Riata lead safety alert at HRS 2012

The Heart Rhythm Society convened a special session on St Jude Medical's most troubled ICD lead. Attendance was off the charts. The conference room was packed, and nervous-looking folk gathered around crowded hallway monitors. It was a sight indeed.

Most of the major names in the story were there: Dr Estes, Dr Robert G Hauser, two doctors named Epstein, and my friend, Dr Chuck Love, among others.

I tapped out some enotes and have some brief comments.

Dr Larry Epstein gave a very nice presentation on "Risk vs Risk." Immediately, as a minimalist, that spoke to me. He focused on what to do with patients with Riata leads without manifest failures. (As for patients with failed leads, it's easy: they need an intervention.)

Starting with the worst of the worst, he said Riata was no Acufix lead. (These prehistoric leads are infamous for the tendency to erode through the atrium and tear into blood vessels.) In other words, Riata leads do not actively harm our patients. But at the end of his talk, he pointed to (potential) future concerns of externalized cables--namely, thrombosis, erosion, and fibrosis. All bad things, for sure. Along these lines, Dr Carrilo, from Miami, showed a slide of an externalized Riata cable with an attached clot. Scary.

Dr Epstein's talk emphasized the need to balance bad choices. He spoke of the risk of leaving the leads in place vs the risk of operating on them. He presented interesting cases that highlight the sudden and abrupt onset of high-voltage failures seen with Riata but then countered with the not-insignificant risk of extraction or even adding additional leads. Like many others have noted, Riata leads are not easy to extract. Dr Carrilo offered amazing pictures of a Riata extraction. This procedure is no heart cath.

Continuing on, Dr Epstein mused that he was most scared that we don't know the mechanism of Riata failure. Paraphrasing: "It's not Fidelis; the externalized cable issue with Riata amps the concern of abandoning [leaving in] the lead."

The other notable talk came from Dr Love. In his aptly named presentation, "Should we trust Durata?" he addressed the most pressing concern for heart-rhythm doctors. The question: "With all the other leads available, does Durata offer enough advantages to outweigh concerns that it too closely resembles Riata?"

Dr Love did not back away. He showed a number of technical slides to back up his contention that Durata is 85% different from Riata. He liked Durata's internal design, which brings internal cables closer together. He explained that this decreases shear force. Next, he talked about the positives of Optim insulation. St Jude's Optim insulation adds significantly to the improved Riata ST design changes, is what I took from his message. Comparing it with other "reliable" ICD leads, Dr Love said Durata looked competitive. He quoted Durata's excellent performance data and noted follow-up on Durata is now available through five years.

I was surprised. It was an overwhelmingly positive assessment of Durata. This is telling coming from Dr Love. He has an excellent reputation, and I trust him. When Chuck speaks, I listen.

That said, the naysayers on Durata worry that as of now, the numbers of patients past five-year follow-up with Durata are very small. And that is the issue: time. Has enough time passed that we can be comfortable?

In the Q&A following, Dr Epstein worried that we don't know whether Durata design will prevent internal abrasions or simply delay them. Dr Love responded that we are likely to see rare cases of internal failures with Durata—no lead is perfect—but so far its performance looked excellent. Also, he added that Optim insulation appears very biostable and the follow-up of Durata has been more robust than for Riata.

Here's a question that was brought up by an astute colleague after the talk: Why hasn't someone published the results of bench testing on the three leads? Take a Riata lead and put it on a machine that flexes it millions of time. Do it for Riata ST and then Durata. Then tell us how much better Durata performs. Where are those data? Knowing that Durata measured better on bench stress tests might allay at least some fear.

My take-home

ICD lead durability is now front and center. This is good—for a lot of reasons. Not just that we know about specific devices. There's a bigger picture here.

For me, one of the grandest messages from Riata and Fidelis is how wrong we can be about stuff that sounds so good. Take lead diameter, for example. Years ago, low profile was what we needed. It was surely better than the clunky fat leads we were using. The Riata and Fidelis debacles smack this idea down. I've seen numerous posters here that all show small-diameter leads perform worse than their fatter brethren. There's even a nice clinical paper from an Iowa group that reports lead size did not predict vein occlusions. (They say size does not matter.)

So, yes, this story illustrates the need for staying skeptical, thinking critically, and emphasizing the importance of avoiding disease in the first place.

JMM

See also:

Riata revelations: ICD lead failure rates, mechanisms take HRS center stage

Your comments

	Riata lead safety alert at HRS 2012
	# 1 of 1	May 13, 2012 10:49 (EDT)
	Dom	I appreciated the posting of this article.  As a scientist, and an ICD patient...a couple items to address; First, your closing statement.  I took a bit of offense to "avoiding disease in the first place."  While I'm most likely not alone, my rather uncommon situation was due to a secondary infection of a viral cold seven years prior to implantation. Let me preface this discussion by saying, I was never sick, never smoked, rarely drank, worked out constantly ironically had great cardio endurance and after being sick for a couple weeks, knew something was wrong.  I would enter trigeminy after working out.  During those seven years (age 29 to 36) I constantly inquired about the PVCs I had, "passed" several stress test...and was dismissed as "a very healthy young man...with a benign occurrence of PVC".  I accepted those responses until ending up in an emergency room, and being discharged...just before an excellent cardiologist/electrophysiologst team saw me and worked me up for an entire week until finally realizing the underlying issues.  I owe them my life, 12 times (# of shocks) from my St. Jude defibrillator equipped with Riata leads. So “avoiding disease” I tried with earnest…but still here I am. So, now what to do?  I'm due for a generator change soon...just about 8 years after implantation, with a relatively simple & quick procedure.  Then the letter regarding the recall (received in Feb of 2012) arrived in the mail.  Now, I am a scientist, work with clinical & pre-clinical data consistently.  I understand and accept "side effect" data for my Amiodaraone...because population and incidence rate are more important than a list of potential concerns.  However, I'm faced with an agonizing decision. - Change the generator and do nothing about the leads since "knock on wood", the leads do not appear to be damaged (no X-ray study yet) or yank those suckers out (yank most likely isn't the best term here, but a little poetic license please).   So, while St. Jude and excellent physicians and clinics are posting failure rates and success rate data regarding incidence and or extraction ...we need to remember…those percentages are people.  And as more data comes in, those numbers seem to be increasing, not leveling out.  So...what to do?  It's been a long haul since 2004 when for that year I had a very difficult time accepting what had happened.  Cardiomyopathy?  Me??  I’m 37.  At weight, and healthy, my cholesterol @ 135!  Kick-butt triglycerides and an HDL/LDL ratio envied by my friends. To make things worse, I had a toddler and an infant daughter.  Now, 11 and 8 and a 3 year old son to boot, I'm faced with that "ticking time bomb" concern or dry success/failure statistics to help me make a decision.   The very nature of implantation of a defibrillation/sensing lead requires embedding of the lead into heart tissue.  Extracting that lead with the dangers of clot formation, torn cardiac muscle...and, gulp death... I'm not one to be pessimistic...I'm asked to speak with new patients, speak at ICD support groups and generally have a pretty positive attitude now.  I mean, how many people can look at a cat and ask "Really, only 9 lives huh?" after being shocked/paced 12 times from v-fib I’m pretty lucky!   So...while discussion is continuing among professionals, what are patients to do?  Sit back?  Hide in the closet (quote from a patient in a recent Wall Street Journal article)...take a proactive approach, or wait for all the data to be analyzed?  For me, I’m back to feeling a bit overwhelmed when I think about it…and wonder if like in 2004 even when I’m not thinking about it…I am.  Thank you...and please keep the information flowing.

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