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Published on: June 3, 2018
Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed
Raj R Makkar1, Philipp Blanke2, Jonathon Leipsic2
1Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
Insights
Subclinical leaflet thrombosis (HALT) was more common in transcatheter aortic valves initially but not at one year. Persistent HALT may increase transcatheter aortic valve gradients over time.
Area of Science:
- Cardiology
- Radiology
- Biomedical Engineering
Background:
- Subclinical leaflet thrombosis, identified as hypoattenuated leaflet thickening (HALT) and reduced leaflet motion on 4D CT, is a potential form of bioprosthetic valve dysfunction.
- The FDA mandated CT imaging to investigate HALT's natural history, differences between transcatheter aortic valve replacement (TAVR) and surgical valves, and its clinical implications.
Purpose of the Study:
- To assess the incidence and natural history of HALT in patients undergoing TAVR versus surgical aortic valve replacement (SAVR).
- To evaluate the association between HALT and valve hemodynamics and clinical outcomes.
Main Methods:
- The PARTNER 3 CT substudy randomized 435 low-risk patients with aortic stenosis to TAVR or SAVR.
- Serial 4D CT scans were performed at 30 days and 1 year post-procedure and analyzed by a core laboratory.
Main Results:
- HALT incidence increased from 10% at 30 days to 24% at 1 year. Spontaneous HALT resolution occurred in 54% of cases, while new HALT emerged in 21% at 1 year.
- HALT was more frequent in TAVR vs. SAVR at 30 days (13% vs. 5%), but not at 1 year (28% vs. 20%).
- Persistent HALT at both 30 days and 1 year was associated with significantly increased aortic valve gradients at 1 year.
Conclusions:
- Subclinical leaflet thrombosis was more frequent in TAVR compared to SAVR at 30 days, but this difference diminished at 1 year.
- The long-term impact of HALT on thromboembolic events and structural valve degeneration requires further investigation.
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.
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