Everyone knows that cannibalism was practiced widely in pre-Colombian Mexico. Go online and you will quickly learn that 15,000 to 20,000 Aztecs were sacrificed each year. This “fact” colors our view of that civilization, and makes it a bit easier to give a pass to the conquistadors who, for all their own rapacity, brought “civilization”…
New York Times: Indiana Cardiologist Accused Of Performing Unnecessary Procedures
October 18, 2015 by Leave a Comment
Just when you thought it was safe to read the paper again, along comes a New York Times report suggesting that not all cardiologists have learned the seemingly obvious lessons from the overuse scandals from the past decade. In a front page article in Sunday’s business section, Julie Creswell writes about the ongoing controversy and scandal involving cardiologist Arvind Gandhi,…
Prophylactic ICDs Appear Effective In Less Severe HF Patients
June 3, 2014 by Leave a Comment
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…
Routine Shock Testing Not Required During ICD Implantation
May 9, 2014 by Leave a Comment
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…
Athletes With Defibrillators Don’t Need To Quit Sports
May 21, 2013 by Leave a Comment
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…
Study Questions Role Of Dual-Chamber ICDs For Primary Prevention
May 14, 2013 by Leave a Comment
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…
Bruise Control: Continued Warfarin Beats Heparin Bridging During Device Implantation
May 9, 2013 by 1 Comment
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…
ICD Investigation: DOJ Sends Resolution Model To Hospitals
August 30, 2012 by 1 Comment
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…
Guest Post: Feds Turn Corner in ICD Investigation; Hospital Liability Divided into Categories
August 7, 2012 by Leave a Comment
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…
Robert Hauser, ICD Watchdog, Offers Viewpoint On Riata Controversy At HRS
May 16, 2012 by Leave a Comment
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…
HRS 2012: More Clarity on DOJ ICD Investigation, “Incidental PCIs” Still Excluded
May 12, 2012 by Leave a Comment
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….
Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel
April 26, 2012 by 1 Comment
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…
FDA Posts Results of Cameron Subcutaneous ICD Pivotal Trial
April 23, 2012 by Leave a Comment
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…
20 Deaths Linked to New Problem with Riata Leads
March 28, 2012 by 1 Comment
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…
What To Do When Federal Investigators Knock On The Door
March 26, 2012 by 2 Comments
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…
Women and ICDs: More Complications and Fewer Benefits
February 6, 2012 by Leave a Comment
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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