<< To Homepage >>
<<Archives>>
January-March 2007 Archives:
March 19, 2007 -- 9:25pm EDT "Fantastic Voyage" Redux
Today's CNN piece by Aaron Smith profiles two companies in the imaging field, one of which, Volcano Therapeutics, we also have written about. Intravascular Ultrasound or IVUS may have an important role assisting in the accurate placement of stents, and also in assessing, over time, whether the stents have maintained their position. While it's not a crew of physicians and scientists, like Donald Pleasance, Arthur Kennedy and, did we say, Raquel Welch(?) the tiny ultrasound camera on the tip of the Volcano catheter can act like a hi-tech security cam, sending back astounding color-coded images of the interior spaces of the coronary artery, and alerting the physician to potential blood clots and other problems -- something becoming more important in the era of concerns over late stent thrombosis with drug-eluting stents. The medical community thinks it's a valueable idea too. Sales for Volcano's system jumped 20% in the last quarter, and highly-regarded Milan-based cardiologist Dr. Antonio Colombo has stated that he will use IVUS for every stent placement he does. For more on IVUS, see our article on Angioplasty.Org. « permalink » « send comment » « back to top » March 7, 2007 -- 6:02am EST And The Winner Is... This announcement has not been confirmed but, since I didn't get enough of the Oscars this year, I thought I'd take a shot at predicting the winners (from those nominated at the December panel). For Best Picture: Extended Antiplatelet Therapy. Currently dual antiplatelet therapy (aspirin plus clopidogrel/Plavix or ticlopidine/Ticlid) extends for 3 months (Cypher) or 6 months (Taxus). I'll bet on a recommendation of 12 months for patients with low risk of bleeding complications. This change is clearly the front-runner, having previously been recommended by all major cardiology and surgical organizations in January's Joint Science Advisory (a.k.a. The Golden Globes). Best Director will be, I think, a caution to prescribing physicians to consider a bare-metal stent in patients who, for economic, clinical or other reasons, have a high likelihood of non-compliance with antiplatelet therapy or who are going to be needing surgical procedures which will require cessation of antiplatelet therapy. This one has gotten the clear recommendation of several groups as well. The question is whether it will become part of the label. Finally for Best Actor/Actress, I vote for the "off label" label -- some language that advises prescribing physicians that the results and benefits of DES that have been demonstrated in clinical trials may differ from those when the device is used "off label". This is a dark horse, because of the complicated concept of the label defining the off-label, but I'll go with it. If the announcement is made, I'll be posting the results later « permalink » « send comment » « back to top » March 5, 2007 -- 11:53pm EST Dueling Thromboses Adding to this coincidence of events in Washington is Wednesday's "Workshop With The FDA" session at the CRT 2007 meeting, run by Dr. Ron Waksman (not Waxman) of the Washington Hospital Center. This all-day session will bring together a wide variety of industry, government and physicians to hash out the issues surrounding late stent thrombosis in drug-eluting stents. And the clinical issues are complex -- it will be interesting to see what a Congressional Committee is able to come up with in this area, since the large inclusive panel of experts that the FDA convened in December felt there wasn't enough solid data to make a definitive statement about "off-label" use of DES, other than a recommendation for longer clopidogrel therapy, more care in patient selection and more study of the incidence of late stent thrombosis. As for the marketing issues -- this information has not been aired much before. Stay tuned.... « permalink » « send comment » « back to top » March 2, 2007 -- 12:37pm EST Not Just a River in Egypt The thrust of this somewhat ungrammatically titled presentation is to communicate the latest DES safety data to the audience of physicians, and to counter the negative headlines that have been dogging Boston Scientific (and Cordis) for the past six months. That would explain why, "immediately following" the DES session, the audience will be entertained by "An Evening with Bob Woodward", in which the WaPo reporter will discuss his recent book on the Iraq War: As if there weren't enough literary faux pas for one evening, the brochure directs attendees to register for the symposium at: www.bostonscientific.com/coronary/events 'Nuff said. « permalink » « send comment » « back to top » February 28, 2007 -- 6:45pm EST Argument Resurrected: Stents vs. Surgery But the Times article left out a few problems associated with bypass surgery, such as vein grafts closing up (they then get reopened using...ahem...stents). Also there's a growing body of evidence that many bypass patients experience "cognitive decline'. In the recent 5-year follow up of the Octopus study, 50% of the patients were classified as having "cognitive decline", leading Yale-based MD Harlan Krumholz to suggest that this risk be made part of the informed consent for CABG patients. And then there's Dana Carvey...but read the full article.... « permalink » « send comment » « back to top »
February 15, 2007 Don't Have a Heart Attack in Stars Hollow Poor Richard Gilmore, a major character in "The Gilmore Girls", which takes place in Stars Hollow, a small fictional town in Connecticut, had a heart attack while lecturing at his alma mater, Yale University. Fast forward to last week's episode, where he's taken to a New Haven hospital. Prognosis is: he's had a heart attack and he's "got a blockage that's bigger than we thought" and he is going to have to get "emergency bypass surgery". He spends the next several hours lolly-gagging around in his hospital bed while everyone prepares for his surgery. He's taken in, operated on and accordingly to the surgeon, he'll be just fine. Except he probably won't be just fine. Why? Because enough time has passed, even in the bizarre world of TV time, that Poor Richard's ticker muscle has died from lack of Oxygen (a different cable network). Bypass may provide new blood flow, but to what? A deceased section of myocardium? What he should have had was an angioplasty, immediately. This would have saved his heart muscle from dying and he would, in fact, have been "fine". All medical studies point to the importance of being revascularized via balloon angioplasty within 90 minutes. The American College of Cardiology has created an initiative to publicize the importance of this concept and to help hospitals reduce what is known as "door-to-balloon time". There is even a web site for D2B ("door-to-balloon"). Oddly enough, one of the moving forces in D2B is Dr. Harlan Krumholz of Yale University. Wait a minute...that's where Poor Richard Gilmore had his heart attack and wound up sitting around waiting for bypass surgery! Attention PR Department of Yale-New Haven Hospital System. Message is not getting through.... Oddly enough again, the set for "The Gilmore Girls" is reportedly right next to the set for "ER". So you say, so what, it's only a TV show! And I reply, well many many years ago, when I was an uninformed youngster, a close relative of mine was sitting on our living room couch, experiencing an odd upset stomach. He seemed pale, was sweating, wanted to leave and drive home. But a guest at dinner had just seen a TV movie in which a man, sitting in a train car, was having very similar symptoms. In the TV movie the man was having a heart attack. Sure enough, so was my relative. If our mutual friend had not seen the TV movie, my relative would not have been taken to the hospital, but would have attempted to drive home -- and would not have made it. So TV movies can be important learning experiences and can communicate, inform, assist. In other words, Hollywood, get it straight! Heart attack victims do not sit around waiting for bypass surgery. They go to a hospital and get a balloon stuck in their hearts ASAP!!! And they get their lives saved. Kind of like the former Health Minister of Canada did on Tuesday. « permalink » « send comment » « back to top » January 12, 2007 -- 7:55pm ET "I can see clearly now" -- IVUS
and Thrombosis Yesterday that idea got the imprimatur of a major professional organization: the Society for Cardiovascular Angiography and Interventions (SCAI). In the SCAI's official journal, Catheterization and Cardiovascular Interventions, a distinguished team of cardiologists (a.k.a. the SCAI Drug-Eluting Stent Task Force) offered a series of practical recommendations for cardiologists about reducing the risks for late stent thrombosis. It was titled "Clinical Alert on Late Stent Thrombosis" and a PDF of the full SCAI article can be found here. My favorite recommendation was "the importance of...meticulous stent implantation." I read it and thought to myself, "I knew it! All along I've had this sneaking suspicion that so much of this thrombosis problem is due to that darn 'unmeticulous' technique." "Meticulous" was the word-of-choice for the press release; the actual article uses the adjective "careful". I feel, however, that "meticulous" is more accurate. It's not that interventional cardiologists are not careful (i.e. "full of care") when they incorrectly place a stent. It's just that they can't see it well enough because, according to the recent J&J/Cordis-sponsored STLLR study of 1,500 patients, this happens 66.5% of the time! Hold on. Did I misread that? You mean your chances are only 1 in 3 of getting a stent implanted "meticulously"? As Scott Huennekens, President and CEO of Volcano Corporation, one of the only two IVUS manufacturers, commented yesterday to the JP Morgan Healthcare conference:
IVUS might cut that figure way down because it allows the cardiologist to look at the artery from the inside out. For example, if a stent has not been fully expanded, this might not be evident using the current "gold standard" of angiography, but IVUS would show this clearly. IVUS technology was invented well over over a decade ago (I know because I produced some of the first training videos about IVUS for cardiologists) yet today in the year 2007, only 12% of stent procedures use IVUS. I think that this is going to change significantly, due in great part to the concerns about late stent thrombosis (again, read our feature on the connection between thrombosis and incorrect stent placement). Recently, highly-respected thought-leader and interventional pioneer Dr. Antonio Colombo of Milan has announced that he is now going to use IVUS in every case he does. Suffice to say, this is an imaging technology that is going to become much more important in the very near future. « permalink » « send comment » « back to top » January 3, 2007 -- 8:39am ET What Balloons and Stents Are Really Good
At « permalink » « send comment » « back to top » January 2, 2007 -- 1:56pm EDT More Stent Concerns? In fact, over the weekend our Forum had a patient write in that reduction in collateral circulation had been observed in his angiograms pre-and-post DES. He has been experiencing pain and other symptoms. Now the JACC report has hit the mainstream media -- an article appearing in the Milwaukee Journal Sentinel, titled "Stents may stifle tiny heart vessels" has been syndicated nationally, appearing today under such headlines as "Study reveals danger of some heart stents", "Study finds `intriguing evidence' of stents' danger" and the ever-popular "Drugs may make stents deadly, study says". Stent controversy, round two coming up... |
In
August of 1964, Dotter appeared in LIFE Magazine (they went
for the mad scientist angle) and the idea of treating arterial
blockages from the inside out was publicized for the first
time. Who's to say sci-fi author