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.