Carbomedics Orbis
UNIVERSAL AORTIC AND MITRAL VALVE
Implantation Considerations
- Multipurpose cuff design allows for variety of implantation techniques
- Sewing cuff readily conforms to a scarred or calcified annulus
- Can be used in either aortic or mitral position
Clinical Considerations
- Unsurpassed safety and clinical record for valve related events
- Same proven clinical results as all Carbomedics products
- Titanium stiffening ring minimizes the possibility of leaflet lock-up or escape
Applications
- Redo procedures
- MIS procedures
- Heavily calcified annulus
- Aortic or mitral procedures
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Carbomedics Clinical Performance
To have an overview of literature on commercially available mechanical heart valves, only papers published after the year 2000 with the longest follow-up terms have been considered in terms of linearized rates of thromboembolism and bleeding events. Both aortic and both mitral implants have been considered. The comparison results have been divided into two groups: A) Long term follow-up and B) Mid - Short term follow-up reports. In the A) group are present Carbomedics, St. Jude Medical and ATS. While in B) only ATS and MCRI On-X are included.
A) Long term FU reports Linearized rates (%/Pt-yr)
Carbomedics
|
|
|
|
AVR |
AVR |
MVR |
MVR |
|
Years |
Study |
N. of patients |
Thromboembolism |
Bleeding |
Thromboembolism |
Bleeding |
|
15 |
Carrier 2006 (A) |
2953 |
0.4 |
0.4 |
0.7 |
0.7 |
|
15 |
Aagaard 2005 (B) |
132 |
0.73 |
0.88 |
1.26 |
1.67 |
|
10 |
Tominaga 2005 (C) |
505 |
1.45 |
0.52 |
1.78 |
0.85 |
|
10 |
Kang 2005 (D) |
850 |
1.2 |
0.92 |
0.72 |
0.82 |
|
10 |
Wu 06 2006 (E) |
774 |
0.7 |
0.3 |
0.5 |
0.4 |
|
10 |
Onoda 2002 (F) |
256 |
0.35 |
0.17 |
0 |
0.34 |
St. Jude Medical
|
|
|
|
AVR |
AVR |
MVR |
MVR |
|
Years |
Study |
N. of patients |
Thromboembolism |
Bleeding |
Thromboembolism |
Bleeding |
|
25 |
Emery 2005 (G) |
4480 |
1.9 |
2.8 |
2.7 |
2.7 |
|
20 |
Ikonomidis 2003 (H) |
837 |
2 |
2.5 |
3.4 |
1.8 |
|
18 |
Lund 2000 (I) |
694 |
1.18 |
2.24 |
na |
na |
ATS Medical
|
|
|
|
AVR |
AVR |
MVR |
MVR |
|
Years |
Study |
N. of patients |
Thromboembolism |
Bleeding |
Thromboembolism |
Bleeding |
|
10 |
Stefanidis 2005 (J) |
177 |
na |
na |
0.45 |
0.0 |
|
11 |
Baykut 2006 (K) |
581 |
1.1 |
0.3 |
1.3 |
0.6 |
B) Mid & short term FU reports: Linearized rates (%/Pt-yr)
ATS Medical
|
|
|
|
AVR |
AVR |
MVR |
MVR |
|
Years |
Study |
N. of patients |
Thromboembolism |
Bleeding |
Thromboembolism |
Bleeding |
|
5 |
Emery 2004 (L) |
342 |
2.6 |
1.8 |
3 |
2.3 |
|
2 |
Emery 2003 (M) |
1146 |
1.85 |
2.33 |
3.19 |
1.28 |
|
2 |
Jazayeri 2003 (N) |
100 |
0.55 |
1.1 |
na |
na |
MCRI On-X
|
|
|
|
AVR |
AVR |
MVR |
MVR |
|
Years |
Study |
N. of patients |
Thromboembolism |
Bleeding |
Thromboembolism |
Bleeding |
|
5 |
Moidl 2002 (O) |
532 |
1.32 |
1.16 |
1.79 |
0.48 |
|
4 |
Williams 2006 (P) |
438 |
1.1 |
0.6 |
1.5 |
1 |
|
4 |
Mc Nichlas 2006 (Q) |
284 |
0.9 |
2.7 |
1.6 |
3.1 |
|
1 |
Laczkovics 2001 (R) |
301 |
1.7 |
0.7 |
1.8 |
0 |
Carbomedics Meta-analysis
After 20 years of clinical experience, long term studies show the excellent reliability of Carbomedics valves.
|
|
|
|
Aortic Valve Replacement |
Mitral Valve Replacement |
||
|
Years |
Study |
N. of patients |
Thromboembolism |
Bleeding |
Thromboembolism |
Bleeding |
|
15 |
Carrier 2006 (A) |
2953 |
0.4 |
0.4 |
0.7 |
0.7 |
|
15 |
Aagaard 2005 (B) |
132 |
0.73 |
0.88 |
1.26 |
1.67 |
|
10 |
Tominaga 2005 (C) |
505 |
1.45 |
0.52 |
1.78 |
0.85 |
|
10 |
Kang 2005 (D) |
850 |
1.2 |
0.92 |
0.72 |
0.82 |
|
10 |
Wu 06 2006 (E) |
774 |
0.7 |
0.3 |
0.5 |
0.4 |
|
10 |
Onoda 2002 (F) |
256 |
0.35 |
0.17 |
0 |
0.34 |
The table shows the clinical performance of Carbomedics valve series as taken from studies with at least 10 years of patients follow-up, published in the last 5 years. Data are expressed as Linearized rates 1(%/Pt-yr).
Grouping the precedent data and calculating the upper confidence limit 2for each complication, results:
|
|
Aortic Valve Replacement |
Mitral Valve Replacement |
Double Valve Replacement |
||||||
|
Event: |
N |
Lin Rates |
UCL |
N |
Lin Rates |
UCL |
N |
Lin Rates |
UCL |
|
Thromboembolism |
78 |
0.62 |
1.12 |
102 |
0.84 |
1.15 |
34 |
0.74 |
1.23 |
|
Bleeding |
66 |
0.52 |
1.11 |
100 |
0.83 |
1.15 |
22 |
0.49 |
1.18 |
|
Thrombosis |
4 |
0.03 |
1.03 |
43 |
0.35 |
1.09 |
11 |
0.24 |
1.13 |
Analyzing the data in order to have numbers to summarize these excellent clinical results of Carbomedics valves, a meta-analysis calculation was performed, obtaining the following results:
|
Event: |
N |
Lin Rates (%/pt-yr) |
UCL (95%) |
|
Thromboembolism |
214 |
0.73 |
1.09 |
|
Bleeding |
189 |
0.64 |
1.08 |
|
Thrombosis |
58 |
0.20 |
1.04 |
Comparing those values with twice the Objective Performance Criteria 3(O.P.C.) used by FDA to evaluate the clinical performance of heart valve prostheses, it is clear that, after at least 10 years, Carbomedics valves show extremely good quality values.
References:
A- Carrier M, Pellerin M, Basmadjian A, Bouchard D, Perrault LP, Cartier R, Page P, Demers P, Hebert Y. Fifteen years of clinical and echocardiographic follow up with the Carbomedics heart valve. - J Heart Valve Dis. 2006 Jan;15(1):67-72
B- Aagaard J, Tingleff J. Fifteen years' clinical experience with the Carbomedics prosthetic heart valve. - J Heart Valve Dis. 2005 Jan;14(1):82-8.
C- Tominaga R, Kurisu K, Ochiai Y, Tomita Y, Masuda M, Morita S, Yasui H. A 10-year experience with the Carbomedics cardiac prosthesis. - Ann Thorac Surg. 2005 Mar;79(3):784-9.
D- Kang CH, Ahn H, Kim KH, Kim KB. Long-term result of 1144 Carbomedics mechanical valve implantations. - Ann Thorac Surg. 2005 Jun;79(6):1939-44.
E- YingXing Wu, Guangqiang Gao, Seema Mody, Gary L. Grunkemeier, Aftab Ahmad Update of the Providence Health System Experience with the Carbomedics Prosthesis. - The Journal of Heart Valve Disease 2006;15:414-420
F- Onoda K, Suzuki T, Kanemitsu N, Yuasa U, Takao M, Shimono T, Tanaka K, Shimpo H, Yada I. Long-term results of valve replacement with the Carbomedics prosthetic heart valve. - Artif Organs. 2002 May;26(5):479-82.
G- Emery RW, Krogh CC, Arom KV, Emery AM, Benyo-Albrecht K, Joyce LD, Nicoloff DM. The St. Jude Medical Cardiac Valve Prosthesis: A 25-Year Experience With Single Valve Replacement. - Ann Thorac Surg. 2005 Mar;79(3):776-82.
H- Ikonomidis JS, Kratz JM, Crumbley AJ 3rd, Stroud MR, Bradley SM, Sade RM, Crawford FA Jr. Twenty-year experience with the St Jude Medical mechanical valve prosthesis. - J Thorac Cardiovasc Surg. 2003 Dec;126(6):2022-31.
I- Lund O, Nielsen SL, Arildsen H, Ilkjaer LB, Pilegaard HK. Standard aortic St. Jude valve at 18 years: performance profile and determinants of outcome. - Ann Thorac Surg. 2000 May;69(5):1459-65.
J- Stefanidis C, Nana AM, De Canniere D, Antoine M, Jansens JL, Huynh CH, Le Clerc JL. 10-year experience with the ATS mechanical valve in the mitral position. - Ann Thorac Surg. 2005 Jun;79(6):1934-8.
K- Baykut D, Grize L, Schindler C, Keil AS, Bernet F, Zerkowski HR. Eleven-year single-center experience with the ATS Open Pivot Bileaflet heart valve. - Ann Thorac Surg. 2006 Sep;82(3):847-52
L- Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. Five-year follow up of the ATS mechanical heart valve. - J Heart Valve Dis. 2004 Mar;13(2):231-8.
M- Emery RW, Van Nooten GJ, Tesar PJ; Investigators for the ATS Clinical Open Pivot Heart Valve Food and Drug Administration Study. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. - Ann Thorac Surg. 2003 Feb;75(2):444-52.
N- Jazayeri S, Gomez MC, Tatou E, Ecarnot A, Saleh M, Bouchot O, Renaud C, Brenot R, David M. Clinical experience and Doppler echocardiographic assessment of the first one hundred ATS AP (advanced performance) prosthetic valve in the aortic position. - J Heart Valve Dis. 2003 Sep;12(5):628-34.
O- Moidl R, Simon P, Wolner E; On-X Prosthesis Heart Valve Trial. The On-X prosthetic heart valve at five years. - Ann Thorac Surg. 2002 Oct;74(4):S1312-7.
P- Williams MA, van Riet S. The On-X heart valve: mid-term results in a poorly anticoagulated population. - J Heart Valve Dis. 2006 Jan;15(1):80-6.
Q- McNicholas KW, Ivey TD, Metras J, Szentpetery S, Marra SW, Masters RG, Dilling EW, Slaughter MS, Mack MJ.North American multicenter experience with the On-X prosthetic heart valve. - J Heart Valve Dis. 2006 Jan;15(1):73-8.
R- Laczkovics A, Heidt M, Oelert H, Laufer G, Greve H, Pomar JL, Mohr FW, Haverich A, Birnbaum D, Regensburger D, Palatianos G, Wolner E. Early clinical experience with the On-X prosthetic heart valve. - J Heart Valve Dis. 2001 Jan;10(1):94-9.
1The Linearized rate, known as Incidence rate is defined as the incidence divided by the sum of the different times each individual was at risk of the disease The incidence of disease is defined as the number of new cases of disease occurring in a population during a defined time interval. The number is useful to epidemiologists because it is a measure of the risk of disease.
2Confidence limits are the lower and upper boundaries / values of a confidence interval, that is, the values which define the range of a confidence interval. A confidence interval gives an estimated range of values which is likely to include an unknown population parameter, the estimated range being calculated from a given set of sample data.
3 The current Food and Drug Administration (FDA) heart valve guidance document uses an objective performance criteria (OPC) methodology to evaluate the clinical performance of prosthetic heart valves. The OPC are derived from the average complication rates of all approved heart valves. The comparison is made with twice the OPC value.
|
PRODUCT |
CATALOG NUMBER |
SIZE |
|
Orbis Universal Aortic Valve |
A1-019 |
19mm |
|
Orbis Universal Mitral Valve |
M2-021 |
21mm |
|
ACCESSORIES |
|
|
|
Valve Sizer |
VS-200 |
19/21mm, 23/25mm, 27/29mm, 31/33mm |
|
Mitral Valve Rotator |
RM-399 |
|
|
Mitral Valve Rotator Handle |
RH-100 |
18/19mm, 21mm, 23mm, 25mm, 27mm, 29/33mm |
|
Aortic Valve Rotator |
AR-150 |
16/19mm, 21mm, 23mm, 25mm, 27mm, 29/31mm |
|
Valve Handle |
VH-100 |
|
The attached file provides MRI information concerning Sorin Group Heart Valve Prostheses and Annuloplasty Devices
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