Key result
Heavy native aortic valve calcification significantly increased the risk of mild aortic regurgitation after TAVI with the direct flow medical prosthesis (OR 7; 95% CI 1.2-37.6; P=0.02).
Why the study?
Does the degree of native aortic valve calcification impact hemodynamics, aortic regurgitation, and survival in patients undergoing TAVI with the direct flow medical prosthesis?
Cohort (n=118)
No
Does the degree of native aortic valve calcification impact hemodynamics, aortic regurgitation, and survival in patients undergoing TAVI with the direct flow medical prosthesis?
The Direct Flow Medical prosthesis provides adequate sizing and hemodynamics regardless of calcification degree, though heavy calcification increases the risk of mild, but not moderate/severe, aortic regurgitation.
Should not yet change prosthesis selection; hypothesis-generating for AR predictors in Direct Flow TAVI.
OBJECTIVES: We present our single center experience with the direct flow medical (DFM) prosthesis addressing the impact of native aortic valve (AV) calcification degree on outcomes. BACKGROUND: The DFM® has been introduced for transcatheter aortic valve implantation (TAVI). The valve has a nonmetallic and inflatable support structure. METHODS: Patients were divided in two groups according to preoperative cardiac computed tomography (CT): group I moderate calcification and group II heavy calcification of the total AV area. We evaluated 118 patients: 53 (45%) group I and 65 (55%) group II. RESULTS: Preoperative trans-AV gradient and calcification extension across the aortic unit were significantly higher in group II (P = 0.008 and P < 0.0001). CT perimeter derived annular diameter (group I 24.7 ± 2.1 mm vs. group II 24.8 ± 1.9; P = 0.6) and implanted prosthesis size (group I 26.1 ± 1.5 mm vs. group II 25.7 ± 1.5; P = 0.1) were similar. Hemodynamics were similar: mean gradient 16.1 ± 5.9 mm Hg (group I) vs. 17.3 ± 6.5 mm Hg (group II) (P = 0.3). Total aortic regurgitation (AR) was mild in 5.7% in group I and 20% in group II (P = 0.03). None developed moderate/severe AR. Heavy AV calcification was the sole independent determinant for mild regurgitation (P = 0.02; OR = 7; 95% CI: 1.2-37.6). Follow-up (289 days; 40-760 days) estimated survival was 88.1% (group I) and 93.8% (group II) (P = 0.3). CONCLUSIONS: Independent of AV calcification degree, adequate sizing and implantation can be achieved with the DFM®. Although higher burden of calcification increases the rate of mild AR, no patient developed moderate and severe AR. Short-term estimated survival was not influenced by calcification degree.
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D’Ancona et al. (2016) conducted a cohort in Aortic valve disease undergoing TAVI (n=118). Heavy native aortic valve calcification vs. Moderate native aortic valve calcification was evaluated on Mild aortic regurgitation (OR 7, 95% CI 1.2-37.6, p=0.02). Heavy native aortic valve calcification significantly increased the risk of mild aortic regurgitation after TAVI with the direct flow medical prosthesis (OR 7; 95% CI 1.2-37.6; P=0.02).
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