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      Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study

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          Abstract

          Background and purpose

          To evaluate the safety and effectiveness of the low-profile braided intracranial stents called the Low Profile Visualized Intraluminal Support (LVIS) devices for stent-assisted coil embolization of wide-necked intracranial aneurysms.

          Materials and methods

          This was a prospective, multicenter, observational study of unruptured and ruptured intracranial aneurysms treated with the LVIS devices. Imaging and clinical data were independently analyzed respectively by CoreLab and Clinical Event Committee. Primary endpoints were clinical safety, effectiveness, and angiographic stability of the results at 6 and 18 months.

          Results

          Ten centers participated in the study; 102 patients were included and 90 patients (42.2% men, 57.8% women) were eventually analyzed, among which 27 (30.0%) had multiple aneurysms. Twenty-three (25.6%) were ruptured aneurysms, four of which (4.4%) were treated in the acute phase. One aneurysm was treated per patient; 92 LVIS and LVIS Jr devices were placed overall. The total aneurysm occlusion rate was 91.0% on immediate post-procedure angiograms, which remained unchanged at 6-month follow-up and was 92.4% at 18-month follow-up. One patient (1.1%) underwent retreatment between 6 and 18 months of follow-up. A modified Rankin score of 0 was documented for most cases immediately after the procedure (86.7%) and at 6-month (86.8%) and 18-month (83.3%) follow-up. The overall permanent morbidity rate at 18 months was 5.6% and the overall rate of events with sequelae related to the stent was 2.2%. The 18-month procedure-related mortality rate was 3.3%. No patient was deemed to require retreatment at 18-month follow-up.

          Conclusion

          The LVIS/LVIS Jr endovascular devices are safe and effective in the treatment of ruptured and unruptured intracranial aneurysms, with acceptable complication rates, very high immediate total occlusion rates, and stable angiographic results.

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          Most cited references21

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          International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion.

          Andrew J. Molyneux, Richard Kerr, Ly-Mee Yu … (2005)
          Two types of treatment are being used for patients with ruptured intracranial aneurysms: endovascular detachable-coil treatment or craniotomy and clipping. We undertook a randomised, multicentre trial to compare these treatments in patients who were suitable for either treatment because the relative safety and efficacy of these approaches had not been established. Here we present clinical outcomes 1 year after treatment. 2143 patients with ruptured intracranial aneurysms, who were admitted to 42 neurosurgical centres, mainly in the UK and Europe, took part in the trial. They were randomly assigned to neurosurgical clipping (n=1070) or endovascular coiling (n=1073). The primary outcome was death or dependence at 1 year (defined by a modified Rankin scale of 3-6). Secondary outcomes included rebleeding from the treated aneurysm and risk of seizures. Long-term follow up continues. Analysis was in accordance with the randomised treatment. We report the 1-year outcomes for 1063 of 1073 patients allocated to endovascular treatment, and 1055 of 1070 patients allocated to neurosurgical treatment. 250 (23.5%) of 1063 patients allocated to endovascular treatment were dead or dependent at 1 year, compared with 326 (30.9%) of 1055 patients allocated to neurosurgery, an absolute risk reduction of 7.4% (95% CI 3.6-11.2, p=0.0001). The early survival advantage was maintained for up to 7 years and was significant (log rank p=0.03). The risk of epilepsy was substantially lower in patients allocated to endovascular treatment, but the risk of late rebleeding was higher. In patients with ruptured intracranial aneurysms suitable for both treatments, endovascular coiling is more likely to result in independent survival at 1 year than neurosurgical clipping; the survival benefit continues for at least 7 years. The risk of late rebleeding is low, but is more common after endovascular coiling than after neurosurgical clipping.
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            Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment.

            David O Wiebers, J P Whisnant, J. Huston … (2003)
            The management of unruptured intracranial aneurysms is controversial. Investigators from the International Study of Unruptured Intracranial Aneurysms aimed to assess the natural history of unruptured intracranial aneurysms and to measure the risk associated with their repair. Centres in the USA, Canada, and Europe enrolled patients for prospective assessment of unruptured aneurysms. Investigators recorded the natural history in patients who did not have surgery, and assessed morbidity and mortality associated with repair of unruptured aneurysms by either open surgery or endovascular procedures. 4060 patients were assessed-1692 did not have aneurysmal repair, 1917 had open surgery, and 451 had endovascular procedures. 5-year cumulative rupture rates for patients who did not have a history of subarachnoid haemorrhage with aneurysms located in internal carotid artery, anterior communicating or anterior cerebral artery, or middle cerebral artery were 0%, 2. 6%, 14 5%, and 40% for aneurysms less than 7 mm, 7-12 mm, 13-24 mm, and 25 mm or greater, respectively, compared with rates of 2 5%, 14 5%, 18 4%, and 50%, respectively, for the same size categories involving posterior circulation and posterior communicating artery aneurysms. These rates were often equalled or exceeded by the risks associated with surgical or endovascular repair of comparable lesions. Patients' age was a strong predictor of surgical outcome, and the size and location of an aneurysm predict both surgical and endovascular outcomes. Many factors are involved in management of patients with unruptured intracranial aneurysms. Site, size, and group specific risks of the natural history should be compared with site, size, and age-specific risks of repair for each patient.
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              Stent-assisted coiling of intracranial aneurysms: clinical and angiographic results in 216 consecutive aneurysms.

              Raphaël Blanc, Jacques Moret, Eric P. Schmidt … (2009)
              Stent-assisted coiling has expanded the treatment of intracranial aneurysms, but the rates of procedure-related neurological complications and the incidence of angiographic aneurysm recurrence of this novel treatment are not yet well known. We present our experience with stent-assisted coiling with special emphasis on procedure-related neurological complications and incidence of angiographic recurrence. Clinical and angiographic outcomes of 1137 consecutive patients (1325 aneurysms) coiled with and without stent-assisted coiling technique from January 2002 to January 2009 were retrospectively analyzed. There were 1109 aneurysms (83.5%) treated without and 216 (16.5%) treated with stents (15 of 216; 6.9% balloon-expandable versus 201 of 216; 93.1% self-expandable stents). Stents were delivered after coiling in 55.1% (119 of 216) and before coiling in 44.9% (97 of 216) of the cases. Permanent neurological procedure-related complications occurred in 7.4% (16 of 216) of the procedures with stents versus 3.8% (42 of 1109) in the procedures without stents (logistic regression P=0.644; OR: 1.289; 95% CI: 0.439 to 3.779). Procedure-induced mortality occurred in 4.6% (10 of 216) of the procedures with stents versus 1.2% (13 of 1109) in the procedures without stents (logistic regression P=0.006; OR: 0.116; 95% CI: 0.025 to 0.531). A total of 52.7% (114 of 216) of aneurysms treated with stents have been followed so far versus 69.8% (774 of 1109) of aneurysms treated without stents, disclosing angiographic recurrence in 14.9% (17 of 114) versus 33.5% (259 of 774), respectively (Fisher exact test P<0.0001; OR: 0.3485; 95% CI: 0.2038 to 0.5960). Stents were associated with a significant decrease of angiographic recurrences, but they were associated with more lethal complications compared with coiling without stents.
              Article 0 comments Cited 117 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Neurointerv Surg
                Journal ID (iso-abbrev): J Neurointerv Surg
                Journal ID (hwp): neurintsurg
                Journal ID (publisher-id): jnis
                Title: Journal of Neurointerventional Surgery
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Print): 1759-8478
                ISSN (Electronic): 1759-8486
                Publication date (Print): July 2018
                Publication date (Electronic): 24 November 2017
                Volume: 10
                Issue: 7
                Pages: 675-681
                Affiliations
                [1 ] departmentDepartment of Interventional Neuroradiology , CHU-Limoges Dupuytren University Hospital , Limoges, France
                [2 ] departmentDepartment of Interventional Neuroradiology , Foundation Rothschild Hospital , Limoges, France
                [3 ] departmentDepartment of Interventional Neuroradiology , CHU Pellegrin , Paris, France
                [4 ] departmentDepartment of Interventional Neuroradiology , Hôpital Saint-Roch , Nice, France
                [5 ] departmentDepartment of Interventional Neuroradiology , La Pitié-Salpétrière , Paris, France
                [6 ] departmentDepartment of Interventional Neuroradiology , Hôpital Bellevue, Saint-Etienne , France
                [7 ] departmentDepartment of Interventional Neuroradiology , Hôpital de la Timone , Marseille, France
                [8 ] departmentDepartment of Interventional Neuroradiology , Hôpital Gui de Chauliac , Montpellier, France
                [9 ] departmentDepartment of Interventional Neuroradiology , Hôpital Maison Blanche , Reims, France
                Author notes
                [Correspondence to ] Dr Christina Iosif, Departments of Interventional Neuroradiology, CHU-Limoges Dupuytren University Hospital, Limoges 87042, France; christina.iosif@ 123456gmail.com
                Author information
                http://orcid.org/0000-0002-1354-4328
                http://orcid.org/0000-0002-4932-1484
                http://orcid.org/0000-0002-5696-5368
                Article
                Publisher ID: neurintsurg-2017-013375
                DOI: 10.1136/neurintsurg-2017-013375
                PMC ID: 6031274
                PubMed ID: 29175829
                SO-VID: 6c3eac34-c975-4cee-8ed9-1d124e167aa3
                Copyright © © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                Date received : 02 August 2017
                Date revision received : 30 October 2017
                Date accepted : 02 November 2017
                Categories
                Subject: New Devices
                Subject: 1506
                Subject: 1548
                Series title: Original research
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Surgery
                Keywords: aneurysm,stent
                Data availability:
                ScienceOpen disciplines: Surgery
                Keywords: aneurysm, stent

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