CardioExchange Archive

March 25th, 2013

Emerging Biomarkers: How Reliable Is the Evidence?

Larry Husten, PHD

Novel biomarkers are the subject of intense controversy, with a bewildering variety of factions and perspectives seeking to elevate or dismiss any of a large number of proposed new measures. Now a new examination of the literature published online in JAMA Internal Medicine suggests that the evidence base used to evaluate novel biomarkers may be seriously compromised by selective reporting bias. […]

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March 22nd, 2013

FDA Proposes Higher Regulatory Scrutiny for Automatic External Defibrillators

Larry Husten, PHD

Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications. “Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist at […]

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March 22nd, 2013

Europe and U.S. Diverge on Two New Drugs

Larry Husten, PHD

The U.S. FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected — for the second time — an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the […]

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March 21st, 2013

FDA Panel Gives Tepid Endorsement to Abbott’s MitraClip

Larry Husten, PHD

The FDA’s Circulatory System Devices advisory panel gave a tepid endorsement to Abbott Laboratories’ MitraClip device on Wednesday. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who  have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing […]

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March 20th, 2013

Controversial PFO Closure Trials Published in NEJM

Larry Husten, PHD

Two controversial trials testing PFO closure in patients with cryptogenic stroke missed their primary endpoints but contained suggestions of possible benefit.

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March 20th, 2013

High Potency Statins Linked to Increased Risk for Acute Kidney Injury

Larry Husten, PHD

Although the beneficial effects of high-potency statins have been well-characterized in clinical trials, these same trials have lacked the power to illuminate rare but potentially important adverse events. A suggestion of one such area of concern, acute kidney injury, was first raised in the SATURN trial. Now, a new study published in BMJ provides further information about this area. […]

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March 18th, 2013

Vena Cava Filters: Little Evidence and Wide Variation in Use

Larry Husten, PHD

Despite the absence of any evidence demonstrating benefit or showing how best to use them, vena cava filters (VCF) are used in most hospitals. Now a new study published in JAMA Internal Medicine suggests that this same lack of evidence results in an extremely broad rate of use in different hospitals. An accompanying viewpoint raises the […]

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March 13th, 2013

FDA Officials Calm Concerns Over Excessive Bleeding with Dabigatran

Larry Husten, PHD

Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases of bleeding associated […]

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March 13th, 2013

Radiotherapy for Breast Cancer Increases Heart Disease Risk

Larry Husten, PHD

The increased risk of radiotherapy for breast cancer seen in this NEJM study may just be the tip of the iceberg.

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March 11th, 2013

Two Trials Explore On-Pump Versus Off-Pump Bypass Surgery

Larry Husten, PHD

For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters. Two large trials presented at the American College of Cardiology meeting in San Francisco and published simultaneously in the New […]

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