A rough day in heart-rhythm news

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.

Ouch.

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.

JMM

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.

Comments

  1. Sam says

    Remember the “pen” is mightier than the “rod”. And, “You can’t buy a house with a pen”!

    • says

      It depends on what the metric is (weight vs footprint), but mostly, it’s not really relevant because they are all sufficiently small.

  2. CardioNP says

    A while back an EP friend was interviewed by a federal inspector general. They asked all kinds of questions about renumeration from ICD manufacturers. Wonder if this is what they were focused on. At the time my friend was not sure which company was the target of the investigation. I thought it might be Biotronic since they were being very aggressive with their sales force at the time.

  3. says

    Right, “ICDs are therapy for sudden death, not back pain”. So let’s insert them in every unfortunate soul who presents with unexplained syncope or LV dysfunction. Just in case. After all, better safe than sorry, right?

    Wrong. Patients trust (or at least used to trust) our physicians to be our best advocates and do us no harm. Unfortunately, patients cringe when we hear stories of top U.S. medical device manufacturers paying kickbacks to induce physicians to implant their ICDs. Sadly, it is not only a testament to immoral behavior on the part of industry, it is also evidence that there are EPs out there willing to accommodate such dishonorable requests.

    Now THAT’S what I call a rough day in heart-rhythm.

    • says

      HC,

      Point taken. The scourge of predatory medicine is a black mark for all doctors, whether it is spinal fusions, coronary stents, or even cardiac devices.

      I have been a long-standing, outspoken advocate for applying clinical judgment in the use of ICDs. Even before I read this important, but infrequently cited Josephson piece, I was mindful of the limitations of ICD, and the flaws of the prophylactic ICD trials. I was on the front lines of the first recalls, and I am still living with the Sprint Fidelis debacle. My wife is a palliative care doctor, so I understand the concept of “all-cause” mortality versus “arrhythmic-mortality.”

      The unfairness of life though, is that swinging pendulums whack everybody–even those that apply (and have applied) critical thinking.

      Perhaps, the present-day intrusions into the doctor-patient relationship are getting to me. As Malcolm Gladwell writes about in his recent book What the Dog Saw, the outlier, egregious (Midei-like) cases don’t follow a predictable normal-curve distribution and therefore their solutions shouldn’t either. This is because the solutions for the few may adversely affect the majority. Such is happening now.

      John