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

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