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

Mean Pressure Gradient (mmHg)

25 (5)

15.03 ± 4.11

7.64 ± 1.61

5.55 ± 2.16

7.29 ± 2.06

5.63 ± 1.99

27 (12)

7.40 ± 3.02

4.08 ± 1.63

3.62 ± 0.93

4.56 ± 1.60

4.20 ± 1.88

29 (3)

12.91 ± 7.20

4.3 ± 0.49

3.45 ± 0.21

3.15 ± 0.94

3.87 ± 1.76

31 (10)

8.95 ± 3.80

4.08 ± 1.22

4.21 ± 1.22

4.24 ± 1.19

4.06 ± 1.14

Overall (30)

9.69 ± 4.71

4.63 ± 1.85

4.05 ± 1.27

4.74 ± 1.88

4.41 ± 1.69

Peak Pressure Gradient (mmHg)

25 (5)

26.15 ± 8.80

15.80 ± 3.93

12.1 ± 4.07

16.83 ± 6.02

12.31 ± 5.18

27 (12)

15.48 ± 5.18

9.43 ± 3.46

8.71 ± 3.00

11.41 ± 1.73

9.22 ± 2.35

29 (3)

24.84 ± 7.00

10.00 ± 1.56

8.15 ± 1.03

6.81 ± 2.24

7.67 ± 2.19

31 (10)

16.99 ± 3.91

9.21 ± 3.57

8.44 ± 3.24

8.85 ± 2.22

8.89 ± 3.77

Overall (30)

18.67 ± 6.86

10.37 ± 3.98

8.95 ± 3.12

10.86 ± 4.26

9.56 ± 3.66

Effective Orifice Area (cm²)

25 (5)

0.98 ± 0.13

2.50 ± 0.48

2.52 ± 0.72

2.45 ± 0.54

2.37 ± 0.44

27 (12)

1.20 ± 0.61

3.10 ± 0.64

2.61 ± 0.35

2.67 ± 0.51

2.68 ± 0.55

29 (3)

1.93 ± 0.24

3.85 ± 1.38

3.46 ± 1.06

2.84 ± 0.53

2.86 ± 0.43

31 (10)

1.50 ± 1.13

2.67 ± 0.70

2.57 ± 0.40

2.49 ± 0.27

2.78 ± 0.42

Overall (30)

1.34 ± 0.77

2.95 ± 0.80

2.69 ± 0.57

2.60 ± 0.43

2.67 ± 0.48

Effective Orifice Area Index (cm²/m²)

25 (5)

0.58 ± 0.03

1.50 ± 0.20

1.43 ± 0.39

1.38 ± 0.26

1.38 ± 0.24

27 (12)

0.83 ± 0.33

2.14 ± 0.55

1.85 ± 0.26

1.82 ± 0.40

1.86 ± 0.52

29 (3)

1.30 ± 0.17

2.52 ± 0.59

2.29 ± 0.48

1.94 ± 0.57

1.88 ± 0.47

31 (10)

0.88 ± 0.60

1.75 ± 0.63

1.67 ± 0.42

1.58 ± 0.26

1.79 ± 0.36

Overall (30)

0.86 ± 0.43

1.96 ± 0.60

1.79 ± 0.41

1.69 ± 0.38

1.75 ± 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%)