May 2009
Archives:
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.
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