Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device

BackgroundThe use of flow diversion to treat intracranial aneurysms has increased in recent years.ObjectiveTo assess the safety and angiographic efficacy of the p64 flow modulation device.MethodsDiversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3–6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography.ResultsA total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10).ConclusionsDiversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.

Endoscopic and Endoscopically-Assisted Resection of Intraventricular Lesions Using a Neuroendoscopic Ultrasonic Aspirator

The development of minimally invasive neuroendoscopy has advanced in recent years. The introduction of the neuroendoscopic ultrasonic aspirator (NUA) broadened the treatment spectrum of neuroendoscopy. We aim to describe our experience with the use of NUA for the resection of intraventricular lesions. Here, we present consecutive retrospective case series of adult and pediatric patients undergoing resection of an intraventricular lesion with a NUA (Endoscopic Neurosurgical Pen, Söring GmbH, Quickborn, Germany) between January 2019 and April 2020. Eight patients between the age of 0.5 and 73 years underwent surgery using NUA and were included in this study. In four patients, an endoscopic assisted (EA) resection of the lesion was undertaken, while in four patients, the lesion was removed using purely endoscopic (PE) resection. In all cases, gross/near total resection was achieved. The average blood loss was 142.5 ± 90.4 mL (range 50–300 mL). Transient morbidity was seen in four patients (50%), while permanent morbidity or mortality did not occur. The NUA seems to be a safe and valuable tool for the minimally invasive resection of intraventricular lesions in selected cases. The type, size, consistency, and vascularization of the lesion limit at times the purely endoscopic use of the NUA.

Treatment outcomes of 1-stage clipping of multiple unruptured intracranial aneurysms via keyhole approaches

OBJECTIVE Complete exclusion of multiple unruptured intracranial aneurysms (UIAs) in one session of intervention may be ideal. However, such situations are not always feasible in terms of treatment modalities and outcomes. The authors aimed to analyze their experience with 1-stage clipping of multiple UIAs. METHODS Medical records between March 2013 and December 2018 were retrospectively reviewed, and 111 1-stage keyhole approaches in 110 patients with 261 multiple UIAs were ultimately included in this study. Clinical and radiological outcomes were analyzed, as well as postoperative complications up to 1 month after the surgery and their risk factors. RESULTS Keyhole approaches included unilateral supraorbital in 87 operations (78.4%), bilateral supraorbital in 12 (10.8%), and others in 12. The mean operative duration was 169.6 minutes (range 80–490 minutes). The highest numbers of aneurysms clipped at once were 2 (73.9%) and 3 (18.9%). Complete exclusion and residual neck of the clipped aneurysms were achieved in 89.3% and 7.3%, respectively. There was no significant difference between pre- and postoperative 1-month neurological states (p = 0.14). The permanent morbidity rate was 1.8% (n = 2), and there were no deaths. Postoperative transient neurological deterioration (TND) with no radiological and electrophysiological abnormalities occurred in 8 operations (7.2%). Hypertension was the only significant risk factor for postoperative TND (adjusted odds ratio 17.03, 95% confidence interval 1.99–2232.24, p = 0.01). CONCLUSIONS One-stage clipping of multiple UIAs via keyhole approaches showed satisfactory treatment outcomes with a low permanent morbidity. Patients with chronic hypertension had a high risk of postoperative TND.

Surgical treatment and outcome of posterior fossa arachnoid cysts in infants

OBJECTIVE The aim of this cohort study was to describe and analyze the surgical treatment and outcome of posterior fossa arachnoid cysts (PFACs) in infants. METHODS Patients presenting with a PFAC at infancy or prenatally, between the years 2000 and 2019, and who were surgically treated before the age of 2 years, were included in this study. Patient data were retrospectively collected including baseline characteristics and surgical variables. Factors related to revision surgery were analyzed through uni- and multivariate analysis. RESULTS Thirty-five patients, of whom 54.3% were male, were included. The cyst was diagnosed prenatally in 23 patients (65.7%). Surgery was typically recommended after a mean cyst follow-up of 3.4 ± 3.9 months, with a mean age at surgery of 6.1 ± 5.1 months. In 54.3% of patients (n = 19), surgery was performed before the age of 6 months. The PFAC was treated purely neuroendoscopically in 57.1% of patients (n = 20), while 28.6% of patients underwent open cyst procedures (n = 10), 5.7% (n = 2) were treated with a shunt, and 8.6% (n = 3) underwent a combined procedure. Additional surgery was required in 31.4% of patients (n = 11; mean 2.36 ± 2.11 surgeries per patient). At the last follow-up (61.40 ± 55.33 months), no mortality or permanent morbidity was seen; radiological improvement was apparent in 83.9% of the patients. Those patients treated before the age of 6 months (p = 0.09) and who presented before surgery with a stable cyst size that was maintained throughout preoperative monitoring (p = 0.08) showed a trend toward higher revision rates after surgical treatment. CONCLUSIONS PFACs in infancy may require surgical treatment before the age of 6 months. Navigated endoscopy was a valid surgical option. Overall mortality or permanent morbidity was rare. Additional surgery was required in up to 30% of the patients; younger age and a preoperatively stable cyst might be risk factors for revision surgery.

The Silk Vista Baby – The UK experience

Background The Silk Vista Baby (SVB) flow diverter (FDS) is the only FDS deliverable via a 0.017 inch microcatheter and is specifically designed for the distal vasculature. We sought to evaluate the safety and efficacy of the SVB. Materials and Methods We performed a retrospective review to identify SVB cases at 4 tertiary neurosurgical centres within the U.K. Clinical, procedural, angiographic and follow-up data were collected. Results We identified 60 patients (35 female, 58%) of average age 54 ± 10.5 (range 30–72) with 61 aneurysms, 50 (81.9%) located in the anterior circulation. The majority of the aneurysms treated were unruptured (46, 75.4%) and saccular (46, 75.4%). Dome size was 6.2 ± 6.2 mm (range 1–36mm) and parent vessel diameter was 2.3 ± 0.4 mm (range 1.2-3.3 mm). An average number of 1.07 devices were implanted. Coils or other devices were implanted in 14 aneurysms (23.3%). At last angiographic follow-up (n = 55), 7.5 ± 4.2 months post-procedure, 32 aneurysms (57.1%) were graded as RRC I, 7 (12.5%) RRC II, and 17 RRC III (30.4%). Clinical complications, excluding death, were seen in 4 patients (6.8%) including 1 delayed aneurysm rupture and 3 symptomatic ischaemic events. Only one patient had permanent morbidity (mRS 1). 3 patients died during follow-up (5.1%); 2 deaths were related to the aneurysms (3.4%) – one ruptured dissecting MCA aneurysm, and one giant partially thrombosed posterior circulation aneurysm. 93% of patients were mRS ≤ 2 at last follow-up. Conclusion The SVB has high rates of technical success and an acceptable safety profile. Distal aneurysms may occlude slower due to relative oversizing of the devices.

Endovascular treatment of vertebral and basilar artery aneurysms with low-profile visualized intraluminal support device

Background The Low-profile Visualized Intraluminal Support (LVIS) device is a self-expanding, nitinol, single-braid, closed-cell device that was recently developed for endovascular embolization of intracranial aneurysms. However, current knowledge regarding the use of LVIS devices to treat vertebral and basilar artery aneurysms is limited. We aimed to evaluate the feasibility, efficacy, and safety of the LVIS device for treating vertebral and basilar artery aneurysms. Methods Between January 2015 and December 2017, patients with vertebral and basilar artery aneurysms treated using LVIS stents were enrolled in this study. We analyzed patients’ demographic, clinical and aneurysmal characteristics, procedural details, complications, and angiographic and clinical follow-up results. Results We identified 63 patients with 64 vertebral and basilar artery aneurysms who underwent treatment with (n = 59) or without (n = 5) LVIS stenting, including 10 patients with ruptured aneurysms. Forty-one aneurysms were located at the vertebral artery, and 23 at the basilar artery. Intraprocedural-related complications developed in three (4.8%) patients, while none of these patients developed morbidities or died during follow-up. Three patients developed post-procedural complications (4.8%). Two patients experienced ischemic events immediately post-procedure. A minor permanent morbidity developed in one of the two patients (1.6%). The mortality rate was 1.6%, for that the patient died of brainstem hemorrhage after 1 month of follow-up. At a mean follow-up of 12.5 months, 39/43 (90.7%) patients had stable or improved aneurysms, and four (9.3%) had recanalized. Conclusions LVIS device of vertebral and basilar artery aneurysms may be an acceptable safety profile and may represent a reasonable treatment option in the short-term. Long-term and larger cohort studies are necessary to validate our results.

Clinical and Angiographic Outcomes After Stent-Assisted Coiling of Cerebral Aneurysms With Laser-Cut and Braided Stents: A Comparative Analysis of the Literatures

Introduction: Stent-assisted coiling (SAC) plays an important role in endovascular treatment of intracranial aneurysms (IAs). This comparative analysis examines the safety and efficacy of SAC in general and compares clinical and angiographic outcomes between laser-cut stents and braided stents.Methods: Relevant English-language studies were identified via a PubMed search for published articles regarding outcomes of SAC using laser-cut stents and braided stents published from 2015 to 2020. Data from 56 studies that met our inclusion criteria were pooled and statistically compared.Results: A total of 4,373 patients harboring with 4,540 IAs were included. Patients were divided into two groups on the basis of stent type: laser-cut stents (2,076 aneurysms in 1991 patients; mean follow-up, 12.99 months) and braided stents (2,464 aneurysms in 2382 patients; mean follow-up, 18.41 months). Overall, the rates of successful stent deployment, thromboembolic events, stent stenosis, periprocedural intracranial hemorrhage, permanent morbidity, mortality, and recanalization were 97.72, 4.72, 2.87, 1.51, 2.14, 1.16, and 6.06%, respectively. Laser-cut stents were associated with a significantly higher rate of successful deployment (p = 0.003) and significantly lower rate of periprocedural intracranial hemorrhage (p = 0.048). Braided stents were associated with a significantly lower rate of permanent morbidity (p = 0.015).Conclusion: SAC of IAs using laser-cut stents or braided stents was effective and safe. Rates of thromboembolic events, stent stenosis, mortality, and recanalization were comparable between the stent types. Braided stents were associated with lower permanent morbidity while laser-cut stents were associated with more favorable rates of successful deployment and periprocedural intracranial hemorrhage.

The Interplay of ECM-Based Graft Materials and Mechanisms of Tissue Remodeling

Wound healing is a complex natural process that involves the recruitment of cells, the renewal of tissue composition, and the reinforcement of structural tissue architecture. Following ischemic injury or chronic disease, wound healing is delayed, and can often result in chronic inflammation or permanent morbidity. Tissue engineering strategies to harness the wound healing process include the use of naturally derived extracellular matrix (ECM) scaffolds with inherent bioactivity to both passively facilitate and actively direct healing toward a successful resolution. As the body heals, the properly designed ECM scaffold is gradually remodeled and integrated into the body, leaving behind organized tissue that provides long-term strength. Herein we explain the interplay of the ECM (i.e., its complex composition and bioactivity) with the cells of the body throughout the process of tissue remodeling, thus explaining how even a tissue-engineered xenograft material can direct the body to restore itself.

Limitations of Flow Diverters in Posterior Communicating Artery Aneurysms

Background: Treatment of intracranial aneurysms with flow diverters (FDs) showed promising results. However, a subset of patients treated for posterior communicating artery (PComA) aneurysms has variable occlusion rates. Especially the fetal type-associated PComA aneurysms seemed to respond differently to treatment. We analyze our series of fetal type PComA aneurysms treated with a FD. The literature on this subject is reviewed. Methods: Data from patients treated with FD for all PComA aneurysms at the RadboudUMC Nijmegen were retrospectively analysed. Primary end-point was complete aneurysm occlusion at six months. Secondary end-points were clinical outcome, treatment safety, and results of secondary treatment after non-closure. The results for the fetal PComA aneurysms were compared to the literature. Results: Nineteen consecutive patients harboring 21 PComA aneurysms were treated. Three aneurysms had ipsilateral fetal type PCA (14.3%). Overall, none of the fetal type PcomA aneurysm showed complete occlusion versus 77.8% of the others (p = 0.03). Mortality and permanent morbidity rates were respectively 5.3% and 0%. Conclusions: FD treatment for PComA aneurysm with fetal type circulation seemed to be less effective compared to other types of PComA aneurysms. Flow characteristics at the PComA bifurcation are thought to be causative Alternative strategies should be considered as first line treatment.

Acute Ischemic Stroke in a 10-Month-Old Baby Recovered With Aspirin

Acute ischemic stroke is rare in children and often brings enduring and permanent morbidity in pediatric population. While there are numerous recommendations for initial treatment, evidence on effectiveness of different therapies among children is limited. Here, we describe a 10-month-old boy who presented with fever, restlessness, seizure and postictal left limb weakness. Examination revealed left hemiplegia and hemiparesthesia. Computed tomography (CT) head showed loss of gray–white matter distinction with diffuse hypodensity in the right temporoparietal lobes and right caudate nucleus. Magnetic resonance imaging (MRI) brain demonstrated diffusion restriction in favor of acute ischemic stroke in the right middle cerebral artery (MCA) territory. Brain MR angiography (MRA) demonstrated complete occlusion of proximal aspect of M1 segment of right MCA. Genetic testing determined a homozygous 4G/4G polymorphism of the PAI-1 gene. Antiplatelet therapy was started after diagnosis and continued for 8 days with antibiotic therapy. Stroke in children and infants is an infrequent condition associated with substantial morbidity and mortality that needs clinicians' care. This case highlights the significance of awareness about stroke in children and emphasizes on further research to compile evidence-based guidelines for acute stroke therapy in children.