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New Implant Better Than Open Heart Surgery?

April 4, 2011

Open heart surgery can be avoided by some with a new type of heart valve that is placed through a tube in an artery, cardiologists report in a study.

However, the downside would be a higher risk of stroke as well as uncertainty on how long these valves would last.

Edwards LifeSciences Corp. developed a heart valve replacement technique that spares patients open heart surgery. It had a lower death rate than open heart surgery at one year.

After one year, 24.2% of patients with the Edwards valve died, compared with the 26.8% of patients who had open heart surgery who died.

Patients suffering from severe aortic stenosis can benefit from the Edwards valve. Aortic stenosis is described as “a clogged valve that impedes the pathway of oxygen-rich blood by making the heart work harder to pump blood through a narrowing opening,” reports AFP.

9% of Americans over the age of 65 suffer from this condition. Up to half of patients die within two years if no treatment is given.

Dr. Edward McNulty, a cardiologist at the University of California, San Francisco, explained how this method works to the AP.

“Through an artery in the groin or the chest, a new heart valve is literally crimped on a balloon and advanced across the narrowed, older, diseased heart valve. The balloon is inflated and the new valve left in place.”

The survival rate from conventional surgery is similar, except that the risk of stroke and other major heart complications are elevated. However, the new method is less invasive, and can be used for patients who are too sick for surgery for a higher chance of survival.

The AP reports that Dr. Elliot Antman, a Brigham and Women’s Hospital cardiologist and American Heart Association spokesperson says that this would be a great option for those who are too sick to have surgery, but that it was too soon to be used for patients who are less sick.

Even though it is less invasive, some patients will still prefer open heart surgery because the fear the possibility of a higher stroke rate of the new method. The study found 5.1% of those who had the valve implanted experienced a stroke, while open heart surgery patients had a stroke rate of only 2.4%.

Despite the higher risk of stroke, cardiologists and heart experts believe that the Edwards valve used in what is called the Sapien method is the next major turning point in heart disease treatment.

AFP reports that this method is already being used in Europe, but has not gained the approval from the U.S. Food and Drug Administration. The agency considers the valve as an investigational device.

“This probably will be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime,” says David Moliterno, professor of medicine at the University of Kentucky.

Dr. Craig Smith, heart surgery chief at Columbia University and New York-Presbyterian Hospital, led the study that consisted of 699 patients. The results were presented at an American College of Cardiology conference in New Orleans.

This clinical trial study, called Partner, was paid for by Edwards Lifesciences Corp. of Irvine, California. The company is currently seeking federal approval to sell the valve for patients who cannot be operated on, and has plans to ask that the valves be used for less sick patients.

As a patient in the study, 89 year old Charles Cohen received an artery-placed valve two years ago at Cedars-Sinai Medical Center in Los Angeles.

The AP reports that Cohen was “a little leery” about either options, but he was hoping for the catheter method.

He says, “Now I walk half a mile,” whereas before he could only walk a block or so before having to stop and rest.

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