St Jude: Retract 'Riata Deaths' Journal Report

April 09, 2012

April 9, 2012 (St Paul, Minnesota)— Taking an unusual step, St Jude Medical is urging [1] the peer-reviewed journal Heart Rhythm to retract a report it published about two weeks ago [2], alleging it contains "inaccurate facts" and "biased analysis" regarding deaths associated with the company's Riata and Riata ST implantable defibrillator leads. It also challenged the very data used in the analysis, which was taken from the FDA Manufacturers and User Facility Device Experience (MAUDE) database.

The report, with Dr Robert G Hauser (Abbott Northwestern Hospital and Minneapolis Heart Institute, MN) as the first author, compared 22 deaths associated with the two St Jude leads and the five associated with Medtronic Quattro Secure ICD leads as identified in MAUDE. It concluded that, unlike the Medtronic leads, the St Jude leads were "prone to high-voltage failure" that in many cases was related to electrical shorting, especially when delivering high-voltage shocks, and likely involved in the 22 deaths.

In a press release aimed at the investment community, St Jude questions the use of MAUDE as the report's data source, noting that the government site prominently states that it "is not intended to be used either to evaluate rates of adverse events or to compare adverse-event occurrence rates across devices."

The company states that it was "not consulted prior to the publication" and unsuccessfully tried to replicate the Hauser et al analysis. "Since the manuscript was published, the company has spent more than 300 hours attempting to reach the same conclusions as Dr Hauser but can find no way of analyzing the MAUDE database that reproduces the same numbers reported in the manuscript."

Indeed, in a second press release issued April 10, St Jude announced that it was posting its own review of the MAUDE database, zeroing in on the adverse reports for the Medtronic Quattro Secure lead that Hauser et al used by way of comparator [3]. According to the St Jude review, the MAUDE database includes 377 deaths associated with the Medtronic Quattro Secure lead, as opposed to the 62 reported by Hauser and colleagues (five of which were deemed lead-related).

For its part, the Hauser report acknowledged that its results "are not definitive; additional confirmatory data are needed." It also says "studies are needed to determine if more frequent or different monitoring may detect an impending Riata or Riata ST lead failure before it results in a catastrophic event."

The Riata tale has been covered in detail by heartwire . St Jude had issued a warning letter about the leads to physicians in December 2010, when it pulled them from distribution, and a stronger safety advisory a year later that the FDA soon reclassified as a class I recall. The leads' internal conductor wires, it was found, could abrade the inside of and erode through their silicone insulation and "externalize," often causing electrical abnormalities and potentially failure to defibrillate.

The recall led to a daylong brainstorming "summit" for clinicians on what to do about it, and a presentation at the American College of Cardiology (ACC) 2012 Scientific Sessions from Hauser describing several types of Riata-related lead failures with the potential for causing sometimes-fatal high-voltage shorts.

That presentation was based largely on the contested journal report, which was released online at about the same time.

In some of its first in-depth coverage of the Riata affair [3], the New York Times brought its readers up to date with the lead's latest issues involving the cable externalizations, which are not blamed for necessarily causing the shorts, and the potentially more hazardous abrasions that are.

It also refers to St Jude contentions that Medtronic is engaged in a "whispering campaign" to promote the idea that the St Jude's Durata line of ICD leads is at risk of the same kind of failures plaguing Riata. That contention is false, Medtronic says in the story.

The Durata leads, which have a different design and insulation from that of Riata and Riata ST, have so far not showed any safety issues but as the replacement for the Riata line haven't been used for nearly as long.

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