Author + information
- Received February 18, 2020
- Revision received March 14, 2020
- Accepted March 15, 2020
- Published online May 11, 2020.
- Philipp Blanke, MDa,∗ (, )@BlankePhilipp,
- 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 Substudy Investigators
- aCenter for Heart Valve Innovation, St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- bDepartment of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- cDepartment of Interventional Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, Ohio
- dDepartment of Cardiac Surgery, University of Michigan Health System–University Hospital, Ann Arbor, Michigan
- eDepartments of Thoracic Surgery and Interventional Cardiology, UPMC Pinnacle, Harrisburg, Pennsylvania
- fDepartment of Cardiothoracic Surgery, Winchester Medical Center, Winchester, Virginia
- gDepartment of Cardiology, Methodist DeBakey Heart and Vascular Center, Houston, Texas
- hDepartments of Thoracic Surgery and Interventional Cardiology, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota
- iDepartments of Cardiac Surgery and Interventional Cardiology, Piedmont Atlanta Hospital, Atlanta, Georgia
- jDepartments of Cardiac Surgery and Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts
- kDepartment of Statistics, Medtronic, Minneapolis, Minnesota
- lDepartment of Cardiothoracic Surgery, Methodist DeBakey Heart and Vascular Center, Houston, Texas
- ↵∗Address for correspondence:
Dr. Philipp Blanke, Cardiac CT Core Laboratory, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.
Background Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear.
Objectives The aim of this study was 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 computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (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 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses.
Conclusions The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283)
This work was funded by Medtronic. Drs. Blanke and Leipsic provide CT core laboratory services (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 a 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 Medical Advisory Boards for Boston Scientific and Edwards Lifesciences. Dr. Yakubov has received institutional research grants from Boston Scientific and Medtronic. Dr. Deeb serves on an Advisory Board and as a proctor for Medtronic; is a consultant and research investigator for Edwards Lifesciences; is a consultant and proctor for Terumo; and is a research investigator for Gore Medical, with all fees paid to his institution. Dr. Gada has received personal fees from Medtronic, Abbott Vascular, Boston Scientific, and Bard. Dr. Mumtaz has received consulting fees from Medtronic, Abbott, the Japanese Organization for Medical Device Development, and Terumo; has received grants and consulting fees from Edwards Lifesciences; and serves on the cardiac events committee for Millipede. Dr. Ramlawi has received grants, personal fees, and nonfinancial support from Medtronic, Liva Nova, and AtriCure. Dr. Kleiman provides educational services to Medtronic. Dr. Meduri serves as the national principal investigator for the REPRISE IV trial, sponsored by Boston Scientific; serves on an Advisory Board and the APOLLO Trial Executive Committee for Medtronic; and is a consultant and an Advisory Board member for Admedus, 4Tech, and Cardiovalve. Dr. Sorajja has received grants and consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting fees from Admedus, Gore, Integer, Abbott Structural, Medtronic, Boston Scientific, Edwards, Cardionomics, and Creganna Medical. Drs. Huang and Boulware are employees and shareholders of Medtronic. Dr. Reardon has received fees from Medtronic for providing educational services. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received February 18, 2020.
- Revision received March 14, 2020.
- Accepted March 15, 2020.
- 2020 American College of Cardiology Foundation
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