Article Text
Abstract
Background and purpose To describe the periprocedural results of the TARGET Registry, an on-going, prospective, non-randomised, multicenter, real-world study of patients with ruptured or unruptured intracranial aneurysms that are embolised with the new generation TARGET Coils. In particular, the aneurysm that were coiled with 100% 360 complex coils only were compared to the aneurysm that were coiled with mixed 360 and helical coil or helical coils only.
Methods Patients with de novo untreated ruptured or unruptured intracranial aneurysms were embolised with either TARGET 360° or Helical coils in 13 US centers. The primary outcome, aneurysm packing density (PD), was assessed at immediate post-procedure. Analysis was by per protocol. The secondary outcomes were modified Rankin’s Scale (mRS) at discharge and the influence of use of 100% 360 coils on clinical and angiographic outcomes. JMP statistical software was used for analysis.
Results 120 patients enrolled to date were eligible for this per protocol analysis. 51 (42.5%) patients with ruptured and 69 (57.5%) with unruptured aneurysms were treated. Mean age was 58.1 ± 13.04 years; 75.6% female, 73.3% white. TARGET 360° coils was used in 60.5%, mixed 360° and Helical Coils in 35.1%, and TARGET Helical Coils in 4.4% of the cases. Immediate complete occlusion rate was seen in 84.4% of the cases. Packing density was the main predictor of complete occlusion (mean PD 28.7 ± 18.1 in those with complete occlusion vs. 20 ± 12, p-value 0.005). Mean PD was 25.4 ± 16.3%. Multivariate analysis showed maximum aneurysm size (p value 0.0001), and use of stent (p value 0.02) to be independent predictors of PD. In-hospital mortality was 0.8% (1/120) and discharge good outcome (mRS 0–2) was seen in 110/120 (91.7%). Poor outcome occurred in 13.7% of the ruptured aneurysm and 4.4% of the unruptured aneurysms. Predictors of discharge outcome included age, rupture presentation, aneurysm neck size, and occlusion grade.
Conclusion In this prospective and core lab adjudicated multicenter Target aneurysm registry, the mean PD was 25.4 ± 16.3% and was the main predictor of complete aneurysm occlusion. Poor outcome was 4.4% in the unruptured aneurysm and 13.7% in the ruptured aneurysms. Predictor of outcome at discharge included age, rupture status, aneurysm occlusion, and aneurysm neck size.
Disclosures O. Zaidat: None. A. Castonguay: None. A. Puri: None. A. Rai: None. A. Badruddin: None. W. Mack: None. A. Alshekklee: None. Q. Shah: None. S. Hussain: None. M. Kabbani: None. K. Bulsara: None. M. Taqi: None. V. Janardhan: None.