Neuroform Atlas Stent for Treatment of Middle Cerebral Artery Aneurysms: 1-Year Outcomes From Neuroform Atlas Stent Pivotal Trial

被引:28
作者
Hanel, Ricardo A. [1 ]
Yoon, Nam [1 ]
Sauvageau, Eric [1 ]
Aghaebrahim, Amin [1 ]
Lin, Eugene [2 ]
Jadhav, Ashutosh P. [3 ]
Jovin, Tudor G. [4 ]
Khaldi, Ahmad [5 ]
Gupta, Rishi G. [5 ]
Johnson, Andrew [6 ]
Frei, Donald [7 ]
Loy, David [8 ]
Malek, Adel [9 ]
Toth, Gabor [10 ]
Siddiqui, Adnan [11 ]
Reavey-Cantwell, John [12 ]
Thomas, Ajith [13 ]
Hetts, Steven W. [14 ]
Jankowitz, Brian T. [15 ]
Zaidat, Osama O. [2 ]
机构
[1] Lyerly Neurosurg, Jacksonville, FL USA
[2] Bon Secours Mercy Hlth St Vincent Med Ctr, Neurosci Dept, Toledo, OH USA
[3] Univ Pittsburgh, Med Ctr, Dept Neurol, Stroke Inst, Pittsburgh, PA USA
[4] Cooper Univ Hosp, Neurol Inst, Camden, NJ USA
[5] Neurosurg WellStar Hlth Syst, WellStar Med Grp, Marietta, GA USA
[6] Northshore Univ Hlth Syst, Dept Neurosurg, Chicago, IL USA
[7] Swedish Med Ctr, Radiol Imaging Associates, Englewood, CO USA
[8] Univ Virginia, Dept Radiol & Med Imaging, Charlottesville, VA USA
[9] Tufts Med Ctr, Dept Neurosurg, Boston, MA 02111 USA
[10] Cleveland Clin, Cerebrovasc Ctr, Cleveland, OH 44106 USA
[11] SUNY Univ Buffalo, Buffalo, NY USA
[12] Virginia Commonwealth Univ, Med Ctr, Richmond, VA USA
[13] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
[14] Univ Calif San Francisco, Intervent Neuroradiol, San Francisco, CA 94143 USA
[15] Cooper Univ Hosp, Camden, NJ USA
关键词
Aneurysms; Angiography; Endovascular treatment; Embolization; Middle cerebral artery; Stent; RUPTURED INTRACRANIAL ANEURYSMS; ENDOVASCULAR COILING; METAANALYSIS; ISAT;
D O I
10.1093/neuros/nyab090
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
BACKGROUND: Heterogeneous effect of endovascular aneurysm therapy has been observed across different anatomic locations. There is a paucity of data for stent-assisted coiling of middle cerebral artery (MCA) aneurysms. OBJECTIVE: To present the results of the MCA aneurysm group from the Neuroform Atlas (Stryker Neurovascular) investigational device exemption (IDE) trial. METHODS: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of wide-neck aneurysms (neck >= 4 mm or dome-to-neck ratio < 2) in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. Follow-up was obtained immediately postprocedure and 2, 6, and 12 mo postoperatively. We herein describe safety and efficacy outcomes, and functional independence of the subjects with aneurysms from all segments of MCA. RESULTS: A total of 35 patients were included (27 MCA bifurcation, 5 M1, 3 M2). The mean aneurysm size was 6.0 +/- 1.8 mm, and the mean neck was 4.4 +/- 12 mm. Technical procedural success was achieved in all patients. A total of 26 patients had follow-up digital subtraction angiography available at 12 mo, with 80.8% (21/26) having complete aneurysm occlusion. Twelve-month safety data were collected for 91.4% (32/35), 8.5% (3/35) had primary safety endpoint, all 3 major ischemic strokes. Mortality occurred in 2 patients beyond 30 d unrelated to procedure (1 gallbladder cancer and 1 fentanyl intoxication). At 1 yr, modified Rankin Score was 0 to 2 in 84.4% (27/32), 3 in 9.4%, and 3 patients were missing. Approximately 5.7% (2/35) of patients were retreated at 12 mo. CONCLUSION: Stent-assisted coiling with the Neuroform Atlas Stent is a viable alternative to clipping for selected MCA aneurysms. Complete aneurysm occlusion rates have improved compared to historical data. Proper case selection can lead to acceptable endovascular results.
引用
收藏
页码:102 / 108
页数:7
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