There is a lot of data out there on each aortic valve option and every patient is unique. As you and your doctors decide which valve option is best for you, it is important to know the outcomes over time.

Click on the years below to see how each aortic valve replacement option compares over time.

Year 1

wte-numbers-33 copy

Ross Procedure

previous

  • Patients do not need to take a blood thinner at any time, but blood pressure medication may be required for a short period immediately after surgery.1
 next

Mechanical Valve

previous

  • Lifelong blood thinner is necessary with a mechanical valve and may require some new lifestyle changes, such as managing intake of leafy green vegetables or alcohol. Simple routine blood tests are necessary to monitor the effectiveness of the blood thinner, but it is possible to perform these tests at home.2
  • The On-X Aortic Valve is the only mechanical valve that requires a lower dosage of blood thinner that can be managed at a low International Normalized Ratio (INR) of 1.5-2.0*,3, compared to all other aortic mechanical valves that are managed at an INR of 2.0-3.0. This lower blood thinner requirement with the On-X Aortic Valve reduces the risk of bleeding, which is a main concern for taking a blood thinner.4

*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

  • Tissue valves, also called bioprosthetic valves, offer the potential opportunity to avoid lifelong blood thinner, but a blood thinner regimen immediately following surgery is sometimes recommended - this means no change in lifestyle in the years following heart valve surgery.3
 next

TAVR

previous

  • TAVR patients have the potential to recover more quickly and have a shorter length of stay in the hospital compared to surgical valve replacement.5
  • While a faster recovery is appealing, even “low-risk” patients have over 3x higher risk of needing a new, permanent pacemaker implanted after TAVR compared to surgical aortic valve replacement.6
  • TAVR patients are also more likely to have a stroke due to mobile blood clots found on the valve compared to patients undergoing open heart surgery with a tissue valve. This could require patients to be treated with a blood thinner.7
 next

Valve-in-Valve

previous

  • High-risk, elderly patients benefit from a quick recovery with the Valve-in-Valve (ViV) procedure.
  • A Valve-in-Valve procedure involves inserting a transcatheter valve inside of a failed tissue valve, meaning no valves are removed. While this helps high-risk patients, the “stacking” of valves inside one another can create a condition called Patient Prosthesis Mismatch (PPM), meaning the size of the implanted tissue valve is too small for the patient’s body and not enough blood is pumped to the body.
  • Patients with severe Patient Prosthesis Mismatch (PPM) before a Valve-in-Valve (ViV) procedure have a higher death rate in the 30-days following surgery and 1-year after surgery.8
  • When placing a valve inside another valve, there is a risk to obstruct, or block, the coronary arteries which bring blood back to the heart muscles. This is a rare but life-threatening occurrence called Coronary Obstruction and can cause high death rates in the 30-days following valve surgery.9
 next

Years 5-10

wte-numbers-32 copy

Ross Procedure

  • Patients are back to a normal life, just like someone who has not had aortic valve surgery.1-2

Mechanical Valve

  • Sustained valve performance since a mechanical valve does not develop Structural Valve Deterioration (SVD) and will not require reoperation because of it, compared to a tissue valve.3
  • Patients continue INR management on their blood thinner regimen.
  • The ability to manage blood thinner at a low INR of 1.5-2.0*,4 with the On-X Aortic Valve reduces the risk of bleeding by >60%, which is a main concern when taking a blood thinner.

*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

  • Tissue valves will begin to wear out, leak, or become stiff and too small again, reintroducing symptoms of valve stenosis and regurgitation. This condition is called Structural Valve Deterioration (SVD) and the progression of SVD reduces blood flow through the implanted tissue valve.3
  • Some tissue valves can begin to fail after only 6 years and may require reoperation as early as 8 years after implant.5,6 Additionally, some patients with SVD may be inoperable.7,8
  • Over time, up to 30% of patients with a tissue valve may need to take a blood thinner, commonly due to Atrial Fibrillation, or “A Fib”.9-11 This removes the potential opportunity of not taking lifelong blood thinner with a tissue valve and may require new lifestyle habits.

TAVR

  • TAVR data at 10 years is limited and only exists for high-risk patients.12
  • Reduced valve performance as 1 in 4 TAVR patients may have moderate to severe Patient Prosthesis Mismatch (PPM), meaning the size of the implanted TAVR valve is too small for the patient’s body and not enough blood is pumped to the body.13-14 This can impact valve performance and ultimately the risk of death.13-14
  • TAVR valves may begin to experience blood leaking around the outside of the valve, called Paravalvular Leak or Regurgitation, which causes an increased death rate if the bleeding is moderate to severe.15

Valve-in-Valve

  • There is not a lot known in this timeframe for Valve-in-Valve (ViV) procedures.
  • Signs of a smaller valve opening begin to occur in 15% of ViV patients around the age of 76 years-old after a median follow-up of 3 years.16

Years 15-20

wte-numbers-3 copy

Ross Procedure

previous

  • The only aortic valve replacement option proven to result in life expectancy and quality of life similar to someone who has not had aortic valve surgery.1,2
  • Almost 9 out of 10 patients continue to live without requiring a second intervention of either valve.2-9
 next

Mechanical Valve

previous

  • Continued valve performance with a mechanical valve without the need for reoperation as a result of Structural Valve Deterioration (SVD).10
  • Patients up to 70 years of age undergoing open heart surgery live longer with a mechanical valve compared to a tissue valve.11-12 This means these mechanical valve patients have a survival benefit.
  • The On-X Aortic Valve is designed to last a patient’s lifetime.
  • The survival benefit and an enhanced lifestyle can be achieved with the On-X Aortic Valve with the >60% reduced bleeding risk compared to other mechanical aortic valve patients.13
 next

Tissue Valve

previous

  • Tissue valves typically last 15 years in elderly patients, but the younger a patient is when they get a tissue valve, the faster they will experience the onset of Structural Valve Deterioration (SVD).10 A second, or additional procedure for a tissue valve patient is unavoidable in this timeframe.
  • Long-term life expectancy is reduced in aortic valve patients up to age 70 with tissue valves compared to patients with mechanical valves.11-12,14
  • When a patient under 55 years of age has aortic valve replacement with a tissue valve, their life expectancy is reduced by 25-40% compared to someone their age and gender that has not had aortic valve surgery.15
 next

TAVR

previous

  • No published data on long-term survival exists.
  • No published data on long-term durability exists.
 next

Valve-in-Valve

previous

  • No published data on long-term survival exists.
  • No published data on long-term durability exists.
 next
Hero-Images-Mobile-WTE

Year 1

Ross Procedure

  • Patients do not need to take a blood thinner at any time, but blood pressure medication may be required for a short period immediately after surgery.1

Mechanical Valve

  • Lifelong blood thinner is necessary with a mechanical valve and may require some new lifestyle changes, such as managing intake of leafy green vegetables or alcohol. Simple routine blood tests are necessary to monitor the effectiveness of the blood thinner, but it is possible to perform these tests at home.2
  • The On-X Aortic Valve is the only mechanical valve that requires a lower dosage of blood thinner that can be managed at a low International Normalized Ratio (INR) of 1.5-2.0*,3, compared to all other aortic mechanical valves that are managed at an INR of 2.0-3.0. This lower blood thinner requirement with the On-X Aortic Valve reduces the risk of bleeding, which is a main concern for taking a blood thinner.4

*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

  • Tissue valves, also called bioprosthetic valves, offer the potential opportunity to avoid lifelong blood thinner, but a blood thinner regimen immediately following surgery is sometimes recommended - this means no change in lifestyle in the years following heart valve surgery.3

TAVR

 

  • TAVR patients have the potential to recover more quickly and have a shorter length of stay in the hospital compared to surgical valve replacement.5
  • While a faster recovery is appealing, even “low-risk” patients have over 3x higher risk of needing a new, permanent pacemaker implanted after TAVR compared to surgical aortic valve replacement.6
  • TAVR patients are also more likely to have a stroke due to mobile blood clots found on the valve compared to patients undergoing open heart surgery with a tissue valve. This could require patients to be treated with a blood thinner.7

Valve-in-Valve

  • High-risk, elderly patients benefit from a quick recovery with the Valve-in-Valve (ViV) procedure.
  • A Valve-in-Valve procedure involves inserting a transcatheter valve inside of a failed tissue valve, meaning no valves are removed. While this helps high-risk patients, the “stacking” of valves inside one another can create a condition called Patient Prosthesis Mismatch (PPM), meaning the size of the implanted tissue valve is too small for the patient’s body and not enough blood is pumped to the body.
  • Patients with severe Patient Prosthesis Mismatch (PPM) before a Valve-in-Valve (ViV) procedure have a higher death rate in the 30-days following surgery and 1-year after surgery.8
  • When placing a valve inside another valve, there is a risk to obstruct, or block, the coronary arteries which bring blood back to the heart muscles. This is a rare but life-threatening occurrence called Coronary Obstruction and can cause high death rates in the 30-days following valve surgery.9

Years 5-10

Ross Procedure

  • Patients are back to a normal life, just like someone who has not had aortic valve surgery.1-2

Mechanical Valve

  • Sustained valve performance since a mechanical valve does not develop Structural Valve Deterioration (SVD) and will not require reoperation because of it, compared to a tissue valve.3
  • Patients continue INR management on their blood thinner regimen.
  • The ability to manage blood thinner at a low INR of 1.5-2.0*,4 with the On-X Aortic Valve reduces the risk of bleeding by >60%, which is a main concern when taking a blood thinner.

*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

  • Tissue valves will begin to wear out, leak, or become stiff and too small again, reintroducing symptoms of valve stenosis and regurgitation. This condition is called Structural Valve Deterioration (SVD) and the progression of SVD reduces blood flow through the implanted tissue valve.3
  • Some tissue valves can begin to fail after only 6 years and may require reoperation as early as 8 years after implant.5,6 Additionally, some patients with SVD may be inoperable.7,8
  • Over time, up to 30% of patients with a tissue valve may need to take a blood thinner, commonly due to Atrial Fibrillation, or “A Fib”.9-11 This removes the potential opportunity of not taking lifelong blood thinner with a tissue valve and may require new lifestyle habits.

TAVR

  • TAVR data at 10 years is limited and only exists for high-risk patients.12
  • Reduced valve performance as 1 in 4 TAVR patients may have moderate to severe Patient Prosthesis Mismatch (PPM), meaning the size of the implanted TAVR valve is too small for the patient’s body and not enough blood is pumped to the body.13-14 This can impact valve performance and ultimately the risk of death.13-14
  • TAVR valves may begin to experience blood leaking around the outside of the valve, called Paravalvular Leak or Regurgitation, which causes an increased death rate if the bleeding is moderate to severe.15

Valve-in-Valve

  • There is not a lot known in this timeframe for Valve-in-Valve (ViV) procedures.
  • Signs of a smaller valve opening begin to occur in 15% of ViV patients around the age of 76 years-old after a median follow-up of 3 years.16

Years 15-20

Ross Procedure

  • The only aortic valve replacement option proven to result in life expectancy and quality of life similar to someone who has not had aortic valve surgery.1,2
  • Almost 9 out of 10 patients continue to live without requiring a second intervention of either valve.2-9

Mechanical Valve

  • Continued valve performance with a mechanical valve without the need for reoperation as a result of Structural Valve Deterioration (SVD).10
  • Patients up to 70 years of age undergoing open heart surgery live longer with a mechanical valve compared to a tissue valve.11-12 This means these mechanical valve patients have a survival benefit.
  • The On-X Aortic Valve is designed to last a patient’s lifetime.
  • The survival benefit and an enhanced lifestyle can be achieved with the On-X Aortic Valve with the >60% reduced bleeding risk compared to other mechanical aortic valve patients.13

Tissue Valve

  • Tissue valves typically last 15 years in elderly patients, but the younger a patient is when they get a tissue valve, the faster they will experience the onset of Structural Valve Deterioration (SVD).10 A second, or additional procedure for a tissue valve patient is unavoidable in this timeframe.
  • Long-term life expectancy is reduced in aortic valve patients up to age 70 with tissue valves compared to patients with mechanical valves.11-12,14
  • When a patient under 55 years of age has aortic valve replacement with a tissue valve, their life expectancy is reduced by 25-40% compared to someone their age and gender that has not had aortic valve surgery.15

TAVR

  • No published data on long-term survival exists.
  • No published data on long-term durability exists.

Valve-in-Valve

  • No published data on long-term survival exists.
  • No published data on long-term durability exists.

References

  1. Mazine A, et al. J Am Coll Cardiol 2018;72(22):2761-77.
  2. American Heart Association, A Patient’s Guide to Taking Warfarin. https://www.heart.org/en/health-topics/arrhythmia/prevention--treatment-of-arrhythmia/a-patients-guide-to-taking-warfarin. Accessed 01-13-2021.
  3. Nishimura RA, et al. J Am Coll Cardiol 2017;70:252-89.
  4. Puskas JD, et al. J Am Coll Cardiol 2018;71:2717-26.
  5. Mack MJ, et al. N Eng J Med. 2019;380:1695-1705.
  6. Kolte D, et al. J Am Coll Cardiol 2019;74:1532-40.
  7. Mayo Clinic, Transcatheter Aortic Valve Replacement (TAVR), https://www.mayoclinic.org/tests-procedures/transcatheter-aortic-valve-replacement/about/pac-20384698. Accessed 01-13-2021.
  8. Chakravarty T, et al. Lancet 2017;389:2383-92.
  9. Ribeiro H, et al. European Society of Cardiology 2018;39:687-95.
Click here to view references for Year 1.

References

  1. Mazine A, et al. J Am Coll Cardiol 2018;72(22):2761-77.
  2. Sharabiani M, et al. J Am Coll Cardiol 2016;67(24):2858–70.
  3. Rodriguez-Gabella T, et al. J Am Coll Cardiol 2017;70(8):1013-28.
  4. Nishimura RA, et al. J Am Coll Cardiol 2017;70:252-89.
  5. Bourguignon T, et al. Eur J Cardiothorac Surg. 2016;1462-8.
  6. Minakata K, et al. J Card Surg. 2015;30(5):405–13.
  7. Rodriguez-Gabella T, et al. J Am Coll Cardiol 2018;71(13):1401-12.
  8. David TE, et al. Ann Thorac Surg. 2010;90(3):775-81.
  9. Briffa N and Chambers J. Circulation 2017;135:1101–3.
  10. Forcillo J, et al. Ann Thorac Surg. 2014;97:1526–32.
  11. Chakravarty T, et al. J Am Coll Cardiol 2019;74(9):1190-200.
  12. Sathananthan J, et al. Catheter Cardiovasc Interv. 2021;97:E431-7.
  13. Chakravarty T, et al. Lancet 2017;389:2383-92.
  14. Pibarot P, et al. J Am Coll Cardiol 2018;11(2):133–41.
  15. Pibarot P, et al. J Am Coll Cardiol 2018;72(22):2712-16.
  16. Freitas L, et al. Circ Cardiovasc Interv. 2018;11:e007038.
Click here to view references for Years 5-10.

References

  1. Mazine A, et al. J Am Coll Cardiol 2018;72(22):2761-77.
  2. El Hamamsy I, et al. Lancet 2010;376(9740):524-31.
  3. David T, et al. J Thorac Cardiovasc Surg 2014;147(1):85-94.
  4. Mazine A, et al. Circulation 2016;134(8):576-85.
  5. Kalfa D, et al. Eur J Cardiothorac Surg 2015;47:159–67.
  6. Sievers H, et al. Euro J Cardiothorac Surg 2016;49:212-18.
  7. Skillington P, et al. Ann Thorac Surg 2013;96:823–9.
  8. Andreas M, et al. Ann Thorac Surg 2014;97:182–8.
  9. Martin E, et al. J Am Coll Cardiol 2017;70(15):1890-99.
  10. Rodriguez-Gabella T, et al. J Am Coll Cardiol 2017;70(8):1013-28.
  11. Glaser N, et al. Euro Heart J. 2016;37:2658-67.
  12. Diaz R, et al. J Thorac Cardiovasc Surg 2018;158(3):706-14.
  13. Puskas JD, et al. J Am Coll Cardiol 2018;71:2717-26.
  14. Kytö V, et al. Ann Thorac Surg 2020;110(1):102-10.
  15. Etnel J, et al. Circ Cardiovasc Qual Outcomes. 2019;12:e005481.
Click here to view references for Years 15-20.
Click here for important safety information.