Raj R Makkar1, Philipp Blanke2, Jonathon Leipsic2, Vinod Thourani3, Tarun Chakravarty4, David Brown5, Alfredo Trento4, Robert Guyton6, Vasilis Babaliaros6, Mathew Williams7, Hasan Jilaihawi7, Susheel Kodali8, Isaac George8, Michael Lu9, James M McCabe10, John Friedman4, Richard Smalling11, Shing Chiu Wong12, Shahram Yazdani13, Deepak L Bhatt14, Jeroen Bax15, Samir Kapadia16, Howard C Herrmann17, Michael Mack5, Martin B Leon8. 1. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: Raj.Makkar@cshs.org. 2. St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. 3. Piedmont Heart Institute, Atlanta, Georgia. 4. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. 5. Baylor Scott and White Healthcare, Plano, Texas. 6. Emory University, Atlanta, Georgia. 7. New York University Langone Medical Center, New York, New York. 8. Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York. 9. Department of Biostatistics, Edwards Lifesciences, Irvine, California. 10. University of Washington, Seattle, Washington. 11. The University of Texas Health Science Center at Houston, Houston, Texas. 12. Cornell University New York, New York, New York. 13. Inova Heart and Vascular Institute (Fairfax Inova), Falls Church, Virginia. 14. Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts. 15. Leiden University Medical Centre, Leiden, the Netherlands. 16. Cleveland Clinic, Cleveland, Ohio. 17. University of Pennsylvania, Philadelphia, Pennsylvania.
Abstract
BACKGROUND:Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. OBJECTIVES: The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. METHODS: The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergotranscatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. RESULTS: The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). CONCLUSIONS:Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.
RCT Entities:
BACKGROUND: Subclinical leaflet thrombosis, characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion observed on 4-dimensional computed tomography (CT), may represent a form of bioprosthetic valve dysfunction. OBJECTIVES: The U.S. Food and Drug Administration mandated CT studies to understand the natural history of this finding, differences between transcatheter and surgical valves, and its association with valve hemodynamics and clinical outcomes. METHODS: The PARTNER 3 (The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients With Aortic Stenosis) CT substudy randomized 435 patients with low-surgical-risk aortic stenosis to undergo transcatheter aortic valve replacement (n = 221) or surgery (n = 214). Serial 4-dimensional CTs were performed at 30 days and 1 year and were analyzed independently by a core laboratory. RESULTS: The incidence of HALT increased from 10% at 30 days to 24% at 1 year. Spontaneous resolution of 30-day HALT occurred in 54% of patients at 1 year, whereas new HALT appeared in 21% of patients at 1 year. HALT was more frequent in transcatheter versus surgical valves at 30 days (13% vs. 5%; p = 0.03), but not at 1 year (28% vs. 20%; p = 0.19). The presence of HALT did not significantly affect aortic valve mean gradients at 30 days or 1 year. Patients with HALT at both 30 days and 1 year, compared with those with no HALT at 30 days and 1 year, had significantly increased aortic valve gradients at 1 year (17.8 ± 2.2 mm Hg vs. 12.7. ± 0.3 mm Hg; p = 0.04). CONCLUSIONS: Subclinical leaflet thrombosis was more frequent in transcatheter compared with surgical valves at 30 days, but not at 1 year. The impact of HALT on thromboembolic complications and structural valve degeneration needs further assessment.
Authors: Denise Traxler; Pavla Krotka; Maria Laggner; Michael Mildner; Alexandra Graf; Berthold Reichardt; Ralph Wendt; Johann Auer; Bernhard Moser; Julia Mascherbauer; Hendrik Jan Ankersmit Journal: Eur J Clin Invest Date: 2021-12-30 Impact factor: 5.722
Authors: Jonathan R Weir-McCall; Kelley Branch; Maros Ferencik; Ron Blankstein; Andrew D Choi; Brian B Ghoshhajra; Kavitha Chinnaiyan; Purvi Parwani; Edward Nicol; Koen Nieman Journal: J Cardiovasc Comput Tomogr Date: 2020-10-01