Mitochondrial DNA copy number is associated with all-cause mortality and cardiovascular events in patients with peripheral arterial disease.

BACKGROUND: Dysfunctional mitochondria have an influence on inflammation and increased oxidative stress due to an excessive production of reactive oxygen species. The mitochondrial DNA copy number (mtDNA-CN) is a potential biomarker for mitochondrial dysfunction and has been associated with various diseases. However, results were partially contrasting which might have been caused by methodological difficulties to quantify mtDNA-CN. OBJECTIVE: We aimed to investigate whether mtDNA-CN is associated with peripheral arterial disease (PAD) as well as all-cause mortality and cardiovascular events during seven years of follow-up. METHODS: A total of 236 male patients with PAD from the Cardiovascular Disease in Intermittent Claudication (CAVASIC) study were compared with 249 age- and diabetes-matched controls. MtDNA-CN was measured with a well-standardized plasmid-normalized quantitative PCR-based assay determining the ratio between mtDNA-CN and nuclear DNA. RESULTS: Individuals in the lowest quartile of mtDNA-CN had a twofold increased risk for PAD which, however, was no longer significant after adjusting for leukocytes and platelets. About 67 of the 236 patients had already experienced a cardiovascular event at baseline and those in the lowest mtDNA-CN quartile had a 2.34-fold increased risk for these events (95% CI 1.08-5.13). During follow-up, 37 PAD patients died and 66 patients experienced a cardiovascular event. Patients in the lowest mtDNA-CN quartile had hazard ratios of 2.66 (95% CI 1.27-5.58) for all-cause-mortality and 1.82 (95% CI 1.02-3.27) for cardiovascular events compared with the combined quartile 2-4 (adjusted for age, smoking, CRP, diabetes, prevalent cardiovascular disease, leukocytes and platelets). CONCLUSION: This investigation supports the hypothesis of mitochondrial dysfunction in peripheral arterial disease and shows an association of low mtDNA-CNs with all-cause-mortality and prevalent and incident cardiovascular disease in PAD patients with intermittent claudication.

Timing of procedural stroke and death in asymptomatic patients undergoing carotid endarterectomy: individual patient analysis from four RCTs.

BACKGROUND: The effectiveness of carotid endarterectomy (CEA) for stroke prevention depends on low procedural risks. The aim of this study was to assess the frequency and timing of procedural complications after CEA, which may clarify underlying mechanisms and help inform safe discharge policies. METHODS: Individual-patient data were obtained from four large carotid intervention trials (VACS, ACAS, ACST-1 and GALA; 1983-2007). Patients undergoing CEA for asymptomatic carotid artery stenosis directly after randomization were used for the present analysis. Timing of procedural death and stroke was divided into intraoperative day 0, postoperative day 0, days 1-3 and days 4-30. RESULTS: Some 3694 patients were included in the analysis. A total of 103 patients (2·8 per cent) had serious procedural complications (18 fatal strokes, 68 non-fatal strokes, 11 fatal myocardial infarctions and 6 deaths from other causes) [Correction added on 20 April, after first online publication: the percentage value has been corrected to 2·8]. Of the 86 strokes, 67 (78 per cent) were ipsilateral, 17 (20 per cent) were contralateral and two (2 per cent) were vertebrobasilar. Forty-five strokes (52 per cent) were ischaemic, nine (10 per cent) haemorrhagic, and stroke subtype was not determined in 32 patients (37 per cent). Half of the strokes happened on the day of CEA. Of all serious complications recorded, 44 (42·7 per cent) occurred on day 0 (20 intraoperative, 17 postoperative, 7 with unclear timing), 23 (22·3 per cent) on days 1-3 and 36 (35·0 per cent) on days 4-30. CONCLUSION: At least half of the procedural strokes in this study were ischaemic and ipsilateral to the treated artery. Half of all procedural complications occurred on the day of surgery, but one-third after day 3 when many patients had been discharged.

ANTECEDENTES: La efectividad de la endarterectomía carotídea (carotid endarterectomy, CEA) en la prevención de un accidente cerebrovascular depende de que este procedimiento tenga pocos riesgos. El objetivo de este estudio fue evaluar la frecuencia y el momento de aparición de las complicaciones tras una CEA, lo que podría clarificar los mecanismos subyacentes y ayudar a establecer una política de altas hospitalarias segura. MÉTODOS: Se utilizaron los datos de los pacientes incluidos en cuatro grandes ensayos de intervención carotídea (VACS, ACAS, ACST-1 y GALA; 1983-2007). Para el presente análisis se utilizaron los datos de pacientes sometidos a CEA por estenosis de la arteria carótida asintomática recogidos inmediatamente tras la aleatorización. Se consideraron diferentes intervalos entre el procedimiento, la muerte o el accidente cerebrovascular: intraoperatorio día 0, postoperatorio día 0, postoperatorio días 1-3 y postoperatorio días 4-30. RESULTADOS: En el análisis se incluyeron 3.694 pacientes. Se detectaron complicaciones graves relacionadas con el procedimiento en 103 (2,8%) pacientes (18 accidentes cerebrovasculares fatales, 68 accidentes cerebrovasculares no fatales, 11 infartos de miocardio fatales y 6 muertes por otras causas). De los 86 accidentes cerebrovasculares, 67 (78%) fueron ipsilaterales, 17 (20%) contralaterales y dos (2%) vertebrobasilares. Los accidentes cerebrovasculares fueron isquémicos en 45 (52%) casos, hemorrágicos en 9 (10%) y no se pudo determinar el subtipo de ictus en 32 (37%). La mitad de los accidentes cerebrovasculares ocurrieron el día de la CEA. De todas las complicaciones graves registradas, 44 (43%) ocurrieron en el día 0 (20 intraoperatorias, 17 postoperatorias y 7 en períodos poco definidos), 23 (22%) entre los días 1-3 y 36 (35%) entre los días 4-30. CONCLUSIÓN: En este estudio, al menos la mitad de los accidentes cerebrovasculares relacionados con la CEA fueron isquémicos e ipsilaterales respecto a la arteria tratada. La mitad de todas las complicaciones de la CEA ocurrieron el día de la cirugía, pero un tercio de los casos se presentaron después del día 3, cuando muchos pacientes ya habían sido dados de alta.

Long-term Clinical Outcome and Functional Status After Arterial Reconstruction in Upper Extremity Injury.

OBJECTIVE/BACKGROUND: To analyse long term outcome, including functional status and prognostic factors, in patients who have undergone arterial repair of civilian upper limb injury. Retrospective data analysis of prospectively collected data was performed. METHODS: This was a retrospective data analysis of prospectively collected data. Records of all patients who had undergone repair of traumatic arterial lesions in the upper limb between 1989 and 2010 were reviewed, and clinical follow up was performed. End points were: long term patency, measured by color Doppler ultrasound; vascular re-intervention; limb salvage rate; and long term functional status using the Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire. The DASH questionnaire is an instrument used to identify a patient's disabilities, in which everyday activities are assessed by 30 questions. The DASH answers are summarized and, using a conversion formula, lead to a score between 0 (full recovery) and 100 (severe disability). The DASH questionnaire was sent to all German-speaking individuals for data supplementation after completion of a clinical follow up study. RESULTS: A total of 117 arterial repairs were performed in 108 patients (87 men, median age 35.7 years). Blunt trauma was the predominant cause of injury (n = 96; 82%). Accompanying nerve lesions (n = 39; 36%) and/or orthopedic injuries (n = 65; 60%) were present in 84 patients (78%). After a median follow up time of 5.3 years (range 0.5-19.7 years), 65 patients (60%) were re-investigated: long-term patency was 97%. The DASH questionnaire was answered by 57 patients (53%). Functional impairment was frequently seen, and determined by neurological injury (including neurological lesions, median DASH score was 40.3 [range 3.5-69.8] vs. 0.8 [range 0-5.8] without; p < .001) and ischemia at time of injury (median DASH score with ischemia 4.2 [range 0-16.9] vs. 0.0 [0-1.7] without; p < .04). CONCLUSION: Favorable long term patency rates after arterial repair in upper extremity injuries can be achieved. Long term functional impairment is a significant problem and determined by associated neurological injury, as well as ischemia at time of injury.

Very urgent carotid endarterectomy does not increase the procedural risk.

OBJECTIVES: The timing of CEA for symptomatic internal carotid artery (ICA) stenosis remains a matter of controversy. Recent registry data showed a significantly increased risk, especially in the very early days after the onset of symptoms. In this study the outcome of CEA in the hyperacute phase has been investigated. METHODS: The outcome of CEA for symptomatic ICA stenosis between January 2004 and December 2013 has been retrospectively analyzed. Patients were divided into four timing groups: surgery within 0 and 2 days, between 3 and 7 days, 8 and 14 days, and thereafter. The post-operative 30 day stroke and death rates were assessed. RESULTS: A total of 761 symptomatic patients (40.1% with transient ischemic attack [TIA], 21.3% with amaurosis fugax, and 38.6% with ischemic stroke) were included, with an overall peri-operative stroke and death rate of 3.3%. A stroke and death rate of 4.4% (9/206) for surgery within 0 and 2 days, 1.8% (4/219) between 3 and 7 days, 4.4% (6/136) between 8 and 14 days, and 2.5% (5/200) in the period thereafter (p = .25 for the difference between the groups) was observed. The timing of surgery did not influence the peri-operative outcome in a multivariate regression analysis (OR 0.93 [0.63-1.36], p = .71). CONCLUSIONS: These data show that very urgent surgery in symptomatic patients can be performed without increased procedural risk. Given the fact that ruptured plaques with neurological symptoms carry the highest risk of a recurrent ischemic event in the first 2 days, treating patients as soon as possible to offer the highest benefit in stroke prevention is recommended.

[Arterial Access Site Complications after Percutaneous Interventions with Special Regard to the Application of Vascular Closure Devices]. / Arterielle Zugangswegkomplikationen nach perkutanen Interventionen unter besonderer Berücksichtigung der Verwendung von Verschlusssystemen.

Due to an increase in the number of performed endovascular procedures, the number of local access site complications is rising too. Used mainly for treatment of peripheral arterial disease and coronary heart disease, endovascular procedures are gaining importance. Access site complications include bleeding, haematoma, pseudoaneurysm, arteriovenous fistula and arterial thrombosis. Aiming to reduce immobilisation, length of hospital stay, costs and access site complications, vascular closure devices (VCD) were introduced in the mid 1990s, but current trials failed to demonstrate the superiority of these devices compared to conventional manual compression if it comes to access site complications. We retrospectively evaluated all patients who were treated surgically due to access site complications between 2001 and 2012 in our institution. In total, 522 patients needed vascular surgery to treat different access site complications. During this period, 90,538 percutaneous interventions were performed in our institution, leading to a total incidence of 0.58 % of access site complications. Depending on the frequency of application of VCDs, patients have been grouped in groups A-C. With the more frequent use of VCDs, the incidence of access site complications increased and, in particular, ischaemic complications were seen more often. In conclusion, the application of VCDs to prevent access site complications is questionable and not justified when looking at published data.

Carotid stenting: is there an operator effect? A pooled analysis from the carotid stenting trialists' collaboration.

BACKGROUND AND PURPOSE: Randomized clinical trials show higher 30-day risk of stroke or death after carotid artery stenting compared with surgery. We examined whether operator experience is associated with 30-day risk of stroke or death in the Carotid Stenting Trialists' Collaboration database. METHODS: The Carotid Stenting Trialists' Collaboration is a pooled individual patient database including all patients recruited in 3 randomized trials of stenting versus endarterectomy for symptomatic carotid stenosis (Endarterectomy Versus Angioplasty in patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Angioplasty versus Carotid Endarterectomy trial, and International Carotid Stenting Study). Lifetime carotid artery stenting experience, lifetime experience in stenting procedures excluding the carotid, and annual number of procedures performed within the trial (in-trial volume), divided into tertiles, were used to measure operator experience. The outcome event was the occurrence of any stroke or death within 30 days of the procedure. The analysis was done per protocol. RESULTS: Among 1546 patients who underwent carotid artery stenting, 120 (7.8%) had a stroke or death within 30 days of the procedure. The 30-day risk of stroke or death did not differ according to operator lifetime carotid artery stenting experience (P=0.8) or operator lifetime stenting experience excluding the carotid (P=0.7). In contrast, the 30-day risk of stroke or death was significantly higher in patients treated by operators with low (mean ≤3.2 procedures/y; risk 10.1%; adjusted risk ratio=2.30 [1.36-3.87]) and intermediate annual in-trial volumes (3.2-5.6 procedures/y; 8.4%; adjusted risk ratio=1.93 [1.14-3.27]) compared with patients treated by high annual in-trial volume operators (>5.6 procedures/y; 5.1%). CONCLUSIONS: Carotid stenting should only be performed by operators with annual procedure volume ≥6 cases per year.

[Treatment of asymptomatic carotid artery stenosis: improvement of evidence with new SPACE-2 design necessary]. / Therapie asymptomatischer Karotisstenosen: Notwendige Klärung der Evidenz mit neuem SPACE-2-Design.

Asymptomatic carotid artery stenosis may be treated with carotid endarterectomy (CEA), carotid artery stenting (CAS) or with best medical treatment (BMT) only. Definitive and evidence-based treatment recommendations for one of these options are currently not possible. Studies showing an advantage of CEA over BMT alone do not meet current standards from a pharmacological point of view. On the other hand, more recent data point to a further stroke risk reduction using BMT according to current standards. Studies on carotid artery stenting as a third alternative treatment are partially insufficient, especially when comparing CAS with BMT. Initiated in 2009, the randomized, controlled, multicenter SPACE-2 trial is intended to answer the question about the best treatment option of asymptomatic carotid artery stenosis; however, to increase recruitment rates as a condition for the successful completion of this important study, the trial design had to be modified.

Age modifies the relative risk of stenting versus endarterectomy for symptomatic carotid stenosis--a pooled analysis of EVA-3S, SPACE and ICSS.

BACKGROUND: Recent randomised controlled trials comparing carotid artery stenting (CAS) with endarterectomy (CEA) for the treatment of symptomatic carotid stenosis were not powered to investigate differences in risks in specific patient subgroups. We therefore performed a pooled analysis of individual patient data from the Symptomatic Severe Carotid Stenosis trial (EVA-3S), the Stent-Protected Angioplasty versus Carotid Endarterectomy trial (SPACE), and the International Carotid Stenting Study (ICSS). METHODS: Individual data from all 3433 patients randomised and analysed in these trials were pooled and analysed with fixed-effect binomial regression models adjusted for source trial. The primary outcome event was any stroke or death. RESULTS: In the first 120 days after randomisation (ITT analysis), the primary outcome event occurred in 153/1725 patients in the CAS group (8.9%) compared with 99/1708 patients in the CEA group (5.8%, risk ratio [RR] 1.53, 95% confidence interval [CI] 1.20-1.95, p = 0.0006; absolute risk difference 3.2, 95% CI 1.4-4.9). Age was the only subgroup variable which significantly modified the treatment effect: in patients <70 years old (the median age), the 120-day stroke or death risk was 5.8% in CAS and 5.7% in CEA (RR 1.00, 0.68-1.47); in patients 70 years or older, there was an estimated two-fold increase in risk with CAS over CEA (12.0% vs. 5.9%, RR 2.04, 1.48-2.82, interaction p = 0.0053). INTERPRETATION: Endarterectomy was safer in the short-term than stenting, because of an increased risk of stroke associated with stenting in patients over the age of 70 years. Stenting should be avoided in older patients, but may be as safe as endarterectomy in younger patients. Determination of the efficacy and ultimate balance between the two procedures requires further data on long-term stroke recurrence.

Carotid endarterectomy within seven days after the neurological index event is safe and effective in stroke prevention.

BACKGROUND: Timing of surgery remains a controversial subject with some concerns persisting that the benefit of early carotid endarterectomy (CEA) offsets the perioperative risks. We investigated the neurological outcome of patients with symptomatic internal carotid artery (ICA) stenosis after surgery in relation to the timing of treatment. METHODS: From January 2005 to June 2010, 468 patients (n = 349 male, 74.6%, median age 71 years) underwent CEA for symptomatic stenosis. Perioperative morbidity and mortality rates were assessed in the 30 days' follow-up. RESULTS: The median time interval between index event and CEA was 7 days; the overall stroke and death rate reached 3.4%. There was no difference in the 30 days' rate of stroke /death rate, depending on the timing of surgery (n = 5/241, 2.1% in patients treated within 1 week vs. n = 10/215, 4.7% in patients treated thereafter, p = 0.12). Patients with a postoperative neurological deterioration had more often an ischaemic infarction on preoperative cerebral computed tomography (CCT) compared with those without deterioration (n = 6/15, 40.0% vs. n = 39/441, 9.0%, p = 0.003). Logistic regression analysis showed that patients with preoperative infarction on CCT had the highest risk for postoperative neurological deterioration. CONCLUSION: An infarction on the preoperative CCT leads to an increased risk for a postoperative deterioration after CEA. Patients should be treated at an early point in time with bland CCTs.

Influence of use of a vascular closure device on incidence and surgical management of access site complications after percutaneous interventions.

AIM: The study aimed to evaluate vascular access site complications (ASCs) after percutaneous interventions (PIs) in our institution for changes in annual incidence and surgical management after increased usage of a vascular closure device (VCD; in all cases: Angioseal™). MATERIAL AND METHODS: All patients who underwent repair of arterial pseudo-aneurysms or access site stenosis/occlusion leading to leg ischaemia (LI) or new-onset disabling claudication (CI) after PIs between 2001 and 2008 were included. Annual rates of procedures and methods of repair of ASC were evaluated. RESULTS: After a total of 58 453 PIs, 352 patients (0.6%) were operated on for: pseudo-aneurysms (n = 300; 0.51%); and local stenosis/occlusion leading to LI/CI (n = 52; 0.09%). Numbers increased significantly with more widespread VCD use: group A (2001-2004: 2860 VCDs; 28 284 PIs; 10.1%): n = 132 (0.47%); and group B (2005-2008: 11,660 VCDs; 30,169 PIs; 38.6%): n = 220 (0.73%) (p < 0.001). In contrast to similar rates of pseudo-aneurysms (group A: n = 124; 0.44%; group B: n = 176; 0.58%; not significant), a significant increase of operations for local stenoses/occlusions was seen with widespread VCD use: n = 8 versus n = 44 (p < 0.001). CONCLUSIONS: In the era of VCDs, complications are rare. However, use of these devices is not without complications, and may require complex reconstructions.

Repair of arterial injury after blunt trauma in the upper extremity - immediate and long-term outcome.

OBJECTIVE: In contrast to upper extremity stab and gunshot wounds, data on management and outcome in blunt trauma (BT) are limited by small numbers and short follow-up periods. METHODS: This study is a retrospective data analysis. All patients who had undergone arterial repair after upper-limb BT were included. Exclusion criteria were artery ligation and/or primary limb amputation. Endpoints included the following: peri-operative death, limb salvage, primary and secondary patency, vascular re-operation and/or intervention. RESULTS: Eighty-nine patients (71 male; median age: 34.6 years, range: 2.5-81.7) underwent reconstruction of 96 arteries after BT since 1989: subclavian (n=16), axillary (n=22), brachial (n=48) and forearm (n=10). Concomitant arm vein lesions were present in 15 patients (17%) and accompanying nerve (n=38; 43%) and/or orthopaedic injuries (n=64; 72%) in 77 patients (87%). The 30-day mortality rate was 2% with the limb-salvage rate being 98%. Six reconstructions occluded during the first week (primary/secondary patency rate: 93%/99%). After a median follow-up time of 5.1 years, 67% of the patients were followed: There were no secondary amputations and no arterial re-interventions. CONCLUSIONS: Arterial repair in upper extremity BT has excellent early and long-term outcome. In contrast to a significant risk of early occlusion, limb loss after repair, late vascular re-intervention and late arterial occlusion or stenosis are rare.

Angiography catheter based bleeding complication at the access site related to neurofibromatosis I.

Neurofibromatosis Type I (NF-I) is one of the most common inherited human diseases with an incidence of 1/3000. Besides the cardinal features, all organs or body structures as well as several arterial regions can occasionally be affected. We present an unusual case of an access-site hematoma following percutaneous transluminal coronary angioplasty in a patient suffering from NF-1. After exposure of the vessels, excessive bleeding from surrounding proliferations of supposedly neurofibromatous or ganglioneuromatous tissue was identified as the sole source of the hematoma. Patients with neurofibromatosis are at considerable risk of obtaining catheter interventions over the years. In this group, we strongly recommend an ultrasound examination of the arterial segment where the arterial access is planned. In case of suspicious findings an alternative approach should be preferred to avoid bleeding complications.

PEPE II--a multicenter study with an end-point heparin-bonded expanded polytetrafluoroethylene vascular graft for above and below knee bypass surgery: determinants of patency.

AIM: The Propaten European Product Evaluation (PEPE II) study was a product evaluation intended to characterize the performance of the GORE PROPATEN vascular graft in above-knee (AK) and below-knee bypass (BK) surgery. METHODS: This prospective multicenter trial enrolled 142 patients with peripheral arterial disease. In 87 patients AK and in 52 patients BK bypasses (including 15 femorocrural) were implanted (67.6% males, 32.4% females). RESULTS: The one-year overall primary and secondary patency rates were 80% and 84.7%, respectively. Overall limb salvage rate at 12-months was 96.2%. The primary patency rate for AK bypasses was 82.7%, for BK femoro-popliteal bypasses 74.2% and for BK tibial-peroneal bypasses 79.4%. Secondary patency rates were 87.3%, 78.8% and 85.1%, respectively. Primary patency rates decreased depending on the number of patent run-off vessels (three 84.3%, two 80.8%, one 73.3%). Subgroup analysis showed that female patients had a significantly higher primary patency rate for BK bypasses (95.5% vs. 67.8%, P=0.037 ) compared to male patients. Subgroup analysis comparing patients younger and older than 70 years did not show a statistically significant difference in patency rates. Twenty-one patients underwent 42 reinterventions after bypass surgery. CONCLUSIONS: Present data show that the end-point heparin-bonded polytetrafluoroethylene graft yields patency rates comparable to those obtained with other graft material in above-knee locations. The encouraging results for BK bypasses suggests that this graft is an excellent option for small diameter vascular reconstructions when autologous vein is unavailable.

68Ga-DOTATOC PET/CT in the localization of metastatic extra-adrenal paraganglioma and pheochromocytoma compared with 18F-DOPA PET/CT. / Comparación entre la PET/TC con 18F-DOPA y la PET/TC con 68Ga-DOTATOC para la localización del paraganglioma maligno extra-adrenal y el feocromocitoma.

OBJECTIVE: 18F-Fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET offers high sensitivity and specificity in the imaging of non-malignant extra-adrenal paraganglioma (PGL) and pheochromocytoma (PHEO) but lower sensitivity in metastatic disease. These tumours are of neuroendocrine origin and can be detected by 68Ga-DOTA-Tyr3-octreotide (68Ga-DOTA-TOC) PET. Therefore, we compared 68Ga-DOTA-TOC and 18F-DOPA as radiolabels for PET/CT imaging for the diagnosis of metastatic extra-adrenal PGL and PHEO. Combined cross-sectional imaging was the reference standard. METHODS: A total of 6 men and 4 women (age range 22-72 years) with anatomical and/or histologically proven metastatic PGL and PHEO were included in this study. Of these patients, 2 male patients suffered from PHEO, while the remaining 8 patients were diagnosed as metastatic extra-adrenal PGL disease. Comparative evaluation included morphological imaging with CT and functional imaging with 68Ga-DOTA-TOC and 18F-DOPA PET. The imaging results were analyzed on a per-lesion basis. The maximum standardized uptake value (SUVmax) of each functional imaging modality in concordant tumour lesions was measured. RESULTS: Compared with anatomical imaging, the per-lesion detection rate of 68Ga-DOTA-TOC was 100% (McNemar, P<0.01), and that of 18F-DOPA PET was 82.3% (McNemar, P<0.8) in metastatic extra-adrenal PGL and PHEO. Overall, 68Ga-DOTA-TOC PET identified 67 lesions; anatomical imaging identified 62 lesions, and 18F-DOPA PET identified 56 lesions. The SUVmax (mean±SD) of all concordant lesions was 29.3±19.9 for 68Ga-DOTA-TOC PET and 12.3±9.1 for 18F-DOPA PET (Mann-Whitney U test, P<0.0001). CONCLUSION: 68Ga-DOTA-TOC PET offers the highest detection rate in metastatic extra-adrenal PGL and PHEO compared to 18F-DOPA PET and even to diagnostic CT, particularly in bone lesions. Combined functional/anatomical imaging (68Ga-DOTA-TOC PET/CT) enables exact tumour extension to be detected in these rare tumour entities, especially in the case of unclear anatomical correlation.

Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2.

BACKGROUND: Treatment of individuals with asymptomatic carotid artery stenosis is still handled controversially. Recommendations for treatment of asymptomatic carotid stenosis with carotid endarterectomy (CEA) are based on trials having recruited patients more than 15 years ago. Registry data indicate that advances in best medical treatment (BMT) may lead to a markedly decreasing risk of stroke in asymptomatic carotid stenosis. The aim of the SPACE-2 trial (ISRCTN78592017) was to compare the stroke preventive effects of BMT alone with that of BMT in combination with CEA or carotid artery stenting (CAS), respectively, in patients with asymptomatic carotid artery stenosis of ≥70% European Carotid Surgery Trial (ECST) criteria. METHODS: SPACE-2 is a randomized, controlled, multicenter, open study. A major secondary endpoint was the cumulative rate of any stroke (ischemic or hemorrhagic) or death from any cause within 30 days plus an ipsilateral ischemic stroke within one year of follow-up. Safety was assessed as the rate of any stroke and death from any cause within 30 days after CEA or CAS. Protocol changes had to be implemented. The results on the one-year period after treatment are reported. FINDINGS: It was planned to enroll 3550 patients. Due to low recruitment, the enrollment of patients was stopped prematurely after randomization of 513 patients in 36 centers to CEA (n = 203), CAS (n = 197), or BMT (n = 113). The one-year rate of the major secondary endpoint did not significantly differ between groups (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530) as well as rates of any stroke (CEA 3.9%, CAS 4.1%, BMT 0.9%; p = 0.256) and all-cause mortality (CEA 2.5%, CAS 1.0%, BMT 3.5%; p = 0.304). About half of all strokes occurred in the peri-interventional period. Higher albeit statistically non-significant rates of restenosis occurred in the stenting group (CEA 2.0% vs. CAS 5.6%; p = 0.068) without evidence of increased stroke rates. INTERPRETATION: The low sample size of this prematurely stopped trial of 513 patients implies that its power is not sufficient to show that CEA or CAS is superior to a modern medical therapy (BMT) in the primary prevention of ischemic stroke in patients with an asymptomatic carotid stenosis up to one year after treatment. Also, no evidence for differences in safety between CAS and CEA during the first year after treatment could be derived. Follow-up will be performed up to five years. Data may be used for pooled analysis with ongoing trials.

Successful treatment of a patient with a severely calcified aorta by an ascending aorta to iliac artery graft--a case report.

Coral reef aorta is a rare, unique entity with extensive calcification of the entire aorta, mainly the supra- and juxtarenal part. The main symptoms are lower limb claudication, hypertension, deterioration of renal function and angina abdominalis. We report a case of successful treatment of a patient with a coral reef aorta by an ascending aorta to iliac artery bypass graft. Five years later the descending aorta was found to be completely occluded with visceral and distal perfusion via the bypass only.

Traveller's thrombosis: international consensus statement.

In 2001, consensus meetings on traveller's thrombosis were held in Vienna and Berlin. The results of these conferences were subsequently published in VASA 2002. In 2006 a follow-up conference was organized in Hall, Tirol, Austria, in order to review new and emerging data and to update the conclusions and recommendations of the 2001 meetings. Prior to the conference key papers from peer-reviewed journals were pre-circulated to all participants. The consensus group discussed the data and drafted an updated statement. Thereafter, the writing group summarised the results including the pre-circulated material and additional papers identified by a formal literature search up to December 2007. In this article current knowledge on the incidence, pathophysiology and prevention of traveller's thrombosis is summarised. The assessment of individual risk is described and recommendations for prevention of traveller's thrombosis are given, based upon the conclusions of the Hall Conference.

30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.

BACKGROUND: Carotid endarterectomy is effective in stroke prevention for patients with severe symptomatic carotid-artery stenosis, and carotid-artery stenting has been widely used as alternative treatment. Since equivalence or superiority has not been convincingly shown for either treatment, we aimed to compare the two. METHODS: 1200 patients with symptomatic carotid-artery stenosis were randomly assigned within 180 days of transient ischaemic attack or moderate stroke (modified Rankin scale score of < or =3) carotid-artery stenting (n=605) or carotid endarterectomy (n=595). The primary endpoint of this hospital-based study was ipsilateral ischaemic stroke or death from time of randomisation to 30 days after the procedure. The non-inferiority margin was defined as less than 2.5% on the basis of an expected event rate of 5%. Analyses were on an intention-to-treat basis. This trial is registered at Current Controlled Trials with the international standard randomised controlled trial number ISRCTN57874028. FINDINGS: 1183 patients were included in the analysis. The rate of death or ipsilateral ischaemic stroke from randomisation to 30 days after the procedure was 6.84% with carotid-artery stenting and 6.34% with carotid endarterectomy (absolute difference 0.51%, 90% CI -1.89% to 2.91%). The one-sided p value for non-inferiority is 0.09. INTERPRETATION: SPACE failed to prove non-inferiority of carotid-artery stenting compared with carotid endarterectomy for the periprocedural complication rate. The results of this trial do not justify the widespread use in the short-term of carotid-artery stenting for treatment of carotid-artery stenoses. Results at 6-24 months are awaited.