"The Heart Rhythm Society (HRS) is aware of an ongoing U.S. Department of Justice (DOJ) civil investigation of Implantable Cardioverter Defibrillator (ICD) implants and has agreed to assist in an advisory role to lend expertise concerning proper guidelines for clinical decision making. As an advisor to this investigation, HRS is reviewing information that does not include either identifiable patient or facility level data. Rather, we are providing insight on the field of electrophysiology to the DOJ. Because this is an ongoing investigation, HRS Staff or Leadership is not available for further comment. HRS will communicate additional information to its membership when permitted to do so by the DOJ."This action comes, no doubt, on the heels of the recent publication in JAMA which reviewed an ICD registry of implantation practices in America from 2006 to 2009 and found 22% of ICD implants were implanted outside published guidelines.
Now all of us know people make money implanting ICD's, including me. Given the time, the expertise, and the management issues involved with the 24/7 care of the patients with these devices, they should.
But no one wants to waste money to our health care system, either, and we must acknowledge there's been a heck of a marketing push to get more devices implanted. This has occurred because many patients who might benefit (legitimately) from these devices remain untreated and, yes, hospitals and medical device companies benefit handsomely from these procedures.
But before witch hunts ensue, we should take a moment and consider the implications of the DOJ's current actions.
First of all, I think most of us would acknowledge that every set of clinical guidelines published has holes. (One only has to look at the latest published atrial fibrillation management guidelines to note that the use of the newly-released anticoagulant dabigatran (Pradaxa) is not mentioned in those guidelines, rendering them already obsolete). Further, the studies upon which recommendations are made in published guidelines are often made on relatively weak data or by people with substantial industry ties. Further, prospective randomized trials are rarely used to make those recommendations.
Simply put, there is no way a published document can cover every clinical circumstance a doctor might encounter when he or she is in the trenches with an individual patient.
So this begs a simple question: If guidelines are not perfect and we must accept that doctors must deviate from them from time to time to work toward the best interest of their patient, what IS the percentage of care (in this case, ICDs) that SHOULD fall outside of guidelines?
Is 0% the correct number?
Is 5%, 10%, 15%, 20%, 22%?
The reality of this situation is that no one knows.
But that does not seem to be stopping the DOJ from investigating doctors for their criminal intent...
... based on the guidelines, of course.
Al-Khatib SM, Hellkamp A, Curtis J, et al. Non-evidence-based ICD implantations in the United States. JAMA 2011; 305:43-49.
Dr. Rich over at the Covert Rationing blog appropriately rips the abuse of the ICD guidelines in his must-read essay.
John Mandrola, MD, another EP, gives his take.
Larry Husten, at Cardiobrief, summarizes.
21 Jan 2011: An now, thanks to new SCD-HeFT data, maybe the 40-day wait period post-MI for ICD's is not such a good idea. Oh wait, that's not in the guidelines.