Artificial heart:

BERLIN HEART: FDA APPROVES THE
FIRST HEART PUMP FOR CHILDREN
In December 2011 the FDA  approved
the first heart pump for children with
heart failure, offering an important
treatment option for patients who are
too small to receive adult implants.

The device from Germany-based
Berlin Heart will be used to keep
children alive until they can receive a
heart transplant. Very few medical
devices are designed specifically for
children, posing major challenges to
doctors and surgeons who treat
pediatric cases of life-threatening
diseases.

Heart failure is rare in children, and the
device was approved under a special
program for diseases that affect fewer
than 4,000 patients per year. Among
infants, the typical wait time for a heart
transplant is more than four months.
Nearly a quarter of all infants die while
waiting for a transplant. And up to 17
percent of all children die while on the
wait list for a transplant.

The Excor Pediatric System heart
device comes in various sizes to
accommodate patients ranging from
infants to teenagers.

The device was studied in a trial of 48
patients, which showed that those
implanted with the Excor device
survived longer than those using a
device similar to a heart-lung machine.
The trial was supported by three FDA
grants totaling $1.2 million.

The Berlin Heart is a ventricular assist
device, used to allow time for children
who are waiting for heart transplants,
whose hearts are not strong enough to
pump blood around their bodies.

The bulk of the device works outside
the body and is intended as temporary
until a permanent heart is found. It may
work on that basis for several months.
Made by a German company of the
same name.


A FRENCH ARTIFICIAL HEART
PROJECT
A French made artificial heart will be
ready for trials in 2011.
The device, which uses electronic
sensors to regulate the heart rate and
blood flow, was developed by Alain
Carpentier, France's leading cardiac
surgeon, and engineers from the
group that makes Airbus aircraft.
“If you show the graphs to a cardiac
surgeon, he will say it's a human
heart,” Professor Carpentier said. “But
no, it’s not a human heart, it’s the
prosthesis.”
The French announcement is the
latest in a race by doctors to produce
a device that could be fitted into the
20,000 patients a year worldwide who
are unable to receive a life-saving
heart transplant because of a shortage
of donors.
Two artificial hearts have been
invented in the US, the Jarvik 7 and
the AbioCor, but both have drawbacks,
according to Professor Carpentier’s
team: the first has wires that protrude
through the skin, and the second can
produce blood clots that can lead to
strokes, they said.
Carmat, the company founded by
Professor Carpentier and EADS,
Europe’s aerospace and defence
giant, says that it is close to
overcoming these hurdles. Sensors in
the artificial heart will automatically
regulate the heart beat, detecting the
body’s needs: increasing the rhythm
when patients are walking, for
instance, and slowing it when they are
resting.
Professor Carpentier said that he had
reduced the risk of clots by creating
the heart with a “pseudo-skin” of
biosynthetic, microporous materials.
“This has been the essential problem
until now,” he said.
“If you get up in the middle of the night
to go to the loo, you need the artificial
heart to know immediately or you’ll
collapse on the floor,” said Philippe
Pouletty, an immunologist whose
private equity firm, Truffle Capital, has
invested €5 million (£4 million) in the
project.
As the artificial heart’s motors
compress the left chamber and open
the right one, oxygen-rich blood from
the left chamber is pumped out into the
body and blood lacking in oxygen fills
the right chamber.

The left chamber is then opened while
the right chamber is compressed,
pumping the deoxygenated blood from
the right chamber back to the lungs
and drawing a fresh supply of oxygen-
rich blood from the lungs into the left
chamber.

Unlike previous artificial hearts, this
one detects the body’s activity level
(and therefore how much oxygen it
requires) and changes its pace
accordingly.


OTHER DEVELOPMENTS
SynCardia Systems Inc has designed
the CardioWest temporary total
artificial heart;

HeartMate from Thoratec, was also
approved for heart patients who are so
old or sick they are not candidates for
a transplant.