Heart valve disease currently poses an important and growing public health problem:
- More than 100 million people worldwide suffer from heart valve disease, including more than 5 million in the U.S. alone35.
- Without an aortic valve replacement, 50% of patients with severe aortic stenosis will die within two years after the onset of symptoms5.
- Approximately 400,000 patients worldwide undergo a heart valve replacement every yeara.
- The demand is estimated to skyrocket over the course of the next decades due to huge demographic changes in developing countriesb, 3, 31.
- A growing number of young patients3 will need a heart valve replacement.
Patients who may benefit from the unique performances of the LTV valve
The LTV valve is designed for all operable patients who need a heart valve replacement, especially young patients and patients in emerging economies.
Young patients suffering from Aortic Valve Stenosis due to congenital abnormalities. Read more...
Aortic valve narrowing and/or deficiency may occur in young patients because of a congenital defect. The most common cause of aortic valve stenosis in young people is a birth defect where only two cups grow instead of the normal three (called a “bicuspid valve”). This disease affects 1.3% of the world population, comprising more than 90 million patients, and is responsible for more deaths and complications than the combined effects of all the other congenital heart defects8.
Over the years these young patients’ defective aortic valve often becomes stiff and narrow because of calcium build-up and may need to be replaced. Young patients who need to have their aortic heart valve replaced may reasonably expect to live for decades, even for more than 50 years, after their heart operation. Unlike tissue valves, mechanical valves whose durability is not limited are therefore often considered the option of choice for young patients suffering from aortic valve disease13, 45, 46. Unfortunately, current mechanical valves carry the inherent risk of obstructive and embolic blood clotting complications, which require potentially dangerous lifelong anticoagulation therapy.
A December 2013 study on patients younger than 65 years of age who have undergone elective isolated mechanical aortic valve replacement, suggests that over the course of a 10-year period, 1% per patient-years will develop thrombosis or bleeding events. According to this study, the survival rates of these patients are actually lower than those of a population of the same age9.
The LTV valve could meet the expectations of these young patients as it is made to last a lifetime without potentially dangerous warfarin anticoagulation therapy. Moreover, it will be available in a wide range of sizes, including small 16 mm size, which would make it the first mechanical heart valve available for children.
Patients in emerging economies—China and India, for example—suffering from valve disease due to rheumatic fever. Read more...
- Rheumatic heart disease affects more than 15 million people worldwide3, 33. An estimated 470,000 new cases of rheumatic fever occur annually, of which 60% (282,000 people) develop rheumatic heart disease3.
- While rheumatic fever is rare in western countries, it is a common disease in emerging economies, where valvular disease represents a severe public-health problem. According to the World Health Organization and various publications32, 33 1 to 2% of school-aged children in China, India and other emerging economies will need a valve replacement before they reach 20 years of age.
- Tissue valves are generally not considered the option of choice in emerging economies, where patients are young, because valve durability is greatly reduced in that population. It is commonly recognized that tissue valves deteriorate faster in young patients13, 21, especially in the high-pressure mitral position39.
On the other hand, current mechanical valves would also represent a suboptimal solution as they require anticoagulation therapy, which is generally difficult to control in emerging economies.
With its unique performances, the LTV valve could meet the requirements of these patients in emerging economies.
Patients unable to tolerate anticoagulation therapy, such as women of child-bearing age. Read more...
Many patients cannot tolerate the anticoagulation therapy required by current mechanical heart valves. This is especially true for women who are pregnant or who may become pregnant as some studies have shown that anticoagulation drugs can cause birth defects.
Certain medical conditions may also make anticoagulation therapy undesirable. This may be the case for patients with a history of bleeding ulcers, high blood pressure, diabetes, kidney or liver disease, stroke or alcohol abuse.
The LTV valve may be appropriate for all these patients.
Adult patients suffering from Aortic Valve Stenosis due to degenerative calcification. Read more...
Aortic stenosis is one of the most common and serious valve disease problems in industrialized countries. According to the American Heart Association, more than 5 million Americans are diagnosed with heart valve disease. A July 2007 study made of the United States population estimates the prevalence to be around 1.5% in people above 18 years old with dramatic increase (above 10% ) in individuals aged older than 65 years2.
Although some people have aortic valve stenosis as a result of congenital abnormalities, this disease more commonly develops during aging as calcium, which amasses in the heart over the course of a lifetime, damages the valve and restricts blood flow through the valve. Like cancer, it can be silently fatal by provoking cardiac cell destruction that leads to irreversible cardiac failure.
The currently widely recommended therapy for patients in the ages 65–75 is surgical valve replacement with a tissue valve that avoids anticoagulation therapy; its limited durability is generally not considered an issue for these patients.
However, while surgical valve replacements performed promptly in these patients halts the disease progression and normalizes their life expectancy (often exceeding 15 years), an August 201225 study from the U.S. Department of Health found that when patients present symptoms of heart failure, the median patients’ life survival—even with surgery—does not exceed three years. This study therefore strongly supports systematic testing for the disease (which could be done today in a few minutes and at a low cost55) for preemptive treatment earlier in the disease course.
Preemptive treatment earlier in the disease course would render even more necessary the use of a valve like the LTV valve, which may be free of warfarin anticoagulation therapy, lasts longer than a tissue valve and thus avoids the need for further re-operation. This is especially true with the increase in the life expectancy.
Adult patients suffering from Mitral Valve Regurgitation due to various factors. Read more...
Valve regurgitation may appear suddenly or may develop gradually over decades due to a variety of causes. It could affect both the mitral and the aortic valve.
While aortic regurgitation is less common—the estimated prevalence is less than 1% in the elderly population—mitral valve regurgitation remains one of the most frequent forms of heart valve disease, and its prevalence increases with age6.
Once mitral valve regurgitation becomes severe, it is generally repaired through specific surgery techniques. If not possible, it is generally replaced by a standard prosthetic tissue valve. However, a tissue valve tends to deteriorate faster on mitral position than on aortic position due to higher mechanical stress during valve closing39.
The lifelong durability of the LTV valve, which may also not require warfarin anticoagulation therapy, could be a good answer for operable patients who need to have their mitral valve replaced.