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

共 28 条

[1] Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial [J].

Becske, Tibor ;

Brinjikji, Waleed ;

Potts, Matthew B. ;

Kallmes, David F. ;

Shapiro, Maksim ;

Moran, Christopher J. ;

Levy, Elad I. ;

McDougall, Cameron G. ;

Szikora, Istvan ;

Lanzino, Giuseppe ;

Woo, Henry H. ;

Lopes, Demetrius K. ;

Siddiqui, Adnan H. ;

Albuquerque, Felipe C. ;

Fiorella, David J. ;

Saatci, Isil ;

Cekirge, Saruhan H. ;

Berez, Aaron L. ;

Cher, Daniel J. ;

Berentei, Zsolt ;

Marosfoi, Miklos ;

Nelson, Peter K. .

NEUROSURGERY, 2017, 80 (01) :40-48

[2] Pipeline for Uncoilable or Failed Aneurysms: Results from a Multicenter Clinical Trial [J].

Becske, Tibor ;

Kallmes, David F. ;

Saatci, Isil ;

McDougall, Cameron G. ;

Szikora, Istvn ;

Lanzino, Giuseppe ;

Moran, Christopher J. ;

Woo, Henry H. ;

Lopes, Demetrius K. ;

Berez, Aaron L. ;

Cher, Daniel J. ;

Siddiqui, Adnan H. ;

Levy, Elad I. ;

Albuquerque, Felipe C. ;

Fiorella, David J. ;

Berentei, Zsolt ;

Marosfoi, Miklos ;

Cekirge, Saruhan H. ;

Nelson, Peter K. .

RADIOLOGY, 2013, 267 (03) :858-868

[3] Predictors of cerebral aneurysm persistence and occlusion after flow diversion: a single-institution series of 445 cases with angiographic follow-up [J].

Bender, Matthew T. ;

Colby, Geoffrey P. ;

Lin, Li-Mei ;

Jiang, Bowen ;

Westbroek, Erick M. ;

Xu, Risheng ;

Campos, Jessica K. ;

Huang, Judy ;

Tamargo, Rafael J. ;

Coon, Alexander L. .

JOURNAL OF NEUROSURGERY, 2019, 130 (01) :259-267

[4] Endovascular Treatment of Intracranial Aneurysms With Flow Diverters A Meta-Analysis [J].

Brinjikji, Waleed ;

Murad, Mohammad H. ;

Lanzino, Giuseppe ;

Cloft, Harry J. ;

Kallmes, David F. .

STROKE, 2013, 44 (02) :442-447

[5] A New Aneurysm Occlusion Classification after the Impact of Flow Modification [J].

Cekirge, H. S. ;

Saatci, I. .

AMERICAN JOURNAL OF NEURORADIOLOGY, 2016, 37 (01) :19-24

[6] Matched Comparison of Flow Diversion and Coiling in Small, Noncomplex Intracranial Aneurysms [J].

Chalouhi, Nohra ;

Daou, Badih ;

Barros, Guilherme ;

Starke, Robert M. ;

Chitale, Ameet ;

Ghobrial, George ;

Dalyai, Richard ;

Hasan, David ;

Gonzalez, L. Fernando ;

Tjoumakaris, Stavropoula ;

Rosenwasser, Robert H. ;

Jabbour, Pascal .

NEUROSURGERY, 2017, 81 (01) :92-96

[7] Safety and efficacy of the Pipeline Embolization Device in 100 small intracranial aneurysms [J].

Chalouhi, Nohra ;

Zanaty, Mario ;

Whiting, Alex ;

Yang, Steven ;

Tjoumakaris, Stavropoula ;

Hasan, David ;

Starke, Robert M. ;

Hann, Shannon ;

Hammer, Christine ;

Kung, David ;

Rosenwasser, Robert ;

Jabbour, Pascal .

JOURNAL OF NEUROSURGERY, 2015, 122 (06) :1498-1502

[8] Extending the Indications of Flow Diversion to Small, Unruptured, Saccular Aneurysms of the Anterior Circulation [J].

Chalouhi, Nohra ;

Starke, Robert M. ;

Yang, Steven ;

Bovenzi, Cory D. ;

Tjoumakaris, Stavropoula ;

Hasan, David ;

Gonzalez, L. Fernando ;

Rosenwasser, Robert ;

Jabbour, Pascal .

STROKE, 2014, 45 (01) :54-58

[9] Flow Diversion for Intracranial Aneurysm Treatment: Trials Involving Flow Diverters and Long-Term Outcomes [J].

Chancellor, Bree ;

Raz, Eytan ;

Shapiro, Maksim ;

Tanweer, Omar ;

Nossek, Erez ;

Riina, Howard A. ;

Nelson, Peter Kim .

NEUROSURGERY, 2020, 86 :S36-S45

[10] Long-Term Follow-Up Results following Elective Treatment of Unruptured Intracranial Aneurysms with the Pipeline Embolization Device [J].

Chiu, A. H. Y. ;

Cheung, A. K. ;

Wenderoth, J. D. ;

De Villiers, L. ;

Rice, H. ;

Phatouros, C. C. ;

Singh, T. P. ;

Phillips, T. J. ;

McAuliffe, W. .

AMERICAN JOURNAL OF NEURORADIOLOGY, 2015, 36 (09) :1728-1734

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