Carbomedics 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. Thromboembolism 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	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

In the table are reported 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 (%/pt-yr)	UCL (95%)	N	Lin Rates (%/pt-yr)	UCL (95%)	N	Lin Rates (%/pt-yr)	UCL (95%)
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 the 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 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.

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
Standard Aortic Valve	A5-019 A5-021 A5-023 A5-025 A5-027 A5-029 A5-031	19mm 21mm 23mm 25mm 27mm 29mm 31mm
IINSTRUMENTATION
Valve Sizer	VS-200	19/21mm, 23/25mm, 27/29mm, 31/33mm
Aortic Valve Rotator	AR-150	16/19mm, 21mm, 23mm, 25mm, 27mm, 29/31mm
Valve Handle	VH-100
Valve Leaflet Tester	VT-100

 

Aagaard J, Tingleff J.
Fifteen years' clinical experience with the CarboMedics prosthetic heart valve.
J Heart Valve Dis. 2005 Jan;14(1):82-8.

Copeland J G III, MD, Sethi G K, MD, and the North American Team of Clinical Investigators for the CarboMedics Prosthetic Heart valve The
Four-Year Experience With the CarboMedics Valve: The North American Experience.
The Annals of Thoracic Surgery 1994;58:630-8

Joseph Craver Emory University Clinic. 1365 Clifton Road NE Suite 3119, Atlanta, GA 30322, USA
CarboMedics® Prosthetic Heart Valve.
European Journal of Cardio-Thoracic Surgery 15 (Suppl. 1) (1999) S3-S11

Ståhlberg K, Mattila I, Heikkilã L, Sipponen J, Verkkala K, Mattila S, From the Department of Thoracic and
Cardiovascular Surgery, Helsinki Un
St. Jude Versus CarboMedics®: Follow-up After Prosthetic Valve Replacement.
The Journal of Cardiovascular Surgery 1997;38:577-80

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.

De Luca L, MD, Vitale N, MD, Giannolo B, MD, Cafarella G, MD, Piazza L, MD, and Cotrufo M, MD, Naples, Italy
Mid-term Follow-up After Heart Valve Replacement with CarboMedics Bileaflet Prostheses.
The Journal of Thoracic and Cardiovascular Surgery 1993;106:1138-65

Butterfield M, MSc, Fisher J, PhD, Davies G A, FRCS, and Spyt T J, FRCS Cardiac Research Unit, killingbeck Hospital, and Department of Mechanic
Comparative Study of the Hydrodynamic Function of the CarboMedics Valve.
The Annals of Thoracic Surgery 1991;52:815-20

Yamauchi M, Eishi K, Nakano K, Sasako Y, Isobe F, Kosakai Y, Kitoh Y, Kawashima Y, From the Department f Cardiovascular Surgery National Card
Valve Replacement with the CarboMedics Bileaflet Mechanical Prosthesis: Clinical Results at Midterm.
The Journal of Cardiovascular Surgery 1996;37:285-9

Carrier M, MD, Pellerin M, MD, Perrault L P, MD, PhD, Pagé P, MD, Hébert Y, MD, Cartier R, MD, Dyrda I, MD, and Con L.
Aortic Valve Replacement With Mechanical and Biologic Prostheses in Middle-Aged Patients.
The Annals of Thoracic surgery 2001;71:S253-6

Andersen P V, MD, Aagaard J, MD Department of Cardiothoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark
Low-Dose Warfarin in Patients With CarboMedics Heart Valve Prostheses.
Asian Cardiovascular Thoracic Annals 2000;8:11-4

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

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