Background Endovenous laser ablation (EVLA) is one of the most accepted treatment options for varicose veins. In previous studies conducted with a laser at 810 to 1320 nm, paresthesia, pain, and ...ecchymosis were common adverse effects. We hypothesized that a lower linear endovenous energy density (LEED), as used with 1470-nm diode laser fibers, would lead to a reduction in adverse events. Methods We conducted a prospective, nonrandomized observational cohort study of 312 consecutively treated lower limbs legs in 286 patients. Of these, a bare laser fiber (ELVeS-plus kit) was used to treat 168 legs in 150 patients (group 1), and a radial fiber (ELVeS-radial kit) was used in 144 legs in 136 patients (group 2). Laser treatment was performed in the great saphenous vein. Follow-up for all patients was 3 months. The primary end point was the occurrence of ecchymosis and bruising. This was correlated to the reduced LEED needed with the 1470-nm diode laser. Results Laser fiber (odds ratio OR, 22.3; 95% confidence interval CI, 20.2-24.5) and body mass index (OR, 0.35; 95% CI, 0.15-0.55) were identified as independent parameters for LEED. In group 2 compared with group 1, LEED in the great saphenous vein could be reduced from 79.4 ± 9.1 to 57.4 ± 10 J/cm ( P < .0001). LEED was an independent parameter for skin bleeding (OR, 1.04; 95% CI, 1.017-1.058). Ecchymosis and bruising were significantly less frequent in group 2 than in group 1 ( P < .0001). The need for analgesia was low, with 103.08 ± 15.34 mg diclofenac-sodium in group 1 vs 82.08 ± 18.86 mg in group 2 ( P < .04). Occlusion with elimination of reflux was achieved in 100% of group 1 and group 2 ( P < 1). No recanalization occurred at follow-up. Conclusion Endovenous laser treatment of varicose veins in the great saphenous vein with the 1470-nm diode laser is safe and highly effective. The lower energy level needed using the radial laser fiber significantly minimized adverse effects compared with the bare laser fiber.
Isolated atherosclerotic common femoral artery (CFA) disease is a rare cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice, little ...is known about outcomes of percutaneous treatment.
A prospectively maintained single-center database was retrospectively analyzed for outcomes of consecutive patients undergoing isolated percutaneous revascularization of CFA disease between 1996 and 2007. In all cases, the intended strategy was balloon angioplasty with provisional stent placement in case of poor angioplasty results. Among 516 consecutive procedures involving the CFA, 419 were excluded because of nonatherosclerotic disease (n = 156) or treatment of additional vascular segments during the same procedure (n = 263). Procedural success (ie,<30% residual stenosis), in-hospital vascular complications (major requiring surgical or percutaneous treatment or minor treated conservatively), and 12-month restenosis and target lesion revascularization (TLR) rates were assessed for the remaining 97 interventions.
CFA bifurcation lesions were present in 40 cases (41.2%) and required treatment of the deep femoral artery in 25 (25.8%). Chronic total CFA occlusions accounted for 11 cases (11.3%). Balloon angioplasty was performed in 96 cases (98.9%), and provisional stent placement was necessary in 37 (38.1%). The procedure was successful in 89 cases (91.8%). Minor and major vascular complications at 30 days occurred in three (3.1%) and four (4.1%) cases, respectively. At 12 months, restenosis greater than 50% and TLR were observed in 19.5% and 14.1% of procedures, respectively.
This series shows that isolated CFA lesions may be safely and efficaciously treated with angioplasty and provisional stent placement.
Background Perioral dermatitis (POD) is a common dermatosis without standard therapy. Objective We sought to evaluate pimecrolimus cream 1% in POD. Methods We conducted a multicenter, randomized, ...double-blind, parallel-group study in adult patients with POD treated twice daily with pimecrolimus cream 1% or vehicle until clearance for up to 4 weeks. Follow-up took place 4 and 8 weeks after treatment. Results Patients treated with pimecrolimus had an average POD Severity Index score of 2.6 compared with 3.5 for patients treated with vehicle. Both groups had baseline scores of 5.2. The between-group difference was 0.9 (95% confidence level 0.4, 1.4, P = .0011). Patients with history of topical corticosteroids benefited most. Pimecrolimus-treated patients reported greater improvement in quality of life. There were no group differences regarding safety. Limitations Pimecrolimus vehicle is not a true placebo. Conclusions Pimecrolimus rapidly improves clinical symptoms and quality of life of patients with POD, being most effective in corticosteroid-induced POD.
Background Hen's egg is the most common cause of food allergy in early childhood. Objective We investigated the efficacy and safety of early hen's egg introduction at age 4 to 6 months to prevent ...hen's egg allergy in the general population. Methods This randomized, placebo-controlled trial included 4- to 6-month-old infants who were not sensitized against hen's egg, as determined based on specific serum antibodies (IgE). These infants were randomized to receive either verum (egg white powder) or placebo (rice powder) added to the first weaning food 3 times a week under a concurrent egg-free diet from age 4 to 6 until 12 months. The primary outcome was sensitization to hen's egg (increased specific serum IgE levels) by age 12 months. Hen's egg allergy (secondary outcome) was confirmed by double-blind, placebo-controlled food challenges. Results Among 406 screened infants, 23 (5.7%) had hen's egg–specific IgE before randomization. Seventeen of 23 underwent subsequent double-blind, placebo-controlled food challenges, and 16 were confirmed as allergic, including 11 with anaphylactic reactions. Of the 383 nonsensitized infants (56.7% male), 184 were randomized to verum and 199 to placebo. At 12 months of age, 5.6% of the children in the verum group were hen's egg sensitized versus 2.6% in the placebo group (primary outcome; relative risk, 2.20; 95% CI, 0.68-7.14; P = .24), and 2.1% were confirmed to have hen's egg allergy versus 0.6% in the placebo group (relative risk, 3.30; 95% CI, 0.35-31.32; P = .35). Conclusion We found no evidence that consumption of hen's egg starting at 4 to 6 months of age prevents hen's egg sensitization or allergy. In contrast, it might result in frequent allergic reactions in the community considering that many 4- to 6-month-old infants were already allergic to hen's egg.
Objectives The study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions. Background ...There is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this finding during long-term follow-up. Methods The study extended the follow-up period of a prospective, randomized, multicenter, double-blind trial comparing polymer-free SES with placebo-coated BMS in the treatment of focal infrapopliteal de novo lesions. The main study endpoint was the event-free survival rate defined as freedom from target limb amputation, target vessel revascularization, myocardial infarction, and death. Secondary endpoints include amputation rates, target vessel revascularization, and changes in Rutherford-Becker class. Results The trial included 161 patients. The mean target lesion length was 31 ± 9 mm. Thirty-five (23.3%) patients died during a mean follow-up period of 1,016 ± 132 days. The event-free survival rate was 65.8% in the SES group and 44.6% in the BMS group (log-rank p = 0.02). Amputation rates were 2.6% and 12.2% (p = 0.03), and target vessel revascularization rates were 9.2% and 20% (p = 0.06), respectively. The median (interquartile range) improvement in Rutherford-Becker class was –2 (–3 to –1) in the SES group and –1 (–2 to 0) in the BMS group, respectively (p = 0.006). Conclusions Long-term event-free survival, amputation rates, and changes in Rutherford-Becker class after treatment of focal infrapopliteal lesions are significantly improved with SES in comparison with BMS. (YUKON-Drug-Eluting Stent Below the Knee - Randomised Double-Blind Study YUKON-BTX; NCT00664963 )
D-dimer might be correlated with prognosis in pulmonary embolism (PE). The predictive value of plasma D-dimer for disease severity and survival was investigated in the lowest and highest D-dimer ...quartile among 200 patients with PE. Patients with high D-dimers were significantly more often hypotensive (P = .001), tachycardic (P = .016), or hypoxemic (P = .001). Pulmonary arterial obstruction index (PAOI) values were significantly higher in the high D-dimer quartile (P < .001). Elevated troponin I (TNI) levels (P < .001), simplified PE severity indices ≥1 (P < .001), right-to-left ventricular (RV/LV) diameter ratios ≥1 (P < .001), and thrombolysis (P = .001) were more frequent in the high D-dimer quartile. D-dimer was associated with RV/LV ratios ≥1 (P = .021), elevated PAOI (P < .001) or TNI levels (P < .001), hypotension (P < .001), tachycardia (P = .003), and hypoxemia (P < .001), but not with long-term all-cause mortality. D-dimer predicts disease severity but not long-term prognosis in acute PE, possibly due to a more aggressive treatment strategy in severely affected patients.
Background Suppression of the adaptive immune system by UV radiation plays an important role in photocarcinogenesis. Exacerbation of skin infections has been proposed as a further consequence of ...UV-induced immunosuppression. Clinically bacterial infections are not a problem. For defense against bacteria, the innate immune response including the release of antimicrobial peptides is much more relevant than the adaptive immune response. Keratinocytes have the capacity to release antimicrobial peptides. Objective We asked whether UV radiation induces antimicrobial peptides in vitro and in vivo. Methods Antimicrobial peptide expression by normal human keratinocytes was measured by real-time PCR and fluorescence-activated cell sorting analysis. Biopsies taken from human volunteers and skin explants were studied with immunohistochemistry. Results Real-time PCR of normal human keratinocytes revealed a dose-dependent increase of human β-defensin-2, -3, ribonuclease 7, and psoriasin (S100A7) after UV radiation. This was confirmed at the protein level by intracellular fluorescence-activated cell sorting and in vitro immunofluorescence analysis. Immunohistochemistry of biopsies taken from healthy volunteers exposed to different UV radiation doses revealed enhanced epidermal expression of antimicrobial peptides after UV exposure. This was also confirmed by exposing human skin explants to UV radiation. Conclusion UV radiation exerts diverse effects on the immune system, suppressing the adaptive but inducing the innate immune response. This may explain why T-cell–mediated immune reactions are suppressed on UV exposure but not host defense reactions against bacterial attacks.
Background Treatment of isolated calf muscle vein thrombosis (ICMVT) is controversial. There are no data from prospective, controlled studies. Objective of this article was to compare the efficacy ...and safety of a short-term course of anticoagulation with compression therapy alone. Methods We prospectively randomized patients with symptomatic, sonographically proven ICMVT in the soleal and/or gastrocnemial muscle veins in two treatment arms. The first received low-molecular-weight heparin for 10 days at therapeutic dosage (nadroparin 180 anti-activated factor X units once daily) and compression therapy for three months, and the second received compression therapy alone. Primary efficacy endpoint of the study was sonographically proven progression of ICMVT into the deep veins and clinical pulmonary embolism (PE) as confirmed by objective testing. Secondary efficacy and primary safety endpoints were major bleeding, death not due to PE, and complete sonographically proven recanalization of the muscle vein. We assessed transient and permanent risk factors for venous thromboembolism. Results One-hundred seven patients were finally ruled eligible for evaluation: 89% outpatients, 11% hospitalized patients. In the heparin group (n = 54) progression to deep vein thrombosis (DVT) occurred in two patients (3.7%), in the group compression therapy alone (n = 53) progression to DVT occurred in two patients (n.s.). No clinical PE and no death occurred. Thrombus recanalization after 3 months was not statistically significant different between the two study groups. No major bleeding occurred. Conclusion The data do not show superiority of a short-term regimen of low-molecular-weight heparin and compression therapy in comparison with compression therapy alone in patients with ICMVT in a rather low-risk population.
Objectives The purpose of this study was to evaluate the technical feasability, safety, and 1-year efficacy of the endovascular treatment of atherosclerotic common femoral artery (CFA) obstructions. ...Background Atherosclerotic CFA obstruction is a known cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice for this condition, little is known about the percutaneous options. Methods Using a prospectively maintained single-center database, we retrospectively analyzed the outcomes of 360 consecutive percutaneous interventions of the CFA for atherosclerotic disease and assessed procedural success, in-hospital complications, and 1-year patency and target lesion revascularization rates. Results Ninety-seven procedures (26.9%) were isolated CFA interventions, whereas 157 (43.6%) and 152 (42.2%) also involved inflow and outflow vessels, respectively. Bifurcation lesions were present in 140 cases (38.9%), and concomitant treatment of the profunda femoral artery was performed on 93 occasions (25.8%). Chronic total CFA occlusions were recanalized in 60 cases (16.7%). Balloon angioplasty was performed as the primary intervention in virtually all cases (98.6%), whereas stenting was needed for suboptimal angioplasty results in 133 procedures (36.9%). Failures—defined as a final angiographic result with a >30% residual stenosis—were observed on 26 occasions (7.2%). In-hospital major (i.e., requiring surgery) and minor (i.e., treated percutaneously or conservatively) complications occurred in 5 (1.4%) and 18 (5.0%) procedures, respectively. One-year follow-up data were available for 281 patients (87.5%). Restenosis >50% by duplex scanning and target lesion revascularization were observed in 74 of 268 (27.6%) and 64 of 322 (19.9%) procedures, respectively. Conclusions This large series suggests that the percutaneous approach may be a valid alternative to surgery for CFA atherosclerotic obstructions.
Background Studies of a limited number of allergens suggested that nonsensitized children produce IgG responses mainly to foodborne allergens, whereas IgE-sensitized children also produce strong IgG ...responses to the respective airborne molecules. Objective We sought to systematically test the hypothesis that both the route of exposure and IgE sensitization affect IgG responses to a broad array of allergenic molecules in early childhood. Methods We examined sera of 148 children participating in the Multicentre Allergy Study, a birth cohort born in 1990. IgG to 91 molecules of 42 sources were tested with the ImmunoCAP Solid-Phase Allergen Chip (ISAC; TFS, Uppsala, Sweden). IgE sensitization at age 2 and 7 years was defined by IgE levels of 0.35 kUA /L or greater to 1 or more of 8 or 9 extracts from common allergenic sources, respectively. Results The prevalence and geometric mean levels of IgG to allergenic molecules in nonsensitized children were lower at age 2 years than in IgE-sensitized children, and they were extremely heterogeneous: highest for animal food (87% ± 13%; 61 ISAC Standardized Units ISU, 95% CI, 52.5-71.5 ISU), intermediate for vegetable food (48% ± 27%; 13 ISU 95% CI, 11.2-16.1 ISU), and lowest for airborne allergens (24% ± 20%; 3 ISU 95% CI, 2.4-3.4 ISU; P for trend < .001 for percentages, P for trend < .001 for levels). IgG4 antibodies were infrequent (<5%) and contributed poorly (<3%) to overall IgG antibody levels. IgG responses at age 2 years were slightly more frequent and stronger among children with than in those without IgE sensitization at age 7 years. Conclusion The children's repertoire of IgG antibodies at 2 years of age to a broad array of animal foodborne, vegetable foodborne, and airborne allergenic molecules is profoundly dependent on the route of allergen exposure and the child's IgE sensitization status and only marginally involves the IgG4 isotype.
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