HYDRODYNAMIC RESULTS

Comparative study of the hydrodynamic function of six sizes 19 mm bileaflet heart valves.
J. Fischer - Eur J Cardiothorac Surg. 1995;9(12):692-5 discussion 695-6.

This figure shows that the largest effective orifice area during forward flow was calculated for Sorin Bicarbon valves.

This figure "shows the mean (± one standard deviation) pressure difference across the valve as a function of root mean square forward flow for the four flow conditions. The pressure difference across all six valves increased as the flow increased [...]. The HP and Bicarbon valves had the lowest pressure differences and these were significantly lower than the other four devices"

In vitro comparison of bileaflet aortic heart valve prostheses. St. Jude Medical, CarboMedics, modified Edwards-Duromedics, and Sorin-Bicarbon valves.
Reul H et al. J - Thorac Cardiovasc Surg. 1993 Sep;106(3):412-20.

HEMODYNAMIC PERFORMANCE

Comparative evaluation of small-size Sorin Slimline and St. Jude HP heart valve prostheses.
Otero E, Pomar JL, Revuelta JM, Rufilanchas JJ. - Ann Thorac Surg. 2005 Apr;79(4):1284-90.
 

 

 

CLINICAL RESULTS

Clinical experience with the Bicarbon heart valve prosthesis.
Misawa Y, Saito T, Konishi H, Oki S, Kaminishi Y, Sakano Y, Morita H, Aizawa K - J Cardiothorac Surg. 2007 Jan 25;2:8.

 

Patients: AVR MVR DVR	107 44 48 13
Mean age	61.2 ± 11.3 years
Implant period	February 1997 to December 2000
Follow-up	100% complete mean follow-up 6.1 ± 1.9 year cumulative follow-up 616 years

 

 

Linearized rates	AVR	MVR
Embolism	1.16% pt-yr	0% pt-yr
Thrombosis	0% pt-yr	0% pt-yr
Bleeding	0% pt-yr	1.05% pt-yr
Non-SVD	0% pt-yr	0.35% pt-yr

POST OPERATIVE DATA

 

Authors Comment
"We analyzed the cases of 105 patients who received a Bicarbon prosthetic heart valve implantation at the mitral and/or aortic position. This long-term single center study with a Bicarbon prosthetic heart valve shows excellent clinical results associated with a low incidence of valve related mortality and morbidity." 

Hemolysis in mechanical bileaflet prostheses: experience with the Bicarbon valve.
Josa M, Castellá M, Paré C, Bedini JL, Cartañá R, Mestres CA, Pomar JL, Mulet J. - Ann Thorac Surg. 2006 Apr;81(4):1291-6. 18

Aortic model: intra-annular position

SIZE	REF	CODE
19 mm	ART 19 LFA	ICV0917
21 mm	ART 21 LFA	ICV0918
23 mm	ART 23 LFA	ICV0919
25 mm	ART 25 LFA	ICV0920
27 mm	ART 27 LFA	ICV0921
29 mm	ART 29 LFA	ICV0922
31 mm	ART 31 LFA	ICV0923

Mitral model

SIZE	REF	CODE
19 mm	ART 19 LFM	ICV0924
21 mm	ART 21 LFM	ICV0925
23 mm	ART 23 LFM	ICV0926
25 mm	ART 25 LFM	ICV0927
27 mm	ART 27 LFM	ICV0928
29 mm	ART 29 LFM	ICV0929
31 mm	ART 31 LFM	ICV0930
33 mm	ART 33 LFM	ICV0931

Bicarbon Fitline valve is composed of leaflets made of pyrolytic carbon deposited on graphite substrate, a titanium alloy coated with Carbofilm housing and a polyacetel support with polytetrafluoroethylene and polyethylene fabrics coated with Carbofilm suture ring.

 

	REF	ARTICLE	DESCRIPTION
	ICV0744 ICV0745	Accessory Kit UNI Cylindrical	Trays + Accessories (with universal Cylindrical Sizers)
	ICV0747 ICV0748	Accessory Kit UNI Profile	Trays + Accessories (with universal Profile Sizers)
	ICV0727	UNI Cylindrical Sizer Set	14 universal cylindrical sizers
	ICV0662	UNI Cylindrical Sizer Set	8 universal cylindrical sizers
	ICV0729	UNI Profile Sizer Set	14 universal profile sizers
	ICV0663	UNI Profile Sizer Set	14 universal profile sizers
	ICV0731	Rotators Set	12 aortic rotators + 12 mitral rotators
	ICV0732	Rotators Set	6 aortic rotators + 6 mitral rotators
	ICV0664	Accessory UNI Handle	1 universal bendable handle to be used with all sizers and mitral rotators
	P0593	Valve holder handle	1 Nitinol bendable handle
	ICV0734 ICV0735	Empty tray	1 empty tray
	VT-100	Occluder tester To be ordered apart (disposable)	10 disposable occluder tester (provided sterile)

Reul H, van Son JAM, Steinseifer U et al.
In vitro comparison of bileaflet aortic valve prostheses: St. Jude Medical, CarboMedics, modified Edwards-Duromedics, and Sorin-Bicarbon™ valves.
J Thorac Cardiovasc Surg 1993;106:412-20.

J.B. Borman, C. De Riberolles
Sorin Bicarbon bileaflet: a ten years experience
Eur J Cardio Thorac Surg 2003; 10: 795-801

Vallana F, Rinaldi S, Galletti PM et al.
Pivot design in bileaflet valves.
ASAIO J; 38: M600-M606, 1992.

Misawa Y et al.
CLINICAL EXPERIENCE WITH THE BICARBON HEART VALVE PROSTHESES.
J Cardiothoracic Surg 2007, 25:2-8

Bottio T, Caprilli L, Casarotto D, Gerosa G.
"Small aortic annulus: the hydrodynamic performances of 5 commercially available bileaflet mechanical valves".
J Thorac Cardiovasc Surg 2004;128(3):457-62

Whitaker D C, James S E, Walesby R K
"A single-center experience of the Sorin Bicarbon heart valve prosthesis: long-term clinical, haematological and haemodynamic results".
J Heart Valve Dis 2004;13:97-102

Vitale N, Cappabianca G, Visicchio G, Fondacone C, Paradiso V, Mannatrizio G.
"Midterm evaluation of the Sorin Bicarbon heart valve prosthesis: single-center experience".
Ann Thoracic Surg 2004;77:527-31

Josa M et al.
HAEMOLYSIS IN MECHANICAL BILEAFLET PROSTHESES: EXPERIENCE WITH THE BICARBON VALVE.
Ann Thorac Surg 2006, 81:1291-6

Erdil N, Cetin L, Nisanoglu V, Dermirkilic U, Sener E, Tatar H.
"Clinical experience with Sorin Bicarbon valve in patients with tight mitral stenosis and elevated pulmonary hypertension (early and mid-term resulys)".
J Cardiovascular Surg 2002;43(4):423-7

Steegers A, Paul R, Reul H et al.
Leakage flow at mechanical heart valve prostheses: Improved washout or increased blood damage?
J Heart Valve Dis 1999;8:312-23.

Di Salvo C, Walesby RK.
Early single centre experience with 192 Sorin Bicarbon™ valves.
J Cardiovasc Surg 1996;37(Suppl. 1):13-15.

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

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