Atrial fibrillation:

In atrial fibrillation, the heart's upper
chambers experience chaotic electrical
impulses. The resulting rapid and
irregular heartbeat causes fatigue,
shortness of breath and exercise
intolerance. Long-term complications
include stroke, serious bleeding,
cardiac arrest and death.
About 2.5 million Americans have atrial
fibrillation, and it's becoming more
common as the population ages: 2 to 3
percent of 60-year-olds have atrial
fibrillation, but the rate rises to 12
percent for 80-year-olds.

Atrial fibrillation, or an irregular
heartbeat, puts people at higher risk of
developing blood clots, which can be
fatal if they travel to the lungs or the
brain where they can cause a stroke.

For the longest time warfarin has been
the treatment of choice for people at
high risk of stroke due to atrial
fibrillation. But the drug interacts badly
with food and other medicines, carries
a high risk of bleeding and requires
regular blood tests.

As of November 2011 at least eight
potential warfarin replacements are
currently being tested by major
drugmakers and two of them approved.

In 2011 the clinical trial findings  put
Eliquis ahead of its two key rivals by
showing superiority to warfarin when it
comes to saving lives.

That is likely to be seized on by Bristol
and Pfizer in an upcoming marketing
fight with Boehringer Ingelheim's
Pradaxa  -- and Xarelto, from Bayer
and Johnson & Johnson , approved for
atrial fibrillation in November 2011.

On the other hand, concerned about
adherence to medical treatment
among elderly patients,  doctors may
be less able to ensure they are taking
drugs correctly once they do not need
regular blood tests. For such patients,
once-daily Xarelto may be a better bet
than twice-daily Eliquis or Pradaxa.

Also: Still, many cardiologists  would
not rush to switch existing patients who
are well-controlled on warfarin -- a
cheap generic medicine -- to the new
and expensive branded products.




BLOOD THINNER PRADAXA
APPROVED BY FDA
In October 2010 German drugmaker
Boehringer Ingelheim won the first U.S.
approval for a new stroke-fighting
medicine that will compete in an
estimated $10 billion market for drugs
to replace the 65-year-old blood
thinner warfarin.
Boehringer's drug, Pradaxa, is cleared
for preventing strokes in patients with
a type of irregular heart beat.
The approval gives Boehringer a head
start over several other drugmakers,
including partners Bayer and Johnson
& Johnson, and Bristol-Myers Squibb
Co and Pfizer, that are working on
competing drugs.

Pradaxa and potential rivals are
alternatives to warfarin, a problematic
medicine originally developed as rat
poison.

Pradaxa is an anticoagulant that acts
by inhibiting thrombin, an enzyme in
the blood that is involved in blood
clotting. The FDA said the safety and
effectiveness of Pradaxa were studied
in a clinical trial comparing Pradaxa
with the anticoagulant warfarin. In the
trial, patients taking Pradaxa had fewer
strokes than those who took warfarin.

PRADAXA APPROVED IN EUROPE
In August 2011 Boehringer Ingelheim’s
Pradaxa has become the first drug in
50 years to be approved in Europe for
stroke prevention in atrial fibrillation  
patients.

Pradaxa is already approved for
preventing blood clots in adults who
have undergone elective total hip or
elective total knee replacement
surgery.



XARELTO BY BAYER FOR ATRIAL
FIBRILLATION  IS AS GOOD AS
WARFARIN
FDA approved it for atrial fibrillation in
November 2011.

Scientists say the new drug,
rivaroxaban (Xarelto by Bayer), is just
as good as warfarin at preventing
blood clots and lowering the risk of
stroke for people with atrial fibrillation.

Tests show it has fewer side-effects,
such as a risk of fatal bleeding on the
brain, and is easier to take. The new
drug is not affected by diet and other
medication as much as warfarin is, so
patients do not need such close
monitoring by doctors to ensure they
are receiving the correct dosage.

The findings, published in August 2011
in the New England Journal of
Medicine, follow studies of 14,000
patients with atrial fibrillation,  carried
out by researchers at the University of
Edinburgh and the Duke University in
North Carolina.






ELIQUIS (APIXABAN) IS PROMISING
DRUG FOR ATRIAL FIBRILLATION
FDA approval is expected by March
2012.

Excitement over Eliquis has grown
since June 2011 when headline results
showed it was better and safer than
warfarin. How much better, however,
only became clear in August 2011
when the actual data was unveiled at
the European Society of Cardiology
annual meeting and published in the
New England Journal of Medicine.

The result means that giving Eliquis
rather than warfarin for 1.8 years -- the
average length of the study -- would
prevent eight deaths for each 1,000
people treated.


ELIQUIS (APIXABAN) TRIAL STOPPED
BECAUSE IT WORKED VERY WELL
Pfizer and Bristol-Myers Squibb's atrial
fibrillation treatment apixaban has
performed so well in a phase III trial
that it has been halted early.

The AVERROES study showed clear
evidence of a clinically important
reduction in stroke and systemic
embolism in patients with atrial
fibrillation, who are considered
intolerant of or unsuitable for vitamin K
antagonist therapy who received
apixaban as compared to aspirin.
AVERROES included 5,600 patients
with patients randomised to receive
either apixaban 5mg twice daily or
aspirin 81mg to 324 mg once daily.
Pfizer and BMS began collaborating on
the drug's development in 2007 after
apixaban had been originally
developed by BMS.

If brought to market, the drug will be
competing against Bayer/Johnson &
Johnson's Xarelto and Boehringer
Ingelheim's Pradaxa. It will also be
competing against Sanofi-Aventis' new
AF treatment Multaq, which received a
limited NICE (UK) approval in March
2011.




CATHETER ABLATION PROCEDURE
AVOIDS DRUGS AND SURGERY
Mayo Clinic researchers are advancing
a less invasive procedure to treat atrial
fibrillation.

For patients, catheter ablation offers
less risk and faster recovery than
open-heart surgery. For cardiologists,
the challenge lies in knowing where to
ablate when they can't directly see the
heart. Mayo's latest innovation helps
its cardiologists do just that by
"immersing" them in a five-dimensional
view of the heart.
Like 3D procedures, the new
technology uses catheters to insert
tiny electrodes into the heart, which
send images of the heart's 3-D
anatomic structure to a computer
screen.

The 5D system, however, uses a
unique computational platform to "take
the physician inside the heart in 5-D,
visualizing the heart walls, the
electrical activity within those walls and
the catheter as the physician
navigates to the treatment site," says
Richard Robb, Ph.D., director of Mayo
Biomedical Imaging Resources. "The
ablation can actually be observed as it
is administered."

Dr. Robb estimates that the new
system potentially increases the
effectiveness of catheter ablation to 95
percent – as effective as open-heart
surgery.

Dr. Robb and Douglas Packer, M.D.,
director of Mayo's Heart Rhythm
Service, are leaders of Catheter
ABlation vs. ANti-arrhythmic drug
therapy for Atrial Fibrillation or
CABANA, a clinical study to evaluate
catheter ablation.

CABANA (Catheter Ablation Versus
Anti-arrhythmic Drug Therapy for Atrial
Fibrillation), the study involves 3,000
patients and 140 centers worldwide.
Led by Mayo, CABANA aims to
discover if ablation is more effective
than medication for treating atrial
fibrillation.

CABANA is the first large-scale study
of the procedure. CABANA's six-year
span allows researchers to examine
the procedure's impact on mortality,
hospital costs and a patient's quality-of-
life. Eventually, catheter ablation may
be a first-line treatment for atrial
fibrillation rather than an option for
patients who don't improve after drug
therapy.



FOR ATRIAL FIBRILLATION
MEDTRONIC DEVICE IS APPROVED
BY FDA
Medical device maker Medtronic Inc.
says the FDA approved its Arctic Front
Cardiac CryoAblation Catheter system
to treat a form of atrial fibrillation in
patients who do not respond to drug
therapy.

Atrial fibrillation causes the upper
chambers of the heart to contract
irregularly, potentially triggering a
stroke. The catheter helps stop the
rapid beating of the heart's upper
chambers by delivering a coolant that
blocks conduction pathways that
trigger atrial fibrillation. It is inserted
through an artery in the groin and then
threaded up to the heart.

Medtronic said regulatory approval
was based on a study that showed
about 70 percent of patients treated
with Arctic Front were free from atrial
fibrillation a year later, compared to 7
percent of patients treated only with
drug therapy.
The system already is approved in
Europe.



IN ARRHYTMIA:  ABLATION  
COMPARED TO MEDICATION
Pharmacologic therapy with anti-
arrhythmia drugs is the first line of
treatment for patients with symptomatic
atrial fibrillation. Today cardiac
electrophysiologists are increasingly
using catheter ablation to treat
patients with atrial fibrillation.  
The cardiac electrophysiologists at
NewYork-Presbyterian Hospital are
very experienced and highly skilled in
the use of catheter ablation to treat
patients with atrial fibrillation, with
some of the best outcomes in the
nation.

Drugs that can suppress atrial
fibrillation include flecainide,
propafenone, sotalol, dofetilide,
dronedarone, and amiodarone.

But in some patients, such drugs are
not sufficient, and catheter ablation
may be a therapeutic option. In
February 2009, the U.S. Food and
Drug Administration approved the first
ablation catheters designed
specifically for the treatment of
paroxysmal atrial fibrillation: the
NAVISTAR THERMOCOOL and EZ
Steer THERMOCOOL  Irrigated
Deflectable  Ablation Catheters.

Using an endovascular approach,
radiofrequency catheter ablation uses
intense energy to destroy sleeves of
atrial tissue surrounding the pulmonary
veins, the source of the arrhythmia.
The "firewall" between the pulmonary
veins and left atrium created via
ablation results in a restoration of
normal heart rhythm.

In some patients, this firewall may
become compromised, and electrical
connections are re-established
between the pulmonary veins and left
atrium, triggering a recurrence of the
arrhythmia. In these cases, a second
ablation procedure may be necessary,
usually several months after the initial
ablation.

A multicenter international study called
the Catheter Ablation versus Anti-
arrhythmic Drug Therapy for Atrial
Fibrillation (or CABANA) Trial will be
the largest study to date comparing
catheter ablation with pharmacologic
treatment for patients with atrial
fibrillation. Funded by the National
Heart, Lung, and Blood Institute, the
phase IV study is enrolling 3,000
patients who will be randomized to
have a catheter ablation procedure or
receive anti-arrhythmic drug therapy.



THE WATCHMAN TRIAL: TO TRAP
BLOOD CLOTS BEFORE THEY EXIT
The WATCHMAN Left Atrial
Appendage Closure Technology is a
device to be permanently implanted at
the left atrial appendage (LAA) to trap
blood clots before they exit.
A small cut is made in a vein in the
groin and a catheter is thread to the
heart and  burrow through to the left
atrial  appendage. The Watchman is
mounted on the end of a catheter.
Once the Watchman is in the right
place, the catheter is pulled back and
the umbrella opens up. It has little
barbs which catch onto the heart
muscle.
Once the tubes are removed, patients
are taken to the coronary care unit
and discharged the next day. Patients
are put on Warfarin for six weeks after
the procedure to prevent clots forming
on the device itself. After that, they are
put on a daily aspirin.
THE Watchman device costs in the UK
privately about USD 15,000.00.




ELECTRICAL IMPULSES TO
RESTORE NORMAL HEART RHYTM
S-ICD, made by Cameron Health in the
U.S.
Clinical trial data shows it is just as
effective as the conventional devices
at delivering electrical impulses to
restore normal rhythm in almost all
episodes.
The battery-operated system has one
wire going across the chest under the
skin - this wire is connected to the
device implanted beneath the skin,
which delivers the shock.
The added distance from the heart
means a more powerful shock can be
delivered than from conventional
devices - about 2.5 times stronger.
It  costs about USD 20,000.00 - similar
to  existing devices - and lasts five
years  before it needs to be replaced.
CAMERON HEALTH


CATHETER ABLATION BY SENSEI
Sensei robotic catheter system by
Hansen: does catheter ablation to
eliminate arrythmia;
Catheter ablation uses radiowaves to
burn the cells that are causing the
rhythm problems.


MEDTRONIC'S ABLATION DEVICE
In one 245-person trial of a Medtronic
ablation device, 70 per cent of patients
who received ablation went a year
without an a-fib episode, compared
with 7 per cent of those on drugs.


Patient community:
stopafib.org