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Safety and efficacy of a new outreach distal access catheter, TACTICS, for coil embolization of unruptured intracranial aneurysms.

ABSTRACT: Background and purpose Current large-bore catheters can be easily and safely placed in the intracranial vessels for the stabilization of microcatheters in several neurointervention scenarios. We considered that a novel 3.4 French catheter (TACTICS, Technorat Corporation, Aichi, Japan) might be useful for intermediate/distal access in a triaxial system. Here, we present our initial experience using the TACTICS catheter for treatment of intracranial aneurysms. Materials and methods A total of 35 endovascular coils were placed to embolize unruptured intracranial aneurysms of the anterior circulation using the TACTICS catheter between December 2016 and November 2017. These procedures were retrospectively reviewed to assess aneurysmal obliteration (Raymond's classification), the volume embolization ratio (VER) and procedural complications in comparison with 96 conventional coil treatments during the 3-year period up to 2016. Data were matched for aneurysmal morphology (location, maximum diameter and aspect ratio) by the propensity method. Results In all procedures, the TACTICS catheter was atraumatically landed beyond the carotid siphon. There were no hemorrhagic or symptomatic ischemic complications. After propensity matching, 68 procedures were assessed (34 in each group). Achievement of Raymond's scale 1 (complete occlusion) showed the same frequency in both groups (50% vs. 50%, p?=?0.23). The VER was significantly higher with the TACTICS catheter than with the conventional method (34.0% vs. 28.7%, p?=?0.003). Conclusion We reviewed our initial experience of the TACTICS catheter. It can be used as an intermediate catheter for safe and effective endovascular coil embolization of anterior circulation aneurysms.

SUBMITTER: Matsushige T

PROVIDER: S-EPMC6116131 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Safety and efficacy of a new outreach distal access catheter, TACTICS, for coil embolization of unruptured intracranial aneurysms.

Matsushige Toshinori T Sakamoto Shigeyuki S Ishii Daizo D Shinagawa Katsuhiro K Shimonaga Koji K Hosogai Masahiro M Kawasumi Tomohiro T Oshita Junpei J Okazaki Takahito T Kurisu Kaoru K

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences 20180521 5

Background and purpose Current large-bore catheters can be easily and safely placed in the intracranial vessels for the stabilization of microcatheters in several neurointervention scenarios. We considered that a novel 3.4 French catheter (TACTICS, Technorat Corporation, Aichi, Japan) might be useful for intermediate/distal access in a triaxial system. Here, we present our initial experience using the TACTICS catheter for treatment of intracranial aneurysms. Materials and methods A total of 35 e ...[more]

PMID: 29783870

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Project description:ObjectivePeriprocedural thromboembolic events are a serious complication associated with coil embolization of unruptured intracranial aneurysms. However, no established clinical rule for predicting thromboembolic events exists. This study aimed to clarify the significance of adding preoperative clopidogrel response value to clinical factors when predicting the occurrence of thromboembolic events during/after coil embolization and to develop a nomogram for thromboembolic event prediction.MethodsIn this prospective, single-center, cohort study, we included 345 patients undergoing elective coil embolization for unruptured intracranial aneurysm. Thromboembolic event was defined as the occurrence of intra-procedural thrombus formation and postprocedural symptomatic cerebral infarction within 7 days. We evaluated preoperative clopidogrel response and patients' clinical information. We developed a patient-clinical-information model for thromboembolic event using multivariate analysis and compared its efficiency with that of patient-clinical-information plus preoperative clopidogrel response model. The predictive performances of the two models were assessed using area under the receiver-operating characteristic curve (AUC-ROC) with bootstrap method and compared using net reclassification improvement (NRI) and integrated discrimination improvement (IDI).ResultsTwenty-eight patients experienced thromboembolic events. The clinical model included age, aneurysm location, aneurysm dome and neck size, and treatment technique. AUC-ROC for the clinical model improved from 0.707 to 0.779 after adding the clopidogrel response value. Significant intergroup differences were noted in NRI (0.617, 95% CI: 0.247-0.987, p < .001) and IDI (0.068, 95% CI: 0.021-0.116, p = .005).ConclusionsEvaluation of preoperative clopidogrel response in addition to clinical variables improves the prediction accuracy of thromboembolic event occurrence during/after coil embolization of unruptured intracranial aneurysm.

Project description:Background and purposeThis study arose from a need to systematically evaluate the clinical and angiographic outcomes of intracranial aneurysms treated with modified coils. We report the procedural safety and clinical outcomes in a prospective randomized controlled trial of endovascular coiling for ruptured and unruptured intracranial aneurysms, comparing polymer-loaded Cerecyte coils with bare platinum coils in 23 centers worldwide.Materials and methodsFive hundred patients between 18 and 70 years of age with a ruptured or unruptured target aneurysm planning to undergo endovascular coiling were randomized to receive Cerecyte or bare platinum coils. Analysis was by intention to treat.ResultsTwo hundred forty-nine patients were allocated to Cerecyte coils and 251 to bare platinum coils. Baseline characteristics were balanced. For ruptured aneurysms, in-hospital mortality was 2/114 (1.8%) with Cerecyte versus 0/119 (0%) bare platinum coils. There were 8 (3.4%) adverse procedural events resulting in neurological deterioration: 5/114 (4.4%) with Cerecyte versus 3/119 (2.5%) with bare platinum coils (P = .22). The 6-month mRS score of ≤2 was not significantly different in 103/109 (94.5%) patients with Cerecyte and 110/112 (98.2%) patients with bare platinum coils. Poor outcome (mRS score of ≥3 or death) was 6/109 (5.5%) with Cerecyte versus 2/112 (1.8%) with bare platinum coils (P = .070). For UIAs, there was no in-hospital mortality. There were 7 (2.7%) adverse procedural events with neurological deterioration, 5/133 (3.8%) with Cerecyte versus 2/131 (1.5%) with bare platinum coils (P = .13). There was a 6-month mRS score of ≤2 in 114/119 (95.8%) patients with Cerecyte versus 123/123 (100%) patients with bare platinum coils. There was poor outcome (mRS ≥3 and 1 death) in 5/119 (4.2%) patients with Cerecyte versus 0/123 (0%) patients with bare platinum coils (P = .011).ConclusionsThere was a statistical excess of poor outcomes in the Cerecyte arm at discharge in the ruptured aneurysm group and at 6-month follow-up in the unruptured group. Overall adverse clinical outcomes and in-hospital mortality were exceptionally low in both groups.

Project description:PurposeHemodynamics play a key role in the management of cerebral aneurysm recanalization after coil embolization; however, the most reliable hemodynamic parameter remains unknown. Previous studies have explored the use of both spatiotemporally averaged and maximal definitions for hemodynamic parameters, based on computational fluid dynamics (CFD) analysis, to build predictive models for aneurysmal recanalization. In this study, we aimed to assess the influence of different spatiotemporal characteristics of hemodynamic parameters on predictive performance.MethodsHemodynamics were simulated using CFD for 66 cerebral aneurysms from 65 patients. We evaluated 14 types of spatiotemporal definitions for two hemodynamic parameters in the pre-coiling model and five in virtual post-coiling model (VM) created by cutting the aneurysm from the pre-coiling model. A total of 91 spatiotemporal hemodynamic features were derived and utilized to develop univariate predictor (UP) and multivariate logistic regression (LR) models. The model's performance was assessed using two metrics: the area under the receiver operating characteristic curve (AUROC) and the area under the precision-recall curve (AUPRC).ResultsDifferent spatiotemporal hemodynamic features exhibited a wide range of AUROC values ranging from 0.224 to 0.747, with 22 feature pairs showing a significant difference in AUROC value (P-value <0.05), despite being derived from the same hemodynamic parameter. PDave,q1 was identified as the strongest UP with AUROC/AUPRC values of 0.747/0.385, yielding sensitivity and specificity value of 0.889 and 0.614 at the optimal cut-off value, respectively. The LR model further improved the prediction performance, having AUROC/AUPRC values of 0.890/0.903. At the optimal cut-off value, the LR model achieved a specificity of 0.877, sensitivity of 0.719, outperforming the UP model.ConclusionOur research indicated that the characteristics of hemodynamic parameters in terms of space and time had a significant impact on the development of predictive model. Our findings suggest that LR model based on spatiotemporal hemodynamic features could be clinically useful in predicting recanalization after coil embolization in patients, without the need for invasive procedures.

Project description:Importance:Unruptured intracranial aneurysms (UIAs) are relatively common in the general population and are being increasingly diagnosed; a significant proportion are tiny (≤3 mm) aneurysms. There is significant heterogeneity in practice and lack of clear guidelines on the management of incidental, tiny UIAs. It is important to quantify the implications of different management strategies in terms of health benefits to patients. Objective:To evaluate the effectiveness of routine treatment (aneurysm coiling) vs 3 strategies for imaging surveillance compared with no preventive treatment or routine follow-up of tiny UIAs. Design, Setting, and Participants:A decision-analytic model-based comparative effectiveness analysis was conducted from May 1 to June 30, 2017, using inputs from the medical literature. PubMed searches were performed to identify relevant literature for all key model inputs, each of which was derived from the clinical study with the most robust data and greatest applicability. Analysis included 10 000 iterations simulating adult patients with incidental detections of UIAs 3 mm or smaller and no history of subarachnoid hemorrhage. Interventions:The following 5 management strategies for tiny UIAs were evaluated: annual magnetic resonance angiography (MRA) screening, biennial MRA screening, MRA screening every 5 years, aneurysm coiling and follow-up, and no treatment or preventive follow-up. Main Outcomes and Measures:A Markov decision model for lifetime rupture was constructed from a societal perspective per 10 000 patients with incidental, tiny UIAs. Outcomes were assessed in terms of quality-adjusted life-years. Probabilistic, 1-way, and 2-way sensitivity analyses were performed. Results:In this analysis of 10 000 iterations simulating adult patients with a mean age of 50 years, the base-case calculation shows that the management strategy of no treatment or preventive follow-up has the highest health benefit (mean [SD] quality-adjusted life-years, 19.40 [0.31]). Among the management strategies that incorporate follow-up imaging, MRA every 5 years is the best strategy with the next highest effectiveness (mean [SD] quality-adjusted life-years, 18.05 [0.62]). The conclusion remains robust in probabilistic and 1-way sensitivity analyses. No routine follow-up remains the optimal strategy when the annual growth rate and risk of rupture of growing aneurysms are varied. When the annual risk of rupture of nongrowing UIAs is less than 1.7% (0.23% in base case scenario), no follow-up is the optimal strategy. If annual risk of rupture is more than 1.7%, coiling should be performed directly. Conclusions and Relevance:Given the current literature, no preventive treatment or imaging follow-up is the most effective strategy in patients with aneurysms that are 3 mm or smaller, resulting in better health outcomes. More aggressive imaging surveillance for aneurysm growth or preventive treatment should be reserved for patients with a high risk of rupture. Given these findings, it is important to critically evaluate the appropriateness of current clinical practices, and potentially determine specific guidelines to reflect the most effective management strategy for patients with incidental, tiny UIAs.

Dataset Information

Safety and efficacy of a new outreach distal access catheter, TACTICS, for coil embolization of unruptured intracranial aneurysms.

Publications

Safety and efficacy of a new outreach distal access catheter, TACTICS, for coil embolization of unruptured intracranial aneurysms.

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