Anger Management

By now, there must be better than twenty-five "articles" in the so-called "press" about the effects that the emotion anger might have in predicting "heart risks," especially in patients with defibrillators. Each of these journalistic articles point to a recently published manuscript in the Journal of the American College of Cardiology as their authoritative reference, and report the "facts" without any journalistic effort to determine the study's credibility or scientific rigor. Certainly, I do not blame the Journal of the American College of Cardiology for publishing the work - the topic is one that warrants evaluation and critical review. (Of course, what the reviewers of the manuscript were thinking is another issue, but more on that later.)

First, for the lay reader of these press stories, it's important to realize that whenever there are so many stories published simultaneously about a single manuscript like this, the press are almost almost always tipped off about the results by a press release with a really interesting photograph. Certainly if it's about being angry, then the press release shows someone really angry. (It's hard to get your point across otherwise, I guess).

Second, one should always look for a medical device company or academic center that wants to promote the technology or researcher (or both). Interestingly, these articles fly around the internet faster than most because these larger subliminal sponsors have PR teams with friends in high places in the press corps. One doesn't have to look too far to note that the second author of the study, Vladimir Shusterman, MD, PhD, is the President of PinMed, Inc., the maker of the T-wave alternans technology used in this study. But that should not sway us, because we also note that Dr. Shusterman is also "a Faculty Member and Director of Noninvasive Cardiac Electrophysiology Laboratories at the Cardiovascular Institute, University of Pittsburgh."

Interesting that a researcher on such a study can wear two hats like this without batting a single conflict-of-interest eye.

But that's not enough. A few more clicks to follow the research (money?) trail, and we find that the lead author of the study and her home institution (Yale) have been working with PinMed, Inc. for quite a while, so long in fact that the lead author has been quoted saying some nice things about the company on their website:

"As a practicing electrophysiologist, I can envision multiple clinical uses for the PELEX system once it is approved by the FDA... I think this technology will be extremely useful, both for my own research applications, and also likely for clinical practice."

Not that this is bad, mind you. Certainly all of us are entitled to our opinions and biases. But it never ceases to amaze me how gullible the press can be when it comes to scientific PR spin and how this little point was not mentioned in the study's limitations, but rather, Dr. Lampert's conflicts mention only a "minimal" conflict with St. Jude Medical.

Finally, there are the issues with the study itself. I find it remarkable that few have questioned a basic premise of the study, that ICD shocks occur more often when people who have a propensity for a tiny increase in T-wave alternans when they get angry, are more likely to have an implantable defibrillator fire. But on the surface, without any fancy schmancy technology, it should be obvious to the casual observer that any defibrillator is more likely to go off when the heart rate is faster than someone whose heart rate is slower: that's how these gizmos work. Certainly, people's hearts might beat faster when they are angry. But any other cause of fast heart rhythm might make them fire as well. In fact, all that has to happen in the most basic defibrillator detection algorithm is the heart rate exceed a programmed rate for a sufficient amount of time and, BAMMO!, the patient gets shocked or might receive anti-tachycardia pacing. Might other things like atrial fibrillation, exercise, sex, anxiety poosibly cause similar therapies? You betcha.

But when one wants to report results for a new-fangled T-wave alternans test that we want the world to use (and maybe on angry people) to predict of their ICD will fire, well we get 62 of them, look for T wave alternans, then follow them for a year to see what their ICD does. Sure enough, 10 of them have some therapies. Yep, t-e-n. Just enough to place these patients into "quartiles" (2 -3 three a quartile???). Then we compare the top and bottom quartile and, yep, there's a statistical difference! Quick, get out the press release!

But alas, if the press had read the paper, they'd find these limitations admitted by the authors:

"Also, the sample size and number of events was small, and these data should be viewed as hypothesis generating. Whether patients who agreed to participate may differ from the overall population, creating a selection bias, cannot be determined. Larger studies may more definitively establish the predictive value of anger-induced TWA. Further, the programming of ICDs was not uniform. Although the rate cutoffs did not differ between high- and low-anger TWA groups, the possibility that differences in detection times or programmed treatment may have contributed to the findings cannot be excluded."

But these limitations don't make headlines, do they? Nope, better to gloss over these fine points and go to press anyway. After all, it's all improving that impact factor, right?

Sheesh, something like this might make someone angry...

.... uh, oh.

-Wes

Procedural Darwinism

New procedures in medicine do not always stay – they must survive.

I have been interested to see Procedural Darwinism at work in my daily practice. Charles Darwin introduced his theory of natural selection of species to the scientific community at the turn of the 20th century. But his work, I have found, is not limited to all creatures great and small – it is related to medical procedures as well. You see, some procedures that heath care professionals perform provide good value to the medical community and the doctors themselves, while other procedures are too time-consuming and too economically under-reimbursed to survive in the ever-frenetic pace of medicine today.

Take the stethoscope, for instance. It is rapidly succumbing to Procedural Darwinism. If it weren’t for the stethoscopes ability to hear breath sounds, it would have been extinct long ago. The echocardiogram is far superior to “hear” heart sounds, and adds procedural survival protection by providing additional size, structure, and functional information regarding the heart with little pain or toxicity to the patient. The echo also reimburses well. The echo will clearly and directly survive Procedural Darwinism.

Although it may be on the “Endangered Procedures” list because it reimburses nothing to the physician, the stethoscope still clings to Procedural Life by providing important value to the physician in a different venue: there is no faster way to detect the early onset of congestive heart failure or pneumonia. Stethoscopes survive, then, by providing indirect economic value to the physician (by making him improve outcomes and therefore referrals). Therefore, by indirect economics, the stethoscope is likely to survive Procedural Darwinism.

But some new procedures may not survive Procedural Darwinism. One such procedure is T-wave alternans testing for the evaluation of patient considered to be at risk for sudden death. For those not familiar with this test – it is like a treadmill test, but much more time-consuming to perform. It uses special (and relatively expensive) electrodes configured in a non-familiar way (to people who do these test for a living), and detects information that cannot be seen by the naked eye (therefore it’s hard to believe/understand/verify by those who do treadmills for a living). It also requires remarkable fortitude to assure reliable data are collected (have to hold the heart rate in a narrow range for a pre-specified amount of time). Worse still, the economics of reimbursement are poor: the “special” electrodes cost $74 a set while the entire inpatient reimbursement is under $150 for a test that takes at least 45-60 minutes per patient to perform in the inpatient setting. While the costs in the outpatient setting are a bit more favorable ($300 reimbursement), there are Medicare coding rules that are complicated to perfect, and therefore – at least in Illinois - difficult to assure collection of any reimbursement in the first place. This procedure, as it stands now, is destined for Procedural Extinction unless something changes.

St. Jude’s recent resuscitation of Cambridge Heart (the maker of the only approved T-wave alternans machine to date) flies against the forces of Procedural Darwinism. St Jude feels they have an answer to counteract their declining defibrillator sales: that the indirect value of T-wave alternans testing in terms of increased referrals for defibrillator implants will justify the hours spent performing the test (and revenues/time lost). If internists are to perform the test, unless they receive a kickback for such a referral to cardiac electrophysiologists, there will be little economic reason to perform this test due to its difficult procedural requirements in terms of time and reimbursement.

T-wave alternans testing will only survive if environmental conditions change: that is, a mandate by Medicare to require the testing for people with weak heart muscles and no prior arrhythmia or heart failure. Even then, the application of this test, when other better reimbursing tests exist (like EP testing), keeps this test likely for extinction.

-Wes