Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms.

BACKGROUND: Robotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases. OBJECTIVE: To evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms. METHODS: This 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. RESULTS: The 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. CONCLUSIONS: This 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.

Feasibility of robot-assisted neuroendovascular procedures.

OBJECTIVE: Geographic factors prevent equitable access to urgent advanced neuroendovascular treatments. Robotic technologies may enable remote endovascular procedures in the future. The authors performed a translational, benchtop-to-clinical study to evaluate the in vitro and clinical feasibility of the CorPath GRX Robotic System for robot-assisted endovascular neurointerventional procedures. METHODS: A series of bench studies was conducted using patient-specific 3D-printed models to test the system's compatibility with standard neurointerventional devices, including microcatheters, microwires, coils, intrasaccular devices, and stents. Optimal baseline setups for various procedures were determined. The models were further used to rehearse clinical cases. Subsequent to these investigations, a prospective series of 6 patients was treated using robotic assistance for complex, wide-necked intracranial saccular aneurysms between November 2019 and February 2020. The technical success, incidence of periprocedural complications, and need for conversion to manual procedures were evaluated. RESULTS: The ideal robotic setup for treatment of both anterior and posterior circulation aneurysms was determined to consist of an 80-cm guide catheter with a 115-cm-long intermediate catheter, a microcatheter between 150 and 170 cm in length, and a microwire with a minimum length of 300 cm. All coils, intrasaccular devices, and stents tested were compatible with the system and could be advanced or retracted safely and placed accurately. All 6 clinical procedures were technically successful, with all intracranial steps being performed robotically with no conversions to manual intervention or failures of the robotic system. There were no procedure-related complications or adverse clinical outcomes. CONCLUSIONS: This study demonstrates the feasibility of robot-assisted neurointerventional procedures. The authors' results represent an important step toward enabling remote neuroendovascular care and geographic equalization of advanced endovascular treatments through so-called telestroke intervention.

Effect of Human Umbilical Cord Perivascular Cell-Conditioned Media in an Adult Zebrafish Model of Traumatic Brain Injury.

The pathophysiological events of secondary brain injury contribute to poor outcome after traumatic brain injury (TBI). The neuroprotective effects of mesenchymal cells have been extensively studied and evidence suggests that their effects are mostly mediated through paracrine effects. Human umbilical cord perivascular cells (HUCPVCs) are mesenchymal stem cells with potential therapeutic value in TBI. In this study, we assessed the effect of HUCPVC-conditioned media (CM) in an established adult zebrafish model of TBI induced by pulsed high-intensity focused ultrasound (pHIFU). This model demonstrates similarities to mammalian outcome after TBI. Administration of HUCPVC-CM 1 h postinjury (hpi) resulted in improved outcome after pHIFU-induced TBI. Western blot and immunohistochemistry results demonstrated that the HUCPVC-CM reduced (p < 0.05) reactive astrogliosis at 24 hpi. Moreover, at 24 hpi, the HUCPVC-CM treatment resulted in reduced apoptosis in HUCPVC-CM-treated zebrafish. Behavioral analysis demonstrated improvement in locomotor activity (p < 0.05) and anxiety (p < 0.05) at 6 and 24 hpi following HUCPVC-CM treatment. Overall, HUCPVC-CM treatment improved acute outcome measures in pHIFU-injured zebrafish. Collectively, the data demonstrate a cell-free treatment approach for traumatic brain injuries.