The primary objective is to evaluate the safety and effectiveness of Stryker second generation Target
Nano Coils in the treatment of ruptured and unruptured small (<7 mm) intracranial aneurysms.
The ...TARGET Registry is a prospective, two-arm study with independent medical event monitoring and core-lab adjudication. This paper describes the second arm of the TARGET registry. Patients with
intracranial aneurysms were embolized with 2nd generation TARGET Nano coils in 12 US centers. The primary efficacy outcome was adequate aneurysm occlusion (RR occlusion grade I-II) on follow-up. Primary safety outcome was treatment-related morbidity and mortality. Secondary outcomes included aneurysm packing density immediately post-procedure, immediate adequate occlusion, aneurysm re-access rate, retreatment rate and clinical outcomes using modified ranking scale. A secondary analysis investigated the influence of using Nano-predominant coils (≥2/3 of total coil-length) vs. non-Nano-predominant coils (<2/3 of total length).
150 patients with 155 aneurysms met the inclusion and exclusion criteria. (31%) patients with ruptured and (69%) with unruptured aneurysms were treated using TARGET coils. Median age was 58.8 (SD 12.7), 74.7% were females, and 80% were Caucasians. Mean follow-up was 5.23 (SD 2.27) months. Peri-procedural mortality was seen in 2.0% of patients. Good outcome at discharge (mRS 0-2) was seen in 81.3% of the cohort. The median packing density (SD) was 29.4% (14.9). Mid-term complete/near complete occlusion rate was seen in 96% of aneurysms and complete obliteration was seen in 75.2% of aneurysms. Patients treated predominantly with Nano coils had higher PD (32.6% vs. 26.1%,
< 0.001). There was no significant difference in clinical and angiographic outcomes. The mid-term mRS0-2 was achieved in 106/109 (97.2%) patients. All-cause mortality was 5/115 (4.3%).
In the multicenter TARGET Registry, 75.8% of aneurysms achieved mid-term complete occlusion, and 96% achieved complete/near complete occlusion with excellent independent functional outcome.
Abstract only Introduction Preliminary in vivo animal intracranial aneurysm (IA) studies have demonstrated promising immediate and follow‐up aneurysm occlusion rates using the novel Saccular ...Endovascular Aneurysm Lattice (SEAL) system. The PRE‐SEALTM IT trial was designed to assess the feasibility, safety, and effectiveness of the SEAL system in patients with previously untreated ruptured and unruptured wide‐neck IA. Methods PRE‐SEAL IT is an on‐going, prospective, interventional, core‐lab adjudicated, single‐arm study performed in Medellin, Columbia. Key inclusion criteria included: 1. Age 20–80 years, 2. Saccular shape, bifurcation, or terminus IA, 3. Wide neck aneurysm with neck size ≥4 mm or dome‐to‐neck ratio <2, and 4. IA diameter 2mm to 25mm. Consented and enrolled patients were treated with the SEALTM device. A follow‐up DSA was performed at 24‐hours, 6 months, and 12 months and a MRA at 3 months. Final clinical follow‐up was at 24‐months. Primary efficacy outcome was achieving complete occlusion (WOS grade A or B) at 6 months angiographic follow up. Primary safety outcome was any stroke with an increase in NIHSS of 4 up to discharge. Results From December 2021 through June 2022, 15 patients have been enrolled into the PRE‐SEAL IT trial. Ten women and 5 men were treated with the SEAL device, with a mean age of 56.8±9.5 years. Of the 15 IA, 12 were anterior circulation (ICA‐T (1), MCA (7), AcomA (3), A2‐A3 (1)) and 3 posterior circulations (Basilar, VBJ‐fenestration, SCA), and 14 were unruptured (93.3%). Mean aneurysm width was 6.1±2.5mm. Immediate post‐procedure complete occlusion (Grade A, B) was achieved in 9 patients (60%) and adequate occlusion (Grade A, B, C) in 13 (86.6%). At 24‐hours follow‐up, 12 patients (80%) had complete occlusion and 15 (100%) achieved adequate occlusion. Six‐month complete occlusion rate (Grade A and B) was 100% (8/8). Interim results were site adjudicated. No cases of intraoperative rupture, or bleeding or re‐bleeding, or clinical stroke were observed. Conclusions The interim results of the PRE SEAL‐IT trial demonstrated promising complete occlusion rates at 24‐hour and 6 month follow‐up with no safety concerns. Trial enrollment will be completed in October, and final 24‐hour results will be presented at the 2022 SVIN Annual Meeting.
To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils.
The TARGET Registry is a ...prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with
intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100% 360-complex coils on clinical and angiographic outcomes.
148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2%) patients with ruptured and 90 (61.8%) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1-67.4), 73% female, and 71.6% were Caucasian. Median follow-up time was 5.9 (IQR 4.0-6.9) months. The majority were treated with TARGET 360-coils (63.7%), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7% of patients. A good outcome at discharge (mRS 0-2) was seen in 89.9% of the full cohort, and in 84.5 and 93.3% in the ruptured and unruptured patients, respectively. The median packing density was 28.8% (IQR 20.3-41.1). Long-term complete and near complete occlusion rate was seen in 90.4% of aneurysms and complete obliteration was seen in 66.2% of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8%) patients and all-cause mortality was seen in 3/148 (2%) patients.
In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0% achieved complete or near complete occlusion with excellent independent functional outcome.
www.ClinicalTrials.gov, identifier: NCT01748903.
The dissecting posterior cerebral artery (PCA) aneurysms are very rare. These aneurysms pose significant treatment challenge and need careful evaluation to formulate an optimal treatment plan in case ...of ruptured or un-ruptured presentations.
Retrospective review of a prospectively collected data.
Seven patients with dissecting aneurysms of the PCA were identified. Six out of seven presented with subarachnoid hemorrhage (SAH) and one with ischemic stroke. Three out of seven were treated with endovascular coil embolization without sacrifice of the parent artery and the rest had parent artery occlusion (PAO) with coil embolization. None of the patients developed new neurological deficits post-procedure. Aneurysm re-occurred in two patients that were treated without PAO.
Endovascular treatment of the dissecting PCA aneurysm is safe and feasible. It can be performed with or without PAO. Recurrence is more common without PAO and close follow-up is warranted.
Endovascular treatment with mechanical thrombectomy (MT) is beneficial for patients with acute stroke suffering a large-vessel occlusion, although treatment efficacy is highly time-dependent. We ...hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared with direct presentation.
STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke because of anterior-circulation large-vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without intravenous tissue plasminogen activator and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0-2) at 90 days. We assessed (1) real-world time metrics of stroke care delivery, (2) outcome differences between direct and transfer patients undergoing MT, and (3) the potential impact of local hospital bypass.
A total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct versus 311.5 minutes for transfer patients (
<0.001). Clinical outcomes were better in the direct group, with 60.0% (299/498) achieving functional independence compared with 52.2% (213/408) in the transfer group (odds ratio, 1.38; 95% confidence interval, 1.06-1.79;
=0.02). Likewise, excellent outcome (modified Rankin Score 0-1) was achieved in 47.4% (236/498) of direct patients versus 38.0% (155/408) of transfer patients (odds ratio, 1.47; 95% confidence interval, 1.13-1.92;
=0.005). Mortality did not differ between the 2 groups (15.1% for direct, 13.7% for transfer;
=0.55). Intravenous tissue plasminogen activator did not impact outcomes. Hypothetical bypass modeling for all transferred patients suggested that intravenous tissue plasminogen activator would be delayed by 12 minutes, but MT would be performed 91 minutes sooner if patients were routed directly to endovascular-capable centers. If bypass is limited to a 20-mile radius from onset, then intravenous tissue plasminogen activator would be delayed by 7 minutes and MT performed 94 minutes earlier.
In this large, real-world study, interhospital transfer was associated with significant treatment delays and lower chance of good outcome. Strategies to facilitate more rapid identification of large-vessel occlusion and direct routing to endovascular-capable centers for patients with severe stroke may improve outcomes.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02239640.
Standard measurement criteria for vertebral artery origin (VAO) stenosis have not yet been established. We propose such criteria and report on interrater agreement using two measurement methods in a ...series of patients referred for endovascular therapy. Three experienced angiography raters independently reviewed magnified cerebral angiograms. The formula 1 − (Ds/Dn) × 100 was used, where Ds is the diameter of the most stenotic portion of the lesion and Dn is normal vessel diameter. The first measurement method allows unrestricted use of the V1 segment for measurement of normal diameter. In the second method, normal diameter is measured in the first portion of the V2 segment with exclusion of any region of poststenotic dilatation. Ten consecutive patients with VAO stenosis were reviewed. The mean degree of stenosis was 71.9% (standard deviation, ± 10.7%) with the first method and 66.9% ± 10.6% with the second method. Average interrater agreement was 80% with the first method and 87% with the second method. The intraclass correlation coefficient (ICC) demonstrated greater interrater agreement when the tortuous proximal V1 segment was excluded in normal diameter measurement (ICC = 0.7750) compared with the unrestricted use of the V1 segment for normal diameter (ICC = 0.7256). The kappa statistic was the best among the 3 raters with 10% variance when the tortuous V1 segment was excluded, at 0.73 (overall agreement, 87%). Our findings indicate that excluding the tortuous V1 portion when measuring normal diameter improves interrater agreement and simplifies the measurement of high-grade VAO stenosis.
Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic ...Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials.
STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis.
A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab-adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2.
This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.
Coexistence of cerebral aneurysm and carotid artery disease may be encountered in clinical practice. Theoretical increase in aneurysmal blood flow may increase risk of rupture if carotid artery ...disease is treated first. If aneurysm coiling is performed first, stroke risk may increase while repeatedly crossing the diseased artery. It is controversial which disease to treat first, and whether it is safe to treat both simultaneously via endovascular procedures. We document the safety and feasibility of such an approach. Review of collected neurointerventional database at our institution was performed for patients who underwent both carotid artery stenting (CAS) and aneurysm coil embolization (ACE) simultaneously. All patients underwent carotid stenting followed by aneurysm coiling in the same setting. Demographic, clinical data, and outcome measures including success rate and periprocedural complications were collected. Five hundred and ninety aneurysms coiling were screened for patients who underwent combined CAS and ACE. Ten patients were identified. Mean age was 67.7 years (range 51-89). The success rate for stenting and coiling was 100% with no immediate complications. The coiling procedure time was extended by an average of 45 min for performing both procedures jointly. No stroke, TIAs, or aneurysmal rebleeding was found on their most recent follow up. Our case series demonstrates that it is safe and feasible to perform CAS and ACE simultaneously as one procedure which may avoid unwanted risk of treating either disease at two separate time sessions.
The endovascular treatment of cerebral aneurysms has been shown to be a safe and effective treatment alternative to surgical management. Technologic advances in coil design, stents, and liquid ...embolic agents may revolutionize such treatment. Cerebral arteriovenous malformation obliteration rates have increased with the advent of newer embolic agents and devices but complications exist, related to the angioarchitecture of the arteriovenous malformations, the types of agents used, and operator experience. Therefore, a multidisciplinary approach with combination therapy should be used. As for understanding the natural history of intracranial atherosclerosis disease, it is to be hoped that the results of recently launched and future randomized clinical trials will clarify the role of intracranial percutaneous transluminal angioplasty and stenting.
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