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Prosthetic Heart Valve | Instructions for Use
18
Number of Aortic Patients Implanted and Number of Patient-
years by Valve Size
All patients implanted, N = 184,
Cumulative follow-up = 411.8 patient-years
Numbers by Valve size
19
mm
21
mm
23
mm
25
mm
27/29
mm
Total
Number of Patients Implanted
17
35
70
38
24
184
Number of Patient-years
36.9
82.2
151.5
85.9
55.3
411.8
Number of Mitral Patients Implanted and Number of Patient-
years by Valve Size
All patients implanted, N = 229,
Cumulative follow-up = 417.9 patient-years
Numbers by Valve size
25
mm
27/29
mm
31/33 mm
Total
Number of Patients Implanted
33
131
65
229
Number of Patient-years
60.2
239.1
118.6
417.9
Aortic Effectiveness Outcomes, Functional New York Heart
(NYHA) Classification
1
All patients implanted, N = 184,
Cumulative follow-up = 411.8 patient-years
NYHA Class
Preoperative
Assessment
(Nd = 184)
Postoperative Assessments
1 Year
(10-14 Months)
(Nf = 138,
Nd = 129)
2
2 Year
(22-26 Months)
(Nf = 66,
Nd = 66)
3 Year
(34-38 Months)
(Nf = 37,
Nd = 36)
N
3
% (n/
Nd)
n
% (n/
Nd)
n
% (n/
Nd)
n
% (n/
Nd)
I
9
4.9
83
64.3
48
72.7
20
55.6
II
91
49.5
35
27.1
12
18.2
10
27.8
III
79
42.9
4
3.1
6
9.1
4
11.1
IV
5
2.7
0
0
0
0
0
0
Undetermined
4
0
0
7
5.4
0
0
2
5.6
Missing
5
0
N/A
9
N/A
0
N/A
1
N/A
Notes:
1. Data does not include results from double valve replacement.
2. Nf = number of patients followed (reproduced from Figure 2); Nd = number
of patients for which NYHA data were collected (not including missing).
3. n = number of patients in each category.
4. Undetermined means data were collected but Class could not be
determined during exam
5. Missing refers to the difference between the number of patients followed,
Nf, and the number of patients for which NYHA data were collected, Nd.
Mitral Effectiveness Outcomes, Functional New York Heart
(NYHA) Classification
1
All patients implanted, N = 229,
Cumulative follow-up = 417.9 patient-years
NYHA Class
Preoperative
Assessment
(Nd = 229)
Postoperative Assessments
1 Year
(10-14 Months)
(Nf = 134,
Nd = 127)
2
2 Year
(22-26 Months)
(Nf = 74,
Nd = 69)
3 Year
(34-38 Months)
(Nf = 44,
Nd = 42)
n
3
% (n/
Nd)
N
% (n/
Nd)
n
% (n/
Nd)
N
% (n/
Nd)
I
5
2.2
85
66.9
35
50.7
14
33.3
II
68
29.7
29
22.8
24
34.8
22
52.4
III
134
58.5
5
3.9
5
7.2
6
14.3
IV
18
7.9
0
0
1
1.4
0
0
Undetermined
4
4
1.7
8
6.3
4
5.8
0
0
Missing
5
0
N/A
7
N/A
5
N/A
2
N/A
Notes:
1. Data does not include results from double valve replacement.
2. Nf = number of patients followed (reproduced from Figure 2); Nd = number
of patients for which NYHA data were collected (not including missing).
3. n = number of patients in each category.
4. Undetermined means data were collected but Class could not be
determined during exam
5. Missing refers to the difference between the number of patients followed,
Nf, and the number of patients for which NYHA data were collected, Nd.
Table 7: Number Implanted and Years by Valve Size
Table 8: Valve Effectiveness Outcomes
