O-024 the ace study multicenter experience: safety and effectiveness of using large volume penumbra pc400 coil and 0.025” microcatheter in treating anterior communicating artery aneurysms

Abstract

Purpose The utility of the Penumbra Coil 400 (PC400) System in embolization of aneurysms in smaller caliber arteries has yet to be characterized. The goal was to assess the safety and effectiveness of the PC400 with the use of the 0.025” ID PXSLIM microcatheter in the anterior communicating artery. Reported herein are the initial clinical experience and long-term results in a subset of the Aneurysm Coiling Efficiency (ACE) registry. Results from conventional coils published in peer-reviewed journals are used as historical controls. Methods Our treatment cohort consisted of 46 aneurysms ranging between 3.5–17 mm in diameter. Patients were treated between March 2012–January 2015 at 16 high volume centers. Six-month follow-up data were assessed. Data on angiographic results and procedural complications were collected prospectively and analyzed. Results The mean aneurysm size was 6.3 ± 2.8 mm, 22 ruptured and 24 unruptured. All aneurysms were treated entirely with PC400 coils, with a mean of 5.0 ± 3.5 coils placed. Sixty-two percent of the cases achieved an initial Raymond Scale of 1, and 28.9% achieved a Raymond scale of 2 post-procedure. Mean packing density was 38.8%±18.5 at immediate post-procedure. The rate of retreatment at 6 months was 0%, while the overall rate of morbidity/mortality caused by stroke at 30 days was 6.5%. Comparison with a recently published meta-analysis of conventional coils showed similar or superior outcomes with lower procedural complication rates, most notably lower overall vasospasm rate of 4% vs. 13%, permanent procedure-related morbidity rate of 2% vs. 6%, lower retreatment rate of 0% vs. 7% and higher long-term (6 months or more) complete and near-complete occlusion of 96% vs. 85% with PC400 coils (Tables 1, 2). Conclusion Initial multicenter experience demonstrates that embolization using the PC400 System and 0.025” ID PXSLIM microcatheter in the small caliber vessel AcomA aneurysms leads to safe and effective short- and long-term outcomes. Disclosures B. Baxter: None. O. Zaidat: None. E. Deshaies: None. M. Kabbani: None. J. Lynch: None. D. Lopes: 4; C; Penumbra, Inc.. A. Turk: None. C. Roth: None. A. Chowdhary: None. G. Rappard: None. M. Knauth: None. P. Schramm: None. F. Hui: None. M. Ollenschleger: None. J. Jacobson: None. A. Shhadeh: None. R. Pergolizzi: None. S. Prothmann: None. A. Khaldi: None. E. Luong: 5; C; Penumbra, Inc. S. Hak: 5; C; Penumbra, Inc. S. Kuo: 5; C; Penumbra, Inc. N. Nguyen: 5; C; Penumbra, Inc. D. Ueda: 5; C; Penumbra, Inc. S. Sit: 4; C; Penumbra, Inc. 5; C; Penumbra, Inc.