Comment on Kilian et al. Comparing Characteristics and Treatment of Brain Vascular Malformations in Children and Adults with HHT. J. Clin. Med. 2023, 12, 2704.

We read with interest the recent article by Killian et al. regarding the characteristics and treatment of brain vascular malformations (VMs) in children and adults with hereditary hemorrhagic telangiectasia (HHT) [...].

Remote Training of Neurointerventions by Audiovisual Streaming : Experiences from the European ESMINT-EYMINT E-Fellowship Program.

BACKGROUND: Remote access of trainees to training centers via video streaming (tele-observership, e­fellowship) emerges as an alternative to acquire knowledge in endovascular interventions. Situational awareness is a summary term that is also used in surgical procedures for perceiving and understanding the situation and projecting what will happen next. A high situational awareness would serve as prerequisite for meaningful learning success during tele-observerships. We hypothesized that live perception of the angiographical procedures using streaming technology is feasible and sufficient to gain useful situational awareness of the procedure. METHODS: During a European tele-observership organized by the European Society of Minimally Invasive Neurological Therapy (ESMINT) and its trainee association (EYMINT), a total of six neurointerventional fellows in five countries observed live cases performed by experienced neurointerventionalists (mentors) in six different high-volume neurovascular centers across Europe equipped with live-streaming technology (Tegus Medical, Hamburg, Germany). Cases were prospectively evaluated during a 12-month period, followed by a final questionnaire after completion of the course. RESULTS: A total of 102/161 (63%) cases with a 1:1 allocation of fellow and mentor were evaluated during a 12-month period. Most frequent conditions were ischemic stroke (27.5%), followed by embolization of unruptured aneurysms (25.5%) and arteriovenous malformations (AVMs) (15.7%). A high level of situational awareness was reported by fellows in 75.5% of all cases. After finishing the program, the general improvement of neurointerventional knowledge was evaluated to be extensive (1/6 fellows), substantial (3/6), and moderate (2/6). The specific fields of improvement were procedural knowledge (6/6 fellows), technical knowledge (3/6) and complication management (2/6). CONCLUSION: Online streaming technology facilitates location-independent training of complex neurointerventional procedures through high levels of situational awareness and can therefore supplement live hands-on-training. In addition, it leads to a training effect for fellows with a perceived improvement of their neurointerventional knowledge.

Flow Diverter Devices in the Treatment of Anterior Communicating Artery Region Aneurysms: Would the Regional Anatomy and the Aneurysm Location Affect the Outcomes?

BACKGROUND: In this study, the authors evaluated the efficacy and the safety of flow diverter devices (FDD) in anterior communicating artery (ACoA) region aneurysms, focusing on anatomical factors that could affect the outcome, such as the location of the aneurysm along the ACoA (centered on ACoA or decentered on the A1-A2 junction) and the anatomy of the ACoA region. METHODS: Clinical, procedural and follow-up data were analyzed. Aneurysms were classified according to the location along the ACoA (centered or decentered on the A1-A2 junction) and on the basis of the anatomical configuration of the ACoA region. Safety was assessed by recording intraprocedural, periprocedural and delayed complications to determine the morbidity and mortality rates. The functional outcome was evaluated with the modified Rankin scale (mRS) prior to and after the endovascular procedure. To assess the efficacy, midterm and long-term clinical, angiographic and cross-sectional imaging follow-ups were recorded. Subgroup analysis according to the different ACoA regional anatomical configurations and the ACoA aneurysm locations were performed. RESULTS: 33 patients (17 males; 16 females) with ACoA region aneurysms were treated with FDDs. 27 aneurysms were located at the A1-A2 junction (82%) while the remaining six aneurysms were centered on the ACoA. No mortality was recorded. The overall morbidity rate was 6% (2/33 procedures). Major complications occurred in 33% (2/6) of ACoA aneurysms and in the 0% of A1-A2 junction aneurysms. Mid-term and long-term neuroimaging follow-ups showed the occlusion of the aneurysm in 28/33 cases (85%). Complete occlusion rates were 93% in the A1-A2 junction aneurysms and 50% in ACoA aneurysms. CONCLUSIONS: The FDD is a safe and effective tool that can be used in the treatment of selected cases of ACoA region aneurysms. The location of the aneurysm along the ACoA and the regional anatomy of the ACoA complex could affect the efficacy and safety.

Flow diverter devices in the treatment of complex middle cerebral artery aneurysms when surgical and endovascular treatments are challenging.

OBJECTIVE: In this study, the authors retrospectively evaluated the effectiveness and the safety of non-surgical middle cerebral artery (MCA) aneurysms treated via the implantation of a flow diverter device (FDD). METHODS: Clinical, procedural and follow-up data were analyzed in order to evaluate the safety and effectiveness of the treatment with the FDD in complex MCA aneurysms. Safety was assessed recording (intra-procedural, peri-procedural and delayed) complications in order to determine the morbidity and mortality rates. Functional outcome was evaluated with modified Rankin Scale (mRS) prior and after the endovascular procedure. To assess the efficacy, midterm and long-term clinical, angiographic and cross-sectional imaging follow-ups were recorded. RESULTS: 47 patients (21 males; 26 females) with MCA aneurysms were treated with FDD. 7 were ruptured. 21 aneurysms were saccular, 19 dissecting, 3 fusiform, 2 blood blister-like and 2 were pseudo-aneurysms. 14 aneurysms were small, 23 large and 10 giant, with a mean size of 15.3 mm. 8 aneurysms were recurrent (Raymond-Roy class III): 2 patients had an aneurysmal sac recanalization after being treated with simple coiling and 6 after being treated with microsurgical clipping. In 4 cases (8.5%), more than one FDD was telescopically positioned in order to treat the aneurysm, for a total of 54 FDDs used. The overall mortality rate was 2.1% (1/47) and the overall morbidity rate was 8.6% (4/47). Midterm neuroimaging follow-ups showed the complete occlusion of the aneurysm in 63% cases, which became 91% at the end of the follow-up. CONCLUSIONS: FDD is a safe and effective tool that can be used in the treatment of complex MCA aneurysms, where conventional neurosurgical treatments can be challenging or ineffective.

Critical Appraisal of Randomized Controlled Trials on Unruptured Brain Arteriovenous Malformations.

OBJECTIVE: Brain arteriovenous malformations management remains controversial despite the numerous, available treatment options. Randomized controlled trials (RCTs) theoretically provide the strongest evidence for the assessment of any therapeutic intervention. However, poorly designed RCTs may be associated with biases, inaccuracies, and misleading conclusions. The purpose of our study is to assess reporting transparency and methodological quality of the existing RCTs. METHODS: A search was performed in the PubMed, Scopus, Embase, clinicaltrials.gov, and Cochrane databases. The search was limited to English literature. We included all published RCTs reporting on the management of unruptured brain arteriovenous malformations. The eligible studies were evaluated by 5 blinded raters with the CONsolidated Standards of Reporting Trials 2010 statement and the risk-of-bias 2 tool. The inter-rater agreement was assessed with the Fleiss' Kappa. RESULTS: A randomized trial of unruptured brain arteriovenous malformations (ARUBA) and treatment of brain arteriovenous malformations (TOBAS) trials were evaluated. ARUBA achieved high CONsolidated standards of reporting trials compliance, while TOBAS showed a moderate one. In ARUBA the introduction, discussion, and other information sections reached the highest compliance rate (80%-86%). The lowest rates were recorded in the results and the methods (62% and 73%, respectively). The inter-rater agreement was moderate to substantial (54.1% to 78.4%). All the examined studies demonstrated a high risk of bias, mainly related to ill-defined intended interventions, missing outcome data, and selection of the reported results. CONCLUSIONS: Our study confirmed the high risk of bias mainly attributed to several protocol violations, deviations, minimal external validity and selection, attrition, and allocation biases of the ARUBA trial. Analysis of the TOBAS trial revealed a moderate overall reporting clarity and a high risk of bias.

Early management of patients with aneurysmal subarachnoid hemorrhage in a hospital with neurosurgical/neuroendovascular facilities: a consensus and clinical recommendations of the Italian Society of Anesthesia and Intensive Care (SIAARTI)-Part 1.

BACKGROUND: Issues remain on the optimal management of subarachnoid hemorrhage (SAH) patients once they are admitted to the referring center, before and after the aneurysm treatment. To address these issues, we created a consensus of experts endorsed by the Italian Society of Anesthesia and Intensive Care (SIAARTI). In this manuscript, we aim to provide a list of experts' recommendations regarding the early management of SAH patients from hospital admission, in a center with neurosurgical/neuro-endovascular facilities, until securing of the bleeding aneurysm. METHODS: A multidisciplinary consensus panel composed of 24 physicians selected for their established clinical and scientific expertise in the acute management of SAH patients with different background (anesthesia/intensive care, neurosurgery, and interventional neuroradiology) was created. A modified Delphi approach was adopted. RESULTS: Among 19 statements discussed. The consensus was reached on 18 strong recommendations. In one case, consensus could not be agreed upon and no recommendation was provided. CONCLUSIONS: This consensus provides practical recommendations for the management of SAH patients in hospitals with neurosurgical/neuroendovascular facilities until aneurysm securing. It is intended to support clinician's decision-making and not to mandate a standard of practice.

Early management of patients with aneurysmal subarachnoid hemorrhage in a hospital with neurosurgical/neuroendovascular facilities: a consensus and clinical recommendations of the Italian Society of Anesthesia and Intensive Care (SIAARTI)-part 2.

BACKGROUND: Questions remain on the optimal management of subarachnoid hemorrhage (SAH) patients once they are admitted to the referring center, before and after the aneurysm treatment. To address these issues, we created a consensus of experts endorsed by the Italian Society of Anesthesia and Intensive Care (SIAARTI) to provide clinical guidance regarding this topic. Specifically, in this manuscript (part 2), we aim to provide a list of experts' recommendations regarding the management of SAH patients in a center with neurosurgical/neuroendovascular facilities after aneurysm treatment. METHODS: A multidisciplinary consensus panel composed by 24 physicians selected for their established clinical and scientific expertise in the acute management of SAH patients with different specializations (anesthesia/intensive care, neurosurgery, and interventional neuroradiology) was created. A modified Delphi approach was adopted. RESULTS: A total of 33 statements were discussed, voted, and approved. Consensus was reached on 30 recommendations (28 strong and 2 weak). In 3 cases, where consensus could not be agreed upon, no recommendation was provided. CONCLUSIONS: This consensus provides practical recommendations (and not mandatory standard of practice) to support clinician's decision-making in the management of SAH patients in centers with neurosurgical/neuroendovascular facilities after aneurysm securing.

A minimally invasive approach for giant middle cerebral artery thrombosed aneurysms treatment.

BACKGROUND: Management of complex thrombosed aneurysms of the middle cerebral artery (MCA) is challenging. Lesions not amenable to endovascular techniques or direct clipping might require a bypass procedure with subsequent aneurysm occlusion. Various bypass techniques followed by surgical or endovascular closure of the aneurysm are available, but an unpredictable extension of the thrombus to the parent vessel and/or to perforator vessels can occur. We presented a multidisciplinary technique with the aim to reduce invasiveness and complications. METHODS: We present two patients, harboring a thrombosed giant MCA bifurcation aneurysm, who were treated with a minimally invasive three-steps multimodality procedure. In both cases, through a limited exposure of the sylvian fissure, a side-to-side anastomosis between the two M2 branches was performed, followed in the immediate postop by an endovascular occlusion of the frontal M2 branch, with the aim of transforming a bifurcation aneurysm in a sidewall aneurysm, that was then treated a few days later by flow diverter deployment. RESULTS: Both patients had excellent outcomes and were discharged after 7 days without neurological deficits. CONCLUSIONS: Treatment of complex thrombosed MCA aneurysms is challenging. Side-to-side M2 anastomosis with the aim of transforming a bifurcation aneurysm in a sidewall aneurysm, suitable to be treated few days later by flow diverter deployment, offers a minimally invasive multimodal approach with the possibility of reducing serious complications.

Intracranial Dural Arteriovenous Fistulas: The Sinus and Non-Sinus Concept.

INTRODUCTION: Dural arteriovenous fistulas (dAVFs) account for 10-15% of all intracranial arteriovenous lesions. Different classification strategies have been proposed in the course of the years. None of them seems to guide the treatment strategy. OBJECTIVE: We expose the experience of the vascular group at Niguarda Hospital and we propose a very practical classification method based on the location of the shunt. We divide dAVF in sinus and non-sinus in order to simplify our daily practice, as this classification method is simply based on the involvement of the sinuses. MATERIAL AND METHODS: 477 intracranial dural arteriovenous fistulas have been treated. 376 underwent endovascular treatment and 101 underwent surgical treatment. Cavernous sinus DAVFs and Galen ampulla malformations have been excluded from this series as they represent a different pathology per se. 376 dAVFs treated by endovascular approach: 180 were sinus and 179 were non-sinus. 101 dAVFs treated with surgical approach: 15 were sinus and 86 were non-sinus. DISCUSSION: Of the 477 intracranial dAVF the recorded mortality and severe disability was 3% and morbidity less than 4%. All patients underwent a postoperative DSA with nearly 100% of complete occlusion of the fistula. At a mean follow-up of 5 years in one case there was a non-sinus fistula recurrence, due to the presence of a partial clipping of "piè" of the vein. CONCLUSIONS: The sinus and non-sinus concept has guided our institution for years and has led to good clinical results. This paper intends to share this practical classification with the neurosurgical community.

Long-term follow-up of the Derivo® Embolization Device (DED®) for intracranial aneurysms: the Italian Multicentric Registry.

BACKGROUND: The flow-diverter devices (FDDs) safety and effectiveness have been demonstrated by large series and meta-analyses. Due to the high occlusion rates and the acceptable morbidity rates of FDDs, the indications for their use are continuously expanding. We presented our Italian multicentric experience using the second generation of DERIVO® Embolization Device (DED®; Acandis, Pforzheim, Germany) to cure cerebral aneurysms, evaluating both middle and long-term safety and efficacy of this device. METHODS: Between July 2016 and September 2017 we collected 109 consecutive aneurysms in 108 patients treated using DED® during 109 endovascular procedures in 34 Italian centers (100/109 aneurysms were unruptured, 9/109 were ruptured). The collected data included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and post-treatment modified Rankin Scale scores. Midterm and long-term clinical, angiographic and cross-sectional CT/MR follow-up were recorded and collected until December 2018. RESULTS: In 2/109 cases, DED® placement was classified as technical failures. The overall mortality and morbidity rates were respectively 6.5% and 5.5%. Overall DERIVO® related mortality and morbidity rates were respectively 0% and 4.6% (5 out of 108 patients). Midterm neuroimaging follow-up showed the complete or nearly complete occlusion of the aneurysm in 90% cases, which became 93% at long-term follow-up. Aneurysmal sac shrinking was observed in 65% of assessable aneurysms. CONCLUSIONS: Our multicentric experience using DED® for endovascular treatment of unruptured and ruptured aneurysms showed a high safety and efficacy profile, substantially equivalent or better compared to the other FDDs.

Early management of patients with aneurysmal subarachnoid hemorrhage in a hospital without neurosurgical/neuroendovascular facilities: a consensus and clinical recommendations of the Italian Society of Anesthesia and Intensive Care (SIAARTI).

BACKGROUND: The immediate management of subarachnoid hemorrhage (SAH) patients in hospitals without neurosurgical/neurointerventional facilities and their transfer to a specialized center is challenging and not well covered in existing guidelines. To address these issues, we created a consensus of experts endorsed by the Italian Society of Anesthesia and Intensive Care (SIAARTI) to provide clinical guidance. METHODS: A multidisciplinary consensus panel composed by 19 physicians selected for their established clinical and scientific expertise in the acute management of SAH patients with different specializations (anesthesia/intensive care, neurosurgery and interventional neuroradiology) was created. A modified Delphi approach was adopted. RESULTS: A total of 14 statements have been discussed. Consensus was reached on 11 strong recommendations and 2 weak recommendations. In one case, where consensus could not be agreed upon, no recommendation could be provided. CONCLUSIONS: Management of SAH in a non-specialized setting and early transfer are difficult and may have a critical impact on outcome. Clinical advice, based on multidisciplinary consensus, might be helpful. Our recommendations cover most, but not all, topics of clinical relevance.

Endovascular Treatment of Symptomatic Intracranial Vertebrobasilar Stenosis: A 10-Year Single Centre Experience Using Balloon-Expandable Coronary Artery Stents.

BACKGROUND: Symptomatic intracranial vertebro-basilar stenoses (SIVBS) are associated with high risk of recurrent ischemic stroke, even in patients receiving the best medical treatment. Although medical treatment is still the standard of care, non-responding patients may require endovascular treatment; balloon-mounted coronary stents (BMCS) could be successfully employed. This study aims to retrospectively analyze our high volume Interventional Neurovascular center ten-year experience in the off-label use of BMCS for the treatment of SIVBS, in order to assess its feasibility and safety. METHODS: We retrospectively analyzed all consecutive patients with SIVBS treated with BMCS in the last ten years in our center. Data collected included patient demographics, stenosis location and characteristics, early (<30 days) and late (>30 days) stroke and death rates, pre-symptomatic and post-treatment modified Rankin Scale (mRS) scores. RESULTS: 42 patients (35 males, average age 65,7 ± 10,7, range 37-85) with SIVBS were treated with BMCS. Thirty-four (80,9%) patients were symptomatic despite ongoing best medical therapy; eight (19,1%) patients were treated in emergency for large vessel occlusion, due to an underlying stenosis. BMCSs were successfully deployed in all cases. The incidence of stroke and death at one month was 7,1% (3/42). The incidence of TIA, stroke and death at long-term follow-up (average time of 3 years) was 14,3% (4,7 per 100 person-years). At long-term follow-up, mRS improved in 82% of patients who underwent elective treatment. CONCLUSIONS: In our experience, the off-label use of BMCS in the endovascular treatment of SIVBS resistant to medical treatment is feasible and safe.

European Reference Network for Rare Vascular Diseases (VASCERN) position statement on cerebral screening in adults and children with hereditary haemorrhagic telangiectasia (HHT).

Hereditary haemorrhagic telangiectasia (HHT) is a multisystemic vascular dysplasia inherited as an autosomal dominant trait. Approximately 10 % of patients have cerebral vascular malformations, a proportion being cerebral arteriovenous malformations (AVMs) and fistulae that may lead to potentially devastating consequences in case of rupture. On the other hand, detection and treatment related-risks are not negligible, and immediate. While successful treatment can be undertaken in individual cases, current data do not support the treatment of unruptured AVMs, which also present a low risk of bleeding in HHT patients. Screening for these AVMs is therefore controversial.Structured discussions, distinctions of different cerebrovascular abnormalities commonly grouped into an "AVM" bracket, and clear guidance by neurosurgical and neurointerventional radiology colleagues enabled the European Reference Network for Rare Vascular Disorders (VASCERN-HHT) to develop the following agreed Position Statement on cerebral screening:1) First, we emphasise that neurological symptoms suggestive of cerebral AVMs in HHT patients should be investigated as in general neurological and emergency care practice. Similarly, if an AVM is found accidentally, management approaches should rely on expert discussions on a case-by-case basis and individual risk-benefit evaluation of all therapeutic possibilities for a specific lesion.2) The current evidence base does not favour the treatment of unruptured cerebral AVMs, and therefore cannot be used to support widespread screening of asymptomatic HHT patients.3) Individual situations encompass a wide range of personal, cultural and clinical states. In order to enable informed patient choice, and avoid conflicting advice, particularly arising from non-neurovascular interpretations of the evidence base, we suggest that all HHT patients should have the opportunity to discuss knowingly brain screening issues with their healthcare provider.4) Any screening discussions in asymptomatic individuals should be preceded by informed pre-test review of the latest evidence regarding preventative and therapeutic efficacies of any interventions. The possibility of harm due to detection of, or intervention on, a vascular malformation that would not have necessarily caused any consequence in later life should be stated explicitly.We consider this nuanced Position Statement provides a helpful, evidence-based framework for informed discussions between healthcare providers and patients in an emotionally charged area.

Comprehensive Aneurysm Management (CAM): An All-Inclusive Care Trial for Unruptured Intracranial Aneurysms.

BACKGROUND: In the absence of randomized evidence, the optimal management of patients with unruptured intracranial aneurysms (UIA) remains uncertain. METHODS: Comprehensive Aneurysm Management (CAM) is an all-inclusive care trial combined with a registry. Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited, and treatment allocation will follow an algorithm combining clinical judgment and randomization. Patients eligible for at least 2 management options will be randomly allocated 1:1 to conservative or curative treatment. Minimization will be used to balance risk factors, using aneurysm size (≥7 mm), location (anterior or posterior circulation), and age <60 years. RESULTS: The CAM primary outcome is survival without neurologic dependency (modified Rankin Scale [mRS] score <3) at 10 years. Secondary outcome measures include the incidence of subarachnoid hemorrhage during follow-up and related morbidity and mortality; morbidity and mortality related to endovascular treatment or surgical treatment of the UIA at 1 year; overall morbidity and mortality at 1, 5, and 10 years; when relevant, duration of hospitalization; and, when relevant, discharge to a location other than home. The primary hypothesis for patients randomly allocated to at least 2 options, 1 of which is conservative management, is that active UIA treatment will reduce the 10-year combined neurologic morbidity and mortality (mRS score >2) from 24% to 16%. At least 961 patients recruited from at least 20 centers over 4 years will be needed for the randomized portion of the study. CONCLUSIONS: Patients with unruptured intracranial aneurysms can be comprehensively managed within the context of an all-inclusive care trial.

Arteriovenous Malformations: Congenital or Acquired Lesions?

OBJECTIVE: Arteriovenous malformations (AVMs) were believed to be congenital. However, an increasing number of de novo AVM cases have questioned this doctrine. METHODS: A consensus meeting of international experts attempted to establish a consensus on the nature of these relatively rare but challenging vascular lesions. In addition, an extensive search of the subject was performed using the PubMed medical database. RESULTS: All participants agreed that genetic factors may play a role in the pathogenesis of AVMs. All but 1 participant believed that an underlying genetic predisposition may be detected later on in a patient's life, whereas genetic variations may contribute to sporadic AVM formation. The presence of genetic variations alone may not be enough for an AVM formation. A second hit is probably required. This consensus opinion is also supported by our literature search. CONCLUSIONS: We discuss the literature on the genetics of AVMs and compare it with the consensus meeting outcomes. The congenital or noncongenital character of intracranial AVMs has an impact on the understanding their biological behavior, as well as their efficient short-term and long-term management.

Giant intracranial aneurysms: natural history and 1-year case fatality after endovascular or surgical treatment.

OBJECTIVE: Clinical evidence on giant intracranial aneurysms (GIAs), intracranial aneurysms with a diameter of at least 25 mm, is limited. The authors aimed to investigate the natural history, case fatality, and treatment outcomes of ruptured and unruptured GIAs. METHODS: In this international observational registry study, patients with a ruptured or unruptured GIA received conservative management (CM), surgical management (SM), or endovascular management (EM). The authors investigated rupture rates and case fatality. RESULTS: The retrospective cohort comprised 219 patients with GIAs (21.9% ruptured GIAs and 78.1% unruptured GIAs) whose index hospitalization occurred between January 2006 and November 2016. The index hospitalization in the prospective cohort (362 patients with GIAs [17.1% ruptured and 82.9% unruptured]) occurred between December 2008 and February 2017. In the retrospective cohort, the risk ratio for death at a mean follow-up of 4.8 years (SD 2.2 years) after CM, compared with EM and SM, was 1.63 (95% CI 1.23-2.16) in ruptured GIAs and 3.96 (95% CI 2.57-6.11) in unruptured GIAs. In the prospective cohort, the 1-year case fatality in ruptured GIAs/unruptured GIAs was 100%/22.0% during CM, 36.0%/3.0% after SM, and 39.0%/12.0% after EM. Corresponding 1-year rupture rates in unruptured GIAs were 25.0% during CM, 1.2% after SM, and 2.5% after EM. In unruptured GIAs, the HR for death within the 1st year in patients with posterior circulation GIAs was 6.7 (95% CI 1.5-30.4, p < 0.01), with patients with a GIA at the supraclinoid internal carotid artery as reference. Different sizes of unruptured GIAs were not associated with 1-year case fatality. CONCLUSIONS: Rupture rates for unruptured GIAs were high, and the natural history and treatment outcomes for ruptured GIAs were poor. Patients undergoing SM or EM showed lower case fatality and rupture rates than those undergoing CM. This difference in outcome may in part be influenced by patients in the CM group having been found poor candidates for SM or EM.Clinical trial registration no.: NCT02066493 (clinicaltrials.gov).

Intracranial Stenting: Is It Still an Option for Treatment of Patients With Intracranial Atherosclerosis?

Intracranial atherosclerotic disease (ICAD) is considered a major cause of recurrent cerebrovascular events. ICAD continues to be a disease without an effective method of reducing the risk of recurrent stroke and death, even with aggressive, highly monitored medical treatment. We reviewed data from three randomized controlled studies that published data comparing intracranial stenting vs. medical treatment for symptomatic severe-ICAD. Ethnic, demographic, clinical, and procedural differences were observed among the data from these trials that might influence their results. Future research should aim at establishing refined selection criteria that can identify high-risk ICAD patients who may benefit from intracranial stenting.

FRED Italian Registry: a multicenter experience with the flow re-direction endoluminal device for intracranial aneurysms.

OBJECTIVE: The introduction of flow-diverter devices (FDDs) has revolutionized the endovascular treatment of intracranial aneurysms. Here the authors present their Italian multicenter experience using the flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms, evaluating both short- and long-term safety and efficacy of this device. METHODS: Between February 2013 and December 2014, 169 consecutive aneurysms treated using FRED in 166 patients were entered into this study across 30 Italian centers. Data collected included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and posttreatment modified Rankin Scale scores, as well as angiographic and cross-sectional CT/MRI follow-up at 3-6 months and/or 12-24 months per institutional standard of care. All images were reviewed and adjudicated by an independent core lab. RESULTS: Of the 169 lesions initially entered into the study, 4 were later determined to be extracranial or nonaneurysmal by the core lab and were excluded, leaving 165 aneurysms in 162 patients treated in 163 procedures. Ninety-one (56.2%) patients were asymptomatic with aneurysms found incidentally. Of the 165 aneurysms, 150 (90.9%) were unruptured. One hundred thirty-four (81.2%) were saccular, 27 (16.4%) were fusiform/dissecting, and the remaining 4 (2.4%) were blister-like. One hundred thirty-seven (83.0%) arose from the anterior circulation.FRED deployment was impossible in 2/163 (1.2%) cases, and in an additional 4 cases (2.5%) the device was misdeployed. Overall mortality and morbidity rates were 4.3% and 7.3%, respectively, with rates of mortality and morbidity potentially related to FRED of up to 2.4% and 6.2%, respectively. Neuroimaging follow-up at 3-6 months showed complete or nearly complete occlusion of the aneurysm in 94% of cases, increasing to 96% at 12-24 months' follow-up. Aneurysmal sac shrinkage was observed in 78% of assessable aneurysms. CONCLUSIONS: This preliminary experience using FRED for endovascular treatment of complex unruptured and ruptured aneurysms showed a high safety and efficacy profile that is comparable to those of other FDDs currently in use.

Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up.

PURPOSE: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year. RESULTS: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment. CONCLUSIONS: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. TRIAL REGISTRATION NUMBER: NCT02390037.