May 7th, 2012
All Dressed Up and No Place to Go: False-Positive Activation of the Cath Lab for Primary PCI
Larry Husten, PHD
Primary PCI is widely recognized as the best early option for patients with ST-segment elevation myocardial infarction (STEMI). However, efforts to deliver primary PCI to the broadest possible population inevitably result in an increased number of false-positive activations of the cardiac catheterization laboratory. Now, a new study published in the Archives of Internal Medicine finds that […]
May 7th, 2012
Politics and Transcatheter Aortic Valve Replacement
Larry Husten, PHD
Larry Husten takes to task a conservative activist who is trying to inject politics where it’s neither needed nor wanted.
May 7th, 2012
Roche Terminates Development of CETP Inhibitor Dalcetrapib
Larry Husten, PHD
Roche announced today that it has ended development of dalcetrapib, its entry into the once-promising class of HDL-raising CETP inhibitors. A data and safety monitoring board recommended that the dal-OUTCOMES phase 3 trial be stopped due to a lack of clinically meaningful efficacy. The DSMB found no evidence of safety problems.
May 4th, 2012
Company Fails To Disclose Details About Heart Failure Risk of Drug
Larry Husten, PHD
Boehringer Ingelheim failed to fully disclose data suggesting that one of its drugs, pramipexole, a dopamine agonist sold under the brand name of Mirapex, is associated with a significantly increased risk of heart failure, according to a recent news report. The drug, which was originally developed for the treatment of Parkinson’s disease, is now also used to treat […]
May 3rd, 2012
WARCEF: No Advantage for Warfarin over Aspirin in Heart Failure
Larry Husten, PHD
A new study offers “no compelling reason” to use warfarin instead of aspirin in heart failure patients who don’t have atrial fibrillation. In a paper published in the New England Journal of Medicine, Shunichi Homma and members of the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) study group report the results of a trial in which […]
May 2nd, 2012
Half the News That’s Fit To Print: NY Times on ECG Screening for Student Athletes
Larry Husten, PHD
A “dizzy” New York Times article exploring whether to screen young athletes for heart risk leaves out relevant research and exaggerates some pretty important numbers.
May 2nd, 2012
CMS Issues National Coverage Decision for TAVR
Larry Husten, PHD
The Centers for Medicare & Medicaid Services (CMS) issued on Tuesday its national coverage decision (NCD) for transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic […]
April 30th, 2012
HeartRhythm Editor Douglas Zipes Defends Peer Review
Larry Husten, PHD
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 Zipes, “there is a well-defined approach that can begin with a letter to the editor or submission of one’s own data for peer […]
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 […]
April 26th, 2012
FDA Advisory Panel Gives Green Light to HeartWare Ventricular Assist System
Larry Husten, PHD
The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted 8-3 that the device […]