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 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.”

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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