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May 26, 2009 -- 5:45pm EDT Breaking News -- Texas Senate Passes Calcium
Scoring Bill 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 « permalink » « send comment » « back to top »
May 26, 2009 -- 12:05am EDT Women's Heart Health at Stanford
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. « permalink » « send comment » « back to top »
May 6, 2009 -- 4:05pm EDT Plavix PPI Study Released 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. « permalink » « send comment » « back to top »
May 4, 2009 -- 12:45pm EDT Effectiveness in Stenting
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.
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.) « permalink » « send comment » « back to top »
May 1, 2009 -- 4:30pm EDT Comparative Effectiveness Research and
The Patient 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 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:
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:
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. « permalink » « send comment » « back to top »
April 21, 2009 -- 5:15am EDT CT Scans for Strokes 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. « permalink » « send comment » « back to top »
April 18, 2009 -- 10:45pm EDT Plavix and PPIs: Update So earlier today reader D.B., a pharmacist in California, sent in this:
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. « permalink » « send comment » « back to top »
April 6, 2009 -- 10:00pm EDT Cardiology Sites Taking Notice of the Radial
Approach to Angioplasty and Stenting (PCI) 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:
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!
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March 24, 2009 -- 1:55pm EDT Is The Scaffolding Coming Down?
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.
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March 11, 2009 -- 7:30pm EDT Broadcasting Live Cases 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 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. « permalink » « send comment » « back to top »
March 10, 2009 -- 6:15pm EDT Bent Out of SHAPE
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:
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:
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. « permalink » « send comment » « back to top »
February 17, 2009 -- 5:00pm EST Medpedia -- OMG!!! According to Medpedia's founder:
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:
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. « permalink » « send comment » « back to top »
February 11, 2009 -- 12:25pm EST Taking Cost-Effectiveness to Heart
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?
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.
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February 6, 2009 -- 5:30pm EST Vote for Radial! 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! « permalink » « send comment » « back to top »
February 5, 2009 -- 5:00pm EST CT Heart Scans, Radiation and the Media 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:
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!
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).
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January 30, 2009 -- 9:50am EST Wrist Angioplasty Gaining Acceptance in
U.S. 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.... « permalink » « send comment » « back to top »
January 28, 2009 -- 10:25am EST Plavix Safety Update 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:
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January 26, 2009 -- 2:30pm EST Plavix, Prilosec, Prevacid, Protonix --
Do I Hear a Nexium? 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:
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:
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January 25, 2009 -- 5:30pm EST Medtronic Seeks Runners -- Stents Included 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:
To apply or recommend someone to be a 2009 Medtronic Global Hero, visit medtronic.com/globalheroes. Good luck! « permalink » « send comment » « back to top »
January 21, 2009 -- 12:20pm EST XIENCE V™ Stent Takes the Lead
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. « permalink » « send comment » « back to top »
January 19, 2009 -- 7:20pm EST When Less is More: Stents, That Is 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.
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. « permalink » « send comment » « back to top »
January 18, 2009 -- 11:30am EST Glad to be of Service!
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.
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January 17, 2009 -- 7:30pm EST FAME: "Back to the Future" 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.
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! « permalink » « send comment » « back to top »
January 15, 2009 -- 8:10pm EST Thank You, Associated Press, for the Too
Many Stents Headline 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. « permalink » « send comment » « back to top »
January 13, 2009 -- 4:45pm EST Dreadlines About Stents Revisited 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:
Amok, as defined by the American Heritage Dictionary:
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:
"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:
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. « permalink » « send comment » « back to top »
January 1, 2009 -- 8:40pm EST New England Journal Criticizes CBS News
on Transradial Angioplasty Report 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:
But she is misreading the inflection that reporter Julie Chen used in introducing the piece. The transcripts reads:
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:
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:
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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Back
in January, I 
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 
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, "
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.
A
couple of months ago 
Two
months ago, 
Last
Friday, my short video, recalling the origins of the "Live Demonstration
Course" in interventional cardiology, was shown during the final
day of 
So
yet another web-based health site was launched today, with great
fanfare in the 
Where
some insight can be found is in
This
week's poll on theheart.org is about the transradial (wrist) approach
to catheterization and angioplasty. The question is "
A
new study, 
And the implications for patients and professionals
are profound. If you are a patient, says Dr. Michael Poon, past
president of the 
Over
the past year, 
Medtronic
(NYSE: MDT) recently 
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.
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.
"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".
As
Editor-in-Chief of the most popular public website devoted to interventional
cardiology, I approached Susan Dentzer's article,