Yince Loh

A prospective, multicenter, randomized trial of the Onyx liquid embolic system and N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations: Clinical article

OBJECT The Onyx liquid embolic system (Onyx) was approved in the European Union in 1999 for embolization of lesions in the intracranial and peripheral vasculature, including brain arteriovenous malformations (AVMs) and hypervascular tumors. In 2001 a prospective, equivalence, multicenter, randomized controlled trial was initiated to support a submission for FDA approval. The objective of this study was to verify the safety and efficacy of Onyx compared with N-butyl cyanoacrylate (NBCA) for the presurgical treatment of brain AVMs. METHODS One hundred seventeen patients with brain AVMs were treated with either Onyx (54 patients) or NBCA (63 patients) for presurgical endovascular embolization between May 2001 and April 2003. The primary end point was technical success in achieving ≥ 50% reduction in AVM volume. Secondary end points were operative blood loss and resection time. All adverse events (AEs) were reported and assigned a relationship to the Onyx or NBCA system, treatment, disease, surgery, or other/unknown. The Data Safety Monitoring Board adjudicated AEs, and a blinded, independent core lab assessed volume measurements. Patients were monitored through discharge after the final surgery or through a 3- and/or 12-month follow-up if resection had not been performed or was incomplete. RESULTS The use of Onyx led to ≥ 50% AVM volume reduction in 96% of cases versus 85% for NBCA (p = not significant). The secondary end points of resection time and blood loss were similar. Serious AEs were also similar between the 2 treatment groups. CONCLUSIONS Onyx is equivalent to NBCA in safety and efficacy as a preoperative embolic agent in reducing brain AVM volume by at least 50%.

Endovascular Thrombectomy for Acute Ischemic Stroke in Failed Intravenous Tissue Plasminogen Activator Versus Non–Intravenous Tissue Plasminogen Activator Patients: Revascularization and Outcomes Stratified by the Site of Arterial Occlusions

Background and Purpose— Intracranial mechanical thrombectomy is a therapeutic option for acute ischemic stroke patients failing intravenous tissue plasminogen activator (IV tPA). We compared patients treated by mechanical embolus removal in cerebral ischemia (MERCI) thrombectomy after failed IV tPA with those treated with thrombectomy alone. Methods— We pooled MERCI and Multi MERCI study patients, grouped them either as failed IV tPA or non–IV tPA, and assessed revascularization rates, procedural complications, symptomatic hemorrhage rates, clinical outcomes, and mortality. We also evaluated outcomes stratified by the occlusion site and final revascularization. Results— Among 305 patients, 48 failed, and 257 were ineligible for IV tPA. Nonresponders to IV tPA trended toward a higher revascularization rate (73% versus 63%) and less mortality (27.7% versus 40.1%) and had similar rates of symptomatic hemorrhage and procedural complications. Favorable 90-day outcomes were similar in failed and non–IV tPA patients (38% versus 31%), with no difference according to occlusion site. Among patients failing IV tPA, good outcomes tended to occur more frequently in revascularized patients (47.1% versus 15.4%), although this relationship was attributable solely to middle cerebral artery and not internal carotid artery occlusions, with no difference in mortality. Among IV tPA–ineligible patients, revascularization correlated with good outcome (47.4% versus 4.4%) and less mortality (28.5% versus 59.6%). Conclusions— The risks of hemorrhage and procedure-related complications after mechanical thrombectomy do not differ with respect to previous IV tPA administration. Thrombectomy after IV tPA achieves similar rates of good outcomes, a tendency toward lower mortality, and similar revascularization rates when stratified by clot location. Good outcomes correlate with successful revascularization except with internal carotid artery occlusions in tPA-nonresponders.

Clinical Outcomes in Middle Cerebral Artery Trunk Occlusions Versus Secondary Division Occlusions After Mechanical Thrombectomy Pooled Analysis of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI Trials

Background and Purpose— The benefit of endovascular revascularization of patients with acute ischemic stroke with middle cerebral artery (MCA) secondary division (M2) occlusions as compared with MCA trunk (M1) occlusions is not known. In this analysis, we compared revascularization status and clinical outcomes in patients with angiographically confirmed MCA M1 versus isolated M2 occlusions treated with mechanical thrombectomy using the Merci Retriever devices. Methods— We retrospectively analyzed the pooled data of patients with MCA strokes from the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI trials. Patient data were dichotomized into 2 groups: MCA M1 occlusions and isolated M2 occlusions. Baseline characteristics, revascularization rates, hemorrhage rates, complications, outcomes, and mortality were evaluated for both groups. Results— Of 178 patients with MCA occlusion treated in the MERCI and Multi MERCI trials, 84.3% had M1 lesions and 15.7% had isolated M2 lesions. Patients with isolated M2 occlusions were revascularized at a higher rate, required a lower mean number of passes, and were associated with a trend toward shorter mean procedure time than patients with M1 occlusions. No statistically significant differences were found between M2 and M1 groups for symptomatic hemorrhage, clinically significant procedural adverse events, favorable 90-day outcome, or 90-day mortality, although in all instances, the M2 outcomes were numerically better than those in M1 subjects. In multivariate analysis, final revascularization was the strongest independent predictor of good outcome at 90 days. Conclusions— Patients with both MCA M1 occlusions and isolated M2 occlusions can achieve a relatively high rate of revascularization and favorable clinical outcomes after mechanical thrombectomy. In fact, patients with isolated M2 occlusions had a higher rate of revascularization, required fewer passes, and had no increased complications compared with patients with M1 occlusions.

Balloon-assisted transarterial embolization of intracranial dural arteriovenous fistulas

OBJECT The authors report their preliminary experience using a balloon-assisted technique (BAT) in the transarterial embolization of intracranial dural arteriovenous fistulas (DAVFs). METHODS The authors reviewed the prospectively collected data obtained in 7 consecutive patients with DAVFs in whom embolization was achieved using transarterially injected Onyx with either the venous or arterial BAT. Procedures were performed at the Division of Interventional Neuroradiology at the University of California at Los Angeles Medical Center between September 2005 and January 2008. RESULTS Three patients presented with cortical venous reflux and 4 did not. Three patients underwent transarterial Onyx-based embolization combined with transvenous balloon protection; the balloon was inflated in the transverse sinus in 2 of these patients and in the superior sagittal sinus in the third. One of them underwent an additional transarterial Onyx embolization with arterial BAT, whereas 4 other patients were treated with arterial BAT alone. The occipital artery was temporarily occluded with the balloon in 4 of these cases, whereas in the fifth, the authors used temporary balloon occlusion of the middle meningeal artery. Angiograms obtained immediately after embolization demonstrated complete or near-complete obliteration of the fistula in 6 patients and partial occlusion in 1 patient. There were no immediate or postprocedural complications. Two patients who presented with intracranial hemorrhage never suffered a second hemorrhage, and all other patients experienced either complete resolution or significant improvement of their symptoms. CONCLUSIONS The BAT provides a new complementary method in the transarterial embolization of DAVFs that are not amenable to transvenous embolization. The venous BAT protects the patency of critical venous pathways, whereas the arterial BAT provides better control of the Onyx-based embolization.

Leukoaraiosis Predicts Parenchymal Hematoma After Mechanical Thrombectomy in Acute Ischemic Stroke

Background and Purpose— The purpose of this study was to determine whether leukoaraiosis (LA) predicts hemorrhagic transformation and poor outcome in patients with acute ischemic stroke treated by mechanical thrombectomy. Methods— We retrospectively analyzed patients with anterior circulation stroke treated with Merci devices and identified LA in the deep white matter (DWM) and periventricular white matter on the preintervention MR images. We dichotomized patients into those with moderate or severe LA in the DWM versus those without. Hemorrhage rates and outcomes were evaluated between 2 groups. We analyzed the association of moderate or severe LA with hemorrhagic transformation and poor outcome. Results— Twenty-six of 105 patients had moderate or severe LA in the DWM. Patients with moderate or severe LA in the DWM were older, had more severe neurological deficits and worse outcome, had higher rates of hemorrhagic transformation and parenchymal hematoma, but had equivalent rates of hemorrhagic infarct and subarachnoid hemorrhage when compared with those without. Patients with only periventricular LA did not have a higher rate of parenchymal hematoma. Moderate or severe LA in the DWM was an independent predictor of hemorrhagic transformation (OR, 3.4; P=0.019) and parenchymal hematoma (OR, 6.3; P=0.005). Patients with parenchymal hematoma were less often independent (modified Rankin Scale ⩽2, 3.8% versus 32.5%; P=0.003) and had greater in-hospital mortality (50% versus 10.4%; P<0.001). Conclusions— Moderate or severe LA in the DWM increases the risk of parenchymal hematoma after Merci thrombectomy for patients with acute stroke. These findings require validation in a larger prospective study.

Predictors of Subarachnoid Hemorrhage in Acute Ischemic Stroke With Endovascular Therapy

Background and Purpose— Subarachnoid hemorrhage (SAH) is a potential hemorrhagic complication after endovascular intracranial recanalization. The purpose of this study was to describe the frequency and predictors of SAH in acute ischemic stroke patients treated endovascularly and its impact on clinical outcome. Methods— Acute ischemic stroke patients treated with primary mechanical thrombectomy, intra-arterial thrombolysis, or both were analyzed. Postprocedural computed tomography and magnetic resonance images were reviewed to identify the presence of SAH. We assessed any decline in the National Institutes of Health Stroke Scale score 3 hours after intervention and in the outcomes at discharge. Results— One hundred twenty-eight patients were treated by primary thrombectomy with MERCI Retriever devices, whereas 31 were treated by primary intra-arterial thrombolysis. Twenty patients experienced SAH, 8 with pure SAH and 12 with coexisting parenchymal hemorrhages. SAH was numerically more frequent with primary thrombectomy than in the intra-arterial thrombolysis groups (14.1% vs 6.5%, P=0.37). On multivariate analysis, independent predictors of SAH were hypertension (odds ratio=5.39, P=0.035), distal middle cerebral artery occlusion (odds ratio=3.53, P=0.027), use of rescue angioplasty after thrombectomy (odds ratio=12.49, P=0.004), and procedure-related vessel perforation (odds ratio=30.72, P<0.001). Patients with extensive SAH or coexisting parenchymal hematomas tended to have more neurologic deterioration at 3 hours (28.6% vs 0%, P=0.11), to be less independent at discharge (modified Rankin Scale ≤2; 0% vs 15.4%, P=0.5), and to experience higher mortality during hospitalization (42.9% vs 15.4%, P=0.29). Conclusions— Procedure-related vessel perforation, rescue angioplasty after thrombectomy with MERCI devices, distal middle cerebral artery occlusion, and hypertension were independent predictors of SAH after endovascular therapy for acute ischemic stroke. Only extensive SAH or SAH accompanied by severe parenchymal hematomas may worsen clinical outcome at discharge.

Higher rates of mortality but not morbidity follow intracranial mechanical thrombectomy in the elderly.

BACKGROUND AND PURPOSE: Mechanical thrombectomy is a promising means of recanalizing acute cerebrovascular occlusions in certain situations. We sought to determine if increasing age adversely affects prognosis. MATERIALS AND METHODS: We reviewed all Merci thrombectomy cases and compared patients younger than 80 years of age with older individuals. We compared these 2 age groups with respect to recanalization rates, hospital LOS, hemorrhagic transformation, and death and disability on discharge. RESULTS: Elderly patients were more likely to die from their stroke than those younger than 80 years of age, regardless of recanalization success (48% versus 15%; OR, 5.5; 95% CI, 2.1–14.1). Among survivors, there was no difference in the probability of having a good functional outcome (mRS, ≤2) by discharge (38% versus 40%; OR, 0.9; 95% CI, 0.3–2.8). Hemorrhagic transformation did not vary between age groups. CONCLUSIONS: Among patients undergoing mechanical thrombectomy for acute cerebrovascular occlusions, increased age conveys a higher rate of stroke-related death, but disability at discharge in this group is similar to that of younger survivors.

Recanalization Rates Decrease with Increasing Thrombectomy Attempts

BACKGROUND AND PURPOSE: Use of the Merci retriever is increasing as a means to reopen large intracranial arterial occlusions. We sought to determine whether there is an optimum number of retrieval attempts that yields the highest recanalization rates and after which the probability of success decreases. MATERIALS AND METHODS: All consecutive patients undergoing Merci retrieval for large cerebral artery occlusions were prospectively tracked at a comprehensive stroke center. We analyzed ICA, M1 segment of the MCA, and vertebrobasilar occlusions. We compared the revascularization of the primary AOL with the number of documented retrieval attempts used to achieve that AOL score. For tandem lesions, each target lesion was compared separately on the basis of where the device was deployed. RESULTS: We identified a total of 97 patients with 115 arterial occlusions. The median number of attempts per target vessel was 3, while the median final AOL score was 2. Up to 3 retrieval attempts correlated with good revascularization (AOL 2 or 3). When ≥4 attempts were performed, the end result was more often failed revascularization (AOL 0 or 1) and procedural complications (P = .006). CONCLUSIONS: In our experience, 3 may be the optimum number of Merci retrieval attempts per target vessel occlusion. Four or more attempts may not improve the chances of recanalization, while increasing the risk of complications.

Basal Ganglionic Infarction Before Mechanical Thrombectomy Predicts Poor Outcome

Background and Purpose— Use of mechanical thrombectomy for acute cerebrovascular occlusions is increasing. Preintervention MRI patterns may be helpful in predicting prognosis. Methods— We reviewed all Merci thrombectomy cases of either terminal ICA or M1 occlusions and classified them according to diffusion MRI patterns of (1) completed basal ganglia infarct (pure M1a), (2) near-completed basal ganglia infarct (incomplete M1a), and (3) relative sparing of deep MCA field (M1b). We compared the M1a and M1b patients with respect to neurological deficit on presentation, recanalization rates, hospital length of stay, and disability on discharge. We also determined whether deep MCA compromise predicted hematomal hemorrhagic transformation (HT) and whether this correlated with worse clinical outcome at discharge. Results— The M1a group had worse pre-Merci NIHSS (21 versus 14, P=0.004), worse discharge NIHSS (12 versus 4, P<0.001), longer hospital length of stay (11.5 versus 6.4 days, P=0.003), and higher rates of discharge mRS ≥3 (OR 8.4, 95% CI 2.1 to 44.7) despite equivalent recanalization rates when compared to the M1b group. The M1a group had a higher rate of parenchymal hematomal HT (OR 6.7, 95% CI 1.02 to 183.3). Patients with such hematomal HT had higher rates of death or dependency discharge (100% versus 60%, OR=infinite). Conclusions— Among patients with ICA and M1 occlusions, preintervention diffusion MRI evidence of advanced injury in the basal ganglia bodes worse dysfunction and disability at discharge, longer hospital stays, and higher rates of hemorrhage after intervention when compared to other diffusion patterns.

Flow control techniques for Onyx embolization of intracranial dural arteriovenous fistulae

Objectives Experience of flow control techniques during endovascular treatment of intracranial dural arteriovenous fistulas (DAVFs) using the Onyx liquid embolic system is reported, with an emphasis on high flow shunts. Methods Data were evaluated in patients with DAVFs treated endovascularly with Onyx. Adjunctive techniques with coils, acrylics and balloon assistance were utilized to reduce the rate of flow with transarterial and transvenous approaches. Results The following types of adjunctive techniques were used in 58 patients who underwent a total of 84 embolization sessions with Onyx: transvenous coiling with transvenous or transarterial Onyx embolization in 36 patients, transarterial coiling with transarterial Onyx embolization in eight patients, arterial or venous balloon assisted technique with transarterial or transvenous Onyx embolization in 11 patients, transarterial high concentration acrylics with transarterial Onyx embolization in one patient and staged transarterial or transvenous coiling and Onyx embolization in two patients. Complete obliteration of the fistulae was achieved in 41 patients (70.7%) and 27 patients (65.9%) with high flow fistulae after endovascular treatment alone. Periprocedural complications were encountered in 16 patients, and 13 complications were associated with the adjunctive techniques. There were four neurologic and two non-neurologic clinical sequelae. Distal Onyx migration occurred in four, microcatheter retention in three and cranial neuropathy in three patients. There was one instance each of cerebellar hemorrhage, thromboembolism, coil stretching and retention, and dissection. 56 survivors experienced complete resolution or significant improvement of their symptoms on follow-up. Conclusions Flow control techniques are safe and effective adjunctive methods in primary endovascular Onyx embolization of high flow DAVFs.