Dr John M

cardiac electrophysiologist, cyclist, learner

A new ‘message’ on expensive medical devices: The ICD as an example

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Nearly six months have passed since “emergency” meetings were called.

Gosh, if I had a dollar for every emergency meeting. It’s amazing how looking back at these crises makes our angst seem silly. Like many things medical, time and deep breaths have a way of sorting things out.

The latest heart-rhythm crisis centered on the DOJ investigation into possible overuse of ICDs (Implantable Cardiac Defibrillators). After many months, it seems calm enough now to write a post reflecting on some of the lessons learned. And where we are now in our thinking about ICDs.

The first part of 2011 was a stormy time to be an ICD-implanter or an ICD hospital. It wasn’t just the DOJ investigation; the debate was also fueled by this well known JAMA study from Duke suggesting one in five ICDs are implanted outside of the evidence base.

What got me thinking about ICDs was getting this congratulations from an industry watcher whom I gave the prediction (earlier this year) that cardiac device implants would be plummeting. She sent these words in an email to me:

I have to give you credit for predicting the ICD market would decline. The third quarter looks very soft (down about 10 percent).

The reasons for the decline in ICD implants are instructive. It taught me a lot. (And when bloggers learn, they like to share.)

I know what you may be thinking? What’s so earth-shattering about the idea that a DOJ investigation and a negative study from Duke resulted in fewer ICD implants?

Let me tell you my thinking…

On the surface, one might argue that enhanced scrutiny of ICDs caused the decline through direct effects. Facts like most ICD-implanting hospitals have instituted pre-implant audits and checklists. Gone are the days when an implanting doctor simply scheduled an ICD or pacemaker. Now, the doctor has to impeccably document that a patient considered for an ICD meets absolute indications. (That these absolutes were penned in 2006 and that clinical judgment has no box on the checklist remains a source of inflammation.)

But if you think ICDs are on the decline just because of these added hurdles, I believe you would be wrong.

I think the main reason for the recent (and future) decline in ICD implants comes from the indirect effects of enhanced scrutiny. By indirect effect, I mean to say there is now a new message about ICDs.

What’s the new ICD message? Who’s hearing it? What was the old message?

Let’s start with the old message on ICDs:

The old message on ICDs held that patients with a weak heart (measured by a low ejection fraction) NEEDED an ICD.

Who was hearing this message?

The main people who heard this message were the general medical community. The doctors on the front lines of medical care, those who control referrals, heard guide-line writers (“experts”) say that patients needed ICDs, or else they could die. ICDs were likened to b-blockers, ACE-inhibitors or statins. Only pills do not deliver 750 volt shocks or get infected with MRSA.

What was the result of the old ICD message?

Patients got referred to implanters of ICDs for the implant, not for a consult that asked,

“Given the competing co-morbidities of my patient and her wishes for a painless and peaceful death, do you think she would benefit from an ICD?” 

At the same time (from 2001 to 2009) the medical community repeatedly heard experts tout the life-saving benefits of ICDs, many ‘installers’ understood that implanting an ICD is easy, well-compensated and doing so avoided conflict with the referring doc. Implanting doctors also knew that all but the most sophisticated patients think doing installing something is better than not.

Going against the ‘message,’ and referring doctors’ wishes, by not implanting the device, proved many fold harder than the thirty minute surgery. So ICD implants rose dramatically from 2001 to 2009.

What’s the new message on ICDs?

The new message on ICDs emphasizes three issues that have always been true, but not part of the original message (or perhaps lost in translation):

  • ICDs are indeed useful, life-saving in fact, but only when skillfully applied in a narrowly-defined group of patients. (There is considerable debate on where these lines of benefit should be drawn and who should be the drawers—doctors or government.)
  • ICDs are not like insurance policies: they confer substantial risk. Recent recalls of ICD leads have highlighted these risks.
  • Patients considered for ICDs should get the benefit of a thorough explanation of what one can expect from an ICD. And how it may affect the end of life.

Whether you like the new ‘message’ or not, three facts remain obvious:

The new ‘message’ is a reality. No patient NEEDs an ICD. The current decline in ICD use will likely continue.

I am conflicted about ICDs. On the one hand, I have always believed that patients considered for an ICD hear the entire story–pros, cons, expectations. I have been a vocal advocate for better patient selection, more skillful ICD management and frank discussions with patients on how an ICD can change the mode of death–from sudden and painless to something less desirable.

But on the other hand, I loathe the idea of government bureaucrats inserting themselves into the doctor-patient relationship. As a thinker and ‘regular’ doctor, I am inflamed when non-clinical statisticians (even ones from Harvard or Duke) make decisions like recommending an ICD seem black or white, right or wrong. It’s hard for me to accept that clinical judgment is not an adequate reason to implant an ICD. Patients are people, not stats, and people often fall into gray areas.

And finally, it’s sad, shameful almost, that we–as a society–value the surgery to implant an ICD so much more than having a difficult discussion with the patient and family. Try explaining the concept of competing causes of death to the patient whose son stands in the corner of the room with his arms folded and face twisted in disgust that I even suggest that an ICD may not help Dad.

Change is constant. Thank goodness.

But are we going in the right direction?

I hope so.

JMM

 

Impending ICD oversight may not be a bad thing…

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At the risk of exposing my naivete, or being too much like the geeky student who sits in the front of the classroom, I can’t help but welcome the upcoming policing of cardiac device implants.  
As recently written by Dr Wes, government policing agencies, the DOJ and RAC folks, are planning to focus on the use of ICDs.  Maybe they know that the ease of ICD implantation, favorable reimbursement, and incredibly vague guidelines have all contributed to the overuse–or misuse–of ICDs.  Maybe they have read this eye-opening appraisal of the major ICD trials.
When not driving at excessive speed on the highway, there is no need to worry about radar speed traps. Likewise when implanting ICDs, if the indications are appropriate, the patient informed (really informed) and the reasons documented in the chart there seems little to fear from DOJ or RAC audits.  If every patient who underwent ICD implantation was evaluated before hand by a heart rhythm expert well versed in ICD indications and the note documentes the ICD indications, there seems little need for concern about audits.  

Maybe enhanced oversight will limit real-life ICD misadventures like the following…

  • the palliative care team having to remove the steri-strips from a recently implanted ICD in a patient with weeks to months left to live.  
  • the patient with depressed cardiac function related to rapid AF who gets an ICD, then an inappropriate shock for rapid AF, rather than treatment of the original problem, the AF.  
  • the patient with low ejection fraction, no prior heart attack and no symptoms of heart failure who inappropriately gets lumped into the “all low EF’s need ICDs” dogma.  
I had planned a post describing new trends in my device practice.  Wes’ story seemed a perfect stimulus.

Although my experience may not mirror the majority of practicing heart rhythm experts, I have noticed a significant decrease in the number of non-CRT (bi-ventricular) implants.  Fewer “regular” ICDs and pacemakers seem to come my way.  Here are a few observations, along with speculation on possible explanations of this observed change in my practice trends.

Pacing trends:

I implant fewer pacemakers for sick sinus syndrome.  As an AF-ologist, more post AF–conversion pauses are treated with primary therapy of the AF, rather than pacing and more drugs–especially in the non-elderly. Successful rhythm control can occasionally supplant the need for a chronic indwelling pacing device. In the non-elderly, this strategy of addressing the root cause (AF) seems much more elegant than having a chronic device which in and of itself does not preclude the need for lifelong medical treatment–in fact, the pacemaker is required because of the medical treatment.   

In the elderly patient with permanent AF, recently validated strategies of less vigorous AF rate control has resulted in fewer cases of bradycardia, and thus fewer single lead ventricular pacemakers.  Additionally, the detrimental effects of RV apical pacing has further lessened pacing enthusiasm. 
ICD implant trends…
I am seeing fewer patients with ischemic cardiomyopathy.  This is likely multifactorial.  Two notions come to mind: first is the idea that in this city’s fairly stable population, many patients with heart damage from remote heart attacks have already been referred for an ICD.  Secondly, it seems possible that the now widespread acceptance of aborting heart attacks by squishing culprit blockages within ninety minutes may have decreased the incidence of persistently damaged hearts.

The Pre-ICD Implant Meeting:

Not only does there seem to be fewer ischemic cardiomyopathy patients in the ICD pool, the pre-implant meeting has resulted in a small, but finite, number of patients who decline the shock-only, non-EF improving ICD.  Years ago, I did away with the idea of meeting the patient just prior to the implant in the pre-op holding area. Like a dinosaur, I cling to the poorly compensated, and often emotionally draining pre-ICD meeting in the office. We discuss all aspects of the ICD.   As death and dying–the elephant in the room–are intimately tied to ICD therapy, this discussion is not easy. Stares and gulps ae not uncommon during these discussions.

What else is discussed in this meeting?  Things like longevity after a shock, things like trading a painless peaceful death for the more drawn out heart failure death, and facts like the ICD will not help dyspnea, chest pain or fatigue.  “Really, I was not aware of any of that information,” is a common patient response.  Although it may sound like I am down on ICD therapy, it is not the case.  Rather, I feel strongly that the details of such a life-altering therapy should be enunciated clearly.

Referral bias…

Referral bias could also play a role in my changing ICD practice. ICD-installing doctors have different philosophies on ICD use.  In a small medical community, one’s ICD philosophy becomes known quickly, and referring doctors have options.  So it seems possible that referring cardiologists who deem an ICD necessary may be more likely to refer to a like-minded electrophysiologist who is less encumbered by the complexities of the ICD implant decision.

Life’s Influences…

It has been written many times that doctors are human. Unlike computers or algorithms, human views our shaped by many of life’s influences.  An undeniably strong influence in my life is exposure to the palliative care world through my wife’s practice.  It is impossible to remain uninfluenced by the seemingly endless stories of human suffering of those unfortunate souls whose death is not sudden and painless.  Ideally, the ICD shock that prevents a painless death should add years of quality of life.  However, and unfortunately, this ideal is often not the case, especially when ICDs are placed in the older  and more diffusely infirmed.  For me, as I age, this tug-of-war between quantity vs quality is an increasingly difficult struggle, and I believe strongly that patients should, at a minimum, be introduced to the complexities of the ICD decision.

CRT device decisions (bi-ventricular) are different than ICD only decisions… 

While the quantity-of-life enhancing prophylactic ICD becomes less prevalent in my practice, the quality-(and quantity)-of-life enhancing CRT device is on the rise. When applied to the appropriate patient, these cardiac synchronizing devices can improve the cardiac output–often dramatically.  This resulting power surge from the heart represents one of an electrophysiologist’s greatest triumphs. Hearing the story of a new found life after implantation of a bi-ventricular device keeps the fire going.  Looking at an echo of a previously awful, but now normal heart after a bi-ventricular device has yet to get old.

Implanting a CRT device that improves both the quality and quantity of one’s life is a much less complex decision. That said, our device companies have rightly given us the choice of implanting the three lead synchronizing CRT device with either an ICD or pacemaker alone. This choice of CRT with or without shocker adds yet another layer of complexity to the decision making process.

Patients ask, “which CRT device is better?”

“Well, they are different,” I add.

That the only trial showing CRT-defibrillator (versus CRT-pcemaker) superiority barely reached statistical difference–but is quoted as if it were a landslide win–makes CRT device choice even more complex.

You can see how complicated this stuff gets.  I have said it before, but the actual installation of the device is many fold less taxing than the discussion of the decisional process.

Unlike the tone of Dr Wes, I must confess that the impending ICD oversight does not worry me.  We will see, though.  The chapter is still open.

JMM