1. Totally Supra Annular Mechanical Heart Valves
LEGGERE:
Totally Supra Annular Mechanical Heart Valves.

2. Heart Valve positioning – annular plane
According to the engineered of the valve, it can be placed in the annulus in a:
INTRA annular positioning
PARTIALLY SUPRA annular positioning
TOTALLY SUPRA annular positioning
Annulus plane
Annulus plane
LEGGERE:
According to the specific design, a Mechanical Heart Valve can be placed in tree different positions in the annulus of the patient: intra annular, partially supra annular or totally supra annular.
Annulus plane

3. Heart Valve positioning – valve components
The valve components that stay INSIDE the patient anuulus are:
INTRA: housing and sewing cuff.
PARTIALLY SUPRA: housing.
TOTALLY SUPRA: none.
LEGGERE
If a valve is placed in an Intra annular positioning, its housing and sewing cuff components will be inside the annulus of the patient.
If a valve is placed in a Partially Supra annular positioning, its housing will be the only component to be placed inside the annulus of the patient.
If a valve is placed in a Totally Supra annular positioning, there will be no components inside the annulus of the patient but all of them (meaning housing, leaflets and sewing cuff) will be above the annulus, seated on it.

4. Heart Valve positioning – dimensions
INTRA annular positioning: The space left to blood flow (IOD) is very limited due to sewing cuff + housing staying inside the patient annulus. So the External Diameter (ED) of the valve will fulfill the patient Tissue Annulus Diameter (ED=TAD).
LEGGERE
If a Mechanical Valve has an intra annular seating, the space left to the blood flow (identified as Internal Orifice Diameter) is very limited due to the presence inside the annulus of the sewing cuff and the housing. So the reported External Diameter of the valve will correspond to the tissue annulus diameter of the patient.

5. Heart Valve positioning – dimensions
PARTIALLY SUPRA annular positioning: The space left to blood flow (IOD) is limited due to the housing staying inside the patient annulus. So the External Diameter (ED) of the valve excluding the sewing cuff, will fulfill the patient Tissue Annulus Diameter (ED=TAD).
LEGGERE
If a Mechanical Valve has a partially supra annular seating, the space left to the blood flow (identified as Internal Orifice Diameter) is still limited due to the presence inside the annulus of the housing only, because the sewing cuff is placed above the annulus of the patient. So the reported External Diameter of the valve, sewing cuff excluded, will correspond to the tissue annulus diameter of the patient.

6. Heart Valve positioning – dimensions
TOTALLY SUPRA annular positioning: The space left to blood flow (IOD) is NOT limited by valve components. So the Internal Orifice Diameter of the valve (IOD) is totally available to blood from passing through and it corresponds to the patient Tissue Annulus Diameter. (IOD=TAD).
LEGGERE
If a Mechanical Valve has a totally supra annular seating, the space left to the blood flow (identified as Internal Orifice Diameter) will not be limited by any valve component. So the Internal Orifice Diameter of the valve is totally available to the blood for passing through. The Internal Orifice Diameter of the valve will than correspond to the tissue annulus diameter of the patient.

7. Heart Valve positioning – sitting comparison
Given a common patient Tissue Annulus Diameter, the Internal Orifice accessible to the blood flow will be maximized only in the TOTALLY SUPRA annular valve:
LEGGERE
Given a common patient Tissue Annulus Diameter, the valve Internal Orifice accessible to the blood flow will be maximized only in a TOTALLY SUPRA annular valve. Please take your time to look at the comparison picture.

8. MHVs available on the mkt
Low
High
Hemodynamic performance
Annulus positioning
Intra Annular
Partially Supra Annular
Totally Supra Annular
ATS Standard
SJM Standard
Bicarbon Overline
Carbomedics Top Hat
SJM HP Regent
ONX
ATS AP 360
Bicarbon Slimline
Bicarbon Fitline
Carbomedics Standard and Reduced
LEGGERE:
Please take your time to read the position matrix for Sorin Group products and competition according to the annular positioning and the resulting hemodynamic valve performance.
Please note that the only Totally Supra Annular Mechanical Heart Valves available on the market are Bicarbon Overline and Carbomedics Top Hat, manufactured by Sorin Group.

9. MHVs available on the mkt – INTRA annular
LEGGERE:
Please take your time to read about the technical specifications of all the Intra Annular mechanical valve models available on the market.

10. MHVs available on the mkt – PARTIALLY supra annular
LEGGERE:
Please take your time to read the technical specifications of all the Partially Supra Annular mechanical valve models available on the market.

11. MHVs available on the mkt – TOTALLY SUPRA annular
LEGGERE:
Please take your time to read the technical specifications of the Totally Supra Annular models available on the market.
Note that the only Totally Supra Annular Mechanical Heart Valve models available on the market are Sorin Carbomedics Top Hat and Sorin Bicarbon Overline.

12. Sorin TOTALLY SUPRA annular MHVs
The only one fitting small annulus as 15 and 16 mm.
The only one that guarantee the largest EOA improving hemodynamic.
LEGGERE
The Sorin Totally Supra annular Mechanical Heart Valves are the only one fitting small annuli as 15 and 16 millimeter, and the only one that guarantee the largest Effective Orifice Area improving hemodynamic performance.
Please note in red that, giving a common patient annulus diameter of 15 millimeter, the only mechanical valves able to fit are Carbomedics Top Hat labeled size 19 and Bicarbon Overline labeled size 16.
Please note in black that the Effective Orifice Areas of the Carbomedics Top Hat and Bicarbon Overline are always higher than the competition.
Please note in blue that, giving a common patient annulus diameter of for example 19 millimeter, Carbomedics Top Hat and Bicarbon Overline labeled sizes are always higher than the competition. So be careful when comparing the Sorin totally supra annular mechanical heart valves to the competitive partially supra annular models.

13. TOTALLY SUPRA annular MHVs
The only TOTALLY SUPRA annular MHVs available on the market are:
Sorin Carbomedics Top Hat Sorin Bicarbon Overline
LEGGERE
Remember that the only totally supra annular mechanical valves available on the market are Carbomedics Top Hat and Bicarbon Overline made by Sorin Group.
Engineered to perform for better patient outcome.

14. Sorin TOTALLY SUPRA Mechanical Heart Valves: key design feature for benefits
TOTALLY SUPRA annular valve: 100 % orifice-to-annulus ratio increases flow by over 40 %.
LEGGERE
Thanks to the specific design, the totally supra annular mechanical valves guarantee 100% orifice to annulus ratio leading to an increase of blood flow up to 40%.

15. Sorin TOTALLY SUPRA Mechanical Heart Valves: key design feature for benefits
The specific TOTALLY SUPRA annular seating leads to:
Prosthesis – annulus 1 to 1 ratio: reduction of PPM also in difficult anatomies; high hemodynamic performance.
Accommodation to diverse annulus anatomies as small aortic.
Reduction of surgical complexities and delivers superior performances: no need to perform root enlargement.
Ideal for DVR: limited interference Mitral - Aortic valves.
LEGGERE
The specific design features of the totally supra annular mechanical valves load to specific patient benefits such as:
Reduction of Patient Prosthesis Mismatch also in difficult anatomies.
Accommodation to diverse annulus anatomies.
Reduction of surgical complexities and no need to perform root enlargement.
Ideal for DVR.

16. Sizing and suturing technique
Totally Supra Annular
Sizing and suturing technique

17. Sizing Trust your sizers! Easy sizing New Sizers & Sizing
Easier, Simpler, more accurate:
Surgeon will implant the right valve size.
Outer Diameter
Internal Diameter
Trust your sizers!

18. Recommended suturing techniques*
* Recommended for Totally Supra Annular seating valves: it doesn’t constrict the annulus to the sewing cuff.

19. NOT recommended suturing techniques* *
* Not recommended for Totally Supra Annular seating valves.

20. Hemodynamic comparisons
LEGGERE:
In the present section you will learn about the Effective Orifice Area Indexed comparisons between Sorin Group and competitors’ models.
EOAI

21. Hemodynamic comparisons - EOAI
Given a common TAD of 19 mm the Bicarbon and Carbomedics TOTALLY SUPRA annular valves:
Are the largest sizes implantable.
Have the highest EOA.
Have no PPM.
LEGGERE
The present chart reports which are the labeled sizes by different manufacturer of mechanical heart valves that fit a patient annulus of 19 millimeter.
You can note that Carbomedics Top hat and Bicarbon Overline are the largest valves possible to implant and record the highest effective orifice areas if compared with competition.
According to Pibarot’s publication in 2000, the risk of moderate patient prosthesis mismatch with Carbomedics Top Hat and Bicarbon Ovelrine is very limited and the risk of severe patient prosthesis mismatch is absent.

22. Hemodynamic performance – Bicarbon Overline
LEGGERE:
In the present section you will learn about the mean and peak gradients with the totally supra annular Bicarbon Overline.
Mean and Peak gradients

23. Hemodynamic performance – Mean and Peak Gradients
Results of Aortic Valve Replacement with the Supra- Annular Sorin Bicarbon Overline Prosthesis - Reyes G., Badia S., Alvarez P., Kallmeyer C., Rodriguez S., Sarraj A., Bustamante J. - The Journal of Heart Valve Disease 2012; 21:
N. of patients
168
Mean age (yrs)
62 ± 9.9
Males
61.9%
Logistic EuroSCORE
6.3 ± 7.4
Mean FU (yrs)
2.3
LEGGERE
The present study by Doctor Reyes reports the Results of Aortic Valve Replacement with the Supra Annular Sorin Bicarbon Overline Prosthesis.
Please take your time to look at the patients’ characteristics and valve size distribution.

24. Hemodynamic performance – Mean and Peak Gradients
Mean Pressure Gradients (mmHg)
(n=168)
Peak Pressure Gradients (mmHg)
(n=168)
42 ± 19
67 ± 29
mmHg
13 ± 5
mmHg
24 ± 8
MPG (mmHg) split per size
PPG (mmHg) split per size
78 ± 24
50 ± 17
64 ± 21
62 ± 32
44 ± 19
37 ± 19
LEGGERE:
Please take your time to read the Mean and Peak Pressure Gradients and the split by Bicarbon Overline sizes.
mmHg
mmHg
26 ± 8
23 ± 8
24 ± 9
15 ± 6
12 ± 4
12 ± 5
Size 18
(n=27)
Size 20
(n=51)
Size 22
(n=24)
Size 18
(n=27)
Size 20
(n=51)
Size 22
(n=24)

25. Hemodynamic performance – Mean and Peak Gradients
Study conclusions:
The decrease in Peak and Mean Gradients was statistically significant (p<0.001) from the preoperative values.
Effective Orifice Area (EOA) was significantly increased from 0.80 ± 0.41 cm2 before surgery to 2.01 ± 0.26 cm2 after 12 months.
No cases of Patient Prosthesis Mismatch (PPM) were observed despite the use of 18 and 20 mm valves.
LEGGERE
The study conclusions report that the decrease in Peak and Mean Gradients was statistically significant from the preoperative values; the Effective Orifice Area was significantly increased after 12 months of follow up; No cases of Patient Prosthesis Mismatch were observed despite the use of 18 and 20 millimeter valves.

26. Hemodynamic performance comparison
LEGGERE:
In the present section you will learn about the Sorin Bicarbon Overline hemodynamic performance versus competition.
Bicarbon Overline vs competition

27. Bicarbon Overline vs high performance competition models – MPG @ 12 months
mmHg
TAD 19
SJM HP: size 19
ATS AP: size 18
Bic. Overline: size 20
TAD 21
SJM HP: size 21
ATS AP: size 20
ONX: size 21
Bic. Overline: size 22
LEGGERE:
Please take your time to read the Mean Pressure Gradients for the totally supra annular Bicarbon Overline versus partially supra annular competitive models in patient annuli of 19 millimeter and 21 millimeter.
Please note that the Bicarbon Overline implanted sizes are always bigger than competition and that the mean pressure gradients recorded are always lower than the competition.

28. Bicarbon Overline vs high performance competition models – PPG @ 12 months
30,3
mmHg
TAD 19
SJM HP: size 19
ATS AP: size 18
Bic. Overline: size 20
TAD 20
SJM HP: size 21
ATS AP: size 20
ONX: size 21
Bic. Overline: size 22
LEGGERE:
Please take your time to read the Peak Pressure Gradients for the totally supra annular Bicarbon Overline versus partially supra annular competitive models in patient annuli of 19 millimeter and 21 millimeter.

29. Take Home Messages
Sorin Group is the only company with Totally Supra Annular MHVs models that are:
Able to accommodate to any anatomy especially small annuli (15-16mm).
Ideal for DVR (limitation of Aortic-Mitral prostheses interference).
Bigger sizes than standard Intra or Partially Supra Annular valves.
Able to:
Reduce Pressure Gradients.
Maximize EOA.
Reduce PPM.
LEGGERE
Take home messages.
Sorin Group is the only company having in its portfolio Totally Supra Annular Mechanical Heart Valves.
The Totally supra annular mechanical valves have specific key features that make them unique:
Able to accommodate to any anatomy, especially small annuli.
Ideal for Double Valve Replacement.
Bigger sizes than standard Intra or Partially Supra Annular valves from competition can be implanted .
Are able to Reduce Pressure Gradients, Maximize the Effective Orifice Areas and reduce patient prosthesis mismatch.