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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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Piotin, Michel Biondi, Alessandra Sourour, Nader Mounayer, Charbel Jaworski, Maciej Goffette, Pierre [UCL] Blanc, Raphaël

(eng) 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.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès libre
Publication date 2018
Language Anglais
Journal information "Journal of neurointerventional surgery" - Vol. 10, no. 12, p. e34 [1-8] (2018)
Peer reviewed yes
Publisher BMJ Publishing Group ((United Kingdom) London)
issn 1759-8478
e-issn 1759-8486
Publication status Publié
Affiliations UCL - SSS/IONS/NEUR - Clinical Neuroscience
UCL - (SLuc) Service de radiologie
MESH Subject Adult ; Aged ; Cerebral Angiography ; Embolization, Therapeutic ; Endovascular Procedures ; Female ; Follow-Up Studies ; Humans ; Intracranial Aneurysm ; Male ; Middle Aged ; Prospective Studies ; Registries ; Time Factors ; Treatment Outcome
Keywords LUNA device ; Aneurysm ; Endovascular procedures ; Flow disruption
Links
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Bibliographic reference Piotin, Michel ; Biondi, Alessandra ; Sourour, Nader ; Mounayer, Charbel ; Jaworski, Maciej ; et. al. The LUNA aneurysm embolization system for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results.. In: Journal of neurointerventional surgery, Vol. 10, no. 12, p. e34 [1-8] (2018)
Permanent URL http://hdl.handle.net/2078.1/221460