Pretreatment Predictors of Very Poor Clinical Outcomes in Medium Vessel Occlusion Stroke Patients Treated with Mechanical Thrombectomy.

BACKGROUND: Acute ischemic stroke (AIS) from primary medium vessel occlusions (MeVO) is a prevalent condition associated with substantial morbidity and mortality. Despite the common use of mechanical thrombectomy (MT) in AIS, predictors of poor outcomes in MeVO remain poorly characterized. METHODS: In this prospectively collected, retrospectively reviewed, multicenter, multinational study, data from the MAD-MT registry were analyzed. The study included 1,568 patients from 37 academic centers across North America, Asia, and Europe, treated with mechanical thrombectomy (MT), with or without intravenous tissue plasminogen activator (IVtPA), between September 2017 and July 2021. RESULTS: Among the 1,568 patients, 347 (22.2%) experienced very poor outcomes (mRS 5-6). Key predictors of poor outcomes were advanced age (OR: 1.03; 95% CI: 1.02 to 1.04; p < 0.001), higher baseline NIHSS scores (OR: 1.07; 95% CI: 1.05 to 1.10; p < 0.001), pre-operative glucose levels (OR: 1.01; 95% CI: 1.00 to 1.02; p < 0.001), and a baseline mRS of 4 (OR: 2.69; 95% CI: 1.25 to 5.82; p = 0.011). The multivariable model demonstrated good predictive accuracy with an area under the receiver operating characteristic (ROC) curve of 0.76. CONCLUSIONS: This study demonstrates that advanced age, higher NIHSS scores, elevated pre-stroke mRS, and pre-operative glucose levels significantly predict very poor outcomes in AIS-MeVO patients who received MT. These findings highlight the importance of a comprehensive risk assessment in primary MeVO patients for personalized treatment strategies. However, they also suggest a need for cautious patient selection for endovascular thrombectomy. Further prospective studies are needed to confirm these findings and explore targeted therapeutic interventions.

Perspectives on Remote Robotic-Assisted Stroke Treatment: A Commentary Paper.

The proved feasibility of robotic-assisted endovascular treatment of intracranial aneurysms has stimulated the idea of a potential application of remote robotics for the treatment of acute ischemic stroke. The possibility of developing a more advanced remote-controlled robotic system capable of performing a complete mechanical thrombectomy procedure would help bridge the health care gap of lack of technical expertise in isolated areas. This possibility could allow a more equitable access to mechanical thrombectomy to a larger number of patients and be a breakthrough for acute ischemic stroke care worldwide. Many aspects around the technical, human, financial, and regulatory requirements should be discussed to implement remote robotic-assisted procedures. In this State of Practice article, we aimed to outline the major challenges that must be considered, as well as proposed solutions. However, different solutions may be applied in different health care systems on the basis of the availability of human and financial resources.

Venous balloon test occlusion for pulsatile tinnitus assessment: A clinical feasibility study.

BACKGROUND: Pulsatile tinnitus (PT) can have huge impact on the patients' quality of life and can be associated with curable vascular anomalies. In the present study, we aim firstly to describe our protocol for venous BTO and secondly to report possible predictors for a positive BTO test. METHODS: All consecutive PT patients undergoing BTO for the purpose of determining eligibility for venous neuro-intervention were included. We recommend BTO for patients when there is uncertainty in the association of the venous pathology identified on non-invasive cross-sectional imaging (CTV or MRV) and the patient's symptoms. RESULTS: Between May 2016 and October 2022, we recorded 29 venous balloon test occlusions fulfilling our inclusions criteria. Over the 29 procedures scheduled, 8 finally did not lead to a successful balloon test occlusion. The main reason was that the patient did not hear the PT on the day the angiogram was performed. Two patients could not have the BTO due to difficulties in venous navigation. After BTO, only four patients of our cohort were scheduled for an endovascular treatment. CONCLUSION: We describe a technique and present a single cohort of venous BTO in severe PT patients with unclear anatomical cause. This angiographic test was useful to exclude patients from endovascular surgery and discuss the most probable cause of the PT. Complexity of vascular PT should support a patient-based approach when discussing interventional treatment.

The butterfly effect: improving brain cone-beam CT image artifacts for stroke assessment using a novel dual-axis trajectory.

BACKGROUND: Cone-beam computed tomography (CBCT) imaging of the brain can be performed in the angiography suite to support various neurovascular procedures. Relying on CBCT brain imaging solely, however, still lacks full diagnostic confidence due to the inferior image quality compared with CT and various imaging artifacts that persist even with modern CBCT. OBJECTIVE: To perform a detailed evaluation of image artifact improvement using a new CBCT protocol which implements a novel dual-axis 'butterfly' trajectory. METHODS: Our study included 94 scans from 47 patients who received CBCT imaging for assessment of either ischemia or hemorrhage during a neurovascular procedure. Both a traditional uni-axis 'circular' and novel dual-axis 'butterfly' protocol were performed on each patient (same-patient control). Each brain scan was divided into six regions and scored out of 3 based on six artifacts originating from various physics-based and patient-based sources. RESULTS: The dual-axis trajectory produces CBCT images with significantly fewer image artifacts than the traditional circular scan (whole brain average artifact score, AS: 0.20 vs 0.33), with the greatest improvement in bone beam hardening (AS: 0.13 vs 0.78) and cone-beam artifacts (AS: 0.04 vs 0.55). CONCLUSIONS: Recent developments in CBCT imaging protocols have significantly improved image artifacts, which has improved diagnostic confidence for stroke and supports a direct-to-angiography suite transfer approach for patients with acute ischemic stroke.

Robotic-assisted intracranial aneurysm treatment: 1 year follow-up imaging and clinical outcomes.

BACKGROUND: The use of robotics in medicine may enable increased technical accuracy, reduced procedural time and radiation exposure, and remote completion of procedures. We have previously described the first-in-human, robotic-assisted cerebral aneurysm treatment using the CorPath GRX Robotic System. In this report we discuss our early experiences and outcomes using this robotic device for endovascular treatment of intracranial aneurysms using stent-assisted coil embolization and flow diversion. METHODS: The patient and disease characteristics, procedural details, and follow-up imaging and clinical outcomes of consecutive patients undergoing robotically-assisted intracranial aneurysm embolization between November 2019 and February 2020 are presented. RESULTS: Six patients underwent robotically-assisted embolization of intracranial aneurysms. Four of the patients were treated with a neck-bridging stent (with or without coiling) and two patients were treated with a flow-diverting stent. Two patients were treated in the subacute period of subarachnoid hemorrhage and four patients were treated electively. All of the procedures could be completed robotically and there was no need for unplanned manual intervention. The technical success rate of the procedures was 100%. There was no morbidity or mortality associated with the procedures. One year follow-up imaging showed that four aneurysms were completely obliterated (Raymond-Roy Occlusion Classification (RROC) class I) and the remaining two were occluded with a residual neck (RROC class II). CONCLUSIONS: The Corpath GRX Robotic System demonstrated a precise control over the microcatheter, wire and stent during aneurysm treatment. Robotic neuro-procedures seem to be safe and effective and demonstrate stable occlusion results in the midterm follow-up.

Biomodex patient-specific brain aneurysm models: the value of simulation for first in-human experiences using new devices and robotics.

BACKGROUND: With the recent advent of advanced technologies in the field, treatment of neurovascular diseases using endovascular techniques is rapidly evolving. Here we describe our experience with pre-surgical simulation using the Biomodex EVIAS patient-specific 3D-printed models to plan aneurysm treatment using endovascular robotics and novel flow diverter devices. METHODS: Pre-procedural rehearsals with 3D-printed patient-specific models of eight cases harboring brain aneurysms were performed before the first in-human experiences. To assess the reliability of the experimental model, the characteristics of the aneurysms were compared between the patient and 3D models. The rehearsals were used to define the patient treatment plan, including technique, device sizing, and operative working projections. RESULTS: The study included eight patients with their respective EVIAS 3D aneurysm models. Pre-operative simulation was performed for the first in-human robotic-assisted neurovascular interventions (n=2) and new generation flow-diverter stents (n=6). Aneurysms were located in both the anterior (n=5) and posterior (n=3) circulation and were on average 11.0±6.5 mm in size. We found reliable reproduction of the aneurysm features and similar dimensions of the parent vessel anatomy between the 3D models and patient anatomy. Information learned from pre-surgical in vitro simulation are described in detail, including an improved patient treatment plan, which contributed to successful first in-world procedures with no intraprocedural complications. CONCLUSIONS: Pre-procedural rehearsal using patient-specific 3D models provides precise procedure planning, which can potentially lead to greater operator confidence, decreased radiation dose and improvements in patient safety, particularly in first in-human experiences.

Torrents of torment: turbulence as a mechanism of pulsatile tinnitus secondary to venous stenosis revealed by high-fidelity computational fluid dynamics.

BACKGROUND: Pulsatile tinnitus (PT) is a debilitating condition that can be caused by a vascular abnormality, such as an arterial or venous lesion. Although treatment of PT-related venous lesions has been shown to successfully cure patients of the associated 'tormenting' rhythmical sound, much controversy still exists regarding their role in the etiology of PT. METHODS: A patient presented with a history of worsening, unilateral PT. A partial venous sinus obstruction related to the large arachnoid granulation was detected on the right side, and subsequently stented at the right transverse sinus. High-fidelity computational fluid dynamics (CFD) was performed on a 3D model digitally segmented from the pre-stent venogram, with assumed pulsatile flow rates. A post-stent CFD model was also constructed from this. Data-driven sonification was performed on the CFD velocity data, blinded to the patient's self-reported sounds. RESULTS: The patient reported that the PT was completely resolved after stenting, and has had no recurrence of the symptoms after more than 2 years. CFD simulation revealed highly disturbed, turbulent-like flow at the sigmoid sinus close to auditory structures, producing a sonified audio signal that reproduced the subjective sonance of the patient's PT. No turbulence or sounds were evident at the stenosis, or anywhere in the post-stent model. CONCLUSIONS: For the first time, turbulence generated distal to a venous stenosis is shown to be a cause of PT. High-fidelity CFD may be useful for identifying patients with such 'torrents' of flow, to help guide treatment decision-making.

Comparison of intra-aneurysmal flow modification using optical flow imaging to evaluate the performance of Evolve and Pipeline flow diverting stents.

BACKGROUND: Flow diverting stent (FDS) devices have revolutionized the treatment of large and complex brain aneurysms, but there is still room for improvement, particularly on the flow diversion properties and technical challenges associated with stent deployment. In this study we compared flow diversion properties between the new generation Surpass Evolve (Stryker) and the Pipeline Flex (Medtronic) devices by quantitatively evaluating intra-aneurysmal flow modification. METHODS: An in vitro experimental set-up was used, consisting of four patient-specific silicone models with internal carotid aneurysms and a circulating hemodynamic simulation system with pulsatile flow. The Evolve and Pipeline stents were deployed across the neck of each aneurysm model, in a randomized fashion, for a total of eight device deployments. A 60 frames/s digital subtraction angiography run was acquired before and after placement of each FDS. An optical flow-analysis method was used to measure intra-aneurysmal flow modification induced by the stent by calculating a mean aneurysm flow amplitude (MAFA) before and after stent placement and computing a ratio. RESULTS: Average MAFA ratio values calculated from pre- and post-stent placement were significantly lower after deployment of the Evolve (n=4, mean=0.62±0.09) compared with the Pipeline device (n=4, mean=0.71±0.06) (p=0.03). CONCLUSIONS: Our in vitro results show that the Evolve stent had a superior flow diversion effect compared with the Pipeline stent, which-based on clinical evidence-suggest it may promote faster aneurysm occlusion rates in patients.

First-in-human, robotic-assisted neuroendovascular intervention.

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.