‘Death Is Always Cheaper’ – Capsules: The KHN Blog
Sapien artificial heart valve approved by FDA for use in old, frail patients to gain another year
By Christopher Weaver
Sapien Artificial Heart Valve - Read more below news story.
Nov. 14, 2011 - Conventional health care wisdom says that a less invasive procedure will be less expensive: Fewer days in
the hospital and an easier recovery should reduce costs, right?
Well, it’s complicated. A new heart valve device and procedure
approved by the FDA last week costs less than the standard treatment, but it can’t replace that
procedure. Instead, it will allow an estimated 20,000 more patients - who would otherwise be inoperable due to frailty - to get the new valve.
So the money that will be spent on these patients is in addition to the dollars already being spent. The new technology
shows promise to extend the lives of very sick patients, but it doesn’t save money.
Rob Kuhling, a venture capitalist who had invested in a similar new technology, summed it up bluntly: “Death is always
Here are the
details: The standard way to treat
aortic stenosis is open heart surgery. The new Sapien valve by
Edwards Lifesciences can be inserted by threading a catheter from a small incision in the leg
through an artery to the heart. Estimates put the total cost for the new device and hospital stay at about $70,000 versus up to $100,000 for
the open heart procedure and hospital stay in the most complicated patients.
But the Sapien valve hasn’t been approved for people who can now get open heart surgery. Its statistical outcomes don’t
“beat” open heart surgery for patients who are well enough to undergo that demanding, traumatic operation.
The product has been used in Europe since 2007 for patients too sick for open-heart procedures. It has increased stroke
rates in patients who get it, but overall the 365-person trial the FDA reviewed found that 69 percent of patients who got the new valve lived
another year, while only 50 percent of those who received other, nonsurgical treatment survived that long.
Kuhling, of Onset Ventures, invested in a company developing a similar device that has not yet gained approval and is now
owned by Boston Scientific. He said a driving factor in his investment plan was the promise that the new product could reduce the cost of
aortic valve replacement surgeries, and attract value-conscious customers.
For now, though, it is unclear whether the innovation will rise to that goal.
If the Sapien valve gains traction and is ultimately adopted as an alternative to open heart surgery for to some
patients, Kuhling and other investors who spoke with Kaiser Health News hope it could ultimately prove less expensive in those cases.
Right now, Medicare pays Stanford Medical Center up to $100,000 for doing open-heart surgery for complex cases, while
less complicated ones command much lower payments. Analysts expect the valve to gain broader approval next year,
the AP reported.
Kuhling put the target price for the product he invested in, being developed by
Sadra Medical, at around $45,000 for the entire procedure including hospital stays. “People aren’t going to invest in device
companies that don’t have those economics,” he told KHN.
FDA approves first
artificial aortic heart valve placed without open-heart surgery
The U.S. Food and
Drug Administration earlier this month approved the first artificial heart valve that can replace an aortic heart valve damaged by senile
(related to being old) aortic valve stenosis without open-heart surgery.
Senile aortic valve stenosis is a progressive, age-related disease caused by calcium deposits on the aortic valve that
cause the valve to narrow. As the heart works harder to pump enough blood through the smaller valve opening, the heart eventually weakens,
which can lead to problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest.
Once symptoms of senile aortic stenosis occur, more than half of patients die within two years. To restore normal blood
flow, patients with severe aortic valve stenosis need open-heart surgery to replace the diseased valve. However, the procedure is too risky
for some patients.
“Surgery to replace the aortic valve is an effective treatment for severe senile aortic valve stenosis. The Sapien
Transcatheter Heart Valve (THV) is an example of an innovative new device that will provide some people with this condition who can’t undergo
open heart surgery with the option of valve replacement,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological
“The agency remains committed to working with companies who are developing breakthrough treatments that will have a
significant impact on patient care in the U.S.”
The Sapien THV is made of cow tissue and polyester supported with a stainless steel mesh frame. To replace the diseased
valve, the Sapien THV is compressed into the end of a long, thin, tube-like device called a delivery catheter.
The delivery catheter, which is slightly wider than a pencil, and the Sapien THV are inserted into the femoral artery
through a small cut in the leg and threaded to the site of the diseased valve. The heart valve is then released from the delivery catheter and
expanded with a balloon and is immediately functional.
The FDA’s approval of the Sapien THV is based on a study in 365 patients who were not eligible for open-heart surgery.
Half of the patients received the Sapien valve. The other study patients received another treatment that did not require open-heart surgery.
One alternative procedure involved enlarging the aortic valve opening by stretching it with a balloon (balloon valvuloplasty).
Patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and
bleeding complications than patients who did not receive the implant; however, they were more likely to survive one year after surgery.
After a year, 69 percent of the Sapien patients were alive compared with 50 percent of those who received an alternative
Edwards Lifescience, the manufacturer of the Sapien THV, will continue to evaluate the outcomes with the Sapien THV
through a national Transcatheter Valve Therapy (TVT) registry. The Society of Thoracic Surgeons and the American College of Cardiology have
been working with the FDA and the Centers for Medicare and Medicaid Services to facilitate the creation of the national TVT registry that will
serve as a platform for continued evaluation of post market experience with this and future transcatheter devices and procedures for the
treatment of aortic stenosis.
The most common serious and potentially life-threatening side effects in patients receiving the Sapien valve and the
procedure to implant the valve include death, stroke, perforation of the blood vessels, ventricle or valvular structures, damage to the
conduction system in the heart, significant bleeding, and leaks around the new valve.
The Sapien THV is approved for patients who are not eligible for open-heart surgery for replacement of their aortic valve
and have a calcified aortic annulus (calcium build-up in the fibrous ring of the aortic heart valve). The product label advises that a heart
surgeon should be involved in determining if the Sapien THV is an appropriate treatment for the patient.
It is not approved for patients who can be treated by open-heart surgery. Patients who have congenital heart valve
anomalies, have masses or an infection in their hearts, or cannot tolerate anticoagulation/antiplatelet therapy should not receive the Sapien