Incidence, Predictors, and Mid-Term Outcomes of Possible Leaflet Thrombosis After TAVR

Abstract

Objectives: This study sought to clarify the incidence and predictors of hypoattenuated leaflet thickening (HALT) and mid-term outcomes after transcatheter aortic valve replacement.

Background: HALT detected on multidetector computed tomography (MDCT) scanning raised concerns about possible subclinical leaflet thrombosis.

Methods: We studied 70 of 100 consecutive patients from a single-center registry who underwent implantation with the Edwards SAPIEN-XT device. MDCT results, echocardiographic data, and laboratory findings obtained at the 6-month and 1-year follow-ups were analyzed.

Results: Of 70 patients, MDCT scans revealed HALT in 1 patient (1.4%) at discharge, 7 (10.0%) at 6 months, and 10 (14.3%) at 1 year post-transcatheter aortic valve replacement cumulatively. The degree of leaflet immobility correlated with the HALT area on 4-dimensional MDCT (r = 0.68) on the basis of data from 10 patients. HALT was associated with male sex (70% vs. 25%; p = 0.008) and larger sinus of Valsalva (31.0 ± 2.0 mm vs. 28.6 ± 2.6 mm; p = 0.005). HALT was found in 3 of 49 patients with a 23-mm bioprosthesis and in 7 of 21 patients with a 26-mm bioprosthesis (6.1% vs. 33.3%; p = 0.006). D-dimer levels were significantly increased in the HALT group at the 6-month (2.3 μg/ml [interquartile range (IQR): 2.1 to 6.1 μg/ml] vs. 1.1 μg/ml [IQR: 0.8 to 2.2 μg/ml]; p = 0.002) and 1-year (2.7 μg/ml [IQR: 1.7 to 4.8 μg/ml] vs. 1.2 μg/ml [IQR: 0.9 to 2.1 μg/ml]; p = 0.006) follow-ups, despite no differences at discharge. The pressure gradient was decreased in the HALT group at the 1-year follow-up (8.3 ± 0.8 mm Hg vs. 11.1 ± 4.9 mm Hg; p = 0.005). After detecting HALT, additional anticoagulation therapy was not administered. Clinical outcomes, including all-cause mortality (0% vs. 1.7%; p = 1.00) and stroke (0% vs. 0%; p = 1.00), were similar between the groups.

Conclusions: HALT with reduced leaflet motion was not rare but usually subclinical. Valve hemodynamics and mid-term outcomes were uneventful even without additional anticoagulant therapy in our limited number of cases. Male sex, larger sinus and bioprosthesis size, and elevated D-dimer levels during follow-up were associated with this phenomenon.

Keywords: D-dimer; TAVR; aortic stenosis; reduced leaflet motion; thrombosis.