Carbomed Clinical Performance

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- embolism	Bleeding	Thrombo- embolism	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- embolism	Bleeding	Thrombo- embolism	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- embolism	Bleeding	Thrombo- embolism	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- embolism	Bleeding	Thrombo- embolism	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- embolism	Bleeding	Thrombo- embolism	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- embolism	Bleeding	Thrombo- embolism	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 ²for each complication, results:

 

	Aortic Valve Replacement			Mitral Valve Replacement			Double Valve Replacement
Event:	N	Lin Rates (%/pt-yr)	UCL (95%)	N	Lin Rates (%/pt-yr)	UCL (95%)	N	Lin Rates (%/pt-yr)	UCL (95%)
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 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
OptiForm Mitral Valve	F7-023 F7-025 F7-027 F7-029 F7-031 F7-033	23mm 25mm 27mm 29mm 31mm 33mm
ACCESSORIES
Valve Sizer	VS-200	19/21mm, 23/25mm, 27/29mm, 31/33mm
Valve Handle	VH-100
Mitral Valve Rotator	RM-399
Mitral Valve Rotator Handle	RH-100	18/19mm, 21mm, 23mm, 25mm, 27mm, 29/33mm
Valve Leaflet Tester	VT-100

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Geha A S, MD, MS, Massad M G, MD, and Snow N J, MD Division of Cardiothoracic Surgery, University of Illinois at Chicago Medical

Replacement of Degenerated Mitral and Aortic Bioprostheses Without Explantation.
The Annals of Thoracic Surgery 2001;72:1509-14

Aagaard J, Andersen U L, Lerbjerg G, L. IB Andersen Department of Cardio Thoracic and Vascular Surgery, Odense University Hospital, Odense, Denma

Expanding the Use of Total Mitral Valve Preservation in Combination with Implantation of the Carbomedics Heart Valve Prosthesis.
The Journal of Cardiovascular Surgery 1999;40:177-81

The attached file provides MRI information concerning Sorin Group Heart Valve Prostheses and Annuloplasty Devices

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