October 28th, 2011
FDA Advisory Panel Votes 8-2 Against Approval of Medtronic AF Ablation System
Larry Husten, PHD
An FDA advisory panel has recommended against approval of Medtronic’s Ablation Frontiers Cardiac Ablation System for the treatment of symptomatic, drug refractory, persistent atrial fibrillation (AF) or longstanding persistent AF of up to four years in duration. In an 8-2 vote, members of the Circulatory System Devices Panel said that the risks of the device outweighed its […]
October 24th, 2011
Does This Child Have More Than an Arrhythmia?
Thierry Legendre, MD and James Fang, MD
An 11-year-old boy presents with palpitations. He has no family history of heart disease and is asymptomatic while playing competitive sports. His cardiac physical examination is normal, but his ECG (shown below) shows a Wolff-Parkinson-White pattern with a short PR interval and delta waves. A systematic echocardiogram reveals normal LV function, normal atrioventricular valves, and […]
October 10th, 2011
TTOP-AF Trial Proves Efficacy of RF Ablation System, But Not Safety
Larry Husten, PHD
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 patients […]
October 10th, 2011
The Vagaries of Atrial Fibrillation
Shengshou Hu, M.D.
Dr. Wes explores the features of a “full-disclosure” patch heart monitor that doesn’t seem to miss asymptomatic arrhythmias.
September 23rd, 2011
Former NEJM Editor Questions Decision to Publish ARISTOTLE
Alison Bass, MLA and BA
The following guest post is reprinted with permission from the blog of Alison Bass. At a Harvard event last night honoring Paul Thacker, a former investigator for Senator Chuck Grassley, someone in the audience wanted to know how the topic of Thacker’s talk — Dollars for Doctors: Who owns your physician? — was related to the soaring cost of medical care in […]
September 23rd, 2011
Rivaroxaban (Xarelto) Gets Positive Recommendation for AF and DVT in Europe
Larry Husten, PHD
The European Committee for Medicinal Products for Human Use (CHMP) has recommended that rivaroxaban (Xarelto) be approved for the prevention of stroke and systemic embolism in AF, according to Bayer HealthCare. CHMP has also recommended the drug’s approval for the treatment of DVT and for the prevention of recurrent DVT and PE following acute DVT. […]
September 22nd, 2011
Dronedarone (Multaq) Gets Another Drubbing in Europe
Larry Husten, PHD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended new restrictions on dronedarone (Multaq), Sanofi’s embattled and controversial antiarrhythmic drug. CHMP says that dronedarone should only be used for maintaining sinus rhythm in patients with paroxysmal or persistent AF after successful cardioversion. The drug should no longer be used in […]
September 20th, 2011
Significant Declines Observed in Cardiovascular Procedures Performed in Hospitals
Larry Husten, PHD
More evidence is starting to emerge that the overall volume of cardiovascular procedures in U.S. hospitals is in decline. The trend should come as no surprise to those who have been following news about cardiovascular medicine in recent years, as the field has been repeatedly struck by debate, scandal, and controversy related to the potential […]
September 12th, 2011
Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran
Larry Husten, PHD
Reports from Ireland and New Zealand may herald new concerns about Riata defibrillator leads (St. Jude Medical) and dabigatran (Pradaxa). A poster presented at the European Society of Cardiology meeting last month by researchers at the Royal Victoria Hospital in Belfast found that 15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported that […]
September 12th, 2011
Study Finds Risks and Costs Associated with Infection After Device Implantation
Larry Husten, PHD
A large new study has found significant risks and costs associated with infections following the implantation of CIEDs (cardiovascular implantable electronic devices), including ICDs, CRT-Ds, and pacemakers. In a paper published in Archives of Internal Medicine, Muhammad Sohail and colleagues analyzed Medicare data from more than 200,000 patients admitted for CIED implantation, replacement, or revision in 2007, including 5817 admissions with infection. Infection […]