Author + information
- Received November 27, 2013
- Revision received March 26, 2014
- Accepted April 3, 2014
- Published online July 1, 2014.
- Adam B. Greenbaum, MD∗∗ (, )
- William W. O'Neill, MD∗,
- Gaetano Paone, MD†,
- Mayra E. Guerrero, MD∗,
- Janet F. Wyman, DNP∗,
- R. Lebron Cooper, MD‡ and
- Robert J. Lederman, MD§
- ∗Institute for Structural Heart Disease, Division of Cardiology, Henry Ford Health System, Detroit, Michigan
- †Division of Cardiac Surgery, Henry Ford Health System, Detroit, Michigan
- ‡Department of Anesthesiology, Henry Ford Health System, Detroit, Michigan
- §Cardiovascular and Pulmonary Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, Bethesda, Maryland
- ↵∗Reprint requests and correspondence:
Dr. Adam B. Greenbaum, K-2 Cardiac Catheterization Laboratory, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, Michigan 48202.
Objectives This study describes the first use of caval-aortic access and closure to enable transcatheter aortic valve replacement (TAVR) in patients who lacked other access options. Caval-aortic access refers to percutaneous entry into the abdominal aorta from the femoral vein through the adjoining inferior vena cava.
Background TAVR is attractive in high-risk or inoperable patients with severe aortic stenosis. Available transcatheter valves require large introducer sheaths, which are a risk for major vascular complications or preclude TAVR altogether. Caval-aortic access has been successful in animals.
Methods We performed a single-center retrospective review of procedural and 30-day outcomes of prohibitive-risk patients who underwent TAVR via caval-aortic access.
Results Between July 2013 and January 2014, 19 patients underwent TAVR via caval-aortic access; 79% were women. Caval-aortic access and tract closure were successful in all 19 patients; TAVR was successful in 17 patients. Six patients experienced modified VARC-2 major vascular complications, 2 (11%) of whom required intervention. Most (79%) required blood transfusion. There were no deaths attributable to caval-aortic access. Throughout the 111 (range 39 to 229) days of follow up, there were no post-discharge complications related to tract creation or closure. All patients had persistent aorto-caval flow immediately post-procedure. Of the 16 patients who underwent repeat imaging after the first week, 15 (94%) had complete closure of the residual aorto-caval tract.
Conclusions Percutaneous transcaval venous access to the aorta allows TAVR in otherwise ineligible patients, and may offer a new access strategy for other applications requiring large transcatheter implants.
Drs. Greenbaum, O'Neil, Paone, Guerrero, Wyman, and Cooper were supported by the Institute for Structural Heart Disease, Division of Cardiology, Henry Ford Health System. Dr. Lederman was supported by the Division of Intramural Research (Z01-HL006040), National Heart, Lung, and Blood Institutehttp://dx.doi.org/10.13039/100000050, National Institutes of Healthhttp://dx.doi.org/10.13039/100000002. Drs. Greenbaum and Lederman are inventors on patent applications for devices for caval-aortic access; these patent applications have been assigned to their employers, Henry Ford Hospital and the National Institutes of Health, respectively. Drs. Greenbaum and O'Neil were funded intramurally by the Center for Structural Heart Disease, Henry Ford Hospital, Detroit, Michigan. Dr. Lederman was funded by the Division of Intramural Research, National Heart, Lung, and Blood Institutehttp://dx.doi.org/10.13039/100000050, National Institutes of Healthhttp://dx.doi.org/10.13039/100000002, Bethesda, Maryland. Dr. Greenbaum has been a proctor for SentreHeart. Dr. O'Neill has been a consultant for Medtronic and Edwards Lifesciences; he owns equity in Syntheon Cardiology and Aegis Cardiology; and he is also the owner of Accumed Systems. Dr. Cooper has received a grant from PharMEDium LLC; is a co-owner, co-founder, board member, and stockholder of Board Stiff Inc., and has received profits from Board Stiff Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received November 27, 2013.
- Revision received March 26, 2014.
- Accepted April 3, 2014.
- American College of Cardiology Foundation