Many patients are developing a condition known as aortic stenosis, a narrowing of a heart valve. These patients are too old or too sick to under-go open-heart surgery to replace the diseased aortic valve, which controls blood flow into the aorta from the heart. After being diagnosed with this disease, many patients die within two years. A new way of replacing a failing heart valve has been discovered for these patients, without any need for open-heart surgery.
In this new method, a percutaneous heart valve is fixed through a catheter, much like the way an artery-opening stent is implanted. The catheter is placed through a small opening in the groin or chest through blood vessels into a patient’s heart where it deploys the valve. The new valve squeezes the diseased valve and replaces it.
“This study shows that transcatheter valve replacement is a safe and effective option for this life-threatening illness in patients unsuitable for surgical valve replacement,” said Dr. Craig D. Smith, a lead investigator on the study who is a surgeon at New York-Presbyterian Hospital/Columbia University Medical Center.
The results of the study also raised questions on whether only but the sickest patients can undergo the procedure. Those who underwent the surgery had a higher percentage of major strokes and other complications than patients who underwent open-heart surgery. Within 30 days of the procedure, strokes and other problems occurred to patients that were linked to the new procedure.
“Additional studies were need to understand the complications,” said Dr. Smith in a statement.
The study’s results were highly anticipated because Edwards Lifesciences and other major medical device producers such as Medtronic, are in pursuit to bring the first percutaneous heart valve to the market. In Europe, the device has been used for several years, while the Food and Drug Administration have not approved the sale of this device in the United States.
Dr. Martin B. Leon, also of New York Presbyterian Hospital, was the other lead investigator on the study. Dr. Leon had co-founded the company that had developed the new valve technology that was later wanted by Edwards. It has been estimated that the market for these percutaneus devices could reach over $1.5 billion in just six years. But it is still unknown how long the device will last after it is implanted.
In the study, 358 patients with aortic stenosis who were considered too ill for open-heart surgery were placed in two groups. One group received the new valve replacement procedure, while the other group received the treatment originally used for patients who are to sick for surgery. A surgical balloon is inflated inside the failing valve in an effort to expand it. After a year, the rate of death was 20 percent less than the patients who received the standard treatment. Also, the heats of patients who received the valve functioned better on standard test.
