Comparison of LVIS and Enterprise stent-assisted coiling embolization for ruptured intracranial aneurysms: a propensity score-matched cohort study.

The role of a low-profile visualized intraluminal support stent (LVIS) and Enterprise in the treatment of unruptured intracranial aneurysms is well established. Although previous studies have investigated one single type of stent for the treatment of ruptured intracranial aneurysms (RIA), the safety and efficacy between the two types of stents has not been fully explored. Herein we conducted a study to compare the outcomes of the two stents for treatment of RIA. This is a prospective registry database of aneurysmal subarachnoid hemorrhage (aSAH) patients admitted to a single institution between 2018 and 2021. We collected patient baseline information, secondary complications, follow-up angiographic data, long-term prognostic outcomes, and conducted propensity score matching (PSM) analysis with 1:1 ratio and a multivariable logistic regression to compare the outcomes of the two types of stents. A total of 231 patients with RIAs were included in this study, with 108 treated using the LVIS device and 123 treated using the Enterprise device. Before PSM analysis, only the incidence of poor prognosis after 12 months was higher in the Enterprise group comparing to the LVIS group (20% vs. 10%, P = 0.049). After PSM analysis, there was a higher occurrence of delayed cerebral ischemia (DCI) in the Enterprise group compared to the LVIS group (odds ratio [OR] 3.95, 95% confidence interval [CI] [1.20-13.01], P = 0.024). However, no significant difference in prognosis was observed after PSM adjustment. Furthermore, subgroup analysis revealed that patients with female (P = 0.019), hypertension (P = 0.048), and anterior circulation aneurysms (P = 0.019) receiving the Enterprise device had a higher risk of DCI. The overall efficacy of LVIS and Enterprise in the treatment of RIA is comparable, while the incidence of DCI in the LVIS group is lower than that in the Enterprise group after PSM analysis. Registration number: NCT05738083 ( https://clinicaltrials.gov/ ).

Serum interleukin-1 is a new biomarker to predict the risk of rebleeding of ruptured intracranial aneurysm after admission.

Interleukin-1 (IL-1) could induce inflammation of the aneurysm wall, which might be related to intracranial aneurysm rupture. The aim of this study was to investigate whether IL-1 could serve as a biomarker to predict the risk of rebleeding after admission. Data between January 2018 and September 2020 were collected from patients with ruptured intracranial aneurysms (RIAs) and were retrospectively reviewed. The serum IL-1ß and IL-1ra levels were detected using a panel, and IL-1 ratio was calculated as the log10 (IL-1ra/IL-1ß). The predictive accuracy of IL-1 compared with previous clinical morphology (CM) model and other risk factors were evaluated by the c-statistic. Five hundred thirty-eight patients were finally included in the study, with 86 rebleeding RIAs. The multivariate Cox analysis confirmed aspect ratio (AR) > 1.6 (hazard ratio (HR), 4.89 [95%CI, 2.76-8.64], P < 0.001), size ratio (SR) > 3.0 (HR, 2.40 [95%CI, 1.34-4.29], P = 0.003), higher serum IL-1ß (HR, 1.88 [95%CI, 1.27-2.78], P = 0.002), and lower serum IL-1ra (HR, 0.67 [95%CI, 0.56-0.79], P < 0.001) as the independent risk factors for rebleeding after admission. According to the c-statistics, the IL-1 ratio had the highest predictive accuracy (0.82), followed by IL-1ra and IL-1ß (0.80), AR > 1.6 (0.79), IL-1ra (0.78), IL-1ß (0.74), and SR > 3.0 (0.56), respectively. Subgroup analysis based on AR and SR presented similar results. The model combining IL-1 ratio and CM model showed higher predictive accuracy for the rebleeding after admission (c-statistic, 0.90). Serum IL-1, especially IL-1 ratio, could serve as a biomarker to predict the risk of rebleeding after admission.

Neuroform Atlas stent-assisted coiling of ruptured intracranial aneurysms: A multicenter study.

PURPOSE: To assess efficacy, safety and to discuss optimal medical therapy of stent-assisted coiling of ruptured intracranial aneurysms. METHODS: Ruptured intracranial aneurysms treated with stent-assisted coiling in eight different institutions were retrospectively reviewed. Medical treatment regimens varied among the centers, mainly regarding heparin administration and post-procedural single or double antiplatelet therapy. Clinical and angiographic results, including complications and outcomes were analyzed and related to the different therapies. RESULTS: Sixty-one consecutive patients (male/female 23/38), aged 59.1 years (36-86) underwent stent-assisted coiling for ruptured intracranial aneurysm without antiplatelet pre-medication. Intravenous acetylsalicylic acid (ASA) 500mg was administered to all patients immediately after stent deployment. At the same time heparin was given as bolus in 15 patients (24.6%) as part of local protocol. Intravenous glycoprotein 2b/3a inhibitors (antiGP2b3a) were used as bail-out therapy for stent thrombosis. Stent thrombosis occurred in 22 patients (36.1%), of which 4 (6.5%) lead to incomplete and 18 (29.6) to complete occlusion of the stent. Heparin administration had no effect on thrombosis rate. Thrombosis resolution occurred in all cases with intravenous antiGP2b3a (7 tirofiban, 15 abciximab), without increasing overall complication rate. Single antiplatelet therapy with ASA (28 patients, 45.9%) or double antiplatelet therapy including ASA and clopidogrel (33 patients, 54.1%) were administered after procedure, depending on local protocols and on neurointerventionists' experience. Overall complication rate, including ischemia and hemorrhage was higher in patients in which only ASA was administered (21.4% vs. 12.1%). No late stent thrombosis was seen, regardless of whether a single or double antiplatelet regimen was used. Nevertheless, the small sample size suggests caution in interpreting these results. Moreover, a possible bias may arise from the decision whether to modify the maintenance therapy or not depending on the severity of the intracranial hemorrhage in a case-by-case assessment. At three months, 34 out of 38 patients with HH grade 1-2 (89.4%), and 11 out of 23 with Hunt-Hess grade of 3-4 (47.8%) were independent (Modified Ranking Scale 0-2). CONCLUSION: Stent assisted coiling of ruptured intracranial aneurysms is a feasible option when simple coiling is not possible. Optimal medical treatment is still controversial because balance between hemorrhagic and ischemic risks is difficult to evaluate. In our series, heparin bolus had no effect on subsequent stent thrombosis. In all cases peri-operative stent thrombosis was successfully managed using bail-out intravenous antiGP2b3a, which did not increase post-procedural hemorrhage rates. A non-significant trend towards increased complications rate was noticed in patients treated with single antiplatelet therapy versus double antiplatelet therapy.

The safety and outcomes of acutely ruptured intracranial aneurysms with incomplete occlusion after coiling: a case-control study.

BACKGROUND: Incomplete aneurysmal occlusion is a common feature of immediate posttreatment angiography. The safety and outcomes of acutely ruptured intracranial aneurysms (RIAs) with incomplete occlusion after stent-assisted coiling (SAC) and no-stent coiling (NSC) have not been well clarified. Progressive occlusion of stents can promote the complete occlusion of intracranial aneurysms (IAs), but it remains to be determined if progressive occlusion in acutely RIAs with incomplete occlusion after coiling may be enhanced by protective stenting. This study aimed to evaluate the safety and outcomes of those aneurysms after SAC and NSC; And to discover whether the stents can promote progressive aneurysm occlusion in such lesions or not. METHODS: We reviewed 199 patients with acutely RIAs underwent endovascular coiling and developed incomplete occlusion in the past seven years. The patients' clinical and imaging information were recorded and analyzed. Univariate and multivariate analyses were performed to determine the association of recurrence rate with potential risk factors. RESULTS: SAC group had wider aneurysms neck (3.471 mm vs 2.830 mm, P = 0.009) and smaller dome-to-neck ratio (1.536 vs 2.111, P = 0.001) than in NSC group. There was no significant difference between the two groups in total procedure-related complications rate (31.7% vs 23.5%, P = 0.195), procedure-related mortality (6.9% vs 2.0%, P = 0.170) and modified Rankin Scale (mRS) score at 6-month follow-up (P > 0.05). However, SAC group had significantly higher ischemic complications rate (21.8% vs 8.2%, P = 0.007) and complete occlusion rate (65.6% vs 48.3%, P = 0.020), and lower recurrence rate (15.6% vs 28.1%, P = 0.042) than NSC group based on 6-month follow-up angiograms. Additionally, Multivariable analysis showed NSC was an independent risk factor for aneurysm recurrence (Odds Ratio [OR]: 4.061; P = 0.018). CONCLUSIONS: Acutely RIAs with incomplete occlusion after SAC is associated with higher complications rate and mortality, but has an acceptable safety profile and similar clinical outcome compared to NSC, as well as gives patients superior angiography outcome by progressive occlusion of stents.

Endovascular treatment of ruptured intracranial aneurysms in elderly patients: clinical features and treatment outcome.

Management of ruptured intracranial aneurysm in elderly patients is still a major challenge in the treatment of cerebrovascular disease. This study aimed to evaluate safety and efficacy profiles of ruptured intracranial aneurysms in elderly patients treated with endovascular techniques (EVTs). We conducted a retrospective case review of 53 consecutive elderly patients with ruptured intracranial aneurysms treated by EVT between the year 2011 and 2016. The patients' angiographic outcomes, clinical outcomes, and procedure-related complications were reviewed retrospectively. Univariate and multivariate logistic analysis were applied to determine the risk factors of aneurysm recurrence and clinical prognosis. In 29 (54.7%) patients, the treatment was attempted with coiling alone. The vascular remodeled technique was applied in 24 (45.3%) patients. At a median angiographic follow-up of 9 months, 35 (67.3%) aneurysms showed stable, 9 (17.3%) were improvement, and 8 (15.4%) were recurrent. According to the multivariate analysis, the size of the aneurysm was independently associated with increased risk of aneurysm recurrence (odds ratio, 1.92; 95% confidence interval, 1.181-2.211; p = 0.006). High Hunt-Hess grade at admission was an independent predictor of poor functional outcome in the multivariate analysis (odds ratio, 5.93; 95% confidence interval, 1.878-33.63; p = 0.008). In 8 (15.1%) patients, it resulted in procedure-related complications. EVT of ruptured intracranial aneurysms in elderly patients is safe, effective, and have low recurrent rate. Recurrence after EVT for ruptured aneurysms is common in cases of large-size aneurysms. The overall clinical outcome was worst in patients presented with high Hunt-Hess grade.

Review Article Imaging Evaluation for the Size of Saccular Intracranial Aneurysm.

BACKGROUND: In addition to evaluate the morphologic characteristics of intracranial aneurysms, the dimension of the aneurysm is an important parameter for selecting treatment strategies, determining follow-up period, and predicting the risk of rupture. High-resolution vessel wall imaging has an increasingly dominant role in measuring aneurysm size and assessing the risk of rupture accurately. The size of saccular intracranial aneurysm may play an important role as a predictor of the rupture risk. With the rapid improvement in radiological techniques, different noninvasive imaging methods have respective characteristics in saccular intracranial aneurysms (sIA) measurement and morphologic description. Although most studies believe that the larger the aneurysm, the higher the risk of rupture, there is still a synergistic effect of multiple factors (such as location, morphology, history of aneurysmal subarachnoid hemorrhage, and even patient factors) to explain the rupture of small aneurysms. METHODS: A literature search was performed of intracranial aneurysm size and risk of rupture. RESULTS: The specificity and sensitivity of different imaging methods for evaluating intracranial aneurysms varied based on sizes. Rupture risk of aneurysms was associated with multiple factors. A comprehensive assessment that considered aneurysm size in conjunction with other relevant factors would be helpful in guiding options of management. CONCLUSIONS: Accurate measurement of the dimension of sIA is an important basis in the selection of appropriate treatment including intravascular intervention or surgical clipping, as well as for determining the follow-up cycles for conservative or postoperative treatment. A uniform definition of sIA size is recommended to facilitate the integration of similar studies and to accomplish rapid and effective screening of cases in sIA treatment.

Development of a model to predict the risk of multi-drug resistant organism infections in ruptured intracranial aneurysms patients with hospital-acquired pneumonia in the neurological intensive care unit.

OBJECTIVE: This study was developed to explore the incidence of multi-drug resistant organism (MDRO) infections among ruptured intracranial aneurysms(RIA) patient with hospital-acquired pneumonia(HAP) in the neurological intensive care unit (NICU), and to establish risk factors related to the development of these infections. METHODS: We collected clinical and laboratory data from 328 eligible patients from January 2018 to December 2022. Bacterial culture results were used to assess MDRO strain distributions, and risk factors related to MDRO infection incidence were identified through logistic regression analyses. These risk factors were further used to establish a predictive model for the incidence of MDRO infections, after which this model underwent internal validation. RESULTS: In this study cohort, 26.5 % of RIA patients with HAP developed MDRO infections (87/328). The most common MDRO pathogens in these patients included Multidrug-resistant Klebsiella pneumoniae (34.31 %) and Multidrug-resistant Acinetobacter baumannii (27.45 %). Six MDRO risk factors, namely, diabetes (P = 0.032), tracheotomy (P = 0.004), history of mechanical ventilation (P = 0.033), lower albumin levels (P < 0.001), hydrocephalus (P < 0.001) and Glasgow Coma Scale (GCS) score ≤8 (P = 0.032) were all independently correlated with MDRO infection incidence. The prediction model exhibited satisfactory discrimination (area under the curve [AUC], 0.842) and calibration (slope, 1.000), with a decision curve analysis further supporting the clinical utility of this model. CONCLUSIONS: In summary, risk factors and bacterial distributions associated with MDRO infections among RIA patients with HAP in the NICU were herein assessed. The developed predictive model can aid clinicians to identify and screen high-risk patients for preventing MDRO infections.

Safety and efficacy of endovascular treatment for tiny ruptured intracranial aneurysms with low-profile visualized intraluminal support stents.

BACKGROUND: Endovascular treatment for tiny ruptured intracranial aneurysms is known to be technically challenging. Thus, we aimed to investigate the safety and efficacy of low-profile visualized intraluminal support (LVIS) stents in the treatment of tiny ruptured intracranial aneurysms. METHODS: From April 2014 to June 2019, among 90 patients with tiny ruptured aneurysms who were treated at our institution endovascularly, 28 underwent stent-assisted coiling with LVIS stents. The clinical and angiographic results were reviewed. RESULTS: In the LVIS group, complete occlusion was achieved in 27 patients (96.4%). Intraprocedural thrombus formation occurred in 3 patients (10.7%). Follow-up angiography in 24 patients at 6-12 months showed complete occlusion in 23 patients (95.8%) and no aneurysm recurrence. In the coiling-only group, complete occlusion was achieved in 58 patients (93.5%). Intraprocedural aneurysm rupture occurred in 2 patients (3.2%), and postprocedural ischemia occurred in 4 patients (6.5%), with a complication rate of 9.7%. Follow-up angiography in 52 patients at 6-12 months showed complete occlusion in 43 patients (82.7%) and aneurysm recurrence in 7 patients (9.2%). No significant (p > 0.05) differences existed between the two groups. CONCLUSIONS: The LVIS stent is safe and effective in the treatment of tiny ruptured intracranial aneurysms.

Staged stenting strategy of acutely wide-neck ruptured intracranial aneurysms: A meta-analysis and systematic review.

Objective: In the study, we explored the safety and effectiveness of staged stenting strategy for acutely wide-neck ruptured intracranial aneurysms. Methods: Online databases, including PubMed, EMBASE, the Cochrane database, and Web of Science, were retrospectively and systematically searched. The main observation indicators were the procedure-related complication rate, complete occlusion rate, and favorable clinical outcome. Meta-analysis was performed using a random or fixed effect model based on heterogeneity. Results: A total of 5 studies with 143 patients were included. The hemorrhagic complication rate of the initial coiling and staged stenting was 2.8% (4 of 143) and 0, respectively. The ischemic complication rate of the coiling and supplemental stenting was 3.5% (5 of 143) and 2.9% (4 of 139), respectively. There were no deaths due to procedure-related complications in two stages. The aneurysm complete occlusion rate was 25% (95% CI, 0.13-0.03; I2 = 4.4%; P = 0.168) after initial coiling, 54% (95% CI, 0.63-0.64; I2 = 0%; P = 0.872) after staged stenting, and 74% (95% CI, 0.66-0.81; I2 = 56.4%; P = 0.562) at follow-up, respectively. Favorable clinical outcome rate 74% (95% CI, 0.61-0.86; I2 = 50.5%; P = 0.133) after discharge of initial coiling treatment, and 86% (95% CI, 0.80-0.92; I2 = 0; P = 0.410) after discharge from stenting, and 97% (95% CI, 0.93-1.01; I2 = 43.8%; P = 0.130) at follow-up. Conclusion: Staged stenting treatment of wide-neck RIA with coiling in the acute phase followed by delayed regular stent or flow-diverter stent had high aneurysm occlusion rate, favorable clinical outcome rate and low procedure-related complication rate. A more dedicated and well-designed controlled study is warranted for further evaluation of staged stenting treatment compared to SCA in wide-neck RIA.

A single-center comparative study with large sample size on stent-assisted coiling versus coiling alone for the ruptured anterior communicating artery aneurysms: Analysis of safety, efficacy, and prognosis based on propensity score matching.

OBJECTIVE: To compare the safety, efficacy, and prognosis of stent-assisted coiling (SAC) versus coiling alone (CA) in the treatment of ruptured anterior communicating artery aneurysms (ACoAAs). METHODS: The clinical and follow-up data of ruptured ACoAAs treated with endovascular treatment in our center from January 2011 to January 2021 were retrospectively collected. Patients were divided into an SAC group and a CA group based on whether stents were used, after which the two groups were matched for propensity scores. The general clinical data, embolization effect, perioperative complications, clinical, and follow-up results after matching were compared. RESULTS: A total of 354 patients were enrolled, of whom 147 patients (41.5%) received SAC and the rest received CA. Comparison baseline of two groups showed that patients with a larger diameter, wide neck, irregular morphology, and anterior direction were more likely to receive SAC. After propensity score matching, 113 patients were included in each group. Immediately postoperative angiography results showed that the complete embolization rate of patients in the SAC group was significantly lower than that in the CA group (62.8% vs. 76.1%, p = 0.03). There were no significant differences between the two groups in the incidence of perioperative complications, mortality, poor prognosis at discharge or follow-up, mid-term complete occlusion rate and recurrence rate. CONCLUSION: The stent-assisted treatment of ruptured ACoAAs did not increase the risk of perioperative complications or the probability of poor prognosis, indicating that SAC treatment of ruptured ACoAAs is safe and feasible and has a reliable mid-term cure rate.

Endovascular coiling versus microsurgical clipping for ruptured intracranial aneurysms: a meta-analysis and systematic review.

BACKGROUND: The purpose of this analysis is to evaluate the current evidence with regard to the effectiveness and safety between coiling and clipping in patients with ruptured intracranial aneurysms (RIAs). METHODS: We performed a meta-analysis that compared clipping with coiling between July 2000 and September 2021. PubMed, EMBASE, and the Cochrane Library were searched for related articles systematically. And the treatment efficacy and postoperative complications were analyzed. RESULTS: We identified three randomized controlled trials and thirty-seven observational studies involving 60,875 patients with ruptured cerebral aneurysms. The summary results showed that coiling was related a better quality of life (mRS0-2; OR=1.327; CI=1.093-1.612; p<0.05), a higher risk of mortality (OR=1.116; CI=1.054-1.180; p<0.05), higher rate of rebleeding (RR=1.410; CI=1.092-1.822; p<0.05), lower incidence of vasospasm (OR=0.787; CI=0.649-0.954; p<0.05), higher risk of hydrocephalous (RR=1.143; CI=1.043-1.252; p<0.05), lower risk of cerebral infarction (RR=0.669; CI=0.596-0.751; p<0.05), lower risk of neuro deficits (RR=0.720; CI=0.582-0.892; p<0.05), and a lower rate of complete occlusion (OR=0.495; CI=0.280-0.876; p<0.05). CONCLUSION: Coiling was significantly associated with a better life quality (mRS0-2), a lower incidence of postoperative complications, and a higher rate of mortality, rebleeding, hydrocephalous, and a lower rate of complete occlusion than clipping.

Worldwide productivity and research trends of publications concerning stent application in acutely ruptured intracranial aneurysms: A bibliometric study.

Background: Stenting is a common clinical practice to treat acutely ruptured intracranial aneurysm (RIA). Although multiple studies have demonstrated its long-term safety and effectiveness, there is currently a lack of bibliometric analysis on stent application in acutely RIA. This study sought to summarize the current status of research in this field and lay a foundation for further study. Materials and methods: Related publications were searched in the Web of Science Core Collection (WoSCC) database. Data analysis and visualization were performed by R and CiteSpace software. Results: A total of 275 publications published in English from 1997 to 2022 were included in this study. The growth of publications slowed down. The reference co-citation network identified 13 clusters with a significant network (Q = 0.7692) and convincing clustering (S = 0.9082). The research focus was acutely RIA and the application of stents during interventional procedures. The main trends of research were: (1) development of materials, and (2) safety of stent application in acutely RIA. The United States contributed the most articles, and Jianmin Liu was the most prolific author. Mayo Clinic was the leading institution in this field. Most articles were published in Interventional Neuroradiology. Conclusions: This study analyzed the research trends, hotspots and frontiers of stent application in acutely RIA. It is our hope that the results obtained could provide useful information to researchers to get a clearer picture about their future research directions in this field.

Comparison of Enterprise stent 2 with 1 in assisting coiling of ruptured aneurysms: a real-world study.

Aim: To investigate the effectiveness and safety of the Enterprise 2 (E2) stent versus the Enterprise 1 (E1) stent in treating ruptured intracranial aneurysms (RIAs) in China. Materials & methods: The authors conducted an electronic medical record analysis for patients with RIAs who underwent E1/E2 deployment. The main outcomes were immediate complete occlusion (ICO), patient functional outcomes, complications and aneurysm recurrence. Results: Stent deployment was successful in all patients (E2: 90; E1: 270). ICO and patients with good functional outcomes at discharge were similar between E2 and E1 (80.0% vs 75.1% and 78.7% vs 81.1%, respectively). The E2 group had a significantly lower complication rate compared with the E1 group (7.8% vs 16.4%; odds ratio: 0.36; 95% CI: 0.15-0.91; p = 0.031). By 6 months post-discharge, the two groups had comparable patient functional outcomes and aneurysm recurrence (E2 vs E1: 80.2% vs 81.9% and 13.3% vs 14.9%). Conclusion: Compared with the E1 stent, the E2 stent had similar effectiveness but a lower complication risk in treating RIAs.

Stent-assisted coiling vs. coiling alone of ruptured tiny intracranial aneurysms: A contemporary cohort study in a high-volume center.

Objective: This study aims to compare the safety and efficacy of stent-assisted coiling (SAC) with those of coiling alone (CA) for the treatment of ruptured tiny intracranial aneurysms. Methods: We enrolled 245 patients with ruptured tiny intracranial aneurysms treated with coil embolization. Patients were grouped into SAC and CA groups. Baseline characteristics, periprocedural complications, clinical outcomes, and angiographic results were compared between the two groups. In addition, a subgroup analysis was conducted in the SAC group, and patients were regrouped into low-profile visualized intraluminal support (LVIS) and laser-cut groups to compare the perioperative procedure-related complications and clinical and angiographic follow-up outcomes. Results: All baseline characteristics were equivalent between the two groups except for aneurysm size and dome-to-neck aspect ratio. The rates of overall procedure-related complications, intraprocedural rupture, postoperative early rebleeding, intraprocedural thrombosis, postprocedural thrombosis, and procedure-related mortality were comparable between the two groups (P = 0.105, 0.145, 0.308, 1.000, 1.000, 0.160, respectively). Nevertheless, the rate of hemorrhagic complication in the SAC group was significantly higher (P = 0.023). The angiographic follow-up outcomes showed that the SAC group had a higher complete occlusion rate and lower recurrence rate (88.2 vs. 67.1%, 5.4 vs. 15.2%, P = 0.001). The clinical outcomes at discharge and follow-up between the two groups demonstrated no significant differences (P = 0.192 and P = 0.085, respectively). For subgroup analysis, LVIS stents were associated with a significantly higher rate of complete occlusion (P = 0.014) and a lower rate of intraprocedural rupture (p = 0.021). Moreover, multivariate analysis showed that there were no predictors for the overall, hemorrhagic, and ischemic procedure-related complications, while Raymond class was an independent predictor of retreatment (OR = 3.508, 95% CI 1.168-11.603; P = 0.029). Conclusion: Stent-assisted coiling may increase the incidence of hemorrhagic events with favorable angiographic results and comparable clinical outcomes compared with stand-alone coiling. Nevertheless, LVIS stent could improve the safety compared with lazer-cut stent. Simultaneously, considering the better long-term effect, LVIS stent-assisted coiling may be a preferable choice for ruptured tiny intracranial aneurysms.

Understanding intent to treat analyses: An important lesson from the international cooperative study on the timing of aneurysm surgery.

BACKGROUND AND PURPOSE: Intent-to-treat analyses (ITT) are the best way to analyze randomized clinical trials because they preserve the benefits of randomization: to provide an unbiased assessment of relative treatment effects. Yet they play a more fundamental role, which can be demonstrated with observational studies. METHODS: We use a hypothetical RCT to explain why ITT analyses are more appropriate to analyze RCT results. We review the International Cooperative Study on the Timing of Aneurysm Surgery (ICSTAS), a landmark observational study on the management of ruptured aneurysm patients. We discuss the impact of the ICSTAS lesson on the interpretation of future observational studies using Big Data. RESULTS: Per-protocol (or as-treated) analyses can be misleading: The ICSTAS study provided 'as-treated' results clearly in favour of delayed surgery, while overall management or ITT results showed no difference between early and delayed surgery. A contemporary RCT showed that early surgery was best. ICSTAS' lesson is that observational studies can provide misleading results when intent-to-treat categories are not predefined in the first place. CONCLUSION: Intent-to treat analyses are the most appropriate way to analyze data, whether from randomized trials or observational studies. This observation has momentous consequences. A science of medical practice is impossible without predefined questions regarding optimal care.

Rebleeding of Ruptured Intracranial Aneurysm After Admission: A Multidimensional Nomogram Model to Risk Assessment.

OBJECTIVE: Rebleeding is recognized as the main cause of mortality after intracranial aneurysm rupture. Though timely intervention can prevent poor prognosis, there is no agreement on the surgical priority and choosing medical treatment for a short period after rupture. The aim of this study was to investigate the risk factors related to the rebleeding after admission and establish predicting models for better clinical decision-making. METHODS: The patients with ruptured intracranial aneurysms (RIAs) between January 2018 and September 2020 were reviewed. All patients fell to the primary and the validation cohort by January 2020. The hemodynamic parameters were determined through the computational fluid dynamics simulation. Cox regression analysis was conducted to identify the risk factors of rebleeding. Based on the independent risk factors, nomogram models were built, and their predicting accuracy was assessed by using the area under the curves (AUCs). RESULT: A total of 577 patients with RIAs were enrolled in this present study, 86 patients of them were identified as undergoing rebleeding after admission. Thirteen parameters were identified as significantly different between stable and rebleeding aneurysms in the primary cohort. Cox regression analysis demonstrated that six parameters, including hypertension [hazard ratio (HR), 2.54; P = 0.044], bifurcation site (HR, 1.95; P = 0.013), irregular shape (HR, 4.22; P = 0.002), aspect ratio (HR, 12.91; P < 0.001), normalized wall shear stress average (HR, 0.16; P = 0.002), and oscillatory stress index (HR, 1.14; P < 0.001) were independent risk factors related to the rebleeding after admission. Two nomograms were established, the nomogram including clinical, morphological, and hemodynamic features (CMH nomogram) had the highest predicting accuracy (AUC, 0.92), followed by the nomogram including clinical and morphological features (CM nomogram; AUC, 0.83), ELAPSS score (AUC, 0.61), and PHASES score (AUC, 0.54). The calibration curve for the probability of rebleeding showed good agreement between prediction by nomograms and actual observation. In the validation cohort, the discrimination of the CMH nomogram was superior to the other models (AUC, 0.93 vs. 0.86, 0.71 and 0.48). CONCLUSION: We presented two nomogram models, named CMH nomogram and CM nomogram, which could assist in identifying the RIAs with high risk of rebleeding.

Clipping versus Coiling for Ruptured Intracranial Aneurysms: A Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: The treatment strategies of ruptured intracranial aneurysms (RIAs) include surgical clipping and endovascular coiling, and the efficacy and safety of clipping versus coiling are yet controversial. OBJECTIVE: To summarize the available randomized controlled trials to determine the optimal treatment method for patients with RIA. METHODS: PubMed, Embase, and the Cochrane Library were systematically searched for randomized controlled trials published up to September 5, 2017. The summary analysis was performed using a random-effects model. The primary outcomes included poor outcome, mortality, and rebleeding, whereas the secondary outcomes included complete occlusion, incomplete occlusion, severe disability, and vegetative state. RESULTS: We identified 5 trials with data collected from 2883 patients. The summary results indicated that surgical clipping in patients was associated with a high incidence of poor outcome (relative risk [RR], 1.34; 95% confidence interval [CI], 1.18-1.51; P < 0.001), whereas no significant effect was observed on mortality (RR, 1.09; 95% CI, 0.79-1.49; P = 0.608) and rebleeding (RR, 0.65; 95% CI, 0.20-2.06; P = 0.460) compared with endovascular coiling. Furthermore, we noted that surgical clipping significantly increased the incidence of complete occlusion compared with endovascular coiling (RR, 1.30; 95% CI, 1.09 1.55; P = 0.004). Conversely, surgical clipping was associated with a low incidence of incomplete occlusion (RR, 0.67; 95% CI, 0.45-0.99; P = 0.044). No significant differences were noted between surgical clipping and endovascular coiling with respect to the outcomes of severe disability (RR, 1.39; 95% CI, 0.90-2.16; P = 0.140) and vegetative state (RR, 1.35; 95% CI, 0.84-2.17; P = 0.213). CONCLUSIONS: This meta-analysis provides moderate evidence that surgical clipping has few benefits than endovascular coiling for the treatment of RIA.

Validation of a neurovascular comorbidities index for retrospective database analysis.

OBJECTIVE: Comorbidities have a significant effect on patient outcomes. Accounting for this effect is especially important in retrospective reviews of large databases; overpowered studies are at risk for finding significant results because of inaccurate patient risk stratification. The authors previously created a neurovascular comorbidities index (NCI) for patients with an unruptured intracranial aneurysm and found that the model's ability to predict patient outcomes was statistically significantly improved over that of the routinely used Charlson Comorbidity Index (CCI) and Elixhauser Comorbidity Index (ECI). In this study, the authors aimed to validate use of the NCI over that of the CCI and ECI for risk stratification of patients with other neurovascular diseases. METHODS: The authors queried the National (Nationwide) Inpatient Sample database for the years 2002-2012 to compare the accuracy of the previously validated NCI with that of the CCI and ECI with respect to predicting outcomes for patients who had an arteriovenous malformation, a ruptured intracranial aneurysm, carotid artery stenosis, or dural arteriovenous fistula and who underwent surgical intervention. RESULTS: For patients with an arteriovenous malformation, the NCI outperformed the CCI and ECI in predicting poor outcome, hospital length of stay (LOS), and total cost but was equivalent to the CCI in predicting death. For patients with a ruptured intracranial aneurysm, the NCI outperformed the ECI and CCI in predicting death, poor outcome, LOS, and total cost. For patients with carotid artery stenosis, the NCI outperformed the ECI and CCI in predicting LOS, but it was equivalent to the ECI in predicting death and total cost and inferior to the CCI in predicting poor outcome (p < 0.002 for all). An insufficient number of patients with dural arteriovenous fistula who underwent surgical intervention were available for analysis (n < 10), and they therefore were excluded from study. For 11 of 12 metrics, the NCI was the significantly more efficient model. CONCLUSIONS: The NCI outperforms the CCI and ECI by providing more appropriate and efficient risk stratification of patients regarding death, outcome, LOS, and cost. Given this finding, the NCI should be used for retrospective reviews of patient outcomes instead of the CCI or ECI.

Coiling Is Not Superior to Clipping in Patients with High-Grade Aneurysmal Subarachnoid Hemorrhage: Systematic Review and Meta-Analysis.

BACKGROUND: Outcomes of coiling embolization versus clipping for patients with high-grade aneurysmal subarachnoid hemorrhage (aSAH) have not been previously compared. We reviewed current evidence regarding the safety and efficacy of clipping versus coiling for high-grade aSAH. METHODS: We conducted a meta-analysis of studies that compared clipping with coiling in patients with high-grade aSAH published from January 1999 to February 2016 in Medline, Embase, and Cochrane databases based on PRISMA inclusion and exclusion criteria. Binary outcome comparisons between clipping and coiling were described using odds ratios (ORs). RESULTS: Three randomized controlled trials (RCTs) and 16 observational studies were included. There was no statistical difference in good outcome rates between the clipping and coiling groups (OR, 1.44; 95% confidence interval [CI], 0.97-2.13). Subgroup analysis showed no significant difference between the 2 treatments in non-RCTs (OR, 1.49; 95% CI, 0.95-2.36) and RCTs (OR, 1.15; 95% CI, 0.59-2.25). Coiling was associated with higher mortality (OR, 0.55; 95% CI, 0.41-0.75). Lower mortality was associated with clipping in non-RCTs (OR, 0.54; 95% CI, 0.40-0.74), but there was no difference in the RCTs (OR, 0.79; 95% CI, 0.19-3.39). Coiling was not associated with lower rates of complications including rebleeding (OR, 0.62; 95% CI, 0.30-1.29), ischemic infarct (OR, 0.89; 95% CI, 0.53-1.49), symptomatic vasospasm (OR, 0.76; 95% CI, 0.45-1.29), or shunt-dependent hydrocephalus (OR, 1.33; 95% CI, 0.52-3.40). CONCLUSION: The outcome with coiling is not superior to clipping in patients with high-grade aSAH; moreover, coiling has a greater risk of mortality.

Treatment of acutely ruptured wide-necked intracranial aneurysms using self-expanding stent.

OBJECTIVES: To evaluate the effectiveness and safety of self-expanding stent in treatment of acutely ruptured wide-necked intracranial aneurysms in the acute stage. METHOD: Treatment of 38 patients with self-expanding stent was retrospectively analyzed. RESULTS: From January 2009 to May 2014, a total of 38 patients with 44 acutely ruptured wide-necked intracranial aneurysms were embolized with self-expanding stents at our center. Immediate post-operative imaging demonstrated that the aneurysms were densely packed in 17 patients, subtotally embolized in 2 patients, and subtotally embolized with residual aneurysm necks in 19 patients. At discharge, the patients were assessed for prognosis and the results revealed nerve dysfunction in 3 patients (7.9%), coma in 6 patients (15.8%), hospital death in 1 case (2.6%). Twenty-eight (73.7%) patients were asymptomatic at discharge. Ten of the 38 patients were followed up by angiography for a period of 3.7 months on average, which showed complete occlusion in 9 patients (90%), remnant aneurysm necks in 1 patient (10%), and no recanalization was observed in all the followed-up patients. Stent related complications also were recorded. CONCLUSION: Stent-assisted coiling is effective in treating acutely ruptured wide-necked intracranial aneurysms. Angiographic investigation and clinical follow-up is needed for evaluation of long-term clinical outcomes.