The LUNA aneurysm embolisation system has been found to be safe and effective for the treatment of bifurcation and sidewall aneurysms results, published in the Journal of NeuroInterventional Surgery suggest.
Endovascular aneurysm coiling is a valid therapeutic option for treating cerebral aneurysms and endovascular treatment can be considered first for the treatment of ruptured and unruptured aneurysms. However, coiling, either as a standalone procedure or with the use of the balloon-enhanced (or balloon-remodelling) coiling technique, can be limited by the filling of only a limited percentage of the aneurysm volume, introducing the possibility of coil compaction and recanalisation over time.
The authors write: “Difficulty of coiling wide-necked aneurysms can be addressed with the use of adjunctive microstents and stent-assisted coiling is also a valid alternative for treating wide-necked aneurysms. This treatment method is associated with lower aneurysm recurrence rates compared with coiling alone. However, this method has an increased periprocedural rate of haemorrhagic complications related to antiplatelet treatment.”
The LUNA aneurysm embolization system is a flow disruption device intended to treat a broader array of aneurysms. The aneurysm embolisation system is a self-expanding intrasaccular flow disruption device that is placed inside the aneurysm cavity, providing a mesh of metal across the neck of the aneurysm that isolates it from the parentartery blood flow. The shape allows the device to treat either bifurcation or sidewall aneurysms. The purpose of this study was to evaluate the procedural, short-term, and long-term safety and effectiveness of the LUNA aneurysm embolisation system when used in accordance with the manufacturer’s instructions for use.
The LUNA aneurysm embolisation system Post-Market Clinical Follow-Up study was a prospective, multicentre, 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 and 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 six, 12 and 36 months.
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±1.8mm (range, 3.6–14.9mm), and mean neck size was 3.8±1.0mm (range, 1.9–8.7mm).
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 haemorrhage 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.
The authors report: “Our study’s results support the safety and efficacy of the LUNA AES for the treatment of unruptured bifurcation and sidewall intracranial aneurysms of a wide range of sizes. This series represents the first cohort of subjects ever treated with the LUNA AES device. Analysis of the treated population showed excellent LUNA AES implantation success, with implantation in 61/64 aneurysms (95.3%) and limited use of adjunctive implant devices (7/61, 11.5%). Both sidewall and bifurcation aneurysms were successfully treated. Treatment was most effective for small aneurysms and least effective for large aneurysms, though our sample size of large aneurysms was small.”