These devices appear to be especially beneficial for complex cases, such as aneurysms in distal or tortuous locations.
Low-profile visualized intraluminal support (LVIS) devices are safe and effective tools for the treatment of ruptured and unruptured intracranial aneurysms, according to data from the TRAIL prospective trial published online recently ahead of print in the Journal of NeuroInterventional Surgery.
“Low-profile braided stents can be delivered through small-caliber microcatheters and can be resheathed and repositioned for optimal deployment, thus representing an important improvement in the treatment of complex aneurysms in distal locations,” write the authors, led by Christina Iosif, MD (CHU-Limoges Dupuytren University Hospital, Limoges, France).
TRAIL is the first multicenter prospective study to evaluate the safety and effectiveness of the LVIS devices for the treatment of ruptured and unruptured intracranial aneurysms.
Among the 90 patients who were included in the analysis, 42.2% were male and 30% had multiple aneurysms. Overall, 23 aneurysms (25.6%) were ruptured, four (4.4%) of which were treated in the acute phase. One aneurysm was treated per patient, and 92 LVIS and LVIS Jr devices (MicroVention) were placed overall.
Postprocedural angiography revealed a total occlusion rate of 91.0%. This percentage remained unchanged at 6 months and increased to 92.4% at 18-month follow-up. One patient (1.1%) underwent retreatment between 6 and 18 months of follow-up.
Most patients had an mRS of 0 immediately after the procedure as well as at 6-month and 18-month follow-up. The overall permanent morbidity rate at 18 months was low, as were the rates of events with sequelae related to the stent and 18-month procedure-related mortality. No patients required retreatment at 18-month follow-up.
Aneurysm Treatment Using LVIS and LVIS Jr
|
|
Outcome |
|
Postprocedure mRS of 0 |
86.7% |
|
6 Month mRS of 0 |
86.8% |
|
18-Month mRS of 0 |
83.3% |
|
18-Month Permanent Morbidity |
5.6% |
|
Stent-Related Sequelae |
2.2% |
|
18-Month Procedure-Related Mortality |
3.3% |
Promising Findings
“In accordance with previous multicenter retrospective data,” write the authors, “the study demonstrated excellent angiographic outcomes with a very high rate of total aneurysm occlusion rates and acceptable complication rates. The angiographic follow-up, which is the longest published to date for these devices, showed excellent angiographic stability and absence for the need for retreatment.”
They add that the technical feasibility for the device was high (95.2%) and comparable to published results for the Neuroform (Stryker) and Leo (Balt) stents.
“The overall experience in this study showed a very promising performance of the devices, especially regarding complex even double-stent techniques, and is in accordance with other studies regarding braided low-profile endovascular stents,” they conclude. “The low-profile braided intracranial stent technology seems to provide neurovascular physicians with an enhanced tool for addressing challenging wide-necked intracranial aneurysms in distal or very tortuous locations.”
Still, they note, long-term imaging studies should be performed to confirm durability over time.
Source:
Iosif C, Piotin M, Saleme S, et al. Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study. J NeuroInterv Surg. 2017;Epub ahead of print.
Disclosures:
Iosif reports no relevant conflicts of interest.