January-March
2007 Archives:
March 19, 2007 -- 9:25pm EDT
"Fantastic Voyage" Redux
An article in today's CNNMoney.com, titled "Medical
companies take 'Fantastic Voyage' into heart", once again
invokes this classic movie as a metaphor for the field of catheter-based
medicine. This movie has been used in many articles, PowerPoint
presentations and blogs like medGadget --
and with good reason. It has a very real synergy with the field
of interventional medicine, something I
wrote about last year in a tribute to its director Richard
Fleischer:
I always wondered if
the idea for "Fantastic Voyage" came from reality.
The movie was made in 1966 and the trailer (which
you MUST see -- courtesy of the NY Times -- free registration
required) states it was two years in the making. So the
film was conceived in 1964 -- the year in which Dr.
Charles Dotter performed the very first angioplasty. He
not only invented the concept and coined the term, but he made
his own 16mm
movie about it.
In
August of 1964, Dotter appeared in LIFE Magazine (they went
for the mad scientist angle) and the idea of treating arterial
blockages from the inside out was publicized for the first
time. Who's to say sci-fi author Jerome
Bixby didn't read it and say, "Hey. My next screenplay!
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Today's CNN piece by Aaron Smith profiles two companies
in the imaging field, one of which, Volcano Therapeutics, we
also have written about. Intravascular Ultrasound or IVUS may
have an important role assisting in the accurate placement of stents,
and also in assessing, over time, whether the stents have maintained
their position.
While it's not a crew of physicians and scientists,
like Donald Pleasance, Arthur Kennedy and, did we say, Raquel Welch(?)
the tiny ultrasound camera on the tip of the Volcano catheter can
act like a hi-tech security cam, sending back astounding color-coded
images of the interior spaces of the coronary artery, and alerting
the physician to potential blood clots and other problems -- something
becoming more important in the era of concerns over late stent thrombosis
with drug-eluting stents.
The medical community thinks it's a valueable idea
too. Sales for Volcano's system jumped 20% in the last quarter, and
highly-regarded Milan-based cardiologist Dr. Antonio Colombo has
stated that he will use IVUS for every stent placement he does.
For more on IVUS, see
our article on Angioplasty.Org.
March 7, 2007 -- 6:02am EST
And The Winner Is...
Word on the street is that the FDA is
planning to announce labeling changes for drug-eluting stents
later today, during the CRT
2007 meeting in Washington. These changes have been anticipated
ever since the FDA held its panel on stent safety back on December
7-8 and many recommendations were heard.
This announcement has not been confirmed
but, since I didn't get enough of the Oscars this year, I thought
I'd take a shot at predicting the winners (from those nominated
at the December panel).
For Best Picture: Extended Antiplatelet Therapy.
Currently dual antiplatelet therapy (aspirin plus clopidogrel/Plavix
or ticlopidine/Ticlid) extends for 3 months (Cypher) or 6 months
(Taxus). I'll bet on a recommendation of 12 months for patients
with low risk of bleeding complications. This change is clearly
the front-runner, having previously been recommended by all major
cardiology and surgical organizations in January's Joint
Science Advisory (a.k.a. The Golden Globes).
Best Director will be, I think, a caution
to prescribing physicians to consider a bare-metal stent in patients
who, for economic, clinical or other reasons, have a high likelihood
of non-compliance with antiplatelet therapy or who are going to
be needing surgical procedures which will require cessation of
antiplatelet therapy. This one has gotten the clear recommendation
of several groups as well. The question is whether it will become
part of the label.
Finally for Best Actor/Actress, I vote for the "off
label" label -- some language that advises prescribing physicians
that the results and benefits of DES that have been demonstrated
in clinical trials may differ from those when the device is used "off
label". This is a dark horse, because of the complicated concept
of the label defining the off-label, but I'll go with it.
If the announcement is made, I'll be posting the
results later
March 5, 2007 -- 11:53pm EST
Dueling Thromboses
We're talking thromboses or blood clots
-- and oddly enough the same day that Vice-President
Cheney was diagnosed with a thrombosis, specifically a deep
venous thrombosis (DVT) in his leg, Representative Henry Waxman
announced he had sent
a letter, on behalf of the House Committee on Oversight and
Government Reform, to the two drug-eluting stent manufacturers,
Boston Scientific and Cordis, to deliver information to his Committee
about late stent thrombosis and their DES marketing strategies.
Adding to this coincidence of events in Washington
is Wednesday's "Workshop With The FDA" session at the CRT
2007 meeting, run by Dr. Ron Waksman (not Waxman) of the Washington
Hospital Center. This all-day session will bring together a wide
variety of industry, government and physicians to hash out the issues
surrounding late stent thrombosis in drug-eluting stents.
And the clinical issues are complex -- it will
be interesting to see what a Congressional Committee is able to come
up with in this area, since the large inclusive panel of experts
that the FDA convened in December felt there wasn't enough solid
data to make a definitive statement about "off-label" use
of DES, other than a recommendation for longer clopidogrel therapy,
more care in patient selection and more study of the incidence of
late stent thrombosis.
As for the marketing issues -- this information
has not been aired much before. Stay tuned....
March 2, 2007 -- 12:37pm EST
Not Just a River in Egypt
Yesterday's email contained an invite to
the Thursday evening event at next week's CRT
2007 interventional cardiology meeting in DC -- a 75 minute
symposium, sponsored by Boston Scientific, and titled "Drug
Eluting Stents: The Safety, Practicality & Evolution".
The thrust of this somewhat ungrammatically titled
presentation is to communicate the latest DES safety data to the
audience of physicians, and to counter the negative headlines that
have been dogging Boston Scientific (and Cordis) for the past six
months.
That would explain why, "immediately following" the
DES session, the audience will be entertained by "An Evening
with Bob Woodward", in which the WaPo reporter will discuss
his recent book on the Iraq War:
"A
State of Denial"
As if there weren't enough literary faux pas for
one evening, the brochure directs attendees to register for the symposium
at:
www.bostonscientific.com/coronary/events
'Nuff said.
February 28, 2007 -- 6:45pm EST
Argument Resurrected: Stents vs. Surgery
The front page of Sunday's New York Times
reported on the three-decade-old Celebrity
Deathmatch between surgeons and interventional cardiologists.
Titled, In
the Stent Era, Heart Bypasses Get a New Look, the article,
by reporter Barnaby Feder, postulated that, given the recent concerns
over drug-eluting stent problems, in some patients bypass surgery
may be a better solution than stents for treating the problem of
coronary artery disease.
But the Times article left out a few problems associated
with bypass surgery, such as vein grafts closing up (they then get
reopened using...ahem...stents). Also there's a growing body of evidence
that many bypass patients experience "cognitive decline'. In
the recent
5-year follow up of the Octopus study, 50% of the patients were
classified as having "cognitive decline", leading Yale-based
MD Harlan Krumholz to suggest that this risk be made part of the
informed consent for CABG patients.
And then there's Dana Carvey...but read the full
article....
February 15, 2007
Don't Have a Heart Attack in Stars Hollow
Tuesday night TV redux. I once wrote a piece
puntastically titled "Judging
AMI" about how poorly heart attacks are dealt with in
prime-time. Anyway, this time it's again about a TV show (oddly
enough also on Tuesday night) in which a major character has a
heart attack and, behold, they are told that they have to have
emergency bypass surgery!
Poor Richard Gilmore, a major character in "The
Gilmore Girls", which takes place in Stars
Hollow, a small fictional town in Connecticut, had a heart
attack while lecturing at his alma mater, Yale University. Fast
forward to last week's episode, where he's taken to a New Haven
hospital. Prognosis is: he's had a heart attack and he's "got
a blockage that's bigger than we thought" and he is going
to have to get "emergency bypass surgery". He spends
the next several hours lolly-gagging around in his hospital bed
while everyone prepares for his surgery. He's taken in, operated
on and accordingly to the surgeon, he'll be just fine.
Except he probably won't be just fine. Why? Because
enough time has passed, even in the bizarre world of TV time, that
Poor Richard's ticker muscle has died from lack of Oxygen (a different
cable network). Bypass may provide new blood flow, but to what? A
deceased section of myocardium? What he should have had was an angioplasty,
immediately. This would have saved his heart muscle from dying and
he would, in fact, have been "fine".
All medical studies point to the importance of
being revascularized via balloon angioplasty within 90 minutes. The
American College of Cardiology has created an initiative to publicize
the importance of this concept and to help hospitals reduce what
is known as "door-to-balloon time". There is even a web
site for D2B ("door-to-balloon").
Oddly enough, one of the moving forces in D2B is Dr.
Harlan Krumholz of Yale University. Wait a minute...that's
where Poor Richard Gilmore had his heart attack and wound up sitting
around waiting for bypass surgery! Attention PR Department of Yale-New
Haven Hospital System. Message is not getting through....
Oddly enough again, the set for "The Gilmore
Girls" is reportedly right next to the set for "ER".
So you say, so what, it's only a TV show! And I
reply, well many many years ago, when I was an uninformed youngster,
a close relative of mine was sitting on our living room couch, experiencing
an odd upset stomach. He seemed pale, was sweating, wanted to leave
and drive home. But a guest at dinner had just seen a TV movie in
which a man, sitting in a train car, was having very similar symptoms.
In the TV movie the man was having a heart attack. Sure enough, so
was my relative. If our mutual friend had not seen the TV movie,
my relative would not have been taken to the hospital, but would
have attempted to drive home -- and would not have made it.
So TV movies can be important learning experiences
and can communicate, inform, assist.
In other words, Hollywood, get it straight! Heart
attack victims do not sit around waiting for bypass surgery. They
go to a hospital and get a balloon stuck in their hearts ASAP!!!
And they get their lives saved.
Kind of like the former
Health Minister of Canada did on Tuesday.
January 12, 2007 -- 7:55pm ET
"I can see clearly now" -- IVUS
and Thrombosis
Back in November, Angioplasty.Org featured
a report titled, "Intravascular
Ultrasound (IVUS) Imaging Technology May Help Lower Rates of
Late Stent Thrombosis".
Yesterday that idea got the imprimatur of a major
professional organization: the Society for Cardiovascular Angiography
and Interventions (SCAI). In the SCAI's official journal, Catheterization
and Cardiovascular Interventions, a distinguished team of cardiologists
(a.k.a. the SCAI Drug-Eluting Stent Task Force) offered a series
of practical recommendations for cardiologists about reducing the
risks for late stent thrombosis. It was titled "Clinical
Alert on Late Stent Thrombosis" and a PDF of the full SCAI
article can be found here.
My favorite recommendation was "the importance
of...meticulous stent implantation." I read it and thought to
myself, "I knew it! All along I've had this sneaking suspicion
that so much of this thrombosis problem is due to that darn 'unmeticulous'
technique."
"Meticulous" was the word-of-choice
for the press release; the actual article uses the adjective "careful".
I feel, however, that "meticulous" is more accurate. It's
not that interventional cardiologists are not careful (i.e. "full
of care") when they incorrectly place a stent. It's just that
they can't see it well enough because, according to the recent J&J/Cordis-sponsored STLLR
study of 1,500 patients, this happens 66.5% of the time!
Hold on. Did I misread that? You mean your chances
are only 1 in 3 of getting a stent implanted "meticulously"?
As Scott Huennekens, President and CEO of Volcano
Corporation, one of the only two IVUS manufacturers, commented yesterday
to the JP Morgan Healthcare conference:
"There's no other medical device that
I'm aware of that's implanted in the body incorrectly 66% of
the time."
IVUS might cut that figure way down because it
allows the cardiologist to look at the artery from the inside out.
For example, if a stent has not been fully expanded, this might not
be evident using the current "gold standard" of angiography,
but IVUS would show this clearly.
IVUS technology was invented well over over a decade
ago (I know because I produced some of the first training videos
about IVUS for cardiologists) yet today in the year 2007, only 12%
of stent procedures use IVUS.
I think that this is going to change significantly,
due in great part to the concerns about late stent thrombosis (again,
read our
feature on the connection between thrombosis and incorrect stent
placement). Recently, highly-respected thought-leader and interventional
pioneer Dr. Antonio Colombo of Milan has announced that he is now
going to use IVUS in every case he does.
Suffice to say, this is an imaging technology that
is going to become much more important in the very near future.
January 3, 2007 -- 8:39am ET
What Balloons and Stents Are Really Good
At
With the recent confusion about the
role and safety of drug-eluting stents, it's sometimes hard
to remember why balloons and stents are used in the first place
-- one indisputable indication is to stop a heart attack. Read
more about it in Today's
News -- a dramatic story from Canada.
January 2, 2007 -- 1:56pm EDT
More Stent Concerns?
The possible inhibition of collateral vessels
by drug-eluting stents is a disturbing new potential problem for
these devices. The results of a study from University Hospital
in Bern, Switzerland was published in today's Journal of the
American College of Cardiology -- you can read all about it
in Angioplasty.Org's report from last
Friday.
In fact, over the weekend our Forum had
a patient write in that reduction in collateral circulation had
been observed in his angiograms pre-and-post DES. He has been experiencing
pain and other symptoms.
Now the JACC report has hit the mainstream
media -- an article appearing in the Milwaukee Journal Sentinel,
titled "Stents
may stifle tiny heart vessels" has been syndicated nationally,
appearing today under such headlines as "Study
reveals danger of some heart stents", "Study
finds `intriguing evidence' of stents' danger" and the
ever-popular "Drugs
may make stents deadly, study says".
Stent controversy, round two coming up...
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