January 14th, 2011
FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone)
Larry Husten, PHD
The FDA has released a safety communication about severe liver injury associated with Multaq (dronedarone). The FDA said that information about the risk of liver injury would be added to the dronedarone label. The drug’s manufacturer, Sanofi-Aventis, has also sent a letter to healthcare professionals informing them of the warning. The FDA is recommending that doctors advise […]
January 5th, 2011
Study Finds Mixed Long-Term Results for AF Catheter Ablation
Larry Husten, PHD
Long-term results after catheter ablation for AF are decidedly mixed, according to the longest study yet to follow patients after the procedure. In a report in the Journal of the American College of Cardiology, Rukshen Weerasooriya and colleagues followed 100 patients treated at a French hospital for 5 years. After a single procedure, the rates of arrhythmia-free survival […]
January 4th, 2011
Study Suggests Large Proportion of ICD Implantations Lack Firm Evidence Base
John Spertus, MD, MPH
Study Summary by Larry Husten: An analysis in JAMA of the National Cardiovascular Data Registry (NCDR) shows that a substantial proportion of ICD implantations are not supported by a firm evidence base. Sana Al-Khatib and colleagues examined data from 117,707 patients who received ICDs between January 1, 2006 and June 30, 2009, and found that […]
December 20th, 2010
Dronedarone, Rate Control, and Catheter Ablation Incorporated in Updated AF Guidelines
Larry Husten, PHD
A focused update on the guidelines for the management of atrial fibrillation has been released by the American College of Cardiology, American Heart Association, and Heart Rhythm Society. Most notably, the new guidelines incorporate recent data from clinical trials evaluating dronedarone, clopidogrel, strict rate control, and catheter ablation. Here are the major highlights: Dronedarone can reduce […]
December 17th, 2010
FDA Approves Cryoballoon Ablation Treatment for Paroxysmal AF
Larry Husten, PHD
Medtronic announced today that it has received FDA approval for its Arctic Front® Cardiac CryoAblation Catheter system for the treatment of refractory paroxysmal AF.
November 19th, 2010
Darvon and Darvocet Withdrawn from U.S. Market
Larry Husten, PHD
The FDA announced today that Xanodyne Pharmaceuticals had agreed to withdraw Darvon and Darvocet from the U.S. market. The drugs contain the opioid propoxyphene, which the FDA said “puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.” The FDA said it had asked generic manufacturers of propoxyphene to withdraw their products also.
November 15th, 2010
Omega-3s Fail to Show Benefits in Atrial Fibrillation
Larry Husten, PHD
In sharp contrast to earlier studies suggesting a positive effect, a large study of high-dose prescription omega-3 fatty acids found no evidence of benefit in treating atrial fibrillation. The trial, called the Efficacy and Safety of Prescription Omega-3 Acid Ethyl Esters (P-OM3) for the Prevention of Recurrent Symptomatic Atrial Fibrillation, included 663 patients with AF (542 […]
November 15th, 2010
ROCKET AF Hits Chicago
Larry Husten, PHD
ROCKET AF hit the AHA on Monday morning. Results of ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) had been the topic of intense speculation and interest. The trial showed that the experimental factor Xa inhibitor rivaroxaban was as effective as warfarin in […]
November 14th, 2010
ICD-CRT Found Beneficial in RAFT
Larry Husten, PHD
RAFT (Resynchronization-Defibrillation for Ambulatory Heart Failure Trial) randomized 1798 patients with NYHA class II or III heart failure, LVEF < 30%, and a wide QRS complex to either an ICD alone or an ICD-CRT. After a mean followup of 40 months, the rate of death or heart failure hospitalization was 40.3% in the ICD group […]
November 13th, 2010
Study Explores Role of Familial AF in Risk of Developing New AF
Larry Husten, PHD
Although it is well known that there is a heritable component to atrial fibrillation (AF), the precise clinical significance of familial AF has been unclear. Steven Lubitz and colleagues analyzed data from the Framingham Heart Study to assess the incremental predictive value of familial AF in a risk model for new-onset AF. In a presentation at the […]