Feasibility of endovascular repair of ascending aortic pathologies as part of an FDA-approved physician-sponsored investigational device exemption

Ali Khoynezhad, Carlos E. Donayre, Irwin Walot, Matthew Koopman, George E. Kopchok, Rodney A. White

Research output: Contribution to journalArticle

25 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1483-1495
Number of pages13
JournalJournal of vascular surgery
Volume63
Issue number6
DOIs
StatePublished - Jun 1 2016
Externally publishedYes

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Pathology
Physicians
Equipment and Supplies
Feasibility Studies
Tomography
Lebanon
Endoleak
Annual Reports
Thoracic Aorta
Statistical Factor Analysis
Stents
Aorta
Thorax
Software
Stroke
Transplants
Mortality
Therapeutics

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Feasibility of endovascular repair of ascending aortic pathologies as part of an FDA-approved physician-sponsored investigational device exemption. / Khoynezhad, Ali; Donayre, Carlos E.; Walot, Irwin; Koopman, Matthew; Kopchok, George E.; White, Rodney A.

In: Journal of vascular surgery, Vol. 63, No. 6, 01.06.2016, p. 1483-1495.

Research output: Contribution to journalArticle

Khoynezhad, Ali ; Donayre, Carlos E. ; Walot, Irwin ; Koopman, Matthew ; Kopchok, George E. ; White, Rodney A. / Feasibility of endovascular repair of ascending aortic pathologies as part of an FDA-approved physician-sponsored investigational device exemption. In: Journal of vascular surgery. 2016 ; Vol. 63, No. 6. pp. 1483-1495.
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