Endovascular embolization of 150 basilar tip aneurysms with Guglielmi detachable coils: results of the Food and Drug Administration multicenter clinical trial

Joseph M. Eskridge Departments of Neurological Surgery and Radiology, University of Washington, Seattle, Washington

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 M.D.
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Joon K. Song Departments of Neurological Surgery and Radiology, University of Washington, Seattle, Washington

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 M.D.
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and The Participants Departments of Neurological Surgery and Radiology, University of Washington, Seattle, Washington

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Object. To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device.

Methods. The most common presentation in this cohort of patients was headache (53%). All patients were entered into the trial after neurosurgical assessment excluded them as candidates for surgical clipping of their aneurysms. Greater than 90% coil packing was achieved in 75% of the patients. For those patients in whom follow-up information was available, the mean angiographic and clinical evaluation follow-up time for 61 patients with ruptured aneurysms was 13.7 months (range 0–43 months) and that for the 49 patients with unruptured aneurysms was 9.8 (range 0–40 months). Conservative mortality rates included up to 23% for the ruptured aneurysm group and up to 12% for the unruptured aneurysm group; the rebleeding rate for treated ruptured aneurysms was up to 3.3% and the bleeding rate for unruptured aneurysms up to 4.1%. Permanent deficits due to stroke in patients with ruptured or unruptured aneurysms occurred in up to 5% and 9%, respectively. Vasospasm occurred in 8% of the patients; it was associated with two deaths. Periprocedural mortality was 2.7% (four patients with ruptured aneurysms).

Conclusions. Detachable platinum coil embolization is a promising treatment for ruptured basilar tip aneurysms that are not surgically clippable; in selected patients it offers lower incidences of morbidity and mortality compared with conservative medical management. The role of this procedure in unruptured basilar tip aneurysms is unclear with less supportive results. More long-term follow-up evaluation is necessary and results are expected to improve.

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  • 1.

    Anonymous: Guglielmi Detachable Coil (GDC) U.S. Clinical Study Summary. Fremont, CA: Target Therapeutics, 1995 Anonymous: Guglielmi Detachable Coil (GDC) U.S. Clinical Study Summary. Fremont, CA: Target Therapeutics, 1995

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2.

    Drake CG: Aneurysm surgery: past, present, and future. Int Anesthesiol Clin 20:19, 1982 Drake CG: Aneurysm surgery: past, present, and future. Int Anesthesiol Clin 20:1–9, 1982

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3.

    Drake CG, , Friedman AH, & Peerless SJ: Failed aneurysm surgery. Reoperation in 115 cases. J Neurosurg 61:848856, 1984 Drake CG, Friedman AH, Peerless SJ: Failed aneurysm surgery. Reoperation in 115 cases. J Neurosurg 61:848–856, 1984

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4.

    Fernandez Zubillaga A, , Guglielmi G, & Viñuela F, et al: Endovascular occlusion of intracranial aneurysms with electrically detachable coils: correlation of aneurysm neck size and treatment results. AJNR 15:815820, 1994 Fernandez Zubillaga A, Guglielmi G, Viñuela F, et al: Endovascular occlusion of intracranial aneurysms with electrically detachable coils: correlation of aneurysm neck size and treatment results. AJNR 15:815–820, 1994

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5.

    Graves VB, , Strother CM, & Duff TA, et al: Early treatment of ruptured aneurysms with Guglielmi detachable coils: effect on subsequent bleeding. Neurosurgery 37:640648, 1995 Graves VB, Strother CM, Duff TA, et al: Early treatment of ruptured aneurysms with Guglielmi detachable coils: effect on subsequent bleeding. Neurosurgery 37:640–648, 1995

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6.

    Guglielmi G, , Viñuela F, & Dion J, et al: Electrothrombosis of saccular aneurysms via endovascular approach. Part 2: Preliminary clinical experience. J Neurosurg 75:814, 1991 Guglielmi G, Viñuela F, Dion J, et al: Electrothrombosis of saccular aneurysms via endovascular approach. Part 2: Preliminary clinical experience. J Neurosurg 75:8–14, 1991

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7.

    Guglielmi G, , Viñuela F, & Duckwiler G, et al: Endovascular treatment of posterior circulation aneurysms by electrothrombosis using electrically detachable coils. J Neurosurg 77:515524, 1992 Guglielmi G, Viñuela F, Duckwiler G, et al: Endovascular treatment of posterior circulation aneurysms by electrothrombosis using electrically detachable coils. J Neurosurg 77:515–524, 1992

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8.

    Guglielmi G, , Viñuela F, & Sepetka I, et al: Electrothrombosis of saccular aneurysms via endovascular approach. Part 1: Electrochemical basis, technique, and experimental results. J Neurosurg 75:17, 1991 Guglielmi G, Viñuela F, Sepetka I, et al: Electrothrombosis of saccular aneurysms via endovascular approach. Part 1: Electrochemical basis, technique, and experimental results. J Neurosurg 75:1–7, 1991

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9.

    Heros RC: Comment on Graves VB, , Strother CM, , Duff TA, et al: Early treatment of ruptured aneurysms with Guglielmi detachable coils: effect on subsequent bleeding. Neurosurgery 37:647, 1995 Heros RC: Comment on Graves VB, Strother CM, Duff TA, et al: Early treatment of ruptured aneurysms with Guglielmi detachable coils: effect on subsequent bleeding. Neurosurgery 37:647, 1995

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10.

    Heros RC: Intracranial aneurysms. A review. Minn Med 73:2732, 1990 Heros RC: Intracranial aneurysms. A review. Minn Med 73:27–32, 1990

  • 11.

    Hunt WE, & Hess RM: Surgical risk as related to time of intervention in the repair of intracranial aneurysms. J Neurosurg 28:1420, 1968 Hunt WE, Hess RM: Surgical risk as related to time of intervention in the repair of intracranial aneurysms. J Neurosurg 28:14–20, 1968

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 12.

    Jennett B, & Bond M: Assessment of outcome after severe brain damage. A practical scale. Lancet 1:480484, 1975 Jennett B, Bond M: Assessment of outcome after severe brain damage. A practical scale. Lancet 1:480–484, 1975

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13.

    Jennett B, , Snoek J, & Bond MR, et al: Disability after severe head injury: observations on the use of the Glasgow Outcome Scale. J Neurol Neurosurg Psychiatry 44:285293, 1981 Jennett B, Snoek J, Bond MR, et al: Disability after severe head injury: observations on the use of the Glasgow Outcome Scale. J Neurol Neurosurg Psychiatry 44:285–293, 1981

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 14.

    Juvela S, , Porras M, & Heiskanen O: Natural history of unruptured intracranial aneurysms: a long-term follow-up study. J Neurosurg 79:174182, 1993 Juvela S, Porras M, Heiskanen O: Natural history of unruptured intracranial aneurysms: a long-term follow-up study. J Neurosurg 79:174–182, 1993

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15.

    Kassell NF, & Torner C: The International Cooperative Study on Timing of Aneurysm Surgery—an update. Stroke 15:566570, 1984 Kassell NF, Torner C: The International Cooperative Study on Timing of Aneurysm Surgery—an update. Stroke 15:566–570, 1984

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16.

    Kassell NF, , Torner JC, & Haley EC Jr, et al: The International Cooperative Study on Timing of Aneurysm Surgery. Part 1: Overall management results. J Neurosurg 73:1836, 1990 Kassell NF, Torner JC, Haley EC Jr, et al: The International Cooperative Study on Timing of Aneurysm Surgery. Part 1: Overall management results. J Neurosurg 73:18–36, 1990

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17.

    Malisch TW, , Guglielmi G, & Viñuela F, et al: Intracranial aneurysms treated with Guglielmi detachable coil: midterm clinical results in a consecutive series of 100 patients. J Neurosurg 87:176183, 1997 Malisch TW, Guglielmi G, Viñuela F, et al: Intracranial aneurysms treated with Guglielmi detachable coil: midterm clinical results in a consecutive series of 100 patients. J Neurosurg 87:176–183, 1997

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18.

    McDougall CG, , Halbach VV, & Dowd CF, et al: Endovascular treatment of basilar tip aneurysms using electrolytically detachable coils. J Neurosurg 84:393399, 1996 McDougall CG, Halbach VV, Dowd CF, et al: Endovascular treatment of basilar tip aneurysms using electrolytically detachable coils. J Neurosurg 84:393–399, 1996

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19.

    McKissock W, , Richardson A, & Walsh L: Anterior communicating aneurysms: a trial of conservative and surgical treatment. Lancet 1:874876, 1965 McKissock W, Richardson A, Walsh L: Anterior communicating aneurysms: a trial of conservative and surgical treatment. Lancet 1:874–876, 1965

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20.

    Moret J, , Cognard C, & Weill A, et al: [Reconstruction technique in the treatment of wide-neck intracranial aneurysms. Long-term angiographic and clinical results. Apropos of 56 cases.] J Neuroradiol 24:3044, 1997 (Fr) Moret J, Cognard C, Weill A, et al: [Reconstruction technique in the treatment of wide-neck intracranial aneurysms. Long-term angiographic and clinical results. Apropos of 56 cases.] J Neuroradiol 24:30–44, 1997 (Fr)

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21.

    Nichols DA, , Brown RD Jr, & Thielen KR, et al: Endovascular treatment of ruptured posterior circulation aneurysms using electrolytically detachable coils. J Neurosurg 87:374380, 1997 Nichols DA, Brown RD Jr, Thielen KR, et al: Endovascular treatment of ruptured posterior circulation aneurysms using electrolytically detachable coils. J Neurosurg 87:374–380, 1997

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22.

    Nishioka H, , Torner JC, & Graf CJ, et al: Cooperative study of intracranial aneurysms and subarachnoid hemorrhage: a long-term prognostic study. II. Ruptured intracranial aneurysms managed conservatively. Arch Neurol 41:11421146, 1984 Nishioka H, Torner JC, Graf CJ, et al: Cooperative study of intracranial aneurysms and subarachnoid hemorrhage: a long-term prognostic study. II. Ruptured intracranial aneurysms managed conservatively. Arch Neurol 41:1142–1146, 1984

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23.

    Nishioka H, , Torner JC, & Graf CJ, et al: Cooperative study of intracranial aneurysms and subarachnoid hemorrhage: a long-term prognostic study. III. Subarachnoid hemorrhage of undetermined etiology. Arch Neurol 41:11471151, 1984 Nishioka H, Torner JC, Graf CJ, et al: Cooperative study of intracranial aneurysms and subarachnoid hemorrhage: a long-term prognostic study. III. Subarachnoid hemorrhage of undetermined etiology. Arch Neurol 41:1147–1151, 1984

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24.

    Origitano TC, , Wascher TM, & Reichman OH: Sustained increased cerebrospinal blood flow with prophylactic hypertensive hypervolemic hemodilution (“triple-H” therapy) after subarachnoid hemorrhage. Neurosurgery 27:729740, 1990 Origitano TC, Wascher TM, Reichman OH: Sustained increased cerebrospinal blood flow with prophylactic hypertensive hypervolemic hemodilution (“triple-H” therapy) after subarachnoid hemorrhage. Neurosurgery 27:729–740, 1990

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 25.

    Pakarinen S: Incidence, aetiology, and prognosis of primary subarachnoid haemorrhage. A study based on 589 cases diagnosed in a defined urban population during a defined period. Acta Neurol Scand 43 (Suppl 29):1128, 1967 Pakarinen S: Incidence, aetiology, and prognosis of primary subarachnoid haemorrhage. A study based on 589 cases diagnosed in a defined urban population during a defined period. Acta Neurol Scand 43 (Suppl 29):1–128, 1967

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 26.

    Richling B, , Gruber A, & Bavinszki G, et al: GDC system embolization for brain aneurysms—location and follow-up. Acta Neurochir 134:177183, 1995 Richling B, Gruber A, Bavinszki G, et al: GDC system embolization for brain aneurysms—location and follow-up. Acta Neurochir 134:177–183, 1995

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 27.

    Sundt TM Jr, , Kobayashi S, & Fode NC, et al: Results and complications of surgical management of 809 intracranial aneurysms in 722 cases. Related and unrelated to grade of patient, type of aneurysm, and timing of surgery. J Neurosurg 56:753765, 1982 Sundt TM Jr, Kobayashi S, Fode NC, et al: Results and complications of surgical management of 809 intracranial aneurysms in 722 cases. Related and unrelated to grade of patient, type of aneurysm, and timing of surgery. J Neurosurg 56:753–765, 1982

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 28.

    Viñuela F, , Duckwiler G, & Mawad M: Guglielmi detachable coil embolization of acute intracranial aneurysm: perioperative anatomical and clinical outcome in 403 patients. J Neurosurg 86:475482, 1997 Viñuela F, Duckwiler G, Mawad M: Guglielmi detachable coil embolization of acute intracranial aneurysm: perioperative anatomical and clinical outcome in 403 patients. J Neurosurg 86:475–482, 1997

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 29.

    Weir B: Aneurysms Affecting the Nervous System. Baltimore: Williams & Wilkins, 1987, pp 1954 Weir B: Aneurysms Affecting the Nervous System. Baltimore: Williams & Wilkins, 1987, pp 19–54

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 30.

    Wiebers DO, , Torner JC, & Meissner I: Impact of unruptured intracranial aneurysms on public health in the United States. Stroke 23:14161419, 1992 Wiebers DO, Torner JC, Meissner I: Impact of unruptured intracranial aneurysms on public health in the United States. Stroke 23:1416–1419, 1992

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 31.

    Winn HR, , Richardson AE, & Jane JA: The long-term prognosis in untreated cerebral aneurysms: I. The incidence of late hemorrhage in cerebral aneurysm: a 10-year evaluation of 364 patients. Ann Neurol 1:358370, 1977 Winn HR, Richardson AE, Jane JA: The long-term prognosis in untreated cerebral aneurysms: I. The incidence of late hemorrhage in cerebral aneurysm: a 10-year evaluation of 364 patients. Ann Neurol 1:358–370, 1977

    • PubMed
    • Search Google Scholar
    • Export Citation

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