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Amazing Results!
The results were beyond their wildest expectations. Ejection
fraction increased and the amount of scarring and damaged cells
decreased. Heart damage was reversed without
dangerous side effects. At the start of the study Dr. Bolli's
patients had an average ejection fraction of 30.3%. Four months
after receiving stem cells, their ejection fraction was 38.5%.
Some patients followed for a full year improved to an an
astounding 42.5%.
A
control group given nothing but standard maintenance medications
showed no improvement at all.
Dr. Eduardo Marban, director of the Cedars-Sinai Heart
Institute, developed a similar stem cell procedure. He found
that not only did scar tissue decrease – shrinking between 30%
and 47% in patients - but the patients actually generated
new heart tissue. On average, the stem cell recipients
grew the equivalent of 600 million new heart cells, according to
Dr. Marban, who used MRI imaging to measure changes. (A major
heart attack might kill off 1 billion heart cells.)
Dr. Anversa found that the heart contains a type of stem
cell that can develop into either heart muscle or blood vessel
components – whatever the heart needs depending on its injury.
But there usually aren't enough of these heart stem cells
available after a heart attack. To provide a patient more of
these heart stem cells, the doctors removed heart stem cells by
a biopsy and then made millions of copies in a laboratory.
Different Strategies
Drs. Bolli and Anversa and Dr. Marban both used cardiac stem
cells, but Drs. Bolli and Anversa "purified" the cardiac stem
cells so that more than 90% of the infusion was actual stem
cells. Dr. Marban, on the other hand, used a mixture of stem
cells and other types of cells extracted from the patient's
heart. "We found that the mixture is more potent than any
subtype we've been able to isolate," he says. The additional
cells may help by providing a supportive environment for the
stem cells to multiply. Other scientists have produced
improvements in cardiac patients using stem cells derived from
bone marrow, though the results aren't as spectacular as the
above studies.
Dr. Bolli's study (called "SCIPIO') was the first reported
human study of heart derived stem cells. Patients who received
these stem cells had significant improvements in heart function,
physical capacity and scored better on quality-of-life
questionnaires. MRI and ultrasound imaging revealed that areas
where stem cells were infused showed major improvement which
continued over a year.
Editor's Comments:
Though this study was not directed to A-Fib
patients, let's fantasize a bit. This study shows that heart
stem cells can replace scar tissue and fibrosis with normal
beating heart muscle fibers, thereby restoring heart function.
Fibrosis and scarring, which are normally considered
irreversible heart damage, may no longer be permanent.
Though the jury is still out on this, some studies indicate
that fibrosis may lead to, trigger or cause A-Fib. (See
fibrosis in a-fib: chicken or the egg?) And fibrosis is
linked to the threat of an A-Fib stroke (see
Fibrosis Predicts Stroke Risk). if injected stem cells
somehow signal the heart to repair itself, this may turn
fibrosis and scarring back into normal heart muscle.
In the near future a patient with A-Fib, instead of having
to undergo catheter ablation (or surgery), may instead receive
an injection of their own heart stem cells and be cured of A-Fib
and the threat of an A-Fib stroke. The only risk would be
getting a biopsy inside the heart to get a sampling of heart
tissue stem cells, then months later another procedure to insert
the purified and multiplied heart stem cells. Though not simple
procedures, they would probably involve less or at least an
equal amount of risk as a catheter ablation but with no
permanent scarring through ablation.
(This strategy probably couldn't be used in someone who has
already had a catheter ablation [or surgery]. The heart stem
cells might heal the scarring created by the ablation, thereby
causing reconnection or regrowth.)
Right now
the costs of standard (non-heart) stem cell injection is around
$4,000-$5,000 per injection. But currently very few doctors
around the US do it.
Prediction:
The author predicts that heart stem cells injection will
rapidly become a standard treatment option, even for A-Fib
patients. There shouldn't be any political or religious
objections to this heart stem cell therapy, since it doesn't
rely on embryonic stem cells.
Cardiac stem cell injection is probably a major
medical breakthrough for A-Fib patients. Heart stem cell
injection regenerates heart muscle. In Dr. Bolli's words,
"if a phase 3 study confirm this, it would be the biggest
advance in cardiology in my lifetime. We would possibly be
curing heart failure. It would be a revolution." And this
revolution will probably work in patients with A-Fib.
Bolli, R, Anversa, P.
at al "Cardiac stem cells in patients with ischaemic
cardiomyopathy (SCIPIO): initial results of a randomized phase 1
trial." The Lancet, Volume 378, Issue 9806, Pages
1847-1857, November 26, 2011.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61590-0/abstract
doi:10.1016/S0140-6736(11)61590-0
JANUARY 31, 2012
Septum Opening Plugged? You Can Still Have a Catheter Ablation
to Fix your A-Fib.
According to conventional A-Fib practice, if someone had a
closure device installed to plug a hole in the septum, then they
couldn't have a catheter ablation. It would be difficult to get
the catheter through the septum wall since the plug occupied
part of the septum wall. The plugging device would block the
trans-septal puncture needed to get to the left atrium.
But a recent study at the Texas Cardiac Arrhythmia Center in
Austin, Texas by doctors Pasquale Santangeli and Luigi Di Biase
demonstrated that it is feasible and safe to do a catheter
ablation on patients with a septal occlusion device (Amplatzer,
CardioSEAL).
in
most cases( 35) the doctors were able to puncture the septum in
an area not covered by the closure device. In four cases the
doctors were able to puncture through the closure device itself
using normal procedures and instruments, though this did take
longer and involved more fluoroscopy time.
A-Fib Patients with a Septal Closure
Device Often Need Aggressive Treatment
The patients in this study all had A-Fib before the septum
plug was installed. They all progressed to highly symptomatic
A-Fib and were not helped by drugs. Over a period of at least
four years 11 patients progressed to persistent A-Fib. Five with
persistent A-Fib progressed to permanent long-standing A-Fib.
These patients obviously needed an aggressive treatment. (A
septum opening between the left and right atria can lead to clot
formation and stroke {see
Tedy
Bruschi]. Closing off this septal defect helps prevent
stroke and is considered to decrease the risk of developing
A-Fib. But if one already has A-Fib, closing off the septal
defect opening doesn't halt the progression of A-Fib.)
Catheter Ablation Successful through a Septal Closure Device
After a mean follow-up of around 14 months, 77% were
free of A-Fib and atrial tachycardia (this is a high success
rate considering that 67% of the patients had persistent or
long-standing persistent A-Fib which is more difficult to
ablate). There were no significant differences in outcome
between those who had transseptal puncture or puncture through
the closure device. No patients at three and six months
intervals had "interatrial shunt;" i.e., the puncture holes all
closed up by themselves.
The doctors concluded that catheter ablation in patients
with the septal closure device was "feasible, safe and
effective." They added, "Transseptal puncture can easily be
performed in a portion of the native septum not covered by the
device in the majority of patients. Direct access through the
device is also feasible and safe but requires significantly
longer time."
eDITOR'S COMMENTS:
Closing a septal opening decreases the risk of stroke and
possibly also of developing A-Fib. But if someone already has
A-Fib, closing this septal defect doesn't halt the progression
of A-Fib. These patients often need aggressive treatment such as
surgery ( Cox-Maze or Mini Maze).
If you have a closure or plug device installed in your
septum, you now have another option besides surgery to fix your
A-Fib. But be aware that most catheter ablation centers will
still be reluctant to do a PVI in your case and will likely
refer you to a surgeon. Even though PVIs in patients with
septal closure devices can be "easily performed," It may take a
while for the techniques and experiences of the Texas Cardiac
Arrhythmia Center to become common practice in other catheter
ablation centers. Right now you may need to go to Texas or to
another center with experience doing PVIs on patients with
septal closure devices.
If you have a septal closure device installed, be sure and
ask the doctor(s) you are working with if they have experience
in ablating patients with septal closure devices.
Santangeli, P, Di Biase, L,
et al. "Transseptal access and atrial fibrillation ablation
guided by intracardiac echocardiography in patients with atrial
septal closure devices."
Heart Rhythm. 2011 Nov;8(11):1669-75. Epub 2011 Jun 22.
http://www.ncbi.nlm.nih.gov/pubmed/21703215
DECEMBER 29, 2011
Surgical Versus Catheter Ablation---Flawed Study, But Important
Results for Patients
Not
that long ago, surgery was the only way to fix most heart
problems including Atrial Fibrillation (the Cox-Maze operation).
But thanks to new techniques and discoveries like stents and the
Bordeaux Group's discovery in 1994 that a catheter with an
electrode at the end can electrically isolate the pulmonary vein
openings making people A-Fib free, electrophysiologists (EPs)
became more involved in fixing heart problems. Surgeons had less
to do. The last fifteen years saw a tremendous growth in the
number, training and quality of EPs doing Pulmonary Vein
Isolations (PVIs). The author remembers when he could find and
list only ten centers doing PVIs. Now there are over a thousand
in the US alone. A-Fib is indeed an epidemic, but the medical
field has risen to the challenge. Few medical discoveries have
been introduced and received such wide-spread acceptance in such
a short time as catheter ablation (PVI).
FDA Approves
AtriCure Synergy Ablation System
And recently surgeons have gotten back in the game, thanks
in no small part to the work of AtriCure, Inc. whose Synergy
Ablation System was recently approved by the FDA (December 16,
2011). (The FDA approved the AtriCure system "in patients who
have persistent or longstanding persistent Atrial Fibrillation
and are also undergoing surgery for coronary artery bypass
grafting or valve repair or replacement."301
The AtriCure System is and can still be used off-label for
paroxysmal A-Fib. It's probably only a matter of time before the
FDA approves AtriCure's System for paroxysmal, stand-alone
operations such as the Wolf Mini-Maze.)
The FDA approval, though limited, is nevertheless a major
medical breakthrough for A-Fib patients. A-Fib patients now
officially have a choice of treatments.
Catheter or Surgical Ablation?
But which is better---catheter or surgical ablation? Over
the years there have been many multi-center studies and data
developed about the efficacy and safety of catheter ablation.
But that's not the case for the AtriCure system which is a
relatively new treatment.
For what is probably the first time, a recent small study
compared the two treatments head-to-head. AtriCure, Inc.
provided funding for the study "Atrial Fibrillation Catheter
Ablation Versus Surgical Ablation Treatment (FAST)." 59 patients
at St. Antonius Hopital in Nieuwegein, the Netherlands and 64
patients at the Hopital Clinic in Barcelona, Spain were
randomized to receive either a catheter ablation (CA) or
surgical ablation (SA). Patients were selected who had a prior
failed catheter ablation (67%), had a left atrium diameter of 40
to 44 mm and hypertension (28-40 mm is normal), or a left atrium
diameter greater than 45 (33%). (At first glance this seems
like stacking the deck against a successful catheter ablation.
These are more difficult cases requiring more than a simple
Pulmonary Vein Isolation ablation.)
CA
Ablation
At St. Antonius Hospital the Pulmonary Veins were
re-isolated. No additional lines or ablation strategies were
performed regardless of the type of A-Fib. A non-irrigated tip
RF catheter was used.
At the Hospital Clinic an irrigated tip RF catheter was
used. An additional Left Atrium roofline could be made at the
discretion of the operator. Sometimes a Mitral Isthmus line was
also made.
At either site no mention was made of using current mapping
strategies to find and isolate activation sites, or the use of
Complex Fractionated Atrial Electrograms, or Dominant Frequency,
or step-wise ablation protocols typically used in more complex
cases. (See
5-Step Ablation Treatment for Chronic A-Fib.)
According to the study authors "patients in the CA group may
have been undertreated compared with patients in the SA group."302
"More than 40% of (the CA) patients had nonparoxysmal AF and may
have been undertreated by PVI alone...67% had already failed a
prior CA, which may be a more serious predisposition to failure
than anticipated."302
SA
Ablation
The surgical ablation arm used the AtriCure Synergy Ablation
System which uses an RF clamp to ablate and isolate the
pulmonary veins. In addition, 31% of patients had various
additional LA ablation lines at the LA roof, aortic trigone,
mitral isthmus, or box lesion around the PVs. "Part of these
lines were made without verifying that conduction block had
indeed been established."302 (In
a somewhat surprising observation, the authors concluded
"efficacy tended to be a little lower in patients with such
lines."302)
The Left Atrial Appendage was also removed. And Ganglia
areas on the outside of the heart were also ablated. (Ganglia
Ablation is a subject of some controversy that deserves its own
report. There are over 1000 neurons [nerve signal pathways] in
the Ganglia areas. They affect other areas than just A-Fib, such
as the ventricles and the GI tract. See
Merits of GP [Ganglionated Plexi] Ablation.) According
to the authors of this study, "So far, no randomized clinical
trials have quantified the added effect of surgical ganglia
ablation to achieve freedom from AF."302
RESULTS
Efficacy
(As one would expect),
the efficacy of catheter ablation was low---44.4%. What was more
surprising was that the efficacy of Surgical Ablation was only
67.2%, far less than the over 90% success rates often reported
(in unpublished, self-reported, or single-center, non-controlled
series with short duration and lax follow-up). This is all the
more surprising in that the surgical arm, in addition to
isolating the pulmonary veins, often employed additional
extensive lesion sets and burns in the left atrium and elsewhere
on the heart. Whereas the catheter ablation arm was limited in
ablation strategies it used.
Safety
The
procedural adverse event rate for surgery was 23% (approximately
1 out of 4 patients) which was significantly higher than
catheter ablation 3.2% (in line with previously published data).
The main procedural complications in surgery were pneumothorax
(collapsed lung), major bleeding, and the need for a pacemaker.
(In surgical ablation the lungs have to be alternately
deflated and re-inflated to fit the clamp around the pulmonary
veins. Especially in older people whose lungs are no longer as
elastic, this may be hard on the lungs.) These complications
were caused "mostly from direct mechanical injury during the
procedure. About half required additional intervention and/or
prolonged hospitalization."302
"The events reported with CA seemed more transient and did
not require intervention."302
They seemed to center around anticoagulation, with bleeding on
the one hand and transient ischemic attack, stroke and
hemorrhage stroke on the other. (One of the CA patients died of
a hemorrhagic stroke a month after the ablation.)
CA patients tended to stay in the hospital 2.0 days, versus
5.5 days for surgery.
Unlike catheter ablation, "there are no large registries for
minimally invasive surgical ablation that provide good insight
into safety."302
EDITOR'S COMMENTS
Though
not the fault of the study's designers and investigators, the
deck was obviously stacked against catheter ablation. The
success rates were far lower than previously published and
documented data. (For example, the Bordeaux Group reports a 95%
success rate after two ablations using their step-wise ablation
protocol for Persistent A-Fib patients. (See
95% Success Rate in Curing Persistent A-Fib.)
But
what was more surprising was the relatively low success rate for
the surgical arm which seemed to pull out all the stops and use
the newest, most advanced extensive lesion sets and burns to
achieve success.
In terms of safety, a 1-in-4 major adverse event rate is
huge when one considers that the surgeons were probably under
intense scrutiny to perform their best and not make any
mistakes, since so much was riding on this study.
What
the FAST Study means for Patients
This
was probably the first study to provide documented, verifiable,
non-self reporting data on the safety of Surgical Ablation
(Mini-Maze). The results for patients were not good. A 1-in-4
chance of a major adverse event is not acceptable for most
patients.
This study did not address simpler cases of Paroxysmal
A-Fib. But the surgical Mini-Maze operations are generally the
same for Paroxysmal as for more complex cases. Until we get
verifiable data to the contrary, anyone going for a Mini-Maze
operation should expect a 1-in-4 chance of a major adverse
event.
"But what if I've had a failed catheter ablation? Shouldn't
I get one of the more advanced types of Mini-Maze ablations?" A
67% success rate is certainly acceptable and is better odds than
you'd get in Vegas. But one of the more disturbing findings in
this study is that with the more advanced surgical approaches
using ablation lines on the left atrium and burns on other areas
of the heart, "efficacy tended to be a little lower in patients
with such lines."302
The Mini-Maze operations featuring extensive ablation lines and
burns didn't seem to work, at least in this study.
And according to the numbers, you have a better (and much
safer) chance of being A-Fib free if you go to catheter ablation
centers specializing in advanced activation mapping, step-wise
protocols, etc. Unfortunately those centers are relatively few
and far between. The Bordeaux protocol, for example, is
currently used in only a few centers around the world. And
catheter ablation strategies for complex cases currently have
not been standardized, though most centers' strategies are very
similar (See
Comparison of Dr. Pappone's,
Haïssaguerre's, and Reddy's Stepwise Approaches in Ablating for
Chronic A-Fib)
The FAST study, though probably the first of its kind, was a
relatively small study. A-Fib patients shouldn't rely entirely
on the results of this study for their medical decisions. But it
does raise red flags particularly about the safety, but also
about the efficacy, of Mini-Maze operations. The efficacy
results for catheter ablation should probably be discounted,
because of the design bias of the study.
Borsama, L.V.A. et al. "Atrial
Fibrillation Catheter Ablation Versus Surgical Ablation
Treatment (FAST)." CIRCULATION. 111.074047 Published
online before print November 14, 2011.
http://circ.ahajournals.org/content/early/2011/11/13/CIRCULATIONAHA.111.074047.full.pdf
US Food and Drug Administration.
"AtriCure Synergy Ablation System - P100046" December 15, 2011.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm284063.htm
NOVEMBER 28, 2011
Dabigatran (Pradaxa)---Recent
Safety Advisories---Should We Worry?
The Japanese Ministry of Health, Labor, and
Welfare recently issued a safety advisory warning of the
potential for adverse effects following the deaths of five
patients. Of the deceased patients, one had kidney failure and
four were over 80 years old. In Japan there were 81 reported
cases of serious side effects, including gastrointestinal
bleeding, out of 64,000 people who have used dabigatran since it
was first introduced in Japan in 2011.
EDITOR'S COMMENTS
81 out of 64,000 is a very low number
of serious side effects, particularly compared to warfarin. In a
recent study warfarin was implicated in 33% of "adverse drug
events (ADEs)" for seniors requiring emergency hospitalizations.
Of the five patients who died, dabigatran is counter
indicated (shouldn't be used) in patients with renal failure.
Caution is obviously needed in patients over 80 years old. They
should be monitored more closely to determine if they have risk
factors for bleeding. This should be reflected in the labeling
of dabigatran.
The
Australian regulatory authority, the Therapeutic Goods
Administration, issued a "safety advisory" on dabigatran because
of an increase in the number of bleeding-related adverse events
reports. The most common site of serious bleeding for dabigatran
was the gastrointestinal track, whereas for warfarin it is
intracranial.
EDITOR'S COMMENTS
The clinical trials of dabigatran revealed that nearly two
out of five patients could not tolerate dabigatran.
The Pradaxa Fact Sheet from Boehringer Ingelheim states under
"Adverse Reaction from RE-LY" (the clinical trial of Pradaxa):
Patients on Pradaxa 150mg had an increased incidence of
gastrointestinal adverse reactions (35%/yr) compared to warfarin
(24%/yr).
Dabigatran may not be the perfect substitute for warfarin.
If you're taking dabigatran (Pradaxa), watch out for
indigestion, burning, stomach pain (and weight loss). But which
would you rather have---a hemorrhagic (intracranial bleeding)
stroke or indigestion? On the other hand, based on the clinical
trial date there is a danger that dabigatran over time may cause
long-term damage to the gastrointestinal system.
This is a decision you and your doctor have to make depending on
how you react to dabigatran.
Overall, dabigatran, though not perfect and not tolerated by
all A-Fib patients, is nevertheless a welcome addition to the
tools doctors have to prevent A-Fib stroke.
CAVEAT
If you're taking dabigatran and have a major traumatic
accident, emergency doctors have no antidote to stop you from
bleeding to death (with the exception of emergency dialysis
which is not easily done on patients with serious trauma and
bleeding). Whereas doctors can rapidly reverse the anticoagulant
effect of warfarin using vitamin K, plasma factor Vlla, and
factor concentrates.
Also, the degree of warfarin anticoagulation can be easily
assessed, whereas no such tests exist for dabigatran.
But the advantages of dabigatran may outweigh the chances of
a traumatic accident like a car crash which may not be
survivable any way. How likely are you to be in a traumatic
accident? This is again a decision you need to consider with
your doctor.
Wood, Shelley. "Deaths Prompt
Dabigatran Safety Advisory in Japan." HeartWire,
TheHeart.org. 8/17/11
http://www.theheart.org/article/1264365.do
"Dabigatran: Australia issues
bleeding warning" HeartWire, TheHeart.org October 7, 2011
http://www.theheart.org/article/1291757.do
Wood, Shelley "Trauma patients on
dabigatran prompt call for "pragmatic" trials, trauma
surveillance." HeartWire, TheHeart.org. November 24, 2011
http://www.theheart.org/article/1317869.do
Lowes, Robert. "Warfarin tops list
for emergency hospitalizations in seniors." HeartWire.
TheHeart.org. November 25, 2011.
http://www.theheart.org/article/1318469.do
NOVEMBER 26, 2011
Dronedarone
(Multaq)---Time to Stop Taking It?
This report is a compilation of several recent
news reports about dronedarone (Multaq) and what they mean for
A-Fib patients.
1. "Multaq should not be prescribed for patients with
permanent A-Fib." according to Sanofi-Aventis' warning to
doctors. In the PALLAS study, terminated early, patients on
dronedarone were dying at more than twice the rate of those on a
placebo. The ratio of stroke and hospitalization for heart
failure was also more than twice as high.
2. French health authorities concluded that the efficacy of
dronedarone was "insufficient." This could lead to the drug
being dropped from France's drug reimbursement program.
3. The European Medicines Agency stated that, because of the
increased risk of liver. lung and cardiovascular adverse events,
dronedarone "should only be prescribed after alternative
treatment options have been considered."
4. Dr. Steven Nissen of the Cleveland Clinic told the Wall
Street Journal that he thinks the drug is dangerous.
5. Dr. Sanjay Kaul of Cedars-Sinai Medical Center in Los
Angeles added, "It doesn't even appear safe in
intermediate-risk patients.
6. Dr. John Mandrola of Louisville stated, "I don't know any
of my colleagues who would start a patient out on Multaq. It
just doesn't work."
7. The FDA publishes a list of drugs to monitor after having
identified potential signs of serious risks or new safety
information. Dronedarone appeared on this list for the fifth
straight time.
But according to
Dr. Stuart Connolly (McMasters Un., Hamilton Ontario), one of
the co-primary investigators of the PALLAS trial, patients with
non-permanent A-Fib benefit from dronedarone, and he doesn't
think this type of patient should be worried. (But is there
that much of a difference between permanent and non-permanent
A-Fib patients that we shouldn't be worried or concerned? For
example, by the time liver damage shows up in tests, liver cells
have already been damaged, probably permanently.)
EDITOR'S COMMENTS:
So many red flags have been raised about
dronedarone (Multaq) that anyone taking dronedarone should
discuss with your doctor if you can take another antiarrhythmic
med instead. If the worst fears about dronedarone are true, it
may be both ineffective and dangerous. Why take a drug
associated with increased strokes, hospitalizations, heart
failure, liver damage, lung damage and death if it doesn't work?
Even if it did work, the side effects probably wouldn't justify
taking it.
No antiarrhythmic drug is 100% safe and effective for all
A-Fib patients. But until we get more favorable research on
dronedarone, all A-Fib patients should probably consider not
taking it, not just those in permanent A-Fib. It's not worth the
risk of taking a drug that isn't very effective any way.
For a
spirited, lengthy discussion of dronedarone, read Mellanie
True-Hills' article/editorial
http://www.stopafib.org/newsitem.cfm/NEWSID/353/What we have
learned about Multaq/dronedarone
But in her own words, "The maker of Multaq is one
of many organizations that has contributed so that we can do
research and writing to give you the best content."
Wood, Shelley. "Deaths doubled with dronedarone in PALLAS: FDA
and EMA updates" HeartWire,
July 21, 2011
http://www.theheart.org/article/1255799.do
Nainggolan, Lisa. "EMA Adds CV Events
to Review of Dronedarone" HeartWire,
July 12, 2011
http://www.theheart.org/article/1252319.do
O'Riordan, Michael.
"EMA recommends restricting use of dronedarone" HeartWire,
September 20, 2011.
http://www.theheart.org/article/1283205.do
Miller, Reed.
"Dronedarone "dear doctor" letter sums up recent alerts."
HeartWire, August 17, 2011.
http://www.theheart.org/article/1264551.do
NOVEMBER 25, 2011
Successful A-Fib Catheter Ablation Improves Health
It feels so great to be A-Fib free and in
normal sinus rhythm after a successful Pulmonary Vein
Isolation (PVI) procedure that one feels more
healthy. But is one's health actually improved after a
successful PVI?
In an observational long-term study of the impact of A-Fib
ablation, over 4,000 patients from the Murray, Utah
Intermountain Medical Center were followed for over three years.
Compared to matched controls who had A-Fib but did not have an
ablation, ablated patients had a significantly lower risk of
death, stroke, heart failure, cardiovascular hospitalization and
dementia. (People with A-Fib have an increased risk of
developing dementia, because blood is not being pumped properly
to the brain and other organs when in A-Fib.)
Catheter Ablation Superior to Drug
Therapy
The article cited previous studies which showed that
antiarrhythmic drugs, which attempt to return the heart to
normal sinus rhythm, don't improve morbidity and mortality
compared to leaving patients in A-Fib with rate control drugs,
perhaps because current antiarrhythmic meds aren't highly
effective, recurrence rates during therapy are high (44%-67% at
1 year), and adverse events and side effects are common.
Catheter ablation was found superior to drug therapy in
suppressing A-Fib and improving symptoms, exercise capacity, and
quality of life.
Successful Ablation Patients More
Healthy Than People Without A-Fib!
The over 4,000 ablated patients were also matched
with controls who did not have A-Fib. Ablated patients were more
likely to have had hypertension, heart failure, and significant
valvular disease---were more likely to be less healthy than the
controls. But after three+ years of normal sinus rhythm, there
was a trend towards lower long-term adverse events in the A-Fib
ablation group compared to the "healthier" control group (with
the exception of heart failure).
Editor's
Comments:
We know that
we feel better after a successful Pulmonary Vein Isolation (PVI)
procedure. It makes intuitive sense that our heart and body
would function better, that we would be more healthy after a
successful PVI. But it's good to have studies that document this
in no uncertain terms.
But what's even more interesting is that patients A-Fib free
were to some extent healthier than matched controls who never
had A-Fib, even though the patients with A-Fib probably had more
health problems going in than the controls. The authors of this
study didn't speculate on why this occurred. Could it be that
those of us made A-Fib free value normal sinus rhythm more and
take more steps to stay healthy and A-Fib free?
T. Jared Bunch, et al. "Patients Treated with
Catheter Ablation for Atrial Fibrillation have Long-Term Rates
of Death, Stroke, and Dementia Similar to Patients without
Atrial Fibrillation."
J Cardiovasc Electrophysiol. 2011 Aug;22(8):839-45. doi:
10.1111/j.1540-8167.2011.02035.x. Epub 2011 Mar 15.
http://www.ncbi.nlm.nih.gov/pubmed/21410581
See also: Hunter RJ et al. "Maintenance of sinus rhythm
with an ablation strategy in patients with atrial fibrillation
is associated with a lower risk of stroke and death."
Heart
doi:10.1136/heartjnl-2011-300720
http://heart.bmj.com/content/early/2011/09/19/heartjnl-2011-300720.abstract
SEPTEMBER 15, 2011
Dr. Marcos Daccarett, MD, MSc, FACC, FAHA,
FHRS has moved from the University of Utah Hospital to
St. Luke's Idaho Cardiology
Associates in Boise.
SEPTEMBER 12, 2011
Having Trouble Sleeping?---the Aspirin (NASIDs) You're Taking
May Be the Problem
People
with A-Fib are often prescribed the blood
thinner aspirin to help prevent clots and A-Fib stroke. NSAIDs
(aspirin, ibuprofen, etc.) work by inhibiting prostaglandin
synthesis which is involved in pain and inflammation. But they
are also involved in melatonin synthesis and body temperature
regulation.
A recent double blind study found that aspirin and ibuprofen
suppressed melatonin synthesis and attenuated the normal
circadian decrease in body temperature during nighttime hours.
This alteration of normal sleep patters in healthy individuals
by the NSAIDs aspirin and ibuprofen was not found, however, in
all study subjects.
(Editor's Comments: if you're taking aspirin, even at the
lowest dosage 81 mg, and are having trouble getting to sleep,
try taking the aspirin in the morning rather than in the evening
before bedtime. However, you may find that even taking aspirin
in the morning may still affect your sleep.
NSAIDs are the most frequently prescribed medications
worldwide. But one wonders why when considering the documented
side effects to the gastrointestinal tract, liver, kidneys,
central nervous system, endocrine system, and articular
cartilage this article briefly documents.
For example, "researchers estimate that 8-10% of the overall
incidence of end-stage renal (kidney) disease is attributable to
acetaminophen [Tylenol]. The risk is dose dependent with
measurable increases of risk beginning at 105-365 pills per year
or greater than 1000 pills per lifetime." What this means in
non-medical language is if you take more than 1000 acetaminophen
during your lifetime, you stand a good chance of permanently
destroying your kidneys. For a 50-year-old that's only 20 pills
a year. One wonders why so many doctors and hospitals in the US
prescribe or recommend acetaminophen for pain relief, even for
children. [Some researchers do not consider acetaminophen a
NSAID, though it works by the same mechanism---inhibition of
prostaglandin synthesis.] )
Thanks to one of our readers for calling our attention
to this article and to its importance. He had trouble sleeping
when taking 81 mg of aspirin (baby aspirin).
ayatingl(at)gmail.com
NSAIDs -- The Unintended Consequences
Dynamic
Chiropractic
October 20, 1997, Volume 15, Issue 22 by Alan Cook, DC
http://www.chiroweb.com/archives/15/22/06.html
SEPTEMBER 11, 2011
NSAIDs Associated with A-Fib
NSAIDs (nonsteroidal anti-inflammatory
drugs such as aspirin, ibuprofen [Advil, Motrin],
naproxen [Aleve, Naprosyn) and COX-2 inhibitors are associated
with an increased risk of developing A-Fib and/or Flutter.
A Danish study of 32,602 patients with A-Fib or Flutter
found that the use of NSAIDs was associated with an adjusted 17%
increased risk of developing A-Fib or Flutter. There was a
slightly higher risk associated with the use of COX-2
inhibitors.
New users had the highest risk. For those who filled a
prescription for NSAIDs within the previous two months, they had
a 46% chance of developing A-Fib/Flutter. For COX-2 inhibitors
there was a 71% increased risk.
A previous study based on the United Kingdom General
Practice Research Database also found an association between the
use of NSAIDs and A-Fib. But this study found the highest risk
among long term users (for more than one year) rather than
first-time users.
But an "association" doesn't necessarily mean that NSAIDs
cause or trigger A-Fib/Flutter. Perhaps an inflammation
condition increases the risk of A-Fib on the one hand or prompts
the use of NSAIDs on the other. According to Dr. Jerry H.
Gurwitz (Un. of Massachusetts Medical School, Worchester), "The
risk is unproven. But NSAIDs should be used with caution in high
risk patients anyway."
(Editor's Comments: though inflammation may produce
fibrosis, loss of atrial muscle mass and thereby foster A-Fib,
that doesn't explain how nearly one out of two new users filling
prescriptions for NSAIDs developed A-Fib/Flutter within two
months.
Until further research clarifies these points, it's prudent
to consider NSAIDs not just associated with A-Fib but actual
triggers or causes of A-Fib.
These Danish and British studies may be medical
breakthrough research. Avoiding NSAIDs may help prevent
the development and/or triggering of A-Fib/Flutter.)
NSAID use associated with risk of atrial fibrillation or
flutter
July 5, 2011
Michael O'Riordan
http://www.theheart.org/article/1249265.do
NSAIDs and atrial fibrillation
BMJ
2011;
343:d2495
doi:
10.1136/bmj.d2495
(Published 4 July 2011)
Cite this as:
BMJ
2011;
343:d2495
SEPTEMBER 11, 2011
Elderly Shouldn't Use NSAIDs
NSAID (nonsteroidal anti-inflammatory
drugs---such as aspirin, ibuprofen (Advil, Motrin),
naproxen (Aleve, Naprosyn)
use among elderly patients with high blood
pressure and coronary artery disease leads to increased
mortality, heart attacks and stroke. Chronic NSAID users had a
60% increased risk of death, heart attack and stroke. And
according to Dr. Anthony Bavry (Un. of Florida, Gainesville),
"This association doesn't appear to be due to elevated blood
pressure, because chronic NSAID users actually had slightly
lower...blood pressure."
Editor's Note: Many A-Fib patients are elderly. It's all
too tempting to turn to NSAIDs to handle pains big and small.
But what can we elderly do? Acetaminophen (Tylenol) is
associated with kidney failure. COX-2 inhibitors have their own
set of problems. Are there any pharmaceutical pain killers that
are safe to take?
We need to investigate "natural" pain killers. Are there
natural pain relievers that would help us without causing bad
side effects? Has anyone studied natural pain relievers which
A-Fib patients might use? Here is a starting list of natural
pain relievers:
-
Olive Oil
-
Fish Oil
-
Tart Cherries
-
White Willow Bark (like aspirin)
-
Boswella
-
Tumeric (circumin)
-
MSM (Methyl Sulphonyl Methane
-
Feverfew (tanecetum parthenum)
-
Essential Oils (jasmine, peppermint, juniper, rose,
rosemary)
-
Ginger
-
Skullcap Tincture
-
Yucca
-
Cat's Claw
-
Eucalyptus
-
Aloe Vera Gels
-
Kava Kava
- Valerian Root
NSAID use in elderly with
hypertension linked to increased cardiac risk
By Piriya Mahendra
18 July 2011
Am J Med 2011; 124:
614–620
http://www.medwire-news.md/59/93424/Hypertension/NSAID_use_in_elderly_with_hypertension_linked_to_increased_cardiac_risk_.html
Thanks to Ira David Levin for calling our attention to this
article and for pointing out its importance for A-Fibbers.
SEPTEMBER 3, 2011
Silent Clots from Multielectrode Phased-RF Ablation Catheters
In two small studies of catheter ablation, Magnetic Resonant
Imaging (MRI) revealed "subliminal (silent) intracranial embolic
events" (clots, lesions) that normally would not have been
detected if MRI weren't used. These non-randomized studies raise
concerns that catheter ablation may cause small, unnoticeable
clots or lesions in the brain. The studies compared
Multielectrode Phased-RF Ablation Catheters (Medtronic Ablation
Frontiers), conventional Irrigated-Tip Catheters (Navistar
Thermocool, Biosense Webster), and CryoBalloon Catheters Arctic
Front, Medtronic).
In one study using the Multielectrode Phased-RF Ablation
Catheter 38.9% of patients (9 out of 27) experienced silent
cerebral lesions. This was significantly more than a
conventional Irrigated-Tip RF catheter (2 out of 27, 7.4%) or
the CryoBalloon catheter (1 out of 23, 4.3%). (Some reports
cite only the percentages which can be misleading, since the
actual numbers of patients were so small.)
Why
Lesions from Multielectrode Phased-RF Catheters?
Why would a Multielectrode Phased-RF Catheter produce so
many small clots or lesions?
Possibly because, unlike conventional Irrigated-Tip catheters,
it is not irrigated. What may happen is, when heart tissue is
heated, energy is transferred back to the electrode, which as it
heats up can cause char. This char can break off and cause clots
and strokes. Conventional Irrigated-Tip catheters are cooled by
saline solution to reduce or eliminate this heat effect.
MRI-Detected Lesions may be
Insignificant or may Reverse Themselves
A Medtronic spokesperson pointed out that the lesions
detected by MRI have not been clearly linked to neurologic
defect or cognitive decline, and that some studies have shown
that the lesions detected have been shown to reverse on
follow-up.
(These MRI-detected lesions may not have any lasting effect or
may resolve themselves much as a more serious TIA (Transient
Ischemic Attack) often resolves itself and doesn't seem to have
a lasting effect.)
But A-Fib Patients Should Still be
Concerned
Any kind of lesions in the brain are cause for
concern. In the words of Dr. Vivek Reddy (Mount Sinai School of
Medicine, New York), "It can't be a good thing to have all this
stuff in your brain." What do these silent ischemic lesions
mean, how do they affect us? Dr. Jonathan Steinberg (Columbia
College of Physicians & Surgeons, New York) sums up, "We don't
know if some of this is reversible, or if it's such a small
volume of damage that it ultimately is negligible or has no
functional impact."
Need for Further Study
What needs to be done is to follow patients who have had
these MRI-detected lesions to see if they are affected
neurologically over time, to see if these lesions do indeed
resolve themselves and disappear.
EDITOR'S COMMENTS:
These studies, though small, seem to indicate that A-Fib
patients should probably avoid ablations by Multielectrode
Phased-RF catheters until these silent cerebral lesions are
proven to be benign.
But what about conventional Irrigated-Tip and CryoBalloon
catheters? The number of silent lesions was so small in both
studies that it's hard to make decisions based on such limited
sample sizes. (One would expect the CryoBalloon catheter to
produce less silent lesions. In the clinical trials, it was
safer than conventional Irrigated-Tip catheters and produced
less clots. See
CryoBalloon Ablation Safer Than RF)
However, there is a small but real risk of stroke during a
RF catheter ablation procedure even with using an irrigated tip
catheter (less than 0.5%34).
Stroke is less of a risk when using CryoBalloon ablation.
"Silent-embolization
concerns mount for RF ablation catheter."
http://www.theheart.org/article/1260023.do
Siklódy CH, Deneke T, Hocini M, et al. Incidence of
asymptomatic intracranial embolic events after pulmonary vein
isolation. J Am Coll Cardiol 2011; 58: 681-688.
http://www.theheart.org/article/1237547.do
Gaita F, Leclercq JF, Schumacher B, et al. Incidence of silent
cerebral thromboembolic lesions after atrial fibrillation
ablation may change according to technology used: Comparison of
irrigated radiofrequency, multipolar nonirrigated catheter and
cryoballoon. J Cardiovasc Electrophysiol 2011;
DOI:10.1111/j.1540-8167.2011.02050.x.
JULY 20, 2011
Dr. Edward
Gerstenfeld has moved from the Un. of
Pennsylvania to the Un. of California San Francisco where he
will be directing the EP program and performing A-Fib ablations.
JULY 19, 2011
Dronedarone (brand name Multaq) "Risk of Severe Liver Injury."
The FDA notified healthcare professionals and patients about
cases of rare, but severe liver injury, including two cases of
acute liver failure leading to liver transplant in patients
treated with the heart medication dronedarone (Multaq).
Information about the potential risk of liver injury from
dronedarone is being added to the WARNINGS AND PRECAUTIONS and
ADVERSE REACTIONS sections of the dronedarone labels.
If you start feeling nausea, vomiting, fever, anorexia,
malaise, fatigue, right upper quadrant pain, jaundice, dark
urine, or itching, it's recommended you stop taking Multaq and
get in touch with your doctor ASAP.
Your doctor should be testing you for "hepatic (liver) serum
enzymes" especially during the first 6 months of treatment.
(Editor's Note: It's disappointing that the FDA had to
issue this risk notification about Multaq. The FDA found cases
of cellular liver damage "hepatocellular liver injury."280
We can't help but ask if
Multaq may cause long-term damage to the liver, even though it's
tolerated in the short term. How many people taking Multaq have
had their liver serum enzymes tested, know what their benchmark
liver serum enzymes numbers are, and keep track of any rise (not
just whether they are in an acceptable range)?
Is Multaq destined to be yet another antiarrhythmic med that
causes more problems/side effects than it solves? )
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm240110.htm
JUNE 25, 2011
Michelle Straube is
walking
the Alps
to
promote A-Fib Awareness! After being in A-Fib for 30 years she
was made A-Fib free in 2009. Check out her blog Into the
Heart of the Alps for Atrial Fibrillation Awareness: http://bit.ly/hHPG2f.
"We’re
leaving for the first 22 days of our trek this Sunday — still so
much to do, but so excited. Just walking uphill fast is a
miracle, but now I can do that and talk at the same time, or
carry a 20-lb backpack and make it up without wheezing or
dizziness. Life is so good!" See
Michelle Straube's story.
APRIL 24, 2011
Fibrosis Predicts Stroke
Risk
In a study from Dr. Nassir Marrouche
at the Comprehensive Arrhythmia Research and management Center
in Utah, Stage IV (over 35%
fibrosis)
patients were four times more likely to have a stroke than
patients with a low level of atrial fibrosis. And the level of
fibrosis didn't always correlate with standard
CHADS2
risk scores of stroke. 16.5% of patients with a CHADS2
score of 0 (low risk) and 18.5% with a score of 1 (intermediate
risk) had Stage IV atrial fibrosis.
Whether you were in paroxysmal or persistent A-Fib didn't
seem to have an impact on the likelihood of stroke rate.
Women were three times more likely to have a stroke
than men. The researchers hypothesized that, because men
tend to get treatment for A-Fib sooner, women had more extensive
remodeling and fibrosis than men, which led to a higher stroke
risk.264
(Editor's Observations: MRIs to measure fibrosis in the
heart should become a routine diagnostic tool for anyone in
A-Fib. According to this study, the CHADS2 method of
evaluating risk of stroke doesn't work in many cases. Should we
retire the CHADS2 and replace it with a more
empirical, scientific method such as fibrosis measurement?
Some people have argued that there is less risk of stroke if
one is in continuous A-Fib rather than paroxysmal (occasional),
because one might be more at risk of a clot when the heart stops
and starts beating normally. But this study indicates that
whether one is paroxysmal or persistent doesn't seem to
influence the risk of stroke.
The finding that women are three times more likely to have a
stroke than men should be a wake-up call for doctors (and of
course for women)! If women hear from their doctor "It's all in
your mind," or Take a valium," it's time to get a second opinion
ASAP. An A-Fib stroke is a fate worse than death, if you live
through it. Doctors should become more aware of the increased
danger A-Fib presents to women.)
APRIL 14, 2011
PVA(I) Improves
Ejection Fraction
A successful Pulmonary Vein Ablation (Isolation) (PVA(I)
reverses many of the remodeling effects of A-Fib. For example,
enlargement of the left atrium
and the ability of the atria to contract can be reversed after a
successful catheter ablation.58
But there
is some disagreement among researchers as to whether a
successful PVA(I) over time improves
Ejection Fraction.258
In a study from the Bordeaux group, A-Fib patients with
Congestive Heart Failure and an ejection fraction of less than
45% (normal ejection fraction range is 56%-78%), had a PVA(I).
After approximately 12 months, 78% were A-Fib free without meds.
They had significant improvement in left ventricular function
including increases in ejection fraction of approximately 21%
(as well as exercise capacity, symptoms, and quality of life).
The ejection fraction also improved significantly (24%) in the
control group of A-Fib patients without Congestive Heart
Failure.259
(Editor's Note: It's not all that surprising that A-Fib patients
with a low ejection fraction would improve after a successful
PVA(I). But the control group without Congestive Heart Failure
also improved their ejection fractions. In this study a
successful PVA(I) improves ejection fraction even if one has a
relatively normal ejection fraction to begin with.)
259
Hsu, Li-Fern et al. "Catheter Ablation for Atrial
Fibrillation in Congestive Heart Failure." N Eng J Med
2004; 351:2373-2383 December 2, 2004.
http://www.nejm.org/doi/full/10.1056/NEJMoa041018
APRIL 10, 2011
Dabigatran (Pradaxa)
Indigestion, Burning, Stomach Pain, (Weight Loss) Side Effects
If you've started taking Pradaxa, watch out for indigestion,
burning, stomach pain (and weight loss). These are listed as
common side effects of Pradaxa. As many as 35% of people taking
Pradaxa may experiences these symptoms. There is a fine line
between allowing one's body to get used to a new drug, and
deciding this drug isn't for me because of its bad side effects.
The Pradaxa Fact Sheet from Boehringer Ingelheim states
under "Adverse Reaction from RE-LY" (the clinical trial of
Pradaxa):
• Patients on Pradaxa 150mg had an increased incidence of
gastrointestinal adverse reactions (35%/yr) compared to warfarin
(24%/yr).
• The discontinuation rate due to drug-related adverse
events was 21% for Pradaxa 150mg and 16% for warfarin.
"In addition to bleeding, Pradaxa can cause stomach upset or
burning, and stomach pain." (Pradaxa Fact Sheet 101910.pdf)
(Editor's Note: In the RE-LY clinical trial nearly 2 out
of 5 people had gastrointestinal adverse reactions. 35% is a
very high rate of adverse reactions. Pradaxa may not be the
wonder drug we've all been hoping would replace warfarin.
If it has such bad side effects, it may be damaging many more
people's stomachs over a longer period of time.)
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=60264
APRIL 9, 2011
LARIAT ii SUTURE DELIVERY DEVICE
Most A-Fib strokes (90-95%) come from
clots which form in the Left Atrial Appendage. One strategy to
prevent A-Fib stroke is to close off the Left Atrial Appendage.
In most cases this is as effective as taking blood thinner
medications. Though, as with blood thinners, it isn't an
absolute guarantee you will never have an A-Fib stroke.
A novel noose device to close off the Left Atrial Appendage is
inserted from outside the heart
(Lariat
II, SentreHeart, Inc., Palo Alto, CA)
(unlike for example the
Watchman device which is inserted into the LAA from inside
the heart). It is used in
cases where the patient can not tolerate anticoagulants like
Coumadin. (The
Watchman device requires a patient be on anticoagulants for
a couple of months.)
From the inside of the heart a balloon is placed inside the
Left Atrial Appendage to expand it and make it accessible to the
noose device which is inserted from the outside of the heart.
The positioning balloon is withdrawn before the Lariat noose is
closed around the base of the Left Atrial Appendage. The noose
completely closes off the Left Atrial Appendage which dies and
is no longer electrically active. The Lariat II snare device has
been approved by the FDA.
The Lariat device was invented by Dr. William E. "Billy"
Cohn, Director of Minimally Invasive Surgical Technology at the
Texas Heart Institute at St. Luke's Episcopal Hospital.
(Thanks to Beverly Stansfield for calling our attention to the
importance of this device.)
APRIL
8, 2011
Dr. Edward Gerstenfeld
from the Un. of Pennsylvania will be moving to the Un. of
California San Francisco in July, 2011.
APRIL 1, 2011
HALF OF ALL
A-FIB DUE TO AVOIDABLE RISK FACTORS
There are
factors somewhat under our control which my influence or trigger
A-Fib, such as hypertension, diabetes, obesity and smoking. One
study says that half of all cases of A-Fib are due to the above
cardiovascular risk factors, with hypertension the strongest
predictor of A-Fib.253
(Editor's Comment: One wonders why the study didn't
also mention binge drinking as a cause or trigger of A-Fib.
That's certainly something we have control over.)
Maintaining a healthy diet and life style may help
prevent A-Fib. But don't count on them to make you A-Fib free
once you develop A-Fib. However, anything that makes you more
healthy overall might influence the amount and severity of A-Fib
attacks.
The study also found that African Americans have a lower
risk of developing A-Fib, even though they have more risk
factors for A-Fib, such as high blood pressure and obesity.253
MARCH 30, 2011
most beta-blockers can have a harmful effect, except carvedilol
(Coreg)
A new study
casts doubt on the effectiveness of most beta-blockers which
"undermine the structure and function of the heart...Blocking
the beta-receptor alone promotes cardiac remodeling via growth
of cardiac fibroblasts induced by alpha-adrenergic receptor
signaling. The growth of fibroblasts in the heart further
damages the integrity and function of the heart."247
Carvedilol, however, targets both the beta- and
alpha-adrenergic receptors on the heart muscle. Beta-blockers
(like carvedilol) which target both receptors "offer the most
benefit to cardiac patients." A study in 2003 showed that
carvedilol produced a greater survival rate than metoprolol.247
[Thanks to Janet Brown for calling our attention to this
research.]
Nebivolol seems to eliminate most of the common bad side
effects of beta blockers by dilating blood vessels through the
release of nitric oxide. But it also only blocks Beta 1
receptors. See
nebivolol.
DECEMBER 20, 2010
FDA APPROVES
CRYOBALLOON ABLATION CATHETER
The
FDA approved
the first cryoablation balloon catheter for A-Fib---the
Arctic Front system
(Medtronic,
Minneapolis, MN). This is a major medical breakthrough
in treating A-Fib.
Cryoballoon ablation appears to be
safer, faster and easier than RF. The cryoballoon can isolate a
pulmonary vein opening in as little as one freeze (about 10
minutes per vein), while an RF ablation requires ablating one
spot at a time. Also, the frozen balloon sticks to the PV
opening, which keeps the catheter stable during the ablation. In
one study of the clinical trial (STOP AF),
there were no strokes,
no pulmonary vein stenosis, no esophageal injury, and no
coronary artery injury as sometimes occurs with RF ablation (RF
ablations typically have a major complication rate of around
4%).
(Added 3/7/11: Results from the North American Arctic Front
STOP-AF trial did show a PV stenosis rate of 3.1% which did not
show up in the European trials. This may have come from the use
of a smaller 23 mm balloon which possibly penetrates too far
into the Pulmonary Vein opening.242
The STOP-AF trial also showed a Phrenic Nerve Palsy
(paralysis, weakening) of 11.2 %. Some of these cases did not
resolve within 12 months (18 %). This Phrenic Nerve damage may
have come from the use of the smaller 23 mm balloon which gets
closer to the Phrenic Nerve. Dr. Kuck has had good results (no
PV stenosis) using only the larger 28 mm balloon.)242
In the clinical trial 69.9% of patients treated with the
Arctic Front Cryoballoon catheter were free from A-Fib at one
year, compared to only 7.3% of patients on meds only.
See
Cryoballoon Safer than RF,
CryoBalloon & RF Ablation---the future of A-Fib treatment,
and
Dr.
Kerwin's explanation of Cryo Ablation.
(The
author predicts that Cryoballoon ablation, perhaps combined with
RF, will become the treatment of choice for Pulmonary Vein
Ablations.)
http://www.theheart.org/article/1166735.do?utm_campaign=newsletter&utm_medium=email&utm_source=20101222_EN_Heartwire
DECEMBER 14, 2010
CLEVELAND CLINIC
SECOND OPINION PROGRAM
The Cleveland Clinic
has developed an online consulting service that A-Fib patients
can use. They will "review your individual situation (including
medical records and test results), answer your questions and
provide you with a comprehensive report - with treatment options
or alternatives, as well as recommendations regarding your
future care needs." The cost is less than $600. There is a
caveat, "Availability of online medical second opinion varies by
state of residence."
(If
anyone uses this service, could you please tell us what you
think of it? Thanks.)
http://eclevelandclinic.org/myconsult
(Thanks to Jerome
Jacobi for calling our attention to this service.)
NOVEMBER 15, 2010
Rivaroxaban
Another Possible Replacement for Warfarin
Rivaroxaban (brand
name Xarelto by Bayer/Johnson & Johnson) tested well as a
replacement for the blood thinner warfarin. Both rivaroxaban and
warfarin block the action of vitamin-K dependent proteins called
clotting factors, but rivaroxaban targets a specific clotting
factor called Xa.
Unlike
dabigatran, rivaroxaban is reversible in cases of serious
bleeds.223
http://newsroom.heart.org/pr/aha/rivaroxaban-has-less-risk-of-brain-221537.aspx
NOVEMBER 3, 2010
Dabibatran Now
Available In Pharmacies
Dabigatran (brand name
Pradaxa by Boehringer Ingelheim) will be priced at a
"wholesale-acquisition" cost of $6.75/day.
According to Dr. Michael Ezekowitz, switching patients from
Coumadin is relatively easy.
If the INR (international normalized ratio) is 2 or less, you
can switch the patient immediately to dabigatran. It only takes
30 minutes to two hours for it to become effective. Dabigatran
produces a 34% reduction in stroke, a 60% reduction in
intracranial bleeds, and fewer bleeds in general.
The only patients who shouldn't take dabigatran are those
with kidney problems (creatinine clearance of less than 15 which
is close to needing dialysis), and patients with mechanical
heart valves
(not part of the original
RE-LY trial).
http://www.theheart.org/article/1142899.do
(Added November 29, 2010.)
Dabigatran (brand name
Pradaxa) is a direct thrombin inhibitor, a newer type of
medication. Thrombin is an enzyme that converts soluble
fibrinogen into insoluble fibrin. Fibrin is a fibrous protein
involved in the clotting of blood. It forms a mesh or clot over
a wound.
Dabigatran is currently
irreversible. In case of a serious bleed, there is no way to
stop the bleed short of dialysis. It takes approximately one day
for dabigatran to leave the body.223
INR tests,
such as for warfarin, aren't good tests for monitoring the
effectiveness of dabigatran. Doctors may use other tests such as
Thrombin-Antithrombin Complex (TAT) (normal levels 0.85-3.2
microgram/l)221
or Prothrombin Fragment 1+2 (normal levels 0.4-1.2 nmol/l)222.
OCTOBER 31, 2010
Anticoagulants
and Antiplatelets Don't Mix
If someone is taking
an
anticoagulant like warfarin to prevent A-Fib stroke,
wouldn't it be more effective to also take an
antiplatelet like aspirin as well since they work
differently?
That doesn't seem to
be the case.
A Danish study, reported in Hans Larson's October The
AFIB Report,
indicates that
combining anticoagulant and antiplatelet meds in the same
patient is associated with a substantially higher risk of fatal
or non-fatal internal bleeding.
And there was no
indication that combining warfarin with an antiplatelet
(aspirin, clopidogrel, or both) reduced the risk of
ischemic
stroke.
http://www.afibbers.org/afib103jh.pdf
Larson, Hans. The AFIB Report. "Anticoagulation-Dangerous
combinations" Number 103, October, 2010. p. 8.
Hansen, ML, et al. "Risk of bleeding with single, dual, or
triple therapy with warfarin, aspirin, and clopidogrel in
patients with atrial fibrillation." Archives of Internal
Medicine, Vol. 170, No. 16, September 13, 2010, pp. 1433-41.
OCTOBER 30, 2010
Flutter Ablation should be Combined with Left Atrium A-Fib
Ablation
Hans Larson, in his
October The AFIB Report, points out that trying to cure
A-Fib with only a right atrium Flutter ablation "is usually
fruitless with a success rate somewhere between 5 and 10%."
But what if someone only has Atrial Flutter and not A-Fib?
Since a Flutter ablation in the right atrium is relatively
simple and doesn't take much time, should an A-Fib ablation in
the left atrium be done at the same time? Some Flutter may
originate in the left atrium, or the Flutter may mask A-Fib
which may appear later after a successful Flutter ablation? "As
many as half of all patients ablated for Flutter may later
develop A-Fib."
Researchers at Ball Memorial Hospital in a small study of
patients with lone right atrium flutter gave some patients a
right atrium Flutter ablation only, while others received both a
Flutter and an A-Fib ablation at the same time.
After a 16-month follow-up, 87% of the group that had
received both a Flutter and an A-Fib ablation were free of any
arrhythmia without the use of any medication. But only 44% of
the Flutter-only group were so lucky. 36% developed paroxysmal
A-Fib and 20% developed persistent A-Fib. The researchers
concluded that adding Pulmonary Vein Isolation ablation to
Flutter ablation for lone atrial flutter provides better
long-term freedom from arrhythmias than just performing a
Flutter ablation by itself.
(Editor's Comments: If someone recommends you get a
Flutter-only ablation, you should probably get a second opinion.
If you have A-Fib and A-Flutter, you are probably wasting your
time on a right atrium Flutter-only ablation.
If you only have documented Atrial Flutter, you should still
get a second opinion. Some Flutter does originate in the left
atrium, or the Flutter may mask A-Fib which can often appear
later. This Ball Memorial Hospital study suggests that anyone
with only Flutter would be better served by both a Flutter and
an A-Fib ablation at the same time.
http://www.afibbers.org/afib103jh.pdf
Larson, Hans. The AFIB Report. "Flutter ablation may
unmask AF" Number 103, October, 2010. p. 6.
Navarrete, A. et al. "Ablation of atrial fibrillation at the
time of cavotricuspid isthmus ablation in patients with atrial
flutter without documented atrial fibrillation derives a better
long-term benefit." Journal of Cardiovascular
Electrophysiology, July 19, 2010 (Epub ahead of print)
OCTOBER 29, 2010
Acupuncture Helps A-Fib---Specific Acupuncture Sites Identified
Hans Larson, in his
October The AFIB Report,
states
that Italian researchers found acupuncture effective in
preventing A-Fib in persistent A-Fib patients who had just
undergone successful cardioversion.
The acupuncture points used in the Italian clinical trial
were:
1. Neiguan (PC-6)
2. Shenmen (HT-7)
3. Xinshu (BL-15)
Acupuncture at the Neiguan and Xinshu points help modulate
and stabilize the autonomic nervous system. Stimulation of the
Shenmen point has a calming and sedative effect on cardiac
excitability.
Patients received 10
weekly acupuncture sessions.
The article also includes two stories of patients whose
A-Fib was eliminated primarily by acupuncture:
http://www.afibbers.org/resources/journeys/Craig.pdf
http://www.afibbers.org/resources/journeys/Girskis.pdf
(Editor's Comment: As Hans Larson points out, now that we know
the exact points to be stimulated, why not use acupuncture for
Paroxysmal A-Fib as well?)
http://www.afibbers.org/afib103jh.pdf
Larson, Hans. The AFIB Report. "Acupuncture: An effective
antiarrhythmic?" Number 103, October, 2010. p. 5.
Lomuscio, A et al. "Efficacy of acupuncture in preventing atrial
fibrillation recurrences after electrical cardioversion."
Journal of Cardiovascular Electrophysiology, August 30, 2010
(Epub ahead of print)
OCTOBER 28, 2010
Vigorous Exercise and A-Fib
Some commentators have
cited recent research on vigorous exercise to say it is
associated with the development of A-Fib. "Vigorous exercise
increases the risk of atrial fibrillation."218
But a close
examination of the observational study used to support this
statement shows that A-Fib is associated only with men under 50
years of age who jogged/ran over four miles a day 5-7 times a
week. This is a level of running usually associated only with
elite athletes. Other types of vigorous exercise such as
cycling, swimming or racquet sports were not associated with an
increased risk of A-Fib.
Why only elite male runners under 50? The authors of this
study hypothesized that several factors might explain the
increased risk of A-Fib in elite male runners under 50 years
old.
- left atrial enlargement
- left ventricular hypertrophy
- left ventricular dilation
- an increase in
parasympathetic tone (the most commonly cited factor)
"Jogging in particular results in greater enhancement of the
parasympathetic nervous system compared to other exercise
types."
"Heightened
parasympathetic tone has been associated with A-Fib onset in
patients with structurally normal hearts; and in animal and
human studies, parasympathetic stimulation frequently induces
and maintains A-Fib, whereas vagal denervation prevents A-Fib."
People over 50 years old have decreased parasympathetic
activity and usually exercise less vigorously as they age.
The authors of this study recognize the benefits of vigorous
exercise for most people. "Exercise has multiple beneficial
effects on cardiovascular health that may lower A-Fib risk." In
particular, exercise lowers blood pressure, improves lipid
profile and glucose control, and decreases risk of
cardiovascular disease.
(Editor's Comments: With the exception of elite male runners
under 50 who run over four miles a day 5-7 times a week,
vigorous exercise does
not increase the
risk of A-Fib, according to this study. Rather, vigorous
exercise may lower A-Fib risk.)
Aizer, A. et al. "Relation of Vigorous Exercise to Risk
of Atrial Fibrillation." The American Journal of Cardiology,
Volume 103, Issue 11, Pages 1572-1577, June 1, 2009
http://www.ajconline.org/article/S0002-9149(09)00549-9/fulltext
OCTOBER 27, 2010
Steroids
Reduce A-Fib Recurrence after an Ablation
For A-Fib
patients (as well as for EPs and Mini-Maze surgeons), the
biggest frustration after an ablation or surgery is the
recurrence of A-Fib. Even the most experienced A-Fib centers
have unacceptably high rates of recurrence. This recurrence is
often due to regrowth/re-connection of previously ablated areas
(see
Marchlinski "Regrowth/Reconnection of Ablated Areas").
http://www.a-fib.com/BostonA-FibSymposium2007.htm#ThirdandFourthPVIsolation/AblationProcedures
Japanese researchers administered intravenous hydrocortisone
to Paroxysmal A-Fib patients the day of their ablation, followed
by oral prednisolone for three days after the ablation. (The
hydrocortisone dosage was 2mg/kg which translates to
approximately 750 mg for a 170 lb. person. The oral prednisolone
dosage was 0.5mg/kg which translates to approximately 190 mg for
a 170 lb person.)
Within the first three days, 31% of individuals treated with
a placebo had a recurrence of A-Fib, compared with only 7% of
those treated with corticosteroids. Corticosteroid treatment did
not decrease A-Fib recurrences between 4 and 30 days after
ablation (A-Fib patients were not given corticosteroid
treatment during these days). The A-Fib-free rate at 14
months post-ablation was greater in the corticosteroid
group---85% versus 71% for the placebo group (a statistically
significant difference [p=0.032), but not nearly as large as the
first days' results).
(Editor's Note: One wonders what would have happened if
the oral prednisolone was continued for more than three days.)
The researchers found that inflammation, highest
body temperature, largest change in body temperature, maximum
C-reactive-protein (CRP) levels, and change in CRP were lowest
among patients with steroid therapy.
(Editor's Note: All of the above are markers or signs of
inflammation which some research links to A-Fib.84
Steroids may work to reduce recurrence of A-Fib by lowering
inflammation after a procedure. Steroid therapy, by reducing
inflammation, may be a safe and effective method of reducing
recurrence of A-Fib after an ablation. Steroid therapy after
ablation may be a medical breakthrough in
the treatment of A-Fib..
Even though this study is small (125 patients) and limited,
A-Fib patients undergoing ablation and/or Mini-Maze surgery
should receive steroid therapy, unless counter indicated. The
steroid therapy should probably be continued for more than three
days. Steroid therapy certainly seems to reduce the recurrence
rate of A-Fib after ablation.)
(Thanks to David Holzman to calling our attention to this
article.)
http://www.theheart.org/article/1139047.do
Koyama, T. et al. "Prevention of Atrial Fibrillation Recurrence
With Corticosteroids After Radiofrequency Catheter Ablation."
Journal of the American College of Cardiology, 2010;
56:1463-1472.
OCTOBER 26, 2010
Increased
PR Interval a Red Flag for developing A-Fib
In the well-known Framingham Heart
Study, people who had PR Intervals longer than 200 ms had twice
the risk of developing A-Fib (as well as three times the risk of
requiring a pacemaker and a 40% increased risk of death from all
causes).
("PR Interval" is
the time it takes for an electrical signal to spread from the
upper chambers of the heart (the atria) to the lower chambers
(the ventricles). A PR Interval of less than 200 microseconds
(ms) is considered normal. A prolonged or increased PR Interval
is known as "first-degree atrioventricular block (AVB)" when the
PR interval exceeds 200 ms.)
(Editor's Note: A prolonged PR Interval may be a sign or marker
for fibrosis, scarring, or other heart conduction problems that
may lead to A-Fib. A routine EKG would show whether you have a
prolonged PR Interval. If so, your doctor should check you
periodically to make sure you aren't developing any progressive
conduction block.)
http://www.theheart.org/article/981659.do
Cheng S. et al. "Long-term outcomes in
individuals with prolonged PR interval or first-degree
atrioventricular block."
JAMA
2009;301:2571-2577.
OCTOBER 26, 2010
Pot
May Lead To or Trigger A-Fib
This year voters in California will vote
to legalize and tax cannabis (pot) which is already approved for
medical use. Pot is widely used in the US and internationally.
In this article from
Israel where pot is the most widely used illegal drug, the
author observed that a 20-year-old male admitted to the hospital
for A-Fib had no other apparent pathological cause of his A-Fib
except "cannabis abuse." He recommends that young people
admitted to the hospital for A-Fib be tested for cannabis abuse,
and be counseled to stop cannabis drug abuse.
"Cannabis abuse is responsible for
a wide range of pathologies, including atrial and ventricular
arrhythmias, cognitive impairment, a rise in the prevalence of
lung, head, and neck tumors, and an increase in the risk of
ischemic cardiovascular events (strokes). Cannabis abuse can
induce A-Fib in predisposed patients."
(Editor's Note: Please
be advised that this is an observational study based on the
author's experience and observations, rather than a clinical
study of cannabis. Also, the term "cannabis abuse" is not
defined. How much cannabis use would be considered "abuse?"
Would any use of cannabis be considered "abuse?"
In spite of the above
reservations, this article may be an important warning,
particularly for young people. If you use pot and develop A-Fib
[whatever your age], you may need to cut your use or stop
using pot all together.
Research Question: Are
there types of pot less likely to trigger A-Fib?)
HAREFUAH. 2005 Jan; 144(1):2-3,72.
Cited in
http://www.raysahelian.com/atrialfibrillation.html
OCTOBER 26, 2010
Watchman Device
Encouraging Results
The original clinical trial for the Watchman device (PROTECT AF)
was completed in 2009. However, doctors in the trial continue to
insert the Watchman device and follow up on patients who have
received it.
In new studies and updates, procedure time to insert the
Watchman device was reduced, implant success was greater, and
the proportion of patients who discontinued warfarin at 45 days
was significantly increased. Device safety improved. Major
bleeds, pericardial effusion, and device embolization dropped
from a hazard ratio of 2.85 to 1.57. According to a study to be
published by Dr. Vivek Reddy (Mount Sinai Medical Center),
pericardial effusions for the most part occurred very early on,
and rates tend to go down with more operator experience.
Dr. Joseph Rodes-Cabau (Quebec Heart and Lung Institute) called
the results "really encouraging." He was particularly impressed
by the reduction in ischemic strokes. "Most of the ischemic
strokes in the device group occurred in the first 7 days." The
rate of ischemic stroke over follow-up was "pretty low...The
concept seems to be right---that thrombus (clot) formation in
the left atrium is mostly in the Left Atrial Appendage, and that
closing it will significantly reduce ischemic stroke."
An FDA advisory panel approved the Watchman device in a close
7-5 vote (PROTECT AF trial presented April, 2009). But the FDA
has mandated a new trial of the Watchman device dubbed PREVAIL
that will randomize 475 patients 2:1. In order to address
several of the concerns raised during the advisory panel
hearing, the trial will focus on enrolling patients with a
CHADS2 score of 2 or higher or CHADS2 1 patients with existing
heart disease. The last follow-up visit will be in September
2013, with the data to be submitted to the FDA one month later.
One problem not addressed in current US trials is whether the
Watchman device can be used in patients who can not tolerate
warfarin at all. (In the original PROTECT AF study, patients who
received the Watchman device also took warfarin for several
weeks.) There is a higher risk of thrombus (clotting) in the
first week after device implementation. A current study in
Europe gives patients six months of Clopidogrel plus aspirin
instead of warfarin. Though this study is ongoing, so far out of
64 patients there has been one serious pericardial effusion and
no strokes or transient ischemic attacks.
A surgical device for LAA occlusion, known as the AtriClip,
has been FDA approved. It is usually used during a Mini-Maze or
other heart operation rather than as a stand-alone operation. (Surgical
devices tend to be more readily approved by the FDA than
catheter devices.)
(Editor's Note: The
Watchman device is considered a low risk procedure with an even
lower risk than a typical catheter ablation, since there is no
ablation involved.
"Pericardial effusion" refers to blood leaking from the
heart into the pericardium, the sac surrounding the heart. This
may occur when the Watchman device is inserted into the Left
Atrial Appendage, and is less likely to happen with operator
experience.
"Device embolism"
refers to clots that form on or are possibly stirred up by
inserting the Watchman device. (There is a similar risk during
catheter ablations.) However. after seven days this risk is
eliminated. To prevent device embolisms, anticoagulants are
administered during and after the Watchman is inserted. In the
Editor's opinion, the payoff of a 90-95% reduction in A-Fib
strokes certainly justifies the small risk of a device embolism.
The Watchman device
not only reduces the risk of an ischemic stroke, but also the
risk of a hemorrhagic stroke by reducing or eliminating the need
to take warfarin or other anticoagulants.
Though the FDA won't
approve the Watchman device till 2013, it is still available for
most people in the US at selected sites. See
http://www.a-fib.com/Facilities.htm#DOCTORSINSTALLINGTHEWATCHMANDEVICE)
http://www.theheart.org/article/1124905.do
OCTOBER 19, 2010
FDA Approves Dabigatran!
The
FDA has approved dabigatran!
A-Fib patients now have an alternative
to warfarin (Coumadin)! See
Dabigatran to Replace Warfarin.
http://www.theheart.org/article/1138703.do
SEPTEMBER 20, 2010
FDA Advisory Panel
Unanimously Approves Dabigatran
An FDA advisory panel
unanimously recommended approval of the anticoagulant
dabigatran---an oral thrombin inhibitor (brand name Pradaxa by
Boehringer Ingelheim). The 18,000 patient RE-LY trial
(Randomized Evaluation of Long-Term Anticoagulant Therapy)
showed low dose dabigatran was as good as warfarin, while
the high dose was better at preventing stroke and systemic
embolism. It doesn't require
anticoagulant monitoring or major diet changes.
(Author's Note: Warfarin is one of the most widely used and
effective anticoagulants. But it's also one of the
most disliked. Dabigatran's recommended approval is a major
medical breakthrough and most welcome news for A-Fib
patients who will no longer have to cope with measuring INR
levels, worrying about diet, vitamin K deficiency, side effects,
etc. It's also welcome news for doctors who won't have to
wrestle with keeping patients at the right INR levels. They will
have an oral anticoagulant that is very effective, has fewer
side effects, and can be administered to a broader range of
patients.
Upon FDA
approval [almost assured] will dabigatran
(and/or
ticagrelor)
replace warfarin? Probably not right away. A-Fib patients doing
well on warfarin and maintaining their INR between 2-3, might be
advised not to switch. Dabigatran (and ticagrelor) do not use
INR to measure their anticoagulant effectiveness. This can be
somewhat disconcerting to A-Fib patients who measure their INR
and know they are being protected from an A-Fib stroke.
Doctors would risk malpractice suites if they would switch
someone from warfarin and that person had a stroke. [A small
number of people on warfarin at the proper INR levels do still
have strokes. Warfarin reduces but doesn't totally eliminate the
threat of an A-Fib stroke.] These new anticoagulants are very
effective, but they are not full proof and most likely will not
totally eliminate the threat of an A-Fib stroke.)
http://www.theheart.org/article/1123797.do
SEPTEMBER 18, 2010
FDA Advisory Panel Approves
the Blood Thinner Ticagrelor
An FDA advisory panel
recommended the approval of the antiplatelet drug ticagrelor
(brand name Brilinta by AstraZeneca). (Clinical trial
PLATO---Platelet Inhibition and Patient Outcomes.) Ticagrelor
reduced the rate of MI (heart attack), stroke, and
cardiovascular death compared with Plavix (clopidogrel).
http://www.theheart.org/article/1106859.do
September 15, 2010
Calcium Supplements
Danger
Calcium supplements
(at least 500mg/day) without vitamin D were associated with a
30% increase in heart attacks. (Vitamin D is necessary for
calcium absorption.)
This increase in heart attacks may occur because "calcium
supplements speed vascular calcification and...increase
cardiovascular events and MI (Myocardial Infarction---heart
attacks) in women." Dr. Ian Reid in an article in Bottom Line
Health adds, "Calcium from supplements, including antacids
such as Tums and Rolaids, elevates blood calcium quickly, which
may contribute to artery disease." Whereas "calcium in foods is
absorbed slowly."217
However, an article in Bottom Line Health points out
that the researchers in this study did not analyze what happens
when calcium is taken with Vitamin D. The study excluded people
who were taking vitamin D. But according to Dr. John Schindler
"Vitamin D is protective from a cardiovascular standpoint."215
The Bottom Line Health article somewhat disputes the
calcium danger findings. "The majority of existing studies have
shown no link between calcium supplements and heart attack
risk," and further suggests that eating calcium-rich foods is a
safe way for most people to boost their intake of calcium.216
(Author's Note: Calcium supplements may also trigger or make
the heart more susceptible to A-Fib attacks. See
WARNING:
DANGER OF TOO MUCH CALCIUM !.)
http://theheart.org/article/1108009.do
SEPTEMBER 3, 2010
Anticoagulant (Coumadin) can be Stopped 3-6 Months after a
Pulmonary Vein Ablation (Isolation)
In a study of 3,355
patients who had a successful PVI, some stopped taking
anticoagulants after 3-6 months, while the second group kept on
taking anticoagulants. Only two of the 3-6 month group and three
of the second group had an
ischemic
stroke. Whereas 13 (2%) of the second group had a major
hemorrhagic stroke.
(Author's Note: From this study there doesn't seem to be
a need or benefit for anticoagulation for more than 3-6 months
after a successful PVI.) "The risk/benefit ratio favored the
suspension of oral anticoagulants after successful A-Fib
ablation even in cases of patients at moderate-high risk of TE
(thromboembolic events---strokes)."
Themistoclakis S. et al. "The risk of thromboembolism and
need for oral anticoagulation after successful atrial
fibrillation ablation." J Am Coll Cardiol. 2010 Feb
23;55(8):735-43.
http://www.ncbi.nlm.nih.gov/pubmed/20170810?dopt=Abstract
SEPTEMBER 2, 2010
A-Fib Patients at Risk
of Dementia
In a study of 37,025
aging patients, 27% developed A-Fib, and 4.1% of these developed
dementia during the five year follow-up. A-Fib was significantly
associated with all types of dementia, particularly in the
younger group (under 70 years of age). And dementia combined
with A-Fib put patients at a high risk of death.
(Author's
Note: Treatment strategies to keep people in A-Fib while
controlling the heart rate (rate control meds) may lead to
dementia and early death.)
Bunch TJ, et al.
"Atrial fibrillation is independently associated with senile,
vascular, and Alzheimer's dementia." Heart Rhythm. 2010
Apr;7(4):433-7. Epub 2009 Dec 11.
http://www.ncbi.nlm.nih.gov/pubmed/20122875?dopt=Abstract
AUGUST 31, 2010
Magnesium
Importance for A-Fib
In a letter
to the editor of BMJ (British Medical Journal) Drs. Dietch,
Wilson and Thomas point out that magnesium is important in
regulating the electrical activity of the heart and can help
cases of acute A-Fib. "Treatment with magnesium may correct
rhythm disturbances in patients with both low and normal
magnesium concentrations." Magnesium is "superior to amiodarone
in treating atrial tachycardias in critically ill patients."
"It is our
impression that magnesium is underused; should we not use it
more widely?"
(Author's Note: Magnesium is a naturally occurring element that
we should be getting from the food we eat. However, almost
everyone today is magnesium deficient, due to the lack of
magnesium and other trace elements in today's over-farmed soil
(some magnesium can be obtained from fish). Because it is a
naturally occurring element, magnesium is considered safe to
take in normal doses. "Magnesium is a relatively safe drug." It
is certainly safer than amiodarone or other antiarrhythmic meds.
In
addition to cases of acute A-Fib, all A-Fib patients may want to
discuss with their doctor whether magnesium supplements might
help their A-Fib.)
http://www.bmj.com/cgi/content/full/312/7038/1101/b
BMJ Letters
"Magnesium is underused in acute atrial fibrillation."
1996;312:1101 (27 April)
AUGUST 29, 2010
Effects of a
Successful Catheter Ablation
In
an analysis of 17 different studies enrolling 869 patients, a
successful catheter ablation significantly decreased (improved)
left atrial diameter and volume,
but had no significant
difference in
ejection fraction and actual emptying fraction.
(Author's Note: It's certainly reason for hope for A-Fib
patients, that a successful A-Fib ablation will not only stop
but reverse some of the remodeling effects of A-Fib.
If before an ablation one's ejection fraction is low, one
would expect an improvement over time as the heart becomes
stronger. But for someone with a normal ejection fraction before
ablation, there may not be much of an improvement. "Ejection
Fraction" just measures what the ventricle does with the
blood it receives, not whether it receives more or less blood
from the left atrium.)
Jeevanantham, V et al. "Meta-analysis of the effect of
radiofrequency catheter ablation on left atrial size, volumes
and function in patients with atrial fibrillation." Am J
Cardiol. 2010 May 1;105(9):1317-26.
http://www.ncbi.nlm.nih.gov/pubmed/20403486?dopt+Abstract
AUGUST 29, 2010
Carotid Sinus
Stimulus or Massage by manual pressure for A-Flutter/A-Fib
Carotid Sinus Stimulation or Massage is a technique used by
doctors to partially block or slow down the flow of blood
through the carotid sinus. It is used to tell the difference
between different types of arrhythmias, and "rarely, may also
terminate the arrhythmias and reestablish sinus rhythm." It is
used in patients "in whom a rapid decrease in heart rate is
desirable."
Dr. Nayab Ali describes why carotid sinus massage may work.
"Vagal Stimulation, by altering the atrial refractory period,
may break the circus movement, atrial reentry, and atrial
response to ectopic focus, thus allowing the sinus node to take
over control."212
Nayab Ali, "Conversion of Atrial Flutter to sinus rhythm by
carotid sinus pressure." Journal of the National Medical
Association, Vol. 74, NO. 8, 1982.
WARNING: Carotid Sinus Stimulus or Massage should
be done only by doctors and not by individual patients on
themselves.
AUGUST 28, 2010
"Radioactivity in Low
Doses is Good for Us."
In 1983 180
apartment building were built in Taiwan. But somehow highly
radioactive Cobalt-60 was mixed into the concrete. The 10,000
people who lived in these apartments for 9-20 years received an
average of 74 millisieverts (mSv) of radiation a year (a typical
catheter ablation using fluoroscopy produces around 15 mSv176---non-x-ray
imaging systems much less).
But cancer rates of people living in these highly
radioactive buildings were
3.6% of
prevailing Taiwanese rates. This is a reduction in cancer
rates of 96.4%. This phenomena is perhaps explained by the
theory of hormesis which holds that intermediate levels of
radioactivity actually stimulate life and improve health.
http://www.jpands.org/vol9no1/chen.pdf
http://www.ecolo.org/documents/documents_in_english/taiwan-cobalt-60-apartmt-04.htm
New
Scientist, "Radiation thresholds." October 30, 2004
(Author's Note: The nuclear theory that any level of radiation
is cumulatively damaging may not be valid [the "Linear No
Threshold [LNT}" theory.] The levels of radiation received
during a typical catheter ablation may not be dangerous, but may
even be healthful.)
AUGUST 28, 2010
CryoBalloon Combined with
RF Ablation---the future of A-Fib treatment
CryoBalloon ablation is
safe and effective in Pulmonary Vein Isolation, but is limited
in treating persistent A-Fib (because it only isolates the
pulmonary veins and not other parts of the heart). Doctors
at Mass General used a combined CryoBalloon and RF ablation to
treat patients with persistent A-Fib.
(Added December 20, 2010:
The FDA approves the CryoBalloon Catheter.)
First a PVI was done using the CryoBalloon catheter.
It took approximately 10 minutes to isolate each vein (a
considerable savings in time compared to a typical RF ablation).
6% of patients required additional RF ablations to
completely isolate the pulmonary veins.
Then an RF catheter was used to ablate
complex fractionated electrograms (CFAEs). Finally linear
ablations were performed with the RF catheter to terminate the
persistent A-Fib.
After a single procedure 86.4% of patients were A-Fib
free without antiarrhythmic drugs (a high success rate for
persistent A-Fib after only one procedure).
(Author's Note: The above study only dealt with cases of
persistent A-Fib. But this combination of CryoBalloon {or
possibly Laser Balloon] and RF will probably become the standard
treatment for all cases of A-Fib.
Because the CryoBalloon is safe, effective, and fast, it
will probably become the normal method of isolating the
pulmonary vein openings. If A-Fib remains after the CryoBalloon
ablation, then RF can be used to ablate other areas of the heart
that produce A-Fib signals. This combination of CryoBalloon and
RF ablation is a major medical breakthrough in
the treatment of A-Fib.)
Heart Rhythm. 2010 Apr;7(4):452-8. Epub 2009 Dec 24
http://www.ncbi.nlm.nih.gov/pubmed/20188229?dopt=Abstract
AUGUST 27, 2010
Bypass Surgery and
A-Fib
It is estimated that
one out of three bypass surgery patients will suffer at least
one episode of A-Fib after surgery. 40% of these will have more
than one A-Fib attack.
Beta-blockers and ACE inhibitors, as well as potassium and
non-steroidal anti-inflammatory drugs (NSAIDS) appear to reduce
the risk of developing A-Fib after bypass surgery.
The risk factors most
associated with developing A-Fib after bypass surgery are:
- Advancing age,
- Past history of A-Fib,
- Chronic obstructive pulmonary disease,
- The discontinuation of beta-blockers and ACE
inhibitors after bypass surgery.
(It was assumed that patients were too sick after surgery to
continue to take beta-blockers or ACE inhibitors. But according
to this study, "the discontinuation of beta-blockers and ACE
inhibitors would be unwise, and their use appears to be
protective.")
(Author's Note: It wasn't clear whether this study
included antiarrhythmic drugs. The author questions whether
administering antiarrhythmic meds after bypass surgery [similar
to what is often done after an A-Fib ablation] might prevent the
development of A-Fib after bypass surgery.)
http://www.scienceblog.com/community/older/2004/3/20042692.shtml
AUGUST 26, 2010
Fibrosis in A-Fib:
Chicken or the Egg?
In a study indirectly related to A-Fib, it was found
that fibrosis leads to or is the cause of the development of
cardiomyopathy, rather than being caused by or a result of
the disease. (People with cardiomyopathy often have A-Fib as
well.) According to Dr. Carolyn Y Ho of Brigham and Women's
Hospital in Boston, MA, "...the development of fibrosis might
play a role in actually driving the development of the disease,
rather than being a reaction to the development of overt
disease."
http://www.theheart.org/article/1109291.do
(Author's Note: Since
fibrosis also occurs in A-Fib, strategies to prevent fibrosis or
to identify factors such as genetics, diet, life style,
chemical/biological markers, etc. which influence the
development of fibrosis may help prevent the future development
of A-Fib. "...targeting fibrosis...may help to forestall the
development of clinical disease."209)
AUGUST 18, 2010
Five-Box
Thorascopic (Mini-)Maze Surgery
Dr. John Sirak of the Ohio State
University has developed a type of Mini-Maze surgery for
A-Fib---the "Five-Box
Thorascopic Maze Surgery" or Total Thorascopic Maze (TTM)
which, according to his web site, has a "cure rate in excess of
95%." (Author's Note: This Mini-Maze surgery may be an
alternative to the full
Cox (Radial) Maze surgery for A-Fib.)
http://www.ohioafib.com/maze-surgery/
(Added 9/25/10: See Sirak et al. "The
Five-Box Thoracoscopic Maze Procedure" Ann Thorac Surg
2010;90:986-989.
http://ats.ctsnetjournals.org/cgi/content/full/90/3/986.
It is not explained in the study what happened to the missing
patients. 48 started, 36 made the 3-month interval, while only 4
completed the 13-month interval.)
AUGUST 9, 2010
Chicago
Cubs Pitcher Carlos Silva has Catheter Ablation
Chicago Cubs pitcher
Carlos Silva had a catheter ablation procedure to correct a
problem with his heart rate (paroxysmal supraventricular
tachycardia). Dr. Bradley Knight performed the two-hour
procedure at Northwestern Memorial Hospital. He is expected to
begin light physical activity in a week, and start a throwing
program early the next week.
Silva had the same procedure as former Cubs player Mark
DeRosa, now with the Giants. DeRosa had the heart work done
during spring training 2008 and was able to play in 149 games
that season.
http://www.washingtonexaminer.com/breaking/cubs-silva-undergoes-heart-procedure-100310124.html
August 8, 2010
40%
Recurrence/Reconnection After Mini-Maze Surgery
In a study of 50
patients who underwent
Mini-Maze surgery, 40% had recurrences of arrhythmias during
the healing process, in a follow-up study of 12 months. PV
reconnection accounted for most recurrences. Most patients'
A-Fib was terminated by catheter ablation, often combined with
antiarrhythmic and rate control meds.208
(Catheter Ablation procedures also have significant
recurrence rates.)
(Author's Note: This article may be very important to
A-Fib doctors and researchers, because it identifies specific
areas of the heart where re-growth/recurrence is likely to
occur. "The relative thickness of human myocardium,
particularly in areas with endocardial ridges, as well as the
presence of blood flow, may explain the discrepant results
between patient outcomes..."
Catheter ablation does follow the contours and ridges of
the heart. Can the catheter be programmed to produce deeper
burns in areas of greater heart thickness like endocardial
ridges? This might be a solution to a very troublesome problem
for both A-Fib doctors and patients.)
The author questions whether other energy sources like Cryo
or Laser might help both surgery and catheter ablation overcome
this problem of re-growth/re-connection after surgery and
ablation for A-Fib.)
JUNE 18, 2010
FDA Approves AtriClip
to Close Off Left Atrial Appendage
The AtriClip LAA Exclusion System
with Preloaded Gillinov-Cosgrove Clip is made by AtriCure, Inc.
(West Chester, OH). The surgeon positions the rectangular-shaped
device around the LAA. The frame assembly of the device consists
of two springs connecting two opposing tubes which are covered
with pressure pads. The springs close the device like a clamp,
leaving behind a Woven Dacon Fabric which eventually becomes
part of the heart. Blood no longer flows into and out of the
Left Atrial Appendage.
The FDA approved the AtriClip on the basis of one trial with
70 patients. It was determined to be "substantially equivalent"
to other devices such as staplers and sutures already FDA
approved.291,292
MAY 22, 2010
Vernakalant
Successful in Stopping A-Fib
For A-Fib patients with underlying heart disease, the
intravenous med Vernakalant converted 51.7% of A-Fib patients to
sinus rhythm after only around 11 minutes. It was shown to be
safe, well tolerated, and associated with greater improvements
in quality of life (the AVRO trial). An FDA advisory panel voted
in favor of vernakalant, but the FDA still has not approved it
in the US.183
http://www.theheart.org/article/1079027.do
(Vernakalant is a medical breakthrough for A-Fib patients
with structural heart disease who cannot use other
antiarrhythmic drugs, if the FDA approves it.)
MAY 21, 2010
Ablation of A-Fib Reduces Risk of Alzheimer's and Dementia
In a large population study (37,908) at the Intermountain
Medical Center in Utah, some patients with A-Fib received
catheter ablation treatment, while others received drug therapy.
After three years of follow-up, the rate of Alzheimer's disease
and all forms of dementia was significantly lower among patients
who underwent catheter ablation. According to Dr. John Day, "In
fact, the rates we saw were similar to those that you'd see in
patients who never had A-Fib to begin with." Catheter ablation
also reduced the risk of mortality and stroke at three years.182*
(Catheter ablation may reduce Alzheimer's and dementia:
1. By improving and/or normalizing blood flow to the brain.
2. By reducing inflammation. There may also be an
inflammatory connection, "with both A-Fib and Alzheimer's
disease associated with high levels of C-reactive protein."
3. By reducing and eliminating
TIAs and
subclinical strokes caused by A-Fib. These mini-strokes produce
amyloid plaque found in Alzheimer's disease patients.)
Catheter ablation reduces the risk of mortality and stroke,
and reduces the risk of Alzheimer's and dementia. Then why leave
A-Fib patients on medications? As Dr. Day suggested, "...if
you have A-Fib and medication isn't working, maybe we should
move toward a potentially curative procedure earlier, rather
than spinning our wheels for years with medication."181
http://www.theheart.org/article/1079365.do
*The title of reference
182
is confusing. I have written the author for a clarification.
MAY 17, 2010
High Dose Steroids May
Cause A-Fib
In a case-control
study in the Netherlands involving 7,983 men and women,
high-dose corticosteroid use significantly increased the risk of
developing A-Fib. (Corticosteroids include meds such as
prednisone, cortisone, hydrocortisone, budesonide,
betamethasone, dexamethasone, Advair. High-dose refers to a
daily dose greater than 7.5 mg of prednisone equivalents.)
But it's dangerous to
suddenly stop taking steroids. Sudden withdrawal can lead to
serious side effects and, in some cases, be life threatening.180
http://www.theheart.org/article/696423.do
May 15, 2010
Dr. Andrea Natale Joins
Scripps
Dr. Andrea Natale has
been named the Director of Interventional Electrophysiology at
Scripps Clinic in La Jolla, CA (April 5, 2010). Here is his
address info:
Scripps Clinic
10666 N. Torrey Pines Rd SW 206
La Jolla, CA 92037
(858) 554-5049
Dr. Andrea Natale, Director of Interventional
Electrophysiology
Dr. Douglas N. Gibson (858) 554-8730
Dr. Natale is also available to help A-Fib patients in other
areas of the US: see
---Austin, Texas Dr. Natale is the Executive Director of the
Texas Cardiac Arrhythmia Institute
---Akron, Ohio
Akron General Medical Center
---Cleveland, Ohio
MetroHealth Medical Center
---San Francisco, CA
Northern California Heart Center
APRIL 15, 2010
Women with A-Fib Have
Higher Risk of Stroke
Women
with A-Fib had a higher stroke risk, more stroke-related
disability, and were less often prescribed blood thinners,
according to researchers analyzing past A-Fib studies comparing
how A-Fib affects men and women. Doctors may be more reluctant
to prescribe warfarin (Coumadin) to women, because some evidence
shows that women have a significantly higher risk of bleeding
from blood-thinning medication.177
(If you are a women with A-Fib, make sure you consult
with your doctor about the risk-benefit of taking blood
thinners. An A-Fib stroke is often a fate worse than death. See
Anticoagulants.)
december 22, 2009
Catheter Ablation
Survey Good Results
The latest worldwide survey of A-Fib ablations includes data
on 20,825 catheter ablation procedures performed on 16,309
patients over a four-year period from 2003 to 2006 (some
patients had more than one ablation). This is almost twice
the number of patients treated compared to the first survey from
1995 to 2002.
The success rate was 70% (A-Fib symptom-free without
having to take antiarrhythmic drugs), which was a major
improvement over the 52% reported in the first survey.
The "overall success rate"---defined as freedom from A-Fib with
or without the use of antiarrhythmic drugs---was similar in both
surveys, at 80%.
More patients with persistent and long-lasting A-Fib were
treated than in the previous survey. Of the 1,108 patients with
long-standing A-Fib, the success rate was 63.1%, while the
overall success rate was 72.3%.
The overall complication rate was 4.5%, down slightly from
the previous survey. But Transient Ischemic Attacks were cut in
half, and Pulmonary Vein Stenosis was reduced by two thirds.
(Pulmonary Vein Ablation is a relatively new procedure. More
experience, improved techniques and equipment, and the sharing
of knowledge have definitely improved the outlook for A-Fib
patients.)
There were 25 procedure-related deaths and 37 strokes,
similar to the previous survey. Atypical Atrial Flutter doubled.
Atrioesophageal Fistula, not reported previously, occurred in
0.04% of patients, of whom 71% died. (The author is not sure
about these figures. 0.04% of 16,309 is only around 7 patients.)
(Atrioesophageal Fistula is less of a problem today. Most
centers now take precautions to prevent Atrioesophageal
Fistula.)
http://www.theheart.org/article/1035905.do
Author's Conclusions
Limitations
of the survey
85
electrophysiology centers in North America, Europe, Asia, and
Australia provided data for this survey. But in the US alone
there are currently around 200 centers performing A-Fib
ablations. The 85 centers providing data may be the most
experienced, larger centers. Are the newer, smaller centers
achieving similar success and complication rates? We simply
don't know. (From the author's limited experience, the newer,
smaller practices seem to be achieving similar success and
complication rates, at least in the US.)
Insufficient
doctors and medical centers for A-Fib
Though
16,000+ patients seems like a huge number, it's very small
compared to the number of people developing A-Fib. Though there
has been a tremendous growth in medical centers and doctors
doing A-Fib ablations, they can not possibly handle all the
cases of A-Fib which some are calling an epidemic.114
Nearly three million people in the U.S. have A-Fib. By the year
2050, the number will be 5.6 million.71
In the US people over 40 have a one in four chance of developing
A-Fib.82
A-Fib needs to become a national and worldwide health issue.
Remarkable progress in a short time
A-Fib patients should be encouraged by the remarkable
progress doctors have made in A-Fib catheter ablation within a
relatively short period of time. The first Pulmonary Vein
Ablation was done a little more than a decade ago. A worldwide
improvement from 52% to 70% success rate is a notable
achievement and a testament to the hard work of A-Fib doctors
everywhere.)
december 19, 2009
Warfarin
to be Taken for Two Months after a PVA(I), but Aspirin
Option for Low Risk Patients
Following a Pulmonary Vein Ablation procedure, patients
should be given warfarin for at least 2 months regardless of
their stroke risk factors (HRS/EHRA/ECAS AF Ablation Consensus
Statement).125
But a recent study found that "low-risk patients with a low
CHADS2 (0-1)
score... can safely be discharged on aspirin alone."171
(Thanks to William Pfeifer for calling our attention to this
research.)
(Author's Note: For safety's sake [and to avoid legal
liability problems], your doctor will probably still want you to
be on warfarin after an ablation.)
december 7, 2009
Fibrosis Measured by MRI
Recent research indicates that A-Fib
Fibrosis
can be measured by an MRI.169,
170
november
23, 2009
Medifocus Free Abstracts of Latest A-Fib Journal Articles
Medifocus provides a listing of the latest medical journal
articles published in MEDLINE, with direct links to the specific
article summaries (abstracts). To subscribe to the free
Medifocus Digest Alert on Atrial Fibrillation, click on this
link:
http://www.medifocus.com/zcr004.php?assoc=afib
NOVEMBER 19, 2009
Dabigatran to Replace
Warfarin (Coumadin)
The above title is presumptuous, because the FDA hasn't yet
approved the oral anticoagulant dabigatran. But the recent
RE-LY trial comparing dabigatran
etexilate (by Boehringer Ingelheim) to warfarin at 951 centers
in 44 countries with 18,113 A-Fib patients produced results that
are hard to ignore. Low dose dabigatran was as good as warfarin,
while the high dose was better at preventing stroke and systemic
embolism.
To paraphrase the lead investigator Dr. Wallentin,
dabigatran does not need frequent blood-test monitoring for INR
levels, isn't affected by possible food-drug or drug-drug
interactions, can be used in many more patients than warfarin,
has few side effects, and is more effective and safer than
warfarin.
(The author predicts that dabigatran will be approved by
the FDA and will quickly replace warfarin as a treatment to
prevent A-Fib stroke. [It is already approved in the European
Union and Canada.]} This is a major medical breakthrough
and most welcome news for A-Fib patients who will no longer have
to cope with measuring INR levels, worrying about diet, vitamin
K deficiency, side effects, etc. It's also welcome news for
doctors who won't have to wrestle with keeping patients at the
right INR levels. They will have an oral anticoagulant that is
very effective, has fewer side effects, and can be administered
to a broader range of patients.
http://www.theheart.org/article/1024935.do
(Thanks to Ira David Levin for calling our attention to this
article.)
NOVEMBER 17, 2009
Rhythm
(Antiarrhythmic) Meds Better Than Rate Control
In a study of 5604
patients with A-Fib who were treated with either antiarrhythmic
or rate control meds, "81% of patients treated with rhythm
control, compared with 33% of patients in the rate-control arm
were in sinus rhythm, after one year... 13% progressed to
permanent A-Fib in the rhythm-control arm, whereas 54% in the
rate-control arm had permanent A-Fib after one year." This
finding disagrees with the AFFIRM trial which indicated there
was no advantage of rhythm control vs. rate control for the
prevention of cardiovascular events.
Author's Note: Though the study found no significant
difference in clinical outcomes, from this patient's perspective
it's certainly better to have a normally beating heart than to
be in A-Fib---from a clinical as well as from a quality of life
aspect. If the study were longer than one year, one would expect
to see more heart problems develop in those still in A-Fib. And
why isn't progressing to permanent A-Fib not considered a
clinical outcome? Anyone who suffers from A-Fib dreads and fears
going into permanent A-Fib.
A disturbing point mentioned in passing in this study is the
high percentage of patients (54%) in the rate-control arm who
progressed to permanent A-Fib within one year! This should be a
wake-up call to all A-Fib patients. If you don't aggressively
try to stop your A-Fib (as with antiarrhythmic meds or a
Pulmonary Vein Ablation. etc.), you can expect your A-Fib to
become permanent within one year (54% chance).
This RECORD AF Registry data was presented at the
American Heart Association 2009 Scientific Sessions by Dr. John
Camm.
http://www.theheart.org/article/1023939.do (Thanks to Ira
David Levin for calling our attention to this article.)
OCTOBER 1, 2009
Dr. Wharton
Audio Presentation on A-Fib Ablation
Dr.
j.
Marcus Wharton of the
Medical Un. of South Carolina has a very informative 18 minute
audio presentation on A-Fib Ablation
http://www.muschealth.com/multimedia/Podcasts/displayPod.aspx?podid=252&autostart=true
August
14, 2009
A-Fib Support Volunteers
Started
We are
very excited about starting a new way of helping people with
A-Fib. Many people who've had A-Fib have generously committed to
serve as
A-Fib Support Volunteers, to help people cope with and be
cured of A-Fib. They've listed their Email addresses and are
there for anyone who needs advice, emotional support, and hope
in getting through the A-Fib ordeal.
JULY 30, 2009
Dronedarone (brand
name Multaq) Now Available in Pharmacies
Dronedarone (brand name Multaq) is now available in
pharmacies in the U.S.
http://www.reuters.com/article/rbssHealthcareNews/idUSLS59493520090728
JULY 2, 2009
Dronedarone (Multaq)
Approved by FDA
Dronedarone (brand name
Multaq by Sanofi-Aventis) was approved by the FDA. This is a
major medical breakthrough for many A-Fib patients. See
Dronedarone.
http://www.theheart.org/article/983519.do.
But there is a caveat.
"Dronedarone is not indicated in patients with severe heart
failure or those with NYHA (New York Heart Association) class 2
or 3 heart failure with a recent decompensation requiring
hospitalization." (Class 2 refers to patients with slight, mild
limitation of activity, class 3 refers to patients with marked
limitation of activity. "Decompensation" refers to rapid
accumulation of fluid in the lungs due to heart problems.) "The
ANDROMEDA trial showed that dronedarone increased the risk of
mortality twofold among those treated by the drug." This is a
major difference from amiodarone which dronedarone is similar to
but with less toxic effects.
Amiodarone is considered safer for patients with structural
heart disease, while dronedarone is not indicated
for patients with severe heart failure.
June 20,
2009
RF & CryoBalloon Produce Parallel Double Vein Lesions to Reduce
Recurrence
Dr. Richard Schilling of the London AF Center is doing
preliminary research to help eliminate regrowth/reconnection of
ablated areas in a Pulmonary Vein Ablation and the recurrence of
A-Fib after ablation.
He uses both RF (Radio Frequency burns) and Cryo (Freezing)
ablation. He first performs a wide encirclement RF ablation
of the left atrium pulmonary vein ostia. Then he supplements
this with
Cryo balloon ablation, which tends to freeze the veins a
little bit closer to the origins of the veins. In effect he
produces two parallel lines of electrical block, which reduces
the chances of recovery of electrical connection between the
pulmonary veins and the left atrium.
This reduces the recurrence of A-Fib after ablation.
Though this procedure
has only been performed in 15 patients with reasonable
follow-up, he has seen a dramatic improvement in the first time
success rate for ablation of paroxysmal A-Fib. This technique is
now being tested in a randomized control trial to see if the
additional cost of using two technologies (RF and Cryo) is
justified by a significant improvement in first time success
rates.
(Editor's Note: Dr. Shilling's innovative technique of using
both RF and Cryo balloon may be a major medical
breakthrough for A-Fib patients. Eliminating
regrowth/reconnection and the recurrence of A-Fib after ablation
may significantly reduce the need for a second ablation and
improve the success rate of
Pulmonary Vein Ablations.)
JUNE 9, 2009
A-Fib
Patients at Greater Risk of Developing Alzheimer's
Researchers have made a
medical breakthrough connection showing a strong
relationship between A-Fib and the development of Alzheimer's.
This finding was presented at the May 15, 2009 Heart Rhythm
Society Scientific Sessions.
In the Intermountain Heart Collaborative Study in Murray, UT
37,025 people were followed for five years:
1. Patients with A-Fib were 44 percent more likely to
develop dementia than others.
2. Younger patients with A-Fib were at a higher risk of
developing all types of dementia, particularly Alzheimer's.
A-Fib patients under age 70 were 130% more likely to develop
Alzheimer's.
3. Patients who had both A-Fib and dementia were 61
percent more likely to die during the study than dementia
patients without A-Fib.
4. Younger A-Fib patients with dementia may be at higher
risk of death than older A-Fib patients with dementia.
Alzheimer's is the most common form of dementia (a general
term for life-altering loss of memory and other cognitive
abilities), and accounts for 60-80 percent of all dementia cases
today. Today Alzheimer's is the sixth leading cause of death in
the US.
"Previous studies have shown that patients with A-Fib are at
higher risk for some types of dementia, including vascular
dementia. But to our knowledge, this is the first
large-population study to clearly show that having A-Fib puts
patients at greater risk for developing Alzheimer's," according
to Dr. T. Jared Bunch, the study's lead researcher.154
(Editor's Note: The study only states there is a strong
connection or relationship between A-Fib and Alzheimer's,
because there may be other factors influencing both the
development of A-Fib and Alzheimer's. But as A-Fib patients we
have to assume until proven otherwise, that
A-Fib causes or leads to Alzheimer's and dementia.
This conclusion makes intuitive sense. In A-Fib, blood is not
being pumped properly to the brain and other organs.
Another conclusion to be drawn from this study is: therapies
which leave patients in A-Fib while controlling the ventricular
rate should be avoided (rate control meds like Metoprolol or
Digoxin), because they may lead to Alzheimer's and dementia.)
May 22, 2009
Dr. Reddy to Mount Sinai
Dr. Vivek Y. Reddy will join the Mount Sinai Medical Center July
1, 2009. He previously was affiliated with the Un. of Miami,
Miller School of Medicine.151
Dr. Andre d'Avila and Dr. Srinivas R. Dukkipati will also
transfer to Mount Sinai in December. (Thanks to contributor Ray
for this info.)
Their address will be:
Cardiac Electrophysiology Laboratories
1468 Madison Av. @ 100th. St.
New York, NY 10029
(212) 241-7911
MAY 11, 2009
Coffee and Caffeine May Not Trigger A-Fib and May Be
Antiarrhythmic
Some research
suggests that coffee and caffeine in moderate to heavy doses may
be antiarrhythmic and may reduce propensity and inducibility of
A-Fib both in normal hearts and in those with focal forms of
A-Fib.143
MAY 8, 2009
Predicting A-Fib Using
ECGs (EKGs)
(For
people with occasional or silent A-Fib, it is sometimes
difficult to get an
ECG or documentation of the A-Fib. By the time one gets to
the Doctor's office or the ER, the A-Fib attack has stopped. It
may now be possible to predict A-Fib simply by examining an ECG
of the heart in sinus rhythm. Doctors can predict A-Fib by
looking at the P wave which is formed when the atria contract.
See EKG Signal.)
The measures used to predict A-Fib are: "P-wave terminal
force, P-wave duration, P-wave area, and PR duration."139
For example, a P-wave duration of greater than 140 milliseconds
is predictive of A-Fib.138
The study found that African Americans "seem to have
more of these ECG predictors than whites, which might
explain why they are at higher risk of ischemic stroke than
whites, despite apparently having a lower prevalence of A-Fib."
They may have intermittent or silent A-Fib which is not
always detected.139
(Editor's Notes: The authors of the above study did not
draw the following conclusions.
Why not use the above A-Fib predictors to develop a
nation-wide program to screen for A-Fib? For example, anyone
over 50 could be screened by a Cardiologist looking at the
patient's ECG. Anyone with A-Fib predictors, even though in
sinus rhythm, could be given a Holter or other monitoring system
to document if the patient has A-Fib. The A-Fib, even though it
may be asymptomatic ("silent"), could then be treated. This
would save many people from an A-Fib stroke or deteriorating
heart health due to progressive A-Fib.)
MAY 5, 2009
FDA Advisory
Panel Approves Watchman Device
An FDA advisory panel on April 24, 2009 approved the Watchman
device (Atritech, Plymouth, MN) with conditions: centers
implanting the device must have surgical backup, and a physician
certification program must be created. The panel also
recommended the creation of a registry, and extended follow-up
of current trials. The FDA usually follows its advisory panel's
recommendations.
Though the vote was split 7-5, "most panel members felt the
sponsor showed the device to be effective." Some panel members
were uncomfortable with the size of the 800-patient study, the
duration of follow-up (two or three years) and the long-term
safety of the device. Some felt a decision on effectiveness was
difficult when there were so few strokes in either arm. (Six
patients in the control Warfarin arm had a hemorrhagic stroke,
four of whom died. No one died who received the Watchman
device.)
The PROTECT-AF study on which the FDA advisory panel based
its approval was a prospective randomized trial comparing
closure of the Left Atrial Appendage by the
Watchman occluder with long-term warfarin therapy (90% of
strokes come from the Left Atrial Appendage). This was a
"noninferiority" study---"the Watchman device was associated
with a reduction in hemorrhagic stroke risk vs. warfarin, and
all-cause stroke and all-cause mortality outcomes were
noninferior to warfarin."
Of the patients
receiving the Watchman device, 87% were able to stop taking
warfarin after day 45. By 12 months, 93% were off warfarin
permanently.
There were problems such as pericardial effusion in the
first implantings of the Watchman device. But these decreased
with experience and improved devices, training, and procedural
modifications. According to Dr. David R. Holmes, Jr., current
effusion rates are now around 1% and "are going to be much more
what we will see as the device rolls out." Dr. Gary Abrams
added, "I think that once the early morbidity from this gets
worked out as people get experience with it, I think it offers
an option for people who need to stay on warfarin for many, many
years."
http://www.theheart.org/article/962955/print.do and
http://www.theheart.org/article/951777.do
Editors
Comments: This
advisory panel's approval of the Watchman device is a
major medical breakthrough
for A-Fib patients.
It is estimated that only 50% of patients who need
anticoagulation protection are receiving warfarin, because it's
so hard to get the right dosage or because people can't tolerate
it. But most A-Fib patients can receive the Watchman device. Dr.
Holmes speculated that the Watchman device might be an option
for up to 70% of patients with nonvalvular A-Fib.
Most of the panel were of the opinion that warfarin can have
"devastating" effects over time. Dr. Jeffrey Brinker said, "the
risk of Coumadin is high, especially in an older population who
fall or who are more fragile," and who are more at risk of a
hemorrhagic stroke. The Watchman device is a most welcome
alternative to warfarin/Coumadin and other blood thinners.
Practical Consequences of the FDA Advisory Panel's Approval:
Coumadin reduces but does not totally eliminate the risk of
stroke. Even with the proper INR levels of Coumadin, a small
number of people with A-Fib have had strokes. The Watchman
device also reduces but does not totally eliminate the risk of
stroke. Like Coumadin, the Watchman is not an absolute guarantee
one will never have a stroke. It basically reduces the risk of
stroke similar to that of a person with a normal heart.
Those of us who hate having to take Coumadin or other blood
thinners will be able to go in for a low risk procedure that
takes as little as 20 minutes, and never have to take Coumadin
again! This is incredibly good news for many of us.
Even while we are waiting for or trying to decide on having
a Pulmonary Vein Ablation, we can have the Watchman inserted and
then not have to worry about an A-Fib stroke.
The Watchman device may become part of most catheter
ablation procedures. If the catheter ablation procedure were
unsuccessful or in case of silent A-Fib attacks after ablation,
we patients would still be protected from an A-Fib stroke by the
closing off of the Left Atrial Appendage.
march 28, 2009
Digoxin May Harm A-Fib
Patients
The AFIB REPORT
by Hans Larson
has the following caution about digoxin. "Recent research has
clearly shown that digoxin should not be used
on a continuous basis in patients with paroxysmal lone A-Fib,
since it is likely to worsen their condition and result in it
eventually becoming permanent." No References Cited)
And, "Digoxin poisoning is a leading cause of hospital
admissions with anywhere between 10 and 30% of patients on the
drug being hospitalized for digoxin intoxication."(No
References Cited)131
March 21, 2009
Dronedarone
Approved by FDA Advisory Committee
Dronedarone
(brand name Multaq) was recommended for approval by an FDA
advisory committee (March 18, 2009). It isn't guaranteed that
the FDA will approve dronedarone, but it usually doesn't
disagree with its committee's recommendations.
(This is a major medical breakthrough for A-Fib-ers,
especially for older patients, for those who can't have a
Pulmonary Vein Ablation or a Mini-Maze surgery, or for those who
have failed these procedures/surgeries. Dronedarone may allow
many of these A-Fib-ers to lead a relatively A-Fib free life.
Dronedarone is similar to amiodarone which is considered the
most effective anti-arrhythmic drug, but without its toxic side
effects. In the ATHENA clinical trial, Multaq (by
Sanofi-aventis) was the only anti-arrhythmic drug "to have shown
a significant reduction in morbidity and mortality in patients
with A-Fib/A-Flutter..." )
http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/03-18-2009/0004991096&EDATE
March 4, 2009
WorldOne research
is an independent market research organization based in London.
We would like to invite patients with ATRIAL FIBRILLATION
for a 15-20minutes research study. This can be completed
via telephone or online.
The Study aims at gaining an understanding of the following
areas:
-
Satisfaction with the treatment for Atrial Fibrillation.
-
Sources
patients utilise in finding information on Atrial
Fibrillation related topics.
- Their
experiences with their condition.
In appreciation of a patient’s time and contribution we
would like to offer a honorarium of $25 on completion of
the study.
We
would like to remind you that the results of the study are
for analytical purposes only and patients confidentiality
will be strictly maintained. Our research is treated in
accordance with Esomar and MRS Code of Conduct.
Should you require further
clarification, please contact me or my colleague Dino
Lista at World One Research on: +44 (0) 207 252 1118 (ext:
1140), or drop me an email to:
anthony.menkiti@w1-research.com.
February 16,
2009
A-Fib.com
Receives HONcode Certification
A-Fib.com complies with the
HONcode
standard of trustworthy health information on the internet.
(The
Health on the Net Foundation in Switzerland tries to guide lay
users and medical professionals to reliable sources of
health-care information online. This HONcode accreditation
indicates that A-Fib.com has been deemed a reliable source of
health information and meets standards, including those related
to the qualification of the authorities cited, privacy of
personal data submitted by a visitor to A-Fib.com, and financial
disclosure of funding sources. It does not guarantee that all
the health information on A-Fib.com is infallible.)
February 15, 2009
Ablation Frontiers' Multi Electrode Catheters Positive
Preliminary Tests
Preliminary tests results of
Ablation Frontiers' multi electrode catheters is very
positive, with an 83% success rate for Paroxysmal A-Fib
patients. See
http://download.journals.elsevierhealth.com/pdfs/journals/1547-5271/PIIS1547527108008679.pdf
February 14, 2009
Insertable Cardiac Monitor by Medtronic Detects A-Fib Signals
Medtronic
has developed an insertable
cardiac monitor to detect A-Fib signals. The Reveal XT is
placed just under the skin of the chest in a short outpatient
procedure. It captures an electrogram (ECG) during an actual
A-Fib episode. To store the ECG the patient places a hand-held,
pager-sized assistant over the Reveal XT and presses a button.
Later, a physician analyzes the stored information, transmitted
via the Medtronic CareLink Network or during an in-office
patient visit. For further info, go to
http://www.medtronic.com.
February 10, 2009
FDA Approves
First Ablation Catheter for A-Fib
The FDA approved the
first ablation catheters for the treatment of A-Fib. The two
radiofrequency catheters, the NaviStar ThermoCool and EZ Steer
ThermoCool Nav
(BioSense Webster), were approved February 6, 2009.
http://www.theheart.org/article/939929.dohttp://www.theheart.org/
article/939929.do See also:
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01953.html
November 25, 2008
FDA Advisory Panel Unanimously Approves First A-Fib Ablation
Catheter
An FDA
panel unanimously recommended approval of an A-Fib Ablation
Catheter, the first to be so recommended. (Up to this point
doctors had been using ablation catheters
off-label.)
http://www.theheart.org/viewArticle.do?primary Key=923617
(As a consequence of this FDA panel decision, Pulmonary
Vein Ablation (Isolation) procedures have officially entered
mainstream medicine and can no longer be considered
"experimental.")
August 11, 2008
Death of Dr. Carolyn Kimme-Smith
A-Fib-ers in Southern California were sadden to learn of the
death of Dr. Carolyn Kimme-Smith who hosted and supported the
local A-Fib support Group in her Newport Beach home.
Dr. Kimme-Smith was a breast cancer survivor who tirelessly
devoted her time and energy to many issues, primarily focused on
early detection of breast cancer. She had a distinguished career
as a full Professor at UCLA's School of Medicine, Dept. of
Radiological Sciences.
Her husband Hal and her three children hosted a memorial
celebration of her life August 9 which filled their home. We all
learned a great deal about this wonderful woman who touched so
many lives.
August 4,
2008
Osteoporosis Drug Alendronate (Fosamax) Linked to A-Fib
The osteoporosis drug alendronate (brand name Fosamax) is linked
to A-Fib. Women who have used alendronate at any time in their
lives have an 86% greater risk of developing A-Fib than women
who have not used the drug.128
July 17, 2008
Nebivolol
(Bystolic) New Beta Blocker Approved by FDA
The FDA recently approved the new beta blocker drug
nebivolol (brand name Bystolic by
Forest/Mylan, a selective beta-1-blocker).126This
is a minor medical breakthrough for A-Fib-ers taking
traditional beta blockers like atenolol or metoprolol who may
feel tired or fatigued due to slower blood flow. (Traditional
beta blockers reduce the effect of excitement and physical
exercise on heart rate and force of heart contraction.)
Nebivolol is an effective beta blocker that also produces
vasodilation (an expansion of the blood vessels) and reduces
peripheral resistance by increasing nitric-oxide release.
Instead of slowing blood flow, nebivolol maintains blood flow
and lowers vascular resistance.
Nebivolol is similar to the newer beta blocker
carvedilol (Coreg), though they act
differently. (Carvedilol is a non-cardioselective beta 1, beta 2
and alpha-receptor blocker, whereas nebivolol is highly
cardioselective [blocking beta 1 receptors only] and produces
vasodilation by nitric-oxide release.)
June 30, 2008
Procanbid No Longer Available
The anitarrhythmic drug
Procanbid will no
longer be available for A-Fib patients. There doesn't seem
to be any generic substitute. King Pharmaceuticals, Inc. which
makes Procanbid issued this statement about its decision. It was
"based upon many factors, including our understanding of current
medical therapy and the general availability of alternative
antiarrhythmics."
June 28, 2008
CryoBalloon Ablation
Safer Than RF
"Cryoablation (with the
CryoCath Arctic Front cryoballoon): Safer than RF..." Dr.
Burghard Schumacher of Germany described a study involving 346
patients with Paroxysmal (293) or Persistent (53) A-Fib.
Following one Cryoballoon ablation, 74% of Paroxysmal patients
were free of A-Fib and in permanent sinus rhythm. But this
figure was much lower for those with persistent A-Fib---just
38%. There were no strokes, no pulmonary vein stenosis, no
esophageal injury, and no coronary artery injury as sometimes
occurs with RF ablation (RF ablations typically have a major
complication rate of around 4%). The main complication reported
was a temporary palsy of the phrenic nerve.
According to Dr. Philippe Ritter, president of Cardiostim,
"Cryoablation (with the Cryoballoon catheter) appears to have a
lower complication rate than RF ablation and is easier to
perform...but we need some more years to look at it and compare
it with RF ablation." (See:
http://www.theheart.org/article/877315.do)
(Editor's Comments: A 74% cure rate for the CryoCath
balloon catheter is similar to current cure rates for RF
ablations for Paroxysmal A-Fib. The low 38% cure rate for
Persistent A-Fib might be due to only having one ablation. Most
RF ablation procedures for Persistent A-Fib now require two or
more ablations. [See:
95% Success Rate in Curing Persistent A-Fib.] Also, in this
study only the Pulmonary Vein openings were treated with the
CryoCath balloon catheter. They did not attempt any other lines
or lesions as is commonly done with current RF ablations for
Persistent A-Fib. Persistent A-Fib is more complex and difficult
to cure. As doctors get more experienced with Cryo, they may
well be able to achieve similar success rates as RF for
Persistent A-Fib.
In the future we may see centers first use Cryoballoon
catheters to isolate the Pulmonary Veins because it is safer,
easier, and uses less fluoroscopic exposure; and secondly use RF
or non-balloon Cryo catheters for linear lesions and to target
other areas of the heart in more complex cases of Persistent
A-Fib. Cryo will probably also be used to ablate near the
esophagus to prevent Atrial-Esophageal Fistula [see
Morady: Boston A-Fib Symposium 2008].
Cryoballoon catheter ablation may also be the answer to the
problem of re-do's. [See
Dr. Marchlinski's presentation on Ablation re-do's.] All too
often RF ablation patients have to return for a second ablation,
because of re-growth and reconduction of the RF ablated areas,
and because PV isolation with RF is difficult to achieve in a
uniform fashion, even with experienced operators.
Circumferential ablation with small-tipped catheters often
results in gaps in the lesions lines and uneven scar formation.
The Cryo balloon catheter ablation may solve the problem of
re-do's, because of its ability to easily and quickly produce
uniform pulmonary vein isolation. [See:
Dr. Kerwin's explanation of Cryo Ablation.])
June 27, 2008
Dronedarone Safe
in ATHENA Clinical Trials
"Dronedarone
safety, efficacy standings bolstered in huge A-Fib trial."
Dronedarone (brand name Multaq by Sanofi-Aventis) is a drug in
clinical trials to replace amiodarone which often has serious
toxic side effects. Both drugs have similar molecular structures
and seem to work in a similar way. But dronedarone (a benzofuran
analog of amiodarone) doesn't have the iodine component that is
largely responsible for amiodarone' s toxic effects on the
lungs, thyroid, eyes and other organs.
In the randomized ATHENA trial over 4,500 A-Fib
patients in 37 countries took either dronedarone or a placebo in
"the largest antiarrhythmic drug trial ever conducted." Patients
who took dronedarone experienced a 24% drop in risk of
Cardiovascular (CV) hospitalizations or death over almost two
years. Unlike other antiarrhythmic drugs, dronedarone seems to
carry a low risk of adverse events. Secondary clinical end
points also improved, such as less hospital admissions for A-Fib
and acute coronary syndromes. According to Dr. Bramah N. Singh
of UCLA, "...in terms of safety, it (dronedarone) is the best
drug we have for atrial fibrillation." See
http://www.theheart.org/article/867591.do.
The trial did not compare the efficacy of dronedarone to
amiodarone, which is the subject of another ongoing randomized
clinical trial called DIONYSUS.
June 16, 2008
A new advancement in mapping techniques may significantly
improve ablation treatments. A specialized
multielectrode
mapping catheter with a 20-pole penta-array produces rapid,
high-density atrial mapping. The whole atrium can be mapped in
less than 8 minutes. It is used with an Ensite NavX mapping
system. See:
http://circep.ahajournals.org/cgi/content/abstract/1/1/14
(Thanks to Dick Inglis for calling our attention to this
article.)
June 8, 2008
Preliminary results very positive for
Chronic A-Fib Clinical Trials. See:
http://ablationfrontiers.com/webdocuments/
poster-heart-rhythm-society-2008.pdf
April 9, 2008
(Good news for A-Fib patients with Chronic [constant] A-Fib.)
Multi Electrode Catheter for Chronic A-Fib Clinical Trials Begin
The first clinical trials focusing on
ablation of
Chronic A-Fib have begun in the US. The study, known as the
Tailored Treatment of Permanent Atrial Fibrillation (TTOP
AF) is sponsored by Ablation Frontiers (http://www.AblationFrontiers.com).
It uses three innovative catheters with multiple electrodes to
produce a variety of different ablations depending on the needs
of the patient. Preliminary data show an 80% success rate after
two ablations with relatively short ablation times. The purpose
of this study is to make effective ablation for Chronic A-Fib
available and feasible to all EPs in all clinics. 25 centers
will be participating in these Chronic A-Fib trials. For a more
detailed, technical description of this study, go to
http://www.ablationfrontiers.com/webdocuments/acc-poster-march-20-2008.pdf.
Patients will be randomly selected into two treatment
groups: for every three patients who apply, two will receive
ablation therapy, the third drug treatments. The trial allows
patients in the control (drug treatment) arm to receive an
ablation if they do not respond to drug therapy (a likely
occurrence).
(This may be a major medical breakthrough
for patients with Chronic A-Fib. In the past, medical centers
were often reluctant to ablate patients with Chronic A-Fib,
because they were more difficult to cure. Some centers, for
example, had rules excluding patients who had Chronic A-Fib for
more than one year. But with the progress of these Chronic A-Fib
clinical trials, most centers will be able to ablate Chronic
A-Fib patients with a success rate similar to Paroxysmal
(occasional) A-Fib patients.)
If you wish to participate in this Chronic A-Fib clinical
trial, a full listing of Medical Centers, Locations, Doctors,
and Contact Information is available at
TTOPAFTrialsContacts.
December 20,
2007
Vice-President Dick Cheney Successfully Electrical Cardioverted
from A-Fib
Vice-President Dick Cheney was diagnosed with A-Fib and
successfully
Electrical Cardioverted back to normal sinus rhythm at
George Washington University Hospital November 27, 2007.113
October 19,
2007 The A-Fib
community is shocked to learn that the Cleveland Clinic did not
renew Dr. Andrea Natale's contract. There is no word yet where
Dr. Natale will work, or where A-Fib patients can be treated by
him. For more information see
http://www.cleveland.com/news/plaindealer/index.ssf?/base/news/119131405528890.xml&coll=2
. You can leave messages for Dr. Natale at his E-mail
address andreanatalemd(at)gmail(dot) com.
September 1,
2007 Dr. Peng-Sheng
Chen is moving from Cedars-Sinai in Los Angeles to become the
new director of the Krannert Institute of Cardiology at Indiana
University.
August 19,
2007
FDA
Approves Genetic Testing Labeling for Warfarin (Coumadin)
The FDA's new labeling for Coumadin will explain that
people's genetic makeup may influence how they respond to the
drug. In the Precautions section, "Periodic determination of
PT/INR is essential. (See DOSAGE AND ADMINISTRATION: Laboratory
control.) Numerous factors, alone or in combination
including changes in diet, medications, botanicals, and genetic
variations in the CYP2C9 and VKORC1 enzymes (see CLINICAL
PHARMACOLOGY, Pharmacogenomics) may influence the response
of the patient to warfarin."105
Genetic variants of the CYP2C9 and VKORC1 genes are
individually responsible for anywhere from 35% to 50% of the
variable dose response to warfarin, FDA officials say. But the
agency stopped short of requiring physicians to use the test:
there are no adequate clinical trials proving that genetic
testing improves warfarin's safety profile; testing is also not
universally available. The CYP2C9 gene is involved in drug
metabolism such that certain variations permit the drug to
remain active in the blood for longer. The VKORC1 gene
represents the site of action of warfarin such that gene
variants could affect patient sensitivity to the drug.
The FDA estimates that 2 million persons start taking
warfarin (the generic of Coumadin) in the U.S. every year to
prevent blood clots, heart attacks and stroke. Warfarin is the
second most common drug--after insulin--implicated in emergency
room visits for adverse drug events.
The FDA's "personalized medicine" initiative may further the
study and application of pharmacogenomics---the science that
predicts a response to drugs based upon a person's genetic
makeup. Healthcare providers may use genetic tests to improve
their estimate of what is a reasonable warfarin dose for
individual patients. Warfarin is only the second drug in which
specific pharmacogenetic details have been used in the label
relating to drug dosing. However, this is the first time a
widely used agent like warfarin has included these types of
genetic details.
(Author's Note: If your doctor puts you on warfarin
(Coumadin) and does not test you for the above gene
variations, you should probably get a second opinion. The tests
cost between $125 and $500 and are fairly widely available.
These tests could save you heart problems related to under- or
over-dosing of warfarin.)
(See
http://www.sciencedaily.com/releases/2007/
08/070817113120.htm) (Thanks to Larry Kushman for calling
our attention to this article.)
July 18, 2007
Bordeaux
Five-Step Ablation Protocol for Chronic A-Fib
The French Bordeaux group now uses a five-step process to treat
Chronic A-Fib.
1. They start by isolating the Pulmonary Vein openings.
 They
also eliminate potentials at the base of the Left Atrial
Appendage, but do not isolate or electrically disconnect the
whole of the LAA which could possibly lead to clots forming in
the LAA and A-Fib stroke. (Ablating at the base of the LAA as
part of the first step in treating A-Fib is a new approach
and may become a very important first step in the ablation
treatment of A-Fib.)
 2.
Next they make a roof line linear ablation linking the Right
Superior Pulmonary Vein with the Left Superior Pulmonary vein
opening to create complete electrical block
3. They then work in the Inferior
Left Atrium and the Coronary Sinus. They make an incomplete
blocking line between the Right Inferior and Left Inferior PVs
in order to slow down the rapid atrial electrical activity.
 They
treat the Coronary Sinus as though it were another heart
structure or Left Atrium, rather than just another vein opening.
They disconnect the CS from the Left Atrium and ablate
potentials along the Mitral Annulus. They also slow down
Coronary Sinus electrical activity by ablating both inside and
outside the CS with a lower wattage power, usually 25 Watts.
(Treating the Coronary Sinus as another Left Atrium is a new
approach. Most current A-Fib ablation procedures tend to
stay away from the Coronary Sinus because of the risk of
Stenosis (swelling). The French Bordeaux group, by using a low
wattage, irrigated tip catheter,
ablates within the Coronary Sinus
without damaging it.)
4. The fourth step is eliminating
organized atrial activity in areas such as:
Anterior Left Atrium & Left Atrial
Appendage
Septum
Posterior Left Atrium
Superior Vena Cava
Right Atrial Septum
5. The fifth step is to create a
Mitral Isthmus blocking linear ablation line from the Mitral
Annulus to the Left Inferior PV. The goal is to eliminate all
potentials along this line.
In practice, even after these five
steps, rapid atrial activity often remains. It has to be mapped,
traced to its source and ablated. Often the top of the Left
Atrial Appendage has to be ablated.
This whole procedure requires a
great deal more time, effort, persistence, skill and experience
than normal left ablation procedures.
(Author’s note: Please be advised that
this five-step process for treating Chronic A-Fib is relatively
new and isn’t available today at most A-Fib medical centers.)
June 20, 2007
President
George Bush may have Chronic A-Fib
An interesting article from the Houston Independent Media Center
suggests that President George Bush may have Chronic A-Fib
http://houston.indymedia.org/news/2004/
12/35839_comment.php#45166.
June 1, 2007
Warfarin
Bests Aspirin for Stroke Prevention in Elderly A-Fib Patients
Results of
the Birmingham Atrial Fibrillation Treatment of the Aged trial
show that even among A-Fib patients older than 75 years,
warfarin was superior to aspirin for primary stroke prevention
without a significant increase in hemorrhage risk. (16th
European Stroke Conference.) [31 May]
May 25, 2007
LOCAL A-FIB SUPPORT
GROUPS FORMING.
Are you interested in forming or participating in a local
A-Fib support group? Our goals would be to share our experiences
with A-Fib, get advice, learn about new developments, and form
friendships with others who understand what A-Fib is like. Those
who have been cured of A-Fib are also encouraged to join (and
perhaps volunteer to mentor a new A-Fib-er). We'd meet for
informal lunch or dinner, or an evening mixer with a speaker.
We are trying to set up the first local A-Fib support group
in the greater Los Angeles/ Southern California area. If you are
interested in participating in this local A-Fib support group or
in forming an A-Fib support group where you live, contact Joyce
at jarintime(at)yahoo.com (the @ is written as "at" to prevent
access by spam mailing lists).
May 25, 2007
A-Fib Decreases Mental
Abilities
Men with A-Fib had
lower levels of cognitive performance compared to men in normal
sinus rhythm in the Framingham Offspring Study. This may be
due to the reduced cardiac output and decreased blood flow to
the brain in persons with A-Fib. Multiple cognitive abilities
were tested over a wide age range (37-89 years).
"...A-Fib may be one of a number of risk factors for
conversion from mild cognitive deficit to dementia."98
In a previous study persons with chronic A-Fib had a 3-fold risk
of cognitive deficit compared with persons in normal sinus
rhythm.99
There were too few women with A-Fib for analysis in this
study. However, in a previous study women with A-Fib had a
higher prevalence of dementia and cognitive impairment.100
(Thanks to Darrel Seife for calling our attention to this
study.)
(Author's Note: This is an important study, especially
for those in Chronic A-Fib. The option of simply staying in
A-Fib while controlling the rate and taking blood thinners to
prevent stroke may no longer be acceptable, because of the risk
of mental impairment and dementia from A-Fib.)
May 13, 2007
Cox Maze
Operation for Patients with Chronic A-Fib
People with Chronic long-standing A-Fib and large left atria
were generally thought not to benefit from a Maze operation.
This Cox maze operation, which also utilizes supplemental RF
ablation, cuts out sections of the atria to reduce atrial size
and improve ejection fraction.97
May 6, 2007
First Ablation Using Visually Guided Endoscopic Catheter by Dr.
Shephal Doshi
Dr. Shephal Doshi of St. John's Health Center in Santa Monica,
CA performed what may be the
first
visually guided catheter ablation for A-Fib, using the
investigational "Visually Guided Endoscopic Ablation System." A
steerable catheter with fiber optics and a transparent dome at
the end works as a video camera using infrared signals to see
through the blood in the heart The system was developed by
CardioFocus, Inc. of Marlborough, MA. For more info call (508)
658-7200 or visit
http://www.cardiofocus.com.96
For a list of the 20 medical centers participating in the
clinical trials of this system, go to:
http://www.cardiofocus.com/afib_trial_enable.htm
April 26,
2007
Additional centers participating in the CryoCath balloon
catheter trials are:
Bay Heart Group,
Iowa Heart Center,
Massachusetts General Hospital,
Mayo Clinic,
Virginia Commonwealth Medical Center
Baylor Heart and Vascular Hospital,
Arrhythmia Associates/Inova Research Center,
Stanford Hospital,
Quebec Heart Institute/Laval Hospital. See
Cryo Cath balloon catheter trials.
April 16,
2007
The University of Chicago Hospitals announces new
developments in their treatment of A-Fib. Joining their staff
are: Drs. John F. Beshai, Martin Burke, Bradley P. Knight, and
Al Lin.
March 21,
2007 A gentleman from
India with A-Fib needs financial help in getting a Pulmonary
Vein Ablation (Isolation) procedure. If you have the financial
means to help him (or if you have any contacts in India), his
E-mail address is: alexander_john123@yahoo.com.
February 8,
2007 The A-Fib ablation
doctors formerly associated with Riverside Methodist
Hospital/MidOhio Cardiology have moved to the Ohio State
University. Their new address is:
The Ohio State
University
DHLRI, Suite 200
473 W. 12th
Avenue
Columbus, OH 43210-1252
(877) 478-2478
Dr. Emile G. Daoud, Dr. Ralph S. Augostini, Dr. John D.
Hummel, Dr. Steven J. Kalbfleisch, Dr. Raul Weiss
January 19,
2007
Cryo Balloon Catheter
Ablation Trials to Begin
Dr. Walter Kerwin of Cedars-Sinai Medical Center in Los
Angeles and Dr. Christopher Cole of Colorado Springs
Cardiologists will begin clinical randomized FDA trials of the
Arctic Front-TM balloon CryoAblation catheter made by CryoCath
Technologies Inc. Patients receiving Cryo (freezing) balloon
ablation will be compared to patients taking antiarrhythmic drug
therapy (Sotalol, Rhythmol or Flecainide).
For every three patients, two will be randomly assigned to
receive a CryoCath balloon ablation, while the third will take
drug therapy (a 2:1 randomized ratio). After 90 days, patients
in the drug therapy group who are still in A-Fib (a likely
occurrence) can cross over and receive a CryoCath balloon
ablation. Patients will be followed carefully during a one year
follow-up.
(To this author, Cryo ablation seems to be significantly
safer for patients than standard RF ablation. However, Cryo
ablations currently take more time to perform than RF ablations.
The Cryo balloon catheter will likely allow a doctor to perform
a Cryo ablation and isolation of the Pulmonary Vein openings
more easily and much faster than current methods. The Cryo
balloon catheter may become a major improvement in the treatment
of A-Fib. It has already been approved in Europe, with close to
100% success rate in isolating the PVs, and 75-80% success in
keeping patients free of A-Fib without anti-arrhythmic drugs.)
The trial will be covered by most good insurance policies
that provide for clinical research participation. Patients will
not be paid or separately charged by the clinical trial for
participation. If you're interested in participating in this
Cryo balloon catheter ablation trial for A-Fib, here is the
contact info:
Cedars-Sinai
Medical Center
8631 W. 3rd. St., Suite 1017-E
Los Angeles, CA 90048
(310)-289-5901
Dr. Walter Kerwin
Colorado
Springs Cardiologists
2222 N. Nevada Ave., Ste 4007
Colorado Springs, CO 80907
(719) 634-6671
Dr. Christopher Cole
The Ohio State
University
DHLRI, Suite 200
473 W. 12th
Avenue
Columbus, OH 43210-1252
(877) 478-2478
Dr. Emile G. Daoud, Dr. Ralph S. Augostini, Dr. John D.
Hummel, Dr. Steven J. Kalbfleisch, Dr. Raul Weiss
(There will be twenty different centers in the US
participating in these cryo balloon ablation randomized trials.
That info will be published here as it becomes available.)
(Added April 26, 2007: Other centers participating in the
CryoCath balloon trials are:
Bay Heart Group,
Iowa Heart Center,
Massachusetts General Hospital,
Mayo Clinic,
Virginia Commonwealth Medical Center,
Baylor Heart and Vascular Hospital,
Arrhythmia Associates/Inova Research Center,
Stanford Hospital,
Quebec Heart Institute/Laval Hospital.)
November 1,
2006
Stereotaxis Starts Computerized Magnetic Ablation Niobe R System
Stereotaxis announces Initial U.S. Clinical Usages of Cardiac
Ablation Catheter with Company's Niobe R) System. The Niobe
system utilizes a computer-controlled magnetic field to remotely
steer a magnetic ablation catheter that applies a consistent,
"soft-touch" contact with the heart which may reduce the risk of
perforation during ablation procedures.94
October 21,
2006 A study comparing
the
Pappone Circumferential Anatomical PV Isolation procedure
with an integrated approach using both the Pappone method
followed by a
Segmental ablation (with electrophysiological confirmation
of PV disconnection) was found to be more effective than the
Pappone method alone. "Electrophysiological confirmation of PV
disconnection could be a useful marker of successful RF
treatment of A-Fib."93
October 14,
2006
Bordeaux Group Reports 95% Success Rate in Curing
Persistent/Chronic A-Fib after Two Ablations
In a major medical breakthrough the French
Bordeaux group reported a 95% success rate in
curing Persistent/Chronic A-Fib.92
See
Jaïs Chronic A-Fib.
August 5,
2006
Four Patients Die after AtriCure (Wolf) Mini-Maze Surgery
According to a Wall Street Journal article by David Armstrong,
four patients are known to have died after having the AtriCure
(Wolf) Mini-Maze surgical operation to cure A-Fib.91
August 5,
2006
Cleveland Clinic Surgeons' Financial Ties to Equipment
Manufacturers
According to a Wall Street Journal article by David Armstrong,
surgeons at the Cleveland Clinic may have or may have had
extensive financial ties to manufacturers of medical equipment
these surgeons use to treat A-Fib patients.91
June 11, 2006
Dr. Andrea Natale and the Cleveland Clinic now call their
catheter ablation procedure to cure A-Fib "Pulmonary Vein Antrum
Isolation (PVAI)." This procedure still involves making
circumferential lesions around the outside of the PV openings.
June 11, 2006
Low-Dose Steroids Prevent Recurrence of A-Fib after Ablation
Low-dose steroids have been reported to prevent recurrence of
A-Fib, possibly because they suppress systemic inflammation.85
June 10, 2006
Dr. Wolf Admonished for Not Revealing Financial Ties to AtriCure
"The Journal of Thoracic and Cardiovascular Surgery has
admonished a Un. of Cincinnati surgeon (Dr. Randall K. Wolf who
developed the Wolf Mini Maze operation for A-Fib) for failing to
disclose financial ties to AtriCure, the West Chester, (Ohio)
maker of heart-surgery equipment he and other researchers
evaluated in a published study." Cincinnati Business Courier
and The Wall Street Journal December 28, 2005.
81 "An AtriCure
filing with the SEC in August, (2005) reports Dr. Wolf owns
18,402 shares of company stock (approximate current value
$140,000) and has warrants or options to purchase 13,913
additional shares of stock. (ArtiCure's recent stock price was
$7.60.) In November, AtriCure reported a four-year royalty
agreement with Dr. Wolf that will pay him a minimum of $200,000
a year up to a total of $2 million over the entire length of the
agreement."81
June 6, 2006
"Pill-In-The-Pocket" Strategy using Flecainide or Propafenone is
Effective
Flecainide or propafenone can be safely self-administered by
outpatients for control of recurrent atrial fibrillation. This
"pill-in-the-pocket" approach resulted in fewer emergency room
visits.
http://www.medscape.com/viewarticle/495111?rss, New
England Journal of Medicine 2004;351:2384-2391.
(There is some disagreement about this strategy. Some say
it might be better to keep patients out of A-Fib by taking
antiarrhythmic meds daily [keeping a fire from starting], rather
than waiting for an A-Fib attack to start [having to put the
fire out once it starts].)
May 27, 2006
Obesity, Smoking, but not Age Affect Recurrence Rates after
A-Fib Ablation
Obesity (BMI over 30) and Smoking, but not Age, affect
reoccurrence rates of A-Fib after ablation. Dr. Dimpi Patel of
the Cleveland Clinic hypothesized that obese patients have
larger left ventricles, often due to hypertension or diabetes,
and left atrial dilation, resulting in an increased substrate
(structure of the heart). These conditions may lead to
reoccurrence of A-Fib after ablation.
In a Mayo Clinic study by Dr. Jared Bunch reoccurrence rates
were basically the same for patients under 50, between 50 and 65
years old, and over 65. (Studies presented at the Heart Rhythm
Society 2006 Scientific Sessions in Boston, MA.
http://www.theheart.org/article/706883.do
May 24, 2006
Long-term Warfarin Use Increases Risk of Bone Fracture in Men
The long-term use of
warfarin appears to increase the risk of bone fractures in men
(not women). Warfarin prevents coagulation by blocking the
vitamin K-dependent activation of certain clotting factors.
Because vitamin K is also used to activate osteocalcin and other
bone matrix proteins, "vitamin K antagonists might increase the
risk of osteoporotic fractures." The study also found that
taking beta-blockers decreased the risk of fractures, perhaps
because they increase bone mass. (Archives of Internal
Medicine, Jan. 23, 2006.)
http://www.medscape.com/viewarticle/522264
April 23,
2006
"Bottom Line Health," Vol. 20, number 5, May, 2006. "Aspirin
vs. stroke. Because aspirin can cause bleeding, it is
typically avoided by people who have had a hemorrhagic stroke,
which occurs when a blood vessel bursts in the brain. New
Finding: In a study of 207 hemorrhagic stroke survivors,
those who took an antiplatelet drug, such as aspirin, were
not at increased risk for another hemorrhage.
Implication: Aspirin therapy may be appropriate for
hemorrhagic stroke survivors who are at high risk for heart
attack or ischemic stroke, in which a blood clot blocks blood
flow to the brain.
April 15,
2006 The Cleveland
Clinic has an E-Clinic Consult program that allows patients to
receive a second opinion and start the registration process at
the Cleveland Clinic. In cooperation with your cardiologist, all
records pertaining to your A-Fib are sent to the C.C. for
evaluation. An extensive medical questioner is also completed.
Then all the data are evaluated by the C.C. cardiology staff. If
deemed a candidate for ablation, the pre-registration process is
then completed, and a procedure date is given for the ablation.
The current fee is $565.
November, 2005
Veterinary Antibiotic Lasalocid Found in Eggs and Poultry Meat
May Trigger A-Fib
A recent report from England suggests that the veterinary
antibiotic "Lasalocid" found in eggs and poultry meat may cause
or trigger A-Fib.
Lasalocid is given as a feed supplement to certain farm
animals particularly poultry as a preventative treatment against
"coccidiosis"---an infectious disease caused by a parasite which
damages the birds' intestines and causes illness and sometimes
death. Outbreaks of coccidiosis are likely to occur when large
numbers of animals are crowded together in warm and moist
conditions. Lasalocid is considered a "highly toxic heart
poison. ...It belongs to a group known as the ionophores, all of
which are potent heart poisons many of which are in regular use
in animal feed."65
(Thanks to Richard Gee of the UK for providing this info.)
June, 2005
Dr. Moussa Mansour of Massachusetts General Hospital reports
that MGH now uses a mapping system called Carto-Merge to do
PVIs. This system incorporates an MRI (or a CT) of the
pulmonary veins with real-time electroanatomical mapping. This
image integration provides the operator with significantly
better navigation of the left atrium and thus a safer and more
effective procedure.
January, 2004 Australia and New Zealand now have
a doctor from the French Bordeaux group practicing in Australia.
Here is his address:
AUSTRALIA
Royal Perth Hospital
Wellington St., Perth 6000
Perth, Australia
(+618) 9224 2388
Fax: (+618) 9389 5261
E-mail: ruk(at)ziplip.com (the @ is written out as "at" to
prevent it from being accessed by spam mailing lists)
Dr. Rukshen Weerasooriya
April 25,
2003
Massachusetts General Hospital Tribute to Dr. Brian McGovern
Brian
McGovern, MD: Remembering a physician, colleague and friend
 Every
seat in the O'Keeffe Auditorium was taken April 19. Two overflow
rooms were filled beyond capacity. The aisles of the auditorium
were crowded with people craning to see the podium and hear the
words of remembrance for a beloved and world-renowned
cardiologist, Brian McGovern, MD (right), who was killed
April 8 in a senseless tragedy that stunned and saddened the
hospital community. The memorial service, which was designed for
McGovern's patients, also included colleagues, family, friends
and MGH employees who came to hear eloquent words and heartfelt
messages about the man who touched so many lives in his
extraordinary 23-year career at the MGH.
"We can't put a good face on this terrible tragedy, but every
time I think of Brian – which will be often – I will aspire in
that moment to be a little more patient, a little nicer, a
little more like the ideal that he personified," said David
Torchiana, MD, chairman and CEO of the Massachusetts General
Physicians Organization. "If that can happen a thousand times to
all of us, maybe a million times over the years, I believe this
world might be a better place."
With McGovern's widow, Anne Jennings, MD, and one of their
daughters, Caitriona, in the audience, Torchiana introduced the
service, which also included tributes from physicians,
colleagues, patients, friends and family members of McGovern.
While each shared personal anecdotes, tearful remembrances and
even a few light-hearted memories, a common theme surfaced:
McGovern was a brilliant physician who possessed the precious
gift of genuine compassion and empathy for all he came into
contact with – patients, friends and colleagues alike.
"When you met him, he made you feel like you were so important
to him and that he was so happy to see you," said Guillermo
Sosa-Suarez, MD, a colleague of McGovern's at St. Peter's
Hospital in Albany, NY. "He drew people to him. They liked him
because of his skills as a physician and because of his personal
warmth."
During his tenure at the MGH, McGovern grew into a master
clinician and was well known as a doctor's doctor – a physician
who many colleagues confided in, consulted with and looked to
for advice and wisdom. He built one of the largest referral
practices in New England and was widely known as an expert in
cardiac arrhythmia.
He was a sought-after lecturer, a highly respected teacher and,
in addition to his commitment to patient care, he devoted much
time to important clinical research. For many years, he served
as medical director for the Ellison 10 Cardiac Step-Down Unit.
Every Wednesday, McGovern traveled to Albany, NY, to see
patients at the highly successful outreach arrhythmia program
that he had founded and built. But beyond the impressive
credentials and the lauded achievements, McGovern was what
Torchiana described as a "good man" who was highly accomplished
yet humble and self-effacing.
"Despite his incredible accomplishments, Brian never took
himself too seriously, which is what we loved most deeply about
him," said Jeremy Ruskin, MD, a colleague of McGovern's in MGH
Cardiology and a close friend. "Everyone knew him for his sense
of humor, which was kind-hearted and borne of intelligence and
generosity. He was always funny, but his humor was never at
anyone's expense. He was able to defuse countless difficult
situations with his humor."
 For
Ruskin, this memorial tribute was a deeply personal one. Ruskin
first met McGovern in 1981 when the young medical school
graduate came to the MGH from Ireland to interview for a
fellowship. During McGovern's training at the MGH and his
subsequent career, Ruskin grew to rely on him for his insightful
medical expertise and thoughtful advice. "Brian was my student,
but he became my teacher," said Ruskin. "I'll always be grateful
for his friendship, his loyalty and everything that he taught
me. A piece of each of us is lost with Brian, but a part of him
is alive in all of us. As we try to take care of each other – as
he did so often for us – we must continue the extraordinary work
he did with such grace, skill and generosity."
It is that extraordinary work of providing the highest quality
patient care that was honored by McGovern's patients, who also
spoke of his compassion, caring and commitment to the many
people who walked into his exam room.
Bud Mueller, MD, was one of those patients. Mueller credited
McGovern for saving his life and saving the lives of thousands
of other cardiac patients. "His expertise and kindness gave and
continue to give individuals and families the ultimate gift –
the gift of time," he said. "His work improved beyond measure
the quality of time for patients by decreasing the anxiety that
is part of the condition that patients and their families must
endure. Brian delved into his life's work in a way that showed
compassion, caring, respect, empathy and love. We should try to
do the same. If we can try to make the world a better place, we
can honor Brian, his wife, his children, his MGH team, and then
Brian can live on in an important way through each of us whose
lives he enriched."
While McGovern touched the lives of many of his patients and his
physician colleagues, the staff of the Arrhythmia Service,
Electrophysiology Laboratory, the Ellison 10 Cardiac Step-Down
Unit and the entire Cardiology Division also are particularly
feeling the void left by the loss of a cherished colleague and
friend.
Katie Lynch, RN, a nurse from Ellison 10, spoke of the profound
impact McGovern had made on the step-down unit staff, both
professionally and personally. "He cared for his patients with
the utmost respect and compassion," she said. "He elevated our
practice to do our very best work. Personally, he made us better
because his happiness and love of life were evident and
contagious. His presence in our lives was a gift from God, and
we will try to honor his memory by caring for patients as he had
taught us."
A
tribute from a friend and colleague
"The
good physician knows his patients through and through, and his
knowledge is bought dearly. Time, sympathy and understanding
must be lavishly dispensed, but the reward is to be found in
that personal bond, which forms the greatest satisfaction of the
practice of medicine. One of the essential qualities of the
clinician is interest in humanity, for the secret of the caring
of the patient is in the caring for the patient."
- Francis Weld Peabody, MD, (1881-1927) renowned physician and
teacher at Harvard Medical School
"No one I've met
in my professional
life embodied these words more than Brian did."
- Jeremy Ruskin, MD
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