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"Mendes Pereira, Vitor"
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First-in-human, robotic-assisted neuroendovascular intervention
2020
Robotic-assisted technology has been used as a tool to enhance open and minimally invasive surgeries as well as percutaneous coronary and peripheral vascular interventions. It offers many potential benefits, including increased procedural and technical accuracy as well as reduced radiation dose during fluoroscopic procedures. It also offers the potential for truly “remote” procedures. Despite these benefits, robotic technology has not yet been used in the neuroendovascular field, aside from diagnostic cerebral angiography. Here, we report the first robotic-assisted, therapeutic, neuroendovascular intervention performed in a human. This was a stent-assisted coiling procedure to treat a large basilar aneurysm. All intracranial steps, including stent placement and coil deployment, were performed with assistance from the CorPath© GRX Robotic System (Corindus, a Siemens Healthineers Company, Waltham, MA, USA). This represents a major milestone in the treatment of neurovascular disease and opens the doors for the development of remote robotic neuroendovascular procedures.
Journal Article
Venous sinus stenting for idiopathic intracranial hypertension: a systematic review and meta-analysis
by
Hilditch, Christopher Alan
,
Radovanovic, Ivan
,
Nicholson, Patrick
in
Angioplasty
,
Bias
,
Clinical outcomes
2019
BackgroundStenting of the intracranial venous sinuses is used as a treatment in certain cases of idiopathic intracranial hypertension (IIH). Interest in, and experience of, this technique is growing, particularly in recent years. We sought to provide an updated systematic review and meta-analysis of the use of venous stenting in these patients, examining clinical outcomes.MethodsA literature search of venous stenting in IIH patients was performed. Using random-effects meta-analysis, we evaluated the following outcomes: clinical resolution of papilledema; headaches and pulsatile tinnitus; recurrence of symptoms after stenting; and complications.ResultsTwenty articles from 18 different centers were included. In a total of 474 patients. 418 were female (88%). The mean age of the patients was 35, while the mean body mass index (BMI) was 35 kg/m2. Median follow-up was 18 months. The overall rate of improvement in papilloedema was 93.7% (95% CI 90.5% to 96.9%), while the overall rate of improvement or resolution of headache was 79.6% (95% CI 73.3% to 85.9%). Pulsatile tinnitus resolved in 90.3% (95% CI 83.8% to 96.70%), while the overall rate of recurrence of IIH symptoms after stenting was 9.8% (95% CI 6.7% to 13%). The rate of major complications was 1.9% (95% CI 0.07% to 3.1%).ConclusionsVenous sinus stenting in patients with IIH who are refractory to medical therapy appears to have an excellent safety profile and is associated with significant improvements in headaches, pulsatile tinnitus, and papilledema.
Journal Article
Overview of Different Flow Diverters and Flow Dynamics
by
Tutino, Vincent M
,
Salem, Mohamed M
,
Machi, Paolo
in
Aneurysms
,
Blood vessels
,
Care and treatment
2020
Abstract
Over the past decade, flow diverter technology for endocranial aneurysms has seen rapid evolution, with the development of new devices quickly outpacing the clinical evidence base. However, flow diversion has not yet been directly compared to surgical aneurysm clipping or other endovascular procedures. The oldest and most well-studied device is the Pipeline Embolization Device (PED; Medtronic), recently transitioned to the Pipeline Flex (Medtronic), which still has sparse data regarding outcomes. To date, other flow diverting devices have not been shown to outperform the PED, although information comes primarily from retrospective studies with short follow-up, which are not always comparable. Because of this lack of high-quality outcome data, no reliable recommendations can be made for choosing among flow diversion devices yet. Moreover, the decision to proceed with flow diversion should be individualized to each patient. In this work, we wish to provide a comprehensive overview of the technical specifications of all flow diverter devices currently available, accompanied by a succinct description of the evidence base surrounding each device.
Journal Article
Robotics in neurointerventional surgery: a systematic review of the literature
2022
BackgroundRobotically performed neurointerventional surgery has the potential to reduce occupational hazards to staff, perform intervention with greater precision, and could be a viable solution for teleoperated neurointerventional procedures.ObjectiveTo determine the indication, robotic systems used, efficacy, safety, and the degree of manual assistance required for robotically performed neurointervention.MethodsWe conducted a systematic review of the literature up to, and including, articles published on April 12, 2021. Medline, PubMed, Embase, and Cochrane register databases were searched using medical subject heading terms to identify reports of robotically performed neurointervention, including diagnostic cerebral angiography and carotid artery intervention.ResultsA total of 8 articles treating 81 patients were included. Only one case report used a robotic system for intracranial intervention, the remaining indications being cerebral angiography and carotid artery intervention. Only one study performed a comparison of robotic and manual procedures. Across all studies, the technical success rate was 96% and the clinical success rate was 100%. All cases required a degree of manual assistance. No studies had clearly defined patient selection criteria, reference standards, or index tests, preventing meaningful statistical analysis.ConclusionsGiven the clinical success, it is plausible that robotically performed neurointerventional procedures will eventually benefit patients and reduce occupational hazards for staff; however, there is no high-level efficacy and safety evidence to support this assertion. Limitations of current robotic systems and the challenges that must be overcome to realize the potential for remote teleoperated neurointervention require further investigation.
Journal Article
Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification
by
Diaz, Orlando
,
Cawley, C Michael
,
István, Istvan Szikora
in
aneurysm
,
Aneurysms
,
Cerebral Angiography - methods
2023
BackgroundThe pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.MethodsPREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.ResultsAs per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge–Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.ConclusionsThe PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.Trial registration NCT02186561.
Journal Article
Braid stability after flow diverter treatment of intracranial aneurysms: a systematic review and meta-analysis
2025
BackgroundThe aim of this study was to evaluate the overall rates of braid changes associated with flow diverter (FD) treatment for intracranial aneurysms (IAs). Additionally, we sought to provide an overview of the currently reported definitions related to these complications.MethodsA systematic search was conducted from the inception of relevant literature up to April 2023, encompassing six databases. The included studies focused on patients with IAs treated with FDs. We considered four main outcome measures as FD braid changes: (1) fish-mouthing, (2) device braid narrowing, (3) device braid collapsing, and (4) device braid deformation. The data from these studies were pooled using a random-effects model.ResultsA total of 48 studies involving 3572 patients were included in the analysis. Among them, 14 studies (39%) provided definitions for fish-mouthing. However, none of the included studies offered specific definitions for device braid narrowing, collapsing, or deformation, despite reporting rates for these complications in six, five, and three studies, respectively. The pooled rates for braid changes were as follows: 3% (95% CI 2% to 4%, I2=27%) for fish-mouthing, 7% (95% CI 2% to 20%, I2=85%) for narrowing, 1% (95% CI 0% to 3%, I2=0%) for collapsing, and 1% (95% CI 1% to 4%, I2=0%) for deformation.ConclusionThe findings of this study suggest that FD treatment for IAs generally exhibits low rates of fish-mouthing, device braid narrowing, collapsing, and deformation. However, the lack of standardized definitions hinders the ability to compare device outcomes objectively, emphasizing the need for uniform definitions for FD braid changes in future prospective studies on FD.
Journal Article
Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms
2024
BackgroundRobotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases.ObjectiveTo evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms.MethodsThis prospective, international, multicenter study enrolled patients with brain aneurysms that required endovascular coiling and/or stent-assisted coiling. The primary effectiveness endpoint was defined as successful completion of the robotic-assisted endovascular procedure without any unplanned conversion to manual treatment with guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. The primary safety endpoint included intraprocedural and periprocedural events.ResultsThe study enrolled 117 patients (74.4% female) with mean age of 56.6 years from 10 international sites,. Headache was the most common presenting symptom in 40/117 (34.2%) subjects. Internal carotid artery was the most common location (34/122, 27.9%), and the mean aneurysm height and neck width were 5.7±2.6 mm and 3.5±1.4 mm, respectively. The overall procedure time was 117.3±47.3 min with 59.4±32.6 min robotic procedure time. Primary effectiveness was achieved in 110/117 (94%) subjects with seven subjects requiring conversion to manual for procedure completion. Only four primary safety events were recorded with two intraprocedural aneurysm ruptures and two strokes. A Raymond-Roy Classification Scale score of 1 was achieved in 71/110 (64.5%) subjects, and all subjects were discharged with a modified Rankin Scale score of ≤2.ConclusionsThis first-of-its-kind robotic-assisted neurovascular trial demonstrates the effectiveness and safety of the CorPath GRX System for endovascular embolization of cerebral aneurysm procedures.Trial registration number NCT04236856
Journal Article
Deep learning-based cerebral aneurysm segmentation and morphological analysis with three-dimensional rotational angiography
by
Spears, Julian
,
Nishi, Hidehisa
,
Mendes Pereira, Vitor
in
Algorithms
,
aneurysm
,
Aneurysm, Ruptured
2024
BackgroundThe morphological assessment of cerebral aneurysms based on cerebral angiography is an essential step when planning strategy and device selection in endovascular treatment, but manual evaluation by human raters only has moderate interrater/intrarater reliability.MethodsWe collected data for 889 cerebral angiograms from consecutive patients with suspected cerebral aneurysms at our institution from January 2017 to October 2021. The automatic morphological analysis model was developed on the derivation cohort dataset consisting of 388 scans with 437 aneurysms, and the performance of the model was tested on the validation cohort dataset consisting of 96 scans with 124 aneurysms. Five clinically important parameters were automatically calculated by the model: aneurysm volume, maximum aneurysm size, neck size, aneurysm height, and aspect ratio.ResultsOn the validation cohort dataset the average aneurysm size was 7.9±4.6 mm. The proposed model displayed high segmentation accuracy with a mean Dice similarity index of 0.87 (median 0.93). All the morphological parameters were significantly correlated with the reference standard (all P<0.0001; Pearson correlation analysis). The difference in the maximum aneurysm size between the model prediction and reference standard was 0.5±0.7 mm (mean±SD). The difference in neck size between the model prediction and reference standard was 0.8±1.7 mm (mean±SD).ConclusionThe automatic aneurysm analysis model based on angiography data exhibited high accuracy for evaluating the morphological characteristics of cerebral aneurysms.
Journal Article
First clinical multicenter experience with the new Pipeline Vantage flow diverter
2023
BackgroundFlow diversion is an innovative and increasingly used technique for the treatment of intracranial aneurysms. New flow diverters (FDs) are being introduced to improve the safety and efficacy of this treatment. The aim of this study was to assess the safety, feasibility, and efficacy of the new Pipeline Vantage (PV) FD.MethodsPatients with intracranial aneurysms treated with the PV at 10 international neurovascular centers were retrospectively analyzed. Patient and aneurysm characteristics, procedural parameters, complications, and the grade of occlusion were assessed.Results60 patients with 70 aneurysms (5.0% with acute hemorrhage, 90.0% located in the anterior circulation) were included. 82 PVs were implanted in 61 treatment sessions. The PV could be successfully implanted in all treatments. Additional coiling was performed in 18.6%, and in-stent balloon angioplasty (to enhance the vessel wall apposition) in 24.6%. Periprocedural technical complications occurred in 24.6% of the treatments, were predominantly FD deployment problems, and were all asymptomatic. The overall symptomatic complication rate was 8.2% and the neurological symptomatic complication rate was 3.3%. Only one symptomatic complication was device-related (perforator artery infarctions leading to stroke). After a mean follow-up of 7.1 months, the rate of complete aneurysm occlusion was 77.9%. One patient (1.7%) died due to aneurysmal subarachnoid hemorrhage which occurred before treatment, unrelated to the procedure.ConclusionsThe new PV FD is safe and feasible for the treatment of intracranial aneurysms. The short-term occlusion rates are promising but need further assessment in prospective long-term follow-up studies.
Journal Article