Robert J Lederman1, Vasilis C Babaliaros2, Toby Rogers3, Annette M Stine4, Marcus Y Chen4, Kamran I Muhammad5, Robert A Leonardi6, Gaetano Paone7, Jaffar M Khan4, Bradley G Leshnower2, Vinod H Thourani8, Xin Tian9, Adam B Greenbaum10. 1. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood institute, National Institutes of Health, Bethesda, Maryland. Electronic address: lederman@nih.gov. 2. Emory University Structural Heart and Valve Center, Atlanta, Georgia. 3. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood institute, National Institutes of Health, Bethesda, Maryland; Medstar Heart and Valve Institute, Medstar Washington Hospital Center, Washington, DC. 4. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood institute, National Institutes of Health, Bethesda, Maryland. 5. Oklahoma Heart Institute, Tulsa, Oklahoma. 6. Lexington Medical Center, West Columbia, South Carolina. 7. Henry Ford Hospital, Center for Structural Heart Disease, Detroit, Michigan. 8. Emory University Structural Heart and Valve Center, Atlanta, Georgia; Medstar Heart and Valve Institute, Medstar Washington Hospital Center, Washington, DC. 9. Office of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health (NIH), Bethesda, Maryland. 10. Emory University Structural Heart and Valve Center, Atlanta, Georgia; Henry Ford Hospital, Center for Structural Heart Disease, Detroit, Michigan.
Abstract
OBJECTIVES: The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label. BACKGROUND: Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known. METHODS: The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT). RESULTS: 100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury. CONCLUSIONS: Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824). Published by Elsevier Inc.
OBJECTIVES: The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label. BACKGROUND: Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known. METHODS: The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT). RESULTS: 100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury. CONCLUSIONS: Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824). Published by Elsevier Inc.
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