Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy
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. The U.S. Food and Drug Administration mandated CT studies to understand th...
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| Veröffentlicht in: | Journal of the American College of Cardiology Jg. 75; H. 24; S. 3003 |
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23.06.2020
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| Abstract | 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.
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.
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.
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).
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. |
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| AbstractList | 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.
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.
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.
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).
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. 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.BACKGROUNDSubclinical 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.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.OBJECTIVESThe 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.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.METHODSThe 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.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).RESULTSThe 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).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.CONCLUSIONSSubclinical 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. |
| Author | Makkar, Raj R McCabe, James M Bax, Jeroen Babaliaros, Vasilis Thourani, Vinod Kapadia, Samir Chakravarty, Tarun Mack, Michael Williams, Mathew Lu, Michael Bhatt, Deepak L Jilaihawi, Hasan Kodali, Susheel Leipsic, Jonathon Brown, David Wong, Shing Chiu Guyton, Robert Blanke, Philipp George, Isaac Smalling, Richard Herrmann, Howard C Leon, Martin B Trento, Alfredo Friedman, John Yazdani, Shahram |
| Author_xml | – sequence: 1 givenname: Raj R surname: Makkar fullname: Makkar, Raj R email: Raj.Makkar@cshs.org organization: Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: Raj.Makkar@cshs.org – sequence: 2 givenname: Philipp surname: Blanke fullname: Blanke, Philipp organization: St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada – sequence: 3 givenname: Jonathon surname: Leipsic fullname: Leipsic, Jonathon organization: St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada – sequence: 4 givenname: Vinod surname: Thourani fullname: Thourani, Vinod organization: Piedmont Heart Institute, Atlanta, Georgia – sequence: 5 givenname: Tarun surname: Chakravarty fullname: Chakravarty, Tarun organization: Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California – sequence: 6 givenname: David surname: Brown fullname: Brown, David organization: Baylor Scott and White Healthcare, Plano, Texas – sequence: 7 givenname: Alfredo surname: Trento fullname: Trento, Alfredo organization: Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California – sequence: 8 givenname: Robert surname: Guyton fullname: Guyton, Robert organization: Emory University, Atlanta, Georgia – sequence: 9 givenname: Vasilis surname: Babaliaros fullname: Babaliaros, Vasilis organization: Emory University, Atlanta, Georgia – sequence: 10 givenname: Mathew surname: Williams fullname: Williams, Mathew organization: New York University Langone Medical Center, New York, New York – sequence: 11 givenname: Hasan surname: Jilaihawi fullname: Jilaihawi, Hasan organization: New York University Langone Medical Center, New York, New York – sequence: 12 givenname: Susheel surname: Kodali fullname: Kodali, Susheel organization: Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York – sequence: 13 givenname: Isaac surname: George fullname: George, Isaac organization: Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York – sequence: 14 givenname: Michael surname: Lu fullname: Lu, Michael organization: Department of Biostatistics, Edwards Lifesciences, Irvine, California – sequence: 15 givenname: James M surname: McCabe fullname: McCabe, James M organization: University of Washington, Seattle, Washington – sequence: 16 givenname: John surname: Friedman fullname: Friedman, John organization: Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California – sequence: 17 givenname: Richard surname: Smalling fullname: Smalling, Richard organization: The University of Texas Health Science Center at Houston, Houston, Texas – sequence: 18 givenname: Shing Chiu surname: Wong fullname: Wong, Shing Chiu organization: Cornell University New York, New York, New York – sequence: 19 givenname: Shahram surname: Yazdani fullname: Yazdani, Shahram organization: Inova Heart and Vascular Institute (Fairfax Inova), Falls Church, Virginia – sequence: 20 givenname: Deepak L surname: Bhatt fullname: Bhatt, Deepak L organization: Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts – sequence: 21 givenname: Jeroen surname: Bax fullname: Bax, Jeroen organization: Leiden University Medical Centre, Leiden, the Netherlands – sequence: 22 givenname: Samir surname: Kapadia fullname: Kapadia, Samir organization: Cleveland Clinic, Cleveland, Ohio – sequence: 23 givenname: Howard C surname: Herrmann fullname: Herrmann, Howard C organization: University of Pennsylvania, Philadelphia, Pennsylvania – sequence: 24 givenname: Michael surname: Mack fullname: Mack, Michael organization: Baylor Scott and White Healthcare, Plano, Texas – sequence: 25 givenname: Martin B surname: Leon fullname: Leon, Martin B organization: Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York |
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| Keywords | hypoattenuated leaflet thickening subclinical leaflet thrombosis reduced leaflet motion leaflet thrombosis |
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| SubjectTerms | Aged Aortic Valve Stenosis - surgery Bioprosthesis - adverse effects Canada - epidemiology Female Four-Dimensional Computed Tomography Heart Valve Prosthesis - adverse effects Humans Male Postoperative Complications - diagnostic imaging Postoperative Complications - epidemiology Postoperative Complications - etiology Thrombosis - diagnostic imaging Thrombosis - epidemiology Thrombosis - etiology Transcatheter Aortic Valve Replacement - adverse effects Transcatheter Aortic Valve Replacement - mortality United States - epidemiology |
| Title | Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy |
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