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

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…

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St. Jude Seeks Retraction of Hauser Article On Riata Leads

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:…

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Dollars For Heart Docs: 2015 Edition

–Cardiologists received more than $200 million from industry in 2015. In 2015 cardiologists and other cardiovascular specialists received more than $200 million dollars from industry, according to new data released by Medicare. More than 30,000 physicians in cardiovascular medicine received industry payments in 2015, though many of these payments were relatively small amounts. But more…

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Guest Post: How Sure Can We Be About Optisure?

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…

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2012 In Review: A Bad Year For Conventional Wisdom

This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company,…

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

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…

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Single Case Report Casts New Doubts About St. Jude Durata ICD Leads

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…

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Heart Rhythm Editor Douglas Zipes Defends Peer Review

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…

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

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…

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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 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…

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Guest Post: Lessons from the Riata Recall– Part III

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…

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20 Deaths Linked to New Problem with Riata Leads

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…

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Software Tool Could Provide Early Warning of ICD Lead Failure

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…

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Guest Post: More Lessons From the Riata ICD Lead Recall

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…

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

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…

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ACC 2012 Roster of Late-Breaking Clinical Trials

The American College of Cardiology has released the roster of late-breaking clinical trials that will be presented in March at the ACC Scientific Sessions: ACC.12 Opening Session and Late-Breaking Clinical Trials Saturday, March 24, 2012, 8:00 a.m. – 10:00 a.m. Effect of Transendocardial Autologous Bone Marrow Mononuclear Cell Delivery on Functional Capacity, Left Ventricular Function…

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Guest Post: Report from the Riata ICD Lead Summit

Second update: Click here to review the slides from the meeting (posted by the Minneapolis Heart Institute), Update: Click here to read a statement from St Jude Medical in response to this post. Editor’s Note: Edward J. Schloss (Twitter ID @EJSMD), the medical director of cardiac electrophysiology at the Christ Hospital in Cincinnati, OH, returned…

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Women and Younger Patients May Be At Higher Risk For Sprint Fidelis Failure

Women, younger patients, those with hypertrophic cardiomyopathy, and those with arrhythmogenic right ventricular dysplasia or channelopathies may be more likely to develop Sprint Fidelis lead failure. Robert Hauser and colleagues at the Minneapolis Heart Institute, the Mayo Clinic, and Beth Israel Deaconess Medical Center analyzed data from 1023 patients who received Fidelis leads and 1668…

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US Judge rejects $296 million plea agreement for Guidant

A US federal judge rejected a proposed $296 million plea agreement which would have allowed Guidant to settle the investigation into the company’s handling of defective ICDs. As reported here last week, cardiologists Barry Maron and Robert Hauser, who originally brought the case to public attention, wrote a letter to the judge urging him to…

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Guest Post: the long afterlife of Joshua Oukrop

Editor’s Note: In response to a plea agreement in which Boston Scientific would pay $296 million to resolve the well-known case involving defective Guidant ICDs that the company failed to disclose, the New York Times and the Minneapolis Star Tribune report that the two cardiologists who first brought the issue to public attention have sent…

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Public reporting of PCI outcomes: unintended consequences

Risk-adjusted outcomes of PCI have been published in New York for more than a decade, and since 2003 in Massachusetts. Two interventional cardiologists at the Brigham and Women’s hospital in Boston review the unintended consequences that may be caused by public reporting in the latest edition of JACC. Their analysis, they write, “raises concern over…

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NY Times: why is the ICD registry languishing?

 In 2004 Medicare mandated the creation of a national ICD registry, which has been run since then by the ACC and HRS. Now, New York Times reporter Barry Meier, who has been instrumental in bringing to light ICD problems in the past, notes in a February 26 story that the ICD registry is languishing for lack…

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Sprint Fidelis leads: is the risk greater than feared?

The failure rate of Medtronic’s Sprint Fidelis leads may be much higher than previous estimates, according to a new report by Robert Hauser and David Hayes in HeartRhythm. The two investigators (Hauser was the first to spot the problems with the Medtronic leads) looked at the rate of lead failure among patients who received the…

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