Hospitals are looking at new ways to treat heart disease, and a new, minimally invasive procedure is being tested as a possible alternative to open-heart surgery. El Camino Hospital is one of four hospitals in California to take part in clinical trials for a new heart-valve replacement procedure, and so far the results have been encouraging, hospital officials said.
The medical procedure is called the CoreValve System, designed by Medtronic to treat patients with aortic stenosis -- a common heart disease caused when the aortic valve narrows and fails to open and close properly. Aortic stenosis can lead to heart failure and increases the risk of sudden cardiac arrest.
In the procedure, an artificial valve is inserted through one of three arteries and guided into the aortic valve of the heart, where it expands and replaces the faulty valve. The artificial valve is composed of two parts: a metal frame and heart tissue from either a pig or a cow. The metal frame is made of nitinol, a self-expanding metal that has "shape memory," meaning it can contract and re-expand into the correct shape once it reaches the aortic valve.
El Camino Hospital's clinical study of the new procedure was for patients at extreme and high risk. The results showed that replacing the aortic valve with the device, rather than performing open-heart surgery, lowered the rate of mortality and increased the rate of recovery for patients. The Food and Drug Administration has since approved the use of the CoreValve System on both risk groups.
To celebrate the milestone, the hospital hosted a reunion last week of patients and surgeons who took part in the study. They gathered on the first floor of the hospital lobby for a progress report by Medtronic on the performance of the new treatment.
Cindy Mancillas was one of the many patients at the reunion. An 83-year-old grandmother from San Francisco, Mancillas said she enjoys traveling through Europe, likes to walk everywhere she goes, and hasn't driven since 1987. Her active lifestyle became difficult about six years ago when she started to develop problems related to aortic stenosis.
"It greatly curtailed activities," Mancillas said. "I couldn't climb stairs or castles on vacations. I was holding everyone up."
But her problem was two-fold: She needed surgery to replace her aortic valve, but her lungs were too weak for her to undergo open-heart surgery. Mancillas was one of the "high risk" patients who qualified for the clinical study because her only other option was an unsafe procedure.
Age is the "basic cause" for the disease, according to Dr. James Joye, interventional cardiologist at El Camino Hospital. As you get older, the aortic valve narrows due to excessive calcium deposited on the valve's "leaflets." Joye said the disease primarily affects people in their mid-80s to early 90s -- a group of people that often can't handle open-heart surgery, which involves sawing open the breastbone, cutting out a heart valve and putting in a new one.
"We're talking about a very sick group of people," Joye said. "This is an alternative to surgery with excess risk."
Mancillas said she underwent the surgery two months ago, and since then has been "amazed" with the results. She's been in a cardiac rehabilitation program at a San Francisco medical center, and is able to walk five city blocks without any problems. She's also able to do errands, like go to the grocery store, on her own again.
Mancillas said she also hopes to travel to Eastern Europe again as well.
"I've gotta see Prague one more time," Mancillas said.
Joye, one of the surgeons at El Camino Hospital who does the CoreValve replacement procedure, said one of the striking differences between open-heart surgery and the new method is the recovery time. He said patients are still in the thick of recovery a month after open-heart surgery, whereas patients who undergo the new process are "firing on all cylinders" by that time.
"It's changing the face of the way we treat this disease," Joye said.