Primary results from the CLEAR study of a novel stent retriever with drop zone technology.

BACKGROUND: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. OBJECTIVE: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. METHODS: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). RESULTS: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). CONCLUSIONS: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. TRIAL REGISTRATION NUMBER: NCT04514562.

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.

Optical coherence tomography of the intracranial vasculature and Wingspan stent in a patient.

A 67-year-old man with medically refractory vertebrobasilar insufficiency and short segment occlusions of the intracranial vertebral arteries was treated with angioplasty and stent placement. Fifteen hours after the procedure the patient developed symptoms of posterior fossa ischemia and repeat angiography showed thrombus formation within the stent which was treated with thrombolytic and aggressive antiplatelet therapy. Angiography revealed lysis of the clot, but concerns regarding the mechanism of the thrombotic phenomenon prompted frequency-domain optical coherence tomography (FDOCT) assessment. FDOCT provided excellent visualization of the stent and vessel wall interactions, as well as excluding residual flow-limiting stenosis, obviating the need for further intervention. The potential utility of FDOCT in the evaluation of intracranial atherosclerotic disease and additional intracranial applications are discussed.

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.

Optical coherence tomography of the intracranial vasculature and Wingspan stent in a patient.

A 67-year-old man with medically refractory vertebrobasilar insufficiency and short segment occlusions of the intracranial vertebral arteries was treated with angioplasty and stent placement. Fifteen hours after the procedure the patient developed symptoms of posterior fossa ischemia and repeat angiography showed thrombus formation within the stent which was treated with thrombolytic and aggressive antiplatelet therapy. Angiography revealed lysis of the clot, but concerns regarding the mechanism of the thrombotic phenomenon prompted frequency-domain optical coherence tomography (FDOCT) assessment. FDOCT provided excellent visualization of the stent and vessel wall interactions, as well as excluding residual flow-limiting stenosis, obviating the need for further intervention. The potential utility of FDOCT in the evaluation of intracranial atherosclerotic disease and additional intracranial applications are discussed.

Role of intraarterial therapy for cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage.

Aneurysmal subarachnoid hemorrhage (SAH) accounts for a significant percentage of morbidity and mortality among patients admitted to neurosurgical centers throughout the world. Even for individuals surviving beyond the initial presentation and intervention for aneurysmal SAH, the occurrence of cerebral vasospasm has the potential to induce a second tier of complications that can be just as devastating as the inciting event. However, despite numerous studies and some initial advancements in management, therapeutic modalities are limited to help prevent or treat this complex entity. Historically, the mainstay of treatment for cerebral vasospasm has been a combination of hypervolemia, hemodilution, and hypertension. In addition, other systemic therapies such as oral nimodipine, statins, and intravenous magnesium, as well as intensive glucose control, appear to have some promise, although they are limited at times by adverse effects. To avoid these adverse consequences and perhaps gain some modicum of efficacy, attempts have been made to use endovascular techniques to physically dilate vessels or to administer drugs directly to the site of action and thus avoid many of the untoward effects of systemic pharmacotherapy. Controversy still remains over the success of intraarterial therapy, the drugs or techniques to be used, and the best timing of this therapy. Based on the currently available literature, it is impossible to assess the most effective intraarterial therapy. Randomized controlled trials that can control for baseline factors and technical expertise are needed to provide more conclusive data. Clinical pharmacists should be actively involved in assisting interventional radiologists and neurosurgeons in providing safe and appropriate pharmacotherapy in this promising but controversial arena of intraarterial drug delivery.

Microsurgical management of pineal region lesions: personal experience with 119 patients.

BACKGROUND: Lesions of the pineal region are histopathologically heterogeneous but often accompanied with severe progression of clinical signs. Surgical treatment remains challenging because of the close vicinity of the deep venous system and the mesencephalo-diencephalic structures in this region. We present the surgical approaches and techniques in a consecutive series of 119 patients treated by the senior author (J.H.) between 1980 and 2007 at 2 different neurosurgical university centers in Kuopio and Helsinki, Finland. METHODS: Of the included patients, 107 (90%) presented with pineal region tumors and 12 (10%) with vascular malformations. The ITSC route was used for removal of the lesion in 111 (93%) patients and the OIH approach in 8 (7%) patients. All except one patient were operated on in a sitting position. RESULTS: We reviewed all clinical data and radiographic images and analyzed all surgical videos. The pineal lesions were removed completely in most cases (88%). There was no surgical mortality. Twenty-two (18%) of the patients had complications in the postoperative period; these included 1 epidural hematoma, 9 transient Parinaud syndrome, 2 meningitis, 3 wound infections, 2 transient memory disturbances, 2 mild hemiparesis, 1 CSF fistula, and 2 cranial nerves palsies (IV and VI). During a 3.5-year follow-up, 12 patients with malignant lesions died; all patients with benign tumors survived. CONCLUSIONS: The ITSC route is a safe and effective surgical approach, associated with low morbidity, complete lesion removal, and definitive histopathologic diagnosis. Considering risk vs benefit, we therefore believe that the surgical treatment can be offered in most cases as the first treatment option for pineal tumors.

Intrathecal granuloma in a patient receiving high dose hydromorphone.

Intrathecal granuloma formation has commonly been described with morphine therapy. It has been suggested that a high concentration of intrathecal morphine may be responsible for this complication. Much less commonly, intrathecal hydromorphone has been associated with intrathecal granuloma formation. In the current case we report the evaluation and management of an intrathecal granuloma in a patient receiving a relatively high concentration of intrathecal hydromorphone. A nonsurgical, conservative approach to management involves stopping the infusion and observing the patient for improvement as the granuloma mass often slowly resolves once the infusion is stopped. Cessation of the infusion or addition of clonidine to the IDDS admixture in conjunction with close clinical monitoring may be reasonable treatment options in patients with an asymptomatic or mildly symptomatic inflammatory mass. In the current study, rapidly declining neurologic function with a confirmed inflammatory mass adherent to the spinal canal necessitated urgent surgical intervention. Though use of intrathecal hydromorphone still represents an off label application, this opiate is commonly employed as an alternative first line analgesic agent. This case report highlights the potential of high-dose and high infusate concentration intrathecal hydromorphone to form an inflammatory granuloma.

Microsurgical treatment of third ventricular colloid cysts by interhemispheric far lateral transcallosal approach--experience of 134 patients.

BACKGROUND: Colloid cysts are rare tumors (incidence 3.2/1000000 pear year) located in the anterosuperior part of the third ventricle. In this article, we present our microneurosurgical experience on 134 patients focusing on the nuances of ITA with demonstrative videoclips. METHODS: This surgical series is based on the microsurgical experience of the senior author (JH) at 2 Finnish neurosurgical centers (Helsinki and Kuopio, 1980-2007). Surgical anatomy is demonstrated, and the pitfalls of the different surgical steps are analyzed to avoid complications. The series reflects the whole patient profile of Southern and Eastern Finland, without any selection bias. RESULTS: There was no surgical mortality, and morbidity remained mainly transitory among 134 patients treated by ITA. CONCLUSIONS: Favorable overall outcome of this series demonstrates that removal of third ventricular colloid cyst via transcallosal approach is a direct and safe way to treat these lesions.

Cervical intradural extramedullary cavernoma presenting with isolated intramedullary hemorrhage.

Among cavernomas of the central nervous system, spinal ones are rare. The true incidence of spinal cavernomas is unclear, but with widespread use of magnetic resonance imaging the number of cases is increasing. Furthermore, cavernomas represent only 5-12% of all vascular anomalies of the spinal cord, with a mere 3% reported to be intradural and intramedullary in location. Cervical spine intradural extramedullary cavernomas are very seldom seen, and only 4 cases have been reported in world literature previously. In this report, a unique case of an intradural extramedullary spinal cavernoma was surgically treated in a patient who presented only with an intramedullary hemorrhage.

Prevention of visual loss caused by shunt failure: a potential role for optic nerve sheath fenestration. Report of three cases.

Ophthalmological problems such as papilledema, loss of visual acuity, and oculomotor palsies are common in patients with shunt malfunctions. The authors report on three patients with shunts who presented with visual loss. In each case, the diagnosis of shunt malfunction was delayed because other classic signs and symptoms of intracranial hypertension were absent. All three patients underwent optic nerve sheath fenestration (ONSF) with resultant stabilization or improvement of visual symptoms before the shunt malfunction was recognized and treated. Consideration of these cases suggests a potential protective role of ONSF for patients with shunt malfunction.

Linezolid for the treatment of a heteroresistant Staphylococcus aureus shunt infection.

The emergence of multidrug-resistant bacteria as the cause of ventriculoperitoneal shunt infections is a disconcerting phenomenon that often requires the use of alternative antimicrobials due to resistance against commonly used agents. The following is a case report describing the successful treatment of a ventriculoperitoneal shunt infection caused by a heteroresistant strain of Staphylococcus aureus with linezolid. Linezolid may have utility in treating pediatric CNS infections due to its tolerability, excellent blood-brain barrier penetration, and activity against multiple resistant Gram-positive organisms such as S. aureus, vancomycin-resistant Enterococcus faecium and Streptococcus pneumoniae.