Friday, August 29, 2008

ICD's for the Over-80 Crowd

I call it "device creep:" a form of extrapolation of clinical trial data to justify the addition of more advanced (and expensive) technologies.

It happens all the time in my field.

Start with an 82-year old with sick sinus syndrome and the need for a permanent pacemaker. Before their procedure, the heart's pumping function, or ejection fraction, is evaluated and found to be, say, 31%. Now, based on data from the NIH-sponsored SCD-HeFT trial, an implantable cardiac defibrillator (ICD) is considered to not only support the heart rate, but also to play potential role in the primary prevention of sudden cardiac death in this higher-than-average-risk patient. But why stop there? After all, the EKG was evaluated and demonstrates an underlying left bundle branch block. A quick review of the chart confirms an admission for heart failure in the last year, and voila', a biventricular ICD is justified on the basis of CARE-HF and the MIRACLE trial to provide cardiac resynchronization in hopes of improving heart failure symptoms, too!

A talk then ensues with the patient and their family. The pros and cons of each technology and the limitations of the data are reviewed. Jointly, the group comes to a clinical consensus about which device to receive. Usually (but not always), a "cover all the bases" approach is taken, since cost is usually not considered in these discussions.

And the difference in price between a pacemaker and biventricular pacemaker-defibrillator?

About three-fold.

So what's the best option?

The does a nice job reviewing the controversies surrounding "device creep" in those over the age of 80 with sinus node disease as they review a timely article by Dr Michael O Sweeney of the Brigham and Women's Hospital, Boston, MA published before print in the Journal of Cardiac Electrophysiology. Cardiologists, electrophysiologists and heart failure experts weigh in from both sides of the debate: (1) co-morbidities matter, (2)this is a uniquely American debate since other countries already ration these expensive technologies, and (3) the convergence of an aging population and tightening resources will make discussions like these more and more common the field of cardiac electrophysiology. Perhaps Dr. Lynne Warner Stevenson from the Brigham and Women's Hospital said it best:
"As we look at the healthcare problem in the US, we're going to have to make some exceedingly difficult decisions. We're going to have to be either rational or be severely rationed. And a relatively easy target is to reduce the number of expensive procedures that do not provide anticipated benefit."
But in when does a person reach the age where technology provides no "anticipated benefit?" What benefits should we measure?

Read the whole thing. It's worth it. Then ask yourself: what if you were 80 and facing this decision: what would you do?



Anonymous said...

I just had this conversation with a 78 yo with NICM, EF about 30. Discussed risks/benefits/alternatives. He was not keen to proceed.

What frustrates me is the knee jerk reaction to implant ICDs or BiV devices into anyone who meets criteria w/o consideration of comorbidities. I wish HRS would come up with some reality based guidelines; perhaps before CMS does and decides to ration devices.


Lisa said...

From the standpoint of a cancer patient...I take beta blockers for my heart problems and haven't had any devices offered...but the patient is only hearing "this is what my doctor is recommending" and his family may not be in a position to argue it without seeming to say "Grandpa is old and not worth the extra for the ICD." My doctors came in and said "you need a port" and put one in. They didn't discuss any alternative with me and I didn't have any idea what the port cost until I saw the EOB after the insurance paid for it. The same happened with the anti-emetic (granted with LQTS they were limited by the Arizona CERTS list) but they wrote a perscription and I went to the pharmacy and filled it. I found out after the fact that the perscription cost $615 for 3 pills. And nobody mentioned that there were older, but maybe less effective medications that I could have been given a trial of. I have learned the hard way to ask if there are any other options and is the option they are offering going to affect my survival or quality of life, and by how much. But for the most part patients and their families don't know to ask that.

Anonymous said...

This is a problem of our own making--by that I don't mean that doctors, device companies, or even lawyers created the problem, but rather our society did. It is our system of beliefs that every person is entitled to the same rights as the next, and that access to the highest quality health care is one such God-given right. It is, as my college economic professor called it, the "Gucci loafer" problem--everyone believes they deserve Gucci loafers, but not everyone can afford them--unless we're not talking about Gucci loafers, but ICDs, in which case cost is no object (because some-one else is paying), and the market effect becomes obvious.

As it turns out, though, many doctors do have a sense of social responsibility, and will ration devices on the basis of acieving some larger societal goal--like not bankrupting the health care system. We generally refer to this activity as exercizing "clinical judgment", but really it is almost always just rationing. For example, if we withold ICDs in otherwise healthy 85 year old individuials, are we really doing so because we feel the risk of them dying from the procedure is higher than the risk of them dying from a cardiac arrest that might be recuscitated from a life-saving shock? Or are we instead saying that the net expected life-year gained from the device is not worth the cost? If it is the former, I'd refer you to the US death statistics (1/5 of all deaths are from sudden cardiac death), or suggest you find a more skilled ICD implanter. On the other hand, if your reason for non-ICD referral is the latter, then call it what you like, but it is "rationing", and raises a number of questions, ranging from the scientific, to the philosophical, to the legal. First the "scientific"--retrospective analysis of respected clinical studies show benefit from ICDs is not reduced in the elderly, and may even be greater. Next the "philosophical"--as a physician you have a duty to the patient, but as a member of society you also have a duty to the larger community. By failing to offer an ICD on cost-benefit grounds you are placing your duty to the patient below your duty to society, which is morally suspect. I know that I want my doctor to place my health above anyone else's finances (including society at large). The legal implications are obvious, but in the end a bad reason for making any clinical decision.

So what do I believe? I believe rationing belongs in Washington with the policy makers, not at the bedside. But I also believe that blindly following practice guidelines reduces doctoring to something that could be replaced with a computer algorithm. In the end the scientific data are clear, but what I don't know is the patient's valuation of length of life vs. quality, includng post-operative pain and potential for spurious ICD shocks.I discuss all this with the patient, and together we arrive at a decision. What I DO NOT do is insert myself into the patient's role in this discussion by deciding for him. I don't presume to know what my patient would want; I ask him.