A revolutionary approach to repair damaged heart valves without requiring people to undergo chest-cracking surgery should be limited to the highest-risk patients until more is known about the technique, doctors said.
Edwards Lifescience Corp.’s aortic valve is threaded into the cardiac chamber, rather than inserted in an open heart operation. Patients given the device, called Sapien, were just as likely to be alive a year later as those who underwent surgery, according to data reported yesterday at the American College of Cardiology meeting. They also had higher stroke rates and lower bleeding risks, the study found.
The research included only the highest-risk, oldest patients and shouldn’t be applied to healthier people, said Michael Crawford, chief of clinical cardiology at the University of California, San Francisco. Cardiologists are anticipating a wave of demand from healthier patients who don’t want to undergo the pain of surgery or a longer recovery time, he said.
“It’s definitely going to change practice in treating this disease,” Crawford said at the meeting in New Orleans, after the results were presented. “Patients don’t want surgery. As good as surgery is, they just don’t want it. If there is an alternative, they are going to go for that as long as the risks and costs are reasonable.”
Edwards fell 59 cents, or less than 1 percent, to $85.48 at 4:04 p.m. in New York Stock Exchange composite trading. The shares have risen 70 percent in the past 12 months.
$2.4 Billion in Sales
If Sapien and Medtronic’s CoreValve are cleared for use in the U.S., they could generate sales of $2.4 billion and account for more than one in three aortic valve repairs by 2015, Larry Biegelsen, a Wells Fargo Securities analyst in New York, said in a note to investors today, increasing his estimates. The study results may lead to Sapien’s approval next year for high-risk surgery patients. Approval for sicker patients who can’t withstand surgery is expected in October.
The results should improve with time because the study used Edwards’s first-generation device and 19 of the 26 centers had no prior experience with it, “whereas the surgeons in the trial were probably the best and most experienced in the US and Canada,” Biegelsen said.
About 200,000 Americans suffer from aortic stenosis, when the valve that serves as the gateway between the heart’s main pumping chamber and the aorta becomes stiff and stifles oxygen-rich blood flow to the body. Open-heart surgery, the approach used for half a century to sew a new valve into place, is remarkably effective, studies show. Death rates are less than 1 percent and the valves last for a quarter century.
Surgery Survival Fears
Many patients eschew the operation even though they qualify for it, fearing they may not survive it or recover well, said Ralph Brindis, president of the American College of Cardiology and an interventional cardiologist at Kaiser Permanente in Oakland, California. Overall, as many as 100,000 people aren’t getting the treatment they need, he said.
Brindis said he plans to stick with surgery for lower-risk patients until more information, and newer valves that reduce stroke risks, are available.
“It’s going to take awhile to ramp up expertise in centers,” outside of the universities conducting studies of the new valves, Brindis said. “There are a lot of things that need to be put in place to ensure that as this genie gets out of the bottle we can reproduce the safety and efficacy as it gets delivered into the community.”
Risk of Stroke
Physicians highlighted the increased risk of stroke and neurological complications, questions about durability, and concerns about leakage from valves inserted through a catheter.
“People obviously want to go with the simpler device, but you have to balance it with the stroke risk,” said Robert Bonow, professor of cardiology at Northwestern University and director of the Center for Cardiovascular Innovation at Northwestern Memorial Hospital in Chicago. “It’s troublesome that the stroke risk grows over time.”
Some people already are going to Europe where Sapien and a rival device from Minneapolis-based Medtronic Inc. are approved for sale, UCSF’s Crawford said.
Doctors and patients should carefully weigh the differing risks of the two treatment approaches, said Patrick Serruys, professor of cardiology at the Thoraxcenter of Erasmus Medical Center Hospital in Rotterdam.
A stroke at the age of 84, the average of those in the study, is a major catastrophe, he said. Other patients are able to function a few days after a less-invasive procedure.
Open the Door
“It’s good news for the elderly,” Serruys said. “And it’s going to open the door for the less risky patients.”
Already researchers are talking to officials at the U.S. Food and Drug Administration and other regulatory agencies worldwide about including less risky patients in future studies, he said. The procedure is now used in people who have about a 10 percent risk of dying in the hospital, he said. The plan is to lower that to a 4 percent risk in the U.S. and 3 percent in Europe, he said.
Edwards is studying its next-generation transcatheter valve, which is smaller and may be more durable, said Larry Wood, Edwards’s vice president of transcatheter valve replacement. The device, called the Sapien XT, accounts for nearly all of the company’s sales in Europe, he said in a telephone interview.
Between 60,000 and 70,000 patients in the U.S. get open-heart aortic valve replacement each year, Wood said. Thousands of others forgo surgery, he said. An open-heart operation in which the ribs must be separated can take weeks or months to fully recover from, versus just days for catheter valves.
“We think a less invasive approach could get these patients off the sidelines and make it a larger market,” he said in a telephone interview.
The first look at the data is impressive and the success rates are likely to get better as doctors and the valve design improve, said Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio. Until additional, long-term data are available, doctors must ensure the right patients are treated, he said.
“This is a very solid result and will provide high-risk patients with options,” he said in an interview. “I would not offer patients at lower risk this procedure without more evidence of its benefit. When the practice of medicine gets ahead of the science, we make mistakes.”