Neurology ·
Registry finds similar short-term safety for on- and off-label aneurysm treatment
A multicenter registry analysis included 401 patients with unruptured cerebral aneurysms treated using intrasaccular flow disruption. Short-term outcomes did not differ significantly between on-label and off-label aneurysm locations, but incomplete follow-up data limit conclusions about long-term occlusion.
- 401 patients treated for unruptured aneurysms were included.
- Discharge functional outcomes did not differ significantly by location.
- Long-term occlusion could not be assessed because of missing data.
Researchers analyzed NeuroVascular Quality Initiative–Quality Outcomes Database registry data for 401 patients treated with intrasaccular flow disruption (IFD) for unruptured cerebral aneurysms: 329 treatments were in on-label locations and 72 in off-label locations. The primary outcome was modified Rankin Scale (mRS) score at discharge. Secondary outcomes included intraoperative complications, later mRS scores and aneurysm occlusion. The mean patient age was 64.6 years, and mean follow-up was 512 days.
At discharge, mRS scores of 0–2 were recorded in 94.1% of the on-label group and 97.5% of the off-label group (p=0.615). Intraoperative complications occurred in 3.6% and 2.8%, respectively (p>0.999). Occlusion at discharge, defined as Raymond-Roy class 1, was reported in 54.1% versus 56.0% (p=0.929). Propensity score matching, which included 68 patients per group, likewise found no significant differences in the reported outcomes.
The findings support comparable observed short-term safety across the two location categories in this registry, but do not establish equivalence. Missing data on occlusion at last follow-up prevented assessment of long-term efficacy; the authors note that further follow-up is needed.
In practice
For clinicians considering intrasaccular flow disruption for unruptured cerebral aneurysms, this multicenter registry found no significant differences in discharge functional status or reported complications between on-label and off-label treatment locations. These observational findings describe outcomes in selected real-world patients and do not establish equivalence or support changing treatment decisions. Long-term efficacy remains uncertain because substantial missing follow-up occlusion data prevented analysis.
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Journal of Neurosurgery: Real-world safety of intrasaccular flow disruption for unruptured cerebral aneurysms: a multicenter analysis of on-label versus off-label aneurysm location treatment in the NeuroVascular Quality Initiative–Quality Outcomes Database registry ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.