PMID- 32234463 OWN - NLM STAT- MEDLINE DCOM- 20201231 LR - 20210128 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 75 IP - 19 DP - 2020 May 19 TI - Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study. PG - 2430-2442 LID - S0735-1097(20)34583-6 [pii] LID - 10.1016/j.jacc.2020.03.022 [doi] AB - 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). CI - Copyright (c) 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Blanke, Philipp AU - Blanke P AD - Center for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: phil.blanke@gmail.com. FAU - Leipsic, Jonathon A AU - Leipsic JA AD - Center for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. FAU - Popma, Jeffrey J AU - Popma JJ AD - Department of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. FAU - Yakubov, Steven J AU - Yakubov SJ AD - Department of Interventional Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, Ohio. FAU - Deeb, G Michael AU - Deeb GM AD - Department of Cardiac Surgery, University of Michigan Health System-University Hospital, Ann Arbor, Michigan. FAU - Gada, Hemal AU - Gada H AD - Departments of Thoracic Surgery and Interventional Cardiology, UPMC Pinnacle, Harrisburg, Pennsylvania. FAU - Mumtaz, Mubashir AU - Mumtaz M AD - Departments of Thoracic Surgery and Interventional Cardiology, UPMC Pinnacle, Harrisburg, Pennsylvania. FAU - Ramlawi, Basel AU - Ramlawi B AD - Department of Cardiothoracic Surgery, Winchester Medical Center, Winchester, Virginia. FAU - Kleiman, Neal S AU - Kleiman NS AD - Department of Cardiology, Methodist DeBakey Heart and Vascular Center, Houston, Texas. FAU - Sorajja, Paul AU - Sorajja P AD - Departments of Thoracic Surgery and Interventional Cardiology, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota. FAU - Askew, Judah AU - Askew J AD - Departments of Thoracic Surgery and Interventional Cardiology, Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota. FAU - Meduri, Christopher U AU - Meduri CU AD - Departments of Cardiac Surgery and Interventional Cardiology, Piedmont Atlanta Hospital, Atlanta, Georgia. FAU - Kauten, James AU - Kauten J AD - Departments of Cardiac Surgery and Interventional Cardiology, Piedmont Atlanta Hospital, Atlanta, Georgia. FAU - Melnitchouk, Serguei AU - Melnitchouk S AD - Departments of Cardiac Surgery and Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts. FAU - Inglessis, Ignacio AU - Inglessis I AD - Departments of Cardiac Surgery and Interventional Cardiology, Massachusetts General Hospital, Boston, Massachusetts. FAU - Huang, Jian AU - Huang J AD - Department of Statistics, Medtronic, Minneapolis, Minnesota. FAU - Boulware, Michael AU - Boulware M AD - Department of Statistics, Medtronic, Minneapolis, Minnesota. FAU - Reardon, Michael J AU - Reardon MJ AD - Department of Cardiothoracic Surgery, Methodist DeBakey Heart and Vascular Center, Houston, Texas. CN - Evolut Low Risk LTI Substudy Investigators LA - eng SI - ClinicalTrials.gov/NCT02701283 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200328 PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 SB - IM CIN - J Am Coll Cardiol. 2020 May 19;75(19):2443-2445. PMID: 32408978 CIN - J Am Coll Cardiol. 2020 Oct 13;76(15):1810-1812. PMID: 32805348 CIN - J Am Coll Cardiol. 2020 Oct 13;76(15):1812. PMID: 33032743 MH - Aged MH - Aged, 80 and over MH - Aortic Valve/diagnostic imaging/surgery MH - Aortic Valve Stenosis/*diagnostic imaging/*surgery MH - Bioprosthesis/*trends MH - Echocardiography, Four-Dimensional/trends MH - Female MH - Heart Valve Prosthesis/*trends MH - Humans MH - Male MH - Prospective Studies MH - *Prosthesis Design MH - Risk Factors OTO - NOTNLM OT - aortic stenosis OT - aortic valve replacement OT - hypoattenuated leaflet thickening OT - leaflet thrombosis EDAT- 2020/04/03 06:00 MHDA- 2021/01/01 06:00 CRDT- 2020/04/03 06:00 PHST- 2020/02/18 00:00 [received] PHST- 2020/03/14 00:00 [revised] PHST- 2020/03/15 00:00 [accepted] PHST- 2020/04/03 06:00 [pubmed] PHST- 2021/01/01 06:00 [medline] PHST- 2020/04/03 06:00 [entrez] AID - S0735-1097(20)34583-6 [pii] AID - 10.1016/j.jacc.2020.03.022 [doi] PST - ppublish SO - J Am Coll Cardiol. 2020 May 19;75(19):2430-2442. doi: 10.1016/j.jacc.2020.03.022. Epub 2020 Mar 28.