title: First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation.
abstract: OBJECTIVE
  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 the reduction of procedural stroke. Procedural mobilisation of debris is a known source of cerebral embolisation. Mechanical protection by transient filtration of cerebral blood flow might reduce the embolic burden during TAVI. We aimed to evaluate the feasibility and safety of the Claret CE Pro™ cerebral protection device in patients undergoing TAVI.
  
  
  RESULTS
  Patients scheduled for TAVI were prospectively enrolled at three centres. The Claret CE Pro™ (Claret Medical, Inc. Santa Rosa, CA, USA) cerebral protection device was placed via the right radial/brachial artery prior to TAVI and was removed after the procedure. The primary endpoint was technical success rate. Secondary endpoints encompassed procedural and 30-day stroke rates, as well as device-related complications. Deployment of the Claret CE Pro™ cerebral protection device was intended for use in 40 patients, 35 devices were implanted into the aortic arch. Technical success rate with delivery of the proximal and distal filter was 60% for the first generation device and 87% for the second-generation device. Delivery times for the first-generation device were 12.4±12.1 minutes and 4.4 ± 2.5 minutes for the second-generation device (p<0.05). The quantity of contrast used related to the Claret CE Pro System was 19.6 ± 3.8 ml. Captured debris was documented in at least 19 of 35 implanted devices (54.3%). No procedural transient ischaemic attacks, minor strokes or major strokes occurred. Thirty-day follow-up showed one minor stroke occurring 30 days after the procedure, and two major strokes both occurring well after the patient had completed TAVI.
  
  
  CONCLUSIONS
  The use of the Claret CE Pro™ system is feasible and safe. Capture of debris in more than half of the patients provides evidence for the potential to reduce the procedural cerebral embolic burden utilising this dedicated filter system during TAVI.
authors.affiliation: Contilia Heart- and Vascular Center, Elisabeth Krankenhaus Essen, Essen, Germany. c.k.naber@contilia.de
authors.forename: Christoph K
authors.initials: CK
authors.lastname: Naber
authors.forename: Alexander
authors.initials: A
authors.lastname: Ghanem
authors.forename: Alexander A
authors.initials: AA
authors.lastname: Abizaid
authors.forename: Alexander
authors.initials: A
authors.lastname: Wolf
authors.forename: Jan-Malte
authors.initials: JM
authors.lastname: Sinning
authors.forename: Nikos
authors.initials: N
authors.lastname: Werner
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmitz
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D001938:Brazil; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D016009:Chi-Square Distribution; D057505:Embolic Protection Devices; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome