May 2005 Archives:
May 26, 2005
Surgery vs. Stents
in today's New England Journal of Medicine that is all over
the news concludes that for patients with coronary narrowing in
more than one artery, coronary artery bypass surgery (CABG) has
a lower mortality than a similar group of patients who were treated
with stents. Hence the multitudinous onslaught of headlines about
this, my favorite being in Forbes, Bypass
Beats Stents for Heart Surgery. Yeah, like bypass IS surgery
and stents are not surgery, last I looked.
Anyway, this is an extremely important and complex
topic which I plan to discuss fully in a subsequent post, but let
me just throw out two quickies here to counter the incredibly shallow
reporting I've read in the papers and seen on the fake TV news.
Question: Where did the data come from?
Answer: New York State cardiac registries from 1997-2000
Comment: First stent approved in U.S. (Palmaz-Schatz) in
1994. So this comparative data was taken from the first 3-6 years
experience of a brand new technology. More than a decade of refinement
has vastly improved the stent procedure and the equipment. In the
past two years the bugaboo of restenosis has been massively reduced
by the introduction of drug-eluting stents. The mortality and morbidity
measured in the stent wing of this study would most likely be quite
different using today's technology. I call "foul". What
were the stats like for bypass surgery in its first 6 years??
Question: How long out were the patients
Answer: The procedures were compared at 3 years.
Comment: The authors were surprised that the divergence
in results occurred after only 3 years. Think how surprised they
would have been if the study had gone 5-7 years longer when, as
a backgrounder from
the Royal Brompton in London states:
"Ten years after CABG around 1/2 of vein
grafts are blocked and of the remaining 50% half are severely
Granted, the IMA is the main artery used in CABG,
but in multivessel grafting, vein grafts are still used -- and I
might add, very often reopened by angioplasty when they fail.
I will discuss this study in a more detailed and
measured way in a future post.
May 25, 2005
Does MultiSlice Computed Tomography, or
MSCT, have the potential to change how patients get selected for
treatment of coronary artery disease? You bet (and several companies
are). A study in today's
JAMA reports that 84% of the patients studied who did not
have significant disease could have been screened out using
MSCT instead of the more invasive coronary angiography (commonly
known as a "cath") -- a very common procedure (over two
million done in the U.S. annually) which, while safe and relatively
low-risk, still involves threading a catheter into the heart from
an incision in the thigh or wrist, and has a complication rate
The current standard pathway to the cath lab starts
with EKGs and/or an ultrasound stress test, then possibly a thallium
stress test (with radiation tracking) and finally a cardiac catheterization,
currently the "gold standard" of diagnosis for coronary
narrowing. The cardiologist can see clearly where and how significant
the narrowing is, and will often treat the blockage on-the-spot by
sliding in a balloon and stent through the catheter already in place,
adding only 15-20 minutes to the diagnostic procedure and, voila!
But what about the patients who get to the cath
lab and find there is no blockage (in this study, they constituted
44% of the sample)? They've undergone a somewhat uncomfortable and
expensive procedure and have subjected themselves to the possibility
of a 1.8% chance of complications (arrhythmia, stroke, coronary artery
dissection, access site bleeding, trauma to the femoral artery and
nerves). Not a lot, but it is if you're the patient who experiences
Additionally MSCT is rapidly increasing in quality.
The JAMA study was done with a Brilliance
16 unit from Philips Medical Systems. But Philips, as well as
GE Healthcare, Siemens and Toshiba have already developed 40 and
64 slice units that surpass the one used in the study, and the authors
concluded that "With rapidly improving technology, MSCT may
well evolve from a useful complement to invasive angiography to a
clinically viable alternative" -- MSCT may actually rival catheterization
in diagnostic accuracy (in fact, the MSCT scans actually reveal information
about the calcification of the plaque that is not seen under fluoroscopic
This means less invasive diagnosis for patients,
lower healthcare costs for hospitals. The new units cost between
$1-2 million, but scans are about $700 -- a catheterization costs
5-10 times that. Two millions caths a year in the U.S. Do the math.
May 22, 2005
Quick Addition to "Revolutionary New
When I said yesterday that the "revolutionary
new treatment" I saw on ABC Nightly News looked a lot like
John Simpson's AtheroCath directional atherectomy device from 15
years ago, I wasn't the only one. The FDA states in its "Safety
and Effectiveness" approval for the new SilverHawk catheter
(issued February 15) that the new device was "substantially
equivalent" to the AtheroCath -- which is why it did not need
to go through extensive clinical trials. And while it is an improved
small German study done last year showed a 22% restenosis rate
after 6 months. A different, and potentially more effective, treatment
for peripheral artery disease is currently being studied by Dr.
Mike Dake at Stanford, using Cook's Zilver® PTX™ Drug-Eluting
Stent which elutes paclitaxel, the same drug used in Boston
Scientific's Taxus stent.
May 21, 2005
ABC News "Discovers" Revolutionary
New Treatment to Unclog Arteries
I had just sat down Wednesday night to
relax after a hard day's work writing about balloons and stents,
when Charlie Gibson introduces the ABC
Nightly News medical breakthrough feature with: "It's
back to the future. 15 years ago, before there were balloons
or stents...". Sorry Charlie, but if your researchers had
only Googled "balloons" and "stents", they
could have accessed our "History" section,
where they immediately would have seen that your intro was off
by...oh, by about double. The first successful balloons were
used to open up leg arteries in 1974. Okay, so who cares...(answer
below -- hint, there's money involved).
Then the report shows a cutting device -- they
dub it a "roto-rooter" (never heard that one before...oh
wait, Dr. Charles Dotter, inventor of the concept of angioplasty,
used the roto-rooter comparison 50 years ago!! -- don't believe me?
Go to the video!
-- seems we are going back to the future -- of journalism, that is).
Anyway to me this animation they're showing looks
suspiciously like a directional atherectomy catheter, similar to
the one John Simpson invented in the late 80's and made into the
startup company DVI, which got folded into Guidant. It was called
the AtheroCath® and a new version of it is currently sold as
the Flexi-Cut®. You can read all about directional atherectomy
(with pictures, even) in our Devices
Reporter John McKenzie continues about Mr. McLanahan,
the patient with the blocked leg artery:
"So McLanahan tried something very different
-- a new, minimally invasive procedure that actually removes
plaque from the artery using a miniature drill. The drill's blade
cuts the plaque, which is then pushed into an extended nose cone
and pulled out of the body.... Later this year, doctors will
try using the procedure to remove plaque from the arteries around
the heart as an alternative to cardiac angioplasty and stents."
Then they show the little bits of icky-yellow-white
gummy cheesy plaque the device took out. I remember shooting that
scene numerous times during '80's training courses. Except those
were heart procedures. In fact this type of device has already been
used for the heart -- and the results were less than stellar. Stents,
especially drug-eluting stents, have taken over the lion's share
of treating coronary arteries -- and very successfully.
The name of the device being shown to millions
of viewers was not mentioned (ABC News wouldn't want to be seen as "selling" anything)
but there was a small title on the 3-D animation of the drill --
it read "FoxHollow Animation". FoxHollow
Technologies -- Founder and Chairman of the Board? John B. Simpson,
PhD, MD. Went public last October. Stock shot up 16%
yesterday, due mainly to the ABC News report.
Now there's nothing wrong with this. If a new improved
atherectomy catheter has been optimized for leg arteries, that's
great (leg arteries have historically not done as well with balloons
and stents as coronaries and carotids have). But "Revolutionary" it's
not. As for the heart, if it should prove more successful than its
predecessor, it will, like several other similar devices, not be
so much an alternative, but rather what's become known as a "niche
device" -- used in very specific situations -- it certainly
will not replace stents. Something will eventually -- but it most
likely will not make a loud whirring sound.
I just wonder where our news is coming from and
why journalists don't do research anymore? Aren't they the least
bit curious about anything??
May 19, 2005
Regarding Heart Attacks and Angioplasty
A study from
The Netherlands in American Journal of Cardiology today shows the
impact of delaying angioplasty treatment for heart attack, and
re-enforces the New York Times article discussed below.
May 16, 2005
Extra! Extra! Read All About It! Heart
page New York Times today -- a story of three heart attacks
(part of the excellent NYT series "Class Matters")
is a "must-read". Go buy the paper to see the full
import they give this story: a third of the front page plus a
full two-page spread inside.**
Three victims, three "class" strata,
three different outcomes. The upper middle-class architect fares
the best. He knew to choose the right hospital and within two hours
was on the cath lab table with his coronary artery opened by a balloon
and a stent in place -- his heart attack had been stopped in its
tracks. He reports that he is better off now than he was before his
heart attack -- not so for the other two New Yorkers profiled.
One went to a hospital where thrombolytic therapy
was administered, but with no angioplasty facility available. The
patient was moved the next day to a different hospital and got a
balloon and stent, but his cardiologist states, "...yes, he
would have been better off had he been to a hospital that was doing
The last, a working-class 59-year-old woman who
labored as a housekeeper, didn't know she was having a heart attack
(unlike the other two) and went to an ER with long lines, delays,
and wound up never even getting an angiogram. Virtually no emergency
treatment. And her recovery, or non-recovery, shows it -- she is
sicker and needs far more medical care now, as her doctor states
at the end of the article , "You're becoming a full-time patient,
There's been much talk in the medical profession
about healthcare delivery in urban vs. rural areas, or about the
fine differences between this stent and that stent, but here are
three people, living within a few square miles of each other (in
fact, the "top" and "bottom" wound up in hospitals
literally one block apart) and the future of their time on earth
has been completely determined by their access to healthcare and
healthcare information. I wonder if the writer was patterning Heaven,
Hell and Purgatory, because that's the way the stories are resolved.
Why isn't it routine in the triage of heart attack
victims to be brought to facilities where the best treatment is available
(the "gold standard" for most cardiologists being angioplasty).
It's unconscionable that, in this society, the awareness of this
information for both healthcare professionals and healthcare consumers
is so lacking. But I will leave that volatile topic to my partner
and guest-blogger (below).
I would like to comment on a related thread in
the story. While there are classes in this society, they are not necessarily rigid
(although some would rightly dispute this view) -- there is this
thing called education. And in today's society, an educated patient
is the best patient -- one who has the highest chance for a good
result, given their condition. The NYT piece discusses Mr. Miele,
the architect who had the most successful outcome:
"An important link in the safety net that
caught Mr. Miele was his wife.... While Mr. Miele was still in
the hospital, she was on the Internet, Googling
Ms. Gora (who fared worst) also had a computer
-- she had used it to find cheap prices for cigarettes -- she has
since stopped smoking.
You'll note that if you Google "stents" or "angioplasty" you
will find our site Angioplasty.Org.
And I hope that our feature on "Angioplasty
and Heart Attack" can help patients and their caregivers
understand to say to the taxi-driver with the siren and flashing
red light, "take me to a hospital that does angioplasty!"
My point is that if you or a loved one has a medical
condition, find out everything you can about how to cure it, or manage
it -- and if a crisis or acute symptom occurs, what to do about it.
Use the internet, work with your doctor -- but in the current state
of things, a great deal of how well you fare is up to you.
** To read this story
by Janny Scott online, you need to be registered (no charge) at nytimes.com.
However, a non-photo no-registration-required version can be found
in a number of NY Times affiliated sites, such as the Wilmington-Star
News (NC). But I highly recommend the original -- let the NY
Times know this is an important subject.
May 16, 2005
Why Patient Education? Because It Saves
from guest-blogger, Deborah
As someone who has spent much of her career promoting medical innovation and
patient participation in healthcare, I was heartbroken and appalled reading
New York Times feature story profiling the disparities in heart disease
treatment in America.
In the Times article only one of three heart attack
victims received the "gold standard" of care -- emergency
angioplasty followed by on-going disease management.
Each year thousands of physicians and manufacturers
flood industry meetings (TCT, ACC)
to celebrate, debate and market the latest technologies and treatments.
But emergency angioplasty has been the preferred treatment for heart
attack for several years. It was one of the first
topics raised on our site when we began in 1997. One has to ask,
why is this best practice still not a universal standard?
In fact, in terms of real improvements in patient
care, emergency angioplasty
to curtail heart damage may be the most solidly evidence-based
application of interventional cardiology procedures. Yet at industry
meetings the emphasis always seems to be on the marketing of new
and better technologies. Who is making sure that known innovations
are diffused, that people find their way to receiving the best that
medicine has to offer right now?
The profession has also known for decades the absolute necessity of post-procedure
support and disease management for heart patients. We know interventions are
not a cure for heart disease. Why is this message so often not reaching practice
levels? What is the responsibility of the leading physicians and healthcare
companies to not only pursue research into new and better technologies, but
also ensure that already established protocols and knowledge are implemented,
so that more lives are actually saved?
I ask this question in part because it has become increasingly difficult to
maintain corporate underwriting for Angioplasty.Org.
It's hard to measure a bottom-line result from educating patients. But we still
believe that public education is essential to saving lives.
Angioplasty.Org reaches 700,000 people a year,
but we are just a tiny effort to promote innovation to the public,
to help people seek out the best care and participate in their own
recovery. And, unfortunately, the people who get the short end of
healthcare in America, the poor and the uneducated, are the least
likely to find websites like this one.
Nonetheless, according to recent research nearly
half of all heart disease patients are on the Internet; 70%
of patients now turn to the internet first for healthcare information.
We receive many letters
from patients who find our site after undergoing an unexpected
angioplasty. These people are desperate for information and support.
There is no question about it: there needs to be
far more investment in bringing quality information to the public,
the media and the profession if new technologies are going to effect
the real bottom line: saving lives.
May 9, 2005
Take Your Meds -- Part II
I've talked about the interplay of stents
and dollars in previous business news. But here's a couple items
that show how such an interplay may affect the patient's healthcare.
HealthDay, a good source of health news,
reported last week the news that Drug-Coated
Stents Show Shortfalls. And I talked about the problem of late
stent thrombosis in my previous entry below. This was all prompted
by an Italian
study published in the May 4 issue of JAMA which reported that
in the "real world", stent thrombosis (fatal in 45% of
the cases studied) occurred twice as often as in clinical trials.
Was this true? Was there in fact a shortfall to this "revolutionary
new stent technology"?
The study has some pretty strong cred. One of the
authors was Dr. Antonio Colombo, a pioneer in the use of stenting
and, as Dr. Paul Yock points out in this video
clip, one of the first cardiologists to show (via intravascular
ultrasound) that the chief cause for the high rate of stent thrombosis
in the early days of stenting was the gross underexpansion of the
stent. That is, by not expanding the stent fully, a gap was created
between the stent and the arterial wall, a perfect place for blood
cells to collect...and thrombose (clot). So Dr. Colombo knows from
whence he speaks.
And while underexpansion of stents was still one
of the cautions in this most recent report, the most likely chief
cause of this doubled rate was the "premature withdrawal" of
antiplatelet drug therapy -- specifically clopidogrel (Plavix) or
ticlopidine (Ticlid), along with aspirin. These drugs work together
to make the blood "slippery" and keep it from clotting.
Recommended durations of taking these drugs vary from 3-6 months,
even up to a year or more, and aspirin for life. The result? In a
clinical trial that includes follow-up and monitoring post-stenting,
patient compliance (sticking with the meds) is pretty high.
But then there's the "real world" --
where patients may not comply because they're not aware of how important
these post-procedure drugs are (they think they're "cured")
-- or possibly, as reported in another study today in the American
Heart Association's Circulation Rapid Access, the post-treatment
regimen may place too high a financial burden on the patient. This
study, from the well-known Mid-America Heart Institute, showed that
patients who faced such financial burdens did better post-procedure
(more relief from angina, etc.) having bypass surgery. Because bypass
surgery (CABG), once done, does not require the amount of medications
that percutaneous therapies do to achieve relief from angina and
other quality-of-life benefits -- at least that's one of the speculations
in the study (which, by the way, was submitted to Circulation a year
To extrapolate some of these thoughts to the problem
of stent thrombosis with the new drug-eluting stents -- the problem
is not with the stent per se, but with the "Reality" (in-joke)
that their use requires taking a relatively expensive drug for 3-6
months, or a year, something which certain people, who don't have
the best medical insurance, may find prohibitive. Back in an October
issue of The Lancet (sorry, subscription only to read) Dr. Mark
J Eisenberg of Montreal, suggested that physicians should perhaps
be cautious when implanting drug-eluting stents in patients who have
a high likelihood of non-compliance with post-stent drug therapy:
“What can we do to avoid late thrombosis
after implantation with a drug-eluting stent? First, we should
strongly reflect on the potential clinical consequences before
we insert such a stent. Will the patient need a subsequent surgical
procedure necessitating the interruption of antiplatelet therapy?
If so, a drug-eluting stent might not be the best choice. Will
the patient be compliant with prolonged antiplatelet therapy?
If not, a bare-metal stent might be preferable.”
Is the answer that cardiologists recommend that
their poorer, or "financially burdened", patients be sent
to bypass surgery instead of taking advantage of the latest and greatest "revolution" in
minimally invasive heart treatment?
The authors of the Circulation article say this
is not necessarily indicated by their findings and that more study
is needed. But it's a damn good question....I welcome and will reprint
comments on this topic!
May 3, 2005
Take Your Meds!!!
I will post a more in-depth piece on this
shortly, but the news today in the Journal
of the American Medical Association is very important, and
it has been discussed
in this blog before.
Drug-eluting stents (DES) work by supressing the
growth of excess endothelial cells around the stent, thus preventing,
or at least significantly reducing, the tendency of the cells to
grow back and form a blockage to the flow of blood. But the blood
also "sees" the metal stent and occasionally has a greater
tendency to want to clot. This has been a known characteristic of
drug-eluting stents and is why blood-thinning drugs have routinely
been prescribed for at least three months for sirolimus stents (a.k.a.
Cypher) and six for paclitaxel-coated stents (a.k.a. Taxus). Many
cardiologists prescribe these drug for at least a year, and aspirin
for life (at least aspirin is cheap!).
As it turns out, the "real-world" experience
of drug-eluting stents in this study showed a clotting or thrombosis
in twice as many patients as in the clinical studies. It's quite
likely that a significant part of this increase was due to premature
withdrawal of the antiplatelet medications discussed above. 29% of
the patients who stopped taking Plavix or ticlopidine and aspirin
too soon experienced thrombosis. And this is not a minor complication:
45% of those patients died.
Hence the title of this entry: Take Your Meds!
I will discuss this study in more detail -- but
one concern is whether or not there actually is a difference in the
two drug-eluting stents with regard to thrombosis, or whether there
is a significant difference between any drug-eluting stents and the
earlier bare metal variety. (Most cardiologists queried think that
there is not a large enough trial to say one way or the other right
now). Dr. Martin Leon has stated, that drug-eluting stents, as
a class, may prove to be more thrombogenic (greater tendency
to clot) and therefore patient compliance to antiplatelet therapy
And again, to put perspective on what double the
thrombosis rate means: the rate in this study was 1.3% (slightly
more than one in a hundred) as contrasted with a lower rate of 0.4-0.6%
(one in two hundred) that has been observed in clinical trials (this
lower figure is similar to the frequency of thrombosis in bare metal