Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU)

Atasoy, Dilara; Kandasamy, Naga; Hart, Jonathan; Lynch, Jeremy; Yang, Shih-Hung; Walsh, Daniel; Tolias, Christos M.; Booth, Thomas C.

doi:10.3174/ajnr.a6314

Cited by 17 publications

(11 citation statements)

References 40 publications

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“… 23 A more recent study in 41 patients with 44 unruptured cerebral aneurysms reported no thromboembolic or hemorrhagic events during procedures, one periprocedural thromboembolic event (2.4%) in a patient who also had atrial fibrillation, and no thromboembolic events during follow-up. 29 In the present study, there were three thromboembolic events during follow-up, resulting in an event rate of 1.5%, consistent with previous reports and much lower than thromboembolic event rates of up to 6.5% reported for previous-generation PEDs. 15 30 Taken together, these findings support low thrombogenicity and improved safety of the PED-Shield relative to its predecessors.…”

Section: Discussionsupporting

confidence: 92%

Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

Rice

Galdámez

Holtmannspötter

et al. 2020

J NeuroIntervent Surg

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BackgroundThe first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.MethodsThe SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.ResultsOf 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.ConclusionsThe findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population.Clinical trial registration-URLhttp://www.clinicaltrials.gov. Unique identifier: NCT02719522.

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Section: Discussionsupporting

confidence: 92%

Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

Rice

Galdámez

Holtmannspötter

et al. 2020

J NeuroIntervent Surg

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“…3 Even third-generation FDs with surface modifications with synthetic biocompatible phosphorylcholine seem to have similar outcomes compared with previous generations of FDs. [5][6][7] Noncompliance with dual antiplatelet therapy and resistance to clopidogrel therapy are also known causes of in-stent thrombosis; however, there is controversy regarding the use of platelet function testing prior to FD implantation and converting known nonresponders to other antiplatelet medications such as ticagrelor or prasugrel. 8 Although certainly attention to patient compliance and identifying clopidogrel nonresponders before FD treatment should reduce the incidence of thrombosis formation, we would still have some patients who may have this complication regardless of clopidogrel responsiveness and compliance with medications.…”

Section: Discussionmentioning

confidence: 99%

Postprocedural Thrombosis following Endovascular Treatment of Intracranial Aneurysm with Flow Diverters or Coiling: A Histologic Study

Larco

Abbasi

Liu

et al. 2021

AJNR Am J Neuroradiol

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Endovascular treatment of aneurysms with flow diverters or coiling is sometimes complicated by intraprocedural or postprocedural thrombosis along or within the devices. Thrombus composition and structure associated with such complications may provide insights into mechanisms of thrombus formation and clinical strategies to remove the thrombus. We present a retrospective histopathologic study of 4 patients who underwent mechanical thrombectomy due to acute occlusion of either implanted flow diverter devices or along coils during the treatment of intracranial aneurysm.ABBREVIATIONS: CitH3 ¼ anti-citrullinated H3; FD ¼ flow diverter; Gp ¼ glycoprotein; RBC ¼ red blood cell; vWF ¼ von Willebrand factor; WBC ¼ white blood cell E ndovascular treatment of intracranial aneurysms is becoming

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“…Complete aneurysm occlusion was obtained in 70.8 % at 6-month and 77.2 % at 12-month. In a non-industry-sponsored study (PEDSU = Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms) with DAPT, the cumulative morbidity and mortality at 1-year were slightly higher (6.8 % and 2.3 %, respectively) [40]. Complete aneurysm occlusion was reported in 69.2 % at 6-month and 82.7 % at 18-month.…”

Section: Ia Coiling: Limits and Additional Techniques (Balloon-assistmentioning

confidence: 98%

Editorial: What is the future of the endovascular treatment of intracranial aneurysms?

Piérot¹

2020

Endovasc. Neurorad.

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Intracranial aneurysms rapture is a common cause of mortality or morbidity worldwide. For this reason, in case of rupture, early treatment of the aneurysm is mandatory. The evaluation of unruptured intracranial aneurysms continue to increased due to the improvements in invasive and non-invasive neuroimaging. Securing of this life-threatening condition, considering all demographical and procedural factors is necessary for improving treatment results and patients outcome. The endovascular treatment has become frontline therapy of cerebral aneurysms treatment during the last 20 years, and without a doubt its recent advances shifted this boundary even further. Nowadays endovascular armamentarium continues to grow rapidly. Neuro-interventional procedures have tremendously improved their efficiency and continue to improve device’s safety. However some types of aneurysms are not really easy to treat with ordinary endovascular technique as it can result in devastating consequence, Firstly, it is not always applicable to complex aneurysms or very large neck aneurysms. Secondly, durability of the of the aneurysm occlusion is not guaranteed in all cases even after usage of the remodeling technique or regular stenting. New devices are introduced to decrease these limits. Two new innovative techniques that are increasingly used for endovacular occlusion of the complex aneurysms are flow diversion and intrasaccular flow disruption. The objective of this review is to provide a comprehensive overview of novel paradigms and latest research of flow diversion and intrasaccular flow disruption devices, its current application, limitation and future prospective. The obvious advantages of these new technologies proved progressive expansion of their utilization to the extent that they will ultimately replace standard coiling in an increasing number of cases going forward. The future of the endovascular treatment of intracranial aneurysms is bright. Fast gro-wing improvement in vascular access, treatment modalities and device delivery continue to increase number of patients with intracranial aneurysms treated with endovascular approach versus surgical clipping.

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Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU)

Cited by 17 publications

References 40 publications

Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

Postprocedural Thrombosis following Endovascular Treatment of Intracranial Aneurysm with Flow Diverters or Coiling: A Histologic Study

Editorial: What is the future of the endovascular treatment of intracranial aneurysms?

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