New developments in St Jude Medical’s Riata lead failure

There is a big story out today in the small world of electrophysiology. I’ll try to give it a non-technical wide-angle view.

My friend and fellow real world doctor, Dr. Jay Schloss from Cincinnati is at it again. Jay conitunes on his quest to give doctors and patients the most useable information possible on the matter of St Jude Medical’s (SJM) lead woes.

As a person whose everyday job entails implanting cardiac devices, I feel compelled to join the conversation.

Here goes:

Dr. Schloss’ most recent piece, published today, not in a medical journal, but on the blog of Larry Husten, Cardiobrief, addresses the contentiously debated views on SJM’s troubled defibrillator leads.

My summary of the background:

SJM has a real problem with their defibrillator leads. No lead is perfect, but the Riata family is especially troubled: 1) In too high a percentage, Riata leads are externalizing (coming apart) inside the body, and 2) It’s now clear from Dr Robert Hauser’s recent report that internal lead shorts have resulted in patient deaths—when the life-shaving shock fails. That patients have died because Riata leads failed has upped the volume of this previously mundane medical device failure. Further complicating the matter for SJM is the fact that their current lead Durata, shares many of the same design features as its troubled parents. SJM says its current lead has a ‘super’ insulation and will hold up; many of us have our doubts. How much confidence to have in SJM’s leads wasn’t bolstered by this report on their LV pacing leads, which also look dubious.

To no one’s surprise, St Jude Medical had a response to all this bad news. They had choices in how to respond; clearly, different options were discussed in the boardroom. One approach would have been to admit that Riata/Riata ST leads have a problem; apologize for the human error of engineering; state clearly they are doing their best to follow and identify patients before a bad outcome occurs and then go on to support their (supportable) belief that Durata will hold up. That’s not the path they chose. Rather, they took the view that the best defense is a good offense. SJM publicly and loudly asked for retraction of the paper in Heart Rhythm. Their chief complaint with the Dr. Hauser paper was not that their own lead had tragic failures but that the number of deaths with the Medtronic Quattro lead (their competitor) were undercounted. In other words, they didn’t defend their failures; they set out to impugn their competitor’s product. We were bad, but they were worse.

This debate went public. The WSJ and NYTimes and many more mainstream media outlets carried the story. My social media and EP colleague, Dr Wes Fisher is all over this story.

Amidst the storm, enters the calm, well-mannered and thoughtful Dr. Jay Schloss…again. For free, on his own time, with no residents and fellows, or research nurses, Jay looked at every case that St Jude submitted in their response—hundreds of them. Then, he took the time to write about them in a research-type manner. His detailed report speaks for itself.

I’ll offer a summary: Jay found–as most expected– that the SJM-reported deaths related to Medtronic’s Quattro lead were either indeterminate or not lead-related. Dr Hauser’s report rightly included only deaths that were felt certain to be directly lead-related. Remember, all (or many) patents that die with an ICD get reported, but clearly not all are lead-related. Ever diplomatic, Dr. Schloss calls these differing ways to look at the data: “significant methodological differences.”

I have three concluding remarks:

Dr Schloss should be commended on this important work. He has provided excellent and unbiased information. Even more inspiring is that he has done this out of a passion for his work–helping patients with heart disease. To me, this is really cool. So good!

Second, a note on St Jude Medical’s strategy for dealing with Dr Hauser’s peer-reviewed and well-vetted report on Riata-related deaths: I’m disappointed. I can’t help feeling they tried to hoodwink us. Of course, it’s not fair to count non-lead-related deaths. And what of the public tantrums? Look, I’m a SJM customer. They make good products, that help me, help patients. But come on guys? In medicine, the rule of thumb in cases of complications is to be truthful, contrite and more helpful–not defensive and accusatory.

Finally, How about the role of social media? Naysayers point to the wily-nilyness of Facebook and blawgs. But times have changed–for the better. Now, social media not only allows, but amplifies, the important voices of real docs who are embroiled in real messes.  No longer is the only word on clinical matters coming from protected ivy-walled academic centers. I’m not knocking the voices of academia. We need their work, but us regular doctors often want to know what are fellow regular doctors are thinking and doing. I tell patients who have challenging problems that recruiting more minds to work on the problem almost always helps. So yes, I believe social media stands to help both patients and doctors alike.

JMM

Comments

  1. says

    Nice post John. The basic rule: “Be truthful” – holds up. No one expects perfection. But dishonesty leads to distrust – with ultimate worse outcome for the ordeal. Your description is the reason for my increasing skepticism of “the system” (albeit despite my 30-plus previous years of “trusting” … ). THANKS for your honest look at the situation.

  2. Melissa Jacobs says

    I have been reading your blog since I got my ICD in August 2010. I always enjoy reading and have learned a lot. Thanks for writing.

    Unfortunately, this whole mess involves me somewhat. I have a Durata lead. My other two are from Boston Scientific. All this “muck” of information and indecision on the part of the SJM and doctors leaves a patient wondering what in the heck to do and worry about whether their ICD is going to be there for them when they need it. I hope someone quickly comes up with a strategy for what to do with patients who have the Riata leads and I certainly hope that SJM has a team of engineers testing the heck out of the Durata lead to determine if it is indeed going to perform as poorly as the Riata.

  3. says

    Melissa – Would seem to be something that might benefit from directly asking the folks at SJM (to at least get them to commit on paper to your very valid concern about whether your device is likely to be functional for you in the event you need it …. ). This is not with intention of a “medicolegal” inquiry – but rather a patient wanting to know if it is safe for her to entrust her life in SJM …

  4. says

    Beyond the potentially catastrophic problems with the Riata and Riata/ST, this story is really about how poorly the leadership at St. Jude Medical has handled the crisis. Very telling of the organization’s culture.

    I’ve been reading about the likelihood of a problem with the Riata ever since St. Jude pulled the product from the market in December of 2010. But not much attention was paid to it until the publication of the Irish study last September, and finally after the acceptance of Dr. Hauser’s manuscript by Heart Rhythm.

    Why has it taken us this long to realize there was a problem of this magnitude? And what guarantee do we have the same won’t happen with the Durata? Shall we just trust St. Jude to monitoring that lead as well? Their behavior alone is enough for patients to think twice before consenting to having a St. Jude lead implanted in their body. Why take a chance when there are more reliable products available?

  5. Clarence says

    I have a suspect lead, and right from the start, it seemed deceptive, no one is mentioning the studies from ireland, or that the use of xrays dont work (except to keep numbers down) I feel let down by the medical community on this one.
    I dont trust the manufacturer, the hospitals, or physicians in this issue.

    I did a youtube vid, in hopes of getting at least one persons viewpoint who have these and how it feels, especially now. The further I go, the worse it seems to get.
    http://youtu.be/l5tdodzy13Y

    one persons view, I just had to say my part. I looked up icd lead problems and it reflects stock prices…nice.