Doctoring ICD/Pacemaker

Shocking revelations…

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.


5 replies on “Shocking revelations…”

Nice article which exposes the monetary incentive for medical device installation. If a little is good then more is better; not really.
Patients also need to be good consumers of health care. There is a risk to every medical intervention which must be weighed against the benefit.
If you come to the ER with a shock,you will get admitted to telemetry and you will be monitored and have your device queried. Those costs are significant also.

John, you have captured a solid part of the issues. Unfortunately, like many things in medicine (and elsewhere), it is "all about the money". Physicians convince themselves that "more is better" and that doing something is better than doing nothing. COMPANION showed only a 1% absolute difference between CRT-P and CRT-D, with the majority of mortality reduction being caused by CRT alone. Yet, we continue to get referrals for patients on hemodialysis, octogenarians, nonogenarians and so many others that do not really benefit much from prophylactic ICD implants. In addition, even many EPs do not know how to program devices properly,as they are committed to ablation procedures and rely on the reps to do programming and evaluations for them. Somehow ans someway, this needs to all stop.

Thanks Richard and Chuk,

And, I agree wholeheartedly with your Companion observations.



Thanks for the post. Too many ICDs are being implanted — absolutely. For every patient saved, how many more live with regret and anxiety and the root of both, i.e. inappropriate shocks? We (patients) sign on too willingly, EPs implant too heedlessly. The system is working against a thoughtful decision process for both groups.

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