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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Guest Post: FDA Clarifies Riata Imaging Recommendations

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…

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

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. …

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Guest Post: Feds Turn Corner in ICD Investigation; Hospital Liability Divided into Categories

Editor’s Note: The following article is reprinted with permission from Report on Medicare Compliance, an independent publication not affiliated with hospitals, government agencies, consultants or associations and published by Atlantic Information Services, Inc.  The Department of Justice is apparently about to take a big step forward in its national false claims investigation of Medicare billing for implantable…

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Guest Post: An Electrophysiologist Looks At The New HRS/ACCF Pacemaker Guidelines

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. Overview of the New HRS/ACCF Pacemaker Guidelines by Edward J Schloss MD  Since the development of the first dual chamber pacemakers in the 1980s, doctors…

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New ICD Lead Technology Creates New Set of Problems: A Perspective From One Electrophysiologist

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. Why I Don’t Like DF-4: A Personal Perspective by Edward J Schloss MD  Since the first human implantable cardioverter defibrillator (ICD) implant in 1980,…

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FDA Once Again Delays Approval Of Apixaban (Eliquis)

The FDA has once again delayed approval of apixaban (Eliquis), the much-anticipated oral anticoagulant. Bristol-Myers Squibb and Pfizer announced today that it had received a a Complete Response Letter (CRL) to the New Drug Application (NDA) for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The two…

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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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Growing Popularity Of Dabigatran Leads To Increased Complications

Since its approval in the United States in October 2010 dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now…

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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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HRS 2012: More Clarity on DOJ ICD Investigation, “Incidental PCIs” Still Excluded

In a guest post, electrophysiologist Edward J. Schloss recounts a talk at Heart Rhythm Scientific Sessions 2012 by Suneet Mittal which provided a detailed account of his group’s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines….

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Guest Post: Shedding Light On Riata At The Heart Rhythm Society Meeting

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…

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In AF, Women Have A Bigger Risk Of Stroke Than Men

When compared to elderly men with atrial fibrillation, elderly women with AF have a significantly elevated risk for stroke. This increased risk occurs regardless of warfarin use, according to a new study published in JAMA. Meytal Avgil Tsadok and colleagues reviewed data from Quebec, Canada on more than 80,000 AF patients at least 65 years of age. Much of…

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Guest Post: The Dark Side of EKG Screening in Athletes

The following guest post is reprinted with permission from DrWes, the blog written by Westby G. Fisher, a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL. The Dark Side of EKG Screening in Athletes by Westby Fisher They sat nervously with their son in the doctor’s office, wondering why they…

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Half the News That’s Fit To Print: NY Times On ECG Screening For Student Athletes

There may be no more horrifying medical catastrophe than the sudden death of a young athlete on the playing field in front of a large crowd of friends, family, and community. But it’s also a dizzyingly complex subject with no easy solutions. Experts are divided. The American Heart Association recently reaffirmed that it does not recommend…

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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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Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel

The FDA’s Circulatory System Devices panel voted 7-1 on Thursday that the benefits of the Cameron Health subcutaneous ICD system (S-ICD) outweigh the risks in appropriately selected patients. Unlike all previous ICDs, the S-ICD is much easier to implant because it is does not require threading a lead to connect the device to the heart. Panel member Rick…

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When You’re Hot You’re Hot: Salim Yusuf Second Most Influential Scientist in 2011

McMaster University’s Salim Yusuf has tied for second place in the annual ranking of the “hottest” scientific researchers, according to Thomson Reuter’s Science Watch.  Yusuf was a co-author of 13 of the most cited papers in 2011. Only one other researcher, genomic pioneer Eric Lander of the Broad Institute of MIT, had more highly-cited papers than Yusuf. Two of…

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Study Sheds Light on Cardiac Device Infective Endocarditis

A new study sheds light on a rare but highly dangerous complication associated with device implants: cardiac device infective endocarditis (CDIE). Approximately 10-23% of device infections result in CDIE, leading, in one estimate, to an overall rate of 1.14 cases per 1,000 device-years. In a paper published in JAMA, Eugene Athan and colleagues analyzed data from 3,284…

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FDA Posts Results of Cameron Subcutaneous ICD Pivotal Trial

In preparation for Thursday’s meeting of the FDA’s Circulatory System Devices advisory panel, the FDA has released the results of the pivotal trial for the Cameron Health subcutaneous ICD system (S-ICD). The results have not been previously available. Unlike previous ICDs, which require threading a transvenous lead to the heart, the S-ICD system contains no leads…

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Million Dollar Bonuses For Five Ohio State University Electrophysiologists

Five Ohio State University electrophysiologists received 2011 bonus payments greater than $1 million, resulting in total pay for the year for each cardiologist of about $2 million. The news was first reported by the Dayton Daily News and subsequently covered by Heartwire. Five out of the 7 bonuses that topped $1 million at OSU went to the…

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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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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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St Jude Withdraws Older LV CRT Leads From Market

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…

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