title: Feasibility of endovascular repair of ascending aortic pathologies as part of an FDA-approved physician-sponsored investigational device exemption.
abstract: OBJECTIVE
  Endovascular treatment of ascending aortic lesions has been reported, but to date, no FDA-approved studies have been conducted to define feasibility and the use of endografts in this particular location or to analyze the critical factors involved.
  
  
  METHODS
  Patients were consented for entry into an FDA-approved physician-sponsored investigational device exemption study to investigate the outcome of those with ascending aortic pathologies. These patients were suitable according to the instructions for use for endovascular repair with a Valiant Captivia (Medtronic, Inc, Minneapolis, Minn) thoracic stent graft, a device designed specifically for deployment in the ascending aorta. All patients had sequential gated-cardiac computed tomography scans, with data being entered into the VQI Complex TEVAR software (West Lebanon, NH). All procedures were performed in a hybrid room, with the capability to convert to an open repair to ensure maximal patient protection. The first five patients constituted the feasibility study, with continued enrollment based on initial results and submission of an annual report to the FDA.
  
  
  RESULTS
  Thirty-nine patients were screened, and six patients were entered into the physician-sponsored investigational device exemption study. Although there was no early mortality, there was one late death. All patients had sequential computed tomographies and cardiac echocardiograms with no evidence of migration, one type 1a endoleak, one postoperative stroke, and regression of the aortic lesions in the excluded aortic segment.
  
  
  CONCLUSIONS
  In this feasibility study, the preliminary evaluation of endovascular treatment for ascending aortic pathologies demonstrates uniform accuracy of deployment and secure fixation up to 17.5 months of follow-up. There is positive remodeling of the excluded aortic segments similar to surveillance studies involving the descending aorta.
authors.affiliation: Division of Cardiothoracic Surgery, Cedars-Sinai Medical Center, Los Angeles, Calif. Electronic address: akhoy@cshs.org.
authors.forename: Ali
authors.initials: A
authors.lastname: Khoynezhad
authors.affiliation: Department of Surgery, David Geffen UCLA School of Medicine, University of California, Los Angeles, UCLA School of Medicine, Harbor-UCLA Medical Center, Torrance, Calif.
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Donayre
authors.affiliation: Department of Surgery, David Geffen UCLA School of Medicine, University of California, Los Angeles, UCLA School of Medicine, Harbor-UCLA Medical Center, Torrance, Calif.
authors.forename: Irwin
authors.initials: I
authors.lastname: Walot
authors.affiliation: Department of Surgery, David Geffen UCLA School of Medicine, University of California, Los Angeles, UCLA School of Medicine, Harbor-UCLA Medical Center, Torrance, Calif.
authors.forename: Matthew C
authors.initials: MC
authors.lastname: Koopmann
authors.affiliation: Los Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Torrance, Calif.
authors.forename: George E
authors.initials: GE
authors.lastname: Kopchok
authors.affiliation: Department of Surgery, David Geffen UCLA School of Medicine, University of California, Los Angeles, UCLA School of Medicine, Harbor-UCLA Medical Center, Torrance, Calif.
authors.forename: Rodney A
authors.initials: RA
authors.lastname: White
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001011:Aorta / Q000000981:diagnostic imaging / Q000601:surgery*; D001018:Aortic Diseases / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D055424:Cardiac-Gated Imaging Techniques; D000072226:Computed Tomography Angiography; D018795:Device Approval; D004452:Echocardiography; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061330:Multidetector Computed Tomography; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration