Riata and Fidelis: Shining a light on ICD risk

There is an important debate going on in electrophysiology.

The issue of the moment involves the imperfect durability of human-made implantable cardiac devices. Yes, ICDs have again taken center stage.

Just off the heels of the recent Sprint Fidelis debacle comes the St Jude Riata defibrillator lead recall. Although fewer Riata leads (78 000 Riata vs 268 000 Fidelis) have been implanted, medical decision making concerning Riata may pose greater challenges than those of Fidelis. That's saying a lot, as dealing with Fidelis leads has been stressful.

Here's my quick summary of the Riata situation:

Riata (and Riata ST) defibrillator leads have a serious design problem. In a not-insignificant (and debatable) percentage of cases, these leads can exhibit a unique mechanism of failure involving internal wires wearing through their insulation. These abrasions can lead to the exposure of bare metal in the heart—called externalization.  In addition to dramatic and frightening visuals, externalized wires cause two other significant issues: higher electrical failure rates, which might mean a patient receives painful inappropriate shocks or the opposite—the lead might not work to pace or defibrillate when needed; breach of insulation allows "body material" to infiltrate the lead's central core, which makes these leads very difficult to extract. Reports of disastrous Riata lead extractions have emerged, and all have agreed that Riata extraction is more difficult than Fidelis.

This is terrible news.

Externalized Riata lead [Source: Ellis C. Riata Lead Summit, January 2012]. Registration required

Dr Robert Hauser has weighed in with this New England Journal of Medicine Perspective article. He bemoans St Jude's delayed response; questions the design differences between the recalled Riata and currently approved Durata leads; and emphasizes the need for more robust postapproval monitoring of ICD hardware.

St Jude Medical's chief medical officer, Dr Mark Carlson, addressed three specific issues in his rebuttal letter, also published in the NEJM letter section.

First, Dr Carlson contends that St Jude did indeed initiate an ongoing forward-looking trial of patients with Riata leads. Second, he states St Jude's position on Durata: that its sufficiently different design makes Durata less apt to show externalized cables. He emphasizes Durata's many patient-years of follow-up and that no similar externalizations have been reported with the newer lead design. Third, Dr Carlson believes St Jude has well addressed postmarket surveillance:

"We have regularly communicated that St Jude Medical began prospective, actively monitored registries assessing the performance of our Optim/Durata leads more than five years ago. Collectively, those studies now include 10 836 leads implanted at 292 sites by 571 physicians and represent the largest postmarket surveillance program in the history of implantable stimulation devices.”

My friend and fellow electrophysiologist, Dr Jay Schloss, adds much-needed clarity to this complex situation with this easy-to-read guest post published on the blog Cardiobrief. As a non–foundation-supported EP trying to take the best care of his patients and make a difference in his spare time, Dr Schloss's take is worth a look.

As an implanting electrophysiologist who was spanked hard by the Fidelis debacle, I am following this situation closely.

Questions that buzz around in my head include:

• Is Durata sufficiently different from Riata? Three recent case reports to the MAUDE database describe Durata abrasions. Each has been "corrected" by further data (provided by St Jude) that explain away the abrasions. Should these three cases make us think, where there's smoke . . . ?


• Has the duration of Durata follow-up been long enough to warrant comfort with the lead? Many of the Riata failures manifested late (three to four years) after implant. Mean follow-up for Durata has not yet reached this time frame.


• How should Riata patients be followed? Some have suggested using serial fluoroscopy to look for externalizations. But why look if no agreed-upon therapy exists? Miraculously, not all externalized leads exhibit electrical failure. What's more, extracting these leads exposes the patient to great risk. Unlike the Fidelis story, the only deaths from Riata leads have occurred during extraction procedures.


• What are the best means to protect patients from device hardware failures? Common sense tells us that prospectively detecting all potential flaws before approval would be both impossible and futile. And worse, acting on the ill-conceived idea that premarket testing could eliminate all future defects would surely stifle innovation and limit patients' access to life-saving devices.  Who would disagree with enhancing postapproval surveillance? But when would a "recall" be called? How many case reports would trigger an alert? Sorting out noise from real problems will require nuance—a prickly concept in today's world of black-and-white quality measures.


• Does Durata offer our patients any advantage? Why not use more tried-and-true leads from other companies? I wonder a lot about that one. But if this were your philosophy, when would you ever try new stuff? Balancing how best to incorporate new technology represents one of the greatest challenges for cardiologists.

And then the big picture:

• How much do current recalls like Fidelis and Riata add to the already-complex decision of implanting an ICD in the first place?

Clearly there are ICD proponents, antagonists, and agnostics. But regardless of one's opinion of ICDs, recent lead recalls shine a bright light on the real risk of living with permanent cardiac devices. Doctors and patients alike tend to focus on the benefits of an intervention. Optimism is indeed heart-healthy. Making good medical decisions, however, means considering the risk of treatment with that of no treatment. Failures of ICD hardware, sometimes seen years after implant, along with the need for more surgery (extraction, lead revision, and generator changes) only serve to increase the inherent risks of living with an ICD.

And in parting, the least-zoomed view . . . 

This kind of sobering news only strengthens my resolve to emphasize the best way to treat heart disease—preventing it!

JMM

Your comments

	Riata and Fidelis: Shining a light on ICD risk
	# 1 of 9	February 24, 2012 11:26 (EST)
	RN	One comment on numbers. According to St Jude's 2010 Dear Doctor letter, approximately 227,000 Riata leads were sold worldwide. The 78,000 number refers to remaining implanted leads in the US.
	# 2 of 9	February 24, 2012 02:41 (EST)
	Worried	Do all abrasions lead to externalized cables?  What happens if the internal abrasion occurs under a shocking coil? Optim might help with externalized cables but is the underlying cause of the internal abrasion fixed?  Will there still be this abrasion in the durata lead the?
	# 3 of 9	February 25, 2012 11:33 (EST)
	John Mandrola	Good clarification. Should have made this clearer.
	# 4 of 9	February 29, 2012 07:26 (EST)
	pichon michel	De plus en plus la tecnhique prend le pas sur l'humain, de nouvelles technologies et thérapies qui en découllent montent en puissance depuis une vingtaine d'années et ce particulièrement en cardiologie interventionnelle.Je m'en réjouis encore aujourd'hui, mais en réflexion sur un plan "philosophique" je prends la pause (in standby attitude...) les possibilités scientifiques dans ce domaine sont de jour en jour plus performentes dans une pratique à tous les niveaux,  la spécificité de telle ou telle application demande de plus en plus de spécialisation, de formation de femmes et d'hommes médecins, cardiologues, rythmologues,demain "biomanologues" . La course infernale a ses limites jalonnées par la capacité humaine à intègrer tout cela!!!. je pose cette question qui me semble résumer les problèmes rencontrés avec ces sondes défectueuses, et la thérapie même cause indirecte de ces dysfonctionnements, la limite de la capacité humaine scientifique a-t'elle dépassé celle de son exploitation dans le concret du soin aux malades??... Une rélexion à mes yeux s'impose, et ce avec tous les acteurs de la situation, faut-il en passer par là pour une plus grande maîtrise des problèmes posés !...
	# 5 of 9	March 1, 2012 09:18 (EST)
	Neal	From the frying pan to the fire huh!!
	# 6 of 9	March 2, 2012 04:39 (EST)
	Bob	Bravo, John Mandrola! The greatest emphasis needs to be placed on PREVENTION! We live in a society of ever growing proportions...morbid obesity & sloth is rampant. Having recently retired from Medtronic CRDM sales, I saw far too many patients who, aside from genetic predispositions, could have, in large measure, prevented their heart disease/heart failure with sound lifestyle practices. We all need to emphasize diet & exercise as priorities in our lives regardless of age or circumstance.
	# 7 of 9	March 8, 2012 10:55 (EST)
	Toogoofy	Not all AICD patients have to get one due to their "slothful" ways. I was 21 when I got my first AICD and in great physical condition. I got stuck with a genetic malady Hypertrophic cardiomyopathy. My first device was recalled two years later in the Guidant debacle. My second device lasted a whopping 4 years so I've had three AICDs in 9 years. I just wish we were notified as soon as we have a recal on our vehicles. I had a reflector that wasn't up to DOT standards. I got a certified letter from Suzuki telling me not to ride my motorcycle until I had it changed out. When my AICD was recalled I found out through the New York Times. Not a good place to find out that your safety net had holes in it!
	# 8 of 9	March 9, 2012 12:04 (EST)
	Porsche MD	FOOL ME ONCE. After the Medtronic Fidelis fiasco and Guidant recalls with mounting patient dissatisfaction, the companies had us all convinced(and continue today) that all device companies are the same with expected failures and recalls. Funny, I don't hear Boeing making excuses that their new Dreamliners may have an "expeted number" of crashes because they have changed their engineering and manufacturing processes while they added some new innovative features, with airliners that have improved fuel economy and improved aerodynamics (and a really big first class lounge).    Doing my own independent research years ago, I discovered a little known German company, Biotronik, which had the reliability and performance record in Europe similar to a Porsche; I discovered they had an impeccable saftey record with very little visibilty, but a headquarters in the US.   I have since started requesting BIOTRONIK high energy devices be implanted in my patients who need an ICD specifically as a result of my own research and critical analysis of device failures.  Fortunatelly, my practice has not had to deal with angry and distraught patients dealing with recalled devices over the last 5 years.  My method of prevention has been to choose the safest device for my patients.    Toogoofy has had 3 ICD implants and also has been frustrated with recalls and he mentions recalls on automobiles.  For those docs who are tired of recalls on devices, then just "SAY NO".   If you are tired of recalls and don't want your Ford Pinto to wreck and catch on fire,  complain to the manfacturer then stopy driving the clunker.  Otherwise you may want to drive a Porsche; they may be hard to find, but after you drive one, you will never go back, any your patients will be there to thank you.
	# 9 of 9	March 12, 2012 04:21 (EDT)
	Renae	Recalls!

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