Prophylactic ICDs Appear Effective In Less Severe HF Patients

ICDs are routinely implanted in heart failure patients with ejection fractions (EFs) of 35% and lower to prevent sudden cardiac death. However, the benefits in patients at the higher end of the spectrum– between 30% and 35%– have not been well demonstrated in clinical trials, since few patients in this range have been enrolled in…

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Routine Shock Testing Not Required During ICD Implantation

When cardiologists implant defibrillators in patients at high risk of dying from a heart rhythm disorder they nearly always perform a defibrillation test in which they induce a lethal arrhythmia, ventricular fibrillation, to make sure the device accurately detects the arrhythmia and terminates it with an appropriate shock. But routine defibrillation testing has never been…

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Athletes With Defibrillators Don’t Need To Quit Sports

Although the American College of Cardiology and the European Society of Cardiology now advise people with ICDs not to participate in vigorous sports, a new study offers strong support for people with ICDs who want to take part in sports. Although a large number of people with ICDs are elderly heart failure patients who are unlikely…

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Study Questions Role Of Dual-Chamber ICDs For Primary Prevention

Dual-chamber ICDs are implanted in a majority of primary prevention patients without a pacing indication who receive an ICD. Although there are a number of theoretical advantages with dual-chamber devices, these devices are more likely to cause complications. Although CMS requires providers to justify the medical necessity of dual-chamber devices, current guidelines from the AHA/ACC…

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Bruise Control: Continued Warfarin Beats Heparin Bridging During Device Implantation

Many patients receiving an ICD or a pacemaker are already receiving oral anticoagulants. Current guidelines recommend replacement of the oral anticoagulant with the temporary use of heparin as a bridging strategy. Now a new study, BRUISE CONTROL (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial), offers convincing evidence that this strategy is not…

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AHA Urges More Education And Support For ICD Patients

Despite, and perhaps sometimes because of, their life-saving benefits, ICDs are associated with a host of complex psychosocial problems, but clinicians and caregivers receive little training to deal with these problems. In response to these concerns, the American Heart Association (AHA) has published a scientific statement in Circulation to provide a “comprehensive review of what is and…

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ICD Investigation: DOJ Sends Resolution Model To Hospitals

DOJ Summary Chart

Hospitals across the country received emails from the US Department of Justice on Thursday containing a proposed “Resolution Model” that will allow the hospitals to begin to settle the long-standing and much-feared DOJ investigation into improper Medicare billing for ICDs. The action appears to confirm an article, published earlier in August in Report on Medicare…

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

Report on Medicare Compliance header

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

Photo of Durata promotional truck at HRS courtesy of Dr. Wes

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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Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel

S-ICD

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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FDA Posts Results of Cameron Subcutaneous ICD Pivotal Trial

S-ICD

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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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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What To Do When Federal Investigators Knock On The Door

For more than a year now 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…

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Women and ICDs: More Complications and Fewer Benefits

After consulting an electrophysiologist, women are just as likely as men to receive an ICD but they suffer more complications and are less likely to benefit from the device, according to a new study from Canada published in Annals of Internal Medicine. Derek MacFadden and colleagues analyzed data from 6,021 patients treated at 18 ICD…

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