BACKGROUND: We studied the evolution over time of diffusion weighted imaging (DWI) lesion volume and the factors involved on early and late infarct growth (EIG and LIG) in stroke patients undergoing endovascular treatment (EVT) according to the final revascularization grade. METHODS: This is a prospective cohort of patients with anterior large artery occlusion undergoing EVT arriving at 1 comprehensive stroke center. Magnetic resonance imaging was performed on arrival (pre-EVT), <2 hours after EVT (post-EVT), and on day 5. DWI lesions and perfusion maps were evaluated. Arterial revascularization was assessed according to the modified Thrombolysis in Cerebral Infarction (mTICI) grades. We recorded National Institutes of Health Stroke Scale at arrival and at day 7. EIG was defined as (DWI volume post-EVT–DWI volume pre-EVT), and LIG was defined as (DWI volume at 5d–DWI volume post-EVT). Factors involved in EIG and LIG were tested via multivariable lineal models. RESULTS: We included 98 patients (mean age 70, median National Institutes of Health Stroke Scale score 17, final mTICI≥2b 86%). Median EIG and LIG were 48 and 63.3 mL in patients with final mTICI<2b, and 3.6 and 3.9 cc in patients with final mTICI≥2b. Both EIG and LIG were associated with higher National Institutes of Health Stroke Scale at day 7 ( ρ =0.667; P <0.01 and ρ =0.614; P <0.01, respectively). In patients with final mTICI≥2b, each 10% increase in the volume of DWI pre-EVT and each extra pass leaded to growths of 9% (95% CI, 7%–10%) and 14% (95% CI, 2%–28%) in the DWI volume post-EVT, respectively. Furthermore, each 10% increase in the volume of DWI post-EVT, each extra pass, and each 10 mL increase in TMax6s post-EVT were associated with growths of 8% (95% CI, 6%–9%), 9% (95% CI, 0%–19%), and 12% (95% CI, 5%–20%) in the volume of DWI post-EVT, respectively. CONCLUSIONS: Infarct grows during and after EVT, especially in nonrecanalizers but also to a lesser extent in recanalizers. In recanalizers, number of passes and DWI volume influence EIG, while number of passes, DWI, and hypoperfused volume after the procedure determine LIG.
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.
BackgroundFlow diverters have emerged in recent years as a safe and effective treatment for intracranial aneurysms, with expanding indications. The Derivo embolization device (DED) is a second-generation flow diverter with a surface finish that may reduce thrombogenicity. We report our multicenter experience evaluating its safety and efficacy.MethodsWe retrospectively analyzed all patients treated with the DED in eight centers in Spain between 2016 and 2020. Demographics, clinical data, procedural complications, morbidity and aneurysm occlusion rates were collected.ResultsA total of 209 patients with 250 aneurysms were treated (77.5% women). The majority of aneurysms were located in the internal carotid artery (86.8%) and most (69.2%) were small (<10 mm) with a median maximum diameter of 5.85 mm and median neck size of 4 mm. DED deployment was successful in all cases, despite two malfunctioning devices (1%). Major complications occurred in nine patients (4.3%), while mild neurologic clinical events were registered in 23 (11%); four patients died (1.9%). A total of 194 aneurysms had an angiographic follow-up at 6 months and showed complete aneurysm occlusion in 75% of cases. Twelve-month follow-up was available for 112 of the treated aneurysms, with a total occlusion rate of 83%.ConclusionThe DED is a second-generation surface-modified flow diverter that presents an option for treatment of intracranial aneurysms with comparable safety and efficacy to other available flow diverter devices. Nonetheless, risks are not negligible, and must be balanced against the natural history risk of cerebral aneurysms, considering the tendency to widen indications for treatment of smaller and less complex lesions in day-to-day use.
Introduction: After achieving successful reperfusion some acute stroke patients still exhibit persistent perfusion deficits. These deficits have been defined in a heterogeneous manner by using CBF, CBV or Tmax maps as a perfusion deficit in the previous ischemic penumbra (impaired microcirculation perfusion-IMP) or inside the infarcted tissue (no reflow-NR). The significance, frequency and pathophysiology of this phenomenon are so far unknown. Methods: Prospective cohort of patients with isolated anterior intracranial occlusion undergoing endovascular treatment (EVT) and achieving complete recanalization (final mTICI≥2B). Brain MRI was performed on arrival (pre-EVT) and <2h after EVT (post-EVT). Infarcted tissue was segmented on DWI pre-EVT. Pre and post-EVT perfusion maps were obtained with Olea software. NR was defined in the post-EVT perfusion maps as the region inside the infarcted tissue which showed a CBV<15% compared to the contralateral side, while IMP was the equivalent area inside the previous tissue in penumbra. We evaluated the association between both NR and IMP and NIHSS at 24h, NIHSS at discharge and modified Rankin score (mRS) at three months adjusting by baseline NIHSS and final mTICI. Results: Thirty-five patients were included. All of them had IMP areas and 25 (71%) had NR areas. The median volume of NR and IMP was 3.43ml [IQR 1.43-8.81], corresponding to 17.9% of the infarcted tissue [IQR 4.2-50.3] and 33.9ml [IQR 14.0-69.3] (27.7% [IQR 8.2-51.2] of the penumbra) respectively. Patients with NR areas had higher NIHSS at 24 h and at discharge and higher mRS at 3 months. Volume of NR was independently associated with higher NIHSS at 24 h and at discharge. No independent association was found with IMP volume. Neither NR nor IMP were associated with hemorrhagic transformation. Patients receiving rTPA previous to EVT showed higher perfusion values inside the infarct than patients with primary EVT (2.31 mL/100g [1.48-2.43] vs 0.92 [0.7-1.47] p=0.02), although NR areas appeared in the same proportion in both groups. Conclusions: No reflow phenomenon can be a marker of poor outcome in the early evaluation of successfully recanalized stroke patients especially when the persistent perfusion deficit is located inside the infarcted tissue.
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