Mortality after treatment of intracranial aneurysms with the Pipeline Embolization Device

BackgroundThe Pipeline Embolization Device (PED) is reported to be a safe treatment tool for aneurysms. However, mortality occurs in a few cases, and this has not been clearly studied. We conducted a multicenter study to retrospectively evaluate the causes of, and risk factors for, mortality in patients with intracranial aneurysms treated with the PED.MethodsWe retrospectively reviewed the prospectively maintained databases of patients with intracranial aneurysms treated by PED placement at 14 academic institutions from 2014 to 2019. Patients’ data, including clinical and radiographic information, were analyzed with an emphasis on mortality-related complications.ResultsA total of 1171 consecutive patients underwent 1319 PED procedures to treat 1322 intracranial aneurysms. The mortality rate was 1.5% (17/1171), and in 1.3% of the patients (15/1171), deaths were caused by delayed aneurysmal rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms associated with PED procedures. Multivariate analysis showed that previous treatment (OR, 12.657; 95% CI, 3.189 to 50.227; P<0.0001), aneurysm size ≥10 mm (OR, 4.704; 95% CI, 1.297 to 17.068; P=0.019), aneurysm location (basilar artery) (OR, 10.734; 95% CI, 2.730 to 42.207; P=0.001), and current subarachnoid hemorrhage (OR, 4.505; 95% CI, 0.991 to 20.474; P=0.051) were associated with neurological complications resulting in mortality.ConclusionsDelayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression were the main causes of mortality in patients with intracranial aneurysms treated with the PED. Large basilar aneurysms are associated with an increased risk of postoperative death and require increased attention and caution.

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Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2020-015943 ◽

2020 ◽

Vol 12 (11) ◽

pp. 1107-1112 ◽

Cited By ~ 1

Author(s):

Hal Rice ◽

Mario Martínez Galdámez ◽

Markus Holtmannspötter ◽

Laurent Spelle ◽

Konstantinos Lagios ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Neurological Complications ◽

Parent Artery ◽

Unique Identifier ◽

Clinical Trial Registration ◽

Pipeline Embolization Device ◽

Link Type ◽

Post Market ◽

Safety Endpoint ◽

Primary Safety Endpoint

BackgroundThe first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.MethodsThe SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.ResultsOf 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.ConclusionsThe findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population.Clinical trial registration-URLhttp://www.clinicaltrials.gov. Unique identifier: NCT02719522.

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Angiotensin-(1-7) Protects against the Development of Aneurysmal Subarachnoid Hemorrhage in Mice

Journal of Cerebral Blood Flow & Metabolism ◽

10.1038/jcbfm.2015.30 ◽

2015 ◽

Vol 35 (7) ◽

pp. 1163-1168 ◽

Cited By ~ 23

Author(s):

Kenji Shimada ◽

Hajime Furukawa ◽

Kosuke Wada ◽

Yuan Wei ◽

Yoshiteru Tada ◽

...

Keyword(s):

Subarachnoid Hemorrhage ◽

Protective Effect ◽

Receptor Antagonist ◽

Intracranial Aneurysms ◽

Aneurysmal Subarachnoid Hemorrhage ◽

Cerebral Arteries ◽

Aneurysm Rupture ◽

Dependent Manner ◽

Aneurysmal Rupture ◽

Mas Receptor

Angiotensin-(1-7) (Ang-(1-7)) can regulate vascular inflammation and remodeling, which are processes that have important roles in the pathophysiology of intracranial aneurysms. In this study, we assessed the effects of Ang-(1-7) in the development of intracranial aneurysm rupture using a mouse model of intracranial aneurysms in which aneurysmal rupture (i.e., aneurysmal subarachnoid hemorrhage) occurs spontaneously and causes neurologic symptoms. Treatment with Ang-(1-7) (0.5 mg/kg/day), Mas receptor antagonist (A779 0.5 mg/kg/day or 2.5 mg/kg/day), or angiotensin II type 2 receptor (AT2R) antagonist (PD 123319, 10 mg/kg/day) was started 6 days after aneurysm induction and continued for 2 weeks. Angiotensin-(1-7) significantly reduced the rupture rate of intracranial aneurysms without affecting the overall incidence of aneurysms. The protective effect of Ang-(1-7) was blocked by the AT2R antagonist, but not by the Mas receptor antagonist. In AT2R knockout mice, the protective effect of Ang-(1-7) was absent. While AT2R mRNA was abundantly expressed in the cerebral arteries and aneurysms, Mas receptor mRNA expression was very scarce in these tissues. Angiotensin-(1-7) reduced the expression of tumor necrosis factor-α and interleukin-1β in cerebral arteries. These findings indicate that Ang-(1-7) can protect against the development of aneurysmal rupture in an AT2R-dependent manner.

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Use of Coils in Conjunction With the Pipeline Embolization Device for Treatment of Intracranial Aneurysms

Neurosurgery ◽

10.1227/neu.0000000000000579 ◽

2014 ◽

Vol 76 (2) ◽

pp. 142-149 ◽

Cited By ~ 58

Author(s):

Ning Lin ◽

Adam M. Brouillard ◽

Chandan Krishna ◽

Maxim Mokin ◽

Sabareesh K. Natarajan ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Neurological Complications ◽

Controlled Study ◽

Group Differences ◽

Pipeline Embolization Device ◽

Complex Anatomy ◽

Risk Of Rupture ◽

Aneurysm Occlusion ◽

Occlusion Rate

ABSTRACT BACKGROUND: Coiling in conjunction with Pipeline embolization device (PED) placement could provide immediate dome protection and an intraaneurysmal scaffold to prevent device prolapse for intracranial aneurysms with high rupture risk and complex anatomy. OBJECTIVE: To report results after treatment of aneurysms with PED with coils (PED+coils group) or without (PED-only group) at a single-institution. METHODS: In this case-controlled study, records of patients who underwent PED treatment between 2011 and 2013 were retrospectively reviewed. RESULTS: Twenty-nine patients were treated with PED+coils and 75 with PED-only. No statistically significant between-group differences were found in terms of age, sex, aneurysm location, medical comorbidities, and length of follow-up. Aneurysms treated by PED+coils were larger (16.3 mm vs 12.4 mm, P = .02) and more likely to be ruptured (20.7% vs 1.3%, P = .001) or dissecting (34.5% vs 9.3%, P = .002). PED deployment was successful in all cases. At the latest follow-up (mean, 7.8 months), complete aneurysm occlusion was achieved in a higher proportion of the PED+coils group (93.1% vs 74.7%, P = .03). Device foreshortening/migration occurred in 4 patients in the PED-only group and none in the PED+coils group. Fewer patients required retreatment in the PED+coils group (3.4% vs 16.0%, P = .71). Rates of neurological complications (10.3% PED+coils vs 8.0% PED-only, P = .7) and favorable outcome (modified Rankin Scale score = 0-2; 93.1% PED+coils vs 94.7% PED-only, P = .6) were similar. CONCLUSION: PED+coils may be a safe and effective treatment for aneurysms with high risk of rupture (or rerupture) and complex anatomy. Coiling in conjunction with PED placement provided a higher aneurysm occlusion rate and reduced the need for retreatment.

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High-Resolution Vessel Wall Magnetic Resonance Imaging of Small Unruptured Intracranial Aneurysms

Journal of Clinical Medicine ◽

10.3390/jcm10020225 ◽

2021 ◽

Vol 10 (2) ◽

pp. 225

Author(s):

Łukasz Zwarzany ◽

Ernest Tyburski ◽

Wojciech Poncyljusz

Keyword(s):

Magnetic Resonance Imaging ◽

Risk Factors ◽

Magnetic Resonance ◽

High Resolution ◽

Vessel Wall ◽

Intracranial Aneurysms ◽

Aneurysm Rupture ◽

Resonance Imaging ◽

Aneurysm Wall ◽

Conventional Risk Factors

Background: We decided to investigate whether aneurysm wall enhancement (AWE) on high-resolution vessel wall magnetic resonance imaging (HR VW-MRI) coexists with the conventional risk factors for aneurysm rupture. Methods: We performed HR VW-MRI in 46 patients with 64 unruptured small intracranial aneurysms. Patient demographics and clinical characteristics were recorded. The PHASES score was calculated for each aneurysm. Results: Of the 64 aneurysms, 15 (23.4%) showed wall enhancement on post-contrast HR VW-MRI. Aneurysms with wall enhancement had significantly larger size (p = 0.001), higher dome-to-neck ratio (p = 0.024), and a more irregular shape (p = 0.003) than aneurysms without wall enhancement. The proportion of aneurysms with wall enhancement was significantly higher in older patients (p = 0.011), and those with a history of prior aneurysmal SAH. The mean PHASES score was significantly higher in aneurysms with wall enhancement (p < 0.000). The multivariate logistic regression analysis revealed that aneurysm irregularity and the PHASES score are independently associated with the presence of AWE. Conclusions: Aneurysm wall enhancement on HR VW-MRI coexists with the conventional risk factors for aneurysm rupture.

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Flow diverter stents in the treatment of recanalized intracranial aneurysms

Interventional Neuroradiology ◽

10.1177/1591019921990507 ◽

2021 ◽

pp. 159101992199050

Author(s):

Erol Akgul ◽

Hasan Bilen Onan ◽

Irem Islek ◽

Mehmet Tonge ◽

Yavuz Durmus ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Demographic Data ◽

Previous Treatment ◽

Flow Diverter ◽

Serious Adverse Events ◽

Clinical Complications ◽

Tertiary Hospitals ◽

The Mean ◽

Technical Complication

Background We assessed the safety and efficacy of flow diverter stents (FDSs) in the treatment of recanalized or residual intracranial aneurysms treated endovascularly. Materials & Methods Patients whose recanalized or residual aneurysms were treated with FDSs in five tertiary hospitals were reviewed retrospectively. The patients’ demographic data, aneurysm characteristics, types of previous treatment, and clinical complications, or serious adverse events associated with FDSs, as well as the results of neurological and angiographic follow-up assessments, were recorded. Results Eighty-six patients (37 males) with 87 aneurysms were included in this study. Eighty (91.9%) aneurysms were in the anterior and seven (8.1%) in the posterior circulation. The initial treatment methods were the primary coiling or balloon remodeling technique in 69 (79.3%) and stent-assisted coiling in 18 (20.7%) aneurysms. The endovascular procedure was successful in all patients. Complications occurred in four patients, for a total complication rate of 4.6%. A technical complication developed in one patient (1.2%). An in-stent thrombosis treated with tirofiban was seen in two cases. Late in-stent stenosis exceeding 50% was treated with balloon angioplasty in one patient. The mean length of follow-up was 21.0 months. The first angiographic follow-up (3–6 months) revealed the complete occlusion of 74 aneurysms (85.1%). While 76 aneurysms (87.4%) were occluded at the last angiographic follow-up (mean: 26.0 months), 11 aneurysms (12.6%) were still filling. Morbimortality was zero. Conclusion The drawback of endovascular treatment is aneurysmal remnants or recurrences, which is safely and durably amenable to flow diversion.

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Cognitive impact of COVID-19: looking beyond the short term

Alzheimer s Research & Therapy ◽

10.1186/s13195-020-00744-w ◽

2020 ◽

Vol 12 (1) ◽

Author(s):

Scott Miners ◽

Patrick G. Kehoe ◽

Seth Love

Keyword(s):

Endothelial Cells ◽

Immune Activation ◽

Angiotensin Receptor Blockers ◽

Amyloid Β ◽

Neurological Complications ◽

Cerebral Hypoperfusion ◽

Cerebral White Matter ◽

Ischaemic Damage ◽

Hospitalised Patients ◽

Increased Risk

AbstractCOVID-19 is primarily a respiratory disease but up to two thirds of hospitalised patients show evidence of central nervous system (CNS) damage, predominantly ischaemic, in some cases haemorrhagic and occasionally encephalitic. It is unclear how much of the ischaemic damage is mediated by direct or inflammatory effects of virus on the CNS vasculature and how much is secondary to extracranial cardiorespiratory disease. Limited data suggest that the causative SARS-CoV-2 virus may enter the CNS via the nasal mucosa and olfactory fibres, or by haematogenous spread, and is capable of infecting endothelial cells, pericytes and probably neurons. Extracranially, SARS-CoV-2 targets endothelial cells and pericytes, causing endothelial cell dysfunction, vascular leakage and immune activation, sometimes leading to disseminated intravascular coagulation. It remains to be confirmed whether endothelial cells and pericytes in the cerebral vasculature are similarly targeted. Several aspects of COVID-19 are likely to impact on cognition. Cerebral white matter is particularly vulnerable to ischaemic damage in COVID-19 and is also critically important for cognitive function. There is accumulating evidence that cerebral hypoperfusion accelerates amyloid-β (Aβ) accumulation and is linked to tau and TDP-43 pathology, and by inducing phosphorylation of α-synuclein at serine-129, ischaemia may also increase the risk of development of Lewy body disease. Current therapies for COVID-19 are understandably focused on supporting respiratory function, preventing thrombosis and reducing immune activation. Since angiotensin-converting enzyme (ACE)-2 is a receptor for SARS-CoV-2, and ACE inhibitors and angiotensin receptor blockers are predicted to increase ACE-2 expression, it was initially feared that their use might exacerbate COVID-19. Recent meta-analyses have instead suggested that these medications are protective. This is perhaps because SARS-CoV-2 entry may deplete ACE-2, tipping the balance towards angiotensin II-ACE-1-mediated classical RAS activation: exacerbating hypoperfusion and promoting inflammation. It may be relevant that APOE ε4 individuals, who seem to be at increased risk of COVID-19, also have lowest ACE-2 activity. COVID-19 is likely to leave an unexpected legacy of long-term neurological complications in a significant number of survivors. Cognitive follow-up of COVID-19 patients will be important, especially in patients who develop cerebrovascular and neurological complications during the acute illness.

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Current Trends and Characteristics of Hepatocellular Carcinoma in Patients with Autoimmune Liver Diseases

Cancers ◽

10.3390/cancers13051023 ◽

2021 ◽

Vol 13 (5) ◽

pp. 1023

Author(s):

Eirini I. Rigopoulou ◽

George N. Dalekos

Keyword(s):

Risk Factors ◽

Hepatocellular Carcinoma ◽

Liver Diseases ◽

Treatment Modalities ◽

Primary Biliary Cholangitis ◽

Autoimmune Liver Diseases ◽

Increased Risk ◽

Liver Cancers ◽

Medium Risk ◽

Causes Of Mortality

Hepatocellular carcinoma (HCC), the commonest among liver cancers, is one of the leading causes of mortality among malignancies worldwide. Several reports demonstrate autoimmune liver diseases (AILDs), including autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC) to confer increased risk of hepatobiliary malignancies, albeit at lower frequencies compared to other liver diseases. Several parameters have been recognized as risk factors for HCC development in AIH and PBC, including demographics such as older age and male sex, clinical features, the most decisive being cirrhosis and other co-existing factors, such as alcohol consumption. Moreover, biochemical activity and treatment response have been increasingly recognized as prognostic factors for HCC development in AIH and PBC. As available treatment modalities are effective only when HCC diagnosis is established early, surveillance has been proven essential for HCC prognosis. Considering that the risk for HCC is not uniform between and within disease groups, refinement of screening strategies according to prevailing demographic, clinical, and molecular risk factors is mandated in AILDs patients, as personalized HCC risk prediction will offer significant advantage in patients at high and/or medium risk. Furthermore, future investigations should draw attention to whether modification of immunosuppression could benefit AIH patients after HCC diagnosis.

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Peri-Procedural Morbidity and Mortality Associated with Stent-Assisted Coiling for Intracranial Aneurysms

Interventional Neuroradiology ◽

10.1177/159101991301900106 ◽

2013 ◽

Vol 19 (1) ◽

pp. 43-48 ◽

Cited By ~ 10

Author(s):

K. Wang ◽

Y. Sun ◽

A-M. Li

Keyword(s):

Intracranial Aneurysms ◽

Cerebral Aneurysms ◽

Mortality Rates ◽

Stent Migration ◽

Aneurysm Rupture ◽

Morbidity And Mortality ◽

Unruptured Aneurysms ◽

Ruptured Aneurysms ◽

Attractive Option ◽

Technological Improvements

Despite experience and technological improvements, stent-assisted coiling for intracranial aneurysms still has inherent risks. We evaluated peri-procedural morbidity and mortality associated with stent-assisted coiling for intracranial aneurysms. Patients with cerebral aneurysms that were broad-based (>4 mm) or had unfavorable dome/neck ratios (<1.5) were enrolled in this study between February and November 2011 at our center. Aneurysms were treated with the self-expanding neurovascular stents with adjunctive coil embolization. Seventy-two consecutive patients (27 men and 45 women; 22–78 years of age; mean age, 52.8 years) underwent 13 procedures for 13 ruptured aneurysms and 64 procedures for 73 unruptured aneurysms. Nine [11.7%, 95% CI(4.5%–18.9%)] procedure-related complications occurred: one and eight with initial embolization of ruptured and unruptured aneurysms, respectively. Complications included six acute in-stent thromboses, one spontaneous stent migration, one post-procedural aneurysm rupture, and one perforator occlusion. Three complications had no neurologic consequences. Two caused transient neurologic morbidity, two persistent neurologic morbidity, and two death. Procedure-related neurologic morbidity and mortality rates, respectively, were as follows: overall, 5.2% (95%CI, 0.2%–10.2%) and 2.6% (95%CI, 0%–6.2%); ruptured aneurysms, 7.7% (95%CI, 0%–36%) and 0% (95%CI, 0%–25%); unruptured aneurysms, 4.7% (95%CI, 0%–9.9%) and 3.1% (95%CI, 0%–7.3%). Combined procedure-related morbidity and mortality rates for ruptured and unruptured aneurysms were 7.7% (95%CI, 1.7%–13.7%) and 7.8% (95%CI, 1.8%–13.8%), respectively. Stent-assisted coiling is an attractive option for intracranial aneurysms. However, stent-assisted coiling for unruptured aneurysms is controversial for its comparable risk to natural history.

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Reduced Efficacy of the Pipeline Embolization Device in the Treatment of Posterior Communicating Region Aneurysms with Fetal Posterior Cerebral Artery Configuration

Neurosurgery ◽

10.1093/neuros/nyx293 ◽

2017 ◽

Vol 82 (5) ◽

pp. 695-700 ◽

Cited By ~ 14

Author(s):

Anil K Roy ◽

Brian M Howard ◽

Diogo C Haussen ◽

Joshua W Osbun ◽

Sameer H Halani ◽

...

Keyword(s):

Cerebral Artery ◽

Clinical Symptoms ◽

Posterior Cerebral Artery ◽

Neurological Complications ◽

Class I ◽

Class Iii ◽

Pipeline Embolization Device ◽

Independent Association ◽

Incomplete Occlusion

Abstract BACKGROUND Aneurysms at the origin of the posterior communicating artery (PcommA) have been demonstrated to be effectively treated with the pipeline embolization device (PED). Much less is known about the efficacy of the PED for aneurysms associated with a fetal posterior cerebral artery (fPCA) variant. OBJECTIVE To study PED treatment efficacy of PcommA aneurysms, including fPCA aneurysms. METHODS A prospectively maintained university database of aneurysm patients treated with the PED was retrospectively reviewed. Demographics, treatment details, and imaging were reviewed for all PcommA and fPCA aneurysms. RESULTS Out of a total of 285 patients treated with PED, 50 patients (mean age 57.5 ± 12.2 yr, 42 females) with unruptured PcommA (9 fPCA) aneurysms were identified. Mean follow-up duration was 14.0 ± 11.6 mo (48 patients). Roy-Raymond class I occlusion on follow-up magnetic resonance or catheter angiography (mean time 11.7 ± 6.8 mo) was achieved in 30 patients (62.5%), class II occlusion in 11 patients (22.9%) and class III occlusion in 7 patients (14.5%). The PcommA was occluded in 56% of patients without any clinical symptoms. No deaths or permanent neurological complications occurred. In fPCA aneurysms, class I occlusion was seen in 1 patient, class 2 occlusion in 2 patients, and class III occlusion in 6 patients. Multivariate analysis revealed an independent association between incomplete occlusion and fPCA configuration (OR 73.65; 95% CI: 5.84-929.13; P = .001). CONCLUSION The PED is a safe and effective treatment for PcommA aneurysms, although fetal anatomy should increase consideration of traditional endovascular techniques or surgical clipping.

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Neonatal Intracranial Hemorrhage and Phenobarbital

PEDIATRICS ◽

10.1542/peds.77.4.443 ◽

1986 ◽

Vol 77 (4) ◽

pp. 443-450

Author(s):

Karl C. K. Kuban ◽

Alan Leviton ◽

Kalpathy S. Krishnamoorthy ◽

Elizabeth R. Brown ◽

Rita Littlewood Teele ◽

...

Keyword(s):

Clinical Trial ◽

Intraparenchymal Hemorrhage ◽

Double Blind ◽

Germinal Matrix ◽

Specific Effects ◽

Increased Risk ◽

Severe Hemorrhage ◽

Institutional Differences ◽

Phenobarbital Administration

We enrolled 280 intubated babies with birth weights of less than 1,751 g in a double-blind randomized prospective clinical trial to evaluate whether phenobarbital influences the likelihood of developing subependymal-intraventricular-intraparenchymal hemorrhage. Phenobarbital was associated with an increased risk of developing any subependymal-intraventricular-intraparenchymal hemorrhage and was not associated with a diminished risk of either severe hemorrhage or germinal matrix hemorrhage. This increased risk was apparent even after we considered the influence of phenobarbital levels, timing of phenobarbital administrations, institutional differences, quality of ultrasound scans, gestational age- and birth weight-specific effects, ascertainment bias, and other possible confounders of phenobarbital administration.

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