Open Heart Surgery

Open Heart Surgery

Open-heart surgery (OHS), also known as traditional heart surgery with a sternotomy, requires an incision in your chest to expose the heart. OHS for aortic valve replacement is a proven method that has been successfully performed since the 1960s.1

  • Surgical aortic valve replacement with open heart surgery is proven to have better outcomes for patients who are overall healthy and strong enough to recover from this type of surgery.2,3

When considering open heart surgery for aortic valve replacement, you have several options including the Ross Procedure, a mechanical valve and a tissue valve.

Compare your aortic valve replacement options over time.

Ross Procedure

previous

  • A surgical operation that uses a patient’s own healthy and living pulmonary valve, called a pulmonary autograft, to replace the damaged aortic valve.
  • This is the only aortic valve replacement option proven to result in life expectancy and quality of life as if they did not have valve surgery.4,5
  • It is important to note that this procedure should be performed by a surgeon familiar with this technique.

Visit www.TheRossProcedure.org to learn more about the Ross Procedure.

 next

Mechanical Valve

previous

  • Long-lasting valves made of durable materials that do not undergo Structural Valve Deterioration (SVD) 
  • Most mechanical heart valves are bileaflet, meaning that they have two “leaflets” to control the blood flow to a single direction.6
  • While mechanical valves are often more durable, the risk for blood clot formation is higher, so lifelong use of blood thinner medication is necessary.
  • The On-X Aortic Valve is in a category of its own as the only mechanical valve made of pure pyrolytic carbon designed to last a patient’s lifetime and approved to be used safely with less blood thinner compared to other mechanical valves.*,7
    • This lower blood thinner requirement results in a significantly lower risk for bleeding by >60%.8

Visit www.HeartValveChoice.com to learn more about the On-X Aortic Valve.

* After 3 months standard therapy. See On-X Prosthetic Heart Valve Instructions for Use, https://www.onxlti.com/ifu/hv/, Accessed 12-04-2019.

 next

Tissue Valve

previous

  • Also called “bioprosthetic valves”, tissue valves are made with animal tissue, typically pig or cow. Some tissue valves are mounted on a frame or stent, while others are stentless.
  • Tissue valves typically do not require lifelong blood thinners.
  • The downside to tissue valves is limited durability. Over time, these valves will begin to break down, leak, or become stiff and too small again, reintroducing symptoms of valve stenosis and regurgitation with a condition called Structural Valve Deterioration (SVD).
    • Only tissue valves develop SVD and there is no known medical therapy to prevent or treat SVD.7
    • SVD causes patients to feel tired and short of breath as their new aortic tissue valve deteriorates.9-11
    • Implanted tissue valves that develop SVD may require reintervention, and the younger a patient is when they get a tissue valve, the faster they will experience the onset of SVD.7,9
 next

Minimally Invasive Surgery

Minimally Invasive Surgical Aortic Valve Replacement

Minimally invasive surgical aortic valve replacement uses a smaller incision than a traditional open-heart surgery and has the potential to shorten hospital stays, quicken recovery and rehabilitation, and has better cosmetic results.12 Minimally invasive aortic valve replacement can be done using a mechanical valve or a tissue valve, but it is important to note that this surgery should be performed by a surgeon familiar with this technique. This smaller incision can be done through several approaches, two that are commonly used are shown below.

Mini or Hemi-Sternotomy

Right Thoracotomy

Compare your aortic valve replacement options over time.

Mechanical Valve

  • Long-lasting valves made of durable materials that do not under go Structural Valve Deterioration (SVD) 
  • Most mechanical heart valves are bileaflet, meaning that they have two “leaflets” to control the blood flow to a single direction.6
  • While mechanical valves are often more durable, the risk for blood clot formation is higher, so lifelong use of blood thinner medication is necessary.

Tissue Valve

  • Also called “bioprosthetic valves”, tissue valves are made with animal tissue, typically pig or cow. Some tissue valves are mounted on a frame or stent, while others are stentless.
  • Tissue valves typically do not require lifelong blood thinners.
  • The downside to tissue valves is limited durability. Over time, these valves will begin to break down, leak, or become stiff and too small again, reintroducing symptoms of valve stenosis and regurgitation with a condition called Structural Valve Deterioration (SVD).
    • Only tissue valves develop SVD and there is no known medical therapy to prevent or treat SVD.7
    • SVD causes patients to feel tired and short of breath as their new aortic tissue valve deteriorates.9-11
    • Implanted tissue valves that develop SVD may require reintervention, and the younger a patient is when they get a tissue valve, the faster they will experience the onset of SVD.7,9

TAVR

Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter Aortic Valve Replacement (TAVR) is a relatively new technology typically performed in patients over the age of 75 to avoid the risk of surgery.13 In this procedure, the old, diseased aortic valve is not removed but rather a new tissue valve is inserted inside of the diseased aortic valve using a large catheter. A TAVR procedure can be done through either a transfemoral or a transapical approach.

There is little long-term published TAVR data on survival (life expectancy) or durability and there continues to be various generations of TAVR devices as this technology continues to evolve.

Compare your aortic valve replacement options over time.

Click the years below to learn about the evolution of TAVR.

arrowright_btn-25x25
arrowright_btn-25x25
arrowright_btn-25x25
arrowright_btn-25x25
2002 copy

The first TAVR procedure
is performed.14

2007 copy

TAVR introduced in daily practice for inoperable patients at high surgical risk. Mean Age = 80 years old.15

2016 copy

TAVR indications expand to patients at intermediate surgical risk. Mean Age = 81 years old.13,16-17

2019 copy

TAVR expanded to low surgical risk patients. Mean Age = 75 years old.13,18-19

LOW RISK ≠ YOUNG PATIENTS 

Future-of-TAVR copy

Will the value of TAVR vs. open heart surgery outweigh the unknown long-term outcomes and durability concerns?

Valve-in-Valve

Valve-in-Valve Procedure

Tissue valves, also called bioprosthetic valves, have the downside of a limited lifespan, or limited durability. These valves begin to breakdown and deteriorate, developing a condition called Structural Valve Deterioration (SVD).

There is no known medical therapy to prevent or treat SVD, so over time a tissue valve is likely to need replacing with another valve operation.8 This second valve operation can be done through either open-heart surgery, minimally invasive surgery, or a Valve-in-Valve (ViV) procedure.

A Valve-in-Valve (ViV) procedure does not remove the failed, diseased valve but rather inserts a second transcatheter valve inside the previous failed tissue valve.

Compare your aortic valve replacement options over time.

Click on the steps below to see the process leading up to a Valve-in-Valve procedure.

Step 1
calcification_1000x850

Patient’s own aortic valve becomes diseased and calcified, requiring replacement.

Step 3
ProEXR File Description =Attributes= cameraAperture (float): 36 cameraFarClip (float): 3.40282e+038 cameraFarRange (float): 39370.1 cameraFov (float): 24.739 cameraNearClip (float): 0 cameraNearRange (float): 0 cameraProjection (int): 0 cameraTargetDistance (float): 538.19 cameraTransform (m44f): [{0.999955, -0.000516554, 0.00943813, 23.9083}, {0.00945225, 0.0546463, -0.998461, -345.946}, {-1.74623e-010, 0.998505, 0.0546488, 88.5385}, {0, 0, 0, 1}] channels (chlist) compression (compression): Zip16 dataWindow (box2i): [0, 0, 3299, 3961] displayWindow (box2i): [0, 0, 3299, 3961] gamma (float): 1 lineOrder (lineOrder): Increasing Y pixelAspectRatio (float): 1 screenWindowCenter (v2f): [0, 0] screenWindowWidth (float): 1 tiles (tiledesc): [64, 64] type (string): "tiledimage" =Channels= A (half) B (half) G (half) R (half)

Tissue valve develops SVD and requires reoperation, or a ViV procedure, as early as
8 years after implant.21

Step 2
ProEXR File Description =Attributes= cameraAperture (float): 36 cameraFarClip (float): 3.40282e+038 cameraFarRange (float): 39370.1 cameraFov (float): 24.739 cameraNearClip (float): 0 cameraNearRange (float): 0 cameraProjection (int): 0 cameraTargetDistance (float): 538.19 cameraTransform (m44f): [{0.999955, -0.000516554, 0.00943813, 23.9083}, {0.00945225, 0.0546463, -0.998461, -345.946}, {-1.74623e-010, 0.998505, 0.0546488, 88.5385}, {0, 0, 0, 1}] channels (chlist) compression (compression): Zip16 dataWindow (box2i): [0, 0, 3299, 3961] displayWindow (box2i): [0, 0, 3299, 3961] gamma (float): 1 lineOrder (lineOrder): Increasing Y pixelAspectRatio (float): 1 screenWindowCenter (v2f): [0, 0] screenWindowWidth (float): 1 tiles (tiledesc): [64, 64] type (string): "tiledimage" =Channels= A (half) B (half) G (half) R (half)

Patient has tissue valve implanted for surgical aortic valve replacement. This valve can start to fail after only 6 years.20

Step 4
ProEXR File Description =Attributes= cameraAperture (float): 36 cameraFarClip (float): 3.40282e+038 cameraFarRange (float): 39370.1 cameraFov (float): 24.739 cameraNearClip (float): 0 cameraNearRange (float): 0 cameraProjection (int): 0 cameraTargetDistance (float): 538.19 cameraTransform (m44f): [{0.999955, -0.000516554, 0.00943813, 23.9083}, {0.00945225, 0.0546463, -0.998461, -345.946}, {-1.74623e-010, 0.998505, 0.0546488, 88.5385}, {0, 0, 0, 1}] channels (chlist) compression (compression): Zip16 dataWindow (box2i): [0, 0, 3299, 3961] displayWindow (box2i): [0, 0, 3299, 3961] gamma (float): 1 lineOrder (lineOrder): Increasing Y pixelAspectRatio (float): 1 screenWindowCenter (v2f): [0, 0] screenWindowWidth (float): 1 tiles (tiledesc): [64, 64] type (string): "tiledimage" =Channels= A (half) B (half) G (half) R (half)

Transcatheter valve is inserted inside the first failed tissue valve, this is a ViV procedure. What happens next since there is no long-term data on ViV?

Hero-Images-Mobile-AVR

Open Heart Surgery

Open Heart Surgery

Open-heart surgery (OHS), also known as traditional heart surgery with a sternotomy, requires an incision in your chest to expose the heart. OHS for aortic valve replacement is a proven method that has been successfully performed since the 1960s.1

  • Surgical aortic valve replacement with open heart surgery is proven to have better outcomes for patients who are overall healthy and strong enough to recover from this type of surgery.2,3

When considering open heart surgery for aortic valve replacement, you have several options including the Ross Procedure, a mechanical valve and a tissue valve.


Compare your aortic valve replacement options
over time.

Ross Procedure

  • A surgical operation that uses a patient’s own healthy and living pulmonary valve, called a pulmonary autograft, to replace the damaged aortic valve.
  • This is the only aortic valve replacement option proven to result in life expectancy and quality of life as if they did not have valve surgery.4,5
  • It is important to note that this procedure should be performed by a surgeon familiar with this technique.

Visit www.TheRossProcedure.org to learn more about the Ross Procedure.

Mechanical Valve

  • Long-lasting valves made of durable materials that do not undergo Structural Valve Deterioration (SVD) 
  • Most mechanical heart valves are bileaflet, meaning that they have two “leaflets” to control the blood flow to a single direction.6
  • While mechanical valves are often more durable, the risk for blood clot formation is higher, so lifelong use of blood thinner medication is necessary.
  • The On-X Aortic Valve is in a category of its own as the only mechanical valve made of pure pyrolytic carbon designed to last a patient’s lifetime and approved to be used safely with less blood thinner compared to other mechanical valves.*,7
    • This lower blood thinner requirement results in a significantly lower risk for bleeding by >60%.8

Visit www.HeartValveChoice.com to learn more about the On-X Aortic Valve.

* After 3 months standard therapy. See On-X Prosthetic Heart Valve Instructions for Use, https://www.onxlti.com/ifu/hv/, Accessed 12-04-2019.

Tissue Valve

  • Also called “bioprosthetic valves”, tissue valves are made with animal tissue, typically pig or cow. Some tissue valves are mounted on a frame or stent, while others are stentless.
  • Tissue valves typically do not require lifelong blood thinners.
  • The downside to tissue valves is limited durability. Over time, these valves will begin to break down, leak, or become stiff and too small again, reintroducing symptoms of valve stenosis and regurgitation with a condition called Structural Valve Deterioration (SVD).
    • Only tissue valves develop SVD and there is no known medical therapy to prevent or treat SVD.7
    • SVD causes patients to feel tired and short of breath as their new aortic tissue valve deteriorates.9-11
    • Implanted tissue valves that develop SVD may require reintervention, and the younger a patient is when they get a tissue valve, the faster they will experience the onset of SVD.7,9

Minimally Invasive Surgery

Minimally Invasive Surgical Aortic Valve Replacement

Minimally invasive surgical aortic valve replacement uses a smaller incision than a traditional open-heart surgery and has the potential to shorten hospital stays, quicken recovery and rehabilitation, and has better cosmetic results.12 Minimally invasive aortic valve replacement can be done using a mechanical valve or a tissue valve, but it is important to note that this surgery should be performed by a surgeon familiar with this technique. This smaller incision can be done through several approaches, two that are commonly used are shown below.

Mini or Hemi-Sternotomy

Right Thoracotomy


Compare your aortic valve replacement options
over time.

Mechanical Valve

  • Long-lasting valves made of durable materials that do not under go Structural Valve Deterioration (SVD) 
  • Most mechanical heart valves are bileaflet, meaning that they have two “leaflets” to control the blood flow to a single direction.6
  • While mechanical valves are often more durable, the risk for blood clot formation is higher, so lifelong use of blood thinner medication is necessary.

Tissue Valve

  • Also called “bioprosthetic valves”, tissue valves are made with animal tissue, typically pig or cow. Some tissue valves are mounted on a frame or stent, while others are stentless.
  • Tissue valves typically do not require lifelong blood thinners.
  • The downside to tissue valves is limited durability. Over time, these valves will begin to break down, leak, or become stiff and too small again, reintroducing symptoms of valve stenosis and regurgitation with a condition called Structural Valve Deterioration (SVD).
    • Only tissue valves develop SVD and there is no known medical therapy to prevent or treat SVD.7
    • SVD causes patients to feel tired and short of breath as their new aortic tissue valve deteriorates.9-11
    • Implanted tissue valves that develop SVD may require reintervention, and the younger a patient is when they get a tissue valve, the faster they will experience the onset of SVD.7,9

TAVR

Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter Aortic Valve Replacement (TAVR) is a relatively new technology typically performed in patients over the age of 75 to avoid the risk of surgery.13 In this procedure, the old, diseased aortic valve is not removed but rather a new tissue valve is inserted inside of the diseased aortic valve using a large catheter. A TAVR procedure can be done through either a transfemoral or a transapical approach.

There is little long-term published TAVR data on survival (life expectancy) or durability and there continues to be various generations of TAVR devices as this technology continues to evolve.


Compare your aortic valve replacement options
over time.

Click the years below to learn about the evolution of TAVR.

2002

The first TAVR procedure
is performed.14

arrow-down-25x25-1

2007

TAVR introduced in daily practice for inoperable patients at high surgical risk. Mean Age = 80 years old.15

arrow-down-25x25-1

2016

TAVR indications expand to patients at intermediate surgical risk. Mean Age = 81
years old.13,16-17

arrow-down-25x25-1

2019

TAVR expanded to low surgical risk patients. Mean Age = 75 years old.13,18-19

LOW RISK ≠ YOUNG PATIENTS 

arrow-down-25x25-1

FUTURE
OF
TAVR

Will the value of TAVR vs. open heart surgery outweigh the unknown long-term outcomes and durability concerns?

Valve-in-Valve

Valve-in-Valve Procedure

Tissue valves, also called bioprosthetic valves, have the downside of a limited lifespan, or limited durability. These valves begin to breakdown and deteriorate, developing a condition called Structural Valve Deterioration (SVD).

There is no known medical therapy to prevent or treat SVD, so over time a tissue valve is likely to need replacing with another valve operation.8 This second valve operation can be done through either open-heart surgery, minimally invasive surgery, or a Valve-in-Valve (ViV) procedure.

A Valve-in-Valve (ViV) procedure does not remove the failed, diseased valve but rather inserts a second transcatheter valve inside the previous failed tissue valve.


Compare your aortic valve replacement options
over time.

Click on the steps below to see the process leading up to a Valve-in-Valve procedure.

Step 1
calcification_1000x850

Patient’s own aortic valve becomes diseased and calcified, requiring replacement.

Step 2
ProEXR File Description =Attributes= cameraAperture (float): 36 cameraFarClip (float): 3.40282e+038 cameraFarRange (float): 39370.1 cameraFov (float): 24.739 cameraNearClip (float): 0 cameraNearRange (float): 0 cameraProjection (int): 0 cameraTargetDistance (float): 538.19 cameraTransform (m44f): [{0.999955, -0.000516554, 0.00943813, 23.9083}, {0.00945225, 0.0546463, -0.998461, -345.946}, {-1.74623e-010, 0.998505, 0.0546488, 88.5385}, {0, 0, 0, 1}] channels (chlist) compression (compression): Zip16 dataWindow (box2i): [0, 0, 3299, 3961] displayWindow (box2i): [0, 0, 3299, 3961] gamma (float): 1 lineOrder (lineOrder): Increasing Y pixelAspectRatio (float): 1 screenWindowCenter (v2f): [0, 0] screenWindowWidth (float): 1 tiles (tiledesc): [64, 64] type (string): "tiledimage" =Channels= A (half) B (half) G (half) R (half)

Patient has tissue valve implanted for surgical aortic valve replacement. This valve can start to fail after only 6 years.20

Step 3
ProEXR File Description =Attributes= cameraAperture (float): 36 cameraFarClip (float): 3.40282e+038 cameraFarRange (float): 39370.1 cameraFov (float): 24.739 cameraNearClip (float): 0 cameraNearRange (float): 0 cameraProjection (int): 0 cameraTargetDistance (float): 538.19 cameraTransform (m44f): [{0.999955, -0.000516554, 0.00943813, 23.9083}, {0.00945225, 0.0546463, -0.998461, -345.946}, {-1.74623e-010, 0.998505, 0.0546488, 88.5385}, {0, 0, 0, 1}] channels (chlist) compression (compression): Zip16 dataWindow (box2i): [0, 0, 3299, 3961] displayWindow (box2i): [0, 0, 3299, 3961] gamma (float): 1 lineOrder (lineOrder): Increasing Y pixelAspectRatio (float): 1 screenWindowCenter (v2f): [0, 0] screenWindowWidth (float): 1 tiles (tiledesc): [64, 64] type (string): "tiledimage" =Channels= A (half) B (half) G (half) R (half)

Tissue valve develops SVD and requires reoperation, or a ViV procedure, as early as
8 years after implant.21

Step 4
ProEXR File Description =Attributes= cameraAperture (float): 36 cameraFarClip (float): 3.40282e+038 cameraFarRange (float): 39370.1 cameraFov (float): 24.739 cameraNearClip (float): 0 cameraNearRange (float): 0 cameraProjection (int): 0 cameraTargetDistance (float): 538.19 cameraTransform (m44f): [{0.999955, -0.000516554, 0.00943813, 23.9083}, {0.00945225, 0.0546463, -0.998461, -345.946}, {-1.74623e-010, 0.998505, 0.0546488, 88.5385}, {0, 0, 0, 1}] channels (chlist) compression (compression): Zip16 dataWindow (box2i): [0, 0, 3299, 3961] displayWindow (box2i): [0, 0, 3299, 3961] gamma (float): 1 lineOrder (lineOrder): Increasing Y pixelAspectRatio (float): 1 screenWindowCenter (v2f): [0, 0] screenWindowWidth (float): 1 tiles (tiledesc): [64, 64] type (string): "tiledimage" =Channels= A (half) B (half) G (half) R (half)

Transcatheter valve is inserted inside the first failed tissue valve, this is a ViV procedure. What happens next since there is no long-term data on ViV?

References

  1. Harken DE, et al. J Thorac Cardiovasc Surg 1960;40:744–762.
  2. Otto CM, et al. Circulation. 2021;143: doi: 10.1161/CIR.0000000000000923.
  3. Kytö V, et al. Ann Thorac Surg 2019;110(1):102-10.
  4. Mazine A, et al. J Am Coll Cardiol 2018;72(22):2761-77.
  5. El Hamamsy I, et al. Lancet 2010;376(9740):524-31.
  6. Rajashekar P. J Pract Cardiovasc Sci 2015;1:289-93.
  7. Nishimura RA, et al. J Am Coll Cardiol 2017;70:252-89.
  8. Puskas JD, et al. J Am Coll Cardiol 2018;71:2717-26.
  9. Rodriguez-Gabella T, et al. J Am Coll Cardiol 2017;70(8):1013-28.
  10. "Aortic Stenosis", Mayo Clinic [Online]. Available: https://www.mayoclinic.org/diseases-conditions/aortic-stenosis/symptoms-causes/syc-20353139 [Accessed 01-04-2021].
  11. "Aortic Valve Regurgitation", Mayo Clinic [Online]. Available: https://www.mayoclinic.org/diseases-conditions/aortic-valve-regurgitation/symptoms-causes/syc-20353129 [Accessed 01-04-2021].
  12. Kaczmarczyk M, et al. Kardiochirurgia i Torakochirurgia Polska = Polish Journal of Cardio-thoracic Surgery 2015;12(2):103-110.
  13. Carroll JD, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2020; doi: 10.1016/j.athoracsur.2020.09.002.
  14. “Fifteen Years of TAVR; Where Are We Now?” American College of Cardiology, 20 Jul. 2017.
  15. Kappetein AP, et al. Eur Heart J. 2012;33:2403-18.
  16. Leon MB, et al. N Engl J Med. 2016;374:1609-20.
  17. Makkar RR, et al. N Eng J Med. 2020;382:799-809.
  18. Popma JJ, et al. N Engl J Med. 2019;380:1706-15.
  19. Mack MJ, et al. N Eng J Med. 2019;380:1695-1705.
  20. Bourguignon T, et al. Eur J Cardiothorac Surg. 2016;1462-8.
  21. Minakata K, et al. J Card Surg. 2015;30(5):405–13.
Click here to view references
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