First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation.

摘要: Aims: We describe the first-in-human experience with a novel cerebral embolic protection device used during transcatheter aortic valve implantation (TAVI). One current challenge of TAVI is reduction procedural stroke. Procedural mobilisation debris known source embolisation. Mechanical by transient filtration blood flow might reduce burden TAVI. aimed to evaluate feasibility and safety Claret CE Pro™ in patients undergoing Methods results: Patients scheduled for were prospectively enrolled at three centres. The (Claret Medical, Inc. Santa Rosa, CA, USA) was placed via right radial/ brachial artery prior removed after procedure. primary endpoint technical success rate. Secondary endpoints encompassed 30-day stroke rates, as well device-related complications. Deployment intended use 40 patients, 35 devices implanted into arch. Technical rate delivery proximal distal filter 60% first generation 87% second-generation device. Delivery times first-generation 12.4±12.1 minutes 4.4±2.5 (p<0.05). quantity contrast related Pro System 19.6±3.8 ml. Captured documented least 19 (54.3%). No ischaemic attacks, minor strokes or major occurred. Thirty-day follow-up showed one occurring 30 days procedure, two both patient had completed Conclusions: system feasible safe. Capture more than half provides evidence potential utilising this dedicated