Clinical Results of the Advanced Neurovascular Access Catheter System Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA).

BACKGROUND: The Advanced Neurovascular Access (ANA) thrombectomy system is a novel stroke thrombectomy device comprising a self-expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, the ANA device allows distal aspiration combined with a stent retriever to mobilize the clot into the funnel where it remains copped during extraction. We investigated the safety and efficacy of ANA catheter system. METHODS: SOLONDA (Solitaire in Combination With the ANA Catheter System as Manufactured by Anaconda) was a prospective, open, single-arm, multicenter trial with blinded assessment of the primary outcome by an independent core lab. Patients with anterior circulation vessel occlusion admitted within 8 hours from symptom onset were eligible. The primary end point was successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b-3) with ≤3 passes of the ANA device in combination with stent retriever, before the use of rescue therapy in the intention to treat population. Primary predefined analysis was noninferiority as compared to the performance end point observed in HERMES (High Effective Reperfusion Using Multiple Endovascular Devices). RESULTS: After enrollment of 74 patients, an interim analysis was conducted, and the trial Steering Committee decided to terminate recruitment due to safety and performance objectives were reached. Mean age was 71.6 (SD 8.9) years, 46.6% women and median National Institutes of Health Stroke Scale on admission 14 (interquartile range, 10-19). Successful reperfusion within 3 passes before rescue therapy was achieved in 60/72 (83.3% [95% CI, 74.7%-91.9%]) with a rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 2c-3) of 60% (95% CI, 48.4%-71.1%; 43/72 patients). After noninferiority was confirmed (P<0.01), the ANA device also showed superiority in the rate of successful reperfusion with ≤3 passes (P=0.02). First-pass successful recanalization rate was 55.6% (95% CI, 44.1%-67.0%), with a first-pass complete recanalization rate of 38.9% (95% CI, 27.6%-50.1%). Rescue therapy to obtain a modified Thrombolysis in Cerebral Infarction score 2b-3 was needed in 12/72 (17%) patients. At 90 days, the rate of favorable functional outcome (modified Rankin Scale score 0-2) was 57.5% (95% CI, 46.2%-68.9%), and the rate of excellent functional outcome (modified Rankin Scale score 0-1) was 45.2% (95% CI, 33.8%-56.6%). The rate of severe adverse device related was 1.4%. CONCLUSIONS: In this clinical experience, the ANA device achieved a high rate of complete recanalization with a preliminary good safety profile and favorable 90 days clinical outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04095767.

Primary endovascular treatment for acute ischemic stroke in teenage patients: a short case series.

PURPOSE: To analyze the safety and efficacy of primary endovascular treatment (EVT) for acute ischemic stroke (AIS) in patients younger than 18 years of age. METHODS: Review of 4 patients < 18 years of age with AIS, prospectively enrolled in an electronic database registry for acute ischemic stroke patients who underwent thrombectomy at tertiary centers, from January 2011 to February 2017. Clinical and imaging data were analyzed. RESULTS: All patients were female. Patients 1 to 4 were 14, 13, 16, and 13 years old, respectively. Patients 1 and 3 had left middle cerebral artery occlusion, patient 2 basilar occlusion, and patient 4 right tandem occlusion. Mean NIHSS score was 13 (7-19) on arrival and 4 (0-5) at 24 h. Patient 2 had Osler-Weber-Rendu disease and patient 4 a previously surgically repaired complete atrioventricular canal. All patients presented with clinical-radiological mismatch. CT/CTA was used in patients 1 and 4 and MRI/MRA in patients 2 and 3. Stent retriever was used in 3 patients (patients 1, 3, and 4) and direct aspiration first-pass technique in 1 (patient 2). All 4 procedures resulted in successful recanalization and 3-month functional independence. CONCLUSION: Primary EVT is reported in patients 13 to 16 years of age with AIS due to large vessel occlusion and clinical-radiological mismatch. Procedures were safe and effective with prompt recanalization and good clinical outcome.

Association Between Time to Reperfusion and Outcome Is Primarily Driven by the Time From Imaging to Reperfusion.

BACKGROUND AND PURPOSE: A progressive decline in the odds of favorable outcome as time to reperfusion increases is well known. However, the impact of specific workflow intervals is not clear. METHODS: We studied the mechanical thrombectomy group (n=103) of the prospective, randomized REVASCAT (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset) trial. We defined 3 workflow metrics: time from symptom onset to reperfusion (OTR), time from symptom onset to computed tomography, and time from computed tomography (CT) to reperfusion. Clinical characteristics, core laboratory-evaluated Alberta Stroke Program Early CT Scores (ASPECTS) and 90-day outcome data were analyzed. The effect of time on favorable outcome (modified Rankin scale, 0-2) was described via adjusted odds ratios (ORs) for every 30-minute delay. RESULTS: Median admission National Institutes of Health Stroke Scale was 17.0 (14.0-20.0), reperfusion rate was 66%, and rate of favorable outcome was 43.7%. Mean (SD) workflow times were as follows: OTR: 342 (107) minute, onset to CT: 204 (93) minute, and CT to reperfusion: 138 (56) minute. Longer OTR time was associated with a reduced likelihood of good outcome (OR for 30-minute delay, 0.74; 95% confidence interval [CI], 0.59-0.93). The onset to CT time did not show a significant association with clinical outcome (OR, 0.87; 95% CI, 0.67-1.12), whereas the CT to reperfusion interval showed a negative association with favorable outcome (OR, 0.72; 95% CI, 0.54-0.95). A similar subgroup analysis according to admission ASPECTS showed this relationship for OTR time in ASPECTS<8 patients (OR, 0.56; 95% CI, 0.35-0.9) but not in ASPECTS≥8 (OR, 0.99; 95% CI, 0.68-1.44). CONCLUSIONS: Time to reperfusion is negatively associated with favorable outcome, being CT to reperfusion, as opposed to onset to CT, the main determinant of this association. In addition, OTR was strongly associated to outcome in patients with low ASPECTS scores but not in patients with high ASPECTS scores. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692379.

Outcomes of a contemporary cohort of 536 consecutive patients with acute ischemic stroke treated with endovascular therapy.

BACKGROUND AND PURPOSE: We sought to assess outcomes after endovascular treatment/therapy of acute ischemic stroke, overall and by subgroups, and looked for predictors of outcome. METHODS: We used data from a mandatory, population-based registry that includes external monitoring of completeness, which assesses reperfusion therapies for consecutive patients with acute ischemic stroke since 2011. We described outcomes overall and by subgroups (age ≤ or >80 years; onset-to-groin puncture ≤ or >6 hours; anterior or posterior strokes; previous IV recombinant tissue-type plasminogen activator or isolated endovascular treatment/therapy; revascularization or no revascularization), and determined independent predictors of good outcome (modified Rankin Scale score ≤2) and mortality at 3 months by multivariate modeling. RESULTS: We analyzed 536 patients, of whom 285 received previous IV recombinant tissue-type plasminogen activator. Overall, revascularization (modified Thrombolysis In Cerebral Infarction scores, 2b and 3) occurred in 73.9%, 5.6% developed symptomatic intracerebral hemorrhages, 43.3% achieved good functional outcome, and 22.2% were dead at 90 days. Adjusted comparisons by subgroups systematically favored revascularization (lower proportion of symptomatic intracerebral hemorrhages and death rates and higher proportion of good outcome). Multivariate analyses confirmed the independent protective effect of revascularization. Additionally, age >80 years, stroke severity, hypertension (deleterious), atrial fibrillation, and onset-to-groin puncture ≤6 hours (protective) also predicted good outcome, whereas lack of previous disability and anterior circulation strokes (protective) as well as and hypertension (deleterious) independently predicted mortality. CONCLUSIONS: This study reinforces the role of revascularization and time to treatment to achieve enhanced functional outcomes and identifies other clinical features that independently predict good/fatal outcome after endovascular treatment/therapy.

Posterior Fossa Venous Drainage.

This paper aims to make simple the evaluation of the main veins related to the brainstem and cerebellum. Posterior fossa venous drainage is best understood in context with its three main collectors: superior: toward the Vein of Galen; posterior: toward the torcular complex; and anterior: toward the superior petrosal sinus. A fourth possible drainage path, often harder to distinguish, is directed toward the inferior petrosal sinus. Veins of these four systems are frequently connected to one another. Despite traditionally being considered less regular than its arterial disposition, posterior fossa venous anatomy follows specific patterns that are easy to identify. The three more representative veins of each venous confluent have been selected, to help in recognizing them angiographically. Since pial large veins are primarily located over the surface of the encephalon, most related anatomical structures can be confidently identified. This is of special interest when angiographic 2D or 3D studies are evaluated and provide fundamental assistance in locating precise structures. To better aid in understanding venous disposition, an overview of embryologic and fetal development is also discussed.

Transradial access for diagnostic angiography and interventional neuroradiology procedures: A four-year single-center experience.

PURPOSE: The objective of this study was to assess the efficacy and safety of transradial access for diagnostic angiography and interventional neuroradiology procedures. METHODS: This was a retrospective analysis of a single-center experience based on 225 patients attended between August 2015 and October 2019, in which transradial access was used for diagnostic angiography and endovascular interventions. Ultrasound-guided access was done at the level of the forearm or anatomical or snuffbox (distal transradial access). Conventional forearm transradial access was done in 179 procedures (right, left and bilateral in 169, 5 and 5, respectively), while distal transradial access was done in 46 cases (41 right and 5 left). Primary outcome measures included successful catheterization, need to change access, or technical complications. RESULTS: In the group of 131 diagnostic angiographies, the technique success rate was 100% to target the right vertebral artery, 97% for the right internal carotid, 93.5% for the left internal carotid, 82% for the left vertebral artery, and 100% for both common and external carotid arteries. All patients were discharged within 2-4 h after the procedure. A total of 94 interventional procedures were performed, including aneurysms in 39 cases, stroke in 34, and other procedures (carotid stents, arteriovenous malformations, carotid-cavernous fistula) in the remaining 21. The overall technical success in both diagnostic angiographies and interventional procedures was 97.7%. In four cases of diagnostic angiography and in 1 intervention, it was necessary to switch from transradial access to transfemoral access. Three cases of hematoma related to the access site were recorded. CONCLUSIONS: In our experience, transradial access is an alternative approach for diagnostic angiography and neuro-interventions.

Cost-effectiveness of mechanical thrombectomy using stent retriever after intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone in the treatment of acute ischaemic stroke due to large vessel occlusion in Spain.

INTRODUCTION: To assess the cost-effectiveness of stent-retriever mechanical thrombectomy and intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone in patients with acute ischaemic stroke due to large vessel occlusions in Spain. MATERIALS AND METHODS: Clinical data were taken from the SWIFT PRIME clinical trial. A lifetime Markov state transition model defined by the modified Rankin Scale score was developed to estimate costs and health outcomes (life years gained and quality adjusted life years). A Spanish National Health System perspective (direct medical costs) was considered. Resource utilisation and utilities were obtained from available published data and endorsed by an expert panel. Costs (€, 2016) were obtained from various Spanish sources. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Stent-retriever thrombectomy after intravenous tissue plasminogen activator was associated with better outcomes (1.17 life years gained and 2.51 quality adjusted life years) and savings of €44,378, resulting in a dominant therapy over intravenous tissue plasminogen activator alone. A net monetary benefit of €119,744 was obtained considering a willingness-to-pay threshold of €30,000/quality adjusted life year gained. The combined therapy was also dominant in all sensitivity analyses, deterministic and probabilistic. DISCUSSION: The results were consistent with a previously published cost-effectiveness analysis and reinforce the likeliness of the selection of stent-retriever mechanical thrombectomy plus intravenous tissue plasminogen activator over intravenous tissue plasminogen activator alone. CONCLUSION: Stent-retriever thrombectomy after intravenous tissue plasminogen activator is a dominant alternative over intravenous tissue plasminogen activator alone (more effective and less costly) for the treatment of acute ischaemic stroke patients with large vessel occlusions in the Spanish setting.

Treatment of distal anterior cerebral artery aneurysms with the Pipeline Embolization Device.

Aneurysms of the anterior cerebral artery (ACA) located distal to the anterior communicating artery complex (ACOM) remain challenging to treat with surgical clip reconstruction as well as with endovascular coil-embolization strategies. We have treated five complex geometry distal ACA aneurysms with endoluminal reconstruction using the Pipeline Embolization Device (PED). Two aneurysms were of the dysplastic fusiform type. Three aneurysms were of complex saccular configuration. Three aneurysms were treated electively at the outset with PED. One patient had previously undergone aborted clip reconstruction, and one was treated for recurrent aneurysm growth after coil embolization. The mean diameter of the ACA in this cohort was 1.96mm proximal to the aneurysm and 1.79mm distal to the aneurysmal segment. A single PED of 2.5mm inner diameter was the sole treatment in four cases. Two PEDs, telescopically overlapped across the aneurysm, were used in the remaining case. All devices were deployed successfully. No parent artery occlusion or stenosis was observed. In all cases an associated branch vessel arising from the vicinity of the aneurysm or incorporated into its neck was covered by the endoluminal construct. At follow-up angiography, robust antegrade flow was maintained in the jailed branch. One patient experienced asymptomatic, delayed occlusion of the jailed branch. Complete aneurysm occlusion was seen in all patients. We confirm that PED can be deployed in parent vessels smaller than 2mm diameter, and that endoluminal reconstruction with the PED may be a safe and effective treatment alternative for selected distal ACA aneurysms.