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Randomized Controlled Trial
. 2020 Jun 23;75(24):3003-3015.
doi: 10.1016/j.jacc.2020.04.043.

Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy

Raj R Makkar  1 , Philipp Blanke  2 , Jonathon Leipsic  2 , Vinod Thourani  3 , Tarun Chakravarty  4 , David Brown  5 , Alfredo Trento  4 , Robert Guyton  6 , Vasilis Babaliaros  6 , Mathew Williams  7 , Hasan Jilaihawi  7 , Susheel Kodali  8 , Isaac George  8 , Michael Lu  9 , James M McCabe  10 , John Friedman  4 , Richard Smalling  11 , Shing Chiu Wong  12 , Shahram Yazdani  13 , Deepak L Bhatt  14 , Jeroen Bax  15 , Samir Kapadia  16 , Howard C Herrmann  17 , Michael Mack  5 , Martin B Leon  8
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Free article
Randomized Controlled Trial

Subclinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Valves: PARTNER 3 Cardiac Computed Tomography Substudy

Raj R Makkar et al. J Am Coll Cardiol. .
Free article

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 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.

Keywords: hypoattenuated leaflet thickening; leaflet thrombosis; reduced leaflet motion; subclinical leaflet thrombosis.

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