Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

被引：67

作者：

Hanel, Ricardo A. ^{[1
]}

Cortez, Gustavo M. ^{[1
]}

Lopes, Demetrius Klee ^{[2
]}

Nelson, Peter Kim ^{[3
]}

Siddiqui, Adnan H. ^{[4
]}

Jabbour, Pascal ^{[5
]}

Pereira, Vitor Mendes ^{[6
,7
]}

Istvan, Istvan Szikora ^{[8
]}

Zaidat, Osama O. ^{[9
]}

Bettegowda, Chetan ^{[10
]}

Colby, Geoffrey P. ^{[11
]}

Mokin, Maxim ^{[12
]}

Schirmer, Clemens M. ^{[13
]}

Hellinger, Frank R. ^{[14
]}

Given, Curtis ^{[15
]}

Krings, Timo ^{[16
]}

Taussky, Philipp ^{[17
]}

Toth, Gabor ^{[18
]}

Fraser, Justin F. ^{[19
]}

Chen, Michael ^{[20
]}

Priest, Ryan ^{[21
]}

Kan, Peter ^{[22
]}

Fiorella, David ^{[23
]}

Frei, Donald ^{[24
]}

Aagaard-Kienitz, Beverly ^{[25
]}

Diaz, Orlando ^{[26
]}

Malek, Adel M. ^{[27
]}

Cawley, C. Michael ^{[28
]}

Puri, Ajit S. ^{[29
]}

Kallmes, David F. ^{[30
]}

机构：

[1] Lyerly Neurosurg, Baptist Neurol Inst, 800 Prudential Dr,Weaver Tower B,11th Floor, Jacksonville, FL 32207 USA

[2] Advocate Aurora Hlth, Brain & Spine Inst, Park Ridge, IL USA

[3] NYU Langone Med Ctr, Intervent Radiol, New York, NY USA

[4] Univ Buffalo, Dept Neurosurg, Jacobs Sch Med & Biomed Sci, Buffalo, NY USA

[5] Thomas Jefferson Univ Hosp, Dept Neurosurg, Philadelphia, PA 19107 USA

[6] Toronto Western Hosp, Div Neuroradiol, Dept Med Imaging, Toronto, ON, Canada

[7] Toronto Western Hosp, Dept Surg, Div Neurosurg, Toronto, ON, Canada

[8] Natl Inst Neurosci, Dept Neuroradiol, Budapest, Hungary

[9] Mercy Hlth St Vincent Med Ctr, Neurosci Inst, Toledo, OH USA

[10] Johns Hopkins Univ, Sch Med, Dept Neurosurg, Baltimore, MD 21205 USA

[11] Univ Calif Los Angeles, Dept Neurosurg, Los Angeles, CA USA

[12] Univ S Florida, Dept Neurosurg, Coll Med, Tampa, FL USA

[13] Geisinger Hlth Syst, Dept Neurosurg, Danville, PA USA

[14] Florida Hosp, Dept Radiol, Neurosci Inst, Winter Pk, FL USA

[15] Baptist Hlth Lexington, Dept Radiol, Lexington, KY USA

[16] Toronto Western Hosp, Dept Med Imaging, Toronto, ON, Canada

[17] Univ Utah Hlth, Dept Neurosurg, Salt Lake City, UT USA

[18] Cleveland Clin, Cerebrovasc Ctr, Cleveland, OH 44106 USA

[19] Univ Kentucky, Dept Neurol Surg, Lexington, KY USA

[20] Rush Univ, Dept Neurol Surg, Med Ctr, Chicago, IL USA

[21] Oregon Hlth & Sci Univ, Dotter Intervent Inst, Charles T Dotter Dept Intervent Radiol, Portland, OR 97201 USA

[22] Baylor Coll Med, Dept Neurosurg, Houston, TX 77030 USA

[23] SUNY Stony Brook, Cerebrovasc Ctr, Dept Neurosurg, Stony Brook, NY 11794 USA

[24] Swedish Med Ctr, Dept Neuroradiol, Englewood, CO 80110 USA

[25] Univ Wisconsin, Sch Med & Publ Hlth, Dept Neurol Surg, Madison, WI USA

[26] Houston Methodist Res Inst, Cerebrovasc Ctr, Houston, TX USA

[27] Tufts Med Ctr, Dept Neurosurg, Boston, MA 02111 USA

[28] Emory Univ, Sch Med, Dept Neurointervent Radiol & Neurosurg, Atlanta, GA USA

[29] Univ Massachusetts, Med Sch, Dept Radiol, Worcester, MA 01605 USA

[30] Mayo Clin, Dept Radiol, Rochester, MN USA

来源：

JOURNAL OF NEUROINTERVENTIONAL SURGERY | 2023年 / 15卷 / 03期

关键词：

ENDOVASCULAR TREATMENT; ARTERY ANEURYSMS; NATURAL-HISTORY; DIVERSION; COILING;

D O I：

10.1136/neurintsurg-2021-018501

中图分类号：

R445 [影像诊断学];

学科分类号：

100207 ;

摘要：

Background The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. Methods PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms <= 12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. Results As per the protocol of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. Conclusions The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.

引用

页码：248 / +

页数：8

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