Heart valve replacement and repair:

There are several types of heart valve
disease:

Valvular stenosis. This occurs when a
heart valve opening is smaller than
normal due to stiff or fused leaflets.
The narrowed opening may make the
heart work very hard to pump blood
through it. This can lead to heart
failure and other symptoms.

Valvular insufficiency. Also called
regurgitation, or "leaky valve", this
occurs when a valve does not close
tightly. If the valves do not seal, some
blood will leak backwards across the
valve. As the leak worsens, the heart
has to work harder to make up for the
leaky valve, and less blood may flow to
the rest of the body.



FDA APPROVES EDWARD
LIFESCIENCE'S HEART VALVE FOR
US MARKETS

In November 2011 the FDA  approved
the first artificial aortic valve that can
replace a valve damaged by senile
aortic valve stenosis without requiring
surgery.

The Sapien Transcatheter Heart
Valve,   made by Edwards Lifescience
of California,  is approved for patients
who are not eligible for open-heart
surgery for replacement of the aortic
valve and have a calcified aortic
annulus.

FDA officials noted that the product
label advises that a heart surgeon
should be involved in determining
whether the device is appropriate.  

The approval was supported by data
from 365 patients who were not eligible
for surgery. Half of the patients were
assigned to the aortic valve. Of those
patients, 69% were alive after 1 year,
compared with a 1-year survival rate of
50% among the other half of the
patients, who received alternative non-
surgical treatments including balloon
valvuloplasty.


_____
In August 2011 Medtronic Inc. said that
European regulators have approved a
type of heart valve that is implanted in
the body without major surgery.

Medtronic's  31-millimeter CoreValve
System received the CE Mark for sale
in Europe. The valve is the largest
available in the world, and adds to the
company's portfolio of two other sizes
of the so-called transcatheter valves.

The CoreValve system provides a
minimally invasive treatment option for
patients with symptomatic, severe
aortic stenosis, an abnormal narrowing
of the aortic valve, who cannot tolerate
open-heart surgery.

Roughly 300,000 people worldwide
have been diagnosed with the
condition, according to Medtronic.
Since 2007, Medtronic's CoreValve
has been implanted in more than
15,000 people worldwide.

The valve is not available for use in
the United States, and probably won't
be until 2014. The pivotal clinical trial
of the device needed for Food and
Drug Administration (FDA) approval is
underway.

_______
Little Canada-based St. Jude Medical
Inc. is also working on a transcatheter
valve. The European clinical trial for its
Portico valve will begin possibly in late  
2011, with a launch in Europe
expected in the first half of 2013,
pending regulatory approval.

St. Jude will submit an application to
the FDA to begin a clinical trial in the
first half of 2012.



VALVE REPLACEMENT FOR A 101
YEAR OLD WOMAN
When Doris Snyder celebrated her
102nd birthday on August 10, she was
that much closer to the expected birth
of her first great-granddaughter who's
due to arrive early September. She is
very excited about the milestone, which
might not have been possible were it
not for a cutting-edge, experimental
procedure that replaced one of Doris'
heart valves weeks earlier when she
was 101. The valve had been
rendered useless by aortic valve
stenosis—hardening from calcium
deposits that restrict the flow of blood
from the heart.

The clinical trial that provided Doris'
new heart valve is  called PARTNER.
The Bluhm Institute of the
Northwestern Memorial Hospital in
Chicago is among the trial's pioneering
sites.
The technique  is evaluated for
patients who are considered too weak
to undergo conventional open-heart
surgery. It uses expandable-stenting
technology to insert a prosthetic valve
while the heart continues beating,
eliminating the need for
cardiopulmonary bypass and its
associated risks.

"Patients who are too weak to be
surgically treated have very limited
options for valve replacement," said
Charles J. Davidson, who is also a co-
principal investigator for the trial.  
Davidson says the procedure builds
upon the balloon aortic valvuloplasty,
but is a "more durable treatment."

Spry and amazingly keen, Doris had
never encountered any major health
issues. Doris exemplifies the fact that
your state of health is not necessarily
defined by your age, said a consultant.
"She's healthier than a lot of people
much younger than her."  

Edwards LifeSciences are the makers
of the experimental prosthetic valve.


HEARTMATE ll  HEART PUMP
DELIVERED 2 YEAR SURVIVAL
A new, continuous flow heart pump, or
left ventricular assist device (LVAD),
delivered better two-year survival in
advanced heart failure patients than
the current pulsatile model.

In the HeartMate II Destination Therapy
Trial, researchers tested a new device
that helped heart failure patients who
weren’t responding to optimal medical
therapy and weren’t eligible for a heart
transplant. They found significant
improvement in outcomes of patients
who received the continuous flow
LVAD (HeartMate II) compared to
those who received a pulsatile flow
LVAD (HeartMate XVE), the only FDA-
approved device for treating such
patients.

The newer pump is smaller, operates
quietly and has demonstrated superior
durability. Interestingly, it also pumps
blood continuously, which reduces the
systolic blood pressure. It is believed
that in the future there will be little
need for pulsatile blood pumps.



MITRA CLIP TO REPLACE OPEN
HEART SURGERY FOR VALVE
REPAIR
MitraClip, from Abbott Laboratories,not
yet approved by the Food and Drug
Administration. If approved, the device
would enable surgeons to repair leaky
heart valves without the need for full-
blown open heart surgery. They could
do it through two tiny keyholes instead.

The MitraClip is inserted with a
catheter through a leg vessel to
correct mitral regurgitation, which
occurs when the mitral valve doesn’t
close properly causing blood to flow
backward. The condition, which can
lead to heart failure, affects more than
8 million people in the U.S. and
Europe. The defect is currently
managed with drugs or repaired with
surgery.

For decades, patients with severe
mitral regurgitation underwent a
procedure called the double orifice
technique, in which a surgeon sews
together two sides of the mitral valve,
leaving the ends open and ensuring
blood flows in the proper direction. The
MitraClip procedure mimics that
surgery without the intensive
operation, inserting the clip through a
catheter in the leg and clamping the
two sides of the valve shut.

The trial, dubbed Everest II, was
designed to see whether the MitraClip
would be safer than open-heart
surgery and “non- inferior” in terms of
effectiveness.

The device met the study’s goal for
effectiveness.


VALVE-IN-VALVE  PROCEDURE
REPLACES FAILING ANIMAL-BASED
HEART VALVES
Replacing failing artificial animal-based
heart valves by implanting mechanical
valves inside them is an effective
option for high-risk patients, according
to research reported in Circulation: a
Journal of the American Heart
Association. In the study, physicians
from Canada and the United Kingdom
describe how 24 high-risk patients
whose previous implants failed
received transcatheter valve-in-valve
implantation, where a new artificial
valve is seated within a previously
implanted valve made of pig or cow
tissue.

The new valve is inserted on a
catheter through a small incision
between the ribs or through a puncture
in a blood vessel in the leg. Placed
inside the old surgically implanted
valve and expanded by inflating a
balloon, the new valve pushes the old
one out of the way.

Once expanded and opened, the new
valve opens and functions similarly to
the patient's own valve. The
advantage is that failing surgical
valves can be replaced without the
need for open-heart surgery.
Many, but not all, surgical valves can
be replaced this way.

The procedure is offered only to
selected patients with failed surgical
valves who would be poor candidates
for another operation.



OTHER DEVELOPMENTS
On-x prosthetic heart valve by Life
Technologies trial;

Own stem cells repair heart valve;