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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

Parameter

Valve size (N)

Pre-procedure

Discharge

1-Month

6-Month

12-Month

Mean Pressure Gradient (mmHg)

19 (11)

59.94 ± 24.05

16.02 ± 6.47

14.07 ± 3.87

14.70 ± 3.18

16.50 ± 7.52

21 (13)

58.24 ± 18.63

14.51 ± 5.45

12.14 ± 3.02

13.73 ± 4.28

14.66 ± 5.80

23 (3)

22.49 ± 14.42

10.13 ± 1.23

9.39 ± 0.61

7.42 ± 2.48

7.49 ± 2.25

25 (3)

24.23 ± 24.04

9.70 ± 2.30

8.99 ± 2.12

11.41 ± 3.44

13.47 ± 5.57

Overall (30)

52.71 ± 24.47

13.99 ± 5.60

12.13 ± 3.49

13.17 ± 4.15

14.49 ± 6.58

Peak Pressure Gradient (mmHg)

19 (11)

92.04 ± 33.42

27.19 ± 9.83

24.55 ± 6.12

26.04 ± 5.14

27.71 ± 11.10

21 (13)

91.49 ± 24.86

24.72 ± 8.06

22.35 ± 5.16

24.05 ± 6.17

24.55 ± 8.94

23 (3)

39.35 ± 29.20

17.80 ± 1.91

16.66 ± 1.18

14.13 ± 5.13

13.21 ± 2.8

25 (3)

38.48 ± 36.22

15.54 ± 3.19

15.60 ± 3.46

20.35 ± 8.31

24.07 ± 14.25

Overall (30)

82.30 ± 34.93

23.75 ± 8.64

22.03 ± 6.02

23.33 ± 6.67

23.25 ± 10.80

Effective Orifice Area (cm2)

19 (11)

0.72 ± 0.21

1.59 ± 0.67

1.48 ± 0.31

1.73 ± 0.22

1.78 ± 0.28

21 (13)

0.68 ± 0.10

1.47 ± 0.55

1.49 ± 0.20

1.75 ± 0.30

1.83 ± 0.23

23 (3)

1.32 ± NA

1.38 ± 0.11

1.88 ± 0.40

2.08 ± 0.03

2.32 ± 0.13

25 (3)

2.48 ± 1.97

1.60 ± 0.24

1.92 ± NA

1.83 ± 0.14

1.84 ± 0.11

 

Overall (30)

0.89 ± 0.70

1.53 ± 0.54

1.56 ± 0.30

1.79 ± 0.25

1.85 ± 0.27

Effective Orifice Area Index (cm2/m2)

19 (11)

0.46 ± 0.14

0.98 ± 0.47

0.96 ± 0.20

1.10 ± 0.14

1.16 ± 0.22

21 (13)

0.40 ± 0.09

0.89 ± 0.37

0.93 ± 0.14

1.05 ± 0.27

1.08 ± 0.22

23 (3)

0.85 ± NA

0.81 ± 0.18

1.20 ± 0.24

1.25 ± 0.12

1.48 ± 0.06

25 (3)

1.41 ± 1.08

0.93 ± 0.18

1.15 ± NA

1.06 ± 0.11

1.07 ± 0.10

Overall (30)

0.54 ± 0.39

0.93 ± 0.38

0.99 ± 0.19

1.09 ± 0.20

1.14 ± 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]
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Journal of Cardiothoracic Surgery

ISSN: 1749-8090

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