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Prosthetic Heart Valve | Instructions for Use
16
Mitral Preoperative Patient Demographics
All patients implanted, N = 229,
Cumulative follow-up = 417.9 patient-years
Patient Characteristic
N
% (n/N)1
Age at implant in years
59.2 ± 10.6
Gender:
• Male
86
37.6%
• Female
143
62.4%
NYHA Clas-
sification:
• I
5
2.2%
• II
68
29.7%
• III
134
58.5%
• IV
18
7.9%
• Unknown
4
1.7%
Valve Lesion:
• Stenosis
29
12.7%
• Insufficiency
111
48.5%
• Mixed
87
38.0%
• Other
2
0.9%
Aortic Preoperative Patient Demographics
All patients implanted, N = 184,
Cumulative follow-up = 411.8 patient-years
Patient Characteristic
N
% (n/N)1
Age at implant in years
60.2 ± 8.4
Gender:
• Male
121
65.8%
• Female
63
34.2%
NYHA Clas-
sification:
• I
9
4.9%
• II
91
49.5%
• III
79
42.9%
• IV
5
2.7%
• Unknown
0
0.0%
Valve Lesion:
• Stenosis
86
46.7%
• Insufficiency
39
21.2%
• Mixed
59
32.1%
• Other
0
0%
Table 5: Preoperative Patient Demographics
Notes: 1. n = number of patients in each category; N = total number
of study patients.
Notes: 1. n = number of patients in each category; N = total number of study
patients.
Complication
Early Events
Late Events
2
Freedom from Event
3
, % [SE]
n
% (n/N)
4
n
%/pt-yr
1 Year Postoperative (n=134)
3 Year Postoperative (n=44)
Mortality (all)
9
3.9%
9
2.2%
95.4% [1.4]
89.2% [2.7]
Mortality (valve-related)
1
0.4%
2
0.5%
99.5% [0.5]
97.2% [1.7]
Endocarditis
0
0.0%
3
0.7%
99.0% [0.7]
99.0% [0.7]
Explant
1
0.4%
3
0.7%
98.0% [1.0]
98.0% [1.0]
Hemolysis
5
0
0.0%
0
0.0%
100.0% [0]
100.0%[0]
Hemorrhage
6
(all)
4
1.8%
6
1.4%
96.4% [1.3]
94.4% [2.0]
Hemorrhage (major)
4
1.8%
2
0.5%
97.0% [1.2]
97.0% [1.2]
Perivalvular Leak (all)
2
0.9%
3
0.7%
98.0% [1.0]
97.1% [1.2]
Perivalvular Leak (major)
1
0.4%
1
0.2%
99.4% [0.6]
99.4% [0.6]
Nonstructural Valve Dysfunction
0
0.0%
1
0.2%
100.0% [0]
99.1% [0.9]
Reoperation (valve-related)
3
1.3%
5
1.2%
97.0% [1.2]
97.0% [1.2]
Structural Valve Dysfunction
0
0.0%
0
0.0%
100.0% [0]
100.0% [0]
Thromboembolism
2
0.9%
7
1.7%
97.0% [1.2]
96.3% [1.4]
Thrombosis
0
0.0%
0
0.0%
100.0% [0]
100.0% [0]
Notes:
1. Data does not include results from double valve replacement.
2. Late events calculated as linearized rates based on total patient-years.
3. Freedom from event was calculated based on the method of Kaplan-Meier. SE = Standard Error.
4. n = number of patients in each category; N = total number of study patients.
5. Blood studies conducted at a core laboratory established that the valve creates a low level of fully compensated hemolysis typified by an increase in SLDH
with a mean within normal range, a decrease in haptoglobin to below normal in 69% AVR and 65% MVR patients at 1-year, and all other analytes within normal
range.
6. The anticoagulant agents used were reported. The target International Normalized Ratio was 2.5 to 3.5 in AVR and 3.0 to 4.5 in MVR.
Table 4: Mitral Replacement Observed Adverse Event Rates
1
All patients implanted, N = 229, Cumulative follow-up = 417.9 patient-years
