Sistema de Salut de Catalunya
Institut Català de la Salut
[Mendes Pereira V, Spears J] Division of Neurosurgery, Department of Surgery, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada. [Rice H, De Villiers L] Department of Neurointervention, Gold Coast University Hospital, Southport, Queensland, Australia. [Sourour N, Clarencon F] Department of Interventional Neuroradiology, Hopital Universitaire Pitie Salpetriere, Paris, France. [Tomasello A] Secció de Neuroradiologia Intervencionista, Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2024-03-27T10:05:36Z
2024-03-27T10:05:36Z
2024-03-14
Aneurysm; Brain; Stent
Aneurisma; Cerebro; Stent
Aneurisma; Cervell; Stent
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
This study was funded by Siemens Healthineers Endovascular Robotics.
Article
Published version
English
Aneurismes cerebrals - Tractament; Embolització terapèutica; Vasos sanguinis - Cirurgia; Robòtica en medicina; DISEASES::Nervous System Diseases::Central Nervous System Diseases::Brain Diseases::Cerebrovascular Disorders::Intracranial Arterial Diseases::Intracranial Aneurysm; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Hemostatic Techniques::Embolization, Therapeutic; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Surgical Procedures, Operative::Minimally Invasive Surgical Procedures::Endovascular Procedures; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Surgical Procedures, Operative::Surgery, Computer-Assisted::Robotic Surgical Procedures; ENFERMEDADES::enfermedades del sistema nervioso::enfermedades del sistema nervioso central::enfermedades cerebrales::trastornos cerebrovasculares::enfermedades arteriales intracraneales::aneurisma intracraneal; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::técnicas hemostáticas::embolización terapéutica; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::intervenciones quirúrgicas::procedimientos quirúrgicos mínimamente invasivos::procedimientos endovasculares; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::intervenciones quirúrgicas::cirugía asistida por ordenador::procedimientos quirúrgicos robotizados
BMJ
Journal of NeuroInterventional Surgery;16(4)
https://doi.org/10.1136/jnis-2023-020161
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
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