ABSTRACT
Background: The primary objective is to evaluate the safety and effectiveness of Stryker second generation Target® Nano Coils in the treatment of ruptured and unruptured small (<7 mm) intracranial aneurysms. Methods: The TARGET Registry is a prospective, two-arm study with independent medical event monitoring and core-lab adjudication. This paper describes the second arm of the TARGET registry. Patients with de novo intracranial aneurysms were embolized with 2nd generation TARGET Nano coils in 12 US centers. The primary efficacy outcome was adequate aneurysm occlusion (RR occlusion grade I-II) on follow-up. Primary safety outcome was treatment-related morbidity and mortality. Secondary outcomes included aneurysm packing density immediately post-procedure, immediate adequate occlusion, aneurysm re-access rate, retreatment rate and clinical outcomes using modified ranking scale. A secondary analysis investigated the influence of using Nano-predominant coils (≥2/3 of total coil-length) vs. non-Nano-predominant coils (<2/3 of total length). Results: 150 patients with 155 aneurysms met the inclusion and exclusion criteria. (31%) patients with ruptured and (69%) with unruptured aneurysms were treated using TARGET coils. Median age was 58.8 (SD 12.7), 74.7% were females, and 80% were Caucasians. Mean follow-up was 5.23 (SD 2.27) months. Peri-procedural mortality was seen in 2.0% of patients. Good outcome at discharge (mRS 0-2) was seen in 81.3% of the cohort. The median packing density (SD) was 29.4% (14.9). Mid-term complete/near complete occlusion rate was seen in 96% of aneurysms and complete obliteration was seen in 75.2% of aneurysms. Patients treated predominantly with Nano coils had higher PD (32.6% vs. 26.1%, p < 0.001). There was no significant difference in clinical and angiographic outcomes. The mid-term mRS0-2 was achieved in 106/109 (97.2%) patients. All-cause mortality was 5/115 (4.3%). Conclusion: In the multicenter TARGET Registry, 75.8% of aneurysms achieved mid-term complete occlusion, and 96% achieved complete/near complete occlusion with excellent independent functional outcome.
ABSTRACT
Background The outcome of mechanical thrombectomy for large vessel occlusion (LVO) in patients with acute ischemic stroke (AIS) is time-dependent. In the current stroke workflow, the pre-hospital delay is one of the most common reasons for an increase in door-to-groin puncture time (DGPT). In the present study, we sought to compare the difference in (DGPT) before and after the implementation of the Ventura Emergent Large Vessel Occlusion Score (VES) protocol for LVO. Methods VES was implemented in the Ventura County of California by Emergency Medical Services (EMS). We performed a retrospective analysis to compare DGPT of patients undergoing endovascular treatment (EVT) pre- and post-VES implementation. Mean and standard deviation was reported for the continuous variable 'time for intra-arterial (IA) treatment' in minutes. The Mann-Whitney test was used for the comparison of the variable between the two groups. analyses were performed using SAS v9.4 (SAS Institute Inc., Cary, NC) with a significant p-value of ≤0.05. Results A total of 304 (males: 142 and females: 162) patients were alerted of the stroke code by the EMS. VES was positive in 139 patients. Of these, 64 (46%) were males and 75 (54%) were females. VES score of 1, 2, 3, and 4 were recorded in 57 (41%), 44 (31.6%), 31 (22.3%), and 7 (5%) patients, respectively. A total of 48 VES-positive patients underwent EVT. There were 62 patients who underwent EVT before the implementation of the VES protocol. The mean DGPT for the EVT among post-VES patients was 65 minutes, which was significantly (p=0.0009) shorter than the mean DGPT of 109 minutes among pre-VES patients. Conclusion VES is a simplified and effective tool for identifying LVO in the field. Implementation of VES showed significantly reduced DGPT in LVO patients.
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
OBJECTIVE: The objective of this study was to evaluate the prognostic significance of neurological manifestations in falciparum malaria. METHODS: We analyzed adult patients with malaria admitted from 2001 to 2003, diagnosed by asexual forms of Plasmodium falciparum in peripheral blood films and identified cases of malaria with neurological involvement. A patient was classified as having neurological involvement if they reported or had one or more of the following symptoms; headache, altered mental status, seizures, neck rigidity, brisk reflexes, cranial neuropathy and hyper or hypotonia. RESULTS: A total of 454 patients were included in the study. Out of these, 123 (27%) were diagnosed as complicated (severe) malaria and 331 (73%) as uncomplicated malaria at admission. Overall 70 (15.4%) patients had evidence of neurological involvement at initial evaluation. Twenty-seven patients out of 123 (22%) with complicated malaria and 43 patients out of 331 (13%) with uncomplicated malaria had neurological involvement. Over all, 16 (4%) patients died, 13 (11%) had complicated malaria (n=123) and 3 (1%) had uncomplicated malaria (n=381). Mortality in patients having neurological involvement (n=70) was 9 (13%) as compared to 7 (2%) in patients with malaria having no neurological involvement (n=384). This difference was statistically significant (p=0.012). Seizure was identified as predictor of mortality on Univariate analysis [OR 5.091 (1.835-14.121)]. CONCLUSION: Fifteen percent of patients with falciparum malaria admitted to our hospital had neurological symptoms and neurological involvement was associated with increased mortality.
