Valve Diameter Dimensions - Edwards...
6
The Aortic Valve Guide Measurements that affect valve selection
Transcript of Valve Diameter Dimensions - Edwards...
The Aortic Valve Guide
Measurements that affect valve selection
The stent outer diameter alone is not enough to make clinically relevant
decisions at the time of implant due to differences existing between the
labeled size and other measurements of the bioprothesis.1 For any valve,
three dimensions of diameter may be taken into account: OD, ED, and ID.
For a given ED, the labeled size and the ID can vary significantly from
product to product.
The ID identifies the largest potential diameter of the valve opening;
the larger the ID, the better the hemodynamic performance.1
ED ID
MitroflowMosaic Ultra / Hancock II UltraPERIMOUNT valveMagna Ease valve
26
26
26
26
23
21
19
21
19
18.5
18
20
Mitroflow
192123
15.417.319
17.518.520.5
182022
182022
Mosaic Ultra / Hancock II Ultra
PERIMOUNTvalve
Magna Easevalve
OD (Labeled Size) Internal Diameter (ID)
1. Dalmau, MJ (2007). One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic bioprothesis in the aortic position: a prospective randomized study. Interact CardioVasc Thorac Surg, 6, 345-349. 2. Sievers, HH (2005). Prosthetic aortic valve replacement. J Thorac Cardiovasc Surg, 129, 961-965.
Brief Summary: Aortic BioprosthesesIndications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve. Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests. Complications and Side Effects: stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any of which could lead to reoperation, explantation, permanent disability, and death. Warnings: Alternative therapies should be considered in the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children, adolescents, young adults, and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.
For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
Edwards and Magna Ease are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, PERIMOUNT, and Magna are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.
Mosaic, Mosaic ULTRA, Hancock II, and Hancock II ULTRA are trademarks of Medtronic, Inc. SJM Biocor and Epic are trademarks of St. Jude Medical, Inc. Mitroflow is a trademark of Sorin Bio-medica Cardio Srl.
© 2010 Edwards Lifesciences Corporation. All rights reserved. AR05888
Valve Diameter Dimensions
OD(Labeled Size)
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
Examples of OD (mm)
Examples with same ED (mm)
21
19
23
IDAORTIC BIOPROSTHESESLABELED SIZE (OD) (mm) ED ID/ED
RATIOPROFILE HEIGHT
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic
Mosaic Ultra
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
18
18
18
17.5
17.5
19
15.4
20
20
20
18.5
18.5
19
21
17.3
22
22
22
20.5
20.5
21
23
19
24
24
26
25
24
25
21
26
26
28
27
26
25
28
23
28
28
31
30
28
27
29
26
0.75
0.75
0.69
0.70
0.73
0.76
0.73
0.77
0.77
0.71
0.69
0.71
0.76
0.75
0.75
0.79
0.79
0.71
0.68
0.73
0.78
0.79
0.73
13
14
14
13.5
13.5
14
11
14
15
15
15
15
14
15
13
15
16
16
16
16
15
16
14
IDAORTIC BIOPROSTHESES ED ID/EDRATIO
PROFILE HEIGHT
27
25
29
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Mitroflow
24
24
24
22.5
22.5
23
25
21
26
26
26
24
24
25
27
22.9
28
28
28
26
26
27
24.7
30
30
32
33
30
29
31
29
32
32
35
36
32
31
33
31
34
34
37
39
34
33
33
0.80
0.80
0.75
0.68
0.75
0.79
0.81
0.72
0.81
0.81
0.74
0.67
0.75
0.81
0.82
0.74
0.82
0.82
0.76
0.67
0.76
0.82
0.75
16
17
17
17.5
17.5
16
17
15
17
18
18
18.5
18.5
17
19
16
18
19
19
20
20
19
16
*All dimensions reflect the manufacturers’ published information. Edwards Lifesciences and Medtronic indicated that the dimensions are nominal dimensions.
LABELED SIZE (OD) (mm)
Bioprosthetic Aortic Valve Dimensions measured in mm*
In choosing an aortic bioprosthesis, labeled size alone is not a sufficient
indicator to determine patient relevancy.1 This Aortic Valve Guide outlines
the valve dimensions of the Carpentier-Edwards PERIMOUNT Magna Ease
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT Magna
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT
pericardial aortic bioprosthesis, as well as competitive valves from
St. Jude Medical, Medtronic, and Sorin.
• Stent Outer Diameter (OD): Diameter of the tissue annulus; also known
as the labeled size
• External Sewing Ring Diameter (ED): The full diameter of the valve
• Stent Internal Diameter (ID): The largest potential diameter of the valve
opening; the larger the ID, the better the hemodynamic performance1
• Profile Height: The total height of the valve
There is More to Valve Dimension Than the Labeled Size1,2
ID
ED
ODLabeled Size
ProfileHeight
edwards.com
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
21
19
23
IDAORTIC BIOPROSTHESESLABELED SIZE (OD) (mm) ED ID/ED
RATIOPROFILE HEIGHT
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic
Mosaic Ultra
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
18
18
18
17.5
17.5
19
15.4
20
20
20
18.5
18.5
19
21
17.3
22
22
22
20.5
20.5
21
23
19
24
24
26
25
24
25
21
26
26
28
27
26
25
28
23
28
28
31
30
28
27
29
26
0.75
0.75
0.69
0.70
0.73
0.76
0.73
0.77
0.77
0.71
0.69
0.71
0.76
0.75
0.75
0.79
0.79
0.71
0.68
0.73
0.78
0.79
0.73
13
14
14
13.5
13.5
14
11
14
15
15
15
15
14
15
13
15
16
16
16
16
15
16
14
IDAORTIC BIOPROSTHESES ED ID/EDRATIO
PROFILE HEIGHT
27
25
29
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Mitroflow
24
24
24
22.5
22.5
23
25
21
26
26
26
24
24
25
27
22.9
28
28
28
26
26
27
24.7
30
30
32
33
30
29
31
29
32
32
35
36
32
31
33
31
34
34
37
39
34
33
33
0.80
0.80
0.75
0.68
0.75
0.79
0.81
0.72
0.81
0.81
0.74
0.67
0.75
0.81
0.82
0.74
0.82
0.82
0.76
0.67
0.76
0.82
0.75
16
17
17
17.5
17.5
16
17
15
17
18
18
18.5
18.5
17
19
16
18
19
19
20
20
19
16
*All dimensions reflect the manufacturers’ published information. Edwards Lifesciences and Medtronic indicated that the dimensions are nominal dimensions.
LABELED SIZE (OD) (mm)
Bioprosthetic Aortic Valve Dimensions measured in mm*
In choosing an aortic bioprosthesis, labeled size alone is not a sufficient
indicator to determine patient relevancy.1 This Aortic Valve Guide outlines
the valve dimensions of the Carpentier-Edwards PERIMOUNT Magna Ease
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT Magna
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT
pericardial aortic bioprosthesis, as well as competitive valves from
St. Jude Medical, Medtronic, and Sorin.
• Stent Outer Diameter (OD): Diameter of the tissue annulus; also known
as the labeled size
• External Sewing Ring Diameter (ED): The full diameter of the valve
• Stent Internal Diameter (ID): The largest potential diameter of the valve
opening; the larger the ID, the better the hemodynamic performance1
• Profile Height: The total height of the valve
There is More to Valve Dimension Than the Labeled Size1,2
ID
ED
ODLabeled Size
ProfileHeight
edwards.com
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
21
19
23
IDAORTIC BIOPROSTHESESLABELED SIZE (OD) (mm) ED ID/ED
RATIOPROFILE HEIGHT
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic
Mosaic Ultra
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
18
18
18
17.5
17.5
19
15.4
20
20
20
18.5
18.5
19
21
17.3
22
22
22
20.5
20.5
21
23
19
24
24
26
25
24
25
21
26
26
28
27
26
25
28
23
28
28
31
30
28
27
29
26
0.75
0.75
0.69
0.70
0.73
0.76
0.73
0.77
0.77
0.71
0.69
0.71
0.76
0.75
0.75
0.79
0.79
0.71
0.68
0.73
0.78
0.79
0.73
13
14
14
13.5
13.5
14
11
14
15
15
15
15
14
15
13
15
16
16
16
16
15
16
14
IDAORTIC BIOPROSTHESES ED ID/EDRATIO
PROFILE HEIGHT
27
25
29
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Epic Supra / SJM Biocor Supra
Mitroflow
Magna Ease valve
Magna valve
PERIMOUNT valve
Mosaic / Hancock II
Mosaic Ultra / Hancock II Ultra
Epic / SJM Biocor
Mitroflow
24
24
24
22.5
22.5
23
25
21
26
26
26
24
24
25
27
22.9
28
28
28
26
26
27
24.7
30
30
32
33
30
29
31
29
32
32
35
36
32
31
33
31
34
34
37
39
34
33
33
0.80
0.80
0.75
0.68
0.75
0.79
0.81
0.72
0.81
0.81
0.74
0.67
0.75
0.81
0.82
0.74
0.82
0.82
0.76
0.67
0.76
0.82
0.75
16
17
17
17.5
17.5
16
17
15
17
18
18
18.5
18.5
17
19
16
18
19
19
20
20
19
16
*All dimensions reflect the manufacturers’ published information. Edwards Lifesciences and Medtronic indicated that the dimensions are nominal dimensions.
LABELED SIZE (OD) (mm)
Bioprosthetic Aortic Valve Dimensions measured in mm*
In choosing an aortic bioprosthesis, labeled size alone is not a sufficient
indicator to determine patient relevancy.1 This Aortic Valve Guide outlines
the valve dimensions of the Carpentier-Edwards PERIMOUNT Magna Ease
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT Magna
pericardial aortic bioprosthesis, the Carpentier-Edwards PERIMOUNT
pericardial aortic bioprosthesis, as well as competitive valves from
St. Jude Medical, Medtronic, and Sorin.
• Stent Outer Diameter (OD): Diameter of the tissue annulus; also known
as the labeled size
• External Sewing Ring Diameter (ED): The full diameter of the valve
• Stent Internal Diameter (ID): The largest potential diameter of the valve
opening; the larger the ID, the better the hemodynamic performance1
• Profile Height: The total height of the valve
There is More to Valve Dimension Than the Labeled Size1,2
ID
ED
ODLabeled Size
ProfileHeight
edwards.com
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
The Aortic Valve Guide
Measurements that affect valve selection
The stent outer diameter alone is not enough to make clinically relevant
decisions at the time of implant due to differences existing between the
labeled size and other measurements of the bioprothesis.1 For any valve,
three dimensions of diameter may be taken into account: OD, ED, and ID.
For a given ED, the labeled size and the ID can vary significantly from
product to product.
The ID identifies the largest potential diameter of the valve opening;
the larger the ID, the better the hemodynamic performance.1
ED ID
MitroflowMosaic Ultra / Hancock II UltraPERIMOUNT valveMagna Ease valve
26
26
26
26
23
21
19
21
19
18.5
18
20
Mitroflow
192123
15.417.319
17.518.520.5
182022
182022
Mosaic Ultra / Hancock II Ultra
PERIMOUNTvalve
Magna Easevalve
OD (Labeled Size) Internal Diameter (ID)
1. Dalmau, MJ (2007). One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic bioprothesis in the aortic position: a prospective randomized study. Interact CardioVasc Thorac Surg, 6, 345-349. 2. Sievers, HH (2005). Prosthetic aortic valve replacement. J Thorac Cardiovasc Surg, 129, 961-965.
Brief Summary: Aortic BioprosthesesIndications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve. Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests. Complications and Side Effects: stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any of which could lead to reoperation, explantation, permanent disability, and death. Warnings: Alternative therapies should be considered in the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children, adolescents, young adults, and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.
For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
Edwards and Magna Ease are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, PERIMOUNT, and Magna are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.
Mosaic, Mosaic ULTRA, Hancock II, and Hancock II ULTRA are trademarks of Medtronic, Inc. SJM Biocor and Epic are trademarks of St. Jude Medical, Inc. Mitroflow is a trademark of Sorin Bio-medica Cardio Srl.
© 2010 Edwards Lifesciences Corporation. All rights reserved. AR05888
Valve Diameter Dimensions
OD(Labeled Size)
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
Examples of OD (mm)
Examples with same ED (mm)
The Aortic Valve Guide
Measurements that affect valve selection
The stent outer diameter alone is not enough to make clinically relevant
decisions at the time of implant due to differences existing between the
labeled size and other measurements of the bioprothesis.1 For any valve,
three dimensions of diameter may be taken into account: OD, ED, and ID.
For a given ED, the labeled size and the ID can vary significantly from
product to product.
The ID identifies the largest potential diameter of the valve opening;
the larger the ID, the better the hemodynamic performance.1
ED ID
MitroflowMosaic Ultra / Hancock II UltraPERIMOUNT valveMagna Ease valve
26
26
26
26
23
21
19
21
19
18.5
18
20
Mitroflow
192123
15.417.319
17.518.520.5
182022
182022
Mosaic Ultra / Hancock II Ultra
PERIMOUNTvalve
Magna Easevalve
OD (Labeled Size) Internal Diameter (ID)
1. Dalmau, MJ (2007). One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic bioprothesis in the aortic position: a prospective randomized study. Interact CardioVasc Thorac Surg, 6, 345-349. 2. Sievers, HH (2005). Prosthetic aortic valve replacement. J Thorac Cardiovasc Surg, 129, 961-965.
Brief Summary: Aortic BioprosthesesIndications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve. Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests. Complications and Side Effects: stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any of which could lead to reoperation, explantation, permanent disability, and death. Warnings: Alternative therapies should be considered in the presence of conditions affecting calcium metabolism or when calcium containing chronic drug therapies are used, including children, adolescents, young adults, and patients on a high calcium diet or maintenance hemodialysis. Should be used with caution in the presence of severe systemic hypertension or when anticipated patient longevity is longer than the known longevity of the prosthesis.
For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
Edwards and Magna Ease are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, PERIMOUNT, and Magna are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.
Mosaic, Mosaic ULTRA, Hancock II, and Hancock II ULTRA are trademarks of Medtronic, Inc. SJM Biocor and Epic are trademarks of St. Jude Medical, Inc. Mitroflow is a trademark of Sorin Bio-medica Cardio Srl.
© 2010 Edwards Lifesciences Corporation. All rights reserved. AR05888
Valve Diameter Dimensions
OD(Labeled Size)
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
Examples of OD (mm)
Examples with same ED (mm)
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