Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study.

BACKGROUND: Catheter retention and difficulty in retrieval have been observed during embolization of brain arteriovenous malformations (bAVMs) with the Onyx liquid embolic system (Onyx). The Apollo Onyx delivery microcatheter (Apollo) is a single lumen catheter designed for controlled delivery of Onyx into the neurovasculature, with a detachable distal tip to aid catheter retrieval. This study evaluates the safety of the Apollo for delivery of Onyx during embolization of bAVMs. METHODS: This was a prospective, non-randomized, single-arm, multicenter, post-market study of patients with a bAVM who underwent Onyx embolization with the Apollo between May 2015 and February 2018. The primary endpoint was any catheter-related adverse event (AE) at 30 days, such as unintentional tip detachment or malfunction with clinical sequelae, or retained catheter. Procedure-related AEs (untoward medical occurrence, disease, injury, or clinical signs) and serious AEs (life threatening illness or injury, permanent physiological impairment, hospitalization, or requiring intervention) were also recorded. RESULTS: A total of 112 patients were enrolled (mean age 44.1±17.6 years, 56.3% men), and 201 Apollo devices were used in 142 embolization procedures. The mean Spetzler-Martin grade was 2.38. The primary endpoint was not observed (0/112, 0%). The catheter tip detached during 83 (58.5%) procedures, of which 2 (2.4%) were unintentional and did not result in clinical sequelae. At 30 days, procedure related AEs occurred in 26 (23.2%) patients, and procedure-related serious AEs in 12 (10.7%). At 12 months, there were 3 (2.7%) mortalities, including 2 (1.8%) neurological deaths, none of which were device-related. CONCLUSION: This study demonstrates the safety of Apollo for Onyx embolization of bAVMs. CLINICAL TRIAL REGISTRATION: CNCT02378883.

Technical note on endovascular treatment of concomitant carotid occlusion in large vessel occlusion stroke: The "single-cross" technique.

BACKGROUND: Emergent large vessel occlusive (ELVO) stroke secondary to underlying carotid occlusive disease is frequently encountered in endovascular ischemic stroke therapy and trials. Up to 29% of all cerebral vascular accidents are attributed to severe carotid occlusive disease, and recent interventional trials have demonstrated this occurrence in 18.6-32.2% of ELVO stroke. We present a novel technique using the stent retriever guide wire to expedite angioplasty and/or stent placement for associated carotid occlusive disease during mechanical thrombectomy of ELVO stroke. This technique utilizes the "waiting time" during stent retriever integration within the thrombus as an opportunity to initiate revascularization of the cervical carotid, using the deployed stent retriever guidewire as an ad hoc rapid exchange wire while the stentriever serves as a potential surrogate distal embolic protection device. We present 23 cases using this novel endovascular approach, which we have called the single-cross technique, as the cervical lesion is only traversed once during therapy. METHODS: A case series of 23 consecutive patients who underwent a novel endovascular technique for treating tandem ICA origin and intracranial occlusive lesions is presented. Endpoints measured were time to re-perfusion, rates of intracranial hemorrhage and clinical outcomes (mRS at 30 and 90 days). RESULTS: Average procedure time for revascularizing both the carotid and intracranial lesions was 52 min. A symptomatic ICH rate of 9% was observed. Seventy-four percent of patients had an mRS of 0-2 at follow-up. CONCLUSIONS: The single-cross technique appears to be a safe and effective option for treating tandem occlusive lesions in the setting of ELVO.

Impact of Balloon Guide Catheter Use on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry.

Background and Purpose- Mechanical thrombectomy has been shown to improve clinical outcomes in patients with acute ischemic stroke. However, the impact of balloon guide catheter (BGC) use is not well established. Methods- STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter study of patients with large vessel occlusion treated with the Solitaire stent retriever as first-line therapy. In this study, an independent core laboratory, blinded to the clinical outcomes, reviewed all procedures and angiographic data to classify procedural technique, target clot location, recanalization after each pass, and determine the number of stent retriever passes. The primary clinical end point was functional independence (modified Rankin Scale, 0-2) at 3 months as determined on-site, and the angiographic end point was first-pass effect (FPE) success rate from a single device attempt (modified Thrombolysis in Cerebral Infarction, ≥2c) as determined by a core laboratory. Achieving modified FPE (modified Thrombolysis in Cerebral Infarction, ≥2b) was also assessed. Comparisons of clinical outcomes were made between groups and adjusted for baseline and procedural characteristics. All participating centers received institutional review board approval from their respective institutions. Results- Adjunctive technique groups included BGC (n=445), distal access catheter (n=238), and conventional guide catheter (n=62). The BGC group had a higher rate of FPE following first pass (212/443 [48%]) versus conventional guide catheter (16/62 [26%]; P=0.001) and distal access catheter (83/235 [35%]; P=0.002). Similarly, the BGC group had a higher rate of modified FPE (294/443 [66%]) versus conventional guide catheter (26/62 [42%]; P<0.001) and distal access catheter (129/234 [55%]; P=0.003). The BGC group achieved the highest rate of functional independence (253/415 [61%]) versus conventional guide catheter (23/55 [42%]; P=0.007) and distal access catheter (113/218 [52%]; P=0.027). Final revascularization and mortality rates did not differ across the groups. Conclusions- BGC use was an independent predictor of FPE, modified FPE, and functional independence, suggesting that its routine use may improve the rates of early revascularization success and good clinical outcomes. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239640.

A Prospective Multicenter Trial of the TransForm Occlusion Balloon Catheter: Trial Design and Results.

BACKGROUND AND PURPOSE: Adjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm™ Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC. METHOD AND STUDY DESIGN: The TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients. RESULTS: The performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use. CONCLUSION: BACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results.

Interhospital Transfer Before Thrombectomy Is Associated With Delayed Treatment and Worse Outcome in the STRATIS Registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke).

BACKGROUND: Endovascular treatment with mechanical thrombectomy (MT) is beneficial for patients with acute stroke suffering a large-vessel occlusion, although treatment efficacy is highly time-dependent. We hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared with direct presentation. METHODS: STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke because of anterior-circulation large-vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without intravenous tissue plasminogen activator and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0-2) at 90 days. We assessed (1) real-world time metrics of stroke care delivery, (2) outcome differences between direct and transfer patients undergoing MT, and (3) the potential impact of local hospital bypass. RESULTS: A total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct versus 311.5 minutes for transfer patients (P<0.001). Clinical outcomes were better in the direct group, with 60.0% (299/498) achieving functional independence compared with 52.2% (213/408) in the transfer group (odds ratio, 1.38; 95% confidence interval, 1.06-1.79; P=0.02). Likewise, excellent outcome (modified Rankin Score 0-1) was achieved in 47.4% (236/498) of direct patients versus 38.0% (155/408) of transfer patients (odds ratio, 1.47; 95% confidence interval, 1.13-1.92; P=0.005). Mortality did not differ between the 2 groups (15.1% for direct, 13.7% for transfer; P=0.55). Intravenous tissue plasminogen activator did not impact outcomes. Hypothetical bypass modeling for all transferred patients suggested that intravenous tissue plasminogen activator would be delayed by 12 minutes, but MT would be performed 91 minutes sooner if patients were routed directly to endovascular-capable centers. If bypass is limited to a 20-mile radius from onset, then intravenous tissue plasminogen activator would be delayed by 7 minutes and MT performed 94 minutes earlier. CONCLUSIONS: In this large, real-world study, interhospital transfer was associated with significant treatment delays and lower chance of good outcome. Strategies to facilitate more rapid identification of large-vessel occlusion and direct routing to endovascular-capable centers for patients with severe stroke may improve outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry.

BACKGROUND AND PURPOSE: Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials. METHODS: STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis. RESULTS: A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab-adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2. CONCLUSIONS: This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Intravascular frequency-domain optical coherence tomography assessment of carotid artery disease in symptomatic and asymptomatic patients.

OBJECTIVES: The goal of this study was to investigate carotid plaque characteristics in symptomatic versus asymptomatic patients with the use of nonocclusive optical coherence tomography (OCT). BACKGROUND: The identification of asymptomatic patients with carotid disease who are at risk of stroke remains a challenge. There is an increasing awareness that plaque characteristics may best risk-stratify this population. We hypothesized that OCT, a new high-resolution (∼ 10 µm) imaging modality, might be useful for the identification of low-risk versus high-risk carotid plaque features and help us to understand the relationship between carotid diameter stenosis and plaque morphology to ischemic stroke. METHODS: Fifty-three patients undergoing diagnostic carotid angiography were studied with OCT. Data analysis was carried out by imaging experts who were unaware of the clinical characteristics of the study population. RESULTS: Plaque with American Heart Association type VI complicated features was more common in symptomatic than asymptomatic patients (74.1% vs. 36.4%, p = 0.02). This was largely driven by differences in the incidence of thin-cap fibroatheroma with rupture (40.7% vs. 13.6%, p = 0.056) and thrombus (67.7% vs. 36.4%, p = 0.034). Conversely, non-type VI plaques were more common in asymptomatic than symptomatic patients (63.6% vs. 25.9%, p = 0.02). No association between the degree of stenosis and plaque morphology was identified. CONCLUSIONS: This retrospective analysis of carotid OCT data supports the hypothesis that the evaluation of carotid plaque characteristics with this high-resolution imaging technique has the potential to alter the understanding and treatment of carotid artery disease.

Frequency-domain optical coherence tomography assessment of very late vascular response after carotid stent implantation.

Intravascular optical coherence tomography is a high-resolution invasive imaging modality that allows the evaluation of vascular responses after stent implantation in a micron-scale level. We describe for the first time two patients with very late vascular response after carotid artery stenting that exhibit two different patterns of low-signal intensity (LSI), "ill-appearing" neointima: the first patient shows layered LSI neointima leading to stent restenosis, coupled with the presence of intraluminal thrombus, whereas the second patient demonstrates another pattern of non-restenotic LSI stent strut coverage, suggestive of lipid laden neointima (ie, "neoatherosclerosis"), recently associated with stent failure in coronary arteries.

The emergency use of endografts in the carotid circulation to control hemorrhage in potentially contaminated fields.

We report our experience with the use of endoluminal grafts to control emergency bleeding in two patients with tracheoinnominate fistulas and three patients with carotid blowouts. Systemic infectious complications were not seen. However, rebleeding occurred in one patient, and extensive stent coverage to control bleeding was required in a second. Survival was usually limited by the patient's cancer. There was one long-term survivor without cancer whose tracheostomy was placed for neurologic compromise. A review of the literature for similar cases identified 18 additional endografts placed for carotid blowout and 3 placed for tracheoinnominate fistulas. Overall, infectious complications occurred in only two patients, whereas rebleeding occurred in eight patients. On the basis of these findings, we believe that endografts are useful to control emergency hemorrhage in these two pathologies because treatment is usually palliative, given the poor survival secondary to the underlying disease. However, more extensive graft coverage may be necessary considering the erosive nature of these processes.

Combined transarterial N-butyl cyanoacrylate and coil embolization of direct carotid-cavernous fistulas. Report of two cases.

The authors report two cases of traumatic carotid-cavernous fistulas treated successfully with combined N-butyl cyanoacrylate glue and coil embolization via a transarterial approach. In both cases complete occlusion of the fistula was achieved, with preservation of the parent carotid artery. Casting of the cavernous sinus with a liquid embolic agent was well tolerated and produced no complications of cranial nerve palsy. This technique provides interventionalists with yet another treatment option in these often complex cases.

Spontaneous intracranial arterial dissection in the young: diagnosis by CT angiography.

BACKGROUND: Spontaneous carotid artery dissections have been rarely reported in children. Diagnosis has traditionally been confirmed by catheter arteriography. More recently diagnosis has been made by magnetic resonance imaging and magnetic resonance angiography; however the sensitivity of these techniques has yet to be determined. The authors are unaware of reports of carotid dissection confirmed by dynamic computed tomography (computerized tomographic arteriography) in the young. CASE PRESENTATION: We recently evaluated a fourteen year-old male following the development of transient neurologic symptoms. There was no antecedent illness or trauma. Dynamic computed tomography revealed an intracranial dissection involving the supraclinoid segment of the left internal carotid artery (confirmed by catheter arteriography). Studies for vasculitis, pro-thrombotic states, and defects of collagen were negative. CONCLUSION: Spontaneous carotid artery dissection is a potential cause of transient neurological symptoms and ischemic stroke in the pediatric population. Dynamic computed tomography appears to be a reliable diagnostic tool which can lead to early diagnosis.

Interhemispheric lipoma connected to subcutaneous lipoma via lipomatous stalk.

Lipomas are rare intracranial lesions and are generally thought to be asymptomatic. The vast majority of intracranial lipomas are viewed as incidental findings on imaging studies and treated conservatively. Intracranial lipomas are frequently accompanied by additional intracranial congenital malformations, but only rarely has an association with subcutaneous lipomas been described. We report an infant with a subgaleal lipoma in the region of the anterior fontanelle connected to a large interhemispheric (pericallosal) lipoma via a tiny lipomatous stalk. Because of this association, infants who present with a subcutaneous lipoma of the scalp might be considered for MR imaging to evaluate for an intracranial component.

Percutaneous sacroplasty for the treatment of sacral insufficiency fractures.

OBJECTIVE: The purpose of this article is to illustrate the effectiveness and utility of percutaneous sacroplasty in the treatment of sacral insufficiency fractures. We also outline the technical considerations in performing the procedure. CONCLUSION: Percutaneous sacroplasty is an effective treatment for sacral insufficiency fractures. Most patients experience significant relief within the first 48 hr.

Imaging of the brain, including diffusion-weighted imaging in methylmalonic acidemia.

Methylmalonic acidemia (MMA) is a multifactorial autosomal recessive inborn error of organic acid metabolism, often presenting with neurologic findings. We report the imaging findings in a case of a child with classic neurological and laboratory findings for MMA. Imaging studies demonstrated abnormalities within the basal ganglia, particularly the globi pallidi (GP). Diffusion-weighted abnormalities seen in patients with MMA during an acute episode of metabolic acidosis and at follow-up are discussed. The authors are aware of only one prior report of serial examinations demonstrating resolution of restricted diffusion in the GP. The biochemical and pathophysiologic basis of the imaging findings of MMA are explained.

Stereotactic radiosurgery associated neurotoxicity.

Stereotactic radiosurgery (SRS) is an evolving therapeutic modality for well demarcated intracranial lesions. Since the inception of stereotactic radiosurgery the types of parenchymal CNS lesions addressed by this mode of treatment has increased. All modern stereotactic radiosurgical procedures employ several common features. Patients are fitted with a stereotactic head frame or fiducial markers followed by radiographic imaging which allows for external reference points and three-dimensional mapping of the intracranial lesion. Armed with this information a highly conformal treatment plan is developed to deliver a high dose of radiation to a sharply defined target, with rapid dose fall-off outside the lesion volume. While an extremely effective therapeutic option, SRS is not without risk of neurotoxicity, with radiation necrosis being the most commonly recognized complication. The neurotoxic effects of SRS are reviewed and discussed.