy necessary to ablate the vein is generated as heat by high-frequency current (radiofrequency) by laser light or by steam. Advantages of this procedure include low invasiveness, subcutaneous infusion anesthesia (SIA), low perioperative morbidity and rapid restoration of mobility of patients.

The actual role of hyaluronic acid-based and calcium hydroxylapatite soft tissue fillers: a guide for a practicing dermatologist.

Soft tissue fillers (STFs) together with botulinum toxin have profoundly improved our possibilities to rejuvenate the face and other parts of human body. Among many types of STFs currently used for esthetic and medical indications in routine clinical practice dominate hyaluronic acid-based STFs and calcium hydroxylapatite. Collagen fillers (bovine, porcine and human) are gradually leaving the market replaced mostly by hyaluronic acid-based STFs. This review presents an overview of the physicochemical properties, mechanisms of action and techniques used for the correct placement of hyaluronic acid-based STFs and calcium hydroxylapatite and the most common esthetic indications for these fillers. Finally, we present the recent data on their efficacy and most common complications encountered.

Reprinted article "Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up".

PURPOSE: To study intermediate clinical outcomes, rates of recurrent varicosities and neovascularisation, ultrasound changes of the GSV, and the quality of life changes in patients from EVOLVeS trial. METHODS: Forty five patients were re-examined 1 year and 65 two years after treatment. Follow-up visits included clinical examination with CEAP classification and calculation of venous clinical severity score (VCSS), ultrasound examination, and a quality of life questionnaire. RESULTS: The clinical course of the disease (CEAP, VCSS) was similar in the two treatment groups. 51% of the GSV trunks occluded by RFO underwent progressive shrinkage with the external diameter decreased from 6.3 SD 1.4 mm at 72 h after treatment to 2.9 SD 1.5 mm at 2 years. An additional 41% of the GSV became undetectable by ultrasound at 2-year follow up. In two patients we observed re-opening of an initially closed GSV lumen. Neovascularisation was found in one RFO case and in four S and L cases. Cumulative rates of recurrent varicose veins at combined 1 and 2 years follow-up were 14% for RFO and 21% for S and L (NS). The difference in global QOL score in favour of RFO re-appeared at 1 year and remained significant at 2 years after treatment. CONCLUSION: The 2-year clinical results of radiofrequency obliteration are at least equal to those after high ligation and stripping of the GSV. In the vast majority of RFO patients the GSV remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Recurrence and neovascularisation rates were similar in the two groups although limited patient numbers prevent reliable statistical analysis. Improved quality of life scores persisted through the 2-year observations in the RFO group compared to the S and L group.

Subcutaneous injection of liquid and foamed polidocanol: extravasation is not responsible for skin necrosis during reticular and spider vein sclerotherapy.

BACKGROUND: Cutaneous necrosis is one of the most annoying complications of reticular and spider vein sclerotherapy. The precise incidence of the complication is not known, although various sources reported incidence between 0.2% and 1.2%. Among a few mechanisms proposed to explain it, extravasation of the sclerosant into the perivascular tissue has been cited as the major cause. OBJECTIVES: The aim of the experimental study in rats was to examine the potential of various concentrations and volumes of polidocanol in both liquid and foam forms to cause cutaneous necrosis after superficial subcutaneous injection. METHODS: Twenty-four female Sprague Dawley rats were injected subcutaneously different concentrations (0.5%, 1%, 2% and 3%) of polidocanol as well as different preparations of polidocanol (liquid vs. foam) and volumes (0.1-0.5 mL). The animals were sacrificed 10 days after injections and biopsy specimens were obtained. RESULTS: Cutaneous necrosis was not seen at volumes <0.5 mL regardless of the concentration or form of polidocanol injected. Foam preparation was shown to be less potent in inducing necrosis with a minimal strength being 2% in comparison with the liquid form where 1% was sufficient to produce overt cutaneous necrosis. CONCLUSIONS: This experimental study shows that extravasation of polidocal in usual circumstances of sclerotherapy of spider and reticular veins cannot be a significant cause of cutaneous necrosis rarely observed in this setting. It is particularly true for the foamed polidocanol where 1% strength seems safe if injected extravascularly in volumes up to 0.5 mL.

Primary defect in alpha-adrenergic responsiveness in patients with varicose veins.

Responsiveness of superficial hand veins to local infusions of noradrenaline was compared in patients with primary varicose veins and in healthy volunteers by use of the dorsal hand vein technique. Patients with varicose veins required significantly higher doses of noradrenaline for half-maximal venoconstriction than the dose required by control subjects (geometric mean, 11.6 ng/min in patients compared with 4.8 ng/min in control subjects; p = 0.006). Noradrenaline responsiveness in varicose veins was not significantly different from hand vein responsiveness in the same patients. Our findings indicate a constitutional decrease in venous alpha-adrenergic receptor responsiveness in patients with varicosities. Dilation of varicose veins does not further affect noradrenaline-induced venoconstriction.

Studies on the effect of short-term oral dihydroergotamine and troxerutin in patients with varicose veins.

OBJECTIVE: To evaluate the clinical efficacy and pharmacologic effects of dihydroergotamine and troxerutin on varicose veins. METHODS: A double-blind, randomized, placebo-controlled parallel-group study was conducted in 53 patients with primary varicose veins. Patients received either a fixed combination of 3 mg dihydroergotamine and 300 mg troxerutin three times a day or placebo for 3 weeks. Symptomatic improvement was assessed by a self-assessment score, venocontracting effects on a varicose vein were quantified by the venous compliance technique (VCT), and changes in venous dysfunction were measured by digital photoplethysmography (DPPG). RESULTS: A significant reduction (p < 0.01) of subjective symptoms was observed in both groups. Results from VCT and DPPG after the therapy with dihydroergotamine and troxerutin or placebo were not significantly different (p > 0.05) from pretreatment values. Furthermore, no significant intergroup difference was observed when the before- and after-therapy differences of values of the self-assessment scores (VCT and DPPG) were compared. CONCLUSION: In our study, 3 weeks of treatment with a fixed drug combination of 3 mg dihydroergotamine plus 300 mg troxerutin three times a day had no measurable effect compared with placebo on any of the evaluated end points.

Foreign body granulomas due to injectable aesthetic microimplants.

We present two types of "new" foreign body granulomas caused by the injectable aesthetic microimplants Bioplastique and Artecoll. We report the clinical and histopathologic findings in five patients who had undergone treatment of mainly facial contour abnormalities with one of these implants. All patients were women, and the mean age was 45 years (age range 24-72 years). Two patients presented after treatment with Bioplastique; in three patients, augmentation was achieved by using Artecoll. Unsatisfactory cosmetic effects led to excision of the implants in four patients; in one patient, parts of the implant were excised during another cosmetic intervention. Subsequent histopathologic examination showed features of foreign body granulomas with distinctive cystic spaces. The clue to the diagnosis is the particular configuration of these cystic spaces and the characteristic shape of the foreign bodies. Bioplastique granuloma presents with irregularly shaped cystic spaces of varying size containing jagged, translucent, nonbirefringent foreign bodies whereas Artecoll granuloma shows numerous round vacuoles nearly identical in size and shape enclosing round and sharply circumscribed, translucent, nonbirefringent foreign bodies. These specific histopathologic findings unequivocally allow the correct diagnosis in spite of sparse clinical information.

Varicose vein stripping--a prospective study of the thrombotic risk and the diagnostic significance of preoperative color coded duplex sonography.

Insufficiency of epifascial veins promotes venous ulceration and increases thromboembolic risk in general surgery patients. Epifascial varicose vein stripping is therefore considered the most effective prophylactic procedure. Thromboembolic risk of patients undergoing this surgical procedure has not yet been prospectively evaluated but appears to be lower than in general surgery patients. The gold standard of preoperative assessment of varicose surgery patients is ascending pressure phlebography, but this technique is invasive, time consuming and costly. We prospectively investigated 100 consecutive varicose vein surgery patients for postoperative thrombosis. Ascending pressure phlebography (APP) and colour coded duplex sonography (CCDS) were performed before and 10 to 21 days after the stripping operation in 100 and 70 patients, respectively. APP revealed no postoperative deep vein thrombosis in all 100 limbs investigated (0 percent; 95 percent confidence interval: 0 to 2.95). With regard to epifascial vein reflux there was good agreement between APP and CCDS (quadratic weighted kappa: 0.76). In 67 out of 73 superficial veins investigated excellent agreement of diagnostic accuracy was found for both diagnostic procedures (91.78 percent; 95 percent confidence interval: 82.96 to 96.92). We conclude that thrombotic risk of varicose vein surgery is low in properly selected patients. CCDS provides a high degree of accuracy in diagnosis of reflux and regular vein morphology and should therefore replace APP; however, APP does remain essential in the preoperative workup of atypical anatomical variants.

Imbalance between the endothelial cell-derived contracting factors prostacyclin and angiotensin II and nitric oxide/cyclic GMP in human primary varicosis.

1. The role of the endothelium in the vasomotor control of human veins in the lower extremity is little understood. We tested the hypothesis that the production of relaxing and contracting factors is altered in endothelial cells from varicose saphenous veins which may predispose to the decreased vessel tone observed in primary varicosis. 2. We determined the intracellular accumulation of guanosine 3':5'-cyclic monophosphate cyclic GMP; a measure of nitric oxide production and the release of endothelin and prostacyclin (measured as its stable metabolite 6-keto-prostaglandin F1alpha) from cultured cells derived from the long saphenous veins of patients with primary varicosis (Varicose saphena group, n = 27) or from patients undergoing coronary artery bypass surgery (Healthy saphena group, n = 22). In addition, levels of endothelin, angiotensin II, bradykinin, cyclic GMP and cyclic AMP in plasma from patients with primary varicosis and healthy volunteers (n = 8-11 in each group) were determined. 3. Although basal cyclic GMP levels were similar, more cyclic GMP accumulated in response to histamine (1-100 micromol l[-1]) in cells from varicose saphenous veins (0.75 +/- 0.1 pmol per well) than in cells from veins without varicosis (0.27 +/- 0.05 pmol per well). Furthermore, the relaxant potency of nitroprusside (1 nmol l(-1) - 300 micromol l[-1]) in vitro was higher for varicose veins (mean EC50 = 5.9 micromol l(-1); n = 8) than healthy veins (mean EC50 = 20.0 micromol l(-1); n = 7). 4. The production of prostacyclin was significantly less in cells from varicose than healthy saphenous veins (66 +/- 8.7 and 121 +/- 20.1 nmol g(-1) protein), but the production of endothelin was similar in both groups. Prostacyclin (3 nmol l(-1) 30 micromol l[-1]) consistently contracted rings of varicose saphenous vein in vitro with a mean EC50 value of 10-20 micromol l(-1) (n = 7); the maximum tension generated was approximately 50% of that of a completely depolarizing solution of K+ (120 mmol l[-1]). 5. In plasma from patients with varicose veins, levels of cyclic GMP were higher than in healthy controls (9.2 +/- 0.03 and 7.2 +/- 0.02 nmol l[-1]), levels of angiotensin II were lower (81 +/- 11.5 and 147 +/- 21.7 pmol l[-1]), and levels of endothelin, cyclic AMP, and bradykinin were not different. 6. It is concluded that endothelial cells from diseased saphenous veins secrete less constrictor mediators than cells from healthy veins and that in diseased veins the nitric oxide/cyclic GMP system is up-regulated which may shift the balance of vasoactive factors towards vasodilatation and contribute to the development of primary varicosis.

Effects of serotonin and noradrenaline on superficial hand veins in patients with primary hypertension and in healthy volunteers.

In vitro and animal experiments suggest that a constitutional increase in vascular responsiveness to serotonin (5-HT) may play a role in the development of essential hypertension. We have studied the potential alterations in vascular responsiveness to the direct and catecholamine-potentiating effects of exogenous 5-HT in patients with essential hypertension, by comparing in vivo responsiveness of superficial hand veins to local infusions of 5-HT or to coinfusions of 5-HT and noradrenaline in unmedicated hypertensive patients and in healthy control subjects. The dorsal hand vein compliance technique was employed. There was no significant difference between patients and control subjects in the maximal 5-HT-induced venoconstriction or in the doses required for half-maximal venoconstriction (ED50) for 5-HT. Coinfusions of a constant dose of 5-HT caused a significant leftward shift in the dose response curve for noradrenaline as compared with noradrenaline alone. This was indicated by a 9.7 +/- 13.7 fold and a 10.4 +/- 13.8 fold increase in the ED50 for noradrenaline in the patient and control groups, respectively (p = 0.89 between study groups). Our results argue against a generalized increase in responsiveness to the direct or catecholamine-potentiating effect of 5-HT in vivo in vascular smooth muscle, associated with hypertension.

Anaphylactic shock following peritumoral injection of patent blue in sentinel lymph node biopsy procedure.

Recently, sentinel lymph node dissection has been established for early staging of malignant melanoma. We describe an anaphylactic reaction due to patent blue injection in sentinel lymph node procedure, which was proven by positive results in intradermal testing with patent blue 1:100.

Cryosurgery of lentigo maligna.

Lentigo maligna denotes flat, pigmented lesions predominantly in areas of actinic damage that have the propensity to become malignant. More than 10 years may pass before lentigo maligna evolves into an invasive neoplasma. As an invasive process, it is termed lentigo maligna melanoma (LMM), and it has the potential for both lymphatic and hematogenic metastases. Because of the size and location of the lesions, cosmetically unsatisfactory scars may result from conventional surgery. Therefore, alternative means of treatment, including cryosurgery, have been employed. We report on 12 patients suffering from lentigo maligna who had been treated successfully by cryosurgery between 1984 and 1990. The average follow-up period was 51.4 months, and the recurrence rate was 8.3 percent. Knowing that microinvasive components can be demonstrated in 15 percent of lentigo maligna lesions, we retrospectively reassessed our patients by immunohistochemical procedures with S-100 protein. Although intradermal microinvasion could be confirmed in one patient, no recurrence had been observed within 61 months of follow-up. Provided that patients are selected properly and extension of cryonecrosis is monitored, cryosurgery may prove an efficient alternative to conventional surgery in the treatment of lentigo maligna.

[NK cells and the nervous system]. / NK-Zellen und Nervensystem.

Light- and electron-microscopic studies of human, mouse, rat and guinea pig tissue subjected to PAP and ABC immune reactions revealed, that a monoclonal antibody against human natural killer cells (LEU 7) reacted also specifically with neural elements. In man, not only NK cells, but also myelin sheaths, oligodendrocytes, neurones, astroglial and ependymal cells as well as some enterochromaffin cells were labelled. Similar results, with the exception of negative ependymal cells, were obtained in the laboratory animals investigated. Controls and experiments using another monoclonal antibody against human natural killer cells (VEP 13) were negative. The presence of an antigen shared by human natural killer cells and neural elements could be of importance for the pathogenesis of demyelinating disorders.

[Isolation of Neisseria meningitidis from the urethra and cervix]. / Isolation von Neisseria meningitidis aus Urethra und Zervix.

Meningococcal infections of the urogenital tract were considered rare until recently, but over the past few years an increasing number of cases of this hitherto uncommon infection have been reported. The rising incidence of N. meningitidis isolated from these sites has important epidemiological implications. The need for careful diagnostic procedures is emphasized.

Multicentre, randomised controlled trial of four-layer bandaging versus short-stretch bandaging in the treatment of venous leg ulcers.

BACKGROUND: Aim of the study was to compare the healing rates of venous ulcers obtained with four-layer bandages (4LB) versus short stretch bandages (SSB). DESIGN: Multicentre, randomised controlled trial performed in 5 centres of the Netherlands and in 2 centres in Austria ("PADS-study" = Profore Austrian Dutch Study). PATIENTS AND METHODS: 112 patients (53 treated with 4LB and 59 treated with SSB) completed at least one post-treatment follow-up, 90 completed the study. Bandaging and ulcer assessment was performed at weekly intervals. Randomisation was carried out for each centre and was stratified according to the size (more or less than 10 cm2) of the ulcerated area. Local therapy consisted of plain absorbing, non-adherent dressings. Time to complete healing was recorded up to a maximum of 16 weeks. The two treatment-groups were comparable regarding their baseline-characteristics. RESULTS: In total 33/53 (62%) of ulcer-patients were healed in the 4LB group, compared with 43/59 (73%) in the SSB group (difference 11%, 95% CI -28% to 7%). 77% of the ulcers with an initial area less than 5 cm2 healed as compared with 33% of the larger ulcers. The different healing rates in the centres could be explained by the different sizes of the treated ulcers. Based on Kaplan-Meier estimates the median healing time was 57 days for the 4LB (95% CI 47-85 days) and 63 days for the SSB (95% CI 43-70 days). CONCLUSION: The ulcer healing rate and the median healing time did not differ among the two types of bandages. The main discriminant criterion for healing was the initial ulcer size. In centres who are experienced users of short-stretch bandages, no statistically significant different healing rates of venous ulcers could be found after 4LB or SSB.

Simple external manual manoeuvres to pass the radiofrequency catheter through a bending segment of a saphenous vein.

Smooth passage of a catheter through a varicose saphenous vein during radiofrequency ablation may prove a challenging task. Various types of venous bending in the transverse and sagittal planes and their combinations within the saphenous compartment may be pretty well appreciated by ultrasound examination. Several simple manual manoeuvres like stretching, pushing or lifting along with limb re-positioning may often help the surgeon to advance the catheter through the segments by temporarily changing their special configuration. In this way the number of patients otherwise considered unsuitable for endovascular catheter procedures like radiofrequency or laser ablation may be considerably reduced.

Telangiectasias resistant to sclerotherapy are commonly connected to a perforating vessel.

Leg telangiectasias resistant to repeated courses of sclerotherapy in patients without deep and superficial venous incompetence are not uncommon. Little is known about factors which may underlie the resistance. Among 26 patients with such telangiectasias we found a direct communication of the vessels with deep and saphenous veins in 65% of patients. Ultrasound-guided injection of 0.5% polidocanol foam into the feeding veins or their perforating segments led to clearance of all the telanagiectasias. In 23% of cases no feeding veins could have been identified by ultrasound. Direct injections of a sclerosant into perforating feeding veins may clear refractory telangiectasias in a majority of patients though it is obvious that other factors may contribute to the failure of sclerotherapy in others.