Abstract 1122‐000074: EnterpriseTM 1 versus EnterpriseTM 2 Stent‐Assisted Coiling in Treating Ruptured Intracranial Aneurysms: A Real‐World Study

Author(s):  
Zhenbao Li ◽  
Zhenbao Li ◽  
Jianwei Xuan ◽  
Xinggen Fang ◽  
Xintong Zhao ◽  
...  

Introduction : Enterprise TM 2 is an innovative, self‐expandable nitinol stent system used in stent‐assisted coiling (SAC) for treating intracranial aneurysms and was formally introduced into clinical use since 2018 in China in replace of Enterprise TM 1, the first‐generation stent being used for a decade. There is a lack of evidence to compare Enterprise TM 1 with Enterprise TM 2 in the real‐world setting. The objective of this study was to investigate clinical effectiveness and safety in treating ruptured intracranial aneurysms (RIA) with Enterprise TM 2 stent (E2 group) versus Enterprise TM 1 stent (E1 group) in China. Methods : We conducted a retrospective analysis of an electronic medical record database at Yijishan hospital of Wannan Medical College. Patients included were those diagnosed with RIA and underwent SAC procedure with Enterprise TM 1 stent or Enterprise TM 2 stent from January 2013 to November 2020 with at least one follow‐up visit post discharge. Main outcomes were immediate complete occlusion (ICO) rate (Raymond‐Roy Occlusion Classification), patient functional outcomes (modified Rankin Score (mRS)), and perioperative procedural‐related complications, operating time and length of stay (LOS) and recurrence rate. Student’s t‐test was used for continuous variables and the Chi‐Square test or Fisher Exact test was used for categorical variables to test significance where appropriate. Factors associated with perioperative procedural‐related complications were explored by logistic regression. Aneurysm recurrence rate was estimated using the Life Table method. Results : A total of 361 eligible patients (E2 group = 91; E1 group = 270) were included in the analysis. There were no differences in demographic characteristics between E2 and E1 groups (mean age: 59.9 vs. 58.4 years; male gender: 27.5% vs. 29.3%). The stent deployment was successful in all patients in both groups. ICO was similar (E2 vs. E1: 79.1% vs.75.1%, P = 0.629) and most of patients achieved good function outcomes (mRS< = 2) at discharge (E2 vs. E1: 77.8% vs. 81.1%, P = 0.592). Overall, E2 group had a lower perioperative procedural‐related complication rate compared with E1 (7.7% vs.16.4%, P = 0.042). After controlling for age and underlying severity of disease (presence of hypertension, Hunt‐Hess Scale, Fisher Grade, and size and height of aneurysms), patients in E2 group had a significantly lower risk of perioperative procedural‐related complications compared with those receiving E1 (OR = 0.35; 95% CI: 0.14‐0.88). The operating time was significantly shorter (165.7± 51.6 vs.190.3±79.6 minutes, P = 0.006) in E2 vs. E1 group. While LOS was also shorter in E2 group (16.7±9.7 vs.19.2±12.6 days), the difference was not statistically significant (P = 0.082). By six‐month post discharge, patients receiving E2 had similar good functional outcomes and aneurysm recurrence compared with those in E1 group (80.2% vs. 81.9%; 13.3% vs. 14.9%, respectively). Conclusions : Compared with the Enterprise TM 1, Enterprise TM 2 had similar clinical effectiveness but with a lower perioperative procedural‐related complication risk. Use of E2 also appeared to be associated with improved clinical efficiency with shorter operating time in treating patients with RIA. The application of Enterprise TM 2 stent demonstrated encouraging clinical benefits in treating RIA in China.

2021 ◽  
pp. neurintsurg-2021-017641
Author(s):  
Kemal Alpay ◽  
Tero Hinkka ◽  
Antti E Lindgren ◽  
Juha-Matti Isokangas ◽  
Rahul Raj ◽  
...  

BackgroundFlow diversion of acutely ruptured intracranial aneurysms (IAs) is controversial due to high treatment-related complication rates and a lack of supporting evidence. We present clinical and radiological results of the largest series to date.MethodsThis is a nationwide retrospective study of acutely ruptured IAs treated with flow diverters (FDs). The primary outcome was the modified Rankin Scale (mRS) score at the last available follow-up time. Secondary outcomes were treatment-related complications and the aneurysm occlusion rate.Results110 patients (64 females; mean age 55.7 years; range 12–82 years) with acutely ruptured IAs were treated with FDs between 2012 and 2020 in five centers. 70 acutely ruptured IAs (64%) were located in anterior circulation, and 47 acutely ruptured IAs (43%) were blister-like. A favorable functional outcome (mRS 0–2) was seen in 73% of patients (74/102). Treatment-related complications were seen in 45% of patients (n=49). Rebleeding was observed in 3 patients (3%). The data from radiological follow-ups were available for 80% of patients (n=88), and complete occlusion was seen in 90% of aneurysms (79/88). The data from clinical follow-ups were available for 93% of patients (n=102). The overall mortality rate was 18% (18/102).ConclusionsFD treatment yields high occlusion for acutely ruptured IAs but is associated with a high risk of complications. Considering the high mortality rate of aneurysmal subarachnoid hemorrhage, the prevention of rebleeding is crucial. Thus, FD treatment may be justified as a last resort option.


2012 ◽  
Vol 155 (2) ◽  
pp. 223-229 ◽  
Author(s):  
Joonho Chung ◽  
Yong Bae Kim ◽  
Chang-Ki Hong ◽  
Jin Yang Joo ◽  
Yong Sam Shin ◽  
...  

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jianhe Yue ◽  
Yuan Xie ◽  
Xiaolin Zhang ◽  
Yongxiang Jiang ◽  
Weifu Chen ◽  
...  

Abstract 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.


2019 ◽  
Vol 11 (5) ◽  
pp. 489-496 ◽  
Author(s):  
Xiaoxi Zhang ◽  
Qiao Zuo ◽  
Haishuang Tang ◽  
Gaici Xue ◽  
Pengfei Yang ◽  
...  

PurposeTo compare the safety and efficiency of stent assisted coiling (SAC) with non-SAC for the management of ruptured intracranial aneurysms.MethodsA meta-analysis that compared SAC with coiling alone and balloon assisted coiling was conducted by database searching. The primary outcomes of this study were immediate occlusion and progressive thrombosis rate, overall perioperative complication rate, and angiographic recurrence. Secondary outcomes included mortality at discharge, hemorrhagic and ischemic complications, and favorable clinical outcome at discharge and at follow-up.ResultsEight retrospective cohort studies with 1408 ruptured intracranial aneurysms (SAC=499; non-SAC=909) were included. The SAC group tended to show a lower immediate complete occlusion rate than the non-SAC group (54.3% vs 64.2%; RR 0.90; 95% CI 0.83 to 0.99; I2=17.4%) and achieved a significantly higher progressive complete rate at follow-up (73.4% vs 61.0%; RR 1.30; 95% CI 1.16 to 1.46; I2=40.5%) and a lower recurrence rate (4.8% vs 16.6%; RR 0.28; 95% CI 0.16 to 0.50; I2=0.0%). With respect to safety concerns, overall perioperative complications in the SAC group were significantly higher (20.2% vs 13.1%; RR 1.70; 95% CI 1.36 to 2.11; I2=0.0%). However, no significant difference was found for mortality rate at discharge (6.3% vs 6.2%; RR 1.29; 95% CI 0.86 to 1.94; I2=0.0%), or favorable clinical outcome rate at discharge (73.4% vs 74.2%; RR 0.95; 95% CI 0.88 to 1.02; I2=12.1%) and at follow-up (85.6% vs 87.9%; RR 0.98; 95% CI 0.93 to 1.02; I2=0.0%; P=0.338).ConclusionsSAC has a lower recurrence rate than non-SAC. Nevertheless, further validation by well designed prospective studies is warranted for determining whether stents improve angiographic outcome without an increased complication rate or unfavorable clinical outcome.


2020 ◽  
Vol 54 (2) ◽  
Author(s):  
Ronnie E. Baticulon ◽  
Kevin Ivan P. Chan ◽  
Peter Paul P. Rivera ◽  
Gerardo D. Legaspi ◽  
Willy G. Lopez

Objectives. To identify factors that predict the occurrence of seizures in patients with aneurysmal subarachnoid hemorrhage (SAH) and to evaluate the efficacy of antiepileptic drugs (AEDs) in preventing in-hospital seizures among patients who undergo clip occlusion of ruptured intracranial aneurysms. Methods. In this retrospective study, the medical charts of 205 patients admitted for aneurysmal SAH in Philippine General Hospital (PGH) and who underwent craniotomy and clipping of aneurysm from January 2011 to June 2014 were reviewed. Demographic, radiologic, and clinical factors were converted into categorical variables and their association with the occurrence of seizures analyzed. The incidence of seizures among patients who received an AED (AED cohort) and those who did not receive an AED (No AED cohort) were compared. Secondarily, the effects of seizures and AED use on early postoperative outcomes were determined using the Glasgow Outcome Scale (GOS) on the day of discharge. Results. Among 205 patients with aneurysmal SAH, 31 (15.1%) developed seizures. 21 (10.2%) had seizures at onset of SAH and only seven (3.4%) had in-hospital seizures. Aneurysm re-rupture (OR 5.26, p-value 0.045) and the presence of a parenchymal clot (OR 2.90, p-value 0.043) were independent predictors for seizure occurrence. There was no significant difference in the incidence of seizures in the AED cohort and in the No AED cohort (4/100, 4% vs. 3/99, 3%, p-value 0.714). AED use was associated with a higher proportion of patients with a discharge GOS score of 3 or less (28.0% vs 12.1%, p-value 0.005). Conclusion. The results of the study do not support the routine use of AEDs in patients with aneurysmal SAH.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S405-S405
Author(s):  
Nicolas W Cortes-Penfield ◽  
Nicolas W Cortes-Penfield ◽  
Melissa LeMaster ◽  
Bryan Alexander

Abstract Background Recent studies suggest that early post-discharge follow-up for patients receiving outpatient parenteral antimicrobial therapy (OPAT) reduces readmission rates. We report our experience implementing a telehealth-based clinic to facilitate early (1-2 week) follow-up for selected OPAT patients perceived to be at high risk for readmission. Methods We identified patients who met criteria for and completed a supplemental OPAT telehealth visit following the initial seven months after implementation of this clinic (11/1/20 – 5/31/21). Clinical criteria triggering intake of patients for these visits included: endovascular or cardiac device-related infection; treatment with vancomycin, oxacillin/nafcillin, or aminoglycosides; ≥2 prior hospitalizations within past 1 year; treating Infectious Disease or OPAT team’s subjective assessment of high readmission risk. Patients planned for &lt; 14 days of OPAT therapy were excluded. Categorical variables were compared using a Chi-square test at the α=0.05 level of significance. Results A total of 49 patients completed a telehealth visit; mean time from discharge to telehealth visit was 12.1 days (SD +/- 3.9). An intervention was made in 27% of these visits (13 of 49 patients), most commonly involving attempted mitigation of an adverse event or line-related complication (7 cases). The all-cause, 30-day readmission rate for this cohort was 6.1% (3 of 49 patients), while the rate for OPAT patients who did not receive an early telehealth visit during the same period was 22.7% (52 of 229 patients) which was statistically significant (p=0.008). This association of benefit was also found when comparing infection-related, 30-day readmission rates (0% vs 7.4%, p=0.049). Conclusion Implementation of OPAT telehealth encounters for high-risk patients resulted in a high rate of intervention to mitigate adverse events of OPAT therapy. Readmission occurred less than one-third as frequently in the telehealth group compared to patients with no early follow-up visit. Telehealth-based encounters appear comparable in effectiveness to those previously reported utilizing in-person visits, introducing efficiencies that may allow for broader implementation of this intervention. Disclosures Nicolas W. Cortes-Penfield, MD, Nothing to disclose Bryan Alexander, PharmD, Astellas Pharma (Advisor or Review Panel member)


Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. 584-591 ◽  
Author(s):  
Gaici Xue ◽  
Qiao Zuo ◽  
Haishuang Tang ◽  
Xiaoxi Zhang ◽  
Guoli Duan ◽  
...  

Abstract BACKGROUND Low-profiled visualized intraluminal support (LVIS) is suggested as a promising stent for complex intracranial aneurysms. However, the safety and efficacy of LVIS-assisted coiling of acutely ruptured wide-necked intracranial aneurysms have not been well reported. OBJECTIVE To evaluate the safety and efficacy of LVIS-assisted coiling of acutely ruptured wide-necked intracranial aneurysms compared with contemporary coiling-only strategy via propensity score matching in a high-volume center. METHODS A retrospective review of patients with acutely ruptured intracranial aneurysms who underwent LVIS stent placement or coiling only from November 2013 to October 2017 was performed. Perioperative procedure-related complications and clinical and angiographic follow-up outcomes were compared. RESULTS All baseline characteristics were equivalent between the 2 groups except for neck size. The immediate angiographic results, procedure-related complications, procedure-related mortality, and clinical outcomes between the 2 groups demonstrated no significant differences (P = .087, P = .207, P = .685, and P = .865, respectively). The angiographic follow-up outcomes of the LVIS-assisted coiling group showed a significantly higher complete occlusion rate and lower recurrence rate compared with the coiling-only group (92.3% vs 59.9%, 4.8% vs 26.1%, P &lt; .001). Multivariable analysis showed no significant predictors for the overall perioperative procedure-related complications, hemorrhagic complications, and ischemic complications. CONCLUSION The LVIS stent is a safe and effective device for stent-assisted coiling of acutely ruptured wide-necked intracranial aneurysms, with comparable procedure-related complication rates, higher complete occlusion rates, and lower recurrence rates at follow-up compared with coiling only.


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