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SNIS 20th annual meeting electronic poster abstracts
E-065 Interim safety and occlusion outcomes of endovascular treatment of large intracranial aneurysms in the sterling registry
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  1. O Zaidat1,
  2. Y Ashouri1,
  3. R Starke2,
  4. A Puri3,
  5. B Jankowitz4,
  6. A Yoo5,
  7. G Marnat6,
  8. Z Kulcsar7,
  9. K Sugiu8,
  10. S Jahshan9,
  11. P Machi10,
  12. G Pero11,
  13. S Castro12,
  14. J Howington13,
  15. C Schirmer14,
  16. C Kilburg15,
  17. C Chivot16,
  18. F Al-Mufti17,
  19. V Da Ros18,
  20. B Gory19,
  21. T Yao20,
  22. A Polifka21,
  23. O Francois22,
  24. A Evans23,
  25. J Machaj24,
  26. R De Leacy25
  1. 1Department of Neuroscience, Mercy Health St. Vincent Medical Center, Toledo, OH, USA
  2. 2Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, FL, USA
  3. 3Department of Radiology, University of Massachusetts, Worcester, MA, USA
  4. 4University of Pennsylvania, Philadelphia, PA, USA
  5. 5Department of Neurology, Texas Stroke Institute, Plano, TX, USA
  6. 6Department of Neuroradiology, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
  7. 7Department of Neuroradiology, University Hospital of Zurich, Zurich, Switzerland
  8. 8Okayama University Hospital, Okayama, Japan
  9. 9Department of Interventional Neuroradiology, Galilee Medical Center, Galilee, Israel
  10. 10Hopitaux Universitaires de Geneve, Geneve, Switzerland
  11. 11Department of Neuroradiology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
  12. 12Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia, Portugal
  13. 13Department of Neurosurgery, Memorial Health University Medical Center, Savannah, GA, USA
  14. 14Department of Neurosurgery, Geisinger Medical Center, Danville, PA, USA
  15. 15University of Utah, Salt Lake City, UT, USA
  16. 16Department of Radiology, Amiens University Hospital, Amiens, France
  17. 17Westchester Medical Center, Valhalla, NY, USA
  18. 18Policlinico Tor Vergata, Rome, Italy
  19. 19CHU Nancy, Nancy, France
  20. 20Norton Neuroscience Institute, Norton Healthcare, Louisville, KY, USA
  21. 21Department of Neurosurgery, University of Florida, Gainesville, FL, USA
  22. 22Az Groeninge, Kortrijk, Belgium
  23. 23Department of Interventional Neuroradiology, University of Virginia School of Medicine, Charlottesville, VA, USA
  24. 24Greenville Health System, Greenville, SC, USA
  25. 25Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA

Abstract

Introduction Endovascular treatment for intracranial aneurysms has been evolving. Since the results of the ISAT and BRAT trial were published, multiple advancement of endovascular devices and procedures have occurred. The aim of this study is to share interim results for large aneurysms (> 10 mm) treated within the STERLING registry.

Methods The STERLING registry (NCT03642639) is a Prospective, Multi-center, Single Arm Study to Obtain ’Real World’ Clinical Data and Characterize the Acute and Long-term Performance of the MICRUSFRAME and GALAXY Coils including the PulseRider Aneurysm Neck Reconstruction Device for the Endovascular Treatment of Intracranial Aneurysms (Cerenovus, Irvine, CA). The primary endpoint was adequate occlusion rate without retreatment at 12 months measured by Independent Core Lab. Secondary outcome measures were packing density, good functional outcome (mRS 0-2), as well as device-related serious events and retreatment rate within 1-year.

Results Among the 450 subjects in the STERLING interim analysis, 44 patients had large aneurysms. Mean (Standard Deviation [SD]) age was 60.6(11.35), and most patients were females (77.3%). Hypertension was prevalent in (59.1%) of the cohort, while half of the cohort were smokers and (13.6%) had a history of SAH. Baseline mRS score was 0 and 1 in 61.4% and 27.3%, respectively. Mean (SD) aneurysm height and width were 11.06 mm (3.78) and 10.67 mm (3.44), respectively. Most aneurysms were in the anterior circulation (84.1%) and (61.9%) were sidewall. Median (IQR) dome to neck ratio was 2.0 (1.70-2.65) and 35 (79.5%) aneurysms had a wide neck. Saccular aneurysm was the most common morphology (86.4%) and (27.3%) were ruptured aneurysms. Most common method of treatment was primary coiling (n=16) followed by coiling+flow diversion (n=12). Mean (SD) packing density was 16.8(8.88). Adequate occlusion on 1-year follow-up was achieved in 86.7% (13/15) and four patients required retreatment within 1-year, resulting in 66.7% (10/15) patients with adequate occlusion without retreatment. There was no occurrence of intraprocedural rupture nor symptomatic intraprocedural thromboembolic events. Clinical outcome was available for unruptured aneurysms for 1 year follow-up and good functional outcome was achieved in 85.7% (12/14). Device related significant adverse events occurred in 1 patient only (2.3%).

Conclusion Early results from the STERLING registry for large aneurysms are promising. Adequate occlusion per Independent Core Lab was achieved in 86.7% and retreatment rates were relatively low over 1-year follow-up. A good functional outcome was achieved in 85.7% of patients

Disclosures O. Zaidat: 1; C; Stryker, Medtronic, Cerenovus, Penumbra, and Genentech. 2; C; Stryker, Medtronic, Cerenovus, Penumbra, and Neuravi. 4; C; ownership interest in Galaxy Therapeutics LLC;. 6; C; honoraria from Codman,Stryker,Penumbra, Medtronic. serves on the endovascular committee as co-chair for NIH StrokeNet Consortium; has served as an expert witness; had a patent for Ischemic stroke.. Y. Ashouri: None. R. Starke: 2; C; Medtronic Neurovascular, Penumbra, Cerenovus, Abbott.,. A. Puri: 1; C; Stryker Neurovascular, Medtronic, Cerenovus. He has received NIH grants. 2; C; tryker Neurovascular, Medtronic, Cerenovus, Microvention, QApel, Perfuze Medical, Arsenal Medical, Merit Medical Agile, Corindus, Imperative Care. 4; C; InNeuroCo Inc, Galaxy therapeutics, Agile Medical, Perfuze medical and Neurotechnology Investors. B. Jankowitz: None. A. Yoo: 1; C; Medtronic, Cerenovus, Penumbra, Stryker, and Genentech. 2; C; Cerenovus, Penumbra, and Zoll. 6; C; Equity interest in Insera Therapeutics. G. Marnat: None. Z. Kulcsar: None. K. Sugiu: None. S. Jahshan: None. P. Machi: None. G. Pero: None. S. Castro: None. J. Howington,: None. C. Schirmer: None. C. Kilburg: None. C. Chivot: None. F. Al-Mufti: None. V. Da Ros: None. B. Gory: None. T. Yao: 2; C; Medtronic. A. Polifka: None. O. Francois,: None. A. Evans: None. J. Machaj: None. R. De Leacy: 2; C; Imperative Care, Cerenovus, Siemens Healthineers, Penumbra. 6; C; equity in Synchron, Endostream, Q’Apel Medical, Spartan Micro, Vastrax.

https://doi.org/10.1136/jnis-2023-SNIS.165

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