The device will meet a need, if and when it reaches the market, one expert says.
LUNA, an intra-aneurysmal flow disruption device, is a safe and effective tool for the treatment of bifurcation and sidewall aneurysms, according to a European manufacturer-sponsored study published online recently ahead of print in Journal of NeuroInterventional Surgery.
“Recently, the concept of intra-aneurysmal flow disruption has emerged as a new paradigm for the treatment of primarily bifurcation aneurysms,” write the authors of the LUNA AES Post-Market Clinical Follow-Up study, which was led by Michel Piotin, MD (Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild, Paris, France).
The LUNA aneurysm embolization system (Medtronic) was used in the study is not yet available outside of clinical trials. It is an ovoid-shaped self-expanding intrasaccular flow disruption device that is placed inside the aneurysm cavity and isolates the neck of the aneurysm from the parent-artery blood flow.
Commenting on the study for Neurovascular Exchange, Laurent Pierot, MD (Hôpital Maison-Blanche, Reims, France), explained that the LUNA is similar to the Woven Endobridge (WEB) device (Sequent Medical), but said it has a rounder shape and is thus indicated for bifurcation or sidewall aneurysms.
Since this trial, the manufacturer has further adjusted the design of their aneurysm embolism system, resulting in the ARTISSE. It remains unclear when either the LUNA or the ARTISSE will reach the market, but Pierot acknowledged that the availability of more intrasaccular devices like these is desirable. “We need to have several devices in the same category,” he said. “We have several flow diverters, we have stents, we have several coils, so we need to have several intrasaccular devices.”
Efficacious for Wide Range of Aneurysm Sizes
The prospective, multicenter, single-arm LUNA AES Post-Market Clinical Follow-Up study enrolled 63 patients with 64 aneurysms. Most of the aneurysms were unruptured (95.2%), and 76.6% were bifurcation aneurysms. Mean aneurysm size was 5.6 ± 1.8 mm, and mean neck size was 3.8 ± 1.0 mm.
Immediate postoperative occlusion rates, assessed using the Raymond-Roy classification scale, were low. At 6 months’ follow-up, however, adequate occlusion rate had increased substantially and remained high throughout the 36-month evaluation period.
Adequate Occlusion Rates by Follow-up Period
|
|
Number of Patients (%) |
|
Immediately Postoperative |
11/63 (18%) |
|
12 Months |
46/59 (78.0%) |
|
36 Months |
42/53 (79.2%) |
No treated aneurysm bled or rebled during the follow-up period. Four patients were retreated by the 12-month follow-up (6.3%), and three were retreated by the 36-month follow-up (4.8%). Prior to the 12-month follow-up, there were two major strokes (3.2%), one minor stroke (1.6%), and three incidents of intracranial hemorrhage in two patients (3.2%).
Only one patient died, for an overall mortality rate of 1.6%. The morbidity rate was 0 at 12 months and 1.8% at 36-months.
All patients had an mRS score of 0-2 at discharge, and this remained the case through the 36-month follow-up period, for which 55 patients underwent full evaluation.
“Overall, our findings not only indicate that LUNA AES treatment according to the manufacturer's indications is indeed safe and effective, but they also suggest that LUNA AES may offer some advantages over current standard therapies,” Piotin and colleagues write. “Its relatively fast deployment reduces procedure time, and our safety and efficacy data point to an extremely low risk of rupture. In addition, LUNA AES is designed as a single-device treatment for an entire aneurysm, eliminating the increased risk of rupture present each time a coil loop is released into the aneurysm.”
May Lead to Reduction in Coiling
Pierot said the findings are similar to those achieved with the WEB device, although longer follow-up data are needed to confirm the outcomes. Safety and efficacy may even be superior to coiling, he noted, but that is impossible to say for sure without a randomized trial.
“Probably in the future we will see a decrease in coiling and an increase in the use of these kinds of intrasaccular devices, but we don’t know for sure,” he said. “It’s [currently] a debate in a lot of congresses what the future will be of coiling. Will coiling decrease? Probably, the evolution will be to have a decrease in coiling and an increase in intrasaccular devices and flow diverters.”
Source:
Piotin M, Biondi A, Sourour N, et al, et al. The LUNA aneurysm embolization system for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results. J NeuroIntervent Surg. 2018;Epub ahead of print.
Disclosures:
- The study received funding from Medtronic.
- Piotin reports consulting for Medtronic, Stryker, MicroVention, Penumbra, and Balt.
- Pierot reports no relevant conflicts of interest.
