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It is a good thing that DrRich is not the only cardiac electrophysiologist writing in the medical blogosphere. If he were, the public would no doubt believe that all electrophysiologists are arrogant, self-important, sarcastic blowhards who insist on expressing themselves in the third person. Fortunately, that DrRich is uniquely afflicted in this manner, and that at least two out of three electrologist appear to be not only brilliant but also reasonably normal people, is nicely demonstrated by the offerings of Dr. Wes and Dr. John M on their respective blogs.

Both of these relatively socially acceptable electrophysiologist bloggers have seen fit to comment on the Million Hearts Initiative, recently introduced with great fanfare in the pages of the New England Journal of Medicine by Drs. Thomas R. Frieden, M.D., M.P.H., and Donald M. Berwick, M.D., M.P.P., on behalf of the United States Department of Health and Human Services. The Million Hearts Initiative aims to prevent a million heart attacks and strokes over the next five years.

The critiques of both Dr. Wes and Dr. John M regarding the Million Hearts Initiative are insightful and well-written, and both offer cogent analyses of the shortcomings of this program. DrRich strongly recommends both for your perusal.

Dr. John M is largely sympathetic with the aims of the Million Hearts Initiative, but finds that at least some of the methods proposed by DHHS to prevent all those heart attacks and strokes are unlikely to do much good. And more importantly, Dr. John notes, the MHI manifesto entirely ignores one of the most important (possibly THE most important) measures to reduce the risk of cardiovascular disease, namely, exercise. Dr. John M is an avid cyclist, and has personal experience with the benefits of exercise. How, he asks incredulously, can you design a major program to prevent cardiovascular events and leave out exercise?

DrRich (who, being a runner for going on five decades, has himself invested much blood, sweat and tears to the proposition that exercise is good for you), also finds this ommission to be quite remarkable. But as usual, DrRich has developed a theory to explain it. Both Dr. Frieden and Dr. Berwick, judging from the string of letters trailing behind their names, are public health experts. Public health experts are known for taking snippets of data from typically flawed clinical trials and, stringing together a chain of mathematical assumptions and conjectures longer than their post-nominal decorations, calculating how many people will be saved (or killed) if this or that public policy is initiated (or withheld). Obviously, for the Million Hearts Initiative, Frieden and Berwick needed to assemble a package of policy interventions whose calculations, when properly jiggered, show that there will be precisely one million beneficiaries. By including exercise in their program (and in their calculations), they would clearly have boosted the results to some awkward and difficult-to-promote value. The “One-Point-Eight Million Hearts Initiative” would just not have had the proper flair.

Like the President says, John, it’s just math.

Dr. Wes is somewhat less charitable toward these eminent public health experts than is Dr. John. John, while criticizing their methods, attributes high motives to them. Wes, on the other hand, is quite cynical about their motives. (In fact, if it were not for his total lack of blustery, third-person-y verbosity, Dr. Wes’ post might well have been written by DrRich.)

Wes suggests that the Million Hearts Initiative is the Feds’ way of distracting the public from noticing that they are doing everything they possibly can to restrict patients’ access to cardiologists, and to restrict spending on cardiovascular medicine.

It is, in fact, striking (at least to cardiologists like DrRich, Dr. Wes, and Dr. John) that this major policy initiative to save a million hearts has no place in it for cardiologists. Cardiologists are never mentioned in the manifesto itself, except obliquely to indicate that their services will not be required. Cardiologists, of course, take care of patients who have already developed significant heart disease. So what the public health experts are telling us is that they are only interested in stopping heart attacks and strokes in people who are apparently disease-free. There’s nothing wrong with that, of course. Preventive medicine is extremely important in cardiovascular disease.

But still. It is at least arguable that the quickest way to prevent a million heart attacks and strokes would be to target those patients who have the highest risk for these events, namely, people with known cardiovascular disease. Cardiologists dedicate their lives to preventing catastrophic events in these high-risk patients – and a tremendous amount of clinical evidence suggests they’re pretty good at it. While the only thing we ever hear these days about stents and implantable defibrillators is that cardiologists over-use them (and so the DOJ is launching criminal investigations to intimidate doctors into using them less frequently), when these kinds of technologies are used appropriately – as they most often are – they are proven to save lives.

But this is most decidedly not what the government’s public health experts are trying to prove. They want nothing to do with actual doctors practicing medicine in the trenches, fighting to save patients with active disease. Rather, they are out to show that the healthcare system can do just fine without all those fancy specialists and all their expensive procedures. They are aiming to advance the Progressives’ long-term agenda of showing that all the really important stuff in healthcare can be accomplished with much cheaper public health initiatives.

As DrRich has pointed out, it is our duty as citizens to maintain our wellness, and the the Million Hearts Initiative is simply the latest initiative by which the Central Authority will help us fulfill that duty. Those who by their own shortcomings develop heart disease or stroke, despite all the wonderful preventive help they receive through programs such as this, have manifestly failed  to fulfill their duty to society and will just have to get by the best way they can. And doctors such as cardiologists, who made the mistake of choosing careers dedicated to caring for such slackers, should not expect to be taken seriously, or overly respected, by the public health experts who are doing the really important work, or by any policy makers for that matter.

None of us cardiologists, nor our patients, should be surprised at being excluded from the Million Hearts Initiative. And won’t we feel bad when the results are in, and it turns out that millions of hearts can indeed be saved without any participation by the heart specialists?

So: Can the public health experts really save a million hearts with the specific steps they say they will take? Examining the strategy which Drs. Frieden and Berwick have laid out in their document, it certainly does not appear so. But, as it turns out, that result will be amenable to “tailoring,” and so the actual values they obtain in their results will be of little consequence.

The Million Hearts Initiative proposes to save a million hearts by doing the following:

A) Make “providers” report more regularly on how well they make little chits on checklists. (These are pretty much the same checklists the providers are already using; it’s the improved reporting standards that will save lives.)

B) Use electronic medical records to track and improve the behavior of providers and patients. (It is not clear exactly how this is supposed to work, though it is easy to imagine many rather spooky initiatives that might be taken, given the creation of a centralized database tracking, among many other intimate details, everybody’s long-term behavioral habits.)

C) Assemble groups of providers into “care teams,” which will somehow employ tag-team counseling efforts to get patients to improve their lifestyles. (Revealingly, it is this gang-nagging, and not novel life-saving technologies, which the public health experts refer to in their document as “clinical innovation.”)

D) Reduce smoking and second-hand smoke. (Fine, but this is merely one of the behavioral changes about which oppressed patients will be mercilessly “counseled” – see Item C.)

E) Get trans-fats out of the food supply. (DrRich has no objection here either, except to note that it was the same public health experts who, 40 years ago, demanded that trans fats be introduced into the food supply in order to crowd out saturated fats.  This is one example of why, when you’re a Progressive, history has always begun just 10 minutes ago.)

And F) Institute a population-wide salt restriction. (This amounts to yet another huge experiment to be perpetrated on the population at large. With luck, after 10 or 20 years this experiment may finally reveal who’s right – the experts who say that a general, population-wide sodium restriction will reduce net mortality, or the experts who say such a sodium restriction will increase mortality. Right now there’s plenty of data to argue for either outcome.)

Will doing these things really save a million hearts? Not in real life. All these things, taken together, don’t amount to very much in terms of actually accomplishing anything useful. But in the final analysis, the public health experts will have a decided advantage. It is plain that, while proving that hearts are actually “saved” by such measures will in fact be impossible, it will be equally impossible to disprove it. This situation is entirely analogous to the one in which the Administration insisted that President Obama’s stimulus package “saved” eight million jobs – since there is no way to prove or disprove that any jobs (or hearts) would have been lost had you done the other thing, any old claim is just as good as the next.  In such situations, the faction which gets to analyze the final data (in this case, those selfsame public health experts) can manipulate the statistical evidence any way they must to “prove” what they aim to prove.

Heck, they probably have their final report written up already.

Readers are advised to forget about saving a million hearts. Instead, save only one. Don’t smoke. Get plenty of exercise. And don’t eat so damned much. And should you develop heart disease despite your best efforts (which happens all too frequently despite what you’ve been told), pray that you can still find a cardiologist who has not been intimidated into withholding those expensive, modern medical therapies that really have been proven to save hearts, and lives.

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Note: DrRich has issued this warning more than once before. It has always gone unheeded. He will now try one more time, with this updated and hopefully more compelling version, not because he actually believes it will do any more good than similar warnings did those other times, but because he is a humanitarian and time is growing short. American physicians will continue to ignore this warning at their own peril.

The history of Western civilization, from prehistoric times until relatively recently (so recently, in fact, that one cannot be absolutely certain the pattern has been broken), has been marked by successive waves of invasions by wild barbarians from the north. (This explains why DrRich will never completely trust the Canadians.)

Every few hundred years, one group of primitives or another – Scythians, Goths, Vandals, Huns, Avars, Norsemen, Bulgars, Mongols, and others named and unnamed – would sweep down upon their betters, upon the more civilized, more culturally and intellectually advanced people to the south, and by the expediencies of slaughter, rape and pillage, would take their land, possessions, freedom, and their lives. The advancing barbarian wave would eventually play itself out, and individual members of the untamed horde would simply settle in place, and over a few generations would become civilized themselves – until the next group of barbarians, in turn, would fall upon them.

It was a cycle as natural as the seasons.

What drove these irresistible barbarian movements? Historians still argue about it. Likely these violent migrations were caused by several different things – famine, plague, encroachment by even nastier barbarians from even farther north, and climate change (though this latter conjecture is now politically incorrect, since the official and proper view of the earth’s climate is that it was absolutely stable for millions of years, until Henry Ford and George Bush came along and bent the temperature curve upwards, like a hockey stick).

The reason DrRich brings all this up, of course, is: to warn his medical colleagues about the cardiologists.

Dear reader, the cardiologists are on the move. Their home turf is being encroached upon, their livelihoods gravely threatened, by the biggest, most ruthless, and most irresistible force on earth – the Feds. And in response they are gathering themselves into a great wave, and they are preparing to overrun the territories of less robust, less terrifying, more civilized (possibly more effete) medical specialists, and make themselves a new home.

Some medical specialists aside from the cardiologists are of course also predatory by nature, but for the most part their territorial incursions are predictable, localized and contained – the orthopedic surgeons and the neurosurgeons, for instance, will fight over lumbar disc surgery. Not so for the cardiologists.

DrRich is a cardiologist, and he knows that the Board Certification papers wielded by cardiologists do not read: “Certified in the practice of cardiac medicine,” but rather, “Certified in the practice of cardiovascular medicine.” Cardiologists, in other words, are officially certified not merely in the practice of heart disease, but also in the practice of any and all disorders affecting the blood vessels.

And DrRich urges his unsuspecting medical colleagues to please notice that blood vessels are prominent features of every organ system in the body. Cardiologists therefore recognize no natural limits to their rightful turf; if it is supplied by the vascular system, it is theirs. And if some other kind of specialist has traditionally claimed sovereignty over some particular organ – say, the liver – their continued success lies entirely in the fact that the cardiologists have not yet chosen to assert their rightful authority. (As it happens, hepatologists are relatively safe, as most cardiologists think of the liver as a particularly uninteresting organ, which, after all, just sits there doing nothing. Many cardiologists, in fact, persist in getting the liver and the kidneys mixed up.) Still, should it ever become convenient for cardiologists to invade the hepatologists’ space, these relatively intellectual, relatively sedentary specialists don’t stand a chance.

What all this means is that when the cardiologists are on the move, nobody is safe. And they are on the move.

Hide the women and children!

The cardiology settlements have been restless for years, continually expanding and growing, and spilling out across their borders to encroach on the turf of their nearby neighbors. They long ago began driving the formerly proud and powerful cardiothoracic surgeons into a sad state of underemployment. More recently they have usurped the formerly sovereign territory of diabetes specialists. They are currently laying siege to sleep medicine (pulmonary specialists) and bariatrics (weight loss specialists). All of these incursions can be related, within one or two degrees of freedom, to heart disease. So these are localized disputes.

But in the last year or so, cardiologists have moved from a state of mere restlessness to a state of high alarm. The ruthless Feds (a mysterious tribe arising from a dark, inexplicable cauldron of a place where even the laws of physics, economics, and human nature do not apply) have taken to attacking the cardiologists where they live – in their home turf of stents and implantable defibrillators. By conducting secret and extensive DOJ investigations as to whether cardiologists are plying their trade according to “guidelines” (a form of tribute acknowledging their state of thrall to the Central Authority), and by threatening to jail them or fine them into professional oblivion (to the point where even the ubiquitous threat of malpractice suits has become a relatively trivial concern), the Feds have forced cardiologists to recognize that it is time for them to move on. It is time to seek out new territory.

There is no telling where they will show up next. If any of you non-cardiologists think you are safe, think again.

To illustrate just how unpredictable the Great Cardiology Migration is likely to become, DrRich will review a few of their recent incursions into the territory of some of the least likely of the medical specialists – the neurologists and the neurosurgeons.

The cardiologists’ encroachment into the field of neurological medicine is not only surprising in itself (for who would have thought that such shoot-from-the-hip, action-addicted specialists would find anything interesting about the brain?), but especially surprising is its scope and its persistence. Cardiologists actually began this process several years ago, under the radar, when they took to blaming imbalances of the autonomic nervous system (i.e., dysautonomia) on mitral valve prolapse. In more recent years, and somewhat more openly, they have attempted to take ownership of migraine headaches.

And now, in recent months, cardiologists have laid claim to the brass ring of the neurological diseases – Alzheimer’s Disease. If they can wrest this common and expensive disorder away from the neurologists, a disorder which people will pay almost any amount of money to prevent or treat, they can set themselves up for generations.

The typical pattern of behavior employed by the cardiology invaders is easy enough to spot. First, they call attention to an alleged association between some cardiac condition (a condition they will manufacture if necessary), and a neurological disorder. Then, immediately, they will assert that (or at least begin behaving as if) the association proves a cause-and-effect relationship. Finally, since they have demonstrated that the neuro problem is produced by a cardiac condition, it will become necessary to refer patients who have (or might develop) that dreaded neuro problem to cardiologists, who, lo and behold, will have invented a well-paying procedure which they claim will treat it.

The best known example is mitral valve prolapse (MVP), a congenital condition in which the mitral valve partially flops open when it should be closed, thus allowing blood to flow backwards (i.e., to regurgitate) across the mitral valve as the heart contracts. (For anyone interested, here’s a brief description of the heart’s chambers and valves.) Now, significant MVP can be a serious medical problem which requires mitral valve surgery. Fortunately, however, this kind of serious MVP is relatively uncommon.

But happily for cardiologists, echocardiography (a non-invasive test using sound waves to create an image of the beating heart) has become so advanced that some degree of trivial MVP, it seems, can be found in almost anybody. According to some studies, as many as 25 – 35% of healthy individuals – people without any cardiac problems or any symptoms whatsoever – can be said to have some degree of MVP. In fact, whether you have MVP or not depends largely on what criteria the echocardiographer uses to make the call, and how badly the referring doctor wants you to have the diagnosis.

Over the years it has become customary to diagnose MVP in young, apparently normal people who have the temerity to complain about the highly disruptive symptoms of dysautonomia (such as fatigue, weakness, strange pains, dizziness, constipation, diarrhea, cramps or passing out), without supplying the kinds of objective physical or laboratory findings which, doctors insist, patients are always obligated to provide. Such thoughtless patients are now routinely sent for echocardiography, so that MVP can be diagnosed (since it can be diagnosed just about whenever it is looked for). The patient is then given the diagnosis of “mitral prolapse syndrome,” even though: a) the MVP is usually so trivial as to be nonexistent; b) the studies which claim to show an association between MVP and these sorts of symptoms are generally based on a gross over-diagnosis of MVP; and c) there is no credible theory based on actual physiology to explain how MVP – even real MVP, much less the trivial kind – might cause such symptoms.

But no matter. “Rule out MVP” has become one of the most common reasons for young, healthy people to be referred for echocardiography, and has become a stable source of income for cardiologists.

The story is similar for the association between patent foramen ovale (PFO) and migraine headaches.

In the developing fetus, the foramen ovale is a hole that is present in the atrial septum (the thin structure that separates the right atrium from the left atrium). At birth, a flap of tissue imposes itself over the foramen ovale, causing it to close. In some people, however – people with PFO – the tissue flap is still capable of flopping open. In people with PFO, the foramen ovale can open for a few moments if the pressure in the right atrium becomes transiently greater than the pressure in the left atrium, such as with coughing, or straining during a bowel movement.

In rare instances, strokes in healthy young patients have been attributed to PFO. The supporting theory is that a stroke can occur when a blood clot happens to be coursing through the right atrium at the precise moment when a person with PFO is coughing (for instance), allowing the clot to move into the left atrium, and on to the brain. And because this theory is at least plausible, in a young person who has an unexplained stroke and is then found to have a PFO, it makes at least some sense to close the PFO.

But the presence or absence of a PFO is a little like the presence or absence of MVP. Its diagnosis depends to some extent on how hard the echocardiographer looks for it, and on how much the referring doctor would appreciate the diagnosis. With modern echocardiographic equipment, at least some sign of PFO can be found in as many as 25% of normal individuals.

Being able to make this nifty diagnosis would be of little use to cardiologists if the only clinical problem it may cause is a one-in-a-million chance of stroke. One cannot make a living, or even make a decent car payment, doing echocardiograms in those extremely rare young patients with cryptic strokes. So it didn’t take long for cardiologists to draw a more useful association – this time, between PFOs and migraine headaches.

While all the things that have to happen in order for a PFO to cause a stroke are very unlikely, at least one can assemble a string of very unlikely events that, should they all occur simultaneously, might possibly produce a stroke. This is not the case with migraine. No plausible theory has been advanced to explain how PFO might cause migraines. The only reason PFO is being invoked as a cause for migraine is that when patients with migraine have been carefully studied for the presence of PFO, an increased incidence of PFO was found. (But again, when PFO is carefully sought in any population of patients, it is more likely to be found.) The only likely reason PFO has not been associated with cancer, red hair, type A personality, or difficulty in memorizing the multiplication tables is that cardiologists have not thought of looking for it (yet) in these conditions.

For cardiologists, the poorly-supported allegation that PFO causes migraine is particularly compelling, since not only can they get paid for the echocardiograms to look for PFOs in migraine sufferers, but also there is an invasive (and lucrative) procedure they can do to close PFOs, to “treat” the migraines. Studies to date have not been successful in showing that closing PFOs improves migraine headaches, but that hasn’t kept cardiologists from screening migraine patients for PFO, then offering them PFO closure as a therapeutic option.

Migraine sufferers are particularly vulnerable to this and many other unproven therapies, since they are often disabled by their condition, and in many cases medical science (or medical ignorance) offers them insufficient help. Consequently, anecdotal stories abound regarding unorthodox therapies that cure migraines. (DrRich, himself a migraine sufferer for many decades, has heard them all.) One undeniable truth is that merely performing PFO closures on enough migraine suffers is guaranteed to produce a patient here or there who will report a positive response. And despite the continued negativity of actual clinical trials so far, that’s what happened.

So, by anecdote – but not by controlled trial – closing PFOs can cure migraines.

But now it gets even worse for the neurologists. Any who ignored the cardiologist’s usurpation of dysautonomia, and who may have felt only a little more concern when cardiologists began to lay claim to migraine headaches, had best sit up and take notice. Because now, cardiologists are laying claim to Alzheimer’s Disease.

Recently, researchers presented a study suggesting that ablation procedures for atrial fibrillation are associated with a lower risk of subsequent Alzheimer’s disease. (Here’s some information on atrial fibrillation and its treatment if you are interested.) The study was presented as an abstract only, so we know relatively little about the specifics.

But, really. Atrial fibrillation and Alzheimer’s are both disorders associated with aging, so it is not surprising that they are associated with each other – in the same way that atrial fibrillation is associated with gray hair, cataracts, and bunions. Ablation for atrial fibrillation is a relatively lengthy and difficult procedure, whose results are relatively middling, and which carries a substantial risk of some really nasty complications. So these ablation procedures are generally reserved for carefully selected, reasonably ideal candidates – usually, the relatively young, relatively healthy atrial fibrillation patients, who are less likely to get Alzheimer’s disease over the next few years whether they have ablations or not.

So there is a lot to be cautious about in interpreting a preliminary study like this one.

But such objections are just quibbles. When this study was reported, the headlines in the typically discerning American press blared: “Ablation Procedures For Atrial Fibrillation Prevents Alzheimer’s.” Whatever the details and limitations of this study, cardiologists can now treat Alzheimer’s. Mission accomplished.

Then, just last week, the American Heart Association and the American Stroke Association released a formal scientific statement to the effect that vascular disorders are an important cause of Alzheimer’s disease. So this new statement clearly plants the flag for the AHA’s chief constituency – the cardiologists (who, DrRich reminds his readers, own vascular disorders).

Remarkably, the American Academy of Neurology, apparently failing utterly to grasp its significance, endorsed the statement. As a result, American neurologists have formally taken the knee before their new masters.

You see how this works?

Now, having for the last time, with an unerring sense of fair play, called this problem to the attention of his non-cardiologist medical colleagues, DrRich would like to finish by emphasizing an overarching point.

You can’t fight the Feds. When the Central Authority, at the point of a gun, decides to reach down into the world of the medical specialists, and dictate which medical services are no longer going to be feasible (all for the noblest of purposes, of course), the affected medical specialists have a limited range of possible responses. And fighting the Feds is NOT among these available responses. It would be more effective – and certainly safer – for doctors to fight against the change of the seasons.

So the affected specialists have only two options. They can contract their horizons, take what’s left, and try to make the best of it. Or, they can do what the Visigoths did when the people of the steppes fell upon them. Strike out against other, weaker tribes and take what’s theirs.

DrRich is not passing any judgment on his cardiology brethren here. (Would you have him judge a she-bear protecting her cubs?) He is just describing what’s happening. You who lie in their path can do with the information as you see fit.

In the meantime, DrRich remains supremely confident that his cardiology colleagues can find a nearly unlimited supply of plunder in this brave new world. They are very robust barbarians.

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In 2007, when the results were published from the COURAGE trial, all the experts agreed that this study would fundamentally change the way cardiologists managed patients with stable coronary artery disease (CAD).*
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*”Stable” CAD simply means that a patient with CAD is not suffering from one of the acute coronary syndromes – ACS, an acute heart attack or unstable angina. At any given time, the large majority of patients with CAD are in a stable condition.
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But a new study tells us that hasn’t happened. The COURAGE trial has barely budged the way cardiologists treat patients with stable CAD.

Lots of people want to know why. As usual, DrRich is here to help.

The COURAGE trial compared the use of stents vs. drug therapy in patients with stable CAD. Over twenty-two hundred patients were randomized to receive either optimal drug therapy, or optimal drug therapy plus the insertion of stents. Patients were then followed for up to 7 years. Much to the surprise (and consternation) of the world’s cardiologists, there was no significant difference in the incidence of subsequent heart attack or death between the two groups. The addition of stents to optimal drug therapy made no difference in outcomes.

This, decidedly, was a result which was at variance with the Standard Operating Procedure of your average American cardiologist, whose scholarly analysis of the proper treatment of CAD has always distilled down to: “Blockage? Stent!”

But after spending some time trying unsuccessfully to explain away these results, even cardiologists finally had to admit that the COURAGE trial was legitimate, and that it was a game changer. (And to drive the point home, the results of COURAGE have since been reproduced in the BARI-2D trial.) Like it or not, drug therapy ought to be the default treatment for patients with stable CAD, and stents should be used only when drug therapy fails to adequately control symptoms.

When the COURAGE results were initially published they made a huge splash among not only cardiologists, but also the public in general. So cardiologists did not have the luxury of hiding behind (as doctors so often do when a study comes out the “wrong” way) the usual, relative obscurity of most clinical trials. Given the widespread publicity the study generated, it seemed inconceivable that the cardiology community could ignore these results and get away with it.

But a new study, published just last month in JAMA, reveals that ignore COURAGE they have.

In a registry-based survey that covered over 500,000 patients treated in over 1,000 hospitals, the new article reports that there has been little change in the use of drug therapy in patients with stable CAD since the COURAGE study was published. Prior to the publication of COURAGE, only 43.5% of patients who received stents had been tried on optimal drug therapy; two years after publication of COURAGE, that number had “increased” to 44.7%. And while the increase was statistically significant, observers have agreed that it is nonetheless trivial, and that the COURAGE trial apparently has made next to no impact on the practice patterns of cardiologists.

This revelation is proving embarrassing to even the usual spokespersons for the cardiology community, the luminaries who are always trotted out to explain the nuances of their colleagues’ sometimes odd behaviors, and to explain why those behaviors, actually, are not only reasonable but commendable. This time they are at a loss.

The best they can do, according to their commentary on TheHeart.org, is to offer two speculations: a) that, sometimes and for mysterious reasons, it can take several years for the results of important randomized trials to “disseminate” down to practicing physicians, and that apparently even the highly-sophisticated cardiology community is not immune to this phenomenon, and b) the cardiologists are waiting for their professional organizations to issue updated “guidelines” on stable CAD that take the COURAGE results into account. (The last official guidelines were published in 2002.)

Regarding this first explanation, DrRich can assure his readers that the results of the COURAGE trial were not slow to disseminate to American cardiologists. The results (and their implications) were, in fact, known immediately to every one – indeed, the buzz was palpable. It was, perhaps, the biggest news in the cardiology world in several years. If any cardiologists missed this seismic event, they are among that tiny, disconnected minority that is still out making house calls and distributing foxglove leaf, and likely would not know what a stent is, let alone be using them indiscriminately.

Regarding the “guidelines” excuse, DrRich is speechless. Since when are cardiologists guilty of following clinical guidelines to a fault?  If doctors, especially cardiologists, are already sticking strictly, in every particular, to sets of guidelines promulgated by committees of distant experts, even when they know those guidelines are out of date and, frankly, wrong, then (if you are an American patient) all is already lost.

DrRich does not buy either of these explanations. So what, then, is the real reason?

Is it greed? This is likely part of the explanation, and is all of the explanation for some cardiologists. (Self-interest plays as large a role in determining the actions of some practicing physicians as it does in determining the actions of those physicians whose reputations and hoped-for futures as “policy experts” requires them to denigrate the motives of practicing physicians every chance they get.) Indeed, DrRich would not be surprised to learn that some cardiologists of a certain age, realizing that the days of wine and roses are rapidly drawing to a close, are scrambling to insert every stent they can – and any other medical accoutrement they can justify deploying – as rapidly as possible, and then get the hell out.

But DrRich is certain that most cardiologists are genuinely trying to do what is best for their patients, and he believes that the failure to respond to the COURAGE trial is too generalized and too widespread to attribute entirely to greed.

Rather, DrRich believes that the results of the COURAGE trial simply fly in the face of your typical cardiologist’s world view. And while they undoubtedly understand those results intellectually, and even accept the results explicitly, they are simply having trouble incorporating those results into their conceptual framework for CAD. And since CAD is their livelihood, their philosophy, their sun, moon and stars, this amounts to an existential crisis.

When Galileo championed the Copernican view of the universe, and backed it up with sound scientific observations, he felt his views would receive approbation from the highest authority. After all, his old friend, the intellectual cleric Barberini (who had supported the publication of his book), was now Pope Urban VIII. But, while as Barberini his old friend could afford to be intellectually pure, as Pope Uban he could not. For Urban to accept Galileo’s work would formally call all Scripture into question, and seriously undermine the integrity and authority of the organization that had provided structure to western civilization for 1000 years. So Galileo had to suffer.

DrRich thinks that cardiologists find themselves in the position of Pope Urban – having the intellect to understand and accept certain surprising scientific results, but unable to put those results into practice without wrecking an entire way of life, and indeed, an entire way of looking at the world. They can either ignore (with, no doubt, some discomfort) the clear results of COURAGE, or abandon the world view that provides their sustenance and gives their lives meaning. That, DrRich thinks, is the real problem.

Regular readers will know that DrRich is not one to articulate a problem, and then simply walk away, leaving everyone to wonder what to do about it. So, as usual, DrRich has a suggestion.

The cure for the cardiologists’ existential problem is to articulate and accept a new world view, one that incorporates the results of COURAGE (and other clinical trial results that may seem puzzling under the old world view), and which places the proper usage of drugs and stents for CAD into a serviceable framework. While adopting this new world view will not be pain-free, it is one to which cardiologists can adapt – just as the Church eventually adapted to the heliocentric view of the cosmos.

And so, as a public service to his cardiology colleagues (and to their patients), DrRich will articulate a new world view on CAD. DrRich has not himself invented this new world view – most academic cardiologists, he believes, already endorse it, at least implicitly. But an explicit statement of the new world view – and an explicit rejection of the old – may help a few of DrRich’s cardiology friends to begin to accept the new “heliocentric” view of CAD, and thus to cure the existential crisis which (he postulates) is holding them back.

The Old World View

The old world view of CAD goes as follows: CAD produces localized plaques in the coronary arteries, which gradually grow out into the artery’s lumen, causing partial blockage of the artery. These “significant” plaques (generally regarded as plaques that are blocking 75 – 80% of the artery’s lumen) can produce angina (because during exertion not enough blood can get through the partial obstruction), and more importantly, can eventually cause ACS. The ACS occurs because the ballooning plaque can eventually rupture, causing a blood clot to form in the vessel, and producing sudden, high-grade occlusion of the artery.

Therefore, the cardiologist’s job is to identify these significant plaques and to stent them. Doing so will relieve “stable” angina, and will prevent ACS.

In the old world view, CAD is a localized process, that can be adequately treated with localized measures. If the location of the offending plaques can be identified (by cardiac catheterization) they can be treated. Heart attacks and death are thereby prevented.

The New World View

Whether or not CAD is producing a few localized “significant” plaques, the atherosclerosis that causes CAD is a generalized, and not a localized, process. That is, there are usually many plaques within the coronary arteries, most of which are not only “insignificant” (less than 75-80% blockages), but may even be nearly invisible during coronary angiography. Furthermore, it now appears that the majority of heart attacks (and other forms of ACS) occur when one of these “insignificant” plaques ruptures.

This is why it is not particularly unusual for somebody who has a “clean” coronary angiography to have a heart attack soon thereafter. And this is why aggressively treating stable but “significant” blockages with stents does not measurably reduce the incidence of heart attack and death.

CAD is a generalized, progressive disease. The treatment of CAD therefore inherently ought to be a medical (and not a localized, quasi-surgical) process. Ideally, one ought to use drugs that stabilize plaques and reduce the risk of rupture (statins, possibly beta blockers), along with drugs that reduce the propensity of blood to clot within the coronary artery, should a rupture occur (aspirin). And research should be aimed at identifying unstable plaques and finding better ways to stabilize them, and not at tweaking stents to render them marginally better than the prior ones.

A stent is fine to use on a significant blockage that is producing stable angina, but what it is accomplishing, one must realize, is merely to treat the symptom of angina – and not to prevent future heart attacks.

There.*

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* Under the new world view as well as the old, when ACS is actually occurring – when a plaque has ruptured and acute occlusion of an artery is taking place – inserting a stent often appears to be beneficial.
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Now that DrRich has entirely relieved the existential crisis all you cardiologists out there have been experiencing (you’re welcome!), all that remains is for somebody to address those few outliers among you who still haven’t heard about the COURAGE trial, or who are doggedly committed to following approved clinical guidelines under all circumstances, come hell or high water, even when they know them to be wrong, or who are just too consumed by greed to do the right thing.

While DrRich would consider it far from his method of choice for changing physicians’ behavior, and is in fact appalled by it, the Department of Justice’s new policy of conducting, Urban-like, inquisitions against physicians who are slow to adopt the Central Authority’s preferred practice patterns, and then criminally prosecuting those who are slow to comply, should work wonders in this regard.

Podcast:

In an earlier post, DrRich offered several potential strategies for doctors and patients to consider should healthcare reformers ultimately succeed in their efforts to make it illegal for Americans to seek medical care outside the auspices of Obamacare. To those readers who persist in thinking that DrRich is particularly paranoid in worrying about such a thing, he refers you to his prior work carefully documenting the efforts the Central Authority has already made in limiting the prerogatives of individual Americans within the healthcare system, and reminds you that in any society where social justice is the overriding concern, individual prerogatives such as these must be criminalized. Indeed, whether individuals will retain the right to spend their own money on their own healthcare is ultimately the real battle. The outcome of this battle will determine much more than merely what kind of healthcare system we will end up with.

DrRich, despite his paranoia on the matter, is a long-term optimist, and believes that the American spirit will ultimately prevail. So, to advance this happy result DrRich (in the previously mentioned post) graciously offered several creative options that could be employed to establish a useful Black Market in healthcare, which will allow individuals to exercise their healthcare-autonomy against the day when such autonomy again becomes legal. His suggestions included offshore, state-of-the-art medical centers on old aircraft carriers; combination Casino/Hospitals on the sovereign soil of Native American reservations; and cutting-edge medical centers just south of the border (which would have the the added benefit of encouraging our government to finally close the borders to illegal crossings once and for all).

As entertaining as it might be to imagine such solutions, a readily available, though much more mundane, option exists today, which is to say, medical tourism.

Medical tourism is where one travels outside one’s own country in order to obtain medical care elsewhere. It is becoming a booming business. A number of superb state-of-the-art medical centers expressly aimed at attracting medical tourists have been established in the Middle East, Singapore, India, China and elsewhere in Asia. These institutions cater to citizens of the world whose own healthcare systems cannot (or will not) provide in a timely fashion (or at all) the level of care patients may desire. Many of these institutions offer modern hospitals, numerous amenities, luxurious accommodations, attentive nursing care, and top-notch doctors – and they do it all for a tiny fraction of what the same care might cost (if you can even find it) in the U.S. and other “first world” nations.

Obviously, medical tourism is not particularly feasible for medical emergencies such as heart attack or stroke, or for chronic illnesses such as diabetes, congestive heart failure, or Parkinson’s disease, which require frequent visits and long-term management.  What is feasible is to become a medical tourist for those one-time medical services that can be scheduled and planned, for which there is a long waiting period at home, or which is simply too expensive in one’s own country. Such medical services often include coronary artery bypass surgery, hip replacements, knee replacements, and numerous minimally-invasive and not-so-minimally-invasive surgical procedures. In other words, medical tourism to a large extent is something one does for elective (i.e., non-emergency) surgery.

These are the very procedures, as DrRich has pointed out, which are now being covertly rationed in the U.S. thanks to the “never events” policy adopted by CMS and private insurers. As a result, certain categories of individuals may soon find it more difficult to obtain elective surgical services than they might have just a few years ago, and medical tourism may accordingly become a more compelling alternative.

It ought not be a surprise, therefore, that the first organization of American physicians to issue a formal policy statement regarding medical tourism is the American College of Surgeons.

The reaction of American surgeons to medical tourism ought to be obvious. They hate it. Elective surgical procedures – the very procedures for which Americans become tourists – are the bread and butter of most surgical specialties. It pains them to think of their prospective patients going off to Singapore for their lucrative bypass surgeries. American cardiac surgeons, for instance (already underemployed, thanks to American cardiologists throwing stents at every tiny coronary artery indentation they they can justify as a “blockage”), are nearly apoplectic at the idea.

It’s always a delight to read formal policy statements which attempt to disguise an entirely self-serving message as a selfless public gesture. The actual message of the surgeon’s policy statement, of course, is, “We hate medical tourism, and if you do it we’ll hate you,” but they say so on a manner which is designed to be polite, politically correct, non-judgmental, helpful and even friendly.

The surgeons in general have made a good effort, as you can see if you’d like to read the policy statement for yourself. It’s pretty much what you would expect – “Go ahead and have your knee replaced in Timbuktu if you want to. It’s your right, so go ahead and devil take the hindmost. Just don’t come crying to me when things go south a month later.”  They do so, however, in an extraordinarily collegial way.

The artful style of their policy statement aside, DrRich is struck by two aspects of the actual substance of the document.

First, the surgeons begin with a litany of dire warnings regarding all the medical considerations one must take into account before trusting one’s health to foreign medical hands:

“Some of the intangible risks include variability in the training of medical and allied health professionals; differences in the standards to which medical institutions are held; potential difficulties associated with treatment far from family and friends; differences in transparency surrounding patient discussions; the approach to interpretation of test results; the accuracy and completeness of medical records; the lack of support networks, should longer-term care be needed; the lack of opportunity for follow-up care by treating physicians and surgeons; and the exposure to endemic diseases prevalent in certain countries. Language and cultural barriers may impair communication with physicians and other caregivers.”

Obviously, these are all very important considerations. What strikes DrRich, however, is that these are the very same considerations (even the warning about endemic diseases, when one considers the MRSA infections which are secretly “endemic” in some American hospitals) which patients must also take into account before agreeing to receive care in any American institution. It may turn out that these considerations are more an issue in top-notch foreign hospitals than in your average American hospital, but DrRich is not convinced this is the case, and the surgeons do not provide any evidence that it is. In other words, DrRich sees this very good advice as being equally applicable whether one is considering becoming a medical tourist, or just a typical American patient.

Second, and more astonishingly, DrRich notes – not so much with interest, but more with awe – that the surgeons are beseeching their patients to consider just how difficult it might be to launch a malpractice suit against foreign doctors. (DrRich himself does not know how difficult this would be. Given that we are being so strongly urged these days to merge the American legal system with several varieties of international law, it might not be such a big problem.) Indeed, a careful reading of this policy statement reveals that the potential difficulty in suing foreign doctors is offered as the chief differentiator, and thus it has become the primary argument in favor of good-old-American-surgery. The surgeons, in essence, are saying, “Let us do your surgery, because we’re easier to sue if we screw up.”

This, from the very body of American physicians who are most at risk for malpractice suits, and who traditionally have been most vociferous in favor of malpractice reform.

DrRich can only shake his head in wonderment. If medical tourism is viewed by surgeons as such a dire threat that they have embraced, as their chief weapon against it, a celebration of the ease of suing American doctors, why, one can only conclude that medical tourism must have caught on far more than most of us realize.

As an American physician who has always been proud of American medicine, DrRich’s innate tendency is to lament the fact that Americans are finding it to their advantage to travel to Mumbai for their hip replacements. But as a patriot, he celebrates the fact that his fellow citizens are willing to go to such lengths to exercise their individual autonomy. He finds it a hopeful sign.

Our would-be oppressors might find it more difficult to hold us down than they may think.

Podcast:

In his last post, DrRich suggested that the Guideline Wars (i.e. the bloody battles over who gets to establish the patient-care guidelines that determine which patients will get which medical services, and which medical specialists will get to provide them) are about to enter the Obamacare phase, in which those who make the guidelines will no longer be medical professional organizations, but agents of the federal government. DrRich helpfully labeled the various guideline panels provided for by the Obamacare legislation as the “GOD panels” (for Government Operatives Deliberating), in order to avoid using the more inflammatory “death panels” terminology favored by certain less sophisticated commentators.

In addition, DrRich pointed out that his own tribe of medical specialists – the cardiologists – may perhaps be in a better position than most other physician tribes to manipulate the deliberations of these GOD panelists. The cardiologists would attempt such manipulations, DrRich suggested, by “pre-spinning” certain critical data from clinical trials, before that data is taken up by the government panels.

From their long experience in fighting the Guideline Wars, cardiologists understand that data from clinical science does not invariably lead to a fixed conclusion (as most proponents of evidence-based medicine seem to believe), but rather, can often be shaped into whatever sort of conclusion one might want to reach. Just as different primitive cultures discerned different constellations when they looked up into the same night sky, so will different groups of experts come to different conclusions when they look at the same clinical data.

Accordingly (DrRich submits), cardiologists have already embarked on the task of pre-spinning the data, such that when the GOD panelists look for the first time up into the vast and chaotic sky of clinical evidence, they will have in hand a map of the constellations as seen by the cardiologists.

To illustrate what he means, DrRich calls his readers’ attention to the SYNTAX trial, a clinical trial designed by cardiologists and their industry partners for the purpose of reaching a specific conclusion, but which (unfortunately for cardiologists) reached the opposite conclusion. If the data from the SYNTAX trial should ever fall into the hands of the GOD panelists (or any other guideline panels) in a pristine fashion, it could spell disaster. So the cardiologists have spent nearly two years attempting to make the data say what they want it to say, and today, after continuously massaging the data, issuing press release after press release, making presentation after presentation, and publishing academic paper after academic paper, it would be at least a little surprising if the God panelists, surveying this body of pre-spun data, would fail to produce clinical guidelines which provide the cardiologists at least some of what they’re after.

The SYNTAX trial randomized 1800 patients with complex coronary artery disease (i.e., CAD that produces either significant blockage in the left main coronary artery, or severe triple-vessel disease) to therapy with either bypass surgery or drug-eluting stents (DES), and assessed their long-term outcomes.

In general, patients with stable CAD (i.e., those who are not currently having a heart attack or unstable angina) do just as well with aggressive medical therapy as they do with invasive therapy. People like the ones enrolled in SYNTAX, however, are the exception to this rule. That is, patients with either of these two specific patterns of complex CAD have been shown to have improved survival if they receive bypass surgery. Indeed, these patients represent a virtual “last stand” for cardiac surgeons – they are nearly the only patients cardiologists (at least some cardiologists) still feel obligated to refer for bypass surgery. And, as one might expect, in their decades-long turf war with cardiac surgeons (a war from which they will not desist until they see the great majority of cardiac surgeons seeking jobs as beer vendors at sporting events), cardiologists have long chafed at this singular remaining obligation to refer.

Accordingly, SYNTAX, a study instigated by cardiologists and sponsored by Boston Scientific (a manufacturer of DES), was intended to show that with modern cardiac stents, stenting yields outcomes that are not significantly inferior to bypass surgery in these patients. Specifically, that is, SYNTAX was designed as a “non-inferiority trial.” This was certainly a modest goal – some might say too modest – but a positive result would enable cardiologists (the gatekeepers to all invasive CAD therapy) to simply keep these patients for themselves, just as they now do with all the other CAD patients. The SYNTAX trial asked the question, “Do I really have to refer these patients to the cardiac surgeon?” And the desired answer was, “No, it apparently is not statistically provable that you absolutely have to refer them, one supposes.” Judging from the study design, that answer would have been plenty rigorous enough for the study designers.

Alas, however, when the one-year follow-up data for the SYNTAX study was analyzed, the results turned out to be negative; stenting was significantly inferior to surgery. The endpoint of the study was a composite called MACCE (Major Adverse Cardiac and Cerebrovascular Events), and in this study included death, heart attack, stroke, and the need for more revascularization procedures. The bottom line is that in SYNTAX, the risk of MACCE was significantly higher for stenting than for bypass surgery. The study failed to meet even the modest non-inferiority goal the cardiologists had devised for it.

The one-year data for the SYNTAX trial was published in the spring of 2009 in the New England Journal of Medicine, just as the battle over healthcare reform was taking shape, and nearly six months after Sarah Palin had reported her mysterious vision of death panels. But whether one wanted to call them death panels, GOD panels, or panels of distinguished monkeys, it was clear by the time SYNTAX was published that the government, and no longer the physicians’ own specialist organizations, would be manufacturing all clinical guidelines in the near future. So disaster loomed.

But, the cardiology community quickly rallied, and launched into a concerted effort to spin the results of SYNTAX from a disaster into a victory, or at least, to something akin to victory. And the efforts of the cardiologists in this regard have been impressive over the last 18 months.

Within minutes of the publication of the original SYNTAX article, scores of press releases were launched, and scores of “experts” were dispatched to give interviews, implying that the SYNTAX study was a major, ground-breaking victory for stenting.

For instance, here’s the link to an article in the New York Times (subsequently reproduced in hundreds of newspapers around the country) entitled, “Heart Stents Found As Effective As Bypass For Many Patients.”

And here’s a triumphant press release from Boston Scientific, the study’s sponsor, in which the negative overall results of SYNTAX are buried deep within the 6th paragraph (following all kinds of positive-sounding fluff), and are difficult to locate even if you are specifically looking for them.

And here’s the more-than-triumphant press release from one of the leading clinical sites for the SYNTAX trial, which reads, in part:

“At NorthShore, we experienced stunning outcomes [emphasis DrRich's] in patients whose only option would have previously been bypass surgery,” said Ted Feldman, M.D, F.S.C.A.I., Director of Cardiac Catheterization Laboratory, NorthShore University HealthSystem, and a lead investigator of the trial. “The data in this study will provide cardiologists with additional information as they determine treatment therapy for patients with complex CAD.”

Most remarkable of all, we have the spectacle of the lead author of the SYNTAX paper, Dr Patrick W Serruys himself, telling Heartwire immediately after publication of the paper, that the paper’s concluding sentence (i.e., “CABG as compared with PCI is associated with a lower rate of MACCE at one year among patients with three-vessel or left main coronary artery disease (or both) and should therefore remain the standard of care for such patients.”), is just plain wrong. Serruys declared that this concluding sentence actually “is not the essence of the trial.” He only allowed that concluding sentence to appear in the paper, he said, “because the New England Journal of Medicine wanted something more conservative.” (Apparently, having the paper appear in a prestigious journal overrode the necessity of having the paper accurately reflect what the authors meant to say.)

In any case, Serruys insisted (despite the conclusion expressed in his ink-not-yet-dry paper) that many patients like the ones enrolled in the SYNTAX trial can safely be treated with stents, and indeed, he announced that he and his co-investigators were hard at work teasing apart the SYNTAX data in order to develop a so-called “SYNTAX score,” that would help cardiologists determine which patients they can treat themselves, without referring them for surgery. So indeed, despite the negative results, and despite the conclusion written in their own paper, the SYNTAX trial was immediately spun by key trial participants themselves into a win (while not a complete victory, still a win).

Before his readers come down too hard on the cardiologists for such behavior, DrRich feels obligated to point out a partially mitigating truth. Namely, cardiologists believe to the depths of their souls, notwithstanding the largely negative body of medical literature to the contrary, that stenting coronary artery blockages – in virtually any configuration and any clinical situation – saves lives. And if they haven’t been able to prove that yet, it’s just because of the vagaries of clinical research. One must not let spurious results from imperfect research block the Truth, lest one allow great harm to come to humanity.

The results of the SYNTAX trial must simply be wrong, cardiologists believe, and so they would be gravely harming patients if they did not take whatever steps were necessary to render the results of SYNTAX more favorable to stenting. To do otherwise would cause thousands of clinicians to make inappropriate decisions.

In this way, DrRich believes, cardiologists are no more guilty than are Progressives, another category of humans who believe with their hearts and souls in something that is simply not true (in the case of Progressives, that the great mass of humanity will willingly suppress their own individual interests in favor of the interests of the collective). Like the Progressives, cardiologists are often very nice, well-meaning, sensitive and compassionate individuals, and some of them would even be fun to go out with for a beer.

In other words, DrRich pleads, cardiologists are not being particularly evil in spinning the SYNTAX trial results; they are simply doing what comes naturally, and what they deeply believe to be the right thing.

This is why the SYNTAX investigators were convinced that, buried within the vast body of clinical data the SYNTAX trial has generated, there simply MUST be something useful to cardiologists. Accordingly, the SYNTAX investigators dived head-first into the proverbial room full of manure, enthusiastically digging for the pony which simply must be in there somewhere.

And indeed they quickly found their pony.

And here it is: While a straightforward analysis of the SYNTAX study shows that bypass surgery wins hands down over stenting, if one delves a bit deeper into the data, one finds that one of the components of the MACCE endpoint – the incidence of stroke – was statistically higher among the patients randomized to bypass surgery. One also finds that the incidence of needing revascularization during follow-up was higher in the stent patients. So, taking these two interesting observations together, the cardiologsts have concluded that patients receiving bypass surgery are trading a reduced need for subsequent revascularization for an increased risk of stroke – a bad trade indeed. Therefore, despite the overall results of the study, they have concluded that stents are better than bypass surgery for at least some patients. (And they promised to discover for us, during the data-mining exercise from which their “SYNTAX score” was subsequently invented, which patients those are.)

And this – the reduced incidence of stroke seen in the stent patients – is the basis for the celebratory statements which were issued by the SYNTAX investigators upon publication of their original paper.

DrRich agrees that, as a general proposition, he would probably rather have an extra invasive cardiac procedure than a stroke, and suspects that most people would say the same thing. But before we all buy what cardiologists are selling here, DrRich would like to make a few observations.

First, the results of the SYNTAX trial are the results. Stenting did not meet even its modest non-inferiority endpoint, and it failed to meet it by quite a lot. Once the pre-designated endpoint of a randomized clinical trial is determined, any remaining observations that can be gleaned from the large amounts of data invariably generated by such trials must be viewed as inconclusive, as merely hypothesis-generating. Such observations are not to be regarded as having sufficient statistical surety to vastly change medical practice, or to figure into evidence-based guidelines. So, another clinical study would need to be conducted to prove the hypothesis that strokes are less frequent with stenting than with bypass surgery in patients like these.

Similarly, the “SYNTAX score” – which indeed was generated and subsequently published as a “guide” for cardiologists treating patients with complex CAD, and which is therefore presumably being used today by cardiologists all over the world to select which of these complex patients they can just go ahead and stent rather than refer for bypass surgery – has no business being incorporated into clinical practice. An exercise like this – in which investigators comb retrospectively through the clinical data, selecting out patients who had good results with stenting, then devising a group of characteristics that appears to differentiate them from those who did not – cannot possibly yield a validated, widely-applicable clinical tool. If they want to claim that their SYNTAX score is clinically useful, they need to conduct another randomized clinical trial to test that hypothesis.

Next, and most remarkably, there’s the almost universally-ignored fact (reported by Dr Friedrich W Mohr, co-principle investigator of the trial), that among patients assigned to bypass surgery in the SYNTAX trial who experienced a stroke, nearly half of them had their strokes PRIOR TO SURGERY. What this means is that, in reality, the bypass surgery itself did not cause those strokes, a fact that ought to cause serious damage to the chief assertion of the stent-proponents. This fact alone turns their pony into a pig. The claim that stenting instead of surgery would have avoided these strokes is largely, if not entirely, spurious. Indeed, if anything, the fact that patients “randomized” to surgery apparently had a lot of strokes in the brief period of time between the act of randomization and the surgery itself ought to make one question whether the selection of therapy was really and truly random, or whether, somehow, patients who looked particularly sick got sent preferentially to the surgeons.

And finally, the clinical choice as it has been starkly painted by many proponents of stenting – that the real trade-off in choosing between stenting and bypass surgery in these patients is the choice between the higher risk of stroke with surgery versus the higher risk of revascularization with stenting – is incomplete and misleading. Presenting the choice in this way clearly favors stenting, and this presentation entirely explains the positive press releases and subsequent media coverage of the SYNTAX trial. But this is not a valid comparison of risks for several reasons:

1) As noted above, the actual risk of stroke posed by performing bypass surgery in the SYNTAX trial has been substantially overstated for public consumption (by implying that the surgery caused those strokes, when half occurred prior to surgery).

2) Surgeons in the SYNTAX trial most often did not employ newer techniques now in routine use, such as off-pump surgery and LIMA grafts, both of which can substantially reduce the risk of stroke and other embolic phenomena.

3) Re-occlusion of the involved arteries (which occurred about equally in both groups in this study, and which spokespersons for SYNTAX seem to brush off as not such a big deal), is an entirely different phenomenon in patients who have received DES than it is in patients who have had bypass surgery. After bypass surgery, re-occlusion tends to occur gradually, and the patient generally experiences recurrent symptoms of angina. But in DES, re-occlusion much more commonly occurs acutely, and catastrophically, leading rapidly to permanent cardiac damage and often, to sudden death.

4) Item # 3 might explain why the composite endpoint of “death, heart attack and stroke” was equal in both groups, even though stroke was significantly higher in the surgery group. That is, in order for the math to work out, the remaining dyad of “death and heart attack” necessarily must have been higher in the stent group. As far as DrRich can tell, this point has never been discussed in public.

5) In order to avoid the catastrophic re-occlusions seen with DES, cardiologists now insist that their DES patients take long-term, even life-long, Plavix, a powerful blood thinner. As the purveyor of a patient-oriented website on heart disease, DrRich cannot tell you how many distressed and stented-up patients have written to him with the following lament:

“My doctor put in one of those drug coated stents and has me on Plavix. He says if I stop the Plavix I could die, and won’t let me stop it for any reason. But I need my gallbladder out because I keep having gallbladder attacks, and the last one gave me blood poisoning. My surgeon says I need the surgery but he won’t do it unless I stop Plavix, and my cardiologist says no stopping the Plavix for any reason. What can I do? Can they just take these stents out so I can stop the Plavix?”

There is no easy answer to this question, at least not that DrRich can find. The DES patient commonly is left in the middle of a pissing match between surgeon and cardiologist. The fear of the cardiologist is that when one stops Plavix, there is a risk of sudden, catastrophic thrombosis of the coronary artery. But surgeons simply cannot operate safely on patients taking this drug. Few cardiologists seem to explain this to their patients before placing DES.

And more to the point at hand, none of the cardiologists spinning the SYNTAX trial are explaining to the public the implications of long-term Plavix. Even if their claims that stenting yields significantly fewer strokes turned out to be accurate, the choice here is clearly NOT a simple one between a higher risk of stroke on one hand, and a higher risk of needing “revascularization” (if they survive the re-occlusion, that is) on the other. There’s a lot more to think about than that, and cardiologists who imply otherwise are being either disingenuous, or delusional.

Just last week, SYNTAX investigators reported on the three-year outcomes in patients enrolled in the trial. The results, similar to the one-year outcomes, remain strongly in favor of bypass surgery at three years, and indeed, the incidence of stroke in stented patients has “caught up” with the incidence of stroke in the surgery patients.

This persistently bad news still does not really phase the cardiologists, who are now saying that the results of SYNTAX don’t really apply any more in any case, because drug-eluting stents have been improved since the trial was done.

It would appear that the cardiologists are going for some sort of official announcement to the effect that that the results of SYNTAX are, for practical purposes, indeterminate, and that what is needed is a new clinical trial, in which patients randomized to DES will receive the latest generation of stents. (Since there is a new generation of stents every year or so, this entire process can be repeated as needed until the cardiologists finally get the results they’re looking for, at which point they can declare final victory and stop.)

Summary:

All medical specialists should take a lesson from the cardiologists. In an era in which specialist organizations will no longer be writing the clinical guidelines for their own specialty, it is necessary to aggressively pre-spin any important clinical data upon which the GOD panels will be deliberating.

Considering the SYNTAX trial as a case study, one sees how it is possible to take the most straightforward results from a very straightforward clinical trial and, if not turn a negative outcome into a positive one, at least introduce enough complications, nuance, spin and uncertainty to cause any self-respecting GOD panelist to hesitate in making a definitive pronouncement on those results. Then, if you couple all the uncertainty you’ve created with a loud call for yet another clinical trial – one that will take into account new equipment, new techniques, new scoring systems &c., and that promises to clear up all the confusion you’ve dug up as a result of the last clinical trial – then you stand a decent chance of at least getting a postponement on any new guidelines harmful to your cause.

And this, you neurologists, gastroenterologists, pulmonologists and all you other, less savvy medical specialists, is how one can manage the GOD panels.

A study in the February 2008 issue of the American Heart Journal shows that cardiologists in New York State are less willing to aggressively treat patients with severe heart attacks than cardiologists in other states, and that the mortality of these patients is significantly higher in New York. The authors of the report attribute this reticence to treat to the existence of public report cards in New York, which publish doctors’ names alongside their procedure-related mortality figures.

The study compared the treatments and the outcomes in 220 New York patients with 325 patients from states without public reporting systems, who had shock (severe circulatory instability) caused by myocardial infarctions (heart attacks). They found that patients in New York were significantly less likely to receive either diagnostic cardiac catheterizations or stents. Both groups of patients were equally likely to receive coronary artery bypass surgery, but the surgery was significantly delayed in patients from New York. Among all patients, the risk of death in the hospital was 50% higher in New York than in other states. But among patients who actually received either stents or bypass surgery, there was no significant difference in mortality.

There are many advantages of physician report cards to a system based on covert rationing. Let us review the many benefits that accrue to the payers:

1) Fewer expensive procedures are being done
2) Fewer emergency procedures are being done (procedures like the ones being avoided in this study are often performed in the middle of the night and on weekends, entailing overtime payments and other excess overhead.)
3) More high-risk patients (destined to be chronically expensive) die expeditiously.
4) The docs who do persist in doing these high-risk procedures stand out even more in the public report cards.
5) Eventually, NOT doing these high risk procedures will become the new de facto standard of care, and outliers then can be dealt with directly (instead of relying on bad report cards to weed them out).
6) All the while, payers can stand upon the altar of altruism, proclaiming transparency and the patient’s right to know.

The inappropriately negative fallout experienced by physicians conducting potentially life-saving procedures on high risk patients, of course, could be easily overcome by appropriate risk-adjustment methodologies (to account, for instance, for the very high mortality predicted for any patient presenting with shock due to myocardial infarction). But doing so would wreck the whole notion of using public report cards to further the cause of covert rationing. (See items 1 – 6, above.)

But, as usual, DrRich has a solution.

It’s called the Designated Driver.

Imagine the distinguished Chief of Cardiology approaching a promising 31-year-old cardiology fellow, who is finally at the end of his long course of training and at last is ready to enter practice, and saying, “Son, you are going to have a brief but spectacular career. You are going to be our Designated Driver.”

For an extraordinary annual salary and immediate vesting in a generous pension plan, this young man is going to have the honor of being the one who gets all the high-risk cases for the group. He will agree to do this as long as it is feasible, that is, as long as he’s not run out of town because his report card is so abysmally bad. Given the inefficiencies of collecting and processing data for report cards (a process controlled by tangled bureaucracies of one flavor or another, and often, by several tangled bureaucracies that have to devise even more tangled processes for some semblance of cooperation), this is likely to take at least 5 years, and in many cases may take 10. With a sufficient number of more “routine” cardiac cases tossed his way by his sympathetic colleagues (to help him buffer his report card statistics), he may be able to survive 12 or even 15 years. But in any case, by the time he is in, say, his late 30s, he’ll be able to retire quite comfortably.

The Designated Driver scheme is a win-win for everybody (almost). Very sick patients can get the procedures they need (i.e., the ethics of medicine can be shored up for a bit). Your typical cardiologist can enjoy his/her long, relatively risk-free career. And your young, aggressive cardiologist will be presented with a glorious challenge not unlike those of the gladiators of antiquity (save that when it’s finally time to face the old “thumbs down,” they will be spirited to a much more agreeable retirement.)

This solution, as brilliant as it is, will attract critics. And those critics will eventually demand or pass laws, regulations, and guidelines to turn the Designated Driver into merely one more manifestation of the federal crime of healthcare fraud, punishable by the usual massive fines and jail time.

So when that time comes we’ll have to think of something else. But for now, given the alternatives, DrRich recommends the Designated Driver to cardiologists in the great State of New York.