BILEAFLET MECHANICAL HEART VALVE

BICARBON FAMILY

THE UNIQUE VAL VE OFFERS OPTIMUM HAEMODYNAMIC AND CLINICAL PERFORMANCE WITH EXCELLENT IMPLANTABILITY

Sorin Biomedica's background as an advanced nuclear research centre provides the foundation for its ceaseless commitment to achieving absolute levels of quality and reliability. Sorin Biomedica Cardio carries on the mission of successfully combining innovative designs, exclusive technologies and first class production capabilities in manufacturing high quality heart valve prostheses. As health care professionals and their patients continue to benefit from the company's long history of providing original medical solutions, Sorin Biomedica Cardio can look back at the past with pride and to the future with great confidence.

BICARBON

Proving Optimum Clinical Performance

The technical characteristics of the Bicarbon TM Heart Valve Prostheses continue to provide excellent results in extensive ongoing clinical evaluations. No structural failure has been reported after 15 years of use and over 165,000 implants worldwide. Superior haemodynamics, durability and safety, negligible thromboembolic complication rates, very low subclinical haemolysis and ease of implantation are the results of constant interaction between Sorin Biomedica Cardio and the Medical Community. The unique combination of clinically proven BicarbonTM design features are:

New soft Carbofilm

sewing rings

TM

coated (PET)

Titanium Carbofilm coated housing Innovative hinge mechanism Aerofoil housing profile Curved pyrolytic carbon leaflets
TM

BicarbonTM Heart Valves continue to provide safety and reliability as the range of models widens and evolves. From the Fitline to the Overline series the BicarbonTM Family offers the perfect solution t o e v e r m o r e demanding patient and surgeon needs.

B I C A R B O N Haemodynamics

Bicarbon takes the bileaflet mechanical valve design one step ahead. Its unique combination of optimized leaflet curvature, large orifice area, aerofoil housing profile and leaflet opening angle result in a superior haemodynamic performance.

The aerofoil housing profile, which gently decreases in width from the inflow towards the outflow side, is intended to optimize The curved profile of the BicarbonTM leaflets separates the valve orifice into three areas, each offering equal resistance to blood flow. This favours laminar blood flow on the outflow side, minimizing turbulence.
BICARBON SOLUTION
WIDE LEAFLETS FLAT LEAFLETS
TM

the organization of the flow. This minimizes blood turbulence, favours pressure recovery and guarantees surface continuity with the suture ring.

The Titanium alloy housing provides optimum rigidity and safety while offering a larger orifice area.

BICARBON SOLUTION

TM

SIZE 27 - Pulsatile conditions.

V m/s 2.0 1.5 1.0 T = 108 ms f = 70 /min Q = 70 ccm 0.5 0
MEASUREMENT AXIS MEASUREMENT VELOCITY PROFILE

80 Opening Angle
The opening angle/curved
The figure shows the velocity profile at peak flow, 108 ms after start of systole. The main features are: three peaks, and essentially flat velocity profile across the whole measurement axis. No recirculation at the right wall and a wash-out vortex within the sinus cavity. Peak reaches only 1.12 m/s. Reul et al (1).

60 Travel Arc
The short travel arc means low regurgitation levels and low energy loss.

leaflet combination minimizes turbulence.

B I C A R B O N Haemodynamics
SJM = ST. JUDE MEDICAL CM = CARBOMEDICS SO = SORIN BICARBONTM

Bicarbon takes the bileaflet mechanical valve design one step ahead. Its unique combination of optimized leaflet curvature, large orifice area, aerofoil housing profile and leaflet opening angle result in a superior haemodynamic performance.

MEAN SYSTOLIC PRESSURE DIFFERENCE at 3.0 - 4.5 - 6.5 - 8.0 L/min C.O.
PULSATILE CONDITIONS
6 5 4

fig.1
SJM = ST. JUDE MEDICAL CM = CARBOMEDICS SO = SORIN BICARBONTM

REGURGITATION at 3.0 - 4.5 - 6.5 - 8.0 L/min C.O.

25.0

fig.4

% OF STROKE VOLUME

mmHg

20.0 15.0 10.0 5.0 0

3 2 1 0

SJM

CM SIZE 27

SO LEAKAGE CLOSURE

As a result of the specific mechanical properties of the valves, and particularly the considerably larger internal orifice diameter of Sorin BicarbonTM, the mean systolic pressure differences varied more than a factor 2 between Sorin Bicarbon and the other valves. Reul et al (1).
PPG MPG

SJM

CM SIZE 27

SO

BicarbonTM has the lowest regurgitation, especially at low cardiac outputs. Reul et al (1)

PEAK AND MEAN PRESSURE GRADIENTS (PPG and MPG) fig.2 25

20 15

ENERGY LOSS
ST. JUDE MEDICAL heart valve, HP cuff CARBOMEDICS ST. JUDE MEDICAL heart valve, Standard cuff ATS SORIN BICARBONTM
500 400

fig.5

mmHg

(mJ)

10 5 0

300 200 100

19

21

23

25

27

29
0

SIZES

Doppler echocardiographic characteristics of 226 consecutive patients were prospectively assessed at a mean follow up of 10 6 months after surgery. One hundred and sixty-six patients were implanted in the aortic position. Badano L. et al. (2)

Cycle Rate 60 b/min Stroke Volume 60 ml

72 b/min 70 ml

80 b/min 80 ml

100 b/min 80 ml

SIZE 19

EFFECTIVE ORIFICE AREA

ST. JUDE MEDICAL

in vivo aortic position

SORIN BICARBONTM

fig.3
2.5 2

The total energy loss across St. Jude HP and Sorin BicarbonTM valves was significantly lower (P<0.05) than for the other four valves. However the difference in energy loss between the St. Jude HP and the Sorin BicarbonTM was small and not statistically significant. Fisher (4).

1.5 1 0.5 0 19mm 21mm 23mm 25mm

SIZES

These outstanding design features favour Low pressure gradients (fig.1 -2) Large effective orifice area (fig.3) Low regurgitation levels (fig.4) Low energy loss (fig.5)

Doppler evaluation of aortic prosthesis under rest conditions in 76 patients (39 St. Jude Standard, 37 Bicarbon T M ) after 3-4 months of follow-up. Flameng et al (3).

(cm2)

B I C A R B O N Durability

Titanium housing, unique hinge mechanism, composite sewing ring and Carbofilm TM coating ensure safety and durability.

PET fabric and CarbofilmTM coating are used in the suture ring to ensure: Tissue ingrowth to minimize the risk of perivalvular leaks. Biocompatibility to minimize pannus formation.
PTFE felt

The Titanium housing ensures correct leaflet retention with twice the
Double velour PET fabric

structural stability and only half the width of solid Pyrolytic Carbon housings. Biocompatibility is assured by the all-over CarbofilmTM coating.
HOUSING - STRUCTURAL STIFFNESS
30 25
force (kgf) CarbofilmTM coated titanium alloy (BicarbonTM)

PET fabric Carbofilm coated

TM

Polyacetal sleeve

Polyester suture yarns Carbofilm coated

TM

20 15 10 5 0.2 0.4 0.6 0.8 deflection (mm)

pyrolytic carbon

Titanium alloy housing Carbofilm coated

TM

Rolling without sliding is the secret of the unique hinge design. (Pyrolytic carbon housings can not offer this option). Friction and wear are minimized by the constantly varying single point of contact between the pivot and the housing. Fewer elements with superior structural properties in Bicarbons simpler assembly means no problems with mechanical failure.

No structural failure has been reported in 15 years of clinical use (1 -14)

BICARBON SOLUTION
TM

B I C A R B O N Thromboresistance
The combination of optimized curved leaflets and the 80 opening angle is intended to generate downstream laminar flow, minimizing turbulence and consequent blood damage.

Unique hinge mechanism, aerofoil housing profile, composite sewing ring and CarbofilmTM coating lead to excellent thromboresistance.

The inflow and outflow portions of the sewin ring are coated with CarbofilmTM to increase the haemocompatibility.

THROMBOEMBOLIC EVENTS

fig.6
Linearized rates % pt-yr

1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 0.3

1.5

THROMBOSIS EMBOLISM

0.9

0.93

0.15 0

Two effluent chimneys permit continuous washing even when the valve is closed. This design feature drastically reduces the risk of blood stasis and the consequent impairment of hinge efficiency.

J. B. Borman et al (6) I. Goldsmith et al (7) F. Casselman et al (8)

CALCULATION OF THE BLOOD DAMAGE INDEX (BDI).

fig.7

1,6 1,4 1,2

SO = SORIN BICARBONTM SJM = ST. JUDE MEDICAL CM = CARBOMEDICS

The aerofoil profile of the housing minimizes turbulence

BDI (10 6)

and blood stasis close to the patient annulus.

1 0.8 0.6 0.4 0.2 0 SO SJM SIZE 27 CM

Hb (red blood cells) LDH (platelets)

The pyrolytic carbon leaflets and the biocompatible Carbofilm

TM

Haemolytic potential was evaluated in BicarbonTM, St. Jude, Carbomedics size 27 in Mitral position during the closed phase (pulsatile conditions).
Sorin BicarbonTM had significantly lower BDI for Red Blood Cell damage, as well as for platelet damage; this was validated by direct haemolysis measurements. Reul et al (5).

coated housing are mirror polished.

B I C A R B O N Implantability

Different sewing ring configurations, rotatability and functional accessories make Bicarbon TM easy to implant.

A complete range of sewing rings featuring different configurations to meet the demands of diverse anatomical and pathological conditions.

Housing and leaflets are radiopaque for easy visualization of anatomical position and leaflet motion during cinefluoroscopy. All components are MRI compatible.

X-ray image

The sewing cuff is mounted on a Polyacetal sleeve with an inner rib which fits flush in a groove on the housing. Orientation of the implanted valve is facilitated by the sleeve coupling, which maintains torque at a constant level.

The BicarbonTM Series Accessory Kits offer a comprehensive and versatile solution to the requirements of surgeons. Universal Sizers, Rotators, Universal sizer Handles and Valve Holder Handle all presented in a new, light and functional box.
(For more details see the BICARBON SERIES ACCESSORY KIT document ICO 870 001 105)

NEW SOFT, PLIABLE CUFF.

Three suture markers on the sewing ring of the aortic valve and four on the mitral provide precise guidance for more accurate placement. BicarbonTM Fitline and BicarbonTM Slimline have new soft and pliable cuff, easier to handle and faster to implant.

B I C A R B O N Models
B ICARBON
TM

B I C A R B O N References
INTRA-ANNULAR MODEL
1. A single centre experience on the Bicarbon heart valve proshesis: long term results D.C. Whitaker, R.K. Walesby J Heart Valve Dis 2004; 13(1):97-102

AORTIC
SIZE 19 21 23 25 REF ART 19 LN ART 21 LN ART 23 LN ART 25 LN ART 27 LN ART 29 LN ART 31 LN CODE PO418 PO419 PO420 PO421 PO422 PO423 PO424

MITRAL
SIZE 19 21 23 25 REF MTR 19 LS MTR 21 LS MTR 23 LS MTR 25 LS MTR 27 LS MTR 29 LS MTR 31 LS MTR 33 LS CODE PO425 PO426 PO427 PO428 PO429 PO430 PO431 PO432

2. "Serial doppler echocardiographic evaluation of small-sized Sorin Bicarbon prostheses" M. De Carlo, A.D. Milano, C. Nardi, G. Mecozzi, U. Bortolotti J Thorac Cardiovasc Surg 2003; 126(2):337-43 3. "Comparative evaluation of small-size Sorin Slimline and St. Jude HP heart valve prostheses." Otero et al. Ann Thorac Surg. 2005 Apr; 79(4):1284-90 4. "Midterm evaluation of the Sorin Bicarbon heart valve prothesis: single-center experience" N. Vitale, G. Cappabianca, G. Visicchio, C. Fondacone, V. Paradiso, G. Mannatrizio, L. de Luca Tupputi Schifosa The Annals of Thoracic Surgery 2004; 77: 527-531 5. Sorin Bicarbon bileaflet valve: a ten year experience J.B. Borman, C. De Riberolles Eur J Cardio Thorac Surg 2003; 23(1):86-92 6. Evaluation of valve-related complications in patients with Sorin Bicarbon prosthesis: a 7-year experience U. Bortolotti, A. Milano, A.DAlfonso, C. Piccin, P. Magagna, A. Fabbri, A. Mazzucco J Heart Valve Dis 2001; 10: 795-801

The Bicarbon Aortic valve features a pliable cylindrical cuff designed for partially supra-annular seating.

TM

27 29 31

The Bicarbon T M Mitral valve features a large compliant cuff designed to conform to the irregularities of difficult annuli, minimizing the potential of perivalvular leakage.

27 29 31 33

B ICARBON FITLINE
TM

INTRA-ANNULAR MODEL

AORTIC
SIZE
REF

MITRAL
CODE SIZE REF CODE

7. Intravascular hemolysis in patients with new-generation prosthetic heart valves: a prospective study G. Mecozzi, A.D. Milano, M. DeCarlo, F. Sorrentino, S. Pratali, C. Nardi, U. Bortolotti J Thorac Cardiovasc Surg 2002; 123(3): 550-6 8. Bicarbon valve European multicenter clinical evaluation J.B. Borman, W.G.B. Brands, L. Camilleri, M. Cotrufo, W. Daenen, I. Grandjbakhch, C. Infantes, A. Khayat, F. Laborde, A. Pellegrini, A. Piwnica, B. Reichart, R. Sharony, R. Walesby, H. Warenbourg Eur J Cardio Thorac Surg 1998; 13:685-93 9. Evaluation of the Sorin Bicarbon Bileaflet valve in 488 patients (519 prostheses) Ira Goldsmith, Gregory Y.H. Lip, Ramesh L. Patel Am J Cardiol 1999; 83:1069-74 10. The Bicarbon heart valve prosthesis: short-term results P. Casselman, P. Herijgers, B. Meyns, W. Flameng, W. Daenen J Heart Valve Dis 1997; 6(4):410-15 11. Single centre experience with the Bicarbon bileaflet prosthetic heart valve in Japan Y. Misawa, T. Saito, S. Oki, Y. Kaminishi, Y. Tezuka, K. Aizawa, H. Takahashi, N. Hasegawa, O. Kamisawa, M. Kato, K. Fuse Art Organs 2002; 26(10):856-61 12. Clinical experience with Sorin Bicarbon valve in patients with tight mitral valve stenosis and elevated pulmonary hypertension (early and mid-term results) N. Erdil, L. Cetin, V. Nisanoglu, U. Dermirkilic, E. Sener, H. Tatar J Cardiovacular Surg 2002; 43(4):423-7 13. Haemodynamic performance of the 21mm Sorin mechanical aortic prosthesis using dobutamine doppler echocardiography I. Radir, I.Y.P. Wan, C. Walsh, P. Wilde, A.J. Bryan, G.D. Angelini Ann Thorac Surg 2001; 72:49-53 14. Normal echocardiographic characteristics of the Sorin Bicarbon bileaflet prosthetic heart valve in the mitral and aortic positions L. Badano, R. Moccheggiani, D. Bertoli, G. De Gaetano, L. Carratino, L. Pasetti, M. Caudullo, A. Budini, B. Mannello,G. Passerone J Am Soc Echocardiogr 1997; 10:632-43 15. "Small aortic annulus: the hydrodynamic performances of 5 commercially available bileaflet mechanical valves" T. Bottio, L. Caprili, D. Casarotto, G. Gerosa J Thorac and Cardiov Surg 2004; 128(3):457-432 16. Postoperative haemodynamics of two bileaflet heart valves in aortic position W. Flameng, A. Vandelplas, K. Narine, W. Daenen, P. Herijgers J Heart Valve Dis 1997; 6:269-73

19 21 23 25 27 29 31

ART 19 LFA ART 21 LFA ART 23 LFA ART 25 LFA ART 27 LFA ART 29 LFA ART 31 LFA

ICV0917 ICV0918 ICV0919 ICV0920 ICV0921 ICV0922 ICV0923

19 21 23

MTR 19 LFM MTR 21 LFM MTR 23 LFM MTR 25 LFM MTR 27 LFM MTR 29 LFM MTR 31 LFM MTR 33 LFM

ICV0924 ICV0925 ICV0926 ICV0927 ICV0928 ICV0929 ICV0930 ICV0931

The Bicarbon Fitline Aortic valve features a conical cuff for precise intraannular seating. The new soft sewing cuff allows for a better handling and suturability.

TM

The BicarbonTM Fitline Mitral valve has a reduced cuff, convenient for continuous suturing and easier handling.

25 27 29 31 33

B ICARBON SLIMLINE PARTIALLY SUPRA-ANNULAR MODEL

TM

AORTIC
SIZE REF CODE

The BicarbonTM Slimline Aortic valve features a reduced sewing cuff. The housing seats intra-annular while the suture rings seats supra-annular, so patients may benefit from improved orifice-to-annulus ratio and excellent haemodynamic performance. The new soft sewing cuff allows for a better handling and suturability.

17 19 21 23 25 27

ART 17 LSA ART 19 LSA ART 21 LSA ART 23 LSA ART 25 LSA ART 27 LSA

ICV0934 ICV0935 ICV0936 ICV0937 ICV0938 ICV0939

B ICARBON OVERLINE
TM

TOTALLY SUPRA-ANNULAR MODEL

AORTIC
SIZE 16 REF ART 16 LOV ART 18 LOV ART 20 LOV ART 22 LOV ART 24 LOV CODE ICV0870 ICV0871 ICV0872 ICV0873 ICV0874

17. In vitro comparison of bileaflet aortic heart valve prostheses H. Reul, A.M. Van Son, U. Steinseifer, B. Schmitz, A. Schmidt, C. Schmitz, G. Rau J Thorac Cardiovasc Surg 1992; 106(3):412-20 18. Comparative study of the hydrodynamic function of six 19mm heart valves J. Fisher Eur J Cardio Thorac Surg 1995; 9:692-6 19. Leakage flow at mechanical heart valve prostheses: improved washout or increased blood damage? Steegers, R. Paul, H. Reul, G. Rau J Heart Valve Dis 1999; 8:312-23

The BicarbonTM Overline aortic valve has been designed for a totally supraannular seating , resulting in a maximization of blood flow.

18 20 22 24

Hydrodynamic Characteristics
BICARBON / BICARBON FITLINE

B I C A R B O N
Specifications
B ICARBON
TM

MATERIALS Leaflets: pyrolytic carbon deposited on graphite substrate Housing: titanium alloy (Ti6A14V) coated with Carbofilm Suture ring: polyacetal sleeve, polytetrafluoroethylene and polyetylene terephthalate fabrics, Carbofilm

All dimensions are nominal

SORIN IN VITRO DATA frequency: 70 bpm; mean aortic pressure: 100 mmHg; aortic position
Systolic pressure drop in pulsatile flow at 4.5 l/min C.O.

SIZE

19

21

23

25

27

29

31

33

B (mm) 19.0 21.2 23.4 25.6 27.8 30.0 32.0 34.0

20

P (mm Hg)

aortic models
10

C (mm) 24.0 26.5 28.5 30.5 33.0 35.5 36.5

mitral models
0 19 21 23 25 27 29

C (mm) 27.5 31.5 34.0 37.5 40.4 42.5 44.5 46.5 6.4 6.8 7.2 7.6 8.0 8.0 8.0

H (mm) 6.0

Prosthesis size

The shaped orifice features inlet diameters which vary in accordance with the aerofoil housing profile (A=min. dimension, A**=max. dimension). The mean value (A*) may be assumed for calculation of the geometric orifice area (O.A.*), which better represents valve performance.

Aortic models: 19 - 31
Regurgitation in pulsatile flow at 4.5 l/min C.O.
20
Leakage volume Closure volume

Mitral models: 19 - 33

B = Tissue Annulus Diameter (TAD) C = External Suture Ring Diameter H = Housing Height

BICARBON/ BICARBON FITLINE

SIZE A (mm) 19 21 23 25 27 29-33 15.2 17.2 19.2 21.3 23.3 25.6 15.5 17.6 19.6 21.7 23.8 26.1 1.76 2.27 2.83 3.45 4.14 5.00

B ICARBON FITLINE
TM

15

% stroke volume

SIZE

19

21

23

25

27

29

31

33

A* (mm) O.A. (cm )

2

10

B (mm) 19.0 21.2 23.4 25.6 27.8 30.0 32.0 34.0

O.A.* (cm2) 1.82 2.33 2.91 3.55 4.26 5.12

C (mm) 23 aortic models

mitral models
19 21 23 25 27 29

25.5

28

30.5

33

35.5 36.5

E.O.A. (cm2) 1.58 2.03 2.57 3.20 3.86 4.73

C (mm) 25.5 27.5 30.0 33.0 35.0 38.5 40.5 42.5 6.4 6.8 7.2 7.6 8.0 8.0 8.0

Prosthesis size

H (mm) 6.0

BICARBON SLIMLINE
SIZE A (mm) A* (mm)
2

BICARBON SLIMLINE

Aortic models: 19 - 31

Mitral models: 19 - 33

B = Tissue Annulus Diameter (TAD) C = External Suture Ring Diameter H = Housing Height

17

19

21

23

25

27

15.2 17.2 19.2 21.3 23.3 25.6 15.5 17.6 19.6 21.7 23.8 26.1

SORIN IN VITRO DATA frequency: 70 bpm; mean aortic pressure: 100 mmHg; aortic position
Regurgitation in pulsatile flow at 4.5 l/min C.O. Systolic pressure drop in pulsatile flow at 4.5 l/min C.O.
20
20
Leakage volume Closure volume

B ICARBON SLIMLINE
TM

O.A. (cm ) 1.76 2.27 2.83 3.45 4.14 5.00

SIZE

17

19

21

23

25

27

O.A.* (cm2) 1.82 2.33 2.91 3.55 4.26 5.12 E.O.A. (cm2) 1.58 2.03 2.57 3.20 3.86 4.73

% stroke volume

15

P (mm Hg)

B (mm) C (mm)
aortic models

17.2 22 6.0

19.2 24 6.4

21.3 27 6.8

23.4 29 7.2

25.6 32 7.6

28.0 34

10

10

0 17 19 21 23 25 27

BICARBON OVERLINE
8.0
SIZE A (mm) A* (mm) O.A. (cm ) O.A.* (cm )
2 2

Prosthesis size

H (mm)
0 17 19 21 23 25 27

16 15.2 15.5 1.76 1.82

18 17.2 17.6 2.27 2.33 2.03

20 19.2 19.6 2.83 2.91 2.57

22 21.3 21.7 3.45 3.55 3.20

24 23.3 23.8 4.14 4.26 3.86

Prosthesis size

Aortic models: 17 - 27

BICARBON OVERLINE
SORIN IN VITRO DATA frequency: 70 bpm; mean aortic pressure: 100 mmHg; aortic position
Regurgitation in pulsatile flow at 4.5 l/min C.O.

B = Tissue Annulus Diameter (TAD) C = External Suture Ring Diameter H = Housing Height

B ICARBON OVERLINE
TM

SIZE
Systolic pressure drop in pulsatile flow at 4.5 l/min C.O.
20
20
Leakage volume Closure volume

16 15.5 17.2 24 6.0

18 17.6 19.2 26 6.4

20 19.6 21.3 28 6.8

22 21.7 23.4 30 7.2

24 23.8 25.6 32 7.6

E.O.A. (cm ) 1.58

A (mm) B (mm)

10

% stroke volume

15

10

C (mm)
aortic models

0 16 18 20 22 24

H (mm)
0 16 18 20 22 24

A = Internal Orifice Diameter (Minimum value) = Internal Orifice Diameter (Mean value) A* A** = Internal Orifice Diameter (Max value) O.A. = Internal Orifice Area (Minimum value) O.A.* = Internal Orifice Area (Mean value) E.O.A. = Effective Orifice Area - measured at 70 b.p.m., mean value over range: 3.0/4.5/6.5/8.0 l/min C.O., 100 mmHg mean aortic pressure.

P (mm Hg)

Prosthesis size

Prosthesis size

Aortic models: 16 - 24

A = Internal Mean Orifice Diameter B = Tissue Annulus Diameter (TAD) C = External Suture Ring Diameter H = Housing Height

Manufactured by: Sorin Biomedica Cardio Srl Tel. +39 0161 487472 Fax +39 0161 487316 13040 Saluggia, VC, Italy

www.sorin.com