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January 27, 2012 -- 5:14pm EST Stent Pioneer Gary Roubin Leaving Lenox Hill
Interventional cardiology pioneer, Dr. Gary Roubin, is leaving Lenox Hill Heart & Vascular Institute in New York, where he has served as chair of Interventional Cardiac & Vascular Services for almost a decade. Dr. Roubin confirmed his departure to Angioplasty.Org and stated that he is "moving on to bigger and more challenging projects." Dr. Roubin's departure was first reported yesterday by Shelley Wood of theheart.org. Roubin told me that he feels he has "much more to contribute to the field of cardiovascular medicine", although looking through his list of accomplishments, one might think that difficult to top because so many of those accomplishments start with the word "First", as in: First abstract on balloon angioplasty in multivessel disease (with Andreas Gruentzig, inventor of the procedure); First balloon expandable coronary stent; First carotid bifurcation stent; First intracranial stent. And speaking of "Firsts", both Dr. Roubin and Lenox Hill figure enormously in the story of angioplasty and stenting. Lenox Hill Hospital is where, in April 1978, the First balloon angioplasty in the U.S. was performed by Dr. Simon Stertzer, on the same day that Dr. Richard Myler performed one at St. Mary's Hospital in San Francisco. And Lenox Hill is where I got involved in this field as well, when I made the First film (ever) on coronary angioplasty in 1979 with Stertzer -- and where I produced the First live demonstration course on the Sones approach to angioplasty. And, yes, Mason Sones himself was in attendance.
I subsequently traveled down to Emory Hospital in Atlanta to work with Dr. Andreas Gruentzig, the inventor of coronary balloon angioplasty, and there I met Gary Roubin, whom Andreas had recruited from Australia. A decade later, the very first coronary stent was approved by the FDA -- it was designed by Gary Roubin and radiologist Cesare Gianturco. Here's an early news report of Roubin's accomplishment:
As fate would have it, Roubin eventually wound up at Lenox Hill Hospital where, for the past decade, he has continued innovating and evangelizing for endovascular solutions to vascular problems -- in particular the use of carotid stenting and the multidisciplinary approach to vascular therapy, where surgeons, interventionalists and clinical cardiologists work together towards the same end: the best and most appropriate treatment for patients. He lectures all over the world on these and many other subjects and, never forgetting the lessons of the "master", he formed and still heads the International Andreas Gruentzig Society. In 2007, he and co-chair, Dr. Bernhard Meier, organized a wonderful and moving event to celebrate the 30th anniversary of the first angioplasty. Having worked closely over the years with Dr. Roubin, including producing a live course with him on carotid stenting (and so, as is the title of this blog, I have been "The Voice in His Ear") I can say that among his many accomplishments, angioplasty pioneer, co-inventor of the first FDA-approved coronary stent, etc., one of his most important contributions has been to carry forth the principles of Andreas Gruentzig in the treatment of patients, not just "blockages", in the care and accuracy of recording and reporting procedural outcomes and in the responsible use of this minimally invasive treatment of coronary artery disease. « permalink » « send comment » « back to top »
January 21, 2012 -- 8:05pm EST FAME II Is Not the "Anti-COURAGE": Stents and Angioplasty in the Spotlight
So is this, as several analysts have suggested, a reversal of the COURAGE trial results? Not according to the principal investigators of both the FAME II trial AND the COURAGE trial, whom I have spoken with in the past 48 hours. I will be posting an in-depth article in the next couple of days about this issue, which is extremely important to the interventional cardiology community. But suffice it to say that both Dr. William Boden, PI for the COURAGE trial, and Dr. Bernard De Bruyne, PI for FAME II agree that the two trials do not negate each other at all, because the patient populations are not the same. FAME II only enrolled patients who had ischemia, documented via Fractional Flow Reserve (FFR). In that population, PCI (a.k.a. stenting or angioplasty) was shown to be the best option. In COURAGE, a much broader patient group was enrolled, using angiographic evidence of blockage of 70% or more. FFR was not used. And in COURAGE, there was no difference in outcomes between patients who had PCI plus OMT, or those who had OMT only. The important finding here is that, when FFR is used as a guide to therapy, PCI is validated as the best option -- without question! But when visual imaging via angiography is the only diagnostic tool, the value of stenting can be debated -- as it has been in numerous controversial cases in Maryland (Dr. Mark Midei, etc.) and Pennsylvania and in many other hospitals. The conclusion, for us at Angioplasty.Org, is that FFR should be used as a mandatory part of all angiograms: in order to clearly document ischemia. Why subject the patient to a catheter-based procedure, with all of the possible adverse events that are seen, and not spend a few minutes performing an FFR measurement -- one which will validate the future course of therapy? Comments? « permalink » « send comment » « back to top »
January 18, 2012 -- 6:30pm EST Does FAME II Trump COURAGE? FFR: Key to Stents and Angioplasty
Positive news today from St. Jude Medical (NYSE:STJ) about FFR as a clinical decision-making tool. The company announced that it is stopping enrollment in its FAME II trial after only 2/3 of the planned patients were included. Why? Because the interim data so clearly favor the use of Fractional Flow Reserve (FFR) to guide stenting (PCI) in stable angina patients that the independent Data Safety Monitoring Board (DSMB) for the trial has concluded that it would be unethical to continue to randomize patients to optimal medical therapy (OMT) alone. Turns out that patients receiving OMT only experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization.
Wait a minute! Did they say that using optimal medical therapy alone was unethical for the treatment of stable angina patients? That's pretty big news! What about the findings of the 2007 COURAGE Trial which were interpreted to show quite a different picture: namely that in stable patients, stenting added nothing more than costs. Although those results were hotly contested by the interventional cardiology community and questions were raised about the inclusion criteria and other aspects of COURAGE, the study had a significant impact on the treatment of stable patients and the use of stents dropped precipitously over the next year. In fact anyone following "Stent News" for the past couple of years would see that the main issues in the headlines have to do with appropriateness of PCI, cardiologists accused of over-stenting, etc. So what is one to make of today's news? Is this a reversal of COURAGE? (And possibly a "reversal of fortune" for stent manufacturers?) The answer is well, sort of: not so much a reversal, but rather a refinement. The real answer has to do with something that I and Angioplasty.Org have been advocating and evangelizing about for years now: better decision-making tools. If you visit our "Intravascular Guidance Center", you'll see many articles on the issue of FFR and how its use can improve patient outcomes AND reduce costs at the same time. One of my most recent pieces is, "FFR: Why Isn't everyone Using It?" -- and that's a great question. And now it seems an ethical question, as well. So, back to COURAGE. In COURAGE, the decision to treat was guided by angiography alone, what Dr. Gary Mintz has called a "silhouette-o-gram." Patients with a 70% or greater blockage, as seen on the angiogram, were eligible for randomization to either OMT or to OMT plus PCI. The results showed no difference in outcomes between the two therapies, leading the medical community to conclude that stenting added nothing in the treatment of stable patients. I've often quoted the then-President of the American Heart Association proclaiming, "Hundreds of thousands of patients may be getting unnecessary stents." Got the picture? Two years later, Nico Pijls and his team showed in FAME that using FFR to measure the severity of the lesion, instead of angiography, led to 1/3 better outcomes and 1/3 less stenting! So FAME II was devised to mash up these two studies: in effect FAME II would be COURAGE using FFR to decide on stenting, rather than angiography. And the result? Well today's news shows pretty strongly that FFR-guided PCI is safer, better and, by extension, cheaper. It's also the opinion of many, including several Wall Street analysts, that these data are going to strengthen the interventional approach to the treatment of coronary artery disease. For example, Larry Biegelsen of Wells Fargo stated:
And Leerink Swann's Rick Wise wrote in a note:
FFR catheters are manufactured by two companies: St. Jude Medical (NYSE:STJ) and Volcano Corporation (NASDAQ:VOLC). The market is pretty much split 50/50 and this is great news for both companies -- Volcano's stock rose 6.75% today; St. Jude's was up 1.68% -- Volcano is a smaller company and FFR constitutes a much greater piece of their pie. Positive for companies, but what about patients? Well, as of right now, the use of FFR can help eliminate the concern over "unnecessary stenting". If the FFR shows a significant blockage in the artery (measured by the intracoronary pressure, and not guessed at by looking at a 2-dimensional shadow X-ray image) then the physician and patient can be reassured that stenting can be beneficial. Of course, this is very preliminary data and compiled analysis will not be presented until later this year at a cardiology meeting TBD. And the FAME II patients will be followed for up to five years. This follow-up data will be very important because it may (and I stress "may") show a mortality difference between PCI and OMT, when guided by FFR, that is. For now, I have a big question. If, as was announced today, the Safety Board judged that it would be unethical to continue randomizing patients to OMT alone, once FFR showed a significant blockage, is it "ethical" to be subjecting patients to invasive angiography and NOT use FFR? Did you know that FFR is used in less than 20% of cases? FFR is currently rated as a Class 1A decision tool in the European Guidelines, but only a Class 2A in the U.S. Perhaps these new data will provide the push needed to upgrade FFR as a treatment tool -- and then, most importantly, to fully reimburse its use: something that may clearly save money AND benefit patients. Sounds perfect, eh? Well, stay tuned.... « permalink » « send comment » « back to top »
January 17, 2012 -- 10:15pm EST AAA Stent Graft Revisited The AAA procedure is definitely more complex than a simple coronary stent procedure, and the catheter incision is larger. But refinements are occurring all the time. For example, today Medtronic received the CE Mark for its newest version of the Endurant II AAA stent graft, reducing the catheter size from 20F to 18F, and introducing other refinements.
But back to the patients. Kevin Morgan (who can be found on Twitter at @FitOldDog) received a stent graft a year-and-a-half-ago. Prior to that, he competed in Ironman triathlons. So, in case you thought that he might be slowed down by this medical condition, check out his blog, athletewithstent.com, where Kevin shares all kinds of thoughts about life after getting an AAA stent graft. And yes he has continued to compete. Now Kevin has launched a new website, "Old Dogs in Training", where he hones in on the whole issue of exercise and training for older folk. (By the way, Kevin is 68 and he notes with pride that he is the first AAA stent graft recipient in the world to finish an Ironman race...pride deserved!) Although Kevin Morgan is a stand-out example, there are many many patients who resume active lives, and become even more active, after a brush with coronary artery disease. Angioplasty.Org's Patient Forum hosts a Topic on "Exercise, Sport, Physical Activity After Stent" and a separate topic just on "Abdominal Aortic Aneurysm (AAA) Stent Grafts", one we started with Kevin Morgan. I urge all patients to browse through these stories, and to send in their own, in an effort to spread the word to others that a diagnosis of CAD or AAA does not necessarily signal an ending, but could be a new beginning...so much depends on how you approach it. « permalink » « send comment » « back to top »
December 21, 2011 -- 2:45pm EST Boston Scientific's New Drug-Eluting Stent in the News Again
I first heard concerns about stent deformation, primarily seen in the PROMUS Element stent made by Boston Scientific (NYSE: BSX), during a presentation at a small interventional meeting last summer. The issue was then reported in two journal articles, just prior to the TCT meeting in November, where it became a topic of much attention -- although most interventional cardiologists felt that it was nothing like the problem of late stent thrombosis, first seen as a "rare" event in the first generation of drug-eluting stents five years ago. I reported extensively on longitudinal stent deformation a few weeks ago when Dr. John Ormiston's article in JACC Interventions was published. Angioplasty.Org's coverage can be read in the following articles:
The Reuters article cites the thinner struts of the new generation of stents as a possible cause. However, it's not necessarily the thinness of the stent struts but the design and structure of the stent lattice that may be a reason for this vulnerability. For example, the photo at the top of this post compares Boston Scientific's Element stent design with Medtronic's new Integrity platform. Which one do you think would be more prone to the so-called "concertina effect"? The Element, in which the peaks and valleys line up and look, well, "squeezable" -- or the Integrity, where the peaks oppose each other?
This issue of stent compression was measured in Dr. Ormiston's study in which he bench-tested seven stents, confirming anecdotal reports that Boston's Element stent platform was more prone to stent compression (only four of the total are shown in this photo). But it's not just thinness because Abbott's XIENCE stent platforms (both the older XIENCE V and newer XIENCE Prime) both fared well, even though they, like the Integrity, boast thinner (and therefore more flexible) struts. And it gets more complicated because another factor cited in Ormiston's study was the number of connectors between the strut hoops. Element uses only two, as does Medtronic's decade-old Driver platform, which also showed a vulnerability to compression, although less than the Element. Abbott's XIENCE has three and the older CYPHER (the least compressible) has six. So do more connectors equal less compression? Sounds correct, except that Medtronic's Integrity, which performed very well, has only two connectors. Ormiston posited that this may be due to Integrity's unique design: it's fashioned from a single wire (hence the name, Integrity). So, no news here: the issue of stent performance is a complex engineering design calculation. What is meaningful, as the Reuters article points out, is that Boston's brand-new design is the basis for its entire product line of new stents. The article quotes Dr. Mark Ricciardi, director of Interventional Cardiology at the University of New Mexico Health Science Center, as saying:
If many interventional cardiologists feels the same way, Boston Scientific's stent division may have some problems, certainly against Abbott's XIENCE, and even more when Medtronic's new Resolute drug-eluting stent receives FDA approval, anticipated sometime next year. Speaking of the FDA, the "news" that prompted the Reuters article was that, when the FDA approved the PROMUS Element last month, it required Boston Scientific to include a caution in its labeling. As previously reported on Angioplasty.Org, the package insert for the PROMUS Element stent devotes Section 6.3 (page 4) to this issue, and the section leads off with this warning:
Dr. Cindy Grines of Detroit Medical Center and editor of the Journal of Interventional Cardiology and author of one of the first reports of the issue of stent compression, is also quoted in the Reuters piece:
Again, longitudinal stent deformation has been reported only in a small percentage of procedures. And, if recognized, it usually can be repaired on the spot. But we would guess that the executives at Boston Scientific are definitely keeping an eye on whether the number of these reports increases, as a result of "reading the label". « permalink » « send comment » « back to top »
December 7, 2011 -- 2:15pm EST A Stent By Any Other Name
The official "Appropriate Use Guidelines" place stent and angioplasty procedures into three categories: Appropriate, Uncertain and Inappropriate. Any patient, potential patient or, for that matter, anyone not steeped in the minutiae of interventional cardiology, would look at those terms and assume that any doctor putting a metal coil into someone's heart when the procedure was labeled "uncertain" or "inappropriate" should be fined or fired or both. Except they would be wrong. These terms specifically relate to the "level of evidence" in the official guidelines, evidence that has been adjudicated by a large committee that looked at clinical trials and studies and came up with categories and subcategories like Ia (the highest) and IIIb or IIc, etc. etc. But, if you are a patient and your particular clinical situation was not included in a large randomized clinical trial (and many are not), then your doctor's decision to treat would most likely fall into the "uncertain" or possibly the "inappropriate" category, even though his or her best medical judgement is that a procedure would benefit you. In other words these terms relate only to how they have been tested in large clinical trials -- i.e. there is clear evidence supporting the use of this particular procedure in this particular situation. Unfortunately, many clinical trials exclude large numbers of patients, often those who are the sickest, specifically because their inclusion will "muddy the waters" so to speak and confound any clear scientific results. For example, the oft-touted COURAGE trial, the one that showed no additional benefit for stenting over optimal medical therapy in stable patients, excluded 90% of the patients who were screened, because they did not fit the study's definition of stable angina. Yes, that's 90%! Only one out of ten patients screened for COURAGE was included in the actual study. I'm not saying that categorizing procedures in terms of levels of evidence is wrong -- there have to be definitions against which medical practice can measure and judge itself. But it's just that guidelines, as I've written before, are NOT rules or laws. They're just there to "guide" judgement. If you are a cardiologist and you have a patient whose condition falls outside the guidelines' medians, then you have to exercise your best clinical decision-making -- yet the procedure you perform, if it is labeled by some type of panel, might be called "uncertain" or "inappropriate". This does not mean "wrong" or "dangerous" or "harmful". It just means there's equivocal or no evidence in published studies for this situation. As FaceBookers would say: "It's Complicated" -- and it is -- for more on these issues regarding Approrpiateness Criteria, read my interview with Dr. Paul S. Chan. But back to my point about words. Cardiologists may have ongoing debates about these issues in journals, at national meetings, etc. but when guidelines or reports on "Appropriate Use of PCI" are issued, these reports are picked up by the public, the media and the evening news, and the precise words and labels used become important, and their intent changes from the strict narrow scientific definitions to broad-based meanings with all sorts of implied understanding (or mis-understanding) among the general population...and these labels usually appear in the headlines (or dreadlines, as I am wont to call them). A prime example are the following dreadlines that appeared right after the July publication of Paul Chan's study in JAMA, which showed that only 4% of PCI procedures were inappropriate:
So my recommendation is that a committee be organized to rework the terminology used in the guidelines -- a kind of guidelines for the guidelines committee. And this committee should be tasked with the goal of creating better labels and ways to communicate the safety and efficacy of these procedures to the public, as well as to the profession, payers and politicians. And, I would highly recommend that such a committee consist not just of doctors and scientists, but of members who are, in effect, wordsmiths: writers, journalists...perhaps even bards.... « permalink » « send comment » « back to top »
December 4, 2011 -- 5:05pm EST Stents, Angioplasty and PCI: The Uncertainty Principle (MEDICARE Style)
The bottom line is that, on November 15, CMS announced "New Demonstrations to Help Curb Improper Medicare, Medicaid Payments". These so-called "demonstrations" will occur in 11 states where claims "historically result in high rates of improper payments": Florida, California, Michigan, Texas, New York, Louisiana, Illinois, Pennsylvania, Ohio, North Carolina and Missouri. You can read their press release and not quite realize what this means, so here's the deal: according to preliminary publications, stenting and angioplasty in non-emergency cases are on the list for audits. CMS will review these cases and, only after the review, will CMS reimburse the providers. For cardiologists, this means that in these 11 states, if they perform a PCI, they and their hospitals will have to wait 30-60 days for a review of their decision -- and, if CMS decides they were wrong, and the stent procedure was "inappropriate", neither they nor their hospitals will be reimbursed. In fact, the hospital will wind up out-of-pocket for the entire incident, overnight stay, etc. But don't worry -- it's just a "demo project" of only 11 states.... A very interesting "demo" indeed, since these 11 states constitute 54% of the entire U.S. population!! Perhaps "demo" stands for "demolition"! Actually it's more like a "time-bomb". This announcement was made just as both the TCT and AHA annual meetings ended and the Veith vascular surgery symposium was just beginning in NYC. Most interventionalists were just getting their bearings back (am I in San Francisco or Orlando or NY and, oh yeah, how many people are coming to Thanksgiving?) and so the press release from CMS didn't get much play -- until the implications were revealed two weeks later in an analyst's letter and a Bloomberg News report on Friday in the San Francisco Chronicle, titled "Hospitals Tumble on Medicare Order for Heart Procedure Audit". And tumble they did. Tenet Healthcare plunged 11%, and heart device manufacturer Medtronic was down 6%; Boston Scientific, Volcano and St. Jude all dropped 7%. Yesterday, Shelley Wood's article in theheart.org detailed the issue for the cardiology community. But the big big question that I have, the elephant in the cath lab, so to speak, is "what is an inappropriate procedure?" and "who makes that decision?" Welcome to the "Uncertainty Principle". The issue of appropriateness of procedures has always been one of our prime concerns on Angioplasty.Org. Back in July, we posted several interviews and articles concerning the subject of "Appropriateness" for PCI (angioplasty and stenting) including an exclusive interview with Dr. Paul S. Chan, author of an extensive study of over a half-million patients that had just been published in JAMA. Appropriateness is a topic that has always followed the field of interventional cardiology. The level of attention usually peaks with certain events, such as the COURAGE trial, which questioned the use of PCI in stable patients, or with the allegations against Dr. Mark Midei for "unnecessary stenting." Paul Chan's review of a half-million PCIs from the NCDR database added a significant amount of data to this debate, but unfortunately the terminology that is used can be very confusing (the terminology comes from the Guidelines, not Chan's study). The categories are "appropriate", "uncertain" and "inappropriate". Here's how Dr. Chan explained them to me:
As for what is appropriate, there's a debate as to whether a 50% narrowing is a reason to do angioplasty; some say 70%. And, of course, these measurements are taken from standard angiography. Many cardiologists feel that angiography alone is not enough and that intravascular measurements, like intravascular ultrasound (IVUS) and fractional flow reserve (FFR) are really necessary to make this judgement. We're also not sure what the massive problem is, because Chan's study showed that only 12% of non-emergency PCIs were "inappropriate" (virtually none of the emergency angioplasties were). So will CMS be equating "uncertain" with "inappropriate" -- because that would be, according to Dr. Chan, a misinterpretation. Or, as I like to think of it, "uncertainty about the uncertain" -- it has a much more quantum physics feel to it. But "uncertain" is definitely not the same as inappropriate. It just means that, in this particular situation, the patient's clinical situation is not addressed or covered by the various published studies and trials and that there is no consensus about treatment. It does not mean the doctor's decision to do the procedure was incorrect. But back to the crux of the issue: who are these CMS people who will be auditing the decisions of cardiologists? And what criteria will they use? I mean there's a significant level of debate about this issue within the interventional cardiology community as it stands. Go to any interventional meeting and listen to the panel discussions. These are not a bunch of thieves trying to figure out how to gyp the government. These are respected scientists trying to digest and discern the vast amount of data generated by the hundreds of studies and presentations on display. Yes, there are guidelines, but guidelines are NOT rules or laws. They address average populations, they give guidance to physicians (hence the name). And yes, there are definitely outliers...and liars. There are a very few physicians who are out to defraud, but they do exist -- one Maryland doc was recently sentenced to 8 years in prison for unnecessary stenting. Again, regarding these audits, what measures will be used? An angiogram? A percentage stenosis? What about using FFR to determine if a narrowing is causing ischemia. The FAME study showed that stenting is best done when the FFR is .80 or lower -- but FFR is not fully reimbursed in the U.S. so we have a conundrum whereby CMS may not reimburse a stent procedure that they determine is inappropriate, but the very test that might answer the question of appropriateness is also not reimbursed. You could call it a "no-win" situation; I call it a Cath-22! You can read more about the FFR issue in our article, "FFR: Why Isn't Everyone Using It?" which brings me to another question: why would both Volcano and St. Jude's stocks fall so much on this news? Both companies manufacture FFR catheters which, one would think, should be a boom industry in a field where decision-making is so desperately looking for a threshold number to put down in the patient's chart and prove to CMS that, yes, this procedure was "appropriate"! Go figure -- and by all means, send me your comments! « permalink » « send comment » « back to top »
December 2, 2011 -- 7:30pm EST Women's Heart Disease and Intravascular Ultrasound (IVUS)
Now a similar tale has been broadcast by CBS affiliate WGCL-TV in Atlanta about how a type of coronary narrowing more typical in women may not be seen on a standard angiogram because it's evenly distributed along the arterial wall or channel and doesn't appear as a "spike" or sudden narrowing -- yet it may be restricting the flow of blood to the heart just the same. Once again -- angiography alone is not enough to accurately diagnose coronary artery disease and guide its treatment. Dr. Habib Samady of Emory University Hospital in Atlanta, Georgia explains more in this story and video clip on the WGCL-TV web site, reported by Kara Pesavento. (Emory, by the way, was the nexus for coronary angioplasty in the U.S. -- it's where Andreas Gruentzig moved to from Switzerland 30 years ago and where he taught thousands of doctors how to perform his then controversial new procedure.) « permalink » « send comment » « back to top »
December 2, 2011 -- 5:55pm EST Stent as Concertina
This is an issue that was first raised a little over a month ago and it has been the subject of a number of news articles. It's been dubbed "the concertina effect" but its scientific name is "longitudinal stent compression" or "longitudinal stent distortion" and it's of concern because once a stent has been correctly sized and placed in just the right position to keep a blockage open...well, you don't want it moving or changing shape.
Yet this can occur during an angioplasty -- rarely, but more often in some particular stents than in others, according to a bench-test that was published this week in JACC Cardiovascular Interventions. For a complete report on this bench-test, read our article, "New Boston Scientific Stent Shows Significant Shortening Compared to Other 2nd Generation DES" and, if you are an interventional cardiologist, read our follow up piece, "Avoiding and Repairing Coronary Stent Distortion", which contains tips and tricks from Dr. John A. Ormiston, lead author of the JACC study. « permalink » « send comment » « back to top »
November 29, 2011 -- 6:15pm EST iFR: A New Way to Judge Stents and Angioplasty for Coronary Blockages?
For several years now, I've been advocating for expanded use of functional measurement, otherwise known as Fractional Flow Reserve (FFR), as a way of determining whether or not a blocked artery is actually causing ischemia. A new measurement, made possible by recent advances in computer technology, called iFR (instant wave-Free Ratio™) may provide the momentum that pushes this concept into mainstream cardiology.
It's a no-brainer really. Measure the blood flow across the blockage instead of looking at a shadow image (or, as Dr. Gary Mintz calls it, a "silhouette-o-gram"). What may look like a significant narrowing may in fact not be limiting blood flow. And vice-versa. But, according to Dr. Neal S. Kleiman of the Methodist DeBakey Heart and Vascular Center in Houston, only 6% of U.S. patients undergoing angioplasty have their FFR measured (this was noted in the Sept. 13 issue of the Journal of the American College of Cardiology). There are a number of reasons for this: many hospitals have not invested in the necessary equipment to measure FFR; there is a perception that FFR adds too much time to the procedure; standard FFR involves administering a vasodilator such as adenosine, which may affect patients negatively, or may even be contraindicated. And then there is there BIG reason! As Dr. David J. Cohen, Director of Cardiovascular Research at Saint Luke’s Mid America Heart Institute, told me after his recent TCT presentation showing the clear cost-effectiveness of FFR:
That certainly took me aback. Would a cardiologist really do what may be an unnecessary procedure just for the money? Well, certainly not any of the cardiologists I know and talk to. But given the recent spate of "unnecessary stenting" lawsuits and legal actions, I would have to think about this for a minute.... I did, and what was obvious to me was that, if a cardiologist could quote a number that would show a stent, angioplasty, PCI was warranted, then these controversies would disappear. And FFR provides such a number. Below .80 you should revascularize the patient. Above .80 it's a question, but probably not.
This brings me to iFR, as described by Dr. Justin Davies in his interview with Angioplasty.Org. iFR is a faster and less invasive way of determining whether or not a blockage is ischemia-producing. It does not require adenosine infusion and it removes virtually all of the objections that a cardiologist may have to using functional measurement, rather than angiography alone. Right now it's only in the research phase and not yet approved for use, but its implications are clear: more appropriate stenting, better outcomes, less invasive measurement. « permalink » « send comment » « back to top »
November 11, 2011 -- 1:50pm PST How Do We Know That TCT 2011 is Done?
While a number of the 12,000 attendees started leaving and catching planes to their home bases all over the world yesterday, some to Florida for the beginning of yet another major heart meeting, the AHA, and some who will be off next week to the Veith Symposium in New York, the real evidence that TCT is over for the year is this view of the Exhibit Area, taken moments ago: rugs rolled up, fork lifts rolling forward, hi-tech exhibits slid into wooden framed crates....
Next year, TCT will be held in Miami, Florida on October 22-26, 2012 and the following year will be back in San Francisco.
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November 8, 2011 --11:50pm PST SRO Times 5 for Transradial Symposium at TCT2011
Today I saw hard statistical evidence that the transradial approach is growing exponentially in the U.S. This photo, taken this afternoon, during the half-day transradial symposium at TCT2011 says it all. 800 cardiologists were packed into room 104 of the Moscone Center in San Francisco to hear 5 hours of presentations and discussions on the transradial approach to diagnostic angiography, angioplasty and stent placement. As transradial pioneer Dr. Tejas Patel said to me after the session, inadvertently doing a San Francisco shout-out, "It was a Full House!" It was more than a full house, with doctors lined up against the back and side walls and, of course, people leaving and more coming in. Most likely, well over 1,000 cardiologists attended all or part of this session.
What's striking is that two years ago, the TCT meeting held its first half-day seminar on the transradial approach. This is a technique where catheter access is made via the radial artery in the wrist instead of the femoral artery in the groin. It was touted as having fewer complications, less bleeding and much greater patient comfort, and was used extensively in Europe, Canada, India, Japan -- pretty much everywhere except in the U.S. So in 2009 transradial was sort of a fringe topic, and the TCT organizers booked a room that held about 130 people. (Mind you, the entire meeting attracts over 11,000 attendees.) As I wrote back then in this blog, the demand rapidly outpaced the room, with over 100 cardiologists crowding the hallway outside the room to hear the presentations. A second room was quickly opened, offering an audio and slide feed. I said back then that "radial was hot". But now I'd say "on fire". Today's session was still SRO, but the audience was fives times as large as two years ago. That's what is called in clinical trials "statistically significant"! « permalink » « send comment » « back to top »
October 5, 2011 -- 12:10pm EDT In Memoriam: J. Willis Hurst, MD
Above all he was a teacher. Countless cardiologists went through his classes at Emory and he shaped the views and outlook of many thousands of physicians. You can read more about Dr. Hurst in a letter from his colleagues, posted on the Emory website. He was a Fellow of Dr. Paul Dudley White, considered the founder of American academic cardiology, and Hurst served as President Lyndon Johnson's personal cardiologist for 18 years. But Hurst also had a hand in fostering what became a revolution in cardiology.
J. Willis Hurst, as Chairman of the Department, was instrumental in meeting Gruentzig's needs, both academically and, well...check out the short video clip below. I had the honor of interviewing Hurst for my documentary, "PTCA: A History" and he told me what Gruentzig asked for in order to come to Emory.
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September 23, 2011 -- 11:20am EDT Cross-Country
Training for Transradial Wrist Angioplasty
So why are only 5% of U.S. procedures done via the wrist while figures in other countries run 50-80%? One reason has been training. In the U.S. cardiology fellows are trained in the femoral (leg/groin) approach, because that's what's practiced at their hospitals. So it's been a self-perpetuating practice. But this is changing. Rapidly.This fall no less than eight major training courses in the transradial technique were scheduled: from North Carolina to San Francisco (you can see these on Angioplasty.Org's list of upcoming transradial approach training courses) -- more than were available during an entire year, maybe two, just a short while ago. Next up on October 14 is a one-day course in San Francisco, the Transradial Intervention Program (TRIP) that since last November has been held at a number of centers by the Society for Cardiovascular Angiography and Interventions (SCAI). The following weekend of October 20-21 is the first advanced two-day course being run by Duke Clinical Research Institute, which also conducted a one-day course last weekend. November brings a course at the Mid-America Heart Institute in Kansas City, MO and then an afternoon of over 20 presentations at the TCT 2011 meeting in San Francisco, the largest annual gathering of interventional cardiologists in the U.S. Patients and physicians who want to learn more about this growing technique can read more about it at Angioplasty.Org's Transradial Access Center. « permalink » « send comment » « back to top »
September 8, 2011 -- 6:45pm EDT Transradial Angioplasty Training in Las
Vegas
And Dr. Richard Heuser has been performing PCIs since the beginning days of balloons and stents -- so his perspective on why the transradial approach offers significant benefits is definitely of import to cardiologists across the U.S. As he states in his interview, if you utilize the transradial approach:
Read the entire interview here.... « permalink » « send comment » « back to top »
July 9, 2011 -- 7:05pm PDT Are Stents Beings Overused? How Much and
Where? In my exclusive interview with Dr. Chan, we talked about the real meaning of this study, what it was meant to do (benchmark the use of PCI in the U.S.) and how it's being (mis) interpreted by the press (I'll be discussing this aspect in a subsequent post).
Dr. Chan also discusses the field of cardiology, its self-reflection, shown in studies like this one, and also some ways in which clinical cardiologists, referring physicians and...patients(!)...need to be brought into the decision-making process. Also, a fact which I haven't seen discussed much in the press: the NCDR is sending member hospitals quarterly reports of inappropriate procedures, mapped to the Appropriate Use Criteria, so they can look at their rates and improve upon them in very specific ways. Read the entire interview here . « permalink » « send comment » « back to top »
July 6, 2011 -- 11:30pm PDT A Perspective on the Appropriate
Use of Angioplasty and Stents In my exclusive interview with Dr. Brindis, I talked with him about the study, his feeling about what it showed, both the positive findings and what he calls "opportunities for improvement." While there was almost 100% adherence to guidelines for acute angioplasties (which made up 71% of the total angioplasties performed) the study also pinpointed the fact that PCIs for non-acute patients had a higher rate of "inappropriates", as defined by the ACC/SCAI Appropriateness Criteria -- and that this rate varied widely from hospital to hospital. This means that those hospitals with higher than average "inappropriate" PCIs needed to look at their cases, their decision-making process and work to bring it closer to the norm.
The crazy thing about much of the news reporting about the publication of this study in JAMA is the implication that an "investigative team uncovered previously unreported data" and exposed the fact that "up to half of angioplasties performed may not be beneficial." The fact is that none of this data would exist if it were not for the ACC, SCAI and physicians like Dr. Brindis, who is a co-author of the JAMA study. And the point of the study was specifically to take a "look-see" at how PCIs were being done in the U.S. and that look showed only 4% of all PCIs could be classified as "inappropriate". Most importantly, the study showed precisely where the inappropriates were happening, and opened up a discussion about how to reduce that number and improve the use of angioplasty. Speaking of inappropriate, I'll be discussing the inaccurate reporting of this study by most of the mainstream media in an upcoming post, but for now, read over our interview with Dr. Brindis. (We'll be posting a companion piece, talking to the study's lead author, Dr. Paul Chan, tomorrow.) « permalink » « send comment » « back to top »
July 5, 2011 -- 4:15pm PDT Angioplasty
and Stents Inappropriate Only 4% of the Time
Titled "Appropriateness of Percutaneous Coronary Intervention", this paper is the first comprehensive look at how closely interventional cardiologists in the U.S. are adhering to the practice guidelines for PCI (angioplasty and stenting) most recently published by the professional cardiology and surgical societies in January 2009. So...cut to the results! Of the 500,154 procedures studied, only 20,731 (4.1%) were deemed "inappropriate". And more than two-thirds of the procedures were done in patients who were having a heart attack or who were unstable and at an extremely high risk for having an acute event. "Great work," Dr. Ralph Brindis, immediate past-President of the American College of Cardiology, told me. He continued:
Actually Dr. Brindis was being generous. The COURAGE Trial put the prevalence of angioplasty in stable patients at 85% when it is actually at 29% -- the exact opposite! So, who cares? What does this matter to patients? Isn't this just another internal dispute in the medical community? Actually, not! The take-home message from this study is of vast importance to patients. Angioplasty, when performed during an acute episode (71% of the time) can save your life. If you think you are having a heart attack, get to a hospital that performs angioplasty ASAP. Angioplasty can stop a heart attack in its tracks! Angioplasty.Org will be reporting in more detail about this study, and will also be posting exclusive interviews with Dr. Paul Chan, lead author of the JAMA study, Dr. Ralph Brindis, immediate past-President of the ACC and guiding light for the NCDR registry, and Dr. Gregory Dehmer, former President of the SCAI and co-author of the Appropriateness Criteria. But take the following incorrect and distorted "dreadlines" from today's news with a grain of salt -- unless, of course, you have high blood pressure:
And stay tuned to Angioplasty.Org. 1 Appropriateness of Percutaneous Coronary Intervention ; JAMA. 2011;306(1):53-61.doi:10.1001/jama.2011.916 « permalink » « send comment » « back to top »
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Last year at this time, I wrote about a patient who had been posting in our 
Having
an coronary angiogram or heart stent placed via the wrist approach
is common in Europe. India and Japan -- much less so in the U.S.
-- even though the wrist (transradial) approach offers lower complications
and higher patient comfort. Some studies have even shown that the
radial approach, with its significantly lower bleeding complications,
is superior in treating heart attacks (STEMI) since those patients
need to be on high levels of anticoagulation meds.
This
weekend Richard R. Heuser, MD, FSCAI and John E. Lassetter, MD, FSCAI
of St. Luke's Hospital and Medical Center in Phoenix, Arizona will
be conducting 
Dr.
Paul Chan 
Dr.
Ralph Brindis is the Immediate Past President of
the American College of Cardiology and helmed the
National Cardiovascular Data Registry (NCDR) since
its inception in 1997 -- this is the registry that
was the source for the data analyzed and reported
in yesterday's JAMA study, "
A
major study of a half-million angioplasties, published today1 in
the Journal of the American Medical Association (JAMA),
refutes two major myths about angioplasty and stent use in the
United States: myth #1, that angioplasty is vastly overused and
unnecessary in most cases; and myth #2, that most angioplasty is
used in stable patients and therefore has little or no benefit
over drugs in reducing death or heart attacks.