Edwards Lifesciences Corp.’s replacement heart valve, designed to be threaded into place, yields similar survival rates and less bleeding than rib-cracking surgery while triggering more strokes, a study found.
The research shows the device, called Sapien, is a viable alternative to open-heart operations for elderly, high-risk patients with a clogged aortic valve, the gateway between the heart’s main pumping chamber and the aorta that carries blood to the body, said Craig Smith, a lead researcher. The Sapien procedure is less painful and patient recovery time is shorter.
The results may lead to Sapien’s approval for high-risk patients in the U.S. by 2012, said Larry Biegelsen, a Wells Fargo Securities analyst in New York. Sapien and a rival made by Minneapolis-based Medtronic Inc. are already sold in Europe, with about $600 million in annual sales, said Larry Wood, Edwards’ vice president of transcatheter valve replacement.
“Recommendations to individual patients will need to weigh the appeal of avoiding open-heart surgery, with its known risks, against less invasive transcatheter aortic valve replacement with different and less well understood risks, as well as the absence of long-term follow up,” said Smith, who is chief of cardiothoracic surgery at New York-Presbyterian Hospital Columbia University Medical Center, in a statement.
In the company-funded study, 19.5 percent of those who underwent open-heart surgery developed major bleeding, compared with 9.3 percent in Sapien patients, and they were almost twice as likely to develop irregular heart rates. The device was shown to increase stroke risk to 5.1 percent after a year, compared with 2.4 percent with the surgery.
72% Share Rise
Edwards, based in Irvine, California-based, fell 1 percent, or 93 cents, to $86.07 in New York Stock Exchange composite trading on April 1. The shares have risen 72 percent in the 12 months before today.
About 200,000 Americans suffer from aortic stenosis, or narrowing of the heart’s aortic valve, including 9 percent of those over age 65. The study, called Partner, was reported at the American College of Cardiology’s annual meeting in New Orleans. It included 699 patients in the top 5 percent of risk from the disease, Edwards’ Wood said in a telephone interview.
The study also found that 3.4 percent of patients given the less-invasive valve died after 30 days, compared with 6.5 percent of those getting standard surgery. The difference, though, disappeared by the end of a year, with 24.2 percent of Sapien patients and 26.8 percent of surgery patients dying.
Vascular complications developed in 11 percent of Sapien patients and 3.2 percent of surgery patients while leaks near the Sapien valve were more common than in surgery patients. The average age of patients in the study was 84.
“The goal was to show our first generation transcatheter valve is comparable to traditional open-heart surgery in a high- risk population,” Wood said. “If we can get comparable results, a less invasive procedure is always more desirable. The Holy Grail would be to prove this is as good or better than open surgery in lower risk patients.”
The initial cost of treatment with Sapien is about $78,000, a second report found, based on earlier work that showed people too sick for open-heart surgery were 45 percent more likely to live if they got the valve rather than supportive medical care.
Added research is needed to see whether the new approach is beneficial in lower-risk patients, Smith said. Edwards already is studying a next-generation transcatheter valve that’s smaller and may be more durable, Wood said.
Expanding the Definition
The company is also in discussions with the U.S. Food and Drug Administration to expand the definition of high-risk patients, which could broaden the market, he said.
Edwards has filed for FDA marketing clearance for Sapien in patients who can’t withstand surgery, and approval is expected in October, Wood said. The company will submit the additional results compared with open-heart surgery in the next couple of months to try to expand use of the device, he said.
The company estimates that 60,000 to 70,000 people in the U.S. undergo aortic valve surgery each year.
The figures miss another large pool of patients who forgo the invasive surgery, and remain undertreated, which accounts for up to half of people with the condition, said Chet Rihal, a cardiologist at the Mayo Clinic in Rochester, Minnesota, when the initial results were released.
“We believe transcatheter aortic valve implantation is the most compelling opportunity in the cardio device space,” Wells Fargo’s Biegelsen wrote in a March 1 note to investors. Positive results from the study, the first scientifically rigorous comparison against standard surgery, “will help drive market acceptance and reimbursement in our view.”
50% Death Rate
The initial Partner study found 50 percent of those who can’t withstand surgery die within a year.
Different methods used to insert the transcatheter valves yielded small differences in success rates.
After one year, 29 percent of patients who had Sapien inserted straight into the heart through their ribs had died, compared with 27.9 percent of surgery patients. In a less sick group treated through the femoral artery, 22.2 percent died, compared with 26.4 percent of surgery patients. The differences weren’t statistically significant.
Medtronic has started the pivotal trials needed for U.S. approval of its device, known as CoreValve, it is proceeding quickly, said Kathleen Janasz, a Medtronic spokeswoman.
There is evidence the new valves are expanding the market in Europe, rather than replacing surgery, Woods said.
“This has gone very quickly in Europe, but many are patients who weren’t being treated previously,” he said. “It’s more market expanding rather than cannibalizing surgery.”