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May 26, 2009 -- 5:45pm EDT
Breaking News -- Texas Senate Passes Calcium
Scoring Bill
On Saturday May 23, the Texas State Senate
passed the Texas Heart Attack Preventive Screening Bill (HR 1290)
by a vote of 26-5. This is significant because it mandates insurers
in Texas to cover Calcium Scoring, the first legislature to do
so. There was some controversy
back in March when this bill was being discussed, but it
has now passed. More details shortly.
Late update: Leaders of the Society for
Heart Attack Prevention and Eradication (SHAPE) have issued a press
release explaining how this legislation will benefit patients
and reduce costs. They are urging Texas Governor Rick Perry to sign
the bill into law
May 26, 2009 -- 12:05am EDT
Women's Heart Health at Stanford
In
my recent interview with Dr. Jennifer Tremmel, Clinical Director
of Women's Heart Health at Stanford, we discussed some of the ways
in which heart disease manifests itself differently in women than
in men, and how treatment for women has been skewed by the historical
context. As Dr. Tremmel noted:
In cardiology, we started doing research
back in the late 40's early 50's -- predominately on men, so
women made up only about a quarter of the patients in most
trials. And we've been applying that data to both sexes, assuming
it would be fine. But men's outcomes have improved over time
and women's have not, until very recently -- so one would theorize
that applying the same data to both men and women is not the
way to go.
About a decade ago we started to have more
data coming out about women and how they differ from men
and how we might treat them differently, approach them differently
so they would have better outcomes. And this applies to everything.
How risk factors impact the sexes differs, how women present
with coronary disease differs from men, what tests are more
accurate in women differs from men, and how they do with
our procedures, PCI, CABG, differs -- they tend to have worse
outcomes, although that is improving.
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One specific area where Dr. Tremmel recently
has made changes, and this was the focus of our interview, was
in the vascular access site she uses in catheter-based procedures.
She notes that women have higher rates of bleeding complications
than men when the femoral (groin) access site is used -- and it
is used in more than 90% of procedures in the U.S. This increased
bleeding risk prompted Dr. Tremmel to examine, learn and utilize
the radial (wrist) approach to angioplasty. She now tries to perform
100% of her procedures through the wrist and, as a result, has
had virtually no complications.
More information about Women's Heart Health
at Stanford can be found here.
My full interview with Jennifer Tremmel can be found here.
May 6, 2009 -- 4:05pm EDT
Plavix PPI Study Released
Back
in January, I discussed the
latest, and somewhat confusing information about whether or not the
use of Proton Pump Inhibitors (PPI) interfered with the effectiveness
of antiplatelet drugs like Plavix (clopidogrel) -- an extremely important
medication for stent patients. Plavix can lead occasionally to bleeding
complications and may cause stomach upset. A relatively new class
of drugs, including Nexium, Prilosec, Prevacid and Protonix, were
supposed to be very effective in countering stomach upset and possibly
gastrointestinal bleeding.
But a
study released today at the SCAI annual meeting showed a greater
than 50% increase in major adverse cardiac events in stent patients
who were taking both clopidogrel and a PPI.
The message was that PPIs have probably been over-prescribed
for this particular patient population. The recommendation to patients
was to consult their cardiologists, and not unilaterally change their
drug regimen (and specifically not to stop taking Plavix --
early cessation of clopidogrel carries an increased risk of stent
thrombosis which can lead to heart attack or death). The recommendation
to physicians was to look more carefully at why each individual patient
might or might not benefit from a PPI, but probably not to give it
prophylactically -- and also to return to an earlier class of drugs,
called histaminergic (H2) blockers (Zantac, Tagamet) or even common
antacids.
Of course, a reader of an earlier posting on this
blog, D.B. who is a pharmacist in California, already figured
this out for himself.
Oddly enough, the incidence of gastrointestinal
bleeding that required hospitalization was very low across the board,
but numerically lower in patients who were not taking PPIs.
May 4, 2009 -- 12:45pm EDT
Effectiveness in Stenting
Aside
from stents themselves, there's a whole toolbox of devices and techniques
that are candidates for "comparative effectiveness" in
that they may be able to increase the success of interventional procedures
-- or even target patients who need these procedures more accurately.
As Volcano Corp.'s CEO Scott Huennekens wrote in a recent
Washington Times op-ed piece:
The United States needs to focus on treating
the right patient at the right time with the right method to
lower health care costs, improve patient outcomes and foster
research and development.
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Huennekens' piece was titled, "Obama
effectiveness proposal: a tool for finding faster, less expensive
medical solutions? " and he details why he agrees with
and supports President Obama's decision to study "comparative
effective research" -- primarily because there are a number
of ways that new technologies, many of them (of course) manufactured
by his company, will be useful for interventional cardiology.
Among
them is intravascular ultrasound (IVUS) which shows more accurate
information about stent placement and expansion than can be seen
on an angiogram. Last July Angioplasty.Org posted an article titled, "Intravascular
Ultrasound (IVUS) May Reduce Drug-Eluting Stent Thrombosis by a Third" showing
the results of a study, led by Dr. Ron Waksman of Washington Hospital
Center.
Another is Fractional Flow Reserve (FFR) which
can measure whether or not a blockage seen to be significant on an
angiogram is in fact obstructing blood flow, and how much. The recently
published FAME study, detailed in our piece, "Better
Outcomes for Stents When Fractional Flow Reserve (FFR) is Used",
showed 28% reduction in major cardiac events when FFR was used to
determine which blockages to stent and which to leave alone. Also
one-third less stents were used: more effective therapy and more
cost-effective too.
We continue to cover other areas where the effectiveness
of catheter-based therapy can be improved. Our Transradial
Access Center details the ways in which bleeding complications
can be reduced, just by changing the access site for diagnostic and
interventional procedures. And we're closely following the use of
other imaging modalities, like Cardiac CT angiography (CCTA) which
shows promise in eliminating a significant number of invasive diagnostic
caths by accurately ruling out coronary disease -- and Optical Coherence
Tomography (OCT) which may help in determining stent strut coverage
and whether it is safe for the patient to stop taking antiplatelet
drugs, such as Plavix.
Innovation in medicine may not only be cost-effective,
it may be profitable as well. In an
excerpt from The Wall Street Transcript's annual Medical Device issue,
Matt Dolan of ROTH Capital Partners predicts that, counter to some
companies, Volcano is looking at a continued growth rate of 20%.
Very effective, indeed.
(By the way, the photo posted with Scott Huennekens'
op-ed on the Washington Times web site is NOT Huennekens, but Montana
Senator Max Baucus -- go figure.... Huennekens is pictured correctly
at the top of this article.)
May 1, 2009 -- 4:30pm EDT
Comparative Effectiveness Research and
The Patient
More
than a billion dollars has been allocated to "Comparative Effectiveness
Research" in the U.S. Federal government's stimulus package,
yet the term continues to be confused with "cost-effectiveness".
They are not the same, and in an attempt to clarify the difference,
Angioplasty.Org will be posting a number of articles and interviews
in the near future about these issues: specifically how they impact
the field of interventional cardiology.
But in the short term, here are a few quick
looks.
In March we posted an
article about the SYNTAX study which compared bypass surgery
to stenting in multivessel disease. The results were not a "yes
or no", but more nuanced. Surgery was still the preferred
treatment for patients with severe multivessel disease. But for
patients with less severe situations, stenting was just as effective
("comparative effectiveness") -- in fact, the authors
cited patient preference as an important decision factor. We
quoted Dr. Elizabeth Nabel, Director of the National Heart, Lung,
and Blood Institute (NHLBI):
This study is an example of Comparative
Effectiveness Research which is...a rigorous evaluation of
two different types of treatments... towards the same medical
condition. And it evaluates the effectiveness of both those
approaches.
It may be that what we're coming down to
is a discussion between the patient and the medical and surgical
team, really focusing on patient preferences, complexity
of coronary anatomy and potential risks and benefits, depending
upon their medical state and their co-morbidities.
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This concept of a partnership between the patient
and physician is echoed in an op-ed piece in today's Baltimore
Sun by Ruth R. Faden and Jonathan D. Moreno. Titled "Power
for Patients: Comparative effectiveness research will help people
make better health choices", the article emphasizes the
importance of patients' control over their treatment, but in tandem
with their physicians, and based on the most current information:
Critics charge that comparative effectiveness
research will lead to "one-size-fits-all" guidelines that cater
to a non-existent average patient for the sake of making the
system more efficient. In fact, patients will be empowered
by rigorous, evidence-based recommendations that are specific
to the needs of particular patient groups. Research on comparative
effectiveness would provide data to help each patient make
the best possible choice with his or her doctor.
Patients want the right to make decisions
with their doctors in order to pursue what is in their own
best interests. Choosing blindly is an empty right; choosing
with evidence respects patients' rights and enhances quality.
This is a case in which good ethics demands good facts.
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We at Angioplasty.Org concur. Each month, 30,000
readers visit our Cardiology
Patients' Forum, looking for the latest information to help them
make complex decisions. We always encourage those readers who post
questions to discuss the information they find with their physicians.
One thing we have found, and this is backed up
by research:
Online health seekers, particularly those
faced with chronic diseases, want access to the type of in-depth
information their doctors read, they want the latest news on
the latest studies, they want to know what top doctors recommend.
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That is why, at Angioplasty.Org, all of our articles
are available to all readers, whether patients or healthcare professionals
-- to help foster the partnership that is so critical for "effective" treatment.
Comparatively speaking, that is.
April 21, 2009 -- 5:15am EDT
CT Scans for Strokes
In
today's Wall Street Journal, Thomas M. Burton discusses
the controversy over the use of CT scans to diagnose and triage treatment
for stroke victims in his article, "Doctors
Push for More Scans in Stroke Cases".
It's an important topic, and one which Dr. Nick
Hopkins, head of the Toshiba Stroke Center, discusses in more detail
during our
interview, posted in Angioplasty.Org's Imaging
and Diagnosis Section.
Stroke has been called a "heart attack in
the brain". If only it were that simple. A heart attack is caused
by a sudden stoppage of blood to the heart -- the treatment: open
up the blockage.
But strokes can have two different causes -- and
the treatments for these two different types of stroke are totally
opposite. An ischemic stroke, the "heart attack in the brain" type,
is treated with clot-busting drugs, and/or a clot-retrieval device,
threaded to the brain via a catheter, not unlike angioplasty.
But the second type of stroke is caused by an aneurysm
or other type of bleeding complication. Giving a clot-buster in this
situation would be disastrous.
Luckily, a CT scan of the brain immediately tells
the physician which type of stroke the patient is having. And luckily
again, CT scans can be done very quickly in an Emergency Department
set up for this type of diagnostic procedure. Furthermore, as Dr.
Hopkins points out, there's yet another advantage to the CT scan
-- it also shows the viability of the brain tissue. If significant
parts of the patient's brain tissue have died, attempting to reperfuse
(increase circulation) in those parts may cause even worse complications,
such as hemorrhage.
The controversy detailed in Burton's article is
over official guidelines for the use of CT, with implications for
reimbursement. I won't get into the details, because you should read
his piece, but this is just one more issue where advances in imaging, being
able to see, have profound implications for being able to
treat.
April 18, 2009 -- 10:45pm EDT
Plavix and PPIs: Update
A
couple of months ago I
wrote about the confusion surrounding the combination of Plavix
and Proton Pump Inhibitors (PPIs) -- the FDA had just issued a statement
that there was concern that PPIs may interfere with Plavix, the news
media carried many stories warning of a potential risk, but the ACC,
AHA and SCAI urged patients not to change their medications without
consulting their cardiologists (Plavix is critical for stent patients
in order to reduce the risk of stent thrombosis).
So earlier today reader D.B., a pharmacist in California,
sent in this:
Great site. My wife had 2 stents inserted
in January and doing OK. My concern about PPI's and Plavix
brought me to your site. I believe your...article contains
the latest info. Are you aware of any new info? I'm planning
to switch my wife from the PPI, Protonix to a H2 blocker, Pepcid.
Have you read anything about the effectiveness of H2 blockers
helping to control stomach irritation from Plavix & ASA? Thanks
again for your site and blog.
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In fact, there are two recent updates.
One is a study in the current issue of Thrombosis
and Haemostasis, an official publication from the European
Society of Cardiology. The article, "Impact
of proton pump inhibitors on the antiplatelet effects of clopidogrel",
shows a definite effect in the inhibition of clopidogrel's antiplatelet
function when using omeprazole (a.k.a. Prilosec) but, interestingly
enough, the other PPIs tested showed no such effect. However, it
was a study that measured platelet reactivity and not clinical
results, so the other PPIs are still not out of the woods. In fact
an editorial in the same issue recommends against the use of PPIs
with Plavix (clopidogrel) which goes against the recommendations
of the American societies.
The second update (or future update) may clear
some of this up in a few weeks. New results from the Medco
study are scheduled to be presented at the annual SCAI meeting
in Las Vegas May 6-9, so we'll be reporting on that when it breaks.
It will be interesting to see if guidelines and recommendations will
change as a result.
As for H2 blockers (like Pepcid) they were by and
large replaced when PPIs hit the market. There is question how effective
they are in this situation, and they also had some side-effects,
but were never shown to inhibit antiplatelet drugs like Plavix.
April 6, 2009 -- 10:00pm EDT
Cardiology Sites Taking Notice of the Radial
Approach to Angioplasty and Stenting (PCI)
Two
months ago, I
wrote about a poll on theheart.org, which asked the question: "Should
radial access become the default choice for PCI?" Well,
as of today, the poll is still on their home
page. Evidently radial access is a popular enough topic to
warrant two whole months of display.
This is interesting on several levels: one, this
poll has been posted and open for voting on theheart.org considerably
longer than previous polls; two, as of this morning (see graphic
above) over 500 votes have been tallied from healthcare professionals
who read theheart.org (this is a lot of votes for a typical poll
on their site!); and three, the vote is 50/50! -- and has been so
over
the past couple of months, sometimes going up to 52/48 in favor of
radial.
This last point, the vote results, is even more
interesting because the most recent data from the NCDR database shows
that less than 3% of angioplasties done in the U.S. are done via
the radial artery in the wrist; the mainstay of catheter-based procedures
in this country remains the femoral artery in the leg/groin. (Not
so around the world, where 50% or greater is the norm. In fact those
cardiologists who are proficient with the radial technique tend to
use it in 70-80% of their cases.)
So if less than 3% of PCIs are done via the wrist,
why is the vote 50/50? Is it because many cardiologists from outside
the U.S. have been voting? Or is it because many cardiologists feel
that
radial should be the preferred access site -- but they just
don't practice it themselves? Or, more likely, aren't trained in
it?
For two years now, Angioplasty.Org has been offering
a special section on this technique, our Transradial
Access Center, offering information to both physicians and patients
about the advantages of the radial approach: less complications,
greater patient comfort, cost-effectiveness, etc. And we've also
been listing training opportunities, U.S. hospital centers where
radial is practiced, interviews with key cardiologists who use it.
And we've seen increasing interest in the radial approach as a result.
In fact, today the weekly poll on another "professionals
only" cardiology site, CRTonline.org,
asks the question:
"How frequently should radial access
for PCI be used? Greater than 50%, between 20-50% or less than
20%."
Only 64 votes have been cast at present, and almost
half are saying "less than 20%", so it will be "interesting" to
see how this goes as the week progresses.
So...to you radialists out there, go
vote!!
Late Update: Alas! theheart.org has taken down
its poll -- glad I got a screenshot of the final tally.
Later Update: The poll at theheart.org -- is
back online!
March 24, 2009 -- 1:55pm EDT
Is The Scaffolding Coming Down?
Today's good news about Abbott's
bioabsorbable stent brings the following analogy to mind.

Scaffolding
on Building |
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A stent
is often described as a "scaffold" inside the artery.
Indeed, in the era of POBA (Plain Ol' Balloon Angioplasty)
elastic recoil of the arterial plaque could reblock the freshly-opened
artery, or the ragged interior surface left after the balloon
fractured the plaque would lead to increased rates of restenosis. |
| So
angioplasty pioneers developed the stent, a scaffold to hold
the artery open. Recoil virtually disappeared. Abrupt closure,
which led to emergency CABG 3-5% of the time, was reduced by
a factor of 20. And while stents reduced restenosis, these
devices produced their own unique brand of complications. |
|

Scaffolding
in Artery |
Unlike their construction counterpart, scaffolding
inside the artery cannot be removed when the job is finished. Metal
stents are permanent. They (hopefully) get covered over by endothelial
cells and are incorporated into the lining of the artery, but cell
growth can occur inside the stent, reblocking the blood flow (in-stent
restenosis) or in the case of drug-eluting stents, the endothelial
healing can be delayed, causing platelets to aggregate around the
bare metal structure, causing a blood clot and possible heart attack
(late stent thrombosis).
These complications are small in number (very small
in the case of late stent thrombosis) but they complicate what should
be a simple task. Fix the arterial wall until it heals and then "Take
Down The Scaffolding!"
There's also the issue of the "straight-jacket",
as Dr. Charles Simonton of Abbott calls it. A metal stent must, by
its presence, restrict the normal natural flexibility of the coronary
artery (which is beating and moving all the time). Certainly the
newer stents with thinner struts are better, but patients with 7,
8 or more stents can get into the realm of what's called a "full-metal
jacket". And too much metal can compromise future therapy as
well -- bypass surgery, for example.
Enter (or exit!) the bioabsorbable stent. As recent
results have shown, the stent, having done its job, disappears after
two years. Normal motion is restored to the artery which, in many
ways, acts like it did before the stent was placed, except that the
blockage is gone.
These are, of course, hopes. The early trial was
only 30 patients. Abbott announced a second phase today which will
bring the total to 110. All agree that larger trials with more patients
and more complex anatomy must be done. All also agree that this technology,
if it proves as safe and effective as the small trial, could revolutionize
the treatment of coronary artery disease yet again.
March 11, 2009 -- 7:30pm
EDT
Broadcasting Live Cases
Last
Friday, my short video, recalling the origins of the "Live Demonstration
Course" in interventional cardiology, was shown during the final
day of CRT
2009, an interventional meeting chaired by Dr.
Ron Waksman of the Washington Hospital Center.
The venue was the "FDA Workshop: Should Live
Cases be Broadcast to Meetings? Regulation in Education and Training."
Recently U.S. Representative Henry
Waxman and Senator Charles
Grassley have been concerned about the ethical implications
of broadcasting live cases involving angioplasty, stents, and related
devices. So, as a pioneer in the development of this educational
format, I felt obliged to offer the historical context. In fact,
coronary angioplasty would not exist if it were not for the live
demonstration course.
The early live cases we did in the eighties focused
a great deal on the patient -- Dr.'s Gruentzig, Dick Myler, etc.,
would have active live conversations with the patient -- the audience
got to know them a bit and the human side of the patient and physician
experience was transmitted, along with the medical techniques. This
real-time, holistic look into the cath lab was a key educational
component of these courses. And, everyone on the team and in the
audience felt invested in each patient's best outcomes.
Those of us who participated in creating those
courses had no question
that a live case broadcast was an advantage for the patient who chose to be
included, not a negative. And, we saw how viewers' participation in the entire
unfolding case, and observing the decision-points, was a powerful physician
training tool.
While demonstration case broadcast has radically
changed, it's worth looking at the effect this approach had on the
profession, and identifying what factors, perhaps even guidelines,
need to be present to determine its continuing potential to be an
effective and ethical educational tool moving forward.
My video (supported by a grant from Abbott Vascular)
is currently viewable at CRTonline's version of YouTube, called CardioTube.
March 10, 2009 -- 6:15pm EDT
Bent Out of SHAPE
Today the Texas House of Representatives has
been holding a public hearing on bill HB 1290, sponsored by Rep.
Rene Oliveira, which mandates that any health insurance plan that
covers medical screening must also cover Coronary Artery Calcium
(CAC) screening, a test which currently is NOT covered by Medicare
or by most insurance. This would be a major step forward for this
imaging technology.
Two
years ago, the Houston-based Society
for Heart Attack Prevention and Eradication (SHAPE) group issued
a set of guidelines for early detection of heart disease. As
reported on Angioplasty.Org, the SHAPE recommendations generated
quite a bit of controversy at the time, with passionate advocacy
of the test on the part of the SHAPE authors, and comments from
others in the cardiology community, such as Dr. Philip Greenland
of Northwestern, who called the report "an apparent effort
to subvert the long-standing evidence-based guidelines approaches" of
the major heart societies, such as the ACC and AHA. A Texas bill,
virtually the same as the current one, was voted down in committee.
Which is why, to everyone's surprise, Dr.
Morteza Naghavi, founder of SHAPE and Chairman of the SHAPE Task
Force, stated in a Friday press release that, "We are also
pleased to know that the American Heart Association has elected
to support the bill as well."
Well, not exactly.
As Larry Husten, former editor of theheart.org, reported
last night in his blog CardioBrief,
the AHA has denied any endorsement. He writes that the AHA spokesperson
said:
...he had told the Texas legislators that “I
don’t know if we are there yet” and that without better scientific
evidence the AHA would be unable “to put a card in favor” of
the legislation.
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I contacted Dr. Naghavi of SHAPE. He told me that
he'd been informed of the AHA endorsement during a conference call
last Thursday by Michael Gray of Rep. Olivera’s staff. Reportedly
Joel Romo of the AHA had conveyed news of the AHA's support to Mr.
Gray and was "upbeat about it."
This afternoon the SHAPE Society sent me the following
statement:
"After the public announcement of the March
10 hearing of the Texas Heart Attack Prevention Screening Bill,
our SHAPE representative was informed by Michael Gray, from
Congressman Oliveira's office, that the verbal commitment he
had received from AHA representative, Joel Romo, to support
the bill is no longer on the table. We are extremely disappointed
that, only hours prior to the hearing, AHA has backed out from
supporting such monumental bill, and, instead, wished to remain "neutral".
However, SHAPE remains hopeful that as new studies uncover
in the field, AHA will reconsider its position."
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Obviously, there's just a bit of politics going
on here, most of it outside the House of Representatives.
What's interesting is that among the many distinguished members of
the SHAPE Task Force are Dr. Pamela Douglas, a past-president of
the American College of Cardiology and Dr. Valentin Fuster, a past-president
of the American Heart Association.
Angioplasty.Org will be posting an in-depth report
on the SHAPE recommendations and their implications in today's healthcare
environment. Stay tuned.
Late Update: SHAPE has revised its press
release and removed the reference to the AHA endorsement, but
you can still read the cached
version here.
February 17, 2009 -- 5:00pm EST
Medpedia -- OMG!!!
So
yet another web-based health site was launched today, with great
fanfare in the New
York Times, CNET and
other news outlets.
According to Medpedia's founder:
[James] Currier is aiming to build the
most complete database of information from medical professionals
and combine it with forums for consumers and patients to share
treatment stories, raise questions and directly engage with
the physicians editing Medpedia’s content.
|
Since the New York Times featured a screen shot
of a page titled "Coronary Artery Angioplasty", I felt
it was fair game to critique the information on the
angioplasty page and its sister page on "Cardiac
Stents".
Cutting to the chase, I am far from impressed.
In fact, I read these two pages and my reaction, as per the title
of this posting, was OMG!!! If the information contained in these
two entries is any indication of the accuracy of the rest of Medpedia,
I would definitely advise patients to go elsewhere.
The entries on angioplasty and stents are
riddled with outdated and blatantly incorrect information about
interventional treatments for coronary artery disease. I am truly
surprised, given the sources that Mr. Currier cites in his statement
to the New York Times:
Mr. Currier said Harvard Medical School,
the National Health Service in England, the Centers for Disease
Control and Prevention, and the School of Public Health at
the University of California, Berkeley, are among the medical
organizations that have donated more than 7,000 pages of content
to Medpedia. Some institutions, including the N.H.S., the American
Heart Association and the University of Michigan Medical School,
will encourage staff and faculty members to contribute to Medpedia.
|
It sounds impressive, to be sure, but here is just
a sampling of the misinformation (with corrections) on the topic
of angioplasty and stents:
Medpedia states: "A heart attack occurs
when blood flow through a coronary artery is completely blocked.
Sometimes the accumulation of plaque causes the blood vessel to
burst and a blood clot to form on the vessel surface." Bizarre
to say the least. Arteries bursting?? This is not even close to
a description of a heart attack.
In describing an angioplasty, Medpedia states: "The
doctor passes a long, thin, flexible tube (the catheter) through
the sheath, over the guide wire, and up to the heart. The catheter
is moved to the blockage, and the guide wire is removed." Perhaps
this may be seen as wonkish, but the guide wire is NEVER
removed during the procedure. It is the "rail" over which
all catheters are advanced. It is only removed when the procedure
is over and the patient is judged stable.
In describing "cardiac stents", Medpedia
states: "The meshwork of stents is usually made of metal,
but sometimes a fabric is used. Fabric stents, also called stent
grafts, are used in large arteries." Well...except that
(1) "fabric stents" actually contain metal and (2) they
have nothing whatsoever to do with coronary artery disease or cardiac
stents -- stent grafts are used, sometimes, to treat a triple A --
Abdominal Aortic Aneurysm -- this is an unrelated medical issue which
has nothing to do with blocked coronary arteries.
Medpedia states that: "In about 20% of
cardiac stent placements, the artery narrows again within six months
of the angioplasty." Correction: with drug-eluting stents
(DES), the numbers for restenosis are in the single digits. This
is not news -- DES were introduced in the U.S. five years ago!
Medpedia states that: "Treatment with
radiation can also limit this growth [restenosis]. For this procedure,
a doctor places a wire where the stent is placed. The wire releases
radiation and stops cells around the stent from growing and blocking
the artery. This procedure, involving intracoronary radiation,
is known as brachytherapy." Unfortunately for Medpedia,
not only has brachytherapy not
been proven useful, but both companies making brachytherapy
equipment ceased manufacturing several years ago.
And I could go on, but I'll end with this...Medpedia
states that "Metal stents preclude patients from having
a magnetic resonance imaging (MRI) test within the first few months
following the procedure." Except that the FDA approved
both the Cypher and Taxus DES for immediate MRI FIVE YEARS AGO! In
fact on Angioplasty.Org, we have a Patient
Forum Topic just answering questions about this issue. Correction
-- it is perfectly safe to have an MRI immediately following stent
placement.
As a rough estimate, it would seem that much of
the information about interventional medicine on Medpedia is five
years old.
Angioplasty.Org has been online since 1997, has
thousands
of patient postings, and reports the most current news
about stents, angioplasty and interventional medicine. Considering
the quality of the information about this area that I've seen on
Medpedia, I would not call it Web 2.0 -- rather Web minus 1.25.
February 11, 2009 -- 12:25pm EST
Taking Cost-Effectiveness to Heart
The current economic environment is forcing
many issues into sharper focus. Cost-effective medical therapy is
one and it presents the Obama administration with a major challenge,
as Alicia Mundy reports in
Monday's Wall Street Journal:
The drug and medical-device industries
are mobilizing to gut a provision in the stimulus bill that
would spend $1.1 billion on research comparing medical treatments,
portraying it as the first step to government rationing....
The administration hopes to expand coverage while limiting
use of treatments that don't work well.... The House version
of the stimulus package sent shudders through the drug and
medical-device industry. In a staff report describing the bill,
the House said treatments found to be less effective and in
some cases more expensive "will no longer be prescribed."
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I'm all for expanding medical coverage: it's dis-heartening
(sorry!) how many patients write into our Forum,
unable to afford critical medications like Plavix because
they've lost their insurance -- some have stopped taking it; some
have had heart attacks as a result. So to expand coverage to more
people, the money is going to have to come from somewhere.
But my immediate reaction to hearing that government
might be "comparing medical treatments" to determine which
are "effective" is not so much the "I'm not going
to let bureaucrats tell me what I can and can't do" stance,
as it is the fact that, at least in the field of the treatment of
heart disease, there are so many unresolved questions within the
medical specialties themselves. And each new study or trial often
(not always) adds new and confounding information. I mean we still
aren't sure how long Plavix needs to be taken post stenting. Should
we use bare-metal or drug-eluting stents, when and in whom -- or
no stents at all because the Fractional
Flow Reserve is above 80? CT Angiogram or not? Or should we reverse
the historical trend and put interventions on the shelf, a la COURAGE,
and stay with medical therapy only for most?
If doctors can't agree on the best therapies, how
can government agencies do so?
Where
some insight can be found is in The
Editor's Page of the current JACC Cardiovascular Interventions. Dr.
Spencer B. King, III, a pioneer of coronary angioplasty, discusses
the opportunity for medicine in this era of "danger". One
thought stood out for me:
Science and technology have been at the
heart of interventional cardiovascular medicine and must also
drive medical intervention. Through clinical research, we have
created an extensive evidence base that is currently being
enforced through various mechanisms, but does one-size evidence
fit all? It would be ludicrous to put a stent in every patient
with angina without clear evidence of what the treatment was
to accomplish. On the other hand...the suggestion that everyone
with an abnormal C-reactive protein needs massive statin therapy
is the one-size-fits-all concept that, along with direct-to-consumer
advertising, drives medical costs. Medicine must be personalized
in order to be effective and cost-effective...the era of "every
therapy for everyone" is over. The opportunity for medicine
is to harness the power of technology, medical informatics,
genetics and personalized prevention, and therapy for the best
outcome for our patients.
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Personalized medicine. It's a concept that's been
bandied about for a while now, but with new and exciting developments
in decoding genetic markers, along with the hard work of physician
teams and medical societies who have been authoring Appropriateness
Criteria, the idea is being recognized as critical: a variety of
available therapies is needed to treat a variety of individuals and
physicians need to use the most current data to triage the right
patients to the right therapy.
Headlines in the popular press that proclaim "medical
therapy trumps stents" or "CT scans are useless and costly" are
meaningless, unless applied to specific patients with specific individual
clinical situations. Stents or statins can be great for the right
patient; not so much so for the wrong one.
So, as someone who has never been able to walk
into Macy's and just buy a suit off-the-rack, I sincerely hope the
push towards cost-effectiveness does not put much stock in the concept
of one-size-fits-all medicine.
February 6, 2009 -- 5:30pm EST
Vote for Radial!
This
week's poll on theheart.org is about the transradial (wrist) approach
to catheterization and angioplasty. The question is "Should
radial access become the default choice for PCI?" (scroll
down to access the item.)
We, at Angioplasty.Org,
have been bringing this technique of catheter-based interventions
to the forefront and now, theheart.org (part of WebMD) has taken
up the question.
The current voting is 47% to 53%, slightly
favoring femoral -- but this almost 50/50 vote is interesting,
since currently in the United States, only 3% of PCIs are done
radially. If you favor the radial approach, let your voice be heard!
February
5,
2009 -- 5:00pm EST
CT Heart Scans, Radiation and the Media
A
new study, published
yesterday in JAMA, describes a wide variation in
the measured radiation exposure from CT angiograms,
depending on
which of 50 centers did the scans, what methods were used and, to some
extent, which scanner was used. This report predictably resulted in
"glowing" headlines about CT angiograms -- and not the good
kind of glowing.... Here's a sampling:
However, the point of this study was not to show
that CT scans of the heart have suddenly been found to be dangerous!
In fact, the doses recorded at the high end were what was considered
"normal" less than a year ago (e.g.
NY Times, June 29, 2008). Strikingly, as the accompanying
editorial
by Dr. Alfred Einstein states:
"The estimated overall median effective
dose for CTA...was 12 mSv, somewhat less than the value reported
in several earlier studies using 64-slice scanners."
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What is actually real important news,
for both medical professionals and patients, is that,
using dose reduction strategies, CT angiograms of excellent quality
were done with exposures of only 2.1 mSv, approximately what New
York City residents are exposed to annually, just from walking
around. That's why I titled Angioplasty.Org's coverage, "CT
Scans of the Heart Can Be Done with Low Radiation Dose." That's
news!
And the implications for patients and professionals
are profound. If you are a patient, says Dr. Michael Poon, past
president of the SCCT, ask the imaging center where you have been sent
for a CT angiogram, "'What method are you using to lower the
dose?'
And if they don't know what you're
talking about, I would say, 'See you later!'"
For imaging professionals, the PROTECTION I study
in JAMA has a clear message: learn the latest dose reduction strategies
and work with your equipment vendor to implement them. With radiation
at these low levels, CT angiography may mount a challenge to the
most often-prescribed nuclear stress test, which carries radiation
doses from 12-21 mSv. Of course, you never read headlines such
as "Nuclear Stress Test Zaps Patients" because it's been around
so long.
Ever since multislice CT scanners
became available in
2002-2003, industry and the imaging profession have been
working on ways to reduce the radiation exposure. The PROTECTION
I study in JAMA shows some positive results, but since 2007, when
that data was collected, technology has advanced significantly
-- enough so that Dr. Tony DeFrance, for example, regularly
performs 320-slice scans with Toshiba's AquilionOne scanner at
1 or 2 mSv. Likewise, physicians such as Dr. Michael Poon are using
GE Lightspeed units, and getting in similar ranges. Philips and
Siemens have
also developed low dose strategies.
As evidenced at the start of this post, whenever
a study about CT angiography is published, the popular press jumps
on the story with accompanying "dreadlines", doing a disservice
to the technology, those who practice it, and certainly to patients.
A shining, and unfortunately rare, exception to
this recent spate of news stories, was Dr. Nancy Snyderman, Chief
Medical Correspondent for NBC News, who discussed her own CT heart
scan with Matt Lauer on yesterday's "Today Show" (video below).
January 30, 2009 -- 9:50am EST
Wrist Angioplasty Gaining Acceptance in
U.S.
Over
the past year, the
transradial approach, doing angioplasty and inserting coronary
stents using the wrist as the access site, has gotten significant
attention. Peer-reviewed studies and presentations at meetings have
consistently shown decreased bleeding complications, increased patient
comfort and safety, and lower cost.
A big question is why it isn't used more
in the U.S. -- in Europe, Asia and South America it's done far
more often (40-50% as opposed to 2%) than the "standard" femoral
approach which uses an artery in the groin.
One answer is training and interest. Traditionally
cardiologists aren't trained to do radial procedures during their
fellowships. Another is the perception that certain complex interventional
procedures are more difficult to do via the wrist.
But this may be changing. Yesterday Dr.
John Coppola of St. Vincent's Hospital in New York held one
of his radial courses -- and it did not need to be promoted,
because it was filled to capacity even before being announced.
Terumo Interventional, which makes equipment specifically for
the radial technique, told me that all the training courses in
the U.S. that they are involved in currently have a waiting list
-- this certainly was not the case only a year ago.
This past fall major meetings like TCT and
ISET have been featuring symposia
on the radial technique, and a recent article, "Radial-access
PCI safe and successful in high-risk patients and complex lesions",
published on theheart.org, generated far more online comments from
cardiologists than the average story. And a
recent study of 600,000 patients, published in JACC Interventions,
showed a sharp uptick in radial procedures in the last quarter
of 2007. (More current data is not yet available.) And the popular
press has been reporting more as well: the CBS "Early Show" recently
did a
two-minute segment, with Dr. Howard Cohen sitting on a park
bench showing catheters to host Julie Chen!
So all of these movements are showing a gain for
the wrist approach in the U.S.
One big reason, of course, is that results
show lower bleeding complications, and lower mortality with the
wrist approach: a safer approach to both angioplasty and diagnostic
cardiac catheterization.
Support for these views can be found in the many
peer-reviewed journal articles listed in the Reference
and Bibliography section of Angioplasty.Org's Radial
Access Center (now in its second year). But one
such study, published in JACC back in 2005, recently was brought
to my attention.
A Stanford
study of 3,500 consecutive patients undergoing angioplasty
showed the incidence of retroperitoneal hematoma (RPH) at 0.74%.
This is a very serious complication, where bleeding occurs at the
femoral access site, but backwards into the large abdominal space
in the body. It's often not recognized until well after the procedure
and it can be very dangerous, resulting in serious blood loss,
increasing morbidity and mortality. This means 1 in 135 patients
will suffer this complication. And it was significantly more common
in women.
The radial approach virtually eliminates this complication.
Stay tuned....
January 28, 2009 -- 10:25am EST
Plavix Safety Update
Monday's
post about the FDA
statement on the safety of Plavix (clopidogrel) when used in
conjunction with proton pump inhibitors (PPI) such as Prilosec, Prevacid,
Protonix, Nexium, etc., made reference to a joint statement by the
American College of Cardiology Foundation, American Heart Association
and the American College of Gastroenterology.
So here is a link to the paper, titled: "ACCF/ACG/AHA
2008 Expert Consensus Document on Reducing the Gastrointestinal
Risks of Antiplatelet Therapy and NSAID Use".
The summary states:
In appropriate patients oral antiplatelet
therapy decreases ischemic risks, but this therapy may increase
bleeding complications. Of the major bleeding that occurs,
the largest proportion is due to GI hemorrhage. Concomitant
use of NSAIDs further raises the risk of GI bleeding. Gastroprotection
strategies consist of use of PPIs in patients at high risk
of GI bleeding and eradication of H. pylori in patients with
a history of ulcers. Communication between cardiologists, gastroenterologists,
and primary care physicians is critical to weigh the ischemic
and bleeding risks in an individual patient who needs antiplatelet
therapy but who is at risk for or develops significant GI bleeding.
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January 26, 2009 -- 2:30pm EST
Plavix, Prilosec, Prevacid, Protonix --
Do I Hear a Nexium?
Gimme a "P"! Or more precisely,
a PPI (Proton Pump Inhibitor). And to add a few more initials,
gimme an FDA, which today issued an "Early
Communication about an Ongoing Safety Review of clopidogrel bisulfate
(marketed as Plavix)".
The basic concern is that some recent studies
have questioned whether the effectiveness of Plavix may be compromised
by a group of drugs known as Proton Pump Inhibitors (PPI). Presented
as an abstract at the AHA in November, a
major study by Medco, the nation's leading pharmacy benefit manager,
looked at almost 17,000 patient benefit records and found a 74% increase
in heart attacks in patients taking both Plavix and PPIs together.
These include the drugs in my title, plus a few more. (Compounding
the concern is that Prilosec is also available over-the-counter.)
PPIs are often prescribed for patients who are taking Plavix, because
Plavix, especially when taken with aspirin, can cause upset stomach
and gastric bleeding and these PPIs are effective in reducing those
adverse reactions.
The problem is that PPIs may also inhibit the
enzyme that activates clopidogrel. While some studies have shown
this to be true, others have not. Also, this is not the first time
that Proton Pump Inhibitors have come under review by the FDA. In
August 2007, the FDA started
a review, based on some small studies showing an increase in
heart problems. But the clopidogrel connection was not involved there.
One of the problems is that all drug eluting stent
patients are required to take aspirin and clopidogrel for a year,
at least. Stopping prematurely can lead to stent thrombosis (blood
clots in the stent) and heart attack or death. So, if a drug is found
to inhibit Plavix, it could be dangerous.
However, the
CREDO study, also presented at this year's AHA, found that
there was no interaction, that patients taking PPIs showed an
increase in cardiovascular events at one-year whether the patient
was on Plavix or not. And that Plavix had a beneficial effect
in reducing cardiovascular events whether the patient was taking
PPIs or not.
Confused?
The conflicting results between these two major
studies prompted the AHA, ACC and American College of Gastroenterology
to issue a statement to patients not change their medications without
consulting their clinician. The SCAI also issued a similar statement,
and concluded by stating:
"SCAI is eager for the findings of ongoing
studies, including the large, randomized study COGENT-1, which
is expected to clarify the possible interactions between clopidogrel
and PPIs."
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Unfortunately, Cogentus Pharmaceuticals, the company
sponsoring the COGENT-1 trial announced on Thursday that it is filing
for bankruptcy and that the trial was being terminated.
Still confused?
Wait....other recent studies have also shown
various genetic markers which indicate not all patients process
Plavix efficiently -- this is not news to those who have been discussing "Plavix
resistance" in some patients for some time.
So many questions about a drug that every stent
patient must take!
In today's notice, the FDA recommends:
- Healthcare providers should continue to
prescribe and patients should continue to take clopidogrel
as directed, because clopidogrel has demonstrated benefits
in preventing blood clots that could lead to a heart attack
or stroke.
- Healthcare providers should re-evaluate
the need for starting or continuing treatment with a PPI,
including Prilosec OTC, in patients taking clopidogrel.
- Patients taking clopidogrel should consult
with their healthcare provider if they are currently taking
or considering taking a PPI, including Prilosec OTC
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January 25, 2009 -- 5:30pm EST
Medtronic Seeks Runners -- Stents Included
Medtronic
(NYSE: MDT) recently announced that
it is looking for runners from around the world who have benefited
from medical technology to participate in the company's 4th Annual
Medtronic Global Heroes program. The photo to the left is of Alberto
Salazar, a world-renown marathon champion. He is Medtronic's
honorary captain for the program. Salazar is 50 and in 2007 collapsed
from sudden cardiac arrest. He was revived via CPR and had an implantable
cardioverter-defibrillator (ICD) to treat arrhythmia. He continues
to train runners and had three participating in last summer's Olympics
in Beijing. He is "committed to spreading the word about running
and living safely with a chronic health condition."
I am always amazed at the number of people who
continue their athletic activities after having a device implanted
(most could outrun me with no difficulty -- but that's another story...).
Our Forum Topic, "Exercise,
Sport, Physical Activity After Stent", has the stories of
scores of stent and heart patients who continue to run, ride horses,
etc. (By the way, I confirmed with Medtronic that patients who have
coronary stents are eligible for the competition
-- as long as there is no concurrent untreated coronary disease.
Individuals with abdominal aortic stent grafts are not eligible.)
More from Medtronic's press
release:
Known as The Most Beautiful Urban Marathon
in America™, the Medtronic Twin Cities Marathon is a three-day
weekend celebration of fitness that includes the Medtronic
TC Family Events and TC 5K, the Medtronic TC 10 Mile, and the
marathon.
Up to 25 runners will be selected to receive
a paid entry for themselves and a guest to the Medtronic
Twin Cities Marathon or the Medtronic TC 10 Mile and a travel
package that includes airfare for the Global Hero and guest
to the Twin Cities. The 28th Annual Medtronic Twin Cities
Marathon weekend will take place Oct. 2-4, 2009.
The deadline for applications
is March 31, 2009.
In addition to providing race entries and
travel expenses, the Medtronic Foundation will donate $1,000
to a select non-profit patient organization that educates
and supports people who live with the Global Hero’s medical
condition. To qualify as a Global Hero, runners must currently
be using a medical device therapy to treat the following
disease categories: heart disease, diabetes, chronic pain,
spinal disorders, or neurological, gastroenterology and urological
disorders. Eligible medical devices include any pacemaker
or implantable cardioverter defibrillator (ICD), any spinal
device, any neurological device, any insulin pump, or any
heart valve. All runners with eligible medical devices are
welcome to apply with no restriction on manufacturer.
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To apply or recommend someone to be a 2009 Medtronic
Global Hero, visit medtronic.com/globalheroes.
Good luck!
January 21, 2009 -- 12:20pm EST
XIENCE V™ Stent Takes the Lead
| In sharp
contrast to the current gloomy picture in the healthcare sector,
Abbott (NYSE: ABT) reported this morning that its 4th quarter
2008 global sales rose 10.1% over 2007, and that the company's
XIENCE V
drug-eluting stent was a significant contributor to the bottom
line. The company stated: |
|
 |
Worldwide medical products sales increased
15.6 percent; with 58.9 percent growth in global vascular sales
driven by the continued success of the XIENCE V™ drug-eluting
stent (DES), which became the market-leading DES in the U.S.
during the fourth quarter.
|
The XIENCE V was
approved by the FDA in July and is part of the new generation
of stent technology, which I characterized last May as "DES
2.0", composed not just of new stent technologies, like
XIENCE V and Medtronic's Endeavor, but a new way of looking at
the process of stenting: when is it beneficial?, how to do it better?,
how to verify proper placement?, etc.
Interestingly enough, another company involved
in DES 2.0 is Volcano.
The company doesn't make stents, but innovates in imaging technologies
like IVUS, OCT and Volcano also has been reporting
double-digit growth, recently reporting a boost in sales of
its FFR functional measurement products, due in great part to the
striking results from the FAME trial. It seems that FFR (or Fractional
Flow Reserve) is becoming a hot property in its own right --
St. Jude Medical just acquired Radi Systems, the other manufacturer
of FFR devices.
And more innovations will be coming: Abbott and
others are working on biodegradable stents that will completely disappear
when their work is done, Cardiac CT has made significant advances
in lowering the radiation dose without compromising image quality
and, in the near future, may be incorporating the ability to perform
perfusion measurement, currently the territory of the nuclear stress
test.
Clearly the word for the future in healthcare is cost-effectiveness (well,
okay, it's a hyphenated word...). But new technologies are going
to have to prove that they can reduce costs AND benefit patient care.
Of course, any advance in patient care will have the effect of reducing
costs down the road (less repeat procedures, less care needed for
chronic conditions, etc.).
Whether innovation is enough to turn the economic
tide, at least in the device industry, is yet to be seen, but these
recent figures certainly are good news.
January 19, 2009 -- 7:20pm EST
When Less is More: Stents, That Is
So many news reports about the recent FAME
study in the New England Journal of Medicine drive home
a message that is not exactly correct. The "Stents May Be Overused" headline
is misleading. And here's why.
Yes, the FAME study did show that when FFR (Fractional
Flow Reserve) was used routinely to measure whether or not a coronary
lesion was ischemic, less stents were implanted per patient,
and the resulting decrease in major cardiac events was significant.
But stenting, as an important therapy, was never
called into question. The patient population for the FAME study consisted
of patients with multivessel disease -- and 94% of these patients
had stents implanted. Yes, that's 94%! It's just that the number
of stents per patient was lower, on the average:
two stents instead of three.
In
fact Nico Pijls, the co-principal investigator for FAME, told Angioplasty.Org
that, rather than reduce the total number of stents used, the use
of FFR could easily expand the patient population that could benefit
by stents. For example, patients with multiple blockages might only
have only 2 that are measured as ischemic, and thus would be candidates
for stenting, rather than surgery.
He characterized the FAME results as a refinement
of stenting, and that they actually may expand the use of the procedure
as well.
You can read Angioplasty.Org's exclusive interview
with Dr. Pijls here.
January 18, 2009 -- 11:30am EST
Glad to be of Service!
In response to my
recent post about Jane Brody's misleading
article in the New York Times, an article that one might see
as upsetting to a stent patient, reader BC (not me) writes in:
Thank you!, Thank you! I was one of those
misled by what I had read in the popular press (additional
articles aside from Ms. Brody’s latest) and was feeling
awful on both counts: that I had had the stents put in and
that I had to keep taking those awful meds with their associated
awful side effects.
You really put me at ease,
Which lowers my blood pressure,
Which puts me at lower risk for another “coronary event.”
|
The reader, by the way, had a heart attack a year-and-a-half
ago, and two bare-metal stents inserted in a very critical artery
to prevent "another coronary event". He also made lifestyle
changes and feels better today than he has in years. He also continues
reading the New York Times.
January 17, 2009 -- 7:30pm EST
FAME: "Back to the Future"
The leading story about stents this past week
has been the publication of the FAME study and how a new St. Jude
Medical device that measures blood pressures inside the artery can
reduce the number of unnecessary angioplasty and stent procedures.
Well...it's not a new device; it's definitely not
a new concept; and St. Jude doesn't exactly get the credit for it
either, since their chief role was to acquire
the company that created the product. But it is an important
study!
First off, read Angioplasty.Org's article
on the FAME study, which clarifies some of this; then read my
exclusive interview with the FAME study's co-principal investigator,
Dr. Nico Pijls.
OK.
Now, let's get in the time machine and return to the genesis of coronary
angioplasty. It's 1977 and Andreas Gruentzig has fashioned a balloon
catheter to open a blockage in a patient's coronary artery. The balloon,
which he is holding in the picture to the left, not only can open
a blockage in a coronary artery but, oddly enough, also has the capability
of measuring the blood flow or pressure at the proximal and distal
ends of the stenosis (a.k.a. "blockage"). If the blockage
is significant, the two pressures are widely divergent, demonstrating
that there is a diminished blood flow through this arterial segment.
These "pressure gradients" would be displayed on the monitor
behind him, if there were an actual procedure going on.
Gruentzig continually monitored the pressure gradient
during procedures and, when the distal and proximal pressures were
similar, due to the dilatation or expanding of the balloon and compression
of the plaque, he judged the procedure finished. Optimal dilatation
of the stenosis had been achieved! Gruentzig was also very conservative
regarding the ability
of angioplasty to achieve a result. He called dilatation "a
controlled injury" of the artery and was adamant that the decision
to intervene needed to be made with great care and understanding
of the downsides of the procedure.
In these early days, the measurement of pressures
required a separate lumen, which made the balloons were pretty wide
and unable to get into narrow arterial spaces. Then Dr. John Simpson
invented a much thinner balloon catheter: he got into the narrow
spaces, but he sacrificed the ability to measure pressures. Gruentzig
was not entirely comfortable with this "advance". But unfortunately
he died in a plane crash in 1985, and well....
Fast-forward to the 21st century. For two decades,
angioplasty has been done without monitoring the procedure with pressure
gradients. Decisions were made primarily by eye (a.k.a. the oculo-stenotic
reflex): there's a narrowing there; let's put in a stent.
Now, thanks to Dr. Nico Pijls and others, cardiologists
can measure pressures with a guide wire, using Doppler sensors et
al. We are now able to measure gradients and make intelligent, data-based
decisions about whether or not to dilate a blockage.
The results? Well, don't intervene on a lesion/blockage
that is not significant. It may do more harm than good. Gruentzig
would have said the same. And now the FAME study reaffirms what he
already knew, but which has been forgotten through the years.
Back to the Future!
January 15, 2009 -- 8:10pm EST
Thank You, Associated Press, for the Too
Many Stents Headline
You see -- I made a bet. When I interviewed
Dr. Nico Pijls on Monday (he is the co-principal investigator of
the FAME study) I predicted that on Wednesday and Thursday, after
the embargo for the publication of his FAME study in the New England
Journal of Medicine was lifted, we would see headlines (or, as
I now call them, "dreadlines") invoking the mantra that "too
many stents are being used", "angioplasty doesn't work",
etc.
Dr. Pijls hoped this wasn't the case, but I was
pretty confident that it would be. However, yesterday I became a
bit concerned, because most of the popular press seemed to report
this results of this trial fairly accurately -- that is, until the
Associated Press article came out.
"Fewer
clogged arteries may need stent treatment" is the AP's
dreadline, and that kind of sets up the article. I mean if I had
a clogged artery, I would want it opened. Of course, the FAME trial
in no way suggests that a "clogged artery" should not
be stented. The FAME study is about arteries that show up as having
a blockage, but they are not significant blockages. Any artery
that is "clogged", should be opened.
But these are symantics, and the AP is interested
in...well here's the opening sentence: "A new study gives fresh
evidence that many people with clogged heart arteries are being overtreated
with stents". Overtreated -- once again implying that there
are cardiologists who can't wait to stick a stent in your artery.
The study results also were reported by KABC in
Los Angeles thus: Study:
Stents could be harmful.
For a rational explication of the FAME study results,
check out our exclusive
interview with Dr. Pijls.
But I welcome the AP article, because now I won
my bet.
January 13, 2009 -- 4:45pm EST
Dreadlines About Stents Revisited
My last
entry was about the January 1 article in the New England
Journal of Medicine which took health care journalists to task
for glossing over facts, for not presenting a truthful picture of
complex issues, etc., etc., etc. This is a concept I have written
about extensively, even critiquing
the critique in NEJM. It's a phenomenon I have dubbed, "Dreadlines" --
where a news article wants to grab your attention, so it invokes
serious illness or death as a journalistic strategy.
So only days after the NEJM article, the New
York Times published a piece by esteemed health reporter Jane
Brody, titled "More
Isn’t Always Better in Coronary Care". And in case
you were wondering where this article was headed, you might just
take the lead sentence:
"Ira’s story is a classic example of invasive
cardiology run amok."
Amok, as defined by the American Heritage
Dictionary:
"In a frenzy to do violence or kill;
in or into a jumbled or confused state; in or into an uncontrolled
state or a state of extreme activity; crazed with murderous frenzy."
Yow! Got the image? Hordes of out-of-control invasive
cardiologists running around, crazed and sticking stents into patients'
arteries with neither rhyme nor reason: killer cardiologists!!
If Ms. Brody was not envisioning such a dramatic
picture, perhaps she should have used a more accurate term -- however,
her article certainly delivers the message that angioplasty, stenting
and interventional cardiology in general are being grossly over-used: an
assumption that is not only untrue, but dangerous!!
Dangerous? How can a mere article in the "newspaper
of record" be dangerous? Is the pen mightier than the catheter?
Is there such a thing as a "killer journalist"?
My answer is "yes". And here is why.
Two years ago, the CHARISMA study was presented at the American College
of Cardiology. The study's take-home message was that aspirin plus
Plavix did not add benefit, and that in a subset of patients, it
slightly increased heart attacks and mortality. But the study had
nothing to do with stent patients. If you had a stent, it was critical
that you continued to take both aspirin and Plavix. I wrote about
this extensively and issued a warning to stent patients "Don't
Stop Taking Your Meds". But patients read the popular press
headlines (or rather the "dreadlines") which totally misreported
the study and stated: "Plavix plus aspirin may be a risky combination", "Plavix
with aspirin is deadly for some", and so on. And patients did
stop taking their meds. And in the next couple of weeks, patients
with stents wound up having heart attacks. I know this to be true,
verified by cardiologists I have spoken to.
So reading (or seeing) the news can cause heart
attacks!
That being said, I would also like to state that
nowhere in Jane Brody's brief 800-word story is the issue of emergency
angioplasty mentioned. Ms. Brody and the popular press have been
delivering the message for quite a while now that angioplasty and
stents are overused and that you should do everything you can to
avoid them.
There's only one catch: if you are having a heart
attack, you need to get to a cath lab ASAP so that a balloon can
open up your blocked artery and prevent your heart muscle from dying.
90 minutes is what you should aim for. This is not hype; this is
fact: backed up by multiple studies over the past two decades.
Angioplasty saves heart muscle.
But the retail press would have you believe otherwise.
As Dr. Gregory Dehmer, former president of the SCAI, told me a few
days ago:
"Right
after the COURAGE Trial was published, and this is not the fault
of the investigators of the COURAGE Trial -- it's the fault of
the way the media rolled the story out -- because I remember
watching the 5 O' Clock national news and the headline was "Angioplasty
Doesn't Work".
So the next week I'm back in good old Texas
and I get called in for an acute MI and there's a cardiology
fellow trying to convince the patient in the Emergency Room that
'you're having a heart attack and this [angioplasty] is what
we need to do' -- and the patient is like 'But I saw the news
and they say it doesn't work.'"
"It doesn't work". Thank you Jane Brody.
Her article goes into more detail about the types of plaque that
cause heart attacks, etc. and it leaves you with the sense that doctors
don't really know what they're talking about. But her article depends
almost entirely on the observations of one single physician: Dr.
Michael Ozner, author of the book, "The Great American Heart
Hoax". His idea, that more resources should be put into prevention,
is completely correct. But his statement that:
“Interventional cardiology is doing cosmetic
surgery on the coronary arteries, making them look pretty, but
it’s not treating the underlying biology of these arteries.”
is misleading. It is true that interventional cardiology
is not treating the underlying biology of the arteries, but it is
possibly preventing an acute event in those arteries -- one that
just might save your life or, at least, save your heart muscle. There
have been many recent studies that have proven this to be true. Yet
Brody's article quotes decade-old studies to make her point -- a
point which is, in fact, misleading at best.
January 1, 2009 -- 8:40pm EST
New England Journal Criticizes CBS News
on Transradial Angioplasty Report
As
Editor-in-Chief of the most popular public website devoted to interventional
cardiology, I approached Susan Dentzer's article, Communicating
Medical News — Pitfalls of Health Care Journalism, published
in today's issue of the New England Journal of Medicine,
with great interest. I unfortunately was a bit disappointed, specifically
with her criticism of a September 24, 2008 CBS News segment about
transradial angioplasty.
A leading thesis of the article is that journalists
need to be aware that their reports can influence the behavior
of clinicians and patients -- and on that point we agree completely.
After all, one of the significant tasks that Angioplasty.Org has
taken on over the years has been to correct misleading news stories
about the field of interventional cardiology. Recent important
examples include the flawed coverage of both the CHARISMA and COURAGE trials.
We also are very aware that many patients
and healthcare professionals respond to these "retail press" stories
by going to search engines to delve further. For example, traffic
on Angioplasty.Org spikes every time a major story about stents
or angioplasty hits the newswires.
Moreover, we agree with Ms. Dentzer that
the popular press often will characterize the results of a study
incorrectly, in order to concoct what we have dubbed a "dreadline".
And these scare headlines have consequences. Cardiologists we have
interviewed confirm that in March of 2006 some stent patients stopped
taking Plavix and aspirin together, based on faulty headlines about
the CHARISMA trial, and subsequently suffered heart attacks. There
is a definite danger in misreporting -- and for that we applaud
Ms. Dentzer's article.
But in her article, she cites a recent 105-second
TV segment about the transradial approach to angioplasty that aired
on CBS's "Early Show" and she takes it to task for incorrect
reporting. Since we host the major online source of information in
the U.S. about the transradial approach, and since we feature an
interview with Dr. Howard Cohen, the subject of the CBS News piece,
and since we are also aware that CBS News logged onto our site in
the week preceding their report to research the issue, we must take
issue with the New England Journal critique of this piece.
We, in fact, were impressed with the accuracy of
the reporting by interviewer Julie Chen. Moreover, since I featured
the CBS report in this blog, I feel obligated to defend my choice.
Ms. Dentzer critiques:
First, the interviewer incorrectly described
all angioplasty as "the opening of blocked arteries through
the wrist."
But she is misreading the inflection that reporter
Julie Chen used in introducing the piece. The transcripts reads:
This morning...in our special series "Heart
Watch": Angioplasty...which is the opening of blocked arteries...through...the
WRIST! Joining us is cardiologist Dr. Howard Cohen.
Ms. Chen was very specifically drawing attention
to the fact that the wrist approach was not the norm for angioplasties --
which was the entire point of this very short piece. Her second question
to Dr. Cohen clarifies this:
...only 1 out of 100 angioplasties performed
in this country is done this way and it's better. Why so few?
Other criticisms that the NEJM article levels at
CBS is that, although Dr. Cohen states the wrist approach is cheaper,
he is not given time to "to cite the study on which his assertions
were based." The answer is that there are far too many such
articles to cite in a short TV clip. But anyone motivated enough
to Google "transradial
angioplasty" will surely come to our special
section on the Radial Approach at Angioplasty.org/PTCA.org and
find our extensive
bibliographic references on the transradial approach. Television
news is, alas, not a medium conducive to footnotes.
Finally, Ms. Dentzer faults CBS by not placing
the discussion in context. She states:
Completely absent was any discussion of when
and why angioplasty should be done, let alone of the large, year-older
study that raised important questions about whether too many
angioplasties were being performed.
This is a reference to the results of the March
2007 COURAGE
Trial -- an important question and one which we have dealt with
in some detail. But it is certainly not possible to discuss this
responsibly in a short TV feature. In fact, to CBS and Dr. Cohen's
credit, the one major contraindication to the wrist approach is stated
twice -- patients without flow from two arteries are not candidates.
But I am not writing this blog merely to criticize
the NEJM article on its finer points. Yes, it is critical to report
medical news accurately, but in the case of the wrist approach to
angiography and angioplasty, it is also important to publicize new
and different techniques, so that a safer yet radically underutilized
method of performing catheter-based procedures can gain acceptance.
Recent multiple reports have shown a 50% reduction in mortality associated
with the transradial approach for diagnostic angiography and angioplasty,
yet only 1-5 procedures out of 100 in the U.S. use this approach.
For publicizing an underutilized yet safer procedure
like transradial angioplasty, a 105-second feature on national network
TV ain't a bad thing.
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