For some patients it’s a terrible sensation; they are left scared and persistently anxious.
For others it’s just a thump in the chest.
But for nearly all patients shocked by their ICD (internal cardiac defibrillator), it means they are still alive.
Today was a sad day for electrophysiology–a branch of cardiology that has the prevention of sudden death as one of its primary missions. I am a newbie, a mere debutante, an apprentice master of the obvious, and even I know it isn’t good to share the news with the US Department of Justice.
There were two headlines. The first story is one well known to all ICD-implanting hospitals.
This ‘important message’ came today in my inbox:
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.
The second EP-news item of the day was that ICD-maker, St Jude Medical, agreed to pay $16 million in fines to settle claims that they paid kickbacks to implanting cardiologists.
Specifically, the suit alleged that St Jude used post-market studies (with their accompanying per-patient stipends) as a guise to financially lure doctors to implant their devices.
The DOJ said:
It is critical that physicians base their decisions on which medical device to implant on the best interest of the patient, not on whether a device manufacturer will pay an extra fee or honoraria for the implant.
A bad day indeed.
What’s behind this curtain of ‘news’ is the notion that ICD decision-making is really complicated. Evaluating and treating real-life patients at risk of sudden death is much different than interpreting t-tests.
I have been a strong advocate of applying clinical judgment in the decision to recommend an ICD—a tenet that is overtly expressed in the guidelines. But now, based on the palpable fear in my community, and the tone of the HRS statement, I am worried that this heavy swinging pendulum will cost lives.
Remember, ICDs are therapy for sudden death, not back pain.
Ed Note: Those who wish to thoroughly (and I mean thoroughly) understand the complexity of calling an ICD ‘non-evidenced based’ should read Dr Rich’s post on The Abuse of ICD Guidelines.