FDA Logo Senile aortic valve stenosis is a progressive age-related condition that results in problems such as dizziness, chest pain, heart failure, arrhythmias or cardiac arrest. On this front, the U.S. Food and Drug Administration (FDA) has approved of the first artificial heart valve that could supplant a damaged aortic heart valve due to senile aortic valve stenosis without open heart surgery.

Patients of the aforesaid condition usually go through open heart surgery for the replacement of the afflicted valve. But, the process apparently comes with many risks for certain patients.

“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,” specified Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

The Sapien THV constitutes cow tissue and polyster held by a stainless steel mesh platform. In order to replace the impaired valve, the latter is transfixed towards the end of a long and thin device known as the delivery catheter. These 2 are then introduced into the femoral artery through a small abrasion in the leg and hooked to the region of the harmed valve by means of a thread. The heart valve is then freed from the delivery catheter and is expanded like a balloon. The resulting valve functions immediately.

In order to give the approval, a study comprising 365 patients who were not applicable for open-heart surgery was conducted. Around half of these patients were given the Sapien valve. The rest of the subjects received an alternative treatment that did not necessitate open heart surgery. Another such procedure called balloon valvuloplasty was also used.

As per the outcomes, patients who received Sapien seemingly encountered 2 and a half folds higher stroke rates as compared to those who underwent alternative therapies. They also appeared to experience 8 folds of the vascular and bleeding effects seen in patients who were not given the implant. Nevertheless, they seemed to be likelier to survive a year following surgery and about 69% of patients receiving Sapien were alive after 12 months. However, just 50% of people who were exposed to other treatments lived.

There are certain cautions put forward by the FDA regarding the use of Sapien THV which is approved for patients who are not eligible for open heart surgery. Those having congenital heart valve anomalies or heart infections or no tolerance to antiplatelet therapies should not receive this treatment, states the report. The procedure is not approved for individuals who can be treated by open-heart surgery.

Edwards Lifesciences is the manufacturer of the Sapien THV.