scholarly journals Prospective Randomized Open-label Trial to evaluate risk faCTor management in patients with Unruptured intracranial aneurysms: Study protocol

2018 ◽  
Vol 13 (9) ◽  
pp. 992-998 ◽  
Author(s):  
Mervyn DI Vergouwen ◽  
Gabriel JE Rinkel ◽  
Ale Algra ◽  
Jens Fiehler ◽  
Helmuth Steinmetz ◽  
...  

Rationale Unruptured intracranial aneurysms are currently left untreated if the presumed complication risk of preventive endovascular or neurosurgical intervention is higher than the risk of rupture. Aneurysm wall inflammation and blood pressure are attractive modifiable risk factors of aneurysm rupture and growth. Aim To investigate in patients with an unruptured intracranial aneurysm who do not qualify for preventive endovascular or neurosurgical intervention whether a treatment strategy of acetylsalicylic acid 100 mg/day plus intensive blood pressure treatment (targeted systolic blood pressure < 120 mmHg, monitored with a home blood pressure measuring device) reduces the risk of aneurysm rupture or growth compared with care as usual (no acetylsalicylic acid, targeted office systolic blood pressure < 140 mmHg, no home blood pressure measuring device). Sample size We aim to randomize 776 patients 1:1 to the intervention arm or care as usual. Design Bi-national (Germany and the Netherlands) multicenter, prospective, randomized, open-label phase III trial with blinded outcome assessment. Outcomes The primary outcome is aneurysm rupture or growth (increase in any aneurysm diameter by ≥ 1 mm) on repeated MR or CT angiography within 36 ± 6 months after randomization. Discussion The Prospective Randomized Open-label Trial to Evaluate risk faCTor management in patients with Unruptured intracranial aneurysms (PROTECT-U) is the first randomized trial to investigate if a medical strategy reduces the risk of rupture or growth of intracranial aneurysms in patients not undergoing preventive endovascular or neurosurgical aneurysm treatment. Clinical trial Registration: NCT03063541.

2020 ◽  
Vol 132 (1) ◽  
pp. 94-97 ◽  
Author(s):  
Tiziano Tallarita ◽  
Thomas J. Sorenson ◽  
Lorenzo Rinaldo ◽  
Gustavo S. Oderich ◽  
Thomas C. Bower ◽  
...  

OBJECTIVEConcomitant unruptured intracranial aneurysms (UIAs) are present in patients with carotid artery stenosis not infrequently and result in unique management challenges. Thus, we investigated the risk of rupture of an aneurysm after revascularization of a carotid artery in a contemporary consecutive series of patients seen at our institution.METHODSData from patients who underwent a carotid revascularization in the presence of at least one concomitant UIA at our institution from 1991 to 2018 were retrospectively reviewed. Patients were evaluated for the incidence of aneurysm rupture within 30 days (early period) and after 30 days (late period) of carotid revascularization, as well as for the incidence of periprocedural complications from the treatment of carotid stenosis and/or UIA.RESULTSOur study included 53 patients with 63 concomitant UIAs. There was no rupture within 30 days of carotid revascularization. The overall risk of rupture was 0.87% per patient-year. Treatment (coiling or clipping) of a concomitant UIA, if pursued, could be performed successfully after carotid revascularization.CONCLUSIONSCarotid artery revascularization in the setting of a concomitant UIA can be performed safely without an increased 30-day or late-term risk of rupture. If indicated, treatment of the UIA can take place after the patient recovers from the carotid procedure.


2021 ◽  
Vol 10 (8) ◽  
pp. 1712
Author(s):  
Seppo Juvela

The purpose was to study the risk of rupture of unruptured intracranial aneurysms (UIAs) of patients with multiple intracranial aneurysms after subarachnoid hemorrhage (SAH), in a long-term follow-up study, from variables known at baseline. Future rupture risk was compared in relation to outcome after SAH. The series consists of 131 patients with 166 UIAs and 2854 person-years of follow-up between diagnosis of UIA and its rupture, death or the last follow-up contact. These were diagnosed before 1979, when UIAs were not treated in our country. Those patients with a moderate or severe disability after SAH, according to the Glasgow Outcome Scale, had lower rupture rates of UIA than those with a good recovery or minimal disability (4/37 or 11%, annual UIA rupture rate of 0.5% (95% confidence interval (CI) 0.1–1.3%) during 769 follow-up years vs. 27/94 or 29%, 1.3% (95% CI 0.9–1.9%) during 2085 years). Those with a moderate or severe disability differed from others by their older age. Those with a moderate or severe disability tended to have a decreased cumulative rate of aneurysm rupture (log rank test, p = 0.066) and lower relative risk of UIA rupture (hazard ratio 0.39, 95% CI 0.14–1.11, p = 0.077). Multivariable hazard ratios showed at least similar results, suggesting that confounding factors did not have a significant effect on the results. The results of this study without treatment selection of UIAs suggest that patients with a moderate or severe disability after SAH have a relatively low risk of rupture of UIAs. Their lower treatment indication may also be supported by their known higher treatment risks.


Neurosurgery ◽  
2015 ◽  
Vol 77 (3) ◽  
pp. 433-442 ◽  
Author(s):  
Allen L. Ho ◽  
Ning Lin ◽  
Kai U. Frerichs ◽  
Rose Du

Abstract BACKGROUND: As diagnosis and treatment of unruptured intracranial aneurysms continues to increase, management principles remain largely based on size. This is despite mounting evidence that aneurysm location and other morphologic variables could play a role in predicting overall risk of rupture. Morphological parameters can be divided into 3 main groups, those that are intrinsic to the aneurysm, those that are extrinsic to the aneurysm, and those that involve both the aneurysm and surrounding vasculature (transitional). OBJECTIVE: We present an evaluation of intrinsic, transitional, and extrinsic factors and their association with ruptured aneurysms. METHODS: Using preoperative computed tomographic angiography, we generated 3-dimensional models of aneurysms and their surrounding vasculature with Slicer software. Using univariate and multivariate analyses, we examined the association of intrinsic, transitional, and extrinsic aspects of aneurysm morphology with rupture. RESULTS: Between 2005 and 2013, 227 cerebral aneurysms in 4 locations were evaluated/treated at a single institution, and computed tomographic angiographies of 218 patients (97 unruptured and 130 ruptured) were analyzed. Ruptured aneurysms analyzed were associated with clinical factors of absence of multiple aneurysms and history of no prior rupture, and morphologic factors of greater aspect ratio. On multivariate analysis, aneurysm rupture remained associated with history of no prior rupture, greater flow angle, greater daughter-daughter vessel angle, and smaller parent-daughter vessel angle. CONCLUSION: By studying the morphology of aneurysms and their surrounding vasculature, we identified several parameters associated with ruptured aneurysms that include intrinsic, transitional, and extrinsic factors of cerebral aneurysms and their surrounding vasculature.


2021 ◽  
pp. 77-80
Author(s):  
Katarzyna Wójtowicz ◽  
Przemysław Kunert ◽  
Łukasz Przepiórka ◽  
Andrzej Marchel

<b><i>Introduction:</i></b> The timing of treatment remains unresolved for patients with unruptured intracranial aneurysms (UIAs) and headaches, particularly when the pain is short term, localized, and related to the aneurysm site. We lack evidence to support the notion that when a headache accompanies an aneurysm, it elevates the risk of rupture. <b><i>Results:</i></b> We describe 2 cases of fatal subarachnoid hemorrhage in patients with a history of headache and known aneurysms. Both of these patients had good indications for treatment: a young age and an aneurysm &#x3e;7 mm, and both were qualified for elective surgery. However, both patients died of fatal aneurysm ruptures before the planned surgery. <b><i>Conclusion:</i></b> These cases suggested that treatment should be started as soon as possible, when a UIA is diagnosed based on a short-term period of severe headaches or when a UIA is observed and then severe headaches appear. There is no straightforward guideline for treatment timing in these patients. However, in this era of UIAs, the significance of sentinel headaches should be reevaluated. Given the incidence of headaches in the general population and the very low risk of aneurysm rupture, there may be a tendency to neglect the role of headache as a possible warning sign.


2018 ◽  
Vol 129 (6) ◽  
pp. 1492-1498 ◽  
Author(s):  
Masaomi Koyanagi ◽  
Akira Ishii ◽  
Hirotoshi Imamura ◽  
Tetsu Satow ◽  
Kazumichi Yoshida ◽  
...  

OBJECTIVELong-term follow-up results of the treatment of unruptured intracranial aneurysms (UIAs) by means of coil embolization remain unclear. The aim of this study was to analyze the frequency of rupture, retreatment, stroke, and death in patients with coiled UIAs who were followed for up to 20 years at multiple stroke centers.METHODSThe authors retrospectively analyzed data from cases in which patients underwent coil embolization between 1995 and 2004 at 4 stroke centers. In collecting the late (≥ 1 year) follow-up data, postal questionnaires were used to assess whether patients had experienced rupture or retreatment of a coiled aneurysm or any stroke or had died.RESULTSOverall, 184 patients with 188 UIAs were included. The median follow-up period was 12 years (interquartile range 11–13 years, maximum 20 years). A total of 152 UIAs (81%) were followed for more than 10 years. The incidence of rupture was 2 in 2122 aneurysm-years (annual rupture rate 0.09%). Nine of the 188 patients with coiled UIAs (4.8%) underwent additional treatment. In 5 of these 9 cases, the first retreatment was performed more than 5 years after the initial treatment. Large aneurysms were significantly more likely to require retreatment. Nine strokes occurred over the 2122 aneurysm-years. Seventeen patients died in this cohort.CONCLUSIONSThis study demonstrates a low risk of rupture of coiled UIAs with long-term follow-up periods of up to 20 years. This suggests that coiling of UIAs could prevent rupture for a long period of time. However, large aneurysms might need to be followed for a longer time.


Stroke ◽  
2007 ◽  
Vol 38 (4) ◽  
pp. 1404-1410 ◽  
Author(s):  
Marieke J.H. Wermer ◽  
Irene C. van der Schaaf ◽  
Ale Algra ◽  
Gabriël J.E. Rinkel

2008 ◽  
Vol 108 (5) ◽  
pp. 1052-1060 ◽  
Author(s):  
Seppo Juvela ◽  
Matti Porras ◽  
Kristiina Poussa

Object The authors conducted a study to investigate the long-term natural history of unruptured intracranial aneurysms and the predictive risk factors determining subsequent rupture in a patient population in which surgical selection of cases was not performed. Methods One hundred forty-two patients with 181 unruptured aneurysms were followed from the 1950s until death or the occurrence of subarachnoid hemorrhage or until the years 1997 to 1998. The annual and cumulative incidence of aneurysm rupture as well as several potential risk factors predictive of rupture were studied using life-table analyses and Cox's proportional hazards regression models including time-dependent covariates. The median follow-up time was 19.7 years (range 0.8–38.9 years). During 2575 person-years of follow up, there were 33 first-time episodes of hemorrhage from previously unruptured aneurysms, for an average annual incidence of 1.3%. In 17 patients, hemorrhage led to death. The cumulative rate of bleeding was 10.5% at 10 years, 23% at 20 years, and 30.3% at 30 years after diagnosis. The diameter of the unruptured aneurysm (relative risk [RR] 1.11 per mm in diameter, 95% confidence interval [CI] 1–1.23, p = 0.05) and patient age at diagnosis inversely (RR 0.97 per year, 95% CI 0.93–1, p = 0.05) were significant independent predictors for a subsequent aneurysm rupture after adjustment for sex, hypertension, and aneurysm group. Active smoking status at the time of diagnosis was a significant risk factor for aneurysm rupture (RR 1.46, 95% CI 1.04–2.06, p = 0.033) after adjustment for size of the aneurysm, patient age, sex, presence of hypertension, and aneurysm group. Active smoking status as a time-dependent covariate was an even more significant risk factor for aneurysm rupture (adjusted RR 3.04, 95% CI 1.21–7.66, p = 0.02). Conclusions Cigarette smoking, size of the unruptured intracranial aneurysm, and age, inversely, are important factors determining risk for subsequent aneurysm rupture. The authors conclude that such unruptured aneurysms should be surgically treated regardless of their size and of a patient's smoking status, especially in young and middle-aged adults, if this is technically possible and if the patient's concurrent diseases are not contraindications. Cessation of smoking may also be a good alternative to surgery in older patients with small-sized aneurysms.


2017 ◽  
Vol 127 (1) ◽  
pp. 96-101 ◽  
Author(s):  
Jian Guan ◽  
Michael Karsy ◽  
William T. Couldwell ◽  
Richard H. Schmidt ◽  
Philipp Taussky ◽  
...  

OBJECTIVEThe choice between treating and observing unruptured intracranial aneurysms is often difficult, with little guidance on which variables should influence decision making on a patient-by-patient basis. Here, the authors compared demographic variables, aneurysm-related variables, and comorbidities in patients who received microsurgical or endovascular treatment and those who were conservatively managed to determine which factors push the surgeon toward recommending treatment.METHODSA retrospective chart review was conducted of all patients diagnosed with an unruptured intracranial aneurysm at their institution between January 1, 2013, and January 1, 2016. These patients were dichotomized based on whether their aneurysm was treated. Demographic, geographic, socioeconomic, comorbidity, and aneurysm-related information was analyzed to assess which factors were associated with the decision to treat.RESULTSA total of 424 patients were identified, 163 who were treated surgically or endovascularly and 261 who were managed conservatively. In a multivariable model, an age < 65 years (OR 2.913, 95% CI 1.298–6.541, p = 0.010), a lower Charlson Comorbidity Index (OR 1.536, 95% CI 1.274–1.855, p < 0.001), a larger aneurysm size (OR 1.176, 95% CI 1.100–1.257, p < 0.001), multiple aneurysms (OR 2.093, 95% CI 1.121–3.907, p = 0.020), a white race (OR 2.288, 95% CI 1.245–4.204, p = 0.008), and living further from the medical center (OR 2.125, 95% CI 1.281–3.522, p = 0.003) were all associated with the decision to treat rather than observe.CONCLUSIONSWhereas several factors were expected to be considered in the decision to treat unruptured intracranial aneurysms, including age, Charlson Comorbidity Index, aneurysm size, and multiple aneurysms, other factors such as race and proximity to the medical center were unanticipated. Further studies are needed to identify such biases in patient treatment and improve treatment delineation based on patient-specific aneurysm rupture risk.


2004 ◽  
Vol 17 (5) ◽  
pp. 1-6 ◽  
Author(s):  
Leodante B. da Costa ◽  
Thorsteinn Gunnarsson ◽  
M. Christopher Wallace

Aneurysmal subarachnoid hemorrhage (SAH) carries a grim prognosis, with high mortality and morbidity rates. The mortality rate in the first 30 days postrupture is estimated to be in the range of 40 to 50%, and almost half of the survivors will be left with a neurological deficit. Unlike patients with aneurysmal SAH, those with unruptured intracranial aneurysms usually experience no neurological deficit, and their treatment is prophylactic, aiming to reduce the risk of future bleeding and its consequences. The risk of rupture therefore assumes special importance when making decisions regarding which patient or aneurysm to treat. In previous reports the risk of bleeding for unruptured aneurysms has been stated as approximately 2% per year. The retrospective part of the International Study of Unruptured Intracranial Aneurysms (ISUIA) reported very low annual bleeding rates (0.05–1%) and high surgical morbidity and mortality rates (8–18%), prompting discussion in which the benefits of prophylactic treatment in the majority of these lesions were questioned. Prospective data from the second part of the ISUIA recently included rupture rates ranging from 0 to 10% per year. The aim of this paper was to review the evidence that is currently available for neurosurgeons to use when making decisions regarding patients who would benefit from treatment of an unruptured intracranial aneurysm.


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