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

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.

Keywords: LUNA device; aneurysm; endovascular procedures; flow disruption.

Figure 1

The LUNA aneurysm embolization system (AES) is a self-expandable, round-ovoid implant made from a double layer of 72 nitinol 25 µm wires. The mesh (made of a total of 144 wires) is secured at proximal and distal ends, and clearly marked with radiopaque markers. Available sizes for the device are 4.5–8.5 mm. The delivery system provides for distal navigation through all 0.027-inch compatible commercially available microcatheters. The detachment of the LUNA AES is mechanical and controlled by the operator activation of a delivery handle.

Figure 2

Occlusion example. (A) Baseline angiography for a patient with a 8.0 mm anterior communicating saccular aneurysm. (B) Plain radiograph during the LUNA aneurysm embolization system (AES) implantation. (C) Immediate control angiogram after implantation showing flow reduction within the aneurysm. The same patient at 36-month follow-up with 3D angiography: (D) early arterial phase of angiography; (F) late arterial phase showing complete circulatory exclusion of the aneurysm.