Impending ICD oversight may not be a bad thing…

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

4 comments

  1. If the regulators telling us whether we can or cannot implant an ICD are as thoughtful and informed as you, we have nothing to be worried about.

    Unfortunately, in most cases, regulatory coverage decisions are handed down by agencies with incomplete information working off a checklist that may not include the most recent appropriate guidelines. The gatekeepers do not have a personal stake in the outcome of their decision. They are poorly accessible. They are not part of the care team and they do not share personal or legal responsibility for their actions. They do not have the capacity to see shades of gray, nor do they have the oppportunity to look a patient in the eye and make decisions on that basis.

    No doubt this type of regulation will cut back on unindicated ICDs and save money. I fear worthy patients will be denied, or at best forced to go through onerous "hoops" to get permission.

    As Dr. Rich would say, this is covert rationing.

    Jay

  2. Thanks for the column, Dr. John. I also read the other two posts. Of the three of you, as EPs, hands down, I wish it'd been you I'd consulted before the implant. Perhaps I would NOT be an ICD user now. Regardless of how that sounds, it would be a good thing (and I'd still be alive — I'm one of the prophylactic owners). We need some brakes on this technology, which, fabulous or not, is not a simple life-saver with no consequences for patients. It's too bad the brakes might be provided by regulators rather than EPs themselves, but honestly, with implant costs what they are (mine was just under $150,000), is it surprising? Good luck to us all, I guess.

  3. I see massive abuse every day and I also see millions of dollars wasted on patients who are comatose or dying of cancer.Some patients cannot sign their own consent and their families are guilted out on the phone by the physician. They receive bi v icds and I do not believe we should be spending all of this money on the few when we should be spending money on the many who could benefit on care for a longer period of time. This is a shameful practice and should stop at once! Some physicians are greedy and out of control!

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