Heart procedures:




A SIMPLE FILTER COULD CUT THE
HIGH RISK OF STROKE DURING THE
TAVI PROCEDURE
It's a classic Catch-22: A revolutionary,
minimally invasive heart repair
procedure (TAVI) now being
investigated in America, and already
being performed by European doctors,
could save the lives of older people
who might not be able to withstand
open-heart surgery to repair their
heart valves. However, up to 15
percent of all patients undergoing this
procedure -- called TAVI, for
transcatheter aortic valve implantation
-- suffer a stroke on the operating
table.

Foreseeing the risk years ago as TAVI
was being developed, Israeli
cardiologist Dr. Dov Shimon invented a
novel way to prevent stroke, which
happens when hardened bits of
calcium come dislodged during the
TAVI procedure, passing through the
heart and going into the brain.

His innovation is a filter against these
embolisms. Fitted onto the aortic arch,
the medical device, now under
development by the Israeli company
SMT Research and Development in
Herzliya Pituach, ensures that particles
do not get into the blood flowing to the
three main vessels leading from the
heart.

The company  was founded in 2005
and has already raised $15 million,
$10 million of which is from the
healthcare equity fund OrbiMed. It is
running its first human clinical trials in
Europe, and similar clinical trials are to
begin in the United States in 2012. In
15 surgeries performed in Holland
using the SMT device, not one stroke
has occurred.




TAVI (TRANSCATHETER
AORTIC-VALVE IMPLANTATION)
TRIAL SHOWS GOOD RESULTS
One-year data from the PARTNER
clinical trial, published in July 2011,
similarly to results a year ago,  
demonstrate that transcatheter
aortic-valve implantation, compared
with standard therapy, results in
significantly lower rates of death
among patients who cannot undergo
surgery for aortic stenosis.

TAVI  has been available overseas
and in Canada for some time now, in
the US FDA is reviewing it now.  It is
made by Edwards Lifesciences.

Aortic valves, which regulate blood flow
from the heart into the aorta, can fall
victim, typically with age and the onset
of cardiovascular disease, to stenosis
(failure to open) and insufficiency
(which leads blood to flow in the wrong
direction back into the heart). Aortic
stenosis results in a poor quality of life
and a high rate of death,
approximately 50 percent, in the first
two to three years after diagnosis
without surgical intervention.
Approximately 300,000 Americans
suffer from severe aortic stenosis.

At one year, patients who underwent
TAVI showed a 45 percent reduction in
the rate of death from any cause
compared with patients who received
standard therapy.  Among survivors at
one year, the rate of cardiac symptoms
was significantly lower among patients
who had undergone TAVI, as
compared with those who had received
standard therapy (25.2 percent vs.
58.0 percent).


The multicenter PARTNER trial, which
has more than 1,000 patients, began
in 2007 and will be completed in 2014.
The results reported here reflect only
the cohort of patients who are not
considered candidates for surgery.
The other arm of the trial, which
compares transcatheter valves with
surgically implanted valves, is ongoing.

In clinical practice, at least 30 percent
of patients with severe symptomatic
aortic stenosis do not undergo surgery
for replacement of the aortic valve
because of advanced age, left
ventricular dysfunction, or the
presence of multiple coexisting
conditions.

The replacement valve used in the
PARTNER trial is made of pericardial
tissue leaflets hand-sewn onto a metal
frame and implanted via a catheter into
the left ventricle. It is then positioned
inside the patient's existing valve using
a balloon to deploy the frame, which
holds the valve replacement in place.
The procedure is performed on a
beating heart, without the need for
cardiopulmonary bypass and its
associated risks.

The transcatheter valve procedure
takes about 90 minutes, compared with
four to six hours for open-heart
surgery. In open-heart surgery, the
surgeon cuts through the breastbone,
stops the heart, removes the valve,
and replaces it. Open-heart surgery
can require a two- to three-month
recovery period, compared with only a
few days for the transcatheter
approach.




BEATING HEART TRANSPLANTS
WITH  TRANSMEDICS ORGAN BOX
The world's first beating heart
transplant was performed in Germany
in 2006, using an organ box invented
by TransMedics Inc., a private medical
device company in Andover, Mass., as
part of a multi-center study in Europe.

A "beating heart" transplant is an
experimental operation that's mostly
been done in Europe. The donor heart
is placed into a special box that feeds
it blood and keeps it warm and ticking
outside the body.

Currently there is a great deal of rush:
the harvesting , delivering and
transplanting  must be done within   4
to 6 hours before  the organ starts to
deteriorate.
Research has shown that the longer it
takes to remove a heart and transplant
it, the greater the patient's chance of
death or heart disease.

But what if a heart could beat on its
own after removal from a cadaver?

The new high-tech heart box circulates
blood from the donor to the heart so
that it continues throbbing while in
transit from hospital to hospital.

Transmedics  is currently funding a
UCLA-led experiment, which will enroll
128 patients nationwide, randomly
chosen to get a beating heart
transplant or the traditional kind.

About 100 patients, mostly in Europe,
have had a beating heart transplant,
according to TransMedics.

Early signs from two European
experiments involving 54 patients are
encouraging. There has been 97%
survival a month after the operation
and few episodes of rejection and
heart-related complications. But since
there were no comparison groups in
either study, it's impossible to know
whether a beating heart transplant is
actually better.

The current U.S. study is the first to
test the methods head-to-head.



THORACAB:  BYPASS WITHOUT
CUTTING THROUGH THE
BREASTBONE
The surgeon uses a special surgical
camera. Because he can see where he
is going on a big screen, he doesn't
need to completely open up the patient.
He is working through the space
between the ribs, using high definition
imaging technology and advanced
surgical instruments, so the patient
recovers much faster and with less risk
of infection.
The procedure is suitable for most
heart bypass patients, including older
people who are not fit enough for
open-heart surgery.
Most need only stay in hospital for up
to four days, and recover in two to
three weeks. It really is a brilliant
innovation.

Comparison of Coronary Artery
Bypass Surgery Approaches

1.ThoraCAB  Beating-Heart,
2.Off-Pump Open Chest  
3.Traditional, Open Chest  

Keeps the breastbone intact (no
splitting)
1.YES
2.NO
3.NO

Minimally invasive approach (small
incisions)
1.YES, 3- to 5-inch incision at side of
chest
2.NO
3.NO

Performed on a beating heart
1.YES
2.YES
3.NO

Performed with robotic assistance
1.YES, typically
2.NO
3.NO

Eliminates the need for a heart-lung
bypass machine
1.YES
2.YES
3.NO

Number of grafts
1.Any
2.Any
3.Any

Typical length of stay in hospital
1. 2 to 4 days
2. 5 to 7 days
3. 5 to 7 days

Typical recovery time
1. 1 week to 10 days
2. 4 to 8 weeks
3. 4 to 8 weeks


*Other factors, such as the location of
blockages, the health of the patient,
and the patient's previous surgical
history affect which surgical approach
is selected. Hospital stay and recovery
time may vary depending on
associated risk factors.



OTHER DEVELOPMENTS

Transcatheter Pulmonary Valve
Replacement "Melody" by Medtronic;