Multicenter Randomized Controlled Trial of APERTO-Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Percutaneous Transluminal Angioplasty in Dysfunctional Hemodialysis Grafts and Native Fistulae.

PURPOSE: to assess the safety and efficacy of APERTO-Paclitaxel-coated balloon angioplasty versus standard angioplasty for the treatment of dysfunctional hemodialysis shunts and native arteriovenous fistulae. METHODS: consecutive patients with dysfunctional dialysis related to underlying efferent vein stenosis were included and randomized 1:1 to either APERTO-paclitaxel drug-coated balloon (study arm) or standard percutaneous transluminal angioplasty (control arm). Primary endpoint is time from treatment until dialysis access dysfunction according to standardized Kidney Disease Outcomes Quality Initiative (KDOQI)-guidelines and assessed by Kaplan-Meier survival curves and tested for significance with log-rank analysis. Secondary endpoints include device, technical, and clinical success of the index angioplasty procedure. RESULTS: The study included 103 patients (n=51 study-group) with a de novo (n=33) dysfunctional native arteriovenous fistula (n=79) in the forearm (n=60). The majority of included patients were male with a mean age of 69.8 years, presenting with a dysfunctioning autologous arteriovenous fistula in the forearm. Device-related complications did not occur in any of the included patients. Functional hemodialysis access without need for re-intervention at 1 year after index procedure was found in n=10 (19.6%) and n=5 (9.6%) of patients treated with, respectively, paclitaxel drug-coated balloon and percutaneous transluminal angioplasty (p=0.612). A nonsignificant benefit of paclitaxel drug-coated balloon (n=5; 25%) over percutaneous transluminal angioplasty (n=1; 11%) was found (p=0.953) in de novo lesions in autologous fistulas. CONCLUSION: APERTO-paclitaxel drug-coated balloon is a safe balloon catheter to manage dysfunctional hemodialysis access; however, longer period of adequate hemodialysis circuit functioning after endovascular index stenosis treatment, using APERTO-paclitaxel drug-coated balloon versus percutaneous transluminal angioplasty could not be demonstrated. CLINICAL IMPACT: APERTO-paclitaxel drug-coated balloon catheter is a safe device to manage dysfunctional hemodialysis access. Compared to conventional angioplasty balloon, the APERTO drug-coated balloon will not result in longer period of adequate hemodialysis circuit functioning. A non-significant benefit of APERTO drug-coated balloon was found in de novo lesions in autologous fistulas.

Reliability and accuracy of 3-mm and 2-mm maximum intensity projection CT angiography to detect intracranial large vessel occlusion in patients with acute anterior cerebral circulation stroke.

PURPOSE: To evaluate the reliability and accuracy of thick maximum intensity projection (MIP) CTA images to detect large-vessel occlusion (LVO) in the anterior circulation in patients with acute stroke. METHODS: A total of 140 acute stroke patients (41 with and 99 without LVO) were evaluated by two neuroradiologists for LVO using axial 3-mm and 2-mm MIPs. RESULTS: Interobserver agreement was substantial using 3-mm MIPs (ĸ = 0.67) and almost perfect using 2-mm MIPs (ĸ = 0.82). Using 3-mm MIPs, sensitivities were 80.5% and 68.3%, with specificities of 98.0% and 96.0%. Using 2-mm MIPs, sensitivities were 82.9% and 73.2%, with specificities of 98.0% and 99.0%. Sensitivity and specificity of 3 mm and 2 mm MIPs were not statistically significantly different (P ≥ 0.375). The majority of LVOs in the distal intracranial carotid artery, and/or M1-segment were correctly identified: 96.0% (observer 1, 3-mm MIPs), 88.0% (observer 2, 3-mm MIPs), 96.0% (observer 1, 2-mm MIPs), and 96.0% (observer 2, 2 mm MIPs). Using 3-mm MIP images, observers 1 and 2 missed 7/15 (46.7%) and 9/15 (60.0%) of isolated M2-segment occlusions, respectively. Using 2-mm MIP images, observers 1 and 2 missed 5/15 (33.3%) and 6/15 (40.0%) of isolated M2-segment occlusions, respectively. CONCLUSION: Thick (2-3 mm) axial MIPs are not useful to detect proximal LVO in the anterior circulation.

Radiology workload in clinical implementation of thrombectomy for acute ischemic stroke: experience from The Netherlands.

PURPOSE: To investigate the number of acute stroke patients undergoing CT angiography (CTA) for suspected large vessel occlusion (LVO) and those eligible for thrombectomy in relation to the population. METHODS: Consecutive patients in a Western population who underwent CTA for suspected LVO of the proximal anterior circulation between January and August 2019 were included. The date and time of CTA and the number of patients eligible for thrombectomy were assessed. Our hospital's service area population was estimated using the Central Bureau for Statistics data. One-way analysis of variance with post-hoc tests and chi-squared tests were used for statistical analyses. RESULTS: Of 520 patients (49% males, mean age of 72 years) undergoing CTA, 84 (16.2%) were eligible for thrombectomy. Our hospital's service area population was estimated at 420,000. Therefore, 3.6 CTA scans were performed and 0.6 patients were eligible for thrombectomy per 100,000 people per week. The number of patients undergoing CTA and the number of patients eligible for thrombectomy both did not significantly differ between any days of the week (P > 0.05). A total of 236 (45%) and 284 patients (55%) underwent CTA during office and on-call hours, respectively. The percentage of patients eligible for thrombectomy did not significantly differ between office and on-call hours (P = 0.834). CONCLUSION: Our study estimated the number of stroke patients undergoing CTA for suspected LVO and those eligible for thrombectomy in relation to the population. Numbers were essentially the same throughout the week, and during office and on-call hours. Our data can be used to make adequate staffing plans.

Diagnostic performance of single-phase CT angiography in detecting large vessel occlusion in ischemic stroke: A systematic review.

PURPOSE: To systematically review the diagnostic performance of single-phase CT angiography (CTA) in detecting intracranial large vessel occlusion (LVO). METHOD: MEDLINE and Embase were searched for studies investigating the diagnostic performance of single-phase CTA in detecting LVO. Study quality was assessed. Sensitivity and specificity were calculated and meta-analyzed with a bivariate random-effects model. Heterogeneity was assessed with a chi-squared test. RESULTS: Eleven studies were included. High risk of bias with regard to "patient selection", "reference standard", and "flow and timing" was present in 4, 1, and 2 studies, respectively. In 7 studies, it was unclear whether reference tests were interpreted blinded to CTA readings. There was variability in types of vessel segments analyzed, resulting in heterogeneous sensitivity and specificity (P < 0.05). Two studies provided data for the proximal anterior circulation (distal intracranial carotid artery, A1-, A2-, M1- and M2-segments), with pooled sensitivity of 88.4 % (95 % CI: 62.2-97.2 %) and pooled specificity of 98.5 % (95 % CI: 33.2-100 %). One study suggested that multiphase CTA improved agreement between nonexperts and an expert in detecting A1-, A2-, M1-, M2-, and M3-segment occlusions compared to single-phase CTA (ĸ = 0.72-0.76 vs. ĸ = 0.32-0.45). No other included study reported added value of advanced CTA (CT perfusion, 4D-CTA, or multiphase CTA) compared to single-phase CTA in detecting proximal anterior circulation LVO. CONCLUSION: There is lack of high-quality studies on the diagnostic performance of single-phase CTA for LVO detection in the proximal anterior circulation. The added value of advanced CTA techniques in detecting proximal anterior circulation LVO is not completely clear yet.