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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

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May 26, 2009 -- 12:05am EDT

Women's Heart Health at Stanford
Jennifer Tremmel, MDIn 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.

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.

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May 6, 2009 -- 4:05pm EDT

Plavix PPI Study Released
NexiumBack 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.

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May 4, 2009 -- 12:45pm EDT

Effectiveness in Stenting
Scott HuennekensAside 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.

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.

intravascular ultrasoundAmong 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.)

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May 1, 2009 -- 4:30pm EDT

Comparative Effectiveness Research and The Patient
U.S. CapitolMore 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.

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.

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.

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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