Endovascular Treatment Of Unruptured Aneurysms Research Articles

Abstract Number ‐ 141: Microemboli Monitoring After Intrasaccular Flow Disruption: Single‐center Experience

Introduction The management of wide‐necked bifurcation aneurysms can be challenging due to multiple factors. Intrasaccular flow disruption with the Woven EndoBridge (WEB) has demonstrated a safe and effective profile. Current microemboli data after the WEB device placement is non‐existent. We evaluated the rate of embolic signals (MES) after WEB device implantation. Methods We performed a retrospective analysis of a prospectively maintained database including patients who underwent WEB device implantation for the treatment of unruptured intracranial aneurysms between 2021 and 2022. Variables studied included patient demographics, modified Rankin Scale (mRS) before and 3 months post‐treatment, comorbidities, aneurysm characteristics, platelet inhibition tests, and activated clotting time. All patients were on aspirin and a P2Y12 inhibitor and had therapeutic levels on platelet aggregation assays. Intraoperative heparin was given in all cases to keep a therapeutic ACT. P2Y12 drugs were stopped after the procedure. In all patients, MES monitoring was performed in the immediate postoperative period and >12 hours after the procedure. Results 34 patients with 34 aneurysms were analyzed. Mean age was 67.4 years and 85% were females. Mean aneurysm size was 13.1 ± 2.0 mm and mean neck size 4.4 ± 1.5 mm. Locations were middle cerebral artery bifurcation and M1‐M2 segment (n = 13), basilar artery tip (n = 10), anterior communicating artery (n = 8), internal carotid artery terminus (n = 2) and pericallosal artery (n = 1). A single WEB was implanted in 100% of the cases. MES were negative in all cases. 3‐month mRS remained stable or improved in all cases. No procedure‐related complications were seen. Conclusions Our findings reinforce the safety profile of intrasaccular flow disruption. These findings differ from a previous analysis of unruptured aneurysms in our institution where a 7.7% incidence of MES was reported after endovascular treatment of unruptured aneurysms with primary or assisted coiling.

Safety and Efficacy of Low-dose Prasugrel in the Endovascular Treatment of Unruptured Aneurysms in the Elders (≥ 75Years).

The effectiveness and safety of low-dose prasugrel (PSG) premedication for endovascular treatment of unruptured intracranial aneurysms (UIAs) have been widely reported. In this study, we evaluated the clinical outcomes of elders patients (≥ 75years) treated with PSG. Atotal of 200patients with 209 UIAs who were administered PSG as premedication (20 mg loading and 5 mg maintenance with 100 mg aspirin) between March 2018 and December 2021 were retrospectively enrolled. Among them, 39patients were aged 75years or over (elders group), and 161patients were aged under 75 years (control group). Patients' clinical data were collected, and outcomes were compared between the two groups. Of the 200patients with PSG, 9cases (4.5%) had overall complications (7ischemic, 2hemorrhagic). In the comparison between the elders group and the control group, no significant differences were observed in the overall complication rates (elders group vs. control group; 2.6% vs. 5.0%, P = 1.00). Moreover, the rates of poor clinical outcome were comparable (2.6% vs. 1.2%, P = 0.48). The subgroup analysis of patients with stent-assisted procedures revealed no significant differences in complication rates (0% vs. 1.6%, P = 1.00) or poor clinical outcomes (0% vs. 0%, P = 1.00) during maintenance with aspirin 100 mg or PSG 5 mg. The complication rates in the elders treated with low-dose PSG premedication were similar to those in the control. Low-dose PSG premedication could be prescribed without any additional risk for the endovascular treatment of UIAs in elders patients.

Abstract 1122‐000056: Trends in the Endovascular Treatment of Intracranial Aneurysms in a Single Institution During 10 Years

Introduction : Endovascular treatment of intracranial aneurysms has increased compared to microsurgery since the creation of the Guglielmi Detachable Coils (GDC), and is the treatment of choice in several centers worldwide. Our study aimed to analyze the trends over time of number of patients, number of aneurysms, rupture status, location, size and endovascular technique employed in a retrospective cohort of consecutive intracranial aneurysms treated during a 10‐year period. Methods : Data extracted from clinical records, surgical reports, angiographies and CT scans of 765 consecutive patients who underwent endovascular treatment of 845 intracranial aneurysms at our institution between January 2010 and December 2020 was carried out. The Mann‐Kendal test was used to assess time trends. The moving average technique was also employed, using one lagged observation, the current observation and one forward observation in order to create smoother curves. The statistical software Stata v14.0 (StataCorp, College Station, TX, USA) was used. Results : We evaluated 765 patients who underwent 845 endovascular treatments of intracranial aneurysms. Women represented 81% of the cohort. Mean age was 53.9 ± 14.6 years. We identified a significant increase in the number of patients (p = 0.016; p for moving average = 0.005) and in the number of aneurysms over time (p = 0.003; p for moving average = 0.003). For ruptured aneurysms, we did not find changes in the trends over time (p = 0.117; p for moving average = 0.1), whereas in the case of unruptured aneurysms, we identified a significant increase in their treatment (p = 0.029; p for moving average = 0.001). Posterior communicating (p = 0.042: p for moving average = 0.002), paraclinoid (p = 0.06; p for moving average = 0.019) and posterior fossa aneurysms (p = 0.813; p for moving average = 0.028) increased their frequency of treatment over time. Anterior communicating (p = 0.235; p for moving average = 0.21), middle cerebral artery (p = 0.431; p for moving average = 0.347) and internal carotid artery aneurysms (p = 1; p for moving average = 0.754) did not show differences over time. We did not identify changes over time in large (p = 0.31; p for moving average = 0.213), as well as width (p = 0.35; p for moving average = 0.876) and neck diameter (p = 1; p for moving average = 0.815). Balloon‐assisted coiling (p = 0.01; p for moving average = 0.003), flow diverters (p = 0.016; p for moving average < 0.001) and stent‐assisted coiling (p = 0.531; p for moving average = 0.014) showed a positive trend over time. Simple coiling (p = 0.75; p for moving average = 0.184) did not show significant variations over time. Conclusions : We identified a positive trend in the endovascular treatment of unruptured aneurysms, as well as posterior communicating artery, paraclinoid and posterior fossa aneurysms. Assisted‐coiling techniques and flow diverters also showed a positive trend over time. These results are in accordance with the increasing trends in endovascular treatment of intracranial aneurysms worldwide.

Risk Factors Associated with ICU-Specific Care in Patients Undergoing Endovascular Treatment of Unruptured Intracranial Aneurysms.

Multiple studies suggest routine postoperative intensive care unit (ICUs) stays in presumed high-risk neurosurgical procedures may be unnecessary. Our objective was to evaluate the risk factors associated with ICU-specific needs in patients undergoing elective endovascular treatment of unruptured intracranial aneurysms. A retrospective review of consecutive patients undergoing elective endovascular treatment of unruptured aneurysms was performed between January 2010 and January 2020 in a single academic medical center. Patient demographic information, aneurysm and treatment characteristics, intraoperative and postoperative complications, as well as ICU-specific needs, were abstracted. The primary outcome was ICU-specific needs. A total of 382 patient encounters in 344 unique patients were abstracted. 13.6% (52 of 382) of patient encounters had an ICU-specific need. Multivariate analysis revealed that age [adjusted odds ratio (OR) 1.04, 95% confidence interval (CI) 1.01-1.07, p = 0.03], procedure duration greater 200min (adjusted OR 2.75, 95% CI 1.34-5.88, p = 0.007), and any intraoperative complication (adjusted OR 20.41, CI 7.97-56.57, p < 0.001) were independent predictors of postoperative ICU-specific needs. The majority of ICU-specific needs (94%, 49 of 52) occurred within 6h of surgery. Our results show that age, procedure duration greater than or equal to 200min, and intraoperative complication were independent predictors of postoperative ICU-specific needs in patients presenting for elective endovascular treatment of unruptured intracranial aneurysms. The majority of ICU-specific needs and associated complications occurred in the immediate postoperative period. This data can be used to help decide the appropriate postoperative level of care in this patient population.

Reduction of thromboembolic complications during the endovascular treatment of unruptured aneurysms by employing a tailored dual antiplatelet regimen using aspirin and prasugrel

BackgroundThromboembolic complications (TECs) are frequent during the endovascular treatment of unruptured aneurysms. To prevent TECs, dual antiplatelet therapy using aspirin and clopidogrel is recommended for the perioperative period. In patients...

Relationship between cerebral aneurysm wall stiffness and rupture risk

Haemorrhage stroke is a major issue for public health care. The prevalence of intracranial aneurysms in the general population ranges between 3 and 6.6% (Wardlaw and White 2000). Fortunately, very few aneurysms rupture. The incidence of ruptured aneurysms is approximately 0.5% per year. However, patients are stressful and wants to be treated. But, endovascular treatment of unruptured aneurysms, which is the safest treatment, is not without risk and has about 1% mortality rate (Sluzewski et al. 2001). So, unruptured intracranial aneurysms represent a dilemma for the physicians. In 2011 (Costalat et al.), we have proposed an indicator base on the relationship between the mechanical properties of wall aneurysm tissues and the rupture risk. First conclusions suggested that the softer tissue is, the higher rupture risk is. The present study aims to confirm these results, initiates with only 16 samples, studying 26 more aneurysms.

Endovascular treatment of unruptured aneurysms of cavernous and ophthalmic segment of internal carotid artery with flow diverter device Pipeline.

BackgroundIntra-arterial treatment of aneurysms by redirecting blood flow is a newer method. The redirection is based on a significantly more densely braided wire stent. The stent wall keeps the blood in the lumen of the stent and slows down the turbulent flow in the aneurysms. Stagnation of blood in the aneurysm sac leads to the formation of thrombus and subsequent exclusion of the aneurysm from the circulation. The aim of the study was to evaluate flow diverter device Pipeline for broad neck and giant aneurysm treatment.MethodsFifteen patients with discovered aneurysm of the internal carotid artery were treated between November 2010 and February 2014. The majority of aneurysms of the internal carotid artery were located intradural at the ophthalmic part of the artery. The patients were treated using a flow diverter device Pipeline, which was placed over the aneurysm neck. Treatment success was assessed clinically and angiographically using O’Kelly Marotta scale.ResultsControl angiography immediately after the release of the stent showed stagnation of the blood flow in the aneurysm sac. In none of the patients procedural and periprocedural complications were observed. 6 months after the procedure, control CT or MR angiography showed in almost all cases exclusion of the aneurysm from the circulation and normal blood flow in the treated artery. Neurological status six months after the procedure was normal in all patients.ConclusionsTreatment of aneurysms with flow diverter Pipeline device is a safe and significantly less time consuming method in comparison with standard techniques. This new method is a promising approach in treatment of broad neck aneurysms.

Prophylactic Antiplatelet Medication in Endovascular Treatment of Intracranial Aneurysms: Low-Dose Prasugrel versus Clopidogrel.

Prophylactic antiplatelet medication is beneficial in decreasing thromboembolic complications during endovascular treatment of unruptured intracranial aneurysms. The efficacy may be limited by variability of individual response to antiplatelet medication, especially clopidogrel. We compared the efficacy of 2 antiplatelet medications, low-dose prasugrel and clopidogrel, in patients undergoing endovascular treatment of unruptured aneurysms. From November 2014 to July 2015, 194 patients with a total of 222 unruptured aneurysms underwent endovascular treatment at a single institution. Laboratory and clinical data from the prospectively maintained registry were used in this study. Antiplatelet medication was given the day before endovascular treatment (prasugrel 20 mg or 30 mg or clopidogrel 300 mg). Response to the antiplatelet medication was measured by the VerifyNow system. Periprocedural adverse event rates between the 2 groups were compared. There were no significant differences in the baseline characteristics of patients and aneurysms between the 2 groups. The P2Y12 reaction unit values were lower (clopidogrel group versus prasugrel group, 242.7 ± 69.8 vs 125.7 ± 79.4; P < .0001) and percentage inhibition values were higher (22.1% ± 19.7% vs 60.2 ± 24.7%; P < .0001) in the prasugrel group. There were no thromboembolic events, but there was 1 procedural bleed in each group, without any clinical consequences. The prasugrel group showed more effective and consistent platelet inhibition. We may omit the antiplatelet response assay with the low-dose prasugrel premedication before the endovascular treatment of patients with unruptured aneurysms. Further study is required to determine whether there is benefit of this strategy regarding clinical outcome.

Current Trends and Results of Endovascular Treatment of Unruptured Intracranial Aneurysms at a Single Institution in the Flow-Diverter Era.

During the past several years, the number of unruptured aneurysms treated with endovascular techniques has increased. Traditionally, coil embolization was the treatment of choice for these lesions; however, recently flow diversion has become a viable, and in some cases superior, treatment option. The current single-center study presents results and trends of endovascular treatment with flow diversion and coil embolization in an unselected group of patients with unruptured intracranial aneurysms in a "real world" setting during the flow-diverter era. Three hundred ten patients with 318 treated unruptured aneurysms from June 2009 to May 2015 were included. Patient demographics, clinical characteristics, aneurysm/treatment characteristics, and outcomes were collected prospectively. We studied the following: intensive care unit admission/reasons, perioperative and mid-/long-term complications, target aneurysm rupture, retreatment/recurrence rates, and long-term neurologic outcome using the mRS. The flow-diverter group had a larger mean aneurysm size (12.3 ± 8.6 mm versus 8.7 ± 6.3 mm, P < .0001). There were no significant differences in the immediate (P = .43) and mid-/long-term complication rates (P = .54) between groups. Periprocedural neurologic morbidity and mortality rates were 2.1% and 0.5% in the coiling group and 2.5% and 1.6% in the flow-diverter group. Patients with coiling were more likely to be retreated than those with flow diversion (14.8% versus 5.7%, P = .009). Worsening of the mRS due to the target aneurysm was noted in only 3.2% of patients. The endovascular treatment of unruptured aneurysms can be performed with very low rates of neurologic complications. Both flow-diverter and coil therapy were safe and effective.

Morbidity and mortality of patients with endovascularly treated intracerebral aneurysms: does physician specialty matter?

OBJECT Endovascular treatment of cerebrovascular pathology, particularly aneurysms, is becoming more prevalent. There is a wide variety in clinical background and training of physicians who treat cerebrovascular pathology through endovascular means. The impact of clinical training background on patient outcomes is not well documented. METHODS The authors conducted a retrospective analysis of a large national database, the University HealthSystem Consortium, that was queried in the years 2009-2013. Cases of both unruptured cerebral aneurysms and subarachnoid hemorrhage treated by endovascular obliteration were studied. Outcome measures of morbidity and mortality were evaluated according to the specialty of the treating physician. RESULTS Elective embolization of an unruptured aneurysm was the procedure code and primary diagnosis, respectively, for 12,400 cases. Patients with at least 1 complication were reported in 799 cases (6.4%). Deaths were reported in 193 cases (1.6%). Complications and deaths were varied by specialty; the highest incidence of complications (11.1%) and deaths (3.0%) were reported by neurologists. The fewest complications were reported by neurosurgeons (5.4%; 1.4% deaths), with a higher incidence of complications reported in cases performed by neurologists (p < 0.0001 for both complications and deaths) and to a lesser degree interventional radiologists (p = 0.0093 for complications). Subarachnoid hemorrhage was the primary diagnosis and procedure for 8197 cases. At least 1 complication was reported in 2385 cases (29%) and deaths in 983 cases (12%). The number of complications and deaths varied among specialties. The highest incidence of complications (34%) and deaths (13.5%) in subarachnoid hemorrhage was in cases performed by neurologists. The fewest complications were in cases by neurosurgeons (27%), with a higher incidence of complications in cases performed by neurologists (34%, p < 0.0001), and a trend of increased complications with interventional radiologists (30%, p < 0.0676). The lowest incidence of mortality was in cases performed by neurosurgeons (11.5%), with a significantly higher incidence of mortality in cases performed by neurologists (13.5%, p = 0.0372). Mortality rates did not reach statistical significance with respect to interventional radiologists (12.1%, p = 0.4884). CONCLUSIONS Physicians of varied training types and backgrounds use endovascular treatment of ruptured and unruptured intracerebral aneurysms. In this study there was a statistically significant finding that neurosurgically trained physicians may demonstrate improved outcomes with respect to endovascular treatment of unruptured aneurysms in this cohort. This finding warrants further investigation.

E-047 hemorrhagic complications in patients with dual antiplatelet therapies

<h3>Background</h3> Antiplatelet use is common during endovascular treatment of cerebral aneurysms as it prevents thromboembolic complications. P2Y12 receptor antagonist, Clopidogrel, as well as cyclooxygenase inhibitor, aspirin are used in combination for patients undergoing stent coiling or flow diversion. Periprocedural hemorrhage with the use of dual antiplatelets continues to be of significant concern and is reported to occur in 2–24% of patients undergoing endovascular occlusion of cerebral aneurysms. We have utilized dual antiplatelets (aspirin and clopidogrel) for all patients undergoing endovascular treatment of unruptured cerebral aneurysms. We aim to report the rate of periprocedural hemorrhage for patients undergoing endovascular treatment of unruptured aneurysms and its relation to platelet function analysis based upon aspirin and clopidogrel (P2Y12) assays performed preoperatively. <h3>Methods</h3> We conducted a retrospective review of patients who underwent elective intracranial aneurysm coiling between January 2005 and August 2014. These patients were either placed on dual antiplatelet agents for 6 months in instances where stents were used or the clopidogrel was discontinued postoperatively and the aspirin continued indefinitely in cases of uneventful coil embolization. The primary outcome of interest was the occurrence of a clinically significant hemorrhagic event from the periprocedural time period up to 6 months post treatment. We also evaluated other risk factors which contributed to hemorrhagic complications in our population including the role of super therapeutic (aspirin VerifyNow &lt;450 and clopidogrel related platelet inhibition &gt;50%) platelet inhibition as measured with VerifyNow assays. <h3>Results</h3> During the study period, 412 patients underwent elective aneurysm coiling and had been placed on dual antiplatelets. Among this population, 24 (2%) systemic hemorrhage events and 5 (1%) CNS hemorrhage events occurred. Super therapeutic platelet inhibition was present in 8 of the 24 patients with systemic hemorrhages and 2 of the 5 patients with central nervous system (CNS) hemorrhages (p = 0.68). Nine (2.2%) patients were identified as clopidogrel non responders and placed on prasugrel. Of these 9 patients one presented with systemic hemorrhage. In the 148 patients who had dual antiplatelet therapy continued for 6 months after placement of a stent, 10 patients had systemic hemorrhage events and 4 had CNS hemorrhage events. All five patients with CNS hemorrhage had a decline in clinical functioning with 2 patients at mRS 2 and three patients were deceased (mRS 6). <h3>Conclusions</h3> Use of dual antiplatelets did not lead to a high incidence of hemorrhages and hemorrhagic complications were not related to super therapeutic platelet inhibition. Those patients with CNS hemorrhagic complications did have significant decline in clinical functioning. <h3>Disclosures</h3> R. Shastri: None. A. Pandey: None. T. Wilson: None. W. Stetler: None. D. Giles: None. M. Davis: None. N. Chaudhary: None. J. Gemmete: None. B. Thompson: None.

Effect of structural remodeling (retraction and recoil) of the pipeline embolization device on aneurysm occlusion rate.

During endovascular treatment of unruptured aneurysms with the Pipeline Embolization Device, an oversized device is often selected to achieve better wall apposition; however, this device oversizing could be related to overelongation and possible delayed enlargement of the stented region. The purpose of this study is to investigate the relationship between oversize and treatment outcome. The DynaCT images of 14 aneurysms treated by a single Pipeline Embolization Device were retrospectively analyzed. 3D images of the deployed device were compared with those acquired at the 6-month follow-up for qualitative and quantitative evaluation. The diameter and length of the Pipeline Embolization Device were measured at both time points and compared for determination of the device changes. Structural changes of the device have been observed, and it was found that the Pipeline Embolization Device influences the vessel curvature in some cases. On average, it increases its diameter by 0.23 mm and decreases its length by 2.88 mm within 6 months of initial deployment. Excessive elongation beyond its nominal length is correlated with a lower aneurysm occlusion rate at the 6-month follow-up. Not only does a Pipeline Embolization Device reconstruct the aneurysm and parent artery, but its entire structure goes through a gradual remodeling process. The relative deformation between the device and the artery indicates suboptimal wall apposition. Device oversizing does not have a direct effect on shortening or recoil. The aneurysm occlusion rate, however, is lowered by overelongation of the Pipeline Embolization Device.

Aneurysmal wall enhancement and perianeurysmal edema after endovascular treatment of unruptured cerebral aneurysms

Perianeurysmal edema and aneurysm wall enhancement are previously described phenomenon after coil embolization attributed to inflammatory reaction. We aimed to demonstrate the prevalence and natural course of these phenomena in unruptured aneurysms after endovascular treatment and to identify factors that contributed to their development. We performed a retrospective analysis of consecutively treated unruptured aneurysms between January 2000 and December 2011. The presence and evolution of wall enhancement and perianeurysmal edema on MRI after endovascular treatment were analyzed. Variable factors were compared among aneurysms with and without edema. One hundred thirty-two unruptured aneurysms in 124 patients underwent endovascular treatment. Eighty-five (64.4 %) aneurysms had wall enhancement, and 9 (6.8 %) aneurysms had perianeurysmal brain edema. Wall enhancement tends to persist for years with two patterns identified. Larger aneurysms and brain-embedded aneurysms were significantly associated with wall enhancement. In all edema cases, the aneurysms were embedded within the brain and had wall enhancement. Progressive thickening of wall enhancement was significantly associated with edema. Edema can be symptomatic when in eloquent brain and stabilizes or resolves over the years. Our study demonstrates the prevalence and some appreciation of the natural history of aneurysmal wall enhancement and perianeurysmal brain edema following endovascular treatment of unruptured aneurysms. Aneurysmal wall enhancement is a common phenomenon while perianeurysmal edema is rare. These phenomena are likely related to the presence of inflammatory reaction near the aneurysmal wall. Both phenomena are usually asymptomatic and self-limited, and prophylactic treatment is not recommended.

The Emergence of Endovascular Treatment–Only Centers for Treatment of Intracranial Aneurysms in the United States

Because of the availability of new technology, the spectrum of endovascular treatment for intracranial aneurysms has expanded widely. Some centers have started offering only endovascular treatment to patients with intracranial aneurysms (endovascular treatment-only centers [ETOCs]). Our objective was to identify the proportion and outcome of patients treated at ETOCs in the United States. We determined the proportion of ETOCs in the United States using Nationwide Inpatient Survey data files from 2010. We compared short-term outcomes between ETOCs and endovascular and surgical treatment centers (ESTCs). The outcomes studied were none to minimal disability, moderate to severe disability, in-hospital mortality, postprocedure complications, length of stay, and hospital charges. Out of 85 hospitals performing endovascular treatment of unruptured aneurysms, 13 (15%) were categorized as ETOCs. Out of the 10,447 patients with unruptured aneurysms, 1245 (12%) were treated at ETOCs. ETOCs were more likely to be nonteaching hospitals (55% versus 45%, P=.02). The rates of in-hospital mortality (1.2% versus 1.8%) and none to minimal disability (88% versus 84%) were similar in patients treated at ETOCs and ESTC hospitals. The mean hospitalization charges were similar, but length of stay (4±7 days versus 6±10 days, P<.0001) was significantly shorter among patients treated at ETOCs. Only 2.7% patients required secondary neurosurgical procedures at the ETOCs compared with 5.8% in ESTCs (P=.09). The recent emergence of ETOCs and provision of treatment with comparable outcomes and shorter length of stay at these hospitals may change the pattern of intracranial aneurysm treatment in the United States.

Are Routine Intensive Care Admissions Needed after Endovascular Treatment of Unruptured Aneurysms?

Routine intensive care unit monitoring is common after elective embolization of unruptured intracranial aneurysms. In this series of 200 consecutive endovascular procedures for unruptured intracranial aneurysms, 65% of patients were triaged to routine (non-intensive care unit) floor care based on intraoperative findings, aneurysm morphology, and absence of major co-morbidities. Only 1 patient (0.5%) required subsequent transfer to the intensive care unit for management of a perioperative complication. The authors conclude that patients without major co-morbidities, intraoperative complications, or complex aneurysm morphology can be safely observed in a regular ward rather than being admitted to the intensive care unit.

Long-term excess mortality of patients with treated and untreated unruptured intracranial aneurysms

Background and aimSubarachnoid haemorrhage (SAH) patients have an excess mortality proportion in long-term outcome studies because of the high rate of cerebrovascular and cardiovascular deaths. The aim of the present...

In-hospital outcomes associated with stent-assisted endovascular treatment of unruptured cerebral aneurysms in the USA

BackgroundAdjunctive stenting has increasingly become an acceptable option for the endovascular treatment of unruptured aneurysms. The Nationwide Inpatient Sample (NIS) was used to compare US in-hospital outcomes related to coiling...

The design of the Canadian UnRuptured Endovascular versus Surgery (CURES) trial.

Once a decision has been made to treat an intact aneurysm, the best treatment remains uncertain. Both surgical and endovascular management strategies are commonly performed for these lesions. Surgical clipping, for years the standard treatment, is gradually becoming supplanted by endovascular treatment. However, there is no randomized data available to compare the results of surgery versus endovascular treatment of unruptured aneurysms (UIAs). We report the design of the Canadian UnRuptured Endovascular versus Surgery (CURES) trial to compare angiographic and clinical outcomes following treatment of UIAs. The Canadian pilot phase will serve two purposes: i) to determine feasibility of the pivotal international study, and ii) to determine the incidence of treatment failure, a composite primary end-point comprising the occurrence of either: failure to accomplish aneurysm obliteration with the initial treatment modality, a major saccular aneurysm remnant or recurrence, or intracranial hemorrhage following treatment at one year. The pivotal international study will address which strategy leads to the best overall clinical outcomes in terms of mortality, morbidity, and clinical efficacy. CURES is designed to be a pragmatic management trial with loose inclusion criteria. The pilot study plans to enroll 260 patients, a size sufficient (at 80% power and 0.05 significance) to detect a decrease in the incidence of treatment failure from 13% to 4%. The formulation of specific hypotheses for the pivotal phase awaits the preliminary CURES morbidity and mortality results. The CURES trial intends to test surgical versus endovascular management strategies for the treatment of unruptured intracranial aneurysms.

未破裂脳動脈瘤のコイル塞栓術 未破裂脳動脈瘤に対する脳血管内手術の効果と安全性に対する検討―地方中核都市における経験をもとにした検討―

We report the safety and midterm effectiveness of endovascular treatment of unruptured aneurysms in our institution. Fifty aneurysms in 48 patients were included in this study. The overall rate of adverse events related to the treatment was 6%. Thromboembolic complications and intraoperative rupture were encountered in 2 (4%) and 1 (2%), respectively. The procedure-related morbidity rate was 2% (1 case) and there were no procedure-related deaths. Evaluation of the postoperative anatomic results indicated complete occlusion (CO) in 30 aneurysms (60%), neck remnants (NR) in 12 aneurysms (24%), and dome filling (DF) in 8 aneurysms (16%). On the otherhand, the latest follow-up magnetic resonance angiography with source images, indicated CO in 26 aneurysms (68%), NR in 6 aneurysms (16%), and DF in 6 aneurysms (16%), respectively. The recurrence rate of the embolized aneurysm is relatively low, and there was no bleeding after endovascular treatment during the follow-up period. Our results are comparable to those of previous reports in the literature. Endovascular treatment of unruptured aneurysms is safe and effective, with low morbidity and mortality rates.

Long-Term Follow-up Study of Endovascularly Treated Intracranial Aneurysms

Long-term follow-up studies after endovascular treatment for intracranial aneurysm are still rare and inconclusive. The aim of this study was to assess long-term clinical and angiographic outcome of patients with endovascularly treated aneurysms. The Clinical outcome of all 185 patients with endovascularly treated aneurysms were analyzed and 77 out of 122 surviving patients were examined with MRI and MRA nine to 16 years (mean 11 years) after the initial endovascular treatment. Sixty-three patients were deceased at the time of follow-up. The cause of death was aneurysm-related in 34 (54%) patients. The annual rebleeding rate from the treated aneurysms was 1.3% in the ruptured group and 0.1% in the unruptured group. In long-term follow-up MRA 18 aneurysms (53%) were graded as complete, 11 aneurysms (32%) had neck remnants and five aneurysms (15%) were incompletely occluded in the ruptured group. Occlusion grade was lower in the unruptured group with 20 aneurysms (41%) graded as complete, 11 (22%) had neck remnants and 18 (37%) were incomplete. However, only three aneurysms were unstable during the follow-up period and needed retreatment. Endovascular treatment of unruptured aneurysms showed incomplete angiographic outcome in 37% of cases. However, annual bleeding rate was as low as 0.1%. Endovascular treatment of ruptured aneurysms showed incomplete angiographic outcome in 15% of cases and the annual rebleeding rate was 1.3%.