Good bye St. Jude Medical

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Anonymous

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Another Tip of an Iceberg? Data from Belfast Raises Concern about the Tendril Lead

A weak link in any cardiac rhythm management device is the pacemaker or defibrillator lead(s). Several lead recalls have occurred. Recently, Lau and colleagues,1 from Belfast, provided important evidence to the world pacing and defibrillation community warning of risks to patients related to problems with the St. Jude Riata lead. One abstract altered our world.

Their first observations, reported some time ago, indicated something was amiss with the Riata lead.2 Other reports indicated various problems3–13 even though some would say that these issues were “clinically acceptable,”14 especially when the lead was implanted in a non-apical position (with regard to perforation, at least).15

Now, we are in the midst of a potentially serious recall of the Riata lead directly related to information that arose from rather humble observations made in Belfast. The long-term risks and the best methods to ameliorate those risks are emerging, but are by no means certain.16

In this present case report,1 Dr. Lau raises concerns regarding a St. Jude pacing lead. Two years after implantation of a St. Jude Tendril ST 1788/ST lead, extraction was performed due to the presence of suspected infective endocarditis. Upon extraction, evidence for an external insulation breach was present near the lead tip in this non-apical lead implant. Based on the information available, and considering that there may have been trauma to the lead during the extraction process, the removed lead appeared to show evidence for a highly suspicious, and ongoing, “inside-out” abrasion that was associated with disruption of the outer insulation. It was unlikely that this abrasion was due to the removal process.

These data raise concern about the Tendril pacemaker lead. The pacemaker and lead system appeared to be functioning within acceptable limits on interrogation so there was no way to know that this was actually occurring. This type of lead failure has been reported only with defibrillation leads previously.

Similar to issues raised several years ago in a singular case report by the same investigative group that many may have simply passed by, we now know that there can be serious problems with the Riata lead. Our level of concern about the Tendril lead is now raised by the observations made in this case report.

I congratulate, and thank, Dr. Lau for bringing these observations to our attention. No one likes to hear about potentially serious lead issues, but we are better off knowing than remaining in the dark. It will be important to pay careful attention to any further problems with Tendril leads. Hopefully, this case report does not reflect a larger and more serious issue that could be with us for years to come.

References
Kodoth V, Cromie N, McEneaney D, Wilson C, Lau E, Roberts MJ. Riata lead failure: A report from Northern Ireland Riata lead screening programme. Irish J Med Sci 2011; 180(Suppl 11):371–409.
Lau EW, Shannon HJ, McKavanagh P. Delayed cardiac perforation by defibrillator lead placed in the right ventricular outflow tract resulting in massive pericardial effusion. Pacing Clin Electrophysiol 2008; 31:1646–1649.
Chien WW, Chin J. Acute perforation in spite of implantation with an “antiperforation” defibrillator lead. Pacing Clin Electrophysiol 2009; 32:1598–1599
Hermanides R, Ottervanger J, Elvan A, Ramdat Misier A. Life-threatening perforation of a defibrillation lead. Neth Heart J 2009; 17:113–114.
Krebsbach A, Alhumaid F, Henrikson CA, Calkins H, Berger RD, Cheng A. Premature failure of a riata defibrillator lead without impedance change or inappropriate sensing: A case report and review of the literature. J Cardiovasc Electrophysiol 2011; 22:1070–1072.
Lloyd MS, Shaik MN, Riley M, Langberg JJ. More late perforations with the riata defibrillator lead from a high-volume center: an update on the numbers. Pacing Clin Electrophysiol 2008; 31:784–785.
Morrison TB, Ackerman MJ, Rea RF. Subacute perforation of the St. Jude Riata implantable cardioverter-defibrillator lead: a report of two pediatric cases. Pediatr Cardiol 2009; 30:834–836.
Rordorf R, Canevese F, Vicentini A, et al. Delayed ICD lead cardiac perforation: Comparison of small versus standard-diameter leads implanted in a single center. Pacing Clin Electrophysiol 2011; 34:475–483.
Vlay SC. Concerns about the Riata ST (St. Jude Medical) ICD lead. Pacing Clin Electrophysiol 2008; 31:1–2.
Turakhia M, Prasad M, Olgin J, et al. Rates and severity of perforation from implantable cardioverter-defibrillator leads: a 4-year study. J Interv Card Electrophysiol 2009; 24:47–52.
Erkapic D, Duray GZ, Bauernfeind T, De Rosa S, Hohnloser SH. Insulation defects of thin high-voltage ICD leads: an underestimated problem? J Cardiovasc Electrophysiol 2011; 22:1018–1022.
Ellis CR, Rottman JN. Increased rate of subacute lead complications with small-caliber implantable cardioverter-defibrillator leads. Heart Rhythm 2009; 6:619–624.
Danik SB, Mansour M, Singh J, et al. Increased incidence of subacute lead perforation noted with one implantable cardioverter-defibrillator. Heart Rhythm 2007; 4:439–442.
Porterfield JG, Porterfield LM, Kuck KH, et al. Clinical performance of the St. Jude Medical Riata defibrillation lead in a large patient population. J Cardiovasc Electrophysiol 2010; 21:551–556.
Corbisiero R, Armbruster R. Does size really matter? A comparison of the Riata lead family based on size and its relation to performance. Pacing Clin Electrophysiol 2008; 31:722–726.
Hauser RG, McGriff D, Retel LK. Riata ICD lead failure: analysis of explanted leads with a unique insulation defect. Heart Rhythm 2011; DOI: 10.1016/j.hrthm.2011.12.019.
 












Anonymous said:
Another physician's view

http://www.innovationsincrm.com/cardiac-rhythm-management/2012/march/236-iceberg-revisited
Click to expand...

Are you serious? This doc uses Carlson as a source. What do u think Carlson will say? My God im sure Starks told him whatever u do don't let them take our pacing leads down. It's all we have left!!! Stand alone I could buy this is a non issue. But with what is going on w all their other leads it makes sense that their Brady leads are failing. I've seen it first hand. Truth is this company has a flawed design and it catching up to them. I agree it's the end for stj.
 






yep, this guy is certainly going to have egg to wipe off his face. While hes at it he might as well wipe the lipstick his STJ rep left on his junk off at the same time. Seriously, how dumb do you have to be to just dismiss this based on STJ's response.

Not once has STJ presented any data publicly or privately to demonstrate they understand how the Riatas are failing and how the Durata or Tendrils are not subject to the same issue. All they talk about is how Optim has better abrasion resistance. Thats great but if im hanging a 10lb light, its equally bad to use a chain that can support 1lb or 5lb. Even though the 5lb chain is 5x stronger, its still going to fail. They obviously dont have a good way to predict abrasion or they would have stopped selling Riata (and tendril) a long time ago.
 






St. Jude Wrestles With Image Woes.

Article Stock Quotes Comments (4) more in Health | Find New $LINKTEXTFIND$ ».Email Print Save ↓ More .
.smaller Larger By CHRISTOPHER WEAVER And ANJALI ATHAVALEY
St. Jude Medical Inc. STJ -4.27%is struggling to protect its heart-rhythm division from a growing image problem.

The problems involve the Riata lead, a wire that connects defibrillators to heart tissue and that St. Jude stopped selling in 2010. A recent medical study tied a malfunction in Riata to at least 20 deaths, and now some doctors are scrutinizing the company's newer product, the Durata lead. The Durata has some design similarities to the older Riata, though it hasn't been linked to patient problems to date.

Enlarge Image

Close."I decided to stay away from it until the dust settles and we know more about how the Riata problem happens," said Samir Saba, director of electrophysiology at the University of Pittsburgh Medical Center, who has financial relationships with both St. Jude and its competitor Medtronic Inc. MDT -1.91%
Doubts about Durata could weigh on St. Jude's foothold in the nearly $7 billion global market for implantable defibrillators—matchbox-size devices that zap a misfiring heart beat into normal rhythm.

Shares in the company, with a market capitalization of $12.4 billion, have fallen 10% over the last month.

St. Jude reports first-quarter earnings next week. It is expected to see a modest gain in its 28% share of the cardiac-rhythm management market, which includes defibrillators, on the strength of a new product unveiled in November.

But investors will be closely watching for signs that concerns over the leads will have an impact down the road. The Durata device has been implanted in 145,000 Americans.

St. Jude said concerns about Durata are unfounded and that design changes will prevent a repeat of the Riata episode, in which wires broke through their silicone coating in some patients.

The leads have been prone to sometimes-lethal short circuiting, which some doctors believe may be related to protruding wires. St. Jude said it has no evidence of any connection.

Adding to the company's challenges is that St. Jude said last week it will stop selling two other models of leads because of safety problems. St. Jude said that no incidents of death or serious injuries have been reported as a result of the problems, and the problems are perceived as more minor. But "it's still egg on their face," said Michael Matson, an analyst at Mizuho Securities USA.

St. Jude has retained the services of the Population Health Research Institute at McMaster University in Ontario, Canada, to examine Durata's durability and performance data, and expects the group to submit its findings to peer-reviewed journals following a May meeting of the Heart Rhythm Society, a medical specialty group.

Doctors will "understand there is a lot of history to give them confidence," said Eric Fain, the president of the company's rhythm-management group.

Some doctors remain confident in Durata, and said they're awaiting evidence of problems before giving up on the leads, which have a slim profile and may fit more easily in smaller heart vessels. "We can't extrapolate that because there's a problem with the Riata that there will definitely be a problem with Durata," said Joshua Cooper, attending clinical electrophysiologist at the Hospital of the University of Pennsylvania who has received lecture fees from St. Jude and its competitors, and continues to use Durata.

Other physicians are limiting use or have stopped using Durata altogether, saying more data are needed on the leads, which were introduced in 2008. Hartford Hospital in Hartford, Conn., stopped implanting them in December after the U.S. Food and Drug Administration announced a Class I recall of Riata, meaning it believed the device could kill or seriously harm patients.

"In my mind, if you look at the construction of Durata versus Riata leads, the inner part is very similar," said Steven Zweibel, director of electrophysiology at the hospital. Dr. Zweibel has in the past received fees from St. Jude and its competitors.

In containing the fallout from the Riata leads, St. Jude has pursued an unusually aggressive public-relations strategy that has included pushing for a retraction of the Riata study, authored by Robert G. Hauser, a Minnesota cardiologist, and published online in the Heart Rhythm Journal last month, and calling out competitors for using its problems to their advantage. St. Jude said the study misstated the differences between Riata's safety record and competitors. Dr. Hauser has said he stands by the findings.

Competing device makers have sought to leverage Riata's problems by comparing the discontinued product to Durata, according to documents reviewed by The Wall Street Journal. The documents, including purported emails between sales managers and senior executives at Medtronic and Boston Scientific Corp., BSX -3.44%were gathered by members of St. Jude's sales force and provided to an outside attorney working on behalf of St. Jude.

One purported Boston Scientific email instructs sales representatives to tell customers that "Durata=Riata=Durata=Riata," and that Durata may face the same problems as the earlier leads.

"While we provide our sales force with relevant information about competitor's products, we do not provide guidance to physicians about how to manage competitor issues," said Denise Kaigler, a Boston Scientific spokeswoman, in an emailed statement. Christopher Garland, a Medtronic spokesman, said the company would not enter a public dispute with St. Jude.

Many doctors also said they still don't know how to handle patients implanted with the older Riata leads. So far, St. Jude has advised doctors to monitor patients and suggested they screen problems with X-rays if electrical abnormalities are found, but the company doesn't advise removing the lead.

Edward J. Schloss, director of electrophysiology at the Christ Hospital in Cincinnati, said he urged St. Jude to offer doctors more specific guidance about what to do with Riata patients.

Dr. Schloss said doctors can do "a high-voltage, lead-integrity test" that he calls "somewhat painful" to patients. He said he hopes St. Jude can advise doctors whether they should be bringing patients in to do that test.

Meanwhile, patients with Riata leads continue to face unexpected problems. Two such patients were lucky enough to be at Brigham & Women's Hospital in Boston one weekend late last year when their Riata leads short-circuited, according to Laurence M. Epstein, chief of the arrhythmia service there.

"They survived because they had their life-threatening arrhythmias in the hospital," said Dr. Epstein. "With a high-voltage short, there may be no warning."

—Thomas M. Burton contributed to this article.
Write to Christopher Weaver at christopher.weaver@wsj.com and Anjali Athavaley at anjali.athavaley@wsj.com

A version of this article appeared April 14, 2012, on page B1 in some U.S. editions of The Wall Street Journal, with the headline: St. Jude Wrestles With Image Woes.
 






Anonymous said:
. . . All they talk about is how Optim has better abrasion resistance. . . . . They obviously dont have a good way to predict abrasion or they would have stopped selling Riata (and tendril) a long time ago.
Click to expand...

And Houser: "According to St Jude Medical (SJM), Optim is 50 times more abrasion-resistant than silicone"

This poster has got it exactly right. The problem is that the abrasion test chosen is not a very close simulation of the things that are actually happening. MDT probably has a closer simulation, because they got it right in the choice of material!
 






Anonymous said:
And Houser: "According to St Jude Medical (SJM), Optim is 50 times more abrasion-resistant than silicone"

This poster has got it exactly right. The problem is that the abrasion test chosen is not a very close simulation of the things that are actually happening. MDT probably has a closer simulation, because they got it right in the choice of material!
Click to expand...

Easy there giving MDT all of the credit. There are 3 other companies that got something right in their choice of materials used in their leads. Or, you can simply say that SJM's design which is quite different than the other 3 CRM companies is seriously flawed in a few ways it seems.
 






Anonymous said:
Easy there giving MDT all of the credit. There are 3 other companies that got something right in their choice of materials used in their leads. Or, you can simply say that SJM's design which is quite different than the other 3 CRM companies is seriously flawed in a few ways it seems.
Click to expand...

Fair enough about giving credit.
But the performance is a result of both the design and the choice of materials. MDT is the only one that has the abrasion-resistant silicone!
 












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