Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis \u3e 50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2+/-10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585

Neurosurgeons Deliver Similar Quality Care Regardless of First Assistant Type: Resident Physician versus Nonphysician Surgical Assistant

OBJECTIVE: There are limited data evaluating the out-comes of attending neurosurgeons with different types of first assistants. This study considers a common neurosurgical procedure (single-level, posterior-only lumbar fusion surgery) and examines whether attending surgeons deliver equal patient outcomes, regardless of the type of first assistant (resident physician vs. nonphysician surgical assistant [NPSA]), among otherwise exact-matched patients. -METHODS: The authors retrospectively analyzed 3395 adult patients undergoing single-level, posterior-only lumbar fusion at a single academic medical center. Primary outcomes included readmissions, emergency department visits, reoperation, and mortality within 30 and 90 days after surgery. Secondary outcome measures included discharge disposition, length of stay, and length of surgery. Coarsened exact matching was used to match patients on key demographics and baseline characteristics known to independently affect neurosurgical outcomes. -RESULTS: Among exact-matched patients (n [ 1402), there was no significant difference in adverse postsurgical events (readmission, emergency department visits, reoperation, or mortality) within 30 days or 90 days of the index operation between patients who had resident physicians and those who had NPSAs as first assistants. Patients who had resident physicians as first assistants demonstrated a longer length of stay (mean: 100.0 vs. 87.4 hours, P \u3c 0.001) and a shorter duration of surgery (mean: 187.4 vs. 213.8 minutes, P \u3c 0.001). There was no significant difference between the two groups in the percentage of patients discharged home. -CONCLUSIONS: For single-level posterior spinal fusion, in the setting described, there are no differences in short-term patient outcomes delivered by attending surgeons assisted by resident physicians versus NPSAs

Transcriptome-wide association study of breast cancer risk by estrogen-receptor status

Previous transcriptome-wide association studies (TWAS) have identified breast cancer risk genes by integrating data from expression quantitative loci and genome-wide association studies (GWAS), but analyses of breast cancer subtype-specific associations have been limited. In this study, we conducted a TWAS using gene expression data from GTEx and summary statistics from the hitherto largest GWAS meta-analysis conducted for breast cancer overall, and by estrogen receptor subtypes (ER+ and ER-). We further compared associations with ER+ and ER- subtypes, using a case-only TWAS approach. We also conducted multigene conditional analyses in regions with multiple TWAS associations. Two genes, STXBP4 and HIST2H2BA, were specifically associated with ER+ but not with ER- breast cancer. We further identified 30 TWAS-significant genes associated with overall breast cancer risk, including four that were not identified in previous studies. Conditional analyses identified single independent breast-cancer gene in three of six regions harboring multiple TWAS-significant genes. Our study provides new information on breast cancer genetics and biology, particularly about genomic differences between ER+ and ER- breast cancer.Peer reviewe

Use of Micropatterned Thin Film Nitinol in Carotid Stents to Augment Embolic Protection

Stenting is an alternative to endarterectomy for the treatment of carotid artery stenosis. However, stenting is associated with a higher risk of procedural stroke secondary to distal thromboembolism. Hybrid stents with a micromesh layer have been proposed to address this complication. We developed a micropatterned thin film nitinol (M-TFN) covered stent designed to prevent thromboembolism during carotid intervention. This innovation may obviate the need or work synergistically with embolic protection devices. The proposed double layered stent is low-profile, thromboresistant, and covered with a M-TFN that can be fabricated with fenestrations of varying geometries and sizes. The M-TFN was created in multiple geometries, dimensions, and porosities by sputter deposition. The efficiency of various M-TFN to capture embolic particles was evaluated in different atherosclerotic carotid stenotic conditions through in vitro tests. The covered stent prevented emboli dislodgement in the range of 70%–96% during 30 min duration tests. In vitro vascular cell growth study results showed that endothelial cell elongation, alignment and growth behaviour silhouettes significantly enhance, specifically on the diamond-shape M-TFN, with the dimensions of 145 µm × 20 µm and a porosity of 32%. Future studies will require in vivo testing. Our results demonstrate that M-TFN has a promising potential for carotid artery stenting

Comparison of 4f-PCC and and-exanet alfa for reversal of apixaban- and rivaroxaban-associated ICH

Introduction/Hypothesis: Four-factor prothrombin complex concentrates (4F-PCC) and andexanet alfa are two reversal agents commonly used in the management of intracranial hemorrhage (ICH) associated with oral factor-Xa inhibitor use. The limited data available has not identified an agent with superior clinical efficacy. The purpose of this study was to evaluate and compare clinical outcomes in patients who experienced an ICH while taking apixaban or rivaroxaban and were reversed with 4F-PCC or andexanet alfa. Methods: This retrospective cohort included adult patients that received 4F-PCC or andexanet alfa for the initial management of an apixaban- or rivaroxaban-associated ICH. Patients that received 4F-PCC or andexanet alfa for any other indication were excluded. A primary outcome of excellent or good hemostatic efficacy at 12 hours post-reversal was assessed. Secondary outcomes evaluated were change in hematoma volume size at 12 hours, functional status at discharge, the need for surgical intervention or additional hemostatic agents post-reversal, new thrombotic event within 30 days, 28-day all-cause mortality, discharge disposition, and hospital and intensive care unit (ICU) lengths of stay. Results: Seventy patients were included in this study (4F-PCC, n = 47; andexanet alfa, n = 23). Median baseline hematoma volumes were similar between the 4F-PCC and andexanet alfa groups (15.7 vs 22.3 mL, p = 0.25). Baseline ICH scores were significantly higher in the andexanet alfa group (2 vs 3, p = 0.03). For the primary outcome, 21 patients were included in the 4F-PCC group and 12 in the andexanet alfa group. The rate of effective hemostasis was similar between the 4F-PCC and andexanet alfa groups (66.7% vs 75%, p = 0.62). There were no statistically significant differences between the groups for secondary outcomes, including 28-day mortality and thrombotic complications within 30 days of reversal. Conclusions: In patients who experienced an ICH while taking apixaban or rivaroxaban, 4F-PCC and andexanet alfa were found to have similar rates of excellent or good hemostatic efficacy

An Intraoperative Look at a Residual/Recurrent Tentorial Dural Arteriovenous Fistula

BACKGROUND: Dural arteriovenous fistulas (dAVFs) often are treated via transarterial or transvenous embolization. Incomplete penetration of the draining vein/occult residual often will become apparent on follow-up angiography, requiring repeat embolization, or at times, surgical resection. CASE DESCRIPTION: A 41-year-old woman presented with cerebellar hemorrhage from a tentorial dAVF treated with transvenous coil embolization. Follow-up angiography disclosed a residual/recurrent fistula treated with transvenous Onyx embolization. After further follow-up angiography demonstrated another occult residual/recurrence, the fistula was disconnected with the tentorial dura excised via a retrosigmoid approach. Six-month follow-up angiography demonstrated no recurrence. CONCLUSIONS: Although endovascular treatment of dAVFs is generally first-line therapy, surgical disconnection of fistulas, particularly high-risk residual/recurrent fistulas, is an excellent option in well-selected cases

Comparison of 4-factor prothrombin complex concentrate and andexanet alfa for reversal of apixaban and rivaroxaban in the setting of intracranial hemorrhage.

The purpose of this study was to evaluate and compare clinical outcomes in patients who experienced intracranial hemorrhage (ICH) while taking apixaban or rivaroxaban and were reversed with four-factor prothrombin complex concentrates (4F-PCC) or andexanet alfa (AA). This retrospective cohort included adult patients that received 4F-PCC or AA for the initial management of an apixaban- or rivaroxaban-associated ICH. A primary outcome of excellent or good hemostatic efficacy at 12 h post-reversal was assessed. Secondary outcomes evaluated were change in hematoma volume size at 12 h, functional status at discharge, need for surgical intervention or additional hemostatic agents post-reversal, new thrombotic event within 28 days, 28-day all-cause mortality, discharge disposition, and hospital and intensive care unit lengths of stay. A total of 70 patients were included (4F-PCC, n = 47; AA, n = 23). For the primary outcome analysis, 21 patients were included in the 4F-PCC group and 12 in the AA group. The rate of effective hemostasis was similar between the 4F-PCC and AA groups (66.7% vs 75%, p = 0.62). There were no statistically significant differences between the groups for secondary outcomes, including 28-day mortality (40.4% vs 39.1%, p = 0.92) and thrombotic complications within 28 days of reversal (17.0% vs 21.7%, p = 0.63). In patients who experienced an ICH while taking apixaban or rivaroxaban, 4F-PCC and AA were found to have similar rates of excellent or good hemostatic efficacy