The Voice in the Ear -- Burt's Blog
<< To Homepage >>

May 2005 Archives:
26» Surgery vs. Stents
25» Image Makers: the Promise of MSCT
22»Quick Addition to "Revolutionary New Treatment"
21» ABC News "Discovers" Revolutionary New Treatment
19» Regarding Heart Attacks and Angioplasty
16» New York Times Article on Heart Attacks
16» Patient Education Saves Lives (guest blogger)
9» Take Your Meds -- Part II!!!
3» Take Your Meds!!!

May 26, 2005

Surgery vs. Stents
The study in today's New England Journal of Medicine that is all over the news concludes that for patients with coronary narrowing in more than one artery, coronary artery bypass surgery (CABG) has a lower mortality than a similar group of patients who were treated with stents. Hence the multitudinous onslaught of headlines about this, my favorite being in Forbes, Bypass Beats Stents for Heart Surgery. Yeah, like bypass IS surgery and stents are not surgery, last I looked.

Anyway, this is an extremely important and complex topic which I plan to discuss fully in a subsequent post, but let me just throw out two quickies here to counter the incredibly shallow reporting I've read in the papers and seen on the fake TV news.

Question: Where did the data come from?
Answer: New York State cardiac registries from 1997-2000
Comment: First stent approved in U.S. (Palmaz-Schatz) in 1994. So this comparative data was taken from the first 3-6 years experience of a brand new technology. More than a decade of refinement has vastly improved the stent procedure and the equipment. In the past two years the bugaboo of restenosis has been massively reduced by the introduction of drug-eluting stents. The mortality and morbidity measured in the stent wing of this study would most likely be quite different using today's technology. I call "foul". What were the stats like for bypass surgery in its first 6 years??

Question: How long out were the patients studied?
Answer: The procedures were compared at 3 years.
Comment: The authors were surprised that the divergence in results occurred after only 3 years. Think how surprised they would have been if the study had gone 5-7 years longer when, as a backgrounder from the Royal Brompton in London states:

"Ten years after CABG around 1/2 of vein grafts are blocked and of the remaining 50% half are severely diseased"

Granted, the IMA is the main artery used in CABG, but in multivessel grafting, vein grafts are still used -- and I might add, very often reopened by angioplasty when they fail.

I will discuss this study in a more detailed and measured way in a future post.

« comment »        « back to top »

May 25, 2005

Does MultiSlice Computed Tomography, or MSCT, have the potential to change how patients get selected for interventional treatment of coronary artery disease? You bet (and several companies are). A study in today's JAMA reports that 84% of the patients studied who did not have significant disease could have been screened out using MSCT instead of the more invasive coronary angiography (commonly known as a "cath") -- a very common procedure (over two million done in the U.S. annually) which, while safe and relatively low-risk, still involves threading a catheter into the heart from an incision in the thigh or wrist, and has a complication rate of 1.8%.

The current standard pathway to the cath lab starts with EKGs and/or an ultrasound stress test, then possibly a thallium stress test (with radiation tracking) and finally a cardiac catheterization, currently the "gold standard" of diagnosis for coronary narrowing. The cardiologist can see clearly where and how significant the narrowing is, and will often treat the blockage on-the-spot by sliding in a balloon and stent through the catheter already in place, adding only 15-20 minutes to the diagnostic procedure and, voila! Artery opened.

But what about the patients who get to the cath lab and find there is no blockage (in this study, they constituted 44% of the sample)? They've undergone a somewhat uncomfortable and expensive procedure and have subjected themselves to the possibility of a 1.8% chance of complications (arrhythmia, stroke, coronary artery dissection, access site bleeding, trauma to the femoral artery and nerves). Not a lot, but it is if you're the patient who experiences one....

Additionally MSCT is rapidly increasing in quality. The JAMA study was done with a Brilliance 16 unit from Philips Medical Systems. But Philips, as well as GE Healthcare, Siemens and Toshiba have already developed 40 and 64 slice units that surpass the one used in the study, and the authors concluded that "With rapidly improving technology, MSCT may well evolve from a useful complement to invasive angiography to a clinically viable alternative" -- MSCT may actually rival catheterization in diagnostic accuracy (in fact, the MSCT scans actually reveal information about the calcification of the plaque that is not seen under fluoroscopic angiography).

This means less invasive diagnosis for patients, lower healthcare costs for hospitals. The new units cost between $1-2 million, but scans are about $700 -- a catheterization costs 5-10 times that. Two millions caths a year in the U.S. Do the math.

« permalink »          « send comment »          « back to top »

May 22, 2005

Quick Addition to "Revolutionary New Treatment"
When I said yesterday that the "revolutionary new treatment" I saw on ABC Nightly News looked a lot like John Simpson's AtheroCath directional atherectomy device from 15 years ago, I wasn't the only one. The FDA states in its "Safety and Effectiveness" approval for the new SilverHawk catheter (issued February 15) that the new device was "substantially equivalent" to the AtheroCath -- which is why it did not need to go through extensive clinical trials. And while it is an improved version, a small German study done last year showed a 22% restenosis rate after 6 months. A different, and potentially more effective, treatment for peripheral artery disease is currently being studied by Dr. Mike Dake at Stanford, using Cook's Zilver® PTX™ Drug-Eluting Stent which elutes paclitaxel, the same drug used in Boston Scientific's Taxus stent.

« comment »        « back to top »

May 21, 2005

ABC News "Discovers" Revolutionary New Treatment to Unclog Arteries
I had just sat down Wednesday night to relax after a hard day's work writing about balloons and stents, when Charlie Gibson introduces the ABC Nightly News medical breakthrough feature with: "It's back to the future. 15 years ago, before there were balloons or stents...". Sorry Charlie, but if your researchers had only Googled "balloons" and "stents", they could have accessed our "History" section, where they immediately would have seen that your intro was off by...oh, by about double. The first successful balloons were used to open up leg arteries in 1974. Okay, so who cares...(answer below -- hint, there's money involved).

Then the report shows a cutting device -- they dub it a "roto-rooter" (never heard that one before...oh wait, Dr. Charles Dotter, inventor of the concept of angioplasty, used the roto-rooter comparison 50 years ago!! -- don't believe me? Go to the video! -- seems we are going back to the future -- of journalism, that is).

Anyway to me this animation they're showing looks suspiciously like a directional atherectomy catheter, similar to the one John Simpson invented in the late 80's and made into the startup company DVI, which got folded into Guidant. It was called the AtheroCath® and a new version of it is currently sold as the Flexi-Cut®. You can read all about directional atherectomy (with pictures, even) in our Devices Section.

Reporter John McKenzie continues about Mr. McLanahan, the patient with the blocked leg artery:

"So McLanahan tried something very different -- a new, minimally invasive procedure that actually removes plaque from the artery using a miniature drill. The drill's blade cuts the plaque, which is then pushed into an extended nose cone and pulled out of the body.... Later this year, doctors will try using the procedure to remove plaque from the arteries around the heart as an alternative to cardiac angioplasty and stents."

Then they show the little bits of icky-yellow-white gummy cheesy plaque the device took out. I remember shooting that scene numerous times during '80's training courses. Except those were heart procedures. In fact this type of device has already been used for the heart -- and the results were less than stellar. Stents, especially drug-eluting stents, have taken over the lion's share of treating coronary arteries -- and very successfully.

The name of the device being shown to millions of viewers was not mentioned (ABC News wouldn't want to be seen as "selling" anything) but there was a small title on the 3-D animation of the drill -- it read "FoxHollow Animation". FoxHollow Technologies -- Founder and Chairman of the Board? John B. Simpson, PhD, MD. Went public last October. Stock shot up 16% yesterday, due mainly to the ABC News report.

Now there's nothing wrong with this. If a new improved atherectomy catheter has been optimized for leg arteries, that's great (leg arteries have historically not done as well with balloons and stents as coronaries and carotids have). But "Revolutionary" it's not. As for the heart, if it should prove more successful than its predecessor, it will, like several other similar devices, not be so much an alternative, but rather what's become known as a "niche device" -- used in very specific situations -- it certainly will not replace stents. Something will eventually -- but it most likely will not make a loud whirring sound.

I just wonder where our news is coming from and why journalists don't do research anymore? Aren't they the least bit curious about anything??

« comment »        « back to top »

May 19, 2005

Regarding Heart Attacks and Angioplasty
A study from The Netherlands in American Journal of Cardiology today shows the impact of delaying angioplasty treatment for heart attack, and re-enforces the New York Times article discussed below.

« comment »        « back to top »

May 16, 2005

Extra! Extra! Read All About It! Heart Attack!!
Front page New York Times today -- a story of three heart attacks (part of the excellent NYT series "Class Matters") is a "must-read". Go buy the paper to see the full import they give this story: a third of the front page plus a full two-page spread inside.**

Three victims, three "class" strata, three different outcomes. The upper middle-class architect fares the best. He knew to choose the right hospital and within two hours was on the cath lab table with his coronary artery opened by a balloon and a stent in place -- his heart attack had been stopped in its tracks. He reports that he is better off now than he was before his heart attack -- not so for the other two New Yorkers profiled.

One went to a hospital where thrombolytic therapy was administered, but with no angioplasty facility available. The patient was moved the next day to a different hospital and got a balloon and stent, but his cardiologist states, "...yes, he would have been better off had he been to a hospital that was doing angioplasty."

The last, a working-class 59-year-old woman who labored as a housekeeper, didn't know she was having a heart attack (unlike the other two) and went to an ER with long lines, delays, and wound up never even getting an angiogram. Virtually no emergency treatment. And her recovery, or non-recovery, shows it -- she is sicker and needs far more medical care now, as her doctor states at the end of the article , "You're becoming a full-time patient, aren't you?"

There's been much talk in the medical profession about healthcare delivery in urban vs. rural areas, or about the fine differences between this stent and that stent, but here are three people, living within a few square miles of each other (in fact, the "top" and "bottom" wound up in hospitals literally one block apart) and the future of their time on earth has been completely determined by their access to healthcare and healthcare information. I wonder if the writer was patterning Heaven, Hell and Purgatory, because that's the way the stories are resolved.

Why isn't it routine in the triage of heart attack victims to be brought to facilities where the best treatment is available (the "gold standard" for most cardiologists being angioplasty). It's unconscionable that, in this society, the awareness of this information for both healthcare professionals and healthcare consumers is so lacking. But I will leave that volatile topic to my partner and guest-blogger (below).

I would like to comment on a related thread in the story. While there are classes in this society, they are not necessarily rigid (although some would rightly dispute this view) -- there is this thing called education. And in today's society, an educated patient is the best patient -- one who has the highest chance for a good result, given their condition. The NYT piece discusses Mr. Miele, the architect who had the most successful outcome:

"An important link in the safety net that caught Mr. Miele was his wife.... While Mr. Miele was still in the hospital, she was on the Internet, Googling stents."

Ms. Gora (who fared worst) also had a computer -- she had used it to find cheap prices for cigarettes -- she has since stopped smoking.

You'll note that if you Google "stents" or "angioplasty" you will find our site Angioplasty.Org. And I hope that our feature on "Angioplasty and Heart Attack" can help patients and their caregivers understand to say to the taxi-driver with the siren and flashing red light, "take me to a hospital that does angioplasty!"

My point is that if you or a loved one has a medical condition, find out everything you can about how to cure it, or manage it -- and if a crisis or acute symptom occurs, what to do about it. Use the internet, work with your doctor -- but in the current state of things, a great deal of how well you fare is up to you.

** To read this story by Janny Scott online, you need to be registered (no charge) at However, a non-photo no-registration-required version can be found in a number of NY Times affiliated sites, such as the Wilmington-Star News (NC). But I highly recommend the original -- let the NY Times know this is an important subject.

« comment »        « back to top »

May 16, 2005

Why Patient Education? Because It Saves Lives
from guest-blogger, Deborah Shaw
As someone who has spent much of her career promoting medical innovation and patient participation in healthcare, I was heartbroken and appalled reading today's The New York Times feature story profiling the disparities in heart disease treatment in America.

In the Times article only one of three heart attack victims received the "gold standard" of care -- emergency angioplasty followed by on-going disease management.

Each year thousands of physicians and manufacturers flood industry meetings (TCT, ACC) to celebrate, debate and market the latest technologies and treatments. But emergency angioplasty has been the preferred treatment for heart attack for several years. It was one of the first topics raised on our site when we began in 1997. One has to ask, why is this best practice still not a universal standard?

In fact, in terms of real improvements in patient care, emergency angioplasty to curtail heart damage may be the most solidly evidence-based application of interventional cardiology procedures. Yet at industry meetings the emphasis always seems to be on the marketing of new and better technologies. Who is making sure that known innovations are diffused, that people find their way to receiving the best that medicine has to offer right now?

The profession has also known for decades the absolute necessity of post-procedure support and disease management for heart patients. We know interventions are not a cure for heart disease. Why is this message so often not reaching practice levels? What is the responsibility of the leading physicians and healthcare companies to not only pursue research into new and better technologies, but also ensure that already established protocols and knowledge are implemented, so that more lives are actually saved?

I ask this question in part because it has become increasingly difficult to maintain corporate underwriting for Angioplasty.Org. It's hard to measure a bottom-line result from educating patients. But we still believe that public education is essential to saving lives.

Angioplasty.Org reaches 700,000 people a year, but we are just a tiny effort to promote innovation to the public, to help people seek out the best care and participate in their own recovery. And, unfortunately, the people who get the short end of healthcare in America, the poor and the uneducated, are the least likely to find websites like this one.

Nonetheless, according to recent research nearly half of all heart disease patients are on the Internet; 70% of patients now turn to the internet first for healthcare information. We receive many letters from patients who find our site after undergoing an unexpected angioplasty. These people are desperate for information and support.

There is no question about it: there needs to be far more investment in bringing quality information to the public, the media and the profession if new technologies are going to effect the real bottom line: saving lives.

« comment »        « back to top »

May 9, 2005

Take Your Meds -- Part II
I've talked about the interplay of stents and dollars in previous business news. But here's a couple items that show how such an interplay may affect the patient's healthcare.

HealthDay, a good source of health news, reported last week the news that Drug-Coated Stents Show Shortfalls. And I talked about the problem of late stent thrombosis in my previous entry below. This was all prompted by an Italian study published in the May 4 issue of JAMA which reported that in the "real world", stent thrombosis (fatal in 45% of the cases studied) occurred twice as often as in clinical trials. Was this true? Was there in fact a shortfall to this "revolutionary new stent technology"?

The study has some pretty strong cred. One of the authors was Dr. Antonio Colombo, a pioneer in the use of stenting and, as Dr. Paul Yock points out in this video clip, one of the first cardiologists to show (via intravascular ultrasound) that the chief cause for the high rate of stent thrombosis in the early days of stenting was the gross underexpansion of the stent. That is, by not expanding the stent fully, a gap was created between the stent and the arterial wall, a perfect place for blood cells to collect...and thrombose (clot). So Dr. Colombo knows from whence he speaks.

And while underexpansion of stents was still one of the cautions in this most recent report, the most likely chief cause of this doubled rate was the "premature withdrawal" of antiplatelet drug therapy -- specifically clopidogrel (Plavix) or ticlopidine (Ticlid), along with aspirin. These drugs work together to make the blood "slippery" and keep it from clotting. Recommended durations of taking these drugs vary from 3-6 months, even up to a year or more, and aspirin for life. The result? In a clinical trial that includes follow-up and monitoring post-stenting, patient compliance (sticking with the meds) is pretty high.

But then there's the "real world" -- where patients may not comply because they're not aware of how important these post-procedure drugs are (they think they're "cured") -- or possibly, as reported in another study today in the American Heart Association's Circulation Rapid Access, the post-treatment regimen may place too high a financial burden on the patient. This study, from the well-known Mid-America Heart Institute, showed that patients who faced such financial burdens did better post-procedure (more relief from angina, etc.) having bypass surgery. Because bypass surgery (CABG), once done, does not require the amount of medications that percutaneous therapies do to achieve relief from angina and other quality-of-life benefits -- at least that's one of the speculations in the study (which, by the way, was submitted to Circulation a year ago).

To extrapolate some of these thoughts to the problem of stent thrombosis with the new drug-eluting stents -- the problem is not with the stent per se, but with the "Reality" (in-joke) that their use requires taking a relatively expensive drug for 3-6 months, or a year, something which certain people, who don't have the best medical insurance, may find prohibitive. Back in an October issue of The Lancet (sorry, subscription only to read) Dr. Mark J Eisenberg of Montreal, suggested that physicians should perhaps be cautious when implanting drug-eluting stents in patients who have a high likelihood of non-compliance with post-stent drug therapy:

“What can we do to avoid late thrombosis after implantation with a drug-eluting stent? First, we should strongly reflect on the potential clinical consequences before we insert such a stent. Will the patient need a subsequent surgical procedure necessitating the interruption of antiplatelet therapy? If so, a drug-eluting stent might not be the best choice. Will the patient be compliant with prolonged antiplatelet therapy? If not, a bare-metal stent might be preferable.”

Is the answer that cardiologists recommend that their poorer, or "financially burdened", patients be sent to bypass surgery instead of taking advantage of the latest and greatest "revolution" in minimally invasive heart treatment?

The authors of the Circulation article say this is not necessarily indicated by their findings and that more study is needed. But it's a damn good question....I welcome and will reprint comments on this topic!

« comment »        « back to top »

May 3, 2005

Take Your Meds!!!
I will post a more in-depth piece on this shortly, but the news today in the Journal of the American Medical Association is very important, and it has been discussed in this blog before.

Drug-eluting stents (DES) work by supressing the growth of excess endothelial cells around the stent, thus preventing, or at least significantly reducing, the tendency of the cells to grow back and form a blockage to the flow of blood. But the blood also "sees" the metal stent and occasionally has a greater tendency to want to clot. This has been a known characteristic of drug-eluting stents and is why blood-thinning drugs have routinely been prescribed for at least three months for sirolimus stents (a.k.a. Cypher) and six for paclitaxel-coated stents (a.k.a. Taxus). Many cardiologists prescribe these drug for at least a year, and aspirin for life (at least aspirin is cheap!).

As it turns out, the "real-world" experience of drug-eluting stents in this study showed a clotting or thrombosis in twice as many patients as in the clinical studies. It's quite likely that a significant part of this increase was due to premature withdrawal of the antiplatelet medications discussed above. 29% of the patients who stopped taking Plavix or ticlopidine and aspirin too soon experienced thrombosis. And this is not a minor complication: 45% of those patients died.

Hence the title of this entry: Take Your Meds!

I will discuss this study in more detail -- but one concern is whether or not there actually is a difference in the two drug-eluting stents with regard to thrombosis, or whether there is a significant difference between any drug-eluting stents and the earlier bare metal variety. (Most cardiologists queried think that there is not a large enough trial to say one way or the other right now). Dr. Martin Leon has stated, that drug-eluting stents, as a class, may prove to be more thrombogenic (greater tendency to clot) and therefore patient compliance to antiplatelet therapy is critical.

And again, to put perspective on what double the thrombosis rate means: the rate in this study was 1.3% (slightly more than one in a hundred) as contrasted with a lower rate of 0.4-0.6% (one in two hundred) that has been observed in clinical trials (this lower figure is similar to the frequency of thrombosis in bare metal stents).

« comment »        « back to top »