The Sapien Transcatheter Heart Valve (THV), an artificial aortic heart valve that can be placed without open-heart surgery, has been approved by the US FDA (Food and Drug Administration). The artificial heart valve replaces an aortic heat valve that is damaged by senile aortic valve stenosis.
Senile aortic valve stenosis is a progressive disease that can affect elderly patients. There is an accumulation of calcium deposits on the aortic valve, causing the valve to become narrower. In order to get adequate amounts of blood pumped through the smaller valve opening, the heart has to work much harder; it eventually weakens because of the long-term extra effort, resulting in chest pains, heart failure, arrhythmia (irregular heartbeat), fainting, or cardiac arrest (heart stops completely).
Patients with severe aortic valve stenosis will usually have to undergo surgery to replace the valve.
According to the FDA, over half of all individuals die within two years of the onset of senile aortic stenosis. Unfortunately, some patients are unable to undergo the open-heart surgery needed to replace the faulty valve.
Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said:
“Surgery to replace the aortic valve is an effective treatment for severe senile aortic valve stenosis. The Sapien Transcatheter Heart Valve (THV) is an example of an innovative new device that will provide some people with this condition who can’t undergo open heart surgery with the option of valve replacement.
The agency remains committed to working with companies who are developing breakthrough treatments that will have a significant impact on patient care in the U.S.”
The Sapien THV is made of polyester and cow tissue, it is supported with a mesh frame made of stainless steel. The device is compressed into a delivery catheter and inserted through a small cut in the leg, into the femoral artery, and threaded all the way up to where the diseased valve in the heart is located. The heart valve is then separated from the catheter and expanded with a balloon.
The FDA based its approval on a study involving 365 patients with senile aortic valve stenosis who were not eligible for open-heart surgery. They were divided into two groups:
- The Sapien valve group
- A cohort group – they received other treatment that did not need open-heart surgery – balloon valvuloplasty; the aortic valve is enlarged by stretching it with a balloon
Below are some highlighted results from the trial:
- 69% of those in the Sapien valve group were still alive ofter one year compared to 50% in the other group
- Those in the Sapien valve group had 2.5 times more strokes
- Patients in the Sapien valve group had eight times as many vascular and bleeding complications
The makers of Sapien THV, Edwards Lifesciences Corporation, will carry on the evaluation patient outcomes through the national TVT (Transcatheter Valve Therapy) registry. The American College of Cardiology as well as the Society of Thoracic Surgeons are liaising closely with the FDA and CMS (Centers for Medicare and Medicaid Services) to create a national TVT registry.
The following side effects are possible for those receiving the Sapien valve – stroke, perforation of the blood vessels, perforation of ventricle or valvular structures, significant bleeding, damage to the heart’s conduction system, and leaks around the new valve – all are potentially life-threatening.
The Sapien THV is approved for:
- Individuals not eligible for open-heart surgery to have their aortic valve replaced, and have calcium accumulation in the fibrous ring of the aortic heart valve (calcified aortic annulus)
The heart surgeon needs to be involved in deciding whether a patient is suitable for Sapien THV treatment, according to the product label.
The FDA adds that this device is not approved for open-heart surgery usage. Patients with the following conditions or circumstances should not be treated with Sapien THV: Those who cannot tolerate antiplatelet/anticoagulation therapy, individuals with congenital heart valve abnormalities, and patients with masses or an infection in their hearts.
Michael A. Mussallem, Chairman and CEO of Edwards Lifesciences Corporation, said:
“This day marks an important milestone for inoperable American patients who have long been awaiting a therapeutic option for the often debilitating symptoms associated with severe aortic stenosis. We are extremely proud of the dedication of the heart teams and the patients involved in the clinical trial for this therapy, who have paved the way for this therapy to help even more people around the world.”
Written by Christian Nordqvist