ABSTRACT
Background and Purpose: To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils. Methods: The TARGET Registry is a prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with de novo intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100% 360-complex coils on clinical and angiographic outcomes. Results: 148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2%) patients with ruptured and 90 (61.8%) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1-67.4), 73% female, and 71.6% were Caucasian. Median follow-up time was 5.9 (IQR 4.0-6.9) months. The majority were treated with TARGET 360-coils (63.7%), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7% of patients. A good outcome at discharge (mRS 0-2) was seen in 89.9% of the full cohort, and in 84.5 and 93.3% in the ruptured and unruptured patients, respectively. The median packing density was 28.8% (IQR 20.3-41.1). Long-term complete and near complete occlusion rate was seen in 90.4% of aneurysms and complete obliteration was seen in 66.2% of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8%) patients and all-cause mortality was seen in 3/148 (2%) patients. Conclusion: In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0% achieved complete or near complete occlusion with excellent independent functional outcome. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT01748903.
ABSTRACT
Background and Purpose- It remains unclear how experience influences outcomes after the advent of stent retriever technology. We studied the relationship between site experience and outcomes in the Trevo Acute Ischemic Stroke multicenter registry. Methods- The 24 sites that enrolled patients in the Trevo Acute Ischemic Stroke registry were trichotomized into low-volume (<2 cases/month), medium-volume (2-4 cases/month), and high-volume centers (>4 cases/month). Baseline features, imaging, and clinical outcomes were compared across the 3 volume strata. A multivariable analysis was performed to assess whether outcomes were influenced by site volumes. Results- A total of 624 patients were included and distributed as low- (n=188 patients, 30.1%), medium- (n=175, 28.1%), and high-volume (n=261, 41.8%) centers. There were no significant differences in terms of age (mean, 66±16 versus 67±14 versus 65±15; P=0.2), baseline National Institutes of Health Stroke Scale (mean, 17.6±6.5 versus 16.8±6.5 versus 17.6±6.9; P=0.43), or occlusion site across the 3 groups. Median (interquartile range) times from stroke onset to groin puncture were 266 (181.8-442.5), 239 (175-389), and 336.5 (221.3-466.5) minutes in low-, medium-, and high-volume centers, respectively (P=0.004). Higher efficiency and better outcomes were seen in higher volume sites as demonstrated by shorter procedural times (median, 97 versus 67 versus 69 minutes; P<0.001), higher balloon guide catheter use (40% versus 36% versus 59%; P≤0.0001), and higher rates of good outcome (90-day modified Rankin Scale [mRS], ≤2; 39% versus 50% versus 53.4%; P=0.02). There were no appreciable differences in symptomatic intracranial hemorrhage or 90-day mortality. After adjustments in the multivariable analysis, there were significantly higher chances of achieving a good outcome in high- versus low-volume (odds ratio, 1.67; 95% CI, 1.03-2.7; P=0.04) and medium- versus low-volume (odds ratio, 1.75; 95% CI, 1.1-2.9; P=0.03) centers, but there were no significant differences between high- and medium-volume centers (P=0.86). Conclusions- Stroke center volumes significantly influence efficiency and outcomes in mechanical thrombectomy.
