The hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.

Please cite this article as: Lammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, MuellerHuelsbeck S, Rand T, Funovics M, Wolf F, Rastan A, Gschwandtner M, Puchner S, Ristl R, Schoder M, Heparin-bonded covered stents versus bare metal stents for complex femoro-popliteal artery lesions: the randomized VIASTAR trial, Journal of the American College of Cardiology (2013), doi: 10.1016/ j.jacc.2013.05.079.

Objectives The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested.Background Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory.Methods In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.Results Mean +/- SD lesion length was 19.0 +/- 6.3 cm in the Viabahn group and 17.3 +/- 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p=0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p=0.009). In lesions >= 20 cm, (TransAtlantic InterSociety Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p=0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p=0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 +/- 0.23 compared with the BMS group (0.85 + 0.23; p < 0.05) at 12 months.Conclusions This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparinbonded covered stents compared with BMS in lesions >= 20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN (R) endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244) (C) 2013 by the American College of Cardiology Foundation

Treatment of infrapopliteal arteries has developed to a standard technique during the past two decades. With the introduction of innovative devices, a variety of techniques has been created and is still under investigation. Treatment options range from plain balloon angioplasty (POBA), all sorts of stent applications, such as bare metal, balloon expanding, self-expanding, coated and drug-eluting stents, and bio-absorbable stents, to latest developments, such as drug-eluting balloons. Regarding the scientific background, several prospective, randomized studies with relevant numbers of patients have been (or will be) published that are Level I evidence. In contrast to older studies, which primarily were based mostly on numeric parameters, such as diameters or residual stenoses, more recent study concepts focus increasingly on clinical features, such as amputation rate improvement or changes of clinical stages and quality of life standards. Although it is still not decided, which of the individual techniques might be the best one, we can definitely conclude that whatever treatment of infrapopliteal arteries will be used it is of substantial benefit for the patient. Therefore, the goal of this review is to give an overview about the current developments and techniques for the treatment of infrapopliteal arteries, to present clinical and technical results, to weigh individual techniques, and to discuss the recent developments.

Major concerns after aortic aneurysm repair are caused by the presence of endoleaks, which are defined as persistent perigraft flow within the aortic aneurysm sac. Diagnosis of endoleaks can be performed with various imaging modalities, and indications for treatment are based on further subclassifications. Early detection and correct classification of endoleaks are crucial for planning patient management. The vast majority of endoleaks can be treated successfully by interventional means. Guidelines for Imaging Detection and Treatment of endoleaks are described in this article.

Purpose: To determine the clinical outcome and the success of stent application for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia (CLI).Materials and Methods: In this ethics board-approved randomized prospective study, PTA or stent application was performed on 131 lesions in 88 patients with CLI. The primary end points were clinical improvement after endovascular treatment and limb salvage rate. Secondary end points were defined by the minimal lumen diameter (MLD) before and after the revascularization procedure, percentage of residual diameter stenosis (DS), binary restenosis rate (>50% DS and >70% DS), and incidence of target lesion revascularization at 9-month follow-up.Results: At 3 months, the clinical status in the PTA group was less improved than that in the stent group (P = .008). At 9 months, there had been five minor and two major amputations in the PTA group and five major and five minor amputations in the stent group. MLD was significantly larger and the percentage of DS was significantly less in the stent group at completion angiography. At 9 months, the angiographic control showed better trends for the stent group in comparison to the PTA group despite that no significant differences were detected (MLD, 1.19 mm +/- 0.92 vs 1.02 mm +/- 1.02; DS, 38.68% +/- 25.47 vs 43.31% +/- 28.37).Conclusion(:) Infrapopliteal stent application is an effective treatment modality in CLI. The PTA and stent groups were essentially equal at 3 and 9 months except for the difference in clinical improvement in the stent group at 3 months. (C) RSNA, 2011

Purpose:To report a systematic review of the literature published on the outcomes of stenting for below-the-knee disease in patients with critical limb ischemia (CLI). Methods:Potentially relevant studies of stent implantation in the infragenicular arteries in ≥5 patients with ≥1-month follow-up were systematically sought in BioMedCentral, ClinicalTrials.gov, The Cochrane Collaboration Register of Controlled Trials (CENTRAL), Google Scholar, and PubMed. Data were abstracted and pooled with a random-effect model to generate risk estimates with 95% confidence intervals (CI). Interaction tests were performed to compare different stent types. A risk of bias assessment was conducted separately, as were appraisals for small study bias, statistical heterogeneity, and inconsistency. Results:Eighteen nonrandomized studies were retrieved comprising 640 patients. After a median follow-up of 12 months, binary in-stent restenosis occurred in 25.7% (95% CI 11.6% to 40.0%), primary patency in 78.9% (95% CI 71.8% to 86.0%), improvement in Rutherford class in 91.3% (95% CI 85.5% to 97.1%), target vessel revascularization in 10.1% (95% CI 6.2% to 13.9%), and limb salvage in 96.4% (95% CI 94.7% to 98.1%). Head-to-head comparisons showed that sirolimus-eluting stents were superior to balloon-expandable bare metal stents in preventing restenosis and increasing primary patency (both p<0.001); sirolimus-eluting stents were also better than paclitaxel-eluting stents in terms of primary patency (p<0.001) and repeat revascularizations (p=0.014). Conclusion:Percutaneous infragenicular stent implantation after failed or unsuccessful balloon angioplasty is associated with favorable clinical results in patients with CLI. Notwithstanding limitations of primary studies, sirolimus-eluting stents appear superior to bare metal and paclitaxel-eluting stents in terms of angiographic and/or clinical outcomes.

Transarterial chemoembolization (TACE) involves the emulsification of a chemotherapeutic agent in a viscous drug carrier, delivered intra-arterially to liver tumor for maximum effect. TACE reduces arterial inflow, diminishes washout of the chemotherapeutic agent, and decreases systemic exposure. Despite evidence of some clinical success with TACE, a new type of microspheres with drug-eluting capabilities may offer a precisely controlled and sustainable release of the chemotherapeutic agent into the tumor bed. In animal trials tumor necrosis (approaching 100%) was greatest at 7 days, with significantly lower plasma concentrations of doxorubicin than in control animals treated with doxorubicin intra-arterially. Clinically, drug-eluting microspheres loaded with doxorubicin, either at 75 mg/m(2) or at a fixed dose of 150 mg, were used recently and no severe disorders of the hepatic function were observed postprocedure, while a substantial reduction of the fetoprotein levels occurred. An interim analysis of the first 15 patients from the Hong Kong group at 3 months showed an objective response rate of 61.54% and 53.84% according to EASL criteria and RECIST criteria, respectively, and a survival rate of 93.3%. In this paper we present how to use microspheres loaded with doxorubicin and review their clinical value and preliminary performance for treatment of unresectable liver cancer.

Purpose: To evaluate the feasibility and accuracy of automated analysis software for use with multicletector computed tomographic angiography (CTA) in the exact grading of internal carotid artery stenosis.Methods: A retrospective pilot trial was performed using CTA datasets from 87 stenotic carotid arteries in 46 consecutive patients (34 men; median age 73.5 years) with known cerebrovascular disease. Internal carotid artery (ICA) stenosis was graded according to NASCET criteria by 2 experienced vascular radiologists in consensus using axial source images as well as curved planar reformations and digital subtraction angiography (DSA). These results were then compared to those obtained from the automated CTA analysis software and the results of manually adapted automated CTA analysis.Results: Measurements from automated CTA analysis as well as manually adapted automated CTA analysis correlated significantly to those of axial/reformatted CTA and DSA (r=0.53 and r=0.82, r=0.58 and 0.70, respectively, all p < 0.05). Compared to axial/reformatted CTA measurements, automated CTA analysis had a median difference of -16%, while manually adapted automated CTA had a difference of -10%. Corresponding differences in a comparison with DSA were +4% and -2%, respectively. Circumferential calcification or kinking of the ICA origin did not significantly interfere with these differences (all p > 0.05). Sensitivities for the detection of ICA stenosis > 70% by manually adapted automated CTA analysis and automated measurement were 44.2% and 34.9%, respectively, versus axial/reformatted CTA. Compared with DSA as the gold standard, the sensitivities were 54.2% and 62.5%, respectively. Specificities for both methods and gold standards all exceeded 90%.Conclusion: Commercially available automated CTA analysis is a feasible tool, but sensitivities are still not sufficient for clinical application.

Purpose: To report about the endovascular treatment of isolated iliac artery aneurysms (IIAA) with stentgraft placement and transluminal or CT-guided embolization of the internal iliac artery or the combination of these methods.Methods and materials: Over a period of 5.6 years, 36 interventions were performed in 20 patients with 23 IIAAs. In a retrospective analysis patient records were reviewed. The CT-angiography follow-up was evaluated for the presence of re-perfusion of the IIAA and for change of aneurysm diameter.Results: Primary success was achieved in 15/23 aneurysms (65%), and secondary success in 21/23 aneurysms (91%). In 5/23 cases two interventions and in 1/23 cases three interventions were necessary to achieve secondary success. Embolization alone, as a therapy for aneurysms involving only the internal iliac artery, had a success rate of 27%. No procedure-related minor or major complications occurred.Mean decrease of aneurysm size during a mean observation period of 14.1 months was 6.9% which was not significant (P = 0.3; 95% confidence interval +7-21%).Conclusion: Endovascular therapy of isolated iliac artery aneurysms performed percutaneously has become a treatment alternative to open surgical repair. This method is feasible and safe with low procedure-related morbidity and mortality. However, on average more than one intervention has to be performed to achieve successful permanent exclusion of the aneurysm and embolization alone in isolated internal iliac artery aneurysms is not sufficient. (C) 2007 Elsevier Ireland Ltd. All rights reserved.

Background, The aim of this study was to determine the technical success after endovascular treatment of acute type B aortic dissections and to evaluate true and false lumen diameter changes at long-term follow-up.Methods. Twenty-eight patients with acute type B-dissection who were treated by stent graft repair presented with rupture (n = 1), contained rupture (n = 2), compromised branch vessels (n = 14), pleural effusion (n = 11), rapid aortic diameter progression (n 5), persistent pain (n = 3), refractory hypertension (n 10), and an aortic diameter of more than 4 cm (n = 4). Taking into account the perfusion status of the false lumen, diameter changes were monitored in the thoracic aorta at the level of the stented segment (L1), distal to the stent graft (1,2), and at the level of the celiac trunk (1,3).Results. Severe complications in 9 patients (32%) resulted in 3 deaths for a 30-day mortality rate of 10.7%. Primary sealing of the entry tear was achieved in 86%. At all levels, the true lumen diameter increased significantly after stent graft placement. At the 1-year follow-up, the false lumen in L1 was thrombosed in 90% and the mean difference of diameter reduction was highly significant. In L2, complete false lumen thrombosis occurred in 60% with a significant diameter decrease. In L3, the false lumen thrombosed in only 22%, and the mean difference of false lumen diameter increase reached significance at the 2-year follow-up.Conclusions. Ninety percent of patients were treated successfully with thrombosis of the false lumen in the stented segment. False lumen perfusion distal to the stent graft resulted in diameter increase in several patients leaving these segments an area of concern.

Introduction We evaluated the feasibility of multidetector CT angiography (MDCTA) in the examination of vertebral artery (VA) pathologies and correlated the results with those of color Doppler sonography (CDS).Methods In this retrospective cohort analysis, we identified 65 patients with suspected cerebrovascular disease, who underwent MDCTA and CDS of the supraaortic vessels within a maximum period of 1 month. We evaluated the feasibility and image quality of MDCTA in this indication, compared the value of reformatted images and axial source images in the grading of stenoses and correlated these results with those of CDS.Results The image quality of the MDCTA examination was classified as good in 64 patients (98.5%) and as moderate in 1 patient (1.5%). Axial source images and reformatted images agreed perfectly in terms of stenosis detection and grading as well as the detection of hypoplastic VAs (kappa=1). The correlation between MDCTA and CDS was moderate (kappa=0.56) in terms of stenosis detection and quantification and poor (kappa=0.35) in terms of detection of hypoplasia of the VA.Conclusion MDCTA is a feasible method for the evaluation of VA pathologies providing a good image quality. Image reformatting does not add any diagnostic value to the interpretation of axial source images. The correlation between MDCTA and CDS is only moderate, reflecting the clinically important limitations of CDS in this indication.

To achieve a high spatial resolution in MR imaging that allows for clear visualization of anatomy and even histology and documentation of plaque morphology in in vitro samples from patients with advanced atherosclerosis. A further objective of our study was to evaluate whether T2-weighted high-resolution MR imaging can provide accurate classification of atherosclerotic plaque according to a modified American Heart Association classification.

PURPOSE:To compare the measurements of internal carotid artery (ICA) stenosis obtained from multidetector computed tomographic angiography (CTA) and digital subtraction angiography (DSA) based on the NASCET and ECST grading methods.METHODS:In a retrospective cohort analysis from data at a tertiary care university clinic, the CTA and DSA images from 69 consecutive patients (52 men; mean age 70.3+/-8.0 years, range 51-85) who underwent both imaging studies within a maximum period of 28 days were interpreted by 2 radiologists blinded to the results of the other modality. The exact degree of ICA stenosis was calculated for both modalities according to NASCET and ECST guidelines.RESULTS:The agreement between both stenosis grading methods was comparable for CTA (R2=0.87) and DSA (R2=0.84); mean differences in stenoses grades between ECST and NASCET were 13.9% (CTA) and 12.9% (DSA, p>0.05). Corresponding results for the intermodality correlation were almost equal for NASCET (R2=0.59) and ECST (R2=0.55), with mean differences of 13.4% and 13.5%, respectively (p>0.05). Sensitivity and specificity of CTA for detecting occlusions was 100% for both modalities and grading systems. For detecting stenoses >70%, the sensitivity and specificity were 90.9% and 54.9%, respectively, for NASCET and 94.7% and 46.3%, respectively, for ECST. For stenoses >50%, the values were 95.8% and 59.6%, respectively, for NASCET and 96.4% and 42.5%, respectively, for ECST.CONCLUSION:The introduction of multidetector CTA cannot overcome the confusion in the exact grading of ICA stenosis because the application of both tested modalities as well as both grading methods results in clinically important differences.

Während Angioplastie (PTA) und Stentbehandlung im Bereich der Beckengefäße sich zu etablierten interventionellen Standardverfahren entwickelt haben, ist die endovaskuläre Behandlung von Läsionen der A. poplitea und auch der Unterschenkelgefäße noch in Diskussion. Gründe hierfür sind bei der A. poplitea v. a. die ungünstigen mechanischen Faktoren, die hohe Traktionskräfte am Gefäß wirken lassen und besonders die Gefäßpathologien, die neben der stenosierenden Atherosklerose auch andere spezifische Ausprägungen wie Aneurysmen, Embolien, Entrapmentsyndrome und die zystische Adventitianekrose umfassen. Mit neuen Stentdesigns wird versucht, der hohen mechanischen Beanspruchung in dieser Region gerecht zu werden, und die Kurzzeitergebnisse sind vielversprechend.

Objective: The purpose of the study was to determine technical and clinical results in endovascular repair of thoracic aortic diseases necessitating stent-graft anchoring across the arch vessels.Methods: The causes for endovascular treatment in 58 patients (aged 20 to 84 years) were aneurysms (n = 32), acute type A (n = 2) and type B dissections (n = 17), posttraumatic transections (n = 4), iatrogenic dissection (n = 1), and penetrating ulcers with an intramural hematoma (n = 2). Surgical revascularization of arch vessels was performed in 26 patients before stent-graft implantation. Intentional overstenting of the left subclavian artery resulted in complete occlusion in 8 and was partial in 24 patients.Results: The 30-day mortality rate was 3.4%. Overall, 19 major postprocedural complications occurred in 14 (24%) patients. Among patients with left subclavian artery occlusion, 2 patients had major (1 paraplegia, 1 critical arm ischemia), and 3 minor (2 temporary vertebrobasilary symptoms, I transient arm claudication) complications. Fourteen (25%) patients had an early endoleak, of whom 5 were treated successfully with a secondary endovascular procedure, 2 necessitated open surgical conversion, and 7 were treated conservatively, with spontaneous sealing of the endoleak in 3. In 53 (91%) in whom computed tomographic follow-up was longer than 3 months (mean, 30.1 months, range, 3 to 85), the aortic diameter along the stented segment decreased in 24, was stable in 19, and increased in 10 patients.Conclusion: Fixation of the stent graft in the aortic arch can expand the applicability of endovascular repair. Intentional overstenting should be performed with caution to avoid ischemic problems after complete occlusion of left subclavian artery.

Purpose: To evaluate multidetector computed tomographic angiography (CTA) versus published color Doppler sonography (CDS) velocity criteria in the grading of internal carotid artery (ICA) stenosis.Methods: Sixty-eight consecutive patients (50 men; mean age 70.2 +/- 8.1 years, range 51-85) with known ICA stenosis and complete CTA and CDS data for 127 carotid arteries were enrolled in this retrospective analysis. The degree of stenosis was determined using CDS velocities according to 5 published sets of criteria, as well as the criteria used at the authors' institution. These outcomes were then correlated using kappa-statistics with the results of multidetector CTA according to NASCET.Results: The best overall agreement was achieved applying the criteria sets of Hwang (kappa=0.70) and AbuRahma (kappa=0.68). All 5 occlusions were correctly identified with both modalities. CTA detected 73 ICA stenoses >70%; the best correlation was with the application of Hwang criteria, which correctly identified 69 (94.5%) >70% stenoses. In order of increasing tendency to underscore the grade of stenosis, the corresponding results for the other criteria sets were 62 (84.9%) for Mittl, 59 (80.8%) for AbuRahma, 55 (75.3%) each for Nicolaides and Filis, and 50 (68.5%) for Nederkoorn. CTA detected 85 stenoses >50%; the sensitivity of all applied CDS criteria sets exceeded 90%.Conclusion: Grading of ICA stenosis >70% with CDS and CTA results in clinically relevant discrepancies, with higher grades of stenoses assessed by CTA. The choice of CDS grading criteria is of significant clinical importance, especially in the identification of high-grade ICA stenosis.