Heart valve replacements occur in over 300,000 people in the US and Europe every year.1 The aortic valve may need to be replaced in order to treat aortic stenosis or aortic regurgitation.
Surgical Aortic Heart Valve Replacement Options
Aortic heart valves can be surgically replaced with prosthetic or manufactured heart valves. There are two types of prosthetic heart valves: tissue valves and mechanical valves.
Tissue valves are not as durable as mechanical valves in the aortic position and have a tendency to wear out and possibly require replacement as early as 5 years, especially for patients younger than 65 years old.2,3 The gradual degradation of tissue valves can cause symptoms to return several years prior to a reoperation to replace the failed valve.
All mechanical valve patients require anticoagulation therapy with the blood thinner warfarin, which creates a risk of bleeding.2 Tissue valve patients usually do not require long-term therapy,4 however, up to 1/3 of patients with a tissue valve require blood thinner for other heart or vascular conditions (e.g., atrial fibrillation and deep venous thrombosis).5 Even though anticoagulation is not prescribed for all tissue valve patients, there is still a similar risk for complications as there is for properly anticoagulated mechanical valve patients.6
The American Heart Association provides guidelines of treatment options for patients with heart disease. These guidelines4 provide the following recommendation for aortic prosthetic valve selection based on patient age:
|Valve Type||Patient Age (years)|
|Mechanical||preferred option*||reasonable option*|
|Tissue||reasonable option^||preferred option^|
|Homograft (Ross Procedure)||reasonable option**|
*Unless anticoagulation is not desired, cannot be managed, or is contraindicated.
^A tissue valve is recommended for “any age [patient] for whom anticoagulant therapy is contraindicated, cannot be managed appropriately, or is not desired.”
**Ross Procedure may be considered in young patients when VKA anticoagulation is contraindicated or undesirable.
On-X Aortic Heart Valve
The On-X Aortic Valve is the only mechanical valve with FDA and CE approval for significantly less blood thinner (warfarin).*,7 The American Heart Association guidelines state that less blood thinner may be reasonable for patients with the mechanical On-X Aortic Valve.4 In a prospective randomized clinical trial, On-X Aortic Valve patients with a reduced blood thinner dose had > 60% fewer bleeding events without an increase in risk of stroke.7 The On-X Aortic Valve, as a mechanical heart valve, has a much lower risk of reoperation than tissue valves with the additional benefit of less bleeding risk than other mechanical aortic valves because of the significantly lower amount of anticoagulation required.
If you are under the age of 70 years and need aortic valve replacement, ask your doctor about the On-X Aortic Valve, the only mechanical valve that is both likely to last a lifetime2,4 and safer with significantly less blood thinner.7
*After 3 months standard therapy. See On-X Prosthetic Heart Valve Instructions for Use.7
Minimally Invasive Surgery Options
There are minimally invasive surgical techniques for aortic heart valve replacement, including the On-X Aortic Valve and Transcatheter Aortic Valve Replacement (TAVR) Valve in Valve (VIV). Ask your doctor if you are a candidate to receive an On-X Aortic Valve with minimally invasive surgery.
TAVR VIV is an aortic valve replacement procedure in which a new tissue valve is placed inside a failing tissue valve. This procedure is neither a long-term proven therapy, nor a reasonable option for the majority of tissue valve patients due to the size of their existing valve4 being too small, and as a result, restricting blood flow.8,9
- HCUP and iData market research reports, data on file.
- van Geldorp M et al., J Thorac Cardiovasc Surg. 2009;137:881-6.
- Wang M et al., Ann Thorac Surg 2017;104:1080-7.
- Nishimura R et al., Circulation. 2017;135:e1159-95.
- Briffa N and Chambers J. Circulation. 2017;135:1101–3.
- Nishimura R et al., Circulation. 2014;129:e521-643.
- On-X Prosthetic Heart Valve Instructions for Use.
- Dvir D et al., JAMA. 2014;312:162-70.
- IMS US Sales Report, Q4, 2010 to Q3, 2016. Perimount models 2700, 2800, and 3300. Report run by CryoLife Marketing, 04/10/2017. Data on file.