Guest Post: Shocking revelations at the HRS…

(The following guest post is reprinted with permission from the blog of Dr John Mandola, an electrophysiologist in Louisville, KY.)

Defibrillators (ICDs) are in the news today. Few medical treatments are more misunderstood, both by doctors and patients, than the ICD.

It was a huge observational study presented today in Denver at the annual HRS (Heart Rhythm Society) meeting. In 88,804 ICD patients from 2500 centers, researchers studied how ICD programming related to inappropriate shocks. They concluded: (translation to follow)

“Strategic programming of faster VT/VF detection thresholds, longer detection durations, SVT discriminators, and ATP for FVT reduced shocks. Clinical actions to reduce morbidity from shocks should include ensuring adequate rate control for pts with AF as well as programming to increase the VT/VF detection rate and duration thresholds.”

The translation goes something like this: programming an ICD skillfully, like you know something about the heart rhythm, is better than just implanting the device with its nominal factory settings. Taking the time to tailor ICD programming to the specific patient reduces the likelihood of inappropriate shocks, which are not only painful, but also portend a higher risk of future morbidity. Inappropriate shocks are horrible. Although they cannot be absolutely prevented, they can surely be minimized with sound doctoring.

That could be it–the end of the story. Just program the darn thing smartly, and let’s move on. However, if that were the case, than why would someone need to study 88,000-plus patients?

The interesting part of the story, and probably the impetus for the study, is that, in the real world, many ICDs are programmed nominally rather than strategically. How, or why does this happen?

In the interest of brevity, here are three possible explanations, often overheard at EP luncheons. Undoubtedly, there are more, and other thoughts are welcome.

First, there are too many ICDs implanted. The science that showed ICD benefit is difficult to apply clinically. It requires critical reading of the studies, and careful consideration of a patient’s entire story, including the need to discuss sudden death. “No one told me I could I could die,” is often heard form the surprised patient.

Our “expert-decreed” ICD implantation guidelines offer little real help. Present guidelines are too broad, so much so, that as long as a low ejection-fraction patient isn’t dying in the next month, an ICD can be justified on paper, even though it makes little clinical sense. That ICDs are well-reimbursed, and easy–even somewhat soothing–to implant fuels the fire of overuse. And finally, ICDs are used to prevent dying. Emotion and the tacit assumption of cardiologists that death is failure, further plays into the misunderstanding of ICD therapy.

Second, there are too many implanters. Way back, around the turn of the century, industry sponsored ICD trials showed mortality benefits from prophylactic ICD implantation. Although the patient cohort deriving benefit from the ICD was specifically defined, the headlines read that any weak heart (low ejection fraction) should have an ICD. Revelations like these were fueled both by industry, and possibly (as the more cynical observer might suggest), industry-sponsored professors. The cynical might also suggest that industry–bolstered by much hoopla in the mainstream media–convinced governing bodies, like ACC/AHA and HRS, that there were not enough electrophysiologists to meet the upcoming ICD demand, and that weekend courses were sufficient to train one to implant ICDs. Shazam, soon there were plenty of doctors to implant the well-reimbursed ICD. Now six years later, the same governing bodies have changed their mind, and recommended that only board-certified electrophysiologists be credentialed to implant ICDs. Hmm?

Third, “strategic” ICD programming requires thinking. It isn’t just the diploma, or the passing grade on the test that programs the ICD, it’s a thinking clinician–a master of the obvious. For example, one who considers that a 55 year old hypertrophic cardiomyopathy patient who avidly exercises, is probably going to get his heart rate higher than the nominally programmed 165bpm on the treadmill. Or, that anti-tachycardia pacing of tachycardia might save the conscious patient a shock. Or, that the patient with rapidly conducting AF requires both strategic VT detection-programming, and concomitant medical therapy.

Compensation for the “install” is the same whether the doctor knows these things or not. Intelligent programming of cardiac devices is yet another example of how quality–in this case, the quality of ICD therapy–will prove difficult to quantify. No worries, just measure how well doctors fill out forms, like most hospital’s pre-implant ICD checklist, which laughingly presumes that checking the right box implies sound judgement.

And then there are the device company representatives who help some doctors implant and program devices.

Stop. No doctors need help from the reps. It never happens.


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