Carbomedics Carbo-Seal
ASCENDING AORTIC PROSTHESIS
Implantation Considerations
- Low porosity, zero-preclot Gelweave graft provides superior handling and flexibility
- Minimizes interference and suture stress of coronary ostia implantation
- Pliable, cork-shaped sewing cuff conforms to annulus, minimizing potential perivalvular leaks
- Titanium stiffening ring allows valve rotatability in-situ
Clinical Considerations
- Collagen gel encourages fast, secure intimal attachment
- Collagen gel hydrolyzes within 14 days
- Full-sized standard aortic valve provides excellent hemodynamics
- Titanium stiffening ring minimizes the possibility of leaflet lock-up or escape
- Unsurpassed safety and clinical record for valve related events
Applications
- Ascending aortic aneurysms
- Infective aortitis
- Marfan's Syndrome
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Below is an overview of literature on commercially available mechanical heart valves. The information used has been gathered exclusively from papers published after the year 2000 and those that have had sufficient follow-up studies. Thromboenbolism and bleeding events have been considered in both aortic and mitral implant situations. The results have been divided into two groups.
A) Long term FU reports Linearized rates (%/Pt-yr)
Carbomedics
|
|
|
|
AVR |
AVR |
MVR |
MVR |
|
Years |
Study |
N. of patients |
Thrombo- |
Bleeding |
Thrombo- |
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 |
Thrombo- |
Bleeding |
Thrombo- |
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 |
Thrombo- |
Bleeding |
Thrombo- |
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 |
Thrombo- |
Bleeding |
Thrombo- |
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 |
Thrombo- |
Bleeding |
Thrombo- |
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 |
Thrombo- |
Bleeding |
Thrombo- |
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 patient 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 2 for 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 |
|
Thrombo-embolism |
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 |
A meta-analysis calculation was then performed, the analysis of which shows the excellent clinical results of Carbomedics valves:
|
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 high 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.
1 The 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.
2 Confidence 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.
Carbo-Seal
Giovanni Battista Luciani, Gianluca Casali, Luca Barozzi,Alessandro Mazzucco
AORTIC ROOT REPLACEMENT WITH THE CARBOMEDCS CARBO-SEAL COMPOSITE GRAFT: 7-YEAR EXPERIENCE WITH THE FIRST 100 IMPLANTS - Ann Thorac Surg 1999;68(6):2258-62
Patients: Between January 1979 and December 1998, 273 patients underwent composite aortic root replacement. One-hundred-six received the Carbo-Seal composite prosthesis (group 1) and 84 other types of composite grafts (group 2). Demographic and operative variables were similar in the 2 patient groups, except for an older mean age in group 1 (58+/-12 versus 50+/-12 years, p = 0.001).
Results and conclusion:
- Operative mortality was lower in group 1 patients (3 of 106, 3% versus 10 of 84, 12%, p = 0.04).
- Late mortality was higher in group 2 (3 of 103, 3% versus 13 of 74, 18%, p = 0.04), with higher prevalence of prosthetic-related complications (2 of 103, 2% versus 12 of 74, 15%, p = 0.002).
- Reoperation was more prevalent in group 2 (1 of 103, 1% versus 5 of 74, 8%, p = 0.04), and limited to patients having root replacement using the inclusion technique.
Aortic root replacement using the Carbo-Seal composite graft offers excellent long-term results, with negligible prevalence of prosthetic-related complications. Superior performance compared to other available composite grafts in the present series may be influenced by more recent adoption of the Carbo-Seal conduit and concomitant uniform adoption of coronary button technique.
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|
||||
|
Catalog Number |
Valve Size |
Valve Orifice Area (cm2) |
Graft Inner Diameter (mm) |
Minimum Graft Length (cm) |
|
AP-021 |
21 |
207 |
24 |
10 |
|
AP-023 |
23 |
256 |
26 |
10 |
|
AP-025 |
25 |
316 |
28 |
10 |
|
AP-027 |
27 |
384 |
30 |
10 |
|
AP-029 |
29 |
444 |
32 |
10 |
|
AP-031 |
31 |
444 |
34 |
10 |
|
AP-033 |
33 |
444 |
34 |
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urbanski P P, MD, Wagner M, MD, Zacher M, MD, and Hacker R W, MD Herz- und Gefaess-Klinik, Bad Neustadt, Germany
Aortic Root Replacement Versus Aortic Valve Replacement: A Case-Match Study.
The Annals of Thoracic Surgery 2001;72:28-32
Pratali S, MD, Milano A, MD, Codecasa R, MD, De Carlo M, MD, Borzoni G, MD, Bortolotti U, MD The divisions of Cardia
Improving Hemostasis During Replacement of the Ascending Aorta and Aortic Valve with a Composite Graft.
The Journal of Texas Heart Institute 2000;27:246-9
Jack G Copeland III,MD, Luis J Rosado, MD, and Sharon L Snyder, RN, MS Department of Cardiovascular and Thoracic Surgery, University Medical Cente
New Technique for Improving Hemostasis in Aortic Root Replacement with Composite.
The Annals of Thoracic Surgery 1993;55:1027-9
Havel M, Allgemeines Krankenhaus der Stadt Vienna, II Chirurgische Universitätsklinik, Vienna, Austria
Initial Experience with the New Carbo-Seal Composite Graft
Aortic Forum
Ukpabi P, MSc; Marois Y, MSc; King M, PhD; Deng X, PhD; Martin L, RN; Laroche G, PhD; Douville Y, MD, MSc.
The Gelweave Polyester Arterial Prosthesis.
JCC, Vol. 38, Nº 4, 1995
Langley S M, FRCS, Rooney S J, FRCS, Dalrymple-Hay M J R, FRCS, Spencer J M F, FRCS, Lewis M E, FRCS, Pa D
Replacement of the Proximal Aorta and Aortic Valve Using A Composite Bileaflet Prosthesis and Gelatin-Impregnated Polyester Graft (Carbo-Seal): Early Results in 143 Patients.
The Journal of Thoracic cardiovascular Surgery 1999;118:1014-20
The attached file provides MRI information concerning Sorin Group Heart Valve Prostheses and Annuloplasty Devices
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