English
On-X
®
Prosthetic Heart Valve | Instructions for Use
17
Table 6: Operative Patient Demographics
Notes:
1. Ordered by frequency of occurrence, except for valve size.
2. n = number of patients in each category; N = total number of study patients.
3. May be more than one per patient.
Operative Mitral Patient Demographics
All patients implanted, N = 229,
Cumulative follow-up = 417.9 patient-years
Variable
Category
1
N
% (n/N)2
Etiology
3
Rheumatic
86
37.6%
Degenerative
62
27.1%
Calcific
36
15.7%
Endocarditis
16
7.0%
Prosthetic Valve Dysfunction
6
2.6%
Congenital
4
1.8%
Other
38
16.6%
Concomitant
Procedures
3
None
130
56.8%
Coronary Artery Bypass Graft
44
19.2%
Tricuspid Repair
22
9.6%
Closure of Atrial Appendage
12
5.2%
Mitral Repair
12
5.2%
Maze Procedure
12
5.2%
Septal Defect Closure
8
3.5%
Ventricular Aneurysm Repair
3
1.3%
Muscularization
2
0.9%
Tricuspid Replacement
1
0.4%
Explant of Annuloplasty Ring
1
0.4%
Pre-existing
Conditions
3
Atrial Arrhythmias
137
59.3%
Pulmonary Hypertension
108
46.8%
Systemic Hypertension
88
38.1%
Hyperlipidemia
88
38.1%
Congestive Heart Failure
80
34.6%
Other
77
33.3%
Coronary Artery Disease
67
29.0%
Cigarette Smoker
64
27.7%
Left Ventricular Dysfunction
47
20.4%
Cerebrovascular Accident
43
18.6%
Diabetes Mellitus
40
17.3%
Angina
38
16.4%
Myocardial Infarction
30
13.0%
Hyperthyriodism
27
11.7%
Chronic Obstructive Pulmonary Disease
25
10.8%
Endocarditis
18
7.8%
Gastroinestinal Ulcer
18
7.8%
Chronic Kidney Failure
13
5.6%
Carotid Artery Disease
12
5.2%
Coronary Artery Bypass Graft
10
4.4%
Cancer
10
4.4%
Previous Mitral Valve Replacement
9
3.9%
Cardiomyopathy
8
3.5%
Pacemaker Implant
6
2.6%
Valve Size
25 mm
33
14.4%
27/29 mm
131
57.2%
31/33 mm
65
28.4%
Operative Aortic Patient Demographics
All patients implanted, N = 184,
Cumulative follow-up = 411.8 patient-years
Variable
Category
1
n
% (n/N)2
Etiology
3
Calcific
92
50.0%
Degenerative
51
27.7%
Rheumatic
24
13.0%
Congenital
18
9.8%
Endocarditis
8
4.4%
Prosthetic Valve Dysfunction
0
0.0%
Other
6
3.3%
Concomitant
Procedures
3
None
141
76.7%
Coronary Artery Bypass Graft
21
11.4%
Myotomy
10
5.4%
Mitral Repair
5
2.7%
Aorta Repair or Replacement
4
2.2%
Tricuspid Repair
1
0.5%
Muscle Bridge
1
0.5%
Tricuspid Replacement
0
0.0%
Explant of Annuloplasty Ring
0
0.0%
Maze Procedure
0
0.0%
Closure of Atrial Appendage
0
0.0%
Ventricular Aneurysm Repair
0
0.0%
Other
0
0.0%
Pre-existing
Conditions
3
Systemic Hypertension
90
48.9%
Hyperlipidemia
83
45.1%
Angina
42
22.8%
Coronary Artery Disease
42
22.8%
Diabetes Mellitus
33
17.9%
Atrial Arrhythmias
25
13.6%
Left Ventricular Dysfunction
23
12.5%
Congestive Heart Failure
22
12.0%
Myocardial Infarction
12
6.5%
Cerebrovascular Accident
10
5.4%
Carotid Artery Disease
7
3.8%
Endocarditis
4
2.2%
Cardiomyopathy
3
1.6%
Pacemaker Implant
2
1.1%
Coronary Artery Bypass Graft
1
0.5%
Previous Aortic Valve Replacement
1
0.5%
Previous Mitral Valve Replacement
0
0.0%
Other
27
14.8%
Valve Size
19 mm
17
9.2%
21 mm
35
19.0%
23 mm
70
38.0%
25 mm
38
20.6%
27/29 mm
24
13.0%
