Know The Facts

Know the Facts

Long active lives come from thoughtful, informed decisions shared between patients and their physicians.

Today, there are multiple options for aortic and mitral valve replacement, that’s why it’s important to ask questions and know the facts. Only in this way can the right decision be made about which valve best meets your needs today and for years to come.

The durability of each valve replacement option is the main determining factor for reoperation in patients requiring aortic or mitral valve replacement, that’s why it is important to understand which option provides sustained valve performance without deterioration.

Valve Durability

Mechanical Valves

Mechanical valves are designed to last a lifetime for patients of all ages.2

On-X® Aortic Heart Valve
On-X® Mitral Heart Valve

Tissue Valves

Tissue valves, also called “bioprosthetic valves”, can fail as early as 5 years in the aortic position3 and as early as 4 years in the mitral position4 for patients younger than 65 years old.

Over time, tissue valves begin to deteriorate – these valves will break down, leak, or become too stiff and too small again. This deterioration reintroduces symptoms of valve stenosis and regurgitation by a condition called Structural Valve Deterioration (SVD).1

Move the slider below to see the difference in a newly implanted tissue valve compared to a deteriorated tissue valve with calcification.

Tissue ValveTissue Valve
  • Only tissue valves develop SVD.5
  • There is no known medical therapy to prevent or treat SVD.
  • The younger a patient is when they get a tissue valve, the faster they will experience the onset of SVD.5

Mike Aronson

On-X Heart Valve Recipient

“When I. was 46, we decided to go with a tissue valve. We were told it would last between 12-15 years, which I thought was pretty good at the time.  I thought it would buy me some time. Unfortunately, after seven years my valve ripped."

Mike Aronson

On-X Heart Valve Recipient

Most patients under 65 years old often face the decision to choose between a tissue valve or a mechanical valve for their aortic or mitral valve replacement surgery. Choosing a tissue valve likely means at least one more operation in the future and choosing a mechanical valve means lifelong blood thinner medication. Let’s look at what this choice really means for patients planning to live long, active lives.

Reality of Reoperation

Mechanical Valves

 

  • Mechanical valves are designed to last a lifetime so patients can live without the fear of reoperation.1

Tissue Valves

 

  • Only tissue valves develop Structural Valve Deterioration (SVD), as the valve begins to break down, leak, or become too stiff and too small again, reintroducing symptoms of valve stenosis and regurgitation. Choosing a tissue valve likely means at least one more operation in the future, if not multiple operations.
  • The reality is that tissue valve patients experience valve disease all over again and it could be years between starting to experience symptoms and actually having another surgery. In fact, up to 17% of patients who develop SVD from tissue valves are not candidates for another reoperation.2-3
  • The tissue valve patients that do undergo reoperation have an increased risk of death.3

Reality of Blood Thinner

Mechanical Valves

 

  • Mechanical valves have a higher risk for blood clot formation, so lifelong use of blood thinner medication is necessary and may require new lifestyle habits.
  • The On-X Aortic Valve is in a category of its own as the only mechanical valve FDA and CE approved to be used safely with less blood thinner, managed at an INR of 1.5 – 2.0 compared to other mechanical aortic valves with a required INR range of 2.0 – 3.0.*,8
  • The ability to manage blood thinner at a low INR of 1.5 – 2.0*,8 with the On-X Aortic Valve reduces the risk of bleeding by >60%, which is a main concern when taking a blood thinner.9

Tissue Valves

  • Tissue valves typically only require short term blood thinner medication (3 to 6 months), but there is a potential for a lifelong requirement.4,8
  • 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”.5-7 This removes the potential opportunity of not taking a lifelong blood thinner with a tissue valve and may require new lifestyle habits.

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


Fred Hoiberg

On-X Heart Valve Recipient

“Having the peace of mind, not having to go through another surgery, and not putting my family through that difficult situation was very important to me.”

Fred Hoiberg

On-X Heart Valve Recipient

Life expectancy, also referred to as “survival”, after aortic or mitral valve replacement is determined by several factors, including patient age as well as the type of valve and procedure. Below are several facts regarding valve replacement with mechanical or tissue valves in patients of varying ages.

Life Expectancy

Age ~40 at Time of Aortic Valve Surgery

  • For patients ~40 years old at the time of surgery who received a tissue valve in the aortic position, one study found that the life expectancy was reduced by 20 years compared to the general population who had not undergone valve replacement.1

Age 50 - 69 at Time of Aortic Valve Surgery

  • In one study focused on patients aged 50 to 69 years old who underwent their first valve replacement for only the aortic valve, the long-term life expectancy was significantly better with patients who received a mechanical valve compared to those who received a tissue valve.2

Age 40-70 at Time of Mitral Valve Surgery

  • For mitral valve replacement patients between 40 to 70 years old, one study found that patients who received mechanical valves lived longer than the patients who received tissue valves.3
In fact, according to the 2020 ACC/AHA Guidelines on mitral valve replacement, a mechanical valve is the preferred option for a patient <65 years old over a tissue valve.4

Mischel Satunas

On-X Heart Valve Recipient

“You don’t realize how good you are going to feel because you get used to feeling so bad, and you don’t realize how bad you felt until you start feeling good."

Mischel Satunas

On-X Heart Valve Recipient

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Q

Know the Facts References

Valve Durability 

  1. Rodriguez-Gabella T, et al. J Am Coll Cardiol 2017;70(8):1013-28. 
  2. Data on file: Lifetime of On-X Valve Study. 
  3. Wang M, et al. Ann Thorac Surg 2017;104:1080-7. 
  4. Kaneko T, et al. J Thorac Cardiovasc Surg 2014; 147:117-26. 
  5. Dvir D, et al. Circulation 2018;137:388-99. 

 

Reoperation vs. Blood Thinner 

  1. Data on file: Lifetime of On-X Valve Study. 
  2. David TE, et al. Ann Thorac Surg 2010;90:775– 81. 
  3. Rodriguez-Gabella T, et al. J Am Coll Cardiol 2018;71(13):1401-12. 
  4. Nishimura RA, et al. J Am Coll Cardiol 2017;70:252-89. 
  5. Briffa N and Chambers J. Circulation 2017;135:1101–3. 
  6. Forcillo J, et al. Ann Thorac Surg. 2014;97:1526–32. 
  7. Chakravarty T, et al. J Am Coll Cardiol 2019;74(9):1190-200. 
  8. Otto CM, et al. Circulation. 2021;143: doi: 10.1161/CIR.0000000000000923. 
  9. On-X Instructions for Use, https://www.onxlti.com/ifu/hv/ 

 

Life Expectancy 

  1. Bourguignon T, et al. Ann Thorac Surg 2015;99(3):831-37. 
  2. Glaser N, et al. Euro Heart J 2016;37:2658-67. 
  3. Goldstone AB, et al. New Engl J. Med 2017;377:1847-57. 
  4. Otto CM, et al. Circulation 2021;143: doi: 10.1161/CIR.0000000000000923. 

Important Safety Information

Why On-X

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