title: First-in-Man Transcervical Surgical Aortic Valve Replacement Using the CoreVista System.
abstract: OBJECTIVE
  This study aimed to evaluate a novel device system for surgical aortic valve replacement (SAVR) using a unique new less invasive access approach. The hypothesis is that SAVR can be performed through a short transverse incision in the neck, similar to that used for transcervical thymectomy avoiding chest disruption.
  
  
  METHODS
  A new device system was developed to provide retraction, step-by-step illumination, and on-screen visualization for the new approach. Preliminary feasibility studies were performed in cadavers. Comprehensive risk analysis was performed, and training was implemented in Thiel preserved cadavers. For the first-in-man clinical case, a 63-year-old woman with symptomatic critical aortic stenosis (The Society of Thoracic Surgeons risk, 11%) and heavily calcified aortic valve was selected. A short transverse incision was made in the neck; the device was introduced, and the sternum was elevated; femorofemoral cardiopulmonary bypass was established; substernal dissection was guided by the sequenced illumination, and high-definition visualization was provided by the device, allowing for optimal exposition of the aorta and aortic valve; and a 23-mm Medtronic ENABLE sutureless valve prosthesis was implanted. Procedure success was evaluated according to the standardized composite end point definition of "device success" proposed by the Valve Academic Research Consortium.
  
  
  RESULTS
  Access, delivery, and deployment of the valve prosthesis were successful. The correct position and intended performance of the valve were demonstrated (mean gradient, 6 mm Hg; aortic valve area, 2.5 cm) with the absence of moderate or severe prosthetic aortic regurgitation. Only one valve prosthesis was used.
  
  
  CONCLUSIONS
  Transcervical SAVR with sutureless valve is feasible using this novel access system. The new approach has potential to offer patients substantially shorter stay and fewer, less serious complications, as has been observed in transcervical thymectomy. Further studies are merited.
authors.affiliation: From the *Medical University of Graz, Graz, Austria; †Universidad Nacional de Asuncion Medicina, Paraguay, San Lorenzo, Paraguay; and ‡Golden Jubilee National Hospital, Glasgow, United Kingdom.
authors.forename: Otto E
authors.initials: OE
authors.lastname: Dapunt
authors.forename: Olev
authors.initials: O
authors.lastname: Luha
authors.forename: Adrian
authors.initials: A
authors.lastname: Ebner
authors.forename: Piotr
authors.initials: P
authors.lastname: Sonecki
authors.forename: Cristiano
authors.initials: C
authors.lastname: Spadaccio
authors.forename: Fraser W H
authors.initials: FW
authors.lastname: Sutherland
mesh_terms: D001024:Aortic Valve Stenosis / Q000601:surgery*; D002315:Cardiopulmonary Bypass / Q000295:instrumentation / Q000379:methods*; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D006801:Humans; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation; D009333:Neck / Q000601:surgery; D025321:Surgery, Computer-Assisted / Q000379:methods; D016896:Treatment Outcome