October 16th, 2013
FDA Advisory Panel: No Expanded Indication for Vascepa Without Outcomes Trial
Larry Husten, PHD
An FDA advisory panel today failed to recommend an expanded indication for Vascepa, the purified EPA fish-oil product from Amarin. Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dL). The proposed new indication would have greatly expanded the patient population eligible to receive Vascepa to the 20% of […]
October 16th, 2013
Redefining MI After Revascularization
Beth Waldron, MA
James de Lemos reflects on a new definition of “clinically relevant myocardial infarction after coronary revascularization” from the Society for Cardiovascular Angiography and Interventions (SCAI). The SCAI proposal is published in JACC. KEY FEATURES of the NEW DEFINITION The new SCAI definition of MI after revascularization differs in several ways from the 2012 Universal Definition […]
October 15th, 2013
First Leadless Pacemaker Gains Approval in Europe
Larry Husten, PHD
St. Jude Medical announced on Monday that the world’s first leadless pacemaker has gained CE Mark approval in Europe. The company also announced that it was buying Nanostim, the company that developed the innovative device. The FDA recently granted conditional approval for an Investigational Device Exemption (IDE) application and a pivotal clinical trial, St. Jude […]
October 15th, 2013
Former ACC CEO Takes Reins of Cardiovascular Research Foundation
Larry Husten, PHD
The Cardiovascular Research Foundation (CRF) announced today that it has appointed Jack Lewin as its next President and Chief Executive Officer. Lewin is the former CEO of the American College of Cardiology. In April 2012, the ACC announced his abrupt departure from the college. No explanation was ever given for the sudden change. The CRF said that Lewin will […]
October 15th, 2013
Questions Remain About George W Bush’s Stent
L. David Hillis, MD
The National Journal reported yesterday that “George W. Bush’s recent heart problems were far more dangerous than generally believed — potentially life-threatening, in fact.” The Journal cited “an authoritative source”: “He was more than 95% occluded. With a blockage like that in a main artery you’re supposed to die. He was pretty lucky they caught it.” On the […]
October 14th, 2013
Selections from Richard Lehman’s Literature Review: October 14th
Richard Lehman, BM, BCh, MRCGP
This week’s topics include CRT in HF with a narrow QRS complex, a trial of edoxaban vs. warfarin for symptomatic VTE, and more.
October 14th, 2013
The Benefits of Switching From Hydrochlorothiazide to Chlorthalidone: What’s Stopping Us?
Nicholas Bergfeld, BS, BA
Nicholas Bergfeld wonders what it will take to convince the medical community and the government that switching from hydrochlorothiazide to chlorthalidone is effective, economical, and life-saving for patients.
October 10th, 2013
CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel
Larry Husten, PHD
The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about the CardioMEMS Champion HF Pressure Measurement System. The small implantable device provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that […]
October 10th, 2013
Prevalence of Cardiovascular Disease Likely to Increase Despite Gains in Treatment
Larry Husten, PHD
It is the best of times and the worst of times in the battle against cardiovascular disease. On the one hand, mortality rates from cardiovascular disease in the U.S. have dropped by more than half in the last 30 years, likely due in large part to improvements in treatment for elevated blood pressure and cholesterol […]
October 10th, 2013
How Well Do Standard ECG Criteria Detect RV Hypertrophy?
Isaac Russell Whitman, MD
Isaac Whitman and Steven Kawut discuss their study of the sensitivity and specificity of electrocardiographic criteria in screening for MRI-detected right ventricular hypertrophy in patients without clinical cardiovascular disease.