Repeated failure of the bio-prosthetic aortic valve or Mitral valve, which raises the chances of fatality or severe complications in patients of symptomatic heart disease, has lead to a new breakthrough in artificial valve technology.
The US Food and Drug Administration (FDA) recently approved the use of Edward Lifescience LLC’s Sapien 3 Transcatheter Heart Valve, which will replace the Aortic or Mitral valve in case of failure. The use of the new valve has also been expanded to high-risk patients by the FDA, giving a new lease on life for patients of symptomatic heart disease.
As per experts in cardiovascular devices at the FDA, this is the first time any regulatory agency was approving a transcatheter heart valve as a valve-in-valve treatment to replace the bio-prosthetic mitral or aortic valves in case of failure from repeat surgery.
This new approval offers patients with failing surgical bio-prosthetic aortic or mitral valves a less-invasive treatment option.
What Causes Aortic Or Mitral Valve Failure?
A condition called Stenosis causes the bio-prosthetic aortic or mitral valve to fail over time. The prosthetic valve narrows and causes the heart to work harder to pump blood when the valve does not close completely or blood leaks backwards, or a combination of both.
Doctors often perform a repeat open-heart surgery to widen the valve, which often raises the chance of complications and even fatality for certain patients.
The Sapien 3 THV was originally approved by the FDA as a replacement for the transcatheter aortic valve replacement (TAVR), which served as an alternative option to surgical aortic valve replacement for patients with native aortic stenosis with no immediate risks and only surgical complications.
In 2016, however, the FDA expanded the use of Sapien 3 THV to include high risk patients at facing risks including death.
In 2017, the Sapien 3 THV has been expanded as a valve-in-valve treatment.
In the valve-in-valve procedure, the replacement valve is inserted inside the failing valve through the patient’s blood vessel or a small incision in the patient’s chest, offering a safe, breakthrough alternative to repeat surgery.
The Sapien 3 THV has an innovative frame design, comprising of a tri-leaflet bovine pericardial tissue valve with a balloon-expandable, radio-opaque, cobalt-chromium frame, and an inner and outer polyethylene terephthalate (PET) fabric.The inflow of the valve is covered by an outer PET cuff that enhances para-valvular sealing. The cobalt chromium alloy frame and wide strut angles provide fatigue resistance and high radial strength for circularity. The large cells on the side of the outflow make an easy access for the coronary arteries.
Why Sapien 3 THV Was Approved
The data was evaluated by the FDA from the Transcatheter Valve Therapy Registry. The test subject sample group consisted of 314 patients who had undergone aortic valve-in-valve procedures and 311 patients who had undergone mitral valve-in-valve procedures.
The registry data showed that more than 85% of the test subjects who underwent aortic or mitral valve-in-valve procedures experienced scientifically and medically agreeable improvement in heart failure symptoms 30 days post-procedure, in coinciding with the standards of New York Heart Association (NYHA) Classifications. In both aortic and mitral valve-in-valve patients, the observed fatality rates were substantially lower than the expected rate for repeat surgery, after using THV.
The NYHA Classification system rates heart failure symptoms.
Who Should Avoid Sapien 3 THV
The Sapien 3 THV is proscribed for patients who cannot tolerate blood thinners or blood coagulants for preventing clots. Those having an active infection in the heart or elsewhere, too, are forbidden from being administered THV.
There are complications and risks involved in every surgical procedure. Patients that undergo Sapien 3 THV valve-in-valve procedure face potential complications such as death, heart attack, respiratory failure, heart failure, or renal failure or bleeding.