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Chronic thromboembolic pulmonary hypertension (CTEPH) is a subgroup of pulmonary hypertension that differs from all other forms of PH in terms of its pathophysiology, patient characteristics and treatment. For implementation of the European Guidelines on Diagnosis and Treatment of Pulmonary Hypertension in Germany, the Cologne Consensus Conference 2016 was held and last updated in spring of 2018. One of the working groups was dedicated to CTEPH, practical and controversial issues were commented and updated. In every patient with suspected PH, CTEPH or chronic thromboembolic disease (CTED, i.e. symptomatic residual vasculopathy without pulmonary hypertension) should be excluded. Primary treatment is surgical pulmonary endarterectomy (PEA) in a multidisciplinary CTEPH centre. Inoperable patients or patients with persistent or recurrent CTEPH after PEA are candidates for targeted drug therapy. There is increasing experience with balloon pulmonary angioplasty (BPA) for inoperable patients; this option, like PEA, is reserved for specialised centres with expertise in this treatment method., (Copyright © 2018. Published by Elsevier B.V.)

Background: Recent randomized trials have shown the treatment benefits of use of a drug-coated balloon (DCB) over conventional percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal disease. However, the effectiveness and safety of DCB for dialysis patients remain unclear.Methods and Results:Consecutive dialysis patients, who underwent PTA or DCB for femoropopliteal disease, were assessed retrospectively via 2:1 propensity score matching. Effectiveness and safety endpoints, including binary restenosis, clinically driven target lesion revascularization (CD-TLR), amputations, major adverse cardiac events (MACE), and deaths, were compared between groups. A total of 278 dialysis patients with 339 limbs were eligible for matching: 84 limbs from 77 patients treated with PTA and 46 limbs from 37 patients treated with DCB were compared after matching. Baseline patient and lesion characteristics were not different between groups. Patients treated with DCB had significantly higher rates of freedom from binary restenosis (52.4% vs. 18.6%, P<0.001) and CD-TLR (56.4% vs. 25.9%, P=0.001) at 2 years compared with patients treated with PTA. Both groups had similar outcomes for amputation, MACE, and death. Cox proportional analysis showed that treatment with DCB was independently associated with a reduction of binary restenosis (hazard ratio [HR] 0.368, P=0.001) and CD-TLR (HR 0.390, P=0.004)., Conclusions: This study suggested superior 2-year outcomes using DCB compared with PTA and similar safety profiles in dialysis patients with femoropopliteal disease.

The aim of this study was to describe our experience in the treatment of various pathological conditions of the cranial and spinal blood vessels and hypervascularized lesions using dual lumen balloon catheters. Twenty-five patients were treated with endovascular techniques: two with vasospasm of cerebral blood vessels caused by subarachnoid hemorrhage, one with a hypervascularized metastasis in the vertebral body, two with spinal dural fistula, four with cerebral dural fistula, three with cerebral arteriovenous malformations, and 13 with aneurysms. The dual lumen balloon catheters were used for remodeling of the coil mesh, injection of various liquid embolic agents, particles and nimodipine, for the prevention of reflux and deployment of coils and stents. The diameter of catheterized blood vessels varied from 0.7 mm to 4 mm. Two complications occurred: perforation of an aneurysm in one case and gluing of the tip of balloon catheter by embolic material in another case. All other interventions were uneventful, and therapeutic goals were achieved in all cases except in the case with gluing of the tip of balloon catheter. The balloons effectively prevented reflux regardless of the type of the embolic material and diameter of blood vessel. The results of our study show that dual lumen balloon catheters allow complex interventions in the narrow cerebral and spinal blood vessels where the safe use of two single lumen catheters is either limited or impossible., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: The incidence of pulmonary vein stenosis (PVS) as complication after pulmonary vein isolation (PVI) for atrial fibrillation (AF) has decreased in the last decade. However, as PVI for AF is becoming more prevalent, the incidence remains considerable in absolute terms. The purpose of this meta-analysis is to investigate the optimal approach for management of PVS after PVI for AF., Methods and Results: We searched electronic scientific databases for studies comparing plain balloon angioplasty (BA) versus stenting for PVS after PVI for AF. Aggregate data were pooled to perform a meta-analysis. The primary and secondary outcomes were restenosis requiring repeated intervention and procedure-related complications, respectively. A total of 4 studies, treating 315 PVS in 188 patients (BA, n=171 versus stent, n=144 PVS) were considered. After a median follow-up of 32months, the overall incidence of restenosis was 46%. A percutaneous therapy with BA was associated with a higher risk for restenosis requiring repeat intervention compared to stent (risk ratio - RR, 95% confidence interval [95% CI]=2.18 [1.64-2.89], p<0.001). Procedure-related complications were comparable between BA and stent (RR [95% CI]=0.96 [0.19-4.96], p=0.96). The time to diagnosis of PVS after PVI for AF did not modify the treatment effect for the primary outcome with BA versus stent (p for interaction=0.16)., Conclusions: In patients presenting PVS after PVI for AF, a percutaneous therapy with BA is associated with higher risk for restenosis requiring repeat intervention as compared to stent. These percutaneous therapies display comparable safety., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: The effect of balloon pulmonary angioplasty (BPA) on improvement in functional and hemodynamic parameters in chronic thromboembolic pulmonary hypertension (CTEPH) is known, but the quality of life (QoL) of patients treated with BPA has never been studied before.Methods and Results:Twenty-five patients with inoperable or persistent CTEPH were enrolled in the study and filled out the 36-item Short Form (SF-36v2) questionnaire twice: prior to commencement of BPA treatment and after ≥3 BPA sessions. In addition WHO functional class, distance on the 6-min walk test (6MWT) and hemodynamic parameters such as right atrial pressure (RAP), mean pulmonary artery pressure (mPAP), cardiac index (CI) and pulmonary vascular resistance (PVR) were assessed. QoL improved significantly in all domains, except for physical pain. Improvement in RAP (10.5±3.4 vs. 6.2±2.2 mmHg; P<0.05), mPAP (51.7±10.6 vs. 35.0±9.1 mmHg; P<0.05), CI (2.2±0.5 vs. 2.5±0.4 L/min·m 2 ; P=0.04), PVR (10.4±3.9 vs. 5.5±2.2 Wood units; P<0.05), functional class (96% vs. 20% in WHO class III and IV, P<0.05) and improvement in 6MWT distance (323±135 vs. 410±109 m; P<0.05) was observed. The only significant correlation was between the mental component summary score of QoL after completion of treatment and percentage improvement in the 6MWT (-0.404, P<0.05)., Conclusions: Alongside improvement in functional and hemodynamic parameters, BPA also provides significant improvement in QoL.

Although stopping smoking, lowering blood pressure and reducing lipid levels will reduce global stroke risk and cardiovascular mortality, these remain leading causes of death and disability especially in ageing populations. Further prevention strategies are needed and, in the first part of this review, we explore the potential benefits of appropriate screening for carotid artery disease to reduce stroke and identify those who may have related cardiac disease. Although whole-population carotid screening is an inefficient and costly means of identifying candidates with tight carotid stenosis who might warrant intervention, it can identify many people with lower levels of stenosis who may benefit from cardiovascular risk-reducing medications. Longer-term benefits and cost-effectiveness of any targeted screening program needs further evaluation. Patients with carotid stenosis are known to be at increased risk of stroke and vascular death. Whilst randomized clinical trials and guidelines have reported stroke hazards and benefits of interventional treatment for carotid stenosis, uncertainty remains about their optimal medical management. In the second part of this review we discuss Level I evidence for medical and surgical treatment of asymptomatic carotid stenosis, reasons for the current lack of consensus on interventional management of these patients and future studies which may help to clarify which groups will (and which will likely not) benefit from interventions.

Background: Clinical outcome after pulmonary vein isolation (PVI) may be linked to both durability of PVI and the antral lesion size. Data on balloon-guided technologies are scarce. We investigated the size of the isolated surface area (ISA) acutely after PVI achieved by cryoballoon (CB) or laser balloon (LB), both using voltage mapping.Methods and Results:In 40 patients (73% male, mean age 66±9 years), a bipolar voltage map before and after PVI in sinus rhythm was acquired to delineate the isolated antral surface area (IASA, contiguous area of low voltage <0.5 mV) and the ISA (relative size of the low-voltage area in relation to the whole antral surface area including the posterior wall). IASA (CB: 57±14 cm 2 vs. LB: 42±15 cm 2 ; P=0.002) as well as ISA (65±8% vs. 54±10%; P=0.001) were significantly larger in the CB than in the LB group. No periprocedural complications occurred. During a mean follow-up of 326±142 days, 4/20 and 5/20 patients experienced an AF/AT recurrence in the CB and LB groups, respectively. No differences in clinical outcome were observed between patients with a large (≥55%) or small (<55%) ISA., Conclusions: Balloon-guided PVI is associated with antral lesion formation. CB-guided PVI is associated with the largest ISA as compared with LB procedures. ISA size did not correlate with clinical outcome after a single procedure in the present study population.

We summarize an HTA report regarding patient values of drug-eluting stents and balloons for treatment of atherosclerotic disease in the lower extremities. We found 17 randomized controlled trials, 4 cohort studies and 13 case series. The total number of studied patients was substantial (about 3,000) but there was a strong heterogeneity regarding site of lesion, symptom pattern, device, drug used and outcome measures, making the analysis difficult and based on relatively small subgroups. We found low certainty of evidence (GRADE ++) for a reduced risk of restenosis in patients with critical ischemia and lesions below the knee, and also a modest beneficial effect on ischemic symptoms in a mixed patient population. However, we also identified a worrying safety signal, with increased risk for amputation in a group of patients with below-the-knee disease and critical ischemia. The results highlight the need for a structured system for validation of medical devices, a system analogous to that currently used for evaluation of new pharmacological products.

Background: Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown., Objectives: This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions., Methods: We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test., Results: At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions., Conclusions: The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Increasing patient demands, costs and emphasis on safety, coupled with reductions in the length of time surgical trainees spend in the operating theatre, necessitate means to improve the efficiency of surgical training. In this respect, feedback based on intraoperative surgical performance may be beneficial. Our aim was to systematically review the impact of intraoperative feedback based on surgical performance., Setting: MEDLINE, Embase, PsycINFO, AMED and the Cochrane Database of Systematic Reviews were searched. Two reviewers independently reviewed citations using predetermined inclusion and exclusion criteria. 32 data-points per study were extracted., Participants: The search strategy yielded 1531 citations. Three studies were eligible, which comprised a total of 280 procedures by 62 surgeons., Results: Overall, feedback based on intraoperative surgical performance was found to be a powerful method for improving performance. In cholecystectomy, feedback led to a reduction in procedure time (p=0.022) and an improvement in economy of movement (p<0.001). In simulated laparoscopic colectomy, feedback led to improvements in instrument path length (p=0.001) and instrument smoothness (p=0.045). Feedback also reduced error scores in cholecystectomy (p=0.003), simulated laparoscopic colectomy (p<0.001) and simulated renal artery angioplasty (p=0.004). In addition, feedback improved balloon placement accuracy (p=0.041), and resulted in a smoother learning curve and earlier plateau in performance in simulated renal artery angioplasty., Conclusions: Intraoperative feedback appears to be associated with an improvement in performance, however, there is a paucity of research in this area. Further work is needed in order to establish the long-term benefits of feedback and the optimum means and circumstances of feedback delivery., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Recent data suggest that infrapopliteal percutaneous transluminal angioplasty (PTA) is a reasonable primary therapy for critical limb ischaemia (CLI). Based on the transatlantic intersociety consensus (TASC) classification, this has been found to be true for lesions classified as A, B or C. We report our experience with infrapopliteal PTA stratified by TASC classification., Methods: A retrospective study of patients who underwent infrapopliteal PTA with or without stenting from October 2007 to July 2011 was conducted, revealing 83 limbs. The primary outcome variables were freedom from reintervention and freedom from index limb amputation. Secondary outcomes were technical success, post-operative complications and survival. TASC classification was assessed for the individual vessel(s) chosen for intervention., Results: Median age was 76 years and radiological success was 86.75%. Average follow-up was 15 months. At 1 and 2 years, freedom from re-intervention, or amputation was 65.1% and 55.6%. Limb salvage was 77.7%. Within 2 years, 2% underwent bypass and 18% repeat infrapopliteal PTA. The 30-day mortality was 5%. Overall survival was 84.5%, 71.8% and 61.6% at 1, 2 and 3 years. Eighty-two per cent were classified as TASC D lesions. Radiological success was achieved in 100% of TASC C lesions in contrast to 86.7% of TASC D lesions. There was not a statistically significant relationship between primary outcomes and TASC D classification., Discussion: Given the encouragingly high rates of radiological success and limb salvage, an attempt at PTA is indicated as an alternative to primary amputation even in patients with radiologically demonstrated severe disease., (© 2013 Royal Australasian College of Surgeons.)

Diabetic foot (DF) is a chronic and highly disabling complication of diabetes. The prevalence of peripheral arterial disease (PAD) is high in diabetic patients and, associated or not with peripheral neuropathy (PN), can be found in 50% of cases of DF. It is worth pointing out that the number of major amputations in diabetic patients is still very high. Many PAD diabetic patients are not revascularised due to lack of technical expertise or, even worse, negative beliefs because of poor experience. This despite the progress obtained in the techniques of distal revascularisation that nowadays allow to reopen distal arteries of the leg and foot. Italy has one of the lowest prevalence rates of major amputations in Europe, and has a long tradition in the field of limb salvage by means of an aggressive approach in debridement, antibiotic therapy and distal revascularisation. Therefore, we believe it is appropriate to produce a consensus document concerning the treatment of PAD and limb salvage in diabetic patients, based on the Italian experience in this field, to share with the scientific community., (Copyright © 2013 Elsevier B.V. All rights reserved.)

Carotid artery stenosis is the major cause of the stroke associated with ischemic origin and carries increased mortality and morbidity. Since carotid artery endarterectomy (CEA) was first performed in 1950, in conjunction with the advanced technology and increased experience under the guidance of randomized controlled trials, balloon angioplasty and carotid artery stenting, which have similar mortality and morbidity, have become comparable with CEA. Determining the optimal treatment option for each patient is the most important issue in carotid artery stenosis. Today, there have been improvements in technology and recent advances in the cardiovascular sciences. Moreover, there is increased experience, increased attention to patient selection, and a team approach to find the most suitable treatment for the patient. In this review, we briefly discuss the current treatment approaches for carotid artery stenosis under the guidance of the modern studies.

Current clinical practice standards are addressed for the invasive interventional management of post-hemorrhagic cerebral vasospasm (PHCV) in patients with aneurysmal subarachnoid hemorrhage. The conclusions, based on an assessment by the Standards Committee of the Society of Neurointerventional Surgery, included a critical review of the literature using guidelines for evidence based medicine proposed by the Stroke Council of the American Heart Association and the University of Oxford, Centre for Evidence Based Medicine. Specifically examined were the safety and efficacy of established invasive interventional therapies, including transluminal balloon angioplasty (TBA) and intra-arterial vasodilator infusion therapy (IAVT). The assessment shows that these invasive interventional therapies may be beneficial and may be considered for PHCV-that is, symptomatic with cerebral ischemia and refractory to maximal medical management. As outlined in this document, IAVT may be beneficial for the management of PHCV involving the proximal and/or distal intradural cerebral circulation. TBA may be beneficial for the management of PHCV that involves the proximal intradural cerebral circulation. The assessment shows that for the indications described above, TBA and IAVT are classified as Class IIb, Level B interventions according to the American Heart Association guidelines, and Level 4, Grade C interventions according to the University of Oxford Centre for Evidence Based Medicine guidelines.

We present a case of a 73 year-old man with, long-segment thigh stenosis in the right common and internal carotid artery with occlusion left common carotid artery. Complex angioplasty with modification proximal and distal system protection was successful performed. There were no procedure-related complications. We concluded that in very complex, multilevel lesions in carotid artery, there is a place for safe double system protection. This maneuver can increase safe of the carotid artery stenting and minimise potential complications.

We present the case of a 12 month-old infant with critical coarctaion of aorta, arch hypoplasia, atrial and ventricular septal defects who underwent interventional treatment with stent implantation due to recoarctation of aorta. In neonatal period the patient went through complete surgical correction. At the age of four months balloon angioplasty of recurrent coractation was conducted. Eight months later the patient was hospitalised with heart failure (HF) symptoms. Clinical and echographic examination confirmed critical stenosis of aortic isthmus. We performed heart catheterisation with stent implantation to transverse and descending arch with immediate reduction of gradient from 45 mm Hg to 0 mm Hg, widening of the isthmus from 2 to 8 mm and gradual regression of HF symptoms. At 3 years of observation the patient has not presented with any signs of recurrence of the stenosis. The child remains free of HF symptoms with arterial hypertension controlled with pharmacotherapy and with good left ventricular function on echocardiographic examination.

The work was aimed at comparatively studying the outcomes of carotid endarterectomy and carotid stenting for optimal therapeutic decision-making in patients presenting with carotid artery stenoses. We examined and treated a total of one hundred and sixty-seven patients. In the group of endarterectomy, we performed a total of 91 operations in 85 patients, and in the group of carotid stenting, a total of 87 stenting procedures were carried out on the internal carotid artery with cerebral protection in 82 patients. This was followed by analysing both short- and long-term outcomes with a follow-up period ranging from 1 year to 3 years. We examined the following postoperative parameters: «stroke + lethality», incidence of transitory ischaemic attacks, as well as the rate of craniocerebral neuropathy and acute myocardial infarction. In the remote period we evaluated the prevalence rate of the parameter «stroke + myocardial infarction + lethality», as well as restenosis recurrence. In the carotid-endarterectomy group, the predictors of unfavourable surgical outcomes were contralateral occlusion (p=0.048) and cardial pathology (p=0.0245). In the group of carotid stenting, these predictors turned out to be a heterogeneous atherosclerotic plaque with an uneven or ulcerated contour (p=0.004), and the degree of cerebrovascular insufficiency (p=0.005).

Background: The efficacy of cutting or plain balloon angioplasty (CBA or PBA) has not been analyzed for the treatment of drug-eluting stent (DES) restenosis vs bare metal stent (BMS) restenosis., Methods and Results: The 252 in-stent restenosis (ISR) lesions in 224 consecutive patients treated by CBA (n=167) or PBA (n=85) between July 2002 and December 2007 were analyzed. At 6-month angiographic and 12-month clinical follow-up, CBA and PBA showed similar efficacies: repeat-ISR (37.0% vs 37.8%, P=0.90), late loss (0.62+/-0.60 vs 0.61+/-0.47 mm, P=0.92), and target lesion revascularization (18.3% vs 22.4%, P=0.50). This comparable efficacy was maintained for treatment in the DES-ISR and BMS-ISR subgroups. However, target lesion-related myocardial infarction (n=9) occurred more frequently in the CBA than in the PBA arm (6.2% vs 0%, P=0.03), most of which developed early after ISR treatment (n=7; 54+/-26 days). Independent predictors of repeat-ISR were diffuse ISR and smaller pretreatment minimal lumen diameter, both of which might imply heavier plaque burden in the ISR group., Conclusions: Plain or cutting balloon angioplasty for ISR seems to be comparable, as the angiographic or clinical endpoints were not affected by initial stent type but by parameters related to the plaque burden of the ISR lesion. However, CBA might be associated with higher risk of myocardial infarction than PBA, suggesting more attention to dual-antiplatelet therapy after its use for ISR.

Background and Purpose: Intracranial cerebral atherosclerosis causes ischemic stroke in a significant number of patients. Technological advances over the past 10 years have enabled endovascular treatment of intracranial atherosclerotic stenosis. The number of patients treated with angioplasty or stent-assisted angioplasty for this condition is increasing. Given the lack of universally accepted definitions, the goal of this document is to provide consensus recommendations for reporting standards, terminology, and written definitions when reporting clinical and radiological evaluation, technique, and outcome of endovascular treatment using angioplasty or stent-assisted angioplasty for stenotic and occlusive intracranial atherosclerosis., Summary of Report: This article was written under the auspices of Joint Writing Group of the Technology Assessment Committee, Society of NeuroInterventional Surgery, Society of Interventional Radiology; Joint Section on Cerebrovascular Neurosurgery of the American Association of Neurological Surgeons and Congress of Neurological Surgeons; and the Section of Stroke and Interventional Neurology of the American Academy of Neurology. A computerized search of the National Library of Medicine database of literature (PubMed) from January 1997 to December 2007 was conducted with the goal to identify published endovascular cerebrovascular interventional data in stenotic intracranial atherosclerosis that could be used as benchmarks for quality assessment. We sought to identify those risk adjustment variables that affect the likelihood of success and complications. This document offers the rationale for different clinical and technical considerations that may be important during the design of clinical trials for endovascular treatment of intracranial stenotic and occlusive atherosclerosis. Included in this guidance document are suggestions for uniform reporting standards for such trials. These definitions and standards are primarily intended for research purposes; however, they should also be helpful in clinical practice and applicable to all publications., Conclusions: In summary, the definitions proposed represent recommendations for constructing useful research data sets. The intent is to facilitate production of scientifically rigorous results capable of reliable comparisons between and among similar studies. In some cases, the definitions contained here are recommended by consensus of a panel of experts in this writing group for consistency in reporting and publication. These definitions should allow different groups to publish results that are directly comparable.

Critical limb ischemia (CLI) remains a poorly understood, rarely reported, and inconsistently treated major global healthcare epidemic. The incidence in the US is estimated at 1% of the population aged 50 years and older and at approximately double that rate in the over-70 age group. These frequencies are expected to increase significantly with the aging population and the expected increase in diabetes. Within 1 year of being diagnosed with CLI, 40% to 50% of the now 20 million US diabetics will experience an amputation, and 20% to 25% will die. The estimate for treating CLI in the US alone is $10 to $20 billion per year, but just a 25% reduction in amputations could save $2.9 to $3.0 billion annually. Infrainguinal bypass surgery (IBS) utilizing autogenous saphenous vein has been considered the "24-carat gold standard" treatment for CLI, but over the last decade, endovascular therapy has emerged to seriously challenge IBS, which has created considerable controversy. Despite an overall lack of "hard" level I data, many interventionists are questioning the role of IBS as a first-line CLI therapy or are at least now considering IBS a "tainted" gold standard ("14-carat"). This review will examine the available evidence, but there should be no doubt regarding the huge global clinical and economic impact of CLI and amputations.

This is the first comprehensive national registry that will provide data characterizing contemporary results of carotid endarterectomy (CEA) and carotid artery stenting (CAS). Carotid endarterectomy (CEA) has become the standard revascularization therapy to prevent stroke in patients with carotid artery disease, while carotid artery stenting (CAS) offers a percutaneous alternative in selected patients. Given the rapid growth in the numbers of CAS procedures being performed, there is a critical need for a national program to assess quality outcomes. The Carotid Artery Revascularization and Endarterectomy (CARE) Registry was developed through a multispecialty collaboration resulting in a comprehensive data collection tool for carotid revascularization procedures. The intent of the CARE registry is to collect and analyze clinical data to measure clinical practice, patient outcomes, and enable quality improvement for carotid revascularization. Finally, the CARE Registry satisfies the Center for Medicare and Medicaid Services (CMS) data reporting criteria for reimbursement., (2008 Wiley-Liss, Inc.)

Angioplasty and stenting of the carotid artery has become an accepted procedure in properly selected patients with carotid artery stenosis. The potential for devastating neurologic complications and significant hemodynamic changes separates endovascular treatment of the carotid artery from other percutaneous peripheral vascular procedures. In this article, the technique for carotid artery angioplasty and stenting is described and the strategies for management of the hemodynamic changes occuring with carotid stenting are reviewed.

Objectives: This study aims to determine safety, short and mid-term outcomes of Carotid Artery Stenting (CAS) and Endarterectomy (CEA) during the last 6 years in a single vascular surgery center., Methods: We retrospectively reviewed 2624 consecutive carotid revascularizations performed between December 2000 and December 2006 in 2176 patients with severe carotid artery stenosis (symptomatic > or = 70%, asymptomatic > or = 80%), of which 1589 were CEA and 1035 CAS. Patients were followed up at 1, 3, 6 and 12 months after the procedure and then yearly., Results: The percutaneous procedure was successful in 99.2% of the cases. No intra-procedural death occurred. The overall death and stroke rates at 30 days, 1 year and 3 years were 1.54%, 2.86%, 7.43% in the CAS group and 2.07%, 3.55%, 6.95% in the CEA group, respectively (p value not significant in any case)., Conclusions: At our vascular surgery centre the results of CEA and CAS are similar. CAS has become our standard of care in preventing strokes and is an effective alternative to CEA for low-risk patients as well.

Background: Primary stenting with self-expanding nitinol stents of the superficial femoral artery yielded improved morphological and clinical results compared with balloon angioplasty with optional stenting until 12 months in a randomized controlled trial. We now report 2-year data on restenosis and clinical outcomes of these patients., Methods and Results: Of 104 patients with chronic limb ischemia and superficial femoral artery obstructions, 98 (94%) could be followed up until 2 years after intervention for occurrence of restenosis (>50%) by duplex ultrasound and for clinical and hemodynamic outcome by treadmill walking distance and ankle brachial index. Restenosis rates at 2 years were 45.7% (21 of 46) versus 69.2% (36 of 52) in favor of primary stenting compared with balloon angioplasty with optional secondary stenting by an intention-to-treat analysis (P=0.031). Consistently, stenting (whether primary or secondary; n=63) was superior to plain balloon angioplasty (n=35) with respect to the occurrence of restenosis (49.2% versus 74.3%; P=0.028) by a treatment-received analysis. Clinically, patients in the primary stent group showed a trend toward better treadmill walking capacity (average, 302 versus 196 m; P=0.12) and better ankle brachial index values (average, 0.88 versus 0.78; P=0.09) at 2 years, respectively. Reintervention rates tended to be lower after primary stenting (17 of 46 [37.0%] versus 28 of 52 [53.8%]; P=0.14)., Conclusions: At 2 years, primary stenting with self-expanding nitinol stents for the treatment of superficial femoral artery obstructions yields a sustained morphological benefit and a trend toward clinical benefit compared with balloon angioplasty with optional stenting.

Objective: To evaluate endoluminal occlusion of the inferior vena cava (IVC) during surgical treatment of renal cell carcinoma (RCC) with either retrohepatic (level II) or suprahepatic (level III) caval tumour thrombus., Patients and Methods: From January 2000 to February 2005, 31 patients with renal vein/IVC involvement (T3b/c) of 278 who had a radical nephrectomy, were selected for review. Of these 31, 13 consecutive patients with RCC presenting a thrombus level II or III were prospectively treated with endoluminal occlusion of the free IVC cranial to the thrombus, to avoid dissection of the suprahepatic IVC or the subdiaphragmatic IVC. The occlusion balloon was positioned using transoesophageal echocardiography (TEE) control through a cavotomy at the ostium of the renal vein. Thrombectomy and radical nephrectomy were then performed. The operative duration, peri-operative bleeding, and complications during and after surgery were assessed. Overall patient survival time, disease-free survival and development of metastasis were calculated., Results: Caval thrombectomy was successful in all patients. The IVC needed to be replaced with an expanded polytetrafluoroethylene graft in three patients and a patch closure after lateral cavectomy was used in four. There was no case of air embolism. One case of asymptomatic tumour migration was detected during the procedure by TEE. The mean (sd) and median (range) operative duration was 170 (29) and 170 (120-210) min, and the mean number of units of packed red cells transfused during hospitalization was 5 (5) and 3 (0-16). There was no peri-operative mortality. The complications were one splenectomy and one early thrombosis of the IVC. The mean (range) follow-up was 22.1 (2-50) months. Distant metastases occurred in seven patients; there was no local or IVC tumour recurrence. Four patients died from metastatic progression and six are alive with no progression., Conclusion: Endoluminal occlusion of the IVC with TEE monitoring for level II and III thrombus avoided a suprahepatic or subdiaphragmatic approach to the IVC. This technique caused no major complications and was very reliable, due to TEE monitoring. Segmental resection and reconstruction of the IVC could also be used for adherent thrombi.

Endovascular treatment of cervical carotid artery stenosis is a rapidly expanding area of clinical competence, and physicians from various subspecialties are already performing carotid artery stenting. As a result of the diverse specialty backgrounds of physicians performing carotid artery stenting, consensus regarding the establishment of credentialing standards remains elusive. In the following manuscript we review the physician credentialing process, published data, and national society position statements applicable to carotid artery stenting.

Objective: To evaluate the impact of routine stenting, compared with balloon angioplasty, in unselected patients presenting with ST segment elevation myocardial infarction (STEMI)., Design: Randomised trial., Setting: Tertiary referral centre., Participants: All patients presenting with STEMI randomly assigned to stenting or balloon angioplasty. No exclusion criteria were applied., Main Outcome Measure: The primary end point was combined death or reinfarction at one year's follow up., Results: 1683 consecutive patients with STEMI were randomly assigned before angiography to stenting (n = 849) or balloon angioplasty (n = 834). A total of 785 patients (92.5%) in the stent group and 763 patients (91.5%) in the balloon group actually underwent primary angioplasty. The groups were comparable in terms of postprocedural TIMI (thrombolysis in myocardial infarction) flow, myocardial blush grade, and distal embolisation. No difference was observed in clinical outcome at both intention to treat (14% v 12.5%, not significant) and actual treatment analyses (12.4% v 11.3%, not significant)., Conclusions: Compared with balloon angioplasty, routine stenting does not seem to reduce death and reinfarction in a large cohort of unselected patients with STEMI.

A simple model for extra-Binomial variability is the Beta-Binomial. A complication in testing the Binomial against the Beta-Binomial alternative is that the Binomial lies on the boundary of the Beta-Binomial, which forces modifications to the usual asymptotic arguments. In this paper, we propose a Bayesian test using a pair of approximate Bayes factors, one for the case in which the maximum likelihood estimator (MLE) of the extra-Binomial variability is zero and one for the case in which it is positive. These approximate Bayes factors are easy to compute. We evaluate the operating characteristics of the Bayes factors and find them to be more powerful than the likelihood ratio test. We then apply the method to three data sets, including one in which the issue is whether a logistic regression intercept should be considered a random effect. In each case, our approximate Bayes factors are close to the exact Bayes factors, which may also be computed with additional effort., (2004 John Wiley & Sons, Ltd.)

Primary angioplasty (PA) for acute myocardial infarction (AMI) has emerged as the standard of care in hospitals with cardiac interventional facilities. The benefits from the PA are time dependent, but recent data raise concerns regarding the timeliness of delivery of care in AMI and the level of benefit achieved by current standards. We assessed the effectiveness of an extensive multidisciplinary quality improvement initiative in reducing door-to-balloon (DTB) times in PA. The PA process was divided into six separate time periods, which were assessed individually. Subsequent quality initiatives resulted in a dramatic reduction in the mean DTB time (141.3 minutes preintervention compared to 95.1 minutes postintervention; P < 0.001).

Several statistical methods can be used to test for differences in placebo-controlled dichotomous multi-arm studies. These tests include linear and quadratic trends, Dunnett's test, Hochberg's test, and the overall chi-square test. We computed the power of these tests under a wide variety of alternatives. For two arms versus a control, the power was computed exactly. For more than two arms, the power was calculated from 100000 simulations per alternative. Against monotonic alternatives, the linear trend test tended to be superior. Against convex alternatives, the quadratic trend test tended to be superior. Against general alternatives, Dunnett's test, Hochberg's test, and the overall chi-square test were superior and had very similar power curves. The Hochberg test was generally less powerful than Dunnett's test but the difference was offset by its increased power to reject multiple hypotheses. These results remained nearly constant over a wide range of sample sizes, average event rates and average effect sizes., (Copyright 2003 John Wiley & Sons, Ltd.)

Background: In patients with acute myocardial infarction treated with thrombolysis, longer times to treatment are associated with increasingly worse clinical outcome. This relation may be different for treatment with primary angioplasty., Methods: We analyzed the pooled data of the German acute myocardial infarction registries Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) and Myocardial Infarction Registry (MIR) to determine the influence of prehospital delays on hospital mortality rates. Primary angioplasty was performed in 1063 patients and thrombolysis in 7552 patients., Results: In patients treated with thrombolysis, in-hospital time to treatment was constantly 30 minutes median. In patients treated with primary angioplasty, in-hospital time to treatment increased from 60 minutes median up to 87 minutes median with increasing prehospital delay. Hospital mortality rates slightly decreased with increasing prehospital delays in patients treated with primary angioplasty (P for trend =.02). However, in patients treated with thrombolysis, mortality rate was nonsignificantly increased (P for trend =.11). Logistic regression analysis showed no significant difference in mortality rates between primary angioplasty and thrombolysis for prehospital delays of <3 hours. However, when prehospital delay was >3 hours, thrombolysis was independently associated with a higher mortality rate compared with primary angioplasty., Conclusions: Compared with thrombolysis, primary angioplasty is independently associated with a lower mortality rate in prehospital delays of >3 hours. The reason for this may be a time-dependent loss of efficacy to achieve reperfusion for thrombolysis but not for primary angioplasty.

The most frequent cause of secondary arterial hypertension is renal artery stenosis. The aetiology of renal artery stenosis is mainly atherosclerotic (75-80%), in the remaining cases fibromuscular dysplasia is the causative factor. Renovascular hypertension has a poorer prognosis than spontaneous because it is more resistant to antihypertensive treatment, signifies an increased risk for the development and progression of malignant hypertension and may lead to irreversible renal dysfunction due to ischaemia. Renal revascularisation has been proved an effective treatment modality in patients with arterial hypertension or renal failure due to renal artery stenosis. However, surgical treatment is associated with the mortality rate of 6-9% due to the concomitant presence of ischaemic heart disease, cerebral and peripheral arteriosclerosis. Percutaneous transluminal renal angioplasty is equally effective in the treatment of arterial hypertension as surgical operation, leading to the improvement or stabilisation of renal function. The advent of renal stenting has markedly changed the efficacy and safety of procedures with PTRA becoming an alternative to surgery. The high efficacy of PTRA is associated with low mortality and relatively few complications as compared with surgical treatment. However, there is continuous discussion concerning the efficacy of percutaneous and surgical renal revascularisation in arterial hypertension. PTRA is currently increasingly frequently recommended in patients with renovascular hypertension not only to control blood pressure but also to protect renal function.

The aim of this study was to analyse the results of intensive therapy unit management of aneurysmal subarachnoid haemorrhage incorporating angioplasty in the protocol. Two hundred consecutive patients were treated using a detailed protocol that included nimodipine, early aneurysm repair, and surveillance angiography. Angiography was performed on days 5 to 7 (or when the clinical state suggested the presence of vasospasm). If angiographic vasospasm was identified, irrespective of whether clinical vasospasm was present or absent, papaverine was selectively administered. In patients with vasospasm blood pressure was elevated to 160-180 mmHg and selective papaverine administration was repeated daily until vasospasm resolved. In cases requiring more frequent administration of papaverine, or in whom papaverine failed to adequately reverse spasm, balloon angioplasty was considered and for clinically refractory cases barbiturate coma was introduced. 43% of patients underwent papaverine administration and of these the average number of separate papaverine procedures was four (maximum 23). 26% of patients developed neurological deficits though to be due to vasospasm whilst 17% underwent papaverine angioplasty without clinical signs of vasospasm. Twelve patients (6%) were entered into barbiturate coma. There was a 5.5% mortality and no difference in outcome between patients who developed angiographic vasospasm and those who did not. For those developing clinical vasospasm, 71% were independent and 10% were dead at follow up compared with 84% reaching independent grades and 4% dead in those not developing clinical vasospasm. These differences failed to reach a significant difference. The average Intensive Therapy Unit stay for aneurysmal subarachnoid haemorrhage patients was 13.1 days with a mean cost to the hospital of $AUD 24,379. This protocol appears to be both a clinically and cost effective method of managing aneurysmal subarachnoid haemorrhage., (Copyright 2000 Harcourt Publishers Ltd.)