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HeartRhythm Editor Douglas Zipes Defends Peer Review (30 Apr 2012)

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…

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Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel (27 Apr 2012)

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 Advisory Panel Gives Green Light to HeartWare Ventricular Assist System (26 Apr 2012)

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…

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When You’re Hot, You’re Hot: Salim Yusuf Second Most Influential Scientist in 2011 (25 Apr 2012)

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 and Harvard, had more highly-cited papers than Yusuf. Two…

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Study Sheds Light on Cardiac Device Infective Endocarditis (25 Apr 2012)

A new study sheds light on a rare but highly dangerous complication associated with device implants: cardiac device infective endocarditis (CDIE). Approximately 10% to  23% of device infections result in CDIE, leading, in one estimate, to an overall rate of 1.14 cases per 1000 device-years. In a paper published in JAMA, Eugene Athan and colleagues analyzed data…

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Meta-Analysis Compares Drug-Eluting and Bare-Metal Stents for Primary Angioplasty (24 Apr 2012)

A new meta-analysis comparing drug-eluting stents (DES) and bare-metal stents (BMS) in patients with MI has provoked opposing take-away messages from the study authors and an editorialist. The authors emphasize the reduction in target-vessel revascularization (TVR) associated with DES, but the editorialist focuses on several potential DES weaknesses suggested by the study. In the paper, published…

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FDA Posts Results of Cameron Subcutaneous ICD Pivotal Trial (23 Apr 2012)

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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Aliskiren (Tekturna) Gets New Warning and Contraindication from FDA (20 Apr 2012)

The FDA has issued new warnings about antihypertensive drugs containing the direct renin inhibitor aliskiren (including Tekturna, Amturnide, Takamio, and Valturna) when used in combination with ACE inhibitors or angiotensin-receptor blockers (ARBs). The FDA now states that these drug combinations are contraindicated in patients with diabetes, and it is adding a new warning to avoid…

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Arizona Cardiac Surgeons Pay $100,000 to Settle HIPAA Violations (19 Apr 2012)

An Arizona cardiac surgery group has agreed to pay $100,000 to resolve an investigation into potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In the agreement, the surgical group did not offer an admission of liability but did agree to implement a corrective action plan in addition to the payment….

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AHA: No Convincing Evidence That Periodontal Disease Causes CV Disease (18 Apr 2012)

Demonstrating once again that association and causation should not be confused, the American Heart Association today published a scientific statement in Circulation asserting that there is no convincing evidence showing that periodontal disease causes cardiovascular (CV) disease or that treating periodontal disease will reduce CV disease risk. The statement does not rule out the possibility that periodontal…

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