El Camino Hospital became one of the first hospitals in California to adopt a new minimally invasive system to treat patients with narrowed, failing aortic heart valves who are considered to be at high risk to undergo surgery.
The U.S. Food and Drug Administration (FDA) approved the Medtronic CoreValve@ System to treat patients with severe aortic stenosis who are at high risk for surgery based on groundbreaking research showing the transcatheter heart valve had superior survival rates at one year when compared to open-heart surgery, the current gold standard for aortic valve replacement. The CoreValve System also demonstrated low rates of procedural complications, including stroke, one of the most concerning complications of valve replacement because it can affect survival and quality of life.
"The CoreValve System demonstrated exceptional clinical outcomes during the U.S. pivotal trial," said Rhonda Robb, vice president and general manager of Catheter Based Therapies at Medtronic. "We are pleased that the CoreValve System is now available to the broadest range of patients with severe aortic stenosis."
El Camino Hospital was one of 45 U.S. sites involved in the High Risk Study of the CoreValve U.S. Pivotal Trial, which led to the FDA approval of the CoreValve System.
"The recent FDA approval of the CoreValve System is a significant milestone for patients with severe aortic stenosis who previously had no other treatment options," said James Joye, D.O., interventional cardiologist at El Camino Hospital. "We are proud to have been one of the only community hospitals in the nation to participate in the groundbreaking clinical results that led to this approval."
"El Camino Hospital is a leader in advanced therapies for the most complex heart conditions and has performed more than 100 CoreValve procedures," said Vincent Gaudiani, M.D., cardiothoracic surgeon and medical staff member at El Camino Hospital and the Palo Alto Medical Foundation (PAMF). "Our deep expertise and optimal outcomes with this innovative procedure uniquely positions us to help more patients in our community achieve better quality of life."
Aortic stenosis is a common heart problem caused by a narrowing of the heart's aortic valve due to excessive calcium deposited on the valve leaflets. When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and increased risk for sudden cardiac death.
The CoreValve System replaces a diseased aortic heart valve through a minimally invasive procedure, without open-heart surgery and without surgical removal of the diseased valve. The device is typically inserted via an artery in the leg or upper chest, and then guided through the arteries into the heart. Once in place, the CoreValve System expands and takes over the original valve's function to enable oxygen-rich blood to flow efficiently out of the heart.
The CoreValve System initially was approved by the FDA in January 2014 to treat patients who are too ill or frail to undergo surgery. With this latest approval, El Camino Hospital now also offers the CoreValve System to patients who are considered at high risk for a surgical heart procedure, serving a broader range of U.S. patients than any other transcatheter aortic valve.
The advanced design of the CoreValve System is suitable for patients with native valves of nearly all sizes, and it is delivered through the smallest available delivery system, making it possible to treat patients with vascular systems that are small or difficult to navigate. Additionally, the valve's self-expanding frame enables physicians to deliver the device in a controlled manner, allowing for accurate placement.