Author + information
- Received October 23, 2018
- Revision received November 20, 2018
- Accepted November 26, 2018
- Published online March 4, 2019.
- Robert J. Lederman, MDa,∗ (, )
- Vasilis C. Babaliaros, MDb,
- Toby Rogers, PhD, BM, BCha,c,
- Annette M. Stine, RNa,
- Marcus Y. Chen, MDa,
- Kamran I. Muhammad, MDd,
- Robert A. Leonardi, MDe,
- Gaetano Paone, MDf,
- Jaffar M. Khan, BM, BCha,
- Bradley G. Leshnower, MDb,
- Vinod H. Thourani, MDb,c,
- Xin Tian, PhDg and
- Adam B. Greenbaum, MDb,f
- aCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood institute, National Institutes of Health, Bethesda, Maryland
- bEmory University Structural Heart and Valve Center, Atlanta, Georgia
- cMedstar Heart and Valve Institute, Medstar Washington Hospital Center, Washington, DC
- dOklahoma Heart Institute, Tulsa, Oklahoma
- eLexington Medical Center, West Columbia, South Carolina
- fHenry Ford Hospital, Center for Structural Heart Disease, Detroit, Michigan
- gOffice of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health (NIH), Bethesda, Maryland
- ↵∗Address for correspondence:
Dr. Robert J. Lederman, Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Building 10, Room 2c713, MSC 1538, Bethesda, Maryland 20892-1538.
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)
- aortocaval fistula
- caval-aortic access
- nonfemoral access
- structural heart disease
- transcatheter electrosurgery
This study was supported by the National Heart, Lung, and Blood Institute Division of Intramural Research grant Z01-HL006040 (to Dr. Lederman). Dr. Lederman is a coinventor on and may receive royalties from patents assigned to the NIH for devices not tested in this protocol. Dr. Babaliaros has been a consultant for Edwards Lifesciences and Abbott Vascular; and has received institutional research support from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr. Rogers is a coinventor on patents assigned to NIH for devices not tested in this protocol; has been a consultant for Medtronic; and has been a proctor for Edwards Lifesciences and Medtronic. Dr. Muhammad has been a proctor for Edwards Lifesciences and Medtronic. Dr. Leonardi has been a consultant for Abbott Vascular and St. Jude Medical; and a proctor and paid speaker for Edwards Lifesciences. Dr. Paone has been a consultant and proctor for Edwards Lifesciences. Dr. Leshnower has served on the Speakers Bureau for Medtronic. Dr. Thourani has been a consultant for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Gore Medical. Dr. Greenbaum has been a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; holds equity in and has been a scientific advisor for Transmural Systems; and has received institutional research support from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 23, 2018.
- Revision received November 20, 2018.
- Accepted November 26, 2018.
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