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      The LUNA aneurysm embolization system for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results

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          Abstract

          Background and purpose

          Intrasaccular aneurysm flow disruption represents an emerging endovascular approach to treat intracranial aneurysms. The purpose of this study was to determine the clinical and angiographic outcomes of using the LUNA aneurysm embolization system (AES) for treatment of intracranial aneurysms.

          Materials and methods

          The LUNA AES Post-Market Clinical Follow-Up study is a prospective, multicenter, single-arm study that was designed to evaluate device safety and efficacy. Bifurcation and sidewall aneurysms were included. Aneurysm occlusion was assessed using the Raymond-Roy classification scale. Disability was assessed using the Modified Rankin Scale (mRS). Morbidity was defined as mRS >2 if baseline mRS ≤2, increase in mRS of 1 or more if baseline mRS >2, or mRS >2 if aneurysm was ruptured at baseline. Clinical and angiographic follow-up was conducted at 6, 12 and 36 months.

          Results

          Sixty-three subjects with 64 aneurysms were enrolled. Most aneurysms were unruptured (60/63 (95.2%)); 49 were bifurcation or terminal (49/64 (76.6%)). Mean aneurysm size was 5.6±1.8 mm (range, 3.6–14.9 mm), and mean neck size was 3.8±1.0 mm (range, 1.9–8.7 mm). Though immediate postoperative adequate occlusion was low (11/63, 18%), adequate occlusion was achieved in 78.0% (46/59) and 79.2% (42/53) of the aneurysms at 12 months and 36 months, respectively. Four patients were retreated by the 12-month follow-up (4/63 (6.3%)) and three patients were retreated by the 36-month follow-up (3/63 (4.8%)). There were two major strokes (2/63 (3.2%)), one minor stroke (1/63 (1.6%)) and three incidents of intracranial hemorrhage in two subjects (2/63 (3.2%)) prior to the 12-month follow-up. There was one instance of mortality (1/63, 1.6%). Morbidity was 0% (0/63) and 1.8% (1/63) at the 12-month and 36-month follow-ups, respectively.

          Conclusions

          LUNA AES is safe and effective for the treatment of bifurcation and sidewall aneurysms.

          Clinical trial registration

          ISRCTN72343080; Results.

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          Most cited references24

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          Endovascular treatment of unruptured aneurysms.

          We sought to better define the morbidity of endovascular Guglielmi detachable coil (GDC) treatment of unruptured cerebral aneurysms and to discuss its role in the prevention of subarachnoid hemorrhage. We conducted an observational study from August 1992 to June 1999 of 125 unruptured aneurysms treated with GDC in 116 patients: 91 women (78.4%) and 25 men (21.6%), aged 30 to 78 years (mean age, 50.6 years). Immediate and late clinical results were recorded for any neurological event or hemorrhage related to the treated unruptured aneurysm. Angiographic results are reported as immediate, early (2 to 12 months), intermediate (12 to 30 months), and late follow-up (>30 months). Immediate angiographic results showed complete obliteration (class 1) in 59 (47.2%) or residual neck (class 2) in 53 aneurysms (42.4%), leaving 6 residual aneurysms (4.8%) and 7 failures (5.6%). Early follow-up angiograms, available in 100 treated aneurysms (84%), revealed class 1 in 52% and class 2 in 41%. Intermediate angiograms, available in 53 aneurysms (44.5%), showed class 1 in 47.2% and class 2 in 43.4%, while late results, available in 37 lesions (31.1%), had class 1 and 2 in 48.6% and 37.8%, respectively. Six patients suffered a permanent neurological deficit at last follow-up (5.2%), with a good outcome in 5 patients and fair outcome in 1 patient. There was no mortality. There was no aneurysmal rupture during a mean clinical follow-up of 32.1 months. Endovascular treatment with GDC for unruptured aneurysms is relatively safe. Its role in the prevention of aneurysmal rupture remains to be determined, preferably by a randomized study.
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            Stent-assisted coiling of intracranial aneurysms: clinical and angiographic results in 216 consecutive aneurysms.

            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.
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              Immediate clinical outcome of patients harboring unruptured intracranial aneurysms treated by endovascular approach: results of the ATENA study.

              The management of unruptured intracranial aneurysms remains controversial and the results of endovascular treatment are not precisely known because no prospective data exist. The first prospective multicenter study (ATENA) was conducted in Canada and France to determine clinical outcome and risks of this treatment. Six hundred forty-nine patients harboring a total of 1100 aneurysms from 27 Canadian and French neurointerventional centers were prospectively and consecutively treated by endovascular coil embolization. Of these, 739 unruptured intracranial aneurysms were treated during 700 procedures. Aneurysms were selectively treated in the great majority of cases (98.4%) with coils alone (54.5%), the balloon remodeling technique (37.3%), or stenting (7.8%). Endovascular treatment failed in 32 aneurysms (4.3%). Technical adverse events with or without clinical modification were encountered in 15.4% of patients and included thromboembolic complications (7.1% per procedure), intraoperative rupture (2.6% per procedure), and device-related problems (2.9% per procedure). Adverse events associated with transient or permanent neurological deficit or death were encountered in 5.4% of cases. The 1-month morbidity and mortality rates were 1.7% and 1.4%, respectively. Endovascular treatment of unruptured intracranial aneurysms is feasible in a high percentage of cases with low morbidity and mortality rates.
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                Author and article information

                Journal
                J Neurointerv Surg
                J Neurointerv Surg
                neurintsurg
                jnis
                Journal of Neurointerventional Surgery
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                1759-8478
                1759-8486
                December 2018
                18 April 2018
                : 10
                : 12
                : e34
                Affiliations
                [1 ] departmentDepartment of Interventional Neuroradiology , Foundation Rothschild Hospital , Paris, France
                [2 ] departmentDepartment of Neuroradiology and Endovascular Therapy , CHU Besançon , Besançon, France
                [3 ] departmentDepartment of Interventional Neuroradiology , CHU Pitié Salpêtrière , Paris, France
                [4 ] departmentDepartment of Interventional Neuroradiology , CHU Limoges , Limoges, France
                [5 ] departmentSecond Department of Radiology , Medical University of Warsaw , Warsaw, Poland
                [6 ] departmentDepartment of Interventional Neuroradiology , Careggi University Hospital , Florence, Italy
                [7 ] departmentDepartment of Neuroradiology , The Karolinska University Hospital in Solna , Stockholm, Sweden
                [8 ] departmentDepartment of Neuroradiology , Cliniques Universitaires Saint-Luc, Université Catholique de Louvain , Brussels, Belgium
                [9 ] departmentDepartment of Neuroradiology , CHU Nancy , Nancy, France
                Author notes
                [Correspondence to ] Dr Michel Piotin, Department of Interventional Neuroradiology, Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild, Paris 75019, France; mpiotin@ 123456free.fr
                Author information
                http://orcid.org/0000-0002-1354-4328
                Article
                neurintsurg-2018-013767
                10.1136/neurintsurg-2018-013767
                6288707
                29669856
                7760299c-6086-49ef-94db-b3c18fcb21af
                © 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.

                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
                : 14 January 2018
                : 18 March 2018
                : 25 March 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004374, Medtronic;
                Categories
                New Devices
                1506
                1548
                Original research
                Custom metadata
                unlocked

                Surgery
                aneurysm,endovascular procedures,flow disruption,luna device
                Surgery
                aneurysm, endovascular procedures, flow disruption, luna device

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