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O-004 Final Results of the US Humanitarian Device Exemption Study of the Low-profile Visualised Intraluminal Support (LVIS) Device
  1. D Fiorella1,
  2. C Derdeyn2,
  3. A Turk3,
  4. A Boulos4,
  5. O Diaz5,
  6. G Pride6,
  7. P Jabbour7,
  8. H Woo1
  1. 1Neurosurgery, Cerebrovascular Center, Stony Brook University Medical Center, Stony Brook, NY, USA
  2. 2Radiology, Washington University School of Medicine, St Louis, MO, USA
  3. 3Radiology and Neurosurgery, Cerebrovascular Center, Medical University of South Carolina, Charleston, SC, USA
  4. 4Neurosurgery, Cerebrovascular Center, Albany Medical Center, Albany, NY, USA
  5. 5Neuroradiology, Cerebrovascular Center, Methodist Hospital, Houston, TX, USA
  6. 6Neuroradiology and Neurosurgery, Cerebrovascular Center, University of Texas Southwestern, Dallas, TX, USA
  7. 7Neurosurgery, Cerebrovascular Center, Thomas Jefferson Medical Center, Philadelphia, PA, USA

Abstract

Introduction The Low-profile Visualised Intraluminal Support (LVIS) Device is a novel, braided, intracranial microstent designed for stent-assisted coiling. We present the results of a single-arm, prospective, multicenter trial of the LVIS for the treatment of wide-necked intracranial aneurysms

Methods 31 patients with unruptured, wide-necked (neck >4 mm or dome : neck ratio <2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at 6 US centers (IDE G110014). Clinical follow was conducted at 30d and 6 months. Angiographic follow up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. Probable benefit was defined as >90% angiographic occlusion at 6 months. An independent core lab adjudicated angiographic results. An independent clinical events committee adjudicated clinical endpoints.

Results Average aneurysm size was 7.2 mm (STD 3.8) and average neck width was 4.6 mm (STD 3.1). 68% of patients had a dome: neck ratio >2. LVIS placement was technically successful in 29 of 31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months when compared to baseline. 26 of 28 (92.9%) treated aneurysms with 6 month angiographic follow-up demonstrated >90% angiographic occlusion. Of these, 21 (75%) were completely occluded at follow up.

Conclusions The LVIS device facilitated the coil-embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile and very high rates of complete and near complete occlusion at follow up.

Disclosures D. Fiorella: 1; C; Microvention/Terumo, Sequent Medical, NIH, Siemens Medical Imaging. 2; C; JNJ/Codman, ev3/Covidien. 4; C; Vascular Simulations, CVSL. C. Derdeyn: 1; C; Terumo/Microvention. A. Turk: None. A. Boulos: None. O. Diaz: None. G. Pride: None. P. Jabbour: None. H. Woo: None.

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