Angiographic results of surgical or endovascular treatment of intracranial aneurysms: a systematic review and inter-observer reliability study.

PURPOSE: Results of surgical or endovascular treatment of intracranial aneurysms are often assessed using angiography. A reliable method to report results irrespective of treatment modality is needed to enable comparisons. Our goals were to systematically review existing classification systems, and to propose a 3-point classification applicable to both treatments and assess its reliability. METHODS: We conducted two systematic reviews on classification systems of angiographic results after clipping or coiling to select a simple 3-category scale that could apply to both treatments. We then circulated an electronic portfolio of angiograms of clipped (n=30) or coiled (n=30) aneurysms, and asked raters to evaluate the degree of occlusion using this scale. Raters were also asked to choose an appropriate follow-up management for each patient based on the degree of occlusion. Agreement was assessed using Krippendorff's α statistics (αK), and relationship between occlusion grade and clinical management was analyzed using Fisher's exact and Cramer's V tests. RESULTS: The systematic reviews found 70 different grading scales with heterogeneous reliability (kappa values from 0.12 to 1.00). The 60-patient portfolio was independently evaluated by 19 raters of diverse backgrounds (neurosurgery, radiology, and neurology) and experience. There was substantial agreement (αK=0.76, 95%CI, 0.67-0.83) between raters, regardless of background, experience, or treatment used. Intra-rater agreement ranged from moderate to almost perfect. A strong relationship was found between angiographic grades and management decisions (Cramer's V: 0.80±0.12). CONCLUSION: A simple 3-point scale demonstrated sufficient reliability to be used in reporting aneurysm treatments or in evaluating treatment results in comparative randomized trials.

Cervical Internal Carotid Occlusion versus Pseudo-occlusion at CT Angiography in the Context of Acute Stroke: An Accuracy, Interobserver, and Intraobserver Agreement Study.

Purpose To evaluate the diagnostic accuracy and reliability of computed tomographic (CT) angiography to distinguish true cervical internal carotid artery (ICA) occlusion from pseudo-occlusion (defined as an isolated intracranial thrombus that impedes ascending blood flow) in the context of acute stroke. Materials and Methods This was a retrospective study of patients who underwent thrombectomy with preprocedural CT angiography that helps to demonstrate a lack of attenuation in the cervical ICA on the symptomatic side (24 men and 13 women; mean age, 63 years; age range, 30-86 years). Seven readers, including five neuroradiologists and two interventional neuroradiology fellows, independently reviewed the CT angiography images to assess whether there was true cervical ICA occlusion. Their results were compared with digital subtraction angiography (DSA) as the reference standard. Sensitivity and specificity for detecting true occlusion as well as accuracy and diagnostic odds ratio were calculated, with inter- and intraobserver κ statistics. Results Cervical ICA pseudo-occlusion occurred in 12 of 37 patients (32.4%) with nonattenuation of the cervical ICA on the symptomatic side. Interobserver agreement coefficients did not reach the substantial value of 0.61 for either pairs or groups of readers. The cohort's average sensitivity and specificity was 68% (95% confidence interval [CI]: 59%, 76%) and 75% (95% CI: 71%, 80%), respectively, with a diagnostic odds ratio of 8 (95% CI: 3, 18) and only fair interobserver agreement (κ = 0.32; 95% CI: 0.16, 0.47). Conclusion In the context of acute ischemic stroke with ipsilateral ICA nonattenuation at single-phase CT angiography, even specialized radiologists may not reliably distinguish true cervical occlusion from pseudo-occlusion. © RSNA, 2017 Online supplemental material is available for this article.

Surgical clipping or endovascular coiling for unruptured intracranial aneurysms: a pragmatic randomised trial.

BACKGROUND: Unruptured intracranial aneurysms (UIAs) are increasingly diagnosed and are commonly treated using endovascular treatment or microsurgical clipping. The safety and efficacy of treatments have not been compared in a randomised trial. How to treat patients with UIAs suitable for both options remains unknown. METHODS: We randomly allocated clipping or coiling to patients with one or more 3-25 mm UIAs judged treatable both ways. The primary outcome was treatment failure, defined as: initial failure of aneurysm treatment, intracranial haemorrhage or residual aneurysm on 1-year imaging. Secondary outcomes included neurological deficits following treatment, hospitalisation >5 days, overall morbidity and mortality and angiographic results at 1 year. RESULTS: The trial was designed to include 260 patients. An analysis was performed for slow accrual: 136 patients were enrolled from 2010 through 2016 and 134 patients were treated. The 1-year primary outcome, available for 104 patients, was reached in 5/48 (10.4% (4.5%-22.2%)) patients allocated surgical clipping, and 10/56 (17.9% (10.0%-29.8%)) patients allocated endovascular coiling (OR: 0.54 (0.13-1.90), p=0.40). Morbidity and mortality (modified Rankin Scale>2) at 1 year occurred in 2/48 (4.2% (1.2%-14.0%)) and 2/56 (3.6% (1.0%-12.1%)) patients allocated clipping and coiling, respectively. New neurological deficits (15/65 vs 6/69; OR: 3.12 (1.05-10.57), p=0.031), and hospitalisations beyond 5 days (30/65 vs 6/69; OR: 8.85 (3.22-28.59), p=0.0001) were more frequent after clipping. CONCLUSION: Surgical clipping or endovascular coiling of UIAs did not show differences in morbidity at 1 year. Trial continuation and additional randomised evidence will be necessary to establish the supposed superior efficacy of clipping.

Safety and occlusion rates of surgical treatment of unruptured intracranial aneurysms: a systematic review and meta-analysis of the literature from 1990 to 2011.

BACKGROUND AND PURPOSE: Surgical clipping of unruptured intracranial aneurysms (UIAs) has recently been challenged by the emergence of endovascular treatment. We performed an updated systematic review and meta-analysis on the surgical treatment of UIAs, in an attempt to determine the aneurysm occlusion rates and safety of surgery in the modern era. METHODS: A detailed protocol was developed prior to conducting the review according to the Cochrane Collaboration guidelines. Electronic databases spanning January 1990-April 2011 were searched, complemented by hand searching. Heterogeneity was assessed using I(2), and publication bias with funnel plots. Surgical mortality and morbidity were analysed with weighted random effect models. RESULTS: 60 studies with 9845 patients harbouring 10 845 aneurysms were included. Mortality occurred in 157 patients (1.7%; 99% CI 0.9% to 3.0%; I(2)=82%). Unfavourable outcomes, including death, occurred in 692 patients (6.7%; 99% CI 4.9% to 9.0%; I(2)=85%). Morbidity rates were significantly greater in higher quality studies, and with large or posterior circulation aneurysms. Reported morbidity rates decreased over time. Studies were generally of poor quality; funnel plots showed heterogeneous results and publication bias, and data on aneurysm occlusion rates were scant. CONCLUSIONS: In studies published between 1990 and 2011, clipping of UIAs was associated with 1.7% mortality and 6.7% overall morbidity. The reputed durability of clipping has not been rigorously documented. Due to the quality of the included studies, the available literature cannot properly guide clinical decisions.

Intraoperative angiography reloaded: a new hybrid operating theater for combined endovascular and surgical treatment of cerebral arteriovenous malformations: a pilot study on 25 patients.

BACKGROUND: Multimodality treatment suites for patients with cerebral arteriovenous malformations (AVM) have recently become available. This study was designed to evaluate feasibility, safety and impact on treatment of a new intraoperative flat-panel (FP) based integrated surgical and imaging suite for combined endovascular and surgical treatment of cerebral AVM. METHODS: Twenty-five patients with AVMs to treat with combined endovascular and surgical interventions were prospectively enrolled in this consecutive case series. The hybrid suite allows combined endovascular and surgical approaches with intraoperative scanner-like imaging (XperCT®) and intraoperative 3D rotational angiography (3D-RA). The impact of intraoperative multimodal imaging on feasibility, workflow of combined interventions, surgery, and unexpected imaging findings were analyzed. RESULTS: Twenty-five patients (mean age 38 ± 18.6 year) with a median Spetzler-Martin grade 2 AVM (range 1-4) underwent combined endovascular and surgical procedures. Sixteen patients presented with a ruptured AVM and nine with an unruptured AVM. In 16 % (n = 4) of cases, intraoperative imaging visualized AVM remnants ≤3 mm and allowed for completion of the resections in the same sessions. Complete resection was confirmed in all n = 16 patients who had follow-up angiography one year after surgery so far. All diagnostic and therapeutical steps, including angiographic control, were performed without having to move the patients CONCLUSION: The hybrid neurointerventional suite was shown to be a safe and useful setup which allowed for unconstrained combined microsurgical and neuroradiological workflow. It reduces the need for extraoperative angiographic controls and subsequent potential surgical revisions a second time, as small AVM remnants can be detected with high security.

From intraoperative angiography to advanced intraoperative imaging: the geneva experience.

OBJECTIVE: We aimed at the integration of recent flat panel technology in a joint interventional suite for neurosurgeons and neuroradiologists. METHODS: A Flat Panel system, allowing for intraoperative performance of 2D and 3D DSA, for automated segmentation of vascular structures, and for performance of computed tomography, was connected with a surgical microscope and neuronavigation. All surgical and neurointerventional cases were monitored and stored in a prospective data base. RESULTS: N=99 patients were treated neurosurgically: N=63 aneurysm clippings in n=51 patients; n=12 resections of arteriovenous malformations (AVM); n=6 clippings/excisions of dural AV fistulae (dAVF); n=3 EC-IC bypass procedures; n=10 resections of skull base tumours; n=17 spine procedures. All patients had intraoperative imaging for angiographic control and/or for anatomical allocation. Intraoperative 3D-rotational angiography was performed n=54 times in n=42 patients in < 15 min each, with repositioning of aneurysm clips in n=9 patients. CONCLUSION: This hybrid neuro-interventional suite opens a new avenue for intraoperative imaging by the provision of highly resoluted angiographic or CT images, which may be co-registered with a navigation system. In addition, the workflow in treatment of aneurysmal SAH can be improved, as all diagnostic and therapeutic measures can be taken without having to move the patient to other facilities.

Surgical or Endovascular Management of Middle Cerebral Artery Aneurysms: A Randomized Comparison.

OBJECTIVE: There are few randomized data comparing clipping and coiling for middle cerebral artery (MCA) aneurysms. We analyzed results from patients with MCA aneurysms enrolled in the CURES (Collaborative UnRuptured Endovascular vs. Surgery) and ISAT-2 (International Subarachnoid Aneurysm Trial II) randomized trials. METHODS: Both trials are investigator-led parallel-group 1:1 randomized studies. CURES includes patients with 3-mm to 25-mm unruptured intracranial aneurysms (UIAs), and ISAT-2 includes patients with ruptured aneurysms (RA) for whom uncertainty remains after ISAT. The primary outcome measure of CURES is treatment failure: 1) failure to treat the aneurysm, 2) intracranial hemorrhage during follow-up, or 3) residual aneurysm at 1 year. The primary outcome of ISAT-2 is death or dependency (modified Rankin Scale score >2) at 1 year. One-year angiographic outcomes are systematically recorded. RESULTS: There were 100 unruptured and 71 ruptured MCA aneurysms. In CURES, 90 patients with UIA have been treated and 10 await treatment. Surgical and endovascular management of unruptured MCA aneurysms led to treatment failure in 3/42 (7%; 95% confidence interval [CI], 0.02-0.19) for clipping and 13/48 (27%; 95% CI, 0.17-0.41) for coiling (P = 0.025). All 71 patients with RA have been treated. In ISAT-2, patients with ruptured MCA aneurysms managed surgically had died or were dependent (modified Rankin Scale score >2) in 7/38 (18%; 95% CI, 0.09-0.33) cases, and 8/33 (24%; 95% CI, 0.13-0.41) for endovascular. One-year imaging results were available in 80 patients with UIA and 62 with RA. Complete aneurysm occlusion was found in 30/40 (75%; 95% CI, 0.60-0.86) patients with UIA allocated clipping, and 14/40 (35%; 95% CI, 0.22-0.50) patients with UIA allocated coiling. Complete aneurysm occlusion was found in 24/34 (71%; 95% CI, 0.54-0.83) patients with RA allocated clipping, and 15/28 (54%; 95% CI, 0.36-0.70) patients with RA allocated coiling. CONCLUSIONS: Randomized data from 2 trials show that better efficacy may be obtained with surgical management of patients with MCA aneurysms.

Residual Cerebral Aneurysms After Microsurgical Clipping: A New Scale, an Agreement Study, and a Systematic Review of the Literature.

OBJECTIVE: The surgical repair of a cerebral aneurysm does not always lead to complete occlusion. A standardized repeatable method of reporting results of surgical clipping is desirable. Our purpose was to systematically review methods of classifying aneurysm remnants, provide a new scale with precise definitions of categories, and perform an agreement study to assess the variability in adjudicating remnants after aneurysm clipping. METHODS: A systematic review was performed to identify ways to report angiographic results of surgical clipping between 1963 and 2017. Postclipping angiographic results of 43 patients were also independently evaluated by 10 raters of various experience and backgrounds using a new 4-category scale. Agreement between responses were analyzed using κ statistics. RESULTS: The systematic review yielded 63 articles with 37 different nomenclatures using 2-6 categories. The reliability of judging the presence of an aneurysm remnant on catheter angiography was studied only twice, with only 2 raters each time, with contradictory results. Interobserver agreement using the new 4-category scale was moderate (κ = 0.52; 95% confidence interval, 0.43-0.62) for all observers, but improved to substantial (κ = 0.62; 95% confidence interval, 0.47-0.76) when results were dichotomized (grade 0/1 vs. 2/3). CONCLUSIONS: Various classification schemes to evaluate angiographic results after surgical clipping exist in the literature, but they lack standardization. Adjudication using fewer, better defined categories may yield more reliable agreement.

Re-treatment of residual aneurysms after flow diversion: An experimental study.

Aim Flow diverters are increasingly used to treat aneurysms, but treatment is not always effective. The management of aneurysms that fail to occlude following flow diversion is problematic. We aimed to reproduce failures in an animal model and study re-treatment with additional flow diverters alone or with flow diverters and liquid embolic agent. Material and methods Twenty wide-necked aneurysms were created at the carotid-lingual bifurcation in 10 dogs, and were treated with flow diverters 4-6 weeks later. Follow-up angiography was performed at three months. Suitable residual aneurysms were randomly allocated: re-treatment with flow diverters alone ( n = 6), or with the injection of liquid embolic between two layers of flow diverters ( n = 4) or no re-treatment ( n = 2). Angiography was repeated three months later, followed by euthanasia, photography and pathology. Results Patent wide-necked aneurysms were produced in 17/20 attempts (85%); three months after flow diversion there were 15/17 (88%) residual aneurysms. In three cases, re-treatment was not possible because the flow diverter had prolapsed into the aneurysm, leaving 12 aneurysms to study. Re-treated aneurysms showed improved angiographic results at six months (median score of 2; P = 0.03), but residual aneurysms were present in all cases. Parent artery occlusion occurred in two aneurysms treated with flow diverter plus liquid embolic. At pathology, aneurysms were only partially filled with thrombus; leaks through the flow diverters were found in the neointima connecting the arterial lumen to residual aneurysms. Conclusion Re-treatment of residual flow-diverted experimental aneurysms with additional flow diverters did not lead to aneurysm occlusion.

The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research.

OBJECTIVE The management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation. METHODS TOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers randomized allocation of interventional versus conservative management to patients eligible for both options (first RCT), a second RCT testing the role of preembolization as an adjunct to surgery or radiotherapy, and a registry of patients managed using clinical judgment alone. The primary outcome of the first RCT is death from any cause or disabling stroke (modified Rankin Scale score > 2) at 10 years. A pilot phase was initiated at one center to test study feasibility, record the number and characteristics of patients enrolled in the RCTs, and estimate the frequency of crossovers. RESULTS All patients discussed at the multidisciplinary bAVM committee between June 2014 and June 2016 (n = 107) were recruited into the study; 46 in the randomized trials (23 in the first RCT with 21 unruptured bAVMs, 40 in the second RCT with 17 unruptured bAVMs, and 17 in both RCTs), and 61 patients in the registry. Three patients crossed over from surgery to observation (first RCT). CONCLUSIONS Clinical research was successfully integrated with normal practice using TOBAS. Recruitment rates in a single center are encouraging. Whether the trial will provide meaningful results depends on the recruitment of a sufficient number of participating centers. Clinical trial registration no.: NCT02098252 (clinicaltrials.gov).

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.

Unexpected complications with head and neck hydrogel microsphere particle embolization: A case series and a technical note.

Endovascular particle embolization is a common procedure with a relatively safe profile. We report here four cases in which cranial nerves, skin and mucosal ischemic complications occurred with the use of hydrogel microspheres (250-500 µm in size). Given the compressibility and higher penetration potential of microsphere particles compared with polyvinyl alcohol particles of similar size, we suggest oversizing hydrogel microsphere particles for head and neck embolizations.

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.

Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison.

OBJECT: Recent years have been marked by efforts to improve the quality and safety of pedicle screw placement in spinal instrumentation. The aim of the present study is to compare the accuracy of the SpineAssist robot system with conventional fluoroscopy-guided pedicle screw placement. METHODS: Ninety-five patients suffering from degenerative disease and requiring elective lumbar instrumentation were included in the study. The robot cohort (Group I; 55 patients, 244 screws) consisted of an initial open robot-assisted subgroup (Subgroup IA; 17 patients, 83 screws) and a percutaneous cohort (Subgroup IB, 38 patients, 161 screws). In these groups, pedicle screws were placed under robotic guidance and lateral fluoroscopic control. In the fluoroscopy-guided cohort (Group II; 40 patients, 163 screws) screws were inserted using anatomical landmarks and lateral fluoroscopic guidance. The primary outcome measure was accuracy of screw placement on the Gertzbein-Robbins scale (Grade A to E and R [revised]). Secondary parameters were duration of surgery, blood loss, cumulative morphine, and length of stay. RESULTS: In the robot group (Group I), a perfect trajectory (A) was observed in 204 screws (83.6%). The remaining screws were graded B (n = 19 [7.8%]), C (n = 9 [3.7%]), D (n = 4 [1.6%]), E (n = 2 [0.8%]), and R (n = 6 [2.5%]). In the fluoroscopy-guided group (Group II), a completely intrapedicular course graded A was found in 79.8% (n = 130). The remaining screws were graded B (n = 12 [7.4%]), C (n = 10 [6.1%]), D (n = 6 [3.7%]), and E (n = 5 [3.1%]). The comparison of "clinically acceptable" (that is, A and B screws) was neither different between groups (I vs II [p = 0.19]) nor subgroups (Subgroup IA vs IB [p = 0.81]; Subgroup IA vs Group II [p = 0.53]; Subgroup IB vs Group II [p = 0.20]). Blood loss was lower in the robot-assisted group than in the fluoroscopy-guided group, while duration of surgery, length of stay, and cumulative morphine dose were not statistically different. CONCLUSIONS: Robot-guided pedicle screw placement is a safe and useful tool for assisting spine surgeons in degenerative spine cases. Nonetheless, technical difficulties remain and fluoroscopy backup is advocated.

Acute spinal epidural hematoma and cranial interdural hematoma due to a rupture of a posterior communicating artery aneurysm: case report.

BACKGROUND AND IMPORTANCE: We describe an unusual presentation of a ruptured aneurysm of the posterior communicating artery with an acute intracranial hematoma between the dural layers associated with an acute spinal epidural hematoma descending to L1. CLINICAL PRESENTATION: A 35-year-old woman presented 3 hours after ictus with a postcoital headache, neck stiffness, and bilateral abducens cranial nerve palsy. No other neurological deficits were present. Clinically, she had a subarachnoid hemorrhage World Federation of Neurosurgical Societies grade 1. CT scan demonstrates an acute subdural hematoma, extending from the right parasellar region, around the clivus, tentorium, and falx. Angio-CT showed a posterior communicating artery aneurysm and an anterior communicating artery aneurysm and an extension of the hematoma to the cervical spine. This justified a spinal and cerebral MRI that confirmed an extension of the hematoma to the epidural space at the cervical, thoracic, and lumbar levels. Three-dimensional digital subtraction angiography confirmed aneurysms on the right posterior communicating artery and on the anterior communicating artery. Both aneurysms were completely occluded by coiling. With reference to the concept of the cranial subdural compartment described in studies conducted using an electron microscope, this group of hematomas was classified as interdural. CONCLUSION: Ruptured aneurysm of the posterior communicating artery may cause cranial acute interdural hematoma with a typical subarachnoid hemorrhage clinical presentation, and it rarely can extend to spinal epidural space.