A New Valve, Without Open Heart Surgery

The ABC News Medical Unit’s Dr. Mirjana Jojic reports:

Open heart surgery was the only way to get a new heart valve — until now.

As reported by MedPage Today and other outlets, the U.S. Food and Drug Administration yesterday approved a procedure that, for the first time, would allow patients to undergo aortic valve replacement through a small skin cut. And today, Dr. Martin Leon, director of the Cardiovascular Interventional Therapy Program at New York-Presbyterian Hospital / Columbia University Medical Center, performed his 304 th procedure.

“My patient [today] was a frail, 90-year old doctor whose life had become unbearable,” Leon told ABC News. “He couldn’t walk across a room without getting short of breath, and he was constantly getting dizzy and fainting. He came in for the procedure this morning, and within 45 minutes, he had a new valve.”

The valve, called the Sapien Transcatheter Heart Valve, is used to treat aortic valve stenosis, a disease of the elderly that affects the largest heart valve — the aortic valve. With age, the valve becomes thick and stiff and unable to perform its primary duty of helping the heart deliver blood to the body. If the condition becomes serious, over time people begin to feel weak, dizzy, have frequent fainting spells and eventually die of heart failure.

“Before this procedure, patients’ outlook was dismal,” said Leon. “Fifty percent of my patients would die within one year of getting symptoms, and the end of their life would be excruciatingly painful.”

Dr. Leon says that this procedure has had extraordinary results, not only because it has upped patient survival by 20 percent, but because it has improved the quality of life for patients suffering with this condition. Patients are no longer struggling to breathe; they can be more active and spend less time in the hospital and more time enjoying life.

Will open heart surgery now be a thing of the past for valve disease? Not yet, said Leon.

“So far this procedure has only been approved for the sickest of the sick, those people who can’t get surgery,” he said. “Next year we are going to talk to the FDA about expanding their approval to include people who are at-risk, but not necessarily as sick.”

Leon, who developed this procedure with his co-collaborator, Dr. Craig Smith, chairman of the Department of Surgery at Columbia University College of Physicians and Surgeons, now works on a heart valve team of cardiologists, surgeons and other specialists to perfect the valve and make it safer for patients.

“Unfortunately, when it comes to these procedures, cardiologists are usually in one camp, surgeons are in another, and no one can agree on anything,” Leon said. “Now we are working together, and the success of this heart valve in changing people’s lives [for the better] is proof that collaboration is the future of medicine.”