BACKGROUND:Auricular nerve stimulation has been proven effective in different diseases. We investigated if a conservative therapeutic alternative for claudication in peripheral arterial occlusive disease (PAD) via electroacupuncture of the outer ear can be established.PATIENTS AND METHODS:In this prospective, double-blinded trial an ear acupuncture using an electroacupuncture device was carried out in 40 PAD patients in Fontaine stage IIb. Twenty patients were randomized to the verum group using a fully functional electroacupuncture device, the other 20 patients received a sham device (control group). Per patient, eight cycles (1 cycle = 1 week) of electroacupuncture were performed. The primary endpoint was defined as a significantly more frequent doubling of the absolute walking distance after eight cycles in the verum group compared to controls in a standardized treadmill testing. Secondary endpoints were a significant improvement of the total score of the Walking Impairment Questionnaire (WIQ) as well as improvements in health related quality of life using the Short Form 36 Health Survey (SF-36).RESULTS:There were no differences in baseline characteristics between the two groups. The initial walking distance significantly increased in both groups (verum group [means]: 182 [95 % CI 128-236] meters to 345 [95 % CI 227-463] meters [+ 90 %], p < 0.01; control group [means]: 159 [95 % CI 109-210] meters to 268 [95 % CI 182-366] meters [+ 69 %], p = 0.01). Twelve patients (60 %) in the verum group and five patients (25 %) in controls reached the primary endpoint of doubling walking distance (p = 0.05). The total score of WIQ significantly improved in the verum group (+ 22 %, p = 0.01) but not in controls (+ 8 %, p = 0.56). SF-36 showed significantly improvements in six out of eight categories in the verum group and only in one of eight in controls.CONCLUSIONS:Electroacupuncture of the outer ear seems to be an easy-to-use therapeutic option in an age of increasingly invasive and mechanically complex treatments for PAD patients.

In 2010, eight Austrian medical societies proposed a joint position statement on the management of metabolic lipid disorders for the prevention of vascular complications. An updated and extended version of these recommendations according to the current literature is presented, referring to the primary and secondary prevention of vascular complications in adults, taking into consideration the guidelines of other societies. The "Austrian Lipid Consensus - 2016 update" provides guidance for individualized risk stratification and respective therapeutic targets, and discusses the evidence for reducing vascular endpoints with available lipid-lowering therapies. Furthermore, specific management in key patient groups is outlined, including subjects presenting with coronary, cerebrovascular, and/or peripheral atherosclerosis; diabetes mellitus and/or metabolic syndrome; nephropathy; and familial hypercholesterolemia.

Edoxaban is an oral, direct, selective FXa inhibitor, which is characterized by rapid absorption (1–3 h) and an elimination half-life of approximately 8 to 10 h in humans. The safety of edoxaban in patients with nonvalvular atrial fibrillation and its efficacy and safety for prevention of venous thromboembolism (VTE) in patients undergoing major orthopedic surgery, as well as treatment of VTE has been assessed in large clinical trials. Edoxaban for prevention of VTE In dose-ranging studies for the prevention of deep vein thrombosis (DVT) following TKA or THA, edoxaban demonstrated dose-dependent reductions in VTE with a low incidence of bleeding events across dosing groups. Phase III clinical trials demonstrated the efficacy and safety of edoxaban in patients requiring VTE prevention after major orthopedic surgery, leading to its approval in Japan. Edoxaban for the treatment of VTE The Hokusai-VTE study . In this large, double-blind study involving patients with VTE, treatment with heparin followed by oral edoxaban once daily, as compared with standard therapy, was noninferior with respect to efficacy and superior with respect to bleeding. In analyses of safety, the results were consistent with respect to both major bleeding and clinically relevant non major bleeding, with fewer fatal and intracranial bleeds in the edoxaban group, although the between-group difference with respect to major bleeding did not reach statistical significance. The study was a randomized, double-blind clinical trial that was conducted to evaluate edoxaban for the treatment of VTE. The study was designed with the aim of broadening applicability to real-world practice and encouraging the enrollment of all patients, including those with extensive disease. Keywords: edoxaban; venous thromboembolism Received: April 26, 2014; Accepted: July 10, 2014; Published: April 9, 2015 Corresponding Author: Marianne Brodmann, MD, Division of Angiology, Medical University Graz, Austria. E-mail: marianne.brodmann@medunigraz.at .

Deep venous thrombosis as a result of venous wall injury provoked by trauma is a common finding. It often occurs in patients with sportive overstraining, caused by over fatigue of the body structures. In 2007, the entity of acute wiiitis was first described in a letter to the New England Journal of Medicine. Acute wiiitis sums up all affections, mainly skeletal and muscle affections, provoked by playing Nintendo Wii, a very common and loved video-game system. Deep venous thrombosis as a consequence of Nintendo Wii has not been described so far. We present a patient with a massive free floating thrombus of the left pelvic veins originating from the gluteal veins and reaching into the inferior vena cava after playing Nintendo Wii.

BACKGROUND:The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis.METHODS:In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention.RESULTS:The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention.CONCLUSIONS:Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).

Drug releasing balloon (DRB) angioplasty has evolved to a paradigm-shift in the endovascular treatment of peripheral artery disease (PAD). The current evidence base has been fuelled mostly by clinical trials with restrictive eligibility criteria, excluding most patients treated in daily practice.

OBJECTIVES:The aim of BIOLUX P-II (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia. BACKGROUND:DEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce. METHODS:In this prospective, multicenter, randomized first-in-man study, 72 patients were randomized 1:1 to either a Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland) (n = 36) or Passeo-18 PTA (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory. RESULTS:The primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DEB group versus 8.3% in the PTA group (p = 0.239). The primary performance endpoint (patency loss at 6 months) was 17.1% in the DEB group versus 26.1% in the PTA group (p = 0.298), and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively. CONCLUSIONS:The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA.

Purpose: To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI). Methods: In the EXPAND trial ( ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months. Results: Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different. Conclusion: Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.

Purpose: To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery. Methods: The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; www.ClinicalTrials.gov identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death). Results: In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups. Conclusion: In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting.

Objectives: To evaluate the clinical characteristics of patients with pulmonary embolism (PE), negative compression ultrasound (CUS) of the lower limbs and detection of unusual deep vein thrombosis (DVT) sites by means of magnetic resonance (MR) venography.Methods: A retrospective data analysis of PE patients hospitalized at our institution from April 2009 to 2011.Results: From April 2009 to 2011, a total of 762 PE patients were treated at our institution. In 169 of these patients CUS for DVT was negative. In these patients MR venography was performed for further evaluation. We found venous thrombosis at unusual sites in 12 of these patients. Due to free floating thrombus masses and fear of life-threatening PE progression we inserted an inferior vena cava filter in three of these 12 patients. The leading venous thromboembolism risk factor in our patients was immobilization (5 patients, 41.7%).Conclusions: We conclude that especially in patients with PE and negative CUS of the lower limbs a thrombosis of the pelvic veins should be considered in case of symptoms for venous thrombosis in this area. Further diagnostic work-up with MR venography should be scheduled in these patients especially in patients with risk factor immobilization as therapeutic consequences might occur.

Drug-releasing balloons have shown promising results in femoropopliteal disease; however, adequate evidence demonstrating improved outcomes in infrapopliteal arteries is currently lacking. BIOLUX P-II assesses the safety and performance of the novel BIOTRONIK Passeo-18 Lux Paclitaxel-releasing

Vascular Disease Management® September 2014 210 Selected Abstracts From the 4th Annual Amputation Prevention Symposium Abstract 1: A Randomized Clinical Trial of Passeo-18 Lux Drug Releasing Balloon vs Plain Old Balloon Angioplasty for the Treatment of Infrapopliteal Artery Lesions (BIOLUX P-II)1: A Randomized Clinical Trial of Passeo-18 Lux Drug Releasing Balloon vs Plain Old Balloon Angioplasty for the Treatment of Infrapopliteal Artery Lesions (BIOLUX P-II) Marianne Brodmann, MD; Ulrich Beschorner, MD; Marc Bosiers, MD; Patrick Peeters, MD; Ernst Pilger, MD; Dierk Scheinert, MD; Karl-Ludwig Schulte, MD; Thomas Zeller, MD Introduction: Adequate evidence demonstrating improved outcomes of drug-releasing balloons (DRBs) in infrapopliteal arteries is currently lacking. Objective: The BIOLUX P-II trial assesses the safety and performance of the BIOTRONIK Passeo-18 Lux Paclitaxel-releasing balloon compared to the uncoated Passeo-18 balloon in the treatment of infrapopliteal lesions. Methods: BIOLUX P-II is a prospective, international, multicenter, first-in-human, randomized, controlled trial with follow-ups at 30 days, 6 months, and 12 months. Subjects with single or sequential de novo or restenotic lesions in the infrapopliteal arteries (≥30 mm) were included in the study. The safety and performance primary endpoints are major adverse events (MAE) at 30 days and target lesion primary patency at 6 months (assessed by an independent angiographic core laboratory via quantitative vascular angiography), respectively. Results: Seventy-two subjects, 79.2% men, mean age 71.3±9.7 years, were randomized 1:1 at 6 European sites. At baseline, subjects presented with hypertension (86.1%), hyperlipidemia (68.1%), diabetes (66.7%), and critical limb ischemia (77.8%). At 30 days, MAE was 0.0% for the DRB vs 8.3% for POBA, P=.239. At 6 months, target lesion primary patency showed a trend in favor of the DRB of 84.3% vs 75.9% for POBA, P=.330 and major amputations were 3.3% for DRB vs 5.7% for POBA, P=.655. Clinical improvement of Rutherford V subjects was significant for the DRB group (P=.002) compared to POBA (P=.058). Conclusion: The Passeo-18 Lux DRB, as compared to POBA, is associated with favorable functional and clinical outcomes and results in significant clinical improvement of Rutherford V subjects in the treatment of infrapopliteal lesions. Abstract 2: Long-Term Cost Patterns of Directional Atherectomy vs Other Treatment Choices for Diabetes Patients With Peripheral Artery Disease: a 12-Month Analysis of Administrative Claims Data Khusrow Niazi, MD; Katrine L. Wallace, PhD; Michael Grabner, PhD Introduction: Directional atherectomy (DA) is an endovascular therapy that is effective in the treatment of diabetes patients with peripheral artery disease (PAD). Objective: This study was undertaken to assess the prevalence of PAD treatments in a real-world diabetic population and to compare all-cause health care costs of DA with other therapies in diabetes patients over 12 months post treatment. Methods: PAD patients were selected from a large claims database with ≥1 CPT code for a lower extremity PAD procedure between 2005 and 2011. The date of the first CPT code was the index date. Patients were included with ≥12 months of preindex date continuous medical Co py rig ht HM P Co mm un ica ti ns2: Long-Term Cost Patterns of Directional Atherectomy vs Other Treatment Choices for Diabetes Patients With Peripheral Artery Disease: a 12-Month Analysis of Administrative Claims Data Khusrow Niazi, MD; Katrine L. Wallace, PhD; Michael Grabner, PhD Introduction: Directional atherectomy (DA) is an endovascular therapy that is effective in the treatment of diabetes patients with peripheral artery disease (PAD). Objective: This study was undertaken to assess the prevalence of PAD treatments in a real-world diabetic population and to compare all-cause health care costs of DA with other therapies in diabetes patients over 12 months post treatment. Methods: PAD patients were selected from a large claims database with ≥1 CPT code for a lower extremity PAD procedure between 2005 and 2011. The date of the first CPT code was the index date. Patients were included with ≥12 months of preindex date continuous medical Co py rig ht HM P Co mm un ica ti ns

Purpose: Ectopic calcification is often associated with soft tissue inflammation and is seen in a multitude of clinical settings such as chronic renal failure and primary hyperparathyroidism. To further evaluate the specific pathophysiological role of T cells in nephrocalcinosis and dystrophic cardiac calcinosis, we used DBA/2 mice that have a natural splice variant in the ABCC6 gene and are prone to develop ectopic calcifications under high-phosphate diet.

BACKGROUND: The Neutrophil-to-Lymphocyte ratio (NLR) is an easy to perform test from the white blood cell count. An increase in NLR has been associated with vascular endpoints reflecting inflammation in atherosclerotic lesions. Atherosclerosis is a global threat and vascular endpoints, like myocardial infarction or critical limb ischemia (CLI), are a leading cause of death in industrialized countries. We therefore investigated NLR and its association with CLI and other vascular endpoints in peripheral arterial occlusive disease (PAOD) patients. METHODS AND FINDINGS: We evaluated 2121 PAOD patients treated at our institution from 2005 to 2010. NLR was calculated and the cohort was divided into tertiles according to the NLR. An optimal cut-off value for the continuous NLR was calculated by applying a receiver operating curve analysis to discriminate between CLI and non-CLI. In our cohort occurrence of CLI significantly increased with an increase in NLR. As an optimal cut-off a NLR of 3.95 was identified. Two groups were categorized, one containing 1441 patients (NLR≤3.95) and a second group with 680 patients (NLR>3.95). CLI was more frequent in NLR>3.95 patients (330(48.5%)) compared to NLR≤3.95 patients (350(24.3%)) (p<0.001), as were prior myocardial infarction (48(7.0%) vs. 47(3.3%), p<0.001) and stroke (73(10.7) vs. 98(6.8%), p<0.001). Regarding other inflammatory parameters, C-reactive protein (median 5.6 mg/l (2.3-19.1) vs. median 3 mg/l (1.5-5.5)) and fibrinogen (median 412 mg/dl (345.5-507.5) vs. 344 mg/dl (308-403.5)) also significantly differed in the two patient groups (both p<0.001). A NLR>3.95 was associated with an OR of 2.5 (95%CI 2.3-2.7) for CLI even after adjustment for other vascular risk factors. CONCLUSIONS: An increased NLR is significantly associated with patients at high risk for CLI and other vascular endpoints. The NLR is an easy to perform test, which could be used to highlight patients at high risk for vascular endpoints.

Background— Stenting has been shown to improve patency after femoral artery revascularization compared with balloon angioplasty. Limited data are available evaluating endovascular treatment for obstructive lesions of the popliteal artery. Methods and Results— This prospective, randomized, multicenter trial compared primary nitinol stent placement to percutaneous transluminal balloon angioplasty in patients with peripheral artery disease Rutherford-Becker class 2 to 5 who had a de novo lesion in the popliteal artery. The primary study end point was 1-year primary patency, defined as freedom from target-lesion restenosis (luminal narrowing of ≥50%) as detected by duplex ultrasound. Secondary end points included target-lesion revascularization rate and changes in Rutherford-Becker class. Provisional stent placement was considered target-lesion revascularization and loss of primary patency. Two hundred forty-six patients were included in this trial. The mean target-lesion length was 42.3 mm. One hundred ninety-seven patients were available for the1-year follow-up. The 1-year primary patency rate was significantly higher in the group with primary nitinol stent placement (67.4%) than in the percutaneous transluminal balloon angioplasty group (44.9%, P =0.002). Target-lesion revascularization rates were 14.7% and 44.1%, respectively ( P =0.0001); however, when provisional nitinol stent placement was not considered target-lesion revascularization and loss in patency, no significant differences prevailed between the study groups (67.4% versus 65.7%, P =0.92 for primary patency). Approximately 73% of patients in the percutaneous transluminal balloon angioplasty group and 77% in the nitinol stent group showed an improvement of ≥1 Rutherford-Becker class ( P =0.31). Conclusions— Primary nitinol stent placement for obstructive lesions of the popliteal artery achieves superior acute technical success and higher 1-year primary patency only if provisional stenting is considered target-lesion revascularization. Provisional stenting as part of a percutaneous transluminal balloon angioplasty strategy has equivalent 1-year patency and should be preferred over primary stenting. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00712309.

Nephrocalcinosis is characterized by aberrant deposition of calcium in the kidneys and is seen in phosphate nephropathy, primary hyperparathyroidism, and distal renal tubular acidosis. To further evaluate the specific pathophysiologic role of T cells in ectopic calcification, we used DBA/2 mice that are prone to develop nephrocalcinosis and dystrophic cardiac calcinosis. Female DBA/2 mice were depleted of T cells (n = 10) or regulatory T cells (Tregs) (n = 15) using either an anti-CD3 epsilon or an anti-CD25 monoclonal antibody and compared with isotype-treated controls (n = 9; n = 15), respectively. After this immunomodulation, the DBA/2 mice were given a high-phosphate diet for 9 days and the degree of calcification was assessed by microcomputed tomography. Successful depletion was confirmed by flow cytometry of splenocytes. In DBA/2 mice, the high-phosphate diet induced a phenotype of nephrocalcinosis and dystrophic cardiac calcinosis. T.-cell depletion significantly increased renal calcification in microcomputed tomography (P = 0.022). Concordantly, Treg depletion significantly deteriorated acute phosphate nephropathy (P = 0.039) and was associated with a significantly increased mortality rate (P = 0.004). Immunomodulation had no impact on the amount of cardiac calcification. Semiquantitative histopathologic evaluations with Alizarin Red staining independently confirmed the respective radiologic measurements. In summary, our data suggest a pivotal role of T cells, particularly Tregs, in the progression of nephrocalcinosis and emphasize the fact that inflammation deteriorates the outcome in acute phosphate nephropathy.

Peripheral arterial occlusive disease (PAOD) is frequent [ [1] Bertomeu V. Morillas P. Gonzalez-Juanatey J.R. et al. Prevalence and prognostic influence of peripheral arterial disease in patients > or =40 years old admitted into hospital following an acute coronary event. Eur J Vasc Endovasc Surg. 2008; 36: 189-196 Abstract Full Text Full Text PDF PubMed Scopus (67) Google Scholar ]. Although endovascular treatment possibilities improved over the last decades, restenosis rate after percutaneous transluminal angioplasty (PTA) alone in the superficial femoral artery (SFA) varies between 30% and 40% within one year. One possible risk factor for the development of reobstruction is the coexistence of the metabolic syndrome [ [2] Smolock C.J. Anaya-Ayala J.E. Bismuth J. et al. Impact of metabolic syndrome on the outcomes of superficial femoral artery interventions. J Vasc Surg. 2012; 55 ([e1, discussion 93]): 985-993 Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar ].