CardioExchange Archive

June 25th, 2012

What Constitutes a Professional Society’s Endorsement?

Harry Peled, md

Harry Peled directly questions the Heart Rhythm Society about its logo on a sudden cardiac arrest protocol that mentions wearable cardioverter-defibrillator vests.

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May 12th, 2012

HRS 2012: More Clarity on DOJ ICD Investigation, ‘Incidental PCIs’ Still Excluded

Edward J. Schloss, MD

Thursday morning at Heart Rhythm Scientific Sessions 2012, Suneet Mittal MD of Columbia University gave a detailed account of his group’s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines.  The talk served to amplify and clarify points made in his perspective in JACC written with Jonathan Steinberg MD, in March 2012. Not long […]

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April 30th, 2012

Selections from Richard Lehman’s Literature Review: Week of April 30th

Richard Lehman, BM, BCh, MRCGP

This week, Richard looks at endocarditis and ICDs, more stent wars, stroke prevention in A-Fib, and more.

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April 27th, 2012

Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel

Larry Husten, PHD

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 Lange […]

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April 23rd, 2012

FDA Posts Results of Cameron Subcutaneous ICD Pivotal Trial

Larry Husten, PHD

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 to connect the device to […]

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April 5th, 2012

When the Feds Come Knocking

Westby G Fisher, MD and John Mandrola, MD, FACC

CardioExchange welcomes this guest post from electrophysiologists Westby Fisher and John Mandrola. This piece originally appeared on their respective blogs, Dr. Wes and Dr. John M. Slightly over a year ago, the Department of Justice (DOJ) launched an investigation of a large number of institutions regarding concerns that implantable cardiac defibrillator (ICD) procedures were performed for […]

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April 2nd, 2012

Federal Audit of ICD Implants? Preparation Is Key

Jonathan Simon Steinberg, MD

CardioExchange welcomes Dr. Jonathan Steinberg, a Columbia University-affiliated electrophysiologist who also directs the EP program at a large suburban nonteaching hospital. A co-author of a JACC special article that describes the federal audit of his hospital’s ICD implants, Dr. Steinberg answers our questions about the audit process. What should cardiologists do to avoid a federal audit? […]

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March 28th, 2012

20 Deaths Linked to New Problem with Riata Leads

Larry Husten, PHD

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 Riata or Riata […]

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March 27th, 2012

What to Do When Federal Investigators Knock on the Door

Larry Husten, PHD

For more than a year, the federal investigation of hospitals suspected of improperly implanting ICDs has been the subject of considerable rumor and speculation. Now, two cardiologists who were involved in a federal audit at one hospital have published a detailed account of their experience. Jonathan Steinberg and Suneet Mittal are Columbia University-affiliated electrophysiologists who also […]

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February 16th, 2012

What Are the Lessons of the Riata ICD Lead Recall?

Edward J. Schloss, MD

Let’s enforce a robust, active postmarket surveillance system that will allow doctors in the field to draw their own conclusions about the safety of devices based on much better data without hampering innovation.

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