Percutaneous transluminal angioplasty and stenting for symptomatic intracranial arterial stenosis: a systematic review and meta-analysis

OBJECTIVES: The cumulative safety and efficacy measures of percutaneous transluminal angioplasty and stenting (PTAS) for secondary stroke prevention in patients with symptomatic intracranial arterial stenosis (sICAS) have not previously been evaluated using a meta-analytical approach. METHODS: We conducted a systematic review and random effects meta-analysis of all available randomized controlled trials (RCTs) evaluating the safety and efficacy of PTAS (in comparison with medical therapy) for sICAS. RESULTS: Three RCTs (678 total patients) were included in the quantitative analysis. PTAS was associated with a higher risk of recurrent ischemic stroke in the territory of qualifying artery both within 30 days [risk ratio (RR) = 2.21, 95% confidence interval (CI) 1.10-4.43] and 1 year (RR = 1.92, 95% CI 1.10-3.36). PTAS was also related to a higher risk of any ischemic stroke within 30 days from the index event (RR = 2.08, 95% CI 1.17-3.71). The risk for intracranial hemorrhage was found to be higher in PTAS patients both within 30 days (RR = 10.60, 95% CI 1.98-56.62) and 1 year (RR = 8.15, 95% CI 1.50-44.34). The composite outcome of any stroke or death within 1 year (RR = 2.29, 95% CI 1.13-4.66) and 2 years (RR = 1.52, 95% CI 1.04-2.21) was higher in PTAS than in medical therapy. PTAS was associated with a higher risk of any stroke or death within 2 years in the sICAS subgroup located in posterior circulation (RR = 2.37, 95% CI 1.27-4.42). CONCLUSIONS: PTAS is associated with adverse early and long-term outcomes and should not be recommended in patients with sICAS. Further research to identify subgroups of patients who could also serve as candidates for future interventional trials along with efforts to reduce procedure-related complications are needed

Platelet Responsiveness to Clopidogrel Treatment After Peripheral Endovascular Procedures The PRECLOP Study: Clinical Impact and Optimal Cutoff Value of On-Treatment High Platelet Reactivity

ObjectivesThis study aimed to assess the clinical implications and optimal cutoff value of high platelet reactivity (HPR) in patients receiving clopidogrel for peripheral endovascular procedures.BackgroundAs noted in coronary studies, HPR could be related to increased adverse events.MethodsThis prospective trial included patients receiving clopidogrel 75 mg daily, before and after infrainguinal angioplasty or stenting. Platelet inhibition was assessed with the VerifyNow P2Y12 point-of-care test. Primary endpoints were 1-year clinical events rate (composite endpoint of death, major stroke, major amputation, target vessel revascularization, and bypass) according to the P2Y12 reaction units (PRU)-based quartile distribution, the estimation of the optimal PRU cutoff value for predicting clinical outcome, and the identification of independent predictors influencing event-free survival.ResultsIn total, 100 consecutive patients were enrolled. The 1-year cumulative events rate was 4% in the first quartile, 12% in the second, 52% in the third, and 84% in the fourth. Pairwise comparisons demonstrated a significant difference in the composite endpoint between successive quartiles (all p < 0.05 except for the first vs. second quartile). According to receiver-operating characteristic curve analysis, the optimal cutoff value for the composite endpoint was PRU ≥234 (area under the curve: 0.883; 95% confidence interval [CI]: 0.811 to 0.954; p < 0.0001; sensitivity: 92.1%; specificity: 84.2%). Cox multivariate regression analysis identified HPR (PRU ≥234) as the only independent predictor of an increased number of adverse events (hazard ratio: 16.9; 95% CI: 5 to 55; p < 0.0001).ConclusionsOn-treatment HPR is associated with markedly increased adverse clinical events in patients undergoing peripheral endovascular procedures. Point-of-care clopidogrel assessment might be useful in individualizing antiplatelet therapy to attain superior clinical results. (High On-Treatment Platelet Reactivity Following Peripheral Endovascular Procedures [PRECLOP]; NCT01744613

Psychometric properties of the Greek version of the NEI-VFQ 25

<p>Abstract</p> <p>Background</p> <p>To evaluate the reliability and construct validity of a Greek version of the NEI-VFQ-25 in patients with chronic ophthalmic diseases.</p> <p>Methods</p> <p>We developed the Greek version of the instrument using forward and backward translation. One hundred-eighty-six patients responded to the questionnaire. To examine reliability, Cronbach's alpha for each subscale was used as an index of internal consistency. Test-retest reliability was evaluated with intraclass correlation coefficients. Regarding construct validity, both convergent and discriminant validities were calculated by means of multi-trait analysis. Rasch analysis was used to estimate the visual ability required by each item for a particular response, and each patient's visual ability. Correspondingly, instrument validity was evaluated by estimating the distribution of residuals for item and subject measures.</p> <p>Results</p> <p>Four patient groups were studied, each including participants with a single cause of visual impairment. Group 1 consisted of 84 glaucoma subjects. Group 2 included 30 subjects with age-related macular degeneration (ARMD); group 3 included 25 subjects with dry-eye syndrome, whereas group 4 included 18 cataract patients. Twenty-nine healthy individuals comprised the control group. NEI-VFQ scores (mean ± SD) for the glaucoma, ARMD, dry-eye, cataract and control groups were: 76.9 ± 20.2, 70.9 ± 20.2, 81.6 ± 16.5, 73.5 ± 24.0 and 93.7 ± 8.9 respectively. Item analysis revealed no significant data skewing. Cronbach's alpha ranged from 0.678 to 0.926, with most subscales having high internal consistency. Intraclass correlation coefficient ranged from 0.717 to 0.910 for all subscales. All items passed the convergent and discriminant validity tests. Strong correlations were detected between visual acuity and "general vision", "distant activities" and "near activities" subscales. Significant correlations were also detected between visual field deficits and the "peripheral vision" and "general vision" subscales. Rasch analysis revealed potential weaknesses of the instrument that are associated with the assumptions of the model itself. Specifically, low precision of the "agreement" items was detected in the estimation of visual ability. Twenty-three percent of the subjects had fit statistics that fell outside the tolerance box.</p> <p>Conclusion</p> <p>Although traditional validation methods indicated that the Greek version of the NEI-VFQ-25 is a valid and reliable instrument for VS-QoL assessment, Rasch analysis detected significant misfits to the model, especially of the "agreement" items. This means that results of the corresponding subscales should be interpreted with extreme caution.</p

Machine Perfusion Strategies in Liver and Renal Transplantation

Transplantation is the only treatment for patients with end-stage renal and hepatic disease but unfortunately, it is limited worldwide due to the organ shortage. The need to expand the donor pool with the use of donors after cardiac death (DCD) and extended criteria donors (ECD) has led to major improvements in organ preservation. From cold static storage and preservation solutions to different types of machine perfusion, the possibility of successfully transplanting a marginal organ becomes reality. In this chapter, we examine the machine perfusion methods and the advantages of new technology in minimizing ischemic injury and improving the transplant outcome. Τhe establishment of protocols with the use of biomarkers in order to assess the transplant suitability of the graft will eventually provide the ideal opportunity to intervene and improve the quality of the organ

Endovascular Treatment for Acute Basilar Artery Occlusion: A Fragility Index Meta-Analysis

Introduction: High-quality evidence regarding the use of endovascular treatment (EVT) in patients with acute basilar artery occlusion (BAO) has been provided by recently completed randomized controlled clinical trials (RCTs). Methods: We conducted a systematic review and meta-analysis including all available RCTs that investigated efficacy and safety of EVT in addition to best medical treatment (BMT) versus BMT alone for BAO. The random-effects model was used, while the fragility index (FI) was calculated for dichotomous outcomes of interest. Results: Four RCTs were included comprising a total of 988 patients with acute BAO (mean age: 65.6 years, 70% men, median NIHSS: 24, 39% pretreatment with intravenous thrombolysis). EVT was related to higher likelihood of good functional outcome (RR: 1.54; 95% CI: 1.16–2.05; I2 = 60%), functional independence (RR: 1.83; 95% CI: 1.08–3.08; I2 = 79%) and reduced disability at 3 months (adjusted common OR: 1.96; 95% CI: 1.26–3.05; I2 = 59%) compared to BMT alone. Despite that EVT was associated with a higher risk for symptomatic intracranial hemorrhage (RR: 7.78; 95% CI: 2.36–25.61; I2 = 0%) and any intracranial hemorrhage (RR: 2.85; 95% CI: 1.50–5.44; I2 = 16%), mortality at 3 months was lower among patients that received EVT plus BMT versus BMT alone (RR: 0.76; 95% CI: 0.65–0.89; I2 = 0%). However, sufficient robustness was not evident in any of the reported associations (FI < 10) including the overall effect regarding the primary outcome. The former associations were predominantly driven by RCTs with recruitment limited in China. Conclusions: EVT combined with BMT is associated with a higher likelihood of achieving good functional outcomes and a lower risk of death at 3 months compared to BMT alone, despite the higher risk of sICH. An individual-patient data meta-analysis is warranted to uncover and adjust for potential sources of heterogeneity and to provide further insight

Emerging Stent and Balloon Technologies in the Femoropopliteal Arteries

Endovascular procedures for the management of the superficial femoral (SFA) and popliteal artery disease are increasingly common. Over the past decade, several stent technologies have been established which may offer new options for improved clinical outcomes. This paper reviews the current evidence for SFA and popliteal artery angioplasty and stenting, with a focus on randomized trials and registries of nitinol self-expanding stents, drug-eluting stents, dug-coated balloons, and covered stent-grafts. We also highlight the limitations of the currently available data and the future routes in peripheral arterial disease (PAD) stent and balloon technology

Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke

Sonotrombolisis; Endovascular; Cambio de equilibrio clínicoSonothrombolysis; Endovascular; Equipoise shiftSonotrombolisis; Endovascular; Canvi d'equilibri clínicBackground: Results of our recently published phase III randomized clinical trial of ultrasound-enhanced thrombolysis (sonothrombolysis) using an operator-independent, high frequency ultrasound device revealed heterogeneity of patient recruitment among centers. Methods: We performed a post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p < 0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06-0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89-1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0-2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01-2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies

Intravenous thrombolysis for acute ischemic stroke in Greece: the Safe Implementation of Thrombolysis in Stroke registry 15-year experience

Background: Intravenous thrombolysis (IVT) remains the only approved systemic reperfusion treatment for acute ischemic stroke (AIS), however there are scarce data regarding outcomes and complications of IVT in Greece. We evaluated safety and efficacy outcomes of IVT for AIS in Greece using the Safe Implementation of Thrombolysis in Stroke: International Stroke Thrombolysis Register (SITS-ISTR) dataset. Methods: All AIS patients treated with IVT in Greece between December 2002 and July 2017 and recorded in the SITS-ISTR were evaluated. Demographics, risk factors, baseline stroke severity [defined using National Institutes of Health Stroke Scale (NIHSS)], and onset-to-treatment time (OTT) were recorded. Safety outcomes included symptomatic intracranial hemorrhage (sICH) and 3-month mortality rates. The efficacy outcomes evaluated a reduction in baseline NIHSS score at 2 and 24 h following IVT onset, 3-month favorable functional outcome [FFO; modified Rankin scale (mRS) scores of 0-1] and 3-month functional independence (FI; mRS-scores of 0-2). The safety and efficacy outcomes were assessed comparatively with previously published data from SITS national and international registries. Results: A total of 523 AIS patients were treated with IVT in 12 Greek centers participating in the SITS-ISTR during the study period (mean age 62.4 ± 12.7; 34.6% women; median baseline NIHSS score: 11 points; median OTT: 150 min). The rates of sICH were 1.4%, 2.3%, and 3.8% according to the SIST-MOST, ECASS II, and NINDS criteria respectively. The median reduction in NIHSS score at 2 and 24 h was 3 [interquartile range (IQR): 1-5] and 5 (IQR: 2-8) points respectively. The 3-month FI, FFO and mortality were 66.5%, 55.6% and 7.9%. All safety and efficacy outcomes were comparable with available data from SITS-ISTR in other European countries. Conclusions: Our study underscores the safety and efficacy of IVT for AIS in Greece. Additional action is necessary in order to increase the availability of IVT in the Greek population and to include more centers in the SITS-ISTR

Association of Baseline Hyperglycaemia with Outcomes of Diabetic and Non-diabetic Acute Ischaemic Stroke Patients treated with Intravenous Thrombolysis : a Propensity Score Matched Analysis from the SITS-ISTR registry

© 2019 by the American Diabetes Association.Peer reviewedPostprin

Prevalence of Clinical and Neuroimaging Markers in Cerebral Amyloid Angiopathy: A Systematic Review and Meta-Analysis

BACKGROUND: Limited data exist regarding the prevalence of clinical and neuroimaging manifestations among patients diagnosed with cerebral amyloid angiopathy (CAA). We sought to determine the prevalence of clinical phenotypes and radiological markers in patients with CAA. METHODS: Systematic review and meta-analysis of studies including patients with CAA was conducted to primarily assess the prevalence of clinical phenotypes and neuroimaging markers as available in the included studies. Sensitivity analyses were performed based on the (1) retrospective or prospective study design and (2) probable or unspecified CAA status. We pooled the prevalence rates using random-effects models and assessed the heterogeneity using the Cochran Q and I2 statistics. RESULTS: We identified 12 prospective and 34 retrospective studies including 7159 patients with CAA. The pooled prevalence rates were cerebral microbleeds (52% [95% CI, 43%-60%]; I2=93%), cortical superficial siderosis (49% [95% CI, 38%-59%]; I2=95%), dementia or mild cognitive impairment (50% [95% CI, 35%-65%]; I2=97%), intracerebral hemorrhage (ICH; 44% [95% CI, 27%-61%]; I2=98%), transient focal neurological episodes (48%; 10 studies [95% CI, 29%-67%]; I2=97%), lacunar infarcts (30% [95% CI, 25%-36%]; I2=78%), high grades of perivascular spaces located in centrum semiovale (56% [95% CI, 44%-67%]; I2=88%) and basal ganglia (21% [95% CI, 2%-51%]; I2=98%), and white matter hyperintensities with moderate or severe Fazekas score (53% [95% CI, 40%-65%]; I2=91%). The only neuroimaging marker that was associated with higher odds of recurrent ICH was cortical superficial siderosis (odds ratio, 1.57 [95% CI, 1.01-2.46]; I2=47%). Sensitivity analyses demonstrated a higher prevalence of ICH (53% versus 16%; P=0.03) and transient focal neurological episodes (57% versus 17%; P=0.03) among retrospective studies compared with prospective studies. No difference was documented between the prevalence rates based on the CAA status. CONCLUSIONS: Approximately one-half of hospital-based cohort of CAA patients was observed to have cerebral microbleeds, cortical superficial siderosis, mild cognitive impairment, dementia, ICH, or transient focal neurological episodes. Cortical superficial siderosis was the only neuroimaging marker that was associated with higher odds of ICH recurrence. Future population-based studies among well-defined CAA cohorts are warranted to corroborate our findings