November 7th, 2011
ACC and AHA Release New PCI and CABG Guidelines
Larry Husten, PHD
The AHA and the ACC have released updated 2011 guidelines for PCI and CABG. The guidelines are available online on the JACC website (here and here) and on the Circulation website. The new guidelines include for the first time a strong recommendation that hospitals adopt a “heart team” approach in choosing a treatment strategy for patients with coronary […]
November 7th, 2011
TAVI Approval: An Alternate Perspective
Norman Silverman, md
The FDA’s decision to release for general use the Sapien transcatheter aortic heart valve implantation (TAVI) technology ends the conflicting reports of either imminent approval or six months delay for further evaluation. This had created quite a stir. Self-proclaimed patient advocates aver that enough vetting has occurred and decry that excessive regulatory obstruction is denying the […]
November 4th, 2011
FDA Approves Rivaroxaban for Stroke Prevention in AF
Larry Husten, PHD
The FDA has approved rivaroxaban (Xarelto, Johnson & Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the […]
November 4th, 2011
AHA and ACC Update Secondary Prevention Guidelines
Larry Husten, PHD
The AHA and ACC have released an update of their guidelines for secondary prevention in patients with heart disease. The guidelines are available in Circulation and the Journal of the American College of Cardiology. The updated guidelines place a new emphasis on cardiac rehabilitation for patients who have had an MI or CABG. They also stress the importance of diagnosing […]
November 3rd, 2011
FDA Approves TAVR But Remains in the Crosshairs
Richard A. Lange, MD, MBA
I participated in the panel that recommended approval of the Sapien Transcatheter Heart Valve (THV) for patients with inoperable severe aortic stenosis: so-called transaortic valve replacement (TAVR). The recommendation for approval was based on (a) the perceived strength of the results of the PARTNER study; (b) collaboration and support of the Society of Thoracic Surgeons […]
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.
November 3rd, 2011
FDA Advisory Committee Recommends Approval of Vytorin for Pre-Dialysis CKD Patients
Larry Husten, PHD
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Wednesday strongly supported the combination of ezetimibe and simvastatin (Vytorin, Merck) to prevent cardiovascular events in pre-dialysis chronic kidney disease (CKD) patients. But the panel voted against recommending Vytorin for patients with end-stage renal disease on dialysis. The votes were 16-0 in favor of the pre-dialysis […]
November 3rd, 2011
Sapien Transcatheter Aortic Heart Valve Gains FDA Approval
Larry Husten, PHD
After much anticipation and drama, the FDA has approved the Sapien transcatheter heart valve (THV). The news was announced late Wednesday afternoon by the FDA and by Edwards Lifesciences, the manufacturer of the device. Details about the approval are scarce. The FDA said the Sapien THV has been “approved for patients who are not eligible […]
November 2nd, 2011
FDA Approves Abbott’s Xience Prime Drug-Eluting Stent
Larry Husten, PHD
Abbott announced on Tuesday that it had received FDA approval for its Xience Prime everolimus-eluting stent. The cobalt chromium stent is designed to be delivered more easily to complex lesions and will be available in long lengths up to 38 mm. Approval of Xience Prime was based on the SPIRIT Prime clinical trial, an open-label registry […]
November 1st, 2011
No Increased Risk for CV Events with ADHD Drugs, Large Study Finds
Larry Husten, PHD
A large new study may help lay to rest concerns that the widely prescribed ADHD drugs may increase the risk for cardiovascular (CV) events. In a study funded by the Agency for Healthcare Research and Quality and the FDA and published in the New England Journal of Medicine, William Cooper and colleagues analyzed data from 1.2 […]