New Jersey hospitals are performing a new, minimally invasive procedure that puts an aortic valve into patients who are too sick or frail to withstand the stress of open heart surgery -- and who face a heightened risk of death from aortic stenosis, a condition in which the valve calcifies and severely constricts the flow of blood.
The Edwards Sapien valve, developed by Edwards Lifesciences and approved last November for commercial use by the Food and Drug Administration, is inserted into an artery at the groin, then threaded up into the heart where it replaces the aortic valve. New Jersey hospitals that either began doing these procedures earlier this year, or will start doing them soon include Cooper University Hospital in Camden, Hackensack University Medical Center, Morristown Medical Center, Newark Beth Israel Medical Center, Jersey Shore University Medical Center, and Robert Wood Johnson University Hospital.
An estimated 300,000 people in the U.S. suffer from aortic valve disease. Many are elderly, suffer from a variety of medical conditions, or for other reasons are deemed too high risk for open heart surgery, which requires the breastbone to be divided and the patient placed on a heart and lung machine during a surgery that takes three hours or more.
In comparison, the Edwards Sapien valve is inserted during a new procedure known as transcatheter aortic valve replacement (TAVR) and takes about an hour and a half; it is not considered major surgery and generally requires a shorter recovery period.
Rubin Miller, 91, of Englewood Cliffs had TAVR in early April at Hackensack University Medical Center and said “there is no question” that he feels better with his new heart valve: “I feel pretty lucky.”
The retired attorney had a triple bypass surgery in 1993, “and that lasted me pretty good, but in the last two years or so my echocardiogram has not been satisfactory, I have found myself short of breath, and I have had to reduce myself to minimal activities.” Now he and his wife Joan are thinking of taking a cruise: “A new vista has just opened up,” he said.
Cooper did its first TAVR in January and has since done 20 of them, according to Dr. Michael Rosenbloom, head of cardiothoracic surgery. “These are patients who are too frail, too sick to be able to get through a regular operation, but they still have life left in them -- and up until now there was nothing we could offer them.”
Cardiac surgeons consider TAVR a medical breakthrough that saves lives, and whose importance can’t be overstated. “The prognosis for patients with a narrowed aortic valve, once they start having symptoms, is abysmal: Half of them are dead in a year,” said Dr. Jock McCullough, cardiac surgeon at Hackensack. “They have no options; there is no medicine for this. This is a mechanical problem, and the valve has to be replaced.”
A key advantage of TAVR is that, unlike the weeks of recovery required after open heart surgery, it involves a small incision in the groin and “the recovery from that is relatively minimal,” said cardiac surgeon Dr. Steve Xydas of Morristown Medical Center.
He said the patients suffering from aorta stenosis get short of breath because their heart is working overtime to pump blood through the constricted valve, so even minimal physical activity like walking up a flight of stairs taxes the heart. Relatives of these patients, “see their loved one who has a very poor quality of life, getting progressively worse and slipping from the hand of life, and essentially are brought back with this technology.”
Dr. Richard Neibart, chief of cardiac surgery at Jersey Shore University Medical Center, said that for elderly patients without other serious medical problems, life expectancy can be greatly improved by TAVR. “The people who are getting this were not expected to live more than a year, but now may live for several years.”
Dr. Martin Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center has been doing TAVR procedures since 2005 as part of the clinical trial of the device, and is co-principal investigator of a study comparing the Edwards Sapien heart valve to conventional open heart surgery for valve replacement.
“What we learned is that for patients who were too sick for surgery, this device was dramatically effective in prolonging life. There was a 20 percent reduction in mortality the first year after treatment.” And the procedure significantly alleviated symptoms: “Patients felt better and lived longer.” He predicted that TAVR “will become the standard of care for those patients who can’t have surgery” and said there would probably be tens of thousands done in the U.S. over the next few years.
Medicare announced on Tuesday that it would cover TAVR; Leon said Medicare has been covering the cost of the procedure during the clinical trials. Horizon Blue Cross Blue Shield of New Jersey is among commercial insurers that cover TAVR.
Leon noted that at $30,000, the Edwards Sapien is an expensive device. But he said the overall costs of the TAVR procedure is about the same as open heart surgery; he said both have a total cost of between $70,000 and $80,000. “The higher cost of the [Edwards Sapien] device gets offset by the fact that the length of stay in the intensive care unit is about 40 percent less than surgery and days in the hospital were about five days less than surgery.” And after patients have TAVR, they are in better health and less likely to admitted to the hospital to treat complications of heart disease. “This therapy prolongs life and then keeps people out of hospitals.”