Author + information
- Received March 28, 2019
- Revision received May 6, 2019
- Accepted May 31, 2019
- Published online November 4, 2019.
- Toby Rogers, MD, PhDa,b,
- Adam B. Greenbaum, MDc,d@AdamGreenbaumMD,
- Vasilis C. Babaliaros, MDb,
- Annette M. Stine, RNa,
- Jaffar M. Khan, MDa,b,
- William H. Schenke, BSa,
- Marvin H. Eng, MDd,
- Gaetano Paone, MDd,
- Bradley G. Leshnower, MDc,
- Lowell F. Satler, MDb,
- Ron Waksman, MDb,
- Marcus Y. Chen, MDa and
- Robert J. Lederman, MDa,∗ (, )@CathElectroSur
- aCardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
- bMedstar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
- cStructural Heart and Valve Center, Emory University Hospital, Atlanta, Georgia
- dCenter for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan
- ↵∗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, 9000 Rockville Pike, Bethesda, Maryland 20892-1538.
Objectives This study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD).
Background Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study.
Methods Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration–approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up.
Results Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD.
Conclusions The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494).
- early feasibility study
- transcatheter aortic valve replacement
- transcaval access and closure
The study was sponsored by the senior author on behalf of the National Heart, Lung, and Blood Institute. This work was funded by the Division of Intramural Research, National Heart, Lung, and Blood Institute (Z01-HL006040 to Dr. Lederman) and by a Small Business Innovation Research contract (268201600042C-0-0-1) and Small Business Innovation Research grant (2R44 HL137001) to Transmural Systems. Transmural Systems provided direct financial support to the 3 enrolling sites for the costs of clinical research. Drs. Rogers, Khan, and Lederman are co-inventors on patents, assigned to National Institutes of Health, on devices to close transcaval access ports. Dr. Rogers has served as a proctor for Edwards Lifesciences and Medtronic; and is a consultant for Medtronic. Dr. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and owns equity interest in Transmural Systems. Dr. Babaliaros has served as a consultant for Edwards Lifesciences and Abbott Vascular; his employer has research contracts for clinical investigation of transcatheter aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific; and owns an equity interest in Transmural Systems. Dr. Eng has served as a proctor for Edwards Lifesciences. Dr. Paone has served as a proctor for Edwards Lifesciences. Dr. Leshnower has served on the Speakers Bureau for Medtronic. Dr. Waksman has served on the advisory board for Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips Volcano, and Pi-Cardia; is a consultant for Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips Volcano, and Pi-Cardia; has received grant support from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, and Chiesi; has served on the Speakers Bureau for AstraZeneca and Chiesi; and is an investor in MedAlliance. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 28, 2019.
- Revision received May 6, 2019.
- Accepted May 31, 2019.
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