Page 1


Leonardo da Vinci Figure 6. Spirals in art: (1) the drawings of Leonardo da Vinci from Vindzone Library showing spiral flows in the heart cavity.3

La Bockeria et al. European Journal Cardio-thoracic Surgery 2006;295:S251 – S258 3


Enhanced left ventricular mass regression after aortic valve replacement in patients with aortic stenosis is associated with Ayyazimproved Ali, Amit Patel,long-term Ziad Ali, Yasirsurvival Abu-Omar, Amber Saeed, Thanos Athanasiou and John Pepper J Thorac Cardiovasc Surg 2011; 142:285-291 DOI: 10.1016/j.jtcvs.2010.08.084


Plastic Casts of the Left Ventricle Figure 8. Plastic casts of the left ventricle (A. Gorodkov): (1) normal; (2) dilated‌3

3

La Bockeria et al. European Journal Cardio-thoracic Surgery 2006;295:S251 – S258


Francisoco (Paco) Torrent-Guasp Figure 1. Francisco (Paco) Torrent-Guasp.2

Editorital. Torrent-Guasp’s anatomical legacy. European Journal Cardio-thoracic Surgery 2006;295:S18-S20 2


Spiral Flow: unfolding the heart Figure 22. Unscrolling of the myocardial band.

G.D. Buckberg et al. / European Journal of Cardio-thoracic Surgery 29S (2006) S75-S97


Ventricular Rotation Figure 8. Ventricular rotation.1

1

C. Coghlan et al. European Journal Cardio-thoracic Surgery 2006;295:S4-S17


Spiral Flow Figure 4. Right-handed helical flow in the ascending aorta and arch during mid and late systole.

Markl M, Draney MT, Miller DC, et al. J Thorac Cardiovasc Surg 2005;130:456-63


Spiral Flow

Kilner, et al. Circulation 1993;88 [part 1]: 2235-2247


Sinus Circulation

Kilner, et al. Circulation 1993;88 [part 1]: 2235-2247


Spiral Laminar Flow: An Examination of this critical blood flow pattern and the early results of a first in man study. F Vermassen1, J Dick2, JG Houston2, PA Stonebridge2 1 Department of Vascular Surgery, Universitair Ziekenhuis, Ghent 2 Vascular Unit, Tayside University Hospitals Trust, Dund ee

Figure 1. Detecting spiral laminar flow

Figure 2. Characteristic spiral flow pattern in healthy arteries

Non spiral and spiral (helical) flow patterns in stenoses: in vitro observations using spin and gradient echo magnetic resonance imaging (MRI) and computational fluid dynamic modelling. Stonebridge PA, Buckley C, Thompson A, Dick J, Hunter G, Chudek JA, Houston JG, Belch JJ. Int Angiol. 2004 Sep;23(3):276-83.


PROACT Update Status as of Jan. 1, 2013


Enrollment by Group

As of 1/1/2013

– slide 112


AVR High Risk Group Postrandomization Events Event

Major Bleed Minor Bleed Total Bleed

Control (ptyr=675.3) (2.0 – 3.0) N Rate (%/ptyr) 22 3.26 23 3.41 45 6.66

Test (ptyr=606.4) (1.5 – 2.0) N Rate (%/ptyr) 9 1.48 8 1.32 17 2.80

Rate Ratio

95% CI

P-value

0.46 0.39 0.42

0.21-0.99 0.17-0.87 0.24-0.73

0.047 0.021 0.002

(test/control)

Stroke TIA Neurologic Event

3 5 8

0.44 0.74 1.18

5 7 12

0.82 1.15 1.98

1.86 1.56 1.67

0.44-7.77 0.49-4.91 0.68-4.09

0.397 0.448 0.261

Peripheral TE Thrombosis

1 1

0.15 0.15

3 2

0.49 0.33

3.34 2.23

0.35-32.11 0.20-24.56

0.296 0.513

Major Event (Major bleed, stroke, thrombosis) All Above Events

26

3.85

16

2.64

0.69

0.37-1.28

0.234

55

8.14

34

5.61

0.69

0.45-1.06

0.087

Sudden Death Valve-related death

1 1

0.15 0.15

3 2

0.49 0.33

3.34 2.23

0.35-32.11 0.20-24.56

0.296 0.513

Total Mortality

9

1.33

10

1.65

1.24

0.50-3.04

0.643


MVR Group Postrandomization Events Event

Major Bleed Minor Bleed Total Bleed

Control (ptyr=120.2) (2.5 – 3.5) N Rate (%/ptyr) 8 6.66 6 4.99 14 11.65

Test (ptyr=102.8) (2.0 – 2.5) N Rate (%/ptyr) 7 6.81 1 0.97 8 7.78

95% CI

Pvalue

0.98 5.13 1.50

0.31-3.17 0.62-236 0.59-4.12

0.965 0.091 0.360

Rate Ratio (control/test)

Stroke TIA Neurologic Event

4 3 7

3.33 2.50 5.82

1 2 3

0.97 1.95 2.92

3.42 1.28 2.00

0.34-168.5 0.15-15.36 0.46-11.96

0.242 0.784 0.307

Peripheral TE Thrombosis

0 1

0.00 0.83

0 1

0.00 0.97

NA 0.86

NA 0.01-67.13

NA 0.912

Major Event (Major bleed, stroke, thrombosis) All Above Events

13

10.81

9

8.75

1.24

0.49-3.27

0.625

22

18.30

12

11.67

1.57

0.74-3.48

0.206

Sudden Death Valve-related death Total Mortality

0 0

0.00 0.00

1 1

0.97 0.97

NA NA

NA NA

0.278 0.278

1

0.83

2

1.95

0.43

0.01-8.21

0.475


Relationship of TE to Bleed


Summary • AVR High Risk – Hypothesis proven • Non-inferior treatment group • Treatment group meets FDA events criteria (OPC) • In fact, treatment group superior in bleeding event rates. – Application submitted to FDA – Abstract submitted to AATS and accepted • Article and other abstracts to follow

• Follow-up still to short in low risk AVR and MVR for conclusions – Early MVR returns encouraging – Enrollment should close shortly


Proposed Label Change •

Anticoagulation – Patients with On-X® valves should be maintained on long-term warfarin anticoagulation to maintain an International Normalized Ratio (INR) of 1.5 – 2.0 for aortic valve replacement patients and 2.5 – 3.5 for mitral or multiple valve replacement patients. The addition of 81 mg/day of aspirin is also recommended for aortic valve patients able to tolerate aspirin. CAUTION – Studies show stable control of INR provides better clinical results. Also studies show that patients should be regularly monitored and have dose adjustments to avoid INR’s lower than 1.5 or higher than 2.5 for aortic valve patients, as values outside this range are associated with increased risk of adverse events.


Enrollment by Center Center

Total

Current Month

Center

Total

Current Month

Tacoma General, Tacoma

205

3

Forsyth, Winston-Salem

16

1

St. Francis, Indianapolis

88

3

Mary Washington, Fredericksburg

16

1

Maine Medical, Portland, ME

80

3

Beth Israel Deaconess, Boston

15

0

Tucson VA, Tucson

71

0

Baylor, Dallas

15

0

Emory University, Atlanta

71

2

St. Luke’s Roosevelt, New York

15

0

Sentara, Norfolk

55

0

Texas Cardiac, Lubbock

12

0

St. Joseph Mercy, Ann Arbor

40

1

Cotton-O’Neil, Topeka

12

0

Duke University, Durham

39

0

Ohio State University, Columbus

11

1

University of Arizona, Tucson

38

0

Cleveland Clinic Fnd, Cleveland

9

0

UT Southwestern, Dallas

33

1

London Health Sciences, Ontario

9

0

University of Florida, Gainesville

32

1

Cardiac Surg. Assoc, Kissimmee

8

0

Florida Hospital, Orlando

27

0

Texas Heart Institute, Houston

7

0

Oklahoma VA, Oklahoma City

27

1

Johns Hopkins Univ., Baltimore

7

1

UBC, Vancouver

23

0

Washington University, St. Louis

6

0

Providence Heart, Portland, OR

21

0

Univ Catanzaro, Catanzaro, IT

6

0

WakeMed, Raleigh

20

0

University of Oklahoma, OK City

5

0

Loma Linda Univ., Loma Linda

20

1

Civil Hospital, Sassari, IT

3

1

New Mexico Heart, Albuquerque

19

1

Aurora Health Care , Milwaukee

1

0

University of Alberta, Edmonton

17

2

Univ. Pittsburgh, PA

1

1


The Surgical anatomy of the aortic root. Clinical implications

.


PROTOTYPES


Relationship of TE to Bleed


Horstkotte 1994


Files on USB from Jack Bokros • Art.qt (History, design, outcomes) qt.mov • FDA Data Comparisons, Burnett qt.mov • History, Design, Outcomes.ppt • New Sewing Cuff bmp.ppt • Pre FDA IDE Studies qt.mov • PROACT ACC Emory 3 16 2011 JP cb jb.ppt • Reference Index (references referred to in the presentation) • Rom/lat2012a (broad overview, 15 minutes) qt.mov • Ruyra sewing cuff presentation.ppt • Williams So African 10 year data.ppt • Zilla’s critique of bioprostheses qt.mov “qt.mov” means it is a Quicktime movie. If the file does not open, go to Google, search for Quicktime and download the free application.


PHYSIO-ON X sewing ring :

GOALS

-Favor implantation -Avoid forceful implantation -Avoid undersizing -Avoid Tissue damage -Avoid paravalvular leak -Favor double valve replacement (M-Ao)


Files on USB from Jack Bokros • Art.qt (History, design, outcomes) qt.mov • FDA Data Comparisons, Burnett qt.mov • History, Design, Outcomes.ppt • New Sewing Cuff bmp.ppt • Pre FDA IDE Studies qt.mov • PROACT ACC Emory 3 16 2011 JP cb jb.ppt • Reference Index (references referred to in the presentation) • Rom/lat2012a (broad overview, 15 minutes) qt.mov • Ruyra sewing cuff presentation.ppt • Williams So African 10 year data.ppt • Zilla’s critique of bioprostheses qt.mov “qt.mov” means it is a Quicktime movie. If the file does not open, go to Google, search for Quicktime and download the free application.


Enrollment by Group

As of 1/1/2012


AVR High Risk Group Postrandomization Events Event

Major Bleed Minor Bleed Total Bleed

Control (ptyr=448.4) (2.0 – 3.0) N Rate (%/ptyr) 19 4.24 22 4.91 41 9.14

Test (ptyr=405.0) (1.5 – 2.0) N Rate (%/ptyr) 8 1.97 10 2.47 18 4.44

Rate Ratio

95% CI

P-value

2.15 1.99 2.06

0.90-5.66 0.09-4.70 1.16-3.80

0.064 0.066 0.009

(control/test)

Stroke TIA Neurologic Event

3 3 6

0.67 0.67 1.51

5 7 12

1.23 1.73 2.96

0.54 0.39 0.45

0.08-2.79 0.06-1.70 0.14-1.30

0.394 0.153 0.103

Peripheral TE Thrombosis

1 0

0.22 0.00

3 2

0.74 0.49

0.30 NA

0.01-3.75 NA

0.270 0.137

Major Event (Major bleed, stroke, thrombosis) All Above Events

22

4.91

15

3.70

1.32

0.66-2.75

0.400

48

10.70

35

8.64

1.24

0.78-1.97

0.335

Sudden Death Valve-related death

1 1

0.22 0.22

2 2

0.49 0.49

0.45 0.45

0.01-8.67 0.01-8.67

0.505 0.505

Total Mortality

7

1.56

10

2.47

0.63

0.20-1.84

0.348


Summary • AVR High Risk – Showing some differences at average follow-up of 2.3 years • Total bleeding now significantly less in high risk test group

– Non-inferiority appears to be valid hypothesis – Close out and application to occur in 2012

• Sample inadequate in low risk AVR and MVR – Enrollment should close by in 2012 – Low risk AVR now has patients with over 5 years exposure without events; event rates very low both control and test – MVR trending toward better overall in test group


Actual Computational Fluid Dynamic

Velocity vectors downstream of the ATS valve This long region of stagnation and recirculation persists throughout the systolic phase of the cycle.1 When the valve is closed, the pivot is not purgeable. And this is one of the main reasons that the “open pivot� design was initially rejected by Carbomedics before it was later licensed to ATS. [comments by Jack Bokros] 1. Kelly, SGD. Computational fluid dynamics insights in the design of mechanical heart valves. Artificial Organs 2002;26(7):608-13


Area behind the ATS “abutment” is not purgeable.

Positions of reversed flow within the valve housing ring at three different times up to peak systole.

This “cavity” behind the abutment is not purgeable when the valve is closed.


Mean Gradient Aortic (Late) –US FDA Summary of Safety and Effectiveness SIZE

ATS Standard Valve

On-X

19 mm

20.2 +/- 2.8

9.0 +/- 3.2

21 mm

18.0 +/- 1.6

8.1 +/- 3.2

(18mm AP)

23 mm

13.1 +/- 0.8

6.6 +/- 3.1

(20 mm AP)

25 mm

11.1 +/- 0.8

4.2 +/- 2.5

(22 mm AP)

27/29 mm

8.0 +/- 0.8 (25mm AP)

5.5 +/- 3.0


Enhanced left ventricular mass regression after aortic valve replacement in patients with aortic stenosis is associated with improved Ayyaz Ali, Amit Patel, Ziad Ali, Yasir Abu-Omar, Amber Saeed, Thanos Athanasiou and long-term survival John Pepper

J Thorac Cardiovasc Surg 2011; 142:285-291 DOI: 10.1016/j.jtcvs.2010.08.084

SHA24/047001  

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