Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: A randomized care trial.

BACKGROUND: Until recently, the benefits of endovascular treatment in stroke were not proven. Care trials have been designed to simultaneously offer yet-to-be validated interventions and verify treatment outcomes. Our aim was to implement a care trial for patients with acute ischemic stroke. METHODS: The study was offered to all patients considered for endovascular management of acute ischemic stroke in one Canadian hospital. Inclusion criteria were broad: onset of symptoms≤5h or at any time in the presence of clinical-imaging mismatch and suspected or demonstrated proximal large vessel occlusion. Exclusion criteria were few: established infarction or hemorrhagic transformation of the target symptomatic territory and poor 3-month prognosis. The primary outcome was mRS≤2 at 3 months. Patients were randomly allocated to standard care or standard care plus endovascular treatment. ClinicalTrials.gov: Identifier NCT02157532. RESULTS: Seventy-seven patients were recruited in 19 months (March 2013-October 2014) at a single center. Randomized allocation was interrupted when other trials showed the benefits of endovascular therapy. At 3 months, 20 of 40 patients (50.0%; 95% CI: 35%-65%) in the intervention group had reached the primary outcome, compared to 14 of 37 patients (37.8%; 95% CI: 24%-54%) in the control group (P=0.36). Eleven patients in the intervention group died within 3 months compared to 9 patients in the standard care group. CONCLUSION: A care trial was implemented to offer verifiable care to acute stroke patients. This approach offers a promising means to manage clinical dilemmas and guide uncertain practices.

Association between posterior fossa arteriovenous malformations and prenidal aneurysm rupture: potential impact on management.

OBJECT: In patients with posterior fossa arteriovenous malformations (AVMs) who present with hemorrhage, feeding artery aneurysms are often the source of bleeding. The aim of this study was to evaluate the relative proportions of cases of infra- and supratentorial AVMs in which patients presented with prenidal aneurysm rupture. The management and outcome of 9 cases of posterior fossa AVMs associated with prenidal aneurysm rupture are presented. METHODS: The authors retrospectively reviewed 233 consecutive AVM cases involving patients treated at their institution between April 2001 and August 2012. Patients with a prenidal aneurysm as the cause of the hemorrhage were identified. The frequencies of prenidal aneurysm-related ruptures were compared in cases of supra- and infratentorial AVMs. Management and clinical outcome (modified Rankin Scale [mRS] score) of patients with posterior fossa AVMs treated for ruptured prenidal aneurysms were recorded. RESULTS: Of 233 AVMs, 25 (11%) were in the posterior fossa, and in 22 (88%) of these cases, the patients presented with hemorrhage, including 9 patients (41%) who presented with hemorrhage due to prenidal aneurysm rupture. Of 208 patients with supratentorial AVMs, 107 (51%) presented with hemorrhage, including 5 patients (4.7%) in whom the hemorrhage was associated with a prenidal aneurysm (p < 0.01). All 9 patients with posterior fossa AVMs and prenidal aneurysm rupture were treated with early embolization of the offending aneurysm. There was no early rebleeding or clinical complication related to this approach. At the end of follow-up (mean 46.8 months), 2 patients had an mRS score of 0, 1 had a score of 1, 3 had a score of 2, 2 patients were dead (mRS score of 6), and 1 patient was lost to follow-up. CONCLUSIONS: Posterior fossa AVM hemorrhages are frequently associated with prenidal arterial aneurysms. Urgent endovascular treatment of the aneurysm was effective in this case series.

Embolization with larger-caliber coils can increase packing density: Evidence from the pilot phase of a randomized trial.

Background and purpose Endovascular coil embolization of cerebral aneurysms is associated with suboptimal angiographic results in up to 20-30% of patients. Coil packing density has been used as an index of the success of the initial procedure. The trial sought to study the effects of using 15-caliber coils, as compared with 10-caliber coils, on packing density. Methods Does Embolization with Larger coils lead to better Treatment of Aneurysms (DELTA) is an investigator-initiated multicenter prospective, randomized, controlled clinical trial. Patients are randomized 1:1 to embolization with either 10-caliber coils exclusively (control group) or the highest safely achievable proportion of 15-caliber coils and 10-caliber coils if necessary (intervention group) in 4-12-mm aneurysms. The endpoint of the pilot phase of the trial was the capacity to increase packing density of the initial procedure, calculated using a mathematical transformation of the dimensions entered into the case report forms. Secondary outcomes included the total number of coils used per aneurysm, total fluoroscopy time, initial angiographic outcomes and any adverse or undesirable event. Results Seventy patients were recruited between June 2014 and November 2015. Compared with 10-caliber coils, the 15-caliber coil group had a higher median packing density (44% vs 24%, p = 0.017). Results of other outcome measures were similar for the two groups. Conclusion Coiling of small and medium aneurysms randomized to 15-caliber coils achieved higher packing densities compared with coiling using 10-caliber coils.

Endovascular treatment of aneurysms and platinum coil caliber: Study protocol of a randomized, controlled trial.

BACKGROUND: Endovascular coil embolization of cerebral aneurysms is an effective treatment for the prevention of aneurysm rebleeding after subarachnoid hemorrhage. It is also often used in unruptured aneurysms, but it is associated with aneurysm remnants and recurrences in up to 20%-33% of patients. We hypothesized that better aneurysm occlusion rates can be achieved with coils of larger caliber. METHODS: The Does Embolization with Larger coils lead to better Treatment of Aneurysms (DELTA) trial is an investigator-initiated, multicenter, prospective, randomized, controlled clinical trial. To test the hypothesis that 15-caliber coiling systems are superior to 10-caliber coils, 564 patients with aneurysms measuring 4-12 mm will be randomized 1:1 to embolization with either 10-caliber coils exclusively (control group) or the highest safely achievable proportion of 15-caliber coils (intervention group). The primary efficacy endpoint of the trial is the occurrence of a major recurrence or a residual aneurysm at one year. A pilot phase of 165 patients will be conducted to verify feasibility of the coiling strategy, compliance to treatment allocation, safety of a 15-caliber platinum coil embolization strategy, recruitment rates, and the capacity to improve packing density. DISCUSSION: The DELTA trial will test the hypothesis that the use of coils of larger caliber can improve angiographic results of endovascular coiling.

SILK flow diverter for complex intracranial aneurysms: a Canadian registry.

INTRODUCTION: The SILK flow diverter (SFD) is used for the treatment of complex intracranial aneurysms. Small case series have been reported in the literature but few studies with a large number of patients have been published. We present our experience with the SFD for the treatment of intracranial aneurysms in Canada. METHODS: Centers across Canada using SFDs were contacted to fill out a case report form for patients treated with an SFD in their center. Individual centers were responsible for approval from their ethics committee. Image analysis was performed by individual operators. The case report forms were collected and the final analysis was performed. RESULTS: A total of 92 patients were treated with SFDs in eight centers in Canada between January 2009 and August 2013. The aneurysms were located in the posterior circulation in 16 patients and in the anterior circulation in 76 patients. Most aneurysms (75%) were saccular in shape; 22% were fusiform and 3% were blister aneurysms. The size of the aneurysms varied from 2 to 60 mm with the neck varying from 2 to 60 mm. Perioperative morbidity and mortality were 8.7% and 2.2%, respectively. At the last available follow-up, 83.1% of the aneurysms were either completely or near-completely occluded. The rate of complications was higher for fusiform aneurysms (p<0.001). CONCLUSIONS: The SFD appears to be an important tool for the treatment of complex intracranial aneurysms. Treatment outcomes and complication rates remain a problem, but should be considered in the context of available alternative interventions. Ongoing analysis of flow-diverting stents for radiographic and clinical performance is required.

Safety of Abciximab injection during endovascular treatment of ruptured aneurysms.

BACKGROUND AND PURPOSE: We aimed to determine the safety of intra-arterial Abciximab injection in the management of thromboembolic complications during endovascular treatment of ruptured cerebral aneurysms. METHODS: In a monocentric consecutive series of endovascular treatment of 783 ruptured aneurysms, 42 (5.3%) patients received Abciximab after the aneurysm was secured. Bleeding complications were registered and dichotomized as follows: new intracranial hemorrhage and peripheral bleeding. For each patient, World Federation of Neurosurgery (WFNS) subarachnoid hemorrhage (SAH) grade, shunting, and clinical outcomes in the post-operative period and at 3-6 months were recorded. RESULTS: SAH WFNS grades were as follows: grade I n = 14, grade II n = 10, grade III n = 11, grade IV n = 4, grade V n = 3. Ten patients had intracranial hematoma additionally to the SAH prior to embolization. Four patients (9.5%) presented more blood on the post-embolization CT but only one suffered a new clinically relevant intracranial hemorrhage. Two patients (4.8%) experienced significant peripheral bleeding but none were associated with long-term disabilities. Fourteen patients had a shunt installed less than 24 h prior to Abciximab injection and one less than 48 h later. At 3-6-month follow-up, 31 patients (74%) achieved a modified Rankin Scale score (mRS) of 2 or less, six patients (14%) had a mRS of 3-5, three were dead (7%), and two were lost at follow-up. CONCLUSION: When the aneurysm is secured, intra-arterial Abciximab injection is a low complication rate treatment modality for thromboembolic events during embolization of cerebral ruptured aneurysm.

In vitro reproduction of device deformation leading to thrombotic complications and failure of flow diversion.

Flow diverters (FDs) are increasingly used for complex intracranial aneurysms. As these self-expanding devices are deployed across an aneurysm neck, they can undergo deformations. The potential clinical consequences of FD deformations remain unclear. We describe an immediate thrombotic complication attributed to a stereotypical stenotic deformation of an FD extremity that can occur when landing zones are of insufficient length. This case is supplemented with in vitro studies showing the relationship between i) the length of the landing zones and ii) discrepancies between the diameter of the device and recipient vessel, and the severity of FD stenosis. In vitro, a shorter landing zone was associated with a progressive stenotic deformation of the terminal ends of all FDs studied. This deformation was more pronounced when the diameter of the device was oversized compared to the size of the recipient tube. In our clinical case, the presence of this deformation led to an immediate thrombotic complication, requiring deployment of a second stent to correct the observed stenosis. In addition, treatment failure ultimately led to a fatal rupture, a failure that can be explained by residual flows through a more porous transition zone, another characteristic FD deformation which occurs when they are oversized as compared to the parent vessel, but free to expand at the level of the aneurysm. Proper selection of device diameter and length of the landing zone is important, and may decrease the incidence of deformation-related complications.