Trends, Predictors and Outcomes of Ischemic Stroke Among Patients Hospitalized with Takotsubo Cardiomyopathy.

OBJECTIVES: This study assessed the temporal trends in the incidence of ischemic stroke among patients hospitalized with takotsubo cardiomyopathy (TCM) stratified by the subtypes of ischemic stroke (cardioembolic versus thrombotic). Predictors of each stroke subtype, the association with atrial fibrillation (AF), the occurrence of ventricular fibrillation/ventricular tachycardia (VF/VT), cardiogenic shock (CS), in-hospital mortality, length of stay (LOS), and total healthcare cost were also assessed. BACKGROUND: Ischemic stroke in TCM is thought to be primarily cardioembolic from left ventricular mural thromboembolism. Limited data are available on the incidence of thrombotic ischemic stroke in TCM. MATERIALS AND METHODS: We identified 27,970 patients hospitalized with the primary diagnosis of TCM from the 2008 to 2017 National Inpatient Sample, of which 751 (3%) developed ischemic stroke. Of those with ischemic stroke, 571 (76%) had thrombotic stroke while 180 (24%) had cardioembolic stroke. Cochrane armitage test was used to assess the incidence of thrombotic and cardioembolic strokes and multivariate regression was used to identify risk factors associated with each stroke subtype. We compared the incidence of AF, VF/VT, CS, LOS, in-hospital mortality and total cost between hospitalized patients with TCM alone to those with cardioembolic and thrombotic strokes. RESULTS: From 2008 - 2017, the incidence of thrombotic stroke (4.7%-9.5% (p< 0.0001) increased while it was unchanged for cardioembolic stroke (0.5%-0.7% P=0.5). In the multivariate regression, peripheral artery disease, prior history of stroke, and hyperlipidemia were significantly associated with thrombotic stroke, while CS, AF, and Asian race (compared to White race) were associated with cardioembolic stroke. Both cardioembolic and thrombotic strokes were associated with higher odds of IHM, AF, CS, longer LOS and increased cost. Trends in in-hospital mortality and the utilization of thrombolysis, cerebral angiography, and mechanical thrombectomy among patients with TCM and ischemic stroke were unchanged from 2008 to 2017. CONCLUSION: Among patients with TCM and ischemic stroke, thrombotic stroke was more common compared to cardioembolic stroke. Ischemic stroke was associated with poorer outcomes, including higher in-hospital mortality and increased healthcare resource utilization in TCM.

Evaluation of the utility of early routine computed tomography angiography in subarachnoid hemorrhage patient outcomes.

OBJECTIVES: The role of an early CTA approach in neurologically stable patients with nontraumatic SAH has not been assessed. This study explored the use of CTA in clinically stable SAH patients to pre-emptively identify cerebral vasospasm, to evaluate whether this approach is associated with improved clinical outcomes. METHODS: We conducted a retrospective chart review of SAH patients presenting between July 2007 and December 2016 in a single academic center. Patients were divided into two groups: (1) Early CTA (stable patients who underwent a CTA between days 5-8 post-SAH), and (2) Standard Protocol. The co-primary outcomes were a composite of the mRS at discharge and last clinical follow-up (good = 0-2; poor = 3-6). A multivariable binary logistic regression was conducted to compare both groups against outcomes, controlling for potential confounders. RESULTS: A total of 415 patients were included, 103 (24.8%) with early CTA, and 312 (75.2%) undergoing the standard protocol; the mean age was 57 years and 248 (59.8%) patients were female. Patients in the early CTA group had a higher modified Fisher grade (3-4) (87.4% vs 63.1%; p < 0.02). The multivariable analysis showed that early CTA was independently associated with lower poor outcomes at discharge (OR = 0.21, 95% CI 0.07-0.61, p = 0.004). Plus, vasospasm detection was associated with an increased risk of poor outcomes (OR = 4.77, 95% CI 1.41 - 16.10, p = 0.01). Early CTA was not associated with outcomes at clinical follow-up. CONCLUSION: The early CTA surveillance approach was associated with better functional outcomes at discharge when compared to the current imaging standard practice.

Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis.

During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative (< 30 days) functional outcomes (modified Rankin scale [mRS] scores) and complications related to PED treatment at early postoperative and follow-up time points (3-36 months). Multivariate analysis was performed to identify risk factors for complications. A total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6% [813/1171]) with 1322 aneurysms were included in the study. Hypertension, basilar artery aneurysms, and successful deployment after adjustment or unsuccessful device deployment were found to be independent predictors of ischemic stroke, while the use of the Flex PED and incomplete occlusion immediately after treatment were protective factors. An aneurysm size > 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population. ClinicalTrial.gov Identifier: NCT03831672.

Multinational Survey of Current Practice from Imaging to Treatment of Atherosclerotic Carotid Stenosis.

BACKGROUND: In the last 20-30 years, there have been many advances in imaging and therapeutic strategies for symptomatic and asymptomatic individuals with carotid artery stenosis. Our aim was to examine contemporary multinational practice standards. METHODS: Departmental Review Board approval for this study was obtained, and 3 authors prepared the 44 multiple choice survey questions. Endorsement was obtained by the European Society of Neuroradiology, American Society of Functional Neuroradiology, and African Academy of Neurology. A link to the online questionnaire was sent to their respective members and members of the Faculty Advocating Collaborative and Thoughtful Carotid Artery Treatments (FACTCATS). The questionnaire was open from May 16 to July 16, 2019. RESULTS: The responses from 223 respondents from 46 countries were included in the analyses including 65.9% from academic university hospitals. Neuroradiologists/radiologists comprised 68.2% of respondents, followed by neurologists (15%) and vascular surgeons (12.9%). In symptomatic patients, half (50.4%) the respondents answered that the first exam they used to evaluate carotid bifurcation was ultrasound, followed by computed tomography angiography (CTA, 41.6%) and then magnetic resonance imaging (MRI 8%). In asymptomatic patients, the first exam used to evaluate carotid bifurcation was ultrasound in 88.8% of respondents, CTA in 7%, and MRA in 4.2%. The percent stenosis upon which carotid endarterectomy or stenting was recommended was reduced in the presence of imaging evidence of "vulnerable plaque features" by 66.7% respondents for symptomatic patients and 34.2% for asymptomatic patients with a smaller subset of respondents even offering procedural intervention to patients with <50% symptomatic or asymptomatic stenosis. CONCLUSIONS: We found heterogeneity in current practices of carotid stenosis imaging and management in this worldwide survey with many respondents including vulnerable plaque imaging into their decision analysis despite the lack of proven benefit from clinical trials. This study highlights the need for new clinical trials using vulnerable plaque imaging to select high-risk patients despite maximal medical therapy who may benefit from procedural intervention.

Association of masseter area and radiodensity with three-month survival after proximal anterior circulation occlusion.

BACKGROUND: Masseter area (MA), a surrogate for sarcopenia, appears to be useful when estimating postoperative survival, but there is lack of consensus regarding the potential predictive value of sarcopenia in acute ischemic stroke (AIS) patients. We hypothesized that MA and density (MD) evaluated from pre-interventional CT angiography scans predict postinterventional survival in patients undergoing mechanical thrombectomy (MT). MATERIALS AND METHODS: 312 patients treated with MT for acute occlusions of the internal carotid artery (ICA) or the M1 segment of the middle cerebral artery (M1-MCA) between 2013 and 2018. Median follow-up was 27.4 months (range 0-70.4). Binary logistic (alive at 3 months, OR <1) and Cox regression analyses were used to study the effect of MA and MD averages (MAavg and MDavg) on survival. RESULTS: In Kaplan-Meier analysis, there was a significant inverse relationship with both MDavg and MAavg and mortality (MDavg P<0.001, MAavg P=0.002). Long-term mortality was 19.6% (n=61) and 3-month mortality 12.2% (n=38). In multivariable logistic regression analysis at 3 months, per 1-SD increase MDavg (OR 0.61, 95% CI 0.41 to 0.92, P=0.018:) and MAavg (OR 0.57, 95% CI 0.35 to 0.91, P=0.019) were the independent predictors associated with lower mortality. In Cox regression analysis, MDavg and MAavg were not associated with long-term survival. CONCLUSIONS: In acute ischemic stroke patients, MDavg and MAavg are independent predictors of 3-month survival after MT of the ICA or M1-MCA. A 1-SD increase in MDavg and MAavg was associated with a 39%-43% decrease in the probability of death during the first 3 months after MT.

Predicting the degree of difficulty of the trans-radial approach in cerebral angiography.

BACKGROUND: To evaluate anatomical and clinical factors that make trans-radial cerebral angiography more difficult. METHODS: A total of 52 trans-radial diagnostic angiograms were evaluated in a tertiary care stroke center from December 2019 until March 2020. We analyzed a number of anatomical variables to evaluate for correlation to outcome measures of angiography difficulty. RESULTS: The presence of a proximal radial loop had a higher conversion to femoral access (p<0.03). The presence of a large diameter aortic arch (p<0.01), double subclavian innominate curve (p<0.01), left proximal common carotid artery (CCA) loop (p<0.001), acute subclavian vertebral angle (p<0.01), and absence of bovine aortic arch anatomy (p=0.03) were associated with more difficult trans-radial cerebral angiography and increased fluoroscopy time-per-vessel. CONCLUSION: The presence of a proximal radial loop, large diameter aortic arch, double subclavian innominate curve, proximal left CCA loop, acute subclavian vertebral angle, and absence of bovine aortic arch anatomy were associated with more difficult trans-radial cerebral angiography. We also introduce a novel grading scale for diagnostic trans-radial angiography.

Calculation of Prognostic Scores, Using Delayed Imaging, Outperforms Baseline Assessments in Acute Intracerebral Hemorrhage.

Background and Purpose- Patients with intracerebral hemorrhage (ICH) are often subject to rapid deterioration due to hematoma expansion. Current prognostic scores are largely based on the assessment of baseline radiographic characteristics and do not account for subsequent changes. We propose that calculation of prognostic scores using delayed imaging will have better predictive values for long-term mortality compared with baseline assessments. Methods- We analyzed prospectively collected data from the multicenter PREDICT study (Prediction of Hematoma Growth and Outcome in Patients With Intracerebral Hemorrhage Using the CT-Angiography Spot Sign). We calculated the ICH Score, Functional Outcome in Patients With Primary Intracerebral Hemorrhage (FUNC) Score, and modified ICH Score using imaging data at initial presentation and at 24 hours. The primary outcome was mortality at 90 days. We generated receiver operating characteristic curves for all 3 scores, both at baseline and at 24 hours, and assessed predictive accuracy for 90-day mortality with their respective area under the curve. Competing curves were assessed with nonparametric methods. Results- The analysis included 280 patients, with a 90-day mortality rate of 25.4%. All 3 prognostic scores calculated using 24-hour imaging were more predictive of mortality as compared with baseline: the area under the curve was 0.82 at 24 hours (95% CI, 0.76-0.87) compared with 0.78 at baseline (95% CI, 0.72-0.84) for ICH Score, 0.84 at 24 hours (95% CI, 0.79-0.89) compared with 0.76 at baseline (95% CI, 0.70-0.83) for FUNC, and 0.82 at 24 hours (95% CI, 0.76-0.88) compared with 0.74 at baseline (95% CI, 0.67-0.81) for modified ICH Score. Conclusions- Calculation of the ICH Score, FUNC Score, and modified ICH Score using 24-hour imaging demonstrated better prognostic value in predicting 90-day mortality compared with those calculated at presentation.

Increasing Frailty Predicts Worse Outcomes and Increased Complications After Angiogram-Negative Subarachnoid Hemorrhages.

BACKGROUND: The effect of frailty on outcomes after angiogram-negative subarachnoid hemorrhages (ANSAH) is currently unknown. We investigated frailty's effects on ANSAH outcomes, including mortality and in-hospital complications. METHODS: Patients from 2014 to 2018 with non-traumatic subarachnoid hemorrhage and cerebral angiograms with an unidentifiable hemorrhage source were retrospectively reviewed. The cohort was divided into non-frail (modified frailty index [mFI] = 0) and frail (mFI ≥1) groups based on pre-hemorrhage characteristics. Primary outcomes were mortality rate and discharge location. Multivariate logistic regression analyses determined predictors of ANSAH severity and primary endpoints. Receiver operating characteristic curves were used to discriminate risks for primary endpoints comparing mFI, Hunt and Hess and Fisher scores, and age. RESULTS: We included 75 patients with a mean age of 55.4 ± 1.5 years, comprising 42 (56%) women, and 41 (54.7%) with perimesencephalic bleeds. A total of 32 of 75 (42.7%) patients were classified as frail. Frail individuals were 6.2 times less likely to be discharged home (odds ratio [OR] = 0.16; 95% confidence interval [CI]: 0.05-0.5; P = 0.001) and all mortalities occurred in frail patients (12.5% [n = 4 of 32]; P = 0.030). The only independent predictor of mortality was higher mFI (OR = 5.4; 95% CI: 1.5-19.1; P = 0.009), and lower mFI best predicted discharge home (OR = 0.39; 95% CI: 0.17-0.88; P = 0.023). Receiver operating characteristic analysis showed that mFI best predicted both mortality (area under the curve = 0.9718; P = 0.002) and discharge home (area under the curve = 0.7998; P < 0.001). CONCLUSIONS: Frail ANSAH patients have poorer outcomes and increased mortality compared with non-frail patients. Although prospective study is needed, this information significantly impacts our understanding of ANSAH outcomes and frailty should be used for prognostication as it was a better predictor than Hunt and Hess or Fisher scores.

Stent-assisted coiling of cerebral aneurysms: multi-center analysis of radiographic and clinical outcomes in 659 patients.

INTRODUCTION: The endovascular stent-assisted coiling approach for the treatment of cerebral aneurysms is evolving rapidly with the availability of new stent devices. It remains unknown how each type of stent affects the safety and efficacy of the stent-coiling procedure. METHODS: This study compared the outcomes of endovascular coiling of cerebral aneurysms using Neuroform (NEU), Enterprise (EP), and Low-profile Visualized Intraluminal Support (LVIS) stents. Patient characteristics, treatment details and angiographic results using the Raymond-Roy grade scale (RRGS), and procedural complications were analyzed in our study. RESULTS: Our study included 659 patients with 670 cerebral aneurysms treated with stent-assisted coiling (NEU, n=182; EP, n=158; LVIS, n=330) that were retrospectively collected from six academic centers. Patient characteristics included mean age 56.3±12.1 years old, female prevalence 73.9%, and aneurysm rupture on initial presentation of 18.8%. We found differences in complete occlusion on baseline imaging, defined as RRGS I, among the three stents: LVIS 64.4%, 210/326; NEU 56.2%, 95/169; EP 47.6%, 68/143; P=0.008. The difference of complete occlusion on 10.5 months (mean) and 8 months (median) angiographic follow-up remained significant: LVIS 84%, 251/299; NEU 78%, 117/150; EP 67%, 83/123; P=0.004. There were 7% (47/670) intra-procedural complications and 11.5% (73/632) post-procedural-related complications in our cohort. Furthermore, procedure-related complications were higher in the braided-stents vs laser-cut, P=0.002. CONCLUSIONS: There was a great variability in techniques and choice of stent type for stent-assisted coiling among the participating centers. The type of stent was associated with immediate and long-term angiographic outcomes. Randomized prospective trials comparing the different types of stents are warranted.

The Longest Angiographic and Clinical Follow-Up of Microsurgically Treated Giant Intracranial Aneurysms: Experience with 70 Cases.

BACKGROUND: Giant intracranial aneurysms (GIAs), if left untreated, have an extremely poor natural history. Despite many reports about the surgical treatment of GIAs, their long-term clinical and angiographic results are unclear. To our knowledge, this study reports the longest clinical and angiographic follow-up of microsurgically treated GIAs in the English literature. METHODS: Between January 1997 and December 2017, 70 patients with giant anterior circulation aneurysms treated using microsurgery were retrospectively reviewed. The applied microsurgical techniques and especially long-term clinical and angiographic follow-up data were evaluated. RESULTS: The mean aneurysm size was 29.2 mm (range, 25-58 mm). The aneurysm neck was occluded in 61 patients (87.2%). Nine aneurysms were clipped using an aneurysm clip compression technique. In 8 patients (11.4%), the aneurysm neck was found smaller at surgery than expected according to angiographic findings. Postoperative angiograms showed complete occlusion in 52 of 61 patients (85.2%). The treatment results at discharge were excellent-good (modified Rankin Scale score ≤2) in 75.3% of the patients. The overall mortality was 7.6%. At long-term clinical follow-up (mean, 105.2 months), 48 patients (78.6%) showed excellent-good outcome. At late angiographic follow-up (mean, 98.0 months), no recurrence was seen in patients with complete aneurysm closure. CONCLUSIONS: Most giant anterior circulation aneurysms can be successfully clipped, with acceptable morbidity and mortality. Some giant aneurysms have a smaller neck than expected. The aneurysm clip compression technique is useful in clipping of GIAs. This longest clinical and angiographic follow-up in the literature shows that clip ligation has excellent durability in GIAs, also.

Association between initial NIHSS score and recanalization rate after endovascular thrombectomy.

BACKGROUND: National institutes of Health Stroke Scale (NIHSS) score and the presence of successful recanalization are crucial determinants of clinical outcome in patients with major artery occlusion. However, it is unknown whether successful recanalization rate after endovascular therapy (EVT) depends on NIHSS score. METHODS: From our prospective EVT registry, data on patients with an occlusion at the internal carotid artery or middle cerebral artery were analyzed. Successful recanalization was judged as positive when reperfusion of the thrombolysis in cerebral infarction (TICI) scale ≥2b was observed. Successful recanalization rate was also evaluated based on the NIHSS score subgroups: 0-8, 9-16, 17-24, and >24. Multivariate regression analysis was used to evaluate the impact of NIHSS score on successful recanalization. RESULTS: We studied 183 patients (age 76 [68-83], male 110 [60%], NIHSS score 19 [14-24]). One hundred and forty-six (80%) patients had the successful recanalization. Patients achieved the recanalization had lower NIHSS score as 18 (12-23), contrary those failed it had higher NIHSS score as 24 (20-27) (p < .001). Successful recanalization rate was correlated to the NIHSS score grade; 100% in the NIHSS 0-8 group, 88% in 9-16, 81% in 17-24, and only 60% in >24 (p < .001). Multivariate regression analysis showed NIHSS score was an independent parameter of recanalization (odds ratio 0.905 [95%CI 0.837-0.979], p = .013). CONCLUSION: NIHSS score may serve as a predictor of successful recanalization. Recanalization is relatively easier in mild stroke than in those with severe stroke.

Impact of procedural time on clinical and angiographic outcomes in patients with acute ischemic stroke receiving endovascular treatment.

BACKGROUND: Procedural time in patients with acute ischemic stroke (AIS) undergoing mechanical thrombectomy may affect clinical outcomes. We performed a pooled analysis of the effect of procedural time on clinical outcomes using data from three prospective endovascular treatment trials. OBJECTIVE: To examine the relationship between endovascular procedural time and clinical outcomes of patients with AIS following endovascular treatment. METHODS: We analyzed data from SWIFT, STAR, and SWIFT PRIME studies, including baseline characteristics: National Institutes of Health Stroke Scale (NIHSS) score on admission, intracranial hemorrhage rates, and modified Rankin Scale score at 3 months. The Thrombolysis in Cerebral Infarction (TICI) scale was used to grade postprocedure recanalization. We recorded two procedural time intervals: (1) symptom onset to groin puncture and (2) groin puncture to angiographic recanalization. A multivariate analysis was performed using a logistic regression model to analyze predictors of unfavorable outcome. RESULTS: We analyzed 301 patients who had undergone endovascular treatment and had near-complete or complete recanalization (TICI 2b or 3). At 3 months, 122 patients (40.5%) had unfavorable outcomes. The rate of favorable outcomes was significantly higher when the procedural time was <60 min compared with ≥60 min (62% vs 45%, p=0.020). Predictors of unfavorable outcome at 3 months were age (unit 10 years, OR=0.62, 95% CI 0.46 to 0.82, p<0.001), onset to groin puncture time (unit hour, OR=0.61, 95% CI 0.48 to 0.77, p<0.001), groin puncture to recanalization (unit 10 min, OR=0.89, 95% CI 0.80 to 0.99, p=0.032), baseline NIHSS score (20-28 vs 8-10, OR=0.17, 95% CI 0.05 to 0.62, p=0.018), and collaterals (OR=1.48, 95% CI 1.04 to 2.10, p=0.029). CONCLUSION: Procedural time in patients with stroke undergoing mechanical thrombectomy may be an important determinant of favorable outcomes in those with recanalization.

Validation of an extrinsic compression and early ambulation protocol after diagnostic transfemoral cerebral angiography: a 5-year prospective series.

BACKGROUND AND PURPOSE: Access-site complications constitute a substantial portion of the morbidity associated with transfemoral cerebral angiography, yet no standardized protocol exists for femoral closure and practice patterns vary widely. The objective of this single-arm prospective cohort study was to validate the efficacy and safety of a standardized femoral closure strategy for all diagnostic angiography, regardless of antiplatelet regimen. METHODS: A single-arm, prospective study was designed enrolling consecutive patients undergoing diagnostic transfemoral cerebral angiography by a single neurointerventional surgeon from March 2013 - March 2018. The closure protocol consisted of 20 minutes of manual compression to the site of arterial access and 2 hours of bedrest. The primary outcome was hematoma or oozing after manual compression. Demographic, clinic, and laboratory data were collected and analyzed, and patients were stratified by antiplatelet use. RESULTS: Of 525 angiograms, 263 (50.1%) were on patients taking antiplatelet medication, with 66 (12.6%) on dual antiplatelet regimens. Five patients (0.95% of all patients) met the primary outcome: in all five cases, there was no further oozing or enlarging hematoma after the additional compression period. There were not significant differences in primary outcome in groups stratified by antiplatelet use, and there were no instances of delayed hematoma, pseudoaneurysm, or arteriovenous fistula. CONCLUSION: In this single-arm cohort study of 525 consecutive transfemoral angiograms with a standardized extrinsic compression protocol, hemostasis was achieved without complication in >99% regardless of antiplatelet strategy. This protocol is effective and safe for diagnostic transfemoral angiography regardless of a patient's antiplatelet use.

WEB embolization versus stent-assisted coiling: comparison of complication rates and angiographic outcomes.

BACKGROUND: Intrasaccular flow disruption represents a new paradigm in endovascular treatment of wide-necked bifurcation aneurysms. OBJECTIVE: To perform a matched case-control study comparing complications and angiographic outcome using the Woven Endobridge (WEB) device and stent-assisted coiling (SAC). METHODS: Sixty-six patients treated with the WEB at three German tertiary care centers were included and matched with 66 patients treated with SAC based on aneurysm location and unruptured/ruptured aneurysm status. Parameters were retrospectively analysed and compared between the treatment groups using inverse probability of treatment weighting (IPTW) with propensity scores. RESULTS: Procedural complication rates were 12.1% in the WEB group and 21.2% in the SAC group, which was statistically significant after IPTW adjustment (OR=2.2, 95% CI 1.08 to 4.4, p=0.03). Favourable outcome (modified Rankin scale score ≤2) was achieved by 57/66 (86.4%) in the WEB group and 57/66 (86.4%) in the SAC group (p=1.0). At mid-term follow-up, a similar number of aneurysms achieved adequate occlusion (complete occlusion or neck remnant) in the WEB group (93.9%) and in the SAC group (93.9%, p=1.0). Re-treatment was performed in 10.6% after WEB embolization and 12.1% after SAC (p=1.0). CONCLUSIONS: The WEB provides similar mid-term aneurysm occlusion rates to those of SAC, with no additional morbidity and potentially lower complication rates. Long-term outcome analysis will provide a definite conclusion on the use of WEB for intracranial aneurysms.

Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort.

BACKGROUND AND OBJECTIVE: Stent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial. METHOD: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints. RESULTS: 30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths. CONCLUSION: The Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort. CLINICAL TRIALGOV REGISTRATION NUMBER: NCT0234058;Results.

A clinical comparison of Atlas and LVIS Jr stent-assisted aneurysm coiling.

BACKGROUND: Case series have described the safety and efficacy of LVIS Jr and Atlas stent-assisted aneurysm coiling, but their comparative clinical performance has not yet been formally studied. OBJECTIVE: To clinically compare LVIS Jr and Atlas stents, emphasizing comparative rates of technical success and complications. METHODS: Our institutional endovascular database was queried for aneurysms treated by stent-assisted coiling with either the LVIS Jr or Atlas stents. Demographic data, aneurysm information, treatment technique, periprocedural and device-related complications, and initial and follow-up angiographic results were evaluated. RESULTS: Thirty-seven patients underwent Atlas stent placement and 27 patients underwent LVIS Jr stent placement for aneurysm coiling. There was no significant difference in aneurysm location, size, coiling technique, and coil packing density between the two cohorts. The rate of initial Raymond 1 occlusion was significantly greater in the Atlas cohort (57% vs 41%, P=0.03). The rate of postoperative ischemic complications, both clinically apparent and as defined on postoperative MRI diffusion-weighted imaging, did not significantly differ between the two groups. Follow-up DSA demonstrated a significantly greater rate of Raymond 1 or 2 occlusion for the Atlas cohort (100% vs 81%, P=0.04), and a significantly lower rate of in-stent stenosis (0% vs 19%, P=0.04). CONCLUSION: This institutional analysis demonstrates greater obliteration rates and lower in-stent stenosis rates for aneurysms treated via Atlas stent-assisted coiling as compared with those treated via LVIS Jr stent-assisted coiling.

A Meta-Analysis of Risk Factors for the Formation of de novo Intracranial Aneurysms.

BACKGROUND: Understanding the risk factors for the formation of de novo intracranial aneurysms (IAs) is important for patients who have ever suffered a cerebral aneurysm. OBJECTIVE: To estimate the risk factors for the development of a de novo IA to identify which patients need more aggressive surveillance after aneurysm treatment. METHODS: We followed the preferred reporting items for systematic reviews and meta-analyses guidelines and searched the PubMed, CENTRAL, EMBASE, and LILACS databases using the key words cerebral aneurysms, de novo, IAs, risk factors combined using and/or. The search was performed in July 2017.We calculated odds ratios (ORs) and 95% confidence intervals (CIs) using RevMan 5.3 (Cochrane, London, United Kingdom) to evaluate risk factors. Statistical significance was set at P < .05. RESULTS: The analysis included 14 studies involving 6389 patients, of whom 197 patients had de novo IAs. The main risk factors for formation included sex (OR = 1.82, 95% CI [1.30,2.56], P = .0005, female vs male), age <40 yr (OR = 2.96, 95% CI [1.76,4.96], P < .0001), family history (OR = 2.05, 95% CI [1.07,3.93], P = .03), smoking history (OR = 2.73, 95% CI [1.81,4.12], P < .0001), and multiple saccular intracranial aneurysms (sIAs) at first diagnosis (OR = 2.10, 95% CI [1.12,3.91], P = .02), internal carotid artery (ICA) as the initial site (OR = 2.58, 95% CI [1.43,4.68], P = .002). Heterogeneous analysis showed that these I2 were less than 50% and the results were reliable. CONCLUSION: Observational evidence identified multiple clinical and anatomic risk factors for the formation of de novo IAs, including female sex, age <40 yr, family history, smoking history, multiple sIAs at first diagnosis, and IC as the initial site. More aggressive long-term angiographic follow-up with digital subtraction angiography, computed tomography angiography, or magnetic resonance angiography is recommended for these patients.

Selective compromise of hypoplastic posterior communicating artery variants with aneurysms treatable by coil embolization: clinical and radiologic outcomes.

BACKGROUND: Posterior communicating artery (PcoA) compromise may serve as adjunctive treatment in patients with hypoplastic variants of PcoA who undergo coil embolization of PcoA aneurysms. However, procedural safety and the propensity for later recanalization are still unclear. OBJECTIVE: To evaluate clinical and radiologic outcomes of coil embolization in this setting, focusing on compromise of PcoA. METHODS: As a retrospective review, we examined 250 patients harboring 291 aneurysms of hypoplastic PcoAs, all consecutively treated by coil embolization between January 2004 and June 2016. PcoA compromise was undertaken in conjunction with 81 of the treated aneurysms (27.8%; incomplete 53; complete 28). Medical records and radiologic data were assessed during extended monitoring. RESULTS: During the mean follow-up of 33.9±24.6 months (median 36 months), a total of 107 (36.8%) coiled aneurysms showed recanalization (minor 50; major 57). Recanalization rates were as follows: PcoA preservation 40.5% (85/210); incomplete PcoA occlusion 34.0% (18/53); complete PcoA occlusion 14.3% (4/28). Aneurysms >7 mm (HR 3.40; P<0.01), retreatment for recanalization (HR 3.23; P<0.01), and compromise of PcoA (P<0.01) emerged from multivariate analysis as significant risk factors for recanalization. Compared with PcoA preservation, complete PcoA compromise conferred more favorable outcomes (HR 0.160), whereas incomplete compromise of PcoA fell short of statistical significance. Thromboembolic infarction related to PcoA compromise did not occur in any patient. CONCLUSION: PcoA compromise in conjunction with coil embolization of PcoA aneurysms appears safe in hypoplastic variants of PcoA, helping to prevent recanalization if complete occlusion is achieved.