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 […]
December 8th, 2011
How Randomness Affects Quality of Care
John E Brush, MD
Each month I meet with administrators at my hospital to review the quality of our cardiology program. My administrators don’t want excuses. They aim for perfection. But a discussion at our last meeting about door-to-balloon times for STEMI patients changed their minds.
December 7th, 2011
CV Risk of Prostate Cancer Therapy Underappreciated
Larry Husten, PHD
Androgen suppression therapy (AST) for prostate cancer may be a serious risk factor for cardiovascular (CV) disease, according to a Viewpoint published online in Heart. The scope of the problem is widely underappreciated and is rarely considered in clinical practice, write Liam Bourke and colleagues. The subject was also the topic of a 2010 scientific statement from the American Heart […]
December 7th, 2011
FDA Undertakes Safety Review of Dabigatran (Pradaxa)
Larry Husten, PHD
The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of […]
December 6th, 2011
Change in Fitness Appears More Important Than BMI Over Time
Larry Husten, PHD
Experts have been debating the relative roles of obesity and fitness in cardiovascular risk. Now a new report from the Aerobics Center Longitudinal Study, published in Circulation, finds that maintaining or improving cardiorespiratory fitness significantly lowers CV mortality irrespective of changes in BMI. Duck-chul Lee and colleagues followed 14,435 men for 11.4 years. Compared with […]
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 […]
December 5th, 2011
CMS Tightening the Screws on Unnecessary Procedures in Florida and 10 Other States
Larry Husten, PHD
After years of criticism that it has paid billions of dollars for unnecessary procedures, the Centers for Medicare & Medicaid Services (CMS) will soon ramp up efforts to rein in costs for unnecessary procedures. In 2012, CMS will perform an audit before paying for several big ticket cardiology and orthopedic procedures in certain key states. The news has […]
December 2nd, 2011
Follow the Fellows: Which Program Is Right for Me?
Erica Sarah Spatz, MD, MHS, Kathryn Jesseca Lindley, MD, William Kent Cornwell, MD and Aaron C. Earles, DO
For our new series at CardioExchange, “Follow the Fellows,” we have invited physicians from various cardiology fellowship programs to document their course through their training. In this post, the fellows describe how they chose their fellowship programs. You can read their earlier posts here and here. A Long and Winding Road by Erica Spatz, […]
December 1st, 2011
ACC and STS Announce Launch of TAVR Registry
Larry Husten, PHD
Following the approval of the first device for transcathether aortic valve replacement therapy (TAVR) earlier this month, the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have announced the launch of the TVT Registry, a joint initiative that will monitor the rollout of the new technology. The registry was created in response to […]
December 1st, 2011
Meta-Analysis Finds Benefits for Self-Monitoring in Some Warfarin Patients
Larry Husten, PHD
Despite the advent of newer anticoagulants that don’t require monitoring, millions of people will continue to take warfarin for many years to come. Now a new meta-analysis published in the Lancet suggests that some of these patients may benefit from self-monitoring. Carl Heneghan and colleagues analyzed data from 11 trials with 6417 patients on oral anticoagulation and 12,800 […]