Author + information
- Received February 18, 2020
- Revision received March 14, 2020
- Accepted March 15, 2020
- Published online March 28, 2020.
- Philipp Blanke, MDa,# (, )
- Jonathon A. Leipsic, MDa,
- Jeffrey J. Popma, MDb,
- Steven J. Yakubov, MDc,
- G. Michael Deeb, MDd,
- Hemal Gada, MDe,
- Mubashir Mumtaz, MDe,
- Basel Ramlawi, MDf,
- Neal S. Kleiman, MDg,
- Paul Sorajja, MDh,
- Judah Askew, MDh,
- Christopher U. Meduri, MD, MPHi,
- James Kauten, MDi,
- Serguei Melnitchouk, MDj,
- Ignacio Inglessis, MDj,
- Jian Huang, MD, MSk,
- Michael Boulware, PhDk,
- Michael J. Reardon, MDl,
- for the Evolut Low Risk LTI Sub-study Investigators∗
- aCenter for Heart Lung Innovation, St. Paul’s Hospital, University of British Columbia, Vancouver, BC
- bDepartment of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, MA
- cDepartment of Interventional Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, OH
- dDepartment of Cardiac Surgery, University of Michigan Health System – University Hospital, Ann Arbor, MI
- eDepartments of Thoracic Surgery and Interventional Cardiology, UPMC Pinnacle, Harrisburg, PA
- fDepartment of Cardiothoracic Surgery, Winchester Medical Center, Winchester, VA
- gDepartment of Cardiology, Methodist DeBakey Heart and Vascular Center, Houston, TX
- hDepartments of Thoracic Surgery and Interventional Cardiology, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN
- iDepartments of Cardiac Surgery and Interventional Cardiology, Piedmont Atlanta Hospital, Atlanta, GA
- jDepartments of Cardiac Surgery and Interventional Cardiology, Massachusetts General Hospital, Boston, MA
- kDepartment of Statistics, Medtronic, Minneapolis, MN
- lDepartment of Cardiothoracic Surgery, Methodist DeBakey Heart and Vascular Center, Houston, TX
- ↵#Corresponding Author: Philipp Blanke, MD Director, Cardiac CT Core Laboratory St. Paul’s Hospital 1081 Burrard St. Vancouver, BC V6Z1Y6 Tel: 604-682-2344 ext. 62089 Twitter handle: @BlankePhilipp
Background Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic (CT) imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear.
Objective This study sought to determine the frequency, predictors and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement.
Methods A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent CT imaging 30 days and 1 year after TAVR or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year.
Results At 30 days, the frequency of HALT was 31/179 (17.3%) for TAVR and 23/139 (16.5%) for surgery; the frequency of RLM was 23/157 (14.6%) for TAVR and 19/133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47/152 (30.9%) for TAVR and 33/116 (28.4%) for surgery; the frequency of RLM was 45/145 (31.0%) in TAVR and 30/111 (27.0%) for surgery. Aortic valve hemodynamics were not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after implantation of supraannular, self-expanding transcatheter or surgical bioprostheses.
Conclusions We found that the presence of CT imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but that these findings did not correlated with aortic valve hemodynamics after aortic valve replacement in patients at low risk for surgery.
↵∗ A complete list of investigators participating in the Evolut Low Risk LTI Substudy is provided in the online Supplement
Funding: Medtronic, plc
Relationships with Industry: Dr. Blanke and Dr. Leipsic provide CT core laboratory (University of British Columbia) for Edwards LifeSciences, Abbott and Medtronic with no personal compensation. Dr. Blanke is a consultant to Edwards Lifesciences, Abbott, Gore, Circle Cardiovascular Imaging, and Neovasc. Dr. Leipsic is consultant with stock options for Circle Cardiovascular Imaging. Dr. Popma has received institutional research grants from Abbott Vascular, Medtronic, Boston Scientific and Edwards Lifesciences and has served on a Medical Advisory Board for Boston Scientific, and Edwards Lifesciences. Dr. Yakubov receives institutional research grants from Boston Scientific, and Medtronic. Dr. Deeb serves on an advisory board and as a proctor for Medtronic; as a consultant and research investigator for Edwards Lifesciences; as a consultant and proctor for Terumo; and as a research investigator for Gore Medical with all fees paid to his institution. Dr. Gada receives personal fees from Medtronic, Abbott Vascular, Boston Scientific and Bard, Inc. Dr. Mumtaz reports receiving consulting fees from Medtronic, Abbott, the Japanese Organization for Medical Device Development and Terumo; grants and consulting fees from Edwards Lifesciences, and serving on the cardiac events committee for Millipede. Dr. Ramlawi reports grants, personal fees and non-financial support from Medtronic, Liva Nova and AtriCure. Dr. Kleiman provides educational services to Medtronic. Dr. Meduri serves as the National PI for the REPRISE IV trial sponsored by Boston Scientific; serves on an advisory board and the APOLLO Trial Executive Committee for Medtronic and as a consultant, and on the advisory board for Admedus, 4Tech, and Cardiovalve. Dr. Sorajja reports receiving grants and consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences and Medtronic; consulting fees from Admedus, Gore and Integer, Abbott Structural, Medtronic, Boston Scientific, Edwards, Admedus, Gore, Cardionomics and Creganna Medical. Dr Huang and Dr Boulware are employees and shareholders of Medtronic, plc. Dr. Reardon receives fees from Medtronic for providing educational services. All other authors have nothing to disclose.
- Received February 18, 2020.
- Revision received March 14, 2020.
- Accepted March 15, 2020.
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