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Table 2 Hemodynamic performance of the study device in patients with aortic 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)19 (11)59.94 ± 24.0516.02 ± 6.4714.07 ± 3.8714.70 ± 3.1816.50 ± 7.52
21 (13)58.24 ± 18.6314.51 ± 5.4512.14 ± 3.0213.73 ± 4.2814.66 ± 5.80
23 (3)22.49 ± 14.4210.13 ± 1.239.39 ± 0.617.42 ± 2.487.49 ± 2.25
25 (3)24.23 ± 24.049.70 ± 2.308.99 ± 2.1211.41 ± 3.4413.47 ± 5.57
Overall (30)52.71 ± 24.4713.99 ± 5.6012.13 ± 3.4913.17 ± 4.1514.49 ± 6.58
Peak Pressure Gradient (mmHg)19 (11)92.04 ± 33.4227.19 ± 9.8324.55 ± 6.1226.04 ± 5.1427.71 ± 11.10
21 (13)91.49 ± 24.8624.72 ± 8.0622.35 ± 5.1624.05 ± 6.1724.55 ± 8.94
23 (3)39.35 ± 29.2017.80 ± 1.9116.66 ± 1.1814.13 ± 5.1313.21 ± 2.8
25 (3)38.48 ± 36.2215.54 ± 3.1915.60 ± 3.4620.35 ± 8.3124.07 ± 14.25
Overall (30)82.30 ± 34.9323.75 ± 8.6422.03 ± 6.0223.33 ± 6.6723.25 ± 10.80
Effective Orifice Area (cm2)19 (11)0.72 ± 0.211.59 ± 0.671.48 ± 0.311.73 ± 0.221.78 ± 0.28
21 (13)0.68 ± 0.101.47 ± 0.551.49 ± 0.201.75 ± 0.301.83 ± 0.23
23 (3)1.32 ± NA1.38 ± 0.111.88 ± 0.402.08 ± 0.032.32 ± 0.13
25 (3)2.48 ± 1.971.60 ± 0.241.92 ± NA1.83 ± 0.141.84 ± 0.11
 Overall (30)0.89 ± 0.701.53 ± 0.541.56 ± 0.301.79 ± 0.251.85 ± 0.27
Effective Orifice Area Index (cm2/m2)19 (11)0.46 ± 0.140.98 ± 0.470.96 ± 0.201.10 ± 0.141.16 ± 0.22
21 (13)0.40 ± 0.090.89 ± 0.370.93 ± 0.141.05 ± 0.271.08 ± 0.22
23 (3)0.85 ± NA0.81 ± 0.181.20 ± 0.241.25 ± 0.121.48 ± 0.06
25 (3)1.41 ± 1.080.93 ± 0.181.15 ± NA1.06 ± 0.111.07 ± 0.10
Overall (30)0.54 ± 0.390.93 ± 0.380.99 ± 0.191.09 ± 0.201.14 ± 0.22
PPM, n/N (%)None (EOAi > 0.85 cm2/m2)20/30 (66.67%)28/30 (93.33%)25/30 (83.33%)27/30 (90%)
Moderate (EOAi > 0.65 to ≤0.85 cm2/m2)9/30 (30%)2/30 (6.67%)5/30 (16.67%)3/30 (10%)
Severe (EOAi ≤0.65 cm2/m2)1/30 (3.33%)0/30 (0%)0/30 (0%)0/30 (0%)
Total (EOAi < 0.85 cm2/m2)10/30 (33.33%)2/30 (6.67%)5/30 (16.67%)3/30 (10%)
  1. NA Not applicable, PPM Prosthesis–patient mismatch [Pre-operatively, all the patients had aortic regurgitation (alone or in combination with stenosis) in 23 mm and 25 mm groups]