UPDATE 4-Edwards heart valve trial results impress

* Similar one-year death rates for valve vs surgery

* Major stroke 5.1 pct for valve vs 2.4 pct for surgery

* Doctors say benefits outweigh risks for Edwards valve
(Adds physician, researcher comments)

By Debra Sherman and Bill Berkrot

NEW ORLEANS, April 3 (Reuters) – A heart valve replacement
technique developed by Edwards LifeSciences Corp (EW.N: Quote, Profile, Research) that
spares patients open-heart surgery had a slightly lower death
rate at one year, outweighing a higher risk of major stroke.

One year after implantation using the Edwards valve called
Sapien, 24.2 percent of patients died — compared with 26.8
percent of those who underwent open-heart surgery in the highly
anticipated 699-patient study.

Non-inferiority of the Edwards device was “strongly
established,” according to researchers who presented the data
at the American College of Cardiology Scientific Sessions.

The Edwards device led to twice as many major strokes —
5.1 percent versus 2.4 percent for surgery — potentially
making surgery preferable for some patients.

But researchers and doctors said the stroke implications
were not yet fully understood and that recovery times and
hospital stays were dramatically shorter for patients who do
not undergo the procedure in which the chest must be sawed open
and the heart stopped.

“It takes half a year to get back to full activity after
open heart surgery. But we see these patients getting mobilized
in a few days,” said Dr. Mogen Larsen, head of cardiology at
Odense University Hospital in Denmark, who has been implanting
the Edwards valve, which is approved in Europe, for more than
two years.

The 699-patient clinical trial, dubbed Partner, compared
high-risk elderly subjects who had their diseased aortic valves
replaced using the Edwards noninvasive transcatheter valve
system with those who had conventional open-heart surgery.

Dr. Edwin Dizon, a cardiologist at Philippines Heart Center
in Manila attending the meeting, called the Edwards valve data
“quite impressive” despite the potentially heightened chance of
stroke “because the benefit exceeds the risk, and it prolongs

In addition to higher stroke risk, 11 percent of patients
who got the Edwards valve had major vascular complications
after 30 days, compared with 3.2 percent of the surgery group.

But there were also additional clinical advantages seen
with the Edwards system, in which the valve is threaded through
arteries to the heart with a catheter and implanted inside the
old, diseased valve.

New incidences of atrial fibrillation — potentially
dangerous irregular heart rhythms that can lead to stroke and
other problems — occurred in 8.6 percent of those who got the
Edwards valve versus 16.0 percent in the surgery group. They
also had far less major bleeding than the surgery group — 9.3
percent compared with 19.5 percent.

A previous study of the Edwards system proved to be far
superior to standard drug therapy for aortic stenosis in
patients deemed too ill to undergo major surgery.

But it remains to be seen whether the Food and Drug
Administration will embrace the new technique in patients for
whom surgery remains an option, given the heightened stroke
risk seen in the study.

Susan Housholder-Hughes, a nurse practitioner at the
University of Michigan in Ann Arbor, is clearly in favor of

“These are elderly patients that don’t have much stamina
and until now they have had to undergo open heart surgery,
which is like getting hit by a truck,” she said.

“The less invasive procedure should offer them a quicker
recovery and get them back on their feet and doing the things
they enjoy and want to do.”

Edwards is hoping the totality of the data will work in its
favor. The Sapien system is expected to be an important future
growth driver for the company, and how widely its use is
approved by the FDA will likely be an important factor in just
how big a product it can become.

U.S. approval for the Edwards system that is expected to
cost about $30,000, and competes with a similar system
developed by Medtronic Inc’s (MDT.N: Quote, Profile, Research) CoreValve unit in Europe,
could come later this year.

Dr Craig Smith, one of the principal researchers of the
study, said he expects the Edwards system to help tens of
thousands of patients within a short time after U.S. approval
and in a few years “hundreds of thousands.”
(Reporting by Debra Sherman, Bill Berkrot and Ransdell
Pierson; Editing by Eric Walsh, Maureen Bavdek and Gunna

UPDATE 4-Edwards heart valve trial results impress