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:53
|
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
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.
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页码:248 / +
页数:8
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