Guest Post: How Sure Can We Be About Optisure? 2

Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

How Sure Can We Be About Optisure?

by Edward J. Schloss, MD

On March 24, St. Jude Medical announced the global launch of the Optisure family of ICD leads. It’s been a while since a new ICD lead was launched, and I’m probably not the only one who was caught by surprise. I’d like to explore why this approval is important for the ICD community. First, a brief history of ICD leads from St. Jude.

FROM RIATA TO DURATA

St. Jude Medical developed its own line of ICD leads after it purchased the former ICD vendor Ventritex in 1996. The first-generation Riata lead, approved in 2001, was succeeded by the Riata ST line in 2006. These leads were distinguished, in part, by their thin diameter, permitting implantation through a 7 Fr introducer sheath. In that era, implanting physicians’ interest in a thin lead was very strong. Even the high-profile failure of the 7 Fr Medtronic Fidelis ICD lead didn’t seem to dampen that enthusiasm.

Both of St. Jude’s Riata lead families later developed problems. Reports of subacute perforation soon after implant in the Riata ST line arose in the late 2000s. A year or two later, the internal core structure of both the Riata and Riata ST leads was discovered to break down in 25% and 10%, respectively, of these leads, as evident on fluoroscopic evaluation — a process called externalization. This problem, along with noted increased electrical failures of this lead, prompted an FDA class I recall of both product lines in December 2011, in addition to intense scrutiny and discussion in the lay press, investor press, blogosphere, and academic literature.

By the time the Riata and Riata ST leads were recalled, St. Jude had already gotten approval and marketed the successors: Riata ST Optim and, later, the Durata lead. Both these leads shared design similarities with the Riata ST lead, but additional modifications were intended to prevent the failures that the predecessor lines had exhibited. To mitigate the perforation risk specifically, changes in the Durata lead were intended to minimize tip pressure to the myocardium. And both new leads had a new insulator wrapping around the silicon core from Riata ST. This Optim insulation, shown to be more resistant to abrasion, has apparently been successful at preventing the fluoroscopic externalization that had occurred with the earlier leads.

The failure of the Riata leads has been shown to be time-dependent, so the device community has expressed some concern about Durata’s future performance. In addition, FDA has continued to apply pressure, with a January 2013 warning letter about this lead, specifically noting problems detected during a California plant inspection. Early active registry studies of Durata have been highly favorable, but a limited number of Durata problems have been discussed in case reports. Noted ICD critic Dr. Robert Hauser has also reported on a series of Durata failures from the FDA MAUDE database.

INSIDE THE DURATA

The Durata and Riata ST may share some failure mechanisms. In particular, the Swerdlow case report revealed inside–out abrasion under the distal shocking coil, resulting in a short between that coil and the ring-electrode cable, and consequent oversensing. Swerdlow and the Hauser MAUDE study have suggested that a similar form of insulation failure at the proximal shocking electrode could result in failure to defibrillate. (Because Durata and Riata ST have essentially the same internal design and materials at the level of the shocking coils, it is possible that this failure mechanism will occur with the newer leads.)

Moreover, Swerdlow found evidence of disruption of the Optim layer, which he hypothesized was due to Optim degradation, possibly related to hydrolysis of the polymer and cyclical stresses during the 4 years of lead service. The long-term biostability of Optim is critical, because without the Optim layer, the Durata leads are quite similar to Riata ST.

St. Jude has staunchly defended Durata, citing the favorable active registry data and additional testing in a large bibliography on its website. The company’s independent engineering analysis concluded that Swerdlow’s lead was damaged externally as a result of the extraction tools, not Optim degradation (counter to Swerdlow’s assertion).

THE BASICS ABOUT OPTISURE

St. Jude released Optisure this week, its first new ICD lead line since Durata. The product literature describes Optisure as “providing an additional system enhancement for addressing lead complications and improving system reliability.” The company says the slightly thicker 8 Fr lead is “for physicians who prefer a larger lead diameter.”

According to St. Jude, Optisure is built on the basic design of Durata with these additional modifications:

  • 8 Fr lead body
  • additional Optim insulation at the proximal end of the lead
  • new layer of Optim insulation under the SVC shocking coil

FDA filings show Optisure was submitted for approval as a PMA (pre-market approval) supplement on 10/24/12 and approved for release on 02/21/14. The filing links back to the original PMA for the Ventritex TVL lead issued in 1996. It does not appear that a human clinical trial was performed, as is common in PMA supplement approvals.

MY ANALYSIS OF OPTISURE

I’m happy that ICD companies continue to pursue process improvement. If we ever reach the point when we think we have a lead that is “good enough,” that will be really unfortunate. I’ve continued to have some concerns about Durata. ICD lead failures in the Riata lines have not become evident until 4 years of use, and we are only recently accumulating large numbers of Durata leads that have been implanted that long. Fortunately, Optisure’s design attempts to directly address two of the feared possible failure mechanisms of the Durata lead.

First, the increased Optim thickness in the proximal lead is likely to diminish the can/lead abrasion in the pocket, and perhaps in areas of cyclical stress. I find it really ironic and satisfying to read that St. Jude is promoting Optisure “for physicians who prefer a larger lead diameter.” Back in 2010, when I criticized thin ICD leads in an HRS debate, I had a hard time getting people to agree with me. Now, going thicker is a marketing strategy. Times really have changed.

Second, the Optim layer under the proximal shocking coil should help to prevent internal shorts that could cause lead failure. This type of short, if it involves the distal high voltage cable, is especially worrisome, as it may manifest only at the time of clinical or induced ventricular fibrillation. I fear that proximal coil HV shorting may be responsible for many of the Riata and Durata lead failures and deaths documented in MAUDE database entries, such as those published by Hauser (as well as this more recent report). Having a layer of Optim between the silicone core and the SVC shocking coil should help to prevent this shorting, just as it has prevented externalization. Unfortunately, this mitigation will not change the likelihood of shorting under the RV coil (as in Swerdlow’s case) but should help overall lead reliability. St. Jude seems to feel the same way, citing Optisure’s design as an “enhancement for addressing lead complications and improving system reliability.”

WHAT’S NEXT FOR ICDs?

Getting a pacemaker or ICD lead designed, approved, and built is an enormous undertaking. The process has only become more difficult because of increasing regulatory barriers. The formerly common process of PMA supplement approval has come under greater scrutiny. ICD and LV leads that formerly might have been approved under PMA supplement now require large U.S. trials. The trials’ costs, coupled with the fear of another Fidelis or Riata debacle, appear to have stifled lead innovation. Given the development of two new of leadless pacemakers (now being implanted in Europe) and the U.S.-approved subcutaneous ICD, we may be at the beginning of the end of the era of transvenous cardiac leads.

I have to agree with Zheng and Redberg that the PMA supplement process for medical device approval is problematic. The fact that leads from Riata to Optisure were approved on the basis of a dissimilar lead developed by a different company nearly 20 years ago should be ample evidence of this argument. Should Riata leads have gone through a clinical trial? Answering yes may seem logical. The unfortunate reality, however, is that no pre-market clinical trial would have picked up this lead’s late and novel failure mechanism. Even today, I would argue that careful industry engineering and close post-market scrutiny (including FDA-mandated registries) are doing far more to help our ICD patients than any pre-market trial ever could.

Nevertheless, it is critical to improve existing products, especially ICD leads. Most of us agree these are the “weak link in the chain.” I fear that a more highly regulated environment is having the paradoxically adverse effect of forcing us to settle with what we already have. That’s why I tweeted on March 24 that the quick approval of Optisure “both surprises and pleases me.” I wonder if this lead would even have been developed if it had been forced through a long, expensive clinical trial. Would that outcome have been a good thing?

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Guest Post: Case Report Of Durata Lead Failure Raises Fresh Concerns Reply

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Case Report Of Durata Lead Failure Raises Fresh Concerns

by Edward J. Schloss, MD

 A case report of a failed St. Jude Medical Durata ICD lead was published yesterday, raising suspicions that this lead may share some of the same potential failure mechanisms of its troubled predecessor, the Riata lead.

St. Jude’s ICD lead troubles date back to early case reports involving the Riata and Riata ST leads that ultimately led to FDA recall in December 2011.  These leads have since been well documented to be subject both to increased electrical failures and structural breakdown of the lead as has been previously reported.

St. Jude’s Durata lead was designed as a successor to the Riata ST lead and continues to be marketed and implanted.  The Durata lead shared a similar design to the predecessor Riata ST lead with the most notable difference being the addition of a outer coating made of the proprietary co-polymer Optim.  This design modification has been promoted to improve abrasion resistance.  It is hoped that this modification, would prevent the most prominent failure mechanism of the Riata family, inside-out abrasion and cable externalization.
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FDA Releases St. Jude Warning Letter Reply

The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks, short term loans UK and challenges to the company’s Durata and Riata ICD leads.

Click here to read the full post on Forbes.

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Guest Post: New Questions Raised About Latest Generation St. Jude ICD Leads Reply

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

 New Questions About Latest Generation ICD Leads From St. Jude

by Edward J. Schloss

A highly anticipated study analyzing failures of St. Jude Durata and Riata ST Optim ICD leads was published online today in Europace by prominent electrophysiologist and ICD critic Dr. Robert Hauser along with associates from the Minneapolis Heart Institute.

Over the last year St. Jude Medical has been beset with bad news about their ICD leads.  Until recently, the criticism has been confined to issues surrounding their older generation Riata and Riata ST leads (see my coverage in Cardiobrief).  These leads have been shown to be prone to both structural and electrical failures at an increased rate compared to competitive leads.  St. Jude has staunchly defended their newer generation Durata and Riata ST Optim leads, which have an additional layer of Optim copolymer insulation coating which they believe will decrease failures by improving abrasion resistance.  Last week, however, FDA issued a new request for post-market studies including X-ray surveillance of these leads, calling them “sufficiently similar” to Riata and Riata ST to merit increased scrutiny.

Today’s study from Hauser serves as another blow to St. Jude, and may affect implanter confidence in current generation Durata leads.  In the study, Hauser queried the FDA MAUDE database for “abrasion analysis” and reported detailed results.  He found 15 Riata ST Optim and 37 Durata reports.  The predominant abnormality in both groups was external abrasion (i.e. can/lead, or lead/lead), although several internal abrasions were also found.  Most of these abrasions resulted in clinically relevant electrical abnormalities such as low voltage oversensing resulting in inappropriate shocks.  One high voltage failure during a spontaneous ventricular arrhythmia resulted in an ineffective shock and subsequent patient death.

Hauser shied away from making comparisons to other leads in the current study and did not make any attempt to calculate an incidence of lead failure, recognizing the limitations inherent in analysis of a voluntary database.  This stands in contrast to his last Riata/Riata ST MAUDE analysis which provoked a firestorm of criticism including a request for article retraction from St. Jude Medical.
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Guest Post: FDA Clarifies Riata Imaging Recommendations 1

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Additional clarity regarding yesterday’s St. Jude Riata/Riata ST imaging recommendations has arrived in the form of another FDA Safety Communication available at the FDA web site.

According to the FDA, Riata and Riata ST leads “have an increased risk of premature insulation failure that can impact the lead’s ability to function properly.”  They add that there is currently insufficient information to determine the natural history of these insulation failures and risk factors that lead to failure.

FDA recommends physicians perform systematic imaging of their patients with Riata and Riata ST leads because”

“We believe that assessing the current condition of Riata and Riata ST leads is likely to help health care providers develop individualized plans for their patients, which may include recommendations on the frequency of remote monitoring and the necessity and frequency of repeat imaging.”

Specific recommendations of imaging are also spelled out.  Acceptable techniques include:

  • 2 view Chest X-Ray.  OK to use study obtained in last 3-6 months.  Recommend working with radiologist to obtain and interpret images.
  • Fluoroscopy

FDA also suggests that after this initial imaging, physicians “may consider performing fluoroscopy of the lead at the time of the generator replacement to check the lead condition.”  They also believe it is reasonable to repeat imaging to follow up manifest visual abnormalities.

Guidelines for management of specific clinical scenarios generally distill down to providing close follow up with attention to device performance.  They do not recommend extraction or replacement of leads with normal electrical function.

So where does this leave doctors and patients?  In an excellent perspective, cardiac electrophysiologist Dr. John Mandrola probably speaks for many of us when he writes of his frustration with these new mandates.  In medical school, we were taught never to get a test unless it influenced the subsequent management of the patient.  As John writes, “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.”  FDA indicates that physicians should develop “individualized plans for their patients.”  No room, however, is given to the thoughtful provider who may feel that his individualized treatment plan might best not include performing routine x-ray imaging.

Guest Post: FDA Calls For X-Ray Screening Of Riata Leads And Additional Followup Studies 1

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

St. Jude’s troubled implantable defibrillator leads came under a fresh layer of scrutiny today with new FDA imaging recommendations and post-market study requirements.  For the first time, the newer generation Durata and Riata ST Optim leads have been placed under enhanced review.

The problems with St. Jude’s ICD leads date back to the first reports of Riata model lead externalization in 2010.  By December 2011, FDA had issued a class I recall of both Riata and Riata ST models based on the growing body of evidence that these leads had potential for insulation breakdown.  Additional studies have now also shown increased electrical abnormalities of these leads.  Next generation Durata leads, while sharing significant structural similarities to Riata and Riata ST have thus far performed well in prospective trials (See my earlier post about the full scope of the problem.)

FDA Calls for X-Ray Screening of Riata and Riata ICD Leads

Today FDA issued a press release calling for patients to undergo “x-ray or other imaging alternatives” to look for externalization of St. Jude Riata and Riata ST leads.  Specific timing and frequency of testing is not stated and no recommendations are given as to how to act on abnormal findings.  In the release, FDA indicates that x-ray information “will help health care providers develop individualized patient treatment plans.” These recommendations may come as a bit of a surprise to the electrophysiology community.  Routine screening for externalization, while favored in some centers, has not been recommended by St. Jude Medical or the Heart Rhythm Society.  At the Riata Leads Summit this past January, only about half of physician attendees polled planned to do this screening, as I previously reported. 

The link between externalization and lead failure remains uncertain.  During a St. Jude’s sponsored webinar posted last month, Dr. Neal Kay reported “more than 85% of the externalized conductors continue to function normally.”  Later in the lectures, numerous discussants referred to Riata externalization as “cosmetic.”  St. Jude’s data from the Riata Lead Evaluation Study showed externalization rates of 24% in Riata and 9.3% in Riata ST based on prospective fluoroscopic data, but electrical data from that trial is still being collected and has not yet been reported.  A recent VA trial reported increased electrical failures in these leads, but did not include x-ray evaluations.
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Single Case Report Casts New Doubts About St. Jude Durata ICD Leads 1

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

As if on cue, just as the train pulled into the Nice-Ville station for this week’s Cardiostim 2012 meeting on the French Riviera, my Twitter stream and email lit up with news about a MAUDE case report about an externalized Durata:

Non invasive programmed stimulation of icd, revealed undersensing of ventricular fibrillation after induction. Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead.

Wall Street reacted promptly with a 6% drop in St. Jude’s stock price on Tuesday.

Though not widely reported, this was not the first report of an externalized Durata. As I reported previously, at the Riata Lead Summit in Minneapolis in January, St. Jude presented a case of a patient in Alaska with an externalized Durata lead.  At that point, the company was able to dampen negative reaction with an analysis indicating that the externalization was caused by abrasion of the lead in an “outside-in” fashion from contact with a tricuspid valve annuloplasty ring.

Why did this new Durata story provoke such a strong reaction?

• The new MAUDE report arrived without any explanation or reaction from St. Jude Medical.  The first references came from the financial analyst community and filtered out through online sources such as Twitter and Cafepharma.com.  There have been no additional details beyond the brief summary in MAUDE .  St. Jude Medical seemed to be as surprised as everyone else. A St. Jude spokesperson told Reuters: “We will make every effort to learn more about the report as quickly as possible.”

• This is the first important new development since last month’s Heart Rhythm Society Meeting in Boston.  At that meeting, as reported in Med City News, Charles Love of Ohio State, offered a favorable perspective on Durata. This was counterbalanced by unfavorable data about the prior generation Riata lead and a scathing commentary by ICD watchdog Robert Hauser, as I then reported.

• The report comes on the eve of the Cardiostim Meeting here in Nice.  This meeting serves as a European counterpart to last month’s HRS sessions and will provide a ready forum for reaction and consensus building.

• St. Jude has waged an aggressive defense of Durata, promoting “0% Externalized Conductors” in promotional materials (see photo at bottom).  This “all-in” stance may have created lofty expectations for this lead’s performance.  Even a single unsubstantiated case report therefore could create an unfavorable reaction.

It remains to be seen if this case report will be the “tip of the iceberg” or an isolated phenomenon. Its validity is even being questioned, as FDA cannot reveal its source and the details of the report have not yet been made available.

Those of us who have followed medical device failures closely over the years should know not to react too quickly to case reports.  It seemed inevitable to me that there would be at least some Durata externalization reports given that lead’s similarity in design to the Riata ST lead. However, a single case report, or even a few cases reports, do not provide sufficient evidence to indict Durata at this time.  More information may arrive soon in the form of an expected paper from Dr. Hauser on Durata electrical failures in the MAUDE database.

(Photo of Durata promotional truck at HRS courtesy of Dr. Wes)

Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS Reply

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS

by Edward J Schloss MD

The St. Jude Riata ICD lead controversy took center stage at last week’s Heart Rhythm Scientific Sessions in Boston, as previously reported here.  Near the end of the meeting a leading figure in the field, Dr. Robert Hauser, of the Minneapolis Heart Institute, summarized the current state of the Riata crisis and discussed its broader implications. Hauser has played key roles in the Riata and several other similar, highly disturbing cases, including those involving the Sprint Fidelis ICD leads and the Prizm 2 DR ICD device malfunction.

In a troubling revelation near the end of his talk, Hauser suggested that St. Jude’s problems may not end with the now discontinued Riata leads, and that the company’s Durata leads may have failure mechanisms not previously reported.

Hauser first discussed an abstract from Steinberg and associates from Quebec.  These investigators used chest x-rays rather than fluoroscopy to detect Riata externalizations:

They, like others, found a far higher incidence of externalized conductors than what has been reported by St. Jude Medical.  And frankly, this and other reports presented at this meeting raise serious questions about the accuracy of the data that the manufacturer has communicated to us.  What we learned today is that this externalized cable process is time dependent.  It seems to be occurring more frequently in the 1580 leads, particularly in the 8 French, and that with time we are going to see progression.  The fact that these investigators were able to use special chest radiographs to identify externalized conductors is interesting and deserves further study by comparing the sensitivity and specificity of their technique to high-resolution cine-flouroscopy

Hauser then discussed the Riata extraction experience from Royal Victoria Hospital in Belfast, and then offered some practical advice:
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Guest Post: Shedding Light On Riata At The Heart Rhythm Society Meeting 2

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Shedding Light On Riata At The Heart Rhythm Society Meeting

by Edward J Schloss MD

This morning in Boston, HRS 2012 sessions began with a state of the art session on St. Jude ICD leads.  Riata, Riata ST and Durata are being discussed at the first large electrophysiology meeting since this lead came under FDA recall.

It was obvious at the outset, that this is a vital topic to the EP community.  Those who didn’t arrive early were relegated to a remote viewing station.  Even there, the crowd was very large and engaged.

Kenneth Ellenbogen started the presentation with updated data on the VA Riata and Riata ST leads.  Interestingly, this data actually showed an increased failure rate of Riata ST as compared to Riata.  This stands in distinction to data from the Minneapolis Multicenter Data presented later in the late breaking trials session.

Things got interesting with the discussions of the clinical aspects of Riata lead management.  Dr. Larry Epstein of Boston highlighted potential management strategies.  He advised against placement of a sensing lead alone if the lead is failed.  In explaining why “I’m scared about Riata,” he gave the account of a patient with completely normal lead parameters that fortuitously suffered a cardiac arrest in his hospital.  The ICD was ineffective at terminating the arrhythmia and the patient had to be externally defibrillated.  To screen for these sort of silent lead failures, he performs fluoroscopy and high-energy shock delivery on his Riata leads before scheduled generator changes.

Dr. Roger Carillo of Miami outlined his approach to Riata lead management as well.  He expressed concern over the potential for thrombus formation on externalized leads.  He advocated routine fluoroscopic exams on all Riata leads.  He then performs transeophageal echo on externalized leads and anticoagulates those with thrombus.  He presented a step-by-step account of the unique challenges of Riata lead extraction.  Warning of a variety of pitfalls and complications, he added, “if you fail to follow any of these steps, the lead will not forgive you.”

The session ended with more calming words from Charles Love of Columbus.  In his talk on Durata leads, he repeatedly emphasized “it is a very, very different lead.”  He spent some time going over the design of all St. Jude leads and pointed out the potential benefit of the Optim insulation coating added to Durata and Riata ST Optim leads.  Active registries on these newer leads continue to show robust performance approaching 5 years.  He did acknowledge the small numbers of leads in late follow up.  But in the question and answer section, not all were convinced.  Dr. Larry Epstein stated, “I still have issues with trust.”

Heart Rhythm Editor Douglas Zipes Defends Peer Review 4

Rejecting an extraordinary request from industry to retract a controversial paper, Douglas Zipes, the editor-in-chief of HeartRhythm, has written a rare, highly pointed editorial defending the publication process. “If one disagrees with facts/statements in a publication,”  writes the editor, Douglas Zipes, “there is a well-defined approach that can begin with a letter to the editor or submission of one’s own data for peer review to counter the conclusions in the article.”

Zipes was responding to a request from St. Jude alleging numerous mistakes and oversights in an article by Robert Hauser published online in HeartRhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. The company publicly asked the journal, which is published by the Heart Rhythm Society, to retract the article.

“The peer review process is a time-honored, well-choreographed procedure that has served the intellectual world for several hundred years,” writes Zipes. “While occasional decisions may be incorrect, and fail to identify a submission of low (or high) quality, containing incorrect data, or even one that is fraudulent, in the main the system works.”

The publication of an editorial by Zipes was itself unusual, he noted: “I do not write many editorials because I feel my role as editor-in-chief is to be as impartial as possible.” In this case, “however, the recent events that transpired… have compelled me to speak out.”

The Hauser article has received additional public support from electrophysiologist Edward J Schloss. In a detailed review of the Hauser and St. Jude papers, Schloss noted that they  had applied different methodologies in their search of the MAUDE database.

Schloos offered the following comment in response to the Zipes editorial: “I applaud Dr. Zipes and HeartRhythm for publishing Dr. Hauser’s study.  This important work should serve as a call to the cardiology community to increase their vigilance in detecting electrical failures in Riata/Riata ST ICD leads.”

Guest Post: After an Unprecedented Request for a Retraction, A Close Look at the Data 3

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

After an Unprecedented Request for a Retraction, A Close Look at the Data

by Edward J Schloss MD

Last week, St. Jude Medical took the unusual step of requesting a retraction of an article accepted for publication in Heart Rhythm Journal.  In this article Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads, Dr. Robert Hauser et al analyzed patient deaths in the FDA MAUDE database associated with St. Jude Medical and Medtronic ICD leads.  This week, Dr. Douglas Zipes, Heart Rhythm editor, declined that request. (Please see my previous Cardiobrief coverage of Hauser’s article.)

In a company news release, St. Jude accused Hauser’s group of “inaccurate facts and biased analysis.”  The sub-headline reads:  “Research undercounted and excluded MAUDE data reports for Medtronic resulting in substantial factual errors.”

St. Jude’s most prominent concern revolves around the number of reported deaths in the analysis of Riata/Riata ST leads and the comparison lead, Medtronic Quattro Secure.  St. Jude wrote: “using the same search criteria outlined in the manuscript, the company has identified that Dr. Hauser’s research substantially undercounted total deaths in the MAUDE database for Quattro Secure.”  St. Jude counts 377 deaths compared to Hauser’s 62.

In an effort to clarify the reasons for this discrepancy, I undertook an independent analysis of the facts available.  My sources are the original Hauser article and the PDF file from St. Jude listing the details of their database search.  I then examined the methodology of both database searches to compare consistency of data entry.  Finally, I performed an independent review of all MAUDE database entries supplied by St. Jude and attempted to classify the 377 deaths Quattro Secure deaths identified by St. Jude into Hauser’s defined categories:  lead-related, indeterminate, and not lead-related, using the methods he described in his paper.

I hypothesized that differences in search methodology may explain the large discrepancy in numbers of deaths found by Hauser and St. Jude.

Results

The Hauser study queried the MAUDE data using the “simple search feature” entering term “Quattro Secure death.”  Results were “refined” to include only model 6947 leads.  Finally, “Reports were excluded from the study if there was no known lead problem or allegation of lead malfunction, and if a returned product analysis found no anomalies that were not caused by the explant procedure.”  With this methodology, the query returned 62 Medtronic Quattro Secure deaths.

The St. Jude data collection methodology is discussed on page one of the PDF document.  The “simple search” function specified by Hauser is not used.  Rather in the standard search fields, individual entries are made for Brand:  Quattro, Manufacturer:  Medtronic, and Event:  Death.  Results were then refined to model 6947 excluding duplicates.  Also in contrast to the Hauser data, no pre-specified exclusions were indicated. This query listed 377 Medtronic Quattro Secure deaths.

Hauser categorized his 62 deaths as 5 (8%) lead-related, 25 (40%) indeterminate, and 32 (52%) not lead-related.

St. Jude did not categorize the 377 deaths. My individual analysis found 7 (2%) lead-related, 129 (34%) indeterminate, and 241 (64%) not lead-related. (Lead-related death MDR Identifiers were 71402, 1438305, 1523151, 1760409, 1944512, 2016463, and 2025526.) I have asked St. Jude for their own analysis of the data into these categories, but have not received a reply.

Discussion

My review confirmed significant methodological differences in the database query specified by Hauser and St. Jude that may explain the differences in the numbers of deaths reported.  This stands in contrast to St. Jude’s assertion that they used “the same search criteria outlined in the manuscript.”
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Round Two: Heart Rhythm Editor Rejects St Jude Request to Retract Riata Paper Reply

Douglas Zipes, the editor of Heart Rhythm, said the journal will not retract a controversial paper that has raised new safety concerns about St. Jude’s embattled Riata leads.

On Friday (as reported here) St. Jude issued a press release alleging numerous mistakes and oversights in an article by Robert Hauser published online in Heart Rhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. The company publicly asked the journal, which is published by the Heart Rhythm Society, to retract the article.

On Tuesday, the New York Times reported that Zipes stood by the journal’s peer review process and would not retract the article. Zipes said there will be “some changes” to the article “involving what he called ‘inflection'” but that “‘the bulk of the manuscript stays as it is.”

Earlier Tuesday, St. Jude continued its assault on the Hauser article by issuing a press release and posting a link to findings from the MAUDE database. The company contended that Hauser had grossly undercounted the number of deaths tied to Medtronic’s Quattro Secure lead, thereby making its own Riata leads appear far worse by comparison.

Hauser and Zipes have not responded in detail to the St. Jude accusations, but Hauser told CardioBrief on Friday that the authors “stand by the conclusion of our study.” In a series of tweets, electrophysiologist Edward J Schloss (who has published guest posts about Riata on CardioBrief), noted that Hauser and St. Jude had applied different methodologies in their search of the MAUDE database, and that St. Jude may have failed to exclude Quattro deaths with no known lead problems.

St. Jude Seeks Retraction of Hauser Article On Riata Leads 3

St. Jude Medical is seeking the retraction of an article by Robert Hauser in Heart Rhythm linking the company’s Riata and Riata ST leads to 20 or more deaths. In a press release (see below) issued on Friday afternoon, St. Jude alleges numerous mistakes and oversights in the Hauser paper.

In a brief statement to CardioBrief, Hauser wrote:

We stand by the conclusion of our study, namely: “Riata and Riata ST ICD leads appear prone to high-voltage failures that have resulted in multiple deaths.”

In response to a message thread on CafePharma,  St. Jude seeks retraction of Hauser’s manuscript, one anonymous observer started a new thread: Patients seek retraction of their STJ leads.

Dr. Wes has a great perspective on this story.

Click here to review our previous coverage of the Riata controversy.
Click here to read the St. Jude Medical press release…

St Jude Withdraws Older LV CRT Leads From Market Reply

St. Jude Medical today issued an advisory about its QuickSite and QuickFlex Left-Ventricular (LV) Leads, which connect to Cardiac Resynchronization (CRT) devices. The company said it would no longer sell these leads, but that it had received no reports of death or serious injury associated with the problem.

The problem with the LV leads closely parallels the previously-reported problem with the company’s Riata leads. In both cases, there have been reports of externalization of lead conductors with silicone insulation, though the ultimate clinical implications of the reports are unclear.

St. Jude reported that there have been only 39 confirmed cases of externalized conductors, out of 171,000 leads sold worldwide. However, based on its own analysis, the company estimates that 3-4% of QuickSite and QuickFlex leads “may exhibit externalized conductors.”

The company said its newer QuickFlex µ or Quartet LV leads were not affected by the advisory. These leads use the company’s Optim insulation, and there have no reports of externalization in these models.
Click here to read the St. Jude press release…

Guest Post: Lessons from the Riata Recall– Part III 1

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

Lessons from the Riata Recall– Part III

by Edward J Schloss MD

In two earlier posts on Cardiobrief (here and here), I have written in some detail about the St. Jude Riata/Riata ST lead recalls.  In these pieces, I’ve summarized what we know about the design of these leads and their clinical performance. Ultimately I hope this updated information allows clinicians and other interested parties to make intelligent decisions regarding lead follow up and new lead model selection.

This week we’ve seen new important information that sheds additional light on the performance of Riata and Riata ST. As is often the case, new information leads to both new answers and new questions.

Accepted for publication in Heart Rhythm are two new manuscripts that reference these leads.  From frequent contributor Robert Hauser and his group at Minneapolis Heart Institute Foundation comes this review of ICD lead related deaths from the FDA MAUDE database.  Also accepted for publication is a prospective series of Riata and Riata ST leads that underwent fluoroscopic and electrical evaluation from Parvathaneni et al at Vanderbilt.

Hauser’s study has been previously reported on this site (20 Deaths Linked to New Problem with Riata Leads).  It is notable for being one of the first Riata studies focusing on electrical, rather than structural failures.  In the study, 22 (since corrected to 20 by St. Jude review) deaths discovered in the voluntary FDA MAUDE database were linked to failure of the Riata or Riata ST lead.  Interestingly, nearly all deaths appear to be due to failure of the high voltage portion of the lead, and most were directly linked to insulation abrasion.  This is a failure mechanism not commonly seen with other ICD leads, as noted in the article’s comparison to Medtronic Quattro Secure leads (in which failure of the low voltage conductors is the dominant mechanism).  Hauser estimated that failure of the St. Jude leads had an incidence “about 9 times greater than Quattro.”

Close reading of the Hauser data raises some interesting and, at times, troubling points:
Click to continue reading…

20 Deaths Linked to New Problem with Riata Leads 1

Electrical malfunctions, not externalized conductors, may be the cause of 20 or more deaths associated with the troubled Riata ICD leads from St. Jude Medical, according to a new report published online in Heart Rhythm.

Robert Hauser and colleagues at the Minneapolis Heart Institute searched the FDA’s MAUDE database and found 22 deaths caused by Riata or Riata ST lead failure. By contrast, only five deaths were caused by failure of the more widely implanted Quattro Secure lead. The authors reported that the Riata deaths “were typically caused by short-circuits between high voltage components. No death was due to externalized conductors.” As reported previously on CardioBrief, Hauser has played an important role in gathering and disseminating information about ongoing concerns about the Riata leads.

“The deaths are rare, but more frequent than you would expect. It’s another example of our flawed regulatory system,” Hauser told the Wall Street Journal. St. Jude told the Wall Street Journal that Hauser’s article contained several errors. Two deaths were counted twice, reducing the total number of lead-related deaths to 20, according to the company. In addition, St. Jude’s chief medical officer, Mark Carlson, said that some of the deaths were “from well-known causes, including wires that were coiled during surgery and ended up rubbing against the defibrillator.”

Software Tool Could Provide Early Warning of ICD Lead Failure Reply

In recent years defects in ICD leads have caused recalls and provoked broad concerns among health care professionals and patients alike about the safety and reliability of ICDs and other implanted cardiac devices. Now a key player in these events proposes that a computer software program can better monitor ICD leads and provide earlier warnings of possible malfunctions.

In a paper published in Circulation: Cardiovascular Quality and Outcomes, Robert Hauser and colleagues report on their evaluation of DELTA (Data Extraction and Longitudinal Trend Analysis), a commercially available automated surveillance tool, in simulated analyses of lead survival in a population of 1,035 patients with the recalled Sprint Fidelis lead and 1,675 patients with the Quattro lead. Lead failures occurred in 8.1% of the Fidelis leads and 1.4% of the Quattro leads during the study. A simulated analysis of the entire cohort “triggered a sustained alert” for the Fidelis lead 13 months after device approval and a full 2 years before the leads were pulled from the market. A second, propensity-matched analysis triggered an alert 22 months after approval and more than one year before withdrawal from the market.

“The software works,” said Hauser, in an AHA press release. “Looking at ICD patients implanted years ago, we showed that the automated program detects medical device problems faster than current approaches.”

“The results of this multicenter study suggest that an active automated surveillance system could have identified this cardiovascular device problem substantially sooner than was achieved through existing postmarket surveillance methods,” the authors wrote. An earlier alert of the Fidelis problem “could have spared thousands of patients the consequences of receiving a device prone to failure, including the risks and costs of lead replacement.”
Click here to read the press release from the AHA…

Guest Post: More Lessons From the Riata ICD Lead Recall 7

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. This post is longer and far more technical than most of the content published on CardioBrief. Due to the extraordinary nature of the material, however, I believe this post will likely be of considerable interest to many cardiovascular healthcare professionals.

More Lessons From the Riata ICD Lead Recall

by Edward J. Schloss, MD

In an earlier guest post (What are the Lessons of the Riata ICD Lead Recall?) I summarized points from Robert Hauser’s  important perspective in the New England Journal of Medicine regarding the St. Jude Riata ICD lead recall. In this followup, I’d like to discuss St. Jude’s responses to this piece and place the arguments into a broader context.

Last week Mark Carlson MD, Chief Medical Officer of St. Jude Medical, posted a response to Hauser’s perspective, and he made similar points in a letter subsequently published in NEJM. In the original response, Carlson writes “we believe that there were inaccuracies and omissions in the editorial that are important to recognize in order to more fully understand this issue.”

Major points of disagreement in the two pieces include:

  1. Timing of the initiation of a prospective trial looking at Riata externalizations and failures.
  2. Similarities and differences between the currently marketed Durata lead and it’s recalled predecessor Riata ST.
  3. Robustness of the existing St. Jude lead surveillance systems.

Having looked at this issue in some depth, I feel it would be reasonable for me to weigh in on these matters.

Regarding the timing of the recent trial, Dr. Carlson writes:
Click to continue reading…

Guest Post: What Are the Lessons of the Riata ICD Lead Recall? 2

Editor’s Note: The following guest post is published with the permission of its author,  Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH.

What Are the Implications of the Riata ICD Recall?

by Edward J. Schloss, MD

This week the New England Journal of Medicine published an important perspective piece from Robert G. Hauser of the Minneapolis Heart Institute regarding the St. Jude Riata ICD lead recall.

For those involved in cardiac arrhythmia care, Dr. Hauser needs no introduction. He has effectively served a watchdog role for the ICD industry over the last several years.

It was Hauser who first brought to attention the failures of the Guidant Corporation Prizm 2 DR ICD in 2005. That action had far reaching actions including a major New York Times article, a large product recall, and Justice Department fines. The Guidant Corporation was later sold to Boston Scientific.

In 2008, Hauser wrote the seminal article on the Medtronic Fidelis Lead. This lead was found to have excess failures in his clinic, a finding now clearly confirmed in many subsequent studies. Hauser has continued to publish follow up studies showing an increasing failure rate over time. The Fidelis lead recall has had an even more far reaching effect on the medical device industry as well as device doctors and patients.

Ironically, it is now the third large US cardiac rhythm company, St. Jude Medical, that has fallen under Hauser’s scrutiny.

In today’s New England Journal of Medicine, Hauser writes a perspective on the Riata and Riata ST ICD Leads. This lead has exhibited a unique form of failure. The leads have been shown to have exteriorization of the inner conductors through the outer silicone jacket of the lead. This was first recognized fluoroscopically in 2008 and has now been shown in multiple centers to occur in up to 15% of these leads. The functional significance of this exteriorization remains uncertain.
Click to continue reading…