CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

April 10th, 2012

Round Two: Heart Rhythm Editor Rejects St. Jude Request to Retract Riata Paper

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 electrophysiologist Wes Fisher told CardioExchange, 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 blogged extensively about Riata), 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.

Categories: Electrophysiology
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2 Responses to “Round Two: Heart Rhythm Editor Rejects St. Jude Request to Retract Riata Paper”

  1. Steven Greer, MD says:
    April 10, 2012 at 5:57 pm

    Well done HRS. Your society has maintained its independence from the pressures f the medical device industry and did not cave to pressure as the ACC did in 2008 by handing over the i2 interventional meeting to the CRF.

  2. Sandeep Goyal, MD says:
    April 10, 2012 at 6:07 pm

    St Jude has failed to provide an adequate, detailed and timely warning to patients and physicians regarding their faulty leads. Now they are trying to discredit the research and trying to force HRS to withdraw a manuscript. I think, patient and physicians should stop using their products completely as a lesson to them for their intentional non-disclosure, which probably has resulted more harm to patients. Seems like their only goal is to continue to sell their devices without any concern for patient safety. Such companies should be taught a lesson by cutting of their product use. Time to get organized against big industry.