CardioExchange Archive

December 9th, 2011

FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System

Larry Husten, PHD

Members of the FDA Circulatory System Devices Panel on Thursday recommended against approval of the implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks. […]

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December 6th, 2011

FDA Reviewers Raise Questions About CardioMEMS CHAMPION Trial Ahead of Advisory Panel

Larry Husten, PHD

FDA reviewers have raised serious questions about the results of the CHAMPION trial of the implantable CardioMEMS HF Pressure Measurement System (HF System), which provides daily pulmonary artery pressure measurements for the purpose of guiding heart failure treatment. On December 8, the FDA’s Circulatory System Devices Panel is scheduled to review the PMA for the device. (Click here […]

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November 23rd, 2011

CardioMEMS CHAMPION Trial Undergoes Scrutiny From Wall Street Ahead of Next Month’s FDA Panel

Larry Husten, PHD

Note to readers: An earlier version of this story stated that the FDA may be concerned about the conduct of the CHAMPION trial. This statement could be construed as an implication of ethical misconduct or negligence on the part of the trial sponsors or investigators. I apologize if I conveyed this impression in the earlier story. […]

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November 22nd, 2011

Study Examines Role of Surgery for Infective Endocarditis and Heart Failure

Larry Husten, PHD

Although current guidelines recommend valve surgery for patients with infective endocarditis and heart failure (HF), a large prospective registry finds that many of these patients do not undergo surgery — and have much worse outcomes. In a paper published in JAMA, Todd Kiefer and colleagues report on 4166 patients with infective endocarditis enrolled in the International Collaboration on Endocarditis […]

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November 15th, 2011

Hype Aside, Hope for Stem Cell Therapy May Be Emerging from Hibernation

Larry Husten, PHD

Two small studies of cardiac stem cells for the treatment of heart failure have shown promise, but ABC News, CBS News, and other media outlets are throwing around words like “medical breakthrough” and “heart failure cure.” ABC News correspondent Richard Besser was so enthusiastic that anchor Diane Sawyer commented that she had never seen him “so excited.” […]

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November 3rd, 2011

Success in Heart Failure? Hospitalizations Decline

Jersey Chen, MD MPH

Jersey Chen answers questions about his recent study in JAMA documenting that heart failure hospitalization rates declined nearly 30% between 1998 and 2008.

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October 20th, 2011

EMA’s CHMP Finds No Cancer Link for ARBs

Larry Husten, PHD

Following the lead of the FDA earlier this year, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has completed a safety review of angiotensin II receptor antagonists (ARBs) and found no evidence of any increased risk of cancer associated with the drugs. The FDA and EMA safety reviews were initially prompted by a meta-analysis […]

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October 18th, 2011

Heart Failure Hospitalization Rate Drops 30% in 10 Years

Larry Husten, PHD

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 for […]

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October 6th, 2011

J&J Pleads Guilty, Pays $85 Million to Settle Natrecor Case

Larry Husten, PHD

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 to […]

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September 12th, 2011

Arrest: When to Check the Rhythm?

Daniela J Lamas, MD

Editor’s Note: The following guest post by Daniela Lamas is reprinted with permission from Now@NEJM, a blog for physicians about NEJM. The woman slumps to the floor beside her office desk… No one sees her go down…  A colleague hears a thud and rushes in….. He calls her name… No response… He checks for a pulse: […]

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