Help in the management of Riata ICD leads--from the FDA?

It's unrelenting. The bad news just won't stop.

This could only mean yet another story concerning St Jude Medical's Riata family of ICD leads. The troubled leads were recalled in December 2011 after it became clear that they were prone to dramatic and sudden insulation failures in which the lead can externalize in the vasculature, result in inappropriate shocks, or fail to pace or defibrillate. It's a major understatement to say patients with these leads pose vexing clinical management problems. It's no small matter to revise or extract Riata leads. Warning systems such as remote monitoring may not predict lead failures. Tragically, a high-voltage shock—that's needed to defibrillate—can result in shorting of the system and absence of therapy.

Keep in mind too, that in many cases, these potential harm-creators were implanted in asymptomatic patients—who were more likely not to need a shock. (Think numbers needed to treat in the primary-prevention trials.)

Electrophysiologists are struggling mightily. I know I am.

To the news:

Yesterday, the US Food and Drug Administration forcefully inserted itself into the clinical management of patients with Riata leads. The press release was clear and strongly worded. The FDA recommended that patients with a Riata lead undergo "X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead." In addition, it also required St Jude Medical to conduct postmarket surveillance studies on two models of its LV/CRT leads and its currently approved Durata family of leads.

I know what you are thinking: Here we go again—not another Riata story. I wondered the same thing. For the FDA to have made such a bold recommendation, there must have been new news.

No. It turns out that there is no new study on Riata. Rather, I learned from this Wall Street Journal article (published two hours after the press release) that the FDA has been "amalgamizing" the scientific data on Riata and has come up with a few helpful recommendations.

So you ask: What's the big deal? Get an X-ray. And why shouldn't St Jude Medical study Durata closely? It's a lead that shares design similarities to Riata. It could fail, too.

Let me tell you why these simple and well-meaning recommendations trouble me—and why they should trouble you.

Start with this given. I'm absolutely (not 99.9%, but 100%) certain of one fact concerning Riata:

Nobody knows the best way to manage these leads. Not the professors, not us masters of obvious in the clinical world, and surely not the amalgamizers in cubicles at the FDA. The only fair words to use in describing this situation are:

We do not know. ­­­

So what do (some) doctors do when they don't know? They default to doing more tests; to be sure, to learn more, and as the FDA press release wishfully suggests: "to help healthcare providers develop individualized patient treatment plans."

Cough.

Treating uncertainty with willy-nilly testing is one of the most commonly made mistakes in clinical medicine. One of the first lessons young doctors learn is not to do tests unless the results will change what they do. In the specific case of Riata, doing X-rays to determine insulation breaches isn't likely to change what we recommend. For instance, we know that most externalized Riata leads function normally. We also know that normal-appearing Riata leads can fail abruptly. Most important, we know that extraction (or revision) of Riata leads exposes the patient to significant risk. In other words, a negative test doesn't necessarily reassure, and a positive test doesn't always mean trouble.

That's not to say looking for insulation breaches in selected patients isn't helpful. It is. But that's not what the FDA's words say. They don't urge doctors to consider doing X-rays in selected patients; they say patients with Riata "should have" X-rays.

In other words, they make it a medical error not to do a test. It is an ominous precedent when a powerful agency inserts protocol and dogma into a situation best handled with nuance and shared decision-making. I'm surprised and disappointed. I would have thought the tailwinds from the less-is-more and Choosing Wisely movements would have pervaded at the FDA. This powerful agency should well know of the dangers of widespread testing in asymptomatic patients.

That's the doctor side of the argument. It's not the strongest one against the FDA's decree.

Consider the patients' side of the issue. When faced with difficult clinical decisions, I like to put myself in the patient's shoes. What if you had a Riata lead? Would you want an X-ray? If so, how often would you expose yourself to the radiation? And if your lead were externalized but functioning normally, what then? I guess worrying about it would help. That's the thing: patients with Riata leads aren't all the same. A young pacemaker-dependent patient with a Riata lead attached to an older-generation generator (one that does not have remote monitoring capability) may be managed differently from an older patient with a primary-prevention indication. Likewise, if the FDA folks took care of real patients, they would understand that some patients would be devastated to know that their normally functioning lead had an externalization.

The bottom line:

Patients with Riata leads need to be considered carefully and individually. There is no protocol or right answer. Physicians need to keep abreast of the rapidly emerging science on the matter. As we have learned with prior hardware recalls, with time and continued surveillance, a clearer picture emerges. Although we want to protect our patients, for it is we who implanted the troubled lead, it is often the case that doing things isn't always the best answer. Alas, doing things got us into this mess.

Let's close on a positive note. I agree with the FDA's requirement that St Jude closely study its current ICD lead Durata. Here, the FDA is right; Durata shares enough similarities to Riata to make us worry about long-term performance. Enhanced postmarket surveillance of ICD leads should not be controversial. In fact, I would think St Jude would welcome the opportunity to prove to its customers that Durata is reliable. As an implanter of ICDs bent on minimizing harm, I look forward to these studies.

JMM

Your comments

	Help in the management of Riata ICD leads--from the FDA?
	# 1 of 5	August 17, 2012 06:30 (EDT)
	LindaL	Thanks for a healthy perspective on a very thorny topic.  Hopefully the FDA will see it too. Especially the line.......if the FDA took care of real patients.   That will be the day! LL
	# 2 of 5	August 18, 2012 12:13 (EDT)
	Merrill	Thanks for this perspective. I'm the owner/operator of one of these leads, and I want a fluoro, and I want to see the fluoro, at least if it's abnormal. I'm sure that, as you write, everyone's response thereafter might be different, but I for one want the information, then the EP's perspective, and then I want to decide. For me, I've thought only so far as to think I would ask to leave ATP on, but turn the the shock capacity off. I'm one of those primary-prevention people who didn't sign up for the prospect of worrying about hairy looking leads floating around my chest. It's already way more than I bargained for. EPs -- do the x-rays, and hand out a prize for the lucky & a magnet to the folks with a "cosmetic" issue. Least you can do. Good luck to all of us.
	# 3 of 5	August 22, 2012 11:58 (EDT)
	Chris	This issue would not be seeing the light of day if not for a group in Northern Ireland deciding to fluoro all of their Riata patients and then presenting their findings at ESC almost exactly 1 year ago.  Since that time, St. Jude Medical has evaded, denied, changed the subject, avoided, misinformed, dodged, and just about anything else other than owning up to the situation at hand.  The FDA is who forced STJ to issue an advisory in November 2011 - an entire year after their non-advisory of December 2010.  The FDA is who forced STJ to acknowledge similar failures on their LV leads in April 2012.  It is the FDA who has to step in while St. Jude has abandoned their responsibility to understand and determine the root cause of these problems.  Until 3 weeks ago, St. Jude was claiming an incidence rate of 0.1% on Riata leads while every independent group that looked at this issue found rates of externalization to be a magnitude higher. The fact that St. Jude has not yet initiated a fluoro examination of their Riata ST Optim and Durata leads is ridiculous, callous, and possibly criminal.  Afterall, if you don't look, you can't see that you have a problem and you can't communicate it either.  So it is the FDA that once again is forcing St. Jude's hands.  Forcing them to examing all of their leads in robust studies.  Forcing them to understand the root cause which is not silicone insulation.  Forcing them to understand what happens inside the lead underneath the Optim.  Forcing them to understand how prevelant failures underneath the shock coil are.  And they are asking the medical community for help since St. Jude has shown absolutely zero interest in doing this themselves.  Recall St. Jude's CEO comments a few days after the Minneapolis Heart Institute's Riata Summit this past January where a group of independent physicians took time out of their own lives an their own practices to come together to find out what was going on: "You know that meeting last week was from an investor perspective and patient care perspective, I think really was a nonevent. It was lightly attended. The proceedings weren't public. It wasn't webcast. There was a very.  Most physicians who attended that meeting are people that are close to one of our competitors and don't do much business with us and a number of them, my understanding is, really don't, you know, never did implant Riata in the first place. It was really a nonevent from that investor perspective and from the patient care perspective and just kind of general market perception and market behavior, there was you know, there wasn't anything new there and besides the fact that it wasn't public and was, it was kind of a little bit of an odd meeting".  The FDA is far from perfect, but I for one am glad they are interjecting themselves into this issue.
	# 4 of 5	August 23, 2012 08:01 (EDT)
	Journal of Cardiology	Thanks for sharing very effective information.I had gone through your blog.All the best.
	# 5 of 5	September 10, 2012 12:11 (EDT)
	tocker	I am a 51 yo male with a Riata lead (1581) and due for a generator exchange, that was installed in 2006 for Brugada.  After an xray and then a follow-up flourscopy, it was determined that the lead has in fact worked its way through the insulation, though I've not experienced any adverse affects.  After discussing with my EP and a second EP who is trained in revisions, I am considering taking it out in October and replace with a lead from another company that has a longer track record with these leads.  Not sure if this is the right decision, but if I am understanding the discussions from the Riata conference in Minneapolis, this problem will not get better with time.  If you have any advice/comments, it would be greatly appreciated.

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