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      Procedural complexity independent of P2Y12 reaction unit (PRU) values is associated with acute in situ thrombosis in Pipeline flow diversion of cerebral aneurysms

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          Abstract

          Background

          Acute in situ thrombosis is an ischaemic phenomenon during Pipeline embolisation device (PED) procedures with potentially high morbidity and mortality. There is controversy regarding the role of platelet function testing with P2Y12 assay as a predictor of intraprocedural thromboembolic events. There is limited knowledge on whether procedural complexity influences these events.

          Methods

          Data were collected retrospectively on 742 consecutive PED cases at a single institution. Patients with intraprocedural acute thrombosis were compared with patients without these events.

          Results

          A cohort of 37 PED cases with acute in situ thrombosis (mean age 53.8 years, mean aneurysm size 8.4 mm) was matched with a cohort of 705 PED cases without intraprocedural thromboembolic events (mean age 56.4 years, mean aneurysm size 6.9 mm). All patients with in situ thrombosis received intra-arterial and/or intravenous abciximab. The two groups were evenly matched in patient demographics, previous treatment/subarachnoid hemorrhage (SAH) and aneurysm location. There was no statistical difference in postprocedural P2Y12 reaction unit (PRU) values between the two groups, with a mean of 156 in the in situ thrombosis group vs 148 in the control group (p=0.5894). Presence of cervical carotid tortuosity, high cavernous internal carotid artery grade, need for multiple PED and vasospasm were not significantly different between the two groups. The in situ thrombosis group had statistically significant longer fluoroscopy time (60.4 vs 38.4 min, p<0.0001), higher radiation exposure (3476 vs 2160 mGy, p<0.0001), higher rates of adjunctive coiling (24.3% vs 8.37%, p=0.0010) and higher utilisation of balloon angioplasty (37.8% vs 12.2%, p<0.0001). Clinically, the in situ thrombosis cohort had higher incidence of major and minor stroke, intracerebral haemorrhage and length of stay.

          Conclusions

          Predictors of procedural complexity (higher radiation exposure, longer fluoroscopy time, adjunctive coiling and need for balloon angioplasty) are associated with acute thrombotic events during PED placement, independent of PRU values.

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          Most cited references27

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          Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial.

          To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%). PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.
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            International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study.

            Flow diverters are increasingly used in the endovascular treatment of intracranial aneurysms. Our aim was to determine neurologic complication rates following Pipeline Embolization Device placement for intracranial aneurysm treatment in a real-world setting.
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              Pre-procedure P2Y12 reaction units value predicts perioperative thromboembolic and hemorrhagic complications in patients with cerebral aneurysms treated with the Pipeline Embolization Device.

              There is wide variability in the reported incidence of perioperative thromboembolic (0-14%) and hemorrhagic (0-11%) complications after Pipeline Embolization Device (PED) procedures for cerebral aneurysm treatment, which could be partly due to differences in patient response to the P2Y12 receptor antagonist administered while the PED endothelializes. This study aims to identify an optimal pre-procedure P2Y12 reaction units (PRU) value range and determine the independent predictors of perioperative thromboembolic and hemorrhagic complications after PED procedures. We recorded patient and aneurysm characteristics, P2Y12 receptor antagonist administered, pre-procedure PRU value with VerifyNow, procedural variables and perioperative thromboembolic and hemorrhagic complications up to postoperative day 30 after PED procedures at our institution during an 8-month period. Perioperative complications were considered major if they caused a permanent disabling neurological deficit or death. Multivariate regression analysis was performed to identify independent predictors of perioperative complications in our cohort. Forty-four patients underwent 48 PED procedures at our institution during the study period. There were eight thromboembolic and hemorrhagic perioperative complications in our cohort (16.7%), four of which were major (8.3%). A pre-procedure PRU value of 240 (p=0.02) and a technically difficult procedure (p=0.04) were independent predictors of all perioperative complications. A pre-procedure PRU value of 240 (p=0.004) and a history of hypertension (p=0.03) were independent predictors of major perioperative complications. In our cohort, a pre-procedure PRU value of 240 was the strongest independent predictor of all and major perioperative thromboembolic and hemorrhagic complications after PED procedures.
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                Author and article information

                Journal
                Stroke Vasc Neurol
                Stroke Vasc Neurol
                svnbmj
                svn
                Stroke and Vascular Neurology
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2059-8696
                September 2018
                21 April 2018
                : 3
                : 3
                : 169-175
                Affiliations
                [1 ] departmentDepartment of Neurosurgery , Johns Hopkins University School of Medicine , Baltimore, Maryland, USA
                [2 ] departmentDepartment of Neurosurgery , University of California, Irvine School of Medicine , Orange, California, USA
                [3 ] departmentDepartment of Neurosurgery , University of California, Los Angeles , Los Angeles, California, USA
                Author notes
                [Correspondence to ] Dr Alexander L Coon; acoon2@ 123456jhmi.edu
                Article
                svn-2018-000150
                10.1136/svn-2018-000150
                6169609
                e47abd2a-a170-47a4-aab7-532744c7c043
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 21 February 2018
                : 24 February 2018
                Categories
                Original Article
                1506
                Custom metadata
                unlocked

                aneurysm,endovascular,flow diversion,pipeline embolization device,abciximab

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