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 (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

Procedural approaches and angiographic signs predicting first-pass recanalization in patients treated with mechanical thrombectomy for acute ischaemic stroke

Background: First-pass recanalization via mechanical thrombectomy (MT) has been associated with improved clinical outcome in patients with acute ischaemic stroke. The optimal approach to achieve first-pass effect (FPE) remains unclear. No study has evaluated angiographic features associated with the achievement of FPE. We aimed to determine the procedural approaches and angiographic signs that may predict FPE. Methods: We performed a prospective, multi-centre, observational study of FPE in patients with anterior circulation stroke treated with MT between February and June 2017. MTs were performed using different devices, deployment manoeuvres (standard versus \u2018Push and Fluff\u2019 technique), proximal balloon guide catheter (PBGC), distal aspiration catheter (DAC) or both. The angiographic clot protrusion sign (ACPS) was recorded. Completed FPE (cFPE) was defined as a modified thrombolysis in cerebral infarction score of 2c\u20133. Associations were sought between cFPE and procedural approaches and angiographic signs. Results: A total of 193 patients were included. cFPE was achieved in 74 (38.3%) patients. The use of the push and fluff technique (odds ratio (OR) 3.45, 95% confidence interval (CI): 1.28\u20139.29, p = 0.010), PBGC (OR 3.81, 95% CI: 1.41\u201310.22, p = 0.008) and ACPS (OR 4.71, 95% CI: 1.78\u201312.44, p = 0.002) were independently associated with cFPE. Concurrence of these three variables led to cFPE in 82 vs 35% of the remaining cases (p = 0.002). Conclusions: The concurrence of the PBGC, the push and fluff technique, and the ACPS was associated with the highest rates of cFPE. Appropriate selection of the thrombectomy device and deployment technique may lead to better procedural outcomes. ACPS could be used to assess clot integration strategies in future trials

Effect of general anaesthesia on functional outcome in patients with anterior circulation ischaemic stroke having endovascular thrombectomy versus standard care: a meta-analysis of individual patient data

Background: General anaesthesia (GA) during endovascular thrombectomy has been associated with worse patient outcomes in observational studies compared with patients treated without GA. We assessed functional outcome in ischaemic stroke patients with large vessel anterior circulation occlusion undergoing endovascular thrombectomy under GA, versus thrombectomy not under GA (with or without sedation) versus standard care (ie, no thrombectomy), stratified by the use of GA versus standard care. Methods: For this meta-analysis, patient-level data were pooled from all patients included in randomised trials in PuMed published between Jan 1, 2010, and May 31, 2017, that compared endovascular thrombectomy predominantly done with stent retrievers with standard care in anterior circulation ischaemic stroke patients (HERMES Collaboration). The primary outcome was functional outcome assessed by ordinal analysis of the modified Rankin scale (mRS) at 90 days in the GA and non-GA subgroups of patients treated with endovascular therapy versus those patients treated with standard care, adjusted for baseline prognostic variables. To account for between-trial variance we used mixed-effects modelling with a random effect for trials incorporated in all models. Bias was assessed using the Cochrane method. The meta-analysis was prospectively designed, but not registered. Findings: Seven trials were identified by our search; of 1764 patients included in these trials, 871 were allocated to endovascular thrombectomy and 893 were assigned standard care. After exclusion of 74 patients (72 did not undergo the procedure and two had missing data on anaesthetic strategy), 236 (30%) of 797 patients who had endovascular procedures were treated under GA. At baseline, patients receiving GA were younger and had a shorter delay between stroke onset and randomisation but they had similar pre-treatment clinical severity compared with patients who did not have GA. Endovascular thrombectomy improved functional outcome at 3 months both in patients who had GA (adjusted common odds ratio (cOR) 1·52, 95% CI 1·09–2·11, p=0·014) and in those who did not have GA (adjusted cOR 2·33, 95% CI 1·75–3·10, p<0·0001) versus standard care. However, outcomes were significantly better for patients who did not receive GA versus those who received GA (covariate-adjusted cOR 1·53, 95% CI 1·14–2·04, p=0·0044). The risk of bias and variability between studies was assessed to be low. Interpretation: Worse outcomes after endovascular thrombectomy were associated with GA, after adjustment for baseline prognostic variables. These data support avoidance of GA whenever possible. The procedure did, however, remain effective versus standard care in patients treated under GA, indicating that treatment should not be withheld in those who require anaesthesia for medical reasons