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Table 3 Hemodynamic performance of the study device in patients with mitral valve replacement

From: Clinical outcomes and hemodynamic performance of Dafodil™ aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial

ParameterValve size (N)Pre-procedureDischarge1-Month6-Month12-Month
Mean Pressure Gradient (mmHg)25 (5)15.03 ± 4.117.64 ± 1.615.55 ± 2.167.29 ± 2.065.63 ± 1.99
27 (12)7.40 ± 3.024.08 ± 1.633.62 ± 0.934.56 ± 1.604.20 ± 1.88
29 (3)12.91 ± 7.204.3 ± 0.493.45 ± 0.213.15 ± 0.943.87 ± 1.76
31 (10)8.95 ± 3.804.08 ± 1.224.21 ± 1.224.24 ± 1.194.06 ± 1.14
Overall (30)9.69 ± 4.714.63 ± 1.854.05 ± 1.274.74 ± 1.884.41 ± 1.69
Peak Pressure Gradient (mmHg)25 (5)26.15 ± 8.8015.80 ± 3.9312.1 ± 4.0716.83 ± 6.0212.31 ± 5.18
27 (12)15.48 ± 5.189.43 ± 3.468.71 ± 3.0011.41 ± 1.739.22 ± 2.35
29 (3)24.84 ± 7.0010.00 ± 1.568.15 ± 1.036.81 ± 2.247.67 ± 2.19
31 (10)16.99 ± 3.919.21 ± 3.578.44 ± 3.248.85 ± 2.228.89 ± 3.77
Overall (30)18.67 ± 6.8610.37 ± 3.988.95 ± 3.1210.86 ± 4.269.56 ± 3.66
Effective Orifice Area (cm2)25 (5)0.98 ± 0.132.50 ± 0.482.52 ± 0.722.45 ± 0.542.37 ± 0.44
27 (12)1.20 ± 0.613.10 ± 0.642.61 ± 0.352.67 ± 0.512.68 ± 0.55
29 (3)1.93 ± 0.243.85 ± 1.383.46 ± 1.062.84 ± 0.532.86 ± 0.43
31 (10)1.50 ± 1.132.67 ± 0.702.57 ± 0.402.49 ± 0.272.78 ± 0.42
Overall (30)1.34 ± 0.772.95 ± 0.802.69 ± 0.572.60 ± 0.432.67 ± 0.48
Effective Orifice Area Index (cm2/m2)25 (5)0.58 ± 0.031.50 ± 0.201.43 ± 0.391.38 ± 0.261.38 ± 0.24
27 (12)0.83 ± 0.332.14 ± 0.551.85 ± 0.261.82 ± 0.401.86 ± 0.52
29 (3)1.30 ± 0.172.52 ± 0.592.29 ± 0.481.94 ± 0.571.88 ± 0.47
31 (10)0.88 ± 0.601.75 ± 0.631.67 ± 0.421.58 ± 0.261.79 ± 0.36
Overall (30)0.86 ± 0.431.96 ± 0.601.79 ± 0.411.69 ± 0.381.75 ± 0.44
PPM, n/N (%)None (EOAi > 1.2 cm2/m2)28/29 (96.55%)26/27 (96.29%)24/26 (92.31%)24/26 (92.31%)
Moderate (EOAi > 0.9 and ≤ 1.2 cm2/m2)0/29 (0%)1/27 (3.70%)2/26 (7.69%)2/26 (7.69%)
Severe (EOAi ≤0.9 cm2/m2)1/29 (3.44%)0/27 (0%)0/26 (0%)0/26 (0%)
Total (EOAi < 1.2 cm2/m2) 1/29 (3.44%)1/27 (3.70%)2/26 (7.69%)2/26 (7.69%)
  1. PPM Prosthesis–patient mismatch