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First-Trimester Hypertension, Not ACE Inhibitors, Linked to Birth Defects (19 Oct 2011)

Although the teratogenic properties of ACE inhibitors in the second and third trimesters of pregnancy are well-documented, the effects of their use in the first trimester have been unclear. Now a study suggests that hypertension itself, rather than ACE inhibitors or other antihypertensive drugs, is the likely cause of an increased risk for birth defects…

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Heart Failure Hospitalization Rate Drops 30% in 10 Years (18 Oct 2011)

From 1998 through 2008, the rate of heart failure hospitalization in an elderly Medicare population declined by nearly 30%, according to a new study published in JAMA. Jersey Chen and colleagues  (including senior author Harlan Krumholz, editor-in-chief of CardioExchange) analyzed CMS data from 55 million fee-for-service Medicare patients hospitalized for heart failure between 1998 and 2008. After adjusting…

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Sapien Transcatheter Heart Valve Might Be Delayed (17 Oct 2011)

Approval for the highly anticipated Sapien transcatheter aortic heart valve might be delayed for 6 months, until April 2012. The FDA had been expected to reach a decision this month. But now a member of the FDA advisory panel that recommended approval for Sapien, Jeffrey Borer, in a public statement made at the ACC/AATS Heart…

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FDA Advisory Panel Recommends First DES For PAD (14 Oct 2011)

The FDA Circulatory System Devices Panel voted 11-0 on Thursday to support the premarket approval application for the Zilver PTX drug-eluting stent, manufactured by Cook Medical. The self-expanding, paclitaxel-coated stent would be the first DES approved for use in peripheral arterial disease of the above-the-knee femoropopliteal arteries. Cook Medical press release

Coronary Heart Disease Prevalence in U.S. Continues to Decline (13 Oct 2011)

The prevalence of coronary heart disease in the U.S. continues to drop, according to the CDC. Data from the Behavioral Risk Factor Surveillance System (BRFSS) surveys, published in Morbidity and Mortality Weekly Report, show a significant decrease in overall CHD prevalence from 6.7% to 6% from 2006 to 2010. In an apparent paradox, the authors note that the…

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Cardiologist Who Accused Famed Surgeon of Misconduct Is Fired by Northwestern University (11 Oct 2011)

Northwestern University has dismissed the cardiologist who raised troubling questions about Patrick McCarthy, its star cardiac surgeon. The controversy began in 2008 when Nalini Rajamannan, an assistant professor of medicine, accused McCarthy of implanting in one of her patients an experimental annuloplasty ring, the Myxo ring, manufactured by Edwards Lifesciences. McCarthy, who had invented the…

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TTOP-AF Trial Proves Efficacy of RF Ablation System, But Not Safety (10 Oct 2011)

A new trial demonstrates that an investigational RF ablation system is more effective than medical management in treating persistent AF, but the trial failed to meet a key predefined safety goal. At the Venice Arrhythmias 2011 conference, Lucas Boersma presented the results of the TTOP-AF (Tailored Treatment of Persistent Atrial Fibrillation) trial, in which 210…

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FDA Approves Juvisync, Combination of Sitagliptin and Simvastatin (7 Oct 2011)

The FDA has approved a fixed-dose combination tablet consisting of sitagliptin and simvastatin, two drugs previously approved for type 2 diabetes and hypercholesterolemia. Merck will market the new drug as Juvisync. “This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks,…

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J&J Pleads Guilty, Pays $85 Million to Settle Natrecor Case (6 Oct 2011)

The U.S. Department of Justice announced that Johnson & Johnson has pleaded guilty to a misdemeanor and has agreed to pay an $85 million criminal fine to settle charges about the company’s marketing of Natrecor (nesiritide) for off-label use. The government said that Scios, the J&J subsidiary that marketed the drug, “admitted that it intended Natrecor…

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Rivaroxaban Roundup: ATLAS-ACS an AHA Late-Breaker, NEJM Perspective, NYT Overview (6 Oct 2011)

Rivaroxaban (Xarelto, Bayer and Johnson & Johnson) is in the news today. In a rare move, the AHA has added the ATLAS ACS 2-TIMI 51 trial to its roster of Late-Breaking Clinical Trials to be presented next month at the AHA’s Scientific Sessions in Orlando. C. Michael Gibson will present the results on Sunday, November 13, at 5:13 PM….

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